Kornimate/medical-research-clean huggingface dataset:
pv loop & coarctation study

Conditions: Coarctation of Aorta

Summary: coarctation of the aorta accounts for 4-7% of all congenital heart disease. while stent therapy, when feasible, is the standard of care for coarctation, it may not completely improve the work (and afterload) of the heart due to its effects on the elasticity of the aorta. this study will provide the information needed to understand the effects of current management on the cardiac mechanics and work.


Eligibility criteria:
inclusion criteria: * children 6 years of age and older and adults of all races and both sexes referred for elective cardiac catheterization and stent therapy for coarctation * those who provide informed consent for study participant. exclusion criteria: * children who undergo other interventions in addition to the coarctation * children with single ventricle physiology. * renal impairment * participant unwilling to sign a consent form.

Keywords: coarctation of aorta coa
environmental game after appendicitis surgery

Conditions: Healthy

Summary: this study was conducted to determine the effect of environmental play and mobilization on fear and pain levels of children aged 6-12 years who had acute appendicitis surgery.

it was conducted with children aged 6-12 years in the postoperative period in a randomized controlled manner. children in the intervention (n:50) group were mobilized by playing environmental games.the children in the control group (n:50) underwent routine mobilization of the clinic. the data were collected with the "child follow-up form", which was created to evaluate the child's demographic characteristics, physiological parameters, pain and fear.

Eligibility criteria:
inclusion criteria: * being between 6-12 years old, * being open to communication and cooperation, * no visual or hearing impairment, * appendectomy surgery, * first mobilization after surgery. * parent's willingness to participate in the study can be sorted. exclusion criteria: * having a mental or neurological disability, * children with hearing and vision impairment

Keywords: pain fear pediatric surgery game appendicitis
phil evaluation in the endovascular treatment of intracranial dural avf

Conditions: Dural Arteriovenous Fistula

Summary: the primary objective of this study is to demonstrate the safety and efficacy of the phil® liquid in endovascular treatment of dural arteriovenous fistula.

this is an european multi-center observational study. treatments and follow-up visits will be done as per standard of care. the objective of this study is to evaluate the efficacy and safety of the phil® device in the treatment of intracranial dural arteriovenous fistula (davf). the phil® device, a non-adhesive liquid embolic agent, has been ce marked since july 2014. it is intended for use in the embolization of lesions in the peripheral and neurovasculature, including arteriovenous malformations and hypervascular tumors. all patients with an intracranial davf that has not been previously treated and will be treated by embolization with phil® are eligible for this study. a maximum of 70 patients will be enrolled in this study in 16 european institutions. the expected approximate study duration is 38 months.

Eligibility criteria:
inclusion criteria: 1. patient or patient's legally authorized representative has received information about data collection and has signed and dated an informed consent form 2. patient has an intracranial davf that can be treated by embolization with phil® used with or without other embolization products except other non-adhesive liquid embolic agents (i.e. squid, onyx). 3. patient is at least 18 years of age. exclusion criteria: 1. patient has multiple davfs to be treated. 2. patient participates in a study evaluating another medical device, procedure, or medication during the course of davf treatment and follow-up per the study protocol. 3. patient does not give consent to the collection and processing of data required for centralized monitoring 3. any condition that could prevent patient follow up.
association between chronic headache and back pain with childbirth

Conditions: Headache Disorders, Secondary; Post-Dural Puncture Headache; Migraine Disorders; Back Pain; Anesthesia

