louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03663478: Continuous TQL Block for Elective Cesarean Section
Official title: Ultrasound-guided Transmuscular Quadratus Lumborum Catheters for Elective Caesarean Section. A Double Blind, Randomise, Placebo Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Anesthesia, Local
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 32
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 aim of this study is to investigate whether it is possible to prolong time to first opioid with the TQL block by inserting catheters bilaterally, providing continuous analgesia, in patients undergoing elective CS. Our hypothesis is that it will be possible to significantly extend time to first opioid with the blockade by 66.6%, increasing it from a mean of 5.6 hours to a mean of 10 hours.


Eligibility criteria: Inclusion Criteria:

* 18+ years of age.
* Scheduled for elective Caesarean Section in spinal anaesthesia.
* Have received thorough information, verbally and in written, and signed the "Informed Consent" form on participation in the trial.

Exclusion Criteria:

* Inability to cooperate
* Inability to understand Danish
* Allergy to local anaesthetics or opioids
* Excessive daily intake of opioids, according to the discretion of the investigator
* Local infection at the site of injection or systemic infection
* Difficult visualisation of muscular and fascial structures on ultrasound, necessary to correct blockade and catheter placement.

Primary outcomes:
measure: Time to first opioid
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Pain intensity (NRS 0-10/10)
timeFrame: 24 hours postoperatively
measure: Total morphine consumption.
timeFrame: 24 hours
measure: Catheter displacement.
timeFrame: 24 hours
measure: Patient satisfaction with application of the catheters.
timeFrame: 24 hours
measure: The degree of morphine-related side effects (PONV, itching, fatigue, etc.).
timeFrame: 24 hours
measure: Time from operation to ambulation.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Department of anaesthesiology
Study officials:
affiliation: Zealand University Hospital, University of Copenhagen
name: Jens Børglum, MD PhD
role: STUDY_CHAIR
References:
citation: Steingrimsdottir GE, Hansen CK, Borglum J. Ultrasound-guided transmuscular quadratus lumborum catheters for elective caesarean section: A protocol for a single-centre, double-blind randomised trial. Acta Anaesthesiol Scand. 2020 Sep;64(8):1218-1223. doi: 10.1111/aas.13601. Epub 2020 Apr 22.
Clinical trial NCT01961778: Comparison of Treatments for Barrett's Esophagus With High-Grade Dysplasia/Early Adenocarcinoma
Official title: Prospective Randomized Trial Comparing Radiofrequency Ablation and Cryotherapy for the Treatment of Barrett's Esophagus With High-Grade Dysplasia and/or Early Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett's Esophagus
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-10-11
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective randomized study comparing radiofrequency ablation and cryotherapy for the endoscopic treatment of Barrett's esophagus. The study is powered to assess clinical equivalence (non-inferior) of the treatment regimens.

Detailed description: Adult patients found to be suitable candidates for endoscopic treatment of Barrett's esophagus (BE) with high-grade dysplasia (HGD) and/or early adenocarcinoma of the esophagus will be asked to participate in this study. Patients will be randomized to receive either radiofrequency ablation or cryotherapy. All treatments will be performed using standard MGH GI Unit protocol. A total of fifty subjects will be enrolled.

Patients who have contraindications to endoscopic treatment (e.g., bleeding diathesis, pregnancy, severe medical comorbidities, advanced liver disease) or who decline participation in the study will be ineligible. Patients unable to provide their own consent will also be excluded.

This is a single-site study to be conducted at MGH.

After obtaining written informed consent, the patient will be randomized to receive either radiofrequency ablation or cryotherapy. Treatments will be carried out in accordance with standard MGH GI Unit practice. The primary endpoint of the study is the percentage of Barrett's esophagus ablated at the first follow-up visit (typically 2-3 months following therapy). At this point, the patient's role in the study will be terminated. They will continue to receive routine follow-up by their physician as needed.

Eligibility criteria: Inclusion Criteria:

* suitable candidates for endoscopic treatment of Barrett's esophagus (BE) with high-grade dysplasia (HGD) and/or early adenocarcinoma of the esophagus

Exclusion Criteria:

* contraindications to endoscopic treatment (e.g., bleeding diathesis, pregnancy, severe medical comorbidities, advanced liver disease)
* refusal to participate in the study

Primary outcomes:
measure: Percentage of Barrett's esophagus ablated during the initial treatment session.
timeFrame: 2-3 months
Secondary outcomes:
measure: Patient discomfort
timeFrame: 2-3 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Norman S Nishioka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00373178: Metabolic Effects of Treatment in Patients With Recently Diagnosed Type 2 Diabetes
Official title: Metabolic Effects of Treatment in Patients With Recently Diagnosed Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: rosiglitazone
metformin
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: University of Athens
First posted: 2006-09-07
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to investigate the influence of several anti-diabetic regimens (metformin,glitazone,sulfonylurea,glinidine) and diet on metabolic parameters in patients with recently diagnosed type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Recently diagnosed type 2 diabetes
* No previous anti-diabetic medications

Exclusion Criteria:

* Heart failure
* Renal disease
* Liver disease
* Life-threatening diseases

Primary outcomes:
measure: Novel cardiovascular risk factors modification
timeFrame: 2 years
Secondary outcomes:
measure: Lipid and glucose regulation
timeFrame: 2 years
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: AHEPA University Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: Aristotle University of Thessaloniki
Study officials:
affiliation: University Hospital AHEPA,Thessaloniki,Greece
name: Miltiadis Alevizos, PhD
role: STUDY_CHAIR
References:
citation: Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
citation: Kadoglou NP, Tsanikidis H, Kapelouzou A, Vrabas I, Vitta I, Karayannacos PE, Liapis CD, Sailer N. Effects of rosiglitazone and metformin treatment on apelin, visfatin, and ghrelin levels in patients with type 2 diabetes mellitus. Metabolism. 2010 Mar;59(3):373-9. doi: 10.1016/j.metabol.2009.08.005. Epub 2009 Oct 7.
Clinical trial NCT01041378: Efficacy of Intravenous Dexamethasone on Postoperative Caudal Analgesia in Pediatric Orchiopexy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pediatric patients (6 months-5 years) scheduled elective day-case orchiopexy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2009-12-31
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate postoperative pain control for pediatric patients.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients scheduled for elective day-case orchiopexy.

Exclusion Criteria:

* Infants or children with history of steroid allergy, renal, hepatic disease, or contraindication for caudal analgesia.

Primary outcomes:
measure: Children's Hospital of Eastern Ontario Pain Scale, CHEOPS and Faces, Legs, Activity, Cry, and Consolability, FLACC
timeFrame: postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hong JY, Han SW, Kim WO, Kim EJ, Kil HK. Effect of dexamethasone in combination with caudal analgesia on postoperative pain control in day-case paediatric orchiopexy. Br J Anaesth. 2010 Oct;105(4):506-10. doi: 10.1093/bja/aeq187. Epub 2010 Jul 20.
Clinical trial NCT06709378: Effectiveness and Safety of 25-Gauge Needle-Assisted Phacoemulsification of Dislocated Intravitreal Lens Nucleus
Official title: Effectiveness and Safety of 25-Gauge Needle-Assisted Phacoemulsification of Dislocated Intravitreal Lens Nucleus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dislocated Lens
Pars Plana Vitrectomy
Phacoemulsification
Needle
Lead sponsor: Changzhou No.2 People's Hospital
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with dislocated intravitreal lens nuclei who underwent 23G pars plana vitrectomy (PPV) and 25G needle-assisted phacoemulsification and without surgical contraindications exist.

Brief summary: The goal of this observational study is to learn about the effects of 25-gauge (G) needle-assisted phacoemulsification to remove dislocated intravitreal lens nuclei.

Detailed description: Patients with dislocated intravitreal lens nuclei who underwent 23G pars plana vitrectomy (PPV) and 25G needle-assisted phacoemulsification between July 2022 and September 2024 were included. Primary outcomes included best-corrected visual acuity (BCVA) and intraocular pressure (IOP). Secondary outcomes included corneal endothelial cell count (CECC) and the incidence of intraoperative and postoperative complications. These outcomes were statistically analyzed both preoperatively and postoperatively. A minimum follow-up of 6 months was completed for all eyes.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of dislocated intravitreal lens nuclei Signed informed consent

Exclusion Criteria:

Surgical contraindications

Primary outcomes:
measure: Best corrected visual acuity
timeFrame: Preoperatively and postoperatively for at least 6 months.
Secondary outcomes:
measure: Intraocular pressure
timeFrame: Preoperatively and postoperatively for at least 6 months.
measure: Corneal endothelial cell count
timeFrame: Preoperatively and postoperatively for at least 6 months.
Other outcomes:
Locations:
city: Changzhou
country: China
facility: the Second People's Hospital of Changzhou
state: Jiangsu
Study officials:
affiliation: Changzhou No.2 People's Hospital
name: Xincheng Sun
role: STUDY_DIRECTOR
References:
Clinical trial NCT04696978: Study for Perioperative Neurocognitive Disorders After Deep Brain Stimulation Surgery for Parkinson's Disease
Official title: Metabonomics Characteristics and Predictive Value for Perioperative Neurocognitive Disorders After Deep Brain Stimulation Surgery for Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurocognitive Disorders
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: we select Parkinson's patients undergoing elective DBS and observe who occur PND or not.

Brief summary: Perioperative neurocognitive disorders(PND) is common to see in elderly patients. Although PND increases patient mortality as well as hospitalization time, apparent inflammatory factors, and related mechanisms are still unknown. Metabolites could reveal chemical fingerprints left behind by cellular processes, which in turn provide a new aspect to understand the biological process behind. we aim to found the metabolomics can aid the development of diagnostic markers of PND screening, early detection, and further, provide a basis for disease prevention and treatment.


Eligibility criteria: Inclusion Criteria:

* Parkinson's patients undergoing elective deep brain stimulation
* Age ≥55 years
* ASA physical statusⅠ-Ⅲ
* Elementary school or above

Exclusion Criteria:

* patients with ASA physical status\>III
* patients with systemic immune diseases, hematological diseases (hematological tumors or leukemia), patients after transplantation, malignant tumors
* patients with metabolic diseases such as diabetes, ketoacidosis, hyperosmolar syndrome, long-term hypoglycemia,gout
* patients who refused to join the study and lost to follow-up

Primary outcomes:
measure: the level of metabolomics in patients' blood sample
timeFrame: baseline
measure: the level of metabolomics in patients' blood sample
timeFrame: 24 hours after operation
measure: the level of metabolomics in patients' blood sample
timeFrame: 72 hours after operation
Secondary outcomes:
measure: CAM-ICU score
timeFrame: baseline
measure: CAM-ICU score
timeFrame: 24 hours after operation
measure: CAM-ICU score
timeFrame: 72 hours after operation
measure: CAM-ICU score
timeFrame: 1 month after operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
state: Shanghai
Study officials:
References:
Clinical trial NCT01768078: Interest of Intravitreal Corticotherapy as the First-line Treatment for Post-operative Endophthalmitis
Official title: Interest of Intravitreal Corticotherapy as the First-line Treatment for Post-operative Endophthalmitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-operative Endophthalmitis
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 112
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One useful effect of early intravitreal corticotherapy is to diminish inflammatory complications after endophthalmitis, which may cause, at least in part, serious complications (retinal detachment, macular edema) which are, more than the infection, causes of the complications seen after acute endophthalmitis.


Eligibility criteria: Inclusion Criteria:

* All patients male or female with no age limit
* Hospitalized for the diagnosis and treatment of acute endophthalmitis following cataract surgery
* Who had given their consent after being informed about intravitreal corticotherapy

Exclusion Criteria:

* Patients who refused or were unable to give their consent
* Prior intravitreal corticotherapy

Primary outcomes:
measure: Measure the evolution of visual acuity
timeFrame: up to12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Dijon
country: France
facility: CHU
city: Grenoble
country: France
facility: CHU de Grenoble
city: Nancy
country: France
facility: CHU de Nancy
city: Saint Etienne
country: France
facility: CHU de Saint Etienne
city: Strasbourg
country: France
facility: CHU de Strasbourg
Study officials:
References:
Clinical trial NCT06246578: Concordance of Hypoglycemia Measurement With Simultaneous Use of Two Devices for Continuous Glucose Measurement.
Official title: Concordance of Hypoglycemia Measurement in People With Type 1 Diabetes, With Simultaneous Use of Two Devices for Continuous Glucose Measurement: Abbott Freestyle Libre 2 and Dexcom G7
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Type 1 Diabetes
Hypoglycemia
Keywords: Hypoglycemia
Continuous glucose monitoring
Dexcom
Libre
Blood glucose
Lead sponsor: Central Jutland Regional Hospital
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Comparison of nearly simultaneous interstitial glucose values obtained by Dexcom G 7 and Libre 2 sensors for continuous glucose monitoring and blood glucose measured with Contour Next one
Primary purpose: OTHER

Brief summary: The aim of this study is to compare two frequently used sensors for continuous glucose monitoring (CGM); Freestyle Libre and Dexcom G 7. More precisely, the investigators want to investigate if there is any difference in the hypoglycemic range for these two devices.

Detailed description: The investigators are including adults with type 1 diabetes who already are using a Dexcom G 7, in their diabetes treatment. Simultaneously with their Dexcom G7, the participants will get the Libre 2 sensor attached, and are to wear this for a period of 14 days. The Libre sensor is a Freetsyle Libre 2. Glucose data are compared for paired values within a time interval of 5 min or less. In this way the investigators have access to nearly simultaneous glucose values from two different CGM's. In addition, the participants are given a Contour Next One, and are asked to measure their blood glukose with fingerprick if their Dexcom registers a glucose value \< 5 mmol/l.

By this project, we hope to gain more precise information about the two most widely distributed CGMs, and their function in the hypoglycemic area. This, can have impact on healthcare professionals' future therapeutic instructions, regarding the use of insulin adjustment and carbohydrate compensation.

Eligibility criteria: Inclusion Criteria:

Type 1 diabetes Using Dexcom G 7 -

Exclusion Criteria:

Do not want to participate

-

Primary outcomes:
measure: Difference between paired blood glucose values and simultaneous Dexcom and Libre glucose values
timeFrame: 5 minutes or less between the glucose values compared
measure: Difference between paired Dexcom and Libre glucose values
timeFrame: 5 minutes or less between the glucose values compared
Secondary outcomes:
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Silkeborg Regional Hospital
Study officials:
affiliation: Silkeborg Regional Hospital
name: Klavs W Hansen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02575378: Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic Colorectal Cancer
Maintenance Treatment
Chinese Traditional Medicine
Clinical Trial
efficacy
safety
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2015-10-14
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The optimum regimen of maintenance treatment after first-line chemotherapy in patients with metastatic colorectal cancer （mCRC） is unknown. This study was designed to determine the efficacy and safety of maintenance treatment with capecitabine metronomic chemotherapy plus Chinese Traditional Medicine.

In this Prospective, open-label, randomised controlled trial, the investigators will recruit 159 mCRC patients who have finished 18 to 24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR. The patients will then accept Chinese traditional diagnosis and be randomised into two group, capecitabine metronomic chemotherapy only as control group and the metronomic chemotherapy plus Chinese Traditional Medicine as experimental group. This treatment regimen will be continued until progression, death, or an unacceptable adverse event.

The primary endpoint is progression-free survival (PFS). Secondary endpoints are overall survival (OS), quality of life (QOL) and toxic effects.


Eligibility criteria: Inclusion Criteria:

1. unresectable metastatic colorectal cancer with pathological confirmation.
2. patients have accepted 18-24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR.

Exclusion Criteria:

-

Primary outcomes:
measure: Progression-free survival
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: