Kornimate/medical-research-clean huggingface dataset:
a church based intervention to improve diabetes care

Conditions: Type 2 Diabetes

Summary: the purpose of this study it to determine if a culturally appropriate, church based intervention for african americans with type 2 diabetes, will lead to improved glycemic (blood sugar) control.

african americans suffer disproportionately from diabetes and its complications. to reduce this burden of suffering, innovative interventions are needed to improve self-care behaviors including: dietary intake, physical activity (pa), self-monitoring, and medication adherence. the goal of this study (a new dawn) was to develop and test a culturally appropriate, church-based intervention to improve diabetes self-management and glycemic control. twenty-four african american churches in central nc were recruited and randomized to receive the special intervention (si-13 churches, 117 participants) or the delayed intervention (di-11 churches, 84 participants). the si included an 8-month intensive phase consisting of: 1 individual dietary assessment and counseling visit; 12 group sessions; monthly phone contact with a peer counselor (church diabetes advisor (cda)); and 3 printed encouragement messages from the primary care clinician. this was followed by a 4-month reinforcement phase including monthly phone contacts from the cda. at 8- and 12-month follow-up, hba1c was assessed by high-performance liquid chromatography. at baseline, 64% of participants were female and means were: age 59, years with diabetes 9, hba1c 7.8%, systolic blood pressure 139, diastolic blood pressure 76, and bmi 35.0. a total of 174 (87%) participants returned for 8-month measures. adjusting for baseline values and randomization by church, the mean hba1c level was 7.4% for the si and 7.8% for the di (difference 0.4%, 95% confidence interval (ci) 0.1-0.6, p = 0.009). there were no statistically significant differences between groups for bp or bmi. of 82 (70%) si participants completing an 8-month follow-up questionnaire, 65 (79%) were very satisfied with the nutritional component, 63 (77%) were very satisfied with the pa component, and 72 (88%) considered the program to be very helpful overall. in a new dawn, the si was acceptable and produced a modest, but clinically significant, reduction in hba1c. these findings support the acceptability and effectiveness of self-management interventions given in a church setting for african americans with type 2 diabetes.

Eligibility criteria:
inclusion criteria: * age 20 or older * diagnosis of type 2 diabetes (diagnosis at age 20 or greater and no history of ketoacidosis) * clinical care provided by primary care clinician * plans to reside within 50 miles of church for 1 year * has home phone or easy access to one exclusion criteria: * diabetes secondary to another condition * pregnancy/lactation * inability to speak english

Keywords: behavioral intervention
the pk/pd of deoxycholic acid amphotericin b in invasive fungal infection patients with sepsis/septic shock

Conditions: Fungal Infection

Summary: to explore the pk/pd of deoxycholic amphotericin b in invasive fungal infection patients with sepsis/septic shock;to compare the pk/pd of deoxycholic amphotericin b in invasive fungal infection patients with sepsis and septic shock.

this was a single-center study.patients who were diagnosed with in invasive fungal infection receieved deoxycholic acid amphotericin b during the study period.the information was recored including the general condition, infection index, pk/pd index and drug-related side effects.

Eligibility criteria:
inclusion criteria: patients age more than 18 years old; meet the criteria of sepsis 3.0; admitted to icu; patients were suspected or diagnosis of ifi,doctors determined the use of deoxycholic acid amphotericin b. exclusion criteria: serum creatinine≥221umol/l; deoxycholic acid amphotericin b or amphotericin b liposome were used for the past 7 days; patients being treated with rifampicin; unable to tolerate treatment of deoxycholic acid amphotericin b; bmi\ 30; tumors; pregnancy; estimated time of survival\<24h; patients who participated in other studies within 30 days.

