louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02764723: Isobaric Spinal Ropivacaine Versus Hyperbaric Spinal Bupivacaine in Total Knee Arthroplasty in Geriatric Patients
Official title: Isobaric Ropivacaine 15 mg Versus Hyperbaric Bupivacaine 12.5 mg for Spinal Anesthesia in Geriatric Patients Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty in Geriatric Patients
Spinal Anesthesia
Lead sponsor: Al Mouwasat Hospital
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 52
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of spinal anesthesia with isobaric ropivacaine, compared with hyperbaric bupivacaine in geriatric patients undergoing lower limb orthopedic surgery.

Detailed description: 52 patients physical status II-III according to the American Society of Anesthesiologists classification aged 65 years and above of average height, and scheduled for total knee replacement under spinal anesthesia.

Patients were randomly assigned into two equal groups of 26 patients each according to the type of local anesthetic injected in the subarachnoid space , Group I : patients who received an intrathecal injection of 12.5 mg of 0.5% hyperbaric bupivacaine , Group II: patients who received an intrathecal injection of 15 mg of 0.5% ropivacaine.

The investigators compared both groups as regards the extent and duration of sensory and motor block and hemodynamics including heart rate (HR) , non invasive mean arterial blood pressure (MAP) and respiratory depression.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status II-III aged 65 years and above of average height, and scheduled for total knee replacement under spinal anesthesia.

Exclusion Criteria:

* Known hypersensitivity to amide local anesthetics and contraindications to spinal anesthesia.

Primary outcomes:
measure: Changes in the extent and duration of sensory block
timeFrame: within 2 years
measure: Changes in the extent and duration of motor block
timeFrame: within 2 years
measure: Changes in the heart rate
timeFrame: within 2 years
measure: Changes in the non invasive mean arterial blood pressure
timeFrame: within 2 years
measure: Respiratory depression
timeFrame: within 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: D'Souza AD, Saldanha NM, Monteiro AD. Comparison of Intrathecal Hyperbaric 0.5% Bupivacaine, Isobaric 0.5% Levobupivacaine and Isobaric 0.75% Ropivacaine for Lower Abdominal Surgeries. International Journal of Health Sciences and Research (IJHSR). 2014;4(1):22-9.
Clinical trial NCT05585723: French Language Validation of Questionnaires for the Evaluation of Problematic Screen Use.
Official title: French Language Validation of Questionnaires for the Evaluation of Problematic Screen Use.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Smartphone Addiction
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University students, teenagers and parents of teenagers to test understanding of linguistic validation of questionnaires

Brief summary: The main objective of this research is to linguistically validate the Smartphone Addiction Scale, Nomophobia Questionnaire, The Problematic Use of Mobile Phones scale, Smartphone Addiction Proneness Scale, Digital Addiction Scale for Children, Gaming Motivation Scale and Problematic Media Use Measure in French so that they are conceptually equivalent to their original version.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for the SAS, NMP-Q, SAPS questionnaires
* University students over 18 years of age Inclusion criteria for the GAMS questionnaire
* University students over 18 years of age
* Video game players (at least one video game session in the past two weeks) Inclusion criteria for the PUMP and DASC questionnaires
* Adolescents (12-17 years old) Inclusion criteria for the PMUM-SF questionnaire
* Parents of adolescents (this can be parents of adolescents who answered the previous questions)
* Adolescents must have access to at least one screen: smartphone, computer, television, etc (even that of a parent)

Exclusion Criteria:

* Difficulties in understanding the French language
* Cognitive disorders
* Subject under guardianship or subject deprived of liberty
* Opposition to participation in the study

Primary outcomes:
measure: The process of validation will be performed by the forward/backward method (Epstein et al. 2015). The translation will be considered valid when the tests performed by the participants are considered successful.
timeFrame: through questionnaires completion, an average of 1 day
Secondary outcomes:
measure: Evaluation of the internal consistency of the questionnaires after cross-cultural adaptation in French language
timeFrame: through questionnaires completion, an average of 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05341323: Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia
Official title: Comparison Between Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Operative Pain
Keywords: Ketamine
Bupivacaine
tonsillectomy
analgesia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison between the analgesic effect of local infiltration of either Bupivacaine or ketamine in the peritonsillar area before the incision of tonsillectomy to achieve postoperative analgesia


Eligibility criteria: Inclusion criteria

* 3-20 years old patients
* elective tonsillectomy or adenotonsillectomy with or without ventilation tube application.

Exclusion criteria

* allergy to bupivacaine or ketamine
* coagulopathy
* endocrine, neuropsychiatric or cardiopulmonary dysfunction
* increase intracranial pressure (ICP)
* psychiatric illness, history of seizure, patients under chronic analgesic treatment
* history of peritonsillar abscess, tonsillar malignancy.

Primary outcomes:
measure: Postoperative pain
timeFrame: 60 minutes postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag Faculty of Medicine
Study officials:
affiliation: Professor of ENT
name: Ibrahem Risk, Professor
role: STUDY_DIRECTOR
affiliation: Dean of Faculty of Medicine
name: Osama Elshrief, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00154323: The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Bipolar Disorder I or II This Study is Not Being Conducted in the United States.
Official title: A Multi-center, Randomized, Double-blind, Parallel Group, Placebo-controlled 52 Weeks Clinical Trial to Evaluate Efficacy and Safety of Oxcarbazepine p.o.(300-1200 mg/Day) as Adjuvant Therapy in the Bipolar Disorder I or II Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Keywords: Oxcarbazepine, bipolar disorder
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 55
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: Bipolar disorder is a psychiatric illness with clinical characteristics of mixed mania, grandiose delusions, and suicidality. This study will investigate the efficacy a safety of oxcarbazepine in the treatment of patients with bipolar disorder type I or II.


Eligibility criteria: Inclusion Criteria:

* History of bipolar disorder type I or II

Exclusion Criteria:

* Other serious medical conditions
* Treatment with antiepileptic medications

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Duration of remission
Secondary outcomes:
measure: Daily mood fluctuation
measure: Time to new maniac/hypomanic episode
measure: Time to new depressive episode
measure: Number of relapsed patients at study completion and type/severity of episode
measure: Change from baseline in functional activity
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Clinic, Universitary of Barcelona
name: Eduard Vieta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vieta E, Cruz N, Garcia-Campayo J, de Arce R, Manuel Crespo J, Valles V, Perez-Blanco J, Roca E, Manuel Olivares J, Morinigo A, Fernandez-Villamor R, Comes M. A double-blind, randomized, placebo-controlled prophylaxis trial of oxcarbazepine as adjunctive treatment to lithium in the long-term treatment of bipolar I and II disorder. Int J Neuropsychopharmacol. 2008 Jun;11(4):445-52. doi: 10.1017/S1461145708008596. Epub 2008 Mar 17.
Clinical trial NCT00955123: Effects of Prednisolone and Infliximab on the Regulation of Urea Synthesis in Active Inflammatory Bowel Disease
Official title: Effects of Prednisolone and Infliximab on the Regulation of Urea Synthesis in Patients With Active Ulcerative Colitis and Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Keywords: Inflammation
Urea synthesis
Catabolism
Nitrogen balance
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2009-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with active inflammatory bowel disease seen in the out-patients' clinic or admitted to hospital for treatment.

Brief summary: Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with active inflammatory bowel disease (IBD). The investigators have earlier shown that the liver plays an important role in this stress-catabolism by increasing the production of urea during the inflammatory process.

The purpose of this study is to examine the effect of the anti-inflammatory drugs prednisolone and infliximab on the regulation of the urea synthesis in patients with active ulcerative colitis and Crohn's disease.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe active inflammatory bowel disease

Exclusion Criteria:

* Viral or bacterial infections
* Other chronical inflammatory diseases
* Cancer
* Other catabolic diseases
* Treatment with prednisolone or infliximab within the last 8 weeks

Primary outcomes:
measure: Functional Hepatic Nitrogen Clearance
timeFrame: Before and one week after treatment
Secondary outcomes:
measure: Clinical and biochemical measures of inflammation
timeFrame: Before and one week after treatment
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Medicine V, Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Karen Louise Thomsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hjortebjerg R, Thomsen KL, Agnholt J, Frystyk J. The IGF system in patients with inflammatory bowel disease treated with prednisolone or infliximab: potential role of the stanniocalcin-2 / PAPP-A / IGFBP-4 axis. BMC Gastroenterol. 2019 Jun 3;19(1):83. doi: 10.1186/s12876-019-1000-6.
Clinical trial NCT06590623: The Effect of Acute Exogenous Oral Ketone Supplementation on Immune Cells Function and Immune Cells Histone Β-hydroxybutyrylation
Official title: The Effect of Acute Exogenous Oral Ketone Supplementation on Immune Cells Function and Immune Cells Histone Β-hydroxybutyrylation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ketosis, Metabolic
Immune Functions
Histone Deacetylase (HDAC) Activity
Keywords: Ketone supplement
Exogenous ketones
Immune function
β-hydroxybutyrylation
Beta-Hydroxybutyrate
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To conduct a single-arm pilot study to determine how acute ingestion of an exogenous ketone monoester supplement alters the histone lysine β-hydroxybutyrylation and immune function in healthy human monocytes and lymphocytes.


Eligibility criteria: Inclusion Criteria:

* Over the age of 19
* Able to fast overnight

Exclusion Criteria:

* Being a competitive endurance athlete.
* Following a ketogenic diet, low-calorie diet, periodic fasting regimen, or regularly consuming ketogenic supplements.
* Being unable to travel to and from the university
* Being pregnant.
* Having been diagnosed with a chronic disorder of glucose or fat metabolism, including type 2 diabetes, chronic pancreatitis, or gallbladder disease
* Being unable to read or communicate in English.

Primary outcomes:
measure: β-hydroxybutyrylation of histone in human immune cells using Western blotting
timeFrame: Before (fasted state) and 2 hours after the consumption of the exogenous ketone supplement.
Secondary outcomes:
measure: Change in beta-hydroxybutyrate concentration
timeFrame: Capillary beta-hydroxybutyrate will be measured before, 30, 60, 90, 120 and 180 minutes after the consumption of exogenous ketone supplement.
measure: Change in glucose concentration
timeFrame: Capillary glucose concentration will be measured before, 30, 60, 90, 120, and 180 minutes after the consumption of exogenous ketone supplement.
measure: Change in blood pressure
timeFrame: Before, 30, 60, 90, 120 and 180 minutes after the consumption of the exogenous ketone supplement.
measure: Change in resting heart rate
timeFrame: Before, 30, 60, 90, 120 and 180 minutes after the consumption of the exogenous ketone supplement.
measure: Alteration in immune cell functions
timeFrame: Before (fasted state) and 2 hours after the consumption of the exogenous ketone supplement.
measure: Monocytes and lymphocytes Immunophenotyping
timeFrame: Before (fasted state) and 2 hours after the consumption of the exogenous ketone supplement.
measure: Gastrointestinal Disturbance
timeFrame: Before, and at 30, 60, 90, 120, and 180 minutes after consuming the exogenous ketone supplement.
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia Okanagan Campus
state: British Columbia
Study officials:
References:
Clinical trial NCT02763423: Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation for Type 1 Diabetes With Diabetic Ketoacidosis
Official title: The Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation to Treat New-onset Type 1 Diabetes With Diabetic Ketoacidosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ketoacidosis, Diabetic
Keywords: umbilical cord stem cell
diabetic ketoacidosis
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase II trial in individuals who have been diagnosed with type 1 diabetes within the previous 12 months and suffered from diabetic ketoacidosis at onset of disease. The purpose of this study is to determine whether allogeneic umbilical cord mesenchymal stem cell transplantation is effective in the treatment of patients with severe type 1 diabetes.

Detailed description: To assess the clinical efficacy of allogeneic umbilical cord mesenchymal stem cell transplantation in the treatment of patients with severe type 1 diabetes, defined as with the history of diabetic ketoacidosis from diagnosis. All the patients are intravenously administrated with single-dose or double-dose umbilical cord mesenchymal stem cell and followed up for 36 months. Clinical and laboratory manifestations are compared before and after transplantation.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* Duration of disease less than 12 months from diagnosis
* With the history of diabetic ketoacidosis

Exclusion Criteria:

* Pregnancy
* Severe psychiatric disorder
* Severe organic impairment(renal,hepatic,cardiac,pulmonary)
* Active infectious disease
* Previous or present neoplastic disease

Primary outcomes:
measure: Changes from baseline exogenous insulin dose at different time points post treatment
timeFrame: 1 month, 3 months,6 months, 12 months, 24 months, 36 months
Secondary outcomes:
measure: C-peptide level
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months
measure: HbA1c level
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months
measure: titres of islet antigen antibodies
timeFrame: 1 month, 3 months, 6 months, 12 months,24 months, 36 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Dalong Zhu, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang W, Ling Q, Wang B, Wang K, Pang J, Lu J, Bi Y, Zhu D. Comparison of therapeutic effects of mesenchymal stem cells from umbilical cord and bone marrow in the treatment of type 1 diabetes. Stem Cell Res Ther. 2022 Aug 8;13(1):406. doi: 10.1186/s13287-022-02974-1.
Clinical trial NCT01083823: Calling for Care: Cell Phones for Mood Telemetry in Teens
Official title: Calling for Care: Cell Phones for Mood Telemetry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Cyclothymia
Borderline Personality Disorder
Keywords: Mental health telemetry
Mood telemetry
Mood
Bipolar disorder
Affective instability
Cyclothymia
Electronic diaries
Mood diaries
Mood swings
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Motorola Canada Limited
First posted: 2010-03-10
Enrollment: 33
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: We will modify our existing VMQ/VADIS mood telemetry software to run on a Motorola platform, and enhance it to collect information on both mood symptoms (currently covered by the VMQ/VADIS) as well as daily life stressors (currently outside the VMQ/VADIS' scope). By doing so, we will be able us to examine the role of daily stressors in the lives of teens with and without mood swings, to identify how changes in mood triggered by stressful events are similar to or different from mood changes linked to the bipolar disorder, borderline personality disorder, or other forms of affective instability.


Eligibility criteria: Inclusion Criteria:

* Age 14-20yrs,
* Either (i) self-reported healthy with no past / present history of substance use problems OR (ii) self-reported severe mood swings interfering with daily life.
* Fluent in English.

Exclusion Criteria:

* Inability to be trained successfully on the MHT software or to complete questionnaires without assistance.
* Unwillingness to sign / maintain a contract with a cell phone service provider.
* Lack of parental assent / willingness to act as guarantor for cell phone provider contract

Primary outcomes:
measure: usability
timeFrame: After nine months' enrollment
Secondary outcomes:
measure: Validity
timeFrame: Every three months x 9 months
measure: Qualitative feedback
timeFrame: After nine months' enrollment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: David M Kreindler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06151223: A Prospective Registry for Patients at High-Risk for Pancreatic Cancer
Official title: A Prospective Registry for Patients at High-Risk for Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
PDAC
PDAC - Pancreatic Ductal Adenocarcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants at high risk of PDAC will be identified from the providers' calendars, provider referrals, and Mayo Clinic databases.

Brief summary: This study aims to facilitate discovery and validation of tests for early detection in subjects at high risk for pancreatic ductal adenocarcinoma (PDAC) and to facilitate the use of state-of-the-art machine learning-based algorithms that utilize databases and images with the purpose of identifying early stages of pancreatic cancer, as well as people at high-risk.The study also aims to provide a platform for development of an interventional protocol for early detection of PDAC.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 year
* Able to provide written informed consent
* Meets criteria as a High-Risk Individual as defined by protocol

Exclusion Criteria:

* Individual who has a personal history of pancreatic ductal adenocarcinoma (PDAC)
* History of total pancreatectomy

Primary outcomes:
measure: Collection of biospecimen samples (blood and pancreatic juice)
timeFrame: Up to 10 years
measure: Collection of radiology images and videos
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Shounak Majumder, M.D.
role: PRINCIPAL_INVESTIGATOR
References: