louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01427985: Influence of Premedication Protocols for Neonatal Endotracheal Intubation on Cerebral Oxygenation
Official title: The Influence of Two Different Premedication Protocols for Endotracheal Intubation in Neonates on Cerebral Oxygenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Newborn
Preterm
Intubation
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2011-09-02
Enrollment: 24
Sex: ALL
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the influence of premedication drugs Atropin, Fentanyl and Mivacurium and of endotracheal intubation on cerebral oxygenation and cardiac output in term and preterm newborn infants. Two different protocols of premedication are compared.

Detailed description: Influence of the following procedures will be examined:

* Application of Atropin
* Application of Fentanyl
* Application of Mivacurium
* possible desaturation and / or bradycardia during intubation attempts
* restoration of arterial oxygen saturation and / or heart rate after succesful intubation

We aim to examine the change of the following parameters by the use of electrical cardiometry:

* stroke volume
* cardiac output

We compare two different premedication protocols and we evaluate the impact of these protocol on the time needed for intubation and on intubation difficulties .

Eligibility criteria: Inclusion Criteria:

* newborn infant below 44 weeks postmenstrual age
* indication for elective or semi-elective endotracheal Intubation
* parental informed consent

Exclusion Criteria:

* emergency intubation

Primary outcomes:
measure: Change of cerebral tissue oxygen saturation during premedication and intubation
timeFrame: from 1 minute before first study drug until 10 minutes after end of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University Medical Center
state: Baden-Württemberg
Study officials:
affiliation: University of Ulm
name: Manuel B Schmid, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05196685: Is Carotid-Vertebral Doppler Ultrasonography Necessary for Patients With Vertigo?
Official title: Is Carotid-Vertebral Doppler Ultrasonography Necessary for Patients With Vertigo?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vertigo
Carotid Artery Diseases
Keywords: Vertigo
Imbalance
Doppler Ultrasonography
Carotid Artery
Vertebral Artery
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be conducted prospectively on patients who apply to the Cardiovascular Surgery outpatient clinic and undergo Carotid-vertebral artery Doppler ultrasound due to vascular problems.

Brief summary: This study will be carried out prospectively on patients who applied to the cardiovascular surgery polyclinic and the carotid-vertebral artery doppler ultrasound due to the vascular problem. All patients will fill "Balance Disorder Scan Survey" and "Vertigo-Dizziness Imbalance Questionnaire-SS". Patients who score 1 and more are directed to the ear nose throat polyclinic and detailed differential diagnosis. Those who score 0 will be in control group.

Detailed description: Right and left carotid artery flow velocities, intima-media thicknesses (IMT), presence of plaque, vertebral artery flow velocities, and vertebral artery resistance indexes (RI) will be recorded in all patients. Risk factor analysis, Vertigo Symptom Scale (VSS) and Dizziness Handicap Inventory (DHI-S) questionnaires will be applied to the patients in the ENT outpatient clinic. The differential diagnosis of vertigo will be made by performing detailed balance examinations and advanced balance tests.

Eligibility criteria: Inclusion Criteria:

* All patients who have a vascular problem and doppler USG.

Exclusion Criteria:

Patients with impaired cooperation, history of malignancy, presence of central nervous system pathology, presence of neurological disease affecting balance in the history, patients whose use of glasses may cause problems (epilepsy, vision loss, etc.) were excluded from the study.

Primary outcomes:
measure: Carotid Stenosis
timeFrame: 1 year
measure: Resistive Index
timeFrame: 1 year
measure: Intima Media Thickness
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References:
Clinical trial NCT01260285: The Safety of Vardenafil in Patients Undergoing Cardiac Surgery
Official title: The Safety of Vardenafil in Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ischemia-reperfusion Injury.
Lead sponsor: McGuire Research Institute
Sponsor class: OTHER
First posted: 2010-12-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of vardenafil in cardiac surgery patients.


Eligibility criteria: Inclusion Criteria:

* undergoing cardiac surgery

Exclusion Criteria:

* emergent surgery
* recent MI in past 7 days prior to surgery
* ejection fraction \< 35%
* creatinine \> 2.0
* prior CVA
* severe COPD
* recent use of nitrates (within past 48 hours prior to surgery)
* prior CABG
* pregnancy

Primary outcomes:
measure: Hypotension
timeFrame: approximately 5 days
Secondary outcomes:
measure: Ejection Fraction
timeFrame: approximately 5-7 days postop
Other outcomes:
Locations:
city: Richmond
country: United States
facility: McGuire VAMC
state: Virginia
Study officials:
affiliation: McGuire VAMC
name: Ion Jovin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00839085: Comparison of Ascorbic Acid and Grape Seed Extract in Oxidative Stress Induced by on Pump Heart Surgery
Official title: Effect of Ascorbic Acid and Grape Seed Extract "Vitis Vinifera L." in Oxidative Stress Induced by on Pump Coronary Artery by Pass Grafting Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CABG-Induced Oxidative Stress
Keywords: CABG
on pump
Grape seed extract
Vit C
Oxidative stress
Lead sponsor: Tabriz University
Sponsor class: OTHER
First posted: 2009-02-09
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Study aimed to compare the effect of grape seed extract and ascorbic acid in oxidative stress induced by on pump coronary artery by pass grafting surgery.

Detailed description: This study aimed to compare the effect of grape seed extract and ascorbic acid in oxidative stress induced by on pump coronary artery by pass grafting surgery.

There are three groups in the study. 75 candidate of coronary artery by pass grafting surgery were assigned random allocation on the groups (25 in each group).

1. Control
2. GSE (100 mg/6h - PO, 24h before surgery)
3. Vit C (25 mg/kg in pump circulation during surgery)

Eligibility criteria: Inclusion Criteria:

* Candidates for elective CABG surgery with pump for first time
* 3VD

Exclusion Criteria:

* High risk patients
* Those who need another heart surgery beside CABG
* Urgent patients
* Diabetics
* Ischemic time more than 120 min

Primary outcomes:
measure: LVEF
timeFrame: Before and after CABG
Secondary outcomes:
measure: Total Antioxidant Capacity (TAC)
timeFrame: Before ischemia, after ischemia, after reperfusion
measure: MDA
timeFrame: Before, middle and after CABG
measure: GTX
timeFrame: Before ischemia, after ischemia, after reperfusion
measure: SOD
timeFrame: Before ischemia, after ischemia, after reperfusion
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Cardiovascular Research Center
state: East Azerbaijan
Study officials:
affiliation: Drug Applied Research Center, Tabriz Univ Med Sci
name: Hossein Babaei, Pharm D, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tabriz Univ Med Sci
name: Naser Safaei, MD, Surgeon
role: STUDY_CHAIR
affiliation: Tabriz Univ Med Sci
name: Masood Pezaeshkian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tabriz Univ Med Sci
name: Alireza Yaghobi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tabriz Univ Med Sci
name: Ahmad Reza Jodati, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tabriz Univ Med Sci
name: Hossein Babaei, Pharm D, PhD
role: STUDY_DIRECTOR
affiliation: Tabriz Univ Med Sci
name: Rasoul Azarfarin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tabriz Univ Med Sci
name: Mohammad Ali Sheikhalizadeh, CCP
role: STUDY_DIRECTOR
References:
Clinical trial NCT00813085: A Randomized Trial of Electronic Integration of Care for Better Diabetes Outcomes; The COMPETE II Study
Official title: A Randomized Trial of Electronic Integration of Care for Better Diabetes Outcomes; The COMPETE II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Computerized clinical decision support
shared care
patient self-monitoring
quality of care
complex interventions
composite outcomes
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Health Canada
First posted: 2008-12-22
Enrollment: 511
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate whether the use of an electronic diabetes tracker by both patients and family physicians in Ontario improves diabetes outcomes, satisfaction with care and with technology and health data privacy issues. As part of the study, the investigators will be able to test whether practices that use computers perform any better than practices using paper. The investigators also will be developing the first Canadian computerized chart summary for each patient that can be communicated securely in emergencies (the Emergency Health Record) and read by all current electronic systems.


Eligibility criteria: Inclusion Criteria:

* Adult, cognitively intact, consenting people with diabetes within enrolled practices

Exclusion Criteria:

* Non-english speaking
* Cognitively impaired

Primary outcomes:
measure: Comparison of change in diabetes quality of care between intervention and usual care group.
timeFrame: 6 months follow-up
Secondary outcomes:
measure: Change in diabetes risk factor variables, satisfaction with care and technology, quality of life and health care utilization, health data privacy issues.
timeFrame: 6 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St Joseph's Healthcare & Mcmaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Anne M Holbrook, MD,PharmD,MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holbrook A, Thabane L, Keshavjee K, Dolovich L, Bernstein B, Chan D, Troyan S, Foster G, Gerstein H; COMPETE II Investigators. Individualized electronic decision support and reminders to improve diabetes care in the community: COMPETE II randomized trial. CMAJ. 2009 Jul 7;181(1-2):37-44. doi: 10.1503/cmaj.081272.
Clinical trial NCT03450785: Incidence and Risk Factors of Central Line Catheter Related Thrombosis
Official title: Study About the Incidence and Risk Factors of the Central Line Catheter Related Right Internal Jugular Vein Thrombosis in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Line Complication
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 80
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients

Brief summary: Central venous catheters are frequently used for monitoring haemodynamic status and rapidly delivering fluid therapy during the peri- and postoperative periods. Indwelling central venous catheters are typically used 7-14 days postoperatively for additional monitoring and treatment, but patients may develop asymptomatic catheter-related thrombosis, leading to life-threatening pulmonary embolism and death. Early detection helps to avoid such complications. This prospective observational study investigated the risk factors associated with catheter-related right internal jugular vein thrombosis in pediatric patients. The study enrolled 80 pediatric patients who were scheduled to receive central venous catheter. To detect thrombus formation, Doppler ultrasound examinations from the thyroid cartilage level to the supraclavicular region were used after CVC placement and on each of the following days until the catheter was removed.


Eligibility criteria: Inclusion Criteria:

* pediatric patients who were scheduled to catheterize central venous catheter

Exclusion Criteria:

* patients who had skin infections on the right side of the neck, making them unsuitable for placement of the catheter via the right side of the neck
* patients who had blood coagulation lesions or bleeding tendencies
* patients with thrombocytopenia
* patients with a history of right internal jugular vein thrombosis
* patients who presented right internal jugular vein thrombosis or stenosis on preoperative Doppler ultrasound examination

Primary outcomes:
measure: thrombus formation using doppler ultrasound examination of internal jugular vein
timeFrame: after central venous catheter placement and on each of the following days until the catheter was removed (maximum 5 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
References:
Clinical trial NCT02894515: Bioequivalence Study of Idalopirdine in Healthy Subjects
Official title: Interventional, Randomised, Open-label, Two-way Crossover, Single-dose Bioequivalence Study of Idalopirdine in Healthy Subjects Comparing the 10 mg Commercial Tablet (Test) to the 10 mg Clinical Tablet (Reference)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Bioequivalence
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2016-09-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether 2 different tablet compositions are similar regarding absorption (uptake) in the body. One composition was used in the clinical development program and the other is intended for the market


Eligibility criteria: Inclusion Criteria:

* Healthy men and women with a body mass index (BMI) of \>18.5 and \<30 kg/m2.

Exclusion Criteria:

* pregnant or lactating women

Primary outcomes:
measure: Area under the idalopirdine plasma concentration-time curve (AUC0-t) from time zero to the last quantifiable concentration post-dose
timeFrame: baseline to 72 hours post-dose
measure: Maximum observed concentration of idalopirdine (Cmax)
timeFrame: baseline to 72 hours post-dose
Secondary outcomes:
measure: Time to occurrence of Cmax (tmax)
timeFrame: baseline to 72 hours post-dose
measure: Area under the idalopirdine plasma concentration-time curve (AUC0-inf) from time zero to infinity
timeFrame: baseline to 72 hours post-dose
measure: Apparent elimination half-life (t1/2)
timeFrame: baseline to 72 hours post-dose
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: GB1050
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT04931615: ARTISS a Single-centre Randomised Control Study
Official title: The Influence of ARTISS on Post-operative Abdominal Drainage and Seroma Formation in DIEP/MS-TRAM Free Flap Breast Reconstruction Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Neoplasms
Mammaplasty
Keywords: muscle-sparing transverse rectus abdominis myocutaneous flap
Deep Inferior Epigastric Artery Perforator
Lead sponsor: Mid and South Essex NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief summary: The Influence of ARTISS on post-operative abdominal drainage and seroma formation in DIEP/MS-TRAM free flap breast reconstruction patients.

