Kornimate/medical-research-clean huggingface dataset:
erector spinae block versus peng block for hip replacement

Conditions: Pain, Postoperative

Summary: thr (total hip replacement) can be very painful and regional anesthesia is very effective in reducing postoperative pain. erector spinae plane block (espb) and peng (pericapsular nerve group block) are alternative approaches to the hip sensitive nerve branches that resulted to be very promising for hip surgeries. however, no studies investigated the analgesic superiority of either peng or espb. in our study the investigators compare peng (with a lateral femoral cutaneous nerve block) and espb in terms of pain relief expressed as morphine consumption in the first 24 hours after primary thr.


Eligibility criteria:
inclusion criteria: * primary total hip replacement * informed consent exclusion criteria: * allergies to study drugs * spinal anesthesia contraindicated * kidney failure * epilepsy, psychiatric disease, neurologic deficits * revision surgery * neuropathies in the lumbar area * no informed consent * pregnancy * alcohol/opioid abuse * emergency surgery/intensive care
a study evaluating the efficacy of administered maintenance treatments in bipolar disorder i and ii.

Conditions: Bipolar Disorder

Summary: the primary objective of the study is to evaluate the efficacy of administered maintenance treatments in bipolar disorder i and ii, defined as the percentage of patients who experience a relapse episode during the first 9 months after a mood event (manic or depressive).


Eligibility criteria:
inclusion criteria: * subjects who experienced the last acute mood episode during the last 2 months and are in euthymic state (ymrs score ≤12 and ham-d score ≤12) for at least two weeks * diagnosis of bipolar disorder i or ii (as per dsm-iv), with or without rapid cycling * subjects who have been treated with at least one atypical antipsychotic for the management of an acute mood event (manic or depressive) as monotherapy or in combination with other medication * provision of informed consent prior to study participation exclusion criteria: * subjects fulfilling criteria for diagnosis of any other psychiatric condition (except from bipolar disorder i or ii), as per dsm-iv axis ι, concomitant organic mental disorder or mental retardation * subjects who have received treatment with a depot * substance abuse or dependence (with the exception of nicotine dependence), as defined by dsm-iv criteria * inability of subjects to comply with the study protocol.

Keywords: bipolar disorder i and ii mood event manic or depressive greece
the effect of two weeks of voluntary reduced physical activity in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD); Muscle Atrophy

Summary: chronic obstructive pulmonary disease (copd) is the most common pulmonary disease, responsible for considerable morbidity and mortality and is the third leading cause of death worldwide. as well as its consequences in the lungs, copd is well recognized to be associated with a range of important systemic consequences and co-morbidities. interestingly, skeletal muscle dysfunction is noted in both early and advanced disease, suggesting its origins may not be wholly pulmonary. treatment strategies targeting lung function are, unfortunately, of limited value. given the burden of disease, it is becoming increasingly important that investigative and therapeutic work now focuses on other systemic characteristics and sequelae which define the disease phenotype. this is a randomized controlled trial of the effect of 14 days of voluntary reduced activity on muscle mass, muscle strength, body composition, and atrophy signalling in patients with copd and age-matched controls. the primary hypothesis upon which this study is based is that a short reduction in ambulation will induce a transient reduction in quadriceps muscle mass, quadriceps strength and physical performance in patients with copd compared to matched copd patients whose mobility has not been restricted. the secondary hypothesis is that the magnitude of the above changes will be greater in physically inactive copd patients compared to physically inactive age-matched controls. the overall aim of this research is to use an in vivo human model of 14 days of voluntary reduced physical activity to test the above hypotheses. if the model proves feasible, this will allow for earlier proof of concept studies of novel therapeutic agents.

this is a non-commercial randomized controlled trial. 15 patients with copd and 15 age-matched controls will voluntarily reduce their daily step-count to no more than 1500 steps/day, from a baseline of \> 3500 steps/day. before and after 14 days of reduced daily step-count, these 30 participants will undergo measures of appendicular mass, quadriceps strength, exercise tolerance and blood and urinary biomarkers. quadriceps muscle biopsies will also be taken before and after the 14-day intervention. 15 patients with copd will be studied 14 days apart but will not undergo the intervention.

Eligibility criteria:
inclusion criteria: * non-smoking adult patients with copd (gold stage ii-iv) * non-smoking, healthy, age-matched controls * baseline step count \> 3500 steps/day * baseline 6 minute walk distance \> 140m exclusion criteria: * inability to provide written, informed consent * significant co-morbidity limiting exercise tolerance * within 1 month of acute exacerbation of copd * within 1 month of pulmonary rehabilitation * history of venous thrombo-embolism or known increased risk of thrombotic disease

Keywords: physical inactivity skeletal muscle cachexia
safety extension study of oral edaravone administered in subjects with amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Summary: this is a phase 3, international, multicenter, open-label, long-term extension study. the primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with amyotrophic lateral sclerosis (als) for up to 96 weeks.


Eligibility criteria:
inclusion criteria: 1. subjects must provide signed and dated informed consent form (icf) to participate in the study. subjects must be able (in the judgment of the investigator) to understand the nature of the study and all risks involved with participation in the study. 2. subjects must be willing to cooperate and comply with all protocol restrictions and requirements. 3. subjects who successfully completed study mt-1186-a01. exclusion criteria: 1. subjects of childbearing potential unwilling to use a highly effective method of contraception from visit 1 until 3 months after the last dose of study medication. 2. subjects who have a significant risk of suicide. subjects with any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without a specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the c-ssrs at visit 3. subjects who are not eligible to continue in the study, as judged by the investigator. 4. subjects who are unable to take their medications orally or through a peg/rig tube.
resolving inflammatory storm in covid-19 patients by omega-3 polyunsaturated fatty acids -

Conditions: COVID-19

Summary: a study on patients who are hospitalized and tested positive for covid-19 or have a typical ct image of covid-19 infection, to establish if omega-3 polyunsaturated fatty acid (pufa) supplementation by intravenous route is a possible treatment option in covid-19 with minimal risks to the patients.


Eligibility criteria:
inclusion criteria: 1. provision of signed informed consent prior to any study specific procedures. 2. female and male patients ≥18 years of age. 3. covid-19 positive or typical ct image of covid-19 infection. 4. clinical status requiring hospitalization. exclusion criteria: 1. according to omegaven® contraindications (serious bleeding disorders, acute life-threatening condition, including acute shock, acute myocardial infarction, acute stroke, acute emboli, and coma). 2. known hypersensitivity to omegaven® or any of the ingredients. 3. participation in any clinical research study evaluating an investigational medicinal product (imp) within 3 months prior to screening. 4. pregnancy and breastfeeding.

Keywords: inflammatory storm covid-19 infection omega-3 fatty acids inflammatory biomarkers omega-3 index
cbt4cbt-buprenorphine + recovery coach for office-based buprenorphine

Conditions: Opioid-use Disorder

Summary: to conduct an 8-week pilot, randomized trial evaluating the feasibility, acceptability, and efficacy of an integrated intervention involving cbt4cbt-buprenorphine + recovery coach in a population of 60 individuals who meet current dsm criteria for opioid use disorder and are receiving buprenorphine treatment in primary care.

in this pilot study, 50 individuals with oud on buprenorphine will be randomized to either 1) standard of care (n=25) or (2)cbt4cbt-buprenorphine + recovery coach (n=250). this will be an 8-week trial.

Eligibility criteria:
inclusion criteria: * adults (≥18 years) * having a dsm-v diagnosis of oud * sublingual buprenorphine/naloxone and/or buprenorphine * having initiated maintenance treatment for oud for at least 30 days before the screening * self-report or toxicology screening positive for any substance within 30 days of screening; * willing to accept a random assignment to either tau/cbt4cbt-buprenorphine + recovery coach; * having adequate computer skills exclusion criteria: * having a severe medical or psychiatric disability that could impair their ability to perform study-related activities (determined by the clinician) * being pregnant or breastfeeding; * being unable to independently read and/or comprehend the consent form or other study materials * being unable to read/speak english; * having current suicidal ideation based on the patient health questionnaire-9.
study of su011248 in combination with docetaxel in patients with advanced cancer

Conditions: Advanced Solid Tumors; Non Small Cell Lung Cancer

Summary: this study is determining the maximum tolerated dose and safety of su011248 (sunitinib malate, sutent) in combination with docetaxel (taxotere). several dosing regimens will be tested in patients with advanced solid tumors, including non small cell lung cancer.


Eligibility criteria:
inclusion criteria: advanced solid tumor malignancy ecog 0 or 1 exclusion criteria: prior treatment with with high-dose chemotherapy requiring stem cell rescue prior irradiation to ≥25% of the bone marrow (e.g. whole pelvis=25%) patients with centrally located lung lesions unless recently treated with radiotherapy

Keywords: advanced solid tumors, non small cell lung cancer, pulmonary neoplasms, sunitinib (sutent), docetaxel (taxotere), angiogenesis inhibitors
rebamipide in patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: although the aetiology of ra remains to be fully elucidated, interleukin (il)-17 are believed to play a critical role in the pathogenesis of ra. rebamipide is an antiulcer drug that protects gastric epithelial cells,improves gastric defense mechanisms by increasing gastric mucus. rebamipide inhibited interleukin (il)-17, also it inhibits il-1β-induced rasf proliferation.


Eligibility criteria:
inclusion criteria: * patients with active rheumatoid arthritis (disease activity score-28 joints: das-28 \> 3.2) based on the 2010 american college of rheumatology (acr) criteria16 were recruited. rheumatoid patients who received the standard therapy (i.e. one or more conventional dmards) for at least three months. exclusion criteria: 1. history of biological dmards. 2. history of gastrointestinal surgery, gi ulceration,gi bleeding 3. intolerance or allergy to rebamibide or methotrexate 4. smoking or alcohol abuse 5. any changes in using medication (changing the dosage or type of medicines) 6. receive hormone replacement therapy, warfarin, and other anticoagulants
shotgun sequencing in diagnosing febrile neutropenia in patients with acute myeloid leukemia

Conditions: Acute Myeloid Leukemia; Febrile Neutropenia

Summary: this research trial studies the shotgun sequencing of blood samples in diagnosing febrile neutropenia in patients with acute myeloid leukemia. studying samples of blood from patients with acute myeloid leukemia in the laboratory may help identify pathogens and accurately diagnose infections such as febrile neutropenia.

primary objectives: i. to test the hypothesis that shotgun metagenomics is not inferior to standard of care diagnostics in the detection of pathogens in patients with febrile neutropenia. secondary objectives: i. to establish a microbiological diagnosis with known or unknown pathogens in patients in whom standard care failed to yield a pathogenic diagnosis. outline: patients undergo collection of blood samples before and during the episode of febrile neutropenia for up to 6 weeks.

Eligibility criteria:
inclusion criteria: * patients with febrile neutropenia * a primary diagnosis of acute myeloid leukemia (aml) exclusion criteria: * prior history of febrile neutropenia
clinical evaluation of effectiveness and safety of dietary supplement potensa in men with erectile dysfunction

Conditions: Erectile Dysfunction

Summary: this is a randomized, double blind, placebo-controlled, comparative, prospective study (clinical evaluation) of the effectiveness and safety of dietary supplement potensa in men with mild to moderate erectile dysfunction.


Eligibility criteria:
inclusion criteria: * men, 18 years of age or older; * patients diagnosed with "erectile dysfunctions" of various pathogenesis, typical form without complications; * ability to read and understand informed consent in order to participate in the study; * ability to follow study's conditions. exclusion criteria: * oncological illnesses, except those in complete remission for at least 5 years; * conditions that may require emergency or planned hospitalization in the next 6 months; * extragenital endocrine conditions (hormonally active) (thyroid, adrenal glands, pituitary, hypothalamus); * surgeries on sex organ within 1 year of the screening; * any surgeries within 3 months of the screening; * psychiatric illnesses; * diabetes mellitus; * cryptorchidism * taking other dietary supplements that can affect erectile dysfunction within 1 month of participating in the study; * high risk of non-compliance.

Keywords: succinates dietary supplement
preventing adverse drug events with patientsite

Conditions: Adverse Drug Event

Summary: this is a study to better understand the nature and extent of adverse drug events (ades), defined as injuries due to prescription medications, in primary care. we will study whether patientsite (an internet-based communication program for patients and health care providers) can improve clinicians' ability to detect adverse drug events among primary care patients and to mitigate the consequences by sending electronic queries to patients after they receive new medication prescriptions.

* a drug safety module called medcheck was developed for patientsite. this allows physicians to query patients automatically 10 days after they receive a new prescription asking them questions about their new prescription. in this study new enhancements will be tested. * participants will be assigned at random to the intervention group or control group. the intervention group will receive a single electronic patientsite message asking them questions about the new prescription which is then forwarded to their physician. the control group will receive a generic message about medication safety. * to identify adverse drug events, a telephone survey and medical record review will be conducted of patients in the intervention group and controls. * this study will run for 12 months.

Eligibility criteria:
inclusion criteria: * adult patients \>18 * patients that receive a new prescription * proficient in spoken and written english exclusion criteria:

Keywords: adverse drug event patient safety internet portal patientsite preventive health primary care
the safety, tolerability, and pharmacokinetics study of hec113995 pa•h2o tablets in healthy subjects

Conditions: Major Depressive Disorder

Summary: the safety, tolerability and pharmacokinetics study of hec113995 pa•h2o tablets in healthy male and female subjects


Eligibility criteria:
inclusion criteria: * 1. subjects who are willing and are able to provide a written informed consent to participate in the study. * 2. without plan for pregnancy or pregnant within 3 months after enrollment throughout the trial. * 3. subjects aged between 18 and 45 (both inclusive) years old. * 4. healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18 and ≤28 kg/m2 at screening. * 5. subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, chest x-ray and 12-lead electrocardiogram (ecg). exclusion criteria: * 1.subjects with serum creatinine, alt and ast levels ≥1.5 times of the upper limit of normal value at screening. * 2.subjects with a positive serology for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag), hepatitis c virus (hcv) antibodies and/or tp antibodies at screening. * 3. subjects with history of digestive system,urinary system, liver,central nervous system, blood system, endocrine system,respiratory system,immune system,cardiovascular system,and/or malignant tumor or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation;subjects with history of epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma. * 4. known allergic reactions or hypersensitivity to any excipient of the drug formulation(s)# anaphylaxis physique. * 5. use of any prescription or non-prescription medications within 14 days prior to initial dosing#use of any medications known to inhibit or induce cytochrome p enzyme drug metabolism within 28 days prior to initial dosing. * 6. consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing. * 7. positive results from urine drug screen test. * 8. history of alcoholism or drink regularly within 3 months prior to the study(defined as alcohol consumption of \> 21 units/week), or positive results from alcohol breath test. * 9.regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug, or inability to refrain from smoking during the course of the study. * 10. donate blood or lose blood 400 ml or more within 1 month prior to initial dosing. * 11. subjects who plan to receive or have had organ transplants. * 12. subjects who participated in another clinical trial within 3 months prior to initial dosing. * 13. any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.
end tidal co2 and masks: is there a correlation?

Conditions: Hypercapnia

Summary: in light of the ongoing covid-19 pandemic, wearing a mask has become a universal standard as an attempt to reduce the spread of covid-19. as of 2020, more than half of all u.s. states have implemented a state wide mandated mask policy. there are many schools of thought regarding the benefits and risks of donning a mask to prevent the spread of covid-19. there is an unproven theory among some that wearing a mask interferes with our natural respiratory function, causing hypoxia, altered mental status and other various health issues. this dangerous perception has led some to believe wearing a mask is harmful, and encourages against wearing a mask in public. this theory, recently refuted by a study investigating oxygen levels while participants wore masks, performed in 2020 encouraged increased compliance with wearing masks. another study, preformed by evaluated whether gas exchange abnormalities occurred with the use of surgical masks in subjects with and without lung function impairment. the conclusions of the study showed that regardless of lung function impairment, the presence of surgical masks did not impact gas exchange. additionally, a more recent study concluded that the presence of a facemask did not have a significant change in physiologic parameters while during exercise. although there is evidentiary support that facemasks do not negatively affect oxygen status and physiologic capacity, there is not strong evidence examining the relationship between etco2 and facemasks. the relationship between etco2 and facemasks is one of importance because mild decreases in oxygen have much less dangerous effects compared to the effects of rapid accumulations of carbon dioxide. increases in end tidal carbon dioxide lead to confusion, acidosis and in severe cases, respiratory distress and failure. a study performed in 1989 showed that hypercapnia has greater increases in blood pressure, minute ventilation and sympathetic nerve activity than hypoxia. in this newly proposed study, healthy volunteers will all wear the same type of three layer surgical mask. their end tidal carbon dioxide will be measured while at rest without a mask, while resting with a mask and then after walking 100 meters in the mask. while previous studies have focused on changes in oxygen, there is a lack of research dedicated to analyzing end tidal carbon dioxide. this study will hope to show evidence supporting that there is no increase in end tidal carbon dioxide while wearing a mask.


Eligibility criteria:
inclusion criteria: * healthy individuals between the ages of 18 and 75 * consent to participate in this study * resident and ancillary staff exclusion criteria: * patients * inability or refusal consent * inability to walk the predetermined distance * history of lung disease * history of significant cardiac disease * people under the age of 18 and over the age of 75

Keywords: hypoxia respiratory disease surgical mask physiologic capacity oxygen sympathetic nerve activity
a post-marketing surveillance to assess safety and efficacy of telostop plus tab.

Conditions: Hypertension, Dyslipidemia

Summary: post-marketing surveillance of telostop plus tab.

this study will collect clinical data, mainly focused on safety, in korean population as per the requirement of mfds for market authorization.

Eligibility criteria:
inclusion criteria: * the patient who is first prescribed and administered telostop plus tab. exclusion criteria: * the patients who are overreacting to this drug or its components * the patients with severe renal impairment