Kornimate/medical-research-clean huggingface dataset:
glucose in dialysis water in non-diabetics

Conditions: Renal Failure, Chronic

Summary: the purposes are 1. to measure the effect of dialysis with glucose on blood pressure, pulse rate, plasma concentration of glucose, plasma concentrations of glucagon, growth hormone, renin, angiotensin ii, endothelin and body temperature, and 2. to analysis the relationship between changes in blood pressure on the one hand and changes in vasoactive hormones on the other

measurement of hormones and blood pressure during dialysis treatment.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years, 2. both men and women, 3. dialysis treatment for at least three months exclusion criteria: 1. heart failure, 2. chronic liver disease, 3. diabetes mellitus, 4. malignant disease, 5. nephrotic syndrome, 6. lack of compliance, 7 unwillingness to participate

Keywords: chronic renal failure, dialysis, hemodialysis,
immediate art in subjects with opportunistic diseases

Conditions: HIV/AIDS; ANTIRETROVIRAL TREATMENT

Summary: the aim of this study is to compare the clinical response and mortality rate by an opportunistic disease in hiv-infected individuals who start immediate versus conventional antiretroviral therapy. immediate art (iart) is defined as starting antiretroviral therapy in the first 48 hours after the hospitalization. conventional art (cart) is defined as starting antiretroviral therapy once the opportunistic infection is under control at the discretion of infectious disease specialist.

sample size was calculated using formula, of difference in proportions formula using a beta of 0.1, alpha of 0.05 and an expected difference in mortality of 20%, the sample size is 225 subjects in each group. informed consent will be obtained. patients will be allocated to each group (iart or cart) after randomization stratified by the cd4+ t cell count (less or more than 50 cells/mm3). plasma viral load and cd4+ t cell count will be measured at study entry and at weeks 2, 4, 12, 24 and 48 after art initiation. clinical outcomes will be: mortality at 4, 12, 24, and 48 weeks, length of hospitalization (measured in days), clinical and microbiological cure of the opportunistic disease, incidence and severity of immune reconstitution of inflammatory syndrome (iris), and adverse drug reactions and interactions. once 50% of the sample size has completed 30 days of follow-up, a preliminary analysis will be conducted to assess safety and efficacy of iart; if differences in the mortality are observed, the study will be terminated.

Eligibility criteria:
inclusion criteria: * over 18 years old * time from admission to study entry: less than 48 hours * confirmed hiv diagnosis or high probability of hiv infection based on a positive hiv rapid test * having an opportunistic disease * subjects must be naïve to art or have failed their first or second art regimen or must have abandoned art for more than 3 months exclusion criteria: * meningitis due to cryptococcus spp. or for m. tuberculosis * pregnancy

Keywords: hiv/aids art
an evaluation of the reduction in erythema in adult patients with moderate to severe persistent facial erythema associated with rosacea

Conditions: Rosacea; Erythema

Summary: the study will measure the decrease in redness on the face of rosacea subjects


Eligibility criteria:
inclusion criteria: 1. male or non-pregnant, non-lactating female, 18 years of age or older. 2. signed informed consent form that meets all criteria of current food and drug administration regulations. 3. females of childbearing potential must not be pregnant or lactating. 4. females of childbearing potential must agree to the use of a reliable method of contraception throughout the study. 5. have clinical diagnosis of rosacea with persistent (non-transient) facial erythema. 6. have \< 3 inflammatory lesions on the face. 7. have an erythema score of 3 (moderate) or 4 (severe) for both the cea and the psa that is reflective of the overall targeted areas. 8. willing to minimize external factors that might trigger rosacea flare-ups (e.g., spicy foods, hot drinks, hot environments, prolonged sun exposure, strong winds, emotional stress and alcoholic beverages) during the study. exclusion criteria: 1. forms of rosacea that, in the opinion of the investigator, would interfere with the diagnosis or assessment of study endpoints 2. patient has a skin condition that, in the opinion of the investigator, would interfere with the diagnosis or assessment of rosacea 3. patients with active sunburn or excessive facial hair such as beards, sideburns, moustaches, etc. 4. patients with moderate to severe telangiectasial masses 5. history of blood dyscrasia. 6. significant history or current evidence of any uncontrolled chronic or serious disease or medical condition that would, in the judgment of the investigator, would put the subject at undue risk or compromise the study assessments. 7. history or current evidence of raynaud's syndrome, severe, unstable or uncontrolled cardiovascular disease, orthostatic hypotension, uncontrolled hypertension or hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, renal or hepatic or renal impairment, scleroderma, sjögren's syndrome, depression, or narrow-angle glaucoma to an extent that, in the opinion of the investigator, would place the subject at undue risk. 8. female patients taking hormonal contraceptives or oral estrogen for less than one month or those that plan to change the dosage regimen during the course of the study. 9. previous participation in this study. 10. employees of the investigator or research center or their immediate family members. 11. inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.
amount of lactose causing symptoms in people with lactose intolerance and ulcerative colitis

Conditions: Lactose Intolerance; Ulcerative Colitis

Summary: the hypothesis underlying this study is that failure to recognise the role of lactose intolerance among patients with ulcerative colitis has led to inappropriate dietary advice and treatment with drugs that contain lactose as a filler. these failures exacerbate symptoms and lead to the unnecessary use of immune suppressant drugs. there is disagreement amongst researchers regarding the amount of lactose needed to cause symptoms in those who are lactose intolerance. the general consensus is that the amount of lactose in a glass of milk (12 grams) is enough to cause mild symptoms in most patients who are lactose intolerant (1). however, there have been a number of studies and case studies that argue that much lower amounts can cause symptoms (2, 3, 4, 5). this could be as little as 0.02 grams (6). ulcerative colitis is a chronic relapsing inflammatory disease of the colon and rectum, characterised by recurrent episodes of abdominal pain and profuse diarrhoea. the prevalence of lactose intolerance in patients with ulcerative colitis is not greater than in the general population, but there is no evidence as to whether these patients are more sensitive to lactose. this study will identify the threshold at which symptoms of lactose intolerance develop in those who have both lactose intolerance and ulcerative colitis, to provide appropriate advice and treatment in the management of patients with these conditions.


Eligibility criteria:
inclusion criteria: 1. confirmed lactose intolerance demonstrated with a lactose intolerance test. 2. confirmed ulcerative colitis demonstrated with histological and radiological tests. 3. adherence to a lactose free diet for at least four days before the start of the study. exclusion criteria: 1. failure to adhere to a lactose free diet. 2. pregnancy. 3. unwillingness to comply with study outline.

Keywords: lactose intolerance ulcerative colitis lactose threshold
feasibility of an automated bidet intervention to decrease caregiver burden

Conditions: Caregiver Burnout

Summary: this study evaluates the feasibility, including acceptability and preliminary efficacy, of an automated bidet intervention to make it easier for caregivers to assist with toileting.

informal caregivers provide over 30 billion hours of care to older adults each year. they often assist with toileting tasks which are often identified as one of the most physically and emotionally demanding activities of daily living. caregivers receive limited training and support which increases their risk for injury and burnout. one potential strategy to reduce or replace the physical support needed from a caregiver is the used of an automated bidet system. it remains unknown whether an automated bidet can be used successfully with older adults and their caregivers at home. the objective of this feasibility study was to assess the acceptability and preliminary efficacy of a toileting intervention using an automated bidet system and training by an occupational therapy practitioner (ot) to reduce the amount of physical assistance required from caregivers. the investigators will recruit 10 informal caregivers and randomize them to the treatment or waitlist control group. caregivers in the treatment group will receive the automated bidet right away while those in the waitlist control group will not receive any treatment during that time. after 30 days, both groups will participate in a post-test assessment visit. the waitlist control group will then be offered the intervention and invited to participate in a final session after 30 days to complete assessments and a process evaluation (30 days post follow-up).

Eligibility criteria:
inclusion criteria: * (1) provided unpaid care and lived with a care recipient aged 55 years or older * (2) assisted with toileting for at least 6 months * (3) did not have an automated bidet * (4) had a working toilet and bathroom outlet, and (5) their care recipient was willing to participate exclusion criteria: * caregivers scoring 10 or above on the short blessed test, indicating possible cognitive impairment

Keywords: assistive technology informal caregivers occupational therapy toileting
improving screening and follow up for suicidal ideation and behaviors among latinx youth in primary care

Conditions: Suicidal Ideation

Summary: the objective of this proposal is to develop and pilot a systems-level strategy in pediatric primary care to enhance identification and management of suicidal ideation and behavior in latinx youth, particularly those in immigrant families with parents who have limited english proficiency (lep). the investigators will focus on the use of trained community health workers (chws) to increase clinic capacity and quality of suicide risk screening and early intervention, with a focus on safety planning, parent psychoeducation and care coordination. specific aims are 1: to develop site-specific implementation protocols for the integration of chws into sib screening and safety planning for latinx youth and the youths families; 2: to pilot the implementation of the program in a six-month open trial in four pediatric primary care practices representing a range of usual practice settings; and 3: to engage a stakeholder network to explore barriers and facilitators, including costs and billing strategies, to implementation of this approach across a broad range of pediatric primary care settings. parents/guardians of youth who have been referred to and agree to participate in the intervention by the child's primary care provider will participate in a 2-month program consisting of 6-8 phone sessions with a community health worker focusing on safety planning, information/education, program solving and self-care. research participants will be asked to complete a survey via phone at the beginning of the program and another at the end of the program. the participants may also be asked to participate in an additional interview about the study.


Eligibility criteria:
inclusion criteria: * youth has history of suicidal ideation/behavior or non-suicidal self-harm and * youth identifies as latino/latinx/hispanic/latin american and * guardian(s) speaks spanish exclusion criteria: * none
patient blood management in cardiac surgery

Conditions: Surgical Blood Loss

Summary: preoperative anemia is associated with an important increase in transfusions of red blood cells (rbc) compared to a non-anemic patient in cardiac and non cardiac surgery. furthermore transfusion is also an independent factor of morbi-mortality with notably an increase in the infectious risk, immunological, an increase of the risk of cardiac decompensation, respiratory decompensation transfusion related acute lung injury (trali) or transfusion associated cardiac overload (taco), and an increase in mortality of 16%. management of perioperative transfusion is therefore a public health issue. since 2010, the world health organization (who) has been promoting a systematic approach to implement blood management programs for the patient to optimize the use of resources and promote quality and safety of care. improving the relevance of transfusion in cardiac surgery could be achieved by optimizing the management of patients around 2 axis: a:non-drug intervention : review of practices to improve the management of perioperative rbc transfusion b:drug intervention : systematic correction of pre- and postoperative iron, vitamin deficiencies and anemia the aim of this program is to improve the relevance of transfusion in cardiac surgery and to limit the morbidity and mortality induced by transfusion. this program is part of a global project of pre, per and postoperative management of the patient undergoing cardiac surgery programmed under extracorporeal circulation (ecc). it requires a multidisciplinary approach between cardiologists, anesthesiologists and intensivists, perfusionists, cardiac surgeons and paramedical teams to optimize the management of the patient.


Eligibility criteria:
inclusion criteria: * patient scheduled for cardiac surgery under ecc * patient affiliated or beneficiary of a social security scheme * patient having given his consent exclusion criteria: * urgent surgery (less than 48h) * contraindication to iron injection : proven allergic reaction * erythropoietin allergy * protected patients: majors under some form of guardianship or other legal protection; pregnant, breastfeeding or parturient woman.

Keywords: red blood cell transfusion anemia iron deficiency extracorporeal circulation or bypass cardiac surgery
evaluation of an oral nutritional supplement in older hospitalized patients

Conditions: Pneumonia

Summary: study objectives are to verify the loss of lean mass during a hospital stay in a group of older patients; to evaluate the effects of consuming a high-calorie complete and balanced oral nutritional supplement; to collect post-discharge information.


Eligibility criteria:
inclusion criteria: 1. ≥ 55 years of age. 2. admitted to hospital with a disease of respiratory system including acute respiratory diseases (e.g., pneumonia, acute bronchitis) or exacerbation of existing respiratory diseases. 3. anticipated length of hospital stay of at least 3 days. 4. ability to climb a flight of 10 stairs or walk a city block without the help of another person prior to hospitalization. 5. able to consume foods and beverages orally. exclusion criteria: 1. unstable heart failure which requires icu admission. 2. severe respiratory disease requiring long-term, continuous oxygen therapy. 3. diabetes. 4. impaired renal function. 5. impaired liver function. 6. cancer. 7. hospitalized for two or more days in past 4 weeks. 8. requires intubation or tube feeding. 9. expected to be transferred to an advanced care unit. 10. body mass index of ≥ 40 kg/m2. 11. active tuberculosis. 12. ascites or severe edema. 13. acute hepatitis or hiv. 14. disorder of gastrointestinal tract. 15. dementia;brain metastases, eating disorder, significant neurological, psychiatric disorder, other psychological condition. 16. medication/dietary supplements/substances that could modulate metabolism or weight. 17. partial or full artificial lower limb. 18. allergy or intolerance to any of the ingredients in the study products. 19. procedure using iodine-based contrast media within 7 days prior to hospitalization; or, anticipated to need procedure using iodine-based contrast media within 3 days after hospital admission.
phase 1/2 study of bbt-176 in advanced nsclc with progression after egfr tki treatment

Conditions: NSCLC

Summary: this clinical trial is the first-in-human study of bbt-176. the purpose of this trial is to investigate the safety and tolerability of bbt-176 (part 1) and to evaluate the anti-tumor activity of bbt-176 (part 2).


Eligibility criteria:
key inclusion criteria: * provision of signed and dated, written informed consent before any study specific procedures, sampling and analyses * histological or cytological confirmation of advanced and/or metastatic stage iiib/iv nsclc * radiological documentation of disease progression while on a previous continuous (at least 30 days) treatment with an egfr tki monotherapy (including, but not limited to, osimertinib, afatinib, gefitinib, or erlotinib) * patients must fulfill one of the following: * confirmation that the tumor harbors an egfr mutation known to be associated with egfr tki sensitivity (including, but not limited to, exon 19 deletion, l858r, or l861q) * documented partial or complete response or a significant and durable stable disease (at least 6 months), based on the recist or who criteria, after treatment of an egfr tki key exclusion criteria: * treatment with any of the following: * an egfr tki, including but not limited to osimertinib, afatinib, gefitinib, or erlotinib within 8 days of the first dose of study treatment. * any cytotoxic chemotherapy, investigational agents, or anticancer drugs for the treatment of advanced nsclc, between prior egfr tki treatment and bbt-176 treatment * major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment * radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment * patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation within 6 weeks of the first dose of study treatment * any unresolved toxicities from prior therapy greater than nci common terminology criteria for adverse events (ctcae v5.0) grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2 neuropathy related to prior platinum-therapy * spinal cord compression or brain metastases, unless asymptomatic and stable
safety, tolerability, and immunogenicity of a 24-valent pneumococcal conjugate vaccine (vax-24) in healthy infants

Conditions: Pneumococcal Vaccines

Summary: the objective of the study is to evaluate the safety and tolerability of 4 injections of vax-24 (at 3 dose levels) compared to pcv15 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine us concomitant vaccines. stage 1 of the study will comprise 3 dose ascending cohorts. stage 2 of the study will enroll the remainder of the sample size.


