Kornimate/medical-research-clean huggingface dataset:
brief digital cbt for mood and anxiety symptoms in acute psychiatric inpatients

Conditions: Anxiety; Depressive Symptoms; Distress, Emotional; Anxiety and Fear; Anxiety State; Mental Disorders, Severe; Psychiatric Hospitalization

Summary: a randomized control trial examining the feasibility, acceptability, and preliminary efficacy of providing access to the mindshift cbt mobile app via tablet for acute psychiatric inpatients.

psychiatric inpatients expect more psychosocial intervention during their inpatient stay than they receive. during the covid-19 pandemic, existing interventions have been further reduced. mood and anxiety symptoms are common for all inpatients across diagnostic categories. studies have shown that cognitive behavioural therapy (cbt) can be effective for treating these symptoms among inpatients. the purpose of this study is to determine whether the mindshift cbt app (an app based on principles of cognitive behavioural therapy) is an acceptable, feasible, and useable intervention for inpatients. the mindshift cbt app is a tool designed and maintained by anxiety canada. it includes tools for daily mood check-ins, healthy thinking, calming intense emotions, and taking actions to change behaviours associated with anxiety and low mood. it also includes information about the common types of anxiety. the proposed trial includes 12 patients per arm. all participants in control and intervention groups will have access to assigned tablet devices throughout the study period, though only those in the intervention group will have the mindshift cbt app on their device. all participants will undergo assessments at baseline and at the end of the intervention period (1 week).

Eligibility criteria:
inclusion criteria: * admitted to the acute inpatient unit * fluent in english * dynamic appraisal for situational aggression (dasa) score \<=3 * capable to consent to participation as assessed by the treating physician exclusion criteria: * diagnosis of moderate-severe learning disability * diagnosis of moderate-severe neurocognitive disorder

Keywords: inpatient psychiatry psychiatric admission mobile app inpatient cbt
dual point-of-care test for the diagnosis of yaws

Conditions: Yaws

Summary: a dual poc immunoassay simultaneously detecting non-treponemal and treponemal antibodies was developed for the diagnosis of infections with t. pallidum. the assay is designed for use in resource-limited settings where challenging conditions (such as lack of electricity, running water, or laboratory equipment) commonly exist. we sought to compare performance of the dual-poc assay for diagnosis of yaws infection with that of the rpr and tpha as reference standards.

yaws is an infectious disease caused by treponema pallidum subspecies pertenue, a bacterium which closely resembles the causative agent of syphilis, and is spread by skin to skin contact. in the field, yaws is diagnosed on the basis of epidemiological context, evocative symptoms and signs and positive serological tests or dark field microscopy. the darkfield microscopy is not easy to perform , hence the interest in serological tests. the serological tests used to confirm yaws are the same as those used to diagnose syphilis. yaws serologic diagnosis relies on testing for non-treponemal and treponemal antibodies. these antibodies differ markedly with respect to antigenic reactivities and kinetics during the disease process. historically screening for yaws has involved the use of nontreponemal tests, such as rapid plasma reagin or venereal disease research laboratory. positive results of nontreponemal tests of specimens are then confirmed using a more specific treponemal test, such as treponema pallidum haemagglutination. however, the equipment and personnel requirements for conducting and interpreting these laboratory-tests are rarely available in low-resource settings in developing countries where yaws occurs. rapid treponemal tests which detect antibodies to t. pallidum antigen have become popular for the diagnosis of venereal syphilis due to their many advantages. these tests that can be performed outside a laboratory setting with minimal training and using blood collected by a finger prick, which makes them extremely useful in remote areas where laboratories are not available. however, the rapid treponemal tests for syphilis detect treponemal antibodies, which limits their use for interpretation of the disease status since they cannot distinguish between active and past or treated infection. a combined point-of-care (poc) test which detects both treponemal and non-treponemal antibodies has recently been evaluated for the diagnosis of syphilis, and appears promising for yaws diagnosis. the use of the dual poc test would result in the ability to both screen and confirm the serological status of patients with suspected yaws within 15 minutes and give a better indication of active disease.

Eligibility criteria:
inclusion criteria: * children from 2 to 15 years with clinical suspicion of active yaws exclusion criteria: * persons who are unable to sustain venipuncture; persons who do not provide an informed consent, or withdraw consent

Keywords: diagnosis rapid tests non-treponemal serology eradication
paseo intervention for adolescents transitioning to adult hiv care in urban peru

Conditions: HIV Infections

Summary: this study is an evaluation of an intervention (nicknamed "paseo") that aims to facilitate the transition to adult hiv care for adolescents living with hiv in lima, peru. the intervention consists of health systems navigation and accompaniment, monthly check-ins with a lay health worker, enhanced social support provided through peer support groups, education sessions, mental health screening and referral, resolution of acute needs, and individualized adherence support. the study is a two-arm 1:1 randomized evaluation to determine the short- and long-term (i.e., post-intervention) efficacy of the paseo intervention with regard to retention with viral load suppression as well as other indicators of well-being. the cumulative incidence of unsuccessful transition at 12- and 24-months will be compared. the cost and cost-effectiveness of the study intervention in terms of cost per additional successful transition achieved will be estimated. data on implementation considerations essential for uptake, sustainability, and successful adoption by the public sector will be provided.


Eligibility criteria:
inclusion criteria: * adolescent or young person living with hiv and aware of diagnosis * 14 to 21 years of age (may be increased to 23 to meet recruitment targets) * currently taking or eligible for art at a participating facility * scheduled to transition to adult care or previous unsuccessful transition to adult care * willing to participate regardless of the study arm to which they will be assigned * able and willing to provide written informed consent exclusion criteria: * living outside of lima province * participation in the paseo pilot study * current enrollment in another research study * having any condition (social or medical) which the study team considers would make participation unsafe

Keywords: adolescence community-based accompaniment retention antiretroviral treatment social support mental health treatment support adherence
swab sample collection for the detection of bacterial proteases in wounds assay

Conditions: Chronic Wounds With Different Etiologies

Summary: the objective of this study is to collect wound exudate (fluid) swab samples from subjects who have wounds that show clinical signs of infection, as well as from subjects who have wounds that do not show clinical signs of infection. swab samples will be collected from acute and chronic wounds of different etiologies and these will be analysed for bacteria types and markers of infection.


Eligibility criteria:
inclusion criteria: * subject has presented to participating study site with a wound(s) suspected to be infected, as determined by the investigator and/ or study staff - defined as one that through clinical judgment has questionable infection status, and /or shows three or more of the nerds or stones signs of infection); * subject has presented to participating study site with a wound(s) suspected not to be infected, as determined by the investigator and/ or study staff - defined as one that does not show three or more of the nerds or stones signs of infection. * subject is 18 years of age or older. * subject agrees to complete all aspects of the study and provides informed consent exclusion criteria: * subject is less than 18 years of age. * target wound contains a malignancy * subject has hypersensitivity of the wound or painful wound surface which prevents touching/swabbing of the wound surface. * subject is confirmed to be positive for hiv or hepatitis. * subject is unable or unwilling to provide informed consent. * subjects deemed inappropriate for the study by the site's principal investigator.

Keywords: diabetic foot ulcers, venous leg ulcers, pressure sores, acute wounds
a study to learn safety and blood levels of pf-07817883 in healthy people

Conditions: Healthy

Summary: the purpose of this clinical trial is to learn if the study medicine (called pf-07817883) is safe and how it goes in and out of the body in healthy people. pf-07817883 is for the potential treatment of covid-19. participants will take pf-07817883 by mouth up to 2 times a day. this study may also evaluate how much pf-07817883 gets into the body when taken as pill. we may study if people's diets can affect this study medicine. we may also examine how pf-07817883 is processed and removed by the human body. finally, we may look into if pf-07817883 has potential to interact with midazolam.

combined 6-part study. part-1: single ascending dose part-2: multiple ascending dose part-3: relative bioavailability and food effect part-4: metabolism and excretion part-5: drug-drug interaction with midazolam part-6: supratherapeutic exposure part-1,2 and 6 are double blind, sponsor open and part-3,4 and 5 are open label study.

Eligibility criteria:
inclusion criteria: * healthy male or female subjects between ages of 18-60 years. male only in part-4. * body mass index (bmi) of 17.5 to 30.5kg/m2; and a total body weight \>50kg (110lbs). a body weight of \>45 kg may be considered in selected cases. * japanese subjects who have four japanese biologic grandparents born in japan * chinese participants who were born in mainland china and both parents are of the chinese descent. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) * any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, intestinal resection). * positive test result for sars-cov-2 infection at the time of screening or day-1. * have received covid-19 vaccine within 7 days before screening or have received only one of the 2 required doses of covid-19 vaccine * use of tobacco or nicotine containing products in excess of the equivalents of 5 cigarettes per day or 2 chews of tobacco per day * use of prescription or nonprescription drugs and dietary and herbal supplements within 28 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.

Keywords: oral antiviral covid-19 protease inhibitor mpro pf-07817883
polymorphisms in the human matrix metalloproteinase genes mmp1, mmp3, and mmp9: genetic risk factors of primary open angle glaucoma?

Conditions: Glaucoma

Summary: matrix metalloproteinases (mmps) fulfill diverse important molecular functions and play pivotal roles in development, tissue morphogenesis, repair, aging, and inflammatory processes. mmps are also important disease modulating factors, such as cancer, cardiovascular disease, rheumatoid arthritis or macular degeneration. functional genetic variants have been described to fine-tune mmp activities at the gene transcriptional level and have been associated with increased genetic risk of e.g. arteriosclerosis or cancer. mmps are also assumed to play a major role in the remodeling of the extracellular matrix (ecm) in the optic nerve head during glaucomatous optic neuropathy. mmp-1, mmp-3 and mmp-9 have been shown to be up-regulated in a variety of animal models of glaucoma. here, we study three promoter snps within the genes encoding three members of the mmp family. by assessing the prevalence of genetic variants associated with either increased/decreased enzyme activity, we will (i) estimate their contribution to the genetic risk of developing primary open angle glaucoma (poag) and (ii) investigate the potential role of mmps in the functional pathology of poag.


Eligibility criteria:
inclusion criteria: * men and women older than 39 years * primary open angle glaucoma as evidenced from characteristic visual field loss and optic disc cupping (poag group) * healthy subjects matched by age, sex and ethnicity to the poag patients group (control group) exclusion criteria: * exfoliation glaucoma, pigmentary glaucoma * history of acute angle closure

Keywords: glaucoma gene polymorphism metalloproteinase
safety, tolerability, and immunogenicity study of a clostridium difficile toxoid vaccine in healthy adult volunteers

Conditions: Clostridium Infections

Summary: the purpose of this study is to determine the safety and tolerability of a modified c. difficile vaccine at 3 dose levels compared with a placebo control administered via intramuscular injection in healthy adults aged 18-55 years of age.

clostridium difficile is the leading infectious cause of nosocomial diarrhea in developed countries. hospital outbreaks of clostridium difficile-associated diarrhea (cdad) are associated with substantial patient morbidity and mortality. conventional therapy with antibiotics often results in secondary infection with resistant organisms or clinical relapse after discontinuation of the antimicrobial course. new strategies are needed to limit the impact of this opportunistic pathogen. considerable evidence exists that immunity against c. difficile toxins may be effective in controlling cdad. 48 subjects will be enrolled to receive one of three dose levels of modified c difficile vaccine or placebo administered on a 3-dose schedule. the study consists of a 30-day screening period, a 70-day treatment period, one follow-up phone interview 2 months after the last vaccination, and one follow-up clinic visit 6 months after the last vaccination.

Eligibility criteria:
inclusion criteria: * adult males or females, 18-55 years (inclusive) * in good general health * clinical lab tests within normal range * non-pregnant female subjects * able and willing to participate for duration of study and must not participate in any other experimental study for at least 60 days after receiving the last dose of study vaccine exclusion criteria: * evidence of c. difficile infection * evidence of any previous antibiotic-associated diarrhea * active or inactive inflammatory bowel disease, irritable colon syndrome, chronic abdominal pain or other chronic diarrhea * history of malignancy within 5 years * history of anaphylaxis, asthma or severe vaccine or severe allergic drug reaction * known or suspected history of immunodeficiency; * active or inactive immune-mediated or inflammatory disease; * pregnant or lactating female subjects; * history of drug or alcohol abuse disorders; * serology positive for hiv, hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv) * receipt of antibiotic therapy or an investigational drug within prior 30 days * blood or organ donation within prior 30 days

Keywords: clostridium difficile
portion size effects on body weight:free living setting

Conditions: Portion Sizes

Summary: the study purpose was to evaluate the effects of portion sizes on body weight and energy intake in a free-living setting. 223 healthy adults were recruited from an urban worksite and randomized to one of four groups for a six-month period. the groups were: 1) 400 kcal box lunch; 2) 800 kcal box lunch; 3) 1600 kcal box lunch; or 4) no box lunch. participants were required to pick up a box lunch every week day for six months. control participants did not receive a box lunch and were instructed to eat their usual lunch. participants were weighed and dietary intake measured at baseline, one, three and six months. it was hypothesized that at six months, participants in the 1600 kcal box lunch would gain more weight and have higher energy intake than those in the other groups.


Eligibility criteria:
inclusion criteria: * : 1) age 18-60 yrs; 2) nonsmoker; 3) fluent in english; 4) not taking medications that affect appetite or body weight; 5) work at the medical complex full time, including during the lunch hours; 6) not allergic to the foods in the study lunches; 7) willing to eat the foods in the study lunches \[examples were provided of the types of foods\]; 8) not currently on a diet to lose weight; 9) no history of a diagnosed eating disorder; 10) not moving from the area during the next six months; 11) not currently taking part in another research study; 12) not currently pregnant, nursing or pregnant in the last 12 months. exclusion criteria: if the person does not meet the criteria above -
lpr fluorescence pilot

Conditions: Laryngopharyngeal Reflux; Gastro Esophageal Reflux

Summary: comparing the fluorescence signatures from mouthwash samples of patients with laryngopharyngeal reflux (lpr) and healthy volunteers.

the investigators aim to test if the biosensing platform pandra, developed by rosa biotech, may be suitable to distinguish patients with lpr symptoms, both with and without objective evidence of gastroesophageal reflux disease (gord), vs healthy volunteers due to their expected inflammation and cell changes in the laryngo-pharyngeal region. the investigators intend to analyse 20 samples of mouthwash solutions from each of the following groups: a. patients with symptoms of lpr and objective evidence of gord b. patients with symptoms of lpr and no objective evidence of gord c. healthy volunteer group

Eligibility criteria:
healthy volunteers inclusion criteria: * participant is aged 18 or above * participant has capacity to understand written english * participant is not on regular prescription medicines * participant has an rsi score of 0 * participant has a body mass index (bmi) of 18.5 - 34.9 kg/m2 (bounds included) exclusion criteria: * participant has experienced any symptoms of lpr or gord symptoms in the past year * participant has taken any medication for gord/lpr in the past year (e.g. proton pump inhibitors, h2 antagonists, over the counter antacids) * participant has active oral disease * participant has a significant medical diagnosis patients with symptoms of lpr inclusion criteria: * participant is aged 18 or above * participant has capacity to understand written english * participant has an rsi score of \>13 * participant has a body mass index (bmi) of 18.5 - 34.9 kg/m2 (bounds included * participant has been referred for 24hr ambulatory ph-impedance monitoring exclusion criteria: * participant has active oral disease * participant has other ongoing health problems that could account for their lpr symptoms. * participant has not undergone nasoendoscopy within last 6 months or does not have one scheduled within next 6 weeks * previous antireflux surgery (e.g. fundoplication or magnetic sphincter augmentation) * previous bariatric surgery (e.g. gastric bypass or sleeve gastrectomy)
pediatric asthma control under community management model in china

Conditions: Asthma

Summary: the purpose of this study is to learn the pediatric asthma control status under community management model. to learn the differences of pediatric asthma control status when subjects assigned to community hospitals or shanghai childrens medical centre. to learn the treatment adherence and the frequency of asthma attack under community management model.

subjects diagnosed as pediatric asthma at shanghai children's medical center will be consecutively screened and eligible patients will be recruited. for each enrolled patient, basic information as well as baseline medical condition will be collected by the investigators. asthma medicine will be prescribed by the investigator according to patient's asthma severity and control status. the subject will be assigned to the nearest community hospital or shanghai children's medical center, whichever is nearer to the subject's home, for their future onsite visits. the patient's caregiver will be instructed to install the study-specified application program (app) at their smart phone and learn how to use this app. during the study, patients will receive 12 months standard treatment, prescribed by the investigators according to "guideline for the diagnosis and optimal management of asthma in children". the patients' caregiver will be prompted to fill out an asthma control questionnaire and asthma control test via their smart phone app every month. patients will be requested to visit prearranged community hospitals at month 1, 3, 6, 9 and arrange their last visit back to shanghai children's medical center at month 12. during each onsite visit, asthma-related information will be collected by the investigators. meanwhile, subjects will receive pef (\>5 years old) and feno tests for evaluation of lung function and inflammation level. after comprehensive assessment of the patient's symptom control, risk factors, occurrence of exacerbations, and practical issues (cost, ability to use the device, and adherence), the investigator will make the decision on whether stepping up or stepping down asthma treatment. this study ends up without follow-up.

Eligibility criteria:
inclusion criteria: 1. out-patient, female or male, aged less than 18 years old 2. diagnosed as asthma according to "guideline for the diagnosis and optimal management of asthma in children" 3. consent should be obtained by subjects' guardian 4. the subjects or subjects' caregiver must have a smart phone at their disposal exclusion criteria: 1. presenting with differential diagnosis of asthma such as congenital heart disease, gastro-oesophageal reflux, bronchopulmonary dysplasis, bronchiolitis obliterans, etc. 2. allergy to any inhaler cortical steroid 3. subject with other diseases that may interfere the study results judged by the investigators. 4. participation in any analogous clinical study within 3 months

Keywords: pediatric asthma control community