Detailed description: The principle aim of the study is to investigate the effect of ARTISS on abdominal wound drainage whether this could result in earlier drain removal and earlier patient discharge from hospital. The primary outcome investigated will be post- operative abdominal drainage duration in days which is vital information during this Covid pandemic to reduce hospital stay (and therefore possible Covid exposure) which could result in earlier discharge from hospital, as well as significantly reducing cost of the procedure to the NHS and frees in-patient beds for more efficient use of resources.

Eligibility criteria: Inclusion Criteria:

* Female adult (age 18-80)
* Patients planned for immediate or delayed DIEP/MS-TRAM breast reconstruction

Exclusion Criteria:

* Patients who are unable to consent or do not consent
* Clotting disorder
* Pregnancy
* Individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia).
* COVID positive
* Known previous allergic reactions to ARTISS

Primary outcomes:
measure: post-operative abdominal mean drainage duration
timeFrame: 42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Broomfield
country: United Kingdom
facility: Mid and South Essex NHS Foundation Trust
state: Essex
Study officials:
affiliation: Mid and South Essex NHS Foundation Trust
name: Mary Morgan, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05463315: Applying Moziak Device Compared to Standard Manual Compression on Arterio-Venous Fistula Puncture Sites Haemostasis
Official title: A Mixed Methods Sequential Explanatory Study to Evaluate the Effectiveness of Applying Moziak Device Compared to Standard Manual Compression on Arterio-Venous Fistula Puncture Sites Haemostasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Dialysis Arterio-Venous Fistula Puncture Sites
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 96
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
Intervention model description: A Mixed Methods Sequential Explanatory Study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aimed to evaluate the Effectiveness of Applying Moziak Device Compared to Standard Manual Compression Post Dialysis Arterio-Venous Fistula Puncture Sites Haemostasis

Detailed description: application of new device to find a Solution for Nursing Challenge for caring patient Post Dialysis Arterio-Venous Fistula Puncture Sites Haemostasis

Eligibility criteria: Inclusion Criteria:

* All patients undergoing hemodialysis therapy
* Both sex

Exclusion Criteria:

* Less than 18 years old
* Patient has central vascular access

Primary outcomes:
measure: Change the time of Haemostasis post dialysis
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
Study officials:
References:
Clinical trial NCT03864315: To Study the Efficacy of Therapeutic Pulsed Ultrasound in the Treatment of Vitiligo: a Randomized, Intra-individual, Left-right Comparison Study
Official title: To Study the Efficacy of Therapeutic Pulsed Ultrasound in the Treatment of Vitiligo: a Randomized, Intra-individual, Left-right Comparison Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitiligo
Keywords: Vitiligo
Harmonic Generation Microscopy
In Vivo
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study, the investigators demonstrated that in vivo THG microscopy can differentiate vitiligo lesions and normal skin based the optical nature of melanin. This THG-based procedure provides a valuable tool for noninvasive determination of third-order nonlinear susceptibility of melanin within the skin. It can also provide real-time histopathology information for treatment follow-up, without performing invasive skin biopsy.

Detailed description: The investigators initiate this open, randomized, left-right comparative study to evaluate the efficacy of pulsed ultrasound in the treatment of vitiligo on the face or trunk. Face is included in this study because vitiliginous lesions on the face has a better treatment response and causes more psychological distress on the patients than vitiligo affecting other body areas. Thirty adult subjects with vitiligo affecting the face or trunk symmetrically will be recruited. After randomization, subjects will be administrated their ulrasound treatment twice a week for 24 weeks. Their original topical treatment and/or phototherapy will be continued. During follow-up visits, digital photographs will be taken for evaluating the extent of residual depigmentation. In vivo harmonic microscopy and three skin biopsy specimens will be performed at the indicated time points on the depigmented, repigmented areas and surrounding normal skin.

Eligibility criteria: Inclusion Criteria:

1. 20-75 years old
2. With skin type Ⅲ or Ⅳ
3. With Vitiligo
4. Can read the informed consent form
5. Can continue the original treatments

Exclusion Criteria:

1. With segmental vitiligo.
2. Have joined other clinical trials

Primary outcomes:
measure: 30 participants with Vitiligo as assessed by Harmonic Generation Microscopy.
timeFrame: 1-2 hours per case
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yi-Hua Liao
role: PRINCIPAL_INVESTIGATOR
References: