cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality Water Friendly Wound Care

Using virtual reality as a form of distraction during a painful burn wound care procedure in addition to pain medication.

Using virtual reality as a form of distraction during a painful burn wound care procedure in addition to pain medication.The aim of this study is to conduct a randomized controlled trial of Virtual Reality as a means to reduce pain during wound care in patients hospitalized for their burn injuries at Harborview Medical Center Burn Center, and Shriners Hospitals for Children in Galveston, Texas.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 8 years
* Compliant and able to complete questionnaires
* No history of psychiatric disorder
* Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
* Able to communicate verbally
* English-speaking

Exclusion Criteria:

* Age less than 8 years
* Not capable of indicating pain intensity
* Not capable of filling out study measures
* Evidence of traumatic brain injury
* History of psychiatric disorder
* Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems
* Unable to communicate orally
* Receiving prophylaxis for alcohol or drug withdrawal
* Developmental disability
* Any face/head/neck injuries that interfere with the use of Virtual Reality equipment
* Non-English Speaking
* Extreme susceptibility to motion sickness
* Seizure history
Antihypertensives in Non-cardiac Surgical Population

A cohort of hypertension patients undergoing elective non-cardiac surgery was constructed to investigate current status of antihypertensive drug treatment in non-cardiac surgical population.

Perioperative changes in blood pressure (BP) are associated with perioperative risks. However, there is little information regarding the current status of antihypertensive treatment in non-cardiac surgical population. A cohort of 351 hypertension patients aged between 18 to 85-year old undergoing elective non-cardiac surgery was constructed to investigate the application of antihypertensive drugs, systemic involvement, perioperative hemodynamics and internal environment to grasp the perioperative impact of different antihypertensive drugs, and to further provide a reference for the preoperative antihypertensive strategy of surgery patients.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective non-cardiac surgery with hypertension(i.e., with a systolic blood pressure(SBP) of \>=140 mmHg and/or a diastolic blood pressure(DBP) of \>=90 mmHg based on the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) or self-reported use of antihypertensive medication

Exclusion Criteria:

* Patients under the age of 18 years old
* Patients more than 85 years old
* Patients suspected of intracranial hypertension
Using Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Bipolar Depression

The purpose of this study is to evaluate whether repetitive transcranial magnetic stimulation (rTMS) treatment is an effective adjunct treatment to mood stabilizers and Bupropion.


Eligibility Criteria:
Inclusion Criteria:

BD Type I or II subjects diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) in depressed phase.

Age 18 to 70. Rating on the Montgomery-Asberg Depression Rating Scale (MADRS) score \> 20. Rating on the Beck Depression Inventory (BDI-II) \> 20. Rating on the Young Mania Rating Scale (YMRS) \< 8. Non-treated new depressive episode, at least 2 weeks in duration. If recently started on an antidepressant other than Wellbutrin, subject must spend at least 4 weeks at a therapeutic dose before entering the study.

Lithium and epival (Sodium Valproate) in monotherapy or in combination. Novel antipsychotics can be combined with mood stabilizers for at least 4 weeks at a steady dosage prior to the study.

Exclusion Criteria:

History of any DSM-IV Axis I diagnosis other than BD Type I or II Presence of any psychotic symptoms, characterized by a score of 3 or more on item 10 of the MADRS, a score of 6 on item 9 of the MADRS, or a score of 6 or more on item 8 of the YMRS Comorbid active dependence or substance abuse (except nicotine) Prior electroconvulsive therapy failure Pacemaker, automatic implantable defibrillator or implantable pump Aneurysm Clip Heart/Vascular Clip Prosthetic Valve Metal Prosthesis Pregnancy (must do a blood β-HCG test to exclude) Metal or metal fragments in the head Personal or Family history of seizure disorder Increased Intracranial pressure History of stroke, meningitis/encephalitis, moderate to severe traumatic brain injury, neurosurgical procedure Pharmacotherapy using any substances not mentioned in the inclusion criteria, except benzodiazepines at an equivalent dose of less than or equal to 1mg/day of lorazepam.

Failure of previous Wellbutrin treatment. Mood disorder secondary to a medical condition. Subject currently enrolled in any detoxification program
Effect of a Low Calorie Diet Containing Nuts on Systemic and Vascular Inflammation

Accumulating evidence from prospective observational studies and a large clinical trial suggests that nut intake lowers the risk of cardiovascular disease (CVD). Tree nuts are rich in unsaturated fats, soluble ﬁber, antioxidants, and phytosterols. The purpose of this study is to compare the effects of low calorie diets with a mixture of nuts in comparison with low calorie diets in improving inflammatory markers in patients with stable coronary artery disease.

A randomized placebo controlled clinical trial will be conducted in modares hospital in Tehran, Iran. After review of the inclusion and exclusion criteria and explanation of the design of the study, written consent form will be completed. The participants are 66 eligible patients, aged 35-70 years. Intervention group will be received low calories diets as well as 20 percent of daily calories from mixed nuts (peanuts, pistachio and almond) and control group will be received low calories diets for 8 weeks. Fasting blood sample will be taken to measure inflammatory markers (Interleukine-6 \[IL-6\] and Interleukine-10 \[IL-10\] and C-Reactive Protein \[CRP\]).

Eligibility Criteria:
Inclusion Criteria:

* patients with at least one of the cardiovascular risk factors (hypertension, hyperlipidemia, diabetes mellitus)
* patients with coronary artery disease
* willing to participation in the study

Exclusion Criteria:

* َChronic kidney disease stage 3-5
* Any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation
The Effect of 6% Hydroxyethyl Starch 130/0.4 on Blood Loss and Coagulation in Patients Medicated With Antiplatelet Agents Prior to Off-Pump Coronary Bypass Graft Surgery

HES 130/0.4 significantly solution will not affect on coagulation and blood loss in patients medicated with antiplatelet agents prior to off-pump coronary bypass surgery (OPCAB).


Eligibility Criteria:
Inclusion Criteria:

* Eighty patients undergoing OPCAB, who were exposed to anti platelet agents until 5 days prior to surgery were randomly allocated to infuse HES 130/0.4 up to 30 ml/kg and followed crystalloid infusion or infuse crystalloid only during perioperative period,

Exclusion Criteria:

Patient who has

* Valvular disease of heart
* MI within 3 months,patient under 40% of left ventricle preoperative output
* left main artery stenosis
* anemia (hemoglobin \< 12 g/dl), coagulopathy (Platelet \< 100/nl, activated partial thromboplastin time, aPTT) \> 80sec, serum creatinine \> 1.2 mg/dl, respiratory disease(asthma, COPD, PaO2 \< 70 mmHg, pulmonary hypertension or pulmonary edema, etc)
* not consented to this trial
The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages

Sugar-sweetened beverage (SSB) consumption is associated with the development of obesity, type 2 diabetes, and dental caries. The current study attempts to explore whether an educational, science-based intervention is able to produce a measurable negative change in preferences for sugar-sweetened beverages, as well as initiate plans to reduce future SSB consumption in 12-year old children. In the first condition (SSB Intervention), participants will watch a video showing the decay of an egg in various SSBs (Coca-Cola, Sprite, Gatorade, and apple juice), followed by the evaporation of these beverages over a heat source, revealing their sugar content. In the second condition (Water Intervention), participants will watch a video showing an egg maintaining its shell in water, followed by the evaporation of water. In the third condition (Control), participants will watch a video of an egg maintaining its shell in rubbing alcohol, followed by the evaporation of rubbing alcohol. Before and after watching their assigned video, participants will complete survey questions to assess self-reported: SSB consumption intentions, attitudes toward SSBs, and health perceptions of SSBs. Therefore, the aims of this study are to (1) quantify changes in SSB consumption intentions, attitudes towards SSBs, and health perceptions of SSBs from pre-video to post-video, (2) establish the effectiveness of the SSB Intervention and Water Intervention over the control, (3) establish the effectiveness of the SSB Intervention over the Water Intervention, (4) determine the efficacy of incorporating scientific evidence in a public health intervention, and (5) make recommendations for the future application of the method employed in this intervention to future public health campaigns.


Eligibility Criteria:
Inclusion Criteria:

* We will recruit a nationally representative sample of participants through the subdivision of Qualtrics, Qualtrics Panel. Participants must be 12 years old and English speaking.

Exclusion Criteria:

* Any participant that is not 12 years old or does not speak English will be excluded from participation.
Etanercept With Tacrolimus for Psoriasis

The study is designed to evaluate the efficacy of etanercept 50 mg subcutaneously (SQ) weekly plus tacrolimus 0.1% topical ointment twice daily compared to etanercept 50 mg SQ weekly plus placebo ointment twice daily.

The study is designed to evaluate the efficacy of etanercept 50 mg SQ weekly plus tacrolimus 0.1% topical ointment twice daily compared to etanercept 50 mg SQ weekly plus placebo ointment twice daily. Subjects will be either beginning etanercept therapy or already using a stable dose of etanercept when they begin to apply tacrolimus to half of their body and placebo ointment to the other half. The study is double blinded. Total duration of the study is 12 weeks.

Eligibility Criteria:
Inclusion Criteria

* Adults 18 years or older with moderate to severe psoriasis, who are candidates for systemic or phototherapy, with a baseline score of 6 or higher on the target lesion score, and a baseline score of 3 or higher on the Physician's Global Assessment, on each side of the body
* Patients who are already on a stable dose of etanercept for at least 2 months and have the above criteria
* Subjects must have target lesions on each side of the body that are at least 1.5 cm in diameter and roughly symmetrical in appearance and location

Exclusion Criteria

* Inability to understand consent or comply with study requirements
* Pregnancy or unwillingness to use adequate birth control method
* Lactation
* Psoriasis plus ultraviolet A (PUVA) or systemic therapy within the past 4 weeks (other than a stable dose of Enbrel for at least 2 months)
* Ultraviolet B (UVB) or topical therapy (other than over-the-counter moisturizers) within the past 2 weeks
* Active tuberculosis or other opportunistic infection
* Demyelinating disease
* Uncontrolled congestive heart failure
* Known allergy to or any contraindications to using topical tacrolimus or etanercept
* Lack of insurance coverage or inability/refusal to pay out of pocket for etanercept and standard of care laboratory tests and PPD/CXR
Risk Warning Model of Postoperative Delirium and Long-term Cognitive Dysfunction in Elderly Patients

The incidence of postoperative delirium in elderly patients is high, which can lead to long-term postoperative neurocognitive disorders. Its high risk factors are not yet clear. At present, there is a lack of early diagnosis and alarm technology for perioperative neurocognitive disorders, which can not achieve early intervention and effective treatment. By artificial intelligence and autonomously evolutionary neural network algorithm, relying on multi-source clinical big data, we explored the use of Bayesian network to optimize the anesthesia decision-making system in enhanced recovery after surgery, and established risk prediction model for perioperative critical events. It is expected that this method will also help to establish a risk prediction model for postoperative delirium and long-term postoperative neurocognitive disorders. This project plans to collect the perioperative sensitive parameters of anesthesia machine, multi-parameter monitor, EEG monitor,fMRI and HIS system, to explore the evolution process of data characteristics by feature fusion.We also plan to quickly screen key perioperative risk characteristics of postoperative delirium from massive clinical data through feature selection, to explore the high risk factors of long-term postoperative neurocognitive disorders developing from postoperative delirium. Finally, with multi-center intelligent analysis，the risk prediction model of postoperative delirium and long-term postoperative neurocognitive disorders will be constructed.

This project intends to collect and identify clinical monitoring data of anesthesia machine, multi-parameter monitor and brain function monitor on the basis of the team's previous series of studies on cognitive function protection of elderly patients in perioperative period and the research on tracking and warning of critical illness events and decision support services based on artificial intelligence. HIS clinical data and classified and tracked fMRI imaging data were integrated to form a large data set related to perioperative cognitive function of elderly patients. Based on pNCD clinical diagnostic information and fMRI imaging diagnostic information, a brain adverse event prediction system capable of intelligent extraction of clinical key information and real-time early warning was established by using key technologies such as data quality control, real-time collection and identification of multi-source clinical monitoring data, and artificial intelligence adverse event prediction.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥65 years of age who have undergone surgical anesthesia; Sign informed consent

Exclusion Criteria:

* Inability to complete cognitive function assessment; Illiteracy, hearing impairment or visual impairment; He has a history of epilepsy, depression, schizophrenia, Alzheimer's disease and other psychiatric and neurological diseases
Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)

A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with dialysis-dependent chronic kidney disease (DD-CKD)

This is a multicenter, randomized, open-label, active-controlled Phase 3 study of the efficacy and safety of Vadadustat versus Darbepoetin alfa for the maintenance treatment of anemia in participants with DD-CKD

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Receiving chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease for at least 12 weeks prior to Screening
* Currently maintained on erythropoiesis-stimulating agent therapy, with a dose received within 6 weeks prior to or during Screening
* Mean Screening hemoglobin between 8.0 and 11.0 grams per deciliter (g/dL) (inclusive) in the US and between 9.0 and 12.0 g/dL (inclusive) outside of the US
* Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening

Exclusion Criteria:

* Anemia due to a cause other than chronic kidney disease or participants with active bleeding or recent blood loss
* Uncontrolled hypertension
* Red blood cell transfusion within 8 weeks prior to randomization
* Anticipated to recover adequate kidney function to no longer require dialysis
* Severe heart failure at Screening (New York Heart Association Class IV)
* Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure, or stroke within 12 weeks prior to or during Screening
* Hypersensitivity to Vadadustat, Darbepoetin alfa, or any of their excipients
Study of Late Fetal Loss in Poitou-Charentes. GYNE-COVID

Maternal-fetal transmission in the second or third trimester of pregnancy of the SARS-COV-2 virus could explain some late fetal losses.

Finding a cause in the context of fetal loss is essential for parents and caregivers. It helps to understand the history of the disease, to address the possible risk of a recurrence and to plan for future pregnancies.

If the maternal-fetal transmission of COVID 19 is confirmed and that it is responsible for obstetric complications, a preventive action could be proposed to the patients by the preconception vaccination.

The investigators are seeking to clarify the frequency of this transmission is information awaited by caregivers, women, couples in particular when the latter are in distress from late fetal loss.


Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Patient with late spontaneous abortion (≥15 weeks of gestation)
* Benefiting from a Social Security scheme
* Patient who consented to participate in the study
* Free subject, without tutorship, curatorship or subordination

Exclusion Criteria:

* Persons not benefiting from a Social Security scheme or not benefiting from it through a third party.
* Concurrent participation in another clinical research study.
WILD 5 Wellness: A 30-Day Intervention for Residents

The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention amongst resident physicians combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.

Data from the initial pilot of Wild 5 Wellness data reported at the Annual US Psychiatric Congress Meeting demonstrated positive results with their 30-day intervention: This study uses compelling proof that even a non-medication, self-directed, low cost 30-day intervention, focusing on mental wellness offers clinically significant help with mood, anxiety, mindfulness, sleep, social connectivity, and emotional eating (Jain et al., 2015)

The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention amongst residents at Orange Park Medical Center (OPMC) by combining five wellness elements including: exercise, mindfulness, sleep, social connectedness, and nutrition.

Data will be collected to evaluate participants' adherence and response to a 5-pronged 30-day wellness intervention. It is expected that this 30-day integrated, prescriptive, and trackable program will be found to be an efficacious wellness intervention among residents at OPMC.

To the best of our knowledge, even though there is abundant research supporting each of the WILD 5 Wellness elements (exercise, mindfulness, sleep, social connectedness, and nutrition) individually, there is no research exploring the effectiveness of an integrated, prescriptive, and trackable wellness intervention combining these five elements. Therefore, this work will be unique in that it will collect both objective and subjective data to assess the feasibility and effectiveness of this type of wellness intervention. It will lend support to the growing body of research on the efficacy of wellness interventions for a variety of different health conditions, as well as a residency-based population. Finally, it is hoped that positive results will yield increased access to and utilization of this type of intervention, thereby improving resident wellness.

Eligibility Criteria:
Inclusion Criteria:

* participants must be enrolled residents at Orange Park Medical Center (OPMC).

Exclusion Criteria:

* Refusal to participate.
Assessment of the Cognitive Load of the Landed Combatant in Virtual Reality.

To support the landed soldier during operational missions in hostile environment, equipment must be designed to enable soldiers to cope with strong visual, auditory and informational demands. Technological solutions proposed by manufacturers are embodied in increasingly sophisticated systems.

These systems take too little account of the characteristics of the perceptive and cognitive skills of human beings in an action situation.

Cognitive load results from the interaction between, on the one hand, the characteristics of the task and the constraints it imposes, and on the other hand, the resources available to the individual, in terms of skills, motivation, physiological state and social support. The phenomenon of cognitive overload occurs when the individual no longer has sufficient resources to meet the demands of the task, which leads to a deterioration in his performance which, in high-risk situations, jeopardizes his safety.

Tasks are treated differently depending on their level of difficulty. We will base ourselves on Rasmussen's SRK (Skill Rule Knowledge) model, which describes three levels of information processing: level S refers to the (automatic) processing of sensory-motor and cognitive skills, level R refers to the execution of rules and procedures embedded in mental models, and level K refers to the mental activities of elaborating procedures, based on high-level cognitive mechanisms, such as anticipation, evaluation or planning. Multitasking situations are therefore generally composed of tasks of various levels of difficulty which lead to a higher or lower cost of cognitive control.

Thus, this study is aimed at identifying variations in the subjective level of cognitive load of landed combatants (group leaders) as a function of the level of difficulty of primary tasks.


Eligibility Criteria:
Inclusion Criteria:

* to be a soldier in an infantry regiment,
* to be a group leader.

Exclusion Criteria:

* to be in a situation of motor disability,
* to have a cardiac pathology,
* to have a visual pathology not corrected by glasses or contact lenses,
* to have a hearing impairment,
* to have a psychiatric disorder; a progressive neurological or organic pathology requiring drug treatment,
* to take psychotropic drugs,
* to take more than 28 units of alcohol per week,
* to be epileptic.
Dexmedetomidine, Ketamine and Magnesium Sulphate in Caudal Block for Hypospadias Repair

Caudal epidural block is a rapid, reliable, and safe technique that can be used with general anesthesia for intraoperative and postoperative analgesia in pediatric patients Ketamine is a selective antagonist of N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor.


Eligibility Criteria:
Inclusion Criteria:

* Aged 1-7 years
* American Society of Anesthesiologists (ASA) classification I and II, undergoing hypospadias repair.

Exclusion Criteria:

* Developmental delay
* Psychological or neurological disorders
* Difficult airway
* Hyperactive airway disease or children in whom caudal block was contraindicated (e.g., infection at the site of block, bleeding disorder, or abnormalities of the sacrum).