cyrilzakka/clinical-trials huggingface dataset:
Meta-Analysis Accidental Hypothermia in Trauma

This is a systematic literature review and meta-analysis investigating the effect of accidental hypothermia on mortality in trauma patients overall and patients with TBI specifically.

Literature search will be performed using the Ovid Medline/PubMed database. Studies comparing the effect of hypothermia vs. normothermia at hospital admission on in-hospital mortality will be included in meta-analysis.

Accidental hypothermia is a known predictor for worse outcomes in trauma patients, but has not been comprehensively assessed in meta-analysis so far. The aim of this systematic review and meta-analysis is to investigate the impact of accidental hypothermia on mortality in trauma patients overall and patients with traumatic brain injury (TBI) specifically.

Literature search will be conducted using the Ovid Medline/PubMed database. The search strategy will be based on the PICOS strategy.

Scientific articles reporting (1) accidental hypothermia in trauma patients overall or patients with TBI specifically, (2) body temperature and time of measurement, and (3) the impact of accidental hypothermia on outcomes will be included in the qualitative review.

Two meta-analyses will be performed including (1) trauma patients overall and (2) patients with TBI specifically. Studies reporting in-hospital mortality of hypothermic and normothermic trauma patients overall or patients with TBI specifically, based on the temperature measured at Emergency Department admission, will be included in meta-analysis. Meta-analysis will be performed using a Mantel-Haenszel random-effects model. The estimated effect size for mortality will be reported as odds ratio (OR) and 95% confidence interval (CI) for each study as well as for the overall cohort.

Eligibility Criteria:
Inclusion criteria:

* Original scientific articles
* English language
* Study in trauma patients
* Reported body temperature and time of temperature measurement
* Reported impact of accidental hypothermia on outcomes

Exclusion criteria:

* Case reports
* Systematic reviews
* Articles on therapeutic hypothermia
ToolBox Detect: Low Cost Detection of Cognitive Decline in Primary Care Settings

Our study objective is to widely implement and evaluate a user-centered, scalable, electronic health record (EHR)-linked strategy for the routine detection of cognitive decline among diverse primary care settings. This strategy, called ToolboxDetect, will provide an efficient and sensitive cognitive screen that can be easily implemented in everyday clinical settings, and is responsive to patient, family, and caregiver concerns for potential symptoms of cognitive decline (CD) and cognitive impairment (CI).

Our study objective is to widely implement and evaluate a user-centered, scalable, electronic health record (EHR)-linked strategy for the routine detection of cognitive decline among diverse primary care settings. We will conduct a large-scale, primary care practice-randomized trial to implement and comprehensively evaluate ToolboxDetect as a standard of care with AWVs, linked to an EHR (Epic). Diverse, academic and community settings are included to optimize future dissemination efforts.

ToolboxDetect is an iPad-based, self-administered assessment that leverages two well validated measures from the NIH Toolbox Cognition Battery: Dimensional Change Card Sorting (for executive function) and the Picture Sequence Memory (for episodic memory). It takes approximately 7-8 minutes to administer, and for practices randomized to the ToolboxDetect arm, this will be used as the practice standard to fulfill the requirement for cognitive testing as part of the Medicare Annual Wellness Visit (AWV).

The aims of our investigation are to:

1. Evaluate the effectiveness of ToolboxDetect, compared to enhanced usual care, to promote timely detection of cognitive decline and its care management.
2. Disseminate and implement ToolboxDetect among a large Federally Qualified Health Center Network and assess its feasibility and acceptability for use;
3. Investigate the fidelity of ToolboxDetect, and identify any patient, caregiver, healthcare provider and/or system barriers to its optimal, sustained implementation;
4. Determine costs associated with implementing ToolboxDetect from a primary care perspective.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals aged 65 and older will be considered.
2. Adults who may or may not have cognitive impairments.
3. Practices affiliated with Northwestern Medicine and Access Community Health Network.

Exclusion Criteria:

1. Severe, uncorrectable vision or hearing impairment
Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)

Researchers are looking for new ways to treat esophageal squamous cell carcinoma (ESCC). ESCC is a type of cancer that starts in certain cells that line the esophagus. The esophagus is the tube that connects the throat to the stomach. This study will look at ESCC that is either locally advanced unresectable, which means it has spread into tissue near where it started and cannot be completely removed by surgery, or metastatic, which means it has spread to other body parts.

Available treatments for these types of ESCC include pembrolizumab and chemotherapy. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing.

Researchers want to learn about giving pembrolizumab and ifinatamab deruxtecan (I-DXd), a study medicine, with or without chemotherapy to treat ESCC. I-DXd is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.

The main goal of this study is to learn about the safety of I-DXd and pembrolizumab with or without chemotherapy and if people tolerate them. Researchers also want to learn how cancer responds (gets smaller or goes away) to the study treatments.

The master protocol is MK-3475-U06.

Eligibility Criteria:
Inclusion Criteria

The main inclusion criteria include but are not limited to the following:

* The participant must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic squamous cell carcinoma of the esophagus in first-line (1L) setting
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion Criteria

The main exclusion criteria include but are not limited to the following:

* Has had systemic anticancer therapy for locally advanced unresectable or metastatic esophageal cancer
* Has tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula
* Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention
* Has clinically significant corneal disease
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4, OX-40, CD137)
Success of Transitioning Uncontrolled Glaucoma Patients From Prior Mono or Adjunctive Therapy to DuoTrav

The purpose of this study is to assess the safety and efficacy of transitioning uncontrolled glaucoma patients to DuoTrav from other mono or adjunctive therapies.


Eligibility Criteria:
Inclusion Criteria:

* Adults with primary open-angle glaucoma, ocular hypertension or pigment dispersion glaucoma.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Age related.
* Other protocol-defined exclusion criteria may apply.
Promoting Asthma Wellness in Rural Communities

This is a research study that compares the effectiveness of a web-based program (known as Puff City) and another web-based program (of internet sites such as the American Lung Association, American Academy of Asthma, Allergy, and Immunology, etc) that targets five key asthma management issues among rural youth:

1. Improving adherence to asthma controller medication use;
2. Improving compliance of carrying a rescue inhaler at all times for use at the first sign of asthma symptoms;
3. Improving inhaler technique;
4. Smoking reduction or cessation in those who are smokers; and
5. Avoidance of second-hand smoke exposure.

A randomized control trial across three southeastern rural high schools comparing a web-based tailored intervention (known as Puff City) to web-based traditional control education sites.

Eligibility Criteria:
Inclusion Criteria:

* AA ethnicity
* in 9th - 11th grade of selected rural schools
* have an asthma diagnosis and/or asthma-like symptoms by screening eligible on the Lung Health Survey
* have access to a telephone or mobile phone
* being the parent of a student meeting the above criteria with whom the student resides the majority of the time.

Exclusion Criteria:

* Not meeting the above criteria.
A Trial to Evaluate the Safety and PK Profile of HRS4800 in Healthy Subjects

The study will be conducted to evaluate the safety and PK profile of HRS4800 tablets after single oral administration in different dose levels compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Able to understand the purposes and risks of the trial and comply with all study procedures before entering the trial, and provide signed informed consent.
2. Male aged between 18 years and 55 years at screening, inclusive.
3. Total body weight ≥50 kg at screening, and body mass index (BMI) between 19.0 and 26.0 kg/m2, inclusive.
4. Agree to take contraceptive measures and promise not to donate sperm since signing the informed consent form, to 3 months after the administration.
5. No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function), and ECG, as determined by the investigator.

Exclusion Criteria:

1. History of severe digestive system disease or having a digestive disease currently within 3 months of screening or before first dosing, and may affect drug absorption or have safety risks.
2. Severe infections, injuries or surgeries within 3 months of screening or before first dosing, or plan to undergo any surgeries during the trial.
3. ALT, AST, ALP or total bilirubin level exceeds the upper limit of normal (ULN) during screening/baseline visits.
4. Subject's supine systolic BP is ≥140 mmHg or \<90 mmHg; diastolic BP ≥90 mmHg or \<60 mmHg at screening or before first dosing.
5. Positive breath alcohol test after confirmation in a repeat test during screening/baseline visits.
6. Positive drug screening tests,.
7. Whole blood donation or loss of more than 200 mL of blood within 1 month prior to dosing; or blood donation or loss of more than 400 mL of blood within 3 months prior to dosing; or received blood within 2 months prior to dosing.
8. History of allergy to the study drug or any component of it.
PRO-POWER: Hypertension With Risk Factors for a Duration of 24 Weeks With Micardis 80mg/Micardis Plus 80mg/12.5mg

PRO-POWER is an observational cohort study for a period of 24 weeks. All recruited patients will have essential hypertension. In addition, the patients will have at least one other contributing risk factor for cardiovascular events. The study aims to evaluate the safety, efficacy and protection of Micardis 80mg/Micardis plus 80/12.5mg from cardiovascular risks in patients with essential hypertension


Eligibility Criteria:
Inclusion criteria:

