cyrilzakka/clinical-trials huggingface dataset:
"Neighborhood Disadvantage, Sleep and Vascular Health"

The purpose of the study is to find out the effects of neighborhood disadvantage and sleep disparities contribute to racial disparities in cardiometabolic health and blood pressure in young adults.

There are well-documented disparities between Black and white Americans in the incidence of cardiovascular disease, the leading cause of death in America. There are also disparities between Black and White Americans in the incidence of hypertension (high blood pressure; BP), which is the leading risk factor for cardiovascular disease. Our long-term goal is to determine effective strategies to prevent racial disparities in cardiovascular health. In this proposal, the investigators will focus on determining societal and biological mediators of racial disparities in young adults that can be targeted in future interventions. Poor sleep is associated with adverse cardiovascular events and hypertension. Moreover, recent meta-analyses demonstrate that Black adults have consistently poorer sleep health than White adults, including receiving fewer total sleep minutes and having worse overall sleep quality. Neighborhood socioeconomic environments influence health behaviors through both material resources (e.g., access to healthful foods and safe public space) and social norms (e.g. exercise, diet, smoking). A well-documented history of discriminatory policies and practices has resulted in black individuals living in more disadvantaged physical and social environments than whites. As such, they experience greater adverse exposures (e.g., racism, violence and stress), which negatively impact sleep, resulting in dysregulation of cardiometabolic health. Therefore, the investigators seek to determine the role of neighborhood disadvantage and sleep in contributing to racial disparities in cardiovascular health.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Systolic blood pressure greater than 150 mmHg
* Diastolic blood pressure greater than 90 mmHg
* Body mass index above 35 kg/m\^2
* History of cardiovascular disease
* Recent (one year) history of cancer
* History of metabolic disease (e.g. type 2 diabetes)
Discovery of Novel Biomarkers That Will Lead to the Early Detection of Alzheimer's Disease

This study will perform a targeted metabolic analysis in blood and urine samples from subjects attending the Baylor AT\&T Memory Center. The aim is to identify novel biomarkers that can distinguish normal aging subjects with no cognitive impairment from those with mild, moderate or severe cognitive impairment associated with Alzheimer's disease. Subjects will also be screened for B-vitamin deficiencies that may correlate with other metabolic biomarkers and Alzheimer's disease.

All subjects will be clinically assessed using standard measures of clinical care. Cognitive function will be assessed by the Montreal Cognitive Assessment (MoCA). Disease severity will be assessed by the Clinical Dementia Rating Scale (CDR). Social function will be assessed by the Functional Activities Questionnaire (FAQ). Based on clinical assessment, subjects will be classified into one of the following groups.

1. Normal (Spouse or Caregiver)
2. Mild cognitive impairment
3. Alzheimer's disease A. Mild B. Moderate C. Severe

The investigators plan to enroll 60 subjects in each group from 1 and 2; 40 subjects in each of the groups 3A and 3B and 20 subjects in group 3C.

Eligibility Criteria:
Inclusion Criteria:

A. Both Males and females B. Patients at least 40-years of age C. Mild Cognitive Impairment D. Alzheimer 's disease

1. Mild
2. Moderate
3. Severe

Exclusion Criteria:

A. No recent major surgery within the last 6 months B. Free of any malignant disease C. No chronic renal disease D. No other major neurodegenerative disorders (i.e. Parkinson's disease, multiple sclerosis)
Cerebral and Autonomic Responses to Pain in Healthy Humans

Evaluating the intraoperative pain is a major challenge for the anesthesia team. During anesthesia, changes in heart rate and blood pressure are interpreted qualitatively to evaluate the sympathetic response to nociceptive stimulation or the adaptation of analgesia during surgery. The new nociception monitors under development quantitatively explore other variables dependent on sympathetic activity or sympathetic / parasympathetic balance, such as the pulse wave amplitude measurement (Surgical Pleth Index (SPI index)), the pupil dilation reflex, respiratory sinus arrhythmia (ANI, Analgesia Nociception Index), or skin conductance index. Taken independently, these tools provide an assessment of nociception based on variations in the autonomic system, more robust than simply observing heart rate or blood pressure raw values.

However, the relationship between variations in the neurovegetative system and pain can be compromised by various factors or intraoperative events such as hypovolemia, bleeding, certain sympathomimetic or sympatholytic treatments, the hypnosis depth, ventilation variation, fast filling, or body temperature. Moreover, investigators do not know the delay between the application of the painful stimulus and the observation of the variation of the different neurovegetative variables. This constitutes a limit of the practitioners' confidence in these monitoring tools.

The nociception transmission pathways of to the vegetative centers and cortical areas are complex. Investigators hypothesis is that neurovegetative variations in response to nociceptive stimulation are not always associated with a cortical somatosensory response. In this project investigators investigate the relation between cortical (EEG) and vegetative reactions to acute and tonic nociceptive stimuli, as a preliminary step to apply these procedures to assess intraoperative reactions to nociceptive procedures in anesthetized patients.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer over 18 years old
* signed informed consent
* affiliated to a social security

Exclusion Criteria:

* Chronic pathology requiring chronic treatment
* Cardiac rhythm disorders, pacemaker, cardiotropic treatment
* Taking opioid analgesics during the previous week
* Painful chronic, or migraine
* Pathology of the hand, acrosyndrome, carpal tunnel syndrome
* Pregnancy
* People placed under protection of justice
Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in TAVI

TAVI is increasingly adopted as standard treatment for many subgroups of patients with aortic stenosis. However, due to a lack of data there is yet no TAVI-specific guidance regarding the optimum periinterventional drug regimen.

The study evaluates the effect of dual antiplatelet pretreatment on periinterventional embolic cerebral lesions and bleeding complications in patients undergoing transfemoral aortic valve implantation (TF-TAVI).

Patients undergoing TAVI bear a high risk of ischaemic stroke, which is an independent predictor of mortality1. Dual antiplatelet therapy (DAPT) is recommended by current guidelines without clear specifications on the time of initiation of treatment due to a lack of data. While some centers initiate DAPT with aspirin and clopidogrel prior to TAVI to reduce the rate of periinterventional embolic events, others start these medications after the procedure.Data on antithrombotic therapy during TAVI are scarce and no randomized evaluation has been performed to demonstrate what the best strategy is during the procedure.

Therefore, the objective of this clinical trial is to assess the efficacy of pre- versus postoperative dual antiplatelet loading with Aspirin and Clopidogrel on volume of periinterventional cerebral ischemic lesions as quantified by diffusion weight MRI (DW-MRI) and neurocognitive function in patients undergoing transfemoral aortic valve replacement. The statistical trial design assumes superiority of preloading with DAPT regarding the primary endpoint.

Eligibility Criteria:
Inclusion criteria:

* Patients \>18 years and \<90 years
* Patients undergoing TF-TAVI for severe aortic stenosis (combined with aortic regurgitation)
* Informed consent

Exclusion criteria:

* TIA/Stroke within last 90 days
* Aortic valve-in-valve procedures
* TAVI for treatment of isolated aortic regurgitation
* known significant carotid stenosis (\>70%)
* Prior myocardial infarction or revascularization with PCI or CABG within past 3 months
* Clopidogrel and/ or Aspirin within past 7 days
* any other indication for (dual) antiplatelet therapy
* Contraindication to MRI (MRI conditional pacemakers accepted!)
* participation in another interventional trial
* cardiogenic shock (positive shock index OR need for catecholamine support OR systolic bloodpressure \< 90 mmHg) or need for pre-hospital intubation
* cardiac arrest \<90 days prior to randomization
* Pregnant or lactating females
A Study of Anticoagulation Treatment Patterns and Outcomes of Participants Hospitalized With Coronavirus Disease 2019 (COVID-19) in Japan

The purpose of this study is to describe demographic and clinical characteristics of participants who are hospitalized due to coronavirus 2019 (COVID-19), treatment use for COVID-19 and COVID-19 symptoms, and composite outcomes of COVID-19. This study will also compare composite outcomes between COVID-19 participants treated with and without anticoagulant therapy during follow-up period.


Eligibility Criteria:
Inclusion Criteria:

• At least one diagnosis code for COVID-19 (International Classification of Diseases (ICD)-10: U07.1 or B34.2) during hospitalization

Exclusion Criteria:

• None
Effect of Minocycline on Delirium Incidence in Critically Ill Patients

Delirium is a disorder of consciousness characterized by an acute onset and fluctuating course of impaired cognitive functioning. It is associated with unfavorable outcomes in hospitalized patients, including longer hospital length of stay, need for subsequent institutionalization and higher mortality rates. Patients in the intensive care unit (ICU) under mechanical ventilation and older age are at higher risk for the development of delirium. Several studies suggest that minocycline, through its anti-inflammatory effect, was able to prevent neuronal dysfunction in different models of ICU-related diseases. Thus, the present study aimed to evaluate the effect of minocycline on delirium development in critically ill patients. Patients will be randomized into one of two groups: the intervention group that will receive 100mg of minocycline 2 times a day and the placebo group. Medication or placebo will be continued for 28 days or until ICU discharge (whichever occurs first). Delirium will be diagnosed by the CAM-ICU. Coma will be defined by the Richmond Agitation-Sedation Scale (RASS) score of -4 or -5 and biomarkers will be used as alternative outcomes related to the pathophysiology of the disease (IL-1, IL-6, IL-10, and BDNF).


Eligibility Criteria:
Inclusion Criteria:

* Clinical or surgical patients,
* Over 18 years,
* Expected ICU stay of at least 2 days estimated by the attending intensivist,
* Agree to participate in the study

Exclusion Criteria:

* Delirium prior to inclusion,
* Diagnosis of Parkinson's disease
* Diagnosis of dementia,
* Alcohol abuse history,
* Acute neurological condition at admission
* History of psychiatric disease
* Use of antipsychotics
* Pregnant or breastfeeding women,
* Expectation of death within 2 days
* Hospitalized for exclusive palliative care
* Known allergy to minocycline
Age of Red Blood Cells in Premature Infants Study (ARIPI)

To determine if the age of blood transfused to new borns in the NICU setting has an impact on their outcome.


Eligibility Criteria:
Inclusion Criteria:

* birthweight of less than 1250g
* admitted to participating NICU
* consent acquired from proxy for the patient

Exclusion Criteria:

* already received one or more transfusions
* requirement for an exchange transfusion
* will be receiving directed donations
* have rare blood types/difficult cross-match
* proxy has refused consent
* moribund on admission to NICU/expected to die
* mitigating child protection issues
Neuroinflammatory PET Imaging in Autoimmune Encephalomyelitis

Autoimmune encephalomyelitis is a heterogeneous group of central nervous system (CNS) autoimmune diseases characterized by the production of anti-neuron-associated autoantibodies which target neuronal surface proteins, synaptic receptors and intracellular antigens. MRI, as a current first-line imaging tool of CNS inflammation, is difficult to diagnose them because the majority of patients have normal MRI images, and only a few may show local signal or structural abnormalities (including inflammation, edema, or atrophy). The 18 kDa translocator protein (TSPO) expression in the CNS is upregulated in response to microglia activation. DPA-714 is high affinity for binding to TSPO, making 18F-labeled DPA-714 (18F-DPA-714) PET a very promising diagnostic imaging tool for neuroinflammation in patients with autoimmune encephalomyelitis.This study aims to explore the value of 18F-DPA-714 PET in the early diagnosis, therapeutic assessment and prognosis in patients with autoimmune encephalomyelitis.


Eligibility Criteria:
Experimental group:

Inclusion criteria:

1. Patients with onset for less than 2 years
2. Serum autoantibody positive
3. cognitive impairment or movement disorder diagnosed by two or more certified specialists.

Exclusion criteria:

1. Patients who do not meet the clinical、laboratory and imaging criteria of immune-related cognitive and movement disorders
2. Medical history of surgery, trauma, stroke, tumor in brain or spine cord
3. Alcoholism or drug dependence (addiction)
4. Patients with pregnancy

Healthy Volunteers group:

Inclusion criteria:

1. able to understand the purpose of clinical research and test plan
2. In the brain and spine cord MR assessment, it is judged as "normal"

Exclusion criteria:

1. Any major mental illness; history of schizophrenia or schizoaffective disorder
2. Any important neurological disease, such as cerebrovascular disease, inflammation or infectious disease, demyelinating disease, neurodegenerative disease, trauma in brain or spine cord
3. History of alcohol or drug abuse/dependence
4. Medical history of cardiac and lung disease, tumors, blood disease, poorly controlled chronic diseases
5. Patients with pregnancy
A Novel Iron-Based Supplement for Athletes Aged 18-25: Phase II

Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study aims to assess the efficacy of a novel iron supplement in improving iron status, gut microbiome, and exercise performance in endurance-trained females.

Current iron supplements on the market are commonly associated with side effects including gastrointestinal distress, nausea, vomiting, and constipation. As a solution, we have developed a novel delivery system for iron supplementation that overcomes many of these limitations. The goal of this study is to assess the efficacy of a yeast-iron complex in improving iron status, gut microbiome, and exercise performance in young, endurance-trained females with sub-optimal iron status. Participants will consume 40mg of elemental iron every second day for 8 weeks. Before and after supplementation,participants will be assessed for exercise capacity (VO2max), iron status, and the current state of the gut microbiome. each week during supplementation, participants will complete a survey in in which they will report feelings of stress and recovery as well as gastrointestinal symptoms.

Eligibility Criteria:
Inclusion Criteria:

* cis-gendered female 18-25years old
* sub-optimal iron status (ferritin ≤45mcg/ L)
* At least 1 year past the age of menarche
* Engage in moderate to vigorous endurance activity for at least 3 hours a week

Exclusion Criteria:

* Supplemented with iron iron (\>5mg/day), prebiotics, or probiotics in last 3 months
* antibiotic use in last 3 months
* - Energy availability \>30 kcal/kg lean body mass
Dolutegravir Plus Lamivudine Simplified Therapy

Dolutegravir (DTG) is one type of integrase inhibitor, lamivudine (3TC) is one type of reverse transcriptase inhibitor, both of which are HIV medicine prevents HIV from self-multiplying, reduces the viral load. The data of the existing randomized controlled clinical studies show that the simplified two-drug DTG-based regimen is similar to the three-drug regimen in terms of efficacy, but there are no relevant data and reports on the efficacy and safety of DTG+3TC in HIV-infected patients in China so far. This project aims to explore the efficacy and safety of the DTG + 3TC regimen for HIV-infected patients in real clinical environment, to guide clinical application, and to provide a theoretical basis for the selection of simplified schemes for the formulation of guidelines.

This study was done to see if the combination of two anti-HIV medicines, dolutegravir (DTG, Tivicay) and lamivudine (3TC, Epivir) taken once a day, provide a safe, effective, and well-tolerated treatment for HIV.

This study is an open-label, multicentered, single-arm and phase IV clinical trial. 300 HIV-infected patients who received simplified treatment regimen (50mg DTG+ 400mg 3TC, oral, qd) were selected to observe the treatment efficacy. At week 24, 36, 48 and 96, the rate of viral suppression and CD4 cell count were calculated against baseline. In addition, the safety and drug compliance were also monitored.

Eligibility Criteria:
Inclusion Criteria:

1. Age (\> 18 years), male and female;
2. HIV-1 infected;
3. Using a standard three-drug-based regimen for at least 24 weeks. Based on clinical decision making\* decide if patients can be treated with the DTG+3TC simplified scheme for a variety of reasons, such as (but not limited to): patients cannot tolerate the conventional three-drug treatment scheme, renal insufficiency, osteoporosis, bone marrow suppression and for other reasons patients cannot use the conventional three-drug treatment scheme;
4. Initial HIV-1 RNA viral load and CD4 cell count were unlimited.
5. CD4 can be monitored at least three times in the first year (including baseline, 24 weeks of treatment and 48 weeks of treatment). After the first year, CD4 can be detected at least once every six months.
6. State Informed Consent for Free Treatment has been signed;
7. Good compliance and signing Informed Consent

(\* Reference criteria: Refer to APSIRE study, creatinine clearance rate (\> 50 mL/min), no DTG/3TC allergy history, HBsAg negative, no chronic liver disease, no severe liver damage, no pregnancy during the study)

Exclusion Criteria:

1. Has participated in other clinical trials of HIV vaccine or other drug trials in the past three months;
2. Researchers decide if patients could/not complete the scheduled follow-up (factors to consider such as weak, poor compliance, etc.).
3. Has a clear history of DTG or 3TC allergy;
4. HBsAg and/or HBV-DNA positive;
5. Pregnancy during the study period.
Patient Perception Questionnaire Validation

Validation of the patient perception questionnaire relating to CPAP use

This research is designed to validate a questionnaire which aims to predict patient adherence to CPAP, therefore enabling the healthcare provider to better target initiatives to improve adherence.

Eligibility Criteria:
Inclusion Criteria:

* Mild-severe OSA patients
* Over 18
* Naive to CPAP
* Fluent english

Exclusion Criteria:

* Comorbidities
* Other sleep disorders
* Inability to tolerate CPAP
* Shift worker
Evaluation of the Efficiency of Propioceptive Study According to Radiological Stages in Patients With Knee Osteoarthritis

Evaluation of the Efficiency of Propioceptive Study According to Radiological Stages in Patients with Knee Osteoarthritis

Investigators divided patients with knee osteoarthritis into two groups. Group 1 consisted of stage 1 and stage 2 patients. Group 2 consisted of stage 3 and stage 4 patients. Proprioceptive training was applied in both groups. Investigators aim is to evaluate the effect of proprioceptive exercises on knee osteoarthritis according to the radiological level.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with knee osteoarthritis by a specialist physician using MRI, US or radiography and physical examination.
* Being between the ages of 35-70
* Stage 1-2-3-4 according to Kellegran Lawrence (K-L) in radiological examination

Exclusion Criteria:

Having active synovitis

* Having received physical therapy in the last 6 months
* Those with neurological problems that affect walking
* Those with serious respiratory, central, peripheral, vascular and uncontrolled metabolic problems that will prevent exercise
* Has had lower extremity surgery in the past
* Intra-articular steroid injections within the last 6 months
* Using psychoactive drugs
* Those with serious vision, hearing and speech disorders
* Patients with vestibular dysfunction will not be included in the study
Phase I Pilot Study of Liver-Directed Gene Therapy for Partial Ornithine Transcarbamylase Deficiency

OBJECTIVES:

Evaluate the safety and feasibility of administering recombinant adenovirus containing the ornithine transcarbamylase gene to adults with partial ornithine transcarbamylase deficiency.

PROTOCOL OUTLINE: This a dose escalation study to estimate the maximum tolerated dose of recombinant adenovirus encoded with the ornithine transcarbamylase gene.

Patients receive a single dose of virus infused into the liver under fluoroscopic guidance. Groups of 3 patients receive successively higher doses of virus; each cohort is observed for safety for 3 weeks before entry of the next group.

Patients are followed weekly for 1 month, then every 3 months until stable.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Confirmed partial ornithine transcarbamylase deficiency Asymptomatic, i.e., at least 1 month since hyperammonemia --Prior/Concurrent Therapy-- Not specified --Patient Characteristics-- No pregnant or nursing women Negative pregnancy test required of fertile women
Phase II Study of Ribose, Uridine, and Thymidine for a Complex Syndrome Involving Excessive 5'-Nucleotidase Activity

OBJECTIVES: I. Evaluate the efficacy of oral ribose in patients with a complex 5'-nucleotidase syndrome who have not received uridine (UR) and thymidine (TDR).

II. Evaluate the efficacy of UR/oral ribose and UR/TDR. III. Evaluate the efficacy of oral ribose given in combination with UR/TDR.

PROTOCOL OUTLINE: Newly identified patients receive ribose daily for 8 weeks. Patients who improve continue therapy. If improvement then reaches a plateau, uridine (UR) and thymidine (TDR) are added to the regimen.

Patients who receive no benefit after 8 weeks of ribose are treated with UR/TDR. Patients who improve after 8 weeks of this combination continue therapy.

Ribose is added to the treatment regimen for patients on UR/TDR at entry. At maximal improvement, TDR and UR are sequentially tapered.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Complex syndrome with excessive skin fibroblast 5'-nucleotidase activity characterized by: Recurrent infection Seizure disorder Speech impairment Attention deficit and behavior problems --Prior/Concurrent Therapy-- Concurrent uridine and thymidine therapy allowed --Patient Characteristics-- Other: No pregnant women