cyrilzakka/clinical-trials huggingface dataset:
Biological Markers to Identify Early Sepsis and Acute Lung Injury

There are no clear markers to identify sepsis and acute lung injury at early stage in clinical settings which would result in improved survival of the patients. In collaboration with the research team led by Dr. Zhang at St. Michael's Hospital, Toronto, we have initiated a pilot study looking for biological markers to detect severe sepsis and ARDS. We have found that human neutrophils peptides (a-defensins), certain coagulation variables and cytokine levels are very sensitive markers to differentiate severe sepsis, ARDS from cardiovascular diseases in ICU patients. These findings may provide valuable information for therapeutic guideline in clinical practice. The present study will focus on testing 'biological markers' to identify patients with sepsis and acute lung injury. We will examine the roles of three components of markers including inflammation, neutrophil activation and coagulation. We are hoping that this proposed translational research will help develop novel therapeutic strategy in sepsis and acute lung injury patients.


Eligibility Criteria:
Inclusion Criteria:

* Meet diagnostic criteria of ≧2 SIRS or acute lung injury.
* Get agreement of patient's attending physician and inform consent form patient or family.

Exclusion Criteria:

* Use Antibiotics over 24 hrs（only SIRS group）.
* Active bleeding.
* Pregnancy.
* Active Cancer (refer to malignancy which is recently diagnosed, under treatment, or relapsed)
* VS or Subject or Family refuse
Community Support Program for Lung Cancer Screening Volume II

This is a West Philadelphia based community project to improve adherence to lung cancer screening. The overall objective of this project is to demonstrate the impact of a community support program (CSP) on improve adherence to LCS follow-up guidelines in an urban environment. The study will target individuals in the Penn Medicine healthcare system residing in Philadelphia with an upcoming or missed follow-up screening or orders placed but who have not yet scheduled their screenings by offering free transportation coordination to and from the appointment. The study team will also offer to connect those with placed but unscheduled low dose CT orders to connect with Penn Medicine's scheduling staff.


Eligibility Criteria:
Inclusion Criteria:

* Upcoming or missed low dose CT for lung cancer screening
* Philadelphia resident

Exclusion Criteria:

* Lives outside Philadelphia city limits
Immune Response Following COVID-19 Vaccination

Few trials have reported the safety and efficacy of the COVID-19 vaccines. However, these trials were mostly focused on post-vaccination adverse events and short-term antibody detection with none monitoring the presence of immunoglobulin G (IgG) in blood at long-term follow-up after the vaccination. This study aims to evaluate the immune response in post-vaccinated individuals across a follow-up period of one year.

The COVID-19 pandemic started in December 2019 and since then has spread globally claiming over 550, 000 deaths, \>12 million infections and an economic toll in the trillions of dollars to date. The urgent need for a global vaccination program to control this pandemic has prompted the development of several vaccines.

Preliminary reports from few trials evaluating the safety and efficacy of the vaccines have been published (2-4).

However, no trials have yet reported the long-term post-vaccination immune response that would potentially determine the necessity and timing for booster doses of the vaccine.

Therefore, this study is designed to assess the presence of immunoglobulin (Ig) M and G at several time points after the first and the second dose of the vaccine.

Eligibility Criteria:
Inclusion Criteria:

• Individuals that have received first dose of COVID-19 vaccine

Exclusion Criteria:

* Unwilling to provide informed consent
* Unwilling for the follow-up serological test during the 1-year enrollment
A Digital Intervention to Improve Physical Activity and Sleep Behaviors in Youth With Psychiatric Diagnoses

The goal of "GamerFit" is to test the delivery of a theory-based mHealth app that utilizes social support, exergaming, and telehealth coaching to improve PA levels, sleep, and psychiatric symptoms among youth participants (ages 13-17 y) with PD. In order to aid future intervention optimization, up to 65 participants with at least one PD will be randomized, with 30-35 using the GamerFit app with weekly telehealth coaching sessions and 30-35 using a commercial healthy habits app as a comparator group


Eligibility Criteria:
Inclusion Criteria:

* 13-17 years of age (child/participant)
* At least one PD diagnosis (excluding eating disorders) confirmed by parent report of physician diagnosis (child/participant)
* IQ≥85/no intellectual disability that precludes participation confirmed by parent report (child/participant)
* Can understand verbal English-language exergaming instructions (child/participant)
* Physically capable of exercise confirmed by parent report (child/participant)
* Has access to a smart phone or compatible tablet (child/participant)
* Willing to download and use the app (child/participant)
* Willing and able to be present during telehealth coaching sessions (parent)
* Can have a competent translator present during coaching sessions if not fluent in English (parent)

Exclusion Criteria:

- Families for whom the mPIs think the study and/or intervention is clinically/medically inappropriate (e.g. developmental delay, or emotional or cognitive difficulties, if the PI believes these factors will interfere with study/intervention participation)
Nitrate for High Intensity Intermittent Exercise

The objective of the current study is to assess the effect of 6-day dietary nitrate ingestion on high intensity intermittent sports performance in recreational soccer players.

Oral ingestion of nitrate (NO3-) in the form of both nitrate salts and concentrated red beetroot juice has been shown to significantly lower blood pressure at rest and to improve exercise performance during cycle time trials. Furthermore, a positive exercise performance effect of nitrate ingestion has been observed in recreational athletes during intermittent exercise. However, this was achieved after acute supplementation with a substantial dose of dietary nitrate. Whether similar ergogenic effects of nitrate supplementation can be achieved with a more conventional 6-day nitrate supplementation protocol with a lower daily dose remains to be established. Based on the gaps in current literature, our main goal will be to gain further insight into the effects of a 6-day nitrate supplementation protocol on high intensity intermittent exercise performance in recreational athletes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy P
* Players of the first two senior selection teams of a regional soccer club competing at the 3rd KNVB level or higher
* Training ≥2 days a week
* 18-40 years
* Male

Exclusion Criteria:

* Use of medication
* Injury prohibiting them from performing the exercise protocol effectively
* Smoking
* Currently supplementing diet with nitrate
* Lactose intolerance
Comparative Study Between Hyperbaric Therapy and Intravesical Dimethyl Sulfoxide Instillation for Interstitial Cystitis

The purpose of this study is to compare the efficacy of hyperbaric oxygen therapy (HBOT) to intravesical Dimethyl Sulfoxide (DMSO) instillation for the treatment of patients who suffers from Interstitial Cystitis / Painful bladder syndrome.

Interstitial cystitis / painful bladder syndrome (IC/PBS) presents as a pelvic pain condition associated with urinary urgency and frequency. These symptoms impair significantly the patient's quality of life. The etiology is yet not obvious. The current acceptable theory is injury or dysfunction of the Mucus (Glycosaminoglycans) layer that covers the inner surface of the urinary bladder. Abnormal diffusion of toxins from the urine to the walls of the bladder leads to inflammation, pain and scarring.

Many types of treatments were described but most of them were not evaluated in well designed randomized controlled studies. For now, there is no one single treatment that gives good outcome to every patient. Therefore, the treatment of patients with IC/PBS is challenging. In this study, we will compare the efficacy of hyperbaric oxygen therapy (HBOT) to intravesical dimethyl sulfoxide (DMSO) instillation for the treatment of patients who suffers from IC/PBS.

Patients with IC (NIDDK criteria) will be randomized to have either DMSO instillation or HBOT.

Before and after treatments the patients will fill out questionnaires (O'Leary-Sant Interstitial Cystitis Symptom and Problem Index), visual analogue scale for pain and bladder diaries. In addition, urodynamics will be performed before and after treatments. In case of incomplete symptoms remission, patients will be crossed over to have the other treatment.

Eligibility Criteria:
Inclusion Criteria:

* NIDDK diagnosis of interstitial cystitis

Exclusion Criteria:

* Previous treatment of hyperbaric therapy
* Contraindication for hyperbaric therapy (mid-ear pathology, abnormal chest X-ray, Claustrophobia, pregnancy
Internal Jugular Vein Cross Sectional Area

The Trendelenburg position is used to distend the central veins, improving both success and safety of vascular cannulation. The purpose of this study is to measure the cross-sectional area of the internal jugular vein (IJV) in three different positions, using surface ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* adult medical or surgical ICU patients who have preexisting central venous (jugular/subclavian only) catheters.

Exclusion Criteria:

* subjects with only a femoral venous catheter.
* subjects whose CVP measurement by the indwelling catheter exceeds 20cm of water.
* subjects younger than 18 years old.
* inability to obtain informed consent from the subject or the subjects authorized representative.
Systemic Vascular Endothelial Growth Factor (VEGF) Protein Dynamics Following Intravitreal Injections of Ranibizumab Versus Aflibercept in Patients With Neovascular Age-related Macular Degeneration

The purpose of the study was to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic VEGF protein levels in treatment naïve wet neovascular Age-related Macular Degeneration (wAMD) patients in a detailed time course.

A planned study visit schedule was established at the time of baseline visit (day 1) for all patients. Study assessments for patients were performed at screening visit, baseline (day 1), day 2, day 8 (± 1 day to allow for flexibility in scheduling) and as of day 15 through to day 169 at biweekly visits.

Eligibility Criteria:
Inclusion Criteria:

* Visual impairment predominantly due to neovascular AMD.
* Active, newly diagnosed, untreated, angiographically documented, CNV lesion (i.e. leakage on fluorescein angiography plus intraretinal, subretinal or sub-RPE fluid on OCT) secondary to neovascular AMD in line with SmPC of ranibizumab and aflibercept

Exclusion Criteria:

* Stroke or myocardial infarction less than 3 months prior to screening.
* Presence of uncontrolled systolic blood pressure or diastolic blood pressure
* Type 1 or Type 2 diabetes mellitus
* Use of any systemic anti-VEGF drugs
* Use of systemic or inhaled corticosteroids for at least 30 consecutive days within 3 months prior to screening.
* Women who are pregnant or breast feeding or who are menstruating and capable of becoming pregnant\* and not practicing a medically approved method of contraception

For either eye:

* Any active periocular or ocular infection or inflammation
* Uncontrolled glaucoma
* Neovascularization of the iris or neovascular glaucoma
* History of treatment with any anti-angiogenic drugs

For study eye:

* Atrophy or fibrosis involving the center of the fovea at the time of screening or baseline.
* Cataract (if causing significant visual impairment), planned cataract surgery during the study period, vitrectomy, aphakia, glaucoma surgery, severe vitreous hemorrhage, rhegmatogenous retinal detachment, proliferative retinopathy or choroidal neovascularization of any other cause than wAMD
* Irreversible structural damage within 0.5 disc diameter of the center of the macula
* Any intraocular procedure (including cataract surgery, Yttrium-Aluminum-Garnet capsulotomy) within 3 months prior to baseline or anticipated within the next 6 months following baseline.
* Use of intravitreal or topical ocular corticosteroids administered for at least 30 consecutive days within 3 months prior to screening.

For fellow eye

- Retinal or choroidal neovascularization or macula edema of any cause

Other protocol-defined inclusion/exclusion criteria may apply.
"Death Rattle" - A Double Blind, Randomly Controlled, Crossover Trial

Dying patients are often unable to clear secretions from their large airways, resulting in noisy breathing usually described as "death rattle." While there is no evidence that patients find this condition disturbing, the noises may be disturbing to the patient's visitors and caregivers who may fear that the patient is choking to death.

In Israel none of the pharmaceutical drugs listed in the literature exist. Thus, Atropine drops which have been noted in the literature as being used, though according to our knowledge no evidence of clinical trials using sublingual Atropine were conducted.

The study is designed as a randomly controlled, double blind crossover trial. The patient will serve as control for himself, as crossover between placebo and drug (randomly chosen) will take place. The administrator of the drug will be blinded to the medication, each time randomly beginning with a different drug (placebo or Atropine).

We will evaluate Atropine Sulphate 1% ophthalmic drops effect on 33 patients using a noise score scale of 0-3. Noise scores will be taken at the start; 30 min after drug/placebo administration and every hour thereafter. After 4-hours crossover will take place and evaluation will follow the same protocol.


Eligibility Criteria:
Inclusion Criteria:

* : Patients belonging to Home Palliative Care Unit of Clalit Health Services - Southern District, and the Oncology Department of Soroka University Medical Center and suffering from "death rattle" will be recruited for the study.

Exclusion Criteria:

-
Early Cycloergometric Physiotherapy in Critically Ill Patients With Invasive Mechanical Ventilation

Study designed to evaluate the functional and motor effects in critically ill subjects at ICU and hospital discharge with the incorporation of a mobilization program of cycloergometric physiotherapy sessions compared with conventional physiotherapy.

Cycloergometric treatment is described to improve the functional and motor status of critically ill subjects. However, there are few studies comparing cycloergometric physiotherapy and conventional physiotherapy in intensive care subjects under mechanical ventilation. The most relevant of these studies conducted by Burtin et al showed beneficial effects of cycloergometric treatment. However, the duration of the physiotherapy sessions in this study differed between groups as cycloergometric group received a double daily dose of treatment. It is known that the intensity of physiotherapy also affects the functional and motor status.

For this reason, the investigators designed a randomized controlled study with early cycloergometric or conventional treatment, with the same intensity between groups to analyze objective functional and motor endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Criteria of functional independence before hospital admission (Barthel scale \> 70 points).
* Invasive mechanical ventilation \< 72 hours.
* Signed informed consent.

Exclusion Criteria:

* Neuromuscular disease (peripheric or central neurologic disorder).
* Presumed fatal evolution in 48 hours.
* Conditions that impede pedaling movement (leg, pelvis or lumbar spinal surgery or traumatism).
* Admission due to cardiac arrest.
* Pregnancy.
* Thrombopenia less than 50.000.
* Severe agitation.
* Hemodynamic instability with noradrenaline requirements greater than 1 mcg/kg/min.
* Fraction of inspired Oxygen (FiO2) requirements greater that 0.55 and respiratory rate greater than 30 bpm.
EffectiveNess of Low-dose Aspirin in Prevention of Cancer in the Stomach and Oesophagus (GastrointEstinal Cancer Prevention) - United Kingdom ("ENgAGE - UK"): Study to Evaluate the Risk of Cancer in the Stomach and Oesophagus Among New Users of Low-dose Aspirin Using the THIN Database in the UK

Researchers already did studies in low-dose Aspirin for the prevention of heart and blood vessels disease and for the prevention of cancer of the colorectum. In this study, they want to learn whether an effect for the prevention of oesophagus cancer and stomach cancer goes along with the use of low-dose ASA on patients taking this medicine for the prevention of heart and blood vessels disease compared to non-use. To find this out electronic medical records stored in primary care database in the UK, The Health Improvement Network (THIN), will be used.


Eligibility Criteria:
Inclusion Criteria:

* Aged 40-89 years
* Enrolled with the PCP for at least 2 years
* To have a history of computerized prescriptions in THIN for at least 1 year prior to start date

Exclusion Criteria:

* To be exposed to low-dose ASA before entering in the study
* Having a diagnosis of any cancer before entering in the study
Effect of Personal Versus Video Instruction in Elastic Resistance Exercise on Technical Execution (IRMA05)

Resistance training is widely used in training and rehabilitation. During recent years elastic resistance training has become increasingly popular for preventing or relieving neck/shoulder/arm pain among sedentary employees. While most research studies documenting positive effects of such interventions have used training instructors, most training in practice does not use an instructor but rather depends on information from other sources such as the internet. Here the investigators examine - in a outcome assessor blinded randomized controlled trial - the effect of 2 weeks elastic resistance training for the neck/shoulder/arm with personal versus video instruction on technical execution.


Eligibility Criteria:
Inclusion Criteria:

* neck or shoulder pain

Exclusion Criteria:

* blood pressure above 160/100 mmHg
* pregnancy
* life-threatening disease
Dexmedetomidine Enhancing the Recovery After Cardiac Surgery

Enhanced Recovery After Surgery (ERAS) aims to facilitate a quicker and smoother recovery period following surgical procedures. The implementation of these protocols may lead to patients returning to their daily activities sooner, experiencing greater satisfaction with their care, and potentially encountering fewer complications, ultimately contributing to shorter hospital stays. However, a common challenge in the postoperative phase is postoperative delirium(POD). This complication can lead to both immediate and long-term cognitive impairments, negatively impact overall health outcomes, and increase the financial burden on the healthcare system. Interestingly, dexmedetomidine, known as DXM, is a medication that selectively targets certain receptors in the brain and offers sedative properties with minimal impact on breathing. This characteristic is noteworthy because it may help regulate sleep patterns and support the preservation of cognitive function during the recovery period.


Eligibility Criteria:
Inclusion Criteria:

* Patients of American Society of Anesthesiologists Classification (ASA) grade II-III;
* Patients who were planned to have Coronary Artery Bypass Graft (CABG);
* Patients were free of exclusion criteria.

Exclusion Criteria:

* Patients with preoperative high risk for getting Post Operative Delirium or sleep disorders,
* Patients with American Society of Anesthesiologists Classification (ASA) grade\>III;
* Patients with heart failure, left ventricle ejection fraction of \<25%,
* Patients with uncontrolled diabetes mellitus, coagulopathy, or history of uncompensated renal or hepatic diseases
Order Effects of Prematurity Outcome Data

Women recruited from the internet were put in a hypothetical situation of being in labor at 22 weeks of pregnancy, and presented with information in the form of pictographs about survival and disability of babies born at this gestational age.

Participants were randomized to receive these pictographs in a different order (survival or disability first) and to receive descriptiveness level of survival (just numerical information, or also description of course of NICU stay).

Participants were then asked to choose between comfort care and intensive care in this situation. Participants' religiosity, value of the sanctity of life, and health literacy were also assessed.

The National Institute of Child Health and Human Development (NICHD) Workshop on Periviable Birth recommended that information on the chance of survival and risk of disability should be provided separately. The order in which information is presented can affect memory, persuasiveness, and treatment choice, but the effect of order of information presentation in the context of neonatal resuscitation has received little attention. Additionally, the effect of including a description of the long and intense time in the neonatal intensive care unit (NICU) on parental treatment decision making is also unexplored. Current evidence suggests that pictographs best convey numerical information to parents.

Three pictographs were developed based on NICHD data for 22 weeks gestational age (GA) babies who received intensive care. One pictograph displayed information on the rates of disability in the babies who survive. Two pictographs displayed information about how many babies born at 22 weeks survive, with one of these pictographs including a description of the average course of NICU stay.

An internet survey was sent to a U.S. representative sample of women of child-bearing age. A vignette including background on prematurity and the treatment options of intensive care or comfort care for a baby born at 22 weeks GA was presented. Participants viewed the pictographs, evenly randomized to one of four experimental conditions (order of information presentation x level of description of NICU course). Participants were then asked to choose intensive care or comfort care. Participant religiosity, values (quality vs. sanctity of life), autonomy preferences in medical decision making, previous NICU exposure, numeracy, and health literacy were also assessed.

Eligibility Criteria:
Inclusion Criteria:

* Women of childbearing age (defined as 18-50) living in the U.S.

Exclusion Criteria:

* Minors, those unable to read English, and those who only could complete the survey on their phone. (For formatting purposes, a tablet or computer was necessary.)