louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05633797: The Occurrence of Atrial Fibrillation After Totally Endoscopic Cardiac Surgery
Official title: The Occurrence of Atrial Fibrillation After Totally Endoscopic Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Postoperative atrial fibrillation
Minimally invasive cardiac surgery
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to investigate the occurrence of new-onset postoperative atrial fibrillation after totally endoscopic cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* Patients undergoing elective endoscopic cardiac surgery (totally endoscopic coronary artery bypass grafting or endoscopic valve replacement)

Exclusion Criteria:

* Preoperative atrial fibrillation
* Patients that do not understand Dutch or French or English
* Patients that do not have a smartphone
* Concomitant or redo surgeries

Primary outcomes:
measure: The occurence of new-onset postoperative atrial fibrillation using constant electrocardiogram monitoring and photoplethysmography (FibriCheck)
timeFrame: Until 30 days postoperatively
Secondary outcomes:
measure: The effect of the closure of the pericardium on the development of new-onset postoperative atrial fibrillation
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
affiliation: Jessa Hospital
name: Alaaddin Yilmaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03252197: A Randomized Parallel Study for Simulated Internal Jugular Vein Cannulation Using Simple Needle Guide Device
Official title: A Randomized Parallel Study for Simulated Internal Jugular Vein Cannulation Using Simple Needle Guide Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Doctors Attending a Central Line Insertion Training Courses for New Residents of a University Hospital From March 2017 to June 2017
Physicians Who Had Less Than 10 Ultrasound Guided Internal Jugular Vein Cannulation Participate in This Study
Keywords: Ultrasound guided central venous cannulation
new device
first attempt success
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 88
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Two-dimensional ultrasound guided approach does not guarantee first attempt success on internal jugular vein cannulation. New attachable device recently was developed for accurate needle insertion when ultrasound is used. Our randomized parallel simulation study will examine whether this device will improve the first attempt success rate when ultrasound guided internal jugular vein catheterization of simulated internal jugular vein.

Detailed description: This was a prospective, randomized, parallel trial using phantom simulating internal jugular vein.

After informed consent all subjects will be randomized to insert needle for internal jugular vein cannulation of phantom using ultrasound approach with or without this device. Video camera will record all procedure process and ultrasound image in real time. Researchers blinded to the study aim measured outcome variables based on recorded images.

Eligibility criteria: Inclusion Criteria:

1. Adults over 20
2. Resident in clinical hospital
3. Ultrasound-guided internal jugular vein insertion without supervisor experience less than 10

Exclusion Criteria:

1. If they have physical problem that is difficult to perform
2. If they do not want to participate in this study
3. If they can not understand the contents reading the informed consent
4. If they have more than 10 ultrasound guided internal jugular vein insertion without supervisor

Primary outcomes:
measure: First attempt success
timeFrame: Within 2 minutes or after start to insertion attempt
Secondary outcomes:
measure: Posterior wall puncture of the internal jugular procedure, comfort level with procedure
timeFrame: Within 2 minutes or after start to insertion attempt
measure: Carotid artery puncture
timeFrame: Within 2 minutes or after start to insertion attempt
measure: Time to cannulation
timeFrame: Within 2 minutes or after start to insertion attempt
measure: Comfort level
timeFrame: Within 2 minutes or after start to insertion attempt
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Emergency Medicine, Yonsei University College of Medicine, Yonsei University Severance Hospital
Study officials:
References:
Clinical trial NCT04592497: Evaluation of the Safety and Performance of the Very High Power-Short Duration QDOT
Official title: Evaluation of the Safety and Performance of the Very High Power-Short Duration QDOT Strategy in Patients Referred for Atrial Fibrillation Ablation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to compare the safety and short-term performance between THERMOCOOL SMARTTOUCH SF-5D QDOT system used with fast ablation mode and the standard Thermocool Smartouch SF in treatment of patients with atrial fibrillation (AF).

Detailed description: The very high power-short duration (vHPSD) catheter, is a novel CF catheter optimized for temperature-controlled ablation with microelectrodes and 6 thermocouples for real-time temperature monitoring during ablation. The associated vHPSD algorithm modulates power to maintain target temperature during these vHPSD lesions (90 W, 4 s). In preclinical models, vHPSD ablation with this novel catheter has improved atrial linear lesion contiguity, transmurality, and durability and has substantially reduced radiofrequency ablation times, but with a safety profile similar to those of standard irrigated radiofrequency ablation catheters.

The QDOT -FAST study demonstrated the clinical feasibility and safety of vHPSD ablation. Procedure and fluoroscopy times were substantially lower than historical standard ablation with point-by-point catheters.

The aim of the present study is to compare the safety and short-term performance between THERMOCOOL SMARTTOUCH SF-5D QDOT system used with fast ablation mode and the standard Thermocool Smartouch SF in treatment of patients with atrial fibrillation (AF).

Eligibility criteria: Inclusion Criteria:

* Male and female \>18 years old.
* Subjects must provide written informed consent to participate in the study.
* Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.

Exclusion Criteria:

* Pregnant women.
* Patients with iodine contrast media allergy
* Patients with renal failure (GFR \<60ml/min)

Primary outcomes:
measure: procedure time
timeFrame: 1 day
measure: isolation efficacy
timeFrame: 1 day
measure: Recurrence of AF
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
Study officials:
affiliation: Tel Aviv Medical Center
name: Ehud Chorin, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01920997: Qing'E Formula Therapy on Menopausal Symptoms (Healthy Volunteers Recruitment for Control Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: Healthy
normal menstrual cycles
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Wuxi People's Hospital
First posted: 2013-08-13
Enrollment: 50
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy women with normal menstrual cycles aged 40-50

Brief summary: This study will recruit 50 healthy women with normal menstrual cycles aged 40-50, to investigate the expression of their NEI network and urine metabolomics.


Eligibility criteria: Inclusion Criteria:

1. Healthy women with normal menstrual cycles aged 40-50.
2. The score of Kupperman index is less than 15.
3. Not alcoholics or smokers (past or smoking).
4. Get subjects informed consent process should comply with GCP requirements.

Exclusion Criteria:

1. Volunteers with heart, liver, kidney disease or acute or chronic gastrointestinal diseases, or with diseases of blood, endocrine, neurological and other systems.
2. Volunteers are participating in other clinical trials within 3 months.
3. Volunteers who donated blood or loosed blood heavily within 3 months.
4. Volunteers with previous history of mental illness, drug abuse or drug dependence.
5. Volunteers who took drugs within 14 days before the trail.

Primary outcomes:
measure: The expression of NEI network and Urine metabolomics
timeFrame: 2-5 days after menstruation
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT03074097: Rectus Sheath Block: Postoperative Analgesia and Proinflammatory Cytokines
Official title: Effect of Rectus Sheath Block on Opioid Consumption and Serum Level of TNF-α and IL-6 After Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Keywords: Rectus sheath block, Postoperative pain,TNF alpha and IL-6
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Good quality of postoperative analgesia would lead to attenuate or prevent the adverse effects on the common functions of the immune system. We compared the effect of epidural analgesia versus rectus sheath block on postoperative pain and proinflammatory cytokines following malignant urological surgery.

Detailed description: Study groups: 60 patients were included in the study randomly allocated into two groups of 30 patients. Rectus sheath group (RSB): Each patient received bilateral single shot ultrasound guided rectus sheath block under complete aseptic condition in a dose of 30 ml of bupivacaine 0.25% in each side immediately after induction of general anaesthesia. Control group: the patients did not receive any intervention after anaesthesia induction.

Eligibility criteria: Inclusion Criteria:

Male patients their age over 40 years, classified ASA I, II or III, undergoing radical resection of cancer prostate, through midline abdominal incision under general anaesthesia.

Exclusion criteria:

Contraindications to rectus sheath block as patient refusal, coagulopathy, local infection and allergy to bupivacaine. Planned transverse or oblique abdominal incision, extensive existing midline abdominal scarring or pre-existing chronic abdominal pain.

Primary outcomes:
measure: cumulative opioid consumption
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Numerical rating scale (NRS)
timeFrame: 24 hours postoperative
measure: time to first anlgesic request
timeFrame: 24 hours postoperative
measure: serum levels of TNF-α
timeFrame: at 24 hours postoperative
measure: Serum level of IL-6
timeFrame: at 24 hours postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university faculty of medicine
Study officials:
affiliation: Assiut University
name: Waleed S Farrag
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong JY, Lim KT. Effect of preemptive epidural analgesia on cytokine response and postoperative pain in laparoscopic radical hysterectomy for cervical cancer. Reg Anesth Pain Med. 2008 Jan-Feb;33(1):44-51. doi: 10.1016/j.rapm.2007.07.010.
Clinical trial NCT00877097: Effects of Continuous Combined Hormone Replacement Therapy and Clodronate on Bone Mineral Density (BMD) in Osteoporotic Women
Official title: Randomized Clinical Trial on the Effectts of Estradiol 2 mg + NETA 1 mg With or Without Clodronate on Bone Mineral Density and Bone Markers of Osteoporotic Postmenopausal 167 Finnish Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: osteoporosis
Bone mineral density
clodronate
HRT
postmenopausal
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2009-04-07
Enrollment: 167
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent studies suggest that the combination of two inhibitors of bone resorption may induce a greater increase in bone mineral density (BMD) than either agent alone.

In this 5-year partly randomized study the investigators examined the effects of hormone therapy (HT) with or without bisphosphonate on BMD on osteoporotic women.

In the Kuopio Osteoporosis Study (OSTPRE) a population based sample of 3200 women were selected for BMD measurement by Lunar DPX in 1995-1997. In all 167 women aged 61±2.7 years (11±4.9 years postmenopausal), and the T-score \< -2.5 SD at either the lumbar spine or femoral neck were recruited for this sub-study.

They received daily estradiol hemihydrate (E2) 2mg + norethisterone acetate (NETA) 1mg (Kliogest®, Novo Nordisk, Denmark) and were randomized to get additional Boneplac, which consisted of either 800mg clodronate (Bonefos®, Leiras Ltd, Finland) (n=55, KB-group) or placebo (n=55, K-group). In case of contraindications or refusal from HT, the women were offered clodronate 800 mg/day (n=57, B-group) to be taken to empty stomach with a glass of water 30 minutes to two hours before breakfast.

BMD was measured at time intervals 0, 1, 3 and 5-years. All repeated BMD values were interviewed by one investigator and primarily the vertebrae L2-L4 were followed. In case of spinal deformities during the study (38.3%) other lumbar levels were followed. The baseline BMD values (lumbar spine BMD 0.839±0.072 g/cm², femoral neck BMD 0.759±0.094g/cm²) were similar between the groups.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal
* BMD T-score \<-2.5sd

Exclusion Criteria:

* None

Primary outcomes:
measure: BMD once a year
timeFrame: 1996-2002
Secondary outcomes:
measure: bone markers once a year
timeFrame: 1996-2002
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Obstetrics and Gynecology, Kuopio University Hospital
name: Marjo T Tuppurainen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tuppurainen M, Harma K, Komulainen M, Kiviniemi V, Kroger H, Honkanen R, Alhava E, Jurvelin J, Saarikoski S. Effects of continuous combined hormone replacement therapy and clodronate on bone mineral density in osteoporotic postmenopausal women: a 5-year follow-up. Maturitas. 2010 Aug;66(4):423-30. doi: 10.1016/j.maturitas.2010.04.013. Epub 2010 May 23.
Clinical trial NCT02404597: Cardiac Output Monitoring in Burn Patients
Official title: Non-invasive Cardiac Output Monitoring in Patients With Burn Injuries
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Burns
Keywords: Cardiac output
Low blood pressure
Total Body Surface Area (TBSA)
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to describe the use of non-invasive cardiac output monitors (NICOM) in patients with burn injuries and to develop a protocol for NICOM in a burn unit.

Detailed description: Appropriate fluid resuscitation in the first 24 hours after a burn injury directly influences patient outcome and morbidity. Currently, there is some controversy surrounding the over and under-resuscitation and endpoints of resuscitation using older fluid resuscitation formulas in patients with burn injury. The NICOM has been used in the resuscitation of patients with sepsis. The NICOM will be used in patients with burn injury to determine the patient's fluid responsiveness and the need for additional fluid boluses versus medications to increase the patient's blood pressure.

Eligibility criteria: Inclusion Criteria:

1) Burn greater than 20% TBSA (total body surface area)

Exclusion Criteria:

1) Burn less than 20% TBSA (total body surface area)

Primary outcomes:
measure: Total volume of fluid given
timeFrame: 24 hours
measure: Rate of pressor use
timeFrame: Duration of hospital stay, an expected average of 30 days
Secondary outcomes:
measure: Rate of pulmonary edema
timeFrame: Duration of hospital stay, an expected average of 30 days
measure: Rate of acute renal failure
timeFrame: Duration of hospital stay, an expected average of 30 days
measure: Length of stay in intensive care unit (ICU)
timeFrame: 3 months
measure: Length of hospital stay
timeFrame: 3 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Rachael Williams, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02942797: NRS 2002 as a Predictor of Prognosis in COPD With Respiratory Failure
Official title: Nutritional Risk Screening 2002 Should be Used to Predict Prognostic Outcomes in Chronic Obstructive Pulmonary Disease With Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 520
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: Patients diagnosed with chronic obstructive pulmonary disease with respiratory failure during April 2017 to March 2019 at West China Hospital.

Brief summary: This is a prospective study of patients diagnosed with chronic obstructive pulmonary disease (COPD) with respiratory failure and admitted in West China Hospital during April 2017 to March 2019. The following variables will be prospectively studied: age, sex, height, weight, respiratory function indicators, arterial blood gas analysis results, biochemical data, nutritional risk screening 2002 (NRS 2002) score, short-term and long-term prognostic outcomes. The purpose of this study is to assess whether NRS 2002 is a useful prognosis predictor in COPD patients with respiratory failure.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosis of COPD at West China Hospital during April 2017 to March 2019
* Partial pressure of O2 (PaO2) \< 60 mmHg and/or partial pressure of CO2 (PaCO2) \>50 mmHg
* Age ≥ 18 years
* Respiratory rates \> 23 bpm

Exclusion Criteria:

* Pregnancy or during lactation
* Ventilatory dysfunction due to neuromuscular disorders, acute and chronic thromboembolic disease, severe illness in other systems
* Refused to participate in this study

Primary outcomes:
measure: Predictive value of NRS 2002 in identifying COPD patients with respiratory failure who will have poor prognostic outcomes, in terms of mortality
timeFrame: up to 2 years
measure: Predictive value of NRS 2002 in identifying COPD patients with respiratory failure who will have poor prognostic outcomes, in terms of 30-day readmission after discharge
timeFrame: up to 2 years
measure: Predictive value of NRS 2002 in identifying COPD patients with respiratory failure who will have poor prognostic outcomes, in terms of length of stay
timeFrame: up to 2 years
measure: Predictive value of NRS 2002 in identifying COPD patients with respiratory failure who will have poor prognostic outcomes, in terms of complications
timeFrame: up to 2 years
Secondary outcomes:
measure: Collection of Demographics (age, sex)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT01573897: Impact of Sleep Apnea on Diabetic Foot Wound.
Official title: Influence of Sleep Apnea Syndrome and Its Treatment by Positive Airway Pressure Therapy on Transcutaneous Oxygen Tension (PtcO2) in Patients With Foot Wound or at Risk for Foot Wound
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetic Foot
Sleep Apnea
Keywords: Diabetes
Sleep apnea
Diabetic foot
Microcirculation
Lead sponsor: AGIR à Dom
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutives diabetic patients referred to our tertiary diabetes unit (Grenoble University Hopsital, France) for diabetic foot wound

Brief summary: Sleep apnea syndrome (SAS) is a common comorbidity of type 1 and type 2 diabetes. A low transcutaneous oxygen tension (PtcO2) measured on the foot is pejorative prognostic factor for the healing of a diabetic foot wound. SAS causes intermittent nocturnal hypoxia and sympathetic overactivity. The investigators hypothesized that SAS could be a factor reducing the PtcO2.Therefore, the main objective of this study is to assess the variation in PtcO2 between the end of the night and midday in patients with -or at risk of- diabetic foot wound according to the presence or not of sleep apnea syndrome.The secondary objective is to address the microvascularisation of diabetic patients having foot wounds according to their status regarding sleep apnea syndrome.

Detailed description: The study is observational, cross-sectional. Presence of sleep apnea syndrome will be assessed on the same night than the main outcome, that is the difference in PtcO2 between 5:00 AM and 12:00AM. Microvascularisation will be assessed by Laser Speckle Contrast Imaging Analysis (LASCA).

Sample size is estimated at 60 patients based on previous revascularisation studies having PtcO2 as main outcome.

An intermediary analysis is planned after 40 inclusions.

Eligibility criteria: Inclusion Criteria:

* Types 1 or 2 or MODY diabetes with diabetic foot wound (or at risk of foot wound stage 2 and 3 (see reference PMID:18442189).
* Patients covered by social insurance

Exclusion Criteria:

* Patients with sleep apnea syndrome previously treated by positive airway pressure therapy.
* Patients previously treated by additional oxygen therapy. Patient with unstable psychiatric disease

Primary outcomes:
measure: Transcutaneous oxygen tension (PtcO2)
timeFrame: Transcutaneous oxygen tension is assessed at the end of the night (5:00a.m) and at midday (12:00 a.m)
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Diabetes and Endocrinology Unit, Grenoble University Hospital
Study officials:
affiliation: Diabetes and Endocrinology Unit, Grenoble University Hospital
name: Anne-Laure Borel, Pr MD PhD
role: PRINCIPAL_INVESTIGATOR
References: