Kornimate/medical-research-clean huggingface dataset:
a bioequivalence study comparing a fixed dose combination formulation of myrin p forte that contains rifampicin, isoniazid, ethambutol and pyrazinamide per tablet to an equivalent dose of single drug reference preparations of similar combination following oral administration in healthy adults

Conditions: Healthy Volunteers

Summary: this is a bioequivalence trial to evaluate the bioequivalence of myrin p forte against reference drug in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy, male or female, 21 to 55 years of age, body weight no less than 55 kg, body mass index (bmi) of 17.5 to 30.5 kg/m2. healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram (ecg) or clinical laboratory tests. * an informed consent document signed and dated by the subject. * subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), positive hepatitis b surface antigen or human immunodeficiency virus (hiv) serology results. * pregnant or nursing female, * alcohol, drug, smoke user, * sensitive to any study medication or related component, * history or active gout, * history or active tuberculosis, * known optic neuritis or other ophthalmological conditions.

Keywords: bioequivalence healthy volunteers
cardiac mri for the detection of myocardial injury following acute kidney injury

Conditions: Acute Kidney Injury; Cardio-Renal Syndrome; Cardiomyopathies

Summary: the aim of this clinical prospective study is to assess structural and functional myocardial changes in patients after acute kidney injury (cardiorenal syndrome type 3) and intensive care stay by multiparametric cardiac mri.

the aim of the study is to demonstrate any differences in myocardial structure and function using multiparametric cardiac mri in patients after acute kidney injury (cardiorenal syndrome type 3) and intensive care stay and subsequent convalescence compared to a control group with intensive care stay but without kidney injury. furthermore, the correlation between clinical disease severity and cardiac involvement will be investigated.

Eligibility criteria:
inclusion criteria: 1. acute kidney injury and convalescence (gfr \> 45 ml/min/1.73m²). 2. patients who are 18 years of age or older exclusion criteria: 1. underlying cardiac disease, e.g. known myocardial infarction, previous myocarditis, congenital heart disease, cardiomyopathies of other causes 2. known underlying disease wit potential cardiac involvement, e.g. storage disease (e.g. hemochromatosis, fabry disease), inflammatory (e.g. sarcoidosis), endocrinological (e.g. diabetes mellitus, hyper-/hypothyroidism), autoimmune (e.g. systemic lupus erythematosus, dermatomyositis, rheumatoid arthritis), therapeutic (chemotherapy). 3. patients with persistent renal failure and gfr \< 45 ml/min/1.73m² 4. allergy to contrast media 5. patients who are using a intrauterinpessare for contraception 6. pregnant and breastfeeding women 7. patients with contraindications for mri due to implants

Keywords: cardiac mri
efficacy of levocetirizine and cetirizine in reducing symptoms of seasonal allergic rhinitis in ragweed sensitive subjects

Conditions: Rhinitis, Allergic, Seasonal

Summary: controlled conditions of the eeu allow a reliable assessment of the efficacy and a determination of the action onset, action intensity and duration of effect of levocetirizine and cetirizine in order to establish the relative efficacy of these two drugs available for the treatment of sar.


Eligibility criteria:
inclusion criteria: * male/female, aged \>= 16 years * seasonal allergic rhinitis that required pharmacologic therapy each year during the last 2 ragweed pollen seasons * documented seasonal allergy to ragweed pollen * total symptom score of at least 18 points. exclusion criteria: * nasal anatomic deformities ? 50% obstruction * acute sinusitis within 30 days of period 2 * initiated or advanced an immunotherapy regimen * immunotherapy injections within 48 hours of pollen exposure * impaired hepatic function * history of malignancy * intolerance to histamines * asthma requiring medication more than occasionally

Keywords: levocetirizine dihydrochloride xyzal tablet
effects of "vitamin n" nature immersion therapy on stress levels in health care workers in the city of bogotá