Eligibility criteria:
inclusion criteria: 1. healthy male or female infant ≥42 days to ≤89 days (inclusive). 2. full-term infant at least 37 weeks gestational age at birth. 3. afebrile for ≥72 hours with a rectal temperature \<38.0°c (\<100.4°f) or axillary temperature \<37.8°c (\<100.0°f) before receipt of study vaccine.\* 4. able to attend all scheduled visits and comply with the study procedures. 5. subject's parent/legal guardian is able to read and understands the study procedures, alternate treatments, risks and benefits, and provides written informed consent. 6. subject's parent/legal guardian is able to fill out an ediary of solicited ae and take daily axillary temperature and measurements of local injection site reactions for the 7 days after each study vaccination. 7. subject's parent/legal guardian has an e-mail address and access to a computer or smartphone with internet to complete the ediary. exclusion criteria: 1. history of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease. 2. previous receipt of a licensed or investigational vaccine (excluding 1 dose hepatitis b vaccine). 3. known hypersensitivity to any vaccine. 4. known or suspected impairment of immunological function (e.g., asplenia, hiv, primary immunodeficiency). 5. use of any immunosuppressive therapy (note: topical and inhaled/nebulized steroids are permitted). 6. history of failure to thrive. 7. subject has a coagulation disorder contraindicating im vaccination. 8. subject or his/her mother have documented hepatitis b surface antigen-positive. 9. has a known neurologic or cognitive behavioral disorder. 10. has a known clinically significant congenital malformation or serious chronic disorder. 11. receipt of a blood transfusion or blood products, including immunoglobulins. 12. receipt of any investigational study product since birth, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study. 13. any infant who cannot be adequately followed for safety according to the protocol plan. 14. any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.

Keywords: 24 valent pcv pneumonia pneumococcal infection
pharmacokinetic study of multi-dose chloroquine

Conditions: Malaria

Summary: chloroquine (cq) remains an alternative cheap, safe and widely available drug. our previous research has shown that double (50 mg/kg) standard dose cq given in split doses had a 95% efficacy and was well tolerated and safe. still, safety could be an issue when the dose of cq is increased. severe adverse events are caused by high peak concentrations of cq. using split doses of cq avoids high peak concentrations enabling the safe administration of high doses, however, pharmacokinetic data are lacking. children included in the study will be given 50 mg/kg as split doses over 3 days or 70 mg/kg as split doses over 5 days. treatment will be observed. drug concentrations and adverse events will be monitored. on day 1, children and their mother/guardian will be requested to stay at the health centre between 9 am and 6 pm. fifteen children aged 2-10 years with uncomplicated p. falciparum malaria and fulfilling the inclusion criteria will be recruited into each study arm. following the end of treatment, the children will be seen on the morning of day 7, 14, 21 and 28. any child wishing to withdraw during the treatment phase and any child with reparasitaemia during the follow up will be given rescue treatment with arthemeter-lumefantrine or quinine according to treatment guidelines in guinea-bissau. final analysis will include a description of included children, proportions of adverse events and any serious adverse events, drug concentrations and their relation to adverse events, the proportion of children withdrawn or lost to follow up, the cumulative pcr corrected and uncorrected success and failure rates on day 28 and the proportion of early, late clinical and late parasitological treatment failures.


Eligibility criteria:
inclusion criteria: * age ≥ 2 years and \< 10 years. * mono-infection with p. falciparum detected by microscopy. parasitemia of 1.000-100.000/µl asexual forms. * axillary temperature ≥ 37.5 ˚c or a history of fever within 24 hours. * ability to swallow oral medication. * ability and willingness to comply with the study protocol. * informed consent from a parent or guardian exclusion criteria: * signs or symptoms of severe malaria. * presence of general danger signs in children under 5. * persistent vomiting. * presence of severe malnutrition. * any evidence of chronic disease or acute infection other than malaria. * regular medication which may interfere with antimalarial pharmacokinetics. * history of hypersensitivity reactions or contraindications to chloroquine.

Keywords: plasmodium falciparum malaria chloroquine pharmacokinetic children