cyrilzakka/clinical-trials huggingface dataset:
Efficacy of HFNC Versus NIV for Prevent Reintubation in Sepsis Patients

Post extubation respiratory failure occur in 30% of extubated patients. More than 50% of them required reintubation. Noninvasive positive pressure ventilation (NIV) had been reported as an effective tool to prevent post extubation respiratory failure. Recently, high flow oxygen nasal cannula (HFNC) had been successfully used to prevent post extubation respiratory failure and prevent reintubation in comparable with NIV among post cardiothoracic surgery and high risk for reintubated patients. There was no information about HFNC versus NIV in prevention of reintubation among severe sepsis or septic shock patients.

Post extubation respiratory failure occur in 30% of extubated patients. More than 50% of them required reintubation. Noninvasive positive pressure ventilation (NIV) had been reported as an effective tool to prevent post extubation respiratory failure. Recently, high flow oxygen nasal cannula (HFNC) had been successfully used to prevent post extubation respiratory failure and prevent reintubation. The results from recent randomized controlled trials, comparing HFNC with NIV for prevent post extubation respiratory failure among post cardiac surgery and high risk patients, showed no significant different in the treatment outcome.comparable with NIV among post cardiothoracic surgery and high risk for reintubated patients.

About 40-85% of severe sepsis/septic shock patients developed acute respiratory failure, required endotracheal intubation. According to the nature of patients population, usually eldery, multiple co-morbid condition and high APACHE II score, sepsis patients were considerred as high risk for reintubation, after extubated. There was no information about HFNC versus NIV in prevention of reintubation among severe sepsis or septic shock patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sepsis or septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)
* Depended on mechanical ventilator for more than 48 hours
* Plan for extubation due to successful weaning

Exclusion Criteria:

* Patient with tracheostomy
* Recent upper abdominal surgery
* Wound at face that prohibit face-mask application
* Patient or 1st degree relative not agree to participate trial
* Physician prefer either NIV or HFNC for the patient
Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring

The purpose of this study is to determine whether continuous non-invasive arterial pressure (CNAP) monitoring is beneficial to maintain maternal hemodynamic stability and improve the outcomes of maternal and fetal comparing with intermittent oscillometric non-invasive arterial pressure (NIAP)measurement during spinal anaesthesia for cesarean section .

Peri-operative hypotension and fluctuation of arterial blood pressure (BP) during spinal anaesthesia are common. Hypotension causes maternal side-effects such as unconsciousness, dizziness, nausea, and vomiting. The potential fetal side-effects are caused by a reduction in the uterine blood flow with consequent reduced oxygen supply and acidosis reflected by impaired blood gas analyses and impaired Apgar scores. Because of the potential harm to the fetus and the dependency of fetal oxygenation on maternal arterial pressure (AP), it has been strongly recommended to closely monitor mother's arterial pressure and to treat hypotension immediately. Non-invasive arterial pressure (NIAP) measurement is a common method for monitoring in clinical. These hypotension episodes probably would be detected with delay by NIAP measurement on account of its discontinuous. A monitor for continuous non-invasive arterial pressure monitoring (CNAPTM Monitor 500, CNSystems Medizintechnik AG,Graz, Austria) using the volume-clamped method. It can monitor timely and provide beat-to-beat value of arterial pressure.

The purpose of this study is to determine whether continuous non-invasive arterial pressure (CNAP) monitoring is beneficial to maintain maternal hemodynamic stability and improve the outcomes of maternal and fetal.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for elective caesarean section with spinal anaesthesia
* pregnancy week above 36

Exclusion Criteria:

* age\<18 yr
* cardiac arrhythmia
* vascular pathologies of the upper limbs (recent vascular surgery, Raynaud's disease， vascular stenosis)
* contraindication for spinal anaesthesia
* emergency case
Actions to Decrease Disparities in Risk and Engage in Shared Support for Blood Pressure Control (ADDRESS-BP) in Blacks

To use practice facilitation (PF) + community health worker (CHW) facilitation as a practical and sustainable implementation strategy to support the implementation and evaluation of three multi-level evidence-based interventions \[nurse case management (NCM), remote blood pressure monitoring (RBPM), and social determinants of health (SDOH) support\] delivered as an integrated community-clinic linkage model \[Practice support And Community Engagement (PACE) to address patient-, physician-, health system-, and community-level barriers to hypertension (HTN) control in Blacks across 25 primary practices within NYU Langone Health in New York City (NYC) and, in partnership with an established Community-Clinic-Academic Advisory Board and HealthFirst (NYC's largest Medicaid payer).

The goal for the UH3 Implementation Phase (Years 4-7, Intervention) is to evaluate a stepped-wedge cluster RCT of 25 primary care practices in Black patients with uncontrolled hypertension (HTN)

The goal for the UH3 Implementation Phase (Years 4-7, Intervention) is to evaluate a stepped-wedge cluster RCT of 20 primary care practices in Black patients with uncontrolled hypertension (HTN).


Eligibility Criteria:
UH3 IMPLEMENTATION PHASE (Years 4 - 7): INTERVENTION

Inclusion Criteria:

Patients are eligible if he/she:

1. identifies as Black (through EHR code or self-report)
2. is 18-85 years of age
3. has a diagnosis of HTN (identified by ICD-10 codes for HTN)
4. prescribed an antihypertensive medication(s)
5. has a clinic BP \> 130/80 mmHg

Exclusion Criteria:

Patients will be ineligible for the study if they:

1. are deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks)
2. participate in other hypertension-related clinical trials
3. have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR)
4. plan to discontinue care at the site within the next 12 months; or
5. are pregnant or planning to become pregnant in the next 12 months

IMPLEMENTATION EVALUATION

1. NYULH Primary care provider (MD/DO, NP), Clinical Director, Site Administrator, Medical Assistant, or administrative staff employed at the participating practices and interacts with at least five patients with a diagnosis of hypertension; or
2. NYULH Nurse case manager within centralized service; or
3. Staff and leadership of community- and faith-based organizations serving the Black community; or
4. NYULH Organizational leadership; or
5. NYULH Project Staff: Community Health Workers/CHW Supervisor/Practice Facilitators; and
6. Able and willing to provide consent

Exclusion Criteria:

1. Refusal to participate
Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis

The primary purpose of this study is to determine if single and multiple doses of BMS-986184 are safe and well tolerated in healthy male and female subjects. The primary purpose of the proof of mechanism study is to determine safety and efficacy in patients with ulcerative colitis.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Women of childbearing potential must have a negative serum pregnancy test within 24 hours prior to the start of study drug
* Diagnosis of ulcerative colitis confirmed by endoscopic and histologic evidence (if no previous confirmation of diagnosis is available or if diagnosis is not conclusive, at time of baseline endoscopy, histology must be performed and read locally to confirm diagnosis)

Exclusion Criteria:

* Any bacterial, fungal or viral infection, including tuberculosis, HIV, hepatitis B or hepatitis C
* Subjects with history of cancer, lymphoproliferative disease, class III or IV congestive heart failure, myocardial infarction, unstable angina pectoris, or any history of significant ocular disease such as glaucoma or retinal disease

Other protocol defined inclusion/exclusion criteria could apply
Validity of Fluorescence-Based Devices Versus Visual-Tactile Method in Detection of Secondary Caries Around Resin Composite Restorations: Invivo Diagnostic Accuracy Study

This study will be conducted to evaluate the clinical performance and validity of both light-induced fluorescence intraoral camera and laser-induced fluorescence device in comparison to visual-tactile assessment method in detection of secondary caries around margins of resin composite restorations.

Each patient should have at least one resin composite restoration. The restoration will be evaluated by all diagnostic methods. Each examiner will independently record the dental findings using all methods, the visual- tactile assessment method and both fluorescent-aided identification methods. The visual-tactile assessment method includes the use of mirror, probe under good illumination condition, while the fluorescent-aided identification methods will be performed by both light-induced fluorescence intraoral camera and laser-induced fluorescence device. Then Diagnostic performance for caries detection was evaluated, assessing the validity of each diagnostic method in diagnosing secondary caries around margins of resin composite restorations

Eligibility Criteria:
Inclusion Criteria:

* Patients should be over 18 years of age.
* Patients should have an acceptable oral hygiene level.
* Patients should have at least one resin composite restoration.

Exclusion Criteria:

* Patients with a compromised medical history.
* Patients with active severe periodontal disease.
Vascular Endothelial Growth Factor Levels at Hysteroscopic Biopsies Which Taken From Recurrent Pregnancy Loss

The aim of this study is determine vascular endothelial growth factor levels and angiogenesis/vascularity from hysteroscopic endometrial biopsies which taken from patients who has Recurrent Pregnancy Loss.The endometrial vascular endothelial growth factor levels will be measured by immunohistochemical staining methods due to office hysteroscopic endometrial biopsy after the menstruation at follicular phase of menstrual cycle.

This study is a prospective,observational,single-center study.Ethical approval was obtained from the Institutional Review Board.This study will be completed 30 patients with Habitual Abortus.

Endometrial vascular endothelial growth factor levels will be measured using Flk-1 / Kinase Domain Receptor / Vascular endothelial growth factor receptor-2, Ab-1 (Rabbit PAb), Vascular Endothelial Growth Factor (VEGF) Ab-7 (VG1), Cluster of Differentiation 34 (Endothelial Cell Marker) Ab-1 (QBEnd/10), Vascular endothelial growth factor receptor-1 (N-term) (FLT1) antibody kits. All assays will be performed according to the manufacturer's instructions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Recurrent Pregnancy Loss who accept to join the study.

Exclusion Criteria:

* Patients whose age of \<18 and \>45
* Patients with have any pregnancy.
The "Concussion or Brain Bleed" Trial

Researchers are trying to understand the effect of educating patients and encouraging shared decision making on rates of CT scanning in head injured patients by using an already developed app and observing the effect on the health care provider.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Present to the Emergency Department with a blunt head injury within the past 24 hours
* Determined to be low risk by the Canadian CT Head Rules (CCHR), and are being considered for a head CT by the treating provider.

Exclusion Criteria:

* Patients who are pregnant
* Non-English speaking
* In police custody
* Undergoing psychiatric evaluation
* Found to have drug or alcohol intoxication
Tanglewood to Table: A Walking Farmer's Market Group and Control

This program encourages community members to walk approximately 1 mile to the Whitesburg Farmers Market each Thursday or Saturday. The study aims to determine if walking to the market to receive vouchers improve health outcomes beyond controls who receive nutrition education.

In the summer of 2018, community members of Whitesburg, Kentucky (KY) were recruited to join the Tanglewood to Table walking program, and community members of Harlan, KY were invited to serve as controls. Each Thursday or Saturday, participants report whether or not they walked the 1 mile trail to the farmers market, how many steps the walked in the previous 7 days and they reported which fruits and vegetables they consumed the previous week. The control group will receive nutrition education handouts. The program is from June 2018 - January 2019. Participants complete questionnaires about fruit and vegetable consumption and physical activity. Participants also provided physical and biological measurements. Recruiting for the 2018 Walking Program will begin in May.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years
* non-pregnant
* moderate to good health (able to walk approximately 1 mile)

Exclusion Criteria:

* under 18 years
* pregnant
* poor health (unable to walk approximately 1 mile)
* institutionalized adults
* impaired consent capacity
* prisoners
The Long-term Impact of Invasive Meningococcal Disease in Australian Adolescents and Young Adults

Survivors of invasive meningococcal disease (IMD) experience a range of mild to severe sequelae that impact upon their quality of life. The majority of studies to date have focused on the impact of IMD on childhood and very little is known about the impact of the disease on adolescents and young people.

The aim of this study is to assess the physical, neurocognitive, economic and societal impact of IMD on adolescents and young adult Australian survivors.

Hypothesis:

1. Adolescents and young adult survivors who are 2 to 10 years post IMD have significantly poorer outcomes including intellectual functioning and quality of life when compared to healthy controls.
2. IMD imposes a significant financial burden upon individuals, families and society.
3. Serogroup B disease is associated with an increased risk of sequelae when compared to non-B serogroup IMD.

Study design:

This a multi-centre, case-control mixed-methods study. Survivors of IMD (retrospective and prospective cases) and non-IMD healthy controls will be invited to participate in the study.

Retrospective IMD cases admitted in the previous 10 years will be identified through each of the participating hospitals (paediatric and adult hospitals). During the course of the study prospective recruitment of IMD cases will also occur at participating hospitals. Meningococcal foundations/groups will also be approached and asked to advertise and conduct a mail out to their members to inform them about the study.

Healthy controls will be prospectively recruited by "snowballing technique" whereby enrolled IMD cases will be asked to distribute a study information sheet to their healthy friends/acquaintances who are approximately the same age. Control participants may also be identified from databases at each participating site or through community advertising.

Enrolled cases will undergo a neurocognitive, psychological and physical examination 2 - 10 years post IMD admission. A subset of IMD cases will be invited to participate in a semi-structured interview. Controls will also undergo neurocognitive, psychological and physical examination.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 15 to 24 years 11 months at time of IMD admission
* Hospitalised IMD case from 1st January 2006 -with serogroup B or non-B IMD, confirmed by culture or polymerase chain reaction (PCR) in blood or CSF.
* Healthy controls aged 17 to 34 years 11 months at the time of assessment.

Exclusion Criteria:

* Individuals who are not fluent with the English language.
* Control participants with a history of meningitis, encephalitis, or meningococcal disease, intellectual disability, intracranial pathology (eg. traumatic brain injury) that may impact on cognitive functioning, or significant vision and/or hearing loss that may impact on the validity or reliability of the neurocognitive assessment.
Drug Interaction Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult Subjects

The purpose of this study is to assess the effect of ketoconazole at steady state on the pharmacokinetics of a single dose of isavuconazole in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* The subject has a body weight of at least 45 kg and has a body mass index (BMI) of 18 to 32 kg/m2, inclusive
* Results for aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and total bilirubin must not be above the normal range
* The female subject agrees to sexual abstinence, or is surgically sterile, postmenopausal (defined as at least 2 years at Screening without menses), or using a medically acceptable double barrier method (e.g. spermicide and diaphragm, or spermicide and condom) to prevent pregnancy and agrees to continue using this method from Screening until the end of the study; and is not lactating or pregnant as documented by negative pregnancy tests at Screening and Day -1
* The male subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy during the study period

Exclusion Criteria:

* The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes)
* The subject has a positive result for hepatitis C antibodies or hepatitis B surface antigen at Screening or is known to be positive for human immunodeficiency virus (HIV)
* The subject has a known or suspected allergy to any of the components of the trial products or the azole class of compounds or a history of multiple and/or severe allergies to drugs or foods (as judged by the investigator), or a history of severe anaphylactic reactions
* The subject is a smoker (any use of tobacco or nicotine containing products) within 6 months prior to Screening
* The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Day -1, or over-the-counter medications within 1 week prior to Day -1, with the exception of occasionally use of ibuprofen
* The subject has a recent history (within the last 2 years) of drug or alcohol abuse, or a positive drug and/or alcohol screen
Evaluation of Toothbrush Bristles in Plaque Reduction

The purpose of this cross-over clinical research is to evaluate the cleaning efficacy of toothbrushes tufted with two types of tapered bristles and end rounded bristles in removal of interdental plaque with clinical measurement (Plaque Index) and objective measurement (digitally measured plaque area). This study will demonstrate the influence by a type of processing bristles on removal of interdental plaque and determine an agreement between the different evaluation methods.

This is a randomized evaluator-masked crossover study with 10 subjects. Subjects will be randomly allocated to three test groups. Subjects will use the assigned toothbrush at baseline appointment and two times a day for a week. Plaque Index and plaque area will be assessed before/after one time use at baseline and Day 7. Subjects will be assigned to another toothbrush after one week wash-out period.


Eligibility Criteria:
Inclusion Criteria: Individuals may be included in the study if they meet all of the following inclusion criteria:

* Must have read, understood and signed an informed consent prior to being entered into the study
* Must be 18 to 70 years of age, male or female
* Have at least 20 natural or restored teeth
* Must have average Plaque Index of Ramfjord teeth at baseline greater than 2(Quigley and Hein) at screening
* Agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures (other than those provided during the study) any time during the study
* Agree to refrain from regular oral hygiene regimen for 24 hours and eating for 4 hours before the appointment in the study
* Agree to abstain from the use of any dental products other than those provided in the study
* Agree to comply with the conditions and schedule of the study

Exclusion Criteria: Individuals are not eligible for participation in this study if any of the following are noted:

* Physical limitations or restrictions that might preclude normal tooth brushing
* Evidence of gross oral pathology
* Presence of severe gingivitis with 30 or more sites showing bleeding on probing
* Evidence of major soft tissue lesions or trauma at the baseline visit as determined by the Investigator/Examiner
* Chronic disease with concomitant oral manifestations
* Subjects who are currently undergoing, or require, extensive dental work, orthodontic treatment or periodontal surgery or orthodontic treatment in the preceding 3 months
* Currently using bleaching trays
* Eating disorders
* Recent history of substance abuse
* Smoking \>10 cigarettes/day
* Participation in other clinical studies within 14 days of screening
Nurse Led Transitional Care Model in Cardiac Surgery

To evaluate the effectiveness of Nurse Led Transitional Care Model (TCM) on the functional autonomy, quality of life and rehospitalization rates of elderly patients undergoing open heart surgery.

Rate and number of successful cases in open heart surgery has been increasing due to the advances in medical technology and surgery. To improve patient convalescence results and reduce rate of post-discharge readmission to hospital and unplanned post-discharge rehospitalization, home-care and follow-up process of patients should be managed successfully.

A total of 66 elderly patients who agreed to participate in the study between November 2017 and December 2018 were randomly assigned to the intervention (n: 33) and control (n: 33) groups. Patients in intervention group were given care based on the TCM until the post discharge 9th week starting from date of hospitalization. Patients in control group were given standard care services. Functional autonomy and quality of life levels of patients were evaluated at admission to the clinic and at the post-discharge 9th week whereas their repeated admission rates to the clinic and re-hospitalization rates were evaluated at post discharge 2nd, 6th and 9th weeks and finally 6 months. The CONSORT checklist was used to check the procedure.

Eligibility Criteria:
Inclusion Criteria:

* be hospitalized for the first time and for elective open heart surgery;
* have no other surgical intervention other than an open heart surgery,
* have no psychological and mental disorders,
* have no major chronic problems such as kidney problems, neurological problems or cancer,
* be able to speak Turkish,
* be available to be communicated by phone,
* provide consent to participate in the study,
* live at a maximum distance of 50 km from the hospital (for easy access during post-discharge follow-up visits).

Exclusion Criteria:

* ask to leave the study,
* be exposed to a disease or trauma that may affect his/her functional autonomy during the study,
* die throughout the study