cyrilzakka/clinical-trials huggingface dataset:
Feasibility Study for Imaging of Peripheral Tumors With a High-Resolution PET Imaging System

The goal of this clinical research study is to learn if using the PEMFlex Solo II, a high-resolution camera for PET scan imaging, on an area of the body that has, or is suspected to have cancer will give researchers the same or better information about the disease compared to the images taken with a routine PET/CT.

Researchers will compare the images taken using the PEMFlex Solo II to the images taken during your scheduled routine PET/CT scan, as well as any additional routine CT scan(s), magnetic resonance imaging (MRI) scan(s), and/or ultrasound image(s) you may have had within the last 30 days or may have in the next 30 days.

If you agree to take part in this study, right after your already-scheduled routine PET/CT scan is complete, a study staff member will take you to a separate imaging room located in the same clinic area where your routine PET/CT scan was just performed.

You will then sit in a chair as a study staff member positions the PEMFlex Solo II on either side of the area being checked for cancer. It will take about 20 minutes to set up the PEMFlex Solo II and take the PET scan images.

Length of Study:

After the PET scan images have been taken using the PEMFlex Solo II, your participation in this study will be over.

This is an investigational study. The PEMFlex Solo II is commercially available and designed for PET scan imaging of the breast. The use of the PEMFlex Solo II for imaging other parts of the body is investigational.

Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. A signed informed consent.
2. Known or suspected primary or metastatic lesion of the extremities, head or neck as determined by biopsy, physical examination or noninvasive imaging studies including plain films, CT, MR, ultrasound or nuclear medicine imaging.
3. Scheduled for routine clinical imaging at the ACB PET/CT facility.
4. Participant must be at least 18 years of age.

Exclusion Criteria:

1. Uncontrolled blood glucose levels (\>200 mg/dl).
2. Patient is unable to comprehend the requirements of the study.
3. Patient is unable to undergo scanning of the known or suspected lesion with the high-resolution PEM (PET) scanner (due to body habitus, inability to comply with positioning requirements, etc.).
Efficacy of ASIMOMMY® Compared to Domperidone and Placebo in Increasing Breastfeeding: Randomized Single-Blind Controlled Trial in Indonesia

The purpose of this study is assess the efficacy of ASIMOMMY® in increasing breast milk production in postpartum mothers.

Several traditional herbs have been used and is well known since a long time ago by Indonesian people to increase the production of breastmilk, such as Katuk leaves (Sauropus androgynous Folium), Fenugreek (Trigonella foenum-graceum), and Moringa leaves (Moringa oleifera Folium). These plants have been scientifically proven through preclinical and even clinical research. However, not many have been further developed as phytopharmaceuticals that can be used in formal health services.

In previous research, ASI MOMMY® capsules have been successfully produced in accordance to the traditional method of making good herbal drugs, with each capsule containing extracts of Katuk leaf (300 mg), Fenugreek (150 mg), and Moringa leaf (50 mg). This formulation has gone through pharmacodynamic activity test, and acute and subactute toxicity test. Research has shown that ASI MOMMY® is works actively as a galactogogue and is not toxic, therefore it is safe to be given to humans (unpublished),

No research has been done to test the benefits of ASI MOMMY® in increasinng breastmilk production. Therefore, this research is a clinical trial that intends to see the benefits of ASI MOMMY® for increasing breastmilk production in postpartum women. This research is a part of the previous main research that is still ongoing to this day which aims to develop the formulation of ASI MOMMY® as a phytopharmaceutical

Eligibility Criteria:
Inclusion Criteria:

* Mothers 20-35 years old.
* Gestational age at delivery 37-40 weeks.
* Vaginal delivery.
* Normal body mass index (BMI 18.5-24.9 kg/m2).
* Not taking drugs or breast milk enhancement supplements.
* Healthy mother's condition with normal nipples (protruding).
* Healthy baby condition with good suction reflex.
* The baby consumes only breast milk.

Exclusion Criteria:

* Allergy to ASI MOMMY® and Domperidon.
* The mother is taking medications that affect the effects of domperidone (such as antacids, cimetidine, ranitidine, famotidine and nizatidine) or medications that interact with domperidone (such as haloperidol, lithium).
* The mother is in a state of illness requiring hospitalization.
* Mother has HIV AIDS, heart problems, mastitis, and had undergone breast surgery.
* Underweight, overweight and obese mothers.
* Giving birth to twins.
* The baby has a congenital defect that affects the suctioning process of breast milk
* Infants and mothers who did not participate in the treatment until completion (day 7 of the intervention).
Promotion of Influenza Vaccination in Healthcare Workers During the Recruitment Visit

The investigators will compare two groups, an intervention group with a control group. Each employee of the University Hospital of Lausanne (CHUV) and the University Medical Policlinic of Lausanne (PMU) who will do his recruitment visit at the occupational medicine unit of the CHUV between 04/29/16 (end of previous influenza epidemic) and 31/10/16 (the day before the start of the next influenza vaccination campaign) and exert a function in regular contact with patients will be eligible. Depending on his employee number (assigned by the human resources administration, independent of any parameter), he will be placed in the intervention group G1 (odd number) or in the control group G2 (even number). The information concerning the distribution of these two groups will be noted in the computerized medical records of the employee at the occupational medicine unit (Medipho4D software, secured database). Thereafter, the employee will be received by the nurse of the he occupational medicine unit for a recruitment visit according to the usual process. The nurse will perform the study intervention in addition to the usual procedure if it is stipulated ''intervention group'' on the employee's record in the database or only perform the usual steps if it is stipulated ''control group''. At the beginning of the next influenza vaccination campaign (mid-November 2016), employees in the intervention group will receive a letter reminding then about the intervention given during the recruitment visit and inviting them to get vaccinated. During the next influenza vaccination campaign (11.01.16) and until the end of the influenza epidemic that will follow (April 2017), each employee will have the opportunity to be vaccinated at the different vaccination stalls set up by the occupational medicine unit. For each employee vaccinated, the date of vaccination and vaccine name is entered in the electronic medical records of the occupational medicine unit (Medipho4D software) by a nurse or a secretary of the unit. At the end of the human influenza epidemic (April 2017), the data will be extracted from the database (Medipho4D software) and anonymized by an individual not implicated in the study. Data from two groups will be analyzed and compared to assess whether the intervention conducted among newly hired employees promotes influenza vaccination.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Employees of CHUV (University Hospital of Lausanne) or PMU (University Policlinic of Lausanne) who work regularly in contact with patients
* Employees who must do the recruitment visit at the occupational medicine unit of the CHUV

Exclusion Criteria:

* No exclusion criteria
Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis

The primary objective of the study is to determine the activity of selexipag on Raynaud attack frequency in subjects with Raynaud's Phenomenon (RP) secondary to Systemic Sclerosis (SSc).


Eligibility Criteria:
Key inclusion criteria:

* Signed informed consent prior to any study-mandated procedure.
* Male and female subjects aged 18 years and above with a history of recurrent multiple weekly RP attacks secondary to SSc.
* Women of childbearing potential must agree to use a reliable method of birth control.

Key exclusion criteria:

* Known moderate or severe hepatic impairment (i.e. Child-Pugh C).
* Known hypersensitivity to selexipag or drugs of the same class, or any of their excipients.
* Subjects who have received prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostenol, iloprost, beraprost) within 3 months prior to the screening visit.
* Subjects who have received a Phosphodiesterase type 5 (PDE-5) inhibitor within 1 week prior to the screening visit.
* Any dose change or initiation of any of the following drugs within 1 month prior to the screening visit: Calcium channel blockers, Nitrates or nitric oxide donors, ERA's, Alpha-blockers, Antithrombotic agents, NSAIDs (occasional use allowed), Angiotensin Converting Enzyme (ACE) inhibitors, Beta-blockers, Clonidine, Systemic corticosteroids, Fluoxetine.
* Severe renal insufficiency (at randomization).
* Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol
Smart Reminders to Promote Home-based Cognitive Training

This study will examine whether among older adults an adaptive and personalized reminder system can better support adherence to home-based cognitive training over typical reminder systems.

Many cognitive training interventions are associated with poor adherence, and poor adherence is associated with fewer benefits. Further, poor adherence in cognitive intervention studies can interfere with answering fundamental questions regarding intervention efficacy. This study will compare the effects of non-adaptive and smart adherence support systems. Participants will be asked to engage in frequent home-based cognitive training on a computer tablet. In the smart adherence support condition, participants will receive adaptive and tailored reminders based on dynamic algorithms that deploy reminders in a way that considers participant preferences, days and times of previous successful engagement, the success of previous reminder attempts, and answers to brief questions contained within reminder prompts. Parameter weights for these variables will be adjusted dynamically over a 6-month assessment period to ensure that reminders are deployed when they are most likely to be acted upon. This study will investigate adherence to training sessions, multiple times each week for 6 months, representing a large challenge to adherence. Participants will be randomly assigned to one condition or another, and adherence at home will be monitored. This will be an Individually Randomized Group-Treatment Trial (IRGT).

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older
* normal or corrected to normal visual acuity
* must pass a dementia screening

Exclusion Criteria:

* Parkinson's, Alzheimer's disease, or any other neurodegenerative disease
* terminal illness
* blindness or deafness
* severe motor impairment
* not living in the Tallahassee area for the entire 6 month study period
* unable to read at or above 6th grade level
Safety and Efficacy of Nebivolol in the Treatment of Hypertension in African Americans

The purpose of this study is to evaluate the effects of nebivolol on blood pressure and heart rate in African American patients with hypertension.

Despite the established benefits of beta-blockers, their use is limited by their side effect profile and by a perception of reduced efficacy in certain populations such as African Americans (Amudha, 2003). This is a double-blind, randomized, placebo and active-controlled, multi-center, parallel group, forced titration study. Patients will be stratified across all treatment arms by age, gender, and diabetes status (history of diabetes mellitus vs no history of diabetes mellitus). The study consists of 3 periods: screening run-in, double-blind, randomized, forced titration and double-blind, washout period (only for patients who complete the double-blind, forced titration period and who are not participating in the long-term follow-up study). After a 14-28 day, single-blind, placebo controlled, run-in period, which includes washout (if applicable), eligible patients will be randomized to one of 3 treatment regimens for approximately 12 weeks.

This study will test the safety and efficacy of Nebivolol in the treatment of African American patients with hypertension.

Eligibility Criteria:
Inclusion Criteria:

* African Americans with stage 1-2 hypertension

Exclusion Criteria:

* Recent myocardial infarction or stroke
* Contraindications to beta-blocker therapy or stopping prior antihypertensive therapy
Novel Pleural Fluid, Biopsy and Serum Biomarkers for the Investigation of Pleural Effusions

The purpose of this study is to prospectively asses established biomarkers in the diagnosis and prognosis of patients and will include assessment of a number of biomarkers, genomics and proteomics.

A prospective observation study examining the clinical utility of novel pleural fluid, biopsy and serum biomarkers for the investigation of pleural effusions (INVEST). The INVEST study will collect blood, pleural fluid and tissue samples from donors, allowing the opportunity to apply several novel blood and pleural fluid tests with interpretation of results in the context of clinical data and diagnostic suspicion. Through the prospective application of multiple tests, we aim to validate the sensitivity and specificity of existing biomarkers and identify novel markers that aid in the diagnostic pathway of pleural diseases. Because samples and data will be stored for future use, many other different tests, methods and techniques may be used in the future to provide information that we cannot foresee.

Eligibility Criteria:
Inclusion Criteria:

* Undiagnosed pleural effusion or pleural thickening requiring investigation by one of the following:

  * Pleural aspiration
  * Pleural biopsies from medical thoracoscopy or
  * Ultrasound guided biopsies as part of the clinical plan
* Suspected lung cancer undergoing bronchoscopy and biopsies.

Exclusion Criteria:

* Inability to give written informed consent
* Inability to obtain pleural fluid, blood, endobronchial or pleural biopsies as applicable
Efficacy Assessment of Lamina Curved Plate in Managing Oroantral Communication (OACs)

The aim of this study is to assess the success rate, of using a Lamina Curved plate (Osteobiol® Laboratory) in the treatment of persistent OACs over 5mm.

Oroantral communication (OAC) is an abnormal opening that forms between the maxillary sinus and oral cavity. This communication can occur as a result of tooth extraction, maxillofacial surgery or dental infections. Microorganisms from the oral cavity can then colonise the maxillary sinuses, leading to infections. Prompt and effective management of a OAC is essential to prevent complications such as acute or chronic sinusitis, facial pain or inflammation. Closure is usually made surgically with a local flap such as Fat pad flap, palatal or vestibular flap or with natural or synthetic biomaterials.

However, OACs may persist even after attempted closure, and there is also a risk of facial nerve damage during the dissection of the Bichat's flap.

All these factors prompt the evaluation of surgical procedures employed in the treatment of OACs, including the use of the Lamina Curved biomaterial from Osteobiol®. This biomaterial comprises a decalcified flexible plate made of heterologous cortical bone. It serves to reconstruct the sinus floor and isolate the sinus from the oral cavity. The plate is secured using osteosynthesis screws and possesses the characteristic of being resorbable.

The objective of this study is to investigate the success rate, of utilizing the Lamina Curved plate (Osteobiol® Laboratory) and to provide surgeons with an additional reference technique for treating OACs larger than 5mm.

Eligibility Criteria:
Inclusion Criteria :

* All patients with persistent OAC greater than 5mm treated with the use of an Osteobiol® Lamina curved plate
* Age ≥ 18 years
* Patients informed of the study and who did not object.

Exclusion Criteria :

* Follow-up less than 1 month after surgery
* Patient under guardianship
Temporary Pacemaker in Transcatheter Aortic Valve Implantation Patients

During Transcatheter aortic valve implantation (TAVI) procedure, a new valve is implanted. The valve can be CoreValve (Medtronic Company) or Edward SAPIENS (Edwards Company).

All TAVI patients require a temporary pacemaker(PMK), which is usually performed by insertion of a standard temporary electrode through the femoral vein. The temporary PMK is associated with a small but significant rate of complications.

The PMK is usually removed immediately at the end of the TAVI procedure, only when using the Edward SAPIENS valve. The CoreValve valve is more associated with conduction complications, and thus the PMK is later removed in these cases.

PMK Complications seen include:

* Right Ventricle perforation by temporary electrode, leading to Pericardial bleeding, in some cases with Tamponade
* Infection
* Electrode dislocation causing In-effective pacing (and/or sensing)
* Prolonged bed rest
* Prolonged hospitalization
* Access related problems (hematoma, pneumothorax) In a review of a large cohort (1) of patients from Milan (JACC 2012) the rate of tamponade was 4.3% most of which was associated with the temporary PMK.

The investigators had experienced not infrequent occurrences of temporary electrode associated tamponade, either acutely after Transcatheter aortic valve implantation (TAVI) completion, or delayed, in association with the electrode removal.

The tamponade rate in patients with a temporary pacemaker(PMK) was 14/150 (9.3%). Not all tamponade cases were related to the temporary PMK, 2 occurred in the setting of catastrophic annular rupture and one of the first cases was related to the Left Ventricle stiff wire.

The investigators also noted a significant prolongation of bed rest and hospital stay in patients with temporary PMK.

Using a flexible permanent pacing electrode which is actively fixed to the Right Ventricle and is placed through the jugular vein will reduce pacing-related complication rates (due to the flexibility of the electrode), time to ambulation (due to the fixation of the electrode), hospital stay and also unnecessary PMK. Cost will also be reduced due to prevention of complications and reduction in Intensive Cardiac Care Unit time.

Procedure time might be slightly prolonged since the placement of the standard electrode is more timely, however this prolongation is negligible, and the benefits of the flexible permanent pacing electrode are worth this prolongation

Eligibility Criteria:
Inclusion Criteria:

* All TAVI patients

Exclusion Criteria:

* Existing contraindication for either femoral or jugular venous access
* Refused informed consent
* Permanent PMK
* Platelets count less than 50 K.
Efficacy of Insulin Lispro Mix 50/50 Therapy

Insulin therapy with lispro mix 50/50 t.i.d. is a treatment with a single insulin device. The management is comparatively simple and easy, but the curative effect is promising. It is also reported that noninferiority has been observed between basal/bolus therapy (BBT) and prandial premixed therapy (PPT, lispro mix 50/50 t.i.d.).

The purpose of this study is to evaluate whether change of insulin therapy from BBT (long-acting insulin at bedtime plus mealtime rapid-acting insulin) or analog insulin therapy t.i.d. (including therapies with aspart mix 70/30 and lispro mix 75/25) to lispro mix 50/50 t.i.d. improves glycemic control of patients with type 2 diabetes mellitus.

Patients will continue existing insulin therapy for three months. After that, the investigators will change insulin therapy according to the insulin regimen below and continue the therapy for six months.

Patients will terminate from sulfonylurea treatment at the change of insulin therapy. The investigators will not change other oral hypoglycemic agents during the whole study period.

Regimen: Divide the total units of all insulin per day by three and equally apply the amount to mealtime injections of insulin lispro mix 50/50 t.i.d. When the unit is indivisible and the remainder is one unit, add it to the mealtime injection of breakfast. When the remainder is two units, add each unit to mealtime injections of breakfast and dinner.

Patients will terminate from the trial when their HbA1c increases by 1% and stays at the level for more than three months after the change of insulin regimen.

When there is a risk of hypoglycemia at the change of insulin regimen, the investigators will divide ninety percent of the total insulin units per day by three and equally apply the amount to mealtime injections of insulin lispro 50/50. When considered to be safe, the investigators will increase the insulin unit per day to the total insulin unit at the previous treatment within two months.

Eligibility Criteria:
Inclusion Criteria:

Type 2 diabetes patients who are treated with insulin basal/bolus therapy ( long-acting insulin at bedtime and mealtime rapid-acting insulin ) or analog insulin therapy t.i.d. (including therapies with aspart mix 70/30 and lispro mix 75/25) and whose HbA1c is above 7.4%.

Exclusion Criteria:

* Patients with renal failure with serum creatinine level ≧ 2.0
* Patients with hepatocirrhosis
* Patients with proliferative diabetic retinopathy or worse
* Patients with acute infectious disease
* Patients who are treated with steroids
* Patients with cancer
* Pregnant patients
* Patients who are decided to be inappropriate subjects by study physicians
Study to Examine the Safety and Effectiveness of Implanted Skeletal Muscle Cells (Cells Removed From the Thigh Muscle) Into Scarred Areas of Heart Muscle After Heart Attack.

Study to examine the safety and effectiveness of implanted skeletal muscle cells (cells removed from the thigh muscle) into scarred areas of heart muscle after heart attack.


Eligibility Criteria:
Inclusion Criteria:

* Patients recommended for coronary bypass surgery (preferably with cardiopulmonary support)
* Ejection fraction ≥15% and ≤35%
* Left ventricular myocardial infarction (MI - heart attack) ≥4 weeks prior to screening

Exclusion Criteria:

* Need for a rapid surgical coronary revascularization
* Need for any other related cardiosurgical measure during coronary surgery (e.g. mitral valve repair or valve replacement)
* Patients with a left ventricular aneurysm who is a candidate for left ventricular aneurysmectomy or left ventricular reduction surgery; patient receiving left or biventricular (BiV) pacing therapy for heart failure (unless the patient has stabilized after 6 or more months of this therapy)
* Cardiomyopathy presumed to be of non-ischemic origin