louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01621373: Exploratory Propofol Dose Finding Study In Neonates
Official title: Prospective Exploratory Dose-finding Study in Neonates Receiving a Single Intravenous Propofol Bolus for Endotracheal Intubation During (Semi-)Elective INSURE Procedure or Non-INSURE Procedures in Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adverse Reaction to Drug
Neonatal Disorder
Keywords: neonatology
intratracheal intubation
propofol
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to explore the optimal propofol dose in neonates receiving a single intravenous propofol bolus for endotracheal intubation during (semi-)elective INSURE (intubation-surfactant-extubation) procedure (preterm neonates) and (semi-)elective non-INSURE procedures (term-preterm neonates).

Detailed description: The aim of the study is to evaluate the pharmacokinetics and pharmacodynamics of propofol (short acting anesthetic) in 50 neonates to whom the drug is administered as a intravenous bolus. This is part of routine clinical care in patients receiving (semi-) elective intubation. It's the aim to explore the most effective IV propofol dose for a successful INSURE (intubation, surfactant, extubation) procedure and for successful (semi-) elective intubation in non-INSURE procedures. We hereby aim to define the most optimal dose regimen for propofol in neonates.

Intubation condition score was assessed retrospectively by the intubating physician.

Eligibility criteria: Inclusion Criteria:

* Neonates admitted to the Neonatal Intensive Care Unit who need short procedural sedation for (semi-) elective intubation will be considered for inclusion, after informed written consent of the parents.
* Patients can be included if they are hemodynamically stable and did not receive sedative or analgesic agents during the previous 24 hours.

Exclusion Criteria:

* Known propofol intolerance

Primary outcomes:
measure: Effective Dose for 50% of Patients for Succesful Intubation and Subsequent Extubation in Case of Planned Extubation After INSURE Procedure
timeFrame: 1 hour after propofol administration
Secondary outcomes:
Other outcomes:
measure: Intubation Condition Score
timeFrame: After final intubation.
Locations:
city: Leuven
country: Belgium
facility: Neonatal Intensive Care Unit UZ Leuven
state: Vlaams Brabant
Study officials:
affiliation: UZ Leuven, Belgium
name: Liesbeth Thewissen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smits A, Thewissen L, Caicedo A, Naulaers G, Allegaert K. Propofol Dose-Finding to Reach Optimal Effect for (Semi-)Elective Intubation in Neonates. J Pediatr. 2016 Dec;179:54-60.e9. doi: 10.1016/j.jpeds.2016.07.049. Epub 2016 Sep 2.
Clinical trial NCT02091973: MicroRNA Expression in Everolimus-based Versus Tacrolimus-based Regimens in Kidney Transplantation
Official title: MicroRNA Expression in Everolimus-based Versus Tacrolimus-based Maintenance Immunosuppressive Regimens in Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: microRNA Profiles
Keywords: everolimus
tacrolimus
kidney transplantation
microRNA
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The calcineurin inhibitor drugs including cyclosporin and tacrolimus are well-known as nephrotoxicity. However, these drugs are essential for kidney transplant especially in high immunological risks. To date, however, there is an alternative regimen by using of everolimus-based which showing less toxicity than tacrolimus-based regimen by its mechanisms. Of note, this study aims to evaluate the toxicity by using microRNA profiles detection between everolimus-based and tacrolimus-based immunosuppressive regimen in kidney transplantation.

Detailed description: The author aims to evaluate the effects of two regimens (everolimus-based versus tacrolimus-based) in kidney transplantation recipients. Both of regimens are prescribed only in recipents who have low immunologicla risks. After informed consent, all eligible recipients will be collected blood and urine sample for microRNA profile testing during study periods.

Eligibility criteria: Inclusion Criteria:

* Patients who have given informed consent to participate in the study
* Actual eGFR \> 20-25 ml/min/1.73 m2

Exclusion Criteria:

* Multi-organ transplantation
* Pregnancy
* ABO incompatible blood group
* Second, third, fouth kidney transplantation
* HIV positive, active or carrier in any infections

Primary outcomes:
measure: microRNA profiles
timeFrame: 5 years
Secondary outcomes:
measure: Allograft tissue pathology
timeFrame: At year 2 and 5
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Wiwat Chancharoenthana, MD, Msc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05465473: Effect of Low-level Laser Therapy During Maxillary Molar Distalization Using a Skeletally Anchored Appliance
Official title: Effect of Low-level Laser Therapy During Maxillary Molar Distalization Using a Skeletally Anchored Appliance: A Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Class II Division 1 Malocclusion
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: study will be directed to evaluate the effect of low-level laser therapy during maxillary molar distalization using a skeletally anchored appliance

Detailed description: Effect of low-level laser therapy during maxillary molar distalization using a skeletally anchored appliance

Eligibility criteria: Inclusion Criteria:

* 1- An age range from 14-17 years old. 2- All permanent teeth are present (except for third molars). 3- Bilateral dental Class II malocclusion. 4- Skeletal Class I or mild Class II relationship. 5- Normal or reduced vertical face height. 6- No posterior crowding or spaces.

Exclusion Criteria:

1. Patients who required surgery to correct skeletal discrepancies.
2. Patients with congenital dentoskeletal disorders.
3. Missed or mutilated teeth in maxillary arch.
4. Patients with poor oral hygiene and/or periodontally compromised patients.

Primary outcomes:
measure: rate of molar distalization
timeFrame: from start of treatment until study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Azhar university
Study officials:
References:
Clinical trial NCT03966573: Femoral Lengthening Might Impair Physical Function and Lead to Structural Changes in Adjacent Joints
Official title: Femoral Lengthening Might Impair Physical Function and Lead to Structural Changes in Adjacent Joints; 10 Patients With 27 to 34 Years Follow-up.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leg Length Inequality
Leg; Lengthening
Osteoarthritis, Knee
Osteoarthritis of Hip
Quality of Life
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Sophies Minde Ortopedi
First posted: 2019-05-29
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study evaluates function, quality of life and development of hip- and knee osteoarthritis minimum 15 years after unilateral femoral lengthening on people with idiopathic or post-traumatic anisomelia.

Detailed description: This study has a cross-sectional design, where patients that completed femoral lengthening more than 15 years ago and fulfills the inclusion criteria's are invited to participate. Patients will undergo radiographic imaging to evaluate hip- and knee arthritis, axis deviaton and leg length discrepancy. To evaluate quality of life, function and pain, the participants will complete the forms EQ-5D-5L, Knee osteoarthritis outcome score (KOOS) and International physical activity questionnaire (IPAQ). Bilateral active hip and knee range of motion will be measured with hand held goniometer, and the functional tests 30 seconds sit to stand, hop tests and stair test will be conducted.

Eligibility criteria: Inclusion Criteria:

* Patients with idiopathic or post traumatic leg length discrepancy who are lengthened with the callutasis method minimum 15 years ago

Exclusion Criteria:

* Patients that are lenghtened with innate pathology resulting in shortening of the limb, angle deviation and less musculature, for example congenital femoral deficiency or fibula hemimelia.
* Patients with acquired leg length discrepancy who have had infection in knee or hip joint

Primary outcomes:
measure: hip or knee osteoarthritis
timeFrame: One day
measure: Lower extremity strength
timeFrame: one day
measure: Lower extremity function
timeFrame: one day
measure: Aerob capasity
timeFrame: one day
measure: measure of health related quality of life with EQ-5D-5L
timeFrame: one day
measure: measure of function and pain with Knee Osteoarthritis Outcome Score (KOOS)
timeFrame: one day
measure: measuring physical activity level with International Physical Activity Questionnaire (IPAQ)
timeFrame: one day
measure: Active range of motion
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
citation: Bjorge PA, Tveter AT, Steen H, Gunderson R, Horn J. Femoral lengthening might impair physical function and lead to structural changes in adjacent joints: 10 patients with 27 to 34 years' follow-up. Acta Orthop. 2021 Jun;92(3):329-334. doi: 10.1080/17453674.2020.1866864. Epub 2021 Jan 7.
Clinical trial NCT00347373: Effect of Conjugated Linoleic Acid Supplement on Body Composition
Official title: Conjugated Linoleic Acid and Body Fat Mass in Obese Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: conjugated linoleic acid
obesity
body composition
body fat mass
lean body mass
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Cognis
First posted: 2006-07-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to examine the effects of a low and high dose of conjugated linoleic acid supplement on body composition in obese humans. Individuals with a body mass index between 30 and 35kg/m2 are randomized to receive either placebo, 3.2gCLA, or 6.4g CLA daily for twelve weeks. Changes in body composition, weight, and clinical laboratory values are compared between the three groups.

Detailed description: Sixty healthy obese adult volunteers will be enrolled and randomized into either: 1) placebo, 2) 3.2 g CLA, or 3) 6.4 g CLA groups and supplemented for 12 weeks. Body fat mass (BFM) and lean body mass will be determined by DEXA at baseline and twelve weeks during the intervention. In addition, indirect calorimetry will be performed at baseline and twelve weeks to measure changes in energy expenditure. The effect of CLA supplementation on weight, waist and hip measurements, and BMI will also be determined at 12 weeks. Plasma CLA and pill counts will be measured as an indication of compliance. Several blood parameters will be monitored throughout the study, and five random 24-hour recall surveys will be used to monitor dietary intake of CLA-rich foods, energy, micronutrients and antioxidants.

Eligibility criteria: Inclusion Criteria:

* BMI between 30 and 35 kg/m2

Exclusion Criteria:

* history of chronic disease
* food allergies or intolerances
* drug therapy for diagnosed disease or lipid-lowering
* use of weight-lowering medication or diet
* use of tobacco products
* current or planned pregnancy
* use of CLA supplement in previous 3 months
* current substance abuse
* abnormal clinical laboratory values

Primary outcomes:
measure: Change in body fat mass at 12 weeks
measure: Change in lean body mass at 12 weeks
measure: Change in body mass index at 12 weeks
measure: Change in body weight at 12 weeks
measure: Change in energy expenditure at 12 weeks
Secondary outcomes:
measure: Change in lipid profile at 6 weeks and 12 weeks
measure: Change in clinical laboratory values at 6 weeks and 12 weeks (safety)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Susan E Steck, PhD, MPH, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02645773: Early Intervention With Non-ablative Fractional Laser to Reduce Cutaneous Scarring
Official title: Early Intervention With Non-ablative Fractional Laser to Reduce Cutaneous Scarring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cicatrix
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2016-01-05
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate intervention with early application of non-ablative laser to prevent scarring in the skin

Detailed description: To intervene in scar formation at three different time-points

Eligibility criteria: Inclusion Criteria:

* good health
* men
* Skin type 2-3
* non-smokers
* presenting full medical record

Exclusion Criteria:

* active skin disease in test area
* resent UV-exposure in test area
* history of keloid
* current or resent cancer
* uncontrolled systemical disease

Primary outcomes:
measure: To measure the clinical effect on scarring of non-ablative laser intervention at the three time-points
timeFrame: 3 months after
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Merete Haedersdal, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04853173: Modality of Pain Management in Ambulatory Tonsillectomy Surgery in Adults
Official title: Modality of Pain Management in Ambulatory Tonsillectomy Surgery in Adults: External Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tonsillar Disorder
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Assess pain management modalities in adult outpatient tonsillectomy surgery
Primary purpose: OTHER

Brief summary: No SFORL recommendation for adult ambulatory tonsillectomy. This study would allow the establishment of an ambulatory management during an adult tonsillectomy. This would allow a return home from J0 for the patient and therefore would improve the comfort of the patients and reduce the cost associated with a conventional hospitalization over several days.


Eligibility criteria: Inclusion Criteria:

* programmed Tonsillectomy surgery

Exclusion Criteria:

* Congenital or acquired hemostasis disorder
* Indication of uvulo-bike-pharyngo-plasty
* Contraindication to the use of one of the protocol molecules including pregnancy
* Allergy to analgesic treatments used in the study
* Ongoing analgesic treatment that cannot be interrupted

Primary outcomes:
measure: Assess pain management modalities in ambulatory tonsillectomy surgery in adults through post-operative pain assessment, with a defined analgesia and anesthesia protocol adapted to ambulatory management.
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
Study officials:
References:
Clinical trial NCT06322173: Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Advanced NGS Sequencing Methods
Official title: Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Advanced NGS Sequencing Methods
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Resistance Bacterial
Lead sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an experimental study without drug and device, non-profit, on biological samples stored at the Tropica Biobank of the DITM. The aim of the project is to verify the performance of NGS-based assays, which can be used in the field of microbiology. The clinical evaluation investigations of NGS technology will be conducted on an adequate number of clinical blood samples and rectal swabs. The analyzes will be compared with the standard microbiology methods used in the DITM diagnostic routine.


Eligibility criteria: Inclusion criteria:

* Samples of patients for whom blood culture and Multi Drug Resistant (MDR) surveillance tests were carried out in rectal swabs at the IRCCS Sacro Cuore Don Calabria Hospital
* Samples for which the Information and consent to the conservation of biological samples for research purposes has been signed at the Tropica Biobank or
* Samples for which, after all reasonable efforts, it was not possible to obtain the signature of the Information and consent to the conservation of biological samples for research purposes at the Tropica Biobank (e.g. patients in intensive care, immobilized patients unable to sign or with serious alterations of consciousness).

Exclusion criteria:

* Absence of data relating to positivity or negativity to the germs of interest
* Absence of stored residual material

Primary outcomes:
measure: Microorganism presence (positive/negative)
timeFrame: Baseline
measure: Microorganism identification
timeFrame: Baseline
Secondary outcomes:
measure: Identification of Gene mutations that convey resistance to antibiotics (resistant/susceptible)
timeFrame: Baseline
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: IRCCS Sacro Cuore Don Calabria hospital
state: Verona
Study officials:
References:
Clinical trial NCT05990673: Dose of Remi in Children
Official title: Determination of the 50% and 95% Effective Dose of Remimazolam for Intravenous Anesthesia Induction in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anesthesia
Keywords: general anesthesia
anesthesia induction
remimazolam
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 25
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Remimazolam has demonstrated the potential as a valuable medication for procedural sedation and general anesthesia. However, the effective dosage of remimazolam in pediatric patients is still unknown.


Eligibility criteria: Inclusion Criteria:

* age from 3 to 12 years old
* patients scheduled for surgery under general anesthesia

Exclusion Criteria:

* American Society of Anesthesiologists status \>=Ⅲ
* Body mass index\>=28kg/m2
* patients who cannot cooperate with intravenous anesthesia induction
* patients with risk of difficult airway
* patients who are allergic to benzodiazepines
* patients with delayed neurologic function

Primary outcomes:
measure: half effective dosage
timeFrame: from injection of remimazolam to loss of consciousness, at an average of 5 minutes
Secondary outcomes:
measure: 95% effective dosage
timeFrame: from injection of remimazolam to loss of consciousness, at an average of 5 minutes
Other outcomes:
Locations:
Study officials:
References:
citation: Tan H, Lou AF, Wu JE, Chen XZ, Qian XW. Determination of the 50% and 95% Effective Dose of Remimazolam Combined with Propofol for Intravenous Sedation During Day-Surgery Hysteroscopy. Drug Des Devel Ther. 2023 Jun 13;17:1753-1761. doi: 10.2147/DDDT.S406514. eCollection 2023.
Clinical trial NCT03403673: Clinical Frailty Scale Validation in Patients Scheduled for Vascular Surgery
Official title: Clinical Frailty Scale Validation in Patients Scheduled for Vascular Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vascular Diseases
Lead sponsor: South Tees Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All vascular patients attending the preoperative assessment clinics.

Brief summary: Major vascular operations put the body under stress. We are trying to find out if the general health of a patient and the stress resulting from surgery can lead to the development of complications after surgery as well as increase the length of time spent in hospital.

There is evidence to suggest that patients who are frail have a higher risk of developing complications after major surgery.

Our aim is to ask you simple questions about your physical ability to perform daily life activities, assess your general health condition and ask you to do simple tasks such as drawing a clock or walking for a short distance to assess your speed of walking. Our main aim is to identify a tool that will assist us to identify patients who are at risk of frailty.


Eligibility criteria: Inclusion Criteria: Patients attending vascular pre assessment clinic Age \> 60 -

Exclusion Criteria: Refusal or inability to provide informed consent. Patients under 60 years of age. Patients not undergoing a vascular procedure.

-

Primary outcomes:
measure: Clinical frailty scale validation in preoperative assessment of patients scheduled for vascular surgery
timeFrame: June 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospitals NHS Foundation Trust
Study officials:
References:
citation: Ayyash R, Knight J, Kothmann E, Eid M, Ayyash K, Colling K, Yates D, Mill A, Danjoux G. Utility and reliability of the Clinical Frailty Scale in patients scheduled for major vascular surgery: a prospective, observational, multicentre observer-blinded study. Perioper Med (Lond). 2022 Jan 31;11(1):6. doi: 10.1186/s13741-022-00240-9.