cyrilzakka/clinical-trials huggingface dataset:
Safety Planning Intervention Telehealth Service Model in Emergency Departments

The purpose of this study is to evaluate the effectiveness and implementation of a suicide prevention strategy delivered via telehealth in Emergency Departments. We will compare implementation of the Safety Planning Intervention plus follow-up calls (SPI+) delivered by Emergency Department (ED) staff to SPI+ delivered via ED referral to an off-site Suicide Prevention Consultation Center (SPCC).

Individuals at high risk for suicide often present to acute care settings, such as emergency departments (EDs), and then typically are hospitalized or referred for outpatient mental health treatment. Patients are at increased risk of suicide attempts and suicide following an ED visit and nearly half do not attend outpatient treatment. Brief, evidence-based clinical interventions, such as the Safety Planning Intervention with post-discharge telephone follow-up (SPI+), can reduce suicide risk, decrease hospitalizations, and increase engagement in outpatient services for suicidal patients discharged from the ED. Leveraging insights from implementation science and collaborative care, we propose a model in which ED staff will connect patients at risk for suicide to ED-credentialed mental health clinicians who are located external to the ED. These off-site clinicians will provide SPI+ via telehealth for ED patients prior to discharge and provide follow-up services after ED discharge as part of an innovative Suicide Prevention Consultation Center (SPCC). All participating EDs will begin in the Enhanced Usual Care phase, in which ED staff will deliver SPI+ to suicidal patients. EDs will then be randomized in pairs to begin referral to the SPCC in 3 month intervals. We will also conduct a cost evaluation to help determine scalability and sustainability.

Eligibility Criteria:
Aim 1/Aim 3:

Inclusion Criteria:

* ED visit at one of our participating sites for a suicide-related event or determined to be at risk for suicide per the Electronic Health Record (EHR) and ED clinical staff
* 18 years of age or older
* Not admitted to an inpatient hospital following the index ED visit as documented in the EHR

Exclusion Criteria:

- Inpatient admission following the index ED visit per the EHR

Aim 2:

Inclusion Criteria:

* ED clinician or leader at one of our participating sites, or ED patient who was referred to the SPCC
* 18 years of age or older
* Able to communicate in English
* Willing to give informed consent

Exclusion Criteria:

* Patients who are at imminent risk of suicide or acutely psychotic at the time of the interview, requiring emergency services and/or precluding ability to provide informed consent
* Patients without a phone for contact
Effect of Duration of Symptoms on the Clinical and Functional Outcomes of Lumbar Microdiscectomy

97 patients in 3 randomized groups were treated by Microdiscectomy for lumbar disc herniation; Group A was operated at 6 weeks of symptoms, Group B at 3 months and group C at 6 months. These patients were followed for 3 years for the clinical and functional outcomes.

150 patients were enrolled in this study and only 97 patients were finally analyzed for primary outcomes measures of Oswestry disability index and Roland-Morris Questionnaire and secondary outcome measures of Visual analogue scale for back pain and leg pain as well as length of hospital stay and time to return for daily activities. Assessments done at different periods of 2 weeks, 3 months, 6 months, 1year, 2 years and 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years
* Disc herniation of L3-4, L4-5 or L5-S1
* MRI showed disc protrusion or extrusion with nerve root compression corresponding to clinical features.

Exclusion Criteria:

* Spondylolysis or spondylolisthesis.
* Spinal deformity like scoliosis.
* Previous spinal surgery or infection.
* Cauda equina syndrome.
* Lumbar segmental instability on dynamic radiograph: translation more than 3 mm or change in angulation more than 10 degrees
* Smoking
* Diabetes Mellitus
* Disc herniation other than levels L3-L4, L4-L5 and L5-S1
* More than single level disc hernaition.
* Body mass index 30 or more than 30
* Contained disc herniation by MRI
Implementation of LUCAS 2 in Helicopter Rescue in South Tyrol

Cardiopulmonary resuscitation (CPR) is used to maintain adequate perfusion of vital organs in cardiac arrest patients and is fundamental for the neurological outcome and survival of these individuals. Unfortunately, the quality of CPR may be inadequate due largely to ineffective chest compressions resulting from rescuer fatigue and interruptions in compressions. The LUCAS device (Lund University Cardiopulmonary Assist System, Jolife, Lund, Sweden), introduced in 2002, is the most extensively tested and applied automated alternative to manual CPR for in-hospital care of cardiac arrest patients and during ambulance transfer; the feasibility of application of this device in helicopter emergency medical service (HEMS) operations, however, has never been addressed. The objective of this project is to equip the three active rescue helicopters in South Tyrol with the LUCAS 2 mechanical chest compression device to answer the question: What is the feasibility and efficiency of using this device for prolonged CPR in cardiac arrest patients requiring CPR during HEMS rescue operations and transport?

This is a non-controlled, observational study. Physiological endpoints: MAP (mean arterial pressure); etCO2 (end-tidal expiratory pCO2); ROSC (return of spontaneous circulation); PaO2 (arterial pO2); PaCO2 (arterial pCO2); endpoints to assess feasibility: time from arrival to start of mechanical compressions, problems during transfer into the helicopter and in-field manoeuvers, problems with application of device, problems with patient transfer to hospital premises, hands-off time, personnel requirements.

Eligibility Criteria:
Inclusion Criteria:

* cardiac arrest with indication of CPR
* informed consent for those regaining legal competence

Exclusion Criteria:

* declaration of death on site
* contraindications of using the device
* age \<18 y
Caffeine Consumption and Mortality in Diabetes

Previous studies suggested an inverse relationship between coffee consumption and mortality in the general population. Furthermore, an inverse association between coffee consumption and serum biomarkers of inflammation and insulin resistance has been described. Prospective studies showed that coffee consumption might be associated with reduction in the incidence of type 2 diabetes. Although caffeine consumption appears to be associated with a decreased risk of developing type 2 diabetes, the relationship between caffeine consumption and mortality in patients with diabetes remains uncertain. The current analysis aimed to assess the effects of caffeine consumption and caffeine source on all-cause, cardiovascular and cancer mortality among patients with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* NHANES participants from 1999 to 2010 above 18-year old, with diagnosis of diabetes

Exclusion Criteria:

* Implausible alimentary reports (defined as consumption of less than 500 kcal/day or more than 3500 kcal/day)
* Missing information on caffeine consumption
* Missing information on mortality
The Affection of Two Chest Management for Enhanced Recovery Program After Video-assisted Thoracoscopic Lobectomy.

Comparing the influences of different chest tube managements for enhanced recovery program after video-Assisted thoracoscopic lobectomy.

The Enhanced Recovery Program has a series of observation data contains hospitalization days, adverse events, drainage, extubation, visual analogue scale(VAS) scores and the number of analgesic using.The investigators plan to enroll 60 patients and divide them into two groups to compare the influences of different chest tube managements for enhanced recovery program after video-assisted thoracoscopic lobectomy.

Eligibility Criteria:
Inclusion Criteria:

* Only single lesion on the targeted lobe
* Considered as invasive carcinoma by preoperative computed tomography (CT) or -diagnosed by intraoperative pathology
* Patients have signed informed consent.

Exclusion Criteria:

* Patients have critical basic disease(diabetes and hypertension).
* Patients who lung function cannot undertake the lobectomy.
* The lesion has the possibility of metastasis.
* Finding serious adhesion to pleura during operation
An Exploratory Trial in Hong Kong to Explore the Effect of a New Formula

This is an exploratory study with the aim to gain insight and potentially generate hypotheses on health benefits of feeding with study product. This study explores in healthy subjects the effect of feeding with the test product compared to the control product in early life.

* Key exploratory objective is to find an effect on body composition.
* Other exploratory objectives are to find an effect on growth parameters.
* Safety and tolerance and the user experience will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, singleton, term born infants.
* Infants aged 6 months(± 2 weeks) at enrolment.
* Infants fed with formula (with or without additional weaning foods or drinks) before enrolment.
* Written informed consent (IC) from parent(s) and/or legally acceptable representative(s) aged ≥18 years at enrolment.

Exclusion Criteria:

* Infants who require a special diet other than Formula with intact cow's milk protein.
* Infants known or suspected to have cow's milk, fish protein, and/or soy allergy and/or lactose intolerance.
* Infants with current or previous illnesses/conditions and/or known or suspected congenital diseases or malformations which could interfere with the study outcomes, as per investigator's clinical judgement.
* Infants with previous, current, or intended participation in any other clinical study involving investigational or marketed products.
* Incapability of infants' parents and/or legally acceptable representative(s) to comply with study protocol as per the judgement of the investigator or investigator's uncertainty about the willingness or ability of parents legally acceptable representative(s) to comply with the protocol requirements.
* Employees and/or infants/family members or relatives of employees of Danone Nutricia, the participating sites, or any other nutrition company that develops Infant, Follow On or Young Child formulae.
Trauma Induced Coagulopathy and Inflammation

While a number of factors are known to be associated with the development of trauma induced coagulopathy (TIC), inflammation, and multi-organ failure, we currently cannot predict which patients are at risk for developing these life threatening conditions with any certainty. In this prospective observational study, we will investigate the many factors that contribute to the development of trauma induced coagulopathy, post injury inflammation and the development of organ dysfunction in order to develop a multi scale computational algorithm of clinical prediction. Using a convenience sample technique, demographic data, physiologic data, blood samples and clinical variables will be collected over 5 days following traumatic injury. A computational model will be used to predict the development of TIC and multi-organ failure.

A prospective, observational, convenience sample of trauma patients 18 years old or older who present to the trauma bay as a trauma alert will be included after evaluation by the on-call trauma surgeon and research assistant. Minimally injured patients will be compared to those with a systolic blood pressure of 90 mmHg or less, the need for blood product transfusion within 1 hour of admission, and/or an ISS (injury severity score) of greater than or equal to 15. Demographic data including past medical/medication history as well as clinical data including continuous vital signs will be recorded. If eligibility criteria are met, the research blood samples will be drawn at the same time as routine clinical samples. Blood samples (approximately 15 ml) will be taken on admission, 3hr, 6hrs, 12hrs, 24 hrs, 48 hrs, and 5 days post admission. Vital signs, number of blood transfusions, volume of crystalloid, administration of medications, and the values of routine laboratories will be monitored continuously for 24 hours, and then cumulatively for up to 5 days. After the last blood draw, we will be following the patient's outcome for up to 30 days. If patients are discharged or die prior to completing the 5 days of blood samples, additional samples and/or clinic appointments for the purpose of research will not be obtained. A computational algorithm will be used to predict the development of trauma induced coagulopathy, inflammation and multi-organ failure.

Eligibility Criteria:
Inclusion Criteria:

* Injured patients presenting to the trauma bay with a trauma alert activation (highest level of activation)
* Age 18 years old or more

Exclusion Criteria:

* Transfer duration to trauma service exceeding 6 hours.
* Known pregnancy
A Comparative Study On The Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity

Background:

Dentine hypersensitivity (DH) causes considerable pain and discomfort to an individual due to number of stimuli on exposed dentine. Different kinds of treatment strategies are used in the resolution of dentine hypersensitivity including the use of propolis and dentine bonding agent. No study had compared the efficacy of propolis and dentine bonding agent.

Objective:

The objective of the study was to find out whether there is a difference in the efficacy of Propolis and seventh generation dentine bonding agent in reducing the dentine hypersensitivity. Comparison within the groups and pairwise comparisons were also recorded in reducing dentine hypersensitivity.

Methods:

In this six month In- Vivo single blinded randomized clinical study, a total number of 52 patients with complain of dentine hypersensitivity were selected in two groups after taking informed consent. Group A and B received 30% ethanolic extract of propolis and dentine bonding agents respectively by a trained operator. Recordings of dentine hypersensitivity were obtained at Day 0, before and after the application of experimental agents, and also on Day 7, 15 and 30 by the principal investigator. Response was measured by Visual Analog Scale and Schiff Cold Air Sensitivity Scale. Statistical Package for the Social Sciences (SPSS) version 20 was used to analyze the data with level of significance set at p \< 0.05. Friedman test was applied to see the comparison within groups and Wilcoxon Signed Rank test was used for Pairwise comparison. Mann Whitney U-Test was applied for comparison between groups.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients reporting to Periodontology department of Dow International Dental College (DIDC) with dentine hypersensitivity
* Patients having age of 20- 45 years
* Systemically healthy patients
* Patients having at least 2 vital teeth with hypersensitivity
* Patients having sensitivity on facial surfaces to air stimulus
* Patients with Score I of Silness and Loe Plaque Index 77
* Patients who used Fluoride dentifrices for hypersensitivity but could not get relief from it.

Exclusion Criteria:

* Patients with carious, cracked or restored teeth, abutment teeth used of removable or fixed prosthesis and tooth with any other dental pathology
* Patients who used analgesics, mood alteration drugs during last six months
* Smoker, pregnant and nursing mothers
* Patients who used tooth whitening or bleaching agents in the last six months
* Patients who were undergoing orthodontic therapy and history of periodontal surgery during last six months
ABTHERA ADVANCE™ Use Without Wittman Patch

The objective of this study is to evaluate the use of the ABTHERA ADVANCE for patients requiring open abdomen due to necrotizing pancreatitis. The institutions traditional approach is to use the ABTHERA Open Abdomen dressing with Wittmann patch. However, the ABTHERA ADVANCE has shown in vitro to have improved tension on the abdominal wall that may obviate the need for costly Wittmann patch placement.

The objective of this study is to evaluate the use of the ABTHERA ADVANCE for patients requiring open abdomen due to necrotizing pancreatitis. The instiutions traditional approach is to use the ABTHERA Open Abdomen dressing with Wittmann patch. However, the ABTHERA ADVANCE has shown in vivotro to have improved fascia movement that may obviate the need for costly Wittmann patch placement.

Primary Objective: Determine the variable cost savings associated with use of ABTHERA ADVANCE™ without the use of Wittmann patch Hypothesis: The hypothesis is that with use of the ABTHERA ADVANCE will lead to reduced variable costs compared to ABTHERA Open Abdomen dressing with Wittmann patch Secondary Objective(s): Determine the rate of abdominal closure, component separation, and mesh placement with the ABTHERA ADVANCE™ without the use of Wittmann patch Hypothesis: The hypothesis is that rate of abdominal closure, component separation, and mesh placement will appear similar with use of ABTHERA ADVANCE compared to ABTHERA Open Abdomen dressing with Wittmann patch

Eligibility Criteria:
Inclusion Criteria:

* Male or Female patients aged ≥ 22
* Severe necrotizing pancreatitis with abdominal compartment syndrome or severe sepsis requiring decompressive laparotomy and/or pancreatic debridement
* Patients that require open abdomen at the conclusion of their index operation

Exclusion Criteria:

* Female patients who are pregnant or lactating
* If in the opinion of the treating physician a patient should not participate in this study.
Multi-Day Evaluation of the TIVA Device

Prospective, randomized, single-center study to evaluate the ability of the device to collect good quality blood samples from patients with peripheral IV access over the length of their stay.


Eligibility Criteria:
Inclusion Criteria:

* Patient will be admitted to the BWH unit 15 for post-surgical care
* Patient is at least 18 years old
* Patient is willing and physically / cognitively able to sign a written consent form
* Patient is willing and able to complete study questionnaires
* Patient is NOT a prisoner

Exclusion Criteria:

* Active hemodialysis
* Hemolytic disorders (e.g., sickle cell disease)
* Pregnancy
A Comparison of Bed Rest Versus Moderate Activity in Preterm Premature Rupture of Membranes (PPROM)

Bed rest has been a commonly prescribed intervention for high risk pregnancies, despite the lack of data to support its benefits, and increasing evidence pointing to potential harms. In this study, the effects of bed rest compared to moderate activity will be on maternal mood and muscle strength will be evaluated in patients with preterm premature rupture of membranes (PPROM).

Historically, bed rest has been considered a beneficial treatment option for patients with high risk pregnancies. The definition of bed rest varies between providers, and can mean anything from being completely bed-bound for months at a time (sometimes called strict bed rest) to walking around within the home a few times a day (sometimes called modified bed rest). Recent studies have highlighted potential harmful effects from bed rest. However, scientific studies need to be carried out to compare the effects of bed rest and moderate activity on the health of mothers and babies.

PPROM is defined as rupture of membranes prior to 37 weeks gestation prior to the onset of labor, and affects approximately 3% of all pregnancies in the Unites States. Women with PPROM are routinely managed in the inpatient setting from the time of diagnosis until delivery. Therefore, PPROM patients are a closely supervised and easily accessible cohort of women.

In this study, participating patients with PPROM will be randomized into two groups: bedrest or moderate activity. Maternal mood and muscle strength will be assessed at enrollment and after delivery to determine whether there are significant differences in these outcomes in the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Gestational age between 23 weeks 0 days - 32 weeks 0 days
* Diagnosed with preterm premature rupture of membranes

Exclusion Criteria:

* Cervical dilation greater than or equal to 3cm
* Active labor
* Evidence of infection
* Inability to provide informed consent
* Requirement for continuous fetal monitoring
Safety of Three Formulations of Ketasyn Administered for 14 Days in Healthy Elderly

AC-1202 (Ketasyn) is a nutritional beverage currently being studied in neurodegenerative conditions including Alzheimer's disease. The current study is a randomized, open-label trial to compare the safety, tolerability, and PK profiles of 3 formulations of Ketasyn administered on a daily basis for 14 days, with and without a 7-day titration period, in normal, healthy elderly volunteers.

Sixty healthy, elderly volunteers between the ages of 55 and 85 will be enrolled at one of four clinical sites in the Tampa/St. Petersburg area. Subjects with a history of GI inflammatory conditions (e.g., IBS or diverticulitis) or other clinically significant abnormalities will be excluded from enrollment. Subjects will be randomized to one of two dosing regimens (with or without a 7-day titration period) and to one of three formulations of Ketasyn containing the identical amount of active ingredient, but different amounts of proteins and carbohydrates. Subjects assigned to Group 1 will receive 10 grams active ingredient daily on Days 1-7, followed by a daily dose of 20 grams active ingredient on Days 8-14. Subjects assigned to Group 2 will receive 20 grams active ingredient on Days 1-14. All subjects will have clinic visits on Day 1 and 14; subjects assigned to Group 1 will also have a clinic visit on Day 8. Subjects will fast prior to each clinic visit and have vital signs and routine lab tests performed prior to dosing. A standard breakfast will be served along with the study product, following which blood samples will be collected for product concentration levels.

Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on physical exam, vital signs, medical history, ECG, or laboratory results

Exclusion Criteria:

* Type 1 or uncontrolled Type 2 diabetes
* History of or current inflammation of GI system, e.g. IBS, diverticular disease, gastric or duodenal ulcers, severe GERD requiring daily medication
* History (within past 60 days) of infections
* Clinically significant renal, hepatic, or hematologic abnormalities