louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01122862: Effect of a Commercial Cosmetic Mouth Rinse on Plaque Re-growth
Official title: A Clinical Study to Evaluate the Effect of a Commercial Cosmetic Mouth Rinse on Plaque Re-growth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Subjects
Keywords: tooth plaque
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-05-13
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: A clinical study to evaluate the effect of a commercial mouth rinse on plaque re-growth


Eligibility criteria: Inclusion Criteria:

* Good general and oral health
* At least 20 natural gradable teeth
* Mean plaque score (Turesky Modification of the Quigley Hein Index) of greater than or equal to 2.00 at the first baseline visit

Primary outcomes:
measure: Plaque Index of Test Mouth Rinse Versus Sterile Water After Day 4 of Treatment Administration
timeFrame: Day 4 post treatment administration
Secondary outcomes:
measure: Plaque Index Score of Test Mouth Rinse Versus Chlorhexidine Mouth Rinse After Day 4 of Treatment Administration
timeFrame: Day 4 post treatment administration
measure: Plaque Index After 24 Hours of Treatment Administration
timeFrame: Day 1 post treatment administration
measure: Interproximal Plaque Index After Day 4 of Treatment Administration
timeFrame: Day 4 post treatment administration
measure: Interproximal Plaque Index After 24 Hours of Treatment Administration
timeFrame: Day 1 post treatment administration
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: GSK Investigational Site
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00572962: Prospective Clinical Observational Cohort Study to Evaluate the Use of a Tissue Separating Mesh (Proceed®) in Laparoscopic Ventral Hernia Repair
Official title: Prospective Clinical Observational Cohort Study to Evaluate the Use of a Tissue Separating Mesh (Proceed®) in Laparoscopic Ventral Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2