Kornimate/medical-research-clean huggingface dataset:
student anxiety & stress study

Conditions: Anxiety; Somatic Symptom Disorder

Summary: the present study is a randomized clinical trial of an emotional awareness and expression intervention (eaet) and a mindfulness meditation intervention (mmt) for wayne state university students with anxiety and somatic symptoms. each of these treatments will be compared to a wait list control condition and to one another to evaluate how well the treatments improve physical and psychological symptoms, stress, and interpersonal functioning of 120 wayne state university students at 4-week and 8-weeks post-randomization. this research is intended to provide an evidence-based approach to working with emotions to improve both anxiety and somatic symptoms in young adults and will illuminate how eaet compares to the commonly used mindfulness training. it is hypothesized that both active interventions will be superior to no treatment, and differences between the two treatments will be explored.

anxiety is an increasingly common condition among college students and is often accompanied by somatic symptoms. these conditions impair students' social, psychological, and academic functioning and outcomes. although students are utilizing campus and community mental health centers at increasing rates, these resources are strained. the present study aims to test the efficacy of two brief treatment options for students. integrating techniques from several emotion-focused therapies, the investigators have developed and tested an intervention encouraging the awareness and expression of habitually suppressed or avoided emotions. this emotional awareness and expression therapy (eaet) has been evaluated with various patient populations including fibromyalgia, irritable bowel syndrome, chronic pelvic pain, and medically unexplained symptoms. results of these trials suggest that the intervention is efficacious in improving physical and psychological well-being, and is equal to or superior to other psychological interventions for somatic conditions. the present study seeks to advance the eaet literature by evaluating the efficacy of the intervention for a broader population and by employing a strong and conceptually different comparison condition: mindfulness meditation training.

Eligibility criteria:
inclusion criteria: university student, reporting at least moderate levels of anxiety (gad-7) and somatic symptoms (phq-15) - exclusion criteria: psychosis, lack of fluency with spoken and written english language -

Keywords: college students anxiety somatic symptoms
the effect of video training o symptom management with heart failure

Conditions: Heart Failure

Summary: the purpose of this clinical study is to compare the effect of video-assisted training on the quality of life and symptom management of patients over the age of 65. the main questions it aims to answer are: -is there a difference between symptom management and quality of life between the first and last follow-up periods of patients in the application and control groups?

heart failure is the primary disease of old age. 20% of the reasons for hospital admission for patients aged 65 and over are due to heart failure.the most common symptoms in patients with heart failure are; fatigue, weakness, dyspnea, orthopnea, paroxysmal nocturnal dyspnea, edema and changes in mental status.due to these physical symptoms; there is a decrease in the functional capacity of patients, difficulty in performing daily life activities, inability to perform self-care, and the incidence of depression and anxiety increases. in symptom management of patients with heart failure; these include knowing the clinical course of the disease, adapting to the disease and treatment, monitoring symptoms, educating the patient on self-care, and regular follow-up after discharge.it is stated that with patient education given to individuals in a planned and regular manner, the frequency and severity of the symptoms experienced decreases, the management and control of the disease is ensured, and thus the patient's quality of life is increased by creating the necessary behavioral changes.due to the increase in the number of internet users in patient education, web-based education becomes more prominent.thanks to video training, patients will be able to experience a permanent learning process by accessing the training content wherever they want, as often as they want.

Eligibility criteria:
inclusion criteria: * 65 years and above * volunteer to participate in the research * diagnosed with heart failure at least six months ago * he/she/his relative has internet access and can use a smartphone * digital literacy scale score over 17 * class i, ii, iii according to nyha classification exclusion criteria: * under 65 years of age * known serious vision and hearing problems * with cognitive impairment

Keywords: quality of life geriatrics nursing
congestive heart failure: causes of sudden worsening

Conditions: Congestive Heart Failure

Summary: the purpose of the study is to recognize main causes of acute decompensation of chronic congestive heart failure.

congestive heart failure (chf) presents a very significant cause of morbidity and mortality. the prevalence of chf is between 2 and 4% and rises with age (in 70- to 80-year-old people is between 10 and 20%). chf is the cause of 5% of all acute hospital admissions and accounts for 2% of expenses on health. the most common causes of worsening of the chronic chf are ischemia, arrhythmias, valvular dysfunction, systemic or pulmonary hypertension, volume overload or fluid retention, high output conditions (infection, anemia, thyrotoxicosis), drugs (nsaids, cyclo-oxygenase (cox) inhibitors, thiazolidinediones) and medication nonadherence. the goal of this study is to determine the proportion of various reasons of acute worsening of chf, using commonly available methods including assessment of serum drug levels.

Eligibility criteria:
inclusion criteria: * able to provide informed consent * aged 19 years or more * history of heart failure of at least one month * examined or hospitalized for acute dyspnea at rest or with minimal exertion * clinical signs of fluid overload defined as at least one of following: * rales * jugular venous distension * peripheral edema * pulmonary congestion on x-ray * nt-probnp above 210 pmo/l exclusion criteria: * none

Keywords: congestive heart failure cardiac failure
substudy of protocol 2019-002498-80 - nct04223050: comparing mortality for low vs high peripheral oxygen saturation in copd-patients with acute exacerbation (o2flow-copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: as protocol nct04223050. this substudy furthermore investigates the role of oxidative stress in the administration of oxygen in copd patients.

studies have shown that oxidative stress plays a critical role in the pathogenesis of copd and its comorbidities. oxidative stress refers to a state in which the activity of oxidants (e.g. reactive oxygen species (ros)) outweighs that of antioxidants. ros can be introduced exogenously by for example cigarette smoke and atmospheric pollution, but is also produced endogenously as a byproduct of atp production in mitochondria or from immune cells during oxidative burst. when high fractions of inspired oxygen are administered, excess o2 can lead to formation of additional ros, which depletes antioxidants and induces an inflammation with leukocyte-derived inflammatory mediators migrating to the site of injury. in turn, this causes cellular hypertrophy, increased surfactant secretion, and cellular influx of monocytes and mast cells. during the final, fibrotic phase of oxygen toxicity, irreversible, persistent destruction of the pulmonary lining have occurred with collagen disposition, thickening of pulmonary interstitial space, and fibrosis. this substudy therefore aim to investigate the relation between oxygen therapy in copd patients admitted with acute exacerbation, oxidative stress, and mortality.

Eligibility criteria:
inclusion criteria: * age 18 years or older * ability to give informed consent * previously diagnosed copd (either confirmed diagnosis at prior hospital - contact or from their general practitioner or confirmed diagnosis by the treating physician in the emergency department (verified by use of relevant medication)) * admitted with acute exacerbation (acute and worsened shortness of breath) of copd * requiring oxygen treatment exclusion criteria: * instability at arrival requiring immediate lifesaving treatment, e.g. intubation or non-invasive ventilation, within the first 30 minutes * expected total length of stay in hospital \< 12 hours * planned transfer to another hospital within 12 hours * unwilling to have repeated arterial blood gas analyses within the first 12 hours * patients judged terminal by treating physician in the emergency department * non-residents of the particular country * expected impossible follow-up * fertile women (\<50 years of age) with positive urine human gonadotropin (hcg) or plasma-hcg * prior participation in the study

Keywords: oxygen oxidative stress mortality
effects of green tea on body weight reduction and gut microbiota

Conditions: Obesity

Summary: the investigators randomly assigned green tea extract, fermented green tea extract, or placebo in adult subjects whose bmi was 25-35 kg/m2. participants were 40 in each group, and treatment duration was 12 weeks. primary outcomes were body weight change and fat mass change from baseline to 12 weeks, and secondary outcomes were metabolic parameteres and gut microbiota.

after screening obese subjects who met the inclusion and exclusion criteria, the investigators randomly assigned the two treatment arms and one placebo arm at 1:1:1 ratio. at baseline, anthropometric and biochemical evaluations were conducted including body weight, body composition (dxa and fat ct), lipid profiles, and liver function test. the tablets were supplied to each participants under double-blind conditions. the investigators obtained blood and stool samples both baseline and final visit at 12 weeks. for improving compliance for treatments, the investigators checked diary for lifestyle and drug compliance every 6 week.

Eligibility criteria:
inclusion criteria: * age 20-60 years * bmi 25-35 kg/m2 * abdominal obesity (waist circumference): male \>90 cm, female \>85cm exclusion criteria: * cardiovascular events within 3 months * uncontrolled hypertension (\>160/100 mmhg) * diabetes mellitus * dyslipidemia under statin therapy * tsh\ 10 uu/ml * elevated creatinine level (twice higher than upper normal limit) * elevated ast/alt level (three times higher than upper normal limit) * pregnancy, lactation
safety and efficacy of alogliptin in indian participants with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to evaluate the safety and efficacy of alogliptin tablets when given as monotherapy or add on therapy in participants who are on standard care for management of type 2 diabetes mellitus (t2dm).

the drug being tested in this study is called alogliptin. alogliptin is being tested to treat people who have type 2 diabetes mellitus (t2dm). this study will look at side effects and glycemic control in people who take alogliptin in addition to standard care. the study will enroll approximately 300 patients. all participants will receive alogliptin tablets at a dose determined based on the creatinine clearance. the recommended dose of alogliptin is 25 mg once daily with normal or mildly impaired renal function (creatinine clearance \[crcl\] ≥60 ml/min), dose of 12.5 mg for participants with moderate renal impairment (crcl ≥30 to \<60 ml/min), and 6.25 mg for participants severe renal impairment (crcl ≥15 to \<30 ml/min). participants with end-stage renal disease (esrd) (crcl \<15 ml/min or requiring hemodialysis) will be excluded, in addition to standard care for the management of t2dm. all participants will be asked to take one tablet every morning each day throughout the study. this multi-center trial will be conducted in india. the overall time to participate in this study is up to 33 weeks. participants will make multiple visits to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.

Eligibility criteria:
inclusion criteria: 1. participants with t2dm who are dipeptidyl peptidase-4 (dpp-4) inhibitor-naive; including alogliptin. exclusion criteria: 1. has contraindication or limitation for administration of alogliptin tablets according to the approved label/prescribing information. 2. participants treated with alogliptin tablets outside the approved label/ prescribing information. 3. has end-stage renal disease (esrd) (creatinine clearance (crcl) \<15 ml/min or requiring hemodialysis).

Keywords: drug therapy
pulmonary hypertension screening in patients with interstitial lung disease for earlier detection

Conditions: Interstitial Lung Disease; Pulmonary Hypertension

Summary: study gms-ph-001 is a multicenter, open-label, non-randomized study to prospectively evaluate screening strategies of pulmonary hypertension (ph) in patients with interstitial lung disease (ild).

in this study, subjects will undergo a broad range of clinical assessments that are potentially associated with ph. study data will be used to identify and weigh specific clinical parameters based on their prognostic significance for right heart catheterization (rhc)-confirmed ph. there is no study drug under investigation in this study. the study consists of 2 study visits: a screening visit and study visit 1. clinical assessments include pulmonary function tests (pfts); high resolution computed tomography (hrct); physical examination; 6-minute walk test; blood draw for clinical laboratory parameters, plasma brain natriuretic peptide (bnp) concentration and plasma n-terminal pro-bnp (nt-probnp) concentration; echocardiography; university of california san diego shortness of breath questionnaire (ucsd sobq); king's brief interstitial lung disease questionnaire (k-bild); 36-item short form survey (sf-36); pulmonary hypertension functional classification self report (ph-fc-sr); investigator's suspicion of ph questionnaire; adverse event (ae) monitoring; and rhc. as the primary objective of this study is to collect a broad range of clinical parameters in patients with ild, it is expected that numerous exploratory and post-hoc analyses will be performed to identify and weigh specific parameters based on their prognostic significance for ph in this patient population with the goal of developing a screening algorithm for ph in patients with ild.

