louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03502395: Serum Opiorphin Level After Intraoperative Intravenous Lidocaine Infusion
Official title: Serum Opiorphin Level After Intraoperative Intravenous Lidocaine Infusion and Its Relation to Post-mastectomy Pain: a Prospective Double Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer, Breast
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A prospective, double blinded and randomized study included women with breast cancer and underwent mastectomy, and randomly allocated into two groups of equal size. Lidocaine group and control group.

Detailed description: Women aged between 18 and 60 years old with breast cancer and underwent mastectomy, ASA I or II were included in the study.

* Group I (lidocaine): Patients were received intravenous 1 mg/kg of 2 % lidocaine as a loading dose (just before induction of anesthesia) then received 2mg/kg /h lidocaine as maintenance dose (with maximum of 200 mg/h) till the end of the operation (skin closure).
* Group II (control):- A standardized equal volume of intravenous bolus dose of normal saline was given as loading dose then normal saline was administered on an equal rate of infusion.

Eligibility criteria: Inclusion Criteria:

* Women aged between 18 and 60 years old with breast cancer and underwent mastectomy, American society of Anesthesiologist I or II

Exclusion Criteria:

* Patients with contralateral breast cancer, metastatic tumor, morbid obesity (BMI\> 40), allergy to an amide local anesthetic, or morphine sulphate, heart block, renal, or liver dysfunction, or substance abuse disorder, or chronic opioid use

Primary outcomes:
measure: Serum Opiorphin level
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Visual analog pain score
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university faculty of medicine
Study officials:
affiliation: Assiut University faculty of medicine
name: Abdelrady S Ibrahim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rougeot C, Robert F, Menz L, Bisson JF, Messaoudi M. Systemically active human opiorphin is a potent yet non-addictive analgesic without drug tolerance effects. J Physiol Pharmacol. 2010 Aug;61(4):483-90.
Clinical trial NCT06072495: Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI
Official title: Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Velopharyngeal Insufficiency
Real Time MRI
Cleft Palate
Keywords: Velopharyngeal Insufficiency
real time MRI
Cleft palate
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Velopharyngeal insufficiency is defined as the inability of the soft palate to isolate the nasopharynx from the oropharynx. It is a frequent sequela in patients with a velopalatine cleft despite anatomical restoration of the soft palate by intravelar veloplasty at 6 months. If rehabilitation by a speech therapist is not successful, a pharyngoplasty can be discussed. In the last ten years, MRI was used in dynamic and static way, to analyzed velopharyngeal muscles, in particular Levator Veli Palatini. MRI could be used to identify the etiology of VPI in those patients, and thus allow personalized rehabilitation and surgical management. The aim of this study is to examine the differences in velopharyngeal motricity as well as velar muscles morphology, positioning, and symmetry of children with repaired cleft palate with different degrees of severity of velopharyngeal insufficiency (VPI), and children with labial cleft (noncleft palate anatomy).


Eligibility criteria: Inclusion Criteria:

* Children aged 7 to 12 years with Isolated cleft lip
* isolated velopalatal cleft
* Without a diagnosis of syndromic cleft or Pierre Robin sequence
* French speaking, and French is the native language
* Operated with a cheiloplasty (for cleft lip) or an intravelar Veloplasty (according to Sommerlad) at the Amiens University Hospital
* Whose follow-up is done at the Amiens University Hospital

Exclusion Criteria:

* Refusal of the parents and/or the patient
* With a contraindication to MRI
* Whose follow-up was initiated in another center and/or whose surgery was performed in another center
* Whose surgical schedule has not been followed
* Patient with severe neurological or neuropsychiatric disorders or Severe speech and language delay not related to the cleft anatomy
* Patients treated with fixed, non-removable orthodontic treatment.

Primary outcomes:
measure: ratio between the diameter of pharynx at rest and during phonation.
timeFrame: day 1
measure: closure distance between the velar knee and the posterior pharyngeal wall
timeFrame: day 1
measure: distance between the velar knee and the posterior pharyngeal wall
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
Study officials:
References:
Clinical trial NCT01038895: Aliskiren Versus Ramipril on Antiproteinuric Effect in Hypertensive, Type 2 Diabetic Patients With Microalbuminuria
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Type 2 Diabetes
Keywords: Hypertension
type 2 diabetes
aliskiren
ramipril
microalbuminuria
blood pressure> 130/80 <180/105 mmHg at the end of the wash-out
type 2 diabetes mellitus well controlled by medication and / or
compliance with diet (HbA1c <7%)
Microalbuminuria in the upper range of normal (> 200 <300 mg/24 h)
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2009-12-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to assess the extent and trend in time of antiproteinuric effect as well as that antihypertensive effect of aliskiren 300 mg / d versus ramipril 10 mg daily in hypertensive patients with type 2 diabetes and microalbuminuria. The investigators will also evaluate:

1. Average of 24 hours, as determined by ABPM, systolic and diastolic blood pressure checks at various visits
2. Average daytime, as determined by ABPM, systolic and diastolic blood pressure checks at various visits 3. Average night, as determined by ABPM, systolic and diastolic blood pressure checks at various visits


Eligibility criteria: Inclusion Criteria:

* blood pressure \> 130/80 \<180/105 mmHg at the end of the wash-out
* type 2 diabetes mellitus well controlled by medication and / or compliance with diet (HbA1c \<7%)
* microalbuminuria in the upper range of normal (\> 200 \<300 mg/24 h)

Exclusion Criteria:

* Pregnancy, lactation or women of childbearing age
* Sitting diastolic blood pressure e 105 mmHg or systolic pressure e 180 at the end of the period of wash-out
* History of hypertensive encephalopathy or cerebrovascular accident within 6 months
* Secondary hypertension
* Heart Failure
* Myocardial infarction within 6 months
* Angina pectoris, clinically significant valvular disease or arrhythmia
* Alteration indices of liver function or renal
* Known hypersensitivity to ACE inhibitors
* All other physiological or pathological condition in the opinion of the physician may affect the evaluation of the parameters under study

Primary outcomes:
measure: Antiproteinuric effect as well as antihypertensive effect of aliskiren 300 mg / daily versus ramipril 10 mg daily in hypertensive patients with type 2 diabetes and microalbuminuria.
timeFrame: 3 months
Secondary outcomes:
measure: Average of 24 hours by ABPM, systolic and diastolic blood pressure
timeFrame: 3 months
measure: Average daytime, systolic and diastolic blood pressure
timeFrame: 3 months
measure: Average night, systolic and diastolic blood pressure
timeFrame: 3 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: University of Pavia
state: PV
Study officials:
affiliation: University of Pavia
name: Roberto Fogari, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02136095: Promising Initial Experience With Intra-operative Fluorescent Cholangiography
Official title: Promising Initial Experience With Intra-operative Fluorescent Cholangiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gall Stone Disease
Keywords: Fluorescent cholangiography
Laparoscopic cholecystectomy
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2014-05-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Intraoperative fluorescent cholangiography (IFC) with concomitant fluorescent angiography is a recently developed method for non-invasive visualisation of the relevant anatomy during laparoscopic cholecystectomy. The objective of this study was to assess the time required by routine-use of IFC and to evaluate success-rate of the procedures.

Methods Thirty-five patients scheduled for laparoscopic cholecystectomy and operated by the same surgeon were consecutively enrolled. A standardized protocol with IFC including concomitant angiography was performed during laparoscopic cholecystectomy. Intra-operative time-registration and exposure of predefined anatomical structures were recorded.


Eligibility criteria: Inclusion criteria:

* Age \> 18 years
* Scheduled for acute- or elective laparoscopic cholecystectomy
* Informed consent

Exclusion criteria:

* Known iodine-hypersensitivity
* Liver- or renal insufficiency
* Known thyrotoxicosis
* Pregnancy or lactation

Primary outcomes:
measure: Time expenditure of IFC with concomitant angiography.
timeFrame: Four months
Secondary outcomes:
measure: Success-rate of the IFC-procedures.
timeFrame: Four months
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Gastroenheden, Hvidovre University Hospital
name: Søren Larsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Larsen SS, Schulze S, Bisgaard T. Non-radiographic intraoperative fluorescent cholangiography is feasible. Dan Med J. 2014 Aug;61(8):A4891.
Clinical trial NCT00332995: Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in Belgium
Official title: Double-blind, Randomized, Placebo Controlled Trial to Study Safety, Local and Systemic Availability of TMC120 From a Vaginal Ring.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV Seronegativity
Lead sponsor: International Partnership for Microbicides, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Tibotec Pharmaceutical Limited
First posted: 2006-06-02
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This Phase I trial will assess the feasibility of using a vaginal ring to deliver the candidate microbicide dapivirine (TMC120) for 7 days. The study population will consist of 13 healthy, sexually abstinent women. Safety and tolerability will be assessed through clinical and laboratory assessments. Feasibility of drug delivery will be assessed by measuring dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma.


Eligibility criteria: Inclusion Criteria:

* Female, age 18-50 years
* Willing and able to provide written informed consent
* HIV-uninfected and otherwise healthy
* Willing to abstain from sexual activity and from use of vaginal products while participating in the study
* Currently using oral contraceptives for pregnancy prevention
* Willing to use oral contraceptives as needed to avoid menstruation while taking part in this study

Exclusion Criteria:

* History of allergy to TMC120 or to the constituents of the vaginal ring
* History of diagnosis of and/or treatment for a sexually transmitted disease within the last three months
* History of genital tract surgery within the last month
* Currently pregnant or breastfeeding, or within two months of last pregnancy outcome
* Currently or within one month of participating in any other clinical research study
* Current vulvar or vaginal symptoms / abnormalities that could influence the study results
* Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption
* Current diagnosis of any genital infection
* Smoking more than 10 cigarettes / day

Primary outcomes:
measure: Safety and tolerability of seven-day use of a vaginal ring containing dapivirine (TMC120).
measure: Assess dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma during and after seven-day use of a vaginal ring containing dapivirine (TMC120).
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Drug Research Unit Gent
Study officials:
affiliation: University Ghent
name: Dr. Luc Van Bortel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06134895: Tramadol and Tramadol Plus Ketamine for Shivering Prevention After Spinal Anesthesia in Lower Segment Caeserian Section
Official title: Randomised Double Blind Comparison of Prophylactic Tramadol and Tramadol Plus Ketamine for Prevention of Shivering After Spinal Anesthesia in Lower Segment Caeserian Section
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Shivering
Keywords: Shivering
Anesthesia, Spinal
Caesarean
Lead sponsor: Ziauddin University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to compare the efficacy of prophylactic use of intravenous tramadol versus tramadol plus ketamine for prevention of shivering under spinal anaesthesia in lower segment caeserian section.


Eligibility criteria: Inclusion Criteria:

* Age between 18 to 40 years
* American Society of Anesthesiologist physical status I and II
* Pregnant female for lower segment caeserian section

Exclusion Criteria:

* Patients with Hypertension
* Patients with hypo- or hyperthyroidism
* Known case of Cardiopulmonary disease, pre-eclampsia and eclampsia
* An initial body temperature 38.00C or, 36.0oC assessed by thermometer

Primary outcomes:
measure: Incidence of shivering
timeFrame: Patients will be monitored from 15-45 mins from the administration of the prophylactic drug
measure: Severity of Shivering
timeFrame: Patients will be monitored from 15-45 mins from the administration of the prophylactic drug
Secondary outcomes:
measure: Time to shivering
timeFrame: 15 mins from the administration of the prophylactic drug
measure: Complications
timeFrame: Patients will be monitored from 15-45 mins from the administration of the prophylactic drug
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Muhammad Arif
state: Sindh
Study officials:
affiliation: Ziauddin University
name: Muhammad Arif
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01257295: Properties of Dietary Fibre and Energy Intake
Official title: Properties of Dietary Fibre and Energy Intake: an Intervention to Study the Effect of Physicochemical Properties of Dietary Fibre on Energy Intake and Underlying Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Male Subjects
Keywords: dietary fiber
energy intake
appetite
satiety hormones
glucose
gastric emptying
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2010-12-09
Enrollment: 29
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Dietary fibers likely have a role in body weight management. They may increase satiety and, as a consequence, reduce energy intake during the next meal. There are, however, many different types of dietary fiber, which have diverse physical properties and can therefore impact these outcomes differently. It is, however, unclear whether dietary fibers with different properties lead to differences in energy intake during the next meal. The objective of this study is to study the effect of pectin in 4 different physicochemical states on ad libitum energy intake and possible underlying mechanisms; i.e. gastrointestinal hormones, gastric emptying rate, feelings of satiety and the method of fiber supplementation. We hypothesize that viscous and gelling fibers will reduce ad libitum energy intake compared to low viscous and low gelling fibers.


Eligibility criteria: Inclusion Criteria:

* Age 18-30 year
* BMI 18.5-25 kg/m2
* Healthy as judged by the participant

Exclusion Criteria:

* Females
* Weight loss or weight gain of more than 5 kg during the last 2 months
* Using an energy restricted diet during the last 2 months
* Lack of appetite for any reason
* Restrained eater: \>2.89, measured by DEBQ (35).
* Smoking
* Heavy alcohol use: \>5 drinks/day (36).
* Reported stomach or bowel disease
* Reported diabetes
* Reported thyroid disease or any other endocrine disorder
* Reported intolerance for pectin, bread, gluten, dairy or not liking of the research foods
* Anemia: Hb\<8.0 mmol/l
* Fasting glucose levels \>5.8 mmol/l
* Blood donation from 6 weeks prior to the study until the end of the study
* Experienced any problems with drawing blood in the past
* Antecubital veins not considered suitable for blood drawing by means of a catheter
* Thesis students or employees of the division of Human Nutrition

Primary outcomes:
measure: energy intake
timeFrame: 3 hours
Secondary outcomes:
measure: appetite sensations
timeFrame: 3 hours
measure: satiety hormones
timeFrame: 3 hours
measure: gastric emptying rate
timeFrame: 3 hours
measure: method of supplementation
timeFrame: 3 hours
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
Study officials:
affiliation: Wageningen University
name: Edith Feskens, PHd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04795895: Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation
Official title: Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation, a Randomization Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation
Keywords: Point-of-care ultrasound,ultrasound
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Introduction: Data using ultrasonography to confirm correct position of the gastric tube is heterogeneous in approach sites, combination exams, and methodology.

Aim: Find the best strategy to confirm gastric tube placement to avoid immediate complication.

Method: A randomized controlled trial was initiated to compare ultrasonography and standard routine method, using non-inferiority design. The study will be conducted in one medical ICU with 59 beds at a medical center. The primary outcome is the correct rate as comparing with the chest radiography in each group. Total 190 patients is needed with estimated 10% drop-out rate.


Eligibility criteria: Inclusion Criteria:

* Clinical indication of nasogastric tube placement
* Age than 20 years old.

Exclusion criteria:

* Facial trauma or head-base fractures
* Esophageal or gastric resection
* Esophageal strictures or alkaline injury
* Open wound in the area to prevent ultrasonography

Primary outcomes:
measure: correct rate as comparing with the chest radiography in each group
timeFrame: 1 day
Secondary outcomes:
measure: procedure time, tube placement confirmation time other than chest radiography method, and additional auscultation method in US group
timeFrame: 1 day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Test2
Study officials:
affiliation: National Taiwan University Hospital
name: Ying-Chun Chien, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05565495: The Effects of ECMO on the Pharmacokinetics of Hydromorphone
Official title: The Effects of ECMO on the Pharmacokinetics of Hydromorphone
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Extracorporeal Membrane Oxygenation
Keywords: Extracorporeal Membrane Oxygenation
Pharmacokinetics
Hydromorphone
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to establish a population pharmacokinetic (PPK) model of hydromorphone in patients under ECMO, and to recommend a dosing regimen when the target effective concentration was reached.

Detailed description: A population pharmacokinetic (PPK) model of hydromorphone in patients under ECMO was established. The patients were given hydromorphone 0.03mg/kg/h by continuous intravenous infusion for 72 hours for analgesia. Blood samples were collected at different time points before and after administration, and quantitative liquid chromatography tandem mass spectrometry was used to detect hydromorphone and its main metabolite, hydromorphone-3-glucuronide.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 80;
* Using hydromorphone for pain relief;
* Using ECMO for more than 96h

Exclusion Criteria:

* Allergic to hydromorphone;
* Use of CRRT during ECMO;
* Liver function Child-Pugh B, C grade;
* Pregnancy;
* Intestinal obstruction;
* Refused to sign the informed consent.

Primary outcomes:
measure: Volume of distribution of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO
timeFrame: Within 4 days
Secondary outcomes:
measure: Clearance of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO
timeFrame: Within 4 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
Study officials:
References: