Kornimate/medical-research-clean huggingface dataset:
web based follow up intervention in obesity treatment for women

Conditions: Obesity

Summary: this study is designed to verify that web based follow up intervention after a classic multidisciplinary face-to-face obesity treatment will reinforced nutrition and exercise self-efficacy, improve drop out rate and advance sustainability after weight loss of obese women. research questions and hypotheses * how does a web based follow up intervention change self-efficacy of women participating in an obesity intervention? * how does a web based follow up intervention affect the drop out rate of women participating in an obesity intervention? * how does a web based follow up intervention influence sustainability of women participating in an obesity intervention?


Eligibility criteria:
inclusion criteria: * women * age 18-80 * bmi 30-40 * internet access * motivation and psychological stability to stay in a long term obesity intervention * no medical conditions prohibiting moderate physical exercise exclusion criteria: * men * age under 18 years * bmi under 30 and above 40 * no internet access * no motivation and psychological stability to stay in a long term obesity intervention * medical conditions prohibiting moderate physical exercise

Keywords: dietary habits and obesity exercise habits and obesity cognition and obesity
dendritic cell vaccine, av-covid-19, to prevent covid-19 infection

Conditions: COVID-19

Summary: this is an adaptive phase i trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with sars-cov-2 spike protein, with or without gm-csf, to prevent covid-19 in adults.

subjects eligible for treatment will be those who at baseline, are not actively infected with sars-cov-2, have no evidence of prior infection with sars-cov- 2 based on serologic testing, and give informed consent for a vaccination with av-covid-19. the patient population will include the elderly and others at higher risk for poor outcomes after covid-19 infection. for this reason, individuals will not be excluded solely on the basis of age, body mass index, history of hypertension, diabetes, cancer, or autoimmune disease. after enrolling for screening, subjects will undergo a nasal swab test to exclude active covid-19 infection and a rapid test for anti-coronavirus antibodies to exclude pre-existing anti-sars-cov-2 antibodies. 50 ml of blood will be collected, from which peripheral blood monocytes will be isolated and differentiated into dc before incubation with sars-cov-2 s-protein, during which time the protein is digested into 9 to 25 amino acid peptide sequences presented on the dendrites of dc in conjunction with histocompatibility class i and class ii molecules. safety and quality testing will be performed on a small quantity of the batch, and the remaining av-covid-19 will be cryopreserved for shipping to the treatment site. once the study drug is ready, if eligible, the subject will be seen at study week-0 for treatment. prior to injection of the study drug, a nasal swab test will be collected to confirm that they are still negative for covid-19, and blood will be drawn to determine baseline levels of anti-sars-cov-2 antibodies. at the treatment site, the product will be thawed and admixed with saline or (saline with gm-csf), and within 5 hours of thawing, will be injected sc via a 25- gauge needle

Eligibility criteria:
inclusion criteria: * 18 years or older, relatively good health, negative for pre-existing sars-cov-2 antibodies, negative for sars-cov-2 infection exclusion criteria: * active covid-19 infection by pcr testing, pre-existing sars-cov-2 antibodies, pregnant, known hypersensitivity to gm-csf, known immune deficiency disease, on active treatment with immunosuppressive agent or corticosteroid, participated in previous covid-19 trial
a study of patients with her2 gene amplified metastatic breast cancer treated with first line herceptin and a taxane

Conditions: Breast Cancer; Metastases

Summary: this study is a phase iv, prospective, nonrandomized, community-based study of clinical outcomes in patients with metastatic breast cancer treated with herceptin and a taxane.


Eligibility criteria:
inclusion criteria: * signed informed consent * available tissue for central laboratory evaluation of her2 status * histologically confirmed, measurable or nonmeasurable but evaluable, her2 positive metastatic breast cancer (her2 positive is defined as 3+ staining by ihc or gene amplification by fish, determined by the local or central laboratory) * life expectancy \>6 months * female, age \>=18 years * ecog performance status of 0, 1, or 2 * adequate bone marrow function as indicated by the following: \*anc \>1500/ul, \*platelet count \>=100,000/ul * adequate renal function, as indicated by creatinine \<=1.5× upper limit of normal (uln) * adequate liver function, as indicated by bilirubin \<=1.5× uln and ast or alt \<2× uln unless related to primary disease * use of an adequate means of birth control (women of childbearing potential) exclusion criteria: * initiation of herceptin \>=4 weeks after beginning taxane chemotherapy * prior chemotherapy for metastatic disease * prior cumulative anthracycline dose of \>360 mg/m2 * history of significant cardiac disease or uncontrolled arrhythmias * ejection fraction of \<50% or below the lower limit of normal * active infection * symptomatic or untreated brain metastases * pregnancy or lactation * concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix * symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest * hypersensitivity to study medications * major organ failure or systemic disease precluding the safe administration of study medications

Keywords: metastatic breast cancer
study to find out the appropriate initial dose of the anticoagulant drug phenprocoumon

Conditions: Pulmonary Embolism; Atrial Fibrillation; Hip Replacement Postoperative; Knee Replacement Postoperative

Summary: oral anticoagulation is often initiated in hospitalized patients. although the therapeutic range of phenprocoumon is narrow, the individual drug demands unfortunately vary greatly between persons. our group recently developed two dosing algorithms for the initiation of anticoagulation based on clinical predictors such as age, gender, body weight and laboratory values. the aim of the proposed study is to prospectively evaluate the efficacy and safety of these two algorithms in medical and orthopedic inpatients, as well as in a group of outpatients and possibly in a geriatric collective.

background: the presently available oral anticoagulants have a very narrow therapeutic range but the interindividual demands to achieve therapeutic anticoagulation (=loading dose) varies greatly. overanticoagulation is a major cause of bleeding complications, whereas insufficient anticoagulation is associated with thromboembolic disease and possibly prolonged hospital stay. a model to predict the loading dose with phenprocoumon (marcoumar®) is therefore highly desirable. in a retrospective analysis of 300 inpatients (152 medical, 148 orthopedic patients) of the cantonal hospital of st. gallen our group identified clinical predictors for the loading dose of phenprocoumon and two dosing algorithms were developed (good ac, henz s. a clinical algorithm to predict the loading dose of phenprocoumon. thromb res. 2007;120(6):921-5.). in order to validate the safety and efficacy of these dosing algorithms we plan this prospective interventional study with three equally sized arms: dosing according to algorithm 1, dosing according to algorithm 2 or dosing according to the estimate of the physician (control).

Eligibility criteria:
inclusion criteria: * consecutive inpatients of the internal medicine and the orthopedic surgery department of the cantonal hospital of st. gallen needing new onset oral anticoagulation exclusion criteria: * patients with prior oral anticoagulation with coumarines within less than 6 weeks, * patents, who received vitamin-k supplements within less than one week before the onset of oral anticoagulation, * patients with liver cirrhosis other than child a, * pregnant women (pregnancy has to be excluded in women of childbearing age), * patients younger than 18 years, and * patients unwilling or unable to give informed consent * patients with (clinically diagnosed) dementia and * persons with insufficient german, french, italian or english language skills)

Keywords: phenprocoumon dosing algorithm loading dose
social and cognitive online training: the scot project

Conditions: Aging; Cognitive Decline

Summary: social isolation and reduced involvement in cognitive activities are associated with repercussions on cognitive well-being and health status in elderly adults. in particular, loneliness and social isolation represent risk factors in favouring cognitive decline and dementia. the social cognition online training (scot) project aims to evaluate the beneficial effects of an online intervention on social-cognitive functioning in healthy elderly subjects.


Eligibility criteria:
inclusion criteria: * cognitively healthy subjects aged above 65 years old * montreal cognitive assessment (moca) equivalent score \> 1 (italian normative values) exclusion criteria: * diagnosis of dementia, based on diagnostic and statistical manual of mental disorders, fifthedition (dsm-v) * history of current or previous neuropsychiatric disorders; * history of current or previous substance abuse;
safety and efficacy study of mpc-4326 for treatment of patients with hiv-1 infection.

Conditions: HIV Infections

Summary: to evaluate the antiretroviral activity and safety of 200 mg bid and 300 mg bid doses of mpc-4326 administered as monotherapy for 14 days to hiv-1 positive patients. patients with an initial treatment response will have the option to continue mpc-4326 in combination with an optimized backround regimen for a maximum of 72 weeks.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age at the time of screening. * have hiv-1-infection. * have a cd4+-lymphocyte count≥100 cells/mm3 * have a screening plasma hiv-1 rna value, measured by the roche amplicor assay, of 2,000 - 500,000 copies/ml (inclusive). * be free from any acute infection or serious medical illness within 14 days prior to study entry. exclusion criteria: * current opportunistic infection characteristic of aids (category c according to the cdc classification system for hiv-1 infection, 1993 revised version, appendix a) that is diagnosed within 30 days or is poorly controlled. * patients with systolic blood pressure \ 140 mmhg or diastolic blood pressure \ 90 mmhg. * a history of seizures (excluding pediatric febrile seizures) or current administration of prophylactic anti-seizure medications. * a history of cerebrovascular accident (cva) or transient ischemic attacks (tia). * patients with the following laboratory parameters within 30 days prior to first dose of study drug: hemoglobin \ 2.5 times the upper limit of normal (patients with a positive hbv surface antigen or hcv antibody test at screening must have ast and alt no more than 1.5 times the upper limit of normal)
sar3419 as single agent in relapsed-refractory diffuse large b-cell lymphoma (dlbcl) patients

Conditions: Diffuse Large B-cell Lymphoma

Summary: primary objective: participants achieving an objective response rate secondary objective: * progression free survival * overall survival * response duration * safety

the screening period = up to 4 weeks prior to sar3419 administration the treatment period = from the day of first administration of sar3419 until the end-of-treatment visit. all patients will receive sar3419 until evidence of disease progression, unacceptable toxicity or other reasons for therapy discontinuation - after therapy discontinuation all patients will enter a safety follow-up period of 42 days starting from the day of administration of the last dose of sar3419 and ending with the end of treatment visit. all patients, regardless whether they have progressed or not, will be followed until death or end of study to evaluate survival for at least 18 months.

Eligibility criteria:
inclusion criteria: * histological diagnosis of diffuse large b cell lymphoma (de novo or transformed) expressing cd19 by immunohistochemistry or flow cytometry analysis (\>30% positivity), based on recent (less than 6 months) or new biopsy. * at least 1 prior specific therapeutic regimen, one of which should have included rituximab (patients previously eligible for transplantation: the salvage treatment followed by intensification and autologous stem cell transplant (asct) will be considered one regimen). * relapsed disease after standard 1st line therapy for aggressive lymphoma - not eligible for high dose chemotherapy with stem cell support. relapsed or refractory disease after two lines of therapy one of which could have included autologous stem cell transplant (asct). relapsed disease is defined as progression after a disease free interval of at least 6 months after completion of last therapy. refractory is defined as progression of disease during prior therapy or within 6 months from its completion. * available paraffin-embedded tissue should have been collected no longer than 6 months prior to first administration of sar3419. cryo-preserved tissue cannot be used. if archival material is not available, a fine needle aspiration (fna) must be obtained. exclusion criteria: * primary refractory patients * patients with primary mediastinal dlbcl the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
iron status in infants in ethiopia.

Conditions: Iron-deficiency; Iron Deficiency Anemia; Aluminium Intoxication

Summary: to assess the impact of soil iron intake from teff flour on iron status in infants in debre zeit, ethiopia.

rationale: teff (eragrostis teff), a major staple crop in several areas of ethiopia, is of special relevance to fe biofortifcation as it provides the population with a regular high consumption of contaminant soil fe due to the traditional threshing procedure under the hooves of the cattle. the bioavailability of soil fe, and hence its contribution to fe requirements, is unknown. data on the bioavailability of soil fe would clarify to what extent the soil fe can be considered as a source of absorbable fe. this information is important in order to establish dietary advice and is essential for the development of iron biofortification (and fortification) policies related to fe nutrition in ethiopia. objective: the overall objective of the project is to generate data to target and tailor biofortification approaches in ethiopia by an intervention trial assessing the impact of soil fe intake from teff consumption on fe status. study design: the intervention trial will be a 7 months partially blinded, randomized control trial (rct) with the following three arms: control-group consuming injera based on traditionally threshed teff (average fe content 50 mg/100g flour), 2) intervention group consuming injera based on lab-threshed teff (average fe content 6.65 mg/100g flour), 3) positive control group consuming the lab-threshed teff together with ferrous sulphate iron drops (additional fe from the drops = 6 mg). study population: 315 children between 18-36 months of age living in debre zeit and surrounding areas will be enrolled. main study parameters/endpoints: the impact of soil fe in teff on fe status will be assessed by measuring the fe status, prevalence of fe deficiency and fe deficiency anemia at baseline, midpoint and endpoint. to assess fe status, hemoglobin (hb), plasma ferritin (pf), soluble transferrin receptor (stfr), c- reactive protein(crp) and alpha 1b glycoprotein (agp) will be determined.

Eligibility criteria:
inclusion criteria: * 18-36 months of age (at screening) * the child is able to eat at least two injera meals per day * the informed consent form has been read and signed by the caregiver (or has been read out to the caregiver in case of illiteracy) exclusion criteria: * severely deficient in hb (\<70g/l) * severe underweight (weight for age z score \< -3), * severe wasting (weight for height z score \< -3) * chronic or acute illness or other conditions that in the opinion of the principle investigator (pi) or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol * participants taking part in other studies requiring the drawing of blood * not planning long-term residence in study site
study to assess efficacy,safety and tolerability of idebenone in the treatment of leber's hereditary optic neuropathy

Conditions: Leber's Hereditary Optic Neuropathy

Summary: this study is meant to assess the effectiveness of idebenone on visual function measures in patients with leber's hereditary optic neuropathy over a 6 months period.

the study involves 6 clinic visits.

Eligibility criteria:
inclusion criteria: * age \> or = 14 years and \< 65 years * impaired visual acuity in at least one eye due to lhon * onset of visual loss due to lhon lies five years or less prior to baseline * confirmation of either g11778a, t14484c or g3460a lhon mtdna mutations at \>60% in blood * no explanation for the visual failure besides lhon * body weight ≥ 45 kg * negative urine pregnancy test at screening and at baseline (women of childbearing potential). exclusion criteria: * treatment with coenzyme q10 or idebenone within 1 month prior to baseline * pregnancy and/or breast-feeding * weekly alcohol intake 35 units (men) or 24 units (women) * current drug abuse * clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 2 times the upper limit of normal of ast, alt or creatinine * participation in another clinical trial of any investigational drug within 3 months prior to baseline * other factor that, in the investigator's opinion, excludes the patient from entering the study

Keywords: leber lhon leber's hereditary optic neuropathy idebenone
use muscadine wine nutraceuticals to improve brain health, cognition, and mental health

Conditions: Cognitive Performance; Memory; Mood; Anxiety

Summary: previous studies have shown that polyphenol-rich foods can positively affect cognitive functions, memory, and mood in humans. we hypothesize that both acute and chronic intake of muscadine wine polyphenols will improve cognitive performance and mood through regulating the hpa axis, alleviating inflammation and oxidative stress, and/or inhibiting monoamine oxidase activities

although the exact biological mechanisms for depression and alzheimer's disease are not fully understood, it's believed that they are caused by a combination of factors. an increasing amount of scientific research has proposed several possible pathophysiologies linking depression and ad. for example, increased production of pro-inflammatory cytokines in the nervous system, oxidative stress induced by chronic inflammation leads to dysregulation of the hypothalamic-pituitary-adrenal (hpa) axis, and disturbance in the brain-derived neurotrophic factor signal pathway. polyphenol has been well recognized for its antioxidant and anti-inflammatory properties. previous studies have shown that polyphenol-rich food such as concord grape juice, blueberries, blackcurrants, and green oats positively affect cognition, memory, and mood in humans. however, no one has examined the effects of muscadine wine polyphenol on cognitive and mental health. in addition, if they do have effects, through what mechanism? this clinical trial will allow us to investigate the questions raised. we hypothesize that intake of muscadine wine polyphenols enhances cognition and memory and improve depression and anxiety in healthy adults over 50 year-old via regulating the hpa axis, alleviating inflammation and oxidative stress, and/or inhibiting monoamine oxidase activities. the research will provide the first clinical evidence of how muscadine wine polyphenols affect the brain and mental health.

Eligibility criteria:
inclusion criteria: * healthy * bmi (18.5-29.9) * body weight ≥110 pounds exclusion criteria: * pregnancy * breast-feeding * smokers * diabetic * heavy drinkers * subjective but not clinically diagnosed cognitive impairment (montreal cognitive assessment score \<26), * inability to understand the cognitive function tasks * intake of medication that might influence the outcome of the study (e.g. psychostimulant) * cannabis product user * clinically diagnosed mental illnesses * cardiovascular and neurological disorders * uncontrolled hypertension
molecular landscape analysis and clinical implications for nsclc patients with rare mutations

Conditions: NSCLC; NSCLC Stage IV; NSCLC, Recurrent

Summary: lung cancer is the most common primary cancer of the lung and is responsible for the ever increasing number of cancer-related deaths worldwide. especially in china, the burden of lung cancer has been rising rapidly due to its large and growing population. histologically, approximately 85% of lung cancers are non-small-cell lung cancer (nsclc). molecular targeted therapy has been shown to dramatically improve the quality of life and survival outcomes of nsclc patients. one of the most important targeted drugs in nsclc has been the epidermal growth factor receptor-tyrosine kinase inhibitors (egfr-tkis), while there exists some other rare targetable mutation in nsclc. emerging evidence underlines that, rather than a single point mutation, some rare mutations present with a wide array of mutations, essentially in nsclc. different rare mutations with nsclc have divergent clinical and therapeutic implications with a particular distinction. therefore, there is an unmet need for more effective therapies for nsclc with rare mutations. in summary, identification of genetic alterations in nsclc with rare mutations is increasingly essential to perform molecular diagnostics and individualized treatments. this project aims to create a registry of patients with nsclc with rare mutations to further the characterization of molecular alterations and develop (novel) treatments based on the detection.


Eligibility criteria:
inclusion criteria: * histologically proven diagnosis of nsclc with rare mutations including egfr rare mutations, alk fusion, ros1 fusion, braf v600e, cmet exon 14 skipping, kras g12c, ret fusion, ntrk fusion, etc. * 18 years of age or older * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * none

Keywords: nsclc rare mutations molecular landscape next-generation sequencing (ngs) targeted therapy immunotherapy chemotherapy