cyrilzakka/clinical-trials huggingface dataset:
Cardiovascular Health & Early Stress

Childhood adversity is highly prevalent, with 59% of the U.S. population reporting at least one adverse childhood experience (ACE). Substantial evidence links childhood adversity to cardiometabolic disease later in the life course, including heart disease, diabetes, and stroke, which are 3 of the top 10 causes of mortality in the United States.

ACEs encompass many possible traumatic and distressing experiences, including abuse, neglect, or severe household dysfunctions. It is not surprising that the experience of those extreme events during the first decade of life has tremendous implications for the individual's psychological and physical health.

Current knowledge supports that ACEs trigger emotional stress, anxiety, fear, and discomfort in the individual. Acute and intense mental stress leads to structural changes in the amygdala, prolonged activation of the hypothalamic-pituitary-adrenal axis, and hyperactivation of the sympathetic nervous system. Then, the body secretes hormones to activate the cardiovascular system to cope with stress with a rapid increase in arterial pressure and heart rate. If the trauma is severe and/or repeated, the resting state for heart rate and blood pressure are readjusted, resulting in these children living in a heightened physiological state of arousal, including higher heart and respiration rates. This status leads to endothelial dysfunction and atherothrombotic activation that can contribute to premature cardiovascular dysfunctions. Notably, there is evidence of a cumulative effect, or dose-response relationship, between the number of reported ACEs and the prevalence of health risk behaviors and chronic diseases. Thus, despite the prevalence of ACEs and the impact on health and society, the mechanisms underlying these dysfunctions are still poorly understood. The present study aims to understand the impact of different types of ACEs on cardiovascular health.

Eligibility Criteria:
Inclusion Criteria:

Cohort 1

* Men and pre-menopausal women
* 18-30 years old

Cohort 2

* males and females
* 9-17 years old

Exclusion Criteria:

Cohort 1

* Evidence of cardiovascular, pulmonary, renal, hepatic or cerebral diseases
* Evidence of pregnancy or currently nursing.
* Having a history of chronic pain
* Having a history of rheumatoid arthritis

Cohort 2

* Evidence of cardiovascular, pulmonary, renal, hepatic or cerebral diseases
* Evidence of pregnancy or currently nursing.
* Having a history of chronic pain
* Having a history of rheumatoid arthritis
No Monitoring of Post-filter Ionized Calcium in Regional Citrate Anticoagulation

Do no monitor of post-circuit ionized calcium affact the filter life time of continueous renal replacement therapy with regional citrate anticoagulation circuit? A randomized control trial

Regional citrate anticoagulation is the gold standard of anticoagulation in patient receiving CRRT. In RCA circuit, there was a monitoring of pre-filter (systemic) ionized calcium and post-filter (circuit) ionized calcium. Pre-filter ionized calcium was monitored for observe the adverse effect of citrate such as hypocalcemia, citrate intoxication. However, post-filter ionized calcium was monitored for adjustment the citrate dose. We find many problem with frequently monitoring of post-ionized calcium such as confusion from markedly abnormal result, how to adjustment the citrate dose ,and increase workload for nurses. We hypothesis that if we can monitoring of post-filter ionized calcium?

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years old and admission in an ICU
* Indication for CRRT
* regional citrate anticoagulation

Exclusion Criteria:

* Acute liver failure defined as AST or ALT \> 5X UNL or TB/DB \> 5X UNL or evidence of cirrhosis
* Severe persistent lactic acidosis (lactate persist \> 8 mg/dL consecutively within 6 hours)
* Receiving heparin anticoagulation
* Severe alkalosis (pH\>7.55) or acidosis (pH\<7.1)
* History of renal allograft
* Known pregnancy
* Patient is moribund with expected death within 24 hr
* Deficiency of ionzed calcium (Cation \< 0.8 mmol/L)
Prospective Observational Registry for Obstructive Sleep Apnea in Patients With Acute Myocardial Infarction

Obstructive sleep apnea (OSA) has been known as a risk factor for coronary artery disease, heart failure, cerebrovascular accident and atrial fibrillation. One study reported that patients with OSA have more atherosclerotic plaque burden in intravascular ultrasonography examination. Among patients who admitted with acute myocardial infarction (AMI), 65.7% (69 of 105) patients were diagnosed with OSA. Other long-term follow-up study revealed that 45.4% of patients (594 of 1311) who performed percutaneous coronary intervention (PCI) were diagnosed with OSA. Moreover, the OSA group was a significant independent predictor of major adverse cardiac and cerebrovascular events (MACCEs).

Polysomnography (PSG) is the gold standard for the diagnosis of OSA. But, PSG is expensive, time-consuming and difficult to perform immediately. Recently, a portable device named WATCH-PAT (Itamar Ltd, Israel) was developed for the diagnosis of OSA. Validation study demonstrated a high correlation between WATCH-PAT and PSG in apnea-hypopnea index, lowest oxygen saturation and sleep time. This result suggested WATCH-PAT can be performed as an alternative or supportive device of PSG. WATCH-PAT. The portable device also can be useful to detect OSA in bus drivers who can be the reason for public traffic accidents. Moreover, WATCH-PAT can be applied to assess postoperative improvement of OSA.

Although OSA is known as one of the risk factors for cardiovascular disease, there is a lack of evidence to recommend of the evaluation of sleep disorder in patient with coronary artery disease. Awareness and compliance for OSA are very low in both patients and cardiologists. Active diagnosis and treatment are definitely needed. Therefore, the primary endpoint of this study is to evaluate the prevalence of OSA in AMI patients who treated PCI. The secondary endpoint is to evaluate the 1-year incidence rate of MACCEs according to the presence or absence of OSA.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 20 years
2. Successful PCI in at least one major epicedial coronary artery

Exclusion Criteria:

1. IABP or other hemodynamic support device
2. Known OSA on CPAP treatment
3. Intubation for mechanical ventilation
4. Sedation given before WATCH-PAT study
5. Cardiogenic shock (SBP\<90mmHg)
6. Heart failure requiring oxygen supplement
7. High risk of malignant ventricular arrhythmia
8. Pregnancy
9. History of malignancy
10. Expected life span \<12 months
11. Inability to provide informed consent
A Study to Investigate Use Patterns and Safety in Simulated Actual Over-the-counter (OTC) Use of Rabeprazole Sodium for the Treatment of Heartburn Symptoms

This is a multi-center, open-label, all-comers OTC actual use study in pharmacy sites where the principal investigator will be a pharmacist.


Eligibility Criteria:
INCLUSION CRITERIA

To be eligible for participation, consumers must:

* Male or female, 18 years of age or older
* Select and purchase the study medication for their own use
* Be able to take part in periodic telephone interviews regarding their use of and experience with the medication
* Give written informed consent for participation

EXCLUSION CRITERIA Consumers will be excluded from participation if they meet any of the following criteria:

* Allergic to rabeprazole
* Currently have trouble or pain swallowing food
* Currently have vomiting with blood
* Currently have bloody or black stool
* Currently pregnant or breast-feeding
* Participated in a study regarding a heartburn medication during the last 12 months
Physical Activity and Glycemic Control

This study will test the effects of daily physical activity on variations in blood glucose control.


Eligibility Criteria:
Inclusion Criteria:

* Young, healthy

Exclusion Criteria:

* Chronic disease
Sensory Supported Swimming for Children With ASD

The purpose of Sensory Supported Swimming is to provide a sustainable, low cost recreational swim program for children with ASD. A secondary purpose is to train general recreation providers and swim instructors to meet the unique needs of children. Specific aims include both program development and research aims as described below.

Specific Aims:

1. Provide more opportunities for families of children with ASD to access a recreational swim program at low cost. (program development) 2. Increase the capacity of swim instructors and general recreation providers working with children with ASD. (Research) 3. Increase physical activity for children with ASD in a way that is a good match for their individual sensory needs. (Research) 4. Increase safety among children with ASD in and around the water so they and their families can swim safely. (Research) 5. Transition swimmers with ASD from a learn-to-swim program to an inclusive swim team. (Program Development) Hypotheses

1. The Sensory Supported Swim Program will increase physical activity of children with ASD.
2. The Sensory Supported Swim Program will increase safety of children with ASD in and around the water.
3. The Sensory Supported Swim Program will increase the capacity of general recreation providers and swim instructors to serve children with ASD.

To decrease risk of drowning, increase opportunities to engage in a lifelong sport, and increase the capacity of general recreation providers, investigators developed a recreational swim program for children with ASD. The purpose of this program is to provide swimming and water safety instruction for children with ASD. A secondary purpose is to train general recreation providers and swim instructors to meet the unique needs of children. Research of this program includes investigating the effects of swimming on health outcomes (i.e., fitness, BMI) of children with ASD. SSS lessons are provided in eight week sessions six times per year. Lessons are individualized according to the child's sensory preferences (as measured by the Sensory Profile). Instructors use evidence-based teaching methods (i.e., visual supports, demonstration, peer and video modelling, sensory modifications) to teach swimming and water safety skills. Children may enroll for as many sessions as desired. Research includes retrospective review of program records.

Eligibility Criteria:
Inclusion Criteria:

* Autism diagnosis (any autism spectrum diagnosis)
* Order of response

Exclusion Criteria:

* Children with sensory impairments (i.e., blindness, deafness)
* Based on the discretion of the program directors, participants that display aggressive or harmful behaviors may be excluded for safety purposes
Overcoming Geography With Technology: Medical Drones Project

In this study, the investigators shall evaluate the use unmanned air vehicles (medical drones) to deliver ART to adult patients eligible/enrolled in community DSD models in Bufumira Islands, Kalangala district. The geography of the islands is ideal for this project because of the flat landscape and water coverage. The investigators hypothesize that the use of drones would be acceptable to patients and stakeholders, reduce facility drug stock outs, increase retention in care by 10% in intervention (at 12 months) compared to the control health centres and be cost neutral (to the patients and health sector perspectives). The investigators will also undertake evaluation of an efficient sample delivery system using medical drones especially for expansive rural areas like Moyo and Adjumani.

Stage one will be a cross-sectional observational study with baseline data collection on ART accessibility, adherence, challenges as well as perceptions and attitudes towards possible medical drones. Stage two will be a non-randomized observational pilot of medical drones at 3 landing sites in Kalangala District, comparing to 3 landing sites without drones, and at five health facilities in Moyo and Adjumani districts. The investigators shall use qualitative and quantitative methods and a process evaluation to assess the feasibility of using drones for ART delivery and determine the impact on patient outcomes. The COVID pandemic has taken hold in Uganda since this protocol was first approved in June 2020, and having received approval from the Ministry of Health, the investigators will extend this pilot to Moyo and Adjumani Districts. The investigators shall use qualitative and quantitative methods and a process evaluation to assess the feasibility of using drones for COVID sample delivery and determine the impact on result turnaround times. Stage two includes a sub-study on validity and quality of transport of biological samples including HIV, STI, TB and COVID diagnostic and monitoring samples.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years) or emancipated minor (15-17 years) who is HIV-infected and receiving antiretroviral therapy in Bufumira sub-county or non PLHIV adult who has attended a government health facility in Bufumira sub-county
* Resident in Kalangala district for at least the preceding 12 months with an intent to stay for a minimum next 12 months (resident is defined as those who spend more than 9 out of 12 months per year in Kalangala district, even if they move within the district)
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
* Willingness to comply with survey procedures

Exclusion Criteria:

* Patients with mental illness or any other medical condition that compromises decision making process.
* Any other clinical condition that, in the opinion of the site investigator, would make the participant unsuitable for the study or unable to comply with joining a DSD group.
Role of Renal Biopsy in the Suspicion of Nephrotoxicity of Immunotherapy (Checkpoint Inhibitors) in Solid Cancer

Checkpoint inhibitors represent a new class of widely used immunotherapy, however with immune-mediated adverse effects, with renal damage estimated at 1.4% and 4.9% depending on the series.

Acute tubulointerstitial nephritis (ATNI) represents the most common type of damage, although there are other types of damage, associated or not with NTIA.

We aim to establish a probability score for the presence of histological NTIA lesions in a patient treated with CPI who presents with acute renal failure in order to guide the nephrologist and oncologist in their management in the event of AKI at the CPI, and determine the usefulness of a PBR to guide the suspension/resumption of immunotherapy +/- associated corticosteroid therapy; avoiding a PBR exposing to a high iatrogenic risk and sometimes impossible.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old Diagnosis of solid cancer treated by immunotherapy such as checkpoint inhibitor, associated or not with chemotherapy Renal failure having benefited from a renal biopsy

Exclusion Criteria:

* None
Pharmacokinetics and Tolerability of Meloxicam Gel Compared to Meloxicam Tablets in Healthy Subjects

Study to gain information on the percutaneous absorption of meloxicam after administration of a topical gel over 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice and local legislation
* Age \>= 18 and \<= 50 years
* Broca \>= -20% and \<= + 20 %

Exclusion Criteria:

* Any findings of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* Hypersensitivity to meloxicam and any of the excipients or non-steroidal antirheumatic agents
* Intake of drugs with a long half-life (\>24 hours) (\<= 1 month prior to administration or during the trial)
* Use of any drugs which might influence the results of the trial (\<= 10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (\<= 2 months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars or \>3 pipes/day)
* Inability to refrain from smoking on study days
* Known alcohol abuse
* Known drug abuse
* Blood donation (\<= 1 months prior to administration)
* Excessive physical activities (\<= 5 days prior to administration)
* History of hemorrhagic diatheses
* History of gastrointestinal ulcer, perforation or bleeding
* History of bronchial asthma
* Any laboratory value outside the normal range of clinical relevance
* History of dermatological diseases
* Skin disease and/or skin lesions at the site of planned application

For female subjects:

* Pregnancy
* Positive pregnancy test
* Breast feeding
Low-Dose Ketamine Infusion During Burn Wound Care

The current standard of care (SOC) (i.e. fentanyl and midazolam) offers limited efficacy for preventing or relieving pain. Ketamine infusions may provide the benefits of analgesia, minimize adverse events, and reduce opioid use. The purpose of this study is to determine if adding a low dose ketamine infusion during wound care will safely provide pain relief for patients with burn injury.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to burn service with thermal injury

Exclusion Criteria:

* unable/unwilling to consent within 72 hours
* unable to report NRS
* known contraindication to ketamine
* \< than 18 years of age
* pregnant
* incarcerated
* TBSA over 50 %
Role of Procalcitonin, C-Reactive Protein, and WBC Count in Prediction of Colorectal Anastomotic Leak

The interest in identifying a biological marker for the early detection of AL is growing. Such a marker could play a vital role in modern fast-track multimodal protocols, allowing safe and early discharge of patients after colorectal surgery with a low rate of readmission. C-reactive protein (CRP) has been identified as a valid parameter for detection of postoperative infectious complications after rectal resection. A serum CRP level greater than 12.4 mg/dL on postoperative day (POD) 4 is considered predictive of septic complications. According to a recent analysis, the changes in the trajectory of CRP levels might be more beneficial than a snipped point. Moreover, the trajectory has a negative predictability of up to 99.3%. Another interesting biomarker is procalcitonin (PCT), the prohormone of calcitonin, produced by parafollicular C cells in the thyroid. Normally, it has a very low plasma concentration in healthy individuals (0.01-0.05 ng/mL), and it increases during severe generalized bacterial, parasitic, or fungal infections, but not in noninfectious inflammatory reactions. Procalcitonin has been described as an early, sensitive, and specific marker of sepsis. Moreover, the plasma concentration of PCT has been used as an early predictor of infection in acute pancreatitis, secondary peritonitis, and infectious complications after thoracic, esophageal, and cardiac surgeries. In addition, elevated white blood cell (WBC) count is associated with AL after gastrointestinal surgeries. Therefore, this study was conducted to evaluate the utility of CRP, PCT, and WBC count trajectories, as separate and combined biomarkers for prediction of AL after colorectal surgery.


