Kornimate/medical-research-clean huggingface dataset:
bct intervention for walking habit among caregivers of people with ad/adrd

Conditions: Inactivity, Physical

Summary: this 12-week trial will test the efficacy of a multi-component, personalized text-message delivered behavior change technique (bct) intervention to encourage habitual physical activity (defined as regular walking of 1,000 or more steps during a one-hour period on 7 consecutive days according to a personalized walking plan) among care providers of persons with ad/adrd via the key mechanism of behavior change (mobc) of automaticity. the main question it aims to answer whether a multi-component, personalized bct intervention to increase a walking habit of 1,000 steps/day will lead to successful development of habitual walking among 60 percent of caregivers enrolled.


Eligibility criteria:
inclusion criteria: * identify as a caregiver (formal/paid or informal/unpaid) for persons with alzheimer's disease or alzheimer's disease related dementias (ad/adrd) * age \>=18 and \<=85 * speak english or spanish as primary language * self-report low levels of physical activity or walking exclusion criteria: * individuals who self-report having been informed by a clinician it is medically or physically unsafe to engage in a walking intervention * does not own or cannot regularly access a smartphone capable of receiving text messages or accessing the internet * does not own or have access to an email address * lives outside the united states

Keywords: caregiver alzheimer's disease alzheimer related dementia physical activity behavior change techniques habit formation
assessment of mgmt promoter methylation in advanced ewing sarcoma treated with temozolomide and irinotecan

Conditions: Ewing Sarcoma Family of Tumors

Summary: this is a biological study in patients with advanced ewing sarcoma who received, according, clinical practice, temozolomide and irinotecan the o6-methylguanine-dna methyltransferase (mgmt) methylation status, will be correlated with the disease clinical data and with the disease response

this is a biological study in patients with advanced ewing sarcoma who received, according, clinical practice, temozolomide and irinotecan. the mgmt methylation status will be correlated with the disease clinical data and with the disease response also in term of metabolic activity (if data will be available) the mgmt methylation analysis will be performed extracting from fresh tumor sample, the dna on the basis of the standard protocols.

Eligibility criteria:
inclusion criteria: 1. histological confirmed diagnosis of ewing sarcoma 2. chemotherapic treatment with temozolomide and irinotecan 3. written informed consent prior to any study related activities exclusion criteria: 1. lack of written informed consent for the study 2. any situation that could interfere with the complete data collection of the clinical data related to the temozolomide and irinotecan treatment

Keywords: ewing sarcoma
effects of fluvastatin on proinflammatory and prothrombotic markers in antiphospholipid syndrome patients

Conditions: Antiphospholipid Syndrome

Summary: the purpose of this study is to determine whether a drug named fluvastatin is beneficial and safe in reducing the risk of cardiovascular disease and blood clots in patients with antiphospholipid antibodies or antiphospholipid syndrome (aps).

the primary objective of the study is to determine the effects of fluvastatin on pro-thrombotic and pro-inflammatory markers in apl-positive lupus and non-lupus patients (primary endpoint) and to determine the safety of fluvastatin in apl-positive lupus and non-lupus patients (secondary endpoint). all eligible patients will sign an irb-approved consent form during the screening visit and give blood for baseline laboratory tests. within a week of the screening visit, all patients will be started on fluvastatin 40 mg daily for three months. at three months patients will be instructed to stop the study medication and they will be followed for another three months. thus, the total duration of the study is six months: first three months is interventional and the last three months is observational.

Eligibility criteria:
inclusion criteria: * persistently antiphospholipid-antibody positive patients (positive lupus anticoagulant test, anticardiolipin antibody ≥ 40 gpl /mpl, and/or anti- β2-glycoprotein i antibody \> 20 sgu/smu) with or without systemic lupus erythematosus exclusion criteria: * younger than 18 year-old * pregnant * planning to get pregnant within the next 6 months * taking other cholesterol lowering agents * taking other immunosuppressive medications (such as methotrexate, azathioprine, cellcept, enbrel, remicade, or rituximab)(hydroxychloroquine \[plaquenil\] during the study period is allowed). * treatment with biologic agents including anti-tnf medications and rituximab * treatment with erythromycin, itraconazole, or clarithromycin * taking prednisone higher than 10 mg daily * taking non-steroidal anti-inflammatory drug (such as motrin, advil, etc) regularly * have a muscle or liver disease * have chronic renal disease requiring dialysis * have hepatitis c and/or hiv infection * have active infections requiring antibiotics * have the diagnosis of a systemic autoimmune disease (such as rheumatoid arthritis or systemic sclerosis) other than lupus * have diagnosis of another chronic condition requiring corticosteroid treatment more than 10mg daily * history of an allergic reaction to cholesterol lowering agents

Keywords: persistently antiphospholipid antibody positive patients
dental implant supported removable dental prostheses

Conditions: Implant Complication; Prosthesis Survival

Summary: to prospectively monitor the survival rate of ankylos® dental implants, comparing delayed versus immediate loading, using abutments with the syncone® concept for implant-supported detachable dental prosthesis (isddp) in the edentulous upper jaw.


