Kornimate/medical-research-clean huggingface dataset:
a global study comparing risankizumab to placebo in adult participants with moderate to severe hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: the primary objective of this study is to assess the safety and efficacy of risankizumab 180 mg and 360 mg versus placebo for the treatment of signs and symptoms of moderate to severe hidradenitis suppurativa (hs) in adult participants diagnosed for at least one year before the baseline visit.


Eligibility criteria:
inclusion criteria: * participant with moderate to severe hs for at least 1 year prior to baseline visit. * hs lesions present in at least two distinct anatomical areas. * draining fistula count of ≤ 20 at baseline visit. * total abscess and inflammatory nodule (an) count of ≥ 5 at baseline visit. * participants are required to use a daily antiseptic wash on their hs lesions. * participant must have a history of inadequate response or intolerance to an adequate trial of oral antibiotics for treatment of hs. exclusion criteria: * participant has a history of active skin disease other than hs that could interfere with the assessment of hs. * participant has active tuberculosis (tb) or concurrent treatment for latent tb or evidence of hepatitis b virus (hbv) or hepatitis c virus (hcv) or human immunodeficiency virus (hiv) infection. * participant has prior exposure to anti-interleukin-1 (anti-il-1) treatment within 3 months or 5 half-lives, whichever is longer, prior to baseline. * participant has received prescription topical therapies (including topical antibiotics) within 14 days prior to the baseline visit. * participant has received systemic non-biologic therapies that can also be used to treat hs within 4 weeks prior to the baseline visit. * participant has received any systemic (including oral) antibiotic treatment within 4 weeks prior to the baseline visit.

Keywords: hidradenitis suppurativa risankizumab placebo
seroprevalence of chikungunya at the end of the first chikungunya outbreak in the french antilles within a sample of patients treated for a hiv infection

Conditions: HIV Infections; Chikungunya Virus Infection

Summary: late 2013, the first indigenous cases of chikungunya have been observed in the french antilles. at the end of may 2014, almost all of the islands of the caribbean were affected by the outbreak. during the large epidemic which affected the island of la réunion in 2005/2006, the attack rate was 38%. the most active period was three months. in this context, knowledge of the attack rate and the epidemic in the caribbean is an important issue for outbreak management and modeling work. as the chikungunya virus had never circulated in the caribbean, determining the seroconversion rate can be achieved by realizing a seroprevalence survey among the general population at the end of the outbreak. another simple method is to estimate the rate in a cohort of patients followed regularly and whose habitat is distributed throughout the territory studied. the follow up of patients infected by the human immunodeficiency virus (hiv) in the french west indies is almost exclusively performed in hospitals in department of infectious and tropical diseases.the high prevalence of hiv and homogeneous distribution of infected patients on all of our territories, allow to hypothesize that the risk of transmission of arboviruses by exposure to mosquito bites is comparable to the general population. this patient cohort is well suited to study the emergence of chikungunya in the french west indie . primary objective : to estimate the cumulative incidence at the end of the first chikungunya outbreak in the french west indies by estimating the prevalence of specific antibodies of chikungunya virus in a sample (randomly constituted) from patients infected by hiv and representative of the general population of martinique and guadeloupe secondary objective : to estimate the frequency of asymptomatic infections by the chikungunya virus in the studied population to estimate the frequency of chronic forms of chikungunya in the studied population


Eligibility criteria:
inclusion criteria: * adult (\> 18 years old) * followed for hiv infection at the 2 investigators centers (1 located at martinique and 1 at guadeloupe) * resident in martinique /guadeloupe ( french west indies) * informed consent signed by the patient exclusion criteria: * patient who lived more than 6 month in an risk area for chikungunya virus infection * patient with or documented chronic rheumatism * patient who has received a blood transfusion during year 2013 or patient who is supposed to receive a blood transfusion during the study * patient who has planned to live outside french west indies during the follow up period
prevention of maternal-fetal cytomegalovirus transmission after primary maternal infection, gw ≤ 14 (precyssion)

Conditions: Congenital Cytomegalovirus Infection

Summary: a phase 3, open-label, single-arm, prospective, multi-center trial of cytotect cp biotest (bt097) for prevention of maternal-fetal cmv transmission after primary maternal cmv infection. the main purpose of the trial is to demonstrate efficacy and safety of cytotect cp biotest in preventing maternal-fetal transmission of cytomegalovirus (cmv).


Eligibility criteria:
inclusion criteria: * written informed consent obtained from subjects indicating that they understand the purpose of and procedures required for the trial and are willing to participate in it * pregnant women, age 18 to 45 years * pregnant women at trial entry with gestational age ≤14 weeks; pregnancy after in-vitro fertilization permitted * detection of early primary cmv infection exclusion criteria: * women with current multiple pregnancy * history of severe pre-eclampsia or severe gestational hypertension (ghtn), which required medical intervention. definition according to awmf guideline (awmf, 2019) * presence of severe disease impairing course of pregnancy (e.g. diabetes, epilepsy, cancer) * congenital or acquired autoimmune disease * known immunosuppressive (e.g., transplanted patients) or immunodeficient condition * known infection with hepatitis b or c, or hiv from the medical history or active infection at screening as assessed by respective virus serology * maternal cmv infection prior to this pregnancy (preconceptional cmv infection) * covid-19 infection at time of inclusion * any signs or symptoms indicating an increased risk of abortion or premature labor or has known negative effect on fetus with exception of a cmv infection * active infection according to torch serology with exception of cmv in the assessment of the investigator * known major fetal anomalies or demise * intolerance to proteins of human origin or known allergic reactions to components of the trial product * selective absolute iga deficiency or known antibodies to iga * known pre-existing clinically relevant risk factors for thrombotic events * known renal insufficiency with serum creatinine levels \>1.4 mg/dl and proteinuria (albuminuria) at screening (≥30 mg/dl or dipstick reading of 1+ and greater) * participation in another clinical trial within 90 days before entering the trial or during the trial * women who are dependent on trial site staff, on biotest ag or its authorized representatives * inability or lacking motivation to participate in the trial * medical condition, laboratory finding, or physical examination finding that in the opinion of the investigator precludes participationinability or lacking motivation to participate in the trial * eligibility for a subgroup where enrollment was stopped

Keywords: cytomegalovirus pregnancy cmvig maternal cmv infection
assessment of hyperkalemia's illness and treatment burden in chronic kidney disease and heart failure patients: hk registry pilot study

Conditions: Hyperkalemia

Summary: overall study aim of this study is to analyse descriptive statistics of patient-reported outcome（pros） which will be used in the hyperkalemia（hk） registry study in hyperkalemia patients with chronic kidney disease（ckd） or heart failure（hf） to describe the practice patterns of hyperkalemia treatment in in clinical practice. based on these assessments, this study will provide the information for the applicability of pro measurements which will be used in the hyperkalemia registry study to the study population, i.e. ckd and/or hf patients with hyperkalemia


Eligibility criteria:
inclusion criteria: * outpatients aged ≥20 years * hyperkalemia patients defined as meeting either of the following criteria: 1. having a history of s-k ≥5.1 mmol/l ≥2 times within 6 months before enrolment 2. having a history of s-k ≥5.5 mmol/l once within 6 months before enrolment 3. currently treated by potassium binders for the treatment of hyperkalemia at enrolment * having been diagnosed as ckd (≥stage 3b) or hfref by investigators as defined below: ckd is diagnosed based on the guidelines of ckd issued by the japanese society of nephrology (jsn, 2018) as being either or both of condition 1 and 2 for ≥3 months 1. clear sign of kidney impairment based on urinalysis, imaging, blood test, or biopsy. especially, existence of ≥0.15 g/gcr of proteinuria (≥30 mg/gcr of albuminuria) is important. 2. gfr \<45 ml/min/1.73m2 within the routine clinical practice, gfr is estimated by serum creatinine, gender, and age using following the formulation. egfr creat (ml/min/1.73m2) = 194 x serum creatinine (mg/dl)-1.094 x age (years)-0.287 (for female patients, x 0.739) ≥stage 3b ckd is diagnosed based on the following egfr categories: * stage 3b: 30 ml/min/1.73m2 ≤ egfr \<45 ml/min/1.73m2 * stage 4: 15 ml/min/1.73m2 ≤ egfr \<30 ml/min/1.73m2 * stage 5: egfr \<15 ml/min/1.73m2 patients with hfref is enrolled if patients meet following criteria within 6 months: 1. ef ≤40% 2. nyha class ii-iv * provision of signed, written, and detailed informed consent * signed written informed consent by themselves exclusion criteria: * currently on any chronic rrt (including hemodialysis or peritoneal dialysis \>30 days, or kidney transplant) within 6 months before enrolment * patients with acute kidney injury at enrolment •patients who took blood transfusion or potassium supplements within 6 months before enrolment * active malignancy or life expectancy of less than 6 months. * patients who have gi disturbance/chronic diarrhoea/stoma, and investigators determine those affect significantly serum k level * patients who have autoimmune disorders, and investigators determine those affect significantly serum k level * patients whose lab data have suspicion for pseudohyperkalemia * patients who are pregnant, lactating, or planning to become pregnant * current participation in interventional studies and/or clinical trials * patients who, in the opinion of the investigators, would be unlikely to comply with self-assessments
short term observational study in deb patients

Conditions: Dystrophic Epidermolysis Bullosa

Summary: the purpose of this study is to better understand disease extent and to identify appropriate methodologies to evaluate (dystrophic epidermolysis bullosa) deb in a quantitative and qualitative manner.


Eligibility criteria:
inclusion criteria: 1. written informed consent is provided. patients 18 years of age and older, and parent(s)/legal guardian(s) of patients younger than 18 years of age, must provide written informed consent prior to participating in the study; additionally, informed assent will be obtained from patients younger than 18 years of age as specified by local requirements. 2. patient must have a documented diagnosis of deb based on genetic analysis showing a mutation in col7a1 or, in the opinion of the investigator, a confirmed diagnosis of deb based on histologic criteria (antigen mapping or electron microscopy). 3. patient must have at least 5 wounds that are suitable for imaging, in the opinion of the investigator, at the time of enrollment. 4. patient is willing and able to undergo the protocol-specified procedures. exclusion criteria: 1. patient has used or is currently using experimental treatment for deb including, but not limited to, bone marrow transplantation, systemic immune suppression, or experimental procedures that involve live cells, with potential for systemic spread such as gene transfer, stem cell infusions, or other cell type injections such that, in the opinion of the investigator, inclusion poses an unacceptable risk to the patient or interpretation of these study data. 2. patient has squamous cell carcinoma with evidence of locally invasive disease or distant metastases. 3. patient is pregnant.
mindfulness-based self-compassion training for menopausal women

Conditions: Menopausal; Crisis; Self-Compassion; Image, Body; Anger

Summary: this study was conducted to determine the effects of mindfulness-based self-compassion training for menopausal women on their genital self-image and self-anger. materials and methods: this study was randomized with 126 menopausal women (study group n=63, control group n=63) between june 2024 and february 2025. mindfulness-based self-compassion training (mbsct) was applied in groups of 10 and 11 participants, twice a week, for 8 sessions of 40 minutes. data were obtained using the personal information form, female genital self-image scale (fgsis), and dsm-v level ii anger scale. research hypotheses: h1: mbsct applied to menopausal women enhances the genital self-image of individuals. h2: mbsct applied to menopausal women reduces individuals' self-anger.

the menopausal period is a period of physical and mental changes in which the body enters the aging process and the functionality of the genital organs decreases. during this period, women face negative body image, low genital self-image, and inadequate sexual functions. perceived negative body image can lead to consequences such as low genital self-image and sexual dissatisfaction. mindfulness-based self-compassion training is a very comprehensive approach that addresses the awareness and acceptance of individuals towards their bodies, as well as encouraging them to live a conscious life. studies found that self-compassion increases well-being during menopause . psychiatric nursing is a special field that works to evaluate, diagnose, and enhance mental health in every area where people are present. however, midwifery has a wide service area with the priority of preventive health services; primarily women's health, and the duties of evaluating, diagnosing, enhancing, and rehabilitating the physical and psychological health of the whole family. in light of this information, increasing the mindfulness and self-compassion levels of women in menopause may increase the place of women who "age" healthily and therefore mentally healthy elderly women, in society and may make a significant contribution to protecting and improving the mental health of society. since the literature review revealed a gap in the literature regarding these areas for women in the menopausal period, this study was conducted to determine the effects of mindfulness-based self-compassion training for menopausal women on their genital self-image and self-anger.

Eligibility criteria:
inclusion criteria: * being between 45 and 70 years old * having no hearing problems * being at menopause in the last year * having no psychiatric illness * having natural menopause * not receiving hormone replacement therapy. exclusion criteria: * those who did not attend two or more training sessions during the study were excluded from the study. * those who entered menopause surgically and received hormone/replacement therapy during the process were not included in the study.

Keywords: self-compassion anger menopause image, body mindfulness
detecting sepsis in patients with severe subarachnoideal hemorrhage

Conditions: Subarachnoid Hemorrhage; Subarachnoid Hemorrhage, Aneurysmal; Sepsis Syndrome; Sepsis; Sepsis, Severe; Sepsis Bacterial

Summary: the study aims to evaluate the suitability of the sofa score implemented by the sepsis 3 guideline to detect sepsis in patients suffering from subrarachnoid hemorrhage.


Eligibility criteria:
inclusion criteria: critically ill patients suffering from moderate to severe subarachnoid hemorrhage (wfns \>2). exclusion criteria: children under the age of 18 years patients with minor subarachnoid hemorrhage \< wfns stage 2.

Keywords: sequential organ failure assessment score
one drop experts program for type 2 diabetes self-management: impact on a1c

Conditions: Type 2 Diabetes Mellitus

Summary: the one drop experts program for type 2 diabetes self-management impact on a1c trial is a 12-week long, prospective, intent-to-treat study that aims to evaluate the impact of the one drop app and experts program on hba1c levels for individuals with uncontrolled type 2 diabetes. a secondary objective will be to evaluate participants who utilize an apple watch in combination with the one drop app and experts program, and assess whether this group is more engaged or experiences a different impact as compared to participants who utilized the one drop app and experts program only.


Eligibility criteria:
inclusion criteria: * self-reported type 2 diabetes diagnosis * has not changed treatment regimen in the last 3 months * hba1c levels ≥ 7.5% by self-report and verified by lab test * motivated to use a daily diabetes self-management coaching program to improve diabetes control * owns and uses an iphone with a compatible ios operating system and has successfully downloaded and used a smartphone application previously exclusion criteria: * current use of a smartphone application to manage their diabetes * currently participating in a diabetes self-management education or coaching program * currently pregnant * does not understand english * history of serious mental illness or dementia * has severe diabetic complications such as severe diabetic retinopathy, chronic kidney disease (stages 4-5), severe diabetic neuropathy, diabetic foot ulcer or infection
characterization of gut microbiota in chronic liver disease with decreased muscle mass

Conditions: Gastrointestinal Microbiome; Sarcopenia; Liver Disease Chronic

Summary: the purpose of this study was to confirm the presence of specific gut microbiota observed in patients with sarcopenia among patients who agreed to analyze gut microbiota through stool among multi-center chronic liver disease cohort patients.

the effect of gut microbiota on liver disease is also well known and many studies are ongoing. a recently published study summarized the differences in the composition of gut microbiota in non-alcoholic fatty liver, steatohepatitis, and cirrhosis, and reported that metabolites from the changed gut microbiota may be a factor influencing non-alcoholic fatty liver disease (nafld) progression. these changes in gut microbiota composition have been reported to affect clinical outcomes in patients by causing an increase in endotoxin, a change in bile acid metabolism, and a decrease in short chain fatty acid. in particular, the reduction of short chain fatty acid is known to be associated with the occurrence of sarcopenia. sarcopenia, which is common in patients with cirrhosis, which is a representative chronic liver disease, is well known as a poor prognostic factor for patients. therefore, this study aims to analyze the distribution of gut microbiota observed in patients with sarcopenia through the gut microbiota investigated in the chronic liver disease cohort patient group and the characteristics of the distribution of gut microbiota for each disease corresponding to chronic liver disease.

Eligibility criteria:
inclusion criteria: * 1. patients who have chronic liver disease (chronic liver disease cohort): alcohol liver disease, non-alcoholic liver disease, liver cirrhosis 2. patients who consented to a study confirming the gut microbiota 3. patients with abdominal computed tomography scan taken one month before or after submitting stool for gut microbiota analysis exclusion criteria: * patients whose height and weight records are missing from the chart review
study to assess length of remission with intensive chemotherapy in rapidly responding aml patients.

Conditions: Acute Myeloid Leukemia

Summary: we previously reported results of a prospective observational study demonstrating that early response defined as reduction in bone marrow (bm) blast counts to less than 5% of bm cells by the fifth day of induction therapy is a strong predictor of remission and overall survival (ofran y, et al. ajh, 2015). the long term survival benefit of early response was confirmed later on after a median follow-up for surviving patients of 53 months (range 17.5-84.5).

patients diagnosed with aml, younger than 61 year of age assigned for intensive chemotherapy, and diagnosed with standard or intermediate risk aml, will undergo bm examination on the fifth day of induction. patients in whom bm blast count at the fifth day of induction will be lower than 5% will proceed therapy with consolidations or autologous sct with-holding the option for allo-sct. mrd monitoring will apply to those with reliable molecular marker.

Eligibility criteria:
inclusion criteria: * aml diagnosis, * treated with 3+7 induction chemotherapy * intermediate/standard risk aml exclusion criteria: * diagnosed of apl * high risk molecular/cytogenetic score
evaluation of everolimus-eluting stents (the k-xience registry)

Conditions: Coronary Artery Disease

Summary: the objective of this study is to evaluate effectiveness and safety of everolimus-eluting stents (xience, abbott) in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus-eluting stents).

this study is a non-randomized, open-label registry to compare the efficacy and safety of everolimus-eluting stents versus sirolimus-eluting stents in patients with coronary artery disease.

Eligibility criteria:
inclusion criteria: * patients received xience stents * the patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethics committee of the respective clinical site. exclusion criteria: * patients with a mixture of other dess * terminal illness with life expectancy \<1 year. * patients with cardiogenic shock