Keywords: blood concentration deoxycholic acid amphotericin b fungal infection
warmed humidified carbon dioxide (co2) for open surgery

Conditions: Hypothermia

Summary: eighty adult patients undergoing open colon surgery will be randomized to either: 1. standard warming measures including heating sheets, warming of fluids, and insulation of limbs and head, or to 2. additional insufflation of humidified carbon dioxide (approx. 36-37ºc, approx. 80-100% relative humidity) via a humidifier with a heated tube (fisher\&paykel) connected to a gas diffuser (cardia innovation ab) that is able to create a local atmosphere of 100% carbon dioxide (humidified ) in the open wound cavity. primary aim the primary aim of this study is to evaluate if humidified carbon dioxide insufflated into an open surgical wound can be used to warm the core, the open wound cavity, and the wound edges during major abdominal surgery. secondary aims secondary aims are to evaluate possible differences between the groups regarding complications and clinical differences including histological signs of desiccation injury of peritoneal samples, time to extubation, core temperature after surgery, icu stay, bleeding volume, hospital stay, postoperative pain, infections, shivering, postoperative signs of restored bowel function including bowel movements, flatus, and first meal.

eighty patients undergoing open colon surgery will be randomized to either standard warming measures including heating sheets, warming of fluids, and insulation of limbs and head or to additional insufflation of humidified carbon dioxide (approx. 36-37ºc, approx. 80-100% relative humidity) via a humidifier with a heated tube (fisher\&paykel) connected to a gas diffuser (cardia innovation ab) that is able to create a local atmosphere of 100% carbon dioxide (humidified) in the wound cavity. wound temperatures will be measured every 10 minutes with an infra-red camera positioned approximately 1m above the wound with a camera support. wound areas and wound edges of stored images will be delineated with a soft ware program. peritoneal samples (3x3x1mm) will be taken at start of the operation, after 30 minutes and before closure of the abdomen. the samples will immediately be stored in rna-later solution, and deep frozen for later analysis of epithelial (peritoneal) and endothelial function/tissue damage.

Eligibility criteria:
inclusion criteria: * major open abdominal surgery (colon surgery) in adults * patient signed informed consent exclusion criteria: * acute surgery

Keywords: abdominal surgery hypothermia wound dessication warming
prevalence and incidence of antibodies against sars-cov-2 among primary healthcare providers in belgium (covid-19)

Conditions: SARS-CoV-2; COVID-19

Summary: this protocol focuses on the seroprevalence in primary care health care providers (phcps) in belgium. phcps manage the vast majority of covid-19 and other patients and therefore are essential to organize health care efficiently. currently however, evidence is lacking on 1. how many phcps get infected or diseased in belgium, 2. the rate at which this happens, 3. their clinical spectrum, 4. their risk factors, 5. the effectiveness of the measures to prevent this from happening and 6. the accuracy of the immunological serology-based point-of-care test in a primary care setting. this study will be set up as a prospective cohort study. all belgian gps in clinical practice will be invited to register online for participation in this national epidemiological study and will be asked to invite the other phcps in their practice to do the same. a model and demography-informed sample of registered gps and other phcps will be selected. these participants will be asked at each testing point to perform a capillary blood sample antibody point of care test (orientgene®) and complete an online questionnaire. all data analysis will be performed and reported after each relevant testing period and at the end of the study.


Eligibility criteria:
inclusion criteria: * any belgian general practitioner (gp) (including those in professional training) currently working in primary care and any other primary health care providers (phcps) from the same gp practice who physically manage (examine, test, treat) patients/clients (frontline phcp), are able to comply with the study protocol and provided informed consent to participate in the study. also phcps having been diagnosed with covid-19 are included. exclusion criteria: * staff hired on a temporary (interim) basis will be excluded as follow-up over time will be compromised. * administrative staff or technical staff without any contact with patients/clients will also be excluded. * phcps who were not active during the inclusion period will automatically be excluded.

Keywords: seroepidemiologic studies primary health care
prediction of the efficacy of activated recombinant human factor vii in adult congenital haemophilia a or b patients with inhibitors by use of thromboelastography

Conditions: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors

Summary: this trial is conducted in europe and the united states of america (usa). the aim of this trial is to evaluate the basal and spiked teg® (thromboelastography) or rotem® (thromboelastometry) profiles of frequently bleeding haemophilia subjects with inhibitors in a non-bleeding state.

the teg parameters are: r time (reaction time), k time (k time (arbitrary measurement)), a (a angle), ma (maximum amplitude) and ly30 (lysis 30 min after ma) while the rotem parameters are: ct (clotting time), cft (clot formation time), a (a angle), mcf (maximum clot firmness) and li60 (lysis index 60 min after ct)

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of congenital haemophilia a or b with a fviii:c clot activity or fix:c clot activity, respectively, less than 5% * presently use of activated recombinant human factor vii (novoseven®) as haemostatic agent for preventive treatment or treatment of bleeding episodes * a documented historical or present record for the presence of inhibitors to factor viii or ix, respectively * a documented history of 2 or more joint bleeding episodes during the preceding 12 months * subjects must be in a non-bleeding state (i.e. no clinical manifestations of active bleeds) exclusion criteria: * subjects who have received any haemostatic treatment for a bleeding episode within the last 7 days prior to this trial * immune tolerance therapy within the last 30 days prior to this trial * clinically relevant coagulation disorders other than congenital haemophilia a or b * thrombocytopenia (platelet count below 60,000 platelets/mcl) * prophylactic haemostatic treatment within 3 days prior to this trial
radiotherapy - cerebrovascular reactivity (rt-cvr study)

Conditions: Brain Neoplasms

Summary: brain tumours often have low oxygen levels, and that makes them more resistant to radiation therapy. if patients breathe the right mixture of oxygen during treatment, radiation may work better. in this study, patients with brain tumour will undergo a special mri test while they breathe different mixtures of oxygen and carbon dioxide to find out whether oxygen levels improve in the tumor. patients will also be asked to repeat this mri test during the second week of radiation therapy, as well as 3 months, 6 months and 1 year after rt. the mri test after rt will help us understand how the blood vessels in the normal brain are affected by radiation.


Eligibility criteria:
inclusion criteria: * patients with primary gliomas visible on mri who are planning to receive radiotherapy or * patients with brain metastases\>1cm who are planning to receive radiotherapy * karnofsky performance status \>60 * age 18 years * patients must be willing to visit toronto western hospital for at least one mri scan prior radiotherapy exclusion criteria: * seizures not controlled with medications, or non compliance with prescribed anti-seizure medication * prior radiation therapy to the brain * pregnancy * unwilling or unable to co-operate with breathing maneuvers * respiratory or cardiac limitations to breathing at 20 l/min * medical contra-indications to limited hypercapnia or hypocapnia (known increased intracerebral pressure, metabolic acidosis or alkalosis) * contraindication to mri (patients weighing\>136 kgs-weight limit for the scanner tables; allergy to mr contrast agent; patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with mri) * other medical conditions deemed by the pi or associates to make the patients ineligible for protocol procedures
pre-emptive analgesia effect in different psycho-emotional status patients during lower third molar surgical extractions

Conditions: Pre-emptive Analgesia in Different Psycho-emotional Status Patients

Summary: to increase the effectiveness of pain control, it is recommended to use drugs before the pain onset, therefore the pre-emptive analgesia method is considered as a method, which allows decreasing the post-operative pain to minimum. previous studies evaluated effectiveness of pre-emptive analgesia but no relation to psycho-emotional status was addressed. our authors believe that the effect of pre-emptive analgesia may vary based on different psycho-emotional status. 45 volunteers who needed extraction of lower third molars were examined and enrolled in the study (study group - 15; placebo - 15; control - 15 volunteers). ibuprofen 400mg together with 500mg paracetamol was used for pre-emptive analgesia. difficulty of the operation, heart rate measurements and operation protocol were documented. surgeon filled his questionnaire after the procedure. patients on consultation, operation day and 10 days postop. filled a questionnaire which consisted of general, special and pain evaluation sections. less favorable psycho-emotional status correlated with more severe pain 6h after operation. this relation was mostly expressed in the control group. psycho-emotional status of placebo patients was accounted for bigger analgesic consumption frequency. postoperative pain in study group was minimal compared to other groups. pre-emptive analgesia enhances patient's psycho-emotional status and sustains postoperative pain control during lower third molar surgical extractions.


Eligibility criteria:
inclusion criteria: * adult patients; * indications for mandibular third molar removal. exclusion criteria: * presence of nsaid usage; * acute inflammation in operating site; * general diseases that might negatively influence the outcomes of operation, such as epilepsy, unstable neurological condition; * anticoagulant usage; * diabetes mellitus; * cardiovascular diseases.
endoscopic ultrasound in detailed t-staging of upper gi malignancies in vitro

Conditions: Gastrointestinal Neoplasms

Summary: in our era of personalized treatment, both the prognosis and the choice of therapy for upper gi malignancies depend on the staging before any treatment. most experts recommend eus (endoscopic ultrasound) as the first line for t-staging but the diagnostic accuracy in clinical practice varies in different centers according to the published data. neither the discrepancy between eus and histological findings nor the variation between centers well explained. so the investigators designed this prospective study. in the present study, the investigators performed eus on the resected specimen after surgery before fixation in formalin, evaluated the invasion of the gi wall, and marked the deepest location with sutures. and try to determine the exact accuracy of eus staging , find the discrepancy between eus and histologic findings.

- eus examination after the surgery, the specimen is filled with 0.9%ns (normal saline ) without cut open，and put into a container filled with 0.9%ns before fixation in formalin. eus will be performed on the resected specimen.the endoscopy move from the distal to proximal side along the longitudinal axis of stomach, evaluate the invasion of gastric wall, and mark the deepest point with sutures under the eus guided. the images were stored . eus images the are reviewed by two endoscopists. they are asked to stage the tumor according to the ajcc(american joint committee on cancer) staging system (7th edition) , assign a level of confidence to the staging, and score the quality of the eus image . * histologic preparations and examination carcinoma invasion into each layer of the gastric wall is diagnosed by an experienced pathologist (l.zw) who is unaware of the findings of the eus imaging. the marked section will be assessed separately. * data analysis the diagnosis between the pathologic findings and eus prediction will be compared. whether the marked point was the deepest in pathologic findings is recorded. and the histological section and the eus image of the marked point is compared.

Eligibility criteria:
inclusion criteria: * patients with upper gi carcinoma * receive surgery as first treatment exclusion criteria: * previous surgery involved the upper gi tract

Keywords: gastrointestinal neoplasms endosonography in vitro staging
impairments that affect correct inhaler use in copd

Conditions: COPD

Summary: inhale is a one-year, multi-site observational research study funded by viatris, with two aims: 1. determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with chronic obstructive pulmonary disease (copd). 2. assess the relationship of cognitive impairment and impaired manual dexterity with patient errors using current pmdis, smis and/or dpis.

to prescribe inhaled therapy for patients with copd, health care professionals (hcps) must make three decisions: short vs long-acting medication, medication class (beta2 agonists, muscarinic antagonists and/or corticosteroids) and delivery system. at present, there is no guidance by national and international groups of experts on selecting the most appropriate delivery system for patients with copd. on the other hand, there is a general belief among hcps that there is no difference in efficacy among pressurized metered dose inhalers (pmdis), slow mist inhalers (smis), dry powder inhalers (dpis), and nebulizer delivery if the patient uses correct inhaler technique. unfortunately, there is extensive evidence that patients with copd exhibit numerous errors using hand-held devices. experts have opined that hcps should consider prescribing nebulizer medications for patients with copd based on various factors or conditions, particularly cognitive impairment and problems with manual dexterity. however, there is little if any supportive evidence for these recommendations. in stable out-patients with an established diagnosis of moderate to very severe copd (pulmonary function tests within the last 12 months that demonstrate fev1 \< 60% predicted required for screening purposes), we hypothesize the following: 1. cognitive impairment (mild to severe) is present in \> 20% of this copd population 2. impaired manual dexterity (minimally functional to nonfunctional) is present in \> 20% of this copd population 3. both cognitive impairment and impaired manual dexterity are associated with patient errors using their current hand-held inhalers. the objectives of this study are: 1. to determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with copd 2. to assess the relationships of cognitive impairment and impaired manual dexterity with patient errors using their current pmdis, smis, and/or dpis.

Eligibility criteria:
inclusion criteria: 1. age \> 60 years 2. \> 10 pack-years smoking cigarettes 3. diagnosis of copd based on gold criteria 4. pulmonary function tests showing fev1 \< 60% predicted (pre-bd). 5. current use of one or more hand-held inhalers (pmdis, smis, and/or dpis). exclusion criteria: 1. current diagnosis of dementia or known cognitive impairment -or- 2. current diagnosis of impairment in manual dexterity including severe rheumatoid arthritis, severe arthritis/weakness of the hand/wrist, parkinson's disease, and/or history of a previous cerebral vascular accident (cva) resulting in significant musculoskeletal deficit (in judgement of pi).

Keywords: copd inhaler
tace combined with penpulimab and anlotinib for advanced hcc

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this multicenter, dual-cohort, prospective real-world study is to explore the efficacy and safety of penpulimab and anlotinib combined with or without tace, as well as the optimum interval of the combination of penpulimab and anlotinib with tace in advanced hcc patients.

the efficacy and safety of transarterial chemoembolization (tace) combined with penpulimab and anlotinib in the treatment of advanced hepatocellular carcinoma (hcc) remain unknown. this is a multicenter, dual-cohort, prospective real-world study with patients receiving normal clinical care. patients in cohort i will receive tace combined with penpulimab and anlotinib (tace-a-a cohort), and patients in cohort ii will just receive penpulimab and anlotinib (a-a cohort). the primary endpoints of this study are the efficacy of penpulimab and anlotinib combined with or without tace in advanced hcc patients. while the secondary endpoints include the safety of penpulimab and anlotinib combined with or without tace, as well as the optimum interval of the combination of penpulimab and anlotinib with tace in advanced hcc patients. the results will provide further evidence for the clinical practice and the design of future trials.

Eligibility criteria:
inclusion criteria: * pathologically or clinically diagnosed hcc patients; * age of 18-80; * barcelona clinic liver cancer (bclc) stage c (ie, china liver cancer staging (cnlc) stage iii); * with expect survival ≥ 3 months; * with obtained informed consent; * will receive penpulimab and anlotinib combined with or without tace. exclusion criteria: * contraindications of penpulimab and anlotinib; * child-pugh c; * key information (such as imaging, liver function, eastern cooperative oncology group(ecog) score, etc.) missing.

Keywords: hepatocellular carcinoma transarterial chemoembolization penpulimab anlotinib
peginterferon alfa-2a plus ribavirin plus amantadine for the treatment of hepatitis c infected patients

Conditions: HCV Infection; Hepatitis C, Chronic

Summary: response to a second-line anti-hcv treatment in non responder patients to a first-line dual therapy remains very poor. preliminary studies of amantadine suggest that this drug could be potentially effective to treat hepatitis c.

background : response to a second-line anti-hcv treatment in non responder patients to a first-line dual therapy remains very poor. preliminary studies of amantadine suggest that this drug could be potentially effective to treat hepatitis c. design : randomized, double-blind, multicenter trial. interventions compared : peg-interferon alfa 2a + ribavirin + amantadine versus peg-interferon alfa 2a + ribavirin + placebo eligibility criteria : chronic hepatitis c, previously treated with combination of interferon plus ribavirin for at least 24 weeks,detectable hcv rna. primary outcome : sustained virological response, defined as an undetectable hcv rna level 24 weeks after the end of anti hcv treatment.

Eligibility criteria:
inclusion criteria: * chronic hepatitis c * previously treated with a combination of interferon plus ribavirin for at least 24 weeks * detectable hcv rna (i.e. non responders) * signed informed consent exclusion criteria: * evidence of another cause of liver disease * liver cirrhosis (child-pugh stage bmc) * alcohol consumption \> 30g/day for women or \> 40g/day for men ; drug abuse * other serious relevant disorders : psychiatric condition (especially depression), cardio-vascular disease, renal decompensation, seizure history, hemoglobinopathy, auto-immune disease

Keywords: hepatitis c, chronic hcv infection treatment failure peg interferon (interferons/therapeutic use interferon alfa-2a/adverse effects) ribavirin (ribavirin/therapeutic use ribavirin/adverse effects) amantadine drug therapy, combination