louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04499755: Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics
Official title: Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Brain Injuries
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 100
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics

Detailed description: The study aims to study the Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics

Eligibility criteria: Inclusion Criteria:

* Children with traumatic brain injury: Moderate and Severe.

Exclusion Criteria:

* Underlying CNS disorders,

Primary outcomes:
measure: Number of patients with improved glasgow coma score
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Pediatrics department - Kafr-Elsheikh University
name: Abeer Salamah, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Emergency Department- Tanta University.
name: Mohamed Elbahnasawy, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05859555: Multimodal Educative Data Feedback for Deprescribing BZD and Related Drugs in Outpatients: a Cluster RCT
Official title: Multimodal Educative Data Feedback for Deprescribing Benzodiazepine (BZD) and Related Drugs in Outpatients: a Cluster Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deprescription
Benzodiazepine (BZD) and Related Drugs
Keywords: Benzodiazepine (BZD) and related drugs
Deprescribing
Safety
Older patients
Lead sponsor: Réseau de soins Delta
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomised controlled trial
Primary purpose: OTHER

Brief summary: Benzodiazepine (BZD) and related drugs are sedative anxiolytics and hypnotics that should be avoided especially in people aged 65 years and older, given the high risk of falling, fracture, dependence, respiratory depression and cognitive disorders. Despite these contraindications, their consumption continues to increase in Switzerland.

Although it can be assumed that deprescribing a drug has a direct benefit, it is nevertheless necessary to determine how to implement this process effectively and safely. To change healthcare professionals' prescribing behaviours for BZD, the most common deprescribing interventions include identification of appropriate patients, education and training of GPs and patients, and gradual and appropriate reduction of the dose of BZD. Thus, the DELTA CARE NETWORK and the DELTA VAUD CARE NETWORK have set themselves the task of evaluating the effectiveness of a multimodal deprescribing intervention for Delta primary care physicians and their patients aged 65 and over, in the cantons of Geneva and Vaud. The goal is to reduce the total BZD prescription rate among this population.

This quality development project is fully in line with the Quality Federal Commission's objectives of efficiency, safety, patient-centred and in the interests of the patient.


Eligibility criteria: Inclusion Criteria:

* Physician who attended a quality cercle in the cantons of Geneva and Vaud
* Prescribed at least one prescription of Benzodiazepines during the year of analysis to patient aged 65 years and older

Primary outcomes:
measure: Rate Benzodiazepine (BZD) and related drugs prescribed by primary care physicians
timeFrame: 9 months
Secondary outcomes:
measure: Rate of patients aged 65 years who took long-term BZD
timeFrame: 18 months
Other outcomes:
Locations:
city: Geneve
country: Switzerland
facility: Réseau de soins Delta SA
state: Petit Lancy
Study officials:
References:
Clinical trial NCT05568355: Garnering Effective Telehealth 2 Help Optimize Multidisciplinary Team Engagement
Official title: Garnering Effective Telehealth 2 Help Optimize Multidisciplinary Team Engagement
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Children With Complex Chronic Conditions
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2022-10-05
Enrollment: 650
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine the effectiveness of the GET2HOME Intervention bundle.


Eligibility criteria: Inclusion Criteria:

* Patients with complex chronic disease based on a Pediatric Medical Complexity Algorithm (PMCA) score of 3 and their families and their primary care providers
* Discharged from pediatric hospital medicine service at our hospital

Exclusion Criteria:

* Patients who live independently without a parent or guardian in the home, including those that live at skilled nursing facilities
* Patients admitted for end of life care
* Patients admitted for suicidal or homicidal ideation
* Patients who previously enrolled in the study
* Patients in county custody

Primary outcomes:
measure: Urgent healthcare reutilization
timeFrame: 30-days post-discharge
Secondary outcomes:
measure: Global Quality of Life Scale
timeFrame: 7-, 30-, 60-, and 90-days post-discharge
measure: Return to baseline
timeFrame: 7-, 30-, 60-, and 90-days post-discharge
Other outcomes:
measure: Percent of participants with transition process failures
timeFrame: 7-days post-discharge
measure: Transition quality
timeFrame: 7-days post-discharge
measure: Urgent healthcare reutilization
timeFrame: 7-days post-discharge
measure: Medical and non-medical out-of-pocket costs
timeFrame: 30-days post-discharge
measure: Caregiver time to manage illness post-discharge
timeFrame: 30-days post-discharge
measure: Primary care provider transition time burden
timeFrame: 10 days post-discharge
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT01241955: Temporal Intervention Trial of a CPR Video in the ICU
Official title: A Temporal Intervention Trial of a CPR Video in the ICU
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Admission to ICU
Keywords: CPR
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2010-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To compare the decision making of family members of patients admitted to the ICU in regards to their CPR preferences for their loved ones with and without the use of a video decision aid.

Detailed description: Surrogate decision makers of patients admitted to an ICU and UNABLE to make decisions for themselves will be asked their choice for CPR preferences for their loved ones. This will occur during the first six months of the study.

After six months, surrogate decision makers of patients admitted to an ICU and unable to make decisions for themselves will view a video decision aid for CPR and then asked their choice for CPR preferences for their loved ones.

Eligibility criteria: Inclusion Criteria:

patient admitted to ICU and unable to make decisions with a known surrogate decision maker

Exclusion Criteria:

Cannot speak English

Primary outcomes:
measure: CPR preferences
timeFrame: within 48 hours of ICU admission
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT02001155: Comparing the Effect of the Water Drinking Test on Intraocular Pressure
Official title: Comparing the Effect of the Water Drinking Test on Intraocular Pressure in Patients With Prior Trabeculectomy or Tube Shunt Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: Water drinking test
trabeculectomy
tube shunt
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants will have open angle glaucoma and have undergone either tube shunt surgery or trabeculectomy. All participants will be matched for range of recent intraocular pressure (average over the prior three visits of \<12 mm Hg, 12 to \<18 mm Hg, or \>18 mm Hg), as well as number of medications (none, 1-2, 3 or more).

Brief summary: A test that was common in the 1960's and was used to detect primary open angle glaucoma was the water drinking test (patients drank 1 quart of water to stress the fluid drainage mechanism of the eyes. Intraocular pressure was then measured over the next hour). Recently this test has been demonstrated as a predictor of peak eye pressure during the day. The purpose of this study is to compare the results of the water drinking test between eyes that have undergone trabeculectomy and eyes that have undergone tube shunt surgery.


Eligibility criteria: Inclusion Criteria:

* prior trabeculectomy or tube shunt for the treatment of glaucoma
* age 21-90 years

Exclusion Criteria:

* inability to give informed consent
* current ocular infection
* more than 1 prior trabeculectomy, or more than 1 prior tube shunt
* previous refractive surgery
* pregnant women
* heart failure
* renal failure or uncontrolled urine retention
* corneal abnormalities preventing reliable IOP measurement

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
Study officials:
affiliation: Wills Eye Hospital
name: Jonathan Myers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Waisbourd M, Savant SV, Sun Y, Martinez P, Myers JS. Water-drinking test in primary angle-closure suspect before and after laser peripheral iridotomy. Clin Exp Ophthalmol. 2016 Mar;44(2):89-94. doi: 10.1111/ceo.12639. Epub 2015 Nov 10.
Clinical trial NCT01613755: Metformin-Dipyridamole Interaction Trial
Official title: The Effect of Dipyridamole on the Pharmacokinetics of Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Keywords: Effect Dipyridamole on pharmacokinetics of metformin
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The antihyperglycemic drug metformin and the thrombocyte aggregation inhibitor dipyridamole are often used concomitantly in patients with diabetes who have suffered a transient ischemic attack or stroke. It has recently been suggested that the gastrointestinal absorption of metformin is mediated by the equilibrative nucleoside transporter 4 (hENT4). Dipyridamole has been reported to inhibit hENT4 transport in vitro. The aim of this research proposal is to study the pharmacokinetic interaction between metformin and dipyridamole. The investigators hypothesize that dipyridamole reduces the gastrointestinal absorption of metformin. If this hypothesis can be confirmed, then the results of this study can explain in part the high variability in plasma metformin concentrations in patients treated with diabetes, and can be used to optimize pharmacotherapy in patients with diabetes.


Eligibility criteria: Inclusion Criteria:

* Age 18-50 years
* Written informed consent

Exclusion Criteria:

* Smoking
* Hypertension (systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg)
* Diabetes Mellitus (fasting glucose \>7.0 mmol/L or random glucose \>11 mmol/L)
* History of any cardiovascular disease
* Concomitant use of medication
* Renal dysfunction (MDRD \<60 ml/min)
* ECG abnormalities, other than firs grade AV-block or right bundle branch block

Primary outcomes:
measure: The area under the curve of the metformin plasma concentration at several timepoints
timeFrame: 10 hours after ingestion of last dose of metformin
measure: Peak plasma concentration (Cmax) of metformin
timeFrame: about 3 hours after intake of last dose of metformin
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: N. Riksen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: G. Rongen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03392155: Performance and Nutrition Program for Athletes in Adaptive Sports
Official title: The Effectiveness of a Performance and Nutrition Program for Athletes in Adaptive Sports
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Physical Disability
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Researchers are trying to evaluate and recommend sustainable and effective health and wellness programs for people with spinal cord injury (SCI) and other physical disabilities.


Eligibility criteria: Inclusion Criteria:

Group1 (Group with spinal cord injury):

* Participants with traumatic or non-traumatic spinal cord injury
* Able to perform progressive exercise program
* Willingness to participate in study

Group 2 (Able-bodied group):

* Functional upper extremity range of motion
* Able to perform progressive exercise program
* Willingness to participate in study

Group3 (Other physical disability group):

* Participants with a physical disability other than spinal cord injury
* Able to perform progressive exercise program
* Willingness to participate in study

Exclusion Criteria:

All groups:

• Any documented or reported health condition that would be contraindicated to a progressive exercise program

Primary outcomes:
measure: Change in The World Health Organization Quality of Life Score (WHOQOL-BREF)
timeFrame: Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28)
Secondary outcomes:
measure: Change in exercise self-efficacy score (for participants not living with spinal cord injury)
timeFrame: Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28)
measure: Change in exercise self-efficacy score (for participants living with spinal cord injury)
timeFrame: Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28)
measure: Change in self-reported un-weighed food records
timeFrame: Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Meegan G Van Straaten
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02487355: Pediatric Caudal Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate in Lower Abdominal Surgeries
Official title: Pediatric Caudal Epidural Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate and Quality of Caudal Anesthesia in Lower Abdominal Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Pain, Postoperative
Keywords: dexmedetomidine
magnesium sulphate
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will conduct to compare the efficacy of Magnesium sulphate \& dexmedetomidine used as adjuvants to bupivacaine in caudal block to provide intra-operative anesthesia as well as post -operative analgesia in pediatric patients.

Detailed description: asdsd

Eligibility criteria: Inclusion Criteria:

* Healthy male and female children, ASA I and II,Aged 6 months to 6 years, , undergoing elective surgical procedures expected to last more than 90 min, and scheduled to receive general anesthesia combined with caudal extradural block

Exclusion Criteria:

* Allergy to local anesthetics,coagulation disorders, infection at site of injection, anatomic abnormalities and congenital anomalies like spina bifid, ASA III or higher, Parental refusal and the current use of Calcium Channel Blockers or Medication that may affect the neurologic system

Primary outcomes:
measure: Time to first analgesic requirement
timeFrame: 24 hours
Secondary outcomes:
measure: Postoperative sedation scores
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Univeristy Hospital
Study officials:
affiliation: assistant professor in anesthesia and intensive care department,faculty of medicine,Assiut univeristy,egypt
name: jehan A Sayed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05405855: eLIFEwithIBD - Living With Intention, Fullness and Engagement With Inflammatory Bowel Disease (Online)
Official title: eLIFEwithIBD (Living With Intention, Fullness and Engagement With Inflammatory Bowel Disease): The Impact of an ICT-based Intervention on Physical and Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to test the acceptability and preliminary efficacy of an online intervention (eLIFEwithIBD) developed for people with inflammatory bowel disease (IBD). The eLIFEwithIBD intervention is an adaptation of the LIFEwithIBD program (delivered in an in-person group format; Trindade et al., 2021), being an ACT, mindfulness, and compassion-based intervention. The eLIFEwithIBD intervention comprises nine sessions focusing on education about IBD, the functioning of the mind, emotions, and fatigue; acceptance of internal experiences; willingness; emotion regulation; values clarification; committed action; mindfulness; compassion; and gratitude. These topics are addressed through videos with therapists, texts, and experiential exercises.


Eligibility criteria: Inclusion Criteria:

* aged between 18 and 65;
* IBD diagnosis (at least from 6 months prior);
* regular access to a computer with internet;
* able to write and read in Portuguese, and give informed consent.

Exclusion Criteria:

* diagnosis of a psychiatric disorder (major depressive disorder, psychotic disorder, bipolar disorder, substance abuse), or suicidal ideation (assessed by the Patient Health Questionnaire-9);
* current psychotherapy use;
* pregnancy.

Primary outcomes:
measure: Psychological distress (DASS-21; Lovibond & Lovibond, 1995)
timeFrame: From Baseline to 4-months follow-up
Secondary outcomes:
measure: Perception of Quality of Life - EUROHIS-QOL 8-item index (Power, 2017); Inflammatory Bowel Disease Questionnaire - UK version (IBDQ-UK; Cheung et al., 2000)
timeFrame: From Baseline to 4-months follow-up
measure: Chronic illness-related shame (Chronic Illness-related Shame Scale - CISS, Trindade et al., 2017)
timeFrame: From Baseline to 4-months follow-up
measure: IBD symptom perception (IBD symptoms scale, Trindade et al., 2019)
timeFrame: From Baseline to 4-months follow-up
measure: Functional impairment (Work and Social Adjustment Scale - WSAS; Mundt et al., 2002)
timeFrame: From Baseline to 4-months follow-up
Other outcomes:
measure: Usability - System Usability Scale (SUS; Brooke, 1986)
timeFrame: 9 weeks
measure: Acceptability and Feasibility - The Acceptability and Feasibility Measures (Weiner et al., 2017)
timeFrame: 9 weeks
Locations:
city: Coimbra
country: Portugal
facility: Inês Trindade
Study officials:
References:
Clinical trial NCT00086255: Tiagabine for the Treatment of Cocaine Dependence - 1
Official title: Tiagabine for the Treatment of Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Cincinnati
First posted: 2004-06-30
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess tiagabine for the treatment of cocaine dependence.

Detailed description: To assess the efficacy and safety of tiagabine in reducing cocaine use in subjects with cocaine dependence. It is hypothesized that tiagabine treatment, compared to placebo, will be associated with fewer days of cocaine use as assessed by self-report confirmed with urine assays for benzoylecgonine (BE). This is a double-blind, placebo-controlled, parallel-group design study, in which, after screening and a 2-week baseline assessment period, subjects will be equally randomly assigned to 1 of 2 treatment groups, tiagabine or matched placebo.

Eligibility criteria: Inclusion Criteria:

Must be at least 18 years of age and be seeking treatment for cocaine dependence. Have the ability to understand, and having understood, provide written informed consent. If female, agree to use a method of birth control as indicated by the clinician. Please contact the participating site in your area for more information.

Exclusion Criteria:

Please contact the participating site in your area for more information.

Primary outcomes:
measure: Drug use
measure: Cocaine use
measure: Addiction severity
measure: Clinical improvement
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center
state: Ohio
city: Dayton
country: United States
facility: Dayton VA Medical Center
state: Ohio
city: Houston
country: United States
facility: University of Texas Hlth Sci Ctr Houston
state: Texas
Study officials:
affiliation: Cincinnati VA Medical Center
name: Eugene Somoza, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winhusen TM, Somoza EC, Lewis DF, Kropp F, Theobald J, Elkashef A. An Evaluation of Substance Abuse Treatment and HIV Education on Safe Sex Practices in Cocaine Dependent Individuals. ISRN Addict. 2014 Mar 4;2014:912863. doi: 10.1155/2014/912863. eCollection 2014.