Kornimate/medical-research-clean huggingface dataset:
mentor moms+ study

Conditions: HIV; Alcohol Consumption

Summary: the goal of this study is to adapt an existing evidence based intervention for use in pregnant and lactating people (plp) who use alcohol. through the pilot rct, we aim to understand if tailored intervention, mentor mothers+, is effective in reducing alcohol use (primary outcome) and improving antiretroviral (prep or art) adherence (secondary outcomes) among pregnant and breastfeeding women living with and without hiv in a community heavily burdened by this syndemic. the investigators will conduct an pilot randomized control trial in 100 pregnant women, recruited during antenatal care (anc) visits within the saldanha bay municipality clinic in cape town, south africa. the rct will involve the delivery of brief, individual motivational interviewing sessions provided by trained mentor mothers from the community who are on either prep (living without hiv) or art (living with hiv) and who stopped or reduced alcohol use during pregnancy. the enrolled participants will be followed for a 6-month period spanning both pregnancy and postpartum stages.

the syndemic of alcohol use and hiv risk in pregnant and lactating people (plp) threatens the health of mother, fetus, children and families in south africa. plp living with hiv who use alcohol may access antiretroviral therapy (art) late or disengage with art care, increasing the risk of vertical hiv transmission. plp not living with hiv who use alcohol are at increased risk of hiv and may require targeted interventions to receive pre-exposure prophylaxis (prep) delivery and adherence counselling. alcohol use also increases risk of hiv acquisition and poor art adherence. the "mentor mother" (mm) intervention model is an evidence-based intervention (ebi) with demonstrated success in improving hiv and antenatal care outcomes. the model utilizes a task-shifting approach; positive deviant peers (mothers) deliver interventions to plp within and outside of the antenatal clinic. our study aims to evaluate the feasibility and acceptability of mm+ on reduction of alcohol use (primary outcome) and prep use (in plp without hiv) and art adherence (in plp living with hiv) (secondary outcomes) in a pilot randomized control trial (rct) in n=100 pregnant women who currently use alcohol. primary outcome: reduced alcohol use following the intervention (at 6m via phosphatidylethanol \[peth\] levels). secondary outcomes: prep and art continued use at 6 months via urine tenofovir levels at 6 months.

Eligibility criteria:
inclusion criteria: * • ≥ 16 years; * pregnancy confirmed; * reported alcohol use during pregnancy (in last 2 months); * lives within 20 kilometers of the study facility; * able and willing to consent to study participation. exclusion criteria: * individuals not meeting the above criteria will be excluded.

Keywords: pregnant postpartum hiv prevention hiv treatment alcohol use breastfeeding
longitudinal evaluation of [18f]gtp1 as a pet radioligand for imaging tau in the brain of participants with alzheimer's disease compared to healthy participants

Conditions: Alzheimer's Disease

Summary: this is an open-label, longitudinal observational study evaluating the imaging characteristics of the tau positron-emission tomography (pet) radioligand \[18f\] genentech tau probe 1 (gtp1) in the brain of participants with prodromal, mild, and moderate alzheimer's disease (ad) compared to healthy participants. the overall goal of this protocol is to evaluate the longitudinal change in tau burden using \[18f\]gtp1, a tau targeted radiopharmaceutical.


Eligibility criteria:
inclusion criteria: for all participants: - availability of a study partner who, in the investigator's judgment, has frequent and sufficient contact with the participant and is able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to accompany the participant and provide information at visits for healthy participants: * healthy with no clinically relevant finding on physical examination at screening and upon reporting for the baseline \[18f\]gtp1 imaging visit * have no cognitive complaint * have a clinical dementia rating scale (cdr) global score = 0 * have a mini-mental state examination (mmse) score of 28-30 for participants with a diagnosis of ad: * participants with mild or moderate ad must meet national institute on aging - alzheimer's association (nia-aa) core clinical criteria for probable ad dementia, with an amnestic presentation * participants with prodromal ad must meet nia-aa core clinical criteria for mild cognitive impairment (mci) * have screening \[18f\]florbetapir pet imaging demonstrating amyloid binding based on qualitative visual read * a brain mri consistent with a diagnosis of ad, with no evidence of non-ad disease to account for dementia or mri exclusion criteria * medications taken for symptomatic treatment of ad must remain stable for at least 30 days prior to screening visit * satisfy one of the following subgroups: approximately 20 prodromal ad (mmse 24-30, cdr = 0.5); approximately 20 mild ad (mmse 22-30, cdr = 0.5 or 1); approximately 20 moderate ad (mmse 16-21, cdr = 0.5 or 1 or 2) exclusion criteria: * current or prior history of any drug or alcohol abuse * participants with any significant psychiatric, neurological, or unstable medical disorder expected to interfere with the study * participants unable to undergo mri and pet scan * for participants contributing csf samples, any contraindication to lumbar puncture * prior participation in other research protocols or clinical care in the last year such a radiation exposure combined with that from the present study exceeds an effective dose of 50 millisievert (msv), the allowable annual limit for research participants as stipulated by the food and drug administration (fda)
intragastric ph and bismuth effect for h. pylori eradication

Conditions: Helicobacter Pylori Infection

Summary: gastric cancer is one of the leading causes of cancer-related deaths worldwide. in taiwan, there are around 3800 fresh cases annually, with about 5% of total cancers cases. gastric cancer development is known to follow a multistate process from non-atrophic gastritis, atrophic gastritis, intestinal metaplasia, dysplasia, and carcinoma; h. pylori infection plays the key role of this carcinogenic process. although h. pylori eradication would result in a marked gastric cancer reduction, treatment success using standard regimens has become more difficult in recent years, and increased antibiotic resistance is considered the most important reason for decreased treatment efficacy. as no specific new medications have been introduced in recent years, novel treatment regimens have been created using different combinations, durations and sequences of available medications. the addition of bismuth improved the cure rates despite a high prevalence of resistance, and resistance of h. pylori to bismuth has not been reported. bismuth absorption is not required for efficacy in h. pylori treatment regimens, suggesting a local mechanism of action. the mechanisms of bismuth with responsible for rapid destruction of h. pylori within the stomach remain unclear. knowledge of the mechanism of action of bismuth compounds against h. pylori would be beneficial in the development of improved treatment regimens in this era of declining eradication success rates. we conduct the pilot study to evaluate the bacteria fragments of h. pylori in specimen through electron microscopy after bismuth therapy and provide insight into the mechanism of action of ph on bismuth therapy. we also help to develop optimal h. pylori therapeutic strategies.


Eligibility criteria:
inclusion criteria 1. age 20-69 2. confirmed h. pylori infection by urea breath test or previous histology 3. scheduled endoscopy 4. mentally competent to be able to understand the consent form for individuals equal to or older than 20 5. able to communicate with study staff for individuals equal to or older than 20 6. without history of gastric cancer exclusion criteria 1.history of gastric cancer deferral criteria: 1. having received antibiotic treatment in the previous 15 days 2. need of time to decide participation

Keywords: electron microscopy helicobacter pylori bismuth
efficacy and safety trial of alk-depot sq mites in subjects with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this trial is performed to assess the efficacy and safety of alk-depot sq mites for treatment of atopic dermatitis


Eligibility criteria:
inclusion criteria: * positive specific ige to house dust mites * atopic dermatitis according to hanifin/rajka * chronic course of atopic dermatitis * scorad larger than 25 points exclusion criteria: * erythrodermia * syst.treatment with gcs or immunosuppressive agents in the prev.4 weeks * history of specific immunotherapy with mites * uv radiation * group 4 topical corticosteroids (european classification)
evaluation of the efficacy and safety of oc-01 nasal spray on signs and symptoms of dry eye disease

Conditions: Dry Eye Disease (DED)

Summary: the objective of this study is to evaluate the safety and effectiveness of oc-01 nasal spray as compared to placebo on signs and symptoms of dry eye disease.

this was a phase 3, multicenter, randomized, controlled, double-masked (including subjects, investigators, study site personnel, and sponsor personnel) study designed to evaluate the safety and efficacy of oc-01 (varenicline) nasal spray 0.6 mg/ml and 1.2 mg/ml in adult participants with ded. the study randomized 758 subjects at least 22 years of age with a physicians' diagnosis of ded and meeting all other study eligibility criteria to receive oc-01 (varenicline) nasal spray or placebo twice daily (bid) for 28 days with three additional long-term follow-up visits at 6 weeks, 6 months, and 12 months. participants who terminated from the study during the treatment period were asked to complete safety assessments (if the participants agree) prior to study exit. participants who were terminated early from the study were not replaced

Eligibility criteria:
inclusion criteria: - have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to visit 1 exclusion criteria: * have had any intraocular surgery (such as cataract surgery) or extraocular surgery in either eye within three months or refractive surgery (e.g. laser-assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or corneal implant) within twelve months of visit 1. * have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with dry eye disease are allowed. * have a systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.) * have a known hypersensitivity to any of the procedural agents or study drug components * have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject.
validation of the second generation of the controlled attenuation parameter (cap) using the mri-pdff as reference

Conditions: Chronic Liver Disease

Summary: chronic liver diseases (clds) represent a major worldwide public health burden. worldwide estimations show that 844 million people have clds, a lot more than other chronic diseases such as diabetes or cardiovascular diseases. cld is most of the time an asymptomatic, progressive, and potentially fatal disease. with its complications it becomes one of the major causes of mortality worldwide. globally, hepatitis b virus and hepatitis c virus, alcoholic liver disease and non-alcoholic steatohepatitis, are the most important causes of liver disease. the diagnosis of liver lesions remains an important issue for these patients. the prognosis and management of liver disease greatly depends on the amount of liver fibrosis. in early stages, it is the main factor predicting long-term outcome of these patients. the liver biopsy still represents the gold standard diagnostic tool for liver fibrosis assessment, although a wide spectrum of noninvasive tools are now commonly used as a surrogate to the liver biopsy. it includes direct and indirect serum markers of liver fibrosis, but also several imaging-based methods, including transient elastography (fibroscan®, echosens, paris, france). even if the liver fibrosis is the key pathological feature of progressive liver disease, the accumulation of excessive hepatic triglyceride, hepatic steatosis, is today recognized as an important factor in the pathogenesis of a number of cld. the magnetic resonance imaging (mri) techniques are sensitive to steatosis and show interesting diagnostic performances, especially the mri using the proton density fat fraction (mri-pdff) which has shown at least equivalence in accuracy for quantifying hepatic steatosis with both 1h magnetic resonance spectroscopy and with histological grade, across several studies. therefore, this technique is now part of the gold standard diagnostic tool to establish the grade of hepatic steatosis. echosens has developed an ultrasonic controlled attenuation parameter (cap) designed to quantify hepatic steatosis using a process based on vibration controlled transient elastography (vcte™). echosens is working on improving the diagnostic accuracy of the cap measurement performed with the fibroscan. this protocol is set-up to compare the diagnostic performances of the first generation of the cap and the second generation of the cap to the reference, the mri-pdff, in patients with cld, all etiologies combined.


Eligibility criteria:
inclusion criteria: * patient must be at least 18 years of age * patient must be able to give written informed consent * patient affiliated to a social security system * patient with a chronic liver disease, all etiologies exclusion criteria: * vulnerable patient * pregnant women * patient with presence of ascites * contra-indication to mri
a study to evaluate the effect of belimumab on vaccine responses in subjects with systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to assess the impact of belimumab on immune response to pneumococcal vaccine in subjects with systemic lupus erythematosus (sle).

all patients in this study will receive belimumab plus standard therapy for sle and vaccination against pneumococcus. patients will be randomized to receive pneumococcal vaccination either 4 weeks prior (early vaccination group) or 24 weeks after (late vaccination group) their first belimumab dose. vaccine response will be assessed 4 weeks after vaccine administration.

Eligibility criteria:
key inclusion criteria: * clinical diagnosis of sle by american college of rheumatology (acr) criteria. * active sle disease. * autoantibody-positive. * have antibodies with titers \>1.0 microgram (mcg)/ml to no more than 9 of the 23 serotypes present in the pneumococcal vaccine. * have the ability to understand the requirements of the study, provide written informed consent, and comply with the study protocol procedures. key exclusion criteria: * pregnant or nursing. * have received any prior treatment with belimumab. * have received a live vaccine within the past 30 days. * have received a pneumococcal vaccination with the past 5 years. * have a history of severe allergic reaction to a vaccine, contrast agents (such as those used for x-rays and ct scans), or biological medicines. * have required management of an infection or have had infections that keep coming back within the past 60 days. * hepatitis b: serologic evidence of hepatitis b (hb) infection based on the results of testing for hb surface antigen (hbsag) and anti-hb core antibody (anti-hbc): * subjects positive for hbsag are excluded. * subjects negative for hbsag but positive for anti-hbc, regardless of anti-hbs antibody status, are excluded. * hepatitis c: positive test for hepatitis c antibody. * known human immunodeficiency virus (hiv) infection. * have current drug or alcohol abuse or dependence. * have a grade 3/4 immunoglobulin (ig)g deficiency (igg level \<400 milligrams \[mg\]/ deciliter \[dl\]) or iga deficiency (iga level \<10 mg/dl). * subjects who have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or suicidal ideation with some intent to act in the last 2 months or who in the investigator's judgment, pose a significant suicide risk.

Keywords: antibodies vaccines sle immune system diseases biological therapy autoimmune diseases pneumococcal vaccines lupus immunoglobulins vaccination belimumab biological agents immunization
understanding acute sarcopenia

Conditions: Sarcopenia

Summary: this study aims to characterise acute changes in muscle mass, strength, physical performance in hospitalised older adults. we will assess the impact of these changes upon physical function at three month follow-up, and assess for the impact of clinical and immune-endocrine factors upon these changes.

study design time-limited cohort study involving serial measurements of bilateral anterior thigh thickness (batt) using ultrasound, handgrip strength, physical performance, and physical function measured using the patient reported outcome measures information system (promis®). we aim to fully characterise changes in these patients, and will perform a comprehensive evaluation of clinical factors including nutrition and physical activity, and measure immune-endocrine markers of inflammation. study participants elective colorectal surgery, emergency abdominal surgery, and medical patients aged 70 years and older planned size of recruitment target 56 elective colorectal patients, 56 emergency abdominal surgery patients, and 56 medical patients with acute infections follow up duration 3 months primary research question does acute change in quadriceps muscle thickness, handgrip strength and/or physical performance within one week of hospitalisation predict change in patient reported physical function at three months?

Eligibility criteria:
inclusion criteria: elective cohort * aged 70 years or older at time of recruitment * expected to undergo an elective major colorectal surgery procedure emergency surgery cohort * aged 70 years or older at time of recruitment * emergency admission * expected to undergo emergency abdominal procedure during admission, or emergency abdominal procedure performed within previous 48 hours medical cohort * aged 70 years or older at time of recruitment * emergency admission for acute bacterial infection or presumed acute bacterial infection exclusion criteria: elective cohort * unable to provide written informed consent at time of recruitment * unable to understand verbal english * life expectancy less than 30 days emergency surgery cohort * unable to provide written informed consent at time of recruitment and no consultee available * unable to understand verbal english * life expectancy less than 30 days medical cohort * unable to provide written informed consent at time of recruitment and no consultee available * unable to understand verbal english * life expectancy less than 30 days

Keywords: acute sarcopenia, muscle, physical function, older adults
changes after suprachoroidal injection.

Conditions: Retina; Change; Intraocular Pressure; Cataract; Macular Edema

Summary: changes after suprachoroidal injection are analyzed for statistical analysis.

changes after suprachoroidal injection of triamcinolone acetonide are noted in various retinal diseases treated by this technique to address its effects over six months of follow-up.

Eligibility criteria:
inclusion criteria: * patients prepared to suprachoroidal injection for various retinal diseases will be enrolled in the study. * bilateral retinal diseases that required interventions as diabetic macular edema, exudative retinal detachment, and serous chorioretinopathies. exclusion criteria: * other retinal diseases that are not expected to improve after steroid injections as central retinal artery occlusion and age-related macular degenerations. * choroidal neovascularization that require anti-vascular endothelial growth factors. * patients refused to have steroid injections even after discussing the nature of their disease with them and the procedure to be done.
strengthening community addiction services in vietnam

Conditions: Addiction, Opioid

Summary: this study aims to develop and test an intervention to enhance the addiction service continuum with the joint effort of commune health workers and family members of people who use drugs in vietnam.

the study will develop and test an intervention to strengthen a continuum of addiction services. the intervention, entitled "community care consortium (ccc)," features community health workers' joint effort with family members to provide patient-centered, individualized addiction care and support. the intervention will be developed and tested through three phases in three regions of vietnam (ninh binh, da nang, and can tho). in phase 1, we will conduct formative studies with commune (community) health workers (chw), community representatives, pwud, and their family members to identify barriers to addiction service utilization and discuss potential strategies to establish a continuum of addiction services. based on the formative study findings, the ccc intervention and its implementation plans will be developed through workgroup meetings with researchers, community members, and target users. in phase 2, the ccc intervention will be piloted in three communes and revised based on acceptability/feasibility data, process evaluation, and feedback from field staff and participants. in phase 3, a randomized controlled trial of the ccc intervention will be conducted in 60 communes, which will be randomized to either an intervention condition or a control condition (30 communes in each condition). a total of 720 pwud, 720 of their family members, and 180 commune health workers (chw) will participate in the study. the intervention outcomes on pwud, chw, and family members will be assessed with the data collected at baseline, 3-, 6-, 9- and 12-month follow-ups.

Eligibility criteria:
inclusion criteria: * age 18 or older * having a history of drug use * having disclosed drug using status to at least one of his/her family members and is willing to invite this family member to our study * currently residing in the selected communes * voluntary written informed consent exclusion criteria: * inability to give informed consent