cyrilzakka/clinical-trials huggingface dataset:
Hemodynamic Efficiency of an Hemodialysis Treatment With High Permeability in Post-resuscitation Shock

Rationale: Despite spontaneous cardiac activity recovery, a shock occurs in more than half of patients after resuscitation for cardiac arrest. This acute circulatory insufficiency presents similar characteristics with septic shock and is responsible of most early deaths. Most frequently, usual treatments are unable to control this shock and to avoid the appearance of multiple organ failure.

Aim of the study: In addition to conventional therapeutics, an early plasma epuration of inflammatory mediators (HDHP) could be able to improve hemodynamic parameters and to reduce the shock duration. This improvement could have an impact on multiple organ dysfunctions and also on early mortality.

HDHP (plasma epuration of inflammatory mediators) will be used in addition to the current clinical practice. The experimental arm will be treated by HDHP device.

The high permeability membrane SepteX is a membrane polyarylethersulfone sold by Gambro that allows the purification of molecules of average size to near 50 kd molecular weight.

We can thus purify molecules larger molecular weight than hemofiltration can with the usual membranes (30 kd). Furthermore, this increase in permeability allows a significant treatment medium-sized molecules in diffusion (hemodialysis), that the usual membranes do not allow. Finally, it is possible to purify certain molecules that hemofiltration including high volume does not allow (TNFalpha for example).

Use of this membrane requires the use of specific set dedicated machine Prismaflex itself with a specific software (Exceed) to ensure the control and security of processing.

2 sessions of HDHP will be performed in the first 48 hours following ICU admission (with inclusion in the first 8 hours).

Eligibility Criteria:
Inclusion criteria

* Comatous patients admitted to the ICU for a sudden cardiac death apparently related to heart disease and requiring catecholamine infusion to treat a shock
* Cardiac arrest in front of witnesses
* Written informed consent obtained from the family or by emergency procedure

Exclusion criteria

* Age under 18 years
* Response to verbal commands (Glasgow score \>7)
* Terminal illness present before the cardiac arrest
* Acquired or innate immune deficit
* Anticoagulation not recommended or high hemorrhagic risk
* pregnancy
* weight \> 100 kg
* without social security
* another clinical trial ongoing
* cardiac arrest from non cardiac etiology
Evaluation of the Effect of Web-designed Training Developed for Asthma Patients

The study is an experimental study with pre-test-post-test control group in order to determine the effect of web-designed training developed for asthma patients on drug compliance, asthma control, and fatigue

In the first stage, it is aimed to develop, implement and evaluate a web designed asthma education program for asthma patients. In the second stage, it is to evaluate the effect of the web-designed education program developed for asthmatic patients on drug ompliance, asthma control, and fatigue The population of the study consists of patients diagnosed with asthma who are registered in Family Health Centers in Eskişehir. The individuals that constitute the target group in the study will be determined through the records of patients diagnosed with asthma registered in the family health center or the list of patients in the J45-Asthma and J46 Status Asthmaticus ICD codes. The sample of the study will be the patients who meet the criteria for inclusion in the study. G power analysis program was used to determine the sample size. The research will be conducted in two groups, an intervention and a control group. The sample size of the research was found to be 200.

In collecting research data; The personal descriptive characteristics form prepared by the researcher, the questionnaire for determining the information needs, Form for evaluation of the skills of using inhalation devices and the opinion form regarding the web-based asthma education program will be used. At the same time, COPD and asthma fatigue scale, drug compliance reporting scale and Asthma Control Test (AKT) will be used.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and over,
* Those who have been diagnosed with asthma for at least one year
* Those with poor asthma control
* Using at least one asthma medication
* Not having a communication problem, such as inability to understand/speak Turkish, that would prevent participating in the research or receiving training,
* Being literate,
* Having an internet connection at home or on their phone,
* Having and using a computer, tablet or smart phone,
* Patients who accepted to participate in the study voluntarily formed the sample of the study.

Exclusion Criteria:

* No internet connection at home or on their phone,
* Do not know how to use the Internet and computer,
* Having a communication problem, such as inability to understand/speak Turkish, that would prevent participating in the research or receiving training,
* Illiterate,
* Diagnosed with another respiratory system disease,
* Diagnosed with cancer or undergoing cancer treatment,
* Those who have been diagnosed with or have had COVID-19,
* Individuals with a psychiatric illness were not included in the study.
Home Non Invasive Ventilation for COPD Patients

Chronic Obstructive Pulmonary Disease (COPD) patients are more likely to develop acute hypercapnic respiratory failure. In the acute phase, non invasive ventilation has been shown to improve mortality and reduce intubation rate. Few studies are available about long term benefits of home non invasive ventilation in COPD patients with chronic hypercapnic respiratory failure who survived after an acute episode. The purpose of this study is to determine whether home non invasive ventilation can reduce recurrent acute hypercapnic respiratory failure in COPD patients who survived an acute hypercapnic respiratory failure episode treated by non invasive ventilation.


Eligibility Criteria:
Inclusion Criteria:

* COPD patients who survived after an acute episode of hypercapnic respiratory failure
* patients weaned from ventilation ( non invasive ventilation or mechanical ventilation) prescribed for acute episode since at least five days with following arterial blood gas : pH \> 7.35 and PCO2 \> = 45 mmHg

Exclusion Criteria:

* severe obstructive sleep apnea ( DI \> 30/h)
* Non COPD cause of respiratory failure
* Serious comorbidity
* Adverse psychological status
Doppler Echocardiography Versus Clinical Targets Guided Therapy on the Outcome of Postpartum Septic Shock.

Postpartum sepsis is widely known as a preventable main cause of maternal morbidity and mortality. According to the World Health Organization, approximately 11% of the estimated maternal deaths worldwide were attributed to sepsis. Recent global assessments indicate that obstetric infections rank as the third most prevalent cause of maternal death, with a prevalence mainly observed in low- and middle-income nations.

The management of septic shock is a major medical concern. Early goal-directed therapy emerged as a novel approach for reducing sepsis mortality and was incorporated into Surviving Sepsis Campaign guidelines in 2012. Early detection of sepsis, rapid initiation of antibiotics and effective resuscitation with fluids, vasopressors, and inotropes were important concerns. However, many randomized trials were done to examine the effect of EGDT on morbidity and mortality and showed that EGDT was not associated with a significant reduction in mortality in patients with septic shock compared to usual care. That it wasn't addressed in recent guidelines in 2016 and 2021.

Eligibility Criteria:
Inclusion Criteria:

* postpartum women, within 6 weeks following delivery
* meeting the third international consensus definitions for septic Shock (2016) (Sepsis-3): acute persisting hypotension requiring vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mm Hg and having a serum lactate \> 2 mmol/L (18 mg/dL) despite adequate volume resuscitation

Exclusion Criteria:

* Patient refusal
* History of any chronic cardiac disease
* Requirement for immediate surgery
* Hypotension attributable to another cause
* Do-not-resuscitate status
* Contraindication to central venous catheter placement
* Difficult transthoracic echocardiographic evaluation
* Primary cardiogenic cause of shock, instead of sepsis.
A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Impact of Nystatin on the Development of Oral Irritation in Patients Receiving High Dose Intravenous Interleukin-2

In patients who are receiving intravenous high dose Interleukin-2, patients will be randomized into two groups: group one will receive nystatin swish and swallow immediately before initiation of IL-2, and the second group will receive a placebo. The patients in each group will be monitored and evaluated for differences in the rate and severity of development of oral irritation during treatment. They will also be studied for differences between the two groups in the number of doses of IL-2 taken.

In patients who are receiving intravenous high dose Interleukin-2, patients will be randomized into two groups: group one will receive nystatin swish and swallow immediately before initiation of IL-2, and the second group will receive a placebo. The patients in each group will be monitored and evaluated for differences in the rate and severity of development of oral irritation during treatment. They will also be studied for differences between the two groups in the number of doses of IL-2 taken.

Eligibility Criteria:
All patients enrolled on high dose intravenous interleukin-2 studies in the Surgery Branch of the National Cancer Institute are eligible, except for patients who are receiving adoptively transferred cells (cloned peripheral blood cells).

All inclusion criteria as stated in the parent immunotherapy protocol apply:

No patients with evidence of oral irritation prior to starting therapy;

No patients with any known sensitivity to nystatin;

No patients receiving systemic antifungals;

No patients with active oral infections.

In additional, all exclusion criteria as stated in the parent immunotherapy protocol.
Development and Validation of an Online Neurobehavioral Evaluation Tool for PTEN Patients

The purpose of this study is to develop a survey completed by parents, caregivers, or other informants that evaluates several important domains of functioning relevant to individuals with neurodevelopmental disorders, including autism spectrum disorder and people with genetic syndromes. Participation in this research will include assisting the research team in the development of the survey measures.

With greater understanding of the biology of PTEN Hamartoma Tumor Syndrome (PHTS), including patients with and without neurodevelopmental disorder (NDD) phenotypes, there is potential to develop novel personalized therapeutics. Given the recent observation that many PHTS patients with and without NDD have significant neurobehavioral manifestations, it will be crucial to broadly track a range of neurobehavioral domains as part of future trials. Unfortunately, there are few well-validated measures that would be appropriate for the full range of presentations in the PHTS population. Further, as a rare genetic syndrome, PHTS patients are geographically distributed making frequent data collection during research very difficult. Thus, the overarching aim of this proposal is to develop and validate an online neurobehavioral evaluation tool (NET) with caregiver-report survey scales and patient-completed webcam-collected performance measures that captures key neurobehavioral information. In partnership with patients, caregivers, and scientist-clinician experts, the study will develop, pilot test, and validate NET survey and performance measures. Specifically, at least 240 caregiver-patient pairs will be recruited (patient ages 4-24) from PHTS without NDD, PHTS with NDD, and controls (sibling and unrelated healthy controls). NET data will be collected at baseline, 1-month, and 4-month follow-up. Aim 1 will focus on the development and validation of brief, psychometrically-sound NET survey scales. Aim 2 will conduct group comparisons on NET measures. Aim 3 will use longitudinal data to evaluate short-term stability of NET survey scales and describe neurobehavioral change within and across study groups. The project will also explore the feasibility of performance measure collection, provide initial psychometric evaluation, and conduct a group comparison of performance measures. If the project aims are achieved, and future validation supports research and clinical use, the NET will be an efficient, reliable, valid, co-normed, multi-modal instrument, that, by virtue of online (at-home) administration, will decrease patient and family burden and increase the temporal resolution and power of future longitudinal studies and clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Has a PTEN Hamartoma Tumor Syndrome diagnosis with or without a neurodevelopment disorder
* Access to a tablet (10+ inch screen), laptop, or desktop computer
* Access to reliable internet
* Able to attend to short videos (30 plus seconds)
* Able to hear audio from a computer device
* Able to see without corrective lenses
Pain on Injection of Propofol: a Comparison of Lidocaine and Alkalinized Lidocaine

Aim: The aim of this study was to compare the efficacy of pretreatment 0.5 mg/kg lidocaine and 0.5 mg/kg alkalinized lidocaine for prevention of propofol induced pain.

Methods: In this double-blind, placebo controlled study, 300 adults patients ASA I or II, scheduled to undergo elective surgery, were randomly assigned into three groups of 100 each. Group L, recevied 0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF), Group A, 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF) and control group received isotonic saline pretreatment in the dorsum of the hand, followed by propofol 30 sec later. A blinded researcher assessed the patient's pain level via a four-point scale.


Eligibility Criteria:
Inclusion Criteria:

* undergoing elective surgery

Exclusion Criteria:

* allergy to the study drug
Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder

A multi-center, open-label, long-term safety study in which approximately 600 subjects diagnosed with opioid use disorder will be enrolled. Following a screening period, all subjects will receive run in SUBOXONE sublingual film followed by an initial injection of open-label high dose (300 mg) RBP-6000. The RBP-6000 monthly injection dose can be adjusted to low dose (100 mg), and back to high dose, based on the medical judgment of the Investigator. Subjects will participate in the study for either 6 or 12 months.

Approximately 600 subjects diagnosed with opioid use disorder will be enrolled; approximately 300 subjects who completed the randomized,double-blind, placebo-controlled study NCT02357901 (RB-US-13-0001) ('roll-over' participants), and approximately 300 subjects who did not participate in study RB-US-13-0001 ('de novo' participants). Following informed consent and completion of screening procedures, all subjects will receive SUBOXONE sublingual film, titrated to response.

After 4-14 days of SUBOXONE sublingual film treatment, subjects will be evaluated for enrollment into the study. Eligible subjects will receive 300 mg RBP-6000 as an initial dose, followed by monthly injections of 100 mg or 300 mg RBP-6000, based on the medical judgment of the investigator.

Subjects who participated in study RB-US-13-0001 ('roll-over' participants) will receive monthly injections for up to 6 months. Subjects who did not participate in study RB-US-13-0001 ('de novo' participants) will receive monthly injections for up to12 months.

At all injection visits continuous electrocardiogram recordings and pulse oximetry will be collected prior to injection and at least 4 hours after injection. Subjects will return to the clinic every 1-4 weeks for laboratory tests, complete study questionnaires, adverse event and injection site assessments.

Eligibility Criteria:
Inclusion Criteria:

De novo subjects:

* Seeking treatment for opioid use disorder (OUD) and for the previous 3 months meet the Diagnostic and Statistical Manual 5 (DSM-5) criteria for moderate or severe OUD
* Appropriate candidate for opioid partial-agonist treatment
* BMI between 18 and 35, inclusive

Roll-over subjects:

* Completed RB-US-13-0001

Exclusion Criteria:

De novo subjects:

* Current diagnosis, other than OUD, requiring chronic opioid treatment
* Current substance use disorder with regard to substances other than opioids, cocaine, cannabis, tobacco or alcohol
* Received medication-assisted treatment for OUD in the 90 days prior to informed consent
* Use (within past 30 days prior to informed consent) or positive urine drug screen (UDS) at screening for barbiturates, benzodiazepines,methadone or buprenorphine
* Treatment for OUD required by court order
* History of recent suicidal ideation or attempt

Roll over subjects:

* Experienced major protocol deviations or adverse events in RB-US-13-0001 which could potentially compromise subject safety
* Discontinued early from study RB-US-13-0001
Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

This study will evaluate the safety and efficacy of intraprostatic administration of botulinum toxin Type A (BOTOX®) compared with placebo to treat urinary tract symptoms due to benign prostatic hyperplasia.


Eligibility Criteria:
Inclusion Criteria:

* Clinical enlargement of the prostate gland
* Body weight ≥ 50 kg or 110 lbs

Exclusion Criteria:

* History of chronic prostatitis
* History of two or more urinary tract infections in the past year or one in the last 6 months
* History of bladder stones
* History of previous prostate surgery
* History of bladder cancer or prostate cancer
* Any previous or current usage of botulinum toxin therapy of any serotype for any urological condition
* Botulinum toxin therapy of any serotype for any non-urological condition or usage (e.g., cosmetic) during the previous 12 weeks prior to study entry
Risk Factors for Postoperative Spinal Epidural Hematoma Following Posterior Thoracic Spinal Surgery in a Single Institute

This is a retrospective, observational single-center study. The studies is to investigate the incidence of posterior epidural spinal hematoma(PSEH) and recognize the risk factors for it in a cohort of patients undergoing posterior thoracic surgery in isolation.

The study enrolled patients from January 2010 to December 2019, patients who developed PSEH after posterior thoracic surgery and underwent the hematoma evacuation. For each PSEH patients, 2 or 3 controls who did not develop the PSEH, underwent the same procedures of similar complexity at the same section of thoracic spine in the same period were collected. The preoperative and intraoperative factors, blood pressure related factors and radiographic parameters were collected to identify possible risk factors by comparing between two groups.

Eligibility Criteria:
Inclusion Criteria:

Subjects satisfying the following criteria will be considered eligible for enrollment in this study:

1. Patient is ≥ 18 years and \< 80 years of age;
2. Patient who received thoracic decompression surgery via posterior approach
3. Patient who diagnosed as symptomatic spinal epidural haematoma and received revision surgery.

Exclusion Criteria:

1. Thoracic spinal stenosis caused by trauma, tumor, infectious, deformity and other disease;
2. Symptomatic spinal epidural haematoma happened at cervicothoracic and thoracolumbar junction;
3. Initial surgeries were performed at other hospital;
4. Incomplete clinical data.
Using Neuroscience to Optimize Digital Health Interventions Across Adulthood

The goal of this study is to investigate the extent to which brain imaging data predict health behavior change, compared to participant self-reports.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults ages 30-80 who read/understand English, 50% male and 50% female, and a maximum of 50% will be white.

Exclusion Criteria:

* Pregnancy
* History of head injury
* Mental illness diagnosis
* Psychoactive medication
* Psychiatric or neurological history
* Claustrophobia
* Ferrous metal implanted within the body (those with fMRI-compatible implanted devices will not be excluded, but the eligibility of their devices will be first verified.)
* Asthma, injuries, or other health conditions which inhibit daily physical activity
* Subjects must not already meet the recommended amount of physical activity of moderate-intensity physical activity for 150 minutes a week or 75 minutes at vigorous-intensity a week.
* Duke students are excluded from this study
Neuromodulation and Fatigue

In this project, we aim to determine any potential effects of a weak electrical current applied to the neck or thoracic area on functional capacity and muscle activation. Healthy individuals will participate in one familiarization followed by three experimental sessions. Fatigability and motor function will be assessed in each test session.


Eligibility Criteria:
Inclusion Criteria:

Healthy individuals between 18 and 50 years old

Exclusion Criteria:

Metal implants or joint replacement. Presence of neuromuscular disease. Skin hypersensitivity.
Hemodynamic Stability During Carotid Endarterectomy.Comparison of LENOXe™ (Xenon 100% v/v) Versus Sevoflurane

The purpose of this study is to compare the hemodynamics effects of two usual hypnotic agents (LENOXe ™ (xenon 100 % v/v) and sevoflurane) during a general anesthesia for carotid endarterectomy in elderly patients. The hypothesis is that the use of the LENOXe ™ (xenon 100 % v/v) allows to obtain per-operating hemodynamic stability non inferior than with sevoflurane.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 55 years, status ASA II
* Carotid endarterectomy elected surgery
* Signed informed consent

Exclusion Criteria:

Related to the patients:

* Histories of hypersensibility in both products used in the study
* uncontrolled arterial High Blood Pressure in the preoperative anaesthesia screening
* Severe cardiac failure (FEVG \< 30 %)
* Major lung or airways disease and\\or required per-operating FiO2\> 35 %
* Elevated intracranial pressure
* Pregnancy, breast feeding
* Major protected, under supervision, under guardianship
* Every patient entering within the framework of the contraindications indicated to §4.3 of the summary of the characteristics of tested products (LENOXe ™ (xenon 100 % v/v), sevoflurane)

Related to the surgery:

* Controlateral carotid stenosis superior to 70 % and\\or preoperative indication in the implementation per-operating of a carotid shunt
* Surgery realized within the framework of an emergency
* Combined Surgery
PE Audit and Feedback Pilot Study

School physical education (PE) is one of the most valuable tools for increasing physical activity and fitness among youth of all backgrounds; however, compliance with existing PE laws is low (and differential by school race/ethnic and family-income composition, contributing to health disparities), and best practices for increasing compliance remain unknown. This study proposes to examine a novel approach for increasing PE law compliance by testing a PE audit and feedback tool (adapted from a tool used by the New York City Department of Education) in Oakland, California schools to determine the effectiveness, adaptability, and scalability of this potential cost-effective approach for increasing PE law compliance and student physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Elementary school in the Oakland Unified School District
* \>50% of students in the school qualify for free or reduced-price meals
* \>80% of students non-white

Exclusion Criteria:

* Having a PE program known by the PE Director to be well-established and/or meet/exceed district expectations for PE