louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04954911: Clinical Performance of the Globe® Mapping and Ablation System for the Treatment of Atrial Fibrillation
Official title: Prospective, Multi-centre, Observational Registry to Evaluate the Clinical Performance of the Globe® Mapping and Ablation System for the Treatment of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Radiofrequency RF Ablation
Globe Mapping and Ablation System
Lead sponsor: Kardium Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-08
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Age 18 years or older
2. Participants with a documented history of atrial fibrillation indicated for ablation using the Globe Mapping and Ablation System before enrolment into registry

Brief summary: This is an observational, multicentre, prospective, post-market product registry for participants with AF for whom ablation by the commercially available Globe Mapping and Ablation System was indicated before enrolment into the registry. The aim of the registry is to confirm the clinical performance and safety of the Globe Mapping and Ablation System in a real-life setting.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. Participants with a documented history of atrial fibrillation indicated for ablation using the Globe Mapping and Ablation System before enrolment into registry
3. Signed informed consent

Exclusion Criteria:

1. Contraindication for catheter ablation with the Globe System
2. Participant is currently participating in an investigational study that would interfere with registry endpoints according to the participating physician's discretion.
3. Physical or mental condition because of which, in the opinion of the physician, the participant is not able to give informed consent or comply with physician instructions.

Primary outcomes:
measure: Freedom from AF at 12 months following ablation with the Globe System
timeFrame: Up to 1 year
measure: Freedom from AF/AFL/AT at 12 months following ablation with the Globe System
timeFrame: Up to 1 year
measure: Device- and procedure-related adverse events within 12 months following ablation with the Globe System
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
state: North Rhine-Westphalia
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
state: Saxony
Study officials:
affiliation: Klinik für Elektrophysiologie/Rhythmologie Herz- und Diabeteszentrum NRW Universitätsklinik der Ruhr-Universität Bochum
name: Herz- und Diabeteszentrum NRW
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02880111: Rates DMBT1 ( Glycoprotein) in Sputum of CF Patients With Pseudomonas Aeruginosa
Official title: Comparison of Rates DMBT1 ( Glycoprotein) in Sputum of CF Patients Colonized Patients Between Chronic and Non-chronic Patients Colonized With Pseudomonas Aeruginosa
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Malignant Brain Tumor
Keywords: Malignant Brain Tumor
patient sputum
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2016-08-26
Enrollment: 1
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CF Patients with or without Pseudomonas aeruginosa chronic colonization status aged 6 years.

Brief summary: Rates of DMBT1 (Glycoprotein like) in Sputum of CF Patients with or without may be different according to their Pseudomonas Aeruginosa chronic colonization status. The aim of this study is to compare rates of DMBT1 (Glycoprotein like) in Sputum of CF patients with or without a Pseudomonas Aeruginosa chronic colonization.

Detailed description: Rates of DMBT1 (Deleted in Malignant Brain Tumor 1) will be compared between 2 groups of 30 CF patients : group 1 : with Pseudomonas Aeruginosa chronic colonization and group 2 30 CF patients without Pseudomonas Aeruginosa chronic colonization.

Eligibility criteria: Inclusion Criteria:

* CF patient 6 years
* Availability of sputum
* Signed Informed consent

Exclusion Criteria:

* Cardiac insufficiency
* Anti-inflammatory drugs on going
* Oral corticosteroid therapy
* Inhaled corticosteroids during the two weeks before inclusion,
* Patient awaiting lung transplantation
* Patient with a past history of heart/lung transplantation
* Patient with a sputum examination positive for : atypical mycobacteria, Burkholderia cepacia, Stenotrophomonas maltophilia,
* Patient chronically colonized with multiresistant Pseudomonas aeruginosa
* Orkambi© or Kalydeco© therapy
* Change of the CF treatment during the last 4 weeks +/- 2 days before inclusion : corticosteroid, pancreatic extracts, antisecretory drugs...

Primary outcomes:
measure: measure glycoprotein-like DMBT1 by Elisa
timeFrame: at 1 months
Secondary outcomes:
measure: measure MUC5B by Elisa
timeFrame: at 1 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Jeanne de Flandre - CHRU de Lille
Study officials:
affiliation: University Hospital, Lille
name: Dominique Turck, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06924411: Ramped Versus Supine Position for Emergent Endotracheal Intubation in Adult Patients; Prospective, Randomized, Comparative Study
Official title: Ramped Versus Supine Position for Emergent Endotracheal Intubation in Adult Patients; Prospective, Randomized, Comparative Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intubation Complications
Keywords: Ramped intubation
Non-supine intubation
Semi-setting intubation
Intubation without aspiration
Ramped versus supine intubation
Intubation with less complications
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Endotracheal intubation is a life saving procedure for critically unwell and injured patients presenting to the emergency department. Prolonged time to successful intubation and multiple failed attempts are associated with a higher incidence of life-threatening adverse events such as hypoxia and hypotension.

Optimal head and neck positioning and clinical experience are important factors for successful endotracheal intubation in patients especially with a difficult airway. This study aims to investigate the rate of successful endotracheal intubation between ramped and supine positions in patients planned for intubation.

The ramped position, where the bed is kept half-flat and the head is elevated up to 35°, is planned to prove that it improves glottic view and facilitate intubation and ventilation.

Varying bed angles and heights during ramped position intubation may explain conflicting evidence regarding the effect of ramped position on intubation success in acute care settings.

Therefore, it seems that finding a simple alternative method for the classic supine technique that can create conditions like the proposed standard conditions for laryngoscopy would be a suitable solution for intubating patients with higher difficulty.

The patient's anatomy and the technique employed for laryngoscopy have a significant effect on the laryngeal view. The technique itself is influenced by a variety of factors including the laryngoscopic force and the skills, experience, and training of the physicians.


Eligibility criteria: Inclusion Criteria:

- Adult patients ≥18 years old and indicated for intubation with variable presentations.

Exclusion Criteria:

* Patients unstable to be positioned in semi setting as spine trauma and polytraumatized patients.

Primary outcomes:
measure: Number of First pass success
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03339011: Digital Motivation to Decrease Inactive Behaviour in Patients With Knee Osteoarthritis
Official title: Effectiveness of Text Messages for Decreasing Inactive Behavior in Patients With Knee Osteoarthritis: a Pilot Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Physical inactivity is a major risk behaviour with a potential for causing premature death, particularly among people with mobility limitations, such as knee osteoarthritis.

Digital motivational interventions (such as SMS) can motive to a healthy behaviour including increased physical activity.

The purpose of this study is to investigate if motivational text messages following an exercise intervention to improve mobility limitations will change the physical activity level in patients with knee osteoarthritis.

This study is designed as pilot randomized controlled trial, with equal randomization (1:1). Eligible participants will be randomised into one of two groups (intervention or control) after completing their baseline measurements. The intervention group will receive weekly motivational text messages and the control group will not receive any attention from the study.


Eligibility criteria: Inclusion Criteria:

* Age ≤18
* Diagnosed with knee osteoarthritis
* Owner of a smart phone or tablet
* Have just finished an exercise program for knee osteoarthritis

Exclusion Criteria:

* Not able to read and understand Danish
* Any condition, which in the opinion of the investigator would put the subject at increased safety risk by participation, or otherwise make the subject unsuitable for this study.

Primary outcomes:
measure: Change from baseline in physical inactivity
timeFrame: 6 weeks
Secondary outcomes:
measure: Change form baseline in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 6 weeks
measure: Transition questionnaire (TRANS-Q) of perceived change in knee symptoms
timeFrame: 6 weeks
measure: Self-reported change in physical inactivity
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Parker Institute, Bispebjerg and Frederiksberg University Hospitals
Study officials:
References:
citation: Bartholdy C, Bliddal H, Henriksen M. Effectiveness of text messages for decreasing inactive behaviour in patients with knee osteoarthritis: a pilot randomised controlled study. Pilot Feasibility Stud. 2019 Sep 7;5:112. doi: 10.1186/s40814-019-0494-6. eCollection 2019.
Clinical trial NCT00792311: Tsui Test as a Predictor of Bupivacaine Consumption in Labour Epidurals
Official title: Tsui Test as a Predictor of Bupivacaine Consumption in Labour Epidurals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Tsui test
Epidural Analgesia
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2008-11-17
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Low current electrical stimulation test, also called the Tsui test, has been used successfully to confirm the catheter location in the epidural space in various patient populations. The results of this study will show whether or not doing a Tsui test can predict inadequate epidural analgesia early in the course of placing the epidural, so that the appropriate measures could be applied immediately upon gathering unfavorable results.

Detailed description: Despite its very high success rate, the epidural technique remains a rather blind technique, and failures continue to occur. The incidence and reasons for failure are not well understood. The Tsui test is not routinely performed with each epidural catheter insertion, but rather it is used when there is suspicion about the catheter location.

In this study, the Tsui test will be performed twice during the epidural procedure, and bupivacaine consumption will be recorded for the first 2 hours.

Information gained from this study could have great impact in clinical practice, since the incidence of inadequate labor analgesia is still relatively high (10-20%), leading to maternal distress and disappointing labor experience.

Eligibility criteria: Inclusion Criteria:

* Women over 18 years of age requesting an epidural for labor and delivery
* Cervix dilated 0-5 cm and pain VAS\>6
* Able to communicate in English
* Informed consent

Exclusion Criteria:

* Refusal to provide written informed consent
* Patients unable to communicate in English
* Contraindication to regional anesthesia
* Allergy or hypersensitivity to lidocaine, bupivacaine or fentanyl
* Sedatives or opioids received prior to insertion of epidural catheter
* Abnormal vertebral anatomy, such as previous spine surgery and scoliosis
* Coexisting neurological disorders
* Patients with implanted electronic devices

Primary outcomes:
measure: Consumption of bupivacaine in mg/hour in the first 2 hours of epidural anesthesia
timeFrame: 2 hours
Secondary outcomes:
measure: Incidence of inadequate epidural block.
timeFrame: 2 hours
measure: Current (mA) needed to elicit motor response; 1. before test dose and 2. 5 minutes after test dose.
timeFrame: 5 minutes
measure: Contraction pattern elicited by the Tsui test at baseline and after test dose.
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Jose CA Carvalho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03710811: Observational Study of Drug Naive Diabetes Receiving Insulin Therapy
Official title: Observational Study of Drug Naive Type 2 Diabetes Receiving Continuous Subcutaneous Insulin Infusion Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes
Keywords: insulin
drug naive
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
Collaborators: name: Zhejiang Provincial People's Hospital
First posted: 2018-10-18
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: drug naive type 2 diabetes and healthy controls

Brief summary: A multi-centre, open-label trial to investigate the efficacy and possible mechanism of Continuous Subcutaneous Insulin Infusion treatment in patients with drug naive type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

for type 2 diabetes:

1. Male or female age ≧ 25 years and ≦75 years old
2. HbA1c ≧8.0%
3. durg naive

for normal controls：

1. Male or female age ≧ 25 years and ≦75 years old
2. Normal glucose tolerance confirmed by oral glucose tolerance test

Exclusion Criteria:

1. Islet antibody positive
2. Athletes, has a history of skeletal muscle injury ( trauma or surgery ), skeletal muscle wasting diseases ( such as mitochondrial myopathy, muscular atrophy, etc )
3. Acute infection(such as cute upper respiratory infection, acute pneumonia)
4. long-term use of non-steroidal anti-inflammatory drugs, corticosteroids and immunosuppressive drugs
5. consists with other endocrine diseases
6. pregnancy
7. cancer
8. use of antibiotics in 3 months
9. chronic digestive inflammations
10. magnetic resonance imaging contraindications

Primary outcomes:
measure: Circulating immunity cell profiles
timeFrame: 7 days
Secondary outcomes:
measure: skeletal muscle parameter
timeFrame: 7 days
Other outcomes:
measure: fasting blood glucose
timeFrame: 7 days
Locations:
city: Nanjing
country: China
facility: at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
state: Jiangsu
city: Hangzhou
country: China
facility: Zhejiang Provincial People'S Hospital
state: Zhejiang
Study officials:
References:
citation: Zhang W, Wang H, Liu F, Ye X, Tang W, Zhang P, Gu T, Zhu D, Bi Y. Effects of Early Intensive Insulin Therapy on Endothelial Progenitor Cells in Patients with Newly Diagnosed Type 2 Diabetes. Diabetes Ther. 2022 Apr;13(4):679-690. doi: 10.1007/s13300-021-01185-w. Epub 2021 Dec 11.
citation: Tang W, Zhang B, Wang H, Li M, Wang H, Liu F, Zhu D, Bi Y. Improved skeletal muscle energy metabolism relates to the recovery of beta cell function by intensive insulin therapy in drug naive type 2 diabetes. Diabetes Metab Res Rev. 2019 Oct;35(7):e3177. doi: 10.1002/dmrr.3177. Epub 2019 May 27.
Clinical trial NCT01095211: B-vitamins Treatment for Improvement of Cognitive Function
Official title: Effect of B-Vitamins on Cognitive Function in Elderly People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Metabolic Improvements
Keywords: folic acid
homocysteine
MMSE scores
methyl malonic acid
betaine
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
Collaborators: name: Geriatrische Rehaklinik
First posted: 2010-03-30
Enrollment: 79
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Observation studies documented a correlation between plasma concentrations of homocysteine and cognitive decline with age. The study hypothesis was that high doses of B-vitamins (as effective homocysteine lowering treatment) can improve cognitive function in elderly people.

Detailed description: We performed a treatment with therapeutic doses of B-vitamins (folic acid, cobalamin, vitamin B6) for 45 days. We collected blood and tested the concentrations of the metabolic markers in blood at start, 3 weeks later and at the end. Cognitive function was tested at start and at the end.

Eligibility criteria: Inclusion Criteria:

* age \> 65 years and glomerular filtration rate (GFR) \> 35 ml/min

Exclusion Criteria:

* acute cancer or those who had coronary or cerebral event or thrombosis in the last 3 months were not eligible for the study.
* furthermore, people who had dementia (mini-mental state-examination scores MMSE \< 15)
* those treated with B-vitamins
* those with renal insufficiency
* those receiving drugs that affect Hcy-metabolism (methotrexate, anti-epileptics, L-dopa) were not allowed to participate

Primary outcomes:
measure: Cognitive function
timeFrame: baseline and 45 days later
Secondary outcomes:
Other outcomes:
Locations:
city: Sankt Ingbert
country: Germany
facility: Dr. Eckert-
state: Saarland
Study officials:
affiliation: Department of Clinical Chemistry, University of Saarland
name: Rima Obeid
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06617611: What Matters to You on the Day of Surgery 2024?
Official title: What Matters to You on the Day of Surgery 2024?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Fear and Worrying
Person-centered Care
Lead sponsor: Gødstrup Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: University of Aarhus
First posted: 2024-09-27
Enrollment: 792
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Danish speaking adults referred to any type of planned surgery on June 6 2024

Brief summary: Research show that between 48-97% of patients referred to surgery experience anxiety and fear related to the procedure. High levels of anxiety and fear lead to increased use of anesthetics and pain as well as increased morbidity after the surgical procedure.

June 6 2024 is the international "What matters to you-day" and thus we mark this day in several Danish hospitals by asking patients referred to surgery: "What matters to you on the day of surgery"? This observational study has three goals:

1. To explore what matters to patients on the day of surgery
2. To explore associations between patients' degree-of-worry and their surgical fear on the day of surgery
3. To explore the characteristics and intensity of degree-of-worry

From 7.00 AM to 11.00 PM patients will be invited to answer:

1. What matters to them on the day of surgery and why it matters
2. How worried they are about their situation using a scale from 1 to 10, and to state why they worry.
3. Eight questions about their fear related to anesthesia and surgery on a scale from 0-10

In the analysis we will investigate the possible association between patients' degree of worry and fear related to anesthesia and surgery. Secondly, we analyse the prevalence of degree of worry and fear according to gender, age, type of surgery and medical speciality.

Finally, we will investigate what themes appear when we analyse the answers to what matters and why patients' worry.


Eligibility criteria: Inclusion Criteria:

* Danish speaking
* 18 years old or above

Exclusion Criteria:

* Patients who are not cognitively intact
* Do not consent to participation
* Patients requiring immediate surgical intervention.

Primary outcomes:
measure: Degree of worry
timeFrame: June 2024
Secondary outcomes:
measure: Surgical fear
timeFrame: June 2024
Other outcomes:
measure: Agreement between degree of worry and surgical fear
timeFrame: 2024
measure: What matters to you
timeFrame: 2025
measure: Integration of the qualitative and quantitative data
timeFrame: 2025
Locations:
city: Herning
country: Denmark
facility: Gødstrup Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Hejdi Gamst-Jensen, SR
role: STUDY_DIRECTOR
affiliation: Gødstrup Hospital
name: Anne H Nielsen, Ass. prof.
role: STUDY_CHAIR
affiliation: University of Aarhus
name: Lone Brix, Lecturer
role: STUDY_DIRECTOR
References:
Clinical trial NCT04445311: Ivermectin in Treatment of COVID-19
Official title: Use of Ivermectin as a Therapeutic Option for Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: COVID
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-06-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: confirmed cases with COVID-19 will receive ivermectin as a therapeutic option as well as standard of care treatment and will be compared to those that will receive only standard of care ttt


Eligibility criteria: Inclusion Criteria:

COVID-19 patients during period of the study more than 18 years old

Exclusion Criteria:

refuse to participate pregnancy or lactation hypersensitivity to ivermectin receive any drug with interaction with ivermectin

Primary outcomes:
measure: time to be symptoms free
timeFrame: within 21 days after enrollment
Secondary outcomes:
measure: hospitalization
timeFrame: within 21 days after enrollement
measure: Mechanical ventilation
timeFrame: within 21 days after enrollement
measure: length of stay
timeFrame: within one month days after enrollement
measure: mortality
timeFrame: within one month days after enrollement
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Waheed Shouman
state: Sharkia
Study officials:
References: