Kornimate/medical-research-clean huggingface dataset:
bariatric surgery and pharmacokinetics of buprenorphine

Conditions: Obesity, Morbid

Summary: changes to gastric ph, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. these factors are potentially influenced by bariatric surgery. little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. in this study the pharmacokinetic effects of bariatric surgery on buprenorphine are investigated.


Eligibility criteria:
inclusion criteria: * preparing to undergo gastric bypass or sleeve gastrectomy in central norway * being a norwegian citizen exclusion criteria: * having previously undergone resections in the gi-tract

Keywords: bariatric surgery gastrointestinal tract biological availability pharmacokinetics buprenorphine
effect of probiotics on regulating gut health and blood lipid in adults

Conditions: Obesity

Summary: the purpose of this study was to evaluate the efficacy of 1 capsules (300 mg per capsule) of nutrarex probiotic capsules per day in regulating gut health and blood lipid in adults by clinical trial.

this experiment is carried out in a controlled manner. before the subjects enter the research experiment, they need to follow their original lifestyle. the habits of maintaining a constant body weight for more than 2 weeks before the test, such as calorie balance in the diet and the amount of activity. then enter the test to carry out the evaluation test of probiotics to the end. 50 subjects were randomized, 25 to placebo and 25 to probiotics. the subjects took one capsules of nutrarex probiotics daily, a total of 300 mg. continue to take it for 4 weeks, and perform blood routine tests. body composition detection, waist and hip circumference measurement, related index analysis and 24-hour dietary questionnaires, gut health questionnaires and stool samples were collected and analyzed for 4 weeks before and after treatment.

Eligibility criteria:
inclusion criteria: * male or female participants * aged 20-65 years old * body mass index in 25-27 kg/m2 or body fat \> 25% for men and \> 30% for women exclusion criteria: * cancer, chronic heart disease, use drugs which pharmacological effects may affect immunity having systemic infections * using probiotics.
nurse-led transfer program with family involvement to reduce icu patient anxiety

Conditions: Transfer Anxiety; Intensive Care Unit Discharge; Cardiac Surgery Recovery; Postoperative Anxiety; Critical Care Transition

Summary: this study aims to evaluate whether including a patient's family member during transfer from the intensive care unit (icu) to the general ward can help reduce anxiety in patients who have undergone cardiovascular surgery. the research is being conducted in a cardiovascular icu in turkey. patients in the intervention group are accompanied by a close relative during the transfer process. their anxiety levels and vital signs are measured before and after the transfer and compared to those of patients transferred without a relative.

this quasi-experimental study investigates the effect of a nurse-led transfer program involving patient relatives on transfer-related anxiety and vital signs in cardiovascular surgery icu patients. the study is conducted in a cardiovascular intensive care unit in turkey between august and october 2024. a total of 150 patients who undergo open-heart surgery and meet the inclusion criteria are enrolled. participants are assigned sequentially to either the control or intervention group. in the intervention group, a structured, nurse-led transfer protocol is applied in three phases: (1) pre-transfer preparation involving the patient's relative, (2) accompanied transfer by a relative and clinical staff, and (3) post-transfer monitoring. the control group receives routine hospital transfer procedures, which do not include family involvement. the primary outcome is the change in patients' state anxiety, measured at three time points (before, immediately prior, and 30-60 minutes after transfer) using the state anxiety inventory (stai-i). secondary outcomes include changes in vital signs (blood pressure, pulse, respiratory rate, and oxygen saturation), recorded at the same time points. the study is designed to contribute to the development of family-centered, nurse-led protocols aimed at improving patient comfort and emotional well-being during icu-to-ward transfers.

Eligibility criteria:
inclusion criteria: * age 18 years or older * undergoing first-time open-heart surgery (e.g., cabg or valve replacement) * glasgow coma scale (gcs) score ≥ 14 prior to transfer * hemodynamically stable at the time of transfer * stayed in the cardiovascular surgery icu for at least 24 hours * experiencing first intra-hospital transfer * presence of a primary caregiver available for transfer support exclusion criteria: * emergency cardiac surgery * neurological or psychiatric disorders in the patient * postoperative complications resulting in prolonged icu stay * emergency intervention required during the transfer * known interpersonal conflict between the patient and the caregiver

Keywords: transfer anxiety patient transfer intensive care nursing
comparison of ultrasonic pachymetry with orbscan in corneal haze

Conditions: Corneal Opacity

Summary: this study is planned to compare the results of ultrasonic and orbscan pachymetry in corneal haze not related to surgery. corneal haze is graded with slit-lamp by a single examiner. ultrasonic and orbscan ii pachymetry measurements are obtained. paired t and kruskal-wallis tests are used to evaluate the difference between ultrasonic and orbscan pachymetry measurements. correlation of the two methods and haze grade is determined with kendall's tau-b correlation analysis.

we planned this study to compare the results of ultrasonic and orbscan pachymetry in corneal haze not related to surgery. in this institutional based, prospective, controlled clinical trial subjects with corneal haze not related to surgery are included. normal eyes are used as control group to calculate the customized acoustic factor. corneal haze is graded with slit-lamp by a single examiner. ultrasonic and orbscan ii pachymetry measurements are obtained by one technician each masked to the other measurement. paired t and kruskal-wallis tests are used to evaluate the difference between ultrasonic and orbscan pachymetry measurements. correlation of the two methods and haze grade is determined with kendall's tau-b correlation analysis. according to the results of the study, we will determine which method is accurate in subjects with corneal haze.

Eligibility criteria:
inclusion criteria: * patients with significant corneal haze on slit-lamp are included in the study group. 50 eyes of 50 age-matched patients with normal eye and clear cornea are included in the control group. only one eye of each subject is included. exclusion criteria: * exclusion criteria to participate in the study are previous ocular surgery, history of contact lens use, glaucoma, and topical ocular medication use, excluding artificial tears.

Keywords: corneal topography, corneal opacity, keratitis, trachoma
retrospective nis to evaluate the patient benefit of tes

Conditions: Retinitis Pigmentosa

Summary: in this retrospective non-interventional study (nis), the subjective and objective benefit of patients with retinitis pigmentosa (and other dystrophies like usher, choroideremia or cone-rod dystrophy), who have been prescribed the therapy of transcorneal electrostimulation (tces) with the okustim system, is assessed.

the medical device okustim received the ce mark (a symbol of free marketability in the european economic area) in 2011 and is commercially available for patients in europe since 2014. since then, patients with retinitis pigmentosa and other dystrophies have regularly applied the therapy of transcorneal electrostimulation (tces) with okustim. so far, the benefits of the therapy and the experiences of the patients with regular, multi-year use have not been systematically recorded. in this retrospective non-interventional study (nis) with patients which have been using tces since \>1 year, data present for visual field, best-corrected visual acuity (bcva) and central foveal thickness (as assessed via oct) is collected. in addition, reasons for discontinuation of therapy and patient satisfaction with tces are assessed via a questionnaire. side-effects are also recorded, if present in the patient files.

Eligibility criteria:
inclusion criteria: * use of tces for \>1year * willing and able to consent exclusion criteria: * not willing and able to consent

Keywords: transcorneal electrostimulation tces tes inherited retinal dystrophy retinopathia pigmentosa retinitis pigmentosa
combination chemotherapy and/or radiation therapy in treating young patients with hodgkin's lymphoma

Conditions: Lymphoma

Summary: rationale: drugs used in chemotherapy, such as chlorambucil, vinblastine, procarbazine, and prednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. radiation therapy uses high-energy x-rays to kill cancer cells. giving more than one drug (combination chemotherapy) together with radiation therapy may kill more cancer cells. purpose: this clinical trial is studying how well giving combination chemotherapy and/or radiation therapy works in treating young patients with hodgkin's lymphoma.

objectives: * establish a uniform practice for the management of children with hodgkin's lymphoma. * document the long-term side effects of such management. * establish whether or not children can be safely managed without staging laparotomy and splenectomy. * establish whether or not chlorambucil, vinblastine, procarbazine hydrochloride, and prednisolone (clvpp) is an effective alternative to mechlorethamine, vincristine, procarbazine hydrochloride, and prednisone (mopp) chemotherapy. outline: this is a multicenter study. patients are assigned to 1 of 3 treatment regimens according to disease stage and presence of bulky mediastinal disease. * involved-field radiotherapy (for patients with stage ia \[nodal\] disease): patients undergo involved-field radiotherapy 5 days a week for 4 weeks. * clvpp chemotherapy (for patients with all other stages of disease and no bulky mediastinal disease): patients receive clvpp chemotherapy comprising oral chlorambucil, oral procarbazine hydrochloride, and oral prednisolone on days 1-14 and vinblastine iv on days 1 and 8. treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. * clvpp chemotherapy and radiotherapy (for patients with all other stages of disease and bulky mediastinal disease): patients receive clvpp chemotherapy as above. patients then undergo radiotherapy to the mediastinum beginning 2 weeks after completing the last course of clvpp chemotherapy. after completion of study treatment, patients are followed periodically. projected accrual: a total of 358 patients were accrued for this study.

Eligibility criteria:
disease characteristics: * biopsy proven hodgkin's lymphoma * any stage allowed patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: stage i childhood hodgkin lymphoma stage ii childhood hodgkin lymphoma stage iii childhood hodgkin lymphoma stage iv childhood hodgkin lymphoma recurrent/refractory childhood hodgkin lymphoma
a real-world study of imraldi® use

Conditions: Arthritis, Rheumatoid (RA); Axial Spondyloarthritis (axSpA); Arthritis, Psoriatic (PsA); Crohn's Disease (CD); Colitis, Ulcerative (UC)

Summary: the primary objective of this study is to evaluate candidate predictors of persistence on adalimumab (imraldi®) participants diagnosed with immune-mediated inflammatory disease in europe (eu). the secondary objectives of this study are to describe participant clinical characteristics at baseline, utilization of imraldi® over time, biologic drug effectiveness over time, participant satisfaction with biologic administration, routine laboratory values and clinical evaluation measurements over time, use of relevant concomitant medication use over time, immunogenicity of biosimilars and to summarize safety events.


Eligibility criteria:
inclusion criteria: * initiation on imraldi® therapy after 18th october 2018, as part of routine treatment immediately after transitioning from at least 16 weeks' treatment with originator adalimumab (humira®) * availability of at least one baseline disease score (i.e. within 16 weeks prior or up to 6 weeks post-initiation of imraldi®) * should provide informed consent to participate in the study exclusion criteria: - unlikely to attend for regular clinic visits for the duration of study follow-up, in the opinion of the investigator

Keywords: biologics non-interventional real-world adalimumab europe
effects of whole body vibration (wbv) on musculoskeletal system of aged women

Conditions: Osteopenia

Summary: a controlled, non-randomized trial will be carried out in 240 postmenopausal women, aged 55-75 years, over a 18-month period. the group 1 received a physical intervention, consisting of whole body vibration (wbv) over 12 months followed by training arrest during 6 months. the group 2 served as sedentary control. wbv training is performed 2 or 3 times per week, with each session lasting 20 minutes. the training included light squats at 35-50 hz and ended up by stretching and relaxation exercises at 50 hz. bone, muscle and postural evaluations will be performed at the beginning, 6, 12 and 18 months in each group with evaluation of bone micro-architectural trabecular and cortical compartments, at the weight bearing tibia and the non weight bearing radius. the primary outcome of the project is the pre, mid, and post evaluations of bone. bone exploration included dual x-ray absorptiometry (dxa) and high resolution peripheral quantitative computed tomography (hr-pqct). bone mass density (bmd) will be evaluated by dxa at lumbar, femoral levels and humeral, macro and micro-architectures of the cortical and trabecular compartments will be evaluated in distal radius and tibia by hr-pqct and bone markers will be analyzed longitudinally. the secondary aim is to assess muscle performance and proprioception. finally will be assessed markers of cartilage degradation and synthesis, no study has been published on this tissue.


Eligibility criteria:
inclusion criteria: * be sedentary (less than 2 hours physical activity of low intensity per week) * fracture risk densitometry risk factors (frax) index between 3 and 10% * consent form signed exclusion criteria: * bone concomitant disease (such as paget's disease, osteomalacia), * endocrinopathy defined on biological criteria (such as cushing's disease, hyperparathyroidism, hyperthyroidism, hypogonadism), * smoking habits (more than 5 cigarettes per day), chronic alcoholism, * treatments received in the previous 6 months affecting bone metabolism such as anabolics, anti-osteoporotic treatment, corticosteroids. * having a prosthesis (femur and knee),or recently placed metal bouts or plates * acute thrombotic problems, * severe heart- and vascular diseases, * recent injuries due to operation or polyclinical intervention, * acute hernia, discopathy, spondylolysis, * epilepsy, * severe migraine, * pacemaker, * every neurodegenerative or neuromuscular disease, * dementia

Keywords: osteopenia whole body vibration women bone microarchitecture bone density
maternal marijuana use and fetal and infant outcome

Conditions: Cannabis Use Disorder; Pregnancy Related

Summary: marijuana and cannabis-containing products are growing in popularity and availability in the united states, and use during pregnancy has increased dramatically. the overarching aim of this proposal is to provide pilot data for a submission which will explore the impact of chronic maternal marijuana use (primary or secondary) on fetal functioning, maternal reflective functioning and infant birth and neurodevelopmental outcomes. chronically marijuana using pregnant women in treatment at the center for addiction and pregnancy will be enrolled and asked to provide information about participants' marijuana and other licit and illicit substance use and feelings about parenting and participants' infant and undergo fetal monitoring at 36 weeks gestation. the neonates will undergo neurobehavioral examination during the first and fourth weeks of life.


Eligibility criteria:
maternal inclusion criteria: * singleton pregnancy less than 36 weeks of gestation * marijuana as a primary or secondary drug of choice maternal exclusion criteria: * significant fetal anomaly * multiple gestation * delivery prior to 36 weeks gestation

Keywords: cannabis
rift valley fever in kenya

Conditions: Rift Valley Fever

Summary: the purpose of this study is to find out how, why, and when rift valley fever (rvf) spreads. participants will be 250 adults and children, aged 1 year and older, from the ijara district, kenya. they will be given a questionnaire, undergo a medical examination that includes an eye exam, and have a 1-teaspoon sample of blood taken from a vein. participation will take about 3 hours.

the objective of this research is to better define the extent and timing of rift valley fever (rvf) virus transmission and its related chronic disease/infection attack rate, during an interepidemic period in a high-risk region that has seen repeated rvf outbreaks. the results will be used to develop and refine predictive algorithms for rvf virus transmission, based on epidemiological, environmental, and remote sensing data, with the ultimate goal of providing improved early detection of significant rvf outbreaks. it is expected that the analysis of test-performance characteristics will determine the best use of serologic assays in kenya's next rvf epizootic/epidemic. the primary outcome measure will be the current rvf-specific seropositivity profile for a cross-sectional survey population in ijara district in northeast kenya. the secondary outcome measures to be studied will be: 1) an assessment of the behavioral factors associated with risk of seropositivity (previous infection) in the study population; and 2) the association of selected long-term ophthalmological and clinical outcomes with seropositivity. the study design for this protocol involves questionnaire administration to consenting participants of ijara district, followed by performance of medical exams, ophthalmologic exams, and phlebotomy on all participants. elisa testing for rvf will then be performed on the blood samples obtained, and all elisa screen-positive samples will have confirmatory testing by plaque-reduction neutralizing antibody testing.

Eligibility criteria:
inclusion criteria: those adults and children residing in selected survey households in the area of ijara town and its 5 km environs who are 1 year of age and older will be eligible, provided: 1. informed consent is obtained and signed, and assent form is obtained and signed from children age 7 and older, 2. subject has understanding of study procedures, and 3. subject is able to comply with study procedures for the entire length of the study. exclusion criteria: 1. age less than 1 year. 2. subjects who immigrated to the study area less than 2 years previously. 3. acutely ill ijara residents. 4. adults and children who cannot provide informed consent or who cannot participate fully in the study procedures will also be excluded.

Keywords: rift valley fever, kenya
ai-assisted white light endoscopy to identify the kimura-takemoto classification of atrophic gastritis

Conditions: Atrophic Gastritis; Artificial Intelligence; Endoscopy

Summary: grading endoscopic atrophy according to the kimura-takemoto classification can assess the risk of gastric neoplasia development. however, the false negative rate of chronic atrophic gastritis is high due to the varying diagnostic standardization and diagnostic experience and levels of endoscopists. therefore, this study aims to develop an ai model to identify the kimura-takemoto classification.

grading endoscopic atrophy according to the kimura-takemoto classification can assess the risk of gastric neoplasia development. the higher the score, the more severe the degree of atrophic gastritis. however, the false negative rate of chronic atrophic gastritis is high due to the varying diagnostic standardization and diagnostic experience and levels of endoscopists. therefore, this study aims to develop an ai model to identify the kimura-takemoto classification of atrophic gastritis to achieve gastric cancer risk assessment.

Eligibility criteria:
inclusion criteria: patients aged 18-80 years who undergo the white light endoscope examination informed consent form provided by the patient. exclusion criteria: 1. patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric; 2. disorders who cannot participate in gastroscopy; 3. patients with progressive gastric cancer; 4. low quality pictures; 5. patients with previous surgical procedures on the stomach or esophageal; 6. patients who refuse to sign the informed consent form;
obstructive airways diseases in pulmonary clinic (oadpc) study

Conditions: Asthma; Chronic Obstructive Pulmonary Disease (COPD)

Summary: this is an observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both chronic obstructive pulmonary disease (copd) and asthma patients.

this is an observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both copd and asthma patients. the study will include adult asthma and copd patients (age \>18). patients will be enrolled on a continuous basis and will be monitored by capnograph and oximeter before and after lung function assessment and also during and after medical treatment.

Eligibility criteria:
inclusion criteria: 1. age \>18 2. ability and willingness to participate the study and sign informed consent form 3. asthma / copd patients exclusion criteria: 1. pregnant women 2. asthma or copd patients with fev1 \> 80% 3. disability or unwillingness to undergo capnography measurement 4. cannot be assessed for fev1 5. oxygen supply \>5 l/min 6. 6. subjects that gone through lobectomy of lung in the last 5 years.

Keywords: asthma chronic obstructive pulmonary disease (copd) capnography
comparison of insulin aspart produced by current process and the nn2000 process

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to compare insulin aspart produced by current process and the nn2000 process.


Eligibility criteria:
inclusion criteria: * healthy * caucasian * normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant * fasting blood glucose below or equal to 6 mmol/l * body mass index (bmi) 22.0-27.0 kg/m\^2 (both inclusive) exclusion criteria: * participated in another clinical study with an investigational drug within the last 4 weeks * any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. occasional paracetamol is acceptable * known or suspected allergy to the trial product or related products * family history of type 2 diabetes