cyrilzakka/clinical-trials huggingface dataset:
Relation of Carotid Artery Plaque Inflammation, Covert Stroke and White Matter Disease

The investigators hypothesize that inflammation in carotid plaque is predictive of the extent of ischemic lesion burden on the brain and will add to risk stratification for individuals with carotid disease.

Objectives:

1. To investigate the relationship of carotid inflammation, as measured by FDG positron emission tomography (PET) to standardized uptake value in atherosclerotic plaque, with the number of covert brain infarcts.
2. To investigate the relationship of FDG PET standardized uptake value with the relative volume of white matter hyperintensity.
3. To correlate vascular inflammation in the entire aorta and aortoiliac vessels to carotid inflammation and cerebral infarcts and white matter disease.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 or greater at time of enrollment
* Written informed consent from patient or legal representative
* Diagnosis of stroke or TIA made by a stroke specialist within 90 days and fulfilling the following criteria:
* A TIA must involve a focal speech/language, motor or visual deficit (transient monocular blindness, amaurosis fugax) referable to the distribution of a carotid artery and lasting less than 24 hours.
* A stroke consisting of deficits as noted above with duration greater than 24 hours and/or confirmed on cerebral imaging. Post event Modified Rankin Score of 2 or less.
* Stroke meets the Trial of ORG 10172 in Acute Stroke Treatment (TOAST) criteria for large artery atherosclerosis
* Carotid Doppler, CTA or MRA confirming the presence of bilateral atherosclerotic disease resulting in carotid stenosis of any degree. Stenosis will be measured following the method used in NASCET for CTA and MRA. Carotid Doppler measurements will follow the criteria defined by the Society for Ultrasound consensus conference.
* 12 lead ECG or Holter monitor confirming the absence of atrial fibrillation.

Exclusion Criteria:

* TIA or stroke in the vertebrobasilar system
* Index event was primary hemorrhage
* History of intermittent atrial fibrillation
* Cardiac source of embolus suspected as cause of index event (artificial valve, segmental or global LV dysfunction, congenital cardiac defect)
* Diagnosis of vasculitis, dissection, or non-atherosclerotic carotid disease (Ehlers-Danlos, Marfans)
* Sinovenous thrombosis, endocarditis or hypercoagulable state
* Pacemaker, ICD or other contraindications to MRI
* Diminished Kidney Function
* Contraindication to radiation exposure (eg: pregnancy)
* Severe Claustrophobia
Functional Massage of Teres Major Muscle

Purpose: Subacromial impingement syndrome is the most common shoulder condition. Myofascial trigger points in teres major muscle can be associated with this syndrome. The investigators objective is to find out if adding manual therapy specifically for teres major trigger points can produce better results in these patients.

Method: A randomized controlled pilot study was carried out. Fifty people were randomly assigned to one of two groups: intervention group or control group. Both groups received a protocolized physical therapy treatment while the intervention group additionally received manual therapy for teres major trigger points.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and over
* Clinical diagnosis of Subacromial Impingement Syndrome.
* Detectable trigger points in teres major muscle.
* Sign informed consent form.

Exclusion Criteria:

* Presence of wounds or cutaneous alterations in the shoulder region
* Previous surgery in the shoulder
* Presence of acute inflammatory process in the shoulder (\< 7 days),
* Being involved in litigation or compensation processes
* Not having a domain of the language that could make the informed consent not understandable.
Individualized NUTRItional RISK and Oriented Nutritional Support

The objective of this study is to evaluate whether, in patients who are given early nutritional counseling, there is a reduction in the length of hospitalization and the rate of nosocomial infections, resulting in a decrease in inpatient costs, compared with patients who do not benefit from this intervention.

Patients admitted from the date following the date of approval of the protocol for the following 12 months will be enrolled at the Departmental Simple Operating Unit Admission Room of the Policlinico Universitario A. Gemelli and who have undergone NRS-2002 screening.

Data only of patients with NRS-2002 \> 3 admitted will be considered and extracted via the Foundation's computer system (Trackcare).

Patients will be managed by caregivers who spontaneously request (as is the case to date) nutritional counseling. Therefore, the study will not change current clinical practice.

Two cohorts will be formed and compared:

Cohort 1: patients at risk of malnutrition (NRS-2002 ≥ 3) who received clinical nutrition counseling within 72 hours of ward admission.

Cohort 2: patients at risk of malnutrition (NRS-2002 ≥ 3) who did NOT receive clinical nutrition counseling beyond 72 hours after ward admission.

Currently, at Fondazione Policlinico Universitario A. Gemelli, the Clinical Nutrition Unit is approached on an ad hoc basis by the individual ward attending physician, without a specific procedure: the physician calls in Clinical Nutrition specialists for consultation if in his or her judgment the patient needs nutritional support. The formation of the two cohorts will be entirely spontaneous, that is, according to current clinical practice, given by the judgment of the ward treating physician. In a spontaneous manner, two cohorts will be formed among patients at risk of malnutrition (NRS-2002 ≥ 3), one of which will have received specialized nutritional support within 72 hours, the other will not. Only patients at risk of malnutrition will be tracked, highlighting outcomes among those in this category who received the targeted intervention at the appropriate times, versus those who did not. The enrollment department is the same for all patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* NRS-2002 ≥3
* Length of stay \> 4 days
* Informed consent to participate in the study

Exclusion Criteria:

* NRS-2002 \<3
* Length of stay \< or = 4 days
* Absence of informed consent
Validation of Existing Diabetes Risk Models in a Swedish Population

The goal of this observational study is to validate existing non-invasive diabetes clinical prediction models in a Swedish population. The main question it aims to answer is: how well 11 existing models will perform in predicting incident type 2 diabetes in participants from the Västerbotten Intervention programme (VIP). Participants in VIP are residents of Västerbotten that are invited for a comprehensive health screening at 30- (until 1995), 40-, 50-, and 60-years of age.

Several type 2 diabetes risk prediction models have been developed but how it will perform in a Swedish population is not known. No diabetes risk prediction model is routinely used in Sweden. The aim of this study is therefore, to validate 11 non-invasive models and to evaluate the performance to predict incident type 2 diabetes in a Swedish population. A population-based cohort from the Västerbotten Intervention programme (VIP) from 1990 to 2020 will be the validation sample. Incident type 2 diabetes within 10-years of follow-up, will be determined by oral glucose tolerance test or through self-reports. A self-administered questionnaire is completed, and anthropometric, clinical, and biochemical measures are obtained at each of the health screening visits. In the statistical analysis the overall performance of the models will be compared using the Brier score. In addition. discrimination and calibration of all the models will be evaluated. Recalibration of models will be done.

Eligibility Criteria:
Inclusion Criteria:

• At least one visit within the Västerbotten Intervention program

Exclusion Criteria:

• Prevalent diabetes at first visit defined by a fasting capillary plasma glucose \>7mmol/L, a 2-hour capillary plasma glucose of ≥12.2 mmol/L or self-reported history of diabetes
Comparison of Orthodontic Molar Protraction with and Without Adjunctive Surgery

This study will compare orthodontic molar protraction with and without adjunctive periodontally accelerated osteogenic orthodontic (PAOO) surgery prior to orthodontic tooth movement.

To the investigators' knowledge, this type of molar retraction in adult patients has not been compared with and without the adjunctive use of PAOO for differences in clinical linear tooth movement and patient centered outcomes (discomfort, change in daily activities, satisfaction with esthetic outcomes) in a controlled study.

Research data and daily clinical observations reveal that molar protraction (forward movement) in adult patients may be prolonged and ideal outcomes may not be achieved with traditional orthodontic tooth movement. One method for enhancing orthodontic tooth movement is the use of surgical access of the local site to initiate a regional tissue reaction to induce trauma, which leads to a limited inflammatory healing process. This process is also known as regional acceleratory phenomenon (RAP), which allows for more rapid bone turnover and has been shown in other protocols to enhance orthodontic tooth movement. While PAOO has been shown to rapidly increase tooth movement, to our knowledge, localized use of PAOO in combination with molar protraction in adults has not been evaluated in a prospective trial for differences in clinical outcomes (tooth movement time, adverse orthodontic outcomes, periodontal and soft tissue defects) and patient-centered outcomes (pain, swelling, change in daily activities, patient assessment of surgical benefit, and patient-assessed esthetics) in a controlled study.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* At least 18 years old
* Must be a patient of the University of Alabama at Birmingham (UAB) Dental School
* Able to read and understand informed consent document
* One or more nonadjacent 1st or 2nd molar teeth that require protraction of ≥ 5 mm in patients undergoing orthodontic tooth movement
* Presence of periodontally healthy, non-carious neighboring teeth, healthy implants or edentulous ridges on either side of the involved site(s)
* No anticipated need for restorative care at the teeth to be treated during the study period.

Exclusion Criteria:

* Non-English speaking
* Less than 18 years old
* Smokers/tobacco users (\>10 cigarettes/day)
* Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
* Presence of active periodontal disease, caries, and/or periapical pathology at teeth to be moved orthodontically
* Previous orthodontic therapy involving molar protraction of teeth to be treated
* Previous periodontal surgery at site(s) to be treated
Prediction Model of Cardiac Risk for Dental Extraction in Elderly Patients With Cardiovascular Diseases

This study intends to investigate the relevant risk factors of perioperation complications or mortality in older patients with cardiac diseases undergoing teeth extraction surgery and this study aims to quantify the risk factors and then to establish the predictive scoring systems.

Hypothesis:Preoperative parameters could predict postoperative complications.

This study intends to investigate the relevant risk factors of perioperative complications or mortality in older patients with cardiac diseases undergoing teeth extraction surgery and this study aims to quantify the risk factors and then to establish the predictive scoring systems.

We hope that the benefits will include less patients becoming seriously postoperative complications and mortality after teeth extraction surgery.We also hope the information will help doctors understand the preoperative risks better and therefore make better informed decisions.This may also reduce the overall cost of surgery for patients and hospitals.

Eligibility Criteria:
Inclusion Criteria:1.Adults ≥60 years age 2.Males with cardiac diseases 3.Females with cardiac diseases 4.Listed for teeth extraction surgery

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Exclusion Criteria:

* 1.patient with malignant arrhythmia 2.Age \<60 years age 3.Adults with learning disabilities or dementia 4.Patient unwilling/unable to consent 5.Prisoners
Mechanical Ventilation Epidemiology in Argentina.

How is the epidemiology of mechanically ventilated patients in the intensive care units of Argentina?

Mechanical ventilation is an indispensable tool in life support and one of the interventions that characterizes intensive care units (ICU).

Epidemiological studies have allowed us to improve knowledge and optimize the treatment of patients with acute respiratory failure.

In Latin America the epidemiological data of mechanical ventilation is poor.

Primary goal of this national, observational, prospective, multicentric epidemiological study: to analyze the survival and describe epidemiological features of patients receiving mechanical ventilation in the Intensive Care Units of Argentina.

Eligibility Criteria:
Inclusion Criteria:

* ICU patients requiring Mechanical Ventilation at least for 12 hours
* ICU patients who initiate Mechanical Ventilation in the Operation Room or the Emergency Room
* ICU patients who initiate Mechanical Ventilation in other institution.

Exclusion Criteria:

* Patients under 18 years old
* Patients in Pediatric ICU
* Patients in Coronary ICU
* Patients without requirements of Mechanical Ventilation
* Patients who have been discharged from ICU and re-enter during the enrollment period
MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)

A study to evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patient is highly unlikely to conceive
* Patient meets one of the 3 categories is naïve to all antihyperglycemic agent (AHA) therapies, or is non-naïve based upon the patient's current diet, medical regimen and screening A1c patient is currently not on AHA with a screening A1c \>=7.5 % and =\<11.0 % patient is currently on either metformin pr sulfonylurea monotherapy with a screening A1c \>=7.0 % and =\<9.0 %

Exclusion Criteria

* Patient has a history of type 1 diabetes mellitus or history of ketoacidosis or has C=peptide value of =\<0.8 ng/mL
* Patient has previously been treated with insulin, thiazolidinedione (TZD) (rosiglitazone or pioglitazone), any Dipeptidyl peptidase-4 (DPP-4) inhibitor (sitagliptin, vildagliptin, or alogliptin), exenatide or has previously been in a clinical study with any DPP-4 inhibitor or incretin mimetic
* Patient is on a weight loss program and is not in the maintenance phase or has started a weight loss medication (e.g. orlistat or sibutramine) within the prior 8 weeks
* Patient has undergone surgery within the prior 30 days or has major surgery planned during the study
* Patient has a medical history of active liver disease including chronic active hepatitis B or C or symptomatic gallbladder disease including primary biliary cirrhosis
* Patient has received treatment with an investigational product within 12 weeks prior to Visit 1
Gastrointestinal Tolerance, Satiation and Sensory Acceptance of Yogurts Containing Dietary Fiber and Coffee Cascara Extract

Coffee processing byproducts, such as coffee cascara (outer skin and pulp of the coffee berry), have potential health promoting properties due to the presence of bioactive compounds. Its use as a novel food ingredient is a means of valorizing this fractioin in the elaboration of functional yogurts. The addition of cascara extract in yogurt affects its texture quality. The addition of dietary fiber can help regain the structure of the yogurt's gel. However, secondary gastrointestinal effects associated with acute fiber ingestion must be considered.The aim of this clinical trial is to study the gastrointestinal tolerance, satiation and sensory acceptance of yogurts containing both coffee cascara extract and different doses of commercial soluble dietary fiber.

Forty healthy volunteers will be recruited and distributed into 4 groups following a randomized, blind, crossover design. Yogurt formulations will be administered two hours after the ingestion of a standardized breakfast, as a snack. Yogurt formulations include:

* Control cascara yogurt with 0% dietary fiber.
* Cascara yogurt with 3% dietary fiber.
* Cascara yogurt with 7% dietary fiber.
* Cascara yogurt with 13% dietary fiber.

The study will be conducted in 4 sessions, with at least 48h of washout period between treatment days. Data on gastrointestinal tolerance, satiation and sensory acceptance will be taken on the same day of the treatment using online surveys.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers.

Exclusion Criteria:

* Food allergies.
* Lactose intolerant.
* Allergic to milk proteins.
* Diagnosed gastrointestinal disease.
* Pregnant, trying to become pregnant or breast feeding.
* Caffeine sensibility.
* Dietary fiber intolerance.
Korea Post Marketing Surveillance (PMS) Study of Vizimpro

Vizimpro will be approved for the treatment of EGFR NSLCL 1L in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with Vizimpro after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of Vizimpro will be observed.


Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. Vizimpro® naïve patients to whom Vizimpro® can be prescribed as per the local labeling (the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations
2. Evidence of a signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study

Exclusion criteria

Patients meeting any of the following criteria will not be included in the study:

1. Patients to whom Vizimpro® is contraindicated as per the local labeling. A. Hypersensitivity to the active substance or to any of the excipients of this product.

   B. This medicinal product contains lactose. Patients with rare hereditary conditions of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
2. Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information.
Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques

The purpose of this research is to assess the severity of tricuspid regurgitation (a disorder in which the tricuspid valve in the heart does not close tight enough) using cardiac magnetic resonance imaging (MRI).

40 patients with moderate or more TR on echocardiography will undergo CMR/MRE with contrast to assess TR severity, and the associated extra-valvular cardiac and liver abnormalities as shown in the flow diagram below. Patients will continue their clinical management by their primary physicians as per the standards of care. 1-year follow up will be conducted via phone to inquire about patient's vital status (dead/alive), symptoms and hospitalizations.

Eligibility Criteria:
Inclusion Criteria:

* Moderate or more tricuspid regurgitation

Exclusion Criteria:

1. Prior tricuspid valve prosthesis
2. Pacemaker/defibrillator that would impede MRI imaging
3. Planned tricuspid valve surgery
4. Primary liver pathology
Acridine Carboxamide in Treating Patients With Recurrent Glioblastoma Multiforme

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of acridine carboxamide in treating patients who have recurrent glioblastoma multiforme.

OBJECTIVES: I. Determine the efficacy acridine carboxzmide in terms of objective response rate and response duration in patients with glioblastoma multiforme. II. Determine the toxicities of this treatment regimen in this patient population.

OUTLINE: This is a multicenter study. Patients receive acridine carboxamide IV continuously over days 1-5. Treatment repeats every 3 weeks for at least 2 courses and up to a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent glioblastoma multiforme Measurable disease on contrast MRI Lesion at least 2 cm in diameter

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN Transaminases no greater than 2 times ULN Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: Normal cardiac function No ischemic heart disease within the past 6 months Normal electrocardiogram Other: No unstable systemic diseases No active uncontrolled infections No prior or other concurrent malignancies except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix No psychological, familial, sociological, or geographical condition that would preclude study Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since prior adjuvant chemotherapy for brain tumor No other prior chemotherapy Endocrine therapy: Must be on stable or decreasing doses of corticosteroids for at least 2 weeks Radiotherapy: At least 3 months since prior radiotherapy to the brain No prior high dose radiotherapy No prior stereotactic boost or implant radiotherapy Surgery: No prior surgery (except biopsy) for recurrent brain tumor At least 3 months since prior surgery for primary brain tumor Other: No other concurrent anticancer agents No other concurrent investigational therapy