louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06043895: EpiFaith CV for Central Venous Catheterization
Official title: The Overall Surgical Time Comparison Between EpiFaith® CV and Conventional Syringe in Central Venous Catheterization
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Catheterization, Central Venous
Equipment Design
Patient Safety
Anesthesiology Devices Associated With Misadventures, Diagnostic and Monitoring Devices
Perioperative Care
Keywords: Central Venous Catheterization
Patient Safety
Visual Feedback
Anesthesiology
Clinical Skill
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: EpiFaith CV provides automatic aspiration and detection of arterial pressure as an alternative to manometry in central venous catheterization. The aim of the study is to evaluate if it may reduce operation time compared with conventional syringe.

Detailed description: Central venous catheterization (CVC) is crucial in modern perioperative and intensive care. Keeping constant and stable negative pressure while advancing the needle had been issue for beginners. Recently, EpiFaith CV provides a new solution for CVC, which facilitates syringe control and precision during assessing vessels. It provides steady aspiration and detection of arterial pressure as an alternative to manometry without the need to disconnect nor more connections. The aim of the study is to evaluate if it may reduce operation time compared with conventional syringe.

Eligibility criteria: Inclusion Criteria (for participants):

* 18 years old and above
* Surgical patients who need to have a central venous catheter placed
* Informed and agree to participate in the study

Inclusion Criteria (for conducting physicians):

* Physicians with \>100 central venous catheter placement experience, including attending physicians and senior residents

Exclusion Criteria (for participants):

* Patient refusal
* Puncture site skin lesions
* Uncorrected coagulation disorder
* Hemodynamic instability
* Not informed and consented to participate in research

Exclusion Criteria (for conducting physicians):

* Not informed and consented to participate in research

Primary outcomes:
measure: The overall surgical time
timeFrame: 1 hour
Secondary outcomes:
measure: Amount of blood drawn
timeFrame: 1 hour
measure: Number of attempts to place guidewire
timeFrame: 1 hour
measure: Arterial puncture rate
timeFrame: 1 hour
measure: Arterial puncture identification rate
timeFrame: 1 hour
measure: Success rate
timeFrame: 1 hour
measure: Likert scale for satisfaction
timeFrame: 1 hour
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Anesthesiology, National Taiwan University Hospital
name: Man-Ling Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02786095: Comparison Study of Drugs for Symptom Control and Complication Prevention of Atrial Fibrillation (AF) (Code-AF Trial)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
anti arrhythmic drug
NOAC
warfarin
coumadin
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-05-30
Enrollment: 20000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with atrial fibrillation

Brief summary: This study is prospective Cohort study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is all patients with atrial fibrillation who visit hospital. The purpose is to analyze complication, composite outcome (all cause mortality, hospitalization, the incidence of stroke, heart failure and cardiovascular event (MACE)) according to the 1) the use of anti-arrhythmic drugs (AADs), 2) use of medication for rate control (beta blocker, calcium channel blocker and digoxin) and 3) use of anticoagulation agents (warfarin, coumadin, an NOAC)


Eligibility criteria: Inclusion Criteria:

* patients with atrial fibrillation
* patients with age more than 19
* patients who agree with study inclusion

Exclusion Criteria:

* patients who do not agree with study inclusion
* patients with age less than 19
* Pregnancy, Breastfeeding

Primary outcomes:
measure: all cause mortality
timeFrame: 3 years
measure: number of hospitalization by heart failure
timeFrame: 3 years
measure: number of recurrent stroke
timeFrame: 3 years
measure: number of cardiovascular events
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine
Study officials:
References:
citation: Kim JY, Park HS, Park HW, Choi EK, Park JK, Kim JB, Kang KW, Shim J, Joung B, Park KM. Clinical Outcomes of Rhythm Control Strategies for Asymptomatic Atrial Fibrillation According to the Quality-of-Life Score: The CODE-AF (Comparison Study of Drugs for Symptom Control and Complication Prevention of Atrial Fibrillation) Registry. J Am Heart Assoc. 2022 Sep 20;11(18):e025956. doi: 10.1161/JAHA.122.025956. Epub 2022 Sep 8.
citation: Kim M, Kim J, Kim JB, Park J, Park JK, Kang KW, Shim J, Choi EK, Lee YS, Park HW, Joung B. Association of Gender With Clinical Outcomes in a Contemporary Cohort of Patients With Atrial Fibrillation Receiving Oral Anticoagulants. Korean Circ J. 2022 Aug;52(8):593-603. doi: 10.4070/kcj.2021.0399. Epub 2022 Apr 26.
citation: Lee KB, Kim TH, Park J, Park JK, Kang KW, Kim J, Park HW, Choi EK, Kim JB, Lee YS, Shim J, Joung B. Stroke and Systemic Thromboembolism according to CHA2DS2-VASc Score in Contemporary Korean Patients with Atrial Fibrillation. Yonsei Med J. 2022 Apr;63(4):317-324. doi: 10.3349/ymj.2022.63.4.317.
Clinical trial NCT06275295: A Retrospective Study of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis
Official title: Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis：a Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pulmonary Fibrosis
Transbronchial Cryobiopsy
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving TBLC for progressive pulmonary fibrosis

Brief summary: The goal of this observational study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（TBLC） in progressive pulmonary fibrosis.

Detailed description: The goal of this observational study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（TBLC） in progressive pulmonary fibrosis. The main question it aims to answer are: • The diagnostic rate of MDD1 or MDD2 based on TBLC. • The rate of hemorrhage, pneumothorax, acute ILD exacerbation and mortality. Participants' medical records will be collected by us.

Eligibility criteria: Inclusion Criteria:

Patients with PPF, ≥18 years of age, unclassified ILD, HRCT ≤3 months, forced vital capacity (FVC)≥50% predicted value, pulmonary carbon monoxide diffusion (DLCO)≥35% predicted value, echocardiography ≤12 months, estimated pulmonary systolic blood pressure ≤40 mmHg, Body mass index (BMI)≤35 kg/m2.

Exclusion Criteria:

Patients with platelet counts below 50,000e+9/L or International Normalized ratio of prothrombin time (INR) above 1.5 are not eligible for TBLC

Primary outcomes:
measure: The diagnostic rate of MDD2 based on TBLC
timeFrame: December，31，2024
Secondary outcomes:
measure: The diagnostic rate of MDD1
timeFrame: December，31，2024
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02233881: Post-marketing Surveillance of Atrovent® in Chronic Obstructive Pulmonary Disease
Official title: Post-marketing Surveillance (as Per § 67(6) AMG [German Drug Law]) of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-09
Enrollment: 4222
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with chronic obstructive pulmonary disease recruited at general practitioners, pneumologists and internists

Brief summary: Study to obtain further information on the tolerability and efficacy of Atrovent® inhalets in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice


Eligibility criteria: Inclusion Criteria:

* Patients of both gender older than 40 years, who suffer from Chronic Obstructive Pulmonary Disease
* Only patients who have not been treated with Atrovent® within the last year are to be considered for inclusion

Exclusion Criteria:

* Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® metered dose inhaler

Primary outcomes:
measure: Change in the clinical picture
timeFrame: after 4 weeks
Secondary outcomes:
measure: Assessment of efficacy by investigator on a 4-point scale
timeFrame: after 4 weeks
measure: Assessment of efficacy by patient on a 4-point scale
timeFrame: after 4 weeks
measure: Number of patients with adverse drug reactions
timeFrame: up to 4 weeks
measure: Assessment of tolerability by investigator on a 4-point scale
timeFrame: after 4 weeks
measure: Assessment of tolerability by patient on a 4-point scale
timeFrame: after 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01906281: Influence of Adipocytokines in Osteoarthritis
Official title: Adipocytokines Influence on Clinical and Ultrasonographic Inflammatory Activity in Patients With Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis, Knee
Endocrine System Diseases
Cardiovascular Risk Factors
Keywords: adipocytokines
osteoarthritis
cardiovascular risk
Lead sponsor: Parc Taulí Hospital Universitari
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 105
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients over 50 years who were referred for rheumatology for symptomatic knee osteoarthritis.

Brief summary: Adipocytokines play an important role in joint inflammation in patients with knee osteoarthritis as measured by ultrasound and high sensitivity protein-C reactive. Adipocytokines could be the link between osteoarthritis and cardiovascular risk factors more prevalent in these patients.


Eligibility criteria: Inclusion Criteria:

* Patients over 50 years old with symptomatic knee osteoarthritis.

Exclusion Criteria:

* Patients with secondary osteoarthritis of the knee
* Any other rheumatologic condition.

Primary outcomes:
measure: adipocytokine level
timeFrame: 18 months
Secondary outcomes:
measure: Ultrasound inflammatory exploration of the knee
timeFrame: 18 months
measure: Ultrasound of carotid artery
timeFrame: 18 months
measure: Cardiovascular risk factors
timeFrame: 18months
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Parc Tauli Sabadell
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Parc Tauli
state: Barcelona
Study officials:
affiliation: Hospital Parc Tauli
name: jordi Gratacos, MD Ph
role: STUDY_DIRECTOR
References:
Clinical trial NCT04703881: Tolerance and Acceptability Evaluation AYMES ActaGain
Official title: Tolerance and Acceptability Evaluation AYMES ActaGain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Lead sponsor: Aymes International Limited
Sponsor class: INDUSTRY
First posted: 2021-01-11
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To evaluate tolerance and acceptability of 'AYMES ActaGain' in patients requiring supplementary oral nutritional support compared with currently available alternatives.

Detailed description: To evaluate tolerance and acceptability of 'AYMES ActaGain' in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference, convenience etc.

To obtain data to support an ACBS submissions for 'AYMES ActaGain' (to allow for prescription in the community at NHS expense).

Eligibility criteria: Inclusion Criteria:

* Male and female patients.
* ≥ 18 years of age.
* Patients of the intended target group (e.g. MUST score ≥ 1, with or at risk of disease related malnutrition) with an anticipated period of nutritional support ≥ 4 weeks.
* Patient is able and willing to provide written informed consent.

Exclusion Criteria:

* Patients with medical or dietary contraindication to any feed ingredients.
* Patients requiring sole enteral tube feeding or parenteral nutrition.
* Patients with chronic renal disease requiring dialysis.
* Patients with liver failure.
* Patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements.
* Patients assessed by a Speech and Language Therapist who require thickened fluids.
* Participation in any other studies that may interfere with this study.

Primary outcomes:
measure: Gastro-Intestinal Tolerance when consuming AYMES ActaGain
timeFrame: 30 days
Secondary outcomes:
measure: Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire
timeFrame: 30 days
measure: Compliance
timeFrame: 30 days
Other outcomes:
Locations:
city: Haywards Heath
country: United Kingdom
facility: AYMES International Ltd.
Study officials:
References:
Clinical trial NCT03627481: Sleep Quality After Nasosinusal Surgery in AERD Patients
Official title: Sleep Quality After Nasosinusal Surgery in AERD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aspirin-exacerbated Respiratory Disease
Sleep
Keywords: endoscopic sinus surgery
Lead sponsor: Instituto Nacional de Enfermedades Respiratorias
Sponsor class: OTHER_GOV
First posted: 2018-08-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aspirin exacerbated respiratory disease presents as a triad composed by asthma, eosinophilic rinosinusitis and intolerance to aspirin and NSAIDS. In subjects with chronic rhinosinusitis sleep alterations have been found, with important improvement after surgery, but those alterations and improvements have not been studied in patients diagnosed with AERD who, due to their comorbidities, may present more severe pre surgical symptoms and a more important post-surgical improvement. The investigators aim to study patients with AERD sleep, quality of life and symptoms before surgery, and one, three and six months post-surgery.


Eligibility criteria: Inclusion Criteria:

* AERD patients.
* Cumbersome nasal polyposis with poor treatment response

Exclusion Criteria:

* Previously diagnosed sleep disorder.
* Psychiatric disorder

Primary outcomes:
measure: Subjective sleep quality assessed by the Pittsburgh sleep quality index.
timeFrame: 6 months
Secondary outcomes:
measure: Objective sleep quality assessed by actigraphy.
timeFrame: Basal; 3 and 6 months
measure: Quality of life assessed by the Asthma Quality of Life Questionnaire
timeFrame: Basal; 1, 3 and 6 months
measure: Nasal symptoms assessed by the SNOT - 22
timeFrame: Basal; 1, 3 and 6 months
measure: Asthma symptoms assessed by the Asthma Control Test.
timeFrame: Basal; 1, 3 and 6 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias
state: Ciudad DE Mexico
Study officials:
References:
Clinical trial NCT05288881: Single Ascending Dose Study of ANX105
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous ANX105 in Normal Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Lead sponsor: Annexon, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Placebo-controlled single ascending dose study.
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ANX105 administered intravenously (IV) to healthy participants.


Eligibility criteria: Key Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
* Have been fully vaccinated with SARS-CoV-2 vaccination according to local guidelines within 14 days prior to Day -1.
* Documented history of vaccinations within 5 years or willing to undergo vaccinations prior to screening visit against encapsulated bacterial pathogens.

Key Exclusion Criteria:

* Clinically significant infection within 30 days prior to Day -1 that required medical intervention.
* Significant allergies to humanized monoclonal antibodies.
* Use of immunosuppressants including high-dose systemic corticosteroids within 30 days prior to Day -1.
* Antinuclear antibodies (ANA) titer ≥1:160 (for either of the 2 ANA results a minimum of 2 weeks apart) at Screening.
* Have poor venous access limiting phlebotomy.
* Donation or loss of \> 500 milliliter whole blood within 30 days prior to Day 1 or donation of plasma within 14 days prior to Day -1.
* Hospitalization during the 4 weeks prior to Screening.

Primary outcomes:
measure: Number of Participants Who Experienced Treatment-Emergent Adverse Events
timeFrame: Up to Week 7
Secondary outcomes:
measure: Amount of Serum Total Hemolytic Complement (CH50)
timeFrame: Up to Week 7
measure: Change from Baseline in Amount of Unbound Complement 1q (C1q) in Serum
timeFrame: Baseline, Week 7
measure: Amount of C1q in Cerebrospinal fluid (CSF)
timeFrame: Up to Week 7
measure: Serum Concentrations of ANX105
timeFrame: Up to Week 7
measure: Maximum Observed Serum Concentration (Cmax) of ANX105
timeFrame: Up to Week 7
measure: Area Under the ANX105 Serum Concentration-Time Curve (AUC)
timeFrame: Up to Week 7
measure: CSF Concentrations of ANX105
timeFrame: Up to Week 7
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Annexon Investigational Site 02
city: Leiden
country: Netherlands
facility: Annexon Investigational Site 01
Study officials:
affiliation: Annexon, Inc.
name: Olga Bandman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01932281: SierraSil Joint Formula 14 as an Ergogenic Aid to Performance in Athletes
Official title: SierraSil as an Ergogenic Aid to Performance in Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Power
Muscle Fatigue
Keywords: muscle power
muscle fatigue
SierraSil
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 10
Sex: MALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether supplementation with SierraSil can improve anaerobic power and reduce muscle fatigue in a group of well-trained athletes.

A secondary purpose is to examine the effect of SierraSil on the severity of delayed onset muscle soreness.

Detailed description: This is a double blind, crossover, pilot study that will examine the effect of SierraSil supplementation on the determinants of human performance. Anaerobic capacity, muscle fatigue, the severity of delayed onset muscle soreness (DOMS) and markers of inflammation will be measured before and after 3 weeks of supplementation with SierraSil or placebo. There will be a 3 week washout period prior to the crossover to ensure SierraSil supplementation has no residual effect.

Eligibility criteria: Inclusion Criteria:

* no contraindications to strenuous exercise

Exclusion Criteria:

* muscle or joint injury
* taking any form of anti-inflammatory or pain medication
* females due to the variability that might be introduced due to the phases of the menstrual cycle

Primary outcomes:
measure: change in total anaerobic capacity
timeFrame: change from baseline at 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Donald C. McKenzie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: