louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00557154: Ultrasound Assisted Peripheral Venous Access in Young Children
Official title: Ultrasound Assisted Peripheral Venous Access in Young Children: A Pilot and Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheterization, Peripheral
Keywords: Pediatrics
Venous access
Emergency
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Children's Miracle Network
First posted: 2007-11-12
Enrollment: 44
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn how the use of ultrasound helps with the placement of an intravenous (i.v.) catheter in young children.

Detailed description: In an academic pediatric Emergency Depratment (ED), we performed a randomized clinical trial of children \< 7 years of age, who required i.v. access and who had failed the first i.v. attempt. We randomized patients to either continued standard i.v. attempts or ultrasound-assisted attempts. Clinicians involved in the study received one hour of training in ultrasound localization of peripheral veins. In the ultrasound group, vein localization was performed by an ED physician who marked the skin overlying the target vessel. Intravenous cannulation attempts were then immediately performed by a pediatric ED nurse who relied on the skin mark for vessel location. We allowed for technique cross-over after two failed i.v. attempts. We recorded success rate and location of access attempts.

Eligibility criteria: Inclusion Criteria:

* Less than 7 years of age
* Emergency Department patients
* Parents available for consent

Exclusion Criteria:

* Critical illness

Primary outcomes:
measure: venous visualization (with ultrasound) and venipuncture success rate
timeFrame: one year
Secondary outcomes:
measure: Anticipated difficulty of venipuncture (rated on visual analog scale)
timeFrame: one year
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Aaron E Bair, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00966654: Effect of GLP - 1 (7-36 Amide) on Myocardial Function Following Coronary Artery Bypass (CABG) Surgery
Official title: Effect of GLP - 1 (7-36 Amide) on Myocardial Function Following Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: CABG
Keywords: CABG
Cardiac Surgical Patient
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2009-08-27
Enrollment: 12
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: This research is being done to see if giving a hormone called GLP-1 can improve heart function and reduce length of stay in the Cardiac Surgical Intensive Care Unit (CSICU) in people who have non-emergent coronary artery bypass graft (CABG) surgery.

Detailed description: After CABG surgery, a condition known as hyperglycemia or high blood sugar often occurs even in patients who have never been diagnosed with diabetes. This high blood sugar can lead to complications after surgery such as infections at the site of the incision. Additionally, if there is any cardiac muscle injury either prior to or during surgery, the injured cardiac muscle can not use glucose (the body's fuel and energy source) as well as it did prior to the injury. This reduced ability to use glucose slows the cardiac muscles ability to repair itself and provide the normal pumping force and function needed to circulate the blood throughout the body. This inability to repair itself and/or provide the normal pumping force and function can make it difficult for the patient as well as increase the length of stay required in the CSICU.

GLP-1 has the ability to lower blood sugar and help cells use glucose for fuel and energy but when the blood sugar becomes low its glucose lowering ability decreases. In this study, we want to see we want to see if GLP-1 may help keep the blood sugar within normal limits and reduce or eliminate the need for insulin. We will also see whether it will help the heart recover more quickly.

Eligibility criteria: Inclusion Criteria:

* Males and Females age \> 18 years of age
* Able to consent
* Scheduled for non-emergent coronary artery bypass graft (CABG)
* Have an ejection fraction \< 35%
* Ischemic patients with Left Ventricular Dysfunction (LVD) who need a valve procedure with their CABG

Exclusion Criteria:

* Emergency coronary artery bypass graft surgery
* Patients with an ejection fraction \> 35%
* Repeat or redo CABG patients
* Patients with a history of pancreatitis
* Pregnant or lactating females

Primary outcomes:
measure: Left Ventricular Systolic Function: Pulmonary Capillary Wedge Pressure
timeFrame: 2 years
Secondary outcomes:
measure: Insulin Infusion Requirements
timeFrame: 72 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Dariush Elahi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01885754: Characterization of Peripheral Muscle Function in Patients With Non-small-cell Lung Cancer
Official title: Characterization of Peripheral Muscle Function in Patients With Non-small-cell Lung Cancer.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Small-cell Lung Cancer
Keywords: Biopsy
Maximal incremental cardiopulmonary test
Muscle strength test
magnetic stimulation
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 56
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with NSCLC

Brief summary: Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer is the leading cancer-related death worldwide and it represents a pressing health issue. Patients with lung cancer are more likely to experience cachexia, a severe debilitating disorder causing fatigue, weight loss, muscle wasting and associated with reduced physical function, increased chemotherapy toxicity and reduced survival. This syndrome occurring in about 80% of advanced cancer patients is the direct cause of death in about 20% of cases. However, despite the importance of cachexia in lung cancer, its mechanisms ans its relation with muscle function and effort tolerance are still unknown.

Aim: To explore muscle function, signaling pathways and its relationship to impaired functional capacity of patients with non-small-cell lung cancer(NSCLC); depending of whether they have cachexic state at diagnosis.

Methods: This study will be conducted at the Institut universitaire de cardiologie et de pneumologie de Québec. 56 patients newly diagnosed of NSCLC will be recruited and separated whether or not they have a cachexic state. The evaluation will need two visits separated by 5 days.

During the evaluation the following tests will be done:

* Anthropometric measures
* Level of daily physical activity
* Pulmonary function test
* Maximal incremental cardiopulmonary exercise test on ergocycle
* Endurance test on ergocycle
* Muscle function tests
* Magnetic stimulation
* Quadriceps biopsy


Eligibility criteria: Inclusion Criteria:

* Men and women with a primary lung cancer diagnosis

Exclusion Criteria:

* Already have undertaken surgery, chemotherapy or radiotherapy treatment
* Having an other cancer in the last five years
* Taking anticoagulation therapy

Primary outcomes:
measure: Maximal quadriceps strength
timeFrame: 1 day (at the time of the diagnosis before any treatment)
Secondary outcomes:
measure: Exercise capacity
timeFrame: 1 day (at the time of the diagnosis before any treatment)
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec
state: Quebec
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: Didier Saey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04550754: Evaluation of the Management of Tramadol Use Disorders
Official title: Evaluation of the Medical Management of Tramadol Use Disorders in Patients Hospitalized for Tramadol Withdrawal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Withdrawal
Keywords: Substance use disorder
Programme de Medicalisation des Systèmes d'Information
tramadol
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Nīmes
First posted: 2020-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults hospitalized in Montpellier University Hospital and Nîmes University Hospital for Tramadol withdrawal

Brief summary: In France, In recent years, there has been a steady increase in reports of abuse and dependence on tramadol. Over 50% of tramadol withdrawal syndromes involve taking tramadol in therapeutic doses, sometimes for short periods of less than a week. Physical dependence can develop when a therapeutic maintenance dose is prescribed for the treatment of mild to moderate pain. Due to its mixed mechanism of action, tramadol withdrawal syndromes are not only characterized by classic signs of opioid withdrawal (muscle pain, mydriasis, sweating, nausea and vomiting, tearing, rhinorrhea, yawning, fever, insomnia, etc.). The properties of this substance on serotonin explain the effects which are added to the morphine-mimetic withdrawal of tramadol. Analysis of spontaneous reports shows "psychological and psychic" signs of withdrawal. Currently, there is no validated protocol for the management of tramadol withdrawal. The main objective is to assess the different options for managing tramadol withdrawal: opioid maintenance therapy and symptomatic treatments, in relation to the addictive and psychiatric co-morbidities in patients. The study also provides insight into the different types of withdrawal syndromes experienced by patients in order to raise awareness among doctors when prescribing tramadol.


Eligibility criteria: Inclusion criteria:

* \>18 years old
* Tramadol actual misuse/addiction
* Patients hospitalized for Tramadol withdrawal

Exclusion criteria:

* \<18 years old
* History of misuse or addiction for tramadol

Primary outcomes:
measure: Medical Management of Tramadol withdrawal syndrome
timeFrame: 1 day
Secondary outcomes:
measure: Tramadol withdrawal syndrome experienced by patients
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: UH Montpellier
name: Hélène Peyrière, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04384354: Digestive Events in Duchenne Muscular Dystrophy Patients
Official title: Digestive Events in Duchenne Muscular Dystrophy Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duchenne Muscular Dystrophy
Keywords: pseudo occlusion
gastrostomy
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 200
Sex: MALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Duchenne muscular dystrophy patients

Brief summary: Relation between clinical and genetic features and acute digestive events in Duchenne muscular dystrophy patients

Detailed description: Clinical Data of the disease Digestive events (pseudo occlusion, gastrostomy, cholecystectomy) Nutritionnal parameters Genetic of dystrophin (approved genetic nationnal Data base, CHU Cochin, Paris France)

Eligibility criteria: Inclusion Criteria:

* all Duchenne muscular dystrophy patients in our center

Exclusion Criteria:

* none

Primary outcomes:
measure: Incidence of digestive events
timeFrame: 11 years
measure: Prevalence of digestive events
timeFrame: 11 years
measure: Risk factors for digestive events (1)
timeFrame: 11 years
measure: Risk factors for digestive events (2)
timeFrame: 11 years
measure: Risk factors for digestive events (3)
timeFrame: 11 years
measure: Risk factors for digestive events (4)
timeFrame: 11 years
measure: Risks factors for digestive events (5)
timeFrame: 11 years
Secondary outcomes:
measure: Nutritional status (1)
timeFrame: 11 years
measure: Nutritional status (2)
timeFrame: 11 years
Other outcomes:
Locations:
city: Garches
country: France
facility: CICIT805
Study officials:
affiliation: APHP/UVSQ
name: CICIT805 Garches
role: STUDY_CHAIR
References:
Clinical trial NCT01289054: A Global Imatinib and Nilotinib Pregnancy Exposure Registry
Official title: A Global Imatinib and Nilotinib Pregnancy Exposure Registry A Post-Authorisation Safety Study (PASS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: All Indications for Glivec/Gleevec and Tasigna
Keywords: Female
Pregnancy
Hematologic Pregnancy
Complications
Registry
Pregnant Registry
CML
GIST
Gleevec
Tasigna
Glivec
Pregnancy Exposure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-02-03
Enrollment: 4
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women exposed to any dose of Gleevec/Glivec or Tasigna during pregnancy or within 6 months prior to conception

Brief summary: This is a voluntary, international, primarily prospective, observational, exposure-registry and follow-up study of women receiving Imatinib and Nilotinib during pregnancy or within six months prior to pregnancy.


Eligibility criteria: Inclusion Criteria:

* Provide sufficient evidence to confirm that exposure occurred during pregnancy or within 6 months prior to exposure.
* Be at least 18 years of age
* Reside in a country supported by the Registry

Exclusion Criteria:

* Cases that do not meet the eligibility criteria are deemed ineligible, including paternal exposures

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Monitor pregnancies exposed to Imatinib or Nilotinib to estimate prevalence of birth defects
timeFrame: During pregnancy or within 6 months prior to conception
Secondary outcomes:
measure: Assess impact on maternal CML disease when treatment is interrupted
timeFrame: During pregnancy or within 6 months prior to conception
measure: Assess post 12 month post-delivery data on maternal and infant status
timeFrame: 12 months after birth
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: INC Research, LLC
state: North Carolina
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00239954: Escitalopram Combination Comparison Study for Adult Patients With Major Depressive Disorder
Official title: Fixed Dose Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Pharmacology Research Institute
Sponsor class: OTHER
First posted: 2005-10-17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness, safety and tolerability of an escitalopram combination treatment compared to single treatments, and to placebo in patients with major depressive disorder.

Detailed description: Both active drugs being tested, alone and in combination, in this study are currently available antidepressants. However, the doses used in this study are lower than the standard approved doses.

Eligibility criteria: Inclusion Criteria:

* Patients must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder
* The patient's current depressive episode must be at least 12 weeks in duration.

Exclusion Criteria:

* Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
* Patients who currently meet DSM-IV criteria for : a. bipolar disorder; b. schizophrenia or any psychotic disorder; c. obsessive-compulsive disorder; d. mental retardation or any pervasive developmental disorder or cognitive disorder.
* Patients who are considered a suicide risk.
* Patients with a history of seizure disorder, or any history of seizure, stroke, significant head injury, or any other condition that predisposes toward risk of seizure.

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale (MADRS)
Secondary outcomes:
measure: Hamilton Depression Rating Scale (HAMD)
Other outcomes:
Locations:
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Northridge
country: United States
facility: Pharmacology Research Institute
state: California
city: Riverside
country: United States
facility: Pharmacology Research Institute
state: California
Study officials:
affiliation: Pharmacology Research Institute
name: Jon F. Heiser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pharmacology Research Institute
name: Nader Oskooilar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01182454: Clinical Test Report for Blood Pressure Meter of CH-658
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Keywords: blood pressure
Lead sponsor: Citizen Systems Japan Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-08-16
Enrollment: 96
Sex: ALL
Minimum age (years): 22
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: community sample

Brief summary: Blood pressure meter model CH-658 was to be assessed against the standard mercury sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.


Eligibility criteria: Inclusion Criteria:

* 96 subjects with a wide range of blood pressure were selected.

Exclusion Criteria:

* Subjects could be taking antihypertensive medication, but excluded in atrial fibrillation or with any sustained arrhythmia.

Primary outcomes:
measure: Measure accuracy of blood pressure meter CH-658
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sone Clinic
city: Toyko
country: Japan
facility: Sone Clinic
Study officials:
References:
Clinical trial NCT01682954: Evaluation of a Lifestyle Intervention for Employees With Prediabetes
Official title: Evaluation of a Lifestyle Intervention for Employees With Prediabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Overweight
Obese
Keywords: lifestyle risk reduction
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-09-11
Enrollment: 78
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: PREVENTION

Brief summary: The purpose of this study is to evaluate the impact of a worksite lifestyle intervention for diabetes prevention among employees with prediabetes.

Detailed description: The lifestyle intervention includes a 16-week group-based program which targets weight reduction through the adoption of a lower fat diet and greater physical activity.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* overweight or obese
* prediabetes with elevated glucose value

Exclusion Criteria:

* recent cardiovascular event
* use of corticosteroids
* concurrent participation in a structured weight loss program
* pregnant or lactating

Primary outcomes:
measure: Body Weight
timeFrame: 4 months
measure: Body Weight
timeFrame: 7 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Carla Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weinhold KR, Miller CK, Marrero DG, Nagaraja HN, Focht BC, Gascon GM. A Randomized Controlled Trial Translating the Diabetes Prevention Program to a University Worksite, Ohio, 2012-2014. Prev Chronic Dis. 2015 Nov 25;12:E210. doi: 10.5888/pcd12.150301.
citation: Miller CK, Nagaraja HN, Weinhold KR. Early weight-loss success identifies nonresponders after a lifestyle intervention in a worksite diabetes prevention trial. J Acad Nutr Diet. 2015 Sep;115(9):1464-71. doi: 10.1016/j.jand.2015.04.022. Epub 2015 Jun 19.
citation: Miller CK, Weinhold K, Marrero DG, Nagaraja HN, Focht BC. A Translational Worksite Diabetes Prevention Trial Improves Psychosocial Status, Dietary Intake, and Step Counts among Employees with Prediabetes: A Randomized Controlled Trial. Prev Med Rep. 2015;2:118-126. doi: 10.1016/j.pmedr.2015.02.003.