Kornimate/medical-research-clean huggingface dataset:
le kip kip: a campaign to change social norms and build sustainable demand for prep among women in south africa

Conditions: Pre-exposure Prophylaxis; HIV Infections

Summary: the purpose of this study is to evaluate the impact of a social media campaign and community engagement activities to promote pre-exposure prophylaxis (prep) use among young women and to influence community norms around prep in south africa. to do this, the investigative team will analyze prep initiation and retention data from the study's implementing partner, tb hiv care, a non-profit organization providing prep to marginalized young women in south africa. the effect of the social media campaign and community engagement will be tested using a short duration cluster randomized trial (crt).

the cluster randomized trial (crt) will not engage in prep provision to individuals, but instead employs geographical regions to serve as units of randomization where social media content and community engagement will be targeted. tb hiv care employs a large team to provide routine service delivery while the crt tests strategies including a social media campaign and community engagement that may amplify prep uptake and persistence among the community, leveraging the programme infrastructure to actually provide services as it is already doing. embedding strategies within the programme ensures that the existing results come from real world contexts and focuses on implementation of support strategies rather than clinical care provision. the crt will be implemented across 10 districts, with 5 districts serving as control sites and 5 as intervention sites.

Eligibility criteria:
inclusion criteria: * eligible to take prep per tb hiv care programmatic criteria * engaged in tb hiv care hiv prevention program exclusion criteria: * not eligible for prep (not at risk for hiv) per tb hiv care programmatic criteria

Keywords: prep pre-exposure prophylaxis hiv prevention cluster randomized trial community-based methods key populations female sex workers adolescent girls and young women south africa
total marrow irradiation with volumetric arc therapy for patients unfit for a 12 gy tbi

Conditions: Haematological Malignancy

Summary: total body irradiation (tbi) is a standard part of the conditioning regimen for bone marrow transplantation (bmt). several randomized trials have shown superior outcomes using tbi compared with non tbi-containing regimens. standard tbi is usually delivered over three days for a total dose of 12 gy with two daily fractions. however, as demonstrated by our group, increasing the tbi dose above 10 gy is not necessarily associated with better outcome in patients undergoing allogenic bmt for hematologic malignancies. for this reason, patients older than 40 or grafted after relapse are treated at our center with a reduced-dose 10 gy tbi regimen. this pilot study wishes to investigate in 10 patients with hematological malignancies unfit for a standard 12 gy tbi conditioning regimen a more targeted, conformal form of treatment, referred as total marrow (tmi), using volumetric arc therapy (vmat). our hypothesis is that using this technique that can allow deliver a higher total dose to the target while at the same time assuring to the organs at risk (oar) the same dose normally delivered with a 10 gy tbi we will improve the therapeutic ratio in these patients.

this is a feasibility prospective pilot study. ten patients ≥ 40 years with hematologic malignancies prior to bone marrow transplant (bmt) will receive a dose escalated hypofractionated total marrow irradiation (tmi) (12 gy in 3 fractions, daily, on 3 consecutive days). the current project is a joint initiative in translational and clinical medical research between the radiation-oncology workgroup and the bone marrow transplant workgroup of university hospitals of geneva (hug).

Eligibility criteria:
inclusion criteria: * karnofsky performance status ≥ 70 * presence of any kind of haematological malignancy in complete remission (cr1, cr2 ore cr3) at time of transplantation, with the exception of patients with myelodysplastic syndrome. * patients that are scheduled for a bmt either using stem cell derived from bone marrow or peripheral blood stem cells. * candidates to receive a 10 gy tbi treatment. * ability to stay still and lying on the treatment couch for at least 45 minutes. * informed consent as documented by signature. exclusion criteria: * karnofsky performance status \<70 intended as a patient unable to work; able to live at home and care for most personal needs with varying amount of assistance needed. * concurrent treatment with other experimental drugs or other anti-cancer therapy. * participation in another clinical trial and any concurrent treatment with any investigational drug within 4 weeks prior to trial entry/randomisation. * inability to comply with study and follow-up procedures.

Keywords: haematological malignancy total marrow irradiation volumetric arc therapy
efficacy of a bevacizumab nasal spray as a treatment for epistaxis in hereditary hemorrhagic telangiectasia (hht)

Conditions: Hereditary Hemorrhagic Telangiectasia; Epistaxis

Summary: hereditary hemorrhagic telangiectasia (hht) is a rare (\~ 1/6000) but ubiquitous genetic disease. it is associated with abnormal angiogenesis and autosomal dominant inheritance, leading to telangiectasias and arteriovenous fistulae. more than 95% of patients are concerned by epistaxis (nosebleeds). these events are spontaneous, repeated, irregular, both diurnal and nocturnal, a source of anemia, disabling and very socially embarrassing. anti-angiogenic treatments, including bevacizumab, are a new therapeutic option in hht. the aim of this study is to evaluate 3 months after the end of the treatment the efficacy on the duration of the nosebleeds with 3 different doses (25, 50 and 75 mg) of bevacizumab administered as a nasal spray in a repeated manner (3 administrations) in patients with hereditary hemorrhagic telangiectasia complicated by nosebleeds. this randomized, double-blind, placebo-controlled, seamless phase ii/iii study is to be carried out on 4 groups of 20 patients for first step and 2 groups of 20 to 40 patients for second step


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * patients who have given their free informed and signed consent. * patients affiliated to a social security scheme or similar. * patients monitored for clinically confirmed hht (presence of at least 3 curaçao criteria) and/or confirmed by molecular biology. * patients who have not undergone nasal surgery in the 3 months prior to inclusion. * patient with nosebleeds of a monthly duration of more than 20 minutes and justified by follow-up grids completed for at least the 3 months prior to the time of inclusion. exclusion criteria: * women who are pregnant or likely to become so in the course of the study. * patients not affiliated to a social security scheme. * patients who are protected adults under the terms of the law (french public health code). * refusal to consent. * patients for whom the diagnosis of hht has not been confirmed clinically and/or by molecular biology. * patients with an on-going infectious condition. * participation in another clinical trial within the 28 days prior to inclusion. * known hypersensitivity to the active ingredient or one of the excipients. * known hypersensitivity to products of chinese hamster ovary cells (cho) or other human or humanized recombinant antibodies. * patients who have incompletely filled in the nosebleed grids in the 3 months preceding the treatment. * patients who do not present with nosebleeds with a monthly average duration over the 3 months preceding the treatment of more than 20 minutes ((duration m1 + duration m2 + duration m3) / 3). remark: only the 3 months strictly preceding the treatment will be taken into account, even if the grids have been completed over a longer period. * patients who have received avastin® intravenously in the 6 months prior to inclusion.

Keywords: epistaxis bevacizumab
impart: provider-assisted hiv partner notification

Conditions: HIV Infections; Partner Communication

Summary: researchers will conduct a 2-arm pilot randomized controlled trial with hiv-infected index patients recruited from two all-male prisons in indonesia to assess the acceptability and feasibility of provider-assisted hiv partner notification (provider referral) and examine its potential to increase the number of partners who are tested for hiv and subsequently linked to prevention and treatment services.

this study compares three options for partner notification: * option 1 (self-tell): participant is encouraged to disclose his hiv+ status to his partner(s) and given information about sites where his partner(s) can receive free hiv testing. * option 2 (tell together): participant discloses his hiv+ status to his partners with a counselor (project staff) present. counselor refers the partner to hiv testing, including a study-affiliated hiv testing site. * option 3 (provider referral): project staff (nurse or peer educator) will notify the partner anonymously - without identifying the participant (index patient). partners are offered immediate hiv testing in their home or at a study-affiliated hiv testing site.

Eligibility criteria:
inclusion criteria for hiv-positive prisoners (n=65): index patients must beat least 18 years of age, hiv-seropositive and aware of their hiv+ status; (hiv-infection documented by a rapid hiv test); sexually active and/or sharing needles in the 12 months before incarceration; incarcerated within the past 3 years and ≥6 months of their prison sentence remaining. we will limit enrollment to index patients who are willing to notify partners and have 1 or more partner(s) who have not yet been notified. inclusion criteria for partners: eligible partners will be persons who participants (index patients) are able to identify by first and/or last name, residential address and/or mobile phone number, and physical descriptors (e.g., approximate height) and have given nurses permission to contact. no named partner will be excluded on the basis of religion, ethnicity, age, sex, or gender identity.

Keywords: contact tracing hiv prevention partner notification
effect of mulligan versus maitland mobilization on lumbar proprioception in patients with chronic nonspecific low back pain

Conditions: Low Back Pain

Summary: this study will be conducted to compare between the effect of mulligan mobilization versus maitland mobilization on pain ,function and lumbar proprioception in patients with chronic nonspecific low pain

low back pain (lbp) is considered as one of the most widespread musculoskeletal disorders, impacting over 80% of the world's population, resulting in work absence, medical consultation, a decline in quality of life, and financial burden. lumbar repositioning error was high around 30° of trunk flexion in individuals with clb. when lumbar proprioceptive deficiencies arise, the activation pattern of back muscles is disturbed, the mechanics of the spinal unit differs from that of a healthy spine, and the recurrence rate of lbp increases . clbp is managed using various intervention modalities, including drug therapy and physical therapy approaches . physical therapy modalities, such as manual therapy, therapeutic exercises, and biopsychosocial techniques, are used for treating lbp. manual therapy is a common and suggested modality for treating clbp that has strong evidence. it is employed in physical therapy practice, including maitland mobilization and mulligan mobilization. mulligan mobilization as well as maitland mobilization has significant effect on pain ,function disability and lumbar repositioning error. but there is gap about which is more beneficial. so we conduct this study to determine which technique is more beneficial for patients

Eligibility criteria:
inclusion criteria: * they had interrupted or continuous lbp symptoms for more than 3 months * both gender exclusion criteria: * specific lbp * those who were pregnant * those with neurological problems

Keywords: mulligan maitland proprioception low back pain
addressing food insecurity: plant-based food prescription program

Conditions: Health Literacy; Nutrition, Healthy; Nutrition Poor; Food Insecurity; Food Insecurity Among Children; Low Income Population

Summary: reduce food insecurity by improving plant-based health food consumption, access, health and nutrition literacy and the health of the food-insecure families we serve.


Eligibility criteria:
inclusion criteria: * participants will be all ages 0-99 (all arms) * families living under the federal poverty line and who have food insecurity (all arms except arm 2 which can include families with income above the federal poverty line who do not have food insecurity). * families cared for in either the pediatric mobile clinic, pediatric, family medicine, internal medicine or med-peds primary care clinics in the uhealth/jackson health system/dade county street response. exclusion criteria: * families who are not under the federal poverty line and are not food insecure (all arms except arm 2, which will include participants of all socioeconomic statuses and regardless of food security status, with no exclusion criteria in this category). * families who are not actively receiving outpatient primary care (all arms).

Keywords: plant-based food prescription program plant-based food prescription food insecurity poverty nutrition education plant-based nutrition literacy plant-based nutrition education
botox® at the time of prolapse surgery for oab

Conditions: Urinary Bladder, Overactive; Pelvic Organ Prolapse

Summary: the purpose of the study will be to assess the efficacy and safety of bladder botox® for overactive bladder symptoms, such as urinary urgency and frequency, given at the time of prolapse surgery.

after being informed about the study and the potential risks, women scheduled for prolapse surgery will be screened for bothersome overactive bladder symptoms. those that qualify and choose to enroll will be randomized to receive either bladder botox® or a placebo at the time of their surgery. neither the patient nor the investigators will know if the patient receives botox® or a placebo. subjects will complete questionnaires and bladder diaries both before and after surgery to determine efficacy and patient satisfaction. potential adverse events, such as urinary tract infections and urinary retention, will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * women scheduled for prolapse surgery * bothersome oab symptoms determined by a score of \>20 on the oab-q sf * willingness to perform clean intermittent catheterization (cic) * ability to follow study instructions and complete required follow up exclusion criteria: * contraindications or allergy to onabotulinumtoxin a * intravesical onabotulinumtoxin a within 3 months of the planned surgery date * total body onabotulinumtoxin a dose of ≥ 400 units in the 3 months prior to the scheduled surgery date. * inability or unwillingness to self-catheterize * post-void residual ≥ 200ml * neurogenic bladder or other neurological diseases that may cause voiding dysfunction * concurrent use of other pharmacological treatment for the treatment of oab symptoms at the time of prolapse repair surgery. * females who are pregnant, think they may be pregnant at the start of the study, planning a pregnancy during the active treatment phase of the study, or who are unwilling or unable to use a reliable form of contraception during the active treatment phase of the study. * inability to speak or read english

Keywords: botulinum toxins, type a mixed urinary incontinence urgency urinary incontinence
influence of the immunosystem in non-celiac glutensensitivity

Conditions: Gluten Sensitivity

Summary: patients with non-celiac gluten sensitivity (ncgs) complain about gastrointestinal and extraintestinal symptoms while consuming gluten-containing cereals. the symptoms strictly correlate with ingestion of gluten-containing cereals and disappear quickly under elimination diets. till now, there are no specific markers to diagnose ncgs. this study aims to determine the effect of a low fodmap diet (fermentable oligo-, di- and monosaccharides and polyols) and a glutenfree diet on the mucosal immunity, clinical symptoms, and psychological well-being. furthermore, the influence of the diets on the microbiome will be analyzed.

patients with gluten-sensitivity are rigourously checked for wheat allergy and celiac disease. genotyping for dq2/8, serological detection of celiac specific antibodies, and gastroduodenoscopy are performed. furthermore, a skin prick test and detection of wheat specific ige are done. after exclusion of celiac disease and wheat allergy patients are considered as patients with ncgs. patients and healthy controls are asked to consume a low fodmap diet for two weeks, followed by a 5 day washout and subsequent two week gluten-free diet. at the beginning and the end of each diet the participants fill in questionnaires concerning nutrition (freiburger nutrition protocol), psychological well-being index (pgwb), gastrointestinal symptom rating score (gsrs), and stool consistency (bristol stool chart). furthermore, stool samples are selected at each time point to determine the microbial pattern. ncgs patients with ongoing complaints will have a second gastroduodenoscopy at the end of the study.

Eligibility criteria:
inclusion criteria: * healthy controls * patients with glutensensitivity exclusion criteria: * patients with glutensensitivity but without celiac disease or wheat allergy

Keywords: gluten sensitivity gluten-free diet fodmap diet microbiome
mood lifters for undergraduates

Conditions: Depression; Anxiety; Mood Disorders; Mental Health Wellness 1; Stress

Summary: large-scale, effective, low-cost, and evidence-based programs that can nimbly translate new research discoveries into prevention and care for psychosocial-based problems are urgently needed since the vast majority of people who need evidence-based care do not receive it. the purpose of this randomized control trial is to investigate the feasibility and efficacy of a mood lifters group template specifically for undergraduate students. mood lifters is an effective peer-led program that improves or maintains mental health. it seeks to help people enhance pleasure, engagement, and meaning in their lives while minimizing depression, fear, loneliness, and other negative feelings via a proprietary peer-based program that offers weekly meetings and other flexible support options. one obstacle to providing mental health care in the us is that it is costly to provide one-on-one therapy by a licensed professional. this is particularly true in large group settings with limited resources (counseling centers) and a large need for mental health care, like universities.


Eligibility criteria:
inclusion: * undergraduate students * at least 18 years of age exclusion criteria include: * active suicidal thoughts or behavior * active psychosis * borderline personality disorder * active mania * unwillingness to attend all sessions or treatment types (e.g., unwillingness to attend remote) * non-undergraduate students.
personalized accelerated intermittent theta burst stimulation for post-acute suicidal ideation

Conditions: Major Depressive Disorder (MDD); Suicidal Ideation

Summary: the goal of this clinical trial is to learn if a fast-acting brain stimulation treatment called transcranial magnetic stimulation (tms) can help people with depression and suicidal thoughts. the treatment is non-invasive (does not involve surgery or medications), is given over 5 days, and uses brain imaging (mri) to guide which part of the brain to target. this study tests whether this treatment is a helpful and practical option for patients who recently went to the hospital for suicidal thoughts and were sent home. we want to see if: 1. this treatment is feasible and acceptable to patients 2. it can reduce depression and suicidal thoughts 3. it can lower the chance of returning to the hospital 4. it affects daily functioning (school, work, relationships) all participants will undergo 5-days of tms treatment within 1 week of leaving the hospital. all participants will complete mri brain scans before and after treatment. they will return for check-ups after 1 week and 4 weeks.


Eligibility criteria:
inclusion criteria: * english speaking * able to provide informed consent * ≥ 15 years old * discharged within the past week from the ed for chief complaint of si * mdd criteria per the mini international neuropsychiatric interview (mini) exclusion criteria: * unable to consent (due to medical condition, psychosis, substance use, etc) * active use of benzodiazepines or medications that would interfere with treatment with tms as per pi discretion * active substance use or severe substance use that in the opinion of the pi would interfere with study participation * untreated, active psychosis * female patient who is breastfeeding, pregnant or who is planning a pregnancy during the study * dementia as documented in medical records * bipolar disorder as determined by the mini * contraindications to receiving tms and/or mri as determined by screening questionnaires * participation in any clinical study with exposure to any investigational treatment or product within the previous 30 days, or plan on concurrent participation in other studies.

Keywords: tms mdd suicidal ideation transcranial magnetic stimulation
plasma exchange for amanita toxin-induced acute liver failure

Conditions: Acute Liver Failure

Summary: retrospective evaluation of the value of additive therapeutic plasma exchange (pex) compared to standard medical therapy (smt) in amanita toxin-associated acute liver failure in children and adolescents within the last 10 years at a international group of liver transplant centers.

amanita toxin-associated acute liver failure is a life-threatening condition that can often lead to the need for an emergency liver transplantation. the disease may also be fatal, particularly in patients who are not eligible for a liver transplant due to advanced age or corresponding comorbidities. therapeutic plasma exchange treatment has been shown to significantly improve patient survival in other cases of acute liver failure and has since become standard treatment for acute liver failure in many, but not all, liver transplant centers. however, no patients with amanita toxin-associated acute liver failure were included in these cohorts. the hypothesis of the planned study is that an additive therapeutic plasma exchange treatment (pex) can improve liver transplantation-free survival in these patients compared to standard medical therapy (smt) alone. since the therapy procedure in different transplant centers in differs with regard to the use of therapeutic plasma exchange, we are therefore planning a multicenter retrospective comparison of pex with smt with regard to transplant-free survival and other clinical endpoints. for this very small cohort of patients with acute liver failure, which also varies in frequency depending on the season and weather conditions, there will certainly never be a sufficiently powered randomized and controlled study. this analysis may change the standard procedure for patients with amanita toxin-associated acute liver failure.

Eligibility criteria:
inclusion criteria: * acute liver failure (presence of hepatic encephalopathy of grade i or higher and a coagulopathy with an inr \> 1.5) * amanita toxin related acute liver failure exclusion criteria: * acute liver failure of other reason than amanita toxin * amanita toxin associated hepatitis or severe hepatitis without fulfilling the criteria of acute liver failure

Keywords: liver failure amanita toxin plasmapheresis liver transplantation