Kornimate/medical-research-clean huggingface dataset:
early use of cryoprecipitate with major hemorrhage protocol (mhp) activation

Conditions: Trauma Injury

Summary: the purpose of this trial is to compare standard of care (soc) massive transfusion protocol to soc massive transfusion protocol plus early use of cryoprecipitate (within 90 minutes of emergency department arrival).


Eligibility criteria:
inclusion criteria: * the patient is judged to be an adult (according to local practice, e.g. 16 years or older in uk) and has sustained severe traumatic injury. in the event the age is unknown, estimated body weight ≥50 kg. * the patient is deemed by the attending clinician to have on-going active hemorrhage and requires activation of the local major hemorrhage protocol for management of severe blood loss and has started or has received at least one unit of any blood component exclusion criteria: * the patient has been transferred from another hospital * the trauma team leader deems the injuries incompatible with life * more than 3 hours have elapsed from the time of injury * prisoner (as defined as someone admitted from a correctional facility) * known "do not resuscitate" orders * enrolled in a concurrent ongoing interventional, randomized clinical trial * patients who wear "opt out" bracelet for study * obvious pregnancy * severely burned
a study to assess the safety and efficacy of an investigational drug (mk-686) in patients with osteoarthritis (0686-006)

Conditions: Osteoarthritis

Summary: this study is being conducted to assess the safety and tolerability of mk-0686 and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.


Eligibility criteria:
inclusion criteria: * patients with a clinical and radiographic diagnosis of osteoarthritis of the hip or knee,either prior nsaid or acetaminophen users within the ara functional class i,ii or iii and with no clinically significant diseases * patients required to demonstrate a flare of the signs and symptoms of oa following withdrawal of nsaid treatment * prior acetaminophen users also required to demonstrate greater than a defined minimum level of signs and symptoms of oa * females must be either post-menopausal or surgically sterilized exclusion criteria: * no history of concurrent arthritic disease * no history of neoplastic disease within a specified duration * no history of disease that causes malabsorption * chronic use of certain medications excluded
safety of the co-administration of three drugs for trachoma and lymphatic filariasis elimination

Conditions: Parasitic Diseases; Bacterial Diseases

Summary: the purpose of this study is to determine whether the triple co administration of albendazole, ivermectin and azithromycine is as safe as the current treatment scheme that consists to treat with albendazole plus ivermectin together and a week later to treat with azithromycin in areas co endemic for lymphatic filariasis and trachoma.

infectious diseases such as trachoma and lymphatic filariasis are public health problems in regions of africa and asia. elimination programs exist for the two diseases, and their treatment by different groups of health workers is both costly and inefficient. thus, a study evaluating the safety and feasibility of an integrated mass treatment of trachoma and lymphatic filariasis with azithromycin associated with albendazole and ivermectin was instituted in 4 villages of the region of sikasso in mali (west africa) co endemic for lymphatic filariasis and trachoma. it was an open label randomized clusters type on the assessment of the safety of the triple co administration of azithromycin, ivermectin and albendazole (experimental regimen) as compared to the administration of the co administration of albendazole plus ivermectin followed by the that of azithromycin a week later (current standard recommended regimen) within subjects of 5 to 65 years old, willing and able to swallow the study drugs. clinical evaluation of adverse events in all study participants was done on day 0, day 8, and day 15 after the treatment.

Eligibility criteria:
inclusion criteria: * must have been residing in the village for at least three months; * must be 90 cm tall or more; * must be between 5 years and 65 years of age; * must not be pregnant; * must not be lactating. exclusion criteria: * subjects under 5 years of age or less than 90 cm in height; * subjects over 65 years of age; * subjects who cannot swallow tablets; * subjects who are sick and bedridden; * pregnant women (clinical appreciation in the study); * lactating women; * history of allergies to the drugs being studied (azithromycin, ivermectin, albendazole).

Keywords: albendazole ivermectin azithromycin lymphatic filariasis trachoma safety
magnesium sulfate vs placebo for placental abruption

Conditions: Abruptio Placentae

Summary: to evaluate the safety and efficacy of magnesium sulfate for preterm suspected abruption.

we hope to learn if there is a difference in the efficacy of intravenous magnesium sulfate versus intravenous saline infusion in the resolution of vaginal bleeding and contractions in patients with a suspected placental abruption.

Eligibility criteria:
inclusion criteria: - vaginal bleeding and contractions consistent with suspected placental abruption between 24 and 34 weeks gestation. exclusion criteria: - preterm labor, severe bleeding necessitating immediate delivery, maternal coagulopathy, fetal distress
safety and efficacy of ibi306 in hefh patients

Conditions: Heterozygous Familial Hypercholesterolemia

Summary: ibi306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (pcsk-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (ldl-r) and thereby restoring ldl-r recycling and low-density lipoprotein cholesterol (ldl-c) uptake. in the phase i study, ibi306 was shown to be safe and well tolerated. there was robust reduction in ldl-c, apo(b), non-hdl-c and lipoprotein (a) in healthy subjects. this study is a randomized, double-blind, placebo-controlled, repeated-dosing, multiple ascending dose trial to evaluate the efficacy and safety of a novel pcsk-9 anti-body, ibi306, in chinese patients with heterozygous familial hypercholesterolemia.

the study plans to enroll 148 patients with heterozygous familial hypercholesterolemia. subjects will maintain a low-fat diet and stable current lipid-lowering therapy for at least 4 weeks and will be randomized into different dose groups at a 1:1 ratio, followed by a 2:1 randomization double-blind treatment with subcutaneous ibi306 150 mg (n=49) or placebo (n=25) every two weeks; or subcutaneous injection of ibi306 450mg (n=49) or placebo (n=25) every four weeks. treatment lasts for 12 weeks. after 12 weeks, each group enters a 12-week open-label treatment, in which ibi306 subjects continue to receive ibi306, and placebo subjects shift to receive ibi306. the primary endpoint is the percent change in ldl-c levels relative to baseline at 12 weeks. secondary endpoints include changes in baseline lipid levels, drug safety, and immunogenicity at 12 weeks and 24 weeks. the exploratory endpoint is the population pharmacokinetic profile of ibi306 in chinese subjects with heterozygous familial hypercholesterolemia. if necessary, the dose of ibi306 will be adjusted accordingly based on the results of the ongoing multi-dose escalation study. after the open period, the subjects will be given a safety visit for 8 weeks.

Eligibility criteria:
inclusion criteria: • subjects must meet all of the following inclusion criteria in order to be included in the study: * provide a signed and dated informed consent form * men or women 18 to 70 years of age at screening * weight ≥ 40 kg during screening * confirmed diagnosis of heterozygous familial hypercholesterolemia * maintain a low-fat diet and stabilize the current lipid-lowering therapy exclusion criteria: • subjects who do not meet any of the following exclusion criteria cannot be included in the study: * patients diagnosed as homozygous familial hypercholesterolemia * dialysis or plasmapheresis performed within 4 months prior to screening * history of liver transplant * subjects adjusted for treatment of statins, ezetimibe, niacin, omega-fatty acids within 4 weeks prior to screening * new york heart association (nyha) grade iii or iv heart failure, or recent detection of left ventricular ejection fraction ≤ 30% * have serious cardiovascular, cerebrovascular, liver and kidney related diseases
the efficacy of a toothpaste to reduce sensitivity

Conditions: Dentin Hypersensitivity

Summary: hypersensitivity


Eligibility criteria:
inclusion criteria: * male and female subjects, ages: 12 years or older. * availability for the eight-week duration of the study. * two sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession. * qualifying response to tactile stimuli (yeaple probe) as defined by a score between 10-50 grams of force. * qualifying response to the air blast stimuli as defined by a score of 2 or 3 on the schiff cold air sensitivity scale. * subjects need to satisfy the qualifying response to stimuli for both parameters assessed (tactile or air blast) on at least two teeth to be entered into the study. * good general health with no known allergies to products being tested. * use of a non-desensitizing dentifrice for one month prior to entry into the study. * signed informed consent form. exclusion criteria: * gross oral pathology, chronic disease, or history of allergy to test products. * advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months. * sensitive teeth with a mobility greater than one. * teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures. * regular use of anticonvulsants, antihistamines, sedatives, tranquilizers, anti-inflammatory drugs, or analgesics. * participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past one month. * current participation in any other clinical study. * allergies to triclosan, or oral care products, personal care consumer products, or their ingredients. * medical condition which prohibits not eating/drinking for 4 hours.
assess the downregulation of hiv-1 when raltegravir is added to a virologically suppressed haart regimen

Conditions: HIV

Summary: the purpose of this study is to determine whether or not adding raltegravir to a fully suppressive antiretroviral regimen will assist in reducing hiv-1 associated chronic inflammation and increase the t-lymphocyte memory cell pool.


Eligibility criteria:
inclusion criteria: 1. at least 18 years of age 2. hiv-positive by western blot or viral load 3. viral load \< 400 copies/ml 4. cd4+ t-lymphocyte count less than 350 cells/mm3 or change in cd4+ t-lymphocyte count \< 100 cells/mm3 for at least one year on stable haart with viral load \< 400 copies/ml for the same period of time exclusion criteria: 1. cd4+ t-lymphocyte count greater than or equal to 350 cells/mm3 or rise in cd4+ t-lymphocyte count greater than or equal to 100 cells/mm3 within one year of study entry 2. viral load \> 400 copies/ml 3. allergy or resistance to raltegravir

Keywords: chronic inflammation memory cells activated t-lymphocytes
tracheotomy with and without dual antiplatelet therapy

Conditions: Tracheostomy Hemorrhage

Summary: platelet-inhibiting drugs are often used after vascular interventions. patients who require such therapies are often critically ill, are treated in intensive care units and often require long-term ventilation. for long-term ventilation a tracheotomy is necessary, which is usually performed as a percutaneous dilatative tracheotomy (pdt). as part of this intervention, there is (theoretically) an increased risk of bleeding/an increased rate of complications in patients with a antiplatelet therapy. in addition, there are various techniques for performing a pdt. the current study aims to investigate the frequency of bleeding/complications taking into account the technique used in pdt.


Eligibility criteria:
inclusion criteria: * patients who underwent percutaneous dilational tracheostomy exclusion criteria: * none
a clinical trial to study the effects of nanoparticle based paclitaxel drug, which does not contain the solvent cremophor, in advanced breast cancer

Conditions: Advanced Breast Cancer

Summary: this study is a multicentre, open label, non-randomized phase i study. the main objectives of the study are to determine the pharmacokinetic profile of the drug at different dose levels in the patients with advanced breast cancer. maximum tolerated dose (mtd) and safety of paclitaxel nanoparticle will also be simultaneously assessed.


Eligibility criteria:
inclusion criteria: * female patients with histopathologically /cytologically confirmed advanced breast cancer, refractory / recurrent\* to previous anthracycline treatment as adjuvant or first line therapy for metastasis. * patients with er/pr -ve or er/pr receptor status unknown (defined as no histopathological evidence for confirmation of er/pr status) * patients must be of 18-65 years of age (inclusive of both) * patients with ecog performance status between 0 - 2 * patients with at least one measurable lesion as per recist exclusion criteria: * patients with er/pr positive status. patients who demonstrate her2 over expression will be excluded. alternatively, the patients enrolled should have previously received trastuzumab. her2 over expression should be demonstrated by ihc 3+, ihc 2+ or with fish/cis. * patients with known history of hypersensitivity to paclitaxel or any other taxane or compounds chemically / biologically related to paclitaxel or excipients. * patients requiring any concurrent chemotherapy, hormonal therapy immunotherapy, therapy with biologicals or radiotherapy for the disease. (patients requiring local radiotherapy for non- target bone lesion will be included). * patients with known cns lesions (brain metastasis or carcinomatous meningitis).
sex-related differences in sympathetic vascular transduction in the setting of hypoxemia

Conditions: Vasodilation; Hypoxia

Summary: the purpose of this project is to identify sex-related differences in the effect of hypoxia on sympathetic vascular transduction.


Eligibility criteria:
inclusion criteria: * healthy adult men and women; * 18-45 years of age; * bmi 18-30 kg/m2; * non-pregnant/non-breastfeeding; * non-nicotine users; exclusion criteria: * pregnancy, breastfeeding, hormonal contraceptives * diagnosed sleep apnea * current smoking/nicotine use/drug use * nerve/neurologic disease * cardiovascular, hepatic, renal, respiratory disease * blood pressure ≥140/90 mmhg * diabetes, polycystic ovarian syndrome * communication barriers * prescription medications * recent covid-19 diagnosis with symptoms
a study to assess regadenoson administration following an inadequate exercise stress test as compared to regadenoson alone for myocardial perfusion imaging (mpi) using single photon emission computed tomography (spect)

Conditions: Coronary Artery Disease (CAD)

Summary: the purpose of this study is to demonstrate that the strength of agreement between single photon emission computed tomography (spect) imaging with regadenoson following inadequate exercise stress testing and spect imaging with regadenoson alone is not inferior to the strength of agreement between two sequential regadenoson spect images without exercise.


Eligibility criteria:
inclusion criteria: * subjects referred for an exercise or pharmacologic stress test spect mpi procedure for the evaluation of coronary artery disease (cad) are eligible for study participation. subjects referred for pharmacologic stress should have a reasonable potential of attempting exercise stress. subject must have one of the following: * a. past ischemia on any prior imaging stress test without invasive intervention on the artery subtending this territory * b. subject with known cad who have symptoms similar to previous ischemic symptoms, or recent onset of symptoms or recently worsened symptoms suggestive of ischemia * c. diamond forrester estimated pretest probability of cad of ≥ 50% * d. history of most recent coronary artery bypass surgery or most recent percutaneous coronary intervention (pci) \> 10 years (patients who are \> 30 days but less than 10 years post coronary artery bypass graft (cabg) or pci can be included if they meet criteria a, b, or e) * e. previously demonstrated 100% occlusion by invasive coronary or computed tomography (ct) angiography without successful intervening revascularization as these foods may alter regadenoson effects exclusion criteria: * subject has a clinically significant illness, medical condition, or laboratory abnormality * female subject who is pregnant or lactating * subject is on dialysis for end stage renal disease or has a history of glomerular filtration rate (gfr) \< 15 ml/min (calculated using mdrd \[modification of diet in renal disease\] formula) * subject has a history of coronary revascularization by either pci or cabg within 1 month prior to the rest myocardial perfusion imaging (mpi) * subject has a pacemaker or an implantable cardioverter defibrillator (icd) * subject has a history of acute myocardial infarction (mi) or high risk unstable angina within 30 days prior to the rest mpi or has had cardiac transplantation * subject has uncontrolled hypertension at any point on visit 2 prior to exercise testing (i.e., systolic blood pressure (sbp) ≥ 180 or diastolic blood pressure (dbp) ≥ 95 mmhg on two consecutive measurements while at rest). * subject has severe aortic stenosis or hypertrophic cardiomyopathy with obstruction or has decompensated congestive heart failure * subject has a history of severe respiratory disease including: asthma, chronic obstructive pulmonary disease (copd) or other bronchospastic reactive airway disease or who is on 24-hour continuous oxygen

Keywords: coronary artery disease (cad) regadenoson pharmacologic stress
goal-directed vs preemptive tranexamic acid administration in total hip arthroplasty

Conditions: Arthritis of Hip

Summary: the present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. the study's primary objective is to compare the amounts of postoperative bleeding using two different txa administration strategies: empirical txa administration vs. viscoelastic test-based goal-directed vs preemptive tranexamic acid administration in total hip arthroplasty. the secondary objectives include comparing the incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. researchers assumed that goal-directed tranexamic acid (txa) administration using viscoelastic field tests would not be inferior to the empirical txa administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. it also would be beneficial in lowering txa-induced thromboembolic complications and seizures.


Eligibility criteria:
inclusion criteria: inclusion criteria patients undergoing following surgery - total hip arthroplasty exclusion criteria: * pregnancy * refusal of allogenic blood transfusion * taking thrombin * history of thromboembolic and familial hypercoagulability disease * recent history of myocardial infarction or ischemic cerebral infarction (within 90 days) * hypersensitive to txa * histroy of convulsion or epilepsy * taking hemodialysis * history of heparin-induced thrombocytopenia
photobiomodulation dosimetry s in patients with orofacial pain

Conditions: Orofacial Pain; Tension-Type Headache

Summary: this project aims to validate a dosimetry model for photobiomodulation treatment in patients with orofacial pain and tension-type headache symptoms. the study will involve 240 participants divided into four age groups. different treatment approaches will be applied, including local photobiomodulation and systemic laser therapy. various physiological measurements will be taken before, during, and after the treatments, including skin type, weight, height, blood pressure, and heart rate. additionally, data from questionnaires on pain and headache symptoms will be analyzed. monte carlo simulation will be employed to validate the model based on these measurements and light transmission. the research addresses the need for effective pain management strategies in cases where medication-based treatments may have unwanted side effects.


Eligibility criteria:
inclusion criteria individuals of both sexes, between 7 and 65 years of age exclusion criteria participants with the following characteristics will be excluded: pregnant individuals individuals with arrhythmia individuals with thrombocytopenia individuals with sickle cell anemia individuals with a pacemaker individuals with alterations in coagulation factors

Keywords: orofacial pain tension-type headache photobiomodulation
treatment of complications to diabetic autonomic neuropathy with vagus nerve stimulation

Conditions: Gastrointestinal Dysfunction; Diabetes Mellitus

Summary: the purpose of the dan-vns study is to investigate the effects of non-invasive vagal nerve stimulation on gastrointestinal symptoms such as nausea, vomiting, bloating, and diarrhea in people with diabetes.

the study is a randomized, double-blinded, sham-controlled, parallel group clinical trial, which will include participants with diabetes and gastrointestinal (gi) problems. these problems may be manifestations of diabetic autonomic neuropathy. participants are randomised to received either active non-invasive transcutaneous vagal nerve stimulation (tvns) or inactive sham stimulation. the study period is divided in two phases. the first phase investigates the effects of short-term, high-intensity tvns treatment on gi symptoms. the second phase investigates the effects of long-term, middle-intensity tvns treatment. the primary outcome of both phases is subjective patient evaluation of gi symptoms by the use of validated questionnaires. a third phase, conducted only on participants, who proved to be responsive to tvns treatment, will investigate the acute endocrine and metabolic response to short-term tvns in a randomised cross-over design. lastly, healthy volunteers will be included in a cross-sectional, descriptive study in order to provide a comparable baseline dataset.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * verified diagnosis of diabetes for a minimum of 1 year and with stable medication * can-score ≥ 1 (measured by the vagus device (medicus engineering, aarhus, denmark) or compass-31 score of ≥ 16 or electrochemical resistance \<50µs (hands) and \<70µs (feet) assessed with the sudoscan device * weighted composite score of gastroparesis cardinal symptom index (gcsi) and gastrointestinal symptom rating scale (gsrs) ≥ 2.3 * ability to read and understand danish * personally signed and dated informed consent documents * willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures exclusion criteria: * significant gi diseases not related to diabetes * significant cardiovascular diseases * gi surgery within 3 months prior to study inclusion * swallowing disorders * blood pressure \ 160/105 * clinically significant bradycardia or tachycardia * implanted portable electro-mechanical medical devices including pacemaker, defibrillator, cochlear implant, and infusion pump * previous surgery of the vagus nerve * active laser treatment for proliferative retinopathy * contraindications for mri * any clinical abnormalities, that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results * pregnancy or intention to become pregnant or father a child during the course of the study * participation in other clinical trials less than three months prior to inclusion, unless such a participation is judged to have no influence on the recordings

Keywords: vagal nerve stimulation gastrointestinal symptoms diabetes mellitus