cyrilzakka/clinical-trials huggingface dataset:
Clinical Impact of a Multiplex Rapid Diagnostic Pneumonia Panel Testing in Critically-ill Patients with Severe Hospital-acquired Pneumonia, Ventilator-associated Pneumonia and Community-acquired Pneumonia with High Risk of Multidrug Resistant Pathogen

The objective of the research is to ascertain the influence of a syndromic mutiplex PCR assay (FilmArray) on the management of patients hospitalised in the ICU for severe respiratory disease.

The diagnostic process for pneumonia has become significantly more intricate over the past decade due to the interference of the biological, radiological, and clinical criteria of patients hospitalised in the intensive care unit with the conventional criteria for the diagnosis of severe respiratory diseases. Additionally, patients who are hospitalised in the ICU are at a heightened risk of contracting other associated infections. Consequently, patients are frequently administered antibiotics, whether or not they are effective, as it is challenging to promptly determine the aetiology of their symptoms using conventional methods.

To enhance the diagnostic and therapeutic aspects of their treatment, we implemented a novel syndromic molecular test in our laboratories. This test is designed to expedite and enhance the management of pneumonia and the stewardship of antibiotics. This research will include 80 to 100 adult patients hospitalized in ICU between Feb 2025 and Feb 2027. It will take place within the Siriraj Hospital, Bangkok, Thailand.

Not provided

Eligibility Criteria:
Inclusion Criteria:

* Patients who have received complete information about the research and who have not objected to the use of its data
* Patients with suspected pneumonia infection

Exclusion Criteria: Patients with following conditions;

* Active immediate life-threatening cardiac arrhythmia, defined as ventricular tachycardia and ventricular fibrillation
* Acute cerebral vascular event, including both acute ischemic stroke or intracranial hemorrhage Acute coronary syndrome
* Cardiogenic shock
* Life-threatening gastrointestinal hemorrhage
* Drug overdose
* Advanced-stage cancer with predicted survival less than 1 year
Endoscopic Diagnosis and Treatment of Acute Nonvariceal Upper Gastrointestinal Bleeding

Acute nonvariceal upper gastrointestinal bleeding (ANVUGIB) is a common critical disease in gastroenterology. Due to the development of modern medical technology, the incidence rate of ANVUGIB has been decreasing in recent years, but its mortality within 30 days is still 11%. Endoscopic hemostasis and drug therapy are the first choice for the treatment of ANVUGIB. After endoscopic hemostasis, it is very important to treat peptic ulcer bleeding with strong acid suppression therapy to maintain gastric pH above 6.0. This study is to study the effect of endoscopic and drug treatment of ANVUGIB.

Acute nonvariceal upper gastrointestinal bleeding (ANVUGIB) is a common critical disease in gastroenterology. It refers to the bleeding caused by the non varicose diseases above the ligament of flexor, including the bleeding of pancreaticobiliary tract and the bleeding caused by the diseases near the anastomotic stoma after gastrojejunostomy. Due to the development of modern medical technology, the incidence rate of ANVUGIB has been decreasing in recent years. A US study shows that the incidence rate of ANVUGIB dropped from 78/10 to 61/10 10000 \[1\] from 2001 to 2009. However, the mortality within 30 days of ANVUGIB is still as high as 11% \[2\]. Peptic ulcer bleeding is the most common cause of bleeding in ANVUGIB. The annual incidence rate is 19.4-57/10 million, and the rate of rebleeding within 7 days is 13.9%, and the mortality rate is 30 in 30 days. A study in China shows that compared with the 1990s, the detection rate of high-risk ulcer has increased, but the overall mortality has not decreased significantly \[4\]. Endoscopic hemostasis is the first choice for the treatment of peptic ulcer. The latest guidelines of our country recommend that patients with upper gastrointestinal bleeding with stable hemodynamics should try their best to have emergency gastroscopy within 24 hours after bleeding, and emergency endoscopic hemostasis is feasible for bleeding lesions \[5\]. After endoscopic hemostasis, it is very important to give strong acid suppression therapy to maintain gastric pH above 6.0 in the treatment of peptic ulcer bleeding \[6-9\]. This study is to analyze the effect of endoscopic and drug treatment of ANVUGIB.

Eligibility Criteria:
Inclusion Criteria:

* From January 2014 to February 2021, patients with acute nonvariceal upper gastrointestinal bleeding underwent emergency endoscopic hemostasis in our hospital.

