cyrilzakka/clinical-trials huggingface dataset:
Optimization of MRI Sequences Used in the Study of Neurodegenerative Diseases

The Inserm NeuroPresage team has been using MRI for more than 20 years in the study of normal ageing and memory pathologies to further the understanding and the characterization of early diagnosis and the cerebral substrates of cognitive deficits in patients, particularly in the context of neurodegenerative diseases.

Two years ago, a new 3T MRI camera was installed at the Cyceron centre. It is more efficient and should make it possible to obtain better quality images and/or to reduce the time required to acquire these images.

In this context, it seems important to test the different sequences that we classically use in our studies, or that we plan to implement in our next studies (learning and text retrieval fMRI task), in order to optimize them, with a view to integrating them in our future studies.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers of legal age
* Affiliation with a social security scheme or beneficiary of such a scheme
* Signing of the protocol informed consent
* For women of childbearing age or capacity, a urine pregnancy test before inclusion

Exclusion Criteria:

* Protected persons in accordance with articles L. 1121-5 to L.1121-8 of the Public Health Code: protected adults, pregnant and nursing women
* Presence of contraindications to MRI examination without contrast agents injection
* Presence of a chronic neurological or psychiatric condition (including substance use disorder)
* History of brain disease (vascular, degenerative, malformative, tumour, or head trauma with loss of consciousness for more than one hour)
* Current or recent use of medications that may interfere with imaging (psychotropic drugs, antihistamines with anticholinergic action, antiparkinsonian drugs, benzodiazepines including muscle relaxants, long-term steroidal anti-inflammatory drugs, antiepileptic drugs, central painkillers)
Effect of Cherry Powder Supplementation on Vascular Function

Examining the effect of four weeks of cherry powder supplementation on flow mediated dilatation


Eligibility Criteria:
Inclusion Criteria:

* physically inactive no prescription medications

Exclusion Criteria:

* physically active taking prescription medication
A Study to Assess an Auto-injector Being Used to Treat a Migraine Attack

The purpose of this research study is to evaluate an investigational auto-injector system for delivering sumatriptan under the skin for a single migraine attack.

The study could take approximately 5 weeks and will include about 3 office visits to the study doctor, the patient will be contacted every 2 weeks until the patient experiences a migraine and uses the auto-injector. The last visit will be done by a telephone follow-up call.

Investigational Plan:

1. Screening Visit \[Visit 0 / 0-14 days prior to receipt of study drug\]
2. Baseline Visit \[Visit 1 / Provision of study drug and subject training\]
3. Treatment Visit \[Visit 2 / within 72 hours after study drug administration\]
4. Follow-up Visit \[Visit 3 / Telephone follow-up 7-10 days after study drug administration\]

Eligibility Criteria:
Inclusion Criteria:

1. Adults 18 to 60 years of age
2. Prior effective use of injectable sumatriptan on at least two occasions within the last two months
3. At least two migraines per month suitable injectable sumatriptan
4. Capable of using a migraine self-injection auto-injector
5. Capable of distinguishing between migraine and other headache types (e.g., tension-type headache)

Exclusion Criteria:

1. Seizure disorders
2. Coronary artery disease (CAD)
3. Cardiac dysrhythmia or pacemaker
4. High blood pressure
5. Liver disease
6. Kidney disease
7. Autoimmune disease
8. History of alcohol or substance abuse
9. Currently pregnant
10. Use of any other investigational drug product within 30 days prior to treatment visit
Autonomic Cardiovascular Control After Heart Transplantation

The purpose of this prospective study is to investigate denervation (ie. surgical cutting of autonomic nerves) and re-innervation (ie. growth of autonomic nerves) in heart transplant recipients. More specifically, we focus on:

1. The physiological consequences of denervation, in particular its consequences for clinical symptoms, orthostatic tolerance (ie. the ability to stand upright) and exercise capacity. We hypothesize that denervation has negative consequences for all these factors.
2. The pathological consequences of denervation and reinnervation, in particular its association to acute rejection and coronary artery disease (cardiac allograft vasculopathy, CAV). We hypothesize that reinnervation protects against acute rejection and development of CAV
3. Donor and recipient factors associated with the reinnervation process. We hypothesize that characteristics of the surgical procedure (such as aorta cross-clamp time) as well as the rehabilitation process of the recipient (such as physical activity) impacts on the reinnervation process.

Heart transplantation is annually offered to more than 3500 patients worldwide. In Norway, the number is approximately 30/year, and all transplants are carried out at one single hospital (Oslo University Hospital, Rikshospitalet).

Normally, the heart function is intimately controlled by the autonomic nervous system (ANS), but all nervous connections are lost during the surgical transplantation procedure, and the transplanted heart thus becomes denervated. In time, regrowth of nerves may cause partial reinnervation of the new heart.

Some evidence suggests that reinnervation improves exercise capacity and reduces episodes of acute rejections and the development of cardiac allograft vasculopathy. The purpose of this study is further to investigate the changes over time with respect to all parts of the autonomic nervous system (the sympathetic, parasympathetic and sensoric part), and the associated physiological and pathological consequences.

The study may provide knowledge which ultimately could help us improve health and quality of live for heart transplant recipients.

Eligibility Criteria:
Inclusion Criteria HTRs:

* Completed heart transplantation during the last 7-12 weeks
* Age \> 16 years and \< 70 years

Exclusion criteria HTRs:

* Peri- or postoperative complications causing permanent dysfunction of the allograft (such as hyperacute rejection episodes, severe myocardial ischemia, etc.)
* Diabetes with HbA1C \> 6,5 % and/or manifest diabetic complications
* Renal failure with plasma creatinine \> 200 µmol/L
* ECG abnormalities (scattered ectopic beats ad minor conduction problems are allowed)
* Permanently bed-ridden

Inclusion criteria healthy controls:

- Age and gender matching the HTRs

Exclusion criteria healthy controls:

* Another chronic disease (such as diabetes mellitus)
* Permanent use of pharmaceuticals (including hormone drugs)
* Pregnancy
Heart to Health: A Combined Lifestyle and Medication Intervention to Reduce Cardiovascular Disease (CVD) Risk

Cardiovascular disease (CVD), including heart disease and stroke, is the leading cause of death in the US. Every year, more than one million Americans have a heart attack, and nearly 800,000 have a stroke. In 2010, heart disease alone is expected to cost the country more than $316 billion in health care and lost productivity.

Both lifestyle changes and medication can reduce the risk of CVD, and this project combines these approaches in the hopes of identifying a practical intervention for use in primary care medical offices. The project combines two previously tested interventions and updates them to meet current guidelines for diet and use of aspirin and cholesterol-controlling drugs (statins).

The research team is delivering the combined intervention in two formats: web-based and counselor-based. Each format has the same content, but the web-based advice is accessed through the Internet by clients at home, a community site, or a primary care office. The other format involves sessions delivered to clients by a counselor either in person at a primary care office or over the telephone. The researchers will compare how effective each format is in reducing participants' risk of coronary heart disease. They will also determine the interventions' effect on participants' diet, physical activity, smoking status, medication adherence, and other health indicators. In addition, the team will compare the two formats' cost-effectiveness and how well the patients, office staff, and clinicians accept the interventions.

Recruited from five family practices, 600 patients representing the geographic and ethnic diversity of North Carolina are taking part in this study. Half the participants are randomly assigned to the web-based intervention; the other half to the counselor-based version. Both groups will also get information on local resources, such as gyms and farmers markets, that can help participants maintain a healthy lifestyle.


Eligibility Criteria:
Inclusion Criteria:

* Established patients
* Men ages 35-79
* Women ages 45-79
* History of CVD (100 participants)
* CHD risk equal or greater than 10%
* elevated CHD risk factor

Exclusion Criteria:

* non-English speaking
* no phone
* treatment of psychosis
* history of alcohol/substance abuse within last 2 years
* pregnancy, breast feeding, or anticipated pregnancy in next 18 months
* history of malignancy, other than non-melanoma skin cancer, that has not been in remission or cured surgically for \>5 years
* recent history (in past year) of hypoglycemic event requiring medical attention
* estimated creatinine clearance less than 30 ml/min
Effects of Propofol and Sevoflurane on Early POCD in Elderly Patients With Metabolic Syndrome

The purpose of this study is to investigate propofol versus sevoflurane anesthesia on the effects of early postoperative cognitive function in elderly patients with metabolic syndrome.

By now, a series risk factors of cardiovascular diseases, which are also related to the development of postoperative cognitive dysfunction (POCD), are becoming more common.The investigators don't know whether propofol based anesthesia has a more severe impact on early postoperative cognitive function than sevoflurane in elderly patients with metabolic syndrome. In this study, the investigators want to investigate propofol versus sevoflurane anesthesia on the effects of early postoperative cognitive function in elderly patients with metabolic syndrome.

Eligibility Criteria:
Inclusion Criteria:

* aged ≥60 years;
* ASAⅡor Ⅲ
* noncardiac surgery and nonneural surgery

Exclusion Criteria:

* Mini Mental State Examination \[MMSE\] score too low
* chronic alcoho and drug abuse
* disturbed renal and liver function
* history of a cerebrovascular accident
* permanent ventricular pacing
* preoperative cognitive deficits
* lack of cooperation
Magnetic Resonance Fingerprinting in the Imaging of Endometrial Cancer

In this context, the aim of this study is to investigate the role of MRF in endometrial cancer. Several applications are possible. Firstly, T1-, T2- and DWI-mappings can be associated to molecular risk group classification, in order to stratify patients' risk without recurring to surgery. MRF parameters can be also correlated to prognosis, both in terms of disease-free survival (DFS) and overall survival (OS).


Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy-proven endometrial cancer;
* Women aged \> 18 years old;
* Signed Informed consent.

Exclusion Criteria:

* Previous history of neoplasm;
* Concurrent malignancies at other sites.
Negative Pressure Therapy in Preventing Infection After Surgery in Patients With Colon, Rectal, Pancreatic, or Peritoneal Surface Cancer

The purpose of this research study is to evaluate if a negative-pressure dressing placed over a surgical incision can reduce the risk of developing a surgical site infection compared to a commonly-used sterile gauze incision dressing. In this study, the negative-pressure dressing will be compared to a standard post-surgical sterile gauze dressing. In this study patients will either receive a negative-pressure dressing or a standard sterile gauze dressing

PRIMARY OBJECTIVES:

I. To determine whether negative pressure therapy applied to closed laparotomy incisions can decrease the incidence of incisional surgical site infections in patients undergoing clean-contaminated resections for colorectal, pancreatic, and peritoneal surface malignancies compared to standard post-operative sterile gauze dressings.

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

ARM I: Patients receive standard sterile dressing (SSD) over their closed laparotomy incision at the conclusion of their surgery.

ARM II: Patients receive negative pressure therapy (NPT) dressing over their closed laparotomy incision at the conclusion of their surgery.

After completion of study treatment, patients are followed up at 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Surgical resection for a colorectal, pancreatic, or peritoneal surface malignancy
* The scheduled procedure will be performed via midline laparotomy
* The planned procedure is a clean-contaminated (class II) case (includes gastric, small bowel, and colorectal resections, as well as bile or pancreatic duct transections)
* Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative)

Exclusion Criteria:

* Emergent cases will not be included in the study
* Pregnant patients will not be included in the study as pregnancy is a relative contraindication for these types of surgical procedures
* Clean (class I), contaminated (class III) and dirty (class IV) procedures will likewise be excluded
* Patients on chronic immunosuppressive medications, including steroids, within the past three months
* Patients with a history of skin allergy to iodine or adhesive drapes
* The planned procedure involves foreign material (such as mesh or subcutaneous drains) being left in the subcutaneous space at the time of surgery (for example, a ventral hernia repair); surgical drains that are placed to drain an intraabdominal space and exit the abdominal wall remote from the incision are allowed in the study
The Effect of Alpha-lactalbumin on Microbiota Composition

To evaluate the effects on microbiota composition after the administration of an oral supplementation based on Alpha-lactalbumin in subjects with dysbiosis.


Eligibility Criteria:
Inclusion Criteria:

* condition of dysbiosis

Exclusion Criteria:

* antibiotic treatment within 1 month
* probiotic or prebiotic treatments
* concomitant inflammatory intestinal diseases
* pregnancy
* neoplastic diseases
* allergy to milk protein (Alpha-lactalbumin)
* substance abuse
Internet Cognitive Behavior Therapy (CBT) for Body Dysmorphic Disorder (BDD)

The primary aim is to develop, and test the feasibility, of a novel and protocol-based cognitive behaviour therapy (CBT) treatment for body dysmorphic disorder (BDD) administered via the Internet.


Eligibility Criteria:
Inclusion Criteria:

* outpatients
* male or female

  -≥ 18 years
* currently living in Stockholm county
* primary diagnosis of BDD according to the DSM-IV-TR
* signed informed consent
* regular access to a computer with Internet access and skills to use the web.

Exclusion Criteria:

* psychotropic medication changes within two months prior to the treatment
* completed CBT for BDD within the last 12 months
* BDD-YBOCS \< 12 at psychiatrist visit
* other primary axis I diagnosis
* current substance dependence
* lifetime bipolar disorder or psychosis
* suicidal ideation
* Axis II diagnosis that could jeopardize treatment participation
* other current psychological treatment that could affect BDD symptoms
COVID-19 Quantitative Antibody Titers & Booster Vaccinations

This is an observational study aiming at describing COVID-19 vaccination outcomes among HIV-positive and HIV-negative individuals, using electronic health records to observe their usual clinical care. This study will describe levels of COVID-19 vaccine response (i.e., Ig spike antibody measurements). Rates of antibody level decay after vaccination will be assessed. The efficacy of using antibody levels to help guide the timing of booster doses among HIV-negative and HIV-positive patients will be evaluated.

The aim of this study is to assess levels of COVID-19 vaccine response through measuring surrogate Ig spike antibody measurements, to determine the rates of antibody level decay after vaccination, and to measure the efficacy of utilizing these antibody measurements to help guide the timing of booster doses among HIV-negative and HIV-positive patients.

The study population will include adults who were fully vaccinated against SARS-CoV-2 virus (i.e., two doses of Pfizer or Moderna vaccines or one dose of the J\&J vaccine), and have received a Roche SARS-CoV-2 Semi-Quant Spike Ig Ab test at least 3 weeks after full vaccination as part of their usual clinical care at AHF Midtown Manhattan Healthcare Center.

Incidence rates of COVID vaccine response levels (i.e., adequate, low, non-response) will be estimated using univariate Poisson regression, overall and by vaccine type. Among individuals with at least two antibody measurements, rates of antibody levels decay will be estimated using univariate linear regression, overall and stratified by HIV status, vaccine type and baseline CD4 cell count. In the sub-population of individuals who received a COVID vaccine booster, vaccination and antibody response will be characterized at least 3 weeks after the booster is received. Univariate linear regression will be used to estimate rates of antibody levels decay, among individuals with at least two antibody measurements, including one after the booster dose. Rates of response decay will be produced overall, and stratified by HIV status, booster type and baseline CD4 cell count.

Eligibility Criteria:
Inclusion Criteria:

* Cared for at AHF Midtown Manhattan Healthcare Center and followed in the OPERA observational database
* Active in care in the last 24 months
* Fully vaccinated against SARS-CoV-2 virus, implemented as 21 days after the second Pfizer or Moderna injections, 21 days after the one J\&J injection
* Received a Roche SARS-CoV-2 Semi-Quant Spike Ig AB test after full vaccination as usual clinical care

Exclusion Criteria:

* Unvaccinated or partially vaccinated against SARS-CoV-2 virus
* Never tested with a SARS-CoV-2 Semi-Quant Total AB test after full vaccination
OEA and LipiSperse Metabolic Study

A placebo controlled, single blind, cross-over study evaluating the short-term effect of oleoylethanolamide (OEA) with LipiSperse supplementation on metabolic pathways in healthy participants.

This study aims to compare the metabolic effects of two different doses of OEA with LipiSperse to a placebo in healthy participants over an 8-hour period. There are three trial arms in this study. Each participant will complete all 3 arms of the study, for a 3-way cross-over.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 30 years and older
* Generally healthy
* BMI 25.0-34.9 kg/m2
* Able to provide informed consent
* Agree to not participate in another clinical trial while enrolled in this trial
* Agree not to change current diet and/or exercise frequency or intensity during entire study period
* Females using a prescribed form of birth control (e.g. oral contraceptive)
* Participant's ability to participate fully and comply with demands of the study including attendance at all scheduled blood collection time points

Exclusion Criteria:

* Have a serious illness e.g. neurological disorders such as MS, kidney disease, liver disease or heart conditions
* History of any glucose or insulin regulation problem, including diabetes.
* Have an unstable illness e.g. thyroid gland dysfunction, uncontrolled mood disorders (e.g., depression, anxiety, bipolar).
* Diagnosed with any known metabolic or endocrine dysfunctions e.g., diabetes, NAFLD, hyperinsulinemia, hypoglycaemia.
* Use of any medication or supplements that may affect any metabolic pathway associated with satiety (e.g., GLP-1, GIP, glucagon), glucose or insulin.
* Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
* Significant change in diet in the past 1-month (e.g., removal of a food group or calorie restriction)
* Active smokers, nicotine use or drug (prescription or illegal substances) abuse
* Chronic past and/or current alcohol use (\>21 alcoholic drinks week)
* Pregnant or lactating women
* Allergic to any of the ingredients in active or placebo formula
* Participants who are or who have participated in any other clinical trial during the past 1 month (excludes RDC clinical trials which are to be assessed on a case-by-case basis).
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
* Regular use within the past 4 weeks of supplements containing OEA and/or LipiSperse
Posterior Circulation ASTRAL Prognostic Score

The goal of this study is to develop a prognostic score for ischemic posterior circulation strokes, based on our previous work on with the ASTRAL scores (Acute STroke Registry and Analysis of Lausanne) on overall stroke prognosis, intracranial occlusion, recanalization and stroke recurrences. The main question it aims to answer is the modified Rankin score in 3 months after the event.

Participants will be patients with acute ischemic stroke of the posterior circulation with mRS priot to event \<3. All the data will be collected retrospectively from patients included in the ASTRAL registry between January 2003 and December 2021. The ASTRAL registry will be used as the derivation cohort of the score. Demographics, acute glucose, NIHSS score and acute imaging of each participant will be used from the derivation cohort in order to create an integer-based prognostic score. After internal validation, we plan to validate the score in external stroke registries to show its validity.


Eligibility Criteria:
Inclusion Criteria:

* Isolated posterior circulation strokes based on clinical or/and imaging evidence.
* Arriving within 24h at hospital since last proof of good health.

Exclusion Criteria:

* no available data for 3 months modified Rankin Score
* modified Rankin Score≥3 prior the event
Staphylococcus Aureus Bacteraemia in Adults

The purpose of this evaluation is to record the management and outcome of adults with S.aureus bacteraemia (SAB) across multiple European, Asian and North American sites and to identify key quality indicators associated with improved outcome.

Staphylococcus aureus (S. aureus) is one of the most common causes of bloodstream infections. Associated mortality has been reported to vary widely (4%-40%) although no obvious explanation for such variation has been identified.

Despite the existence of clinical guidelines, there is considerable variation in the management of S.aureus bacteraemia (SAB) between centres. Part of the variation in clinical management is due to the limited evidence base defining optimal therapy. Fewer than 1500 patients have been recruited to randomised controlled trials in the past 40 years; practice is therefore based largely on experience and observational studies.

The purpose of this evaluation is to record the management and outcome of adults with SAB across multiple European, Asian and North American sites. We aim to establish a broader knowledge base, identify key quality indicators associated with improved outcomes, and to provide comparator data to ensure that patients enrolled in randomized controlled trials are representative of bacteraemic S. aureus patients as a whole. All participating centres are experienced in the management of S. aureus bacteraemia and in conducting evaluations of current management practice and outcomes from S. aureus bacteraemia. Data is checked for plausibility by a centralized data quality control group.

Eligibility Criteria:
Inclusion Criteria:

* S. aureus (methicillin sensitive or resistant) isolated from one or more blood cultures

Exclusion Criteria:

* Recurrent episodes of S. aureus bloodstream infection
* Polymicrobial infection