Kornimate/medical-research-clean huggingface dataset:
an interaction study to evaluate the effect of esomeprazole/acetylsalicylic acid on the metabolism and effect of clopidogrel

Conditions: Healthy Volunteers

Summary: the primary purpose of this study is to assess whether esomeprazole 20 mg/acetyl salicylic acid (asa) 81 mg affect the metabolism of clopidogrel.


Eligibility criteria:
inclusion criteria: * male (aged between 18 and 45 years inclusive) or female (aged between 18 and 55 years inclusive) healthy volunteers * female healthy volunteers must be of non-childbearing potential or be of childbearing potential, be non-lactating and have a negative pregnancy test during the pre-entry visit and be using 1 clinically accepted method of contraception * have a body mass index between 19 and 30 kg/m2 inclusive * no clinically significant abnormal findings at the physical examination as judged by the investigator exclusion criteria: * any clinically significant abnormalities in laboratory screening results as judged by investigator * platelet count \<150 x 10\^9/l on day -1 or any other conditions that would increase the risk of bleeding * previous bone marrow transplant * any clinically important abnormalities in rhythm, conduction or morphology of resting ecg

Keywords: phase 1 cross-over drug-drug interaction esomeprazole acetylsalicylic acid clopidogrel healthy volunteers cardiovascular disease patients with acid associated gastrointestinal symptoms
dysfunction of nutritive blood flow as a determinant of anabolic resistance with age; the role of amino acids in modulating muscle metabolism

Conditions: Old Age (Focus; Not a Recognized Condition)

Summary: the investigators plan to measure changes in muscle protein metabolism in response to feeding, comparing between a single large essential amino acid (eaa) feed (the normal building blocks of protein) and the provision of the same dose in 4 smaller feeds at 45min intervals. the investigators will perform this study in healthy older (65-75y) and younger (18-28) men. the investigators will also explore how feeding affects muscle blood flow as this is important in the delivery of the nutrients we eat to the muscle where they are used. the investigators plan to supplement the feed with arginine, a safe and widely found non-essential amino acid, to explore if this can improve muscle blood flow.

we will provide a 15g mixed essential amino acid feed or 4 x 3.75g. there is sexual dimorphism thus initially we will just recruit males. powering calculations dictate n=8 in each group. we will use well established stable isotope tracer techniques (with 13c6 phenylalanine) to measure muscle protein synthesis and breakdown by gas chromatography - combustion - isotope ratio mass spectroscopy. we will measure leg blood flow by phase shift doppler and muscle microvascular flow by contrast enhanced ultrasound.

Eligibility criteria:
inclusion criteria: * age 65-75 or 18-28 exclusion criteria: * bmi \>30 * diabetes * beta blocker or steroid use * established cerebrovascular, peripheral vascular or ischaemic heart disease.

Keywords: old age sarcopenia essential amino acid arginine contrast enhanced ultrasound muscle microcirculation muscle protein synthesis
predictive value of aortic stiffness on recurrence of atrial fibrillation after disconnection of pulmonary veins (variable).

Conditions: First Ablation of Atrial Fibrillation

Summary: the ablation of atrial fibrillation (fa) by disconnection of pulmonary veins is a burgeoning intervention. it allows a long-term treatment of this arrhythmia with a success rate of about 80%. there are, nevertheless, some recidivism. risk factors for recidivism are poorly codified and need further research. indeed the identification of factors of poor prognosis could lead to not propose this procedure to the patients who present them and at least to inform them of an increased risk of failure. to date, aortic stiffness has not been studied in the context of assessing the risk factors for fa recurrence after ablation. on a physiopathological level, the aortic stiffness leads to increase left ventricle's post-load. cardiac remodeling was observed with diastolic dysfunction and increased left atrial size. that may constitute a substrate for fa recurrence. in the literature, aortic stiffness can be measured in several ways: 1. measurement of systolo-diastolic variation of the inner diameter of the aorta by scanner or transesophageal echography (eto). 2. measuring of the pulse wave velocity. 3. measurement of aortic calcifications. the investigators propose to evaluate the impact of aortic stiffness on the recidivism of fa 6 months after ablation procedure performed in the croix-rousse cardiology's department.


Eligibility criteria:
inclusion criteria : * 18 years old of both sexes, * patient carrying a paroxysmal or persistent atrial fibrillation, benefiting from a first procedure of atrial fibrillation's ablation in the in the croix-rousse cardiology's department. * patient who signed the consent to participate in the study. exclusion criteria : * patient carrying a permanent atrial fibrillation * patient who're in atrial fibrillation during the ablation * atrial fibrillation relapse's history after ablation * pregnant and nursing women * patients refusal.

Keywords: atrial fibrillation first ablation
thoracic surgery combined with intrathoracic hyperthermic perfusion for advanced lung cancer / esophageal cancer

Conditions: Esophageal Cancer; Lung Cancer; Hyperthermic Perfusion

Summary: the goal of this clinical research study is to explore whether intrathoracic hyperthermic perfusion after radical surgery could reduce local recurrence rate(13%) for advanced lung cancer / esophageal cancer. the safety of intrathoracic hyperthermic perfusion right after surgery.


Eligibility criteria:
inclusion criteria: 1. patients must not have received any prior anticancer therapy of cancer. 2. expected r0 resection. 3. histologic diagnosis of squamous cell thoracic esophageal carcinoma of t3-4, any n and any t, n1. (8th union for international cancer control, union for international cancer control(uicc)-tnm). histologic diagnosis of non small cell lung cancer, t2-t3, any n. (8th union for international cancer control, uicc-tnm) 4. age ranges from 18 to 80 years. 5. without operative contraindication. 6. eastern cooperative oncology group (ecog) 0～2. 7. signed informed consent document on file. exclusion criteria: 1. multiple primary cancer. 2. the subject cannot understand and sign the informed consent form(icf). 3. patients with concomitant hemorrhagic disease. 4. any un expected reason for patients can't get operation. 5. pregnant or breast feeding.
single-incision versus conventional laparoscopic surgery for colorectal cancer

Conditions: Colorectal Cancer; Colonic Neoplasms; Rectal Neoplasms; Colon Disease; Colon Cancer; Rectal Cancer; Rectal Diseases

Summary: this study is designed to evaluate the short-term and long-term results after single incision laparoscopic surgery for colorectal cancer（silsc） compared with conventional laparoscopic surgery for colorectal cancer（clsc）.

in order to improve cosmetic effect and reduce postoperative pain, single-incision laparoscopic surgery (sils) is attracting increasing attention. sils is considered to be the next major advance in the progress of minimally invasive surgical approaches to colorectal disease that is more feasible in generalized use. in most previous studies, sils for colorectal cancer was feasible and short-term safe compared to conventional laparoscopic surgery (cls) . however, there is still controversy over its potential better cosmetic effect and less postoperative pain. moreover, the long-term oncologic outcomes are still inconclusive as only a few studies showed long-term survival data. up to now, most studies were limited to their retrospective nature and small samples. so more studies, especially large-scale, randomized controlled trials are needed to establish the best indications for sils for colorectal cancer.

Eligibility criteria:
inclusion criteria: * inclusion criteria: * 18 years \< age ≤85 years * tumor located in colon and high rectum ( the lower border of the tumor is above the peritoneal reflection) * pathological colorectal carcinoma * clinically diagnosed ct1-4an0-2 m0 lesions according to the 8th edition of ajcc cancer staging manual * tumor size of 5 cm or less * ecog score is 0-1 * asa score is ⅰ-ⅲ * informed consent exclusion criteria: * body mass index (bmi) \>35 kg/m2 * the lower border of the tumor is located distal to the peritoneal reflection * pregnant woman or lactating woman * severe mental disease * previous abdominal surgery（except appendectomy and cholecystotomy） * emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer * requirement of simultaneous surgery for other disease

Keywords: sils colorectal cancer
a study to evaluate the effects of basmisanil in participants with cognitive impairment associated with schizophrenia (cias) treated with antipsychotics

Conditions: Schizophrenia

Summary: this multicenter study assessed the effects of 24 weeks of basmisanil treatment on cognition and functioning of stable schizophrenia participants treated with antipsychotics.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia of any type utilizing the mini international neuropsychiatric interview and diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) direct clinical assessments, family informants and past medical records * evidence of stability of symptoms for 3 months at screening, that is, without hospitalizations for schizophrenia or increase in level of psychiatric care due to worsening of symptoms of schizophrenia * participants with schizophrenia clinical symptom severity defined by the following: hallucinatory behavior item score less than or equal to (\</=) 5 and a delusion item score \</= 5 of the panss * participants on a stable regimen of antipsychotic therapy for at least 3 months at screening and receiving no more than two antipsychotics exclusion criteria: * participants with current dsm-5 diagnosis other than schizophrenia including bipolar disorder, schizoaffective disorder and major depressive disorder * clinically significant neurological illness or significant head trauma that affects cognitive function, in the judgment of the principal investigator * full scale intelligence quotient \</=65 on the wechsler abbreviated scale of intelligence at screening * positive result at screening for hepatitis b, hepatitis c, or human immunodeficiency virus-1 and 2 * moderate to severe substance use disorder (other than nicotine or caffeine), as defined by the dsm-5, within the last 12 months * suicide attempt within 1 year or currently at risk of suicide in the opinion of the investigator
multicenter clinical trial for the evaluation of mesenchymal stem cells from adipose tissue in patients with chronic graft versus host disease.

Conditions: Graft Versus Host Disease; Chronic and Expanded Graft Versus Host Disease; Immune System Diseases

Summary: the main purpose of this trial is to assess the safety and feasibility of treatment with two-dose infusion of allogeneic mesenchymal stem cells from adipose tissue expanded in vitro in patients undergoing haematopoietic stem cell transplantation (hsct, who have developed chronic and extensive graft versus host disease (gvhd). mesenchymal stem cells (mscs) express low levels of hla class i molecules, and do not express class ii molecules neither cd40, cd80 and cd86, being unable to induce proliferation of allogeneic lymphocytes. in addition, mscs inhibit lymphocyte proliferation by inhibiting cell division and maintaining these cells in a quiescent state. this supports the hypothesis that mscs are universal suppressors.


Eligibility criteria:
inclusion criteria: patients who develop chronic extensive gvhd as determined by the national institute of health consensus development project on criteria for clinical trials in chronic gvhd (biol blood marrow transplant 2005; 11: 945-955), and which meet the following criteria: 1. they have never received therapy for chronic gvhd. 2. they have de novo or quiescent chronic extended gvhd. exclusion criteria: 1. concomitant severe systemic infection. 2. oncologic or hematological condition relapse. 3. pregnancy. 4. estimated life expectancy less than 1 week. 5. patients who do not give their informed consent.

Keywords: graft versus host disease mesenchymal stem cell allogeneic mesenchymal stem cell adipose tissue allotransplant allogenic mesenchymal stem cells immune system diseases chronic expanded
medication treatment for opioid use disorder in expectant mothers: infant neurodevelopmental outcomes sub-study

Conditions: Opioid-Related Disorders; Drug Addiction; Pregnancy Related; Substance Abuse; Drug Abuse; Neonatal Abstinence Syndrome; Neonatal Opiate Withdrawal Syndrome; Drug Abuse in Pregnancy

Summary: this is a sub-study of nida ctn protocol 0080: medication treatment for opioid use disorder in expectant mothers (moms; unique protocol id: 2019-0429-1). caretakers of the infants delivered by moms participants will be offered the opportunity to enroll in this sub-study, which is designed to evaluate the impact of extended-release buprenorphine (bup-xr), relative to sublingual buprenorphine (bup-sl), on infant neurodevelopment. the additional data collected in this sub-study will be combined with data from the main moms trial.


Eligibility criteria:
inclusion criteria: * the participant must be the caretaker of an infant that was delivered as part of the moms trial (unique protocol id: 2019-0429-1). exclusion criteria: -

Keywords: ctn-0080 clinical trials network medication assisted treatment pharmacokinetics
mydiatext text messaging intervention for diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: to test a text messaging intervention using mydiatext and financial incentives to determine whether such an intervention will improve self-reported self-care behaviors in children 12 to 18 years old. the intervention will consist of daily text messages sent to the subject's personal mobile device. subjects will be incentivized to respond to text messages via a lottery financial incentive. previously developed text messages based on the american diabetes association (ada) behavior goals will be used for this intervention.


Eligibility criteria:
inclusion criteria: * diagnosis of type 1 diabetes for more than 1 year * hba1c greater than or equal to 8% but less than 14%. * have been seen in diabetes clinic in the last 6 months * owns a personal mobile device with unlimited text messaging plan exclusion criteria: * non-english speaking * significant cognitive disability or major organ illness * hemolytic anemia
characterization and differential diagnosis of vertebral osteomyelitis

Conditions: Vertebral Osteomyelitis

Summary: vertebral osteomyelitis is a uncommon disease that can lead to neurologic deficits if not diagnosed in time. the etiologies of vertebral osteomyelitis include pyogenic bacteria, m. tuberculosis, brucella species, and fungus. the aim of this study is to describe the clinical features and microbiological/radiological characteristics of patients with vertebral osteomyelitis, and investigate the useful tips for the differential diagnosis of vertebral osteomyelitis.

besides description of characteristics of patients with vertebral osteomyelitis, we also will investigate the usefulness of 16s rrna gene sequence analysis of biopsy specimen. mri findings during the antibiotic treatment will be monitored and compared for the differential diagnosis of meningitis.

Eligibility criteria:
inclusion criteria: * symptoms or signs consistent with spinal column infection * mri findings suggestive of infection * antibiotic treatment for vertebral myelitis exclusion criteria: * patients already treated more than 2 weeks for osteomyelitis in transferring hospital

Keywords: osteomyelitis 16s rrna spine magnetic resonance imaging
risk factors for low back pain in adults a 23-year prospective cohort study of 14-15-year-old schoolchildren.

Conditions: Low Back Pain

Summary: the incidence of low back pain (lbp) is increasing and prognostic factors for developing lbp are unclear. based on questionnaires, different prognostic factors are being explored over time.

despite the massive efforts of trying to find predictors and prevention for lbp, it remains to be clarified, why some individuals develop severely disabling low back pain while others never experience noteworthy back pain. there is no evidence that numbers of chronically affected individuals have diminished; rather, the incidence of lbp has increased continuously over the last 20 years, which is also reflected in rising numbers of lumbar surgical treatments and rising costs due to health care expenses and sick leave. hence, prevention of lbp in the working population seems more urgent than ever. as lbp is undoubtedly a multifaceted disorder that tends to fluctuate throughout life, there is a need for longitudinal research, exploring the effect of both lifestyle and psychosocial factors on the development of chronic low back pain. the main aims of this study is to identify the prevalence of low back pain and identify whether a history of low back pain during adolescence represents an increased risk of experiencing low back pain later in life.

Eligibility criteria:
inclusion criteria: * being a member of the original western zealand cohort * ability to understand and write in danish * having access to the danish digital mail system "e-boks". (access to e-boks is mandatory in denmark unless you have special needs) exclusion criteria: we have no formal exclusion criterias

Keywords: low back pain prevalence illness perception quality of life cohort study survey
massive open online course (mooc) for women with breast cancer

Conditions: Breast Cancer

Summary: the goal of this clinical trial is to promote person-centered care and improve health literacy and digital health literacy in women with breast cancer through the development of a massive open online course (mooc) co-created with women with breast cancer.


Eligibility criteria:
inclusion criteria: * adult women ( ≥18 years old) * speak spanish * with internet at home or smartphone * currently have or have had breast cancer (currently disease-free) * families/caregivers of women with breast cancer and healthcare professionals involved in breast cancer management (oncologists, gynaecologists, nurses, psycho-oncologists, etc.) exclusion criteria: * no exclusion criteria were applied based on diagnosis date, current or past treatment, nationality, health literacy and digital health literacy level and knowledge about person-centred care or breast cancer. * in the assessment of the mooc's acceptability and effectiveness, participants involved in co-creating the mooc will be excluded.

Keywords: massive open online course digital health literacy health literacy person-centered care
characterization of intestinal microbiota in children with inborn errors of metabolism (iem)

Conditions: Inborn Errors of Metabolism; Propionic Aciduria; Methylmalonic Aciduria; Urea Cycle Disorder

Summary: study around children with inborn errors of metabolism (iem) and their healthy siblings. collection of stool and urine to assess contribution of microbiota to disease severity.

this study aims to collect biological samples (stool and urine) from children with inborn errors of metabolism, iem (like ucd (urea cycle disorder), pa (propionic aciduria) and mma (methylmalonic aciduria) and their healthy siblings. the main focus of the study is to assess the contribution of the intestinal microbiota to disease severity in children that suffer from different forms of iem and potentially find microbiota targets that could be used in the design of therapeutic/prophylactic agents.

Eligibility criteria:
inclusion criteria: * children or siblings of children that have been diagnosed with one of the following diseases: any type of ucd, pa or mma exclusion criteria: * children or siblings of children that have not been diagnosed with one of the following diseases: any type of ucd, pa or mma * use of an investigational drug or device less than 30 days prior to the study, or current enrollment in another investigational drug or device study less than 30 days prior to the study * considered to be poor attendees or unlikely for any reason to be able to comply with the study procedures, in the opinion of the investigator
microcirculation properties of albumin for fluid resuscitation in septic shock

Conditions: Sepsis, Severe; Sepsis; Septic Shock

Summary: the sublingual microcirculation is impaired in sepsis and septic shock. sidestream dark field imaging technology has been developed into a clinical tool to help the clinician assess the microcirculation at the bedside. the ideal resuscitation fluid has not been identified. the investigators aim to use this new bedside technology to establish the microcirculation properties of two popular resuscitation fluids.

sepsis and septic shock are diseases of the microcirculation. recent developments in microcirculation imaging have illustrated the extent of the impairment of the microcirculation in these diseases of critical care. heterogenous flow, stagnation and microthrombi can all be seen clearly in the sublingual region using a sidestream dark field imaging device. one of the key treatments for sepsis and septic shock is timely administration of intravenous fluids. which fluid is administered is a matter for debate which has not been settled by several large trials. de-resuscitation has become increasingly important as physicians realise the implications and associated risks of excess fluid administration in icu. avoiding excess fluid administration at the resuscitation stage is therefore desirable. one of the prevailing theories about the function of albumin or colloid resuscitation is that it remains in the the intravascular space for a longer period of time, thereby continuing to benefit the patient and avoiding administration of excess fluid. however, recently albumin was tested against crystalloid for resuscitation and was shown to be effective but with no improvement in survival. it is possible, however, that albumin is having an initial beneficial effect at a microcirculation level. macrohaemodynamic improvements are not necessarily matched by improvements in blood flow and oxygen delivery to cells, this has been referred to as haemodynamic incoherence. this randomised, prospective study aims to compare crystalloid and albumin resuscitation at a microcirculation level.

Eligibility criteria:
inclusion criteria: * sepsis; suspected source of infection, tachycardia, tachypneic, hyperlactatemia, hypotensive requiring vasopressors, febrile \>38.5degrees celsius * fluid responsive; pulse pressure variability \>10% or passive leg raise positive exclusion criteria: * fluid overloaded; pulmonary oedema, significant peripheral oedema * heart failure, cardiogenic shock, recent mi * receiving regular albumin 20%

Keywords: microcirculation sidestream dark field
a1c fit test: an epidemiological study correlating hemoglobin a1c with results of the air force physical fitness test.

Conditions: Pre-Diabetes; Diabetes; Cardiovascular Risks

Summary: the purpose of this study is to evaluate the prevalence of pre-diabetes and diabetes among those air force personnel who have not passed the air force physical fitness test (afpt) and to evaluate the usefulness of the afpt as a prescreening tool for these disease processes.


Eligibility criteria:
inclusion: * tricare insurance beneficiary (military insurance) receiving care at nellis afb * over the age of 18 and took their afpt within the past 1 month. exclusion: * previous diagnosis of diabetes * pregnant or nursing

Keywords: pre-diabetes diabetes cardiovascular risks