cyrilzakka/clinical-trials huggingface dataset:
Assessing The Role Of Intravenous Lipid Emulsion As A Life Saving Therapy In Pesticides Toxicity

Intravenous lipid emulsion is an established, effective treatment for local anesthetic systemic toxicity. It is also efficacious in animal models of severe cardiotoxicity caused by a number of other medications. Recent case reports of successful resuscitation suggest the efficacy of lipid emulsion infusion for treating non-local anesthetic overdoses across a wide spectrum of drugs. The present study will focus on the potential role of intravenous lipid emulsion as an adjuvant therapy in pesticides toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute pesticide intoxications with poison severity score 2 or 3 admitted in ICU of PCC-ASUH

Exclusion Criteria:

* Patients less than 18 years and more than 65 years.
* Pregnant and lactating females.
* Presence of medical diseases (e.g. renal, hepatic, cardiovascular, neurological diseases and chronic pancreatitis.)
* Allergy to soya-, egg-or peanut protein
Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in Ghana

This is a randomized, blinded, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA™ 2000 device in healthy volunteers in Ghana.


Eligibility Criteria:
Inclusion Criteria:

* Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening;
* Negative tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody;
* Screening electrocardiogram (ECG) deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome);
* Must meet one of the following criteria with respect to reproductive capacity: Surgically sterile or have a partner who is sterile (i.e., vasectomy in males or tubal ligation, absence of ovaries and/or uterus in females). In the case of vasectomy, participants should wait six (6) months post-vasectomy prior to enrolling. Women who are post-menopausal as defined by absence of menstruation for ≥ 12 months. Use of medically effective contraception when used consistently and correctly from Screening until three (3) months following last dose.

Exclusion Criteria:

* Pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until three (3) months following last dose;
* Positive serum pregnancy test during Screening or positive urine pregnancy test prior to any dosing;
* Is currently participating in or has participated in a study with an investigational product within 30 days preceding Day 0;
* Previous receipt of an investigational vaccine product for prevention of Lassa Fever;
* Audiometry testing that demonstrates a hearing level threshold greater than 30 dB for any frequency tested between 500 Hz - 8000 Hz;
* Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles;
* Current or anticipated concomitant immunosuppressive therapy;
* Fever with or without cough or any other concurrent illness which the principal investigator feels is contraindicated to clinical trial participation.
School-Based Obesity Prevention Program

The overarching goal of this initiative is to reduce the prevalence and occurrence of obesity and increase the remission of obesity in children and adolescents through implementation of a Comprehensive School Nutrition Policy designed to promote changes in the school environment that will reinforce students' development of healthy eating and physical activity patterns inside and outside of school.

The proposed research aims to evaluate the effects of a school-based nutrition policy initiative on prevalence, incidence and remission of overweight (BMI \> 95th percentile). It is a partnership between the Food Trust, the School District of Philadelphia and the University of Pennsylvania. Participants are approximately 1500 students from ten schools in grades four through eight. Half of the schools were randomized to a comprehensive School Nutrition Policy Initiative (SNPI) based on CDC's Guidelines to Promote Lifelong Healthy Eating. The SNPI is a community-based intervention administered by the Comprehensive School Nutrition Policy Task Force that is comprised of 40 individuals representing the public and private sectors. The goal of the SNPI is to change the school environment to: support healthy eating, increase physical activity, and decrease the prevalence of childhood overweight and diet-related diseases. The remaining study participants are in five control schools, matched for ethnicity, SES, and type of food service. Most students are African American and qualify for free and reduced meals at school (household income \< 185% of the poverty level adjusted for household size). Assessments of weight, height, intake, activity, inactivity and eating disorder symptomatology are being conducted at baseline and 1 and 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Any child in 4th, 5th, 6th grades in study site schools

Exclusion Criteria:

* Any child not in 4th, 5th, 6th in study site schools
Evaluation of Respiratory Muscle in Patient With Pulmonary Arterial Hypertension

The aim of the study is that evaluation of basic and accessory respiratory muscles and their relationship of six minute walk test in patient with pulmonary arterial hypertension (PAH)


Eligibility Criteria:
Inclusion Criteria:

* patients with diagnosis of pulmonary arterial hypertension
* patients with stabil drug therapy at least three months

Exclusion Criteria:

* patients with obstructive and/ or restrictive lung disease comorbidity
* severe orthopedic and/ or neurological comorbidity
* patients with heart failure
* patients with ischemic heart disease
* uncooperative patients
T-DOC® NXT Clinical Investigation

Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies


Eligibility Criteria:
Inclusion Criteria:

* Male and Female (Adult age 21+)
* Patients with clinical indication for urodynamics (UDS) testing, for any medically necessary reason as per the physician.

Exclusion Criteria:

* Patients who suffer from bladder infections (not including patients with asymptomatic bacteriuria)
* Patients who are pregnant
* Patients with recent (less than 2 weeks) pelvic floor surgery
* Patients who require the use of a suprapubic catheter
* Patients with significant cognitive deficiency that prevent the patient from giving informed consent
Influence of Dietary Nitrate on Time Trial Performance in Swiss Paracycling Athletes

The aim of this study is to investigate wether beetroot juice or sodium nitrate enhances time trial performance in Swiss paracycling athletes compared to the ingestion of a placebo supplement. Furthermore, the effects of beetroot juice and sodium nitrate on performance will be investigated in spinal cord injured and non-injured athletes.

The influence of dietary nitrate on performance will be tested performing a time trial on a handbike. The time trial will be the same as in the Paralympics 2016 in Rio. The subjects perform three trials and receive another supplement for each trial: beetroot juice with 6mmol nitrate, 6mmol sodium nitrate or plain water (placebo supplement). The time to complete the time trial will be the main outcome parameter.

Eligibility Criteria:
Inclusion Criteria:

* healthy paracycling athletes
* healthy, able-bodied, upper-body trained individuals

Exclusion Criteria:

* female
* smoking
* any medication affecting performance
* medical conditions affecting performance
Verification of Prediction Algorithm

Prospective observational clinical study to verify an algorithm used to predict cardiopulmonary events in patients presenting to the emergency department.

A novel algorithm for determining risk of acute cardiac complications, including cardiac arrest, for patients presenting to the ED has recently been reported. Unlike prior risk stratification tools that relied on basic vital sign data, this algorithm utilizes advanced computing of ECG data to solve the risk classification problem. Data will be collected on patients presenting to the emergency department with a primary complaint that is determined to be cardiopulmonary of origin by a clinician.

Verification of the results of the previous studies using this algorithm in a more diverse patient cohorts is required. As such, the proposed study will investigate the accuracy of the algorithm.

Eligibility Criteria:
Inclusion Criteria:

18 years of age or older Admission to emergency department requiring immediate medical attention due to presumed cardiac or pulmonary cause(s) and considered 2nd or 3rd tier priority in triage system.

Exclusion Criteria:

Pregnant or suspected pregnancy Significant trauma Do Not Resuscitate order Known as Ward of the State
Effectiveness of Nasal Endoscope Sterilization Using a Novel Rig-S™ Device

This study compares the sterility of rigid nasoendoscopies after being sterilized with a conventional autoclave machine and a novel rig-S device that uses standard high level disinfectant

There is a standard operating procedure in rigid endoscopy cleaning, and it is performed after each clinical examination. The conventional autoclave is no longer used in the setting of an otorhinolaryngology (ORL) clinic as it is cumbersome and takes a lot of time, and also only cleans one endoscope at a time. There is no standardisation or device that has been reported, and cross contamination has been reported previously. The overturn of patients in the ORL clinic is high, and most practitioners chooses high level disinfectant as a method of sterilising the endoscopes. However, there is no proper device to place these disinfectants in, and results in many cases of broken scopes and cross contamination.

This study compares the sterility of the rigid endoscopes after being sterilised by the high level disinfectant that is placed in a novel rig-S device with the gold standard conventional autoclave.

The investigators selected all the rigid endoscopes performed in our ORL clinic and randomised them before subjecting them for a swab test for bacterial and fungal, and also used a test kit to test the presence of Hepatitis B.

Eligibility Criteria:
Inclusion Criteria:

All rigid endoscopes performed in ORL clinic

Exclusion Criteria:

Flexible endoscopes performed in ORL clinic
Early Detection and Treatment of Respiratory Sleep Disorders in Children With Down Syndrome

Interventional, comparative, open label, single-center study to demonstrate that an early (from 6 months of age) and systematic (every 6 months) screening of Obstructive Sleep Apnea (OSA) by polysomnography (PSG) in children with Down Syndrome during the first 3 years of life is associated with an improved neurocognitive development at the age of 3 years.


Eligibility Criteria:
Inclusion criteria :

Down Syndrome Age 6 months or less for the Study Group Age 30 to 36 months for the Standard Care Group Living in Paris or Paris area (75, 77, 78, 92, 93, 94, 95) Parents or legal representative agreeing with the study requirements and able to understand, date and sign the informed consent form before study enrollment French language is native mother tongue

Exclusion criteria :

Gestationnel age \< 36 completed amenorrhoea weeks Patient who have or had acute CNS suffering signs Patients with Down Syndrome already had continuous positive airway pressure treatment for OSA Patients participating in another clinical study or for whom a participation to another biomedical research is expected before the end or their follow-up
SBRT vs. Conventional Fractionation With HDR Boost for Prostate Cancer

Random assignment between SBRT and conventionally fractionated boost following HDR brachytherapy for prostate cancer.

Many treatment options exist for prostate cancer. One common treatment approach is to combine high-dose rate (HDR) brachytherapy (temporary insertion of radiation into the prostate) and external beam radiation. External beam radiation typically requires daily radiation treatment for three to five weeks. Improvements to radiation planning and delivery has allowed stereotactic body radiation therapy (SBRT) to be implemented in many types of cancer. SBRT has been implemented as a standard treatment option after HDR brachytherapy in response to the COVID pandemic. We are seeking to evaluate whether it is feasible to randomly assign men between SBRT (which will be five treatments of radiation or conventional radiation (3-5 weeks of daily treatment) following HDR brachytherapy

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Informed consent for treatment and study participation completed
* Pathologically proven diagnosis of prostate adenocarcinoma
* ECOG Performance Status 0-2
* No prior history of pelvic radiotherapy, brachytherapy, cryosurgery, HIFU, TURP or radical prostatectomy

Exclusion Criteria:

* Presence of nodal or distant metastasis on staging MRI or CT Abdomen/Pelvis and Bone scan within 90 days of enrolment (CT/MRI/Bone Scan are only required if the clinical risk of metastatic disease is sufficient to warrant these scans)
* Plan for adjuvant chemotherapy post-radiotherapy
* Serious medical comorbidities or other contraindications to HDR brachytherapy
* Presence of inflammatory bowel disease
* Presence of connective tissue disorder seen as a contraindication to radiotherapy
* Medically unfit for general/spinal anesthesia
* Unable or unwilling to complete questionnaires
Hepatitis D Virus Infection Among Hepatitis B Virus Surface Antigen Positive Individuals

Globally, about 248 million people are chronic HBV surface antigen carriers, and about 5% of them also had hepatitis delta virus (HDV) infection as well. The prevalence of HBsAg in Egypt is intermediate (2-7%) .

Hepatitis D virus (HDV) is an incomplete RNA virus that needs hepatitis B surface antigen (HBsAg) to help its replication. HDV is considered a subviral particle because it depends on HBV for its propagation. Combined HDV- HBV infection produces more severe liver affection than HBV alone.

HDV infection leads to both of acute and chronic liver illnesses. Acute HDV infection can occur at the same time with acute HBV infection (coinfection) or can be superimposed on the top of chronic HBV infection. About 20% to 30% of coinfections of HDV and HBV in humans develop fatal fulminant hepatitis versus 2% of patients with acute hepatitis B mono-infection. Worldwide, Hepatitis D virus (HDV) infection present in more than 15 million people and it is endemic in the Middle East . In Upper Egypt, data about the prevalence, clinical, laboratory and virological characters of Hepatitis D virus-infected patients is rare.

This study aims were:

1. To estimate the prevalence of hepatitis D virus infection among HBsAg positive individuals.
2. To determine the clinical, laboratory and virological characters of HDV infected patients.


Eligibility Criteria:
Inclusion Criteria:

* HBV related liver disorder, aged 18-60 years.
* HBsAg positive individuals were divided into different clinical categories according to EASL 2012 and we revised this classification according to EASL 2017. HBeAg negative chronic infection; HBeAg positive chronic infection), Acute hepatitis, Fulminant hepatitis, Chronic hepatitis (HBeAg positive and HBeAg negative), Liver cirrhosis, and Primary HCC.

Exclusion Criteria:

* Dual infection with other viruses as HCV and/or HIV, auto-immune or alcoholic hepatitis.
Laparoscopic Partial Nephrectomy for cT1 Tumors

The aim of the study is to evaluate trifecta and pentafecta outcomes for laparoscopic partial nephrectomy (LNP) in patients with clinical T1N0M0 renal tumor.

From November 2009 to August 2018 a total of 292 patients who underwent LPN by global ischemia were included in the study. The patients were allocated into two groups according to the tumor size; T1a (≤ 40 mm, n=215), T1b (41-70 mm, n=77). Demographics features, clinical tumor characteristics, intraoperative and postoperative outcomes were analyzed. A negative surgical margin, warm ischemia time (WIT) \< 20 min and no postoperative complications (Clavien-Dindo ≥ grade 3) were accepted to achieve the trifecta outcomes. Pentafecta has defined as trifecta criteria plus \>90% preservation of estimated glomerular filtration rate (eGFR) and no stage upgrade of chronic kidney disease 12 months after LPN. Univariable and multivariable analysis were used to identify factors predicting trifecta and pentafecta achievement.

Eligibility Criteria:
Inclusion Criteria:

* Functioning contraleteral kidney
* Patients with complete data
* Patients with single renal tumor on the effected side
* Patients who approved the written consent form

Exclusion Criteria:

* The patients with bilateral renal tumors (n=8, 16 LPNs)
* solitary kidney (n=8)
* horseshoe kidney (n=4)
* pelvic ectopic kidney (n=2)
* graft kidney (n=2)
* those with multiple renal tumors in a single kidney (n=3) or with \> 7 cm renal tumor (n=6)
* Patients who were operated on for colon cancer (n=4), prostate cancer (n=2), endometrial cancer (n=1) or adrenal mass (n=2) within the first year after LPN
Sleep Duration and Blood Pressure During Sleep

The purpose of this study is to examine the impact that sleep duration has on blood pressure (BP) levels during sleep. The investigator will examine the effect of an 8-week sleep hygiene/extension intervention vs. control on sleep BP.

Short sleep duration (SSD), defined as sleeping less than 7 hours per night, affects over 33% of US adults and is associated with increased mortality. SSD is a modifiable risk factor for obesity, type 2 diabetes, and HTN. Cross-sectional studies have demonstrated that SSD is associated with higher sleep BP levels. SSD is also associated with non-dipping BP which is primarily explained by higher sleep BP levels. However, many of the cross-sectional studies have included adolescent participants or have not used reference standard measures of sleep duration such as wrist actigraphy. Manipulating sleep duration experimentally through sleep restriction or deprivation is associated with higher 24-hour and sleep BP levels. In contrast, there is scarce data on the effect of sleep extension on sleep BP levels among adults with SSD.

Eligible community individuals with short sleep duration will be randomized to sleep extension vs. control using 24-hour ambulatory blood pressure monitoring (ABPM) and actigraphy in the naturalistic environment. Individuals will be assessed throughout the study using questionnaires, activity monitoring via a Fitbit device (for 8 weeks), blood pressure monitoring using a 24-hour ABPM device, and heart rate variability monitoring for 24-hours.

Eligibility Criteria:
Inclusion Criteria:

* English speaking adults
* Age 18 and older
* Sleep duration \< 7 hours per night as assessed via daily self-report of sleep hours

Exclusion Criteria:

* Inability to read or write in English
* Pregnant or plans to get pregnant within study period
* Arm circumference \>50 cm
* Lymphedema of the arm or unable to wear ABPM device for 24 hours or wrist actigraphy for 8 weeks
* End-stage renal disease (ESRD) on dialysis
* Unreliable internet or phone/text access
* High risk of Obstructive Sleep Apnea (OSA) (using the Berlin Questionnaire or diagnosis of OSA or use continuous positive airway pressure device)
* High risk of insomnia (using the Insomnia Severity Index), or a known prior history of insomnia, and/or use of prescription sleep aides
* High risk of depression (using the Patient Health Questionnaire Depression Scale: PHQ-8)
* Perimenopausal women who have hot flashes (using the Menopause Rating Scale (MRS) questionnaire, administered only to females age 45-65)
* Plan to travel out of state and/or internationally during the study period
INSPIRES Hearing Health Trial - INnovative Psychological Intervention to REduce Stigma in Hearing Health Trial

Background: Reminding people they are moral adaptable human beings ("self-affirming") reduces the perceived stigma associated with wearing hearing aids and increases actual hearing aid use. The proposed study aims to reduce stigma in a representative sample of people aged over 60 from the general population who may or may not already be wearing hearing aids and improve multiple hearing health outcomes (e.g., attending screening, device use).

Methods/Design: Double-blinded randomized controlled trial in which a representative sample of people aged over 60 from the general population will be asked to complete surveys about hearing stigma, hearing loss and multiple hearing health outcomes. Participants randomized to the control group will only complete the survey; participants in the intervention group will be asked to affirm their values. Six months later, all participants will complete the same survey to assess outcomes.

Discussion: The proposed research will lead to a brief psychological intervention to reduce stigma in relation to hearing loss/aids.

According to self-affirmation theory, defensiveness arises because people are motivated to defend their global sense of self-worth, which in the present case is threatened by perceptions of hearing aids/loss. However, if a person's self-image can be bolstered (affirmed) in a domain that is important to them, thereby preserving self-integrity, the individual should be less likely to process the threatening (i.e., stigmatizing in the present context) information defensively. Accumulated empirical evidence demonstrates that affirming the self: (a) reduces public stigma, (b) reduces self-stigma, and (c) causes meaningful changes in behaviour. Following a pilot-feasibility trial showing that self-affirming caused significant reductions in first-time hearing aid users' anxieties about ageing and increased their hearing aid use by almost 2 hours/day.

Eligibility Criteria:
Inclusion Criteria:

* UK-based adults
* Aged 60+

Exclusion Criteria:

* Adults younger than 60 years
* Not UK-based
The Effect of Therapeutic Play on Pain, Fear, Anxiety and Physiological Parameters and Parents' Satisfaction

In this study, the effect of the therapeutic game applied before treatment on pain, fear, anxiety and physiological parameters and the satisfaction of the parents was investigated.

Therapeutic play is defined as activities structured in accordance with children's age and development, or as a set of interventions to improve the well-being of children in the hospital environment. This method reduces the stress of illness or hospitalization, uses play as a means of self-expression and supports the development of positive coping mechanisms in pediatric patients. In the literature, it is seen that therapeutic play methods such as listening to music, drawing, reading stories, puppets, dolls, virtual reality tools, cartoon applications, watching videos and playing video games are used to reduce the child's pain and anxiety about invasive procedures. Studies conducted to reduce the interactions between children in the same environment during their treatment and care are quite limited. No study has been found to examine the effect of methods that jointly block/reduce vision and hearing during treatment and care on anxiety, fear and pain in children treated together in pediatric clinics.

Eligibility Criteria:
For the Child;

Inclusion Criteria:

* Being in the 3-6 age group,
* At least one day of inpatient treatment in the pediatric clinics of Selçuk Medical Faculty Hospital
* At least one invasive intervention in the treatment plan
* To be able to understand and speak Turkish
* Staying in a room with at least two beds

Exclusion Criteria:

* Having a neurological disorder
* Not having a parent as a companion
* Receiving oral treatment only
* Hearing and vision problems
* Single bed capacity room or isolated room

For the Parent

Inclusion Criteria:

* Staying with their child as a constant companion
* To be able to understand and speak Turkish
* Accepting to participate in the study

The exclusion criteria:

* Not staying with your child all the time