Kornimate/medical-research-clean huggingface dataset:
first in humans to evaluate collagen patches with stem cells in patients with ischemic left ventricular dysfunction

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: it´s a first open-label trial in humans to evaluate the safety and efficacy of epicardial delivery of collagen patches with adipose-derived stem cells in patients with ischemic heart disease and left ventricular dysfunction that remain symptomatic despite optimal medical treatment.


Eligibility criteria:
inclusion criteria: * men and women aged ≥18 years and ≤80 years. * lvef ≤35% as assessed by echocardiography, confirmed by mri if there are no contraindications for this procedure. * history of revascularised or nonrevascularisable coronary artery disease as the cause of ventricular dysfunction. * nyha functional class iii for dyspnea under optimal medical treatment. * ability to perform the exercise test with respiratory gas consumption. mvo2 should be ≥ 10 and ≤ 18 ml/kg/min in the exercise test. * ability to perform a 6-minute walk test \> 100 m and ≤ 400 m. * haemodynamic stability (blood pressure \> 100/40 mmhg, heart rate \ 95%). exclusion criteria: * participation in another clinical trial within 30 days prior to inclusion. * prior treatment with cell or gene therapy. * diagnosis of acute myocardial infarction with 3 months prior to inclusion. * significant coronary artery disease eligible for revascularization. * significant valvular disease eligible for surgery. * presence of uncontrolled ventricular arrhythmias (vr or vf) at the time of implant surgery. * women who are pregnant or breastfeeding. * mental disease or psychological condition that impedes the subject from understanding the nature of the protocol and granting his/her consent. * advanced dementia according to the barthel index. * active systemic infection. * history of primary or acquired immunodeficiency or on immunosuppressive therapy (within 3 months prior to inclusion or if the need for immunotherapy is foreseeable at any time during the study follow-up). * tumour disease, except that eradicated at least 5 years prior to inclusion in the study and without receiving chest radiotherapy. completely eradicated nonmelanoma skin tumours (at any time) not requiring chest chemotherapy or radiotherapy) are permitted. * history of autoimmune disease. * stroke within 12 months prior to inclusion. * respiratory compromise or need for home oxygen therapy. * life expectancy of less than 1 year for any reason.
nasal expiratory resistance in patients with sleep apnea and expiratory flow limitation

Conditions: Obstructive Sleep Apnea

Summary: obstructive sleep apnea (osa) is inherently site-specific. in a physiological controlled intervention study, the investigators seek to determine whether applying expiratory resistance can acutely improve ventilation and sleep in patients with expiratory flow limitation (efl).

collapse of the upper airway can occur at different sites of the pharynx. one common and recognizable form of pharyngeal collapse is prolapse of the soft palate (velopharynx) on expiration, a phenomenon referred to as expiratory flow limitation (efl). in principle, application of nasal positive expiratory pressure should reverse expiratory narrowing, increase ventilation, and prevent the subsequent progressive loss of airflow that leads to arousal from sleep, thereby improving osa. one means to achieve this expiratory pressure is with the use of an added nasal expiratory resistance. accordingly, during a single night protocol, the investigators will examine the effects of increasing nasal expiratory resistance during sleep. during obstructed breathing, patients will be switched acutely, in random order, from normal conditions to an added expiratory resistance (30-80 cmh2o/l.s) or a sham resistance, for short (1 min) and prolonged periods (1 hour), repeatedly overnight. patients participating in the study will be divided into two groups, those exhibiting efl versus those without efl (i.e. with inspiratory flow limitation). the main outcomes of the short physiologic interventions are: * increase in ventilation, and * increased time to a respiratory-related arousal from sleep, relative to sham conditions. the main outcome of the prolonged interventions is: --reduced frequency of respiratory events (ahi; 3% desaturation or arousal) relative to sham conditions. the central objective of the study is to test whether there is a greater improvement in the above outcomes in those with efl versus those without efl. this data will allow us to test whether expiratory resistance is of potential therapeutic benefit specifically in patients with efl rather than those without efl.

Eligibility criteria:
inclusion criteria: * presence of obstructive sleep apnea (ahi\>10/hr) exclusion criteria: * serious co-morbidities including lung disease, heart disease, renal disease * medications affecting respiration or sleep expiratory flow limitation (efl) subgroup inclusion criteria: presence of clear efl on polysomnographic study (reduced flow and increased pharyngeal pressure during expiration as a predominant cause of airflow obstruction). non-efl subgroup inclusion criteria: complete absence of efl on polysomnographic study

Keywords: obstructive sleep apnea expiratory flow limitation
eeg monitoring under anaesthesia in children: towards personalized anaesthesia care

Conditions: Depth of Anaesthesia; EEG; Anesthesia Emergence Delirium

Summary: electroencephalographic recordings (eeg) present an opportunity to monitor changes in human brain electrical activity during changing states of consciousness during general anesthesia. the investigators aim to determine if eeg-guided anaesthesia using the masimo sedline root monitor will result in different anaesthetic requirements, different anaesthetic depth, and emergence characteristics in children under 16 years of age. 200 children under 16 years undergoing routine general anaesthesia under sevoflurane will be randomized to either eeg monitoring or routine care. we will compare the anaesthetic requirements, the patient state index, number of episodes of burst suppression and the incidence and severity of emergence delrium between the two groups.

electroencephalographic recordings (eeg) present an opportunity to monitor changes in human brain electrical activity during changing states of consciousness during general anesthesia. at present, monitoring of the brain under anaesthesia is not routinely employed. since every patient is different and the way their brain response to anaesthetic drugs is different, it is important to adjust the patients' anaesthetic depth according to their brains' response, rather than only relying on routine cardiorespiratory parameters. this is important particularly for children, whose physiological responses and electroencephalographic recordings (eeg) differ from that of adults. 200 children under 16 years undergoing routine sevoflurane general anaesthesia will be randomized to either eeg-guided anaesthesia or routine care. the investigators will compare the anaesthetic requirements, the patient state index, number of episodes of burst suppression and the incidence and severity of emergence delrium between the two groups.

Eligibility criteria:
inclusion criteria: * patients 1-16 years old scheduled to undergo general sevoflurane anaesthesia for surgeries or procedures anticipated to last at between 30 minutes to 4 hours. exclusion criteria: * patients with neurological diseases including seizure disorders * patients with developmental delay or genetic syndromes * patients with craniofacial deformities where it is not possible to place the eeg sensors * patients with severe eczema or skin allergy or atopy. * patients who are having craniofacial surgery where it is not possible to place the eeg sensors * patients whose foreheads are too small to accommodate the eeg sensors. * patients who require sedative premedications.
efficacy and safety of transbronchial bronchoscopic thermal vapor ablation (btva) in heterogeneous emphysema

Conditions: Heterogeneous Emphysema

Summary: efficacy and safety of transbronchial btva in heterogeneous emphysema: a prospective, single-arm, multicenter clinical study


Eligibility criteria:
inclusion criteria: 1. male or female, age ≥40 and ≤75 years old 2. heterogeneous emphysema 3. 20% predicted value ≤ fev1 ≤ 50% predicted value, tlc ≥ 100% predicted value, rv ≥ 150% predicted value, dlco ≥ 20% predicted value 4. 6-minute walking distance (6mwd) \&gt; 140m 5. mmrc index ≥ 2 6. the patients have fully understood the content of the trial and voluntarily signed the informed consent form exclusion criteria: 1. contraindications to bronchoscopy include: myocardial infarction within the past month, active massive hemoptysis, coagulation dysfunction, pregnancy, malignant arrhythmia, severe pulmonary hypertension, extreme systemic failure, and other conditions 2. concomitant diseases that may significantly increase the risk of complications after btva treatment include, but are not limited to: immune system disorders, bleeding disorders, unstable cardiovascular disease, a history of asthma, and alpha-1 antitrypsin deficiency 3. concomitant medications known to significantly increase the risk of complications after btva treatment include, but are not limited to: immunosuppressive drugs (except topical medications), anticoagulants, and antiplatelet drugs 4. receiving morphine derivatives within 4 weeks prior to screening 5. respiratory tract infection or exacerbation of chronic obstructive pulmonary disease (copd) within 6 weeks prior to screening 6. the upper and lower lobes of the other lung have high-grade emphysematous lesions, defined as hrct showing that the low-density attenuation area (less than -950 hu) accounts for more than 40% of the total lung volume. 7. the lobe of the lung where the intended treatment segment is located has large bullae (defined as bullae that occupy more than one-third of the lobe) or paralobular septal emphysema. 8. symptoms or abnormal laboratory values suggesting active infection (e.g., fever, elevated white blood cell count, etc.). 9. patients who have undergone or plan to undergo lung or chest surgery during this study, including but not limited to lung resection or lung transplantation. 10. patients evaluated by specialists to have highly suspected malignant pulmonary nodules. 11. women who intend to become pregnant, are pregnant, or are breastfeeding during the study. 12. patients participating in other drug or medical device clinical trials. 13. the investigator believes the patient has other conditions that make them unsuitable for inclusion in this study.

Keywords: btva heterogeneous emphysema bronchoscopy efficacy and safety
a study of an intravenous drug in pediatric patients with acute asthma (0476-301)

Conditions: Asthma

Summary: this study will attempt to find out if the addition of an intravenous form of a drug that is already used for treating asthma in children will help resolve asthma attacks faster than using the current standard care alone.

the duration of treatment is a one time dose.

Eligibility criteria:
inclusion criteria: * children 6-14 years of age seeking treatment in emergency departments with acute asthma attacks exclusion criteria: * other respiratory conditions (including congenital lung abnormalities) or other acute illnesses that would complicate current treatment and response for asthma
investigating the optimal remifentanil and dexmedetomidine concentration for uterine fibroid ablation

Conditions: Uterine Fibroids (UF)

Summary: this clinical trial aims to find a better drug concentration of remifentanil in uterine fibroid ablation. the main question it seeks to answer is: \[primary hypothesis 1\] remifentanil concentration of 2.0 ng/ml provides better pain control in uterine fibroid ablation. there is a comparison group in this study: researchers will compare remifentanil concentration of 1.0 ng/ml to see if provides similar pain control with fewer side effects. participants will be separated into two groups, one group with a remifentanil concentration of 2.0 ng/ml and the other 1.0 ng/ml. during uterine fibroid ablation, the patient\&#39;s pain index will be recorded (using a visual analogue scale (vas) of 0\~10 points). we will also record vital signs during the procedure.


Eligibility criteria:
inclusion criteria: * aged between 20 and 65 years old * american society of anesthesiology classification i\~iii * female patients diagnosed with uterine fibroids by obstetricians and gynecologists exclusion criteria: 1. patients with heart disease (such as arrhythmia or severe ventricular dysfunction) 2. patients with chronic kidney disease in stage iii or above or dialysis patients 3. long-term alcohol addiction or drug abuse 4. patients with abnormal liver index or chronic hepatitis 5. those who are allergic remifentanil 6. those who refuse to participate in the experiment

Keywords: uterine fibroids (uf) remifentanil
simultaneous meg or fmri and intracranial eeg

Conditions: Epilepsy; Healthy Volunteers

Summary: the semaine project will investigate intracranial eeg (iceeg) simultaneously recorded with either fmri or meg to 1) improve identification of the epileptogenic zone in patients suffering from drug-resistant partial epilepsy, and 2) define the functional organization of neural networks underlying human perception and cognition in order to prevent inadvertent deficits resulting from neurosurgical resection. in particular, high-frequency activity (hfa), as measured with iceeg, has been demonstrated in recent years as a relevant index for both epileptogenic tissue and healthy cortical processing, but its correlates in fmri and meg require further investigation. this will be a pioneering effort in several respects, as the first to directly measure high-frequency neural activity in tandem with fmri, and among the first to do so with meg. in addition to their attractiveness as noninvasive imaging techniques, fmri and meg have the potential to examine whole-brain networks that are not accessible to iceeg's necessarily limited spatial coverage. furthermore, such a campaign of simultaneous recordings will take unprecedented advantage of iceeg as the bridge between the two noninvasive techniques, providing compelling evidence for the links between all three measurements with respect to underlying high-frequency neural activity in both health and disease. this project will therefore lead to improved selection of epilepsy surgery candidates and improved neurosurgical outcomes from the precise mapping of epileptogenic and healthy brain networks. the same techniques will be immediately applicable to functional mapping of other types of neurosurgery populations as well as diagnostic neuroimaging of neurological and psychiatric populations.


Eligibility criteria:
inclusion criteria: * patients aged between 18 and 60 years, not subject of any measure of legal protection * patients suffering from drug resistant partial epilepsy * patient undergoing intracranial video eeg * patients with electrodes implanted in orthogonal * no mri cons-indication * patients who signed a consent form * intellectual capacity to perform cognitive tasks and to sign an informed consent. * affiliation to social security exclusion criteria: * pregnant women * elderly patients under 18 or over 60 years patient not suffering from drug resistant partial epilepsy, or not scheduled for a seeg * mri cons-indication * patients taking psychotropics drugs * claustrophobia * inability to perform cognitive tasks or to give informed consent.

Keywords: epilepsy surgery high frequency activity iceeg fmri meg
an observational study to evaluate the treatment of newvast® tab(atorvastatin) in korean patients with dyslipidemia

Conditions: Dyslipidemia

Summary: in this study, dyslipidemia patients visited the institutions during the study period and the effectiveness and safety of the treatment of newvast® tab(atorvastatin) in real-practice. during the routine medical visit, according to the investigator's judgment, with diagnosis that the newvast® tab(atorvastatin) prescription is appropriate, regardless of medical history and concomitant-medication, and after deciding to start treatment, patients with dyslipidemia who agreed to participate in the study were administered newvast® tab(atorvastatin). as this study is a non-interventional observational study, all subjects received prescriptions according to the routine treatment procedure, and there were no visits or procedures required according to the observational study protocol.

this study is a multicenter, prospective, non-interventional, observational study of patients administering atorvastatin(newvast® tab) to treat dyslipidemia. data will be collected from patients receiving routine treatment at hospitals in south korea. each subject visits the institution according to the protocol that designed the follow-up visits for six months to examine the effectiveness and safety of atorvastatin(newvast® tab). this study will approved by the institutions' irbs and is in compliance with clinical research ethics regulations.

Eligibility criteria:
inclusion criteria: 1. patient was diagnosed with dyslipidemia 2. those who voluntarily consented in writing to this study exclusion criteria: (1) patients for whom use of newvast® tab is prohibited

Keywords: dyslipidemia atorvastatin statin
hiv, buprenorphine, and the criminal justice system (stride2)

Conditions: Human Immunodeficiency Virus; Acquired Immunodeficiency Syndrome; Opiate Addiction; Drug Dependence

Summary: stride2 is a longitudinal, non-randomized study of individuals living with hiv who are dependent on opioids. this study is funded by the national institute on drug abuse (r01da030768, altice, pi; taxman \& lawson, co-pis) and is being conducted by george mason university, yale university, and howard university.

stride2 will assist in identifying and monitoring individuals' hiv risk behaviors and provide resources to seek treatment for their hiv care and substance use. the goal of stride2 is to examine if there are differences in hiv, drug use, and other outcomes between individuals receiving treatment versus individuals actively using, not actively using and not in treatment, and individuals on methadone, suboxone, or in some other treatment.

Eligibility criteria:
inclusion criteria: 1. hiv+, confirmed by rapid hiv test 2. meet dsm-iv criteria for opioid dependence 3. 18 years or older 4. have health insurance that is accepted at lab corp. exclusion criteria: 1. are \<18 years old; 2. are hiv negative; 3. are unable to communicate in english; 4. are not able to provide informed consent; 5. do not meet dsm-iv criteria for opioid dependence; 6. plan to leave the dc area

Keywords: hiv aids opiate addiction drug dependence buprenorphine
efficacy of group intervention to reduce stress symptoms

Conditions: Stress Disorders, Post-Traumatic; HIV Infections

Summary: this research study will examine the usefulness of groups in reducing stress and helping individuals with hiv to stay healthy and avoid problems associated with sexually transmitted diseases. we hope to discover whether being in a group is effective in reducing stress-related symptoms and promoting healthy behaviors.

this is a risk reduction intervention for adults who are living with hiv, are experiencing trauma-related stress symptoms, and are at risk for hiv transmission. by first treating trauma symptoms, the effects of a skills-building hiv risk reduction intervention for adults experiencing trauma-related symptoms such as hyperarousal, dissociation, and avoidance will be enhanced. this is based on a model the proposes trauma-related symptoms have direct effects on hiv risk behavior. therefore, the successful treatment of trauma-related symptoms will facilitate hiv risk behavior change.

Eligibility criteria:
inclusion criteria:must be 18 years or older, must be hiv-positive, report engaging in behavior that could put them at risk for hiv transmission in the past three months, report experiencing one or more trauma-related symptoms within the past three months. exclusion criteria:exclusion criteria include the presence of gross cognitive impairment, dementia, acute psychosis, or severe physical impairment that would preclude adequate comprehension of assessment material and participation in small group intervention.

Keywords: complementary therapies
a non-invasive intervention (breestim) for management of phantom limb pain (plp) after limb amputation (experiment 2)

Conditions: Pain Management

Summary: the purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (breestim) and conventional electrical stimulation (estim) in management of neuropathic phantom limb pain in patients after limb amputation.


Eligibility criteria:
inclusion criteria: * has phantom limb pain (plp) after amputation of one limb, upper or lower limb; * has chronic pain, \>3 months; * is stable on oral pain medications at least two weeks. (patients are allowed to continue their pain medications, i.e., no change in pain medications.) exclusion criteria: * currently adjusting oral pain medications for their plp; * has pain, but not plp (e.g., from inflammation at the incision wound of the residual limb); * has a pacemaker, or other metal and/or implanted devices; * has cognitive impairment from brain injury or are not able to follow commands, or to give consent; * has amputation in multiple limbs; * have asthma or other pulmonary diseases; * are not medically stable; * have preexisting psychiatric disorders; * alcohol or drug abuse; * have a history of seizures/epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants.

Keywords: phantom limb pain breestim