cyrilzakka/clinical-trials huggingface dataset:
HAART Annuloplasty Device Valve Repair Registry

Multicenter US registry study to assess procedure success and long-term (10-year) performance of the HAART 200 and HAART 300 Aortic Annuloplasty Devices when used during aortic valve repair in a routine cardiovascular practice setting.

The HAART Aortic Annuloplasty Devices are three-dimensional annuloplasty rings designed to be implanted intra-annularly in the aortic valve to correct annular dilatation and/or maintain annular geometry of the aortic valve in patients with trileaflet valve morphology (HAART 300) or bicuspid valve morphology (HAART 200) with moderate to severe aortic insufficiency who are undergoing aortic valve repair due to symptoms or as part of a repair for an aortic aneurysm.

The study is a multicenter registry study enrolling both retrospective and prospective participants. Investigators are cardiothoracic surgeons specializing in surgery of the aortic valve and aorta at facilities with suitable infrastructure to support collection of the registry study data. Patients who underwent or will undergo aortic valve repair using either the HAART 300 or HAART 200 Device will be enrolled. All patients known to have received the HAART 300 or HAART 200 Device at participating centers will be contacted and offered the opportunity to enroll in this registry study. Prospective participants will have evaluations prior to surgery, intraoperatively, immediately following surgery, at discharge (or within 90 days), and at 1, 3, 5, and 10 years. In addition to the follow-up clinic visits, phone contacts are scheduled at years 2,4,6, 7, 8, and 9 to maintain participant engagement as well as to ascertain if any safety events have taken place. Retrospective participants who have already received the HAART 300 or HAART 200 Device prior to study enrollment will undergo safety assessment at the time of enrollment in the study.

Eligibility Criteria:
Inclusion Criteria:

* The patient underwent or is undergoing aortic valve repair using either the HAART 300 or HAART 200 Aortic Annuloplasty Device in accordance with the Instructions for Use.
* The patient has reviewed and signed the written informed consent form.
* The patient agrees to return for all follow-up evaluations for the duration of the study.

Exclusion Criteria:

* Retrospective patient that has undergone a subsequent aortic valve replacement procedure.
Prediction of Recurrent Events With 18F-Fluoride

This is a multi-centre observational study. It will make use of the positron emission tomography (PET) tracer 18F-sodium fluoride (18F-NaF) as a marker of coronary plaque vulnerability to detect culprit and non-culprit unstable coronary plaques in patients with recent myocardial infarctions. The investigators will then perform long-term follow-up of these patients to determine the prognostic significance of coronary 18F-NaF uptake

The investigators intend to recruit 700 patients hospitalised with myocardial infarction and proven multivessel coronary artery disease. All patients will undergo a combined CT coronary angiogram (CTCA) and PET scan using 18F-NaF as a tracer. Patients will then have clinical follow-up before undergoing a repeat CTCA at 2 years to assess progression of coronary disease. Clinical review of all patients will continue until study completion (given 2 years of recruitment this is likely to last 4 years) and following this the investigators will continue to monitor for further cardiovascular events via review of patient electronic health records for a further 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥50 years with recent (\<21 days) type 1 myocardial infarction and angiographically proven multi-vessel coronary artery disease defined as at least two major epicardial vessels with any combination of either (a) \>50% luminal stenosis, or (b) previous revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery).
2. Provision of informed consent prior to any study specific procedures

Exclusion Criteria:

1. Inability or unwilling to give informed consent
2. Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial
3. Major intercurrent illness with life expectancy \<2 year
4. Renal dysfunction (estimated glomerular filtration rate ≤30 mL/min/1.73 m2)
5. Contraindication to iodinated contrast agent, positron emission tomography or computed tomography
6. Atrial fibrillation
7. Previous recruitment into the trial
The Effect of Breathing Exercise Applied With Incentive Spirometer

It was conducted as a single-center, prospective, randomized controlled experimental study. Data were collected with the Introductory Information Form, Numerical Rating Scale, Physiological Parameters Follow-up Form and General Comfort Scale.

It was conducted as a single-center, prospective, randomized controlled experimental study. Data were collected with the Introductory Information Form, Numerical Rating Scale, Physiological Parameters Follow-up Form and General Comfort Scale.The study was conducted in three groups. Individuals in the intervention-1 group were asked to perform breathing exercises with IS in addition to the routine practices of the clinic for 5 days in the postoperative period. Individuals in the intervention-1 group were asked to perform breathing exercises with IS in addition to the routine practices of the clinic for a total of 10 days, 5 days in the preoperative period and 5 days in the postoperative period. Individuals in the control group were given only the routine practice of the clinic.

Eligibility Criteria:
Inclusion Criteria:

* Able to communicate in Turkish,
* undergoing cardiac surgery,
* no pain in the preoperative period (0 pain according to VA),
* have no problems with vision, hearing or speech,
* individuals who agreed to participate in the study were included.

Exclusion Criteria:

* Using psychiatric medication,
* Using immunosuppressive medication until 30 days before surgery,
* with neuromuscular disorders,
* having rheumatic disease,
* have had pulmonary surgery before,
* with cerebrovascular injury,
* diagnosed with cardiovascular instability or aneurysm,
* Diagnosed with COPD,
* individuals who do not volunteer to participate in the study
Clinical Evaluation of Fenestration Decompression Combined With Secondary Curettage for Ameloblastoma of the Jaw: Retrospective Radiographic Analysis

Objectives: To investigate the outcomes of fenestration decompression combined with secondary curettage (FDSC) in the surgical treatment of jaw ameloblastoma.

Methods: Medical records of patients diagnosed as multicystic ameloblastoma (MA) or unicystic ameloblastoma (UA) by routine pathology were collected from January 2010 to December 2017 in Ninth People's Hospital, Shanghai JiaoTong University Medical College. Patients were divided into two groups based on the management regimen: FDSC group, and local curettage (LC) group. Patients were followed up for 3-8 years, using panoramic radiography to measure the change of the area of the cystic cavity involved in ameloblastoma and the recurrence or malignant transformation of the tumor in both groups. A total of 233 eligible patients were selected for provisional screening, including 145 patients with MA, and 88 patients with UA.


Eligibility Criteria:
Inclusion Criteria:

-Medical records of patients who were diagnosed with multicystic ameloblastoma (MA) or unicystic ameloblastoma (UA) by routine pathology were collected from January 2010 to December 2017 in Ninth People's Hospital of Shanghai JiaoTong University Medical College.

Exclusion Criteria:

* followed up less than 3 years
* For FDSC group, fenestration decompression failed
* recurrent ameloblastoma
* received other type of surgery;
Capillary Lactate and Transfusion Needs

13% of injured normotensive patients arriving in emergency unit need mass blood-transfusion of six or more units of packed Red Blood Cells. It is currently difficult to predict the need for such a mass blood-transfusion. Indeed hemoglobin point of care testing (hemocue) and blood pressure can be normal during the first hours despite intensive bleeding.

It's well known that blood or arterial lactate measures correlate with trauma severity but these measures are not available in a pre-hospital setting. The investigators want to test whether capillary lactate measures also correlate with trauma severity and can therefore predicts earlier transfusion needs.


Eligibility Criteria:
Inclusion Criteria:

* Adult admitted in vital emergency unit
* Severe trauma
* normotensive (Systolic Blood Pressure \>90mmHg)
* patient subjected to capillary haemoglobin and glucose measurements
* patient beneficiary of social security

Exclusion Criteria:

* pregnant woman
* liver deficiency
* pre-hospital transfusion
* hypothermia below 35°C
* protected persons according to the law
* Nor epinephrine \> 0.1gamma/kg/min
Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers

Vaccines have been responsible for preventing millions of deaths and extending the average human lifespan. Effective vaccines stimulate the cells of the immune system to activate genes and associated functions that bring about protective immunity.This study aims to define cellular functions and genes important for the hepatitis B (HBV) vaccine immune response in healthy individuals. The investigators hypothesize that many genes associated with innate and adaptive immune functions are important for an effective HBV vaccine response.

Vaccines have been responsible for preventing millions of deaths and extending the average human lifespan. Effective vaccines stimulate the cells of the immune system to activate genes and associated functions that bring about protective immunity. Knowledge of those genes and cellular functions activated by effective vaccination can improve our understanding of how the immune system works and define the features necessary for a successful vaccine response. This study aims to define cellular functions important for the hepatitis B (HBV) vaccine immune response in healthy individuals. The investigators will identify those genes that are activated or suppressed in immune cells at various times after each dose of the HBV vaccine. The investigators will explore these vaccine-induced "gene signatures" to characterize the cellular functions associated with an effective immune response to HBV vaccination. The investigators hypothesize that many genes associated with innate and adaptive immune functions are important for an effective HBV vaccine response.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer without significant medical problems
* Willing to receive three doses of an FDA-approved Hepatitis B vaccine

Exclusion Criteria:

* Male or female \< 18 and \> 60 years of age
* Received any vaccine within a month prior to study vaccine
* History of Hepatitis B infection
* History of previous Hepatitis B vaccination(s)
* History of Hepatitis C virus (HCV) infection or positive HCV antibody test
* Participation in another clinical study of an investigational product currently or within the past 90 days, or expected participation during this study
* Positive serum antibody against Hep B surface antigen and/or core Hep B core antigen
* human immunodeficiency virus (HIV) positive
* In the opinion of the investigator, the volunteer is unlikely to comply with the study protocol
* Any clinically significant abnormality or medical history or physical examination including history of immunodeficiency or autoimmune disease
* Is pregnant or lactating
* Currently taking systemic steroids or other immunomodulatory medications including anticancer medications and antiviral medications
* Any clinically significant acute or chronic medical condition requiring care by a primary care provider (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that, in the opinion of the investigator, would preclude participation
* Unable to continue participation for 30 weeks
Community Health Workers in an Interdisciplinary Outpatient CKD Clinic to Optimize Social Care Navigation, Patient Engagement, and Home Dialysis Utilization

The goal of this clinical trial is to learn if this intervention (the CHOOSE Home intervention) is feasible and may lead to more home dialysis usage in a high-risk patient population. The main questions it aims to answer are:

* Will there be an increase in home dialysis selection or initiation over study follow up?
* Will there be a change in patient reported status of Health-Related Social Needs (HRSNs) and patient engagement at 1 year follow up?

Researchers will compare the intervention group that will include interdisciplinary care (IDC) and the integration of a Community Health Worker (CHW) into the chronic kidney disease (CKD) care process to the IDC only control group. The research team will assess whether the intervention led to better social care navigation, enhanced patient engagement, and increased home dialysis use.

The overarching aims of the study are to 1) utilize a community- engaged approach with input from diverse community partners to refine the CHOOSE Home Trial; and 2) evaluate the feasibility, acceptability, and possible effect of the CHOOSE Home Intervention. Feasibility and acceptability will be evaluated using complementary quantitative and qualitative measures and organized into the dimensions of the RE-AIM framework. The investigator team hypothesizes that the CHOOSE Home intervention may lead to increased home dialysis utilization by more effectively addressing health-related social needs and fostering greater patient engagement. This proposal brings together experts in CKD care, SDOH, health equity, implementation and community-engaged research. The results will be used to inform further studies in CKD care delivery to reduce health inequities in home dialysis use and improve the quality of life for patients with CKD.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Advanced CKD (defined by estimated glomerular filtration rate (eGFR) of 25 ml/min/1.73m2 or less using the 2021 CKD-EPI equation)
* English or Spanish speaking
* Provide informed consent
* Followed by a nephrologist at Montefiore and seen within last 12 months
* Willing to receive interdisciplinary care (i.e., nurse practitioner facilitated CKD education and care coordination)
* Has at least one unmet social need amenable to CHW intervention

Exclusion Criteria:

* Active malignancy
* Anticipated survival is less than 1 year as determined by the patient's treating nephrologist
* Opting to do medical management only (non- dialysis supportive care) for management of their kidney failure
* Plan to relocate outside of New York City within the next 12 months
The Effect of Taping in Reducing the Intensity of Pain in Primary Dysmenorrhea

To determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea

Primary dysmenorrhea is defined as cramping pain in the lower abdomen occurring just before or during menstruation, in the absence of other diseases.

About 50-90% of the women experience menstrual pain, and approximately 15% of them suffer from a severe level of pain It is a common cause of absenteeism and reduced quality of life in women.

From 21% to 96% of women with menstrual pain, reported to practice self-treatment either by pharmacological or nonpharmacological interventions. However, there are adverse events associated with the use of these drugs, including stomach ache, diarrhea, nausea, cutaneous reactions, liver or kidney damage or cardiovascular risk after discontinuing medication . Therefore, many patients with menstrual pain usually seek complementary and alternative techniques.

Medical taping concept is an alternative treatment that use elastic adhesive tape, which is applied to the patient's skin under tension.

It has the characteristic to cause elevation of the epidermis and thereby reduce the pressure on the mechanoreceptors below the dermis. This would have the effect of reducing nociceptive stimuli.

Eligibility Criteria:
Inclusion Criteria:

* Women presenting menstrual pain, 4 or more in VAS.
* Have attended gynecological examination in the past 18 months and had ever diagnosed as having a gynecological disorder different from primary dysmenorrhea
* Not have been diagnosed with secondary dysmenorrhea
* Regular menstrual cycles (cycle typical range of 21 to 35 days)
* Do not use an intrauterine contraceptive device (IUD) or taking oral contraceptive pills
* Nulliparous
* Ability to complete questionnaires in Spanish.

Exclusion Criteria:

* Women with mild dysmenorrhea (pain lower 4 in a numeric pain scale range 0-10);
* Women with irregular or infrequent menstrual cycles (outside the typical range of cycle 21 to 35 days);
* Women using an intrauterine contraceptive device (IUD) or taking oral contraceptive pills.
* Women who suffer from diseases diagnosed added
* Women to which it has undergone a surgical procedure for the treatment
* Provide skin lesions in the abdominal wall or in lumbar region
* Use or abuse of drugs or alcohol
Efficacy and Safety of Unfractionated Heparin on Severe Sepsis With Suspected Disseminated Intravascular Coagulation

The primary objective of this study is to estimate the efficacy of unfractionated heparin(UFH) on ICU mortality in severe sepsis with suspected DIC.The Second objective is to estimate the effect of UFH on 28-day mortality,and the change of the Japanese Association for Acute Medicine(JAAM) score and SOFA score. The third one is to evaluate the safety of UFH in severe sepsis patients with suspected DIC.

During the study, the whole process of data validation and registry procedures will be implemented by the Principal Investigator of the study, and monitored by the Ethics Committee of the First Affiliated Hospital of China Medical University.There are 2 research supervisors(2 ICU doctors) to assess the accuracy, completeness and representativeness of registry data, and to report the study process and research results to Principal Investigator.Investigators have also edited a data dictionary including each variable used by the registry and normal ranges of all detection indexes. The standard operating procedures have been formulated to address the registry and data analysis. The feasibility and significance have been assessed carefully and funded by the Health and Family Planning Commission of Liaoning Province(No.LNCC-B01-2014).The sample size is 600 participants through statistic calculation. The plan for missing data and statistical analysis will be implemented by specialized statisticians of China Medical University.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of severe sepsis or/and septic shock
* suspected DIC:the score of Platelets plus International Normalized Ratio in the JAAM criteria is equal or more than 3 scores

Exclusion Criteria:

* consent declined
* pregnant or breastfeeding
* the length during ICU is less than 24 hours
* with other types of shock
* have bleeding or high risk for bleeding
* have an indication for therapeutic anticoagulation
* have a known or suspected adverse reaction to UFH including HIT
* are currently enrolled in another trial
* known or suspected cirrhosis or other severe hepatic diseases
* terminal illness with a life expectancy of less than 28 days
A Study of NGM621 in Participants With Geographic Atrophy

This is a multi-center evaluation of NGM621 in a randomized, double-masked, sham-controlled study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (non-pregnant, non-lactating) subjects ≥ 55 years
* Standard luminance BCVA score of 34 letters or better using ETDRS charts at the starting distance of 4 meters (approximately 20/200 Snellen equivalent or better) in study eye
* Clinical diagnosis of GA secondary to AMD:

  1. Total GA area must be ≥ 2.5 and ≤ 17.5 mm²
  2. If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm² (0.5 DA), with the overall area of GA ≥ 2.5 and ≤ 17.5 mm²
  3. Well demarcated GA with no anatomical evidence of current or prior CNV in the study eye

Exclusion Criteria:

Study Eye

* GA secondary to a condition other than AMD in either eye (e.g., monogenetic macular dystrophies like Stargardt disease, cone rod dystrophy, or toxic maculopathies)
* Any history of or active choroidal neovascularization (CNV)

Both Eyes

* Any history of or active bacterial, viral, fungal, or parasitic infection in either eye in the 3 months prior to randomization
Sperm Separation Efficiency to Maximize Pregnancy Rates: MACS vs. FERTILE Chip

The goal of this observational study is to compare clinical outcomes of two techniques for sperm cell sorting, microfluidic sorting and magnetic activated cell sorting (MACS) technique, in males with high DNA fragmentation within an assisted reproductive treatment. The main questions it aims to answer are:

* Does microfluidic sorting improve pregnancy rate compared to MACS?
* Does microfluidic sorting improve fertilization rate compared to MACS?
* Does microfluidic sorting improve implantation rate compared to MACS?
* Does microfluidic sorting improve blastocyst development rate compared to MACS?

Participants will deposit an eyaculate sample that will be analyzed for DNA fragmentation using a aliquot, then split in two to perform MACS and the microfluidic sorting. Both will be tested for DNA fragmentation (aliquotes) and used for the ICSI treatment with donor oocytes.

Researchers will compare both techniques to see if the selection of the best functional spermatozoa with less DNA fragmentation and clinical outcomes improve.

In assisted reproductive technology (ART), the diagnosis of male infertility has been conducted based on the assessment and analysis of sperm concentration, motility and morphology with the aim of obtaining the best quality of spermatozoa. Any type of damage present in sperm DNA can lead to ART failure. Sperm DNA fragmentation might be the most frequent cause of paternal DNA anomaly transmitted to offspring, and is found in a variable percentage of spermatozoa in subfertile and infertile men. Such DNA fragmentation is negatively correlated with semen quality and consequently, there is a need to develop sperm separation techniques that facilitate retrieval of as many spermatozoa with normal DNA integrity as possible from ejaculated semen.

Because of centrifugation steps associated to swim-up or density-gradient can induce sperm DNA fragmentation via reactive oxygen species (ROS), microfluidic sperm sorters are being used to isolate motile human spermatozoa based on fluid dynamics. It seems to be that using this separation method, spermatozoa do not undergo added physical stress from sources such as a centrifuge. Hence, this new technology has been proposed to minimize DNA damage. In this study, we aim to determine if microfluidic sorting improves the selection of the best functional and with lower DNA fragmentation spermatozoa when compared to magnetic activated cell sorting (MACS) in split semen samples, and increases clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Oocyte recipient patients

Exclusion Criteria:

* Sperm concentration \< 5 Mill/ml
* Percentage of motile sperm \< 15%
Phase1 Syudy to Evaluate the Safety and PK/PD of Human Antithrombin III

To evaluate the PK/PD of single injected human ATIII Products, SKATIII and ATIII, phase1 study in healthy male subjects was designed


Eligibility Criteria:
Inclusion Criteria:

* ages 19 to 40
* Body weight: More than 50kg
* Healthy male subject

Exclusion Criteria:

* Hb\<14g/dL, Hct\<42%
* ATIII hypersensitivity