Eligibility Criteria:
Inclusion Criteria:

* adult patients of either sex who underwent colorectal surgery entailing an anastomosis

Exclusion Criteria:

* Patients younger than 18 years
* Patients with active infection at the time of surgery
* Patients who had received chemotherapy or radiotherapy
* Patients on long-term corticosteroid therapy.
Comparison of Exsufflation Versus Drainage in Primary Spontaneous Pneumothorax

Management of primary spontaneous pneumothorax (PSP) remains unclear. Primary therapeutic goals for PSP include removal of air from the pleural space an prevention of recurrences. The absence of generally accepted and methodologically sound recommendations may account for the extensive variation in practice for air evacuation techniques. Air evacuation may be achieved by simple aspiration (exsufflation) or conventional chest tube drainage. Chest tube thoracotomy remains the most popular technique.Aspiration is a more simple technique, that allows possibility of ambulatory management. The purpose of the present study is to compare simple aspiration performed with a specific thoracentesis device, versus conventional chest tube drainage. Comparison will be performed on immediate efficacity of resolution of the pneumothorax.The hypothesis is that simple aspiration performed with a specific device is not inferior to chest tube drainage for management of a first episode of large size primary spontaneous pneumothorax. A second goal is to measure the efficacy at one week, and the recidive at one year. The trial is randomized, controlled and will include 200 patients for each group. The patients will be enrolled in 29 hospitals in France. Emergency department, thoracic surgery and pulmonary departments of each hospital were primarily contacted for agreement to participate to the study.


Eligibility Criteria:
Inclusion Criteria:

* patients aged more than 18 years and less than 50 years
* first episode of pneumothorax
* primary pneumothorax (absence of known pulmonary disease)
* large size of pneumothorax : presence of a visible rim of air between the lund margin and the chest wall, from the apex to pulmonary base

Exclusion Criteria:

* impossibility to obtain patient consent for psychiatric disease
* patients under justice control
* âgé less than 18 years, or more than 50 years
* impossibility of medical follow de for geographic, social or psychic reasons
* pregnant women
* pneumothorax with acute respiratory insufficiency or bad tolerated
* recidive of pneumothorax
* traumatic pneumothorax
* pneumothorax with pleural effusion
* bilatéral pneumothorax
* pneumothorax with pulmonary disease
The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

Approximately 40% of patients following cryoballoon ablation show signs of parasympathetic denervation. The presence of such effect is related to better outcomes in terms of clinical efficacy (freedom from atrial fibrillation). It could be hypothesized that larger sized balloon (POLARxFIT system) because of more antral position within the left atrium (and hence smaller distance from ganglionated plexi) might enhance this beneficial modulation of the autonomic system of the heart. This study intends to compare the effects of cryoablation employing expandable balloon (POLARxFIT) vs. standard balloon (POLARx) on autonomic system of the heart.


Eligibility Criteria:
Inclusion Criteria:

* primary PVI
* paroxysmal atrial fibrillation
* sinus rhythm at the admission
* participant meets clinical criteria for PVI

Exclusion Criteria:

* LA diameter \<38 mm or \>50 mm
* LVEF \<40%
* intrinsic sinus node disease
* advanced atrioventricular block (PR interval \>300 ms, II or III degree AV block)
* previous cardioneuroablation procedure
* pregnancy
* contraindications to anticoagulation treatment
* any other clinical contraindications to PVI
* known atropine intolerance