* Male or female
* Aged 20 to 80 years old.
* adult with essential hypertension - either newly diagnosed and untreated, or previously treated and uncontrolled
* Sitting blood pressure: systolic BP \> 140 mmHg but \< 180 mmHg, and/or diastolic BP \> 90 mmHg but \< 110 mmHg)
* At least one cardiovascular known risk factor other than hypertension: diabetes/hyperglycaemia, cholesterol /dyslipidemia, a previous cardiovascular event, target organ damage, family history of hypertension or cardiovascular diseases, old age defined as \> 55 years (Males), \> 65 years (Females), smoking, overweight or obese patients or a combination of above risk factors
* Patients who are assessed to benefit from the intake of angiotensin II receptor blocker (ARB) monotherapy or as add-on medication

Exclusion criteria:

* Patients with contraindications to Telmisartan use (as per the Micardis® Tablets package insert).
* Known hypersensitivity to the active ingredient or to any of the excipients of Micardis® .
* Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.
* Patients participating in any other clinical trial.
* Patients already on Micardis® alone or combination
* Pregnant females, or females breast feeding.
Individualized Exercise Programs for Patients Receiving Chemotherapy for Newly Diagnosed Acute or Relapsed Myeloid Leukemia or Lymphoblastic Leukemia

RATIONALE: An individualized exercise program may be effective in lessening fatigue and depression and improving quality of life in patients undergoing chemotherapy for leukemia.

PURPOSE: This clinical trial is studying how well individualized exercise programs work in patients receiving chemotherapy for newly diagnosed acute or relapsed myeloid leukemia or lymphoblastic leukemia.

OBJECTIVES:

Primary

* Determine the effects, in terms of fitness and blood parameters, fatigue levels, and quality of life, of an individualized prescriptive exercise intervention in patients with newly diagnosed acute or relapsed myeloid or lymphoblastic leukemia undergoing chemotherapy.

Secondary

* Determine the feasibility of developing an exercise program for these patients.
* Assess the changes in cardiovascular endurance, muscular strength, selected blood parameters, and response of inflammatory proteins to exercise in these patients.
* Evaluate fatigue, depression, and quality of life of these patients.

OUTLINE: This is a pilot study.

Patients participate in an individualized prescriptive exercise intervention 3 to 4 times per week for 6 weeks (4 weeks in hospital, 2 weeks at home). Exercise begins concurrently with the first course (induction therapy) of chemotherapy. Each exercise session consist of 3-5 minutes of light stretching (stretching component), 5-10 minutes of cycling on the recumbent bicycle (cardiorespiratory component), 5-15 minutes of resistance training including hand dumbbells, exercise tubing, rubber bands, and fit balls (resistance training component), and 5-10 minutes of abdominal exercises (core muscles component).

Quality of life, fatigue, and depression are assessed at baseline and weekly during study intervention.

Blood samples are collected at baseline and at weeks 3 and 6 for cytokine analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Newly diagnosed acute or relapsed myeloid or lymphoblastic leukemia

  * Currently receiving re-induction therapy or designated for chemotherapy treatment
* Expected hospital stay of 3-4 weeks or longer
* Participation in the study must be approved by the physician directly responsible for the patient's care while at University of North Carolina Hospitals

PATIENT CHARACTERISTICS:

* No condition that would compromise the patient's ability to participate in the exercise rehabilitation program, including any of the following:

  * Immune deficiency
  * Acute or chronic bone, joint, or muscular abnormalities
  * Acute or chronic respiratory disease
  * Cardiovascular disease

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Polyacrylate Polyalcohol Copolymer for Vesicoureteral Reflux

Endoscopic correction of VUR has gained its popularity due to its less invasiveness, associated low morbidity and short hospital stay. Although short term follow-up had justified their efficacy; however, long term recurrence and complications following endoscopic correction were also being reported in the literatures (6). Currently, there are insufficient evidences on the efficacy and safety of biocompatible tissue augmenting materials used for endoscopic correction of VUR; particularly on the new tissue bulking agents. (6) Polyacrylate polyalcohol copolymer (PPC)-Vantris ® (Promedon, Cordoba, Argentina) is the newest tissue augmenting biocompatible Acrylics used for endoscopic correction of VUR.


Eligibility Criteria:
Inclusion Criteria:

* Included patients for the study were only those who had 1- 3months and \>1year post-treatment follow-up study with voiding cystourethrogram (VCUG), kidney ultrasound, dimercaptosuccinic acid(DMSA) renal scan, and urine culture.

Exclusion Criteria:

* Excluded cases were patients who had VUR grade 1 and grade 5, no complete follow-up work ups, concomitant neurogenic bladder, anatomical malformation of the urinary tract (obstruction, complete duplicated pelvocaliceal system), previous surgical or endoscopic procedures, and suspected or confirmed dysfunctional voiding by clinical findings or abnormal results (irregular bladder wall, diverticulum) on VCUG or urodynamic study.
Nexium Capsules Helicobacter Pylori Specific Clinical Experience Investigation

The purpose of this study is to confirm the safety profile / factors which impact safety and efficacy in patients given triple therapy for Helicobacter pylori eradication with Nexium + amoxicillin (AMPC) + clarithromycin (CAM), or Nexium + AMPC + metronidazole (MNZ) in usual post-marketing use.

Nexium capsules Specific Clinical Experience Investigation concerning Helicobacter pylori eradication

Eligibility Criteria:
Inclusion criteria:

* Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for gastric ulcer
* Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for duodenal ulcer
* Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for gastric MALT lymphoma
* Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for idiopathic thrombocytopenic purpura
* Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for early gastric cancer

Exclusion Criteria:

- H.pylori negative at the time when the triple therapy is started
High Dose Oral Versus Intramuscular Vitamin D3 Supplementation In Multiple Sclerosis Patients

This study aimed to evaluate oral and injectable routes in treatment of hypovitaminosis D in multiple sclerosis (MS) patients. The investigators aimed to assess the efficacy of each method, using the same Mega dose of 600 000 IU D3, in achieving normal serum 25(OH)D level, the durability of the response, the practicality and the possible toxicity.

Ultraviolet sunlight is too low to produce adequate amounts of vitamin D3, and vitamin D insufficiency lasting 4 to 6 months of the year at latitudes of ≥42° is common in individuals with low vitamin D intake. Vitamin D has strong immunoregulatory effects, and vitamin D supplementation prevents experimental autoimmune encephalomyelitis (EAE), an autoimmune disease in animals that is used as a model of MS.

Recently, emerging data from epidemiologic studies suggest that vitamin D may play an important role in the progression of the development of MS. A longitudinal study in pediatric MS showed a 34% lower risk of relapse for every 10 ng/ml higher 25-hydroxyvitamin D level. A similar magnitude of reduced relapse risk was later reported in an adult MS cohort. Higher vitamin D levels have also been shown to be associated with less subsequent inflammatory MS activity on brain magnetic resonance imaging (MRI). Finally, studies have demonstrated that patients have lower vitamin D levels during MS relapses.

Eligibility Criteria:
Inclusion Criteria:

* with serum 25(OH)D3 concentration ≤ 20 ng/ml

Exclusion Criteria:

* hypercalcaemia, primary hyperparathyroidism, Paget disease, thyrotoxicosis, pregnancy, active malignancy, hypercalciuria, history of liver disease, renal insufficiency, clinically apparent malabsorption syndrome, using drugs containing vitamin D products, calcium, estrogen and drugs known to affect vitamin D metabolism (anticonvulsants, glucocorticoids) or receiving any form of supplements containing vitamin D during last 6 months.
* Participants with serum 25(OH)D concentration≥ 20 ng/ml
Intraoperative Cell Saver Autotransfusion Use for Major Surgical Oncology Operations.

The purpose of this study is to demonstrate the safety and benefit of auto-transfusion filtered blood in patients undergoing major surgical oncology procedures.

Homologous blood transfusions during surgical procedures are becoming more challenging, due to lack of adequate reserves and the significant risks of transfusion reactions. Recent advances in the use of patient's own blood (autologous transfusion) has rapidly gained acceptance in major surgical procedures, however due to the requirement for prior planning and the expense of obtaining and storing a patient's blood prior to surgery this alternative is less than ideal.

This research study utilizes a third alternative, a technique called intraoperative autotransfusion, which successfully salvages a patient's blood during surgery and reinfuses the blood back into the patient. The blood salvaging device uses a filtration device that successfully filters out all tumor cells to prevent re-infusion of viable cancer cells.

This study is designed to demonstrate the safety and benefits of the blood salvaging device on patients undergoing major surgical oncology procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is undergoing a major surgical oncology procedure and has potential for extensive blood loss.
2. Subject is ≥ 18 years of age.
3. Subject or Subject's Legally Authorized Representative (LAR) has signed an IRB-approved informed consent form.

Exclusion Criteria:

1. Subject has medical, social, or psychological factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures.
2. Subject is \< 18 years of age.
3. Subject or Subject's LAR did not sign IRB-approved informed consent form.