cyrilzakka/clinical-trials huggingface dataset:
Impact of 100mL Lipid Emulsion for Intravenous for Suppression of Myocardial Glucose Metabolism in 18F-FDG PET/CT

There is increasing evidence that \[18F\]-2-fluoro-2-deoxy-D-glucose (18F-FDG) PET/CT is useful in the identification and treatment of disease processes that involve cardiac inflammation and infection. Current applications include imaging intra-cardiac device and prosthetic valve infections, evaluating patients with known or suspected cardiac sarcoidosis or other inflammatory cardiomyopathies.

However, because normal myocardium can metabolize both glucose and free fatty acids (FFAs), physiological accumulation of FDG in the myocardium can interfere with the recognition of abnormal FDG uptake.

The use of a low-carbohydrate diet with a prolonged fast ≥ 12 h nutrition followed by a fast of at least four hours is the effective preparation recommended to suppress physiological myocardial FDG uptake.

However, the rate of suppression of physiological accumulation of FDG with this method in our center is only 50%.

Methodology :

Group of 30 consecutive patients with cardiac FDG PET prescribed, prospectively enrolled, compared to a group with the last 30 patients referred for cardiac FDG PET in the nuclear medicine department of the Centre Hospitalier Princesse Grace.

Procedures :

Infusion of 100mL lipid emulsion for intravenous two hours before cardiac FDG PET/CT:

* Infusion rate will be 20 mL/hour during the initial 10 minutes (3 mL Intralipid)
* The dose will be then increased to 40 mL/hour for the next 10 minutes (6 mL Intralipid)
* Finally, for the next 50 minutes the dose will be increased to 100 mL/hour (83mL Intralipid)

Eligibility Criteria:
Inclusion Criteria:

* Patients with an FDG PET/CT prescribed to explore cardiac disease process

Exclusion Criteria:

* renal insufficiency,
* uncompensated diabetes mellitus,
* pancreatitis,
* liver insufficiency,
* hypothyroidism
* metabolic disorders
* sepsis.
* soy protein allergy
Conventional, Overdenture and Palateless Overdenture Oral Health Impact Comparison Study

This study will identify and enroll patients already scheduled to receive guided maxillary implant placement with palateless overdenture. Standard clinical practice will be followed for this multi-stage process. The study purpose is to evaluate the degree of satisfaction during the standard progression in order to determine at which post edentulous stage patients achieve maximum satisfaction using the Oral Health Impact Profile 49 (OHIP 49).

The OHIP 49 will be administered at pre-treatment (edentulous condition) and after each visit (i.e., newly fabricated conventional denture, conversion to a 4 implant retained overdenture and finally a 4 implant retained palateless overdenture). Additionally they will be recalled yearly for 5 years.

Participants will have an interim denture fabricated to be worn for 10-12 weeks. During this time, participants will have 4 implants placed and continue wearing the interim denture. At 8 weeks after implant placement, participants will have locator attachments placed on implants and the interim denture snapped into place, termed the 'overdenture.' After 10-12 weeks of wearing this overdenture, patients will receive a new denture, termed 'final palateless overdenture,' which consists of a denture snapped into the 4 implants without a palate. Participants will be evaluated at a 10-12 week followup from insertion of this prosthesis. Participants will complete questionnaires at each stage of treatment.

One year after delivery of the final palateless overdenture and for five consecutive years patients will be asked to return for a follow up appointment.

Estimated duration of patient participation is approximately 5 years and 8 months (271 weeks). Estimated time for active clinical treatment is 8 months (32 weeks) with understanding of flexibility based on laboratory fabricated denture frameworks and adjustments needed for approval of esthetics.

Eligibility Criteria:
Inclusion Criteria:

* Capable of giving informed consent
* Able and willing to follow study procedures and instructions
* In good general health
* Edentulous in maxillary arch for a period of at least 6 months
* Have adequate bone volume present to place four maxillary implants without necessity of sinus augmentation or hard and soft tissue grafting ( as determined by the investigator following panoramic radiograph acquisition)

Exclusion Criteria:

* ASA (American Society of Anesthesiologists) Class 3+
* Immunocompromised (Including HIV infection)
* Current drug abuse (self-reported as part of the School of Dentistry health history
* Pregnant or plans to be pregnant at any point during trial
* History of IV or oral bisphosphonate use contraindicating dental implant therapy
* Chronic disease with oral manifestations
* Exhibit Oral pathology
* Ongoing medications initiated less than three months prior to enrollment (medications for chronic medical conditions must be initiated at least three months prior to enrollment.)
* Smoker within the past 6 months
* Diabetes
* Known allergies to any materials used in denture fabrication or implant surgery
Medroxyprogesterone +/- Cyclophosphamide & Methotrexate in Hormone Receptor-Negative Recurrent/Metastatic Breast Cancer

The purpose of this study is to evaluate the impact of MPA alone and in combination with low dose oral chemotherapy in patients with ER- and PR- advanced breast cancer.

PRIMARY OBJECTIVES:

I. To determine the clinical benefit rate (complete response \[CR\] + partial response \[PR\] + stable disease \[SD\] \>= 6 months) of medroxyprogesterone acetate (MPA) monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer.

SECONDARY OBJECTIVES:

I. To evaluate the toxicity of MPA and MPA + ldoCM in this patient population. II. To explore the relationship between MPA trough level and clinical benefit. III. To explore genetic determinants of MPA bioavailability and trough concentration.

IV. To explore potential surrogates of biologic activity including Nm-23 expression in primary tumor, change in Nm-23 expression in skin, change in plasma thrombospondin (TSP)-1, change in plasma plasminogen activator inhibitor (PAI)-1 antigen and activity.

OUTLINE: Patients are assigned to 1 of 2 treatment arms.

COHORT I: Patients receive MPA orally (PO) once daily (QD).

COHORT II: Patients receive MPA as in Cohort I, cyclophosphamide PO QD, and methotrexate PO twice daily (BID) on days 1 and 2 of every week.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the breast with measurable locally recurrent or metastatic disease
* Primary tumor must be ER negative and PR negative
* Patients must be post-menopausal
* Patients may have had up to 3 prior chemotherapy regimens for recurrent/metastatic disease
* Adequate organ function as evidenced by laboratory studies outlined in section 3.6 of the protocol
* Patients with treated, asymptomatic brain metastases are eligible provided chronic steroid therapy is not required

Exclusion Criteria:

* Patients must not have extensive pleural effusion or ascites
* Patients must not have history of DVT or pulmonary embolism w/in past 12 mo
* Patients must not have had chemotherapy or hormonal therapy within 2 weeks of study entry
* Patients must not have had radiation therapy within 1 week of study entry.
Measuring Self-Efficacy on Portuguese Respiratory Patients on Pulmonary Rehabilitation

This study aimed to translate and adapt to portuguese an original british instrument useful to measure respiratory patients' self-efficacy specific to the context of Pulmonary Rehabilitation.

Recent updates on Pulmonary Rehabilitation highlight the importance of patients' self-efficacy on long-term adherence to health-enhancing behaviors. The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) is an adaptation of the General Self-Efficacy Scale. This study aimed to translate, culturally adapt and evaluate reliability and validity of PRAISE on Portuguese respiratory patients.Forward-backward translation and pilot testing were performed. Content validity was assessed by a multidisciplinary panel of expert judges. To evaluate reliability and validity, 150 respiratory outpatients on Pulmonary Rehabilitation participated on a cross-sectional study. Descriptive and reliability analyses, and exploratory factorial analysis using principal axis factoring, followed by oblique oblimin factor rotation were conducted to identify construct validity. IBM® SPSS® version 22 was used to perform statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute respiratory disease
* Patients with chronic respiratory disease
* Patients attending a hospital-based Pulmonary Rehabilitation program

Exclusion Criteria:

• Cognitive deficit for answering a questionnaire
Evaluation of the GTX™ 5126 DES Coronary Stent System in the Treatment of Patients With a Lesion in the Coronary Artery

The GTX™ Drug Eluting Coronary Stent System is intended for the treatment of patients with a lesion in the coronary artery.


Eligibility Criteria:
Key Inclusion Criteria:

* Patient has discrete de novo lesion of a coronary artery with symptomatic ischemic heart disease
* Planned treatment of one lesion with a single stent
* Denovo type A, B1 lesions with a Reference diameter between 3.0 and 3.5mm and a lesion length between 5 and 16mm

Key Exclusion Criteria:

* Diabetic (HbA1C \>6.0)
* Platelet count \< 100000 cells/mm3 or \> 700000 cells/mm3; WBC \< 3000 cells/mm3; or a hemoglobin \< 10 g/dl
* Renal dysfunction with creatinine \> 2.0 mg/dl
* Patient has a known pre-dilatation ejection fraction (EF) less than forty five (\<45%)
* Myocardial infarction (MI) less than 3 months prior to intervention
* Patient has type B2, C lesion
* Reference artery diameter \<3.0 or \>3.6 mm
* Target lesion length \< 5mm and \>16 mm
* Other stenosis \>50% in target vessel
* Known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, or cobalt chromium, or a sensitivity to contrast agent that, in the opinion of the investigator, cannot be adequately premedicated.
Youth Empowerment Solutions for Peaceful Communities

This project is an evaluation of an intervention to involve youth in creating community change for peace promotion and violence prevention. The intervention, Youth Empowerment Solutions for Peaceful Communities (YES), includes three components: youth empowerment activities, neighborhood organization development, and community development projects that involve youth and organizations working together.

Hypothesis 1: Efforts to engage youth in the community change process will enhance their attachment to their community, reduce their problem behaviors, and begin to change norms among their peers about community violence and interpersonal problem solving.

Hypothesis 2: Efforts to make community-based organizations more youth-friendly and engaging will assist them to be more effective in reaching their community enhancement goals and will expand youth involvement in their mission.

Hypothesis 3: Efforts to create more health-enhancing land use (e.g., beautification, community gardens, parks development) will improve social organization (e.g., social capital, social cohesion, and social support), and reduce the level of violent incidents and crime in the community.

The program will focus on youth and neighborhood organizations in one middle-school attendance area. A nearby middle-school attendance area will serve as a comparison community. We will assess change in community norms, fear, social cohesion and social capital using an existing community survey of adults in the two neighborhoods. A similar survey will assess changes in youths' social norms, fears, perceptions of social cohesion and social capital, as well as their violent behavior and ethnic identity and pride. We will also compare the intervention and comparison neighborhoods on several community-level measures including police incident data, hospital injury reports, school suspension data, and ratings of neighborhood qualities (e.g., vacant lots, community gardens, social interaction).

The long-term goals of YES are to:

1. modify environmental conditions that contribute to youth violence;
2. promote social norms supportive of community participation and nonviolence;
3. increase perceptions of neighborhood safety among residents; and
4. reduce the incidence of youth violence perpetration and victimization.

Eligibility Criteria:
Inclusion Criteria:

* 7th and 8th graders in the intervention middle-school attendance area
* Neighborhood organizations with at least 10 members serving the intervention middle-school attendance area

Exclusion Criteria:

* Students who have been suspended or expelled during the intervention period
* Neighborhood organizations that serve areas in both the intervention and comparison areas.
Portable Ultrasound to Predict Heart Failure Readmission Risk

The purpose of this research is to use a handheld ultrasound to assess patients with congestive heart failure (CHF) to see if the ultrasound can help predict readmission to the hospital. The study will include patients who are admitted to the hospital for CHF. Participants will have two ultrasounds at hospital discharge and at a follow up visit.

The purpose of this research is to see if a portable ultrasound can help predict readmission to the hospital for patients who are admitted to the hospital for CHF. The study will enroll patients who take part in Mobile Integrated Healthcare as part of their routine care. Participants will have two ultrasounds. The first ultrasound will be at hospital discharge.

Between seven to ten days after hospital discharge participants will be visited at their home in follow-up as the usual standard of care for Mobile Integrated Healthcare. At this visit participants will have a second ultrasound. Participants will be followed for one year for hospital readmission.

Eligibility Criteria:
Inclusion Criteria:

* Primary admission diagnosis is listed as congestive heart failure, with an acute component of decompensation.
* Age greater than 18 years.
* Principal residence within the geographic reach of our MIH program.

Exclusion Criteria:

* pregnant women
rTMS Combined With BWSTT in Stroke With Body Weight Supported Treadmill Training (BWSTT) After Stroke

The study will enroll 5 individuals post-stroke to examine the feasibility and efficacy of a high frequency repetitive transcranial magnetic stimulation (rTMS) combined with body weight supported treadmill training.

The purpose of this pilot study is to examine the feasibility and efficacy of 5Hz repetitive transcranial magnetic stimulation (rTMS) applied to bilateral motor areas as an adjuvant intervention to task-specific body weight supported treadmill training (BWSTT) in individuals with subacute stroke.

Five individuals with a diagnosis of subacute stroke will be recruited and assigned to either high frequency or sham rTMS group.Both groups will receive a comprehensive assessment of their motor function, gait performance and neurophysiological function before the training. Both groups will then go through a 10 week (24 sessions) of gait training with body weight supported treadmill. For the high frequency rTMS group, they will receive 5 Hz rTMS applied to bilateral motor areas prior to each gait training session. For the sham rTMS group, they will receive a sham stimulation prior to the gait training sessions. All participants will receive another comprehensive assessment after the training concludes. The assessor will be blinded to the intervention.

Eligibility Criteria:
Inclusion Criteria:

1. 18-80 years old
2. \< 2 months post stroke at the time of enrollment
3. first time stroke:
4. able to walk \> 25 feet with or without assistive device and with no more than moderate assistance:
5. able to follow 1-step commands
6. able to communicate verbally

Exclusion Criteria:

1. severe medical problems (e.g. recent cardiac infarct, heart failure, cancer)
2. presence of conditions that could affect gait training (e.g. amputation, severe arthritis)
3. bilateral stroke
4. non-ambulatory prior to stroke
5. BMI \> 40
6. any contraindications to TMS (e.g. history of seizure, cardiac pacemaker, metal or magnetic implants)
7. pregnant or potentially to be pregnant
Testing a New App for Children With Glue Ear

To assess whether children with glue ear ( and some normal hearing controls) and their families find the Hear Glue Ear application acceptable and easy to use. Whether the hearing screening section on the app is comparable to the hearing test data obtained from formal audiology hearing tests.

The Hear Glue Ear application aims to provide up-to-date information for families as well as audiobooks, songs and games for children with hearing loss secondary to glue ear, to be able to aid with their developmental skills (particularly speech, language, auditory processing, auditory memory and listening skills) during the period of time when they have glue ear.

Outcome measures include acceptability of the application by the family (provided by questionnaires to the child and an adult parent/ carer), usability of the app (a member of the research team will observe the child using the app and how much difficulty they have such as how many times the researcher has to help/ intervene) and comparison of the hearing screen on the app with formal audiology hearing test result.

Eligibility Criteria:
Inclusion Criteria:

* aged 2-8 years old
* had a formal hearing test at Cambridge audiology clinic and has a diagnosis of gluem ear worse than 25dB at more than 1 frequency or nornmal hearing diagnosed where 20dB or better is recorded at 0.5, 1, 2, 4 KHz

Exclusion Criteria:

* permanent hearing loss
* English not a dominant language (since the app is written in English)
Visceral Adiposity Index and Overactive Bladder

In present study, we aimed to investigate the association between visceral adiposity index and overactive bladder symptoms in female patients aged over 18 years.Between January-2015 and July-2017, 151 female patient with overactive bladder symptoms were evaluated in Recep Tayyip Erdogan University Training and Research Hospital Urology Department. Antropometric and laboratory features including serum lipid levels, AST, ALT, fasting glucose levels, and also urodynamic findings were recorded. Visceral adiposity index was calculated according to gender-specific formula. Participants were divided into two groups according to 7,55 cut-off level for visceral adiposity index levels. Statistical significance were discussed between two groups.

Antropometric and laboratory features including serum lipid levels, AST, ALT, fasting glucose levels were recorded. Urodynamic study was performed all of patients to evaluate bladder functions. Over active bladder questionnaire-8 Turkish validated short form was filled out and recorded for each patients. Detailed medical histories of all patients were obtained before the study. Height, weight, and waist circumference (WC) were measured with the subjects in their underwear. Body mass ındex (BMI) was computed by the formula as the ratio of weight to the square of height (kg/m2). WC was measured on the line between the iliac crest and the lower costal margin parallel to the ground after subjects exhaled. Inclusion criteria of study was female patients who have over active bladder symptomes with or without urinary incontinence. Exclusion criterias of study were male gender, pregnancy, alcohol intake, bladder cancer history, previous incontinence surgery history, presence of neurological disease, urinary infection or bladder stone and pelvic radiotherapy history.

Eligibility Criteria:
Inclusion Criteria:

* Female patients over 18 years aged with overactive bladder symptoms

Exclusion Criteria:

* Male gender, pregnancy, alcohol intake, bladder cancer history, previous incontinence surgery history, presence of neurological disease, urinary infection or bladder stone and pelvic radiotherapy history
Effect of Probiotics on Lipid Management

Dysbiosis of gut microbiota has been reported to be involved in the development of hypercholesterolemia in both humans and animal models. Probiotics have been reported to have ameliorative effects in murine models. However, whether probiotics could help alleviate dyslipidemia in adults remain obscure.

Probiotics are live microorganisms that have been associated with multiple health benefits. However, its protective role in adults has long been controversial. This study aims to examine the effect of 12-week probiotics supplementation on lipid management in Chinese adults. By understanding the mechanism by which probiotics exert the beneficial effects, we can better control the rising prevalence of hypercholesterolemia, which is a major risk factor for cardiovascular diseases.

Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects include men and women 18 to 75 years of age with primary hypercholesterolemia who has a total cholesterol level of 5.18 mmol/L or higher and/ or an LDL cholesterol level of 2.59 mmol/L or higher;
* Absence of any diet, dietary supplement and medication that might interfere with lipid homoeostasis and gut microbiota, especially antibiotics and probiotics.

Exclusion Criteria:

* Triglyceride levels higher than 3.95 mmol/L, or any other systemic, metabolic and cardiovascular or cerebrovascular diseases;
* Type 1 diabetes, type 2 diabetes treated with insulin or other medications;
* Acute illness or current evidence of acute or chronic inflammatory or infective diseases;
* Participation in any diet or lifestyle program more than 2 times per week in the latest 3 months prior to recruitment;
* Mental illness rendering them unable to understand the nature, scope, and possible consequences of the study.
Pharmacogenetics of Response to Sitagliptin (PRS)

This is a research study to find out how different people respond to a medication called sitagliptin. Sitagliptin is an FDA approved medication that is used to treat diabetes. We are asking for healthy, non-diabetic volunteers to participate in this 7-week study. If you agree to participate, you will take part in 2 clinic visits that are 4-6 weeks apart. At the clinic visits you will have an oral glucose tolerance test (OGTT) and other blood tests to see how your body processes glucose (sugar). An OGTT is a test in which your drink glucose and then blood samples are taken afterward at specific time points to measure glucose and insulin in your blood. Each clinic visit will last about 5 hours.


Eligibility Criteria:
Inclusion Criteria:

* • Age: \&gt;18 years old

  * Members of Old Order Amish community in Lancaster, PA

Exclusion Criteria:

* • Pregnancy (reproductive age women will undergo pregnancy tests immediately before receiving the drug)

  * Diabetes: HbA1c \&gt; 6.5% or fasting plasma glucose \&gt;126 mg/dL
  * Estimated glomerular filtration rates (eGFR) \&lt;60 mL/min/1.73 m2
  * Anemia: hematocrit \&lt; 35%
  * Thyroid status: TSH\&lt;0.4 or TSH\&gt;5.5
  * ALT or AST in excess of 2X upper limit of normal
  * Drugs that in the physician's judgment would alter response to sitagliptin
  * Significant health issues that in the physician's judgment could increase the risk for participants.
Safety and Efficacy Study of ONGLYZA (Saxagliptin) Under Conditions of Actual Use

This post marketing surveillance study aims to monitor the safety and efficacy of ONGLYZA under conditions of actual use in patients who are diagnosed with diabetes mellitus type 2 and are prescribed ONGLYZA by their physician.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 2 Diabetes Mellitus
* Prescribed Saxagliptin by patient's attending physician

Exclusion Criteria:

* Known allergic or serious adverse reaction to Saxagliptin
* Pregnant or breastfeeding patients