louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01421264: Gabapentin's Effects on Insomnia in Patients With Recent Concussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insomnia
Keywords: concussion
gabapentin
neurontin
insomnia
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2011-08-22
Enrollment: 21
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this open-label, pilot study the investigators will be assessing gabapentin's effects on insomnia and other concussion-related symptoms in patients with a recent concussion experiencing insomnia.


Eligibility criteria: Inclusion Criteria:

1. Head trauma causing concussion with either no loss of consciousness (LOC) or LOC \< 30 minutes within previous 2 weeks.
2. ISS score at Baseline of \> 14.
3. PCSS score at Baseline \> 5.
4. If brain imaging has been checked, there was no intracerebral hemorrhage noted.
5. Glasgow Coma Scale score of 15 at Baseline.
6. Age of at least 14 years old.
7. Has not taken gabapentin or pregabalin any time since concussion and has no history of intolerance to gabapentin or pregabalin.
8. Has not taken any sleeping pills for previous 2 nights and agrees not to take any for the next 2 weeks.

Exclusion Criteria:

Primary outcomes:
measure: Change in Insomnia Severity Index from Baseline to 1 week
timeFrame: 1 week
Secondary outcomes:
measure: Change in Post Concussion Symptom Scale score from Baseline to 1 week
timeFrame: 1 week
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo, Concussion Clinic
state: New York
Study officials:
References:
Clinical trial NCT01705964: Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation
Official title: Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Status asthmaticus
Asthma exacerbation
Epinephrine
Adjunctive therapy
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2012-10-12
Enrollment: 49
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Project Aim: To determine if intramuscular epinephrine is an effective adjunct to inhaled bronchodilators (β2 agonists) for children with severe asthma exacerbation.

Hypothesis: IM epinephrine is an efficacious adjunct to inhaled bronchodilators (β2 agonists) for children with severe asthma exacerbation.

Intervention: Subjects will be randomly assigned (50% chance) to receive a weight based dose of IM epinephrine 1:1000 or no adjunctive medication. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.

In addition to the study intervention, the standardized treatment pathway based on the current asthma guidelines in use at the investigator's center will be utilized. This pathway includes nebulized albuterol, ipratropium bromide, and systemic corticosteroids. The duration and dosages of these other interventions will be administered at the discretion of the treating provider.


Eligibility criteria: Inclusion Criteria:

1. Age greater than 6 years and less than 18 years
2. Pre-existing diagnosis of asthma
3. Presenting to the ED with an asthma exacerbation

Exclusion Criteria:

1. History of chronic lung or upper airway disease other than asthma
2. History significant, uncorrected congenital heart disease or cardiac arrhythmia
3. History of thyroid disease
4. Impending respiratory failure
5. Allergy to epinephrine
6. Pregnancy
7. PEFR\>60% of predicted and clinical asthma score less than 8

Primary outcomes:
measure: Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15
timeFrame: 15 minutes after the study intervention
Secondary outcomes:
measure: Disposition
timeFrame: At the time a dispostion from the ED is completed (usually within 4 hours of the study intervention)
measure: Change in Percent of Predicted PEFR at t120
timeFrame: 120 minutes after the study intervention
measure: Breaths Per Minute at t120
timeFrame: breaths per minute 120 minutes after the study intervention
measure: Heart Rate at t120
timeFrame: up to 120 minutes after the study intervention
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kosair Children's Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Kerry Caperell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06363864: Investigation of Metabolomics Differences Between Metabolic Syndrome and Healthy Individuals in Taiwan
Official title: Investigation of Metabolite Differences Between Taiwanese Metabolic Syndrome and Healthy Group Through Metabolomics
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Metabolic Syndrome
Lead sponsor: Leeuwenhoek Laboratories Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 1200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy individuals and patients with metabolic syndrom.

Brief summary: The prevalence of metabolic syndrome in Taiwan has been increasing yearly. In this project, the database of blood test results from healthy and metabolic syndromes individuals will be analyzed to identify the small molecules related to the severity of metabolic syndrome. These identified small molecules could be used as biomarkers to predict the development of metabolic syndromes in the future.


