Kornimate/medical-research-clean huggingface dataset:
tenecteplase reperfusion therapy in acute ischemic cerebrovascular events-ⅱ

Conditions: Acute Ischemic Stroke

Summary: a phase ⅲ, multicenter, prospective, randomized, open label, blinded-endpoint (probe) controlled trial of recombinant human tnk tissue-type plasminogen activator (rhtnk-tpa) for injection versus alteplase for acute ischemic stroke within 4.5 hours

to test the hypothesis that rhtnk-tpa is non-inferior to alteplase in thrombolysis treatment when administered within 4.5 hours of ischemic stroke onset.

Eligibility criteria:
inclusion criteria: * age ≥18 years old, no gender limitation; * the time from onset to treatment was \< 4.5h;the time at which symptoms begin is defined as "the time at which they finally appear normal"; * the clinical diagnosis was ischemic stroke (the diagnosis followed the chinese guidelines for the diagnosis and treatment of acute ischemic stroke 2018); * mrs before onset was 0-1 points * baseline nihss 5-25(both included); * informed consent from the patient or surrogate. exclusion criteria: * intended to proceed endovascular treatment; * nihss consciousness score \>2; * allergy to tenecteplase or alteplase; * past history of intracranial hemorrhage ; * a history of severe head trauma or stroke within 3 months; * a history of intracranial or spinal surgery within 3 months; * a history of gastrointestinal or urinary bleeding within 3 weeks; * 2 weeks of major surgery; * arterial puncture was performed at the hemostasis site that was not easily compressed within 1 week; * intracranial tumors (except neuroectodermal tumors, such as meningiomas), large intracranial aneurysms; * intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.); * active visceral bleeding; * aortic arch dissection was found; * after active antihypertensive treatment, hypertension is still not under control: systolic blood pressure ≥180 mm hg, or diastolic blood pressure ≥100 mm hg; * propensity for acute bleeding, including platelet counts of less than 100×109/ l or otherwise; * blood glucose \ 22.22 mmol/l; * oral warfarin anticoagulant with inr\>1.7 or pt\>15 s; * heparin treatment was received within 24 h; * thrombin inhibitors or factor xa inhibitors were used within 48 h; * head ct or mri showed a large infarction (infarcted area \> 1/3 of the middle cerebral artery); * subjects who are unable or unwilling to cooperate due to hemiplegia (todd's palsy) after epileptic seizure or other neurological/psychiatric disorders; * pregnant women, lactating women, or subjects who do not agree to use effective contraception during the trial; * participation in other clinical trials within 3 months prior to screening; * unsuitability or participation in this study as judged by the investigator may result in subjects being exposed to greater risk.

Keywords: rhtnk-tpa acute stroke phaseⅲ acute ischemic stroke rt-pa
effects of transcutaneous electrical nerve stimulation for postoperative quality of recovery after shoulder surgery

Conditions: Quality of Recovery

Summary: transcutaneous electrical nerve stimulation (tens) has been reported to reduce postoperative pain scores and opioid consumption after postoperative. this study aims to evaluate the effect of tens application on recovery quality after interscalene block for shoulder surgery.

shoulder rotator cuff repair and acromioplasty are associated with severe pain after surgery. interscalene block (isb) is the gold standard for shoulder surgery, but the block duration does not exceed 6-8 hours. in addition, after the resolution of isb, patients experience severe pain and need high doses of opioids. rebound pain is observed in the postoperative period after the effect of the nerve block abolition. rebound pain affects the quality of recovery and sleep quality in postoperative. transcutaneous electrical nerve stimulation (tens) is a method of pain relief that uses cutaneously applied electrodes for delivering electrical signals to peripheral nerves through the intact skin. tens is safe and effective for acute postoperative pain treatment. in addition, tens has been used in anesthesia to treat postoperative nausea vomiting, and labor analgesia beyond providing analgesia. we hypothesized that tens application would reduce the incidence of rebound pain, reduce the need for postoperative opioids, and improve recovery and sleep quality. this study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. patients scheduled for elective shoulder surgery will be screened for enrollment in the study.

Eligibility criteria:
inclusion criteria: * undergoing shoulder surgery * having signed a written informed consent form, * asai-iii exclusion criteria: * inadequate indication for interscalene block (coagulation disorder, local infection of block site, diaphragmatic paralysis, allergy to local anesthetics) * neuropathic disorder * severe cardiopulmonary disease * systemic steroid use * chronic opioids use * ucontrolled diabetes * psychiatric disorders, * pregnancy, * severe obesity (body mass index \> 35 kg/m2)

Keywords: interscalene brachial plexus block transcutaneous electrical nerve stimulation rebound pain
healey als platform trial - regimen f abbv-cls-7262

Conditions: Amyotrophic Lateral Sclerosis

Summary: the healey als platform trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of als. regimen f will evaluate the safety and efficacy of a single study drug, abbv-cls-7262, in participants with als.

the healey als platform trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of als. this trial is designed as a perpetual platform trial. this means that there is a single master protocol dictating the conduct of the trial. the healey als platform trial master protocol is registered as nct04297683. once a participant enrolls into the master protocol and meets all eligibility criteria, the participant will be eligible to be randomized into any currently enrolling regimen. all participants will have an equal chance of being randomized to any currently enrolling regimen. if a participant is randomized to regimen f abbv-cls-7262, the participant will complete a screening visit to assess additional regimen f eligibility criteria. once regimen f eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active abbv-cls-7262 or matching placebo. regimen f will enroll by invitation, as participants may not choose to enroll in regimen f. participants must first enroll into the master protocol and be eligible to participate in the master protocol before being able to be randomly assigned to regimen f. for a list of enrolling sites, please see the healey als platform trial master protocol under nct04297683.

Eligibility criteria:
inclusion criteria: * no additional inclusion criteria beyond the inclusion criteria specified in the master protocol (nct nct04297683). exclusion criteria: * the following exclusion criteria are in addition to the exclusion criteria specified in the master protocol (nct nct04297683). 1. based on the metabolism of the compound, the concomitant use of certain inhibitors and inducers of cytochrome p450 enzymes. 2. any clinically significant ecg abnormalities. 3. clinically significant clinical laboratory abnormalities.

Keywords: als placebo-controlled double-blind regimen specific appendix lou gehrig's disease abbv-cls-7262 calico life sciences
a study of bonviva (ibandronate) and alendronate on renal function in postmenopausal women with osteoporosis at high risk for renal disease.

Conditions: Post-Menopausal Osteoporosis

Summary: this 3 arm study will evaluate renal safety after administration of an intravenous (iv) injection or infusion of bonviva, compared to oral alendronate, in patients with postmenopausal osteoporosis, at increased risk of renal disease. patients will be randomized to receive bonviva 3mg intravenous (iv) by a) injection or b) infusion once every 3 months, or alendronate 70mg per oral (po) weekly. the anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * female patients, \>=60 years of age; * \>=5 years postmenopausal; * confirmed osteoporosis, at increased risk for renal disease. exclusion criteria: * inability to stand or sit upright for 30 minutes; * hypersensitivity to bisphosphonates; * malignant disease (other than successfully resected basal cell cancer) within previous 10 years, or breast cancer diagnosed within previous 20 years; * previous administration of an i.v. bisphosphonate; * oral bisphosphonate treatment other than study medication within 30 days prior to the baseline dosing visit and during the study; * history of major upper gastrointestinal disease.
folic acid for prevention of contrast induced nephropathy

Conditions: Kidney Diseases; Urologic Diseases

Summary: the purpose of this study is to determine whether periprocedural administration of folic acid is effective in the prevention of contrast induced nephropathy in patients undergoing coronary cta/angiography/angioplasty.

hyperhomocysteinemia is considered to be independently associated with a greater risk of contrast induced nephropathy (cin) in previous studies. however, the relationship between homocysteine-lowering therapy and cin remains uncertain. folic acid is considered to be the most common agent for homocysteine-lowering therapy. therefore, this study aims to determine whether periprocedural administration of folic acid is effective in the prevention of cin. 400 patients undergoing coronary cta/angiography/angioplasty are going to be initially enrolled. of these patients,200 were randomly assigned to receive a standard dose of folic acid (5mg tid, given at least two days before the procedural and continued for two days after), 200 to receive placebo. blood samples for estimations of serum creatinine were collected at 0, 24 and 48h of contrast agent administration. cin is defined as an elevation of creatinine by ≥ 25% or ≥ 0.5 mg/dl from baseline within 48h. the occurrence of cin and the major in-hospital clinical events were recorded and compared between the intervention and control groups.

Eligibility criteria:
inclusion criteria: * inpatients undergoing coronary cta/angiography/angioplasty exclusion criteria: * exposure to nephrotoxic drugs prior to or during the study period * end-stage renal failure requiring dialysis * allergy to iodine-containing contrast medium * pregnancy * refusal to give informed consent

Keywords: contrast induced nephropathy
association between lrg and histologic remission in ulcerative colitis

Conditions: Ulcerative Colitis in Histologic Remission

Summary: we attempt to clarify the serum leucine-rich α 2-glycoprotein (lrg) level which can predict histologic remission in ulcerative colitis patients in this study. colonoscopy with histology will be performed when histologic remission is predicted, irrespective of symptoms or serum lrg values. serum lrg levels are analyzed by an enzyme-linked immunosorbent assay.

aim: serum leucine-rich α 2-glycoprotein (lrg) may be a noninvasive biomarker for monitoring disease activity in patients with ulcerative colitis (uc). we attempt to clarify the lrg level which predicts histologic remission in uc patients in this study. methods: patients with uc were consecutively enrolled with the measurement of serum lrg. colonoscopy with histology is performed when histologic remission is predicted, irrespective of symptoms or serum lrg values. serum lrg levels are analyzed by an enzyme-linked immunosorbent assay. for the evaluation of uc activity, clinical remission was defined as score 1 or 0 using the partial mayo score and endoscopic remission was defined as score 0 using the mayo endoscopic subscore. and histologic remission is defined as \< grade 2 using geboes score. we analyze the area under receiver operating characteristic (roc) curves to evaluate the diagnostic ability of lrg for predicting histologic remission of uc.

Eligibility criteria:
inclusion criteria: * active uc patients exclusion criteria: * none
wound closure techniques in primary spine surgery

Conditions: Spinal Injuries

Summary: the researchers are trying to determine if there is a difference in blood flow around a wound site when comparing three different types of wound closure techniques.


Eligibility criteria:
inclusion criteria: * ≥ 18 years old * primary diagnosis of spinal stenosis * surgical indication for 1 or 2 level posterior spinal decompression or fusion exclusion criteria: * pregnant or breastfeeding * previous posterior spinal surgery * systemic corticosteroid use * long-term anticoagulation treatment * diagnosis of diabetes mellitus * diagnosis of peripheral arterial disease * current smoker * active infection of any kind or chronic infection with hiv, hepatitis c, or syphilis * iodine allergy
post operative pain of partial pulpotomy using a bioceramic material in patients with symptomatic irreversible pulpitis

Conditions: Endodontic Disease

Summary: the goal of this clinical trial is to assess post-operative pain of partial pulpotomy using a newly introduced bioceramic material in young patients with symptomatic irreversible pulpitis at 24, 48, 72 hours postoperatively using visual analogue scale (vas). the main question\[s\] it aims to answer are: • in patients with symptomatic irreversible pulpitis does the use of bioceramic material in partial pulpotomy decrease amount of post operative pain in comparison to conventional root canal treatment? participants will record the intensity of pain at 24,48, 72 hours postoperatively.


Eligibility criteria:
1. inclusion criteria : 1. subject's age between 9-14 years. 2. both male and female subjects. 3. medically free and healthy subjects. 4. mandibular molar teeth. 5. teeth with symptomatic irreversible pulpitis. 6. teeth with mature closed apices. 2. exclusion criteria: 1. teeth with acute dentoalveolar abscess. 2. subjects having more than one tooth that require root canal treatment. 3. subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the start of treatment. 4. subjects with systemic diseases who have endocrine diseases, infectious diseases or psychological disturbance. 5. teeth with periodontal disease or pulp calcification. 6. subjects taking chronic pain medications.

Keywords: bioceramic material, pulpitis, partial pulpotomy
hyperbaric oxygen therapy and insulin resistance (hotair2) - effect of one hbo session.

Conditions: Obesity; Type 2 Diabetes

Summary: obesity is an epidemic in western society and is the biggest risk factor for insulin resistance and type 2 diabetes. the investigators have recently shown that exposure to hyperbaric oxygen (hbo) leads to an increase insulin sensitivity in males ubjects and that this improvement can be measured in all men, not just those with diabetes. the aim of this study is to investigate the time course of this effect and explore the mechanisms involved. the investigators suspect that insulin sensitivity as measured by hyperinsulinaemic-euglycaemic clamp will be increased within the time-frame of one 2-hour hyperbaric oxygen exposure, and that the improvement will be measurable in females as well as males.


Eligibility criteria:
inclusion criteria: * overweight to obese (bmi 25-35 kg/m2) * age \>18 years (no specific upper age limit) * fit to enter hyperbaric chamber as assessed by hyperbaric physician. exclusion criteria: * personal history of diabetes * personal history of major psychiatric disorders * uise of prescribed or non-prescribed medications which may affect glucose homeostasis (e.g. steroids), * uncontrolled asthma, * current fever or upper respiratory infections * individuals who regularly perform high intensity exercise (\>2 week), * pregnancy, lactation and women who are planning to become pregnant * current intake of \>140g alcohol/week, * current smokers of cigarettes/cigars/marijuana, * current inatke of any illicit substance, * claustrophobia * has donated blood within past 3 months.

Keywords: insulin resistance inflammation hypoxia
safety study of filler agent composed of umbilical cord mesenchymal stem cells and hyaluronic acid

Conditions: Senescence Wrinkles, Acne, Pitting Scar

Summary: the overall goal of this study is to evaluate the safety and exploratory efficacy of the injectable filler agent composed of umbilical cord mesenchymal stem cells and hyaluronic acid for the improvement of wrinkles, acne, pitting scar and so on.


Eligibility criteria:
inclusion criteria: 1. male or female over 18 years; 2. have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures ; 3. suitable for the medical history and physical examination like the following preoperative laboratory tests results: complete blood count, coagulation, biochemistry, electrocardiogram, hepatogram and β-human chorionic gonadotropin (hcg) for women of childbearing age. exclusion criteria: 1. patients unable to undergo surgery liposuction with klein technique as those with severe cardiovascular disease, severe coagulation disorders including thrombophilia and pregnancy; 2. have history or active dermal diseases, inflammation, or any related disease; 3. had invasive aesthetic treatments or surgeries history 6 months before the treatments; 4. had physical or chemical aesthetic treatments 1 months before the study starts; 5. have a known history of allergic reactions like hypersensitivity to hyaluronic acid; 6. patients with limited understanding of the procedure or have poor compliance with the study or follow-up schedule; 7. pregnant or lactating; 8. use of drugs; 9. patients with preoperative results considered inadequate.
safety and immunogenicity of surface antigen, inactivated, influenza vaccine using the strain composition 2008/2009

Conditions: Seasonal Influenza

Summary: annual trial for registration influenza vaccine with the strain composition for season 2008/2009


Eligibility criteria:
inclusion criteria: * subjects eligible for enrollment into this study are male and female adults who are: 1. ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry 2. able to comply with all study requirements 3. in good health as determined by: * medical history * physical examination * clinical judgment of the investigator exclusion criteria: * they have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to: 1. cancer, except for localized skin cancer; 2. advanced congestive heart failure; 3. chronic obstructive pulmonary disease (copd); 4. autoimmune disease (including rheumatoid arthritis); 5. acute or progressive hepatic disease; 6. acute or progressive renal disease; 7. severe neurological or psychiatric disorder; 8. severe asthma. * they have history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g., to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate); * they have a known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from: * receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study; * receipt of immunostimulants; * receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; * suspected or known hiv infection or hiv-related disease; * they have a known or suspected history of drug or alcohol abuse; * they have a bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject; * women who are pregnant, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days); * within the past 12 months, they have: * received more than one injection of influenza vaccine * within the past 6 months, they have: * had laboratory confirmed influenza disease; * received influenza vaccine; * within the past 4 weeks they have received: * another vaccine; * any investigational agent; * they have any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days; 1 - they have experienced an acute exacerbation of a copd within the past 14 days

Keywords: influenza vaccine
a novel iron-based supplement for athletes aged 18-25: phase ii

Conditions: Iron Deficiencies

Summary: female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. this study aims to assess the efficacy of a novel iron supplement in improving iron status, gut microbiome, and exercise performance in endurance-trained females.

current iron supplements on the market are commonly associated with side effects including gastrointestinal distress, nausea, vomiting, and constipation. as a solution, we have developed a novel delivery system for iron supplementation that overcomes many of these limitations. the goal of this study is to assess the efficacy of a yeast-iron complex in improving iron status, gut microbiome, and exercise performance in young, endurance-trained females with sub-optimal iron status. participants will consume 40mg of elemental iron every second day for 8 weeks. before and after supplementation,participants will be assessed for exercise capacity (vo2max), iron status, and the current state of the gut microbiome. each week during supplementation, participants will complete a survey in in which they will report feelings of stress and recovery as well as gastrointestinal symptoms.

Eligibility criteria:
inclusion criteria: * cis-gendered female 18-25years old * sub-optimal iron status (ferritin ≤45mcg/ l) * at least 1 year past the age of menarche * engage in moderate to vigorous endurance activity for at least 3 hours a week exclusion criteria: * supplemented with iron iron (\>5mg/day), prebiotics, or probiotics in last 3 months * antibiotic use in last 3 months * - energy availability \>30 kcal/kg lean body mass

Keywords: iron microbiota endurance. exercise