Conditions: Cortisol Excess; Stress, Psychological; Anxiety; Epigenetic Disorder; Natural Killer Cell Cytokine Production; Environmental Exposure

Summary: recent studies on health personnel in colombia have evidenced the considerable increase in the levels of stress and anxiety, among other psychological disorders, as a product of the covid-19 pandemic that is being experienced since 2019 and that implies a greater demand for attention from the affected citizens, with the consequent work overload and tension due to the risk of contagion. thus, the present work will allow the generation of new knowledge in relation to the benefits of vitamin n therapy in colombia; which can contribute quickly and effectively to the reduction of stress levels, anxiety, insomnia, and depression in individuals, when compared with conventional interventions and result in possible benefits such as the reduction of health problems such as obesity, diabetes, high blood pressure, and diseases associated with the immune system.


Eligibility criteria:
inclusion criteria: * persons over 18 years of age * health care workers * prioritized by the psychosocial risk program * complete vaccination schedule for covid-19 exclusion criteria: * undergraduate students in the area of health sciences * pregnant women * allergies or sensitivity to the intervention * workers who consume immunosuppressants or corticosteroids * workers diagnosed with any type of disease or who have undergone chemotherapy or radiotherapy treatment during the last year * persons who have had exposure to x-rays in the last 6 months

Keywords: forest therapy nature therapy cortisol psychological stress physiological stress anxiety blood pressure natural killer dna methylation
neuro-cognitive function 1 year post icu discharge among vv ecmo survivors

Conditions: Neurocognitive Dysfunction

Summary: in the past three years, in the general intensive care unit in meir medical center, 25 patients were treated with ecmo, of which two patients were treated with va ecmo and the rest with vv ecmo. 70% of the patients survived to hospital discharge. ecmo is indicated as a rescue therapy for patients in critical condition suffering from severe cardiac and/or respiratory failure that does not respond to conservative treatment. it can be used as a bridge to recovery or to heart/lung transplantation. ecmo was introduced in the late seventies of the pervious century. between the years 2006-2011, partly due to the outbreak of the flu epidemic (h1n1), a 433% increase was observed in the use of ecmo worldwide in adults. in light of the outbreak of the covid-19 epidemic in recent years, another significant increase has been observed. there are short-term and long-term complications of ecmo. short-term complications include bleeding, thrombosis, hemolysis, hit, renal and neurological injuries, associated infections, and technical-mechanical problems. long-term complications include significant physical and psychological consequences that may adversely affect the patient's daily function, especially executive function.


Eligibility criteria:
inclusion criteria: all patients treated with vv ecmo who survived to hospital discharge between 2021-2023 - exclusion criteria: -
to estimate the percentage of children and adolescents in tunisia with acceptably controlled diabetes mellitus type 1

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this study is conducted in africa. the aim of this study is to estimate the percentage of children and adolescents below or equal to 15 years in tunisia with acceptably controlled diabetes mellitus type 1.


Eligibility criteria:
inclusion criteria: * written informed consent obtained before any study-related activities. (study-related activities are any procedure related to recording of data according to the protocol). * child or adolescent below or equal to 15 years with diabetes mellitus type 1 * who has been undergoing treatment for diabetes for at least 6 months exclusion criteria: * previous participation in this study. * current participation to a clinical trial
effectiveness of introducing ultra-high b-value diffusion-weighted imaging as a modified abbreviated protocol for breast cancer detection

Conditions: Breast Carcinoma

Summary: the aim of this study is to evaluate the added value of non-contrast abbreviated mri protocol featuring ultra-high b value diffusion weighted imaging to detect, characterize suspicious breast lesions and avoid using contrast.


Eligibility criteria:
inclusion criteria: * • women with suspicious breast mass (birads 4a) * high risk women (positive family history) * women with suspicious axillary lymph nodes by ultrasound * women with dense breasts coming for mri imaging. exclusion criteria: * • contraindications to mri * pacemaker, cochlear implant, claustrophobia, ocular implants * contraindications to contrast administration: * elevated kidney functions * women who haven't undergone reliable mammogram \& ultrasound * women with prior treatment or intervention (e.g. biopsy) * patients' refusal.
empowering families of migrant children and youth with special healthcare needs

Conditions: Patient Navigation

Summary: the goal of this randomized controlled trial is to test if a patient navigator program improves healthcare experiences and outcomes for migrant families caring for a child or youth with special healthcare needs (i.e. chronic health condition). the main questions are, for migrant families with a child or youth with special healthcare needs: does a patient navigator reduces barriers to care? does a patient navigator improve care coordination, caregiver empowerment, caregiver stress and quality of life? what are the healthcare experiences for families with and without the patient navigator intervention? participants will: * receive the intervention, i.e., the patient navigator program, or continue with standard of care for 12 months * fill out questionnaires at 3 time points on barriers to care, caregiver stress, care coordination, and their child's health


Eligibility criteria:
inclusion criteria: * primary caregiver of child/youth ≤18 years who is first- or second-generation migrant, defined as born outside of canada or having parents born elsewhere, respectively (migrants include immigrants, resettled refugees, refugee claimants (asylum seekers), temporary workers or international students, and other individuals without formal immigration status (undocumented)). * children or youth with special health care needs, as defined by the cyshcn screener, which identifies children who are experiencing one or more functional limitation or service use due to a physical, emotional, behavioural, developmental, or other health condition that has lasted or is expected to last at least 12 months. * experiencing care transitions between at least 2 of the following: primary care, community-based care, secondary specialist care, and/or hospital-based (acute) care. exclusion criteria: * caregiver living in canada ≥10 years * families who are receiving available peer navigation support at sites will be excluded to limit cross-over of interventions.

Keywords: child health chronic health diseases patient navigation migrant population refugee immigrant asylum seeker culturally competent care health services research
effects of black tea on type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the primary objective of this study is to evaluate the efficacy of different doses of black tea (150, 300, 450, 600 ml) in the test group compared to 150 ml in the control group, in improving oxidative stress, lipid profiles and insulin sensitivity.

a total of 45 patients of known t2dm (16 males and 29 females) were introduced into the controlled clinical trial and randomly assigned to either test (57.0 ± 7.9 yrs, n=23) or control (55.4 •± 8.3 yrs, n=22) group. patients in control group were instructed to have only one cup (150 ml) of black tea/day, as a 2.5 g tea bag that had to be prepared in a standard way for one week (washout period). patients in the test group were instructed to have 300, 450, and 600 ml (2, 3, and 4 cups, respectively) in weeks 2, 3 and 4 respectively. we assessed the change in serum glutathion, superoxidismutase, total antioxidant capacity, fbs, crp, hba1c, lipid profiles and fibrinogen during the end of each week.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes mellitus exclusion criteria: * intake of antioxidant supplements during previous six months

Keywords: black tea oxidative stress blood lipids insulin sensitivity
does icodextrin reduce the risk of small bowel obstruction?

Conditions: Surgical Adhesions

Summary: the study aims at investigating if icodextrin 4% instilled in abdominal cavity during surgery can reduce the risk of surgery and hospitalisation for small bowel obstruction in patients with colorectal cancer. follow-up data is collected from the swedish national colorectal cancer registry.patients are followed for 5 years postoperatively.the study is a randomized swedish multicenter study and planned to include 1,800 patients. a safety control is planned after 300 included patients.

