cyrilzakka/clinical-trials huggingface dataset:
Cera™ Vascular Plug System Post-Market Clinical Follow-Up

The objective of the study is to collect and evaluate clinical data on patients of the Lifetech Cera™ Vascular Plug System to:

* confirm the performance
* confirm the safety
* identify previously unknown side-effects
* monitor the identified side-effects (related to the procedures or to the medical devices)
* identify and analyse emergent risks

Lifetech Cera™ Vascular Plug System is indicated for arterial and venous embolization in the peripheral vasculature. This study, planned under the MDR requirements, aims to confirm the safety and performance of the Lifetech Cera™ Vascular Plug System, identify previously unknown side-effects, monitor the identified side-effects (related to the procedures or to the medical devices), identify and analyse emergent risks. The Study intends to enroll 132 subjects. The estimated enrollment period is 1 year, and the expected duration of each subject's participation is 1 year (i.e., the follow-up period). Final report shall be completed in 2026.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 85;
2. Life expectancy \> 1 year;
3. Require arterial or venous embolization in the peripheral vasculature;
4. Target embolization site(s) allow for safe insertion of the delivery catheter;
5. Voluntarily sign and date the Informed Consent Form (ICF) prior to any study-related activities commencement;
6. Willing and able to comply with protocol requirements, including all study visits and procedures.

Exclusion Criteria:

1. The subject is pregnant or plan to be pregnant or breast feeding;
2. The subject has a known allergy or hypersensitivity to any of the device materials including: nickel, stainless steel, polytetrafluoroethylene and titanium nitride;
3. The subject has a known allergy or hypersensitivity to contrast agent;
4. The subject has uncorrectable coagulopathy;
5. The subject has planned use of anticoagulant (e.g. direct thrombin inhibitors, factor Xa inhibitors, vitamin K antagonists) or antiplatelet therapy before, during and/or after treatment with the study device, which, in the opinion of the Investigator, would clinically interfere with the study endpoints
6. The subject has an unresolved systemic infection;
7. Subject who cannot tolerate general or local anesthesia;
8. The subject has a connective tissue disorders (e.g. Ehlers-Danlos Syndrome), arteritis (e.g. Takayasu's Disease) or another circulatory disorder;
9. The subject is participating in other drug or medical device clinical trials;
10. Any condition (medical or anatomic) making the subject not suitable for transcatheter embolotherapy according to the opinion of the investigator.
Efficacy and Safety of Single, Low-dose Dexamethasone in Patients After Total Knee Arthroplasty

This study was conducted to determine the efficacy of an additional preemptive, single, low-dose dexamethasone in terms of incidence and severity of postoperative nausea/vomiting (PONV), pain level, and the safety in terms of wound complications in patients managed with our antiemetic protocol based on Ramosetron following TKA.

Postoperative pain and emesis can cause postoperative systemic complications and delay recovery and rehabilitation in patients following total knee arthroplasty (TKA). Furthermore, patients who suffered from severe postoperative pain and emesis tend to be dissatisfied with their surgical treatments. Although contemporary protocols to control perioperative pain and emesis after TKA have been reported to substantially reduce postoperative pain and emesis compared with traditional measures, pain and emesis after TKA remain to be a challenging issue for patients and health care providers. In our previous study, the use of Ramosetron was found to reduce postoperative emetic events, but the antiemetic effects by Ramosetron were incomplete. In search of a further antiemetic measure, we identified the use of dexamethasone as the additional measure fortifying our antiemetic protocol using Ramosetron.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary osteoarthritis, knee
* Scheduled for elective total knee arthroplasty
* Signed written informed consent

Exclusion Criteria:

* Refusing participate
* Contraindication to regional anesthesia
* Severe impairment of bowel motility
* administration of other antiemetic drug within 24hours before surgery
* systemic steroid within 24hours before surgery
* history of cardiovascular \& respiratory disease
* renal \& hepatic failure
Evaluation of pupillometrY for External Ventricular Drains Stop

Placement of an external ventricular shunt is one of the most common neurosurgical procedures in neuro-resuscitation. However, the modalities of its withdrawal are not, the subject of recommendations but rather of service habits. It has been recently demonstrated that pupillary monitoring by an electronic pupillometer was more reliable than standard clinical monitoring in brain injury patients. This tool provides access to a rich pupillary semiology at the patient's bed.

So the goal is to study the evolution of the various pupillary parameters analyzed by the electronic pupillometer during the external ventricular shunt weaning tests and to highlight the predictive factors of failure.


Eligibility Criteria:
Inclusion Criteria:

* All patients for whom the doctor orders an external ventricular bypass clamp test
* Neuro-injured patients and non-neuro-injured patients whose state of health requires sedation and mechanical ventilation

Exclusion Criteria:

* Ophthalmological pathology making impossible to carry out measurements by the pupillometer (chemosis, eyelid edema, enucleation, etc.).
* Pregnant woman.
Use of Defibrillator Information in the Emergency Department

This is a study to determine the feasibility of obtaining information stored in existing Medtronic internal defibrillators in patients who present to the Emergency Department(ED) for any reason. In addition, the study will determine if this information is useful to the ED physician in managing the patient's care, specifically as it relates to heart failure.

This is a prospective observational pilot study to determine if stored data regarding heart function, patient activity level, and other parameters can be used by the ED physician in order to evaluate a patient's cardiac status as it pertains to heart failure. Patients presenting to the ED and who consent have their devices interrogated by research personnel. The data is printed and provided to the treating physician who completes a brief survey about whether the data was useful in managing the patient.All subjects are contacted 30 days after ED or hospital discharge to determine if they have had any ED visits or hospital admissions during that period, and if yes, whether the visits were heart failure related. After all study procedures are performed, a team of 2 cardiologists will review the patient medical record from the study visit, as well as the data obtained from the patient's device in the ED. Each cardiologist, who will be blinded to the other's conclusion, will determine if the patient was having a heart failure exacerbation at the study visit.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* Medtronic IACD present on arrival to Emergency Dept.

Exclusion Criteria:

* minors
* prisoners
* non-Medtronic AICD
* unable to provide consent
* no telephone for 30 day follow up call
Selective Omission of Sentinel Lymph Node Biopsy in Mastectomy for Ductal Carcinoma in Situ: Identifying Eligible Candidates

This study aimed to assess the prevalence of upgrade to invasive breast cancer and axillary lymph node metastasis in patients who were diagnosed with DCIS on biopsy and subsequently underwent mastectomy with axillary surgery to establish the need for SLNB. Furthermore, we explored the clinicopathologic features related to the upgrade to invasive breast cancer and axillary lymph node metastasis.


Eligibility Criteria:
Inclusion Criteria:

1. Women diagnosed with DCIS in preoperative biopsy samples obtained by core needle biopsy, vacuum-assisted breast biopsy, or excisional biopsy
2. Women underwent curative surgery for DCIS

Exclusion Criteria:

1. Patients who received breast-conserving surgery
2. Patients who had concurrent contralateral invasive breast cancer
3. Patients who were in case of ipsilateral breast tumor recurrence
4. Patients whose invasiveness was uncertain in the biopsy samples
Role of CEUS as a Secondary Diagnostic Modality

To determine the role of contrast-enhanced ultrasound (CEUS) as a second-line imaging modality after gadoxetate-enhanced MRI (Gd-EOB-MRI) for identifying hepatocellular carcinoma (HCC) among at-risks observations.

The purpose of our study was to evaluate the diagnostic ability of CEUS with perflubutane to identify HCC on the indeterminate observation in Gd-EOB-MRI and to establish the role of CEUS as a second-line (post-Gd-EOB-MRI) modality for HCC diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* at risk of HCC by Liver Imaging Reporting and Data System (LI-RADS)
* at least one treatment-naïve solid hepatic observation (≥1 cm) while surveillance using US, CT or MRI
* signed informed consent

Exclusion Criteria:

* congestive hepatopathies
* severe cardiovascular dysfunction
* no recent cross-sectional images within 4 weeks
* suboptimal cross-sectional images quality
Study of Ruxolitinib (INCB018424) Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer

This is a clinical trial of orally administered Ruxolitinib (INCB018424) in patients whose disease has progressed following 1 prior chemotherapy regimen (not including anti-androgens or ketoconazole) for metastatic, androgen-independent prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with radiographically-documented metastatic prostate cancer that has progressed while receiving androgen-suppressive therapy in the form of a bilateral orchiectomy or Gonadotropin-Releasing Hormone (GnRH) agonist (eg, leuprolide, goserelin).
* Patients must demonstrate evidence of progressive disease based on 1 of the following criteria: 1) Progressive measurable disease, or 2) Progressive rise in prostate-specific antigen (PSA) level (2 consecutive rises from a prior reference level), or 3) Development of new lesions on bone scan.
* If receiving a GnRH agonist as primary hormonal therapy, the serum testosterone level must be ≤ 50 ng/mL.
* Must have received and progressed during or following 1 prior chemotherapy regimen for metastatic disease (not including an anti-androgen or ketoconazole); or, must have discontinued prior systemic therapy because of poor tolerance or other adverse effects; or, must have refused chemotherapy treatment. Patients having undergone more than 1 prior chemotherapy regimen may be admitted at the discretion of the sponsor.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Baseline serum PSA level of ≥ 10 ng/mL

Exclusion Criteria:

* Received any anti-cancer medications in the 30 days before receiving their first dose of study medication except for GnRH agonists and bisphosphonates.
* Any unresolved toxicity greater than or equal to Grade 2 from previous anti-cancer therapy, except for stable chronic toxicities not expected to resolve, such as peripheral neurotoxicity.
Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Opioid Use Disorder

The overarching goal of this project is to expand the traditional expertise in non-invasive neuromodulation at the University of Minnesota towards developing novel paired-neuromodulation approaches using transcrancial direct current stimulation (tDCS) for new addiction treatments that support long-term abstinence. This study will investigate whether the pairing of dorsolateral prefrontal cortex (DLPFC) stimulation and cognitive training can enhance functional connectivity between DLPFC and nucleus accumbens (NAcc). We have identified higher functional connectivity between DLPFC and NAcc in alcoholics that have successfully maintained abstinence for extended periods of time (7 years). This paired-neuromodulation approach can potentially be used as a therapeutic intervention to decrease substance use probability in addiction (e.g. opioid use disorder). The long term goal is to develop new addiction treatments that support long-term abstinence in opioid use disorder. The overall objective of this proposal is to enhance functional connectivity between DLPFC and NAcc as a therapeutic intervention to enhance cognition and reduce substance use rates in opioid use disorder.


Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of opioid use disorder
* Enrolled in a methadone treatment program for at least 2 months in Hennepin Healthcare and be clinically stable.
* Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for opioid use disorder
* Participants may have current comorbid drug use, but their primary substance use disorder diagnosis must to be based on opioid use.
* Participants must have the intention to remain in the methadone treatment program until the end of the intervention portion of the study.

Exclusion Criteria:

* Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness\>30 min, HIV)
* Head injury resulting in a skull fracture or a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
* Any contraindications for tDCS or MRI scanning (tDCS contraindication: actively receiving treatment for seizures or epilepsy; MRI contraindications; metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder)
* Current active psychosis or mania
* Presence of a condition that would render study measures difficult or impossible to administer or interpret (e.g. current mania, active psychosis)
* Primary current substance use disorder diagnosis on a substance other than opioid except for caffeine or nicotine
* Current stimulant use disorder (need to be free of stimulant use for at least 1 month)
* History of electroconvulsive therapy or cortical energy exposure within the past 12 months, including participation in any other neuromodulation studies
* incarceration
Randomized, Controlled Trial of Kangaroo Mother Care in Increasing the Rate of Weight Gain Among Neonates

A randomized, controlled trial of Kangaroo Mother Care (KMC) to determine the effectiveness in increasing the rate of weight gain among low birth weight neonates.

A randomized, controlled trial of Kangaroo Mother Care (KMC) versus Conventional Care to determine the effectiveness of KMC in increasing the rate of weight gain among low birth weight neonates and if it will decrease sepsis rate and shorten hospital stay among the group.

Eligibility Criteria:
Inclusion Criteria:

* birth weight \<1500 grams and stable neonates (no dependency on oxygen and /or intravenous fluid, ability (at least partial) to feed) with stable vital signs for the past 24 hours (normal temperature (36.5-37.5 °C),
* normal heart rate (120-160 bpm), normal blood pressure per age
* no apnea
* no intravenous lines or with well-secured peripheral line
* no sepsis
* no emerging signs of sepsis
* on IV antibiotic therapy but clinically stable
* can require photo therapy but with stable and not rising total serum bilirubin (TSB) level or TSB is not in high risk zone.

Exclusion Criteria:

* neonates with chromosomal and life threatening congenital anomalies, who were severally ill
* whose mothers are critically ill and whose mothers were unable to comply with the follow up schedule.
Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies

This is a study to evaluate the impact of returning research results that indicate a five-year risk estimate of Alzheimer disease dementia to participants without memory or thinking problems of the Knight Alzheimer Disease Research Center at Washington University in St. Louis.

All participants without memory or thinking problems in a longitudinal observational cohort of aging (Memory and Aging Project) will be offered a five-year Alzheimer dementia risk estimate report that incorporates genetic and either neuroimaging research results or plasma amyloid results as well as demographic information into five-year Alzheimer disease dementia risk estimate. Using a two-year delayed-start randomized clinical trial design, participants will be randomized to receive research results either two weeks (Arm A/C) or one year (Arm B/D) after informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Current Knight ADRC participants who had their clinical assessment in the previous year.
* Minimum age of 65 years old
* Participant must be classified as cognitively normal (CDR® = 0) at their last clinical assessment.
* Participant has either recent research brain MRI and amyloid PET scan results, or recent plasma amyloid measurements (ideally within the past two years, but up to five years will be acceptable due to COVID-19-related delays).
* Participant has genetic research results available including APOE status.
* Participant is currently consented to be contacted for other research opportunities through the Knight ADRC.

Exclusion Criteria:

* There are no exclusion criteria, other than not meeting all of the inclusion criteria listed above.
Vitamin D Levels in Frail Elderly Patients With a Hip Fracture

The purpose of this study is to assess whether all frail elderly admitted with hip fracture has a vitamin D deficiency, and if s-25(OH)D deficiency increases the risk of hip fracture in frail elderly.

Frail elderly are defined as being 65 years of age or older, and living in nursing homes or senior housings.

The investigators' hypotheses state that:

1. Frail elderly with hip fractures will have a suboptimal level of vitamin D.
2. Frail elderly with hip fractures are more likely to have a suboptimal level of vitamin D than frail elderly without any hip fractures during the last ten years.

The study examined frail elderly patients, defined as 65 of age or older and living nursing homes or senior housings.

Cases where taken from a Randomised Controlled Trial (NCT01102010), where the included where frail elderly admitted with a hip fractures to the Orthopaedic Surgery Ward at Aarhus University Hospital.

Controls were frail elderly, without a hip fracture in the previous ten years, admitted to the Geriatric Ward at Aarhus University Hospital.

The investigators will look at all eligible patients' files and record their serum-25(OH)D levels upon admission.

According to sample size calculations 92 patients are needed in the case group, and 138 patients in the control group.

The inclusion period will be from the 18th of January 2010 to the 1st of October 2012 for both groups.

Eligibility Criteria:
Inclusion Criteria, Cases:

* Aged 65 or older
* Living in nursing home or senior housing
* Admitted with hip fracture to the Orthopaedic Ward, Aarhus University Hospital

Exclusion Criteria, Cases:

* No serum-25(OH)D measurement upon admission

Inclusion Criteria, Controls:

* Aged 65 or older
* Living in nursing home or senior housing
* Admitted to the Geriatric Ward, Aarhus University Hospital

Exclusion Criteria, Controls:

* No serum-25(OH)D measurement upon admission
* Hip fracture in the previous ten years
Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance]

This surveillance is conducted to survey the followings under the post marketed drug utilization on the patients who are administrated ENBREL as a treatment for active polyarticular JIA.

1. Primary Occurrence status of Adverse Events; incidence of all adverse events, serious adverse events
2. Secondary Factors affecting safety and to confirm the efficacy such as DAS28.

All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis during registered period (2.5 year).

Eligibility Criteria:
Inclusion Criteria:

* Patients in active polyarticular JIA (restricted to the case of lack of effect by other treatment) during enrollment period (2.5years).
* Patients receiving Enbrel for JIA as diagnosed by a qualified physician.
* Age 5 - 16 years

Exclusion Criteria:

* Patients not administered ENBREL
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 163538 XX

To investigate safety, tolerability, pharmacokinetics including dose proportionality, and pharmacodynamics of BI 163538 XX within a predefined dose range


Eligibility Criteria:
Inclusion criteria:

1. Healthy male subjects
2. overweight or obese

Exclusion criteria:

1. Any relevant deviation from healthy conditions
Effect of Gender on Depression and Periodontal Status

There is a relationship between depression and periodontal disease. This relationship may be double-sided. A psychological state such as anxiety, depression, body image, and self-esteem may be affected from the symptoms of periodontal disease.

Background: Depression is a multifactorial disease characterized by a variety of symptoms. Individuals with psychiatric disorders seem to be more prone to periodontitis. However periodontal disease and depression can be considered bidirectional risk factors. Periodontal diseases can also be an effect on depression. The purpose of the present study was to evaluate the gender-related differences in the relationship between periodontal diseases and depression in male and female adults.

Material and methods: The study population consisted of 339 subjects. Two groups were formed from these patients: 171 females with periodontal disease (71 subjects with gingivitis, 100 subjects with periodontitis); 168 males with periodontal disease (72 subjects with gingivitis, 96 subjects with periodontitis). Clinical periodontal and psychological measures were performed on females and males group.

Eligibility Criteria:
Inclusion Criteria:

* the presence of periodontal diseases

Exclusion Criteria:

* the presence of any systemic disease other than depression
* smoking and alcohol consumption
* the use of any drugs (antidepressants, anti-inflammatory, and antimicrobial medicaments, and hormonal supplements) that affect the periodontal condition
* have received any periodontal treatment in the last six months
* hormonal condition such as pregnancy or lactation
Combining Performance of Call EMS and Simultaneous Chest Compressions in a Lone Rescuer CPR

Investigators designed the novel combining technique that rescuer start the chest compression with one hand during calling for help to the Emergency Medical System (EMS) via a cell phone with another hand when he witnessed the arrest victim. This method may be helpful to reduce the hand-off time and increase the faction time of chest compression until the arrival of EMS members.

To verify this hypothesis, we conducted a random, controlled simulation study.

This study used a random, controlled design in the simulation setting using a manikin. Study participants were recruited from healthy adult (age \> 18 years) laypersons who attended the BLS training courses provided by the BLS training class.

The simulation scenario consists of witness of an out of hospital cardiac arrest and activation of the EMS system with the prepared cellular phone. Interventional method contained the immediate starting of the chest compression with one hand during the calling for help to the EMS via a cell phone with another hand.

We compare the quality of CPR between the novel interventional method (start CPR during Call to EMS) and conventional method (First Call to EMS and then start CPR).

Eligibility Criteria:
Inclusion Criteria:

* All healthy volunteers who attended the basic CPR training class
* Agreement with the simulation trial

Exclusion Criteria:

* volunteers who had some healthy problem which may affect the study results
* Not agreement with the simulation trial