Kornimate/medical-research-clean huggingface dataset:
association between renal and right cardiac functions after urinary sodium depletion following cardiac surgery

Conditions: Cardiorenal Syndrome

Summary: following cardiac surgery, right ventricular function may be altered leading to increase central venous pressure and decrease in renal blood flow. the investigator's standard care includes use of diuretic to avoid interstitial fluid accumulation. the aim of the study is to assess cardiac and renal function before and after depletion by using diuretics

the study will compare cardiac and renal data before and 6 hours after use of diuretic * echocardiographic measure of right function (s wave, tapse, ventricle surfaces, inferior vena cava diameter) and left function (lvef, cardiac output * renal function: cumulative diuresis, creatinine level variation and incidence of acute kidney injury using kdigo classification (creatinine level\>26.5 or diuresis\<0.05 ml kg-1 h-1)

Eligibility criteria:
inclusion criteria: patient undergoing elective cardiac surgery under cardiopulmonary bypass exclusion criteria: * heart transplantation * use of vasopressor * chronic renal disease (dgf under 30 ml min-1) * endocarditis * patient under ecls or cpia * patient under 18-year-old

Keywords: cardiac surgery venous congestion diuretic depletion
efficacy and safety trial of subcutaneous immunotherapy in mite induced asthma

Conditions: Allergic Asthma

Summary: the purpose of this study is to determine whether a short course of subcutaneous immunotherapy is efficacious in mite induced asthma. the efficacy is based on reduction in control medication.

the control of mild-moderate persistent asthma include the need of concomitant medication, as inhaled corticosteroids. however, compliance in perennial asthma is low. the aim of this study is to assess the possibility to reduce the need of concomitant medication through a short-course of subcutaneous immunotherapy.

Eligibility criteria:
inclusion criteria: * mild/moderate persistent asthma * positive skin prick test or specific ige to mites * age: 14-55 years old exclusion criteria: * immunotherapy contraindications * allergy to other inhalant allergens * previous immunotherapy (5 years)with mites

Keywords: specific immunotherapy mite asthma
the effects of pain and pain relief on peripheral nerve excitability

Conditions: Analgesia

Summary: this study will assess changes in nerve excitability of c-fibers, and changes in sympathetic or parasympathetic tone, when the subject experiences pain and pain relief. the investigators will continuously measure blood pressure, heart rate, respiration rate, gastric motility, sympathetic skin response and c-fiber excitability while using thermal stimuli before and after an analgesic.


Eligibility criteria:
inclusion criteria: * healthy participants able to give informed consent. exclusion criteria: * chronic pain conditions * neurological or psychiatric disease * other major diseases * pain medication within the last 24 hours

Keywords: pain excitability microneurography autonomic nervous system
a phase i, randomized, modified single-blind, active-controlled (infants only), four-stage, step-down, comparative, multi-center study

Conditions: Meningococcal Immunization

Summary: the study will include groups of adults, toddlers, and infants who will receive different formulations of tetramen-t, and one group of infants who will receive a control vaccine, menjugate®. the primary objectives and their endpoints will be assessed in infants who receive tetramen-t. the secondary objectives and their endpoints will be assessed only in the subset of infants who receive a booster dose of tetramen-t. primary objectives: 1. to describe the safety profile in infants following three injections of tetramen-t, either a low-dose formulation (2 µg olysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per serogroup with djuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), administered concomitantly with routine vaccines (pentacel®, prevnar®, and engerix-b®). 2. to describe the immunogenicity profile in infants following three injections of tetramen-t, either a low-dose formulation (2 µg polysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per serogroup with adjuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), administered on comitantly with routine vaccines (pentacel®, prevnar®, and engerix-b®). secondary objectives: 1. to describe the safety profile in a subset of infants following a booster dose of tetramen-t, either a low-dose formulation (2 µg polysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per erogroup with adjuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), at 13 months of age. 2. to describe the immunogenicity profile in a subset of infants following a booster dose of tetramen-t, either a low-dose formulation (2 µg polysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per serogroup with adjuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), at 13 months of age.

up to 24 months

Eligibility criteria:
inclusion criteria: -subject is healthy, as determined by medical history and physical assessment. -at the time of vaccination on day 0, subject was the following age: adults: aged ≥18 to \< 40 years toddlers: aged ≥12 to \< 19 months infants: aged 2 months + 28 days (60 to 88 days) * institutional review board (irb)-approved informed consent form signed by the subject or the subject's parent/legal guardian. exclusion criteria: participants are excluded from the study if any of the following criteria apply: * any subject who, in the judgment of the investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
empiric calcium in massive transfusion