Eligibility criteria:
inclusion criteria: * provision of informed consent * extraction sockets should have healed at least 4 months * sufficient bone volume to place six implants in the maxilla * no previous bone augmentation procedures * the mandible can have any kind of dentition as long as a well-distributed contact relationship with the new prosthesis in the maxilla can be established. * accepting to comply with study procedures exclusion criteria: * physical or psychological disorders prohibiting implant treatment * heavy smoking (\>10 cigarettes/day) * present alcohol and/or drug abuse * physical handicap that may interfere with the ability to perform oral hygiene
survey of non-resuscitation fluids in septic shock

Conditions: Septic Shock

Summary: the objective of this study is to survey the type and the amount of non-resuscitation fluids that patients with septic shock receives during their first 5 days of icu admission.

background: several studies indicate that a large part of the fluid intake in intensive care patients consists of fluids that are given for indications other than volume expansion. however, the type of non-resuscitation fluids that hemodynamically unstable icu patients receive has not been well characterized. methods: a multicenter observational cohort study. baseline data including, sex, age, physiological data at admission, source of sepsis, illness severity, and icu and hospital mortality will be collected. fluids administered during the first five days of icu admission will be registered. fluids used as vehicle to administer drugs will be regarded as non-resuscitation fluids and will be characterized in detail. all glucose solutions will be regarded as non-resuscitation fluids. crystalloids delivered at a rate of \< 5 ml/kg/h will be considered as non-resuscitation fluids. parenteral nutrition will be regarded as non-resuscitation fluids. crystalloids delivered at a rate of ≥ 5 ml/kg/h will be considered to be resuscitation fluids. blood products and colloids will be regarded as resuscitation fluids.

Eligibility criteria:
inclusion criteria: * septic shock per sepsis-3 criteria within 24 hrs of icu admission * informed consent from patient or next of kin if required by local ethical review board exclusion criteria: • lack of informed consent (see above)

Keywords: fluid therapy non-resuscitation fluids septic shock
safety and effectiveness of eyepeace on signs and symptoms of dry eye disease

Conditions: Evaporative Dry Eye

Summary: in this study, the eyepeace an eye massager will be compared with a standard-of-care warm compress treatment with evaporative dry eye disease. the objective is to asses the safety and effectiveness eyepeace eye massager is in relieving the signs and symptoms of evaporative dry eye disease.

a prospective, contralateral-eye trial study compared the effects of eyepeace+heated eye mask versus heated eye mask with dry eye patients. following 10 min of heated eye mask on both eyes, eyelid massage therapy was applied to the right eye by device. the efficiency was evaluated at baseline (0 mins), 5 minutes (5 mins), 15 minutes (15 mins), and 30 minutes (30 mins) by having the patient perform the eyelid expression massage under the supervision of an ophthalmologist. non-invasive breakup time (nitbut), tear meniscus height (tmh), tear-film lipid layer (tfll), ocular surface temperature (ost), meibomian gland quality (mgq), meibomian gland expressibility (mgex), best corrected visual acuity (bcva), intraocular pressure (iop), endothelial cell count (ecc), flat-axis keratometry value (k1), steep-axis keratometry value (k2), and central corneal thickness (cct) were examined.

Eligibility criteria:
inclusion criteria: * age ≥18 years * able and willing to comply with the treatment/follow-up schedule * bilateral signs and symptoms of dry eye disease or mgd exclusion criteria: * treat dry eye with medication or massage or fumigation within 1 month * the eyelids or intraocular tumor unfavorable pressure * previous ocular surgery or trauma * barriers to the subjects in the research of ocular surface active allergies, infection or inflammatory bowel disease * intraocular pressure is less than 10 mmhg or more than 21 mmhg * diabetes or other eye table, healthy body, skin diseases, or diseases of the nervous system; * use any may interfere with tears within three months of systemic anti-inflammatory drugs or medicines, such as resistance to anxiety, depression and antihistamines * the local administration of ophthalmology recent history (in the past 30 days) including antibiotics, steroids and non-steroidal anti-inflammatory drug, or long-term use of local ophthalmic drug * researchers determine patients not suitable for this study

Keywords: dry eye eye massage diquafosol eyepeace
eupertstrain 4 study of bordetella pertussis isolates

Conditions: Bordetella Pertussis, Whooping Cough

Summary: this study focus on the genetic changes of b. pertussis clinical isolates. for this panels of b. pertussis isolates has been collected during four periods in different european countries.

b. pertussis is considered as a monomorphic pathogen. however, genetic changes have been observed in several antigens (pertussis toxin, pertactin, filamentous haemagglutinin and fimbriae) included in the current acellular pertussis vaccines between vaccine strains and circulating isolates. to study genetic changes in the b. pertussis populations in europe, four distinct panels have been collected: eupert i in 1999-2001 including 102 isolates, eupert ii in 2004-2005 including 154 isolates, eupert iii in 2007-2009 including 140 isolates and eupert iv in 2012-2015 including 265 isolates. selection criteria have remained unchanged for all four collections, which enables the opportunity to study changes in b. pertussis populations during the last 15 years.

Eligibility criteria:
inclusion criteria: * b. pertussis clinical isolates should be collected from subjects from different regions and be epidemiologically unrelated. * an equal number of isolates from vaccinated and unvaccinated subjects should be collected. optimally, the isolates are preferred to be selected from individuals less than 5 years of age. * for countries with large numbers of isolates in their collections, isolates should be randomly selected according to criteria above. exclusion criteria: * there is no strict exclusion criteria for this study

Keywords: b. pertussis acellular vaccination strain variation
[18f]alf-nota-fapi-04 pet/ct in inflammation and fibrosis in renal diseases

Conditions: 18F-FAPI PET/CT Examination; Renal Puncture Biopsy

Summary: the goal of this observational study is to explore the feasibility of using 18f-labeled fap molecular probe for pet/ct imaging (18f-fapi pet/ct) to accurately evaluate inflammation and fibrosis in renal diseases. the main questions it aims to answer are: * can 18f-fapi pet/ct accurately evaluate the inflammation and fibrosis of kidney disease? * what is the value of 18f-fapi pet/ct as a non-invasive assessment of inflammation and fibrosis in kidney disease? participants will receive \[18f\]alf-nota-fapi-04 pet/ct and renal aspiration biopsy.


Eligibility criteria:
inclusion criteria: * the pitients of nephritis or fibrosis disease exclusion criteria: * hypertension that is difficult to control with medication, and systolic blood pressure exceeding 160mmhg * renal biopsy cannot be performed for severe exclotting disease * complicated with chronic liver disease, myocardial infarction, stroke, and malignant tumor * unable to cooperate with renal puncture biopsy due to language communication or other problems * female patients who are pregnant (or attempting to become pregnant within six months), breastfeeding, or unwilling to use contraception * abnormal cardiopulmonary function or mental state, unable to tolerate prone lying for 20 minutes * alcohol allergy * patients with significant decrease in urine volume due to disease * refusal to sign an informed consent form or inability or unwillingness to comply with the investigator-approved protocol * other circumstances deemed inappropriate by the investigator for participation in the study.
a phase i/ii open-label study of ipilimumab and gm-csf administered to unresectable stage iiic and stage iv melanoma patients

Conditions: Metastatic Melanoma

Summary: the purpose of this study is to test the combination of ipilimumab and gm-csf. both ipilimumab and gm-csf are intended to work with the body's own immune system to attack melanoma cells in the body. this study will also demostrate how safe the combined drugs are when used to treat patients with stage 3 or stage 4 melanoma (metastatic melanoma), which cannot be removed by surgery.


Eligibility criteria:
inclusion criteria: * patients may be entered in the study only if they meet all of the following criteria. 1. male or female patients ≥18 years of age; 2. patients with histological confirmed melanoma (stage iiic or stage iv, american joint commission on cancer); 3. eastern cooperative oncology group (ecog) performance status (ps) of 0 to 2; 4. life expectancy ≥3 months; 5. at least 1 site of radiographically measurable disease by immune-related response criteria (irrc); 6. adequate hematologic, renal, and liver function as defined by laboratory values performed within 42 days prior to initiation of dosing: * absolute neutrophil count (anc) ≥1.0 x 109/l; * platelet count ≥50 x 109/l; * hemoglobin ≥8 g/dl; * serum creatinine ≤3 x upper limit of normal (uln) * total serum bilirubin ≤2 x uln; * serum aspartate transaminase (ast/sgot) or serum alanine transaminase (alt/sgpt) ≤2x uln, and ≤3 x uln if liver metastases are present. 7. fertile males should use an effective method of contraception during treatment and for at least 3 months after completion of treatment, as directed by their physician; 8. pre-menopausal females and females \<2 years after the onset of menopause should have a negative pregnancy test at screening. pre-menopausal females must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 90 days after the last dose of study drug. females of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year; 9. before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures. exclusion criteria: * patients will not be entered in the study for any of the following: 1. treatment with denileukin diftitox within 42 days prior to the start of ipilimumab; 2. prior treatment with ipilimumab; 3. known hypersensitivity to ipilimumab or any of its components 4. received radiotherapy for non cns disease within the 2 weeks prior to commencing study treatment or have not recovered from side effects of all radiation-related toxicities to grade ≤1, except for alopecia; 5. steroids within one week prior to initiation of ipilimumab. 6. pre-existing autoimmune colitis. 7. patients with an allograft requiring immunosuppression; 8. known positive human immunodeficiency virus (hiv) 9. pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives, or avoidance of pregnancy measures; 10. have any other uncontrolled infection or medical condition that could interfere with the conduct of the study.
efficacy/safety of octreotide acetate in patients with uncontrolled acromegaly