icodextrin 7.5% is used in peritoneal dialysis. in animal models and in gynecological surgery a 4% solution of icodextrin has been tested as a possible agent of reducing adhesions by acting as a barrier between peritoneal surfaces. some data support a reduction af adhesions (van den tool et al., brown et al.). however, is not known whether icodextrin reduces the need for surgery or hospitalisation for small bowel obstruction.this study aims to study these parameters as well as complications and survival. patients with colorectal cancer and scheduled for surgery with curative intent will be (after patients acceptance) randomized to have icodextrin 4% instilled in the abdominal cavity or not. patients allocated to icodextrin arm will have 100 ml of icodextrin 4% instilled every 30 minutes during surgery and at end of operation further 1000 ml instilled in the abdominal cavity. postoperative care is performed according to each hospital praxis. follow-up data will be collected from the swedish national colorectal cancer registry. data 30 days postoperatively will be analysed for early small bowel obstruction and other early complications. the study ends 5 years postoperatively with analysis of surgery and hospitalization for small bowel obstruction as well as survival and longterm complications. a safety analysis is planned after the first 300 randomized patients with respect to early (30 days) complications. these data will analysed blindly by external reviewers. randomization (1:1) will be performed at the regional cancer centrum in the uppsala-örebro region. the study aims to randomise 1800 patients.

Eligibility criteria:
inclusion criteria: * colorectal cancer * curative surgery planned * informed consent * age 18-85 exclusion criteria: * local surgery planned * generalized disease * other malignancy * not informed consent

Keywords: small bowel obstruction, surgery, colorectal cancer
characteristics of islet β-cell functions in chinese patients with graves' disease

Conditions: Graves Disease

Summary: patients with gd often present with glucose dysregulation, which, according to most studies, is associated with islet β-cell dysfunctions, enhanced gluconeogenesis and insulin resistance (ir). current studies focus mainly on ir, and a few that investigate islet β-cell functions show inconsistent results. this study examined the characteristics of glucose dysregulation in chinese patients with gd, and furthermore evaluated the effects of thyroid dysfunction on islet β-cell functions and subsequently the carbohydrate metabolism.

thyroid dysfunction is closely associated with glucoregulation. carbohydrate metabolism can be affected with decreased levels of thyroid hormone (th), even more so with an elevated th level. epidemiological data shows that 2%-57% of patients with graves' disease (gd) present with glucose dysregulation, which might also be related to the changes in islet β-cell functions in patients with gd. the incidence of gd has comparable variations geographically, with possibly different underlying mechanisms, such as an excessive intake of iodine resulting in an aggravation of autoimmune reactions from thyroid and consequently an increment in incidence of gd. the same might also be true in glucoregulation and islet β-cell functions in patients with gd. this study aims to examine the characteristics of glucoregulation and islet β-cell functions in patients with gd in different areas of china, using early-phase insulin secretion index (△i30/△g30), glucose area under curve(gauc) and insulin area under curve(insauc).

Eligibility criteria:
inclusion criteria: * patients with graves disease * age-matched healthy checkup subjects exclusion criteria: * patients with a medical history of diabetes, pancreatitis and other related conditions and positive family histories as well as medication history of glucocorticoid and anti-diabetic agents
a clinical study of 6mw3211 injection in the treatment of relapsed/refractory lymphoma

Conditions: Lymphoma

Summary: this study is a single arm, non-randomized, open label phase 2 international, multicenter clinical trial to evaluate preliminary efficacy and safety in subjects with relapsed or refractory lymphoma.


Eligibility criteria:
inclusion criteria: * voluntarily participate in the study and sign the informed consent. * age≥18 years. * subjects with relapsed or refractory lymphoma. * subjects with at least one measurable tumor lesion. * ecog 0-2. * life expectancy≥3 months. * adequate organ functions. exclusion criteria: * subjects who had received anticancer therapy or radiotherapy within 21 days or 5 half-lives (whichever is shorter) before enrollment or received adoptive cellular immunotherapy within 12 weeks. * subjects who had received allogeneic hematopoietic stem cell transplantation or organ transplantation or received autologous hematopoietic stem cell transplantation within 3 months. * subjects with primary or secondary cns lymphoma. * history of another malignancy within 3 years before the first dose of investigational drug. * history of active autoimmune diseases. * systemic immunosuppressive therapy within 2 weeks prior to the first dose of investigational drug. * subjects who experienced grade 3 or above immune-related adverse events (irae) . * documented history of uncontrolled systemic diseases. * subjects who were allergic to any composition of investigational drug. * major surgery within 28 days prior to first dose of investigational drug. * subjects with active infection. * preexisting treatment related toxicity grade ≥ 2 (except alopecia). * subjects with poor treatment compliance. * use of any investigational drug or device within 28 days prior to the first dose of investigational drug. * live vaccine was administered within 28 days prior to first dose of investigational drug. * pregnant or lactating women.
opioid dispensing device for post-operative pain in cancer patients

Conditions: Opioid Use; Breast Cancer

Summary: this research study will evaluate the use of, and participants experience with, a new device called addinex that safely stores and dispenses opioid medication. the purpose of this study is to evaluate the use of the addinex device in cancer patients undergoing cancer-related surgery that require pain control with opioids after the surgery. participants will be asked to answer questions about their medical history and background, fill out questionnaires, use a mobile application associated with the device, and undergo a phone interview one month after stopping use of the device. this study aims to find out how participants like using the addinex device as opposed to a traditional pill bottle. results of this study will help determine if the addinex device could be useful to patients in the future after surgeries, as opposed to typical pill bottles.

this is a non-randomized pilot study to test the use of the addinex system among participants receiving opioids following surgery. the addinex system is designed to dispense opioid medication to participants on a provider-determined schedule, to track participant use of the device, and to allow for return and disposal of unused opioids. this study will determine the feasibility of using addinex for these purposes.

Eligibility criteria:
inclusion criteria: * adult patients (age greater than or equal to 18 years) * planned for major cancer-related surgery and expected to receive a postoperative opioid prescription * must speak english or spanish * must have access to a smartphone or an alternative smart device (e.g., iphone, android phone, ipad, surface, etc.). * co-enrollment in trials involving pharmacologic therapy is allowed exclusion criteria: * patients who are taking opioids daily prior to the surgical procedure * patients unable to physically utilize the device * patients unable to self-administer medications * patients uncomfortable with using iphone or ipad-based technology
the effects of auditory stimulation during sleep on brain networks in schizophrenia

Conditions: Schizophrenia

Summary: in this research study the investigators will use sleep headbands to measure brain rhythms and to improve their coordination across brain regions. the headbands will be worn at home for multiple nights. on some nights the headbands will play soft sounds at specific times during sleep. the investigators are interested in learning whether this timed auditory stimulation may be a strategy to improve the coordination of sleep rhythms across brain regions, improve network communication, and as a result, improve memory. the investigators will study 30 adults aged 18-45 with schizophrenia and 30 demographically matched healthy controls. participants will first have a daytime mri scan, during which they will complete a finger tapping motor sequence task (mst), followed by a week of sleep at home with a sleep headband. they will also do the mst at home on two of the nights. on the final day of the study, participants will return for a second mri scan.


Eligibility criteria:
inclusion criteria: * 18-45 years old * fluent in english * able to give informed consent additional inclusion for adults with schizophrenia: * a dsm-v confirmed diagnosis of schizophrenia * unmedicated or maintained on a stable dose of apds exclusion criteria: * ferrous metal in the body * currently pregnant or breastfeeding * motor problems that preclude finger tapping task * iq \<85 * other neurological disorders, including seizure disorder * significant hearing or vision loss * chronic medical conditions that affect sleep * unstable chronic medical condition such as asthma, diabetes, cystic fibrosis, or cardiac disease * diagnosed sleep disorder, except insomnia * history of head injury resulting in prolonged loss of consciousness or other neurological sequelae additional exclusion criteria for healthy adults: * history of mental illness * current use of psychotropic medications or treatment with medications known to affect sleep or cognition

Keywords: hippocampus neuromodulation sleep spindles thalamocortical circuits auditory stimulation magnetic resonance imaging sleep memory