louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00181116: Levetiracetam for Benign Rolandic Epilepsy
Official title: Efficacy of Levetiracetam for Language Dysfunction Associated With Benign Epilepsy With Centrotemporal Spikes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Keywords: Epilepsy
Benign rolandic
Levetiracetam
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2005-09-16
Enrollment: 6
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to test if the language problems commonly seen in children with benign rolandic epilepsy would improve by switching anticonvulsants to levetiracetam.

Detailed description: This is a 6 month study in which children on another anticonvulsant would have EEG, language testing, and a clinic visit at baseline. They would then be rapidly transitioned off of their current anticonvulsant and onto levetiracetam (Keppra). Repeat EEG and language testing would be done after 6 months to evaluate for improvement.

Eligibility criteria: Inclusion Criteria:

* Ages 6-12
* Benign rolandic epilepsy
* Language difficulties as reported by parents or teachers
* On another anticonvulsant other than levetiracetam

Exclusion Criteria:

* Prior use of levetiracetam
* On 2 or more anticonvulsants
* Language problems prior to epilepsy
* Another seizure disorder
* Status epilepticus within the past 6 months
* Significant psychiatric disease
* Progressive neurologic disease

Primary outcomes:
measure: Language improvement
Secondary outcomes:
measure: Seizure control
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Eric H Kossoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bello-Espinosa LE, Roberts SL. Levetiracetam for benign epilepsy of childhood with centrotemporal spikes-three cases. Seizure. 2003 Apr;12(3):157-9. doi: 10.1016/s1059-1311(03)00004-9.
citation: Kossoff EH, Boatman D, Freeman JM. Landau-Kleffner syndrome responsive to levetiracetam. Epilepsy Behav. 2003 Oct;4(5):571-5. doi: 10.1016/s1525-5050(03)00171-9.
Clinical trial NCT01018316: UMOX - New Device for Oropharyngeal Preoxygenation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preoxygenation
Keywords: preoxygenation
UMOX
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2009-11-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Volunteers

Brief summary: The UMOX is a device that has been designed as an alternative to the conventional face mask for preoxygenation to be used when an optimal preoxygenation with a facemask is difficult to achieve(i.e: when a leak is present. A previous study in our hospital (unpublished data) has shown that the UMOX was only as effective as the conventional mask when a nose clip was used to prevent the patients from breathing in some air through the nose, thus preventing the dilution/contamination of the 100% oxygen delivered.In that study, the verbal indication giving to the subjects to breathe through the mouth was better than no indication at all but still yielded unsatisfactory results.

For this reason, the present study was designed to verify the hypothesis that while using the UMOX for preoxygenation, the verbal indication of breathing 8 vital capacity breaths added to the indication of breathing through the mouth would bring equivalent results -measured by the expired fraction of oxygen- as a preoxygenation of normal tidal breathing through a facemask during 3 to 5 minutes.

Preoxygenation was performed with the 60 volunteers placed in the supine position with 100% oxygen. All volunteers went though preoxygenation with two techniques: 1) breathing normal tidal volumes at a normal respiratory rate for a period of 5 minutes through a tight fitting conventional face mask, and 2) eight deep breaths (i.e. vital capacity breaths) through the UMOX device with verbal indication to use only the mouth to breathe.


Eligibility criteria: Inclusion Criteria:

* ASA I or II, smoker or non smoker

Exclusion Criteria:

* patients under 18 years old or over 65 years old; edentulous patients or those with craniofacial malformations, beards or mustaches; patients that have \>30 kg over their ideal weight; and patients with moderate to severe pulmonary pathology

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT04683016: Disease Perception and Oral Health Impact Profile (OHIP) Before and After Non-surgical Periodontal Treatment
Official title: Disease Perception and Oral Health Impact Profile (OHIP) Before and After Non-surgical Periodontal Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Keywords: Oral Health Impact Profile 14
OHIP 14
non surgical periodontal treatment
brief-Illness Perception Questionnaire
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a diagnosis of Periodontitis will be eligible for the inclusion in the study.