Eligibility criteria: Inclusion Criteria:

* Capable adults weigh ≥ 50 kg

Exclusion Criteria:

* Not Taiwanese
* Having received oral antibiotics, immunosuppressants, and chemotherapy drugs in the past month
* Incapacity
* Limited disposing capacity
* Mental disorders or intellectual disabilities

Primary outcomes:
measure: Concentration changes of small molecules in blood.
timeFrame: Up to six years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01999764: Evaluation of the Effects of Oral QLT091001 in Adults With Impaired Dark Adaptation
Official title: Evaluation of the Effects of Oral QLT091001 in Adults With Impaired Dark Adaptation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Impaired Dark Adaptation
Lead sponsor: QLT Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-03
Enrollment: 43
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase IIa proof-of-concept study to evaluate the effects of oral QLT091001 on adults with impaired dark adaptation.

Detailed description: This proof-of-concept study is a randomized, parallel design of two different oral doses of QLT091001 compared to placebo to evaluate treatment effects in patients with impaired dark adaptation.

Approximately 40 subjects will be enrolled in this study at approximately 7 centers in the US.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects ≥60 yrs with early age-related macular degeneration (AMD) based on LLLC BCVA criterion or evidence of impaired dark adaptation
* Subjects with high luminance high contrast best-corrected visual acuity (HLHC BCVA) of 40 letters (20/40 Snellen) or better in the study eye
* Capable and willing to provide consent

Exclusion Criteria:

* Women of child bearing potential
* Subjects with late AMD or any other optic neuropathy in the study eye
* Subjects with posterior subcapsular cataract or multifocal intra-ocular lens (IOL) in the study eye
* Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 60 days of Day 0 or who have taken any prescription/investigational oral retinoid medication within 6 months of Day 0
* Subjects taking age-related eye disease study (AREDS) supplements containing beta-carotene

Primary outcomes:
measure: Visual Acuity
timeFrame: Through 7 weeks
Secondary outcomes:
measure: Dark Adaptation Time
timeFrame: Through 7 weeks
Other outcomes:
measure: Glare Recovery
timeFrame: Through 7 weeks
Locations:
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Austin
country: United States
facility: Keystone Research Ltd.
state: Texas
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Seattle
country: United States
facility: Proliance Surgeons Inc.
state: Washington
Study officials:
affiliation: QLT Inc.
name: Sushanta Mallick, Ph.D MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT05604664: Clinical Value and Efficacy Index of Lymphadenectomy for Thoracic Escc
Official title: Clinical Value and Efficacy Index of Lymphadenectomy for Thoracic Esophageal Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 1727
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (1) Pathologic findings proved esophageal cancer (8th AJCC/UICC stage T1b-4aN0-3M0). (2) underwent esophagecomy (two-field or three-field LN dissection). (3)The primary tumor was thoracic esophageal cancer.

Brief summary: The goal of this observational study is to to clarify the focus of lymph node dissection during esophagectomy.. The main question\[s\] it aims to answer is:

* provide a basis for accurate staging and the relationship between OS and lymph node dissection


Eligibility criteria: Inclusion Criteria:

1. Pathologic findings proved ESCC (8th AJCC/UICC stage T1b-4aN0-3M0)
2. Underwent esophagecomy (two-field or three-field LN dissection)
3. The primary tumor was thoracic ESCC

Exclusion Criteria:

1. Located outside the thoracic
2. Patients underwent salvage or R1/R2 esophagecomy
3. The number of resected lymph nodes (RLNs) less than 15
4. With neoadjuvant therapy(NT) or salvage chemoradiotherapy(SCRT)

Primary outcomes:
measure: 5-year survival rate of lymph nodes metastases (%) in patients
timeFrame: 2010.1.1-2017.12.30
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Cancer Hospital and Research Institute
state: Sichuan
Study officials:
References:
Clinical trial NCT03917264: Dental Hygiene and Peri-Implant Tissues Homeostasis Ancillary Study
Official title: The Role of Dental Hygiene Procedures in Disruption of Healthy Homeostasis in Tissues Surrounding Dental Implants - Phase I (Ancillary Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-Implantitis
Keywords: implant
titanium
dental
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Royalty Research Fund - University of Washington
First posted: 2019-04-17
Enrollment: 34
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Peri-implantitis is an inflammatory disease that leads to loss of jawbone around dental implants. Recent discoveries have identified increased release of Titanium (Ti) particles around implants as being associated to peri-implantitis. In this ancillary study to the Dental Hygiene and Peri-Implant Tissues Homeostasis trial the objective is to determine potential triggers of increased Ti dissolution from the implant surface and the mechanisms by which Ti dissolution products amplify peri-implant inflammation. Results from this study will determine whether there is a differential response to Ti particles across individuals, which may alter susceptibility to peri-implantitis.


Eligibility criteria: Inclusion Criteria:

* Is the subject ≥ 25 years of age?
* Does the subject have an implant with a probing depth ≥ 5mm, bleeding on probing, and radiographic bone loss of \> 2mm?
* Is the subject committed to the study and the required follow-up visits?

Exclusion Criteria:

- Is the subject immune compromised? Is the subject diabetic? Does the subject take steroid medication? Does the subject regularly use non-steroidal anti-inflammatories? Is the subject pregnant or intending to become pregnant during the duration of the study? Has the subject had previous implantoplasty? Did the subject take any antibiotics in the last 3 months?

Primary outcomes:
measure: Titanium Dissolution
timeFrame: 12 weeks +/- 4 weeks
Secondary outcomes:
measure: Expression of pro-inflammatory cytokines in response to titanium
timeFrame: baseline
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: UTHealth San Antonio
state: Texas
city: Seattle
country: United States
facility: University of Washington School of Dentistry
state: Washington
Study officials:
affiliation: UTHealth San Antonio
name: Georgios Kotsakis, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05258864: Pilot Trial of an Online Personalised Normative Feedback Intervention to Reduce Drinking
Official title: Pilot Randomised Controlled Trial of an Online Personalised Normative Feedback Intervention to Reduce Drinking Among People With Unhealthy Alcohol Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Unhealthy alcohol consumption is common in the UK and causes tremendous harm to the individual, as well as harm to others. A significant gap in providing alcohol support is that most people with unhealthy alcohol consumption will never receive advice to cut down on their drinking. However, many are interested in self-directed interventions to help them evaluate their drinking and to motivate reductions in alcohol use. One such promising intervention uses online personalised normative feedback (PNF) which compares a person's drinking with others in the general population of the same age and sex. PNF interventions are thought to work because many people with unhealthy alcohol consumption overestimate how much others drink. Multiple trials have demonstrated that providing PNF to people with unhealthy consumption reduces their alcohol use . While several UK websites do provide feedback on assessment of risk (e.g., Down Your Drink introductory section, Alcohol Change UK), there appears to be no online intervention that provides PNF for unhealthy alcohol consumption.

The major objective of this pilot project is to conduct a two-arm, parallel group randomised controlled trial (RCT) in which 1,318 participants recruited from the Prolific website who have identified themselves as drinking 14 or more units per week are randomly assigned to one of two groups - a) those who are offered a PNF report, and b) those in a no intervention comparator group. Participants in the comparator group will not be provided any intervention materials but will instead be given a list of the different components of the PNF feedback and will be asked to think about how useful they would find each of them. Follow-up assessment will occur at 1 and 6 months post-randomisation. The project is described as a pilot because it is a preliminary evaluation of the PNF intervention in a UK context.


