louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06024733: Intravenous Anesthesia by Targeted Controlled Infusion Versus Inhalational Anesthesia on the Surgical Stress Response
Official title: Effect of Total Intravenous Anesthesia by Targeted Controlled Infusion on Surgical Stress Response Compared to Inhalational Anesthesia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Total Intravenous Anesthesia
Inhalational Anesthesia
Surgical Stress Response
Target-controlled Infusion
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the effect of total Intravenous anesthesia Target-controlled infusion (TIVA-TCI) with inhalational anesthesia on stress response.

Detailed description: Target-controlled infusion (TCI) techniques have been used to induce and maintain general anesthesia or to provide computer-assisted personalized sedation. Target-controlled infusion (TCI) systems are computer-assisted IV infusion pumps that use pharmacokinetic and pharmacodynamic mathematical modeling to maintain a user-designated target concentration at an effect site (typically the brain).

The clinician enters a desired target concentration for an anesthetic or another agent. The computer calculates the amount of the agent required to achieve the target concentration at the effect site and directs an infusion pump to deliver the calculated boluses or infusions. Therefore, TIVA-TCI allows a more stable hemodynamic profile during surgery, prevents long-acting opioid-induced accumulation and allows rapid recovery from general anesthesia.

Total intravenous anaesthesia (TIVA) regimen with Propofol is a useful anaesthetic technique, effectively controlling responses to tracheal intubation and intense surgical stimulation, while avoiding Inhalational anaesthetics and allowing rapid emergence from anaesthesia .

Eligibility criteria: Inclusion Criteria:

1. Patients subjected to lower abdominal cancer surgery.
2. Patients of both sexes
3. body mass index \< 35 kg/m2.
4. Age from 18 to 60 years.
5. ASA, I-II.

Exclusion Criteria:

1. Patients with a history of severe cardiovascular or respiratory disease.
2. Severe hepatic, renal, or neurological diseases.

Primary outcomes:
measure: The level of the stress response by serum level of insulin-like growth factors
timeFrame: Intraoperative and 24hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT00220233: Olmesartan as an add-on to Amlodipine in Hypertension
Official title: Add-on Study of Olmesartan Medoxomil in Patients With Moderate to Severe Hypertension Not Achieving Target Blood Pressure on Amlodipine 5 mg Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 632
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: This study is to test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with amlodipine alone


Eligibility criteria: Inclusion Criteria:

* Without antihypertensive pre-treatment mean seated BP greater than 160/100 mmHg
* Pre-treatment with amlodipine 5 or 10 mg: mean seated BP greater than or equal to 140/90 mmHg

Exclusion Criteria:

* Secondary hypertension
* Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs

Primary outcomes:
measure: Mean change in trough seated diastolic blood pressure
Secondary outcomes:
measure: Mean change in trough seated systolic BP
measure: Mean change in daytime, nighttime and 24 hour ambulatory blood pressure
measure: Percent of patients achieving target blood pressure goal
measure: Safety and tolerability
Other outcomes:
Locations:
city: Leipzig
country: Germany
city: Sinsheim
country: Germany
city: Tann
country: Germany
city: Weinheim
country: Germany
city: Wiesbaden
country: Germany
Study officials:
name: Peter Brommer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00333333: Mechanism of Thrombocytopenia in Infants
Official title: Mechanism of Thrombocytopenia in Small for Gestational Age Infants Versus Infants With Maternal Preeclampsia Exposure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombocytopenia
Small for Gestational Age (SGA)
Preeclampsia
Keywords: Thrombocytopenia
Small for Gestational Age (SGA)
Preeclampsia
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: The Cardeza Foundation for Hematologic Research
First posted: 2006-06-05
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In utero infants who are small for gestational age or who are exposed to maternal pre-eclampsia

Brief summary: This research project is studying the causes for low platelet levels in preterm infants. Platelets are a component of blood that helps with clotting. The purpose of this study is to determine whether the cause for low platelet levels is the same in infants who are born to mothers with preeclampsia and infants who are small for gestational age.

Detailed description: Thrombocytopenia is a common entity in infants who are born to mothers with preeclampsia and in infants who are small for gestational age. There have been several theories to the mechanism underlying thrombocytopenia in these groups of patients. One mechanism suggests that thrombocytopenia in these populations may be secondary to underproduction of platelets. Other studies have implied that low platelet levels may be due to endothelial activation causing platelet consumption. This study is being performed to help determine the mechanism causing thrombocytopenia in infants born to mothers with preeclampsia and comparing it to the mechanism of thrombocytopenia in infants who are small for gestational age.

Eligibility criteria: Inclusion Criteria:

* Infants who are less than 34 weeks gestation
* Infants born to mothers with preeclampsia
* Infants who are born small for gestational age whose mother did not have preeclampsia

Exclusion Criteria:

* Infants who are greater than 34 weeks gestation
* Infants with known congenital anomalies or known congenital infections

Primary outcomes:
measure: To determine the mechanism of thrombocytopenia in small for gestational age infants versus infants with maternal preeclampsia exposure
timeFrame: Each infant will only be enrolled during the time of birth until cord blood is collected.
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Systems
state: Delaware
Study officials:
affiliation: Christiana Care Health Systems; Thomas Jefferson University Hospital
name: Kelly Zook, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05363033: Evaluation of a Sarcopenia Prediction Model and Development and Effectiveness of a Nursing Guidance Mobile App
Official title: Evaluation of a Sarcopenia Prediction Model and Development and Effectiveness of a Nursing Guidance Mobile App
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prediction of High-risk Populations for Sarcopenia
Keywords: artificial intelligence, nursing, nursing guidance mobile application, prediction model, sarcopenia
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We adopted the convenient sampling method to recruit 120 participants-those who visited the hospital regularly and their accompanying family members

Brief summary: We evaluated a model for the prediction of high-risk populations for sarcopenia in home settings, developed a sarcopenia nursing guidance mobile application, and assessed the effectiveness of this application in influencing sarcopenia-related knowledge and self-care behavior among participants.


Eligibility criteria: Inclusion criteria were being a member of the public, aged ≥20 years and \<80 years, and having experience using mobile devices or smartphones. Exclusion criteria were not belonging to a high-risk population for sarcopenia and/or being unable to use the application platform.

Primary outcomes:
measure: changes in sarcopenia-related knowledge and awareness regarding self-care
timeFrame: 2019~2022
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: Cheng Hsin General Hospital
Study officials:
References:
Clinical trial NCT02982733: Ankaferd Blood Stopper for Hemostasis After Transradial Coronary Angiography
Official title: Ankaferd Blood Stopper as a New Strategy to Avoid Early Complication After Transradial Coronary Angiography: A Randomized, Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radial Artery Injury
Hematoma
Bleed
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In 2008 Goker et al, introduced Ankaferd Blood Stopper (ABS) as a new hemostatic drug. Recently, ABS has been shown to produce local hemostasis by implementing topically after major arterial vessel injury. Reducing the compression time during patent hemostasis by facilitating hemostasis may decrease RAO. To test this hypothesis the investigators planned a three arm randomized study to evaluate the safety and efficacy of Ankaferd blood stopper in adjunct to short-time compression, compared to either short-time compression with conventional sterile gauzes or with a TR band after transradial diagnostic procedures.


Eligibility criteria: Inclusion Criteria:

* All consecutive patients undergoing transradial elective diagnostic coronary procedures between November 2016 and November 2017 at the catheterization laboratory of Acibadem University Kocaeli Hospital were considered to be enrolled in the study.

Exclusion Criteria:

* The only exclusion criteria were an abnormal Barbeau's test before puncture and failure to provide written informed consent.

Primary outcomes:
measure: Radial artery occlusion assessed by reverse Barbeau's test
timeFrame: 24 hours
Secondary outcomes:
measure: Bleeding
timeFrame: 2 hours
measure: Hematoma
timeFrame: 24 hours
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Acibadem University
Study officials:
affiliation: Acibadem University
name: Sevket Gorgulu, Prof
role: STUDY_CHAIR
References:
citation: Gorgulu S, Norgaz T, Sipahi I. Ankaferd blood stopper as a new strategy to avoid early complications after transradial procedures: A randomized clinical trial. J Interv Cardiol. 2018 Aug;31(4):511-517. doi: 10.1111/joic.12514. Epub 2018 Apr 17.
Clinical trial NCT02865733: Study of Remodulin® in Pediatric Pulmonary Hypertension With Single Ventricular Physiology After Fontan Surgery
Official title: Randomized Single-blind Study of Intravenous Maintenance of Remodulin® for the Treatment of Pulmonary Hypertension After Fontan Operation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Hypertension
Keywords: Remodulin®
pulmonary vascular resistance
univentricular physiology
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 36
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine the safety and efficiency of Remodulin®（Treprostinil Injection）to reduce the pulmonary arterial pressure and prevent pulmonary hypertension (PH) after Fontan operation with univentricular physiology.

Detailed description: PH is a significant contributor to the postoperative morbidity and mortality of congenital heart disease, especially after Fontan operation with univentricular physiology. Mild increase of pulmonary vascular resistance may lead to failure of Fontan circulation. Remodulin® has been approved for the treatment of adults with PH, but little is known about the effects in children with PH after Fontan operation. The study aim is to determine the safety and efficiency of Remodulin® to reduce the pulmonary arterial pressure and prevent PH in children after Fontan operation. Meanwhile pharmacokinetics of the drug were checked with or without the peritoneal dialysis.

Eligibility criteria: Inclusion Criteria:

After Fontan procedure, the criteria should be met

1. mPAP greater than 15 mmHg
2. TPG greater than 6 mmHg (exclude the obstruction of cavopulmonary anastomosis)

Exclusion Criteria:

After Fontan surgery :

1. Severe arrhythmia led to low cardiac output
2. Platelets smaller than 50,000\*109/L and obvious bleeding

Primary outcomes:
measure: The primary end point is a composite variable
timeFrame: the first 48 hours after Remodulin used
Secondary outcomes:
measure: Change from base line of pulmonary hemodynamic measurements
timeFrame: baseline and 48 hours
Other outcomes:
Locations:
Study officials:
affiliation: Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Surgery
name: Zhuoming Xu, M.D.,Ph,D.
role: STUDY_DIRECTOR
References:
citation: Chen X, Cai XM, Zhang MJ, Xu JH, Li H, Xu ZM. Pharmacokinetics of treprostinil in children with functional single-ventricle pulmonary arterial hypertension: a randomized controlled trial. Ann Transl Med. 2021 Jul;9(14):1163. doi: 10.21037/atm-21-3188.
Clinical trial NCT03032133: Pain Control After Total Knee Arthroplasty
Official title: Pain After Total Knee Arthroplasty With Either Regional or Local Pain Katheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Total Knee Arthroplasty
Total Knee Replacement
Outcome
Results
Pain
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Mathys Ltd Bettlach
First posted: 2017-01-26
Enrollment: 140
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: Patients are randomized to receive pain control after Total Knee Arthroplasty with either a regional pain catheter or a local intraarticular pain catheter. Pain, analgetic use and mobility is asessed.


Eligibility criteria: Inclusion Criteria:

* Indication to Total Knee Arthroplasty
* Signed informed consent

Exclusion Criteria:

* Chronic pain
* Allergy against local anaesthetics
* Not understanding study or questionnaires

Primary outcomes:
measure: pain
timeFrame: daily until day 7 after surgery
Secondary outcomes:
measure: analgetics
timeFrame: daily until day 7 after surgery
measure: Mobility
timeFrame: daily until day 7 after surgery
measure: Function
timeFrame: preoperative, 3 month, 1 year
measure: Patient reported outcome
timeFrame: preoperative, 3 month, 1 year
measure: Quality of Life
timeFrame: preoperative, 3 month, 1 year
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
Study officials:
affiliation: TU Dresden
name: Jörg Lützner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04662333: Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach
Official title: Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Edentulous Jaw
Keywords: Dental implant
Sinus lift
maxillary atrophy
biomaterials
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients in need for implant-supported restoration in maxillary posterior sites with insufficient residual bone height will be randomly allocated to two different arms. Crestal sinus lift with simultaneous implant placement will be performed in both groups.

Control group: crestal sinus lift with no adjunctive biomaterial; Test group: crestal sinus lift associated with xenogenic bone graft and collagen membrane; Six months after implant placement, implants will be loaded with definitive screw-retained prostheses.

Six months later, patients will be recalled for clinical and radiographic assessment.

Detailed description: Patients in need for implant-supported restoration in maxillary posterior sites with bone deficiencies will be randomly allocated to two different arms.

Full-mouth periodontal chart and standardized radiographs will be evaluated at the time of inclusion.

Crestal sinus lift with simultaneous implant placement will be performed in both groups.

Control group: crestal sinus lift with no adjunctive biomaterial; the healing abutment in this group is made up of PEEK (poly-ether-ether-ketone).

Test group: crestal sinus lift associated with xenogenic bone graft and collagen membrane; the healing abutment in this group is made up of titanium;

Resonance frequency analysis will be performed at the time of implant placement and at 1, 3, 6 months of follow-up.

Both healing abutment will be undersized: this characteristic will allow to harvest a 1mm-wide biopsy of the transmucosal tract at the end of the healing phase (6 months).

Six months after implant placement, impression will be taken and implants loaded with definitive screw-retained prostheses.

Six months later, patients will be recalled for clinical and radiographic assessment.

Eligibility criteria: Inclusion Criteria:

* more than 18 years old
* edentulous in posterior maxilla
* patient in need of sinus augmentation procedure
* residual bone height greater than 3mm

Exclusion Criteria:

* systemic chronic diseases affecting osseointegration
* contraindication for implant therapy
* less than 18 years
* uncontrolled periodontitis
* smoker (more than 10 cig/day)

Primary outcomes:
measure: Complications rate
timeFrame: 12 months
Secondary outcomes:
measure: Peri-implant bone stability
timeFrame: 12 months
measure: Implant stability quotient
timeFrame: baseline, 1 month, 3 months, 6 months
measure: Soft tissue inflammation
timeFrame: 6 months
Other outcomes:
Locations:
city: Siena
country: Italy
facility: AOUS
Study officials:
References:
Clinical trial NCT03107533: Scoliosis Shared Decision Making
Official title: Scoliosis Shared Decision Making
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Scoliosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 25
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adults

Brief summary: Analysis of video encounters between providers, patients, and families will be used to develop a shared decision making tool for patients deciding between surgery and observation for scoliosis treatment.

Detailed description: For patients and parents who are considering scoliosis surgery, a video recording of the encounter will be obtained during their routine clinical visit to discuss surgery/options. This video will then be sent to the shared decision making group at Mayo Clinic, Rochester, Minnesota to run analysis of the data (Shared Decision Making National Resource Center, Knowledge and Evaluation Research Unit, Mayo Clinic). Investigators will follow the patient's electronic medical records for 2 years after their decision of treatment option. No outcome forms will be specifically collected as part of the study, as outcomes forms are currently being collected clinically on all scoliosis patients.

Based off of the initial video recordings, the first visual prototype of the shared decision making tool for scoliosis has been developed. This prototype of the shared decision making tool will be now be used to help test it's efficiency.

Eligibility criteria: Inclusion Criteria:

* Scoliosis curve \>40 degrees, \< 65 degrees
* Risser score \> 2
* Age \> 13 years

Exclusion Criteria:

* Risser score of 0 or 1
* Non-ambulatory scoliosis patients
* Ages 12 year and under

Primary outcomes:
measure: Number of patients who understand disease treatment as determined by analysis of video recording
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Noelle Larson, MD
role: PRINCIPAL_INVESTIGATOR
References: