cyrilzakka/clinical-trials huggingface dataset:
Hepatic Blood Flow Changes During Fluid Challenge Assessed by MRI in Volunteers Subjects.

Hepatic artery and portal flows are both regulated to assume the whole hepatic blood flow. Each counts for respectively 25% and 75%. That so-called "buffer response" assumes that when portal flow increases, hepatic artery flow decreases. During fluid challenge in intensive care unit, fluid challenge is often administered to improve hepatic perfusion. That observation is not demonstrated. The aim of the study is to test buffer response and portal flow during fluid challenge.

Prospective monocentric study at Amiens Hospital University. 20 volunteers subjects will be include after providing informed consent. Fluid challenge will be performed with 500 ml of intra venous NaCl (0.9%). Hepatic blood flow measurement will be performed using MRI.

Eligibility Criteria:
Inclusion Criteria:

* Fasting for the last 12 hours.

Exclusion Criteria:

* Claustrophobia
* Any previous medical history disease;
* Any abdominal surgical disease
* Pregnancy or breastfeeding
Study and Role of Inflammasome in Platelet Activation During Bacterial And/or Viral Sepsis

: Sepsis, now defined as life-threatening organ dysfunction due to a dysregulated host response to infection, is an important global health problem representing about a fifth of all global deaths. It can be associated, in some cases, with multiple organ failure and cytokine storm. The main objective of this study is to estimate and to compare the activation rate of the Nucleotide-binding domain Leucine Rich repeat containing Protein 3 (NLRP3) inflammasome in platelets between five groups of patients suffering from bacterial and/or viral sepsis, with different severity levels according to Sequential Organ Failure Assessment (SOFA) score to precise the platelets' implication in this cytokine storm.

Patients with bacterial or vial sepsis have been shown to exhibit very high levels of pro-inflammatory cytokines (IL1, IL6, IFN, IP10 and MCP1) that may activate the T-helper-1 lymphocytic response (Th1). These cytokines can be produced by several cell types, including blood platelets. IL1 is an important pro-inflammatory cytokine whose expression is increased in various pro-inflammatory contexts, including dengue infection. It induces an increase in endothelial permeability and a pro-thrombotic state, as described in patients infected with COVID-19. It is synthesized as a protein precursor that is cleaved by the NLRP3 (Nucleotide-binding domain Leucine repeat Rich containing Protein 3). Close associations between the deregulation of inflammasome activity and hereditary or acquired diseases suggest an important role of NLRP3 inflammasome in regulating immune responses. The activation of the NLRP3 inflammasome increases caspase 1 activity and induces the production of bioactive IL1 as well as other pro-inflammatory cytokines such as IL18. The major role of NLRP3 platelet inflammasome in the "cytokine storm" has been highlighted in the case of Dengue virus infection. We hypothesize that blood platelets may play an important role in the inflammatory response observed during sepsis through the activation of NLRP3 inflammasome, particularly during its exacerbation.

* Five groups of patients will be constituted: patients with leptospirosis, patients with bacterial infections including in-hospital-acquired-infections, patients with viral infection, patients non infected (control group), patients with viral infection SARS-COv2 +.
* Only one blood collection will be realized

Eligibility Criteria:
Inclusion Criteria:

* For all groups: patients older than 18 years at inclusion and acceptation of participation by the patient, his relative or his legal representative (depending on the situation)
* For groups 1, 2, 3 and 5: Patient with a confirmed sepsis (microbiological confirmation)
* For group 4 : Patient non infected

Exclusion Criteria:

* Refusal of participation by the patient, his relative or his legal representative (depending on the situation)
* Patients subject to a safeguard measure of justice
* Patients younger than 18 years at inclusion
Study of Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients

The purpose of this study is to compare normalization of vitamin D serum level after 6 months of vitamin D supplementation adjusted to baseline vitamin D serum level vs.conventional vitamin D supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Breast adenocarcinoma treated by neoadjuvant or adjuvant chemotherapy within 12 months prior to study enrollment
* WHO performance status 0-1
* Age ≥18 years old
* Affiliation to a social security regime or beneficiary of equivalent social protection
* Written informed consent provided before any study specific procedures

Complementary inclusion criterion for randomization

- Proved vitamin D deficiency as defined by serum vitamin D level lower than 30 ng/ml (75 nmol/L).

Exclusion Criteria:

* Metastatic disease
* History or presence of any other malignancy (except curatively treated nonmelanoma skin cancer or in situ cervix carcinoma) .............

traités dans les 5 ans précédents.

* Contraindication to calcium or cholecalciferol
* Known severe hypersensitivity to vitamin D or to calcium supplementation or to one of the excipients.
* Disease and/or medical conditions accompanied by hypercalcaemia and/or hypercalciuria
* Calcium lithiasis and tissue calcification
* Hypervitaminosis D
* Presence of significant comorbidities:

  i) Uncontrolled endocrine disease ii) Known disorders of calcium phophorus laboratory testing iii) Proved osteopenia or osteoporosis requiring vitamin D and calcium supplements
* Concomitant treatment with other experimental products or another vitamin D calcium treatment
* Pregnancy, breastfeeding or of reproductive potential not using an effective contraceptive method
* Legal inability or restricted legal ability. Medical or psychological conditions not allowing proper study completion or informed consent signature
Study of Norepinephrine Levels and Sympathetic Nervous System Activity

Brain and nerve cells communicate with each other by releasing and picking up chemicals called neurotransmitters. Norepinephrine is a neurotransmitter used by part of the nervous system activated during stress called the sympathetic nervous system. The sympathetic nervous system is involved with regulating blood pressure and pulse rate. Researchers believe the level norepinephrine in the blood can be used to measure activity of the sympathetic nervous system.

This study is designed to answer important questions about rates of release of norepinephrine into the blood stream, removal of released norepinephrine, and the sympathetic nervous system response to stress.

Researchers will attempt to measure levels of norepinephrine and activity of the sympathetic nervous system in patients with high blood pressure, normal patients with family histories of high blood pressure, patients taking drugs that can effect levels of norepinephrine, and patients with diseases or conditions directly affecting the sympathetic nervous system.

In order to examine sympathetic nervous system function in neurocardiological disorders and catecholaminergic effects of dietary manipulations or neuropsychiatric drugs, the protocol calls for evaluations of the kinetics of 3H-norepinephrine or 3H-epinephrine in patients with hypertension, dysautonomias, or disorders thought to involve abnormal catecholaminergic function, and in normotensive normal volunteers. Apparent spillover and clearance rates are estimated based on the norepinephrine or epinephrine concentration during the infusion and their steady-state specific activities, under resting conditions and in response to physiological or pharmacological manipulations thought to affect sympathetic outflows.

Eligibility Criteria:
Must be greater than or equal to 18 years of age.

Must not be pregnant or lactating.
A Comparative Analysis of Healthy Young Adults Stratified by Gender.

This project was planned to examine whether there is a difference between nutrition knowledge level, reward-related eating behaviour and body awareness in healthy young adults according to gender.

Nutritional knowledge is among the factors that affect individuals\&#39; eating habits and diet quality. Food consumption is rewarding in itself as it increases energy and eliminates hunger (an unpleasant sensation); however, daily experiences show that people often eat without hunger. Individuals with high body awareness are expected to be aware of the changes occurring in their body and to change these changes. In the project, nutrition knowledge level, reward-related eating behaviour and body awareness will be compared according to gender in healthy young adults, and all these values will be evaluated through scales. The study data will be collected with a single interview by face-to-face interview method. Each participant will be informed about the study and their written and verbal consent will be obtained. The application time of the questionnaires is expected to take approximately 10 minutes for each participant. In case of a difference between genders for the values investigated, it is aimed to develop individuals\&#39; awareness of these situations. In addition, the relationship between these situations will also be evaluated. It is aimed to create awareness for the situations that are found to be related.

Eligibility Criteria:
Inclusion Criteria:

* 18-30 years old

Exclusion Criteria:

* Under 18 years old
* not volunteering
CBT-I in Primary Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial

This study seeks to investigate an evidence-based, manualized, behavioral health intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I), in individuals with primary brain tumors (PBT) and insomnia. Our project will assess the feasibility and acceptability of recruitment, enrollment, data collection procedures, and retention of individuals with PBT and insomnia in the behavioral health intervention, CBT-I, and investigate the potential benefits of CBT-I within this at-risk and understudied population. In the long term, the goals are to expand treatment options for neuro-oncology patients and improve their mission readiness and overall wellbeing.


Eligibility Criteria:
Inclusion Criteria:

* Primary brain tumor diagnosis (grade I-IV)
* \>/=2weeks post-cranial resection (if applicable)
* \>/=1 month post-radiation therapy (if applicable)
* Able to understand, speak, and read English
* Absence of major cognitive concerns
* Meet Diagnostic and statistical manual of mental disorders version 5 (DSM-V) diagnostic criteria for insomnia
* Reliable internet connection

Exclusion Criteria:

* Major communication difficulties that would prohibit effective intervention
* Inability to attend weekly virtual group meetings
* Inability to understand and provide informed consent
* Currently a prisoner or residing in a correctional facility
Continuous Laryngeal Cuff Pressure Monitoring

The aim of this study is to evaluate the airway seal of LMA during intraoperative manipulation.

The laryngeal mask airway (LMA) is widely used in dental surgery as it provides an unobstructed airway and provides a reliable seal from bleeding and surgical debris. However, there have been few studies of the integrity of the LMA seal during intraoperative surgical manipulation with the use of the LMA.

In general anesthesia using LMA, airway and esophagus cannot be separated completely. Insufficient airway seal become the risk of aspiration in airway management. This study will focus on airway seal following LMA use in dental surgery.

Eligibility Criteria:
Inclusion Criteria:

* NUH patients who will undergo wisdom teeth extraction.

Exclusion Criteria:

* Patients with tooth braces
* Patients who are at risk of aspiration
* Patients with missing any of incisor tooth
* Pregnant woman
* Non-English speaking patients
Toward Understanding Drivers of Patient Engagement With Digital Mental Health Interventions - Part I

This pilot study is a precursor to a subsequent clinical trial that will test the impact of a set of automated motivational messages on patient engagement with a digital mental health intervention. The pilot study aims to systematically employ patient feedback to develop the automated motivational messages that will be used in the subsequent clinical trial.

This is an in situ user-centered design pilot study to generate feedback on the automated motivational messaging the investigators are developing. Participants will download a digital mental health intervention (IntelliCare) to use for three weeks. During this three-week period, participants will receive automated motivational messages on a randomized schedule. That is, each day they will be randomized to either receive an automated motivational message (60% likelihood) or not receive an automated motivational message (40% likelihood). On days when a participant receives a message, the participant will be prompted to complete a brief survey on their reaction to the message received. At the end of three weeks, participants will be asked to complete a qualitative interview to provide further feedback on messages under development.

The primary outcome in this study is participant ratings from the brief surveys provided after automated motivational message delivery. We will also, however, look at participant feedback on messages under development in the qualitative interview as well as whether receiving a message makes users more likely to engage with the DMHI (IntelliCare) during the three hours following message delivery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Patient Health Questionnaire-8 (PHQ-9) score≥10 and/or Generalized Anxiety Disorder-7 (GAD-7) Score≥8 indicating clinically significant depression or anxiety respectively
* Owns a smartphone
* Fluent in English
* Individual has a Mass General Brigham primary care provider

Exclusion Criteria:

* Diagnosis of bipolar disorder, any psychotic disorder, or a current substance use disorder per patient's report or medical record.
* Acute and/or unstable medical problem that may interfere with participation (e.g., scheduled for surgery in the next two months).
Continuity of Care and Outcomes After Discharge From Hospital

1. INTRODUCTION: Continuity of care (COC) occurs when separate elements of patient care are connected. COC is made up primarily of Continuity of Provider (COP) and Continuity of Information (COI). Many authorities believe that COC is essential to high-quality care. Previous studies have shown poor COC in varied populations. Many studies have shown that increased COC has been associated with improved intermediate outcomes. However, no study has definitively determined whether COC or either of its components is associated with important outcomes. The Ontario-Outcomes After the Hospitalization (Ontario-OAtH) study will enroll 5900 adults who are discharged to the community from medical and surgical services from 13 teaching and community hospitals in 5 regions across Ontario. Patients will be followed for 6 months to record details about all interactions with the health care system. This information will give us a detailed measure of both provider and information continuity for all patients over time. The Ontario-OAtH study will have the power to precisely determine whether COC is associated with time to urgent readmission or death after hospital discharge. Since COC is potentially modifiable, the Ontario-OAtH study will give us essential information required for designing interventions to improve outcomes for patients after they are discharged from hospital.

See above

Eligibility Criteria:
Inclusion Criteria:

* discharged to the community from medical and surgical services

Exclusion Criteria:

-
Intraoperative Three Dimensional Fluoroscopy Compared to Standard Fluoroscopy for the Assessment of Reduction of Ankle Fractures With Syndesmosis Disruption

Ankle fractures are common injuries that are being operated routinely. In order to restore the long term function and prevent arthritis of the ankle the broken fragments should be put in place precisely. Inadequate reduction can result in pain and long term disability. Recently, based on MRI studies and clinical studies, a significant number of ankle fractures are apparently fixed with less than optimal results. We suggest that the use of a new device that enables better three dimensional imaging will improve the quality of operations performed for ankle fractures.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with unstable ankle fractures (as classified by the AO as 44B 44C by Lauge Hansen PER4 or SER4) amenable to open reduction and internal fixation.
2. Patients with syndesmotic rupture as evident from the injury films or during clinical testing in the OR be included in the study.
3. Intraoperative testing will include both a cotton Test and a stress view obtained after bimalleolar fixation has been attained.
4. A positive syndesmotic injury will be defined by the criteria of Pettrone et al as follows: a tib/fib clear space \>5mm or tib/fib overlap of \<10mm (on the AP view), or a tib/fib overlap of \<1mm on the mortise view.

Exclusion Criteria:

1. Patients with a pilon fracture (i.e. plafond fractures AO type 43B and C) will be excluded even if associated with a fibula fracture and syndesmosis disruption.
2. Patients with contraindications to operative treatment and diabetics
3. Women of childbearing age will be excluded if they present with a positive pre-op Beta HCG test or if they refuse a B HCG test.
Studies of the Natural History of Rheumatic Disease

This study will explore the causes of rheumatic diseases and why many of them affect certain minority communities more severely. Rheumatic diseases may cause joint pain, stiffness or swelling. Some can involve bones, muscles, tendons or ligaments. Some cause abnormalities of the immune system the body s defense against disease. Some rheumatic diseases are painful or deforming and some can be life threatening. Information obtained from this study will be used to learn about the disparities in rheumatic disease in the minority community and to design further, more targeted, research studies to address this issue.

Patients with known or suspected rheumatic disease 18 years of age or older may be eligible for this study. Candidates will undergo a medical history and physical examination to confirm the diagnosis of rheumatic disease and determine what is needed for evaluation and treatment.

Participants will receive standard medical care for rheumatic disease and arthritis. No experimental treatments, medications or procedures will be included in this study. Procedures may include routine blood tests for blood chemistries, cell counts, and antibodies commonly found in patients with rheumatic disease; a urine test for proteins and cells; and X-rays and other imaging tests to check for abnormalities in the lungs or other organs. All medical information will be kept confidential.

Patients who are found to be eligible for other current NIH research studies will be offered an opportunity to participate in these studies.

...

This protocol will permit the evaluation and treatment of subjects who are members of the minority community, for the purpose to facilitate understanding the pathogenesis and natural history of rheumatic diseases in this community. Patients will be evaluated with a history and physical examination and routine laboratory studies will be obtained as needed to assess diagnosis, disease activity, disease complications and to monitor for treatment-related responses and toxicities. Patients eligible for other research protocols will be offered an opportunity to participate in these studies by signed informed consent. Any medical care recommended or provided to the patient will be consistent with routine standards of practice and will be provided in consultation with the patient s referring physician. All patients referred to this study must have a primary care provider provide a referral. The establishment of this protocol will provide a means to evaluate and treat patients from the minority community, and to generate hypotheses and protocols based on this clinical experience that will address questions of health disparities in the rheumatic diseases.

Eligibility Criteria:
* INCLUSION CRITERIA:

Known or suspected rheumatic disease

Age greater than or equal to 18 years

Willingness and capacity to provide informed consent.

EXCLUSION CRITERIA:

Patients will be excluded if any of the inclusion criteria cannot be met.

Women who are pregnant or breastfeeding at the time of enrollment.
Pharmacokinetics, Pharmacodynamics and Safety Study of Z-213 to Iron Deficiency Anemia

The safety, tolerability, pharmacokinetics and pharmacodynamics of Z-213 will be investigated in patients with iron-deficiency anemia after administration of a single dose (100 mg, 500 mg, 800 mg or 1,000 mg iron).


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild iron deficiency anemia

Exclusion Criteria:

* Patients with anemia caused by conditions other than iron deficiency
* Patients with abnormal laboratory test values at screening for C-reactive protein, Serum phosphorus, Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin
* Patients with liver, kidney or circulatory system disease
* Patients with a history or present illness that is a malignant tumor or autoimmune disease
* Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening
* Patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening