Kornimate/medical-research-clean huggingface dataset:
the children's amalgam trial

Conditions: Dental Caries

Summary: the children's amalgam trial is one of only two randomized trials of its kind, and the only such trial in the united states, to address the potential impact of mercury exposure from amalgam restorations on neuropsychological and renal function in children.

the safety of silver amalgam as a dental restorative material has been controversial since its introduction 150 years ago, but until recently it has been assumed that the exposure to mercury from dental amalgam is limited to the acute placement phase. however, some recent studies have raised safety concerns by demonstrating chronic release of mercury vapor from amalgam fillings during chewing and brushing. the children's amalgam trial (cat) is a two-arm randomized trial of safety, comparing amalgam with a mercury-free restorative material. a single masking procedure is used to ensure that all investigators and staff measuring outcomes are unaware of assigned trial arm. the study follows 534 new england children, aged 6-10 years at enrollment, for 5 years. the children were recruited from two northeastern u.s. communities, one in rural maine, and one in urban massachusetts. no trial subjects received prior amalgam restorations, and all were in need of at least two posterior occlusal fillings. participants were randomized to receive either amalgam or composite material for all posterior restorations at baseline and at subsequent visits. the primary endpoint will be 5-year change in iq scores. secondary endpoints will include measures of other neuropsychological assessments and renal functioning.

Eligibility criteria:
* 6 - 10 years of age at last birthday * fluent in english * no prior or existing amalgam restorations * two or more posterior teeth with dental caries such that restoration would include the occlusal surfaces * no clinical evidence of existing psychological, behavioral, neurologic, immunosuppressive, or renal disorders.
primary aldosteronism in western norway

Conditions: Hyperaldosteronism

Summary: in this study the investigators aim to identify and include consecutively patients with primary aldosteronism (pa) diagnosed in the western and mid-parts of norway, to describe the characteristics of these patients, to explore the cardiac effects of pa before and after specific treatment, and to identify long-term outcomes after treatment. one subgroup of the pa patients perform echocardiography to assess left ventricular systolic myocardial function before and after treatment. one subgroup of pa patients perform cardiac mri to assess myocardial mass, myocardial fibrosis and myocardial function in rest and during stress, before and after treatment. for the cardiac mri substudy, the pa patients are compared with a group of healthy controls, also included in the study. from 2022 onwards, pa patients diagnosed or subtyped with adrenal vein sampling at oslo university hospital will additionally be included in the study, thereby providing a national registration of pa patients.

from june 2013, all newly diagnosed patients with primary aldosteronism (pa) either diagnosed at haukeland university hospital (hus) or admitted to hus for subtype testing with adrenal vein sampling, have been asked for inclusion in the study. all included patients have a base-line study visit where clinical information is registered, and baseline blood and urine samples are collected. echocardiography will be performed in a subgroup of patients before and 1 year after start of specific pa treatment. after start of definite medical or surgical treatment the patients are followed up with regularly new study visits. from 2025 onwards, pa patients diagnosed or subtyped with adrenal vein sampling at oslo university hospital will additionally be included in the study, thereby providing a national registration of pa patients. a subgroup of the included pa study patients also perform a cardiac mri. cine-mri, velocity-encoded mri, mri images during continuous adenosine infusion and mri images after gadolinium contrast injection are performed, and compared to a group of age- and sex-matched healthy controls. from 2025 onwards, pa patients either diagnosed or performing subtyping with adrenal vein sampling at oslo university hospital will likewise be asked for study inclusion.

Eligibility criteria:
inclusion criteria: * verified diagnosis or strong suspicion of primary aldosteronism * age 18-85 exclusion criteria: * active cancer disease at time of inclusion exclusion criteria for subgroup of primary aldosteronism-patients and healthy controls who perform cardiac mri: * asthma/chronic obstructive pulmonary disease , * use of dipyridamole * claustrophobia
prospective assessment of radiation-induced heart injury in left-sided breast cancer

Conditions: Breast Neoplasms; Heart Injuries; Radiation Toxicity

Summary: this study is to prospectively investigate the cardiac dose-sparing effect and clinical benefit of deep inspiration breath-hold (dibh) technique. patients with left-sided breast cancer treated with breast conserving surgery followed by radiotherapy is enrolled. radiotherapy is delivered with either free-breathing or deep inspiration breath-hold (dibh) technique. the cardiac dose parameters and cardiac toxicity are prospective evaluated, and the dose-effect relationship is analyzed.

patients with left-sided breast cancer treated with breast conserving surgery are prospectively enrolled. two types of radiation treatment are delivered based on attending physician's preferences: radiation to whole breast +- regional nodal areas with free-breathing technique, or with deep inspiration breath-hold (dibh) technique. the cardiac dose parameters including heart dose and the dose to left anterior coronary artery are assessed, and the cardiac toxicities regularly assessed with cardiac enzymes,electrocardiogram(ecg) and normal gated single-photon emission computed tomography-myocardial perfusion imaging before, during and after radiation.the dose-effect relationship of heart injuries is analyzed.

Eligibility criteria:
inclusion criteria: 1. left-sided breast cancer 2. underwent breast conserving surgery 3. planned for postoperative whole breast +- regional nodal radiotherapy 4. no basic heart disease exclusion criteria: 1. abnormal cardiac baseline examination 2. history of chest radiation 3. can not tolerate deep inspiratory breath-holding
effects of metformin and fish oil on treatment with clozapine

Conditions: Schizophrenia; Schizo-affective Disorder

Summary: one purpose of this study is to test whether adding metformin will limit some of the unwanted effects of clozapine, compared to not adding metformin. metformin is a medication that is approved by the united states food and drug administration (fda) for the treatment of type-2 diabetes. studies have found that people with type-2 diabetes often lose some weight when they take metformin, however the fda has not approved metformin for weight loss, so for this study the use of metformin is investigational. this study will test whether metformin can help people with schizophrenia or schizoaffective disorders lose weight. another purpose of this study is to test whether adding fish oil will improve the benefit of clozapine and/or limit some of the unwanted effects of clozapine, compared to not adding fish oil. fish oil is a medication used to reduce levels of some fats (triglycerides) in blood. some studies have found that adding fish oil reduces psychosis (voices, suspiciousness). however the fda has not approved fish oil for reducing psychosis, so for this study the use of fish oil is investigational. this study will test whether fish oil can help people with schizophrenia or schizoaffective disorders have less psychosis. fish oil is not an antipsychotic medication.


Eligibility criteria:
inclusion criteria: * male or female patients with clinical diagnoses of schizophrenia or schizo-affective disorder * between 18 and 60 years of age * patients whose treating clinicians have recommended treatment with clozapine (and the patients have agreed and provided signed informed consent for treatment with clozapine) exclusion criteria: * patients who have contraindications to metformin use, such as: * a diagnosis of congestive heart failure * renal impairment (serum creatinine \> 1.5 in males; \> 1.4 in females) * hepatic disease (ast or alt \> 2.0 times upper limit of normal (uln) * positive hepatitis b surface antigen or hepatitis c antibody * total bilirubin\>1.2x uln; majority conjugated * metabolic acidosis (serum co2 \< lower limit of normal), * known hypersensitivity to metformin, * recent (in the past 30 days) or scheduled radiological studies involving iodinated contrast material * alcohol abuse/dependence within the past month * concurrent treatment with drugs that are known to increase metformin blood levels including furosemide, nifedipine, and cationic drugs including cimetidine, amiloride, digoxin, morphine, procainamide, quinidine, ranitidine, triamterene, trimethoprim, and vancomycin * patients with blood dyscrasias that could be worsened by added fish oil * women who are pregnant or breastfeeding

Keywords: schizophrenia schizo-affective disorder
tacrolimus during the implantation and the effect on ischemia-reperfusion injury in liver transplantation

Conditions: Ischemia Reperfusion Injury

Summary: the evaluation of the efficacy of an intraportal infusion with tacrolimus, at the time of liver graft implantation, compared to a control group without immunosuppressive intraportal infusion (placebo: saline solution 0.9%) with respect to the initial liver function measured by the parameters of the liver function (lfp): ast (u/l), alt (u/l), total bilirubin (mg/dl) and the coagulation factors: nt (%), ptt (s), inr.


Eligibility criteria:
inclusion criteria: * multi organ transplantation or retransplantation * abo incompatible donor organ recipients- patients, who are listed on the liver transplant-waiting list at the vienna general hospital and who fulfill the clinical requirements (local allocation) * written informed consent * age \> 18 * first transplantation exclusion criteria: * fulminant failure of the liver * liver-living donor recipients * pregnant or nursing women * allergy/intolerance to antimetabolites, hco-60, el cremophor or similar compounds,steroids or macrolide antibiotics * hiv-positive donors or recipients * participants of another clinical study * patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.
semaglutide and intestinal iron absorption

Conditions: Diabetes Mellitus Type 2; Iron Absorption

Summary: semaglutide belongs to a group of long-acting glucagon-like peptide 1 receptor agonists (glp-1). disorders in iron absorption have been linked to numerous medication, dietary, and nutrient interactions thus far. the study aimed to determine whether there is an effect of concomitant parenteral administration of semaglutide and oral iron preparations on iron absorption in patients with type 2 diabetes (t2dm).

type 2 diabetes mellitus (t2dm) affects over 537 million people worldwide, making it a major chronic and progressive health problem among adults. novel approaches to managing t2dm have been developed as a result of medical advancements. glucagon-like peptide-1 receptor agonists (glp-1 ras) are appealing options for the treatment of t2dm, since they efficiently reduce body weight and haemoglobin a1c with a minimal risk of hypoglycaemia. semaglutide, a long-acting glp-1 ra, has a very high structural homology with endogenous glp-1, high binding affinity to albumin, and resistance to degradation by the intestinal enzyme dipeptidyl peptidase-4. because of these characteristics and his extended half-life, it can be used once weekly. similar to all other glp-1 ras, semaglutide decreases gastrointestinal motility and slows stomach emptying. delay in stomach emptying and intestinal motility can interfere with vitamin, mineral, and drug absorption. iron is one of the essential micronutrients in the human body. on average, 10 - 20 mg of iron is consumed daily through food, but only 1 - 2 mg of iron is absorbed in the duodenum and the first section of the small intestine. it has been shown that drugs which decrease gastrointestinal motility can interfere with iron absorption. however, the relationship between parenteral semaglutide administration and intestine iron absorption has not been the subject of any prior studies. thus, this study aimed to determine whether there is an effect of parenteral administration of semaglutide on iron absorption in patients with t2dm.

Eligibility criteria:
inclusion criteria: * t2dm patients * ages between 45 and 65 * with poorly managed t2dm (hba1c ≥ 7%) * who are candidates for treatment intensification and beginning of parenterally administered semaglutide exclusion criteria: * hypersensitivity to glp-1 ras, * adequately controlled with current glucose-lowering medications, * already treated with glp-1 ra, * type 1 diabetes mellitus or any other form of diabetes, * hemochromatosis, * iron deficiency anaemia, * sideropaenia, * severe chronic illnesses, * malignant neoplasms of any site, * chronic infectious diseases, * chronic rheumatic inflammatory diseases, * malabsorption syndrome, * inflammatory bowel disease, * history of gastrointestinal tract reduction surgery, * medications that interfere with absorption, * perimenopausal women

Keywords: type 2 diabetes mellitus semaglutide iron oral iron absorption test
psychophysical aspects of maximal anaerobic performance

Conditions: Anaerobic Performance

Summary: during anaerobic exercise, the metabolic pathway of glycolysis is used in order to produces high-energy compounds adenosine triphosphate (atp).the level of lactic acid in the blood is a marker to the increased protons concentration and acidosis.nevertheless, the increased level of protons in addition to the release of bradykinin causes pain during the exercise that limited the subject's performance. therefore, it is assumed that the individual pain sensitivity might determine the subject's performance. aims: to investigate the role of the dnic efficiency in prediction of anaerobic performance in humans (2) to study the role of peripheral pro-nociceptive processing in mediating pain during anaerobic exercise and its contribution to the subjects' performance (3) to assess the function of pain-related psychological factors in anaerobic performance.

to the best of our knowledge, no study has investigated the balance between the endogenous anti-nociceptive properties of the individual and the anaerobic-evoke pro-nociceptive activity in determining the maximal performance during anaerobic exercise. moreover, the interaction between psychological factors and pro- and anti- nociceptive processes that are operated during anaerobic exercise, need to be investigated. methods: forty healthy men and women, between the ages of 18-40 will be involved in the study. each participant will complete 3 psychological questionnaires regarding their personality traits: pain catastrophizing scale (pcs), state-trait anxiety inventory and perceived stress questionnaire. pain psychophysics tests will be used for evaluating the individual pain perception, prior and subsequent to the anaerobic exercise: (1) dnic will be tested using a paradigm of two remote noxious stimuli with one, the 'conditioning stimulus' (immersing the hand in tub containing 8°c water), inhibiting the other, the 'test pain' (pressure pain threshold) in order to assess the endogenous analgesia (ea) efficiency (2) heat and pressure pain thresholds, and (3) temporal summation of painful heat and mechanical stimuli that reflect the neuroplasticity of the central nervous system following peripheral noxious stimulation. in addition, anaerobic performance will be evaluated during wingate test,and blood lactate will be measured. gene related pain ill be tested using saliva samples .

Eligibility criteria:
inclusion criteria: healthy volunteers exclusion criteria: pregnancy

Keywords: anerobic exercise pain analgesia diffuse noxious inhibitory control (dnic) psychological stress
efficacy of protein supplemented very low calorie meals on weight loss

Conditions: Obesity; Sarcopenic Obesity

Summary: this randomized clinical trial will evaluate the efficacy and safety of protein supplemented very low calorie meals on weight loss and weight loss maintenance among people with obesity.

approximately 30% of the korean population has obesity or abdominal obesity and is often accompanied by obesity related complications such as cardiovascular disease, diabetes, osteoarthritis and even some types of cancer. however, there are not many lifestyle modification treatments available that have long-term effects other than drugs and surgical treatments in the management of obesity. preserving muscle mass should also be considered in weight loss especially for elderly adults with obesity, because decreased muscle mass and strength can negatively affect morbidity and mortality in the elderly. therefore, the investigators want to evaluate the effectiveness and safety of the protein supplemented very low calorie meals on weight loss, body composition as well as metabolic changes compared with traditional low calorie low fat diet in people with obesity.

Eligibility criteria:
inclusion criteria: * body mass index (bmi ) more than 25 kg/m2 or * waist circumference more than 90 cm in men or 85 cm in women exclusion criteria: * history of treatment with anti-obesity drugs or participation in another weight loss program in previous 6 months * weight changes more than 3 kg during the 6 months before participation * unstable cardiovascular events during the 6 months before participation * uncontrolled mood disorder * history of eating disorder * history of alcohol use disorder * history of gallstone * chronic renal failure (estimated glomerular filtration less than 30 ml/min)
immune response to third dose of covid-19 vaccine in solid organ transplant

Conditions: COVID-19; SARS-CoV-2 Infection; Solid Organ Transplant; Vaccine Response Impaired

Summary: the coronavirus disease 2019 (covid-19) pandemic has claimed over 5 million lives globally. fortunately, a substantial and growing number of sars-cov-2 vaccines with very high efficacy have been developed, manufactured, and rapidly approved. novel mrna vaccines such as the bnt162b2 (pfizer-biontech) and mrna-1273 (moderna) have reported a stunning \>94% efficacy against covid-19. however, global access has not been equitable, with many low- and middle-income countries having no vaccine access or access under emergency use mainly to traditional inactivated sars-cov2-2 vaccines such as bbibp-corv (sinopharm beijing), coronavac (sinovac) and bbv152 (bharat biotech). emerging studies have shown that lower concentrations of neutralizing antibodies (nab) are attained after coronavac than after an mrna-based vaccine in healthy individuals. this difference seems to be more pronounced in immunocompromised patients who are at higher risk of severe covid-19 and death from covid-19. as such, several countries including the united states, israel and chile have recommended a third vaccine dose for high-risk populations. however, it is not currently known which is the best vaccine combination regarding immunogenicity, particularly in these vulnerable patients. this observational study will explore the humoral and cellular response to a sars-cov-2 bnt162b2 vaccine booster in solid organ transplant patients who received two previous doses of the inactivated coronavac or two doses of bnt162b2 vaccines.


Eligibility criteria:
inclusion criteria: * solid organ transplant patients in the last 10 years and currently under immunosuppressive therapy * vaccination with two doses of coronavac vaccine or bnt162b2 vaccines, followed by a booster dose (3d dose) of bnt162b2 vaccine administered in the previous 8-12 weeks. exclusion criteria: * previous sars-cov-2 infection * booster vaccine (3rd dose) administered less than 8 weeks or more than 12 weeks before enrolment * intravenous immunoglobulin therapy 60 days before enrolment * previous sars-cov-2 vaccine different from coronavac or bnt162b2
occipital nerve (c2) stimulation in the treatment of fibromyalgia

Conditions: Fibromyalgia

Summary: the study is designed as a prospective, randomized, double-blind, single center study with a 6 month duration post permanent system implantation. forty patients will be implanted. during trial stimulation, patients will be randomized into one of two study arms for two weeks. crossover will occur at the 2 week study visit to the opposite group. after completion of these two arms, every patient will subsequently complete participation in the third study arm. after completion of the third arm, patients will be evaluated to determine if they are a positive responder responder. if so, the patient will have the option of obtaining the permanent implant.


Eligibility criteria:
inclusion criteria: 1. patients able to provide informed consent to participate in the study; 2. patient has had chronic widespread pain for at least 3 months in all 4 body quadrants; 3. patient has at least 11 out of 18 tender points based on the tender points examination; 4. patient has attempted "best" medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to drugs, physical therapy, acupuncture, etc.); 5. patient medication has remained stable for at least 4 weeks prior to baseline data collection; 6. psychological screening has been completed and the patient has been cleared by a psychologist as a suitable study candidate; 7. patient agrees not to add or increase medication throughout the randomization trial period of the study; 8. patient is willing to cooperate with the study requirements including compliance with the treatment regimen and completion of all office visits. exclusion criteria: 1. patient has current evidence of any psychiatric disorder, as documented by the dsm-iv-tr criteria with psychotic characteristics, (e.g. bipolar disorder, major depressive disorder); 2. patient has been diagnosed with any disease mimicking the symptoms of the fibromyalgia syndrome (e.g. epstein barr, autoimmune diseases, etc.) that is not currently being treated or has not been stable for at least 6 months; 3. patient is currently in active menopause; 4. patient has been diagnosed with sleep apnea and is not currently involved in a treatment regime; 5. patient has a history of substance abuse or substance dependency in the past 6 months prior to baseline data collection; 6. patient currently participating in another clinical study; 7. patient with demand-type cardiac pacemakers, an infusion pump or any implantable neurostimulator device; 8. patient is likely to require an mri evaluation in the future; 9. patient is not willing to maintain current medication regimen; 10. female candidates of child bearing potential who are pregnant (confirmed by positive urine/blood pregnancy test), not using adequate contraception as determined by the investigator, or nursing (lactating) a child.

Keywords: fibromyalgia occipital nerve stimulation