Kornimate/medical-research-clean huggingface dataset:
reentry assist (r-assist)

Conditions: Substance Use Disorder (SUD); Mental Health Disorder; Criminal Recidivism

Summary: this project will aim to develop and pilot test, r-assist, a mobile health application to support individuals with co-occurring substance use and mental health disorders (cod) in their recovery, who have recently released from a participating massachusetts jail.

this phase i project will develop and test an mhealth app called r-assist among individuals with cod recently released from a massachusetts jail. r-assist will offer four core features, including linkages to community resources via the resource locator, on demand, tailored self-help materials, and self-management/organizational tools. the following two aims will be tested: aim 1. r-assist software and content prototype development. the 4 r-assist features will include: 1) daily self-reported symptom and medication management monitoring; 2) a 29-session self-help curriculum, with an accompanying library of recovery resources to support cod symptom management and promote prosocial thinking and behavior; 3) social determinants of health (sdoh) resource finder; and 4) a dashboard to track r-assist engagement. aim 2. a successive cohort study of the r-assist prototype with participants who have recently left jail (n = 38). this will include three successive field focus group cohorts with 18 participants, followed by a small open pilot with 20 participants. this project's four milestones will be executed in preparation for a larger phase ii trial. * milestone 1 (months 1-5): r-assist app development and interface designs o no human subjects involvement * milestone 2 (months 6-7): initial evaluation/refinement of r-assist o to recruit n=18 individuals for this milestone * milestone 3 (months 8-10): open pilot of r-assist o to recruit recruit n=20 individuals for this milestone * milestone 4 (months 11-12): product refinement prior to phase ii and dissemination o no human subjects involvement

Eligibility criteria:
inclusion criteria: * have been released from the participating jail within the past 150 days * own a smartphone (android or ios; 90% met this criterion in our prior studies) * have cod: any substance use disorder (we will allow poly-substance use disorders) and a co-occurring mental health disorder (depression, anxiety, trauma related disorders, bipolar, and/or schizophrenia) * consent to r-assist app use observation and e-tracking * consent to audio recording during interviews and focus groups. exclusion criteria: * acutely suicidal, homicidal, or psychotic * unable to provide informed consent * individuals released with monitoring devices or individuals involved in drug treatment courts

Keywords: substance use disorder mental health criminal-legal involvement
characterizing the use of ofatumumab in a real world setting

Conditions: Relapsing Multiple Sclerosis

Summary: this is a non-interventional primary use of data study utilizing de-identified patient-level onboarding and adherence data managed through the msgo patient support service platform and includes a sub-study to explore the impact of ofatumumab on relevant patient reported outcomes (pros) with respect to clinical outcomes.

this study will be run in two parts. part i will operate as a secondary use of data study and part ii will operate as a non-interventional primary use of data study. part i: this study is descriptive in nature without any key underlying hypothesis and will explore the onboarding and adherence of rms patients in australia to ofatumumab treatment. de-identified patient-level onboarding and adherence data will be primarily generated and managed through the msgo platform which will function as a patient support service. part ii: this part of the study will operate as a non-interventional primary use of data study and will explore the impact of ofatumumab on relevant patient reported outcomes (pros) with respect to clinical outcomes. this part of the study will only be conducted at a selection of participating clinics. patients in this part of the study will also have data collected as part of part i of the study. the data for the pros will be collected through a mobile based application .

Eligibility criteria:
inclusion criteria: * adult patients with relapsing forms of multiple sclerosis (rms) to delay the progression of physical disability and reduce the frequency of relapse * expanded disability status scale (edss) of 5.5 or lower (aligned with the plannedkep criteria). patients accessing ofatumumab through the pbs would have to meet the finalised restriction criteria (to be confirmed). * patients will provide consent to participate in part i of the study through the msgo experience program or patient support program onboarding process. * patients will need to provide additional consent to participate in part ii sub-study. exclusion criteria: * patients diagnosed with primary progressive ms or secondary progressive ms without disease activity in line with the australian product information\].

Keywords: ofatumumab nis rms
dragone study: acquisition and maintenance of paediatric asthma control: usual care vs innovative devices

Conditions: Asthma

Summary: randomized clinical trial to assess acquisition and maintenance of paediatric asthma control through innovative devices supporting usual care. in the first study arm, a new application (dragone) for ios and android will be only used for patient monitoring. in the second study arm, a small portable device (smartone) will also be connected to the dragone app, for daily assessment of the peak expiratory flow (pef). the study duration is 12 weeks. the main outcome of the study is the childhood asthma control test (c-act) score, assessed once every 4 weeks for 12 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate persistent asthma * uncontrolled symptoms (c-act≤ 19) * treated for at least 3 months * fev1 between 60% and 90% of predicted value exclusion criteria: * symptoms of acute respiratory infection * immunological or metabolic systemic disease * major malformations of the upper airways * active smoker
optimisation and performance of reduced preparation ct colography

Conditions: Patients With Potential Colorectal Neoplasia

Summary: to ascertain which of four combinations of low residue diet, reduced laxative dose and oral contrast agent is best tolerated by patients and optimally prepares the colon prior ro ct colonography

ct colonography has been shown to be accurate in detection of colorectal neoplasia in enriched patient populations and is generally preferred by patients to conventional endoscopy and barium enema. it is advocated as an acceptable alternative for colorectal cancer screening and is increasingly used in the investigation of symptomatic patients. ideally, like conventional colonoscopy, ct colonography requires a clean colon, free of residual stool and fluid. there is however good evidence that the arduous bowel purgation regimes required may produce adverse effects such as electrolyte imbalance, and are more detrimental to overall patient experience and compliance than any subsequent investigation. an ability to perform ct colonography with reduced bowel purgation, whilst maintaining acceptable diagnostic accuracy, would undoubtedly make the technique a more attractive proposition both for population screening and investigation of symptomatic patients. interest has been generated in the use of orally ingested dilute barium or ionated contrast medium prior ro ct colonography to "label" or "tag" residual fluid or faecal matter reduced laxative. such oral contrast agents are highly attenuating to x-rays such that labeled residual bowel contents appear white on ct scanning and are readily distinguished from true colonic pathology. despite the early promise of a few limited studies, there is no consensus as to the optimum oral contrast type, dose and concentration. anecdotally barium tends to best label solid residue whereas iodinated contrast best labels fluid, but this assumption has not been proven. furthermore it is known that iodinated contrast tends to draw fluid into the bowel, producing a wet colon, which may not be suited to ct colonography. however, this indrawing of fluid by iodinated contrast such as gastrograffin produces a mild laxative effect, which may obviate the need for further formal purgation. the study aims to establish the optimum reduced preparation-tagging regimen, establish patient experience and document diagnostic performance compared to conventional colonoscopy.

Eligibility criteria:
inclusion criteria: * patients who are under investigation for suspected colonic neoplasia and over 50 years old: 1. symptomatic patients eg. change in bowel habit, rectal bleeding etc. 2. polyp surveillance 3. strong family history 4. suspected neoplasia on previous investigation (e.g. barium enema) exclusion criteria: * patients under 50 patients undergoing surveillance for inflammatory bowel disease (due to poor diagnostic use of ct colonography in this specific patient cohort)

Keywords: colorectal neoplasia ct colonography faecal tagging
pharmacokinetics study of mycophenolic acid in patients with an autoimmune bullous dermatose, pemphigus or cicatricial pemphigoid.

Conditions: Autoimmune Bullous Dermatose

Summary: the main autoimmune bullous dermatoses are pemphigus and cicatricial pemphigoid. pemphigus is an autoimmune dermatological disease characterized by the production of anti-desmoclesin antibodies 1 and 3, affecting the skin and mucous membranes.the cicatricial pemphigoid is an autoimmune dermatological disease, characterized by the production of anti-zone antibodies of the basal membrane and characterized by a predominant mucosal involvement. mycophenolic acid (mpa) is an increasingly used form of corticosteroid. despite its increasing use, pharmacokinetics in autoimmune bullous dermatosis remain little studied.


Eligibility criteria:
inclusion criteria: * age \> or = 18 years. * patient treated by mycophénolate mofétil (mmf) per os (cellcept®) for an autoimmune bullous dermatose (pemphigus or cicatricial pemphigoid) for at least 30 days according to the recommendations (pnds pemphigus and cicatricial pemphigoid has 2011) * patient able to understand the nature, purpose and methodology of the study * patient affiliated to the french social security system or equivalent * patient who have signed an informed consent form exclusion criteria: * pregnant or breast-feeding women or women of childbearing potential without efficient contraception (based on a declaration) * patient under legal protection. * patient deprived of freedom * patient with any altered mental status or any psychiatric condition that would interfere with the understanding of the study.
study of orl-1f (l-fucose) in patients with leukocyte adhesion deficiency type ii

Conditions: Leukocyte Adhesion Deficiency, Type II

Summary: study of orl-1f in patients with leukocyte adhesion deficiency type ii


Eligibility criteria:
inclusion criteria: * diagnosis of leukocyte adhesion deficiency type ii. * less than 18 years old. exclusion criteria: * diagnosis of any other disease that is not a manifestation of leukocyte adhesion deficiency type ii.
assertive community treatment with cbt and sst for schizophrenia

Conditions: Schizophrenia

Summary: this project is an effectiveness trial comparing two psychosocial treatments for schizophrenia: assertive community treatment (act) + cognitive behavioral social skills training (cbsst) v. act, alone.

assertive community treatment (act) is one of the most well-validated treatment models for people with severe mental illness, and act is one of the few evidence-based practices that is widely implemented in community mental health programs; however, existing act approaches have little impact on functioning. the act model provides a unique opportunity for implementation of recovery-oriented ebps throughout community mental health programs in the us. this project will examine the incremental effectiveness of implementing cognitive-behavioral strategies and social skills training in act relative to act, alone. the investigators will begin to examine a potential mechanism of change involving defeatist performance beliefs that can interfere with performance of community functioning behaviors, and will use qualitative methods to identify barriers and factors that contribute to successful implementation.

Eligibility criteria:
inclusion criteria: * dsm-iv-diagnosis of schizophrenia or schizoaffective disorder at any stage of illness exclusion criteria: * unstable assignment (at least 3 months) to an act team; * prior exposure to sst or cbt in the past 5 years * level of care required interferes with outpatient therapy (e.g., current hospitalization for psychiatric, substance use or physical illness).

Keywords: cbsst schizoaffective disorder psychotic disorder cognitive behavioral therapy social skills training assertive community treatment
a digital lifestyle intervention in primary healthcare to prevent cardiovascular disease

Conditions: Cardiovascular Diseases; Lifestyle Factors

Summary: unhealthy lifestyle behaviors are well-established risk factors for cardiovascular disease (cvd) which is the leading cause of death globally and in sweden. digitalization offers new and better possibilities for healthcare to fulfil their responsibility to support healthier lifestyles, however, to ensure scalability and sustained implementation of digital tools within healthcare, digital interventions need to be systematically maintained and delivered by the primary healthcare. the aim of this project is to evaluate whether a digital lifestyle intervention, developed within swedish primary healthcare, can improve clinically important cardiovascular health outcomes and lifestyle behaviors. in this multi-center randomized controlled trial patients, 40-60 years, in swedish primary healthcare will be recruited and randomized to the control or intervention group. all participants will receive standard care consisting of one structured health dialogue focused on lifestyle habits. the intervention group will also receive support through the digital lifestyle intervention for creating healthy habits regarding diet, physical activity, alcohol consumption, and tobacco usage. the primary outcome is ldl-cholesterol at 6 months post-randomization. secondary outcomes 6 months post-randomization are hdl-, total cholesterol, fasting blood glucose, triglycerides, non-hdl, blood pressure, weight, height, bmi, waist circumference, cardiovascular risk evaluation (score2), dietary intake, physical activity, sleep, stress, alcohol consumption, tobacco use, and health-related quality of life.


Eligibility criteria:
inclusion criteria: * attended a health dialogue visit to primary healthcare for patients 40-60 years old * willing to change at least one lifestyle behavior regarding physical activity, diet, smoking/snus, alcohol, sleep, or stress exclusion criteria: * diabetes * heart failure * history of myocardial infarction * history of stroke * pregnancy
ddx17 orchestrate septic vascular endothelial pyroptosis by controlling gasdermin d pore formation

Conditions: Sepsis; Septic Shock

Summary: objective: to investigate the correlation between plasma levels of ddx17 and gsdmd with vascular endothelial dysfunction and prognosis of in sepsis patients. design: a single center, prospective, observational research. participants: patients with sepsis who are hospitalized to southeast university affiliated zhongda hospital and meet the diagnostic criteria for sepsis 3.0. inclusion criteria:1. there is a potential or clear infection; 2. sequential organ failure score (sofa score) increases by more than or equal to 2 points compared to the baseline value; 3. sign informed consent form. exclusion criteria: age\ 80 years old, pregnant women, tumor patients, including diseases that may be complicated with vascular endothelial damage: hypertension, acute and chronic hepatitis (hepatitis caused by virus), liver cirrhosis, pt prolongation after liver transplantation, acute myocardial infarction, chronic tubular nephritis, chronic renal insufficiency/maintenance hemodialysis, renal transplantation, interstitial pneumonia, acute pancreatitis, active phase of systemic lupus erythematosus ulcerative colitis, crohn's disease, hellp syndrome. primary outcome: 28-day mortality. secondary outcome: plasma levels of ddx17 and gsdmd, and their correlation with vascular endothelial injury, severity, and prognosis in sepsis patients.

data collection:recording the population information, including name, sex, bmi, and past history. recording disease-related information's, including diagnosis, infection site, pathogens, organ dysfunction, sofa and apache ii scores. recording treatment measures of patients, including whether to use vasopressor, invasive mechanical ventilation, and continuous renal replacement therapy. recording laboratory examination results, including leukocyte count, pct and hs-crp on d1, d3 and d7, respectively. all patients were followed up to 28 days. patients were distributed to survival group and non-survival group according to the 28-day survival. sample collection: 3 ml of the patient's peripheral blood were drawn on day1, 3, and 7, and the plasma was centrifuged and kept at -80 °c. elisa content detection of ddx17 and gsdmd.

Eligibility criteria:
inclusion criteria: * there is a potential or clear infection; * sequential organ failure score (sofa score) increases by more than or equal to 2 points compared to the baseline value; * sign informed consent form. exclusion criteria: * age\ 80 years old * pregnant women * tumor patients * including diseases that may be complicated with vascular endothelial damage: hypertension, acute and chronic hepatitis (hepatitis caused by virus), liver cirrhosis, pt prolongation after liver transplantation, acute myocardial infarction, chronic tubular nephritis, chronic renal insufficiency/maintenance hemodialysis, renal transplantation, interstitial pneumonia, acute pancreatitis, active phase of systemic lupus erythematosus ulcerative colitis, crohn's disease, hellp syndrome.
cancer screening program for women at high risk for developing ovarian cancer

Conditions: Ovarian Diseases; Ovarian Neoplasms

Summary: the main purpose of this program is to see whether periodically measuring ca-125 (tumor marker) levels in the blood and undergoing transvaginal ultrasounds over time will be effective in the early detection of ovarian cancer.

the program will offer twice yearly ca-125 blood tests and annual transvaginal ultrasounds to monitor women at high risk for ovarian cancer. in addition to the main purpose of providing ovarian cancer screening, the researchers would also like to build a repository of blood specimens for use in ovarian and breast cancer research and to offer genetics counseling sessions to help educate women about risk-reducing options.

Eligibility criteria:
inclusion criteria: * must meet one of the following: * the family contains at least two ovarian or breast cancers in the subject or first or second degree relatives of the subject. * the subject is of ashkenazi jewish ethnicity with one first degree or two second-degree relatives with breast or ovarian cancer, or subject is of ashkenazi ancestry and has had breast cancer. * the subject has a male relative with breast cancer diagnosed at any age. * probability of carrying a brca1/2 mutation given family pedigree of breast and ovarian cancers exceeds 20% (as determined by brcapro 95% posterior probability interval). exclusion criteria: * prior ovarian cancer or peritoneal carcinomatosis * a first or second degree relative with a brca1/2 mutation and has tested negative for exactly the same mutation. * the subject has no ovaries. * less than 30 years of age, unless 25-30 with brca i or ii mutation confirmed * currently pregnant * currently receiving adjuvant chemotherapy or radiation therapy for cancer (excluding tamoxifen). patients who are being treated for local disease may enroll 3 months after completion of last treatment (excluding tamoxifen). * treatment (excluding tamoxifen) for prior metastatic malignancy within the past five years. * intraperitoneal surgery within the last 3 months.

Keywords: women with increased risk for developing ovarian cancer women diagnosed with reproductive cancer women with relatives who have had ovarian or breast cancer
characterizing the cerebrovascular physiology of optimal mean arterial pressure targeted resuscitation

Conditions: Cardiac Arrest

Summary: hypoxic ischemic brain injury is a devastating illness that occurs after cardiac arrest (the heart stopping) and can yield irreversible brain damage, often leading to death. the mainstay in therapy is to optimize the delivery of oxygen to the brain to help it recover. in patients with traumatic brain injury (similar to hibi), the investigators are able to optimize oxygen delivery to the brain with the use of wires placed into the brain that sense the pressure and oxygen in the skull to find the ideal blood pressure for each individual patient. this strategy is associated with improved outcomes. the investigators are conducting a prospective study investigating whether the perfusion within proximity to the optimal map is associated with improved brain oxygenation and blood flow .


Eligibility criteria:
inclusion criteria: * confirmed cardiac arrest with return of spontaneous circulation \> 10 minutes * post resuscitation gcs \< 9 exclusion criteria: * concurrent coagulopathy * prior history of tbi, intracranial hemorrhage, subarachnoid hemorrhage * anticipated cardiac catheterization within next 7 days * anticipated or current use of anticoagulants or anit-platelets
a study to compare the efficacy of guselkumab to fumaric acid esters for the treatment of participants with moderate to severe plaque psoriasis

Conditions: Psoriasis

Summary: the purpose of the study is to compare the efficacy of guselkumab with commercially available active comparator fumaderm initial/fumaderm tablets for the treatment of adult participants with moderate to severe plaque-type psoriasis who have not yet received any systemic therapy.


Eligibility criteria:
inclusion criteria: * have a diagnosis of plaque-type psoriasis for at least 6 months before the first administration of study drug * have a psoriasis area and severity index (pasi) greater than (\>)10 or body surface area (bsa) \>10 at screening and at baseline * have a dermatology life quality index (dlqi) \>10 at screening and at baseline * agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug; for information on bacille calmette-guérin (bcg) vaccination, agree not to receive a bcg vaccination during the study, or within 12 months after the last administration of study drug * no dipstick detection of proteins or glucose in urine. if there are signs of proteins and/or glucose on urine test strip, the urine sample must be analyzed centrally. here, protein and glucose levels must not exceed trace levels, example, \<=(+); one re-test (central urine analysis) is allowed exclusion criteria: * has a history or current signs or symptoms of severe, progressive, or uncontrolled liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances * participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) * known allergies, hypersensitivity, or intolerance to guselkumab or its excipients * is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 12 weeks after the last dose of study drug * any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments