cyrilzakka/clinical-trials huggingface dataset:
High Flow Nasal Cannula Therapy for Early Management of Acute Hypercapnic Cardiogenic Pulmonary Edema in the Emergency Department

High flow nasal therapy (HFNT) has not been well evaluated for treating hypercapnia The purpose of this study is to determine whether high flow nasal therapy (HFNT) can decrease hypercapnia and improve respiratory distress parameters in Emergency Department patients with acute hypercapnic respiratory failure related to cardiogenic pulmonary edema and to compare its efficacy to that of non invasive ventilation.

This is a prospective observational study conducted as a preliminary study to the randomized controlled OPTICAP trial (NCT02874339).

Prospective observational exploratory study including ED patients with a suspected diagnosis of acute hypercapnic respiratory failure related to cardiogenic pulmonary edema who require NIV according to the joint recommendations from the French society of anaesthesia and intensive care and the French society for intensive care.

Patients will receive a 1hr treatment session by either NIV or HFNT, depending on the attending ED physician expertise in using HFNT Repeat evaluation of arterial blood gases and respiratory parameters and dyspnea will be performed before and after treatment sessions according to current guidelines.

Improvement in PaCO2 and other respiratory parameters after 1hr treatment by HFNT will be analysed and compared to that of NIV.

Eligibility Criteria:
Inclusion criteria:

a suspected diagnosis of acute cardiogenic pulmonary edema presenting with any of the following criteria:

* dyspnea (orthopnea or a worsening of dyspnea according to NYHA criteria)
* respiratory rate \>20 b/min
* bilateral crepitant rales at pulmonary auscultation
* pulmonary infiltrate on chest X-ray

signs of respiratory failure or any of the following clinical, laboratory or radiology signs:

* Use of accessory respiratory muscles or paradoxical abdominal movement
* Cardiomegaly (cardiothoracic ratio \>0.5)
* Hypertensive crisis
* PaO2/FiO2 ≤ 300 mmHg breathing O2\> 8L/min or PaO2 ≤ 63mmHg breathing room air

hypercapnia (PaCO2\>45 mmHg at arterial blood gas analysis)

Exclusion criteria:

* acute exacerbation of chronic obstructive pulmonary disease or associated dyspnea from non cardiac origin
* Fever (\>38,5°), sepsis or ongoing infection
* Contra-indication to NIV
Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat and nitrogen absorption in subjects with PEI due to Cystic Fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis
* Confirmed PEI by historical CFA \< 70% without supplementation or current or historical fecal elastase \< 50µg/g stool (within the last 12 months)
* Subjects of 12 years or older
* Currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months
* Clinically stable condition without evidence of acute respiratory disease or any other acute condition
* Females of child-bearing potential must agree to continue using a medically acceptable method of birth control

Exclusion Criteria:

* Ileus or acute abdomen
* History of fibrosing colonopathy
* History of distal ileal obstruction syndrome within 6 months of enrollment
* Use of an immunosuppressive drug
* Any type of malignancy involving the digestive tract in the last 5 years
* Known infection with HIV
Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis

This is a randomized, controlled study evaluating empagliflozin tablets administered daily for 8 weeks. The purpose of the study is to evaluate the efficacy and safety of empagliflozin in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using Mayo score for ulcerative colitis activity. Calculation of the score requires patients to undergo colonoscopy at the start of the study and at week 8.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild or moderate ulcerative colitis newly diagnosed by colonoscopy and biopsy according to Mayo endoscopic scoring of ulcerative colitis.
* Adults (males and/or females) with age range from 18 to 65 years old.
* Patients on treatment with 5-aminosalisylic acid (5-ASA)

Exclusion Criteria:

* Patients with severe ulcerative colitis according to Mayo endoscopic scoring of ulcerative colitis.
* Treatment with systemic or rectal steroids.
* Treatment with immunosuppressants.
* Previously failed treatment with a sulphasalazine.
* Known hypersensitivity to any of study drugs.
* Hepatic and renal dysfunction.
* Pregnancy and lactation.
* History of colorectal carcinoma.
* History of complete or partial colectomy.
* Patients with diabetes mellitus
* Patients with history of lactic acidosis
* Patients with disease states associated with hypoxemia including cardiorespiratory insufficiency
* Positive stool culture for enteric pathogens, positive stool ova and parasite exam.
Multi-center Clinical Study of Early Antibios of Severe Acute Pancreatitis

Strategy of antibiotic therapy in SAP,De-escalate (cefoperazone+metronidazole) or Escalate (meropenem) therapy,which one is better.

SAP is a serious and life-threatening disease and requires intensive and aggressive management of multiple organ failure and severe infectious complications that can develop in these patients. The most common cause of death in patients suffering from severe acute pancreatitis (SAP) is the infection of pancreatic necrosis by enteric bacteria with mortality rates of 30% (range 14- 62%),spurring the discussion of whether or not prophylactic antibiotic administration could be a beneficial approach. Pancreatic infections are more often monomicrobial, especially E. coli in the two first weeks (100% and 62.5%) of onset, with a shift from gram-negative to gram-positive as the pancreatitis progressed.

In order to evaluate the benefit of prophylactic antibiotic application, a number of randomized controlled clinical trials have been published over the past 15 years. Since the results were conflicting and most studies were of low methodological quality and/or statistically underpowered, meta-analyses have been performed to assess this important issue. However, their results ranged from absolutely no effect of antibiotic prophylaxis to positive effects regarding mortality, the incidence of infected pancreatic necrosis and the incidence of extra pancreatic infections.

In order to provide reliable evidence of the effect of antibiotherapy strategy in SAP, we performed a prospective randomized multicenter clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* severe Acute Pancreatitis according to Atlanta criteria revisited in 2012

Exclusion Criteria:

* concurrent sepsis or (peri)pancreatic infection caused by a second disease
* patients with chronic organ failure (chronic renal failure needs kidney replacement, chronic heart failure, decompensate hepatic cirrhosis, chronic obstructive pulmonary disease)
* recurrent or endoscopic retrograde cholangiopancreatography (ERCP), or traumatic or operative pancreatitis
* pregnancy, malignancy or immunodeficiency
* a history of allergy to meropenem, cefoperazone and metronidazole
* a history of antibiotic administration within 48 h prior to enrollment
* possible death within 48 h after enrollment
Influence of Hypoxia on Electroretingraphy (ERG) Measurements

To investigate the influence of induced hypoxia on the ERG.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* under 18 and over 80 years, respiratory diseases, cataracta and corneal hazes, myopia more than 6 dpt, hyperopia more than 3 dpt, allergy for any topical anesthetics in ophthalmology, photic epilepsy, asthma bronchiale.
Patients Navigator for Organized Colorectal Cancer Screening

The main objective is to evaluate the impact of the recruitment and training of a peer-navigator on the participation rate of colorectal cancer screening among underserved area. The role of the navigator is to establish an intervention culturally-tailored to the inhabitants in order to promote the Fecal Occult Blood test (FOBT) and accompany the inhabitants to complementary exams, if needed.


Eligibility Criteria:
Inclusion Criteria:

* person living in the IRIS intervention zones
* person invited by the local management structure to participate in colorectal cancer screening

Exclusion Criteria:

* person not living in the IRIS intervention zone
* person not invited by the local management structure to participate to colorectal cancer screening
Talk STEM Familia: Dual-Language (TSFII)

The study will evaluate Talk STEM Familia (TSF) effects on student and parent scientific academic vocabulary knowledge and usage, scientific academic vocabulary (SAV) learning behaviors, academic self efficacy, and satisfaction with the program, including acceptance of the technology and its usability.

The Investigators will work with research practice partners Lane Educational Services District (ESD) to disseminate bilingual electronic and printed recruitment materials to Latinx families in the elementary and middle schools throughout the 16 school districts in Lane County, OR. Recruitment materials will direct families to contact the project's bilingual staff by phone to receive study details and, following a brief screen, to engage in an informed consent process. 300 eligible Latinx English-learner parent/student dyads will be recruited. Students will be in grade 4-8; families will speak primarily Spanish in the home; and families will have a smartphone, tablet, or computer and Internet access at home.

The Investigators will administer the pre-test to all 300 parent/student dyads via Qualtrics and randomize 150 parent/student dyads to the TSF treatment, 150 parent/student dyads to the treatment-as-usual control condition. Each family will be assigned a non-identifiable user name linked only to their non-identifiable participant ID. The Investigators will then send the TSF program materials and links to the treatment group. These materials will include graphic and video tutorials on TSF set-up and use, including set-up of a wireless bridge that allows researchers to monitor the non-identifiable program usage. Bilingual telephone support will be provided during the 1-month set-up period and throughout the 24-week TSF intervention period. During the intervention, families in the treatment group will be asked to use TSF for 24 weeks. During that time, they will receive 3 notifications/week that prompt them to engage in program games and activities targeting 72 scientific academic vocabulary (SAV) words.

Half way through the 24-week intervention period, the Investigators will administer the mid-test via Qualtrics to all 300 parent/student dyads and following the 24-week intervention, the Investigators will administer the post-test via Qualtrics to all 300 parent/student dyads. Pre-, mid-, and post-test surveys will measure gains in knowledge and usage of the 72 SAV words TSF targets, academic self-efficacy, and academic enabling behaviors. Treatment group dyads will also complete a usability, technology acceptance, and consumer satisfaction survey at post-test. All 300 parent/student dyads will receive a smart speaker at pretest, and $100 at mid-test and post-test.

Following post-test, parent/student dyads in the treatment-as-usual control condition will receive TSF program materials.

Eligibility Criteria:
Inclusion Criteria:

1. Latinx English learner parent with a student (grade 4-8)
2. Speaking primarily Spanish in the home
3. Having a smartphone, tablet, or computer
4. Having Internet in the home
5. Being the student (grade 4-8) of a participating parent

Exclusion Criteria:

1. N/A
Evaluation of Telemedicine Practices for Contraceptive Counseling During the COVID-19 Pandemic: A Randomized Controlled Trial

The goal of this randomized clinical trial is to evaluate the telemedicine practices for contraceptive counseling given to pregnant women during the COVID-19 pandemic. The main questions it aims to answer are:

* Does family planning counseling given to pregnant women by using telemedicine practices have an effect on the knowledge level about family planning?
* Is family planning counseling given to pregnant women by using telemedicine practices effective on satisfaction with family planning services? Participants have attended to contraceptive counseling video call sessions provided via WhatsApp application and they have the opportunity to see the consultant and her materials during these sessions. After these sessions (two weeks later), contraceptive counseling video call session has been repeated, and at the end of this second session, women have been asked to answer the questions in the "Family Planning Knowledge Level Form" and the "Family Planning Services Satisfaction Scale". There is a comparison group (a control group) in this study, and no intervention was made to the women in the control group other than the routine services given in primary care settings.

Researchers will compare the experimental group with control group to see if the telemedicine practices are effective in increasing the knowledge level of pregnant women about family planning and in the satisfaction of family planning services provided by primary health care settings.


Eligibility Criteria:
Inclusion Criteria:

* Women in the third trimester of their pregnancy and who agreed to participate in the study have been included in this study.

Exclusion Criteria:

* Women with psychiatric disorder have been excluded from this study.
Facilitated Telemedicine in the Catholic Health System

Hepatitis C virus is a leading cause of morbidity and mortality globally with the highest prevalence and incidence among people with opioid use disorder. We aim to establish facilitated telemedicine as a standard of care treatment approach at 3 opioid treatment programs operated by the Catholic Health System. This study is a chart review data analysis to evaluate outcomes of facilitated telemedicine integrated into opioid treatment programs and to evaluate the number of individuals who initiate and complete treatment for hepatitis C virus infection.

Hepatitis C virus (HCV) is a leading cause of morbidity and mortality globally with the highest prevalence and incidence among people with opioid use disorder. In 2013, direct-acting antivirals were introduced for HCV treatment: all oral medications with minimal side effects and excellent efficacy when taken for 2-3 months. However, only 34% of eligible individuals received direct-acting antivirals between 2013 and 2022. Moreover, HCV treatment with direct-acting antivirals was substantially lower among people with opioid use disorder. Access to highly effective HCV treatment by the populations with the greatest need remains inadequate.

To address this issue, we propose that facilitated telemedicine could be a bridge to integrate HCV treatment into opioid treatment programs. In our model, telemedicine encounters are facilitated by a case manager who is also a patient advocate and an educator. We recently completed a randomized clinical trial that compared facilitated telemedicine integrated into opioid treatment programs for HCV treatment compared to offsite referral. The HCV cure rate was 90.3% in facilitated telemedicine compared to 39.4% in offsite referral.

In the proposed project, we seek to establish facilitated telemedicine as a standard of care treatment approach at 3 opioid treatment programs operated by the Catholic Health System.

Eligibility Criteria:
Inclusion Criteria:

* evidence of active HCV infection

Exclusion Criteria:

* no evidence of active HCV infection
The Effect of Volitional Pursed-lips Breathing

Simulation of pursed-lips breathing by defined stenoses in pulmonary function diagnostics to quantify the effect of the pursed-lips breathing

Since many years it is recommended for COPD patients to reduce the crossdiameter of the lips in order to improve the exhalation by means of so-called pursed-lips breathing (PLB). But the effects have never been studied quantitatively. In this study, the PLB effect is simulated during lung function diagnostics, using different sized resistors inserted into the routine mouthpiece of the flow sensor to resemble the effective airway resistances of a PLB maneuver. This prospective, randomized study includes 20 healthy subjects and 50 COPD patients, who will perform lung function testing with 4 different sized resistors.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* COPD (GOLD I- IV)
* Stable respiratory situation that allows routine lung funtion
* capable of communication

Healthy:

* Lung Healthy
* capable of communication

Exclusion Criteria:

* Invasive Ventilation
* Other serious acute physical illnesses that require immediate intensive medical treatment
* Acute hypercapnic decompensation with a pH \< 7.35 in the capillary BGA
* Pregnancy or Nursing
* Not able to give consent
* Not willing or able to follow the study protocol
Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in Japanese Adults (V116-002)

The purpose of this study is to compare the safety, tolerability, and immunogenicity of a polyvalent pneumococcal conjugate vaccine (V116) with that of PNEUMOVAX™23 in healthy Japanese adults.


Eligibility Criteria:
Inclusion Criteria:

* is a healthy Japanese male or female ≥20 years of age at time of randomization
* male participants must agree to be abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention
* female participants must not be pregnant or breastfeeding, and is either:
* not a woman of childbearing potential (WOCBP) or
* a WOCBP who agrees to remain abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention

Exclusion Criteria:

* has a history of invasive pneumococcal disease (IPD) within 3 years of Day 1
* has a known hypersensitivity to any vaccine components
* has impaired immunological function
* has a coagulation disorder
* had a recent febrile illness (axillary temperature ≥37.5°C or equivalent) within 72 hours before Day 1
* has a known malignancy that is progressing/requiring treatment
* has received, or is expected to receive, a pneumococcal vaccine outside the study protocol
* has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed the regimen for ≥30 days prior to Day 1
* is receiving immunosuppressive therapy
* has received any non-live vaccine from 14 days prior to Day 1 other than inactivated influenza vaccine
* has received any live vaccine from 30 days prior to Day 1
* has received a blood transfusion or blood products
* has participated in another clinical trial within 2 months of this study
* has clinically relevant drug or alcohol abuse
* has any condition that, in the opinion of the investigator, precludes participation in this study
Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Video-assisted Thoracic Surgery

The study is a case-controlled observational trial. Sixty patients will be divided into 2 groups (good or poor sleepers) depending on their first postoperative night Bispectral index data. Firstly, this study aims to characterise the gut and lung microbiota in patients with lung cancer treated with surgery. Secondly, it aims to evaluate microbiota and its influence on plasma kynurenine.

The study is a case-controlled observational trial. Sixty patients will be divided into 2 groups (good or poor sleepers) depending on their first postoperative night Bispectral index data. Firstly, this study aims to characterise the gut and lung microbiota in patients with lung cancer treated with surgery. Secondly, it aims to evaluate microbiota and its influence on plasma kynurenine.

Eligibility Criteria:
Inclusion Criteria:

* 1. ethnic Chinese;
* 2. age, 18 to 75 years old;
* 3. American Society of Anaesthesiologists (ASA) physical status I or II;
* 4. required VATS for lung surgery and one lung ventilation .

Exclusion Criteria:

* Cognitive difficulties
* Partial or complete gastrectomy
* Previous esophageal surgery
* Previous treated by radiotherapy or surgery
* Inability to conform to the study's requirements
* body mass index exceeding 30 kg/m2
* Deprivation of a right to decide by an administrative or juridical entity
* Ongoing participation or participation in another study \<1 month ago
* preoperative Pittsburgh Sleep Quality Index global scores higher than 6
* recent (\< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or traditional Chinese medicine
Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).

Subjects who completed either OBERON or TITANIA will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo controlled, Parallel Group, Phase 3, extension study to evaluate the safety and efficacy of Tozorakimab in adult participants with symptomatic COPD.

Participants who have completed the study treatment period and have not been prematurely discontinued from IP in one of the predecessor studies, OBERON or TITANIA, will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo-controlled, Parallel Group, Phase 3 extension study to evaluate the efficacy and safety of Tozorakimab versus placebo in adult (40 years and older) participants with symptomatic COPD and with a history of exacerbations

Eligibility Criteria:
Inclusion Criteria:

1. Participants who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor studies.
2. Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.
3. FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit 1.
4. Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.
5. Capable of giving signed informed consent.

Exclusion Criteria:

1. Any clinically significant disorder or abnormal findings (clinical, laboratory, instrumental, etc) or major physical and/or cognitive impairment - which, in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study or impact the interpretation of the study results, or otherwise make the participation of the participant inappropriate.
2. Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
3. Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.
4. Known history of:

   1. Severe allergic reaction to any monoclonal and polyclonal antibody.
   2. Allergy or reaction to any component of the IP formulation.
5. Chronic use (or expected need for chronic use during the study) of immunosuppressive medications (including, but not limited to, systemic corticosteroids), marketed or investigational biologic, or another prohibited medication.
6. Involvement in the planning and/or conduct of the study (applies to both staff employed by the Sponsor and/or staff at the study site).
7. Participants who are not able to comply with the study requirements, procedures, and restrictions.