Eligibility criteria:
inclusion criteria 1. patient gives voluntary written informed consent to participate in the study. 2. patients with a diagnosis of ild based on computed tomography imaging, including: 1. idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis 2. connective tissue disease-associated ild with forced vital capacity (fvc) \<70% 3. hypersensitivity pneumonitis 4. scleroderma-related ild 5. autoimmune ild 6. nonspecific interstitial pneumonia 7. occupational lung disease 8. combined pulmonary fibrosis and emphysema 3. patients must have at least 2 signs or symptoms suggestive of ph, as specified by the study protocol. exclusion criteria 1. prior rhc with mpap \>20 mmhg. 2. currently on a food and drug administration (fda)-approved pulmonary arterial hypertension medication. 3. diagnosed with chronic obstructive pulmonary disease. 4. uncontrolled or untreated sleep apnea. 5. pulmonary embolism within the past 3 months. 6. history of ischemic heart disease or left-sided myocardial dysfunction within 12 months of screening, defined as left ventricular ejection fraction \ 15 mmhg. 7. any other clinical features that, in the opinion of the investigator, might adversely affect interpretation of study data or study safety, or make the patient unsuitable for rhc.

Keywords: ild ph ph-ild
treatment of patients with bone tissue defects using mesenchymal stem cells enriched by extracellular vesicles

Conditions: Segmental Fracture - Bone Loss

Summary: treatment of patients with segmental bone tissue defects using mesenchymal stem cells enriched by extracellular vesicles

the aims of the project are to develop a technology for obtaining mesenchymal stem cells extracellular vesicles; to develop biomedical cell product based on mesenchymal stem cells enriched with own extracellular vesicles; to conduct the clinical trials of the biomedical cell product in the treatment of patients with segmental bone tissue defects

Eligibility criteria:
inclusion criteria: * age 18-50 years; * non-union fractures of the tubular bones of the upper limb; * segmental defects of the bone tissue of the tubular bones of the upper limbs; * absence of severe comorbidity worsening the patient's prognosis. exclusion criteria: * pregnancy; * acute inflammatory processes; * viral hepatitis b and c, hiv infection, syphilis and other viral and bacterial infections; * autoimmune diseases; * allergic reactions in the acute stage, established hypersensitivity to any component of the biomedical cell product; * mental and behavioral disorders that make it impossible for patients to participate in the study, drug and/or alcohol addiction; * patients with malignant tumors including a history.

Keywords: bone defects, mesenchymal stem cells, extracellular vesicles
a prospective multicentre clinical study of dynamic monitoring of plasma ctdna methylation markers to predict recurrence of colorectal cancer after complete resection of peritoneal metastases

Conditions: Colorectal Cancer; Peritoneal Metastases

Summary: the goal of this clinical trial is to explore the predictive effect of postoperative plasma ctdna methylation status on postoperative recurrence free survival (rfs) of colorectal cancer patients with peritoneal metastasis after r0/r1 resection. the main questions it aims to answer are: preoperative and postoperative plasma ctdna methylation detection (colonaiq) was performed in patients with peritoneal metastasis from colorectal cancer who underwent r0/r1 resection. clinical information of patients was collected to explore the predictive effect of postoperative plasma ctdna methylation status on postoperative recurrence free survival (rfs) of colorectal cancer patients with peritoneal metastasis. participants will: the patients were followed up according to the normal review procedure of the hospital and the nccn guidelines until at least 24 months after surgery. the review content included ct/mri imaging evaluation and blood cea (every 3 months). whole-blood samples were obtained for timely plasma separation and ctdna extraction at 1 month after surgery (before the start of postoperative chemotherapy) and every 3 months through 24 months after surgery. one blood sample was obtained when tumor recurrence was first detected on imaging. detection of methylation in tissue and plasma samples 1. gutseer methylation ngs was performed on peritoneal metastatic cancer tissues and paired normal peritoneal tissues. 2. ctdna gutseer methylation ngs was performed on plasma samples before surgery, 1 month after surgery, 24 months after surgery, and when tumor recurrence was first detected by imaging examination. 3. ctdna methylation pcr (colonaiq) was performed on plasma samples before surgery, 1 month after surgery, every 3 months to 24 months after surgery, and when tumor recurrence was first detected by imaging examination.


Eligibility criteria:
inclusion criteria: -1. no gender limit, age greater than 18 years old; 2, ecog score ≤1; 3. life expectancy ≥2 years; 4. colorectal adenocarcinoma/mucinous adenocarcinoma/signet ring cell carcinoma confirmed by histopathology; 5, preoperative pci score ≤20, peritoneal tumor cytoreductive surgery (crs), surgery to achieve r0/1 resection; 6. be able to understand the situation of this study and sign the informed consent. 7. the primary colorectal cancer has undergone r0 resection, and there is no extraperitoneal metastasis (except ovary). exclusion criteria: * 1. combined with primary malignant tumors of other organs (current or within the past 5 years) (excluding patients with skin basal cell carcinoma and cervical carcinoma in situ undergoing radical treatment); 2. severe mental illness or drug abuse; 3, severe heart, lung, vascular disease can not tolerate surgery; 4. pregnant or lactating women.
effect of ceag on inflammation and endothelial function

Conditions: Inflammation; Endothelial Dysfunction

Summary: the purpose of the study is to look at the effect a dietary supplement called ceag \[curcuminoids, epa (omega-3), astaxanthin and gamma linolenic acid (gla)\] has on inflammation and endothelial (inner layer of the blood vessels) function and whether it causes a lowering of blood pressure.the endothelium plays in an important role in blood pressure.

this clinical trial is to assess the efficacy of curcuminoids, epa (omega-3), astaxanthin and gla for improving inflammation and endothelial reactivity over a four week intervention period in individuals with metabolic syndrome. the study also examines the effect of curcuminoids, epa (omega-3), astaxanthin and gla administration on other markers of cardiovascular function and cardiovascular disease risk including total, ldl and hdl-cholesterol, triglycerides, and a multitude of inflammatory markers.

Eligibility criteria:
inclusion criteria: * age 18-75 years * bp 121-140/81-90 mm hg on average * body mass index (bmi) 18-40. exclusion criteria: * free of chronic diseases including cancer or rheumatologic disorders * weight in excess of 350 pounds * bleeding disorder * history of myocardial infarction or all types of revascularization procedures, second or third degree heart block with or without a pacemaker * angina pectoris of any type * concurrent potentially life-threatening arrhythmia or symptomatic arrhythmia clinically significant valvular heart disease * history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, (with the exception of localized basal cell carcinoma of the skin) * serum creatinine \> 2.0 mg/dl * concurrent enrollment in another placebo-controlled trial.

Keywords: endothelium
evaluation of buffer on immune response to oral polio vaccine (opv) in bangladesh

Conditions: Polio

Summary: hypothesis: the immunogenicity of oral polio vaccine (opv) will be enhanced in bangladeshi infants who receive bicarbonate buffer at the time of polio immunization.

the investigators will conduct a study to evaluate the impact of administering bicarbonate buffer on the serologic responses to oral polio vaccine (opv) in bangladeshi infants.

Eligibility criteria:
inclusion criteria: * infants who are 4-8 weeks old * residents of study area exclusion criteria: * received a blood transfusion or any other blood product (such as immune globulin) * likely to move out of study area within the next four months * currently enrolled or planning to enroll in another study * major congenital malformations * neurologic disorders * immunodeficiency