cyrilzakka/clinical-trials huggingface dataset:
Micra Transcatheter Pacing System Post-Approval Registry

Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the Micra Transcatheter Pacing System (Micra system) when used as intended, in "real-world" clinical practice, following commercial release.

The Micra Registry is conducted within Medtronic's Product Surveillance Registry.

The Micra Registry is a global, prospective, observational, multi-site registry. Patients enrolled in the Micra Registry will be prospectively followed for a minimum of 9 years post-implant or until registry closure, patient death, patient exit from the registry (i.e., withdrawal of consent), or unless patient is participating in an acute performance sub-study of the Micra Registry\*.

Enrolled patients will have scheduled follow-up visits at least annually or as prompted by reportable adverse events; however, all Micra system follow-up patient visits are to be reported. Therefore, if more frequent scheduled visits occur per a provider's standard care practice, those visits are reported. The total estimated registry duration is 11 years.

\*Patients contributing to an acute performance sub-study of the Micra Registry do not contribute to the FDA-regulated Post-Approval Study which includes a long-term (minimum 9-year) patient follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient is intended to receive or be treated with a Micra Transcatheter Pacing System and must be enrolled prior to the TPS implant procedure

Exclusion Criteria:

* Patient who is, or is expected to be inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Breast MRI Spectroscopy, Department of Defense (DOD)

The purpose of this new imaging method is to provide physicians with additional information not available with standard imaging methods. This includes information about the make up of different breast diseases. Using spectroscopy data, it may be possible to tell the difference between benign conditions of the breast from malignant tumors and provide more accurate information than can be obtained with regular MRI. Along with the MRI a new method of evaluating the images or pictures will be used. This new method is called spectroscopy and is used routinely on other parts of the body such as the prostate and brain. Pictures produced with this sequence look different than the regular MRI pictures. Performing spectroscopy on a 1.5T magnet adds another imaging sequence (another scan) to the routine MRI protocol, thus increasing exam time (extra 10-15 minutes). This study will enroll patients who are scheduled for a Magnetic Resonance Imaging (MRI) examination ordered by their primary physician.

Our aim is to perform MR Spectroscopy (MRS) on 150 patients at the end of their clinically indicated routine breast MRI guided biopsy and breast MRI guided needle localization examination using a software package from General Electric Medical Systems (Milwaukee,WI). This will add time to the routine examination but will not involve additional injections of contrast. We will analyze the spectroscopic data to determine if benign lesions can be reliably differentiated from malignant ones. The MR Spectroscopy (MRS) will be administered at Memorial Sloan Kettering Cancer Center, 1275 York Ave, NY,NY 10021.

Eligibility Criteria:
Inclusion Criteria:

* Patient needs to be ≥ or = to 18 years of age
* scheduled for diagnostic breast MRI examination or interventional procedure for a suspected or known breast lesion ≥ or = to 1 centimeter

Exclusion Criteria:

* Patients who would be normally excluded from undergoing an MRI examination include:
* Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field
* Patients who are pregnant are excluded from participation of this study
* Patients who are unable to comply or complete the MRI exam due to claustrophobia or high levels of anxiety.
* Patients undergoing chemotherapy
Characterization of Methylation Patterns in Lung Cancer

In this study the investigators will collect Blood,sputum and saliva samples for Characterization of Methylation Patterns in lung Cancer.

Lots of information about the relationship between changes in methylation patterns and various diseases are accumulated in recent years. Characterization of methylation changes that occur in cancer may contribute to the development of methods for early detection of cancer by detecting cancer cells in liquids. Early detection of such changes and their correlation examining different cancers may lead to a diagnostic tool for the early detection of cancers and improve the treatment of these patients. Detection by molecular analysis can be a sensitive method and non-invasive early diagnosis of the disease In this study the investigators will collect Blood,sputum and saliva samples for Characterization of Methylation Patterns in lung Cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected lung tumor

Exclusion Criteria:

* Patients who have active disease other than lung cancer during the sample collecting
Assessment of Skills and Behaviors in Children With Down Syndrome

Parents of children with Down Syndrome can help in describing children's abilities and behavior. Most of the studies evaluating parents of children with Down Syndrome and other intellectual disabilities have focused on parental stress and coping; Additionally, most research has evaluated the perspectives of mothers rather than fathers. For this reason, in this study we aims to evaluate skills and behaviors in children with Down syndrome through the perception of parents.


Eligibility Criteria:
Inclusion Criteria:

* Down syndrome childrens
* Age between 0 and 3 years

Exclusion Criteria:

* Other physical or functional impairment that limits the performance of evaluation
Casting Versus Flexible Intramedullary Nailing in Displaced Pediatric Forearm Shaft Fractures

The forearm is the most common fracture location in children, with an increasing incidence. Displaced forearm shaft fractures have traditionally been treated with closed reduction and cast immobilization. Diaphyseal fractures in children have poor remodeling capacity, and malunion can thus cause permanent cosmetic and functional disability. Internal fixation especially with flexible intramedullary nails has gained increasing popularity, without evidence of a better outcome compared to closed reduction and cast immobilization.

This is a multicenter, randomized superiority trial comparing closed reduction and cast immobilization to flexible intramedullary nails in 7-12 year old children with \> 10° of angulation and/or \> 10mm of shortening in displaced both bone forearm shaft fractures (AO-pediatric classification: 22D/2.1-5.2). A total of 78 patients with minimum 2 years of expected growth left are randomized in 1:1 ratio to either treatment group. The study has a parallel non-randomized patient preference arm. Both treatments are performed under general anesthesia. In the cast group a long arm cast is applied for 6 weeks. The flexible intramedullary nail group is immobilized in a collar and cuff sling for 4 weeks. Data is collected at baseline and at each follow-up until 1 year.

Primary outcome is 1) PROMIS Pediatric Item Bank v2.0 - Upper Extremity and 2) forearm pronation-supination range of motion at one-year follow-up. Secondary outcomes are Quick DASH, Pediatric pain questionnaire, Cosmetic VAS, wrist range of motion as well as any complications (malunion, delayed union, non-union or deep wound infection, peripheral nerve injury, need for re-intervention during 1-year follow-up) and costs of treatment.

The investigators hypothesize that flexible intramedullary nailing results in a superior outcome.

Eligibility Criteria:
Inclusion Criteria:

* 7 to12 year old children
* Open distal radial physis
* Both bone forearm shaft fractures (AO-pediatric classification: 22D/2.1-5.2)
* More than 10 degrees of angulation
* with or without less than 10mm of shortening

Exclusion Criteria:

* Patients with bilateral fractures
* Gustilo-Anderson grade I-III open fracture
* Neurovascular deficit
* Compartment syndrome
* Pathologic fracture
* Patient not able to give a written informed consent
A Follow up Safety Study of Patients Who Participated in Previous Studies of the Drug Org 24448 (Study P05719)(COMPLETED)

This is a safety study evaluating the subjects who participated in previous Organon trials of the drug Org 24448. Patients will undergo a Screening visit, 1 or 2 Evaluation visits, and a possible Follow-Up period. During the visits, study tests, including echocardiograms, will be performed to summarize cardiac functioning.

All subjects who participated in previous Org 24448 trials and who do not meet any of the exclusion criteria are eligible.

Eligibility Criteria:
Inclusion Criteria:

Subjects must:

* be verified by the investigator to have participated in a previous Organon sponsored Org 24448 trial.
* sign an affirmative informed consent before evaluations are conducted;

Exclusion Criteria:

Subjects must not have:

* a concurrent acute condition that could interfere with the conduct or interpretation of the evaluations (e.g. acute psychosis; respiratory illness; current experimental medications). If possible, evaluation of such subjects is deferred until resolution of such conditions.
Value of Radiological Follow up in Children Hospitalized With Lobar Pneumonia

The study intends to assess the utility of performing a follow up X rays in children admitted to pediatric wards with lobar pneumonia. Usually those children are discharged with a recommendation for a follow up X rays but there are no enough studies proving that this recommendation is really necessary.

Thew study will include follow up data in a group of about 200 patients admitted with lobar pneumonia during the years 2006 to 2007. All the clinical and laboratory data will be collected and also the X rays findings.

The findings of follow up X rays if they were performed will also be summarized.

Eligibility Criteria:
Inclusion Criteria: All pediatric patients discharged with the diagnosis of lobar pneumonia.

Exclusion Criteria: Patients with diagnosis of chronic diseases.
Preoperative Nutritional Intervention and Outcomes of Children Submitted to Heart Surgery for Congenital Heart Diseases

The hypothesis of this study is a nutrition preoperatively in infants and children undergoing elective cardiac surgery with cardiopulmonary bypass leads to improvement in nutritional status, intervention, and that this results in good postoperative results.

If this hypothesis is confirmed, there will be subsidies for systematic implementation of nutritional interventions in patients seen in service.

Eligibility Criteria:
Inclusion Criteria:

* Patient with congenital heart disease requiring elective surgical correction;
* Age\> 30 days and ≤ 5 years, with the aim of excluding the neonatal period, which are operated children with complex heart defects, and older children, where the time living with the disease damages the myocardium and the pulmonary circulation, leaving only children with fewer serious and, in general, are less subjected to complex surgery diseases.

Exclusion Criteria:

* Chronic gastrointestinal diseases (defects, malabsorption, celiac disease, inflammatory bowel disease, diabetes mellitus);
* Patients with other organic defects that may compromise the growth and / or nutritional status;
* Patients undergoing emergency surgery;
* Request of parents or guardians at any time;
* Patients receiving exclusive breastfeeding;
* Died during the study period;
* Patients using cardiac pacemaker or other electrical or electronic device that interferes with the reading of the electrical bioimpedance.
Resveratrol-enriched Grape Extract (Stilvid) in Primary and Secondary Prevention of Cardiovascular Disease

Resveratrol can exhibit benefits against cardiovascular diseases (CVDs) although the cardioprotective role of resveratrol as part of the human diet is not yet clear.

The aim of this trial is to evaluate the safety and efficacy of a resveratrol-enriched grape extract (Stilvid) in 150 patients from both primary and secondary cardiovascular prevention.

All the patients are gold-standard medicated (statins and others). A number of cardiovascular risk and safety markers will be evaluated after consuming 1 cap/day for 6 months and 2 caps/day for 6 additional months (total 12 months).


Eligibility Criteria:
Inclusion Criteria:

FOR PRIMARY PREVENTION:

* Lack of known cardiovascular disease (coronary acute syndrome, stable ischemic cardiopathy, peripheric arteriopathy and cerebrovascular diseases).
* Age between 18 and 80 years.
* The above criteria and diabetes mellitus or at least two of the following risk factors:

  1. Active smoking (10 cigarettes or more per day).
  2. Arterial hypertension (\>= 140/90 mmHg).
  3. Hypercholesterolemia (LDL-cholesterol \>130 mg/dL and/or HDL-cholesterol \< 45 mg/dL in women and 50 mg/dL in men).
  4. Obesity (BMI \> 30 kg/m2)

FOR SECONDARY PREVENTION:

* Stable patients who coronary syndrome, cerebrovascular accident or peripheric arteriopathy event occurred at least 6 months or more before the recruitment in the study. In addition:

  1. Age between 18 and 80 years.
  2. Ejection fraction of left ventricle \>=45%.
  3. Functional status I or II according to the New York Heart Association.
  4. Clinic stability in the recruitment (no symptoms of thoracic pain during the last month).
  5. Lack of residual lesions without vascularization in those patients with catheterism.

     Exclusion Criteria:

     FOR PRIMARY AND SECONDARY PREVENTION:
* Patients who do not satisfy inclusion criteria and:

  1. Known allergy to grapes
  2. Pregnancy or lactation
  3. Intake of nutraceuticals
Breathing Synchronized PET/CT Scans for the Detection of Malignant Lung & Liver Lesions and Assessment of Tumor Glycolysis

In this particular study the physicians want to use a new technique of how they obtain the PET/CT pictures. It is called breath-hold (BH) PET/CT". As the name suggests, they will ask the patient to hold their breath for about 20-30 seconds, and only during that time will they obtain pictures. This is repeated several times. In contrast to the standard PET/CT scan, they expect less "blurring" of the pictures, so that they can see the tumor better and measure the uptake of radioactive sugar in the tumor better and more reliably. Basically, this is the difference between taking pictures of a runner as compared to taking pictures of a person standing still. Since PET images need to be obtained over several minutes and people can not hold their breath for this extended time, we break the procedure into several cycles of 20-30 seconds (or longer, if possible) and then add all the "frozen" pictures in the end into one. They want to know if BH PET/CT scan measure changes in the cancer during therapy (i.e., from the baseline scan before therapy to the follow up scan at within 4 weeks later).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Patients with early stage biopsy-proven lung cancer or patients with lung or liver metastases from any primary cancer (metastatic disease proven by biopsy, or clearly established clinically and by imaging studies who are being treated with stereotactic body radiotherapy (SBRT)or an ablation will be eligible.
* Patient has at least one lesion ≥ 1cm in size.
* Signed informed consent

Exclusion Criteria:

* Pregnant women are ineligible.
* Patients who are unable to follow breathing instructions either due to language difficulties or hearing impairment This will be determined either by one of the consenting individuals when they approach the patient to ask for informed consent or prior to acquisition of the clinical PET/CT.
* Patients who are too ill to hold their breath.
Deep Venous Thrombosis in Non-severe COVID-19 Patients Hospitalized for a Neurovascular Pathology

Severe SARS-CoV-2 infection, responsible of COVID-19, is accompanied by many venous thromboembolic events. Antithrombotic treatment is the cornerstone of management of many neurovascular diseases (NVDs) and the benefit-risk ratio is crucial to avoid hemorrhagic complications. Therefore, in non-severe COVID-19 patients affected by NVDs, the diagnostic of deep venous thrombosis (DVT) is challenging. Using bedside Doppler ultrasonography (DUS) of lower limbs, this study investigated the rates of DVT in these patients in stroke unit.


Eligibility Criteria:
* Inclusion criteria:

  * Age\>18 years
  * COVID-19 confirmed with RT-PCER and/or chest CT-scan
  * Acute neurovascular disease defined as transient ischemic attack or acute ischemic stroke or venous cerebral thrombosis or hemorrhagic stroke.
* Exclusion criteria:

  * age\<18
  * Other neurovascular diseases
Maternal Microcirculation & SDF Imaging

This is a study of pregnant women undergoing a cesarean delivery. It will compare their microcirculation before and after the anesthetic. Microcirculation means blood flow to the extremely small blood vessels in the body. It will also look at the differences in microcirculation of participants who receive an infusion of phenylephrine compared to participants who don't. The investigators hypothesize that spinal anesthesia will reduce the vascular density and proportion of perfused vessels.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Physical Status I-II (ASA I - Healthy, ASA II - mild and controlled systemic disease)
* Singleton pregnancies
* 36-42 weeks gestation
* Non-labouring
* Scheduled cesarean delivery
* English speaking
* Age 18-45 years

Exclusion Criteria:

* Cardiovascular disease
* Hypertensive disease of pregnancy (i.e. mild \& severe preeclampsia)
* Allergy to phenylephrine, or any other standardized medication
* Obesity (BMI \> 35 kg/m2)
* Diabetes Mellitus type 1
* Smoker
* Coffee/Caffeine intake within 6 hours of SDF measurement
Self-compassion and Quality of Life After Dementia Diagnosis

This study aims to investigate whether self-compassion is associated with older adult's quality of life after a diagnosis of dementia, and whether perceived threat posed by dementia mediates this relationship. Self-compassion has been found to be positive in supporting individuals in times of difficulty, in adjustment processes and older adults' wellbeing. While different factors have begun to be identified which are associated with individuals' psychological wellbeing and adjustment following a dementia diagnosis, little is known about the influence of self-compassion.

Participants will be recruited via NHS memory clinics, Join Dementia Research and from the community via third-sector organisations. Individuals will be invited to attend a Microsoft Teams/telephone appointment in which informed consent and cognitive screening processes will take place at the start. Eligible participants will then be invited to continue to complete measures administered by a researcher and an interview question. Participants will be offered the opportunity to complete the measures in a second session (within 8 weeks) or using the online survey software, Qualtrics, if preferred.

A small pilot study (n = 5) will take place prior to the main study.


Eligibility Criteria:
Inclusion Criteria:

* An older adult aged ≥ 65 years
* A confirmed diagnosis of dementia received within the past 12 months
* They have knowledge of their diagnosis
* They have English language proficiency
* They have capacity to give informed consent to participation.

Exclusion Criteria:

* They are deemed to lack capacity to give informed consent to participate (as per the Mental Capacity Act, 2005).
* They have a diagnosis of early-onset dementia, defined as individuals who are aged \< 65 at diagnosis
* A score on the MoCA Blind (Nasreddine, 2022b) screening measure of \<7 out of 22, which is calculated as equivalent to \<10 out of 30 on the MoCA (Nasreddine et al., 2005).
Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055

The primary objective is to assess the safety and tolerability of AZD8055 in Japanese patients with advanced solid tumours.


Eligibility Criteria:
Inclusion Criteria:

* Japanese patients with advanced solid tumors for which suitable effective standard treatment does not exist or is no longer effective
* Relatively good overall health other than cancer

Exclusion Criteria:

* Poor bone marrow function (not producing enough blood cells)
* Poor liver or kidney function
* Serious concomitant illness
Effect of Injectable Platelet-Rich Fibrin (i-PRF) in Initial Treatment of Chronic Periodontitis

Current treatments of periodontitis have limited efficacy since they fail to suppress microorganisms satisfactorily over time. The aim of present study was to investigate whether there are differences between initial treatment of chronic periodontitis (SRP) and SRP in conjunction with injectable platelet-rich fibrin (i-PRF) application.

Current treatments of periodontitis have limited efficacy since they fail to suppress microorganisms satisfactorily over time. The aim of present study was to investigate whether there are differences between initial treatment of chronic periodontitis (SRP) and SRP in conjunction with injectable platelet-rich fibrin (i-PRF) application.

Thirty patients with chronic periodontitis who had at least two sites with perriodontal pocket depth (PPD) ≥ 4 mm on contralateral side will be involved in the study. Using a split-mouth design, patients will be treated with SRP + I-PRF -(test group) or SRP only-(control group). Gingival crevicular fluid (GCF) and subgingival plaque will be collected with paper points (DentsplyMaillefer, Tulsa, Oklahoma, USA) at baseline and 1, 3 and 6 months after the treatment. The presence and concentrations of Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Prevotella intermedia (Pi) and Tannerella forsythia(Tf) will be analyzed by real-time polymerase chain reaction (qPCR). Periodontal parameters, including bleeding on probing (BOP), probing pocket depth (PPD) and the clinical attachment level (CAL), will be recorded on both sides, as well as concentration of TNF-alpha (tumor necrosis factor alpha), ALP(alkaline phosphatase) and MMP-8 (matrix-metalloproteinase-8).

Eligibility Criteria:
Inclusion Criteria:

* A minimum of 6 teeth per quadrant;

  * A minimum of 2 teeth in each quadrant with a probing depth (PD) ≥5 mm;
  * Bleeding on probing (BOP) had to be at ≥40% tooth sites;
  * No involvement of furcation;
  * Good general health.

Exclusion Criteria:

* Periodontal therapy within last 12 months;

  * Having surgical therapy;
  * Use of antibiotics over the last 6 months;
  * Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis;
  * Pregnancy or nursing;
  * Current and former smokers.