Kornimate/medical-research-clean huggingface dataset:
a study of herceptin (trastuzumab) in combination with avastin (bevacizumab) and sequential xeloda (capecitabine) or docetaxel in patients with her2-positive locally recurrent or metastatic breast cancer

Conditions: Breast Cancer

Summary: this single arm, open-label study will evaluate the safety and efficacy of herceptin in combination with avastin and sequential xeloda in patients with locally recurrent or metastatic her2-positive breast cancer after early relapse on adjuvant herceptin therapy. patients will receive herceptin at a loading dose of 8mg/kg iv followed by 6mg/kg iv every three weeks, and avastin 15mg/kg every 3 weeks. at first sign of disease progression xeloda 1000mg/m2 bid po will be added on days 1-14 of each cycle, or docetaxel (100mg/m2 iv every 3 weeks) if xeloda is not indicated for a patient. anticipated time on study treatment is until disease-progression on second line treatment and target sample size is \<100.


Eligibility criteria:
inclusion criteria: * male or female patients, age \>/=18 years * locally recurrent or metastatic her2-positive breast cancer * disease progression during or up to 12 months after prior adjuvant therapy with trastuzumab * lvef \>/=55% at baseline exclusion criteria: * prior treatment with bevacizumab or capecitabine * anthracyclines in prior adjuvant or neoadjuvant treatment exceeding cumulative dose of 360mg/m2 for doxorubicin and 720mg/kg for epirubicin * chronic daily treatment with corticosteroids (\>10mg/day methylprednisolone equivalent; excluding inhaled corticosteroids), or aspirin (\>325mg/day), or clopidogrel (\>75mg/day) * clinically significant cardiac disease, or cardiac toxicity during previous trastuzumab therapy * evidence of spinal cord compression or cns metastasis * history of other malignancy, unless disease-free for \>/=5 years or treated curatively for carcinoma in situ of the cervix or non-melanomatous skin cancer
left atrial appendage exclusion for prophylactic stroke reduction trial

Conditions: Ischemic Stroke; Systemic Embolism

Summary: this trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. the objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (laae) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.


Eligibility criteria:
inclusion criteria: * subjects ≥ 18 years of age * documentation of any of the following clinical criteria: * cha2ds2-vasc ≥ 4 with age ≥ 65 * cha2ds2-vasc ≥ 4 with significant left atrium enlargement or elevated nt-probnp * cha2ds2-vasc = 3 with age ≥ 75 * cha2ds2-vasc = 3 with significant left atrium enlargement or elevated nt-probnp * cha2ds2-vasc score = 2 with age ≥ 65 and significant left atrium enlargement or elevated nt-probnp exclusion criteria: * clinically significant atrial fibrillation or atrial flutter: * anytime in the past and * documented by an electrocardiographic recording and * episode lasting 6 minutes or longer1\* * prior procedure involving opening the pericardium or entering the pericardial space * prior laa occlusion, exclusion, or removal (surgical or percutaneous) * planned cardiac surgical procedure using non-sternotomy approaches o partial sternotomies will be allowed. * patients whose planned procedure is a heart transplant or implantation of any ventricular assist devices * active endocarditis * active systemic infection at the time of cardiac surgery requiring antibiotics, including known sars-cov2 infections regardless of symptoms * known allergy to nitinol or nickel sensitivity * known medical condition with expected survival of less than 1 year * other comorbidities that in the investigator's opinion make the subject unsuitable candidate to complete the protocol required visits. * current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial. * mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial. * pregnancy * known severe symptomatic carotid disease
helping hiv infected patients in south africa adhere to drug regimens

Conditions: HIV Infections

Summary: three or more anti-hiv drugs are taken in combination as part of a treatment regimen. these drug regimens must be closely followed in order to be successful. having a support person watch a patient take his or her anti-hiv drugs each day may help a patient follow his or her regimen. this study will see if patient-chosen treatment supporters help patients take hiv medicines correctly and improve their health. study hypothesis: the mean change in cd4 count at 12 and 24 months will be significantly higher in the directly observed therapy-highly active antiretroviral therapy (dot-haart) arm as compared to the self-administered arm.

south africa has one of the worst and fastest growing hiv epidemics in the world. highly active antiretroviral therapy (haart) has been shown both at the individual and public health levels to reduce morbidity, mortality, and vertical and possibly horizontal hiv transmission. however, expenses, feasibility, long-term adherence, and effective delivery of haart remain formidable barriers, particularly in developing nations. recently, international initiatives have provided hope for widespread use of haart at affordable cost in sub-saharan africa. simplified, once-daily haart regimens with directly observed therapy (dot) may help to achieve high levels of treatment adherence, a key component for long-term viral suppression and treatment success. peer advocates have been used to improve adherence with medical therapies in a variety of settings. this study will evaluate the effectiveness and feasibility of dot using patient-nominated peer supervisors to improve adherence to haart in hiv infected adults in south africa. participants will be randomly assigned to either peer-dot-haart or self-administration of a once-daily combination of the western cape province art program medications for 24 months. study measures will include cd4 cell count and hiv viral load, adherence questionnaires, genotypic haart resistance testing, and incidence of new or recurrent opportunistic infections.

Eligibility criteria:
inclusion criteria: * hiv infected * viral load greater than 1000 copies/ml * cd4 count of 200 cells/mm3 or less, or world health organization stage 4 disease * living in the area of the study site * had a known address for more than 3 months * willing to nominate a treatment supervisor (a close family member, sexual partner, friend, or community volunteer) to observe daily ingestion of tablets * willing to disclose hiv status to a treatment supervisor and ready to commit to long-term antiretroviral therapy * acceptable methods of contraception exclusion criteria: * pregnant

Keywords: directly observed therapy dot
atopic dermatitis: sub-saharan africa vs. central europe

Conditions: Atopic Dermatitis

Summary: many people are affected by atopic dermatitis (ad) worldwide. however, clinical studies on ad in sub-saharan africa are rare and there is a lack of knowledge about possible differences in pathogenesis between european and african ad. this study will collect clinical and laboratory data with the aim to compare clinical characteristics and immune responses in ad patients in sub-saharan africa and central europe. furthermore, relevant allergens as well as the nasal, skin and gut micro- and mycobiome will be investigated.

objectives of the project: compare the following aspects in patients suffering from atopic dermatitis (ad) and healthy control (hc) participants in central europe (ce) vs. sub-saharan africa (ssa): * clinical characteristics, life quality, treatments, and family history * immune mapping and barrier characterization of lesional and non-lesional skin * exploration of the serological and cutaneous immune signatures * investigation of the skin, nasal and gut microbiome (including bacteria and fungi) * comparison of the sensitization patterns and putting it into clinical context (food questionnaire, anamnesis about allergic symptoms, analysis of ige and igg levels)

Eligibility criteria:
inclusion criteria: ad patients: * age: ≥18 years * written informed consent given after information about the research project * suffering from active atopic dermatitis * no active skin disease other than atopic dermatitis * no known active inflammatory disease other than atopic dermatitis/atopic diseases hc participants: * age: ≥18 years * written informed consent given after information about the research project * no active skin disease * no known atopic disease (atopic dermatitis, asthma, allergy, allergic rhinoconjuncitivitis) * no known active inflammatory disease exclusion criteria: * known or suspected systemic immunosuppression because of disease * systemic immunomodulatory/-suppressive treatment * glucocorticoids or immunosuppressants (last 4 weeks) or * jak inhibitors (last week) or * omalizumab (last 4 weeks) or * other biologicals e.g. dupilumab (last 2 months) * clinical signs of active bacterial, fungal or viral infection * systemic antibiotic, antimycotic or antiviral treatment 4 weeks prior to start * phototherapy 4 weeks prior to start * active neoplasia * undergoing surgery in the last 2 months * infarction (e.g. stroke), embolism, or thrombosis in the last 2 months * inability to follow the study procedures e.g. due to language problems, dementia etc. of the participant
incremental diagnostic value of tau-pet with [18f]ro948 vs amyloid-pet in patients with cognitive impairment

Conditions: Dementia; Alzheimer Disease

Summary: the objective of the study is to investigate the clinical validity of tau-pet with \[18f\]ro948 vs. amyloid-pet in patients with mild cognitive impairment (mci) or mild dementia

dementia is defined as cognitive impairment associated with loss of autonomy and is usually preceded by a prodromal phase - mild cognitive impairment (mci) - which represents a highly heterogeneous entity comprising different underlying etiologies, of which alzheimer's disease (ad) is one of the most prevalent. several ad biomarkers - including mri, fdg-pet and csf measures of amyloid and tau pathology - have been validated as diagnostic (allowing an early and differential diagnosis of ad) and prognostic (predicting progression from mci to dementia due to ad) tools. in contrast and despite the increasing consensus on their clinical utility, usage of pet markers of amyloid and tau pathology is not yet standard clinical practice. moreover, while the clinical utility of amyloid-pet has been exhaustively investigated, to date no study has prospectively assessed the clinical utility of tau-pet. assessing the clinical utility of diagnostic tools is fundamental for clinical practice. this will be the first study assessing the clinical utility of \[18f\]ro948 tau-pet vs. standard of care amyloid-pet, providing unique information to define appropriate diagnostic algorithms

Eligibility criteria:
inclusion criteria: * written inform consent to participating. * 50 to 85 years of age * a diagnosis of mild cognitive impairment (mci=at least one pathological neuropsychological test but no functional impairment based on the amsterdam iadl score) or mild dementia (both cognitive and functional impairments) * availability of mri within 6 months before screening * prescription of a diagnostic amyloid pet * willing and able to comply with the requirements of the study, as judged by the investigator. exclusion criteria: * the presence of psychiatric disorders, extensive white matter lesions or other stigmata of vascular dementia. * visual and auditory acuity inadequate for neuropsychological testing. * enrolment in previous clinical trials for ad potentially affecting amyloid and/or tau brain load * enrolment in other trials or studies not compatible with \[18f\]ro948 imaging study. * ferromagnetic implants and devices (including implants or devices held in place by sutures, granulation or ingrowth of tissue, fixation devices, or by other means) not eligible for mri scanning. * women of childbearing potential must not be pregnant (negative urine β-hcg on the day of imaging) or breast feeding at screening

Keywords: alzheimer pet amyloid tau
a study to evaluate pharmacokinetic parameters and safety of eliglustat absorption through the mouth

Conditions: Gaucher's Disease

Summary: a study to assess the absorption of eliglustat through the mouth in healthy subjects and the safety of any systemic exposure resulting from oral surface absorption of eliglustat in healthy subjects.

duration of the study for each subject, not including screening, will be 3 days including follow-up.

Eligibility criteria:
inclusion criteria: body weight between 50.0 and 100.0 kg, inclusive, for males, and between 40.0 and 90.0 kg, inclusive, for females, body mass index between 18.0 and 30.0 kg/m2, inclusive. having given written informed consent prior to undertaking any study-related procedure. certified as healthy by a comprehensive clinical assessment (detailed medical history, complete physical examination, laboratory parameters, and ecg). exclusion criteria: participants are excluded from the study if any of the following criteria apply: any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness. any subject who, in the judgment of the investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. the above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
current and past sars-cov-2 infection and covid-19 in healthcare with regard to vaccinations

Conditions: SARS-CoV 2

Summary: to investigate the incidence of sars-cov-2 infections after vaccination, to monitor the development of sars-cov-2 antibody levels after vaccination and to compare this in relation to both previous health \& disease, previous antibody responses and in relation to future disease occurring after vaccination.

the purpose of the study is to analyze the effect of and possible side effects of sars-cov2 vaccinations in the cohort study where data on sick leave, sars-cov2 infections and sars-cov2 antibody levels are well documented even before vaccination. the main outcome measures are the presence of sars-cov-2 (ongoing infection) and the presence of antibodies to sars-cov-2. for the vaccination effect, the factors that are primarily associated with protection against infection are analyzed, such as age, sex, workplace, antibody response to sars-cov-2 and vaccination date. the analyzes are planned to be performed with multivariate logistic regression with relative risk as the outcome measure. data from the analysis of virus antibodies are planned to be performed divided into whether low, medium or high levels of antibodies occur, with the same analysis for possible association with the factors listed above.

Eligibility criteria:
inclusion criteria: * study participant who agreed to be included in the study "studies of ongoing and completed sars-cov-2 infection (which causes covid-19) within the healthcare in stockholm county". * study participant who has received or will receive vaccine against covid-19 and who gives new written consent to the study "studies of ongoing and completed sars-cov-2 infection (which causes covid-19) within the healthcare in stockholm county, with regard to vaccinations". exclusion criteria: * those who have not given informed consent to participate in the study in this study, no initiative is taken for vaccination. the vaccinations are carried out by the healthcare system and of course follow the established exclusion and inclusion criteria for the approved vaccines. all persons who have received the vaccine and who give written consent are eligible to be included in the study.
non-inferiority study of unresectable hepatocelluar carcinoma receiving stereotactic radiotherapy combined with hepatic arterial chemoembolization compared with conversion hepatectomy

Conditions: Hepatocellular Carcinoma Non-resectable; Conversion

Summary: to compare the prognosis and adverse reactions of unresectable hepatocellular carcinoma receiving stereotactic radiotherapy combined with hepatic arterial chemoembolization and conversion hepatectomy


Eligibility criteria:
inclusion criteria: * unresectable hcc patients were diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of hcc or by pathology * patients who received sbrt plus tace have tumor regression, and surgical experts assess that r0 resection could be achieved * cp-a or b classification; * eastern cooperative oncology group (ecog) score 0-1; * platelet count≥50 × 109/l, white blood count≥1.5 × 109/l; * icg r15≤10%; * normal effective liver volume \>30%; * patients infected with hepatitis b virus who are treated with adefovir or entecavir; patients infected with hepatitis c virus whose hcv dna are negative. exclusion criteria: -the patients receive other treatments (such as targeted treatment, immune checkpoint inhibitors,etc) after ck-sbrt plus tace.

Keywords: cyberknife unresectable hepatocelluar carcinoma tace hepatectomy prognosis
does acoustic stimulation during sleep boost slow wave sleep and memory performance?

Conditions: Healthy; Mild Cognitive Impairment; Alzheimer Disease

Summary: with aging the amount of slow wave sleep decreases drastically and this disruption is markedly exaggerated in older adults suffering from mild cognitive impairment and alzheimer's disease. critically, the disruption of slow wave sleep and cognitive decline seem bidirectionally linked forming a vicious cycle. in the long run, improving slow wave sleep might be a useful intervention tool to delay the onset of cognitive decline. the present study aims at improving slow wave sleep and memory functions through a closed-loop acoustic stimulation approach. a closed-loop algorithm is used that detects slow waves in the electroencephalogram and is programmed to present short tones (50 ms) in the rhythm of these waves. this procedure has shown to boost both slow wave sleep as well as memory performance, mainly in young adults and when applied for one night. here, the investigators apply tones via multiple consecutive nights and assess memory performance during this 3-night intervention.


Eligibility criteria:
inclusion criteria: * written informed consent * fluent in german * normal or corrected to normal vision * unimpaired hearing * for healthy group: montreal cognitive assessment score ≥ 26 * for mci group: montreal cognitive assessment score \< 26 * for at risk group: smoker, high cholesterol, high blood pressure and high fasting plasma glucose or smoker, high bmi, physically inactive, unhealthy dietary habits exclusion criteria: * known sleep problems such as insomnia, restless leg syndrome, apnea * irregular sleep pattern * symptoms of depression * history of untreated severe neurological and psychiatric diseases * alcohol or substance abuse * use of medication acting on the central nervous system
pharmacologic intervention for postcessation weight gain

Conditions: Cardiovascular Diseases; Heart Diseases; Obesity

Summary: to test pharmacologic intervention for smoking postcessation weight gain using nicotine gum and phenylpropanolamine (ppa).

background: despite the potential importance of weight gain to smoking relapse, in 1991 there had been virtually no success in eliminating, or even reducing, the weight gain following smoking cessation. two promising pharmacologic methods for reducing postcessation weight gain were nicotine gum and an over-the-counter drug, phenylpropanolamine gum (\[ppa\]. however, the relative efficacy of these two drugs had never been evaluated and the mechanisms of action of both drugs on weight gain were unknown. design narrative: the investigators determined the efficacy of nicotine gum and phenylpropanolamine (ppa) gum relative to a placebo in the reduction of postcessation weight gain throughout a 13-week combined behavioral and pharmacologic treatment program. following cessation of the drugs at the end of treatment, they monitored long-term effects of these drugs on body weight at both a 6- and a 12-month follow-up. they also determined the mechanism of action of both nicotine gum and ppa gum (viz., changes in dietary intake, physical activity, or metabolic rate) on change in weight during the course of treatment and evaluated withdrawal symptoms of smoking cessation as they were moderated by either nicotine gum or ppa gum use during the course of treatment. finally, they investigated whether ppa and nicotine gum produced an incremental effect on smoking cessation (relative to placebo gum) in a sample of female smokers who were at high risk for postcessation weight gain at posttest and at a 6- and 12-month follow-up.

Eligibility criteria:
no eligibility criteria
real world advanced experience of bioresorbable scaffold by smart angioplasty research team (smart reward)

Conditions: Acute Coronary Syndromes

Summary: current drug-eluting stents (des) has demonstrated excellent clinical outcomes in patients with coronary artery disease. however, a continued risk of clinical events even several years after the procedure is reported. stent platform or polymer-associated inflammation may play a role. bioresorbable scaffold (brs) is known to disappear 2 to 3 years after the implantation, which may result in the more favorable very long-term clinical outcomes compared with metallic stents. the initial clinical experiences of brs in relatively simple lesion subsets were comparable to dess. brs, however, is limited by the disadvantageous mechanical characteristics such as thick strut and the risk of fracture by overdilation. there is concern that brs is less optimal for complex lesion subsets such as bifurcation lesions, calcified tortuous lesions, or diffuse long lesions. real world registry is needed to test the feasibility and safety of brs in these complex lesion subsets.


Eligibility criteria:
inclusion criteria: * subject must be between 19 and 70 years old. * patients with a significant lesion in a de novo coronary artery: a percent diameter stenosis (ds) 50% with 1) a positive history of recurrent angina pectoris; (2) objective signs of ischemia at rest (ecg changes) or during exercise test (or equivalent); or (3) abnormal results of any invasive functional diagnostic test (eg, fractional flow reserve) or a percent ds ≥70% even in the absence of the above-mentioned ischemic signs or symptoms. * patients are scheduled for coronary intervention * he/she or his/her legally authorized representative provides written informed consent exclusion criteria: * experience of cardiopulmonary resuscitation * cardiogenic shock * expected survival less than 2 years * pregnancy or breast feeding * opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results