louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01155440: Bowel Function After Laparoscopic Colon Surgery: Effect of IV Lidocaine
Official title: Restoration of Bowel Function After Laparoscopic Colorectal Surgery: Effect of Intravenous Lidocaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colon Cancer
Inflammatory Bowel Diseases
Diverticulitis
Keywords: 60 patients scheduled to have a colorectal surgery
recruit at Montreal General Hospital
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2010-07-01
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: Patients receiving perioperative intravenous lidocaine, post operative restoration of bowel movement will be faster and decrease pain intensity, opioid consumption and side effects, length of hospital stay; probably as a result of a significant opioid sparing and attenuated inflammatory response.

Detailed description: The aim of this study is to assess whether perioperative intravenous lidocaine has an impact on the early postoperative physical activity recovery of patients scheduled for laparoscopic colorectal resection.

The study focuses on patients with colorectal disease, which receive the laparoscopic (assisted) surgical approach.

It is hypothesized that in those patients receiving perioperative and post-operative intravenous lidocaine, bowel function recovery will be faster, probably as a result of a significant opioid sparing, less pain and attenuated inflammatory response.

Eligibility criteria: Inclusion Criteria:

* scheduled to undergo laparoscopic colorectal resection

Exclusion Criteria:

* patients who have trouble to understand, read or communicate either in French or in English
* dementia
* patients suffering from severe physical disability (arthritis, neuromuscular dysfunction, stroke, paraplegia) or inability to walk or conduct daily activity
* patients suffering from severe cardiac or respiratory disease (status ASA IV
* patients suffering from metastatic carcinoma
* patients who have a history of chemoradiation within the six months preceding surgery
* allergy to lidocaine
* morbid obesity
* patients with chronic opioid use.

Primary outcomes:
measure: Restoration of bowel function
timeFrame: 72 hours after an operation
Secondary outcomes:
measure: Pain intensity
timeFrame: within 72 hours after an operation
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: MUHC
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Mingkwan Wongyingsinn, Fellow
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wongyingsinn M, Baldini G, Charlebois P, Liberman S, Stein B, Carli F. Intravenous lidocaine versus thoracic epidural analgesia: a randomized controlled trial in patients undergoing laparoscopic colorectal surgery using an enhanced recovery program. Reg Anesth Pain Med. 2011 May-Jun;36(3):241-8. doi: 10.1097/AAP.0b013e31820d4362.
Clinical trial NCT02246140: Intracranial Arterial Stenosis and Resin of Cannabis Use
Official title: Prevalence of Intracranial Arterial Stenosis in Regular Resin of Cannabis Users Compared to Control Subjects: a Preliminary Study of Feasibility
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cannabis Users
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: There is an association between intracranial arterial stenosis and ischemic stroke in young adults. The aim of this study is to evaluate the prevalence of intracranial arterial stenosis in asymptomatic regular resin of cannabis users in comparison with control subjects.


Eligibility criteria: Inclusion Criteria:

* regular resin of cannabis users

Exclusion Criteria:

* taking vasoactive medications
* taking other illicit drugs

Primary outcomes:
measure: Presence of intracranial arterial stenosis on cerebral MRA
timeFrame: 3 months
Secondary outcomes:
measure: -Silent ischemic stroke on cerebral MRI
timeFrame: 3 months
measure: -new intracranial arterial stenosis at 3 month follow-up
timeFrame: 3 months
measure: -Reversibility of intracranial arterial stenosis at 3 month follow-up
timeFrame: 3 months
Other outcomes:
Locations:
city: Strasbourg,
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Valerie Wolff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02186340: Effects of Inspiratory Muscle Training on Breathing Pattern in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Muscle Weakness Conditions
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The improvement in inspiratory muscle function might result in beneficial changes in breathing pattern during whole body exercise. The hypothesis is the effect of inspiratory muscle training as an adjunct to a pulmonary rehabilitation program improves the breathing pattern during an incremental cycle exercise.


Eligibility criteria: Inclusion Criteria:

* Clinically stable COPD patients
* maximal inspiratory pressure \<100% of the predicted normal value

Exclusion Criteria:

* Major comorbidities preventing successful participation in an 8 week exercise training intervention

Primary outcomes:
measure: Change in breathing pattern during an incremental cycle exercise test
timeFrame: Baseline and 8 weeks follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
Study officials:
affiliation: KU Leuven
name: Rik PT Gosselink, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Charususin N, Gosselink R, McConnell A, Demeyer H, Topalovic M, Decramer M, Langer D. Inspiratory muscle training improves breathing pattern during exercise in COPD patients. Eur Respir J. 2016 Apr;47(4):1261-4. doi: 10.1183/13993003.01574-2015. Epub 2016 Feb 25. No abstract available.
Clinical trial NCT04190940: Interactions of Brain Regions in Visuomotor Adaptation
Official title: Functional Interaction of Thalamus, Basal Ganglia, and the Cerebellum in Visuomotor Adaptation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High Intensity Focused Ultrasound
Deep Brain Stimulation
Keywords: Ultrasound
Thalamus
Cerebellum
Basal Ganglia
Deep Brain Stimulation
High Intensity Focused Ultrasound
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to better understand the roles the cerebellum, basal ganglia, and thalamus play in motor learning. Patients undergoing High Intensity Focused Ultrasound (HIFU) treatment will be receiving an ablation procedure to their thalamus as a part of their medical procedure. Participation in this study will include completing a behavioral task before and after the procedure to see how motor learning task performance differs with and without the thalamus. Similarly, patients undergoing Deep Brain Stimulation (DBS) treatment will have an electrode implanted in their thalamus as a part of their medical procedures. Participation in this study will include completing the motor learning task performance "on" and "off" thalamic electrical stimulation.


Eligibility criteria: Inclusion Criteria:

* Be a patient receiving either high intensity focused ultrasound treatment or deep brain stimulation treatment for Tremor
* Able to provide informed consent and complete study procedures
* Must speak English
* Age 18-85

Exclusion Criteria:

* Not receiving one of the specified inclusion criteria
* Unable to provide consent or complete study procedures
* Women who self-report pregnancy
* Patients who are currently incarcerated

Primary outcomes:
measure: Performance Error on Visuomotor Task
timeFrame: baseline, a week after HIFU treatment, several weeks after DBS implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
Clinical trial NCT00758940: Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL
Official title: A Six-months, Open-labelled Clinical Assessment of Visual Function After Bilateral Implantation of Arcysof ReSTOR Multifocal Intra-ocular Lens
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Visual Outcomes
Keywords: Clinical
assessment
of visual
function
with the Acrysof ReSTOR
multifocal IOL
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An unmasked trial after bilateral implantation of AcrySof® ReSTOR®, SA60D3 IOL . Enrolled are at least 30 patients or as much as possible from the doctor's clinical practice perspective. 6 months follow-up after IOL implant in the 2nd eye


Eligibility criteria: Inclusion Criteria:

* Able to complete all required postoperative visits; Planned cataract removal by phaco; 21 years of age or older, either gender or any race; potential postoperative visual acuity of 20/20; astigmatism ≦1.0D measured by keratometry in study eye(s);clear int

Exclusion Criteria:

* Signs of capsular tear, significant anterior chamber hyphema;zonular rupture; corneal pathology and refractive surgery;hypercritical patient; patients with unrealistic expectations in post-op VA; happy to wear glasses;occupational night drivers

Primary outcomes:
measure: Near,intermediate,distance visual acuity
timeFrame: pre-op;1 week after 1st eye surgery,1month and 6 month after 2nd eye surgery
Secondary outcomes:
measure: contrast sensitivity
timeFrame: 6 month after 2nd eye surgery
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center
state: Texas
Study officials:
References:
Clinical trial NCT01412840: Sterile Water Injections for Relieving Ureterolithiasis Pain
Official title: Sterile Water Injections as a Complementary Method for Relieving Ureterolithiasis Pain- a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ureterolithiasis
Pain
Keywords: Ureterolithiasis
Pain
Complementary
RCT
Lead sponsor: University of Skövde
Sponsor class: OTHER
First posted: 2011-08-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ureterolithiasis pain is a severe condition for which it takes some 30 minutes for standard treatment to yield maximal pain relief, a period during which the patient suffers severe to intolerable pain. It would thus be valuable to further evaluate sterile water injection as a method for achieving rapid relief for this type of pain.


Eligibility criteria: Inclusion Criteria:

* Ureterolithiasis pain, acute onset,
* Requires pain relief,
* Standard treatment prescribed,
* Age 18-60,
* Ability to understand and follow instructions

Exclusion Criteria:

* Other administration of NSAID for analgesia 12 hours prior to intervention,
* Pregnancy with obstructed flow of urine

Primary outcomes:
measure: Change in experience of pain
timeFrame: VAS before treatment and 1,5,10,15,20,30,60,90 and 12o minutes after treatment
Secondary outcomes:
measure: Requirement for additional pain relief
timeFrame: Reported in the protocol up to two hours after treatment
Other outcomes:
Locations:
city: Skövde
country: Sweden
facility: School of Life Sciences, University of Skövde
Study officials:
affiliation: University of Skövde
name: Ingrid Bergh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00229840: Evaluation of Functional MRI and DTI (Imaging Techniques) in Children With Epilepsy and Focal Brain Lesions
Official title: Advanced MR Imaging Evaluation Of Neurosurgical Candidates With Focal Abnormalities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: MRI, fMRI, Epilepsy, Pediatric
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-09-30
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is being done to look at the relationship between brain structure and brain function in patients with epilepsy or focal brain lesions (abnormal areas) that require surgery. This study will look at an imaging technique called magnetic resonance imaging (MRI) for looking at the brain. Specifically, the study will look at functional MRI, which is an imaging technique that can map brain function by taking pictures of the brain as it performs different tasks such as reading, thinking, or moving a body part and diffusion tensor imaging (DTI), which will look at brain structure. These types of imaging may help us learn more about different areas of the brain and how those areas of the brain are used in children with epilepsy. We plan to study 30 children with epilepsy.


Eligibility criteria: Inclusion Criteria:

* children with intractable epilepsy

Exclusion Criteria:

* children requiring sedation for scanning

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Scottish Rite
state: Georgia
Study officials:
affiliation: Emory University/Children's Healthcare of Atlanta
name: Richard Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01026467: Frailty Index and Geriatric Assessment in Predicting Toxicity to Front-Line Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
Official title: A Phase II Study of Fraility Index and Geriatric Assessment as Predictors of Toxicity to Front-Line Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-12-04
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Stage IV Non-Small Cell Lung Cancer

Brief summary: This phase II trial is studying how well a frailty index and geriatric assessment works in predicting toxicity to front-line chemotherapy in treating patients with stage IV non-small cell lung cancer. A frailty index and geriatric assessment prior to treatment may help identify a better treatment regimen

Detailed description: PRIMARY OBJECTIVE:

I. To determine the correlation of the data from the frailty index and geriatric assessment tool with the level of toxicity encountered in the first two cycles of therapy.

OUTLINE:

Patients complete a frailty index and geriatric assessment prior to beginning chemotherapy. Patients receive standard-of-care chemotherapy comprising carboplatin intravenously (IV) and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 2 courses.

Eligibility criteria: Inclusion Criteria:

Pathological documentation of non-small cell lung cancer Stage IV disease Prior adjuvant chemotherapy for the earlier stages of non-small cell lung cancer is allowed Patients with brain metastases are allowed on protocol only if they have received brain irradiation and are neurologically stable Patients with other malignancies are allowed on protocol unless they are receiving active treatment (surgery, radiation, chemotherapy or immunotherapy) for the other malignancy Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Prior palliative chemotherapy Pregnant and/or lactating women Prior radiation therapy other than brain irradiation for brain metastases

Primary outcomes:
measure: Use of the Frailty Index and/or the geriatric assessment in prediction of toxicity
timeFrame: Prior to chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Syracuse VA Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Heidi Klepin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00691067: A Controlled Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness
Official title: A Randomized, Double-blind Placebo-controlled Crossover Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Multisymptom Illness in Gulf War Veterans
Lead sponsor: Bronx Veterans Medical Research Foundation, Inc
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2008-06-05
Enrollment: 65
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We propose to conduct placebo-controlled trial of the glucocorticoid receptor antagonist mifepristone in Gulf War veterans (GWV) with chronic multisymptom illness (CMI) to examine its effects on physical and mental health and cognitive functioning. In addition, we propose to examine whether HPA axis biomarkers or their response to mifepristone are useful predictors of clinical response.


Eligibility criteria: Inclusion Criteria:

* Veteran of the 1991 Gulf War
* Veteran meets criteria for multisymptom illness

Exclusion Criteria:

* Veteran lacks the capacity to provide consent.
* Veteran has a major medical or neurological disorder or traumatic brain injury
* Veteran has morning plasma cortisol level less than 5 mcg/dl or a history of adrenal insufficiency
* Veteran is taking oral corticosteroids
* Veteran has a lifetime diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder
* Veteran has been psychiatrically hospitalized or attempted suicide within the previous 2 years
* Veteran has current suicidal ideation
* Veteran is pregnant or breastfeeding or plans to become pregnant within the year (male or female) not willing to use appropriate forms of contraception during the study and for at least 90 days post treatment.
* Women veterans with diseases of the uterus by history or a family history of uterine cancer
* Known allergy to mifepristone

Primary outcomes:
measure: change in the health components score of the veterans RAND 36-item health survey (VR-36)
timeFrame: baseline, every two weeks, endpoint
Secondary outcomes:
measure: cognitive functioning and measures of depression, fatigue and PTSD
timeFrame: baseline and endpoint
Other outcomes:
Locations:
city: Bronx
country: United States
facility: James J Peters VA Medical Center
state: New York
Study officials:
affiliation: James J Peters VA Medical Center
name: Julia A Golier, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Golier JA, Caramanica K, Michaelides AC, Makotkine I, Schmeidler J, Harvey PD, Yehuda R. A randomized, double-blind, placebo-controlled, crossover trial of mifepristone in Gulf War veterans with chronic multisymptom illness. Psychoneuroendocrinology. 2016 Feb;64:22-30. doi: 10.1016/j.psyneuen.2015.11.001. Epub 2015 Nov 10.
Clinical trial NCT01000467: Pharmacokinetics Study for Probucol
Official title: A Randomized, Open-label, Single-center Clinical Trial to Evaluate the Safety and Pharmacokinetics of Probucol by Multiple Administration in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: PK assessment for healthy male volunteer
Healthy male subjects aged 20 to 40 years
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-10-23
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To evaluate the safety and pharmacokinetics of probucol by multiple oral administration in healthy male subjects.

Detailed description: To evaluate the safety and pharmacokinetics of probucol by multiple oral administration of one 250-mg probucol tablet once daily after breakfast (250 mg/day), two 250-mg probucol tablets once daily after breakfast (500 mg/day), and one 250-mg probucol tablet twice daily after breakfast and dinner (500 mg/day) for 14 days in healthy male subjects.

Eligibility criteria: Inclusion criteria

* Korean
* Male
* Age from 20 to 40 years at time of informed consent
* BMI more than 19.0 and less than 25.0
* Subjects who meet the following criteria at the time of the screening
* Subjects with ECG results without AV block and with both of qTc and QRS width within the standard values

Exclusion criteria

* History or clinical evidence of significant medical history
* Present or previous significant drug allergy to any prescription or OTC medication

Primary outcomes:
measure: Plasma pharmacokinetic (PK) parameters: Auc, Cmax etc.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national univeristy
Study officials:
affiliation: Clinical Trial Center, Seoul National University Hospital
name: Kyung-Sang Yoo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: