cyrilzakka/clinical-trials huggingface dataset:
The Use of Point of Care Ultra Sound for Correct Placement of Central Venous Catheter

Central venous catheter (CVC) is an essential tool in the management of both medical and surgical patients. Establishing venous access is critically important and is sometimes technically challenging. Among the many indications for point of care ultrasound (POCUS), ultrasound-guided venous catheter placement is well described and increasingly used. This study was designed to evaluate the utility of peri procedural transthoracic echocardiography (TTE) as a tool for positioning CVC and for ruling out complications.

Central venous catheter (CVC) is an essential tool in the management of both medical and surgical patients. Establishing venous access is critically important and is sometimes technically challenging. Among the many indications for point of care ultrasound (POCUS), ultrasound-guided venous catheter placement is well described and increasingly used. This study was designed to evaluate the utility of peri procedural transthoracic echocardiography (TTE) as a tool for positioning CVC and for ruling out complications.

The study population will be screened at the internal wards and medical intensive care unit of Soroka Medical Center.

Research candidates' files will be screened routinely by a study coordinator. The study population will be enrolled according to the inclusion and exclusion criteria.

The primary objective for the study is to evaluate whether the use of POCUS in CVC insertion can help inaccurate CVC tip placement, detect misplacement and complications and better than chest X ray.

Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted to internal ward or medical intensive care unit
2. Patients in need for central venous catheter in the subclavian or internal jugular veins

Exclusion Criteria:

1. Subject currently enrolled in another investigational study
2. Surgical patients with open abdomen covered with bogota bag or vac - pac
3. Patients with pneumothorax prior to central venous catheter insertion
4. Patients in need for central venous catheter for hemodialysis
Gamma Globulin Observations and Outcomes Database for Specific Home Infusion Evidence, Patient Care And Research Data (GOOD-SHEPARD)

Primary:

• Demonstrate the utility of a new electronic data capture (EDC) system (CareExchange™) using infusion nurse measured physical, quality of life (QOL), respiratory, and disability assessments.

Secondary:

* Change in Intravenous Immunoglobulin (IVIg) dose effects measured outcomes.
* Change in IVIg dose and timing effects measured outcomes.
* Change in patient status is reflected in measured outcomes.
* Assess the value to physicians from infusion nurse collected outcomes data.
* Identify types of patients by response to IVIg therapy (i.e. natural or poor responders).
* Change in response rate to IVIg therapy by disease state and demographics.

This is a prospective, observational evaluation of immunoglobulin (Ig) therapy in consenting adult and assenting pediatric subjects who receive infusion services from BriovaRx Infusion Services, (Formerly AxelaCare Health Solutions, LLC). Subjects meeting all inclusion criteria who have provided informed consent/assent for trial participation will have validated, physician-prescribed, and standard-of-care outcome measures recorded during normal home infusion visits. Collected data will be de-identified and aggregated into cohorts of like diagnosis for trend analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age at enrollment ≥ 7
* Sign informed consent/assented to participation
* Ability to read and write English
* Understanding of study procedures and ability to comply with study procedures for the entire length of the study
* Receiving IVIg under the discretion of the patient's treating physician in accordance with standard treatment practices
* Have been on or is between doses of IVIg under the discretion of the patient's treating physician in accordance with standard treatment practices
* Being considered to be prescribed IVIg under the discretion of the patient's treating physician in accordance with standard treatment practices
* Determined to be clinically eligible for infusion services by BriovaRx Infusion Services (Formerly AxelaCare Health Solutions, LLC.) in collaboration with the patient's prescribing physician

Exclusion Criteria:

* Children (age ≤ 6 years)
* Prisoners, and other wards of the state
Effect of Simvastatin on Cardiac Function

It is well know that statins have been used to low cholesterol to prevent and treat coronary artery disease for many years. It was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. However, some results were controversial. Also, there is no clinical data available on statin cardiac protection during surgery in China where rheumatic heart disease is prevalent. Thus, the investigators are trying to see whether statins can protect heart injury during cardiac surgery in Chinese. Part of patients will receive statin treatment and part of will not before surgery in the study. Both patients' heart function will be measured and compared after surgery to determine whether statins can protect heart injury during heart surgery.

Cardiac function is crucial for cardiac surgery. The mortality remains very high in patients with poor cardiac function preoperation, long surgical time, complicate or difficult surgical procedure or uncompleted corrected malformation currently. Thus, it is necessary to search other approaches to improve cardiac function for cardiac surgery patients in order to increase the success, decrease complication and mortality in cardiac surgery.

Although statin has been used to low cholesterol to prevent and treat coronary artery disease for many years, it has been reported that statin could protect endothelial function and cardiac function in coronary artery bypass graft. However, some results were controversy. Also, there is no clinical data available on statin cardiac protection during surgery in China where rheumatic heart disease is prevalence.Thus, it is necessary to perform a double blind, randomised clinical trial in China to determine whether statin can protect heart injury during heart surgery in China and what's its mechanism.

Eligibility Criteria:
Inclusion Criteria:

* cyanotic congenital heart disease
* noncyanotic congenital heart disease with pulmonary hypertension
* Heart valve disease,
* other heart and great artery diseases need heart or great artery surgery

Exclusion Criteria:

* Coronary artery disease
* under 10-year-old.
* noncyanotic congenital heart disease without pulmonary hypertension
* poor liver function such AST elevated,Hepatitis
* Gestation women and Breast-feeding women
Fibromyalgia Health Outcome Study on Cost of Treatments

The Real World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments (REFLECTIONS) Study is a 12-month, prospective observational study that will be utilized in approximately 58 care settings in the United States (US) and Puerto Rico. It is designed to examine treatment patterns and health outcomes of adult participants diagnosed by their physician with fibromyalgia (FM) and who are starting any "new pharmacologic agent" for FM.

The primary benefit of this study is enhanced understanding of the disease state of FM and the role that pharmacologic treatment plays, which may help to optimize management of FM. This study will address current gaps in a rapidly growing body of literature on FM.


Eligibility Criteria:
Inclusion Criteria:

* Meet criteria for fibromyalgia (FM) in the opinion of the investigator
* Must be prescribed a 'new' treatment for FM
* Male and female participants at least 18 years of age
* Willing to complete the Informed Consent Document (ICD) and any other required forms to be eligible for study participation
* Currently under the care of the participating physician
* Cognitively able to understand and complete participant self-rated scales in English or Spanish via computer-assisted telephone interview (CATI)
* Available for 12 months to participate in the study

Exclusion Criteria:

* Are investigator site personnel directly affiliated with the study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
* Are Lilly employees
* Are Terminally ill
* Currently participating in other research studies or if beginning a research study while participating in this study
* Unable to respond via telephone for CATI
* Incompetent for interview as deemed by the participating physician
* Unwilling to provide written ICD or other required forms to participate in the study
Calcitonin Therapy on Incidence and Severity of Neuropathic Pain After Spinal Cord Injury

This prospective randomized double blinded study will be conducted to evaluate the effect of early pharmacologic intervention with calcitonin on the incidence or the severity of neuropathic pain after spinal cord injury

Pain after spinal cord injury can be classified into five categories: musculoskeletal, visceral, at-level, above-level, and below-level neuropathic pain. Calcitonin has previously been shown to be effective in the management of acute pain following amputation, vertebral fractures and other neuropathic conditions. Also it was used in a previous study to prevent complex regional pain syndrome in severe hemiplegic patients after stroke

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years, with spinal cord injury at any level and any degree of completeness in the early stage of trauma.

Exclusion Criteria:

* Intake of anticonvulsants medications.
* Evidence of neuropathic pain.
* Evidence of previous allergic reaction to calcitonin.
* Patients with renal, hepatic and cardiac dysfunction or neurological disorders .
* brain damage or major trauma to extremities or abdomen.
Physical Activity Promotion in Children Using a Novel Smartphone Game: A Pilot Randomized Controlled Trial

Increasing physical activity is critical for children's overall health. Smartphone apps using gamification has shown promise to increasing physical activity using game techniques. This study is a 4-week randomized controlled trial using a gamified smartphone app to determine acceptability and preliminary effectiveness to increase physical activity in children.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 8-14 years old
* Not meeting the recommended Canadian physical activity guidelines of 60min per day of moderate-to-vigorous physical activity
* English-literate
* Normal to corrected vision

Exclusion Criteria:

* Diagnosis or injury that prevents physical activity participation
* No access to a smartphone or tablet
Efficacy of Clarithromycin and Flouroquinolones Based Regimens in H.Pylori Eradication in Covid-19 Era

Era of COVID-19 and the related panic lead to widely spread antibiotics misuse especially for azithromycin. Cross sensitivity between azithromycin and clarithromycin can impact success rates of H. pylori treatment regimens.(1) Here we aim to explore this point in Egyptian patients.

Sample size Supposing the cure rate of clarithromycin-based regimen to levofloxacin based regimen is 69% versus 84.5% respectively. Using Medcalc, the minimal required sample size is 116 patients for each arm (type 1 error= 5%, type II error=20%). Each arm increased by 10% to compensate for drop-out. The sample size will be 135 for each arm.

Study Arms:

* Arm 1: The first group will receive (amoxicillin 1g/12 hrs, Clarithromycin 500 mg/12hrs, esomeprazole 40mg/12hrs)
* Arm 2: The second group will receive (esomeprazole 40 mg/12hrs, levofloxacin 500 mg/24 hrs, and amoxicillin 1gm/12 hrs).
* To confirm patient compliance, we will ask patients to bring their remaining medication and counted the rest of their pills. Patients with a compliance of \<80% will be excluded from the study per protocol (PP) analysis.


Eligibility Criteria:
Inclusion Criteria:

* • Patients aged 18-65 years old with newly diagnosed positive H. pylori antigen in stools, urea breath test or H. pylori detected on endoscopy.

Exclusion Criteria:

* • Women who are pregnant or lactating, patients previously treated with H. pylori eradication therapy, those with recent exposure to antibiotics within the previous 3 months, patients who previously underwent gastric surgery, patients with malignant neoplasms, and patients with other severe concomitant diseases like renal, hepatic impairement, heart failure NYHA class II or more, hypoalbuminemia and those with possible clinically significant drug-drug interaction with any of the study's drugs will be excluded.

  * Known allergy to antibiotics.
Ph1 Administration of VSV-IFNβ-NIS Monotherapy and in Combination With Avelumab in Pts With Refractory Solid Tumors

This is a three-part open label phase 1 study designed to determine the safety profile, MTD, PK and tumor and biomarker response after IT or IV administration of a single dose of VSV-IFNβ-NIS, or combined IT followed by IV VSV-IFNβ-NIS, with or without IV avelumab every two weeks, in patients with refractory advanced/metastatic solid tumors.

The study consists of three parts: a single ascending dose escalation of IT VSV-IFNβ-NIS monotherapy, a monotherapy IV regimen selection phase and an expansion phase, designed to explore the safety and efficacy of the chosen monotherapy regimen alone or in combination with avelumab in patients with metastatic colorectal cancer. Monotherapy will also be explored in patients with pheochromocytoma and NET.

Patients are required to have at least 1 measurable lesion per RECIST 1.1, and in the IT-containing arms this lesion should be amenable for a one-time IT injection of VSV-IFNβ-NIS. At least one patient per IT cohort is required to have at least 2 measurable lesions per RECIST 1.1, one for a one-time IT injection of VSV-IFNβ-NIS and one to be used as a control. Priority enrollment in the IT-containing arms will be granted to patients with 2 measurable lesions per RECIST 1.1. At least one patient per dose level should have metastatic colorectal cancer. In order to fulfil these requirements, at least 3 or 4 patients will be required per escalation dose cohort. Other tumor types of particular interest based on prior experience with VSV or oncolytic viruses include malignant melanoma and endometrial cancer. When more than one cohort is open simultaneously, slot assignment will be determined by the sponsor in consultation with the PIs.

Eligibility Criteria:
Inclusion Criteria:

* Be \> 18 years of age on day of signing informed consent.
* Have a histologically confirmed diagnosis of an advanced and/or metastatic solid tumor that is relapsed and/or refractory to standard therapy, as defined as progression on at least one prior line of therapy in the relapsed/metastatic setting and no existing options are felt to provide clinical benefit.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
* Adequate hematological, liver and kidney function.
* Must be willing to implement contraception throughout study and for 120 days after receiving the study drug.

Exclusion Criteria:

* Has been receiving: radiotherapy, chemotherapy, or molecularly-targeted agents or tyrosine kinase inhibitors within 2 weeks or 5 half-lives (whichever is longer) of the start of study treatment; immunotherapy/monoclonal antibodies within 3 weeks of the start of study treatment; nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6 weeks of the start of study treatment.
* Has a history of a bone marrow or solid organ transplant.
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
Ultrasound Assessment of Gastric Contents in Fasted Elderly Patients With Hip Fracture

Evaluation of gastric contents in fasted elderly patients with hip fracture. The gastric contents will be examined by using ultrasonography in fasted elderly patients scheduled for hip fracture surgery. The primary outcome is the number of patients with stomach contents, and the secondary outcome is the component of residual gastric contents.

In the patients who has femur fracture, they are immobilized because of the pain. This condition makes the gastric movement slow, and the pain also contributes to delayed digestion.

In the present study, the gastric content is assessed by using ultrasonography in fasted elderly patients for hip fracture surgery. Ultrasound assessment is performed in the supine position. All patients scheduled elective surgery for hip fracture over 65 years old are objects. The primary outcome is the number of patients with not empty stomach and full stomach, and the secondary outcome is the component of residual gastric contents.

Eligibility Criteria:
Inclusion Criteria:

* Who has hip fracture and agrees with the purpose of the study

Exclusion Criteria:

* gastrointestinal pathology
* history of any type of gastrectomy
* gastrointestinal anomaly
Respiferon Project

Respiratory viral infections (RVIs) represent a major public health problem and a great burden in terms of morbidity and mortality in children and adults worldwide. To ascertain the source of an infection, microbiology laboratories routinely perform a crucial step: the search for the pathogen through Polymerase Chain Reaction (PCR). Due to the extensive variety of pathogens, testing for the existence of all potential viruses, bacteria, or fungi accountable for the infection is an impractical and time-intensive endeavor. Furthermore, the rise of novel pathogens, exemplified by those accountable for the recent SARS-CoV-2 pandemic, underscores the urgency of promptly developing new innovative diagnostic tests.

To address these needs, researchers have dedicated several years to developing indirect methodologies notably centered around utilizing markers derived from the host's immune system. Among these, one particularly promising approach focuses on measuring the expression of interferon-stimulated genes, which are uniquely triggered by viral infections, thereby facilitating viral diagnosis. This methodology's efficacy has been proven in the context of SARS-CoV-2 infections.

This study's objective is to assess the functionality of such a tool across a spectrum of Respiratory Viral Infections (RVIs) prevalent within a French population during the winter season.


Eligibility Criteria:
Inclusion Criteria:

* Positive nasopharyngeal samples for the detection of a virus, for which the replicative character has been established by the viral culture technique (500µL minimum required)
* Samples kept at the CRB since 2018
* Information to patients carried out and non-objection collected-

Exclusion Criteria:

* N/A
Scandinavian Starch for Severe Sepsis/Septic Shock Trial

* By tradition hydroxyethyl starch (HES) is used to obtain fast circulatory stabilisation in critically ill.
* High molecular weight HES may, however, cause acute kidney failure in patients with severe sepsis.
* Now the low molecular weight HES 130/0.4 is the preferred colloid in Scandinavian intensive care units (ICU) and 1st choice fluid for patients with severe sepsis.
* HES 130/0.4 is largely unstudied in ICU patients.
* This investigator-initiated Scandinavian multicentre trial will be conducted to assess the effects of HES 130/0.4 on mortality and endstage kidney failure in patients with severe sepsis.
* The trial will provide important data to all clinicians who resuscitate septic patients.

Fluid is the mainstay treatment in sepsis resuscitation, but the effects of different crystalloid and colloid solutions on outcome remain unknown.

Previously, a high molecular weight hydroxyethyl starch, HES 200, was used, but this was found to cause acute kidney failure in patients with severe sepsis. As kidney failure is an independent risk factor for death in these patients, HES 200 is not used anymore. In stead a lower molecular weight starch, HES 130, has been developed. Presently, this is the preferred colloid in Scandinavian intensive care units (ICU), but the effects of HES 130 in ICU patients are currently unknown. The proposed Scandinavian multicentre study will be conducted to assess if HES 130 contributes to acute kidney failure in patients with severe sepsis. As HES 130 is widely used, the trial will provide important safety data to clinicians who resuscitate septic patients.

Eligibility Criteria:
Inclusion Criteria:

All adult patients who

* Undergo resuscitation in the ICU
* AND fulfillment within the previous 24 hours of the criteria for severe sepsis (SCCM/ACCP)
* AND consent is obtainable either from the patient or by proxy (physician and/or next of kin)

Exclusion Criteria:

The following patients will not be evaluated for inclusion:

* Age \< 18 years old
* Previously randomised in the 6S trial
* Allergy towards hydroxyethyl starch or malic acid
* Treatment with \> 1000 ml's of any synthetic colloid within the last 24 hours prior to randomisation
* Any form of renal replacement therapy
* Acute burn injury \> 10% body surface area
* Severe hyperkalaemia, p-K \> 6 mM
* Liver or kidney transplantation during current hospital admission
* Intracranial bleeding within current hospitalisation
* Enrollment into another ICU trial of drugs with potential action on circulation, renal function or coagulation
* Withdrawal of active therapy
Effect of Television Viewing and Exercise on Appetite, Satiety, and Food Intake in Children

The purpose of this study was to describe the effect of 30 min TV viewing with or without simultaneous moderate exercise using a treadmill on subsequent subjective appetite, satiation, and food intake in normal weight 9 to 14 year old children. It is hypothesized that TV viewing during exercise immediately before mealtime affects food intake regulation through its effect on the control of appetite and satiation.


Eligibility Criteria:
Inclusion Criteria:

* overall healthy, normal weight (between the 5th and 85th BMI percentile for age and gender) 9 to 14 year old boys and girls (peripubertal) born at term and at a normal birth weight, and does not receive any medications

Exclusion Criteria:

* significant learning, behavioral, or emotional difficulties, restricted diet, food allergies to test treatments