Conditions: Acromegaly

Summary: this study evaluated the safety and efficacy of an increased frequency of octreotide acetate injections or an increase in dose in partially responsive acromegalic patients with persistently uncontrolled disease.


Eligibility criteria:
inclusion criteria: * written voluntary informed consent. * patients with biochemically documented active acromegaly who are currently receiving somatostatin-analogues in a conventional treatment regimen (octreotide up to 30 mg/28 days; lanreotide up to 120 mg/28 days) for at least 6 months. * patients with uncontrolled disease defined as patients with a decrease of baseline levels of growth hormone (gh) ≥ 50% during treatment with somatostatin-analogues in a conventional regimen (sandostatin up to 30 mg/28 days; lanreotide up to 120 mg/28 days) for at least 6 months. * baseline (mean of 3 samples) gh level \> 2 µg/l. * insulin-like growth factor i (igf-i) levels above the upper limits of normal for age and gender. other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: acromegaly octreotide acetate partial responder patients
pre-exposure prophylaxis adherence intervention for msm

Conditions: Medication Adherence

Summary: following formative work, the proposed study is an open-label, pilot, randomized, two arm trial where subjects will receive pre-exposure prophylaxis (prep) for 6 months and either a cognitive-behavioral based adherence intervention or health education with supportive counseling.


Eligibility criteria:
inclusion criteria: * male sex at birth * being 18 years old or older * testing hiv-negative at screening * evidence of high risk for hiv acquisition defined by having unprotected anal sex (insertive or receptive) with an hiv-positive male partner or at least a total of three episodes of unprotected anal sex with at least two partners in the last three months * medically cleared to take the study drug (ambulatory performance \>=60 on karnofsky scale, adequate renal function, negative glucose and protein in urine, adequate hepatic function, adequate hematologic function) * able to understand and speak english (for consenting and counseling). exclusion criteria: * participants who are not able to consent due to psychiatric or cognitive concerns * those who have already been prescribed prep * having a history of or current medical conditions that would preclude taking the study drug (e.g., previously diagnosed active and serious infections, acute or chronic hepatitis b, history of pathological bone fractures not related to trauma) * receiving ongoing therapy with art, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion, or other investigational agents * receiving or possibly receiving antiretroviral drugs for an anti-hiv vaccine in a clinical trial * active alcohol or drug use that would interfere with study participation * having other conditions (based on opinion of investigator or designee) that would preclude informed consent, make the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with study procedures

Keywords: prep hiv adherence msm men having sex with men
initial effect size estimation of a smartwatch-based intervention for physical and behavioral activation in depressed patients

Conditions: Depression

Summary: it is well known that physical activity interventions have a robust, if small-to-moderate effect on the amelioration of chronic diseases, including major depressive disorder (mdd) (singh et al. 2023). at the same time, behavioral activation is one of the most effective components of digital cognitive-behavioral therapy for depression (furakawa et al. 2021). here we leveraged smartwatches to provide an interactive tool for delivering a mixed intervention of physical and behavioral activation, with the former addressing physical activity level and the latter pleasant activities including and beyond physical activity (e.g., social, relaxing activities). moreover, given the relationship with physical activity level, we additionally incorporated digital insomnia exercises that have also shown promising effects in the amelioration of depression. our primary aim was to estimate the effects of our digital smartwatch-based intervention in a small sample of depressed patients.


Eligibility criteria:
inclusion criteria: * written consent for voluntary study participation * between 18 and 65 years of age * current diagnosis of a single episode of mild to moderate depressive disorder without psychotic symptoms, according to icd-10 (f32.0, f32.1) * internet access and email address to answer electronic questionnaires * ability to read german exclusion criteria: * acute suicidality * pregnancy and breastfeeding * currently undergoing psychological treatment * current use of psychotropic medication * neurological or internal medical disease * diagnosis of a severe major depression or dysthymia according to icd-10 (f32.2, f32.3, f33.2, f33.3, f34.1) * diagnosis of a psychotic disorder according to icd-10 (f20-f29) in the life history * diagnosis of a bipolar disorder according to icd-10 (f31) in life history * acute substance abuse (e.g., drug use or excessive alcohol and nicotine use) * diagnosis of dissociative disorder (f44) in life history