Exclusion Criteria:

* 1. The age is less than or equal to 18 years old and greater than or equal to 85 years old; 2. Forrest grade IIC and III; 3. Complicated with severe cardiovascular and cerebrovascular diseases or severe liver and kidney diseases (such as heart failure, liver failure, renal failure, etc.); 4. The records of the cases were incomplete.
Smart Glucose Meter Project

Currently, in the U.S., 1 in 3 males and 2 in 5 females born after 2000 are expected to develop diabetes during his or her lifetime. Research has demonstrated that control of blood glucose (BG) reduces the complications of diabetes. As a result, almost half of Americans diagnosed with diabetes, are prescribed finger-stick glucose meters to monitor their BG. The value of this approach is known to be limited by a high rate of patient non-compliance with BG testing, where patients test less often than prescribed. Increased communication between patient and care manager along with feedback has been shown to increase self monitoring of blood glucose (SMBG) test compliance. However, this feedback loop is largely absent from the current, episodic model of patient / care manager interaction and not available in existing BG meters given to diabetic patients.

In this study, we propose to pilot test a cellular-embedded glucose meter. This device can transmit glucose readings directly over a cellular network to a care management server and then the patient will receive feedback on the screen of the glucose meter.

This research program will enroll participants in a 6-month pilot intervention study. In this study, 100 patients with diabetes (Type 1 and Type 2) who are known to be non-compliant with SMBG will be enrolled and randomized to treatment groups (one group will receive a standard glucose meter and the second group will receive the cellular-embedded device) in order to achieve the following specific study aims;

Primary Aim 1: Determine if connecting diabetic patients to care managers via a cellular-enabled glucose meter with feedback will improve SMBG testing compliance.

Secondary Aim 2: Determine if increased testing compliance leads to improvement in overall blood glucose control. This will be measured by a reduction of HbA1c levels.

Secondary Aim 3: Determine whether this intervention leads to significant improvements in patient satisfaction with self-care and patient self-assessment of compliance.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Diagnosis of Diabetes Mellitus (Type 1 or Type 2)
* Currently, non-compliant with prescribed glucose testing regimen
* HbA1c of 7.5 or greater within the last six months

Exclusion Criteria:

* Actively being treated for substance abuse
* Treatment for a thought disorder within the past year
* Non-English speaking
* Persons who are legally blind
* Women who are pregnant
* Cognitively or decisionally impaired as determined by practitioner
* Persons using an insulin pump
Acute Technical Outcomes of the Talent Abdominal Aortic Aneurysm (AAA) Stent-Graft Versus Cook Zenith Stent-Graft

The purpose of this study is to compare acute technical outcomes of the Talent AAA Stent Graft system versus Cook Zenith Endograft at two high volume institutions, Albany Medical Center and St. Peter's Hospital in Albany, NY.

The investigators are comparing the two devices as part of the evolution of endovascular repair (EVAR) for AAAs. The Zenith AAA Endovascular Graft received FDA approval on May 23, 2003, the Talent Abdominal Stent Graft System on April 15, 2008.


Eligibility Criteria:
Inclusion Criteria:

* subject with abdominal aortic aneurysm, with or without iliac involvement
* iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories

Exclusion Criteria:

* less than 18 years of age
* pregnant or lactating
* have contraindications for use of contrast medium or anticoagulation drugs
* are patients who have a condition that threatens to infect the graft
* are patients with sensitivities or allergies to the device materials
YAZ Premenstrual Dysphoric Disorder (PMDD) in China

The purpose of this study is to evaluate the efficacy and safety of YAZ compared to placebo in the treatment of symptoms related to Premenstrual Dysphoric Disorder (PMDD).


Eligibility Criteria:
Inclusion Criteria:

* Chinese women of reproductive age 18-45 years (inclusive) with a diagnosis of Premenstrual Dysphoric Disorder (PMDD)

Exclusion Criteria:

* Any formal psychotherapeutic counselling within 1 month before the screening visit (Visit 1) or used medication for Premenstrual Syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD) including, but not limited to hormones, bromocriptine, GnRH agonists, vitamin B6 (\>100 mg), calcium supplements (\> 1500 mg/day), anxiolytics and antidepressants during the 3 month period prior to Visit 1
* Use of sleeping medication (including melatonin) for more than 3 days per month.
* Pregnancy or less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment
* Obesity (body mass index or BMI \> 30 kg/m2)
* Hypersensitivity to any ingredient of the study drug
Monitors to Improve Indoor Carbon Dioxide (CO2) Concentrations in the Hospital

Ventilation with fresh outdoor air has recently gained considerable attention as a means to reduce the potential risk of indoor aerosol transmission of respiratory pathogens such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing coronavirus disease 2019 (COVID-19). Commercial carbon dioxide (CO2) monitors are increasingly used in schools, long-term care facilities, offices and public buildings to monitor indoor ventilation. However, no formal evidence is available to support the effectiveness of feedback from CO2 monitoring devices. Moreover, modern hospitals have superior indoor air quality control systems.

The aim of this prospective pilot randomized controlled trial (RCT) is to evaluate whether CO2 monitoring devices would be useful as a means to further maintain lower indoor CO2 concentrations in hospitals.

In this pilot, randomized, sham-controlled open-label RCT, hospital rooms will be fitted with Aranet4 Home CO2 sensors.

Each device will continuously measure indoor CO2 concentrations at 1-minute intervals during 4 time periods:

1. Baseline: staff blinded to CO2 levels displayed on sensor

2-3. Sham/Intervention period: sensors on the same ward will be randomized to placebo (sensor not showing CO2 levels to staff) or Intervention (sensor displaying CO2 levels to staff) in a cross-over design

4. Post-intervention phase (3 weeks post-intervention): staff blinded to CO2 levels

Each measurement period will consist of 7 days with no washout period.

Our primary hypothesis is that CO2 sensors will record less time (minutes) with elevated CO2 levels during the intervention period, compared to the Sham periods. However, carry-over effects will be investigated by comparing the Intervention periods to the Baseline and Post-intervention phases.

Note \[February 27, 2021\]: due to technical problems with the Aranet4 device Bluetooth connection, outcome data will be analyzed according to measurement data at 2-5 minute intervals (measurements can be made every minute, but data cannot be downloaded with the current version of the app due to technical problems).

Eligibility Criteria:
Inclusion Criteria:

* Double-bed hospital rooms

Exclusion Criteria:

* Unoccupied rooms
Genetic Evaluation of Families With Endocrine Cancers

This study is being conducted to identify altered genetic factors that may exist and influence endocrine cancers in unrelated MEN1 families with different cancers. A grading system will be developed for endocrine cancers, including pancreatic cancers, thymus gland cancers, parathyroid disease and MEN1 syndrome as low-risk and high-risk to improve screening and timing of surgery.

Participants will be sent a personal medical questionnaire and family history questionnaire to complete prior to their visit. Participants will meet with a genetic counselor face-to-face for up to 120 minutes to complete a personal and family history. Participants will receive genetic counseling including education about MEN1 syndrome and recommendations for the management of this disease. The genetic counselor will also assist participants with coping mentally. The genetic counselor will review the risk, benefits and limitations of genetic testing.

After study eligibility is confirmed and the participant agrees to participate in the study, approximately 10 ml (2 teaspoons) of blood will be taken from the participant for genetic testing. Tumor samples from any prior surgeries will be requested from the Jersey Shore University Medical Center pathology department for review.

The participant's blood sample and any tumor samples will be assigned a unique identifier. Participants will not be identified by name. This identifier, along with the participant's age, sex, ethnicity and if applicable, age of cancer diagnosis (or MEN1 syndrome diagnosis) will be kept at Jersey Shore University Medical Center research department. Medical records will be reviewed for demographics, known cancer risk factors, family history, age and stage at diagnosis of disease, tumor characteristics, previous and current treatments, medication history, test and study results, and pathology/surgery reports. Blood and tumor samples will be sent to the Functional Genomics Facility at The Cancer Institute of New Jersey and Rutgers University Cell \& DNA Repository for processing and/or analysis to identify the genetic pattern in patients at risk for MEN1.

The result of the genetic test for the MEN1 gene will be provided to the participant by either the genetic counselor or study doctor. The genetic counselor or study doctor will interrupt the results for the participant and provide emotional support, if necessary. The results of any altered genes will not be disclosed to the participant.

Medical records will be reviewed annually to determine the status of the participant's disease, if any. Participants will be contacted directly by phone or in person at follow-up clinic visit(s) for the collection of information not recorded in the participant's medical record for up to 20 years.

Eligibility Criteria:
Eligibility Criteria:

* Age ≥ 13 years.
* A signed written informed consent
* Existing patients and their family members of Investigators with MEN1 syndrome.
* Willing to undergo venipuncture to obtain 10 ml of blood and complete genetic counseling and informed consent process.
Understanding COVID-19 Vaccine Immunity in Tissue and Blood

The purpose of this study is to understand the effects of COVID-19 vaccines on the immune system and how the COVID-19 vaccines provide protection and induce long term memory. Adults who are receiving a COVID-19 vaccine will be invited to participate in this study.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18yrs old and higher who are receiving a COVID-19 vaccine

Exclusion Criteria:

* Pregnancy
* Patients with contraindications for lymph node biopsy
* Active cancer
* Current use of immunosuppression drugs
Efficacy of mHealth Applications in Weight Management in a Population Affected by Overweight or Obesity

The purpose of this study is to determine the effectiveness of mobile health applications in improving health outcomes in patients with overweight and obesity. This study will involve a 6-month long commitment where participants will be expected to use an mHealth app daily, weigh themselves and check their fasting blood glucose levels every morning.


Eligibility Criteria:
Inclusion Criteria:

* Between the age of 18-64
* BMI ≥ 25
* Owns or has access to a bathroom weight scale
* Owns a smartphone and willing to download mobile app

Exclusion Criteria:

* On medications that promote weight gain such as antipsychotic, antidepressant, and steroid hormone medications.
* Medications for diabetes such as insulin, thiazolidinediones or sulfonylureas are okay
Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making

This trial studies how well a breast cancer surgery decision aid works in increasing patient engagement in decision making for patients with newly diagnosed stage 0-III breast cancer. The trial also examines barriers to patient engagement even with the use of a decision aid, and if barriers are more likely to be experienced by socioeconomically disadvantaged patients.

The primary and secondary objectives of the study:

PRIMARY OBJECTIVES:

I. Test the effectiveness of a breast cancer surgery decision aid in increasing patient engagement in decision making (measured by knowledge and power) in clinics serving a high proportion of socioeconomically disadvantaged patients.

II. Test the extent to which the effect of a decision aid on patient engagement is mediated through the mitigation of barriers and determine if persistent barriers are disproportionately experienced by socioeconomically disadvantaged patients.

SECONDARY OBJECTIVES:

I. Characterize how persistent barriers influence patient engagement in decision making in order to identify targets for adjunct interventions that could be implemented in clinics serving a high proportion of socioeconomically disadvantaged patients.

Trial Design:

OUTLINE: This is a multi-site cluster randomized trial using a stepped wedge design. Ten clinics will be recruited for participation. All clinics will begin in the usual care arm. Clinics will be randomized to the timing with which they cross-over to the decision aid intervention, with new clinics crossing over every 10 weeks.

ARM I: usual care

ARM II: decision aid intervention

The only difference between patients enrolled before institutional crossover and patients enrolled after institutional crossover is those who are enrolled after institutional crossover will have been offered the decision aid as accepted practice in the clinic.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with stage 0-III breast cancer
* Eligible patients must be planning breast surgery as a component of their definitive treatment
* Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
* Patients with hearing impairment requiring the use of an interpreter are not eligible for this study
* Patients must be able to speak English with the fluency required to have a direct discussion around treatment decision-making (i.e. without interpreter)
* CLINIC STAKEHOLDER (SURGEONS AND CLINIC STAFF): Breast surgeon(s) and nursing staff, medical assistant, or mid-level provider at each participating clinic who participates in the care of patients newly diagnosed with breast cancer
* INSTITUTIONAL: 10 clinics that annually provide surgical care for 120-300 patients newly diagnosed with breast cancer will be selected to participate in this study
* INSTITUTIONAL: Surgeons at eligible clinics must consent to the study as a requirement for site participation
Clinical Trial Comparing Negative Pressure Wound Therapy and Standard Dry Dressings

Negative pressure dressings are currently widely used in wound management. Their use is gradually being extended to surgical scars. However, studies demonstrating a clear benefit are rare, particularly in terms of postoperative discharge, the need for surgical revision due to prolonged oozing and cost.

The aim of this study is to evaluate the benefit of such a device in post-operative revision prosthesis surgery (hip and knee), as well as lower limb amputations.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age ≥ 18 years old
* Planned Surgery :

  1. revision of a hip or knee prosthesis, in 1 or 2 stages, at explantation and/or reimplantation, where
  2. elective amputation of a lower limb (transmetatarsal, trans-tibial (Burgess) or trans-femoral (Gritti-Stokes) level (nb: patients for whom amputation of both lower limbs is planned will be excluded)

Exclusion Criteria:

* Known allergy to dry dressings
* Patient already included in another clinical trial
* Inability to discern and/or inability to follow study procedures
* Known allergy to silver or another component of the system Prevena™
* Amputation for tumor pathology
Investigation of Radiofrequency Device for Treatment of Wrinkles and Rhytides

The purpose of this pilot research study is to collect information on the safety and effectiveness of an experimental device intended to be used to improve the appearance of the skin by reducing the visibility of wrinkles and by reducing the looseness of skin.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 21 years old,
* Apparently healthy,
* Informed consent signed by the subject.

Exclusion Criteria:

* Tobacco smokers,
* History of skin hypersensitivity,
* Current skin disorder or infection (e.g., herpes simplex),
* Prior cosmetic treatments to the face (e.g. Botox) or facial fillers (e.g. Restylane),
* Subjects with a pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants,
* Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site,
* The current or recent use (within the past 12 months) of isotretinoin,
* Pregnancy or breast feeding,
* Insulin dependent diabetic subjects,
* Oxygen dependent subjects,
* Subjects with severe chronic illness, scleroderma, or lupus,
* Subjects with open sores or scars in the treatment region, or
* Subjects with ischemia in the treatment region.