Brief summary: The presence of periodontal diseases in patients has been associated to a worsened quality of life overall. Many different indices have been proposed over time in order to evaluate patient's centred outcomes. In particular, the most thorough questionnaire proposed so far is the Oral Health Impact Profile 49 (OHIP-49), which is composed of 49 questions. Despite its validity being unquestionable, OHIP-49 was found to be too time-consuming for the clinical scenario and, therefore, its shortened 14-question version has been proposed. A more in-depth knowledge of how these parameters change before and after periodontal treatment could enable clinicians to tailor the treatment plan according to the patients' needs.


Eligibility criteria: Inclusion Criteria:

* patients being at least 18 years old
* Patients with a diagnosis of Periodontitis

Exclusion Criteria:

* diagnosis Gingivitis
* diagnosis of periodontal health
* inability or unwillingness to give informed consent

Primary outcomes:
measure: Change in Brief Illness Perception Questionnaire (Brief IPQ) before and after non-surgical periodontal treatment
timeFrame: The questionnaire will be carried out at baseline and re-evaluation (3 months after non-surgical periodontal treatment). The change in the Brief IPQ values at baseline and after 3 months will be considered as the primary outcome measure.
measure: Change in Oral Health Impact Profile 14 before and after non-surgical periodontal treatment
timeFrame: The questionnaire will be carried out at baseline and re-evaluation (3 months after non-surgical periodontal treatment). The change in the OHIP-14 values at baseline and after 3 months will be considered as the primary outcome measure.
Secondary outcomes:
measure: Change in Full Mouth Bleeding Score (FMBS) before and after non-surgical periodontal treatment
timeFrame: FMBS will be calculated at baseline and re-evaluation (3 months after non-surgical periodontal treatment). The change in the FMBS at baseline and after 3 months will be considered as the secondary outcome measure.
Other outcomes:
Locations:
city: Siena
country: Italy
facility: AOUS
Study officials:
References:
Clinical trial NCT04594616: Waitlist-Control Trial of Smartphone CBT for Major Depressive Disorder (MDD)
Official title: Smartphone Cognitive Behavioral Therapy for Major Depressive Disorder: A Randomized, Waitlist-control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Koa Health B.V.
First posted: 2020-10-20
Enrollment: 0
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 investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for major depressive disorder (MDD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in SIGH-D scores than those in the waitlist condition at treatment endpoint (week 8).

Detailed description: The primary aims of this study are to test the efficacy of a Smartphone-based CBT treatment for adults with MDD recruited nationally. Eligible subjects (N=112) will be randomly assigned to 8 weeks of Smartphone-delivered CBT for MDD either immediately, or after a 8-week long waiting period (50-50 chance). The investigators hypothesize that Smartphone-delivered CBT for MDD will be feasible and acceptable to individuals with MDD, and that it will lead to greater reductions in MDD symptom severity compared to the passage of time (waitlist control).

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Current diagnosis of primary DSM-5 MDD, based on MINI
* Currently living in the United States

Exclusion Criteria:

* Psychotropic medication changes within 2 months prior to enrollment (Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period)
* Past participation in ≥ 4 sessions of CBT for depression
* Current severe substance use disorder
* Lifetime bipolar disorder or psychosis
* Acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥ 2 on the suicidal ideation subscale of the C-SSRS
* Concurrent psychological treatment
* Does not own a supported mobile Smartphone with a data plan
* Lack of technology literacy that would interfere with ability to engage with smartphone treatment

Primary outcomes:
measure: Difference in MDD severity (SIGH-D) at the end of treatment/waitlist period.
timeFrame: Endpoint (week 8)
Secondary outcomes:
measure: Difference in functional impairment at the end of treatment/waitlist period
timeFrame: Endpoint (week 8)
measure: Difference in quality of life at the end of treatment/waitlist period: Q-LES-Q-SF
timeFrame: Endpoint (week 8)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sabine Wilhelm, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03506516: Does Mixing Alcoholic Drinks Make Hangover Worse?
Official title: Does Mixing Alcoholic Drinks Make Hangover Worse? A Randomized Controlled Trial in a Naturalistic Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol-Related Disorders
Keywords: alcohol, hangover
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Does mixing alcohol make hangover worse?

Detailed description: Hangover is the most commonly occurring morbidity associated with heavy drinking.

Our aim was to test the hypothesis that mixing alcoholic drinks as compared to drinking one type of alcohol only (beer, wine or spirits) associate with a higher alcohol intake and worse hangover.

Eligibility criteria: Inclusion Criteria:

* written and oral consent
* minimum 18 years old
* participating in Danish Health Research Retreat in Turkey 2016
* will consume alcoholic beverages

Exclusion Criteria:

* underage
* will not consume alcoholic beverages

Primary outcomes:
measure: Acute Hangover Severity Scale (AHSS)
timeFrame: Baseline
Secondary outcomes:
measure: Number of drinks
timeFrame: Baseline
measure: Acute Hangover Severity Scale (AHSS) 2
timeFrame: after 4 hours
measure: Acute Hangover Severity Scale (AHSS) 3
timeFrame: after 8 hours
Other outcomes:
Locations:
Study officials:
affiliation: Zealand University Hospital
name: Ole G Christiansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06137716: Robotic Assisted Hand Rehabilitation Outcomes in Adults After COVID-19
Official title: Development and Clinical Trials of a Rehabilitation Platform to Accelerate the Recovery of Patients With COVID Neuromotor Sequelae
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Robotic Exoskeleton
Post-acute Covid-19 Syndrome
Rehabilitation Outcome
Physical And Rehabilitation Medicine
Lead sponsor: University of Valladolid
Sponsor class: OTHER
Collaborators: name: Centro Hospitalario Padre Benito Menni
First posted: 2023-11-18
Enrollment: 13
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prolonged hospitalization in severe COVID-19 cases can lead to substantial muscle loss and functional deterioration. While rehabilitation is vital, conventional approaches encounter capacity constraints. Therefore, assessing the efficacy of robotic-assisted rehabilitation is crucial for post-COVID-19 fatigue syndrome patients, aiming to improve motor function and overall recovery. The study focuses on evaluating rehabilitation effectiveness in individuals with upper-extremity impairment using a hand exoskeleton-based robotic system.


Eligibility criteria: Inclusion Criteria:

* Over 30 years old
* Patients infected with COVID-19 and has received care at the Centro Hospitalario Benito Menni
* Patients with acute or limited functional or strength impairment in at least one of the upper extremities
* Patients who would complete a rehabilitation program and a series of patient reported outcome questionnaires and a follow up evaluation
* Patients who give inform written consent.

Exclusion Criteria:

* Presence of behavioral disorders
* Dementia (loss of memory of cognitive functions)
* Disorders of consciousness (confusional states and drowsiness)
* Uncontrolled or severely limiting delusions and hallucinations
* Infectious skin diseases
* Rrisk of epileptic seizures due to COVID itself or prior to it
* Severe visual impairments
* Severe spasticity with a Modified Ashworth Scale \>2, joint stiffness in the wrist and fingers
* Pain with a score \>8 on the Visual Analog Scale (VAS) during mobilization of the affected hand.

Primary outcomes:
measure: Barthel Index (BI)
timeFrame: Baseline / 6 weeks
measure: Functional Independence Measure (MIF)
timeFrame: Baseline / 6 weeks
measure: SF-36 Health Questionnaire
timeFrame: Baseline / 6 weeks
measure: Range of motion
timeFrame: Baseline / 6 weeks
Secondary outcomes:
measure: Semi-structured interview
timeFrame: Baseline
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Centro Hospitalario Padre Benito Menni
Study officials:
References:
Clinical trial NCT03390816: Nutritional Status Assessment in the Elderly Suffering From Cancer : a National Cross-UCOG Survey
Official title: Nutritional Status Assessment in the Elderly Suffering From Cancer (NutriAgeCancer) : a National Cross-UCOG Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malnutrition
Cancer
Elderly
Keywords: malnutrition
cancer
elderly
Lead sponsor: Société Francophone d'Onco-Gériatrie
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 1886
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly people, who are more than 70 years old, suffering from cancer, waiting for a treatment decision and taken care of in a hospital

Brief summary: Protein-energy malnutrition (PEM) is a frequent condition in patients suffering from cancer, especially the elderly. According to some studies, this malnutrition has important consequences in this population, by increasing the risk of treatment toxicities, premature interruption of chemotherapy, mortality and risks of complications. Identifying cases of malnutrition is an objective pursued by the National Nutrition and Health Programme and an important task of the "Unités de Coordination en Oncogériatrie".

The main goal of this study is to assess the loss of weight over the 6 month-period preceding the cancer treatment, regardless of kind (chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiation therapy, surgery, comfort care), in the elderly suffering from cancer.


Eligibility criteria: Inclusion Criteria:

* Over 70 years of age
* Suffering from cancer
* Waiting for a treatment decision (whatever it is)
* Hospitalized in a hospital or come to consult in a hospital during the period of inclusion (2 periods of 6 weeks for two consecutive years)
* Affiliated to a social security system

Exclusion Criteria:

* Patient unable to receive information regarding the study and/or provide its non objection regarding the use of its data
* Patient under tutorship or curatorship, deprived of freedom or placed under judicial protection

Primary outcomes:
measure: loss of weight
timeFrame: 3 to 6 month-period preceding the cancer treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Creteil
country: France
facility: Hôpital Henri Mondor
Study officials:
affiliation: APHP
name: Elena PAILLAUD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02801916: Effect of Consuming Oat Bran Mixed in Water Before a Meal on Glycemic Responses in Healthy Humans - a Pilot Study
Official title: Effect of Consuming Oat Bran Mixed in Water Before a Meal on Glycemic Responses in Healthy Humans - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Intolerance
Keywords: Humans
Glycemic response
Oat beta-glucan
Lead sponsor: Glycemic Index Laboratories, Inc
Sponsor class: INDUSTRY
Collaborators: name: DSM Nutritional Products, Inc.
First posted: 2016-06-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Viscous dietary fibers including oat β-glucan are one of the most effective classes of functional food ingredients for reducing postprandial blood glucose. The mechanism of action is thought to be via an increase in viscosity of the stomach contents that delays gastric emptying and reduces mixing of food with digestive enzymes, which, in turn, retards glucose absorption. Previous studies suggest that taking viscous fibers separate from a meal may not be effective in reducing postprandial glycemia. The purpose of this study is to re-assess the effect of consuming a preload of a commercially available oat-bran (4.5, 13.6 or 27.3 g) containing 22% of high molecular weight oat β-glucan (O22) mixed in water before a test-meal of white bread on glycemic responses in 10 healthy humans.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Pregnancy
* Diabetes
* Recent medical or surgical hospitalization
* Use of drugs influencing glucose metabolism
* Use of drugs influencing gastrointestinal function
* Allergy to oats or wheat

Primary outcomes:
measure: Glucose AUC
timeFrame: 0 to 2 hours after test meal
Secondary outcomes:
measure: Peak rise of blood glucose
timeFrame: 0 to 2 hours after test meal
Other outcomes:
Locations:
Study officials:
affiliation: Glycemic Index Laboratories, Inc
name: Thomas MS Wolever, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04272216: An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres
Official title: The RAVI Registry: A Prospective, Multi-Center, Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Fibroid
Arteriovenous Malformations
Hypervascular Tumors
Benign Prostatic Hyperplasia
Lead sponsor: Terumo Medical Corporation
Sponsor class: INDUSTRY
First posted: 2020-02-17
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective, multi-center, registry study to assess the procedural success, technical success, and complication rate of radial access procedures using HydroPearl microspheres.

Brief summary: This registry study is designed to collect data on the procedural success and complication rates in real-world patients undergoing HydroPearl embolization procedures via radial access.


Eligibility criteria: Inclusion Criteria:

1. Subject is ≥ 18 years old
2. Subject is scheduled for a procedure for treatment with HydroPearl microspheres using radial access.
3. Subject is willing and able to complete follow-up requirements
4. Subject is willing and able to sign a written Informed Consent form prior to participating in the registry.

Exclusion Criteria:

1. Unable to have a procedure with radial access for any reason.
2. Participating in another clinical study which, in the opinion of the investigator, could impact the results of this registry.
3. Pregnant or planning to become pregnant during the study.

Primary outcomes:
measure: Procedural Success
timeFrame: During procedure
measure: Technical Success
timeFrame: End of procedure
measure: Freedom from major adverse events and radial access complications
timeFrame: within 30 days post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California - Los Angeles
state: California
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Saint Louis
country: United States
facility: SLU Department of Radiology
state: Missouri
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: UNC
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Marcelo Guimaraes, MD
role: PRINCIPAL_INVESTIGATOR
References: