cyrilzakka/clinical-trials huggingface dataset:
Polyphenols and Risk of Dementia

This project aims to leverage existing data from a large observational prospective study on dementia, the Three-City study, to investigate the relationship between intakes of polyphenols and the risk to develop dementia in the 12 years following dietary assessment.

The study sample includes 1,329 subjects followed for up to 12 years fro dementia after dietary assessment. The aim is to identify a pattern of polyphenol intake (based on 26 flavonoid and non-flavonoid polyphenol subclasses ascertained using a 24-hour dietary recall) associated with the risk of dementia and AD over 12 years in the 3C Bordeaux cohort.

Eligibility Criteria:
Inclusion Criteria:

* 65 years or more, live in Bordeaux area (France)

Exclusion Criteria:

* with dementia at the time of dietary assessment in year 2001-2002
A Study of Adverse Events and Suspected Adverse Drug Reactions of Patients Under Treatment of Apixaban for Venous Thomboembolism (VTE) Treatment

Number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with apixaban, according to therapeutic indications approved in Mexico.


Eligibility Criteria:
Inclusion Criteria:

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

1. Evidence a personally 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.
2. Patients (men and women) \>18 years old.
3. Patients who have received at least one dose of apixaban for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE); prevention of recurrent DVT and PE

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Exclusion Criteria:

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

1. Patients who are participating in a clinical trial.
2. Hypersensitivity to the active substance or to any of the excipients.
3. Active clinically significant bleeding.
4. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk, based on hepatic function tests.
5. Lesion or condition if considered a significant risk factor for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
6. Concomitant treatment with any other anticoagulant agent e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), and oral anticoagulants (warfarin, acenocoumarin, rivaroxaban, dabigatran, etc.) except under specific circumstances of switching anticoagulant therapy.
7. Pregnancy and breast-feeding.
8. Severe acute or chronic psychiatric condition and other significant medical condition.

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Evaluation of Attenuation Correction Accuracy in Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI)

The purpose of this research proposal is to establish a mechanism to develop tools that will allow the investigators to measure the impact of magnetic resonance (MR) acquisition correction sequences for attenuation correction on positron emission tomography (PET) quantitation accuracy.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be ≥ 18 years of age
* Participant can be a male or a non-pregnant female.
* Successful completion of MRI screening form
* Participant must have undergone a PET/CT examination with injection of a standard dose of 18F-fluorodeoxyglucose (FDG) or other PET tracer with a half-life greater than one hour either for clinical or research purposes within 3 hrs of the proposed PET-MRI examination.
* Participant will be fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) provisions

Exclusion Criteria:

* Subjects for whom exposure to a strong magnetic field would be a health risk (e.g., subjects with cardiac pacemakers or non-MR compatible metallic implants)
* Women who are pregnant.
* Subjects who require sedation to participate will be excluded.
* Patient/participant has a medical condition which in the judgment of the investigator might make supine positioning for the duration of the scan unsafe, such as (but not limited to) congestive heart failure or significant pulmonary disease.
Severe and Transient Hypoxemia During Selective Intra-arterial Chemotherapy for Retinoblastoma in Children: Evaluation of the Right-sided Heart Function.

Children having selective ophthalmic artery chemotherapy for retinoblastoma under general anaesthesia may experience troubles during the procedure. The troubles are transient, may be severe and include hypoxemia, hypotension and bradycardia. All children having such trouble always fully recovered without any sequelae or prolonged length of stay. The investigators suspect that these phenomenons are caused by transient pulmonary hypertension.The objective is to see whether transient pulmonary hypertension and right-sided heart failure is present during theses phenomenon by trans-thoracic echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* Retinoblastoma requiring selective ophthalmic artery chemotherapy under general anaesthesia

Exclusion Criteria:

* Obesity
* pre-existing significant heart or pulmonary disease.
Effect of Different Interventions on Glycemic Control and β-cell Function in Newly Diagnosed Type 2 Diabetic Patients

The purpose of this study is to investigate and evaluate the effects of different interventions (1. exenatide, 2. insulin, 3. thiazolidinedione) on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.

One of the fundamental defects in type 2 diabetes mellitus is declining β-cell function. Exenatide targets multiple metabolic disturbances in type 2 diabetes and exerts direct effects on β-cell, which indicates that it may not only contribute to the glucose control but also delay disease progression. There are trials demonstrated efficacy, safety and tolerability of exenatide. However, no study has compared the effects of exenatide with other hypoglycemic therapies with β cell protective function in newly diagnosed and drug-naïve type 2 diabetic patients. This current study is thus designed to evaluate the effects of exenatide, insulin and pioglitazone on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* newly-diagnosed type 2 diabetic patients, drug naïve
* age 30\~70 years
* HbA1c 7.0\~10.0%
* BMI 20\~35 kg/m2, stable body weight (≤10% variation) for at least 3 months prior to screening
* female patients of reproductive age should practice a reliable method of birth control throughout the study

Exclusion Criteria:

* acute or severe chronic diabetic complications
* congestive heart failure (NYHA grade Ⅲ\~Ⅳ)
* severe gastrointestinal disease
* severe osteoporosis or history of pathological fracture,or use of bisphosphonates preparation
* other severe intercurrent illness
* serum aminotransferase (ALT and AST) level higher than 2 times of the upper normal limits and/or serum creatinie≥133µmol/L (1.5mg/dL)
* tested positive for glutamic acid decarboxylase antibody
* use of weight loss drugs, corticosteroids, drugs known to affect gastrointestinal motility, transplantation medications, or any investigational drug
* history of pancreatitis
* serum triglyceride ≥ 5.0 mmol/L
* pregnancy
A Study to Assess the Effect of a High Fat Meal on Surufatinib in Healthy Subjects

This study will be a 2-period study conducted with 26 healthy male or female subjects. Subjects will be randomly assigned to either receive a single dose of surufatinib with food in period 1, then without food in period 2, or vice-versa.

This study will be a single center, open label, randomized crossover, 2-period study conducted with 26 healthy male or female subjects. Subjects will be randomly assigned to 1 of the 2 possible treatment sequences as follows:

* Fed/Fasted: surufatinib with food on Day 1 and surufatinib without food on Day 8
* Fasting/Fed: surufatinib without food on Day 1 and surufatinib with food on Day 8

Eligibility Criteria:
Inclusion Criteria:

* Non-smoking, healthy male or female between the ages of 18 and 55 years old inclusive).
* Body mass index (BMI) \> 18 and ≤ 29 kg/m2.
* Females must be of non-childbearing potential, or of childbearing potential and agree to use a medically acceptable method of contraception.
* Males who have not had a successful vasectomy and are partners of women of childbearing potential must use, or their partners must use, a highly effective method of contraception starting for at least one menstrual cycle prior to and throughout the entire study period, and for 2 weeks after the last dose of study drug. Those with partners using hormonal contraceptives must also use an additional approved method of contraception. No sperm donation is allowed during the study period and for 90 days after study drug discontinuation.

Exclusion Criteria:

* Evidence of clinically significant cardiovascular, hepatic, GI, renal, respiratory, endocrine, hematological, neurological, or psychiatric disease or abnormalities or had a known history of any GI surgery or cholecystectomy.
* Clinically significant illness within 8 weeks or had a clinically significant infection within 4 weeks prior to the first dose.
* Known food allergy to any content of the standard meal to be used in this study.
* Clinically significant deviation from normal in the physical examination, vital signs, or clinical laboratory determinations.
* Systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg.
* The subject has a clinically significant ECG abnormality, or had a family history of prolonged QTc syndrome or sudden death.
* A history of smoking or use of nicotine-containing substances within the previous 2 months.
* A history of drug or alcohol misuse in the previous 6 months.
* Has been diagnosed with acquired immune deficiency syndrome (AIDS) or are positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
* Has participated in a clinical trial of other drug before screening, and the time since the last use of other study drug is less than 5 times the half- life or 4 weeks, whichever is longer, or the subject is currently enrolled in another clinical trial.
* Has received blood or blood products within 4 weeks, or donated blood or blood products within 8 weeks.
* Has used any over-the-counter (OTC) medications or prescription drugs within 2 weeks.
Study to Assess Resource Utilization and Quality of Life of Patients With RRMS Treated With Tecfidera in Greece

This is a non interventional, multicenter clinical trial, in adult patients receiving Tecfidera per approved SmPC and routine clinical practice. The primary objective of this study is to evaluate the total societal costs to the healthcare system related to the use of Tecfidera in RRMS patients. The study will capture data in a simple matter that can be easily interpreted providing an advantage in a country where efforts in the market access arena are in their infancy. For the aforementioned reasons, the proposed study may prove quite valuable in supporting DMF as a cost-effective therapy, valuable not only for patients but for the public health care system as well, providing all the necessary information for the evaluation that need to be examined regarding the positive reimbursement list and future decisions.

The study will take place in Greece. Investigators will participate from a broad geographical distribution in order to ensure a proper representation from all areas of Greece. Investigator's decision to prescribe DMF (Tecfidera®) (according to the indication for treatment as defined in the summary of product characteristics, SmPC and the current clinical practice), should precede entry into the study.

Eligibility Criteria:
Inclusion Criteria:

* Persons aged 18-65 years.
* Patients with a confirmed diagnosis of RRMS.
* Patients for whom the decision to prescribe therapy with Tecfidera®, according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study. The assignment of a patient to this therapeutic strategy is not decided in advance, but falls within current practice, while the prescription of Tecfidera® is clearly separated from the physician's decision to include the patient in the current study.
* Patients must have signed an informed consent document.
* Patients must be able to read, understand and complete the study specific questionnaire.

Exclusion Criteria:

* Patients having other forms of MS, like Clinically Isolated Syndrome (CIS) or progressive forms.
* Patients who have initiated treatment with Tecfidera® more than 7 days before study enrolment or have received DMF at any different time prior to this period.
* Patients that meet any of the contraindications to the administration of the study drug according to the approved SmPC.
* Receipt of any investigational agent within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with Tecfidera®.
Examining the Efficacy of a Single Session Online Mental Health Program

There is a large body of evidence demonstrating that Acceptance and Commitment Therapy (ACT) can be delivered in a self-guided format to improve mental health among college students. However, previous research indicates there are challenges in engaging students in adhering to these time intensive, multi-session self-guided resources. Brief self-guided single session interventions could provide an accessible and acceptable intervention that is easier to adhere to, given their lower intensity and response effort for participation. This proposed study seeks to evaluate a single session online ACT Guide Lite intervention in a sample (n = 100) of Utah State University (USU) college students 18 years of age or older. A randomized controlled trial (RCT) design will be used in which students are randomized to receive ACT Guide Lite or to a waitlist condition in order to test the following predictions: (1) participants assigned to ACT Guide Lite will improve more on the primary therapeutic process of change, psychological flexibility, relative to those not receiving intervention, (2) participants assigned to ACT Guide Lite will improve more on distress, well-being, and interest in seeking help, relative to those not receiving intervention, (3) ACT Guide Lite will be acceptable to college students as indicated by recruitment rates, rates of completing ACT Guide Lite, and self-reported program satisfaction, and (4) areas for future program revisions will also be identified through participants' written feedback on their experiences using the program. USU students will be recruited to participate in the study through the SONA research platform in the Fall 2023 semester. All study procedures will be completed through the secure Qualtrics online research platform, in addition to email and phone contacts prompting relevant steps for the study. All analyses will be run with multilevel modeling with the full intent-to-treat sample to test time by condition interactions.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* a current USU student
* not have used any of the USU ACT Guide programs before

Exclusion Criteria:

* NA
A Study to Evaluate Efalizumab Compared With Cyclosporine As an Immunosuppressant Regimen in De Novo Renal Transplantation

This is a Phase II/III, randomized, open-label, active-controlled, multicenter trial to evaluate the safety and efficacy of efalizumab compared with cyclosporine (CsA), when both are given in combination with Mycophenolate Mofetil (MMF) and corticosteroids after induction therapy with basiliximab, as an immunosuppressant regimen in de novo renal transplantation. A total of 200 subjects undergoing either living or cadaveric renal transplantation will be randomly assigned 1:1 to receive either efalizumab + MMF + corticosteroids or CsA + MMF + corticosteroids.


Eligibility Criteria:
Key Inclusion Criteria:

* Have signed the informed consent form and the HIPAA patient information form (United States only)
* Are ≥ 18 years of age
* Are a transplant recipient of at least one HLA-mismatch kidney
* For subjects of reproductive potential (men and women), are willing to use effective contraception, unless abstinence is the chosen method

Key Exclusion Criteria:

* Have a history of previous renal transplant
* Have had a PRA \> 25% at any time
* Have a history of or evidence of cancer except for basal cell carcinoma that has been excised and cervical carcinoma in situ
* Have a positive T-cell lymphocytotoxic crossmatch with the use of donor lymphocytes and recipient serum
* Have had previous treatment with efalizumab
* Have used any investigational drug within 28 days or 5 half-lives of screening, whichever is longer
* Have a known contraindication to efalizumab
* Have a history of severe allergic or anaphylactic reactions to monoclonal antibodies
* Have had a known allergic reaction or intolerance to any of the following medications: CsA; MMF; Corticosteroids; Basiliximab
* Are allergic to iodinated contrast media that would preclude GFR measurement with iothalamate
Functional Outcomes of a Criterion-based Rehabilitation Protocol for ACL Reconstruction in Amateur Athlete

Although current rehabilitation protocols following anterior cruciate ligament reconstruction (ACLR) are based on the graft remodeling process, there is uncertainty about its time schedule. Moreover, there are individual differences in neuromotor learning and flexibility after ACLR. This study was conducted to investigate the effect of a criterion-based rehabilitation protocol on pain intensity, effusion, and knee function in amateur athletes following ACLR.

Although current rehabilitation protocols following anterior cruciate ligament reconstruction (ACLR) are based on the graft remodeling process, there is uncertainty about its time schedule. Moreover, there are individual differences in neuromotor learning and flexibility after ACLR. This study was conducted to investigate the effect of a criterion-based rehabilitation protocol on pain intensity, effusion, and knee function in amateur athletes following ACLR.


Eligibility Criteria:
Inclusion Criteria:

* Amateur male athletes who underwent ACLR surgery with an autologous hamstring (HS) graft.
* Ranging in age from 18 to 35 years.
* Underwent a pre-operative rehabilitation program with minimal knee effusion, full Extension, good patellofemoral mobility
* Ability to actively control the quadriceps.

Exclusion Criteria:

* ACLR with any graft other than a hamstring graft
* ACL revision surgery
* associated medial or lateral ligamentous injuries
* previous meniscectomy or meniscal repair
* simultaneous meniscectomy or meniscus repair with the ACLR
* cartilage damage.
A Clinical Study Collecting Patients' Experience During Dental Implant Treatment

The study will gather data on patient reported experience (PREM) before, during and after dental implant treatment. Patients scheduled in three treatment groups for either single tooth, multiple teeth or full-arch dental rehabilitation are included in the study and will be treated according standard of care. Additionally, they are asked to report their experience based on pre-defined questionnaire assessing patient acceptance of implant treatment in dentistry. Patients will be followed-up until 1-Year post Final Prosthesis Delivery.

This studies primary endpoint is the completion of the PREM questionnaires. The study is not intended to investigate safety and performance of the used medical devices.


Eligibility Criteria:
Inclusion Criteria:

* Subject signed informed consent
* Subject is at least 18 years old at the time of treatment
* Subject presented with the need of dental implant treatment for single tooth, multiple teeth, or full-arch rehabilitation
* Subject with medical and anatomical conditions that are in accordance with the applicable instructions for use (IFU)
* Subject agree to provide information on her/his experience and outcomes before, during and after the treatment
* Subject has a working e-mail address
* Subject has sufficient English language skills for answering the PREM questionnaires

Exclusion Criteria:

* Anatomical conditions discovered during surgery preventing the use of intended implant system
* Subject with history of allergy or adverse reactions to any materials used
* Uncontrolled unstable systemic disease
* Any ongoing application of medication that is interfering with the dental treatment
* Subject is not willing / unable to complete the PREM questionnaires
* Subject that is planning not to return to the investigational site for follow-up visits within study schedule
* Pregnant or lactating women at the time of implant insertion
Performance of the NGPOD® Device in Verifying the Correct Position in the Stomach of the Naso- or Oro- Gastric Tube in Intensive Care.

In the ICU, scientific societies recommend starting enteral nutrition within 48 hours of admission, if oral nutrition is not available, in order to limit undernutrition. In patients who are sedated, have swallowing problems or cannot ensure adequate caloric intake, it is essential to insert a feeding tube, usually a nasogastric or orogastric tube for the first few weeks.

Placement of a naso- or oro-gastric tube in the intensive care unit is a frequent procedure, and considered to be straightforward. It is usually performed blindly, at the patient's bedside, by a nurse or doctor, according to a departmental protocol or the recommendations of learned societies.

Nevertheless, a number of complications have been reported with naso- or oro-gastric tubes, linked in particular to a route outside the digestive tract : malpositioning/coiling of the tube, epistaxis, sinusitis. The most frequent and potentially severe complications are malpositions in the tracheobronchial tree.

Radiographic control is currently considered in France and by certain learned societies to be the reference method for verifying correct positioning of the probe in the stomach (at the prepyloric antral level). However, thoracic radiography has a number of drawbacks : In intensive care risk of accidental displacement of other medical devices,irradiation, difficulty of interpretation, delay in obtaining the image, time-consuming work for qualified personnel.

An alternative technique using the NGPOD device is proposed as a method of checking the correct positioning of the probe in the stomach. This system enables immediate, rapid (15 seconds), simple and automatic testing at the patient's bedside. The device provides a visual indication of the pH detected at the tip of the gastric tube. The test result is given in binary form: Yes (green signal, probe in stomach) / No (red signal, probe incorrectly positioned).

Study hypothesis and prospects: To make an initial estimate of the sensitivity and specificity of the NGPOD system for checking the positioning of the naso- or oro-gastric tube in the stomach, compared with the recognized gold standard, the chest X-ray.


Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized in intensive care
* Patients aged 18 or over with no upper age limit
* Patients admitted to intensive care with a nasogastric or orogastric tube placed in the operating room (not controlled by radiography) or for whom the placement of a gastric tube in intensive care is indicated.
* Consent to research participation

Exclusion Criteria:

* Patients undergoing limitation and discontinuation of active therapies
* Patients with contraindications to blind gastric tube placement (recent esophageal or gastric surgery, ENT lesions, uncontrolled upper GI bleeding, esophageal or gastric cancer)
* Patients under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection