louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04761159: Ketamin Plus Propofol for Anesthesia Induction
Official title: Effect of Ketamin+Propofol Mixture on Postoperative Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Recovery
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 112
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, controlled
Primary purpose: TREATMENT

Brief summary: ASA I-II 112 pediatric patients will recruit who underwent adenoidectomy-tonsillectomy surgery. Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I; propofol 1,5 mg/kg + ketamin 0,75 mg/kg (2/1 ratio) for group II; propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio) for group III; propofol 3 mg/kg will perform for anesthesia induction. General anesthesia will maintenance with sevoflurane 1-2% and O2/N2O mixture. Morphine 0.1mg/kg IV will be apply for postoperative analgesia at 10 min of anesthesia. Extubation time, length of stay in PACU, Watcha score, FLACC score will record. Than all data will statistically analyse.

Detailed description: ASA I-II 112 pediatric patients will recruit who underwent adenoidectomy-tonsillectomy surgery in this randomised controlled study. The participants will divide into the 4 groups with computered random generation. The Different combination of propofol+ketamin mixture will apply at the induction of anesthesia. The groups will assign as group I,II, III and IV. Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I; propofol 1,5 mg/kg + ketamin 0,75 mg/kg (2/1 ratio) for group II; propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio) for group III; propofol 3 mg/kg will perform for anesthesia induction. Fentanyl 1 microgram per kg and rocuronium 0.6 mg/kg will apply for anesthesia induction to the all participants. General anesthesia will maintenance with sevoflurane 1-2% and O2/N2O mixture. Morphine 0.1mg/kg IV will be apply for postoperative analgesia at 10 min of anesthesia. Extubation time, length of stay in PACU, Watcha score, FLACC score will record. Than all data will statistically analyse.

Eligibility criteria: Inclusion Criteria:

* ASA I-II patients
* Underwent adenoidectomy-tonsillectomy surgery
* Age between 3-12

Exclusion Criteria:

* ASA III-IV patients
* Age; under 3 years old
* Age; above 12 years old.

Primary outcomes:
measure: Delirium score
timeFrame: 30 minutes in PACU
Secondary outcomes:
measure: length of stay in PACU
timeFrame: 30 minutes in PACU
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
References:
Clinical trial NCT02184559: Postoperative Analgesia After Caesarean Section Under ALR: TAP Block Versus Catheter Scar Infiltration
Official title: Postoperative Analgesia After Caesarean Section Under ALR: TAP Block Versus Catheter Scar Infiltration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Scheduled Caesarian Section
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the multimodal postoperative analgesia is to improve the quality of analgesia and reduce side effects of morphine (nausea, vomiting, sedation, urinary retention, respiratory depression ...). In the case of caesarean sections, the quality of analgesia allows one hand to improve the mother-child relationship and the quality of breastfeeding, the other to reduce the risk of postpartum depression and chronic pain . Two methods of administration of local anesthetics have been proven effective for analgesia of the abdominal wall under umbilical: The Transversus Abdominal Block Plan (TAP Block) and infiltration of the scar continues operating. The TAP block was performed under ultrasound guidance by the anesthesiologist after the intervention in a single injection of local anesthetic in the abdominal wall and has a period of limited and variable. The infiltration continues catheter is placed by the surgeon before closing the wound and allows the infusion of local anesthetics for 48 hours.

The purpose of this study was to compare morphine consumption between both techniques, and the quality of analgesia and side effects of morphine


Eligibility criteria: Inclusion Criteria:

* Woman whose age is 18 years
* Encircled Woman requiring a scheduled(programmed) caesarian, under spinal anesthesia or died combined(organized) spinal anesthesia
* Woman ASA I and II
* Term = 37 LIMITED COMPANIES
* Woman primipare or not
* Woman having signed an informed consent writes and making a commitment to respect the instructions of the protocol

Exclusion Criteria:

* Minor Woman
* Woman presenting a contraindication to the anesthesia périmédullaire: constitutional or acquired disorders(confusions) of the haemostasis, the allergy in the local anesthetics, the infectious context (hypertherm \> 38.5 ° C)
* Woman presenting an intolerance or an allergy known about the morphine in the paracetamol or in AIN
* The surgical histories of laparotomy
* The morbid obesity BMI \> 35
* Dysgravidies
* Woman not being affiliated to the national insurance scheme
* Woman under legal protection
* Woman not having signed an informed consent

Primary outcomes:
measure: Consumption morphinize
timeFrame: 48 hours
Secondary outcomes:
measure: Analgesic efficiency
timeFrame: 48 hours
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: loic MONDOLONI
role: STUDY_DIRECTOR
References:
Clinical trial NCT06882759: Relationship of Point-of-care Coagulation Assays with Clinical Outcomes in Cardiac Surgery: a Retrospective Cohort Study
Official title: Relationship of Point-of-care Coagulation Assays with Clinical Outcomes in Cardiac Surgery: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Surgery Requiring Cardiopulmonary Bypass
Keywords: cardiac surgery
viscoelastic testing
point-of-care
ROTEM
cardiopulmonary bypass
bleeding
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac surgery with cardiopulmonary bypass at Toronto General Hospital

Brief summary: The goal of this observational study is to determine the relationship of ROTEM point-of-care coagulation assay parameters with excessive bleeding and clinical outcomes in patients undergoing cardiac surgery at Toronto General Hospital. The main questions it aims to answer are: i) How well does viscoelastic testing (VET) predict the clinical outcome of excessive bleeding in cardiac surgery? ii) Which VET parameters have the greatest accuracy for identification of patients who will have excessive bleeding? iii) 3) What is the prognostic value of abnormal VET parameters with other clinical outcomes after cardiac surgery?


Eligibility criteria: Inclusion Criteria:

* Adult patients ≥ 18 years old
* Underwent a cardiac surgical procedure with cardiopulmonary bypass

Exclusion Criteria:

- Did not undergo viscoelastic testing during surgery

Primary outcomes:
measure: Excessive bleeding
timeFrame: From the end of bypass to the end of postoperative day-1 (POD1)
Secondary outcomes:
measure: Transfusion rate
timeFrame: 1) From time of entry to operating room (OR) to the end of post-operative day-1 (POD1) and post-operative day-7(POD7). 2) from end of cardiopulmonary bypass (CPB) to the end of post-operative day-1 (POD1) and post-operative day-7 (POD7)
Other outcomes:
Locations:
Study officials:
affiliation: University Health Network, Toronto
name: Keyvan Karkouti
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03591159: The Effect of Membrane Sweeping on the Delivery Time and the Need of Induction in Term Pregnancy
Official title: The Effect of Membrane Sweeping on the Delivery Time and the Need of Induction in Term Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delivery, Obstetric
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 256
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pregnancies that extend beyond 42 weeks of gestation are at an increased risk for poor fetal and maternal outcomes. For decreasing the number of these cases, some labor induction techniques are used. The status of the cervix is an indicator for the success of the induction. In these study, investigators investigate the effect of membrane sweeping on the need of induction and the delivery time in term pregnancy.


Eligibility criteria: Inclusion Criteria:

* Age 18-35 years
* Vertex presentation
* No contraindication for vaginal delivery
* No contraindication for labor induction

Exclusion Criteria:

* Active vaginal infection
* Previous uterine surgery
* Systemic disease
* Multiple pregnancy
* Fetal anomaly and suspicious fetal health status

Primary outcomes:
measure: Need of Labor Induction.
timeFrame: During pregnancy. 40 weeks and 6 days for gestational age
measure: Duration of delivery
timeFrame: During delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University School of Medicine Department of Obstetrics and Gynecology
Study officials:
References:
Clinical trial NCT04980859: Zebutinib Combined With Immunochemotherapy in the Treat of Newly Treated CLL Patients Without 17p-/TP53 Mutation
Official title: A Phase III, Single-arm Clinical Trial of Zebutinib Combined With Immunochemotherapy With Limited Course of Treatment for Newly Treated Chronic Lymphocytic Leukemia Patients Without 17p-
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate limited course of treatment of Zebutinib combined with immunochemotherapy for patients with newly treated chronic lymphocytic leukemia without 17p-/TP53 mutation


Eligibility criteria: Inclusion Criteria:

* CLL patients with indications for treatment according to iwCLL;
* CT/MRI shows measurable lesions;
* ECOG score is 0-2;
* No pregnancy plans during treatment

Exclusion Criteria:

* Richter transformation;
* 17p-/TP53 amplification ≥20% (FISH);
* Received steroids within 7 days before starting treatment;
* Have previously received treatments for chronic lymphocytic leukemia;
* Vaccine live attenuated vaccine within 4 weeks of randomization;
* Any life-threatening disease;
* Central nervous system leukemia;
* Apoplexy, history of intracranial hemorrhage;
* HIV or HCV or HBVpositive

Primary outcomes:
measure: MRD conversion rate (minimal residual disease conversion rate)
timeFrame: 30 days
Secondary outcomes:
measure: OS (overall survival)
timeFrame: 3 years
measure: PFS (progression-free survival)
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04490759: QStat Pilot Reference Range Study
Official title: Reference Range Pilot Study for the Quantra Analyzer With the QStat Cartridge
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation Disorder
Lead sponsor: HemoSonics LLC
Sponsor class: INDUSTRY
First posted: 2020-07-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult volunteers with normal coagulation function, approximately equal numbers of males and females across three age group categories (18-30, 31-50 and \>50 years). The racial and ethnic profiles will be representative of the populations at the site.

Brief summary: The objective is to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge.

Detailed description: This is a single center prospective, observational study of a healthy adult population with normal coagulation function to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge. The threshold for the Clot Stability to Lysis (CSL) parameter will be determined from the CSL reference range.

Eligibility criteria: Inclusion Criteria:

* Subject is 18 years or older
* Subject is willing to participate and has signed a consent form
* Subject's laboratory coagulation test results at screening are within each test's normal reference range.

Exclusion Criteria:

* Subject is younger than 18 years
* Subject has a history of a coagulation disorder
* Subject is pregnant or lactating
* Subject is currently taking medications known to alter coagulation
* Subject has one or more laboratory coagulation test restuls outside of the normal reference range at screening
* Subject had a blood transfusion or surgery within the last month
* Drug abuse
* Excessive alcohol consumption
* Subject is unable to provide written informed consent
* Subject is incarcerated at the time of the study
* Subject previously participated in this study

Primary outcomes:
measure: Reference range intervals for measurement of Clot Time (CT) parameter
timeFrame: Baseline, determined from a single blood draw
measure: Reference range intervals for measurement of Clot Stiffness (CS) parameter
timeFrame: Baseline, determined from a single blood draw
measure: Reference range intervals for measurement of Fibrinogen Contribution to Clot Stiffness (FCS) parameter
timeFrame: Baseline, determined from a single blood draw
measure: Reference range intervals for measurement of Platelet Contribution to Clot Stiffness (PCS) parameter
timeFrame: Baseline, determined from a single blood draw
measure: Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter
timeFrame: Baseline, determined from a single blood draw
Secondary outcomes:
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: M3 Wake Research
state: North Carolina
Study officials:
References:
Clinical trial NCT00311259: Melatonin Treatment and Inflammation, Oxidative Stress and Autonomic Function in Connection With Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oxidative Stress
Inflammatory Stress
Myocardial Ischaemia
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2006-04-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: The purpose of this study is to determine whether treatment with melatonin can reduce cell damage and inflammation in connection with laparoscopic gall bladder surgery.

Detailed description: Laparoscopic gall bladder surgery is connected with changes in the body resulting in cell damage and inflammation. Melatonin is a hormone produced in brain and regulate sleep rhythm, temperature, production of other hormones and function of organs. Furthermore melatonin can modify cell damage and inflammation. After surgery the production of melatonin is disturbed. The purpose of this study is therefore to determine whether treatment with melatonin can reduce cell damage and inflammation in connection with laparoscopic gall bladder surgery.

Eligibility criteria: Inclusion Criteria:

* indikation for laparoscopic cholecystectomy
* women between 18 and 70 years old

Exclusion Criteria:

* men
* acute cholecystectomy
* pancreatitis
* renal insufficient
* well-known liver insufficient
* cardiovascular disease (arrhythmia, well-known ischaemic heart disease)
* drug therapy (digoxin, Ca-antagonist, amiodaron, beta-blocker)
* anticoagulation therapy (marevan and marcoumar)
* praeoperative therapy with opioid, anxiolytica and hypnotica)
* well-known sleep disease
* endocrine disease in drug therapy (diabetes mellitus, thyroid disease)
* daily alcohol consumption (more than 5 drinks)
* bad compliance (language difficulty, mental problems etc.)
* pregnancy and breast-feeding
* lack of written consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
Study officials:
affiliation: Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
name: Bülent Kücükakin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kucukakin B, Klein M, Lykkesfeldt J, Reiter RJ, Rosenberg J, Gogenur I. No effect of melatonin on oxidative stress after laparoscopic cholecystectomy: a randomized placebo-controlled trial. Acta Anaesthesiol Scand. 2010 Oct;54(9):1121-7. doi: 10.1111/j.1399-6576.2010.02294.x.
Clinical trial NCT05452109: Effect of Blood Flow Restriction on Football-Related Performance Parameters
Official title: Improvement of Football-Related Performance Parameters: Application of Blood Flow Restrictive Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Occlusion
Soccer
Exercise
EMG
Lead sponsor: Biruni University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2022-07-11
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The blood flow restriction method can have similar or superior effects to high-intensity exercises even in a short duration, which can positively affect some performance parameters, can be applied with low-intensity load and cause hypertrophy in the muscle by providing high metabolic stress, facilitating muscle growth without significantly changing the total training dose. The aim of this study is to investigate whether adding the blood flow restriction method to the classical training program can be more effective than the classical training applied alone in the development of football-related performance parameters.


Eligibility criteria: Inclusion Criteria:

* Being a male between the ages of 18-30 years
* Volunteer to participate in the study
* Playing football in one of the clubs in Istanbul for at least 1 year
* Being in the pre-season of the club
* Absence of any ongoing musculoskeletal problems that limit exercising

Exclusion Criteria:

* Having at least one of the contraindications preventing the application of blood flow restriction (Smoking, previous venous thromboembolism, risk of peripheral vascular disease (ankle-brachial index \<0.9), coronary heart disease, hypertension, hemophilia, etc.).
* History of sports injury in the last 6 months
* Orthopedic lower extremity surgery in the last 1 year
* Body mass index ≥ 30 kg/m2

Primary outcomes:
measure: Evaluation of Muscle Strength and Endurance
timeFrame: 6 weeks
Secondary outcomes:
measure: Evaluation of Lower Extremity Power
timeFrame: 6 weeks
measure: Evaluation of Aerobic Endurance
timeFrame: 6 weeks
measure: Evaluation of Change of Direction Speed
timeFrame: 6 weeks
measure: Evaluation of Reactive Agility
timeFrame: 6 weeks
measure: Evaluation of Dynamic Balance
timeFrame: 6 weeks
measure: Systemic Fatigue
timeFrame: 6 weeks
measure: General Perceived Fatigue
timeFrame: 6 weeks
measure: Evaluation of General Satisfaction and Perceived Performance Change
timeFrame: 6th week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ayse Zengin Alpözgen, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04513509: Rate Control in Patients With Atrial Fibrillation
Official title: The Surrogate Marker of Rate Control in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Rate Control
Cardiopulmonary Exercise Test
Keywords: Atrial Fibrillation
rate control
cardiopulmonary exercise test
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: To search for the best marker for the patients in atrial fibrillation with rate control

Detailed description: In an aging society, the prevalence of atrial fibrillation is increasing. The main treatment strategy is to reduce the complications of embolic stroke and heart failure. Among these patients, a group of them will choose to have "rate control" based on the heart conditions and the preference of the patients. The strategy is to control the ventricular rate by drugs to prevent the heart from failure. However, when the physicians attempt to do so, they encounter two questions: how much is the optimal drug dose? And what is the best marker we are looking to? To answer these questions, the investigators design a prospective, cross-over study to explore this issue. The participants will do cardiopulmonary exercise test (CPET) before and after treatment. They will receive another CPET if drug dose is titrated up. With the study, the investigators will understand whether a resting heart rate can be a good marker for optimal drug dosage, and what is the optimal range of heart rate the physicians should target.

Eligibility criteria: Inclusion Criteria:

1. 20\~90 years old
2. Rate control is preferred after shared decision making

Exclusion Criteria:

1. cannot cooperate with or complete CPET
2. has contraindication for CPET, such as uncontrolled heart failure, hypertension, angina, valvular heart disease, lung function impariment that SaO2\<90% at room air.
3. Ventricular rate below 80/min before any medication
4. Permanent pacemaker implanted

Primary outcomes:
measure: Change of Maximal Oxygen consumption
timeFrame: 0, 3, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chih-Chieh Yu, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References: