cyrilzakka/clinical-trials huggingface dataset:
Detection of Myocardial Dysfunction in Non-severe Subarachnoid Hemorrhage (WFNS 1-2) Using Speckle-tracking Echocardiography (STRAIN)

Subarachnoid hemorrhage (SAH) can cause transient myocardial dysfunction. Recently, it have been reported that myocardial dysfunctions that occur in SAH are associated with poor outcomes. It therefore appears essential to detect theses dysfunctions with the higher sensitivity as possible. Strain measurement using speckle-tracking echocardiography may detect myocardial dysfunction with great sensitivity. The main objective of this study is to assess the prevalence of myocardial dysfunction in "non-severe" SAH (defined by a WFNS grade 1 or 2), using speckle-tracking echocardiography. This study also aims to analyse Strain measurement with classical echocardiography and serum markers (troponin, BNP) of cardiac dysfunction.

Cardiac complication, occurring in the early phase of SAH has been well described. It seems that the pathophysiological mechanism involves vegetative hyperactivity due to the acute cerebral injury. It has been shown that stress cardiomyopathy is associated with delayed cerebral ischemia (DCI) and poor outcomes. Manifestations of stress cardiomyopathy are changes in electrocardiogram, release of cardiac biomarkers such as troponin and BNP, and echography evidence of impaired left ventricle ejection fraction with the use of Simpson technique and regional wall motion abnormalities. These two techniques bear intra-observer variability. A new method is available to assess left ventricular contractility at the bedside. Two-dimensional speckle-tracking images with echocardiography allows one to track a natural myocardial marker within the myocardium by standard transthoracic echocardiography. It provides unique insights into myocardial function such as tissue deformations and strain rate, which is the rate of deformation. This method is more sensitive than classical echographic left ventricular ejection fraction evaluation and bears very low interobserver variability. The Global Longitudinal Strain (GLS) is the most studied parameter.

Early detection of cardiac dysfunction in SAH followed by appropriate monitoring and management may improve outcome in SAH. This is a prospective, observational and mono-center study.

Patients with "non-severe" SAH will benefit from an echocardiography where Left Ventricular Ejection Fraction (LVEF) and GLS will be assessed on day 1, 3 and 7 following the acute injury.

Eligibility Criteria:
Inclusion Criteria:

* patient older than 18 years
* hospitalized in neuro-intensive care unit with a "non-severe" subarachnoid hemorrhage (WFNS 1 or 2)

Exclusion Criteria:

* low echogenicity
* history of cardiac malformation or cardiac surgery
* severe valvular heart disease
* dilated cardiomyopathy
* acute coronary syndrome
* permanent arrythmia
* patient refusal
A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Participants With Mycobacterium Avium Complex (MAC) Pulmonary Disease

The purpose of the study is to evaluate

1. The microbiological response and clinical efficacy of SPR720 compared with placebo in participants with nontuberculous mycobacteria pulmonary disease (NTM-PD).
2. The safety and tolerability of SPR720 in a participants population with NTM- PD
3. The pharmacokinetic (PK) of SPR719, active moiety, following orally (po) administered prodrug SPR720 in a participant population with NTM-PD.


Eligibility Criteria:
Inclusion Criteria:

1. Has a prior diagnosis of NTM-PD due to MAC according to American Thoracic Society (ATS) criteria
2. Has at least one prior lower respiratory culture (sputum or bronchoalveolar lavage \[BAL\]) positive for MAC in the 12 months prior to consent
3. Has an induced sputum culture at Screening positive for MAC by quantitative culture on solid agar
4. Is either treatment naïve and has not received any prior treatment for MAC, OR if previously treated for MAC and meets all of the following criteria:

   1. Has a history of successful treatment with sputum culture conversion to negative
   2. Has recent sputum or BAL culture evidence of recurrent or relapsed disease and
   3. Has been off therapy for at least 3 months prior to consent
5. Has clinical signs and symptoms within the 6 weeks prior to consent that are consistent with NTM-PD ≥2 of the following:

   1. chronic cough
   2. fatigue
   3. frequent throat clearing
   4. shortness of breath (dyspnea)
   5. coughing up of blood (hemoptysis)
   6. excessive mucus (sputum) production
   7. fever (temperature \>38ºC or \>100.4ºF)
   8. night sweats
   9. loss of appetite
   10. unintended weight loss
   11. wheezing
   12. chest pain
6. Has a measured forced expiratory volume in the first second following maximal inhalation (FEV1) % predicted ≥30% within 3 months prior to consent. If prior FEV1% predicted test result is not available, obtain FEV1% predicted at Screening to confirm eligibility

Exclusion Criteria:

1. In the opinion of the Investigator, is not a candidate for a 5-month delay in initiation of standard multidrug therapy to participate in a placebo-controlled clinical trial (e.g., participant has severe symptoms or, extensive disease burden)
2. Has disseminated or extrapulmonary NTM disease
3. Has end-stage NTM-PD or treatment-refractory NTM-PD
4. Has isolation on lower respiratory (sputum or BAL) cultures of any Mycobacterium species other than those included in MAC within the 6 months prior to consent
5. Has any other condition or prior therapy, which, in the opinion of the Investigator, would make the participant unsuitable for this study, including compliance with all study assessments and adherence to the protocol schedule of assessment
6. Prior exposure to SPR720. Participants who are unable to comply with the requirements of the study or who in the opinion of the Investigator should not participate in the study are not eligible

   * Other inclusion and exclusion criteria as per protocol may apply.
Erythropoietin And/Or Iron Sucrose For Perioperative Anemia Management In Hip and Knee Arthroplasty

Perioperative anemia is very common in patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA). This study retrospectively analyzes the use of rHuEPO and iron sucrose in patients undergoing total hip and knee arthroplasty in order to observe the short-term efficacy and safety of rHuEPO and iron sucrose.

This study aims to explore whether short-term use of rHuEPO and iron sucrose can improve postoperative anemia and promote postoperative rehabilitation after hip and knee arthroplasty. According to different therapies of perioperative anemia , included subjects would be divided into rHuEPO monotherapy group, iron sucrose monotherapy group, rHuEPO combined with iron sucrose group and control group (without rHuEPO and iron sucrose).

Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent hip or knee arthroplasty between May 1, 2012 (included) and December 31, 2015 in Peking Union Medical College Hospital
2. Age ≥ 18 years, sex unlimited

Exclusion Criteria:

1. Patients with serious absence of clinical data
2. Patients with rHuEPO contraindication

   1. Patients with uncontrolled severe hypertension
   2. Patients allergic to this product and other mammalian cell derivatives, or to human serum albumin
   3. Co-infected patients
3. Patients definitely allergic to iron sucrose injection
4. Patients with coagulation dysfunction
Recruiting to Clinical Trials on the Telephone

This study examined the use of the telephone for the purpose of informing expectant mothers about a randomized clinical trial assessing neonatal Bacille Calmette-Guérin vaccination. Expectant mothers who were contacted for participation in a vaccination trial (the Calmette study, NCT01694108) were randomized to receive information by telephone or at a face-to-face consultation. The primary outcome was a communication score, consisting of comprehension of information about the study and satisfaction with the information process. The outcome was measured using a questionnaire two weeks after the information was provided and two and a half months after birth.

Informed consent is an essential element of clinical research. Obtaining consent, however, may be challenging. The use of the telephone for giving information and obtaining consent may be practical but little formal research has been done.

This study examined the use of the telephone for the purpose of informing expectant mothers about a randomized clinical trial assessing neonatal Bacille Calmette-Guérin vaccination. Expectant mothers who were contacted for participation in the Calmette Study were randomised to receive information by telephone or at a face-to-face consultation. The primary outcome was a communication score, consisting of comprehension of information about the study and satisfaction with the information process. The outcome was measured using a questionnaire two days after the information was provided and two and a half months after birth.

Eligibility Criteria:
Inclusion Criteria:

* Planning to give birth at Rigshospitalet

Exclusion Criteria:

* Prior contact to the Calmette trial staff
* Unable/unwilling to come to hospital for face-to-face information
* Declining participation in this trial
Facilitated Antegrade Steering Technique in Chronic Total Occlusions (FAST-CTOs)

Prospective, non-randomized, multicenter study in subjects with coronary artery chronic total occlusions (CTOs). Published results of safety and effectiveness of conventional techniques will be used for comparison. Enrollment of up to 149 subjects with a CTO refractory to currently marketed guidewire use and meeting all inclusion/exclusion criteria at up to 15 US clinical sites. Hypothesis is that the BridgePoint Medical System is safe and effective in treating coronary CTOs compared to CTO literature.


Eligibility Criteria:
Inclusion Criteria:

* suitable candidate for non-emergent, coronary angioplasty
* documented coronary CTO lesion with the following characteristics: a) Thrombolysis in Myocardial Infarction (TIMI) 0 flow for at least 90 days; b) satisfactory distal vessel visualization; and c) refractory to currently marketed guidewire crossing via 1 of the following: 1. previous failed attempt to cross CTO within the past 12 months; or 2. unsuccessful CTO crossing w/ guidewire (10-15 min fluoro time); or 3. attempt to cross CTO w/ guidewire results in subintimal guidewire
* angina or ischemia caused by the occluded artery
* at least 18 years of age
* Body Mass Index (BMI) \< 40
* left ventricle ejection fraction \> 20%
* sign the Informed Consent Form

Exclusion Criteria:

* saphenous vein graft (SVG) CTO or an in-stent CTO
* aorto-ostial CTO location. (Ostial bifurcation origins may be considered)
* intolerance to aspirin or a neutropenic response to Ticlopidine/Clopidogrel
* appearance of thrombus or intraluminal filling defects
* severe cerebrovascular disease (history of stroke or TIA within 1 month)
* cardiac intervention within two weeks of the procedure
* renal insufficiency (serum creatinine of \> 2.3 mg/dl)
* active gastrointestinal bleeding
* active infection or fever that may be due to infection
* life expectancy \< 2 years due to other illnesses
* significant anemia (hemoglobin \< 8.0 mg / dl)
* severe uncontrolled systemic hypertension
* severe electrolyte imbalance
* anaphylaxis to angiographic contrast media unless appropriately medicated
* congestive heart failure \[New York Heart Association (NYHA) Class IV\]
* unstable angina requiring emergent percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
* recent myocardial infarction (MI)(within the past two weeks)
* uncontrolled diabetes
* participation in another investigational protocol
* unwillingness or inability to comply with any protocol requirements
* pregnant or nursing
* extensive dissection from refractory guidewire use
* crossing CTO (true lumen) w/ guidewire within 10-15 min of fluoro time
Cardiovascular Effects of a Soccer Match in Viewers With With Coronary Artery Disease

Watching football matches could cause increased blood pressure and heart rate induced by catecholamines and thus increase the incidence of cardiovascular events. However, no studies have evaluated the responses of blood pressure and heart rate in soccer spectators.

This study evaluates the hemodynamic response in Brazilian soccer fans suffering from coronary artery disease during a dispute over a game of your favorite team.


Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease;
* Avai or Figueirense (brazilian soccer teams) fans

Exclusion Criteria:

* Acute coronary syndrome in less than 7 days
MF-4181 for the Reduction of Scars Secondary to Abdominoplasty or Laparoscopy/Laparotomy Gynecologic Procedures

The objective of the study is to evaluate the safety and preliminary efficacy of MF-4181, a hydrogel scaffold, in improving scars and their resulting consequences following abdominoplasty or laparoscopy/laparotomy gynecologic procedures.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between 18 and 60 years of age undergoing abdominoplasty without intraoperative flexion at time of skin excision OR female subjects between 18 and 60 years of age undergoing diagnostic and/or operative laparoscopy/laparotomy gynecologic procedures.
* Weight between 50 and 95 kg with BMI between 20 and 30
* Able and willing to give written informed consent
* Willing to comply with the follow-up schedule

Exclusion Criteria:

* Need of concomitant surgical procedures that would be performed at the same time as the index surgical procedure or that would influence the healing process
* Previous abdominal surgery with scars or adhesions that would limit or complicate the index surgical procedure
* Presence of ventral or umbilical hernia requiring the use of prosthetic material
* Heart disease
* Pregnant or planning to become pregnant during the course of the study; the exception to this exclusion is if ectopic pregnancy is the reason for the procedure
* History of coagulopathy or bleeding disorder
* An American Society of Anesthesiologists (ASA) Score of \>II
* Known diabetes
* Current or history of heavy smoking (i.e., 10 pack years)
* Active skin disorder or other condition that may interfere with healing or history of such a condition
* Planned use of an ON-Q® pain control device (I-Flow Corporation, Lake Forest, CA) or similar incisional intervention post index procedure
* Active collagen vascular disease or vasculitis, e.g., systemic lupus erythematosus, polyarteritis, dermatomyositis, systemic scleroderma or thrombotic thrombocytopenic purpura
* Anticipated use of DERMABOND® or another topical skin adhesive type of wound closure
* Unwilling or unable to return for follow-up visits
* Regular, continuous use of systemic corticosteroid therapy or topical corticosteroid use in the area to be treated
* Current participation or participation within the last 3 months in the study of an investigational drug, device, or biologic
* Unable or unwilling to follow post-operative instructions
* Known hypersensitivity to MF-4181, dextran, or any of its constituent materials
* Previous participation in this study to avoid multiple enrollments of an individual subject.
* Chemotherapy or hormone therapy for cancer within the last 3 months, or probability that these treatments will be required during the 6 months of study participation.
* Current or past radiation therapy in the abdominal incision
PUFA Supplementation in Premature Infants

The purpose of this study is to determine if buccal administration of a concentrated formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain docosahexaenoic acid (DHA) levels in extremely low birth weight (ELBW) infants.

This will be a multi-center, randomized, placebo controlled, double blind trial.

Two doses of PUFA will be compared to placebo- a "high" dose and a "low" dose.

ELBW infants will be enrolled into this study.

Eligibility Criteria:
Inclusion Criteria:

* a) Premature infant born at gestational age less than 34 weeks
* b) Birth weight less than 1000 grams
* c) Legally authorized representative is able to provide written informed consent within the first 72 hours of life, prior to the performance of an protocol-specified evaluations or procedures

Exclusion Criteria:

* a) infants with known metabolic disorder
* b) infants with known congenital gastrointestinal anomaly
* c) infants who are deemed to be inappropriate for enrollment per attending neonatologist
Risk Factors for Atherogenesis in Type 1 Diabetes

To determine risk factors for atherogenesis in Type 1 diabetes.

BACKGROUND:

Individuals with Type 1 diabetes have substantially higher risk for premature atherosclerotic vascular disease (ASVD) than the general population. Risk factors for the development of ASVD have been identified, but linking them to initiation of atherosclerosis was not feasible until recently. Advances in non-invasive imaging now permit early detection of changes in blood vessel function and structure. This imaging provides an opportunity to evaluate risk factors for ASVD and vascular status in a cohort at a critical time for development and early progression of ASVD.

DESIGN NARRATIVE:

Subjects were enrolled from 1987-1992 and were followed from diabetes diagnosis. Standardized protocols for examinations and interviews were implemented and the data base included a valuable longitudinal plasma bank. Because incident cases were enrolled, information was collected from diagnosis on children, adolescents and young adults currently without symptoms of atherosclerosis. The existing database was expanded, the existing resources were used including the plasma bank, and promising new and well established clinical research techniques were incorporated by: (i) measuring plasma lipid levels on stored plasma and on newly collected blood samples, (ii) measuring triglyceride levels on newly collected blood samples, (iii) measuring urinary albumin excretion rates on newly collected specimens (already measured from diagnosis to date), and (iv) assessing endothelial function by brachial artery ultrasound, (v) measuring the intima medial thickness (IMT) of the carotid artery by ultrasound, and (vi) measuring coronary calcium by computed tomography scanning. These activities allowed pursuit of the following specific aims: 1) to determine the relationship between established risk factors for atherosclerosis and the development of pre-clinical atherosclerosis, 2) to determine the relationship between endothelial dysfunction and carotid IMT, and 3) to determine the relationship between coronary artery calcification and carotid IMT. Such information was critical in directing further efforts toward primary prevention of atherosclerosis in individuals with Type 1 diabetes mellitus.

Eligibility Criteria:
No eligibility criteria
Perceptions Regarding Investigational Screening for Memory Problems in Primary Care

The purpose of this study is to conduct a cross-sectional survey of primary care patients to better understand their perceptions of the risks and benefits of a screen and subsequent diagnostic confirmation of dementia.

The Health Belief Model was used to explore the public's acceptance or enthusiasm for early recognition of dementia. Based on this model, prior research and clinical experiences, and a systematic literature review, the PRISM-PC instrument was developed. The PRISM-PC items seek to capture both the patient's acceptance of dementia screening and the patient's perception of potential harms and benefits of such screening. The instrument includes questions regarding screening by performance-based questionnaires, blood tests, or brain imaging.

The PRISM-PC instrument includes 50 items that are organized into 8 sets of questions that cover the following areas:

A) Prior experience with AD (5 items) B) Acceptance of screening for AD (6 items) C) Acceptance of screening for other conditions (2 items) D) Benefits of screening for AD (9 items) E) Stigma of screening for AD (10 items) F) Impact of screening for AD on independence (6 items) G) Suffering of screening for AD (4 items) H) Demographics (7 items) Excluding section A and H (prior experience with AD and demographics), each item of the six other sections is rated on a 5-point Likert scale (strongly agree, agree, don't know, disagree, and strongly disagree).

Based on the previous PRISM-PC pilot study (a survey response rate of 80%) and the Dementia screening and diagnosis study (screening acceptance rate of 90%, positive dementia screening rate of 20% among participants aged 70 and older, and dementia diagnostic acceptance rate of 50%), a total of 1,500 volunteers will be approached. A random selection of 200 participants will be re-administered the questionnaire within one week to test the short-term temporal stability of their responses (test-retest).

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 and older
* At least one office visit to their primary care physician within the last year
* No chart-based diagnosis of dementia or memory problem
* Willing to sign a consent form to participate in the study

Exclusion Criteria:

* Does not speak English
* Too hearing-impaired to hear the informed consent statement or the survey
* Severe mental illness based on the patient's electronic medical charts
Prospective Randomized Study Comparing ePTFE Versus Dacron Graft for Anterior Sector Venous Drainage in Right Lobe Living Donor Liver Transplantation

Living donor liver transplantation (LDLT) using the right lobe (RL) has created a significant increase in graft supply worldwide. However, it is a technically demanding procedure particularly because of the unique functional anatomic characteristics of hepatic venous drainage \[1\].

In the absence of an adequate drainage of the anterior sector (AS) veins, the consequent venous congestion in the RL graft may result in impaired graft regeneration, immediate liver dysfunction, and graft loss even in a liver graft of adequate size \[2\]. To overcome this problem, Lee et al. \[3\] introduced the concept of modified RL graft in which the branches of the middle hepatic vein (MHV) was drained using interposition vascular grafts. Although, the issue of when and how the MHV branches should be drained has been controversial since then, reconstruction of segment 5 and 8 veins using an interposition graft has become a standard procedure during RL LDLT. The vascular graft of choice in this procedure has been cryopreserved homologous vein graft, which provides excellent patency with low infection risk. However, such grafts are often unavailable, particularly in programs where deceased donors are scarce and surgeons must rely on synthetic grafts such as expanded polytetrafluoroethylene (ePTFE) and polyethylene terephthalate (Dacron®). Since we have developed an "intent-to-drain" policy in our LDLT program, we have been using Dacron grafts exclusively \[4\]. Although, complications such as early graft thrombosis, graft infection, and hollow viscous migration remain as major concerns, the safety and efficacy of both ePTFE and Dacron grafts in LDLT has been proven \[5, 6\]. However, to date, none of the previous studies have specifically compared these two different prosthetic materials, addressing graft patency and complication rates in patients undergoing LDLT. The aim of our study is to compare AS venous outflow reconstruction using ePTFE vs. Dacron grafts for their patency and infection rates and outcomes with respect to graft and patient survival in RL LDLT.

Eligibility Criteria:
Inclusion Criteria:

1. Primary Adult Living Donor Liver Transplantation
2. Right Lobe graft with anterior sector venous outflow reconstruction -

Exclusion Criteria:

1. Right Lobe graft without anterior sector venous outflow reconstruction
2. Liver re-transplantation -