Summary: this study uses a single questionnaire to evaluate two separate primary outcomes: 1. to identify association between chronic headache in women who have given birth to children as compared to a control group of women who have raised children but have not given birth to them 2. to identify association between chronic back pain in women who have given birth to children as compared to a control group of women who have raised children but have not given birth to them

chronic headache and back pain have an excess prevalence in women as compared to men. this study uses a single survey that uses logic to assess for association between childbirth and chronic headache and between childbirth and chronic back pain using screening questions. the questions are, "do you suffer from chronic headaches" and "do you suffer from chronic back pain". depending on the answer to the screening question, the subject will be given further questions only related to the syndrome that they endorsed. arm 1) there is an association between chronic headache and childbirth over and above raising children. secondary outcomes are temporal association between onset or worsening of headache and childbirth, association between migraine headache and childbirth, association between chronic headache and anesthetic complications. arm 2) there is an association between chronic back pain and childbirth over and above raising children. secondary outcomes are temporal association between onset or worsening of back pain and childbirth, association between chronic headache and anesthesia.

Eligibility criteria:
inclusion criteria: * female representation exclusion criteria: * none
disrupt pad iii observational study

Conditions: Peripheral Arterial Disease

Summary: the disrupt pad iii study was designed as a randomized controlled trial (rct) with an additional observational registry component. the registry, referred to as the disrupt pad iii observational study (pad iii os), was a global, prospective, multi-center, single-arm registry of the shockwave peripheral intravascular lithotripsy (ivl) system. the objective of this study was to assess the real-world acute performance of ivl in the treatment of calcified, stenotic, peripheral arteries that may not qualify for inclusion in the rct. the study was designed to enroll a maximum of 1500 subjects from up to 60 global sites with a minimum of 200 subjects treated with the s4 ivl catheter, a line extension designed to treat smaller diameter peripheral vessels, including calcified below-the-knee (btk) lesions. subjects were required to have target lesions in the iliac, femoral, ilio-femoral, popliteal, or infra-popliteal arteries with at least moderate calcification as determined by the investigator, defined as calcification within the lesion on both sides of the vessel assessed by angiography. adjunctive therapies such as atherectomy, specialty balloons, and stents were allowed. subjects were followed through discharge.


Eligibility criteria:
inclusion criteria: subjects were required to meet all of the following inclusion criteria in order to be included in this clinical study: 1. subjects intended to be treated with shockwave medical lithoplasty for de-novo or restenotic lesions of the femoral, ilio-femoral, popliteal, and infra-popliteal arteries. 2. subjects presenting with claudication or cli by rutherford clinical category 2, 3, 4, 5, or 6 of the target limb. 3. age of subject is \> 18. 4. subject of subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form. 5. calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending \> 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is \<50mm in length. exclusion criteria: subjects that met any of the following exclusion criteria were not included in this clinical study: 1. subjects with any medical condition that would make him/her an inappropriate candidate for treatment with shockwave lithoplasty as per instructions for use (ifu) or investigator's opinion. 2. subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.

Keywords: intravascular lithotripsy
txa vs. amicar in total knee and hip arthroplasty

Conditions: Blood Loss; Hip Arthritis; Knee Arthritis

Summary: the purpose of this study is to determine the relative effectiveness of two drug agents, tranexamic acid (txa) and aminocaproic acid (amicar), that act through a similar mechanism of action. these agents are used to decrease blood loss that is a result of major surgery, like total joint arthroplasty. a secondary goal will be investigate the cost-analysis of total hospitalization. both txa and amicar are both currently used in the care of patients undergoing total joint arthroplasty. subjects will be randomly assigned to the txa or amicar arm. all data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization stay. our hypothesis is that txa and amicar will have similar effectiveness in preventing intraoperative blood loss and the need for transfusion post-op than amicar. a detailed cost analysis will show that the overall cost of performing the operative procedure, including transfusions, or time, and total costs associated with admission cost will be more decreased with amicar as compared to txa.


Eligibility criteria:
inclusion criteria: * patients electing to undergo primary total hip or knee arthroplasty exclusion criteria: * history of stents * myocardial infarction, * cerebrovascular accident or stroke * deep venous thrombus * pulmonary embolus * late onset color blindness * hypercoagulable state
anti-il6 and corticosteroid monotherapy vs combination in covid-19

Conditions: Critical Illness; Corona Virus Infection; Cytokine Release Syndrome

Summary: the cytokine storms mediated by over production of proinflammatory cytokines have been observed in a large population of critically ill patients infected with covid-19. patients diagnosed with cytokine storms progress to cardiovascular collapse, multiple organ dysfunction and death rapidly. therefore, early identification, treatment and prevention of the cytokine storms are of crucial importance for the patients. immuomedulator such as interleukin-6 (il-6) antagonist, emerged as an alternative treatment for covid-19 patients with a risk of cytokine storms recently. in this study, we aimed to evaluate the safety and efficacy of anti-il6 alone vs anti-il6 corticosteroid combination in patients with covid-19 pneumonia

this study will provide further insight whether anti-il6 alone provide same efficacy and clinical outcome with reasonable side effects profile compared to anti-il6 + corticosteroid and might serve as a corticosteroid sparing agents in covid-19 patient with cytokine storms. data elements will be retrieved from virus registry which is a prospective, non-interventional, multi-center, multi-national observational cross sectional study

Eligibility criteria:
inclusion criteria: 1. adult critically ill patients 2. covid-19 pcr positive 3. presence of clinical and radiological signs of progressive disease, and laboratory evidence indicative of risk for cytokine storm complications. 4. received anti-il6 or corticosteroids as part of covid-19 treatment exclusion criteria: 1. non covid-19 related admissions 2. repeated admission to icus/hospital 3. patient did not receive anti-il6 or corticosteroids
effects of tdcs on craving, relapse and cognitive functions among patients with cocaine use disorder

Conditions: Cocaine Addiction

Summary: repetitive bilateral (left cathodal/ right anodal) transcranial direct current stimulation (tdcs) over the dorsolateral prefrontal cortex (dlpfc) reduces craving and seems to decrease relapse risk in addiction. however, little is known about the relapse rates in cocaine addiction after tdcs, despite the need for neurobiological treatments to reduce the high relapse rates in this population. the current study explores the effects of repetitive tdcs in a larger sample (n=60) of cocaine addicted patients on number of relapse days after three months. we expect that a decrease in relapse risk after tdcs is associated with cognitive control functioning. therefore, risky decision making and inhibitory control will be measured before and after the interventions, and at three months follow-up. ecological momentary assessment (ema) will be used as a reliable measure for relapse, craving and mood.

for this study, 60 cocaine addicted patients will receive real or sham bilateral tdcs (left cathodal/right anodal) over the dlpfc after one week in detox. the participants will receive this two times daily for 5 consecutive days. it is expected that this particular tdcs method will reduce relapse probability, as was previously seen in alcohol addicted patients. furthermore, it is hypothesized that this therapeutic effect is associated with diminished craving and enhanced cognitive control. craving, temptations and relapse, will be explored by means of ecological momentary assessment (ema). the mixed results in previous studies of tdcs on craving may be explained by the fact that craving in addiction is a momentary phenomenon which is difficult to reliably measure with more traditional methods like retrospective self-reports, for which ema provides a solution. cognitive control will be measured by means of inhibitory control during a go/nogo task and reward processing during a gambling task. the tasks will be performed at baseline, one day after the tdcs sessions and at three months follow up.

Eligibility criteria:
inclusion criteria: * aged between 18 and 65 years * meeting the dsm-v criteria for cocaine dependence * the ability to speak, read, and write in dutch at an eight-grade literacy level * no severe withdrawal signs or symptoms at baseline exclusion criteria: * indications of severe psychopathology (psychosis, severe mood disorder) as assessed by a physician * a diagnosis of epilepsy, convulsions or delirium tremens during abstinence of cocaine use * any contraindication for electrical brain stimulation procedures such as electronic implants or metal implants * pregnancy or breast-feeding.

Keywords: cocaine tdcs ema inhibitory control reward processing addiction dlpfc craving cognitive control
a 24-month outcomes of single- vs multiple-visit revascularization

Conditions: Necrotic Immature Permanent Incisors

Summary: the current randomized clinical trial will be conducted to evaluate the 24-month clinical and radiographic outcomes after revascularization of asymptomatic necrotic immature permanent maxillary incisors using single- or multiple-visit protocol.


Eligibility criteria:
inclusion criteria: * compliant healthy patients who had at least one immature maxillary permanent incisor requiring nonsurgical root canal treatment. * patients presenting with a diagnosis of pulp necrosis with chronic apical periodontitis confirmed by history, clinical, radiographic and operative examination. * patient without previous endodontic treatment in affected tooth. exclusion criteria: * patients with systemic conditions (medical, developmental or behavioral) that make routine dental treatment difficult. * patients taking medications that can interfere with healing or hemostasis. * patients with allergy to local anesthetics * children who will not comply to recall program. * teeth with extensive loss of coronal tissue that require restoration with a post * teeth with internal or external root resorption

Keywords: single-visit
safety, tolerability and effects of l-arginine in boys with dystrophinopathy on corticosteroids

Conditions: Dystrophinopathy; Duchenne Muscular Dystrophy; Becker's Muscular Dystrophy

Summary: the purpose of the study is to assess the safety, tolerability, and effects of l-arginine on muscles in boys with dystrophinopathy on corticosteroids. specifically, to see if l-arginine reduces muscle signal abnormalities on mri done pre and post 30 days of l-arginine administration.

dystrophinopathy is a muscular dystrophy (includes duchenne or becker's muscular dystrophy) that can be a lethal muscle disorder resulting from defects in the gene for dystrophin, a structural protein required to maintain muscle integrity. absence of functional dystrophin leaves the muscle membrane vulnerable to damage during contraction. this damage can be exacerbated by an inflammatory response leading to myofiber necrosis. l-arginine is a widely available dietary supplement amino acid postulated to affect dystrophinopathy in several favorable ways: upregulation of utrophin, vasodilation in muscle via nitric oxide, enhanced synthesis of creatine, increase levels of growth hormone. we hypothesize that administration of l-arginine may increase levels of creatine and growth hormone and in turn reduce the extent of myofiber damage in our patients with dystrophinopathy

Eligibility criteria:
inclusion criteria: * confirmation of diagnosis of dystrophinopathy, documented by clinical exam and dystrophin dna mutation analysis * ambulatory male subjects between the ages of 7-11 years * stable dosage of corticosteroids for 3 months prior to entry (screening/baseline day 0) and during treatment period * able to follow instructions and give assent * able to complete nonsedated mr exclusion criteria: * presence of metallic orthopedic hardware in the lower extremity that could affect mri/mrs measurements * routine mri exclusion criteria such as the presence of a pacemaker, cochlear implant, or cerebral aneurysm clip * subjects not capable of cooperating during mr examination * known hypersensitivity to l-arginine * exposure to another investigational agent, investigational supplements, growth hormone within 3 months prior to entry (screening/baseline day 0) or during treatment period * subjects must not be taking l-arginine for at least 4 weeks prior to entry (day 0) * subjects who are non-ambulatory or with daytime ventilatory dependence

Keywords: l-arginine supplement study
the effect of tranexamic acid (txa) on visualization during shoulder arthroscopy

Conditions: Shoulder Arthroscopy; Operative Bleeding; Postoperative Pain

Summary: tranexamic acid has seen an increase in use over the past decade in hip and knee arthroplasty as well as spine surgery with more recent use seen in total shoulder arthroplasty (tsa). the mechanism of action of txa is as a lysine analogue that competitively inhibits the conversion of plasminogen to plasmin thus resulting in its antifibrinolytic activity. investigators have showed that compared with placebo txa had a statistically significant effect on blood and postoperative hemoglobin levels in tsa. to date there are no studies investigating the effect of txa in arthroscopy of any kind or studies examining the ability of txa to aid in surgeon visualization in arthroscopic procedures. the investigators of this study will use change in pump pressure as a surrogate objective measure for surgeon visualization. the hypothesis is that participants who receive txa will have a lower change in pump pressure compared to participants who do not receive txa.


Eligibility criteria:
inclusion criteria: * participants aged 18-80 * participants with an asa (american society of anesthesiologists) score 1-3 * participants with a surgical indication of full thickness small to massive rotator cuff tear. exclusion criteria: * pregnant females, * participants with a known allergy to tranexamic acid, * participants with active thromboembolic disease, * participants with seizure disorder, * participants with prior cerebrovascular accident (cva), * history of cardiac stents or past history of thromboembolic disease, * presence of full-thickness subscapularis tear (\>50%), * participants with irreparable rotator cuff tears.
the effect of renin inhibition on nerve function in diabetes

Conditions: Diabetes

Summary: this study will assess the effect of direct renin inhibition on nerve function in persons with diabetes using a double-blind, placebo-controlled randomized trial involving two treatment arms (i.e., \[1\] 30 participants enrolled and randomized to 300 mg of aliskiren; \[2\] 30 participants enrolled and randomized to placebo).


Eligibility criteria:
inclusion criteria: * individuals \>18 years old with type 1 or type 2 diabetes mellitus. exclusion criteria: * individuals currently taking the maximum dose of an ace inhibitor or an arb. * individuals with a history of a mi, percutaneous coronary interventions, coronary artery bypass graft (cabg) surgery, acute coronary syndromes, recent/on going atrial fibrillation, frequent atrial arrhythmias, frequent ventricular arrhythmias, or acute myocardial ischemia changes. * individuals whose treatment dosage changes 2 months prior to the study for antihypertensive and antidiabetes medications, and the following medications that may affect the ans: anti-tuberculosis drugs, nitrofurantoin, metronidazole, chloramphenicol, perhexiline maleate, amiodarone, clofibrate, tricyclic antidepressants, phenytoin, barbiturates, neuroleptic, antiparkinsonism drugs, and nitrated drugs. * pregnant or lactating females. * individuals with impaired renal function (i.e., creatinine \>1.5 mg/dl), a history of dialysis, nephritic syndrome or renovascular hypertension. * individuals with potassium levels within 0.5 mmol/l of the upper limit of normal (i.e., hyperkalemia).

Keywords: diabetes
lesion detection assessment in the liver: standard vs low radiation dose using varied post-processing techniques

Conditions: Diseases of Liver; Colon Carcinoma; Colorectal Carcinoma; Liver Metastases

Summary: to compare 2 different image creation/processing techniques during a standard ct scan in order to "see" problems in the liver and learn which method provides better image quality. the techniques use new artificial intelligence software to decrease image noise, which helps the radiologist to evaluate.

primary objective: to evaluate whether post-processing software adaptive statistical iterative reconstruction (asir), asir-v, veo 3.0 (ge version of model-based iterative reconstruction (mbir), and deep learning image reconstruction (dlir) is able to preserve lesion detection in the liver and other measures of image quality at reduced radiation doses for computed tomography (ct). secondary objectives: assessment of whether post-processing software enhances lesion detection in the liver and other measures of image quality at standard and reduced radiation doses. assessment of whether dlir and gsi dlir reconstructions perform differently, both in terms of accuracy and image quality metrics such as noise reduction.

Eligibility criteria:
inclusion criteria: 1. patient must be \>/= 18 years of age and \</=90 years of age 2. men and non-pregnant women 3. pathology proven diagnosis of colon or colorectal carcinoma 4. liver metastases on most recent ct examination 5. standard of care ct abdomen examination planned with iv contrast exclusion criteria: 1. patients cannot give informed consent 2. patients cannot undergo ct examination

Keywords: diseases of liver colon carcinoma colorectal carcinoma liver metastases computed tomography ct reduced radiation doses deep learning image reconstructions dlir