Conditions: Hemorrhage; Trauma; Hypocalcemia; Shock, Hemorrhagic

Summary: calcium helps blood to clot and thereby stop bleeding. trauma patients who experience large volume blood loss often require blood transfusions and bleeding is the most common cause of death. the purpose of this study is to see if giving intravenous calcium immediately to patients who require large volume blood transfusion will decrease transfusion requirements, vasopressor use and mortality in bleeding trauma patients.

advancements in the area of transfusion and blood product administration have occurred with the use of viscoelastic assays and whole blood. however, as we resuscitate trauma patients with blood products, hypocalcemia is an inadvertent side-effect. citrate within stored blood binds calcium, causing patients to have hypocalcemia. in addition, outside of transfusion related hypocalcemia there is an independent trauma/inflammation related mechanism for hypocalcemia in the trauma patient. furthermore, calcium is a critical component of the coagulation cascade, and therefore a highly important component of hemostatic resuscitation. hall et al found that patients receiving 13 or more units of prbcs had a much higher prevalence of severe hypocalcemia and at least one ionized calcium \<1.0mmol/l. kronstedt el al reported an association between hypocalcemia and mortality in trauma patients receiving massive transfusion. despite evidence that hypocalcemia occurs with transfusion, and evidence that hypocalcemia in patients with hemorrhagic shock may be associated with increased mortality, there are no randomized controlled trials evaluating the administration of calcium in trauma resuscitation. currently, the joint trauma system revised guidelines for damage control resuscitation from 2019 recommend administering 1g of calcium after the first unit of blood transfusion, and an additional 1g after no more than 4 units of blood administration. however, these recommendations are based on small cohort studies or retrospective studies. the purpose of this study is to evaluate the efficacy of early empiric intravenous calcium administration on transfusion requirements, vasopressor use and mortality in hemorrhaging trauma patients with initiation of a massive transfusion. all trauma patients in which massive transfusion is initiated within 6 hours of arrival will be enrolled. two study arms will be created, one will receive 2g iv calcium with the initial transfusion and the other will only receive calcium supplementation based on routine ionized calcium levels and/or physician discretion. all critical trauma activations will get a baseline ionized calcium as part of their initial labs.

Eligibility criteria:
inclusion criteria: * trauma patients receiving massive transfusion protocol exclusion criteria: * pregnancy * prisoners * known history of hypercalcemia * active hyperparathyroidism * hemophilia
mindfulness and relaxation interventions in individual psychotherapies for children and adolescents

Conditions: Hyperkinetic Disorder; Depressive Disorder; Anxiety Disorder

Summary: the study 'mindfulness and relaxation interventions in individual training psychotherapies for children and adolescents' (mars-ca) aims to examine the effects of short session-introducing interventions with mindfulness elements (siime) on juvenile patients' psychopathological symptomatology and therapeutic alliance at the beginning of the first 24 therapy sessions.

short session-introducing interventions with mindfulness elements (siime) shall be compared with session-introducing relaxation interventions (siri) and no session-introducing interventions (treatment as usual, (tau)). patients between 11 and 19 years and a primary diagnosis of hyperkinetic disorder, depressive disorder or anxiety disorder are invited to participate. psychotherapy will be conducted by trainee therapists at a trainee outpatient clinic for children and adolescents. it is hypothesized that psychopathological symptomatology and therapeutic alliance improve more in the mindfulness condition than in the relaxation condition and tau, and that mindfulness moderates the relationship between therapeutic alliance and psychopathological symptomatology stronger than the relaxation condition and tau.

Eligibility criteria:
inclusion criteria: * a primary hyperkinetic disorder, depressive disorder or anxiety disorder diagnosis * treatment at the center for psychological psychotherapy, university of heidelberg exclusion criteria: * age below 11 or above 19 * insufficient german language skills * psychotic disorder * acute suicidality

Keywords: mindfulness-based intervention session-introducing interventions child and adolescent psychotherapy cognitive-behavioral therapy therapeutic alliance depressive disorder hyperkinetic disorder anxiety disorder
evaluation of the ind one step strep a rapid test vs. culture

Conditions: Strep Throat

Summary: the purpose of this study is to demonstrate the ability of the ind one step strep a test to accurately test a throat swab specimen from a symptomatic patient for the presence or absence of group a streptococcus (strep a) when compared to culture.

group a streptococcus is a principal cause of respiratory infections such as tonsillitis, pharyngitis, and scarlet fever. since pharyngitis can lead to rheumatic fever or acute glomerulonephritis, it is important to differentiate streptococcal pharyngitis from viral disease during early stages of infection. the strep a rapid test is a simple and rapid test which can detect group a streptococcal antigen directly from throat swabs allowing physicians to make a rapid diagnosis and to administer therapy immediately. the ind diagnostic inc. strep a rapid test is a lateral flow immunoassay utilizing colloidal gold reagents labeled with strep a antibody. the test detects either viable or nonviable organisms directly from throat swabs within 10 minutes.

Eligibility criteria:
inclusion criteria: * male and female subjects three (3) years of age or older * patients exhibiting at least 3 of the following symptoms: * fever * sore throat * swollen lymph nodes in the neck * redness of the throat and tonsils * white or yellow patches on the tonsils * must be able to collect 2 throat swab samples from patient exclusion criteria: * patients currently undergoing antibiotic treatment will be excluded from study

Keywords: group a streptococcus strep a rapid test pharyngitis
selecting the right hip prosthesis for young patients

Conditions: Osteoarthritis, Hip

Summary: there have been no previously published clinical randomized studies comparing primoris®, short stem, hip prosthesis with standard uncemented hip arthroplasty in relation to bone density and function development. this is the subject for this study.

the overall purpose of this study is to show whether the primoris® hip prosthesis results in a smaller loss of bone density than standard hip prosthesis, which in the longer term may result in an improved survival of prosthesis no. 2 after revision / replacement of a primoris® hip prosthesis. the primary outcome is periprosthetic bone quality in primoris® hip prosthesis compared to standard hip prosthesis measured by dxa scanning. the secondary outcomes are to assess: 1. the hip function measured by gait analysis. 2. hip strength at pressure gauge. 3. prosthetic migration / migration measured by radio-stereometric analysis (rsa). 4. patient satisfaction measured by proms.

Eligibility criteria:
inclusion criteria: women ≤ 45 years or men ≤ 55 years with hip osteoarthritis, suitable for hip prosthesis. patients who wish to participate in the project and give written consent after oral and written information. exclusion criteria: 1. patients with previous bone disease, metabolic disease, including diabetes, or the use of drugs that affect bone density. 2. smoking more than 20 cigarettes daily 3. patients with fracture in the femur or acetabulum. 4. patients who do not understand the given patient information 5. competing disorder requiring treatment with antiinflammatory drugs (nsaids, steroid, cytostatics). 6. estimated residual life \<10 years 7. rheumatoid arthritis or other arthritis (eg psoriasis arthritis). 8. previous surgery on the relevant hip joint. 9. co-morbidity (asa group 3-5). 10. neurological disorder that compromises motor skills and rehabilitation. 11. pregnancy. 12. osteoarthritis secondary to mb. calvé-legg-perthes / avascular caput necrosis, epiphysiolysis capitis femoris and multiple epiphysic dysplasia. 13. acetabular dysplasia with secondary subluxation (crowe grade ii to iv). 14. previously detected osteoporosis or osteoporosis detected by current dxa scanning. 15. ongoing treatment with osteoporosis medicine (bisphosphonates, estrogen receptor modulators and parathyroid hormone, etc.). 16. aseptic caput necrosis (posttraumatic, idiopathic). 17. varus or valgus deformity in proximal femur (collum angle \ 145 °.) 18. collum femoris assessed too retro- or anteverted.

Keywords: hip arthroplasty
dulce digital-project dulce 2.0 texting study

Conditions: Diabetes

Summary: randomized controlled trial testing the efficacy of a text messaging intervention in a low income, low health literacy group of latino patients. project dulce 2.0 (pd 2.0) will address barriers to participation in health education classes, increasing adherence to treatment and medications and improving diabetes self management behaviors and skills. two community clinic organizations that provide services to a large proportion of latino patients with type 2 diabetes will participate to randomize 200 patients into one of 2 arms: standard diabetes management care (control) only or text messaging and standard care. comparisons between groups will evaluate clinical, behavioral and psychosocial outcomes. intervention: standard care and text messaging. all participants will receive standard diabetes care provided by primary care providers at the clinic. of the 100 that are randomized to the intervention arm will be given instructions on how the text messaging component will be addressed throughout the duration of the study.


Eligibility criteria:
inclusion criteria: * ages 18-75, * type 2 dm, * enrolled at community health center, * latino ethnicity, * non project dulce participant, * hba1c\>/= 8%, must be able to read exclusion criteria: * have a severe illness precluding frequent visits to the clinic, * have a severe medical condition, poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study, any history of malignancy, except subjects who have been disease-free for \>10 years, or whose only malignancy has been basal or squamous cell skin carcinoma, * patients who have a creatinine level greater than 3.5, * any history of drug or alcohol abuse within 12 months prior to the study, * those who are not a permanent resident in the area. * patients who are not willing to use a cell phone with texting capability.

Keywords: high risk latino patients with diabetes
iuni g2+ prospective study

Conditions: Knee Osteoarthritis

Summary: this study is designed to monitor long term clinical outcomes of the iuni g2+ unicompartmental knee replacement

the study subjects will be followed for 10 years post implant. the follow-up visit schedule will include visits at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post implant.

Eligibility criteria:
inclusion criteria: * clinical condition included in the approved indications for use * unicompartmental osteoarthritis of the medial or lateral tibiofemoral compartment * willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits * \> 18 years of age exclusion criteria: * simultaneous bilateral procedure required * bmi \> 35 * treatment for cancer within the past 5 years, with the exception of skin cancer * poorly controlled diabetes * neuromuscular conditions which prevent patient from participating in study activities * active local or systemic infection * immunocompromised * fibromyalgia or other general body pain related condition * advanced tricompartmental osteoarthritis * symptomatic patellofemoral disease * rheumatoid arthritis or other forms of inflammatory joint disease (excluding gout unless it is in the treated knee or limiting overall function) * loss of bone or musculature, osteoporosis, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified. osteoporosis is defined by more than -2.5 standard deviations from the t score as measured on a dual energy x-ray absortiometry scan (dexa) within 2 years of surgery. * advanced loss of osteochondral structure on the affected femoral condyle * compromised acl, pcl or collateral ligament * severe (\>15º) fixed valgus or varus deformity * extension deficit \> 15 º * prior history of failed implant surgery of the joint to be treated * unwilling or unable to comply with study requirements * participation in another clinical study which would confound results
metabolic effects of chronic ketosis (keto-chf metabolic)

Conditions: Heart Failure

Summary: heart failure (hf) is a major public health issue because the disease affects 1-2% of the western population and the lifetime risk of hf is 20%. despite major improvements in the management and care of patients with hf, the 1-year mortality in patients with hf is 13% and \>50% of hf patients are admitted during a 2.5 year period. furthermore, patients with hf have markedly decreased physical capacity and quality of life. thus, there is a need for new treatment modalities in this group of patients. it is well established that patients with heart failure have metabolic disturbances, including disturbed glucose metabolism with increasing insulin resistance, increased lipolysis, and disturbances in skeletal muscle homeostasis. presently there are no data on the clinical metabolic effects of long-term oral ketone-supplementation in patients with chronic hf. in this study we aim to investigate the effect of 14 days modulation of circulating ketone body levels on endogenous protein, glucose, and fatty acid metabolism in patients with hfref.


Eligibility criteria:
inclusion criteria: * chronic heart failure with nyha ii-iii * left ventricular ejection fraction ≤40% * negative urine-hcg for women with childbearing potential exclusion criteria: * known diabetes or hba1c ≥48 mmol/mol * significant cardiac valve disease * severe stable angina pectoris * age \<18 years
tracpatch in total knee arthroplasty

Conditions: Arthroplasty, Replacement, Knee; Osteoarthritis, Knee

Summary: total knee arthroplasty is becoming an increasingly common operation. an important part of a successful overall patient outcome is regaining functional range of motion after surgery. wearable devices for fitness have become increasingly common. this study seeks to utilize wearable technology to enhance the post-operative rehabilitation experience by allowing patients and surgeons to monitor patient recovery in real time. the consensus tracpatch is a wearable device which utilizes an accelerometer, temperature sensor and step count to monitor patient recovery. this tool provides critical, real-time information that may offer a more complete source of data to understand a patient's postoperative clinical and rehabilitation course and guide physician postoperative management. the study hypothesizes that this new technology will improve patient postoperative mobility and patient-physician communication.


Eligibility criteria:
inclusion criteria: * surgical candidate for total knee arthroplasty * greater than 18 years of age * have signed the written informed consent form * have consistent access to an ios or android device with bluetooth capability exclusion criteria: * unwilling or unable to provide consent * not fluent in the language of the informed consent form (english and spanish) * prisoners * pregnant women * wards of the state * have previously undergone a tka on that ipsilateral knee * deformities of \> 10 degrees valgus or varus or flexion contractures of \> 10 degrees. * considered by the surgeon to be a complex arthroplasty

Keywords: wearable technology total knee arthroplasty accelerometer