cyrilzakka/clinical-trials huggingface dataset:
Artificial Valve Endocarditis Reduction Trial

The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).

The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis. The null and alternative hypotheses of this study are:

* Ho: Patients receiving SJM Masters Series valves with Silzone coating will have an equal incidence of PVE when compared to those receiving the conventional cuff.
* Ha: Patients receiving SJM Masters Series valves with Silzone coating will have a reduced incidence of PVE when compared to those receiving the conventional cuff.

Eligibility Criteria:
Inclusion Criteria:

* The patient requires an isolated mitral, isolated aortic, or double (aortic and mitral) valve replacement
* The patient is a candidate to receive an SJM (St. Jude Medical) Masters Series valve(s) with either the conventional cuff or the cuff with Silzone coating
* The patient (or legal guardian) has signed a study-specific consent form agreeing to the randomization, data collection, and follow-up requirements

Exclusion Criteria:

* The patient has a medical condition which contraindicates implantation of the SJM Masters Series with Silzone coating
* The patient already has a prosthetic valve other than the valve being replaced at this time
* The patient requires a tricuspid valve replacement
Imaging of Vesicular Acetylcholine and Dopamine Transporters in Dementia With Lewy Bodies

The general aim of this research project is to determine the relationships between alterations of central cholinergic (ACh) and dopaminergic (DA) systems and neurobehavioral features of dementias with Lewy bodies (DLB).

Both clinical and neurochemical data support the view that DLB is not a homogeneous entity and it can be hypothesized that differential alterations of central ACh systems (i.e. anterior vs posterior vs striatal interneurons) in association or not with a DA nigrostriatal dysfunction could partly support the clinical heterogeneity observed in this disease. ACh in vivo imaging has been relatively underutilized to date and to our knowledge only on the postsynaptic side. Furthermore, ACh/DA interactions and their relationships with the symptomatology of DLB and related pathologies (PDD) had never been investigated.

Neurochemical investigations and observations suggest a crucial physiopathological role of central ACh systems in dementias with Lewy bodies (DLB). Alterations of cholinergic neurons could be involved in the general cognitive decline (central feature) but also in fluctuating attentional performances and rapid eye movement sleep disorder as it was shown in thalamus.

Post synaptic in vivo SPECT imaging recently demonstrated an increase in muscarinic receptors in DLB patients in the occipital cortex that could be associated with the visuospatial dysfunction often reported in DLB or even in visual hallucinations.From a pharmacological point of view, the involvement of ACh systems in DLB is confirmed by the consistently reported efficacy of cholinesterase inhibitor therapy, considered as greater than in AD.

Concerning DA systems, presynaptic in vivo SPECT imaging studies of DA transporter have shown a decreased striatal uptake in DLB patients, different when compared with Parkinson's disease patients or Alzheimer's disease patients.

Strategy, procedure In this project we will use for the first time in vivo molecular imaging of presynaptic molecular target of ACh systems (VAChT) with \[123I\]-iodobenzovesamicol and of DA systems (DAT) with DATSCAN in order to better analyse the link between neurobehavioral profiles of patients and a differential alteration of ACh/DA systems in DLB.

Eligibility Criteria:
Inclusion Criteria:

* Patients: man or woman probable DLB, with and without extrapyramida syndrome
* Healthy subjects: man or woman with no neuropsychiatric disorders

Exclusion Criteria:

* Diagnostic or therapeutic irradiation during the 12 months before SPECT imaging
* Age less than 18 and more than 90
* Iodine sensibility
* Brain-vascular disease, severe brain injury, type I and II diabetes mellitus, thyroid dysfunction, chronic alcoholism
* Pregnant and breast feeding women, women in age to procreate
* Impossibility to undergo MRI study (pace-maker, claustrophobia)
* Persons under guardianship, outside state to express their assent or in emergency situation
* Healthy subjects: cognitive impairment, dementia
Study to Evaluate the Response to Treatment and Safety of 0.03% Tacrolimus (FK506) Ointment Administered in Pediatric Patients With Moderate to Severe Atopic Dermatitis

Objective of this study is to further assess the response to treatment and safety of 0.03% tacrolimus (FK506) ointment when used for 6 months in pediatric patients with moderate to severe atopic dermatitis, known to be responsive to topical steroids.

The main phase is 6 month duration, but the follow-up phase up to 12 months will allow the collection of RTT and safety data in a period which will include all seasons in each patient, to account for seasonal variability which strongly affect AD course.

Eligibility Criteria:
Inclusion Criteria:

* Patient may be male or female of any ethnic group
* Patient is aged 2 years to 15 years (not having completed his/her 16th birthday) and suffers from moderate to severe atopic dermatitis (Rajka/Langeland score of at least 4.5).
* Patient known to be responsive to topical steroids
* Patient's legal representative has given written informed consent. If the patient is capable of understanding the purposes and risks of the trial written informed consent has been obtained from the patient as well. Female patients of childbearing potential must agree to maintain adequate birth control practice during the trial period and during the first four weeks after the end of the study
* Patient meets the following wash-out criteria:

  * Topical corticosteroids
  * Systemic corticosteroids (for the treatment of AD only)
  * Systemic non-steroidal immunosuppressants (e.g. cyclosporine, methotrexate)
  * Other investigational drugs
  * Light Treatments (UVA, UVB)
* Patient has not taken/patient and legal representative agree that the patient does not take for the complete study period any medication or therapy prohibited by the protocol

Exclusion Criteria:

* Patient has a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma
* Patient is pregnant or breast-feeding
* Patient has a skin infection on the affected (and to be treated) area
* Patient has a known hypersensitivity to macrolides in general, to Tacrolimus or any excipient of the ointment
* Patient is simultaneously participating in any other drug trial or less than 28 days have passed between the end of the previous trial and this one
* Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder or condition which, in the opinion of the investigator, may invalidate the communication with the investigator
* Patient is known to be HIV positive
The Study of the Prevalence of Helicobacter Pylori Infection Among HIV/AIDS Cohort

The purpose of the Study is to investigate the prevalence of Helicobacter Pylori infection among the HIV/AIDS group. The study will screen the patients who were confirmed HIV/AIDS in Kaohsiung Medical University Hospital and collect the cases who were suspicious of Helicobacter Pylori infection.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of HIV
* the person who have stomach pain, vomiting or nausea
Comparison of Lighted Stylet and GlideScope for Double-lumen Endobronchial Intubation

We evaluate the GlideScope and lighted stylet for DLT intubation in terms of the intubation time, number of intubation attempts, difficulty in DLT advancement towards the glottis, postoperative sore throat and hoarseness, and hemodynamic responses during intubation in patients with predicted difficult airways.


Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing thoracic surgery requiring endobronchial intubation for one-lung ventilation

Exclusion Criteria:

* presence of sore throat and hoarseness
* requirements for postoperative mechanical ventilation
* at risk of aspiration.
ALICE-Regional Anesthesia in Italy: Complications and Outcomes

Regional anesthesia techniques, with administration of local anesthetics for neuraxial or peripheral route are now playing a central role in modern anesthesia and in particular in the control of postoperative pain. There are many review and meta-analyzes suggesting that a good pain control, and specifically loco regional analgesia, may improve the outcome of patients undergoing surgery.

The control of acute post-operative pain is not the only challenge to be paid by anesthesiologists, because there is still much to be understood in relation to persistent post-surgical pain (PPP), and about the degree of influence that regional anesthesia plays in complete long-term functional recovery of patients.

From the pathophysiological perspective there is not a precise definition of the mechanisms and risk factors that determine the onset of the persistent pain after surgery, but, more in general, it seems to be related to a malfunction of the mechanism of secondary hyperalgesia.

Regional anesthesia could play a key role, as the main determinant of chronic pain is acute post-operative pain. The techniques of regional anesthesia exert a powerful block at the peripheral level, potentially preventing the progression of central pain and the persistence of stimuli that can reach the central nervous system. In addition, during surgery, these techniques can reduce the metabolic alterations and the triggering mechanisms of local and systemic pro-inflammatory mediators' release.

Few perspective studies exist about the influence of regional anesthesia on long-term outcome and persistent pain after surgery.

The objective of the investigators study is to assess in a prospective fashion the role of regional anesthesia/analgesia technique in preventing (or not) persistence pain occurrence after surgical interventions which are mostly associated to pain persistence, and understand if regional anesthesia provides advantages in other post-surgical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* more than 18 ys old
* informed consent

Exclusion Criteria:

* reintervention
* ASA (American Society of Anesthesiologists) status 4 and 5
* emergency surgery
* no informed consent
Spinal Kinematics Variability

This study will test the within and between day variability of spinal kinematics and trunk muscle activity in healthy subjects and chronic low back pain patients during various daily-life activities.

This study will test the within and between day variability of spinal kinematics and trunk muscle activity in healthy subjects and chronic low back pain patients during various daily-life activities. Participants will come twice to the motion laboratory. During the first session, participants will first perform different functional activities (V1), such as sit-to-stand, gait, lifting tasks, stepping up. Their spinal kinematics will be measured with a camera-based system (VICON) using a multi-segment spinal model and trunk muscles activity will be recorded with surface electromyography. After a break, participants will have to perform all the functional activities a second time (V2). These two measures (V1 and V2) will be used to determine the within day variability of spinal kinematics. Finally, all participants will come one week later (V3) to repeat all the measurements to determine the between day variability.

Eligibility Criteria:
Inclusion Criteria:

* sufficient French level to understand the instructions for the tests, the information sheet, the consent form and the questionnaires
* All chronic low back pain patients should present with non-specific low back pain (pain from lower ribs to gluteal folds) for more than 3 months.

Exclusion Criteria:

* pregnancy
* body mass index (BMI) that is above 32
* patients should not have any sign of specific low back pain such as the presence of infection, rheumatological or neurological diseases, spinal fractures, any known important spinal deformities, previous back surgery that limits spinal mobility, tumours
* high level of pain at the time of experiment that prevents repeated movements (severity and irritability)
* other concomitant pain or condition that could compromise the evaluation of spinal kinematics.
A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis

The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.

Upon confirmation of eligibility, participants were randomized in a 22:5:22:5 ratio to the following treatment groups:

* Romosozumab 90 mg/mL
* Placebo 90 mg/mL
* Romosozumab 70 mg/mL
* Placebo 70 mg/mL

After completing a 6-month treatment period, participants entered a 3-month follow-up period with an end of study (EOS) at month 9.

For the analysis of efficacy endpoints, the 2 placebo groups were combined into a single placebo group. For safety analyses, the data for placebo were presented separately for each group.

Eligibility Criteria:
Inclusion Criteria:

Postmenopausal women with osteoporosis at high risk for fracture defined as

* BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck AND
* a history of fragility fracture or at least 2 other risk factors

Exclusion Criteria:

* BMD T score \< -3.50 at the total hip or femoral neck.
* History of hip fracture.
* History of metabolic or bone disease (except osteoporosis).
* Use of agents affecting bone metabolism.
* Vitamin D insufficiency.
* History of solid organ or bone marrow transplants.
* Hyper- or hypocalcemia.
* Hyper- or hypothyroidism.
* Hyper- or hypoparathyroidism.
A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)

A Phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in participants with metastatic Pancreatic Ductal Adenocarcinoma (PDAC).

Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of patients who have received no prior systemic therapy for metastatic PDAC, and Cohort 2 will consist of patients who have received one line of prior systemic therapy for PDAC. In each cohort, eligible patients will be assigned to one of several treatment arms.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma
* For patients in Cohort 1: no prior systemic treatment for PDAC
* For patients in Cohort 2: disease progression during administration of either 5-FU- or gemcitabine-based first-line chemotherapy
* Life expectancy greater than or equal to 3 months
* Availability of a representative tumor specimen that is suitable for determination of programmed death-ligand 1 (PD-L1) and/or additional biomarker status via central testing
* Measurable disease (at least one target lesion) according to RECIST v1.1
* Adequate hematologic and end-organ function test results
* Tumor accessible for biopsy
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs, as outlined for each specific treatment arm
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm

Exclusion Criteria:

* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage procedure (i.e., more than one time per month)
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* History of leptomeningeal disease
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
* Positive human immunodeficiency (HIV) test at screening or at any time prior to screening
* Active hepatitis B or C virus infection or active tuberculosis
* Severe infection within 4 weeks prior to initiation of study treatment
* Prior allogeneic stem cell or solid organ transplantation
* History of malignancy other than pancreatic carcinoma within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death
Comparison of 3 Versus 6-Month Use of CGMS in Non-Insulin Using T2DM Patients

To determine whether 3-month versus 6-month professional CGM utilization improves time spent in target range of 70-140mg/dl in patients with poorly controlled T2DM not treated with insulin.

Patients not receiving any insulin treatment with an HbA1c ≥ 7.5% before their scheduled primary care appointment will be invited to participate in the study and wear professional CGM for at least 3 days at either 3 intervals (baseline, 3-month and 6-month) or 2 intervals (baseline and 6-month). After removal, the downloaded report will provide quantitative data to determine the percent of time spent in the target range. The 6-month data will be analyzed to determine if frequency of professional CGM wear positively affects time spent in target range.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older with a diagnosis of T2DM with a scheduled office visit with primary care provider within the next 4 weeks
2. Last 2 HbA1c values between 7.5 - 10% measured in the last 12 months
3. Treated with non-insulin therapies or therapeutic lifestyle changes
4. Never worn professional CGM or have not worn in last 12 months
5. Willing to perform requirements needed for professional CGM

Exclusion Criteria:

1. Current or previous treatment with any insulin within 3 months at baseline
Effects of Roller Massage on Short-Term Passive Muscle Stiffness

Muscle stiffness is associated with a variety of variables that affect health, however there is limited research on the effect of massage on muscle stiffness, and existing research does not quantify the intensity of massage. Thus trial will determine the effect of roller massage on quadriceps muscle stiffness and passive range of motion.

Following screening for eligibility and consent, subjects will be assigned randomly to one of three groups: a placebo control group and two roller massage groups (treatment groups). The treatment groups will each receive a single bout of roller massage. One treatment group will receive a massage at medium intensity (25 newtons of force directed perpendicular to surface of thigh), the other treatment group at high intensity (45 newtons of force directed perpendicular to surface of thigh). The placebo group will receive a single bout of sham ultrasound. Both placebo and treatments will be delivered to the anterior thigh with the participant in a supine position. Each procedure will last for 10 minutes. In all groups, muscle stiffness, natural oscillation frequency, elasticity, relaxation time, and creep at the vastus lateralis will be measured using a myotonometer. PROM for knee flexion will also be measured in both groups using goniometry. All measurements will be taken at 3 different times: immediately before treatment or placebo, immediately after treatment or placebo, and 30 minutes after treatment or placebo. Myotonometric measurements of the vastus lateralis will be taken 2/3 of the way down between the anterior superior iliac spine and lateral aspect of the patella, in accordance with guidelines for the Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles. For goniometric measurement, participants will be in supine position on an examination table. The investigator will flex the participant's hip to 90 degrees and then, using a dynamometer (to ensure consistent applied force for all participants), flex the participant's knee. To measure knee flexion PROM, the goniometer will be positioned with the axis at the lateral epicondyle of the femur, the stationary arm in line with the lateral midline of the femur toward the greater trochanter, and the moving arm in line with the fibular head and lateral malleolus. During the time between the second and third measurements, subjects will be asked to sit quietly.

Eligibility Criteria:
Inclusion Criteria:

-Age 18-30

Exclusion Criteria:

* Prior history of significant vascular or neuromuscular illness or impairment affecting the lower limbs
* Serious injuries to the back or legs in the last six months
* Discomfort or pain in the back or legs
* Use of pain and anti-inflammatory medications
* Any contraindications to massage treatment or ultrasound
* Body mass index (BMI) \>30 kg/m2.
Clinical Investigation on the Effects of Bayberry Juice Treatment in Adult Subjects With Features of Fatty Liver Disease

Chinese bayberry, one of six Myrica species native to China, is rich in anthocyanins, and cyanidin-3-O-glucoside (C3G) was identified as a major anthocyanin component. In previous animal studies from us and other investigators, anthocyanins have been shown to ameliorate dyslipidemia and hepatic steatosis in different rodent models. The aim of the present study was to examine the effects of Chinese bayberry juice (CBJ) on the serum lipid profile and on levels of biomarkers related to antioxidant status in young adults with features of fatty liver disease.


Eligibility Criteria:
Inclusion Criteria:

* Subject inclusion criteria were age 18-25 y,
* BMI \[body weight divided by height squared (in kg/m2)\] \> 23,
* lack of excessive alcohol ingestion confirmed by careful questioning by the primary physician and dietitians (consumption of less than 70 g alcohol in female and 140 g in male per week), and
* the presence of two of the three following diagnostic criteria of the fatty liver disease: increased hepatic echogenicity compared to the spleen or the kidneys, blurring of liver vasculature and deep attenuation of the ultrasonographic signal.

Exclusion Criteria:

* overuse of alcohol,
* viral hepatitis,
* type 1 or 2 diabetes,
* gastrointestinal or connective diseases,
* chronic pancreatitis,
* liver cirrhosis,
* kidney stones, or renal failure;
* use of acetyl-salicylic acid or other antiplatelet drugs, statins of fibrates, oral hypoglycemic drugs, nitrates, nonsteroidal antiinflammatory drugs, corticosteroids, or drugs interfering with coagulation;
* supplementation with vitamins or antioxidants.
Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood

This is a Randomized double blind trial with the aim to estimate the effectiveness of 3 therapeutic regimes per os on migraine pain:

* metoclopramide 0,15 mg/kg + placebo
* metoclopramide 0,15 mg/Kg + ketoprofen 1 mg/kg
* ketoprofen 1 mg/Kg + placebo

Intensity of pain will be measured with linear 1-10 scale or analogic McGrath type scale every 20 min.

The main objective is the evaluation of healing times from pain in the 3 groups


Eligibility Criteria:
Inclusion Criteria:

* Children 6-17 years old with migraine presenting in emergency room

Exclusion Criteria:

* Informed consensus not obtained
* Occurring migraine still treated
* Hemiplegic migraine