Eligibility criteria: Inclusion Criteria:

Typically consume 14+ standard UK alcohol units per week Willingness to complete a 6-month follow-up survey 18 years of age or older

Primary outcomes:
measure: Number of drinks consumed during a typical week
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
References:
Clinical trial NCT01668264: Imaging Assessment of Diastolic Function
Official title: Combined Echocardiographic and MRI Assessment of Diastolic Function in Patients With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Congenital Heart Disease
Keywords: Pediatrics
Congenital Heart Disease
Diastolic Function
Echocardiograph
MRI
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Diastolic function is poorly studied in children with congenital heart disease. This is mainly due to the lack of validated techniques. Cardiac MRI offers two advantages compared to echocardiography: 1. accurate measurements of ventricular volumes and mass; 2. tissue characterization. The main advantage of echocardiography is a better temporal resolution which allows the study of short events like early relaxation. Overall there is a lack of studies correlating different echocardiographic and MRI parameters of heart function in pediatric populations with congenital or acquired heart diseases. This study will address specific questions on specific groups of patients that might bring more insight into chamber interaction and cardiac function. This study hypothesizes the following:

* Atrial enlargement is a marker of chronic increase in filling pressures and 3D echo might be the best method for follow-up.
* Cardiac remodeling associated with chronic loading results in changes in diastolic properties related to changes in cardiac mass and volume. This is related to changes in cardiac mechanics influencing diastolic parameters. Especially the influence on twisting and untwisting will be studied.
* Regional myocardial fibrosis and scarring may account for regional systolic and diastolic dysfunction with possible prognostic impact


Eligibility criteria: Inclusion Criteria:

* All patients with tetralogy of Fallot post repair, transposition of great arteries after arterial switch operation, aortic valvulopathy (aortic stenosis and aortic regurgitation), coarctation of the aorta and cardiomyopathy, who are planned to undergo a cardiac MRI will be eligible.
* Informed consent

Exclusion Criteria:

* Lack of informed consent
* Need for general anesthesia
* Similar contraindications as for a clinical MRI study apply.

Primary outcomes:
measure: Atrial Volumes
timeFrame: Day 1
Secondary outcomes:
measure: Assess Ventricular Volumes
timeFrame: Day 1
measure: Myocardial Scarring
timeFrame: Day 1
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Luc Mertens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02219464: Nasopharyngeal Versus Nasal Cannula Oxygen Supplementation in Surgery Patients
Official title: Nasopharyngeal Versus Nasal Cannula Oxygen Supplementation in Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxygen Administration During Deep Sedation
Keywords: nasopharyngeal catheter
nasal cannula
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators plan to conduct a randomized, controlled trial comparing nasopharyngeal oxygen supplementation to traditional nasal cannula in patients undergoing oral surgery under moderate sedation.


Eligibility criteria: Inclusion Criteria:

* Patients greater than 16 years of age
* Patients who present for oral surgery or esophagoduodenography and colonoscopy
* Patients who undergo intravenous sedation

Exclusion Criteria:

* Patients who require endotracheal intubation
* ASA class 4 or higher
* Existing esophageal disease such as a perforation or varices

Primary outcomes:
measure: Number of Participants With Oxygen Saturations Below 92%
timeFrame: During surgical procedure
Secondary outcomes:
measure: Number of Participants Who Needed Airway Assistance Interventions
timeFrame: During surgical procedure
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Bret Alvis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00669864: Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin
Official title: Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-05-01
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Currently treated with basal insulin once or twice daily with or without oral anti-diabetic drugs (OADs) for at least 3 months
* HbA1c (glycosylated haemoglobin A1c) within the range of 7.5% to10.0% ( both inclusive)
* BMI (Body Mass Index) maximum 40 kg/m2

Exclusion Criteria:

* Metformin contraindications according to local practice
* Systemically treated with TZDs (thiazolidinediones) for more than one month within 6 months prior to this trial

Primary outcomes:
measure: Change in HbA1c (Glycosylated Haemoglobin A1c)
timeFrame: week 0, week 16
Secondary outcomes:
measure: Change in 8-point Plasma Glucose Profile
timeFrame: week 0, week 16
measure: Percentage of Subjects Achieving HbA1c Less Than 7.0%
timeFrame: week 16
measure: Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
timeFrame: week 16
measure: Hypoglycaemic Episodes
timeFrame: weeks 0-16
measure: Hypoglycaemic Episodes, Diurnal/Nocturnal
timeFrame: weeks 0-16
Other outcomes:
Locations:
city: Beijing
country: China
state: Beijing
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: