louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03265782: Paracetamol Versus Ibuprofen for PDA Closure
Official title: Comparison Between the Effect of Oral Paracetamol Versus Oral Ibuprofen in the Treatment of Patent Ductus Arteriosus in Preterm and Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Patent Ductus Arteriosus
Keywords: efficacy
safety
paracetamol
ibuprofen
PDA
preterms
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 30
Sex: ALL
Minimum age (years): 28
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in treatment of Patent Ductus Arteriosus (PDA) in premature infants

Detailed description: A pilot study through which we have studied efficacy and safety of oral paracetamol and oral ibuprofen in treatment of hemodyamically significant pda in preterm neonates. 30 preterm neonates were included in the study 15 per each group. echo was done in the beginning and during treatment with both drugs to follow up the closure of the duct.

Ibuprofen was given as 10 mg/kg/dose in the 1st day followed by 5 mg/kg/dose in the 2nd and 3rd days with follow up echo was done after finishing the course paracetamol was given as 15 mglkg/6 hrs for three days with follow up echo to check the ductal closure.

Eligibility criteria: Inclusion Criteria:

1. Gestational age ≤ 35 weeks
2. Aged 2-7 days with color Doppler echocardiographic evidence of PDA
3. Urine output more than 1 ml/kg/hr
4. Creatinine concentration level less than 1.8 mg/dl

Exclusion Criteria:

Neonates who have one or more of the following criteria were excluded from the study:

1. Congenital heart diseases of any type including

   * Pulmonary stenosis
   * Anomalus in pulmonary venous drainage
   * Ventricular septal defect
2. Major congenital anomalies as hydrops fetalis
3. Low platelets count (less than 60, 000/mm3)

Primary outcomes:
measure: closure of PDA
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: El-Farrash RA, El Shimy MS, El-Sakka AS, Ahmed MG, Abdel-Moez DG. Efficacy and safety of oral paracetamol versus oral ibuprofen for closure of patent ductus arteriosus in preterm infants: a randomized controlled trial. J Matern Fetal Neonatal Med. 2019 Nov;32(21):3647-3654. doi: 10.1080/14767058.2018.1470235. Epub 2018 May 9.
Clinical trial NCT02284282: Spinal Bupivacaine/Morphine in Laparoscopic Gastro-intestinal Surgery
Official title: Spinal Bupivacaine/Morphine in Laparoscopic Gastro-intestinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Bupivacaine/Morphine in Laparoscopic Surgery
Keywords: Spinal Morphine
Laparoscopic GI-surgery
Post-operative pain
Lead sponsor: Maasstad Hospital
Sponsor class: OTHER
First posted: 2014-11-06
Enrollment: 56
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: The objective of this study is to determine if a single spinal shot of morphine can decrease post-operative opioid-use, and thereby decrease opioid side-effects and lead to a quicker recovery after surgery.

Detailed description: We expect that in laparoscopic gastro-intestinal surgery, a single shot spinal with bupicavaine/morphine will result in a better analgesia in hte first 48 hours. Herby the patients will require less systemic opioids, which will decrease the side-effects. Furthermore, we expect the patients to recover quicker and show an earlier mobilisation and a shorter hospital stay.

The objective of this study is to determine if a single spinal shot of morphine can decrease post-operative opioid-use, and thereby decrease opioid side-effects and lead to a quicker recovery after surgery.

Eligibility criteria: Inclusion Criteria:

* Laparoscopic Gastro-intestinal surgery

Exclusion Criteria:

* Bariatric surgery, gastric surgery, rectal surgery, kidney failure, aorta-valve stenosis, coagulation disorders, emergency surgery

Primary outcomes:
measure: Duration of hospital stay
timeFrame: first 48 hours
Secondary outcomes:
measure: use of piritramide by PCIA-pump in mg
timeFrame: 48 hours
measure: patient-satisfactory on a 4-point scale
timeFrame: 120 hours/ 5 days
measure: the occurence of side-effects (nausea, pruritus, drowsiness)
timeFrame: 120 hours/ 5 days
measure: time to mobilisation
timeFrame: 120 hours/ 5 days
measure: time to bowel movement
timeFrame: 120 hours/ 5 days
measure: abdominal compliance during laparoscopy in L/mmHg
timeFrame: The compliance will be measured for the duration of the surgery, an expected average of 2 hours.
measure: Difficulty of surgery
timeFrame: The difficulty of surgery will be measured for the duration of the surgery, an expected average of 2 hours
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
Study officials:
affiliation: Maasstad Hospital
name: AartJan JW Teunissen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maasstad Hospital
name: Mark V Koning, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koning MV, Teunissen AJW, van der Harst E, Ruijgrok EJ, Stolker RJ. Intrathecal Morphine for Laparoscopic Segmental Colonic Resection as Part of an Enhanced Recovery Protocol: A Randomized Controlled Trial. Reg Anesth Pain Med. 2018 Feb;43(2):166-173. doi: 10.1097/AAP.0000000000000703.
Clinical trial NCT03638882: Cognitive Reserve and Second Language Acquisition
Official title: Boosting Cognitive Reserve Through Adult Second Language Acquisition With Duolingo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Executive Function
Lead sponsor: Rotman Research Institute at Baycrest
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2018-08-20
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Bilingualism has been shown to have a strong protective effect against dementia, delaying the diagnosis of Alzheimer's disease by up to 4 years. The purpose of the study is to test whether learning a second language using Duolingo software could improve cognitive functions in older adults.

Detailed description: This study is a 3-arm, randomized controlled trial. The primary objective of the study is to test the impact of second language acquisition through short-term use of the Duolingo app on cognitive functioning, particularly executive function in older adults compared to a brain training application.

Eligibility criteria: Inclusion Criteria:

* Participants must have normal vision and hearing.
* Participants must be able to travel to Baycrest by personal or study-arranged automobile, or public transportation.
* Participants must be monolingual native English speakers.
* Participants must be willing to provide informed consent.
* Participants must have daily access to a smartphone/mobile device.
* Have not previously studied Spanish formally, nor any other language in the past 10 years.

Exclusion Criteria:

* have a neurological disorder.
* meet DSM-IV-TR criteria for Axis I mood, anxiety, or psychotic or substance abuse disorders.
* Fluent in more than one language.

Primary outcomes:
measure: Change in working memory, n-back
timeFrame: change from baseline to 16 weeks
measure: Change in inhibitory Control, Simon task
timeFrame: change from baseline to 16 weeks
measure: Change in inhibitory Control, DKEFS
timeFrame: change from baseline to 16 weeks
Secondary outcomes:
measure: Change in attention abilities
timeFrame: change from baseline to 16 weeks
measure: Change in language abilities
timeFrame: change from baseline to 16 weeks
measure: change in verbal fluency
timeFrame: change from baseline to 16 weeks
measure: executive function assessed by trailmaking test
timeFrame: change from baseline to 16 weeks
Other outcomes:
measure: Spanish Proficiency (Duolingo group only)
timeFrame: change from baseline to 16 weeks
Locations:
city: Toronto
country: Canada
facility: Baycrest Health Sciences
state: Ontario
Study officials:
References:
Clinical trial NCT04282382: Intraoperative Transfusion Practice in Children
Official title: A Retrospective Analysis of Perioperative Transfusion Management in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transfusion
Keywords: Transfusion, Pediatric, Patient Blood Management
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 66
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pediatric patients being operated an receiving transfusion will be included.

Brief summary: The purpose of this study is to examine factors, impact and outcome on perioperative blood transfusion for pediatric patients.


Eligibility criteria: Inclusion Criteria:

* Operation
* Anaesthesia
* Transfusion (pRBC, plasma or platelets)

Exclusion Criteria:

* No

Primary outcomes:
measure: Number of children being transfused intraoperative
timeFrame: 01.04.2018 to 31.10.2019
measure: Documented transfusion indication
timeFrame: 01.04.2018 to 31.10.2019
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University
state: NRW
Study officials:
References:
Clinical trial NCT04832282: Napoleon Measurement of Gastrojejunal Anastomosis
Official title: Feasibility of a New Method Named Napoleon to Measure Gastrojejunal Anastomosis in Gastric Bypass Patients With Weight Regain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Gastric Bypass
Weight Regain
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2021-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a clinical trial assessing the feasibility of the Napoleon device for measuring the gastrojejunal anastomosis (GJA). The study population is Roux-en-Y gastric bypass (RYGB) patients with weight regain undergoing an endoscopy at Bellevue Hospital Center or Brigham and Women's Hospital. investigators aim for a sample size of up to 100 cases. For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope. Then, they will measure the GJA with Napoleon. Investigators will compare the GJA measurements performed using visual estimation and Napoleon. A survey will be given to all endoscopists to assess the level of ease using Napoleon.


Eligibility criteria: Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. RYGB patient with weight regain age 18-90
2. Scheduled for an endoscopy
3. Willingness and ability to provide informed consent

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. History of prior endoscopies with complications

Primary outcomes:
measure: Mean difference in measured Gastrojejunal Anastomosis size between Napoleon and visual estimation
timeFrame: 8 months
Secondary outcomes:
measure: Proportion of cases with different recommended endoscopic treatment based on GJA size measured by Napoleon Device
timeFrame: 8 months
measure: Level of ease with using Napoleon in terms of placement, extension/retraction, and photo acquisition
timeFrame: 8 months
measure: Additional procedure time needed to incorporate use of Napoleon
timeFrame: 8 months
measure: Proportion of cases with adverse events or unanticipated problems related to use of Napoleon
timeFrame: 8 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
Study officials:
References:
Clinical trial NCT03944382: What Are the Effects of Fibrinogen Concentrate Administration on Biological Parameters
Official title: What Are the Effects of Fibrinogen Concentrate Administration on Biological Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 125
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: all patient who received fibrinogen concentrate

Brief summary: the fibrinogen concentrate are given since 50 years with the dose of 2g for a afibrinogenemia. But this dose has been fixed 40 years ago and from now nobody discuss this quantity. Through this retrospective study the investigators tried to explore the evolution of blood test after a prescription of fibrinogen concentrate

Detailed description: the fibrinogen concentrate are given since 50 years with the dose of 2g for a afibrinogenemia. But this dose has been fixed 40 years ago and from now nobody discuss this quantity. Through this retrospective study the investigators tried to explore the evolution of blood test after a prescription of fibrinogen concentrate.

Eligibility criteria: Inclusion Criteria:

* all patient who received fibrinogen concentrate

Exclusion Criteria:

* none

Primary outcomes:
measure: Evolution of fibrinogen
timeFrame: one day
measure: Evolution of FIBTEM A5®
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Erasme UH
name: Olivier DURANTEAU, Trainee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06888882: Dilated Perivascular Spaces in the Dentate Nucleus on MRI in Patients with Hypertensive Angiopathy or Cerebral Amyloid Angiopathy
Official title: Dilated Perivascular Spaces in the Dentate Nucleus on MRI in Patients with Hypertensive Angiopathy or Cerebral Amyloid Angiopathy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hypertensive Arteriopathy
Cerebral Amyloid Angiopathy
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with lobar intracerebral hemorrhage \[ICH\], subarachnoid hemorrhage or cortical superficial siderosis for CAA or basal ganglion ICH for HA

Brief summary: Hypertensive arteriopathy (HA) and cerebral amyloid angiopathy (CAA) are the two most common forms of cerebral small vessel disease. On MRI, chronic small vessel disease-related abnormalities include white matter hyperintensities, dilated perivascular spaces (DPVS), lacunar infarction, and hemorrhagic features (e.g. cerebral microbleeds, CMB). In the cerebellum, deep CMB involving the dentate nucleus (DN) is associated with HA, whereas the presence of superficial cerebellar CMB are associated with CAA. DPVS are observed in both diseases, predominant in the subcortical white matter (especially in the centrum semiovale) in CAA whereas HA-related DPVS are predominant deep in the brain inside or nearby the basal ganglia.

To the best of our knowledge, DN-DPVS have never been studies systematically in small vessel disease. The researchers want to study DN-DPVS on T2-weighted 3T MRI in patients with HA or CAA and to compare both groups.


Eligibility criteria: Inclusion Criteria:

* Patient registered in the CHU de Nîmes (France) stroke database with lobar intracerebral hemorrhage \[ICH\], subarachnoid hemorrhage or cortical superficial siderosis for CAA or basal ganglion ICH for HA
* Patient managed at the CHU de Nîmes (France) between 01/1/2015 and 31/12/2024
* Patient with T2-weighted MRI performed with a 3T magnet

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: Sex
timeFrame: baseline
measure: Hypertension
timeFrame: baseline
measure: Age
timeFrame: baseline
measure: Time
timeFrame: baseline
measure: MRI view
timeFrame: baseline
measure: hypercholesterolemia
timeFrame: baseline
measure: Hemorrhagic lesion
timeFrame: baseline
measure: Subcortical lobar DPVS
timeFrame: baseline
measure: DPVS of basal ganglia
timeFrame: baseline
measure: Diabete
timeFrame: baseline
measure: Smoking
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
state: Occitanie
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Anissa MEGZARI
role: STUDY_DIRECTOR
References:
Clinical trial NCT01125020: Impact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Transplantation
Hepatocellular Carcinoma
Tumor Recurrence and Metastasis
Survival
Adjuvant Chemotherapy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Changzheng Hospital
First posted: 2010-05-18
Enrollment: 150
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: The study is designed to investigate the effect of postoperative adjuvant chemotherapy in prevention of tumor recurrence and metastasis for hepatocellular carcinoma after liver transplantation.


Eligibility criteria: Inclusion Criteria:

* All liver transplantation patients with hepatocellular carcinoma between Dec 2008 and May 2010 are potentially eligible for enrollment.

Exclusion Criteria:

* Age less than 18 years
* Treatment with other postoperative adjuvant chemotherapy
* Survival is less than 3 months after liver transplantation
* Inability to provide written informed consent prior to study entry

Primary outcomes:
measure: tumor recurrence and metastasis
timeFrame: within the first year after liver transplantation
Secondary outcomes:
measure: Postoperative survival
timeFrame: within the first year after liver transplantation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Zhi-Hai Peng, MD
role: STUDY_CHAIR
References:
citation: Dudek K, Kornasiewicz O, Remiszewski P, Kobryn K, Ziarkiewicz-Wroblewska B, Gornicka B, Zieniewicz K, Krawczyk M. Impact of tumor characteristic on the outcome of liver transplantation in patients with hepatocellular carcinoma. Transplant Proc. 2009 Oct;41(8):3135-7. doi: 10.1016/j.transproceed.2009.08.016.
citation: Soderdahl G, Backman L, Isoniemi H, Cahlin C, Hockerstedt K, Broome U, Makisalo H, Friman S, Ericzon BG. A prospective, randomized, multi-centre trial of systemic adjuvant chemotherapy versus no additional treatment in liver transplantation for hepatocellular carcinoma. Transpl Int. 2006 Apr;19(4):288-94. doi: 10.1111/j.1432-2277.2006.00279.x.
citation: Louafi S, Boige V, Ducreux M, Bonyhay L, Mansourbakht T, de Baere T, Asnacios A, Hannoun L, Poynard T, Taieb J. Gemcitabine plus oxaliplatin (GEMOX) in patients with advanced hepatocellular carcinoma (HCC): results of a phase II study. Cancer. 2007 Apr 1;109(7):1384-90. doi: 10.1002/cncr.22532.
Clinical trial NCT04085120: Ropivacaine/Dexamethasone and 10% Lignocaine Injection in GPN Block for Intractable Cancer Pain
Official title: Comparison Between Ropivacaine/Dexamethasone and 10% Lignocaine Injection in Distal Glossopharyngeal Nerve Block for Intractable Cancer Pain- A Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer, Oropharynx
Pain, Intractable
Cancer Pain
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study will compare the efficacy and safety of Ropivacaine/dexamethasone vs 10% lignocaine injection in distal glossopharyngeal nerve block for intractable cancer pain


Eligibility criteria: Inclusion Criteria:

* Patients with proven carcinoma of the oropharynx and supraglottic larynx with estimated survival of 3 months or more.
* Pain lasting for at least 2 weeks with an average intensity of 5 or more on an 11-point numeric rating scale (NRS) refractory to a combination strong opioids and NSAIDS

Exclusion Criteria:

1. Local infection or skin ulceration at the puncture site
2. Local anaesthetic allergy
3. Psychiatric illness that affected cooperation.

Primary outcomes:
measure: Pain reduction on the basis of the Numeric rating scale (NRS).
timeFrame: 4 weeks
Secondary outcomes:
measure: Brief Pain Inventory (BPI)- short form
timeFrame: 4 weeks
measure: WHO Quality of Life-BREF
timeFrame: 4 weeks
measure: Patient Global Impression of Change (PGIC)
timeFrame: 4 weeeks
measure: Clinical Global Impression of Change (CGIC)
timeFrame: 4 weeks
measure: Analgesic requirement and rescue analgesic requirement
timeFrame: 4 weeks
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: Dinesh Manoharan, MD
role: PRINCIPAL_INVESTIGATOR
References: