Kornimate/medical-research-clean huggingface dataset:
prospective study in pregnant women with hypercoagulopathy

Conditions: Pre-Eclampsia; Eclampsia

Summary: pre-eclampsia is one of the most common causes of maternal and fetal morbidity and mortality. the aim of this study is to identify pregnant women at risk for pre-eclampsia or other cardiovascular complications at a very early state of the disease, and thereby improve the current method of screening.

600 pregnant women will be included in the project and followed in a standardized manner during their pregnancy. on a regular basis blood- and urine samples will be taken throughout their pregnancy and until 1 month after delivery and analyzed for a large variety of coagulation factors in order to identify factors that might predict an increased risk of developing pre-eclampsia and/or cardiovascular events. in addition a dna-sample is taken if consented in order to evaluate genetic factors.

Eligibility criteria:
inclusion criteria: * pregnant women attending the midwife at hilleroed hospital, frederiksborg county, denmark. exclusion criteria: * mental disease. * problems understanding or reading danish.

Keywords: pre-eclampsia pregnancy hypercoagulation screening cardiovascular complications
evaluation of novel biomarkers from acutely ill patients at risk for acute kidney injury

Conditions: Acute Kidney Injury

Summary: the purpose of this study is to collect blood and urine samples that may help identify and validate biomarkers for the early detection and risk assessment of acute kidney injury (aki).


Eligibility criteria:
inclusion criteria: males and females 21 years of age or older; subjects enrolled (first sample collection) from ed or floor admitted to the icu within 24 hours of enrollment; subjects enrolled from icu admitted to the icu within the 24 hours prior to enrollment; expected to remain in the icu for at least 48 hours after enrollment; use of indwelling urinary catheter as standard care expected for at least 48 hours after enrollment; at least one of the following acute conditions within 24 hours prior to enrollment: (respiratory sofa score of ≥ 2 (pao2/fio2 \<300)and/or cardiovascular sofa score of ≥ 1 (map \< 70 mm hg and/or any vasopressor required). patient (or authorized representative) able and willing to provide written informed consent for study participation. exclusion criteria: special populations including women with known pregnancy, prisoners or institutionalized individuals;previous renal transplantation;known acutely worsening renal function prior to enrollment (e.g., any category of rifle criteria. already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment; known infection with human immunodeficiency virus (hiv) or active hepatitis (acute or chronic);patient meets any of the following:active bleeding with an anticipated need for \> 4 units prbc;hemoglobin \< 7 g/dl;any other condition that in the physician's opinion would contraindicate drawing serial blood samples for clinical study purposes.

Keywords: kidney renal
effect of different dosing regimens of clopidogrel before elective percutaneous coronary intervention (pci) on platelet function

Conditions: Coronary Artery Disease

Summary: adequate platelet inhibition before percutaneous coronary intervention (pci) reduces peri-procedural and long-term ischemic complications. documented reduced response to clopidogrel has been associated with subsequent major adverse cardiovascular events. strategies to optimize platelet inhibition pre-pci are under investigation. this study sought to evaluate the effect on platelet aggregation of four different dosing regimens of clopidogrel given before elective pci.


Eligibility criteria:
inclusion criteria: * adult patient with an indication for elective coronary angiography with or without pci exclusion criteria: * major hemorrhagic diathesis or active bleeding * acute myocardial infarction (mi) within 14 days of enrolment * unstable angina with st-segment changes \>1 mm in at least two contiguous electrocardiographic leads at rest or a troponin i level \>0.06 microg/l within 14 days of enrolment * stroke within the past 3 months * platelet count \<100 x 10 9/l * prothrombin time \> 1.5 times control * hematocrit \<25% or hemoglobin level \<100 g/l * alcohol or drug abuse * enrolment in other investigational drug trials within the previous month * use of thienopyridines, glycoprotein (gp) iib/iiia inhibitors, warfarin or acenocoumarol within the previous week * allergic reaction or any contraindication to clopidogrel or aspirin administration

Keywords: angioplasty clopidogrel coronary artery disease platelets percutaneous coronary intervention
quality of life(qol) in korean postmenopausal osteoporosis patients with bisphosphonate treatment

Conditions: Osteoporosis, Postmenopausal

Summary: quality of life (qol) in korean postmenopausal osteoporosis patients with bisphosphonate treatment

cross-sectional quality of life survey using self-administered opsat-qtm questionnaire in korean postmenopausal osteoporosis patients with bisphosphonate treatment

Eligibility criteria:
inclusion criteria: * who have been diagnosed with postmenopausal osteoporosis by physician who have received any oral bisphosphonates (weekly or monthly) at least for 2 months to provide answer of opsat-qtm questionnaire who provide informed consent for study participation exclusion criteria: * do not understand the contents of the questionnaire

Keywords: bisphosphonates opsat-q
comparison of the effectiveness of bowel preparations before colonoscopy

Conditions: Colorectal Neoplasms

Summary: polyethylene glycol is the gold standard of bowel preparation for colonoscopy. the most important disadvantage is high volume of this preparation. sulphate based solution (sbs), low volume peg + ascorbic acid and solution of magnesium citric acid and sodium picosulfate could be suitable substitution of polyethylene glycol.

this study will be unicenter, randomized and single blind. it focuses on studying the effectiveness of four preparations for bowel cleansing before colonoscopy. polyethylenglycol (peg) will be compared as a gold standard of bowel cleansing with low volume preparations: sulfate-based solution (sbs), low volume peg + ascorbic acid and solution of magnesium citric-acid and sodium picosulfate. the effectiveness will be rated according to a quality of bowel preparation (boston bowel preparation scale) and detection of a colorectal neoplasia. the aim of this project is to compare the effectiveness of each four preparations. primary endpoint: to compare a quality of bowel preparation. secondary endpoint: to compare a detection of colorectal neoplasia in those preparations. main hypothesis: peg as a gold standard of bowel cleansing preparation is not worse than the other compared preparations. secondary hypothesis: peg is not worse in detection of colorectal neoplasia than the other compared preparations. methods: there will be 400 patients included in the project with all indications for colonoscopy (age ≥ 18 years, no upper age limit) except the exclusion criteria. the patients will be offered to participate in the study at the endoscopy unit when arranging the examination. in case of agreement they will sign informed consent and they will be educated about the correct process of bowel preparation. they also get all the instructions in printed version and questionnaire of preparation tolerability. the advantages for the patients in study will be earlier date of colonoscopy. on the day of colonoscopy, the patients will submit the questionnaire and undergo standard colonoscopy examination. the quality of a bowel cleansing will be evaluated by the experienced endoscopists who will be blinded about a type of bowel preparation. the effectiveness will be assessed by the degree of bowel cleansing (boston bowel preparation scale) and adr, aadr and number of cancers diagnosed. the ge unit staff will record all results in the on-line study database. results will be statistically evaluated in institute of biostatistics and analyses, masaryk university, iba mu).

Eligibility criteria:
inclusion criteria: • individuls ≥ 18 years old undergoing colonoscopy for all indications except exclusion criteria exclusion criteria: * active idiopathic bowel disease * chronic renal insufficiency * serious internal comorbidity * planned therapeutic colonoscopy * no informed consent signed (with the study and/or with the colonoscopy)

Keywords: colorectal neoplasia colonoscopy quality of bowel cleansing bowel preparation
investigating multigene methylation dynamics in treatment response surveillance for esophageal carcinoma

Conditions: Esophageal Cancer

Summary: the primary objective is to determine whether pretreatment-to-posttreatment changes in circulating multigene methylation levels correlate with objective response rates (orr) assessed by contrast-enhanced ct/mri and levels of serum tumor markers. secondary endpoints include: (a) time-dependent association between methylation fluctuation patterns and progression-free survival (pfs), (b) comparative diagnostic accuracy of methylation indices versus conventional biomarkers, and (c) feasibility of using methylation thresholds to guide adaptive therapy modification.


Eligibility criteria:
inclusion criteria: age at initial diagnosis: 18-75 years (inclusive) confirmed diagnosis: histologically proven esophageal carcinoma with complete medical records, including (a) definitive pathological diagnosis report, (b) tnm staging per ajcc 8th edition criteria cancer history: no prior malignancies at other anatomical sites (excluding cured non-melanoma skin cancers/carcinoma in situ) metastasis status: radiologically confirmed absence of distant metastases in liver, lungs, or other organs via contrast-enhanced ct/mri and whole-body bone scan within 4 weeks before enrollment treatment-naïve status: no previous exposure to (i) esophageal resection surgery, (ii) systemic chemotherapy, (iii) thoracic radiation therapy (\>10 gy), or (iv) pd-1/pd-l1 immune checkpoint inhibitors exclusion criteria: life expectancy \<6 months (as assessed by ecog score ≥4 or palliative performance scale ≤30%) cognitive/psychiatric conditions: a. legally incapacitated individuals without legal guardians, b. active psychotic disorders (e.g., schizophrenia, bipolar disorder) or dementia (mmse score \<24) investigator-determined exclusions
depression and congestive heart failure in outpatients.

Conditions: Heart Failure; Depression

Summary: patients with a diagnosis of chf, nyha class ii, iii or iv will be recruited for a study comparing a nursing intervention addressing chf (sim group) or chf and depression (cim group). participants in the standard illness management program will receive an 8-week, 8-session intervention designed to help them improve daily weighing, salt-restriction, medication management, etc. this intervention will be conducted in a combination of home visits and phone visits. they will also receive interactive, telephone-based daily monitoring that assesses daily weight, dyspnea, fatigue and medication compliance. patients in the comorbid illness management program will receive the same illness management program plus education and behavioral techniques designed to help them cope emotionally with the illness. the comorbid illness management home monitoring will include a twice-monthly screen for depression. major variables: the major outcomes will be depressive symptoms, health-related quality of life, functional status, heart failure symptom severity, and self-care behaviors in heart failure.

background: between 4 and 5% of patients seen at veterans affairs medical centers suffer heart failure. hf is the number one discharge diagnosis within the vha. one of the most significant comorbidities in heart failure is depression. depression predicts increased hospitalization and mortality even after controlling for key prognostic indicators. this hsr\&d study aimed to test the effectiveness of a psychotherapy intervention for depression combined with illness management to illness management alone in veterans with heart failure. objectives: to demonstrate better depression, health-related quality-of-life, and adherence outcomes for an illness management combined with psychotherapy intervention (combo) as compared to an illness management alone program (imo). methods: this was a two-site, two-arm, randomized controlled trial comparing combo to imo. the total number of patients recruited for the study was 148. retention was comparable between groups, though depression severity predicted drop out in the imo condition but not the combo condition. patients completed study assessments at baseline, week 4, week 8 (post-intervention) and at 26- and 52-week follow-up. status: the main study analyses have been conducted. the project team is conducting analysis of secondary hypotheses

Eligibility criteria:
inclusion criteria: * receiving treatment for nyha class 2-4 heart failure. * patients of the iowa city, ia or columbia, mo veterans affairs medical center primary care or cardiac care clinics. * life expectancy greater than 6 months. * must speak english. * must possess a working telephone. exclusion criteria: * presence of major psychiatric illness such as schizophrenia, bipolar disorder and substance abuse (ptsd patients are eligible). * life expectancy less than 3 months. * planned relocation to a nursing home. * marked visual or hearing impairment.

Keywords: home monitoring heart failure depression
biosignals by wearables in thyroid dysfunction

Conditions: Thyrotoxicosis; Hypothyroidism

Summary: this study is a single center observational study to investigate the association between biosignals from wearables and thyroid dysfunction.

an algorithm to predict thyroid dysfunction using heart rate and activity data from wearables was generated based on our previous clinical studies. this study was conducted to collect more data to advance the algorithm. patients with thyroid dysfunction including hypothyroidism and thyrotoxicosis were eligible for this study. during the study period, each subject wears a smart band (fitbit inspire 2 tm) and gets 3 times of thyroid function tests with 1-month interval. study participants will use a mobile app (glandy tm) to collect the symptom scores.

Eligibility criteria:
inclusion criteria: * subjects who were newly diagnosed as thyroid dysfunction (thyrotoxicosis or hypothyroidism) or undergoing treatment * subjects who are able to use wearable devices, smart phones, and mobile apps exclusion criteria: * subjects with restrictions on normal activities due to diseases other than thyroid dysfunction * subjects who are taking medications affecting heart rate * subjects with diseases affecting heart rate (i.e. arrhythmia)

Keywords: wearable device biosignals thyrotoxicosis hypothyroidism mobile app
patient-centered alternative to psychiatric hospitalization for veterans

Conditions: Veterans; Acute Hospitalization

Summary: a variety of models of psychiatric hospital alternative care have been developed over the past several decades. san diego�s short-term acute residential treatment (start) model is one of the best established of these alternatives, comprising a network of 6 facilities with a total of 77 beds. although veterans have been among those served at start programs for many years, no previous study of start or any other model has focused specifically on veterans.

background: a variety of models of psychiatric hospital alternative care have been developed over the past several decades. san diego�s short-term acute residential treatment (start) model is one of the best established of these alternatives, comprising a network of 6 facilities with a total of 77 beds. although veterans have been among those served at start programs for many years, no previous study of start or any other model has focused specifically on veterans. objectives: the study tested the hypotheses that veterans treated in a start program would demonstrate greater improvement in symptoms and quality of life, as well as greater satisfaction with treatment and lower costs of care than veterans treated at the va inpatient unit. methods: this study includes elements of both efficacy and effectiveness studies. va psychiatric unit treatment and start are compared in a randomized trial, with follow up of subjects at 2, 6, and 12 months as they experience real-world treatment-as-usual. symptoms, functioning, quality of life, and satisfaction with services are assessed on multiple standardized measures, as well as by qualitative assessments. status: final report is under preparation.

Eligibility criteria:
inclusion criteria: have to a veteran and in need of acute hospitalization, but able to take care of themselves. (max age is 59) exclusion criteria:
a study to explore the effect of sp-624 on brain network analytics in healthy adults and adults with major depression

Conditions: Major Depressive Disorder; Depression; Healthy

Summary: the main goal of this clinical trial is to learn if the active study drug (code name: sp-624) has any effect on the electrical activity of the brain in adult healthy volunteers and in adults with major depression. another goal of the study is to learn if sp-624 improves memory and learning in adults with major depression. the study will also provide additional information on the safety of sp-624 and how well it is tolerated in adult healthy volunteers and adults with major depression. researchers will compare sp-624 to a placebo (a look-alike substance that contains no drug) to see if sp-624 has any effect on study tests. study participants will: take capsules of study drug (sp-624 or a placebo) once daily for 2 weeks; visit the clinic at screening, day 1 (first dose of study drug), and day 15 (last dose of study drug) for checkups and tests; and have phone call check-ups on day 7 and about 1 week after the last dose of study drug.


Eligibility criteria:
key inclusion criteria: * in generally good health * body mass index (bmi) between 18.0 and 40.0 kg/m2 * willing to comply with the requirements of the study * for participants with depression: must meet study criteria for moderate to severe major depressive disorder key exclusion criteria: * female who is pregnant or breastfeeding. * clinically significant health condition or clinically significant abnormal results on screening health tests * for participants with depression: presence of exclusionary study criteria for co-morbid psychiatric conditions or medication history.
effects of traumeel®s tablets on exercise induced muscle damage and muscle soreness

Conditions: Exercise-induced Muscle Soreness

Summary: to investigate and compare the effects of traumeel®s tablets versus placebo on exercise induced muscle damage and muscle soreness for 72 hours after strenuous eccentric exercise test on downhill treadmill.


Eligibility criteria:
inclusion criteria: * sex: male * age ≥ 18 and ≤ 40 years * bmi ≥ 18.5 and \< 27,5 kg/m2 (who standard for normal range bmi) \[48\] * maximum relative oxygen uptake (vo2max) \< 53 ml/kg x min * general state of good health * non-smoker * medically approved unrestricted participation in sports as shown by diagnostic performance test conducted on treadmill no longer than 3 months prior to study entry * willingness to provide signed informed consent exclusion criteria: * regular eccentric exercise training * weekly training volume ≥ 6 hours * use of dietary supplements (incl. high-dosed vitamins and minerals) * chronic immune deficiency * current infection * heart and/or circulation disorders * abnormal findings on exercise ecg * musculoskeletal disorders * any current clinical condition that requires systemic treatment or might have an impact on study objectives * hypersensitivity to botanicals of the compositae family (e.g. echinacea) * lactose intolerance * illicit drug or alcohol abuse * participation in another clinical trial within 4 weeks prior to study entry

Keywords: muscle exercise soreness damage traumeel
ending the hiv epidemic with equity: an intervention to reduce the impact of racism and discrimination

Conditions: Discrimination, Racial; Stigmatization; HIV

Summary: the scope of this study is to engage ryan white hiv/aids program (rwhap) funded organizations in the south/east us to co-develop context-responsive programs to reduce structural racism and discrimination (srd) against black, indigenous, people of color (bipoc) living with hiv (plh) and bipoc healthcare workers. six rwhap clinics will be selected to participate and be assigned to one of three sequences (two clinics per cluster). all members will complete participate in interactive trainings to raise awareness of and reduce srd, from the clinic policy level, to attitudes, to the clinic environment. all clinic members and select patients will complete self-administered surveys every 6 months over 24 months.

the scope of this study is to engage ryan white hiv/aids program (rwhap) funded organizations in the south/east us to co-develop context-responsive programs utilizing evidence-informed interventions to reduce structural racism and discrimination (srd) against black, indigenous, people of color (bipoc) living with hiv (plh) and bipoc healthcare workers. srd directly impacts access to and uptake of healthcare for bipoc, including engagement in hiv services across the continuum of prevention and care. the proposed intervention, titled transcends, draws on the evidence-based health policy plus (hp+) 'total' facility hiv stigma-reduction intervention and contact theory of demonstrated efficacy in reducing race-related intergroup prejudice. transcends targets the clinics' organizational (e.g.,policies) and systems (e.g., staff attitudes/behaviors) levels to affect patient (e.g., experienced and perceived discrimination, hiv care, mental health) outcomes and staff wellbeing, at the individual level. findings will yield a manual for implementing total-facility srd-reduction processes and content. other rwhap-funded clinics and facilities serving marginalized groups may be able to adopt this manualized yet highly adaptable intervention packet to support bipoc.

Eligibility criteria:
inclusion criteria: * selected ryan white clinics. selection based on the following: first, clinic leaders will complete a 15-min site characteristics survey, assessing suitability for participation and clinic comparability for randomization purposes. staff and leadership at ryan white clinics will next complete an anonymous 15-minute eligibility survey. within each clinic, both clinic staff and patients will be invited to participate. exclusion criteria: * non-ryan white clinics * clinics that do not serve a primarily bipoc population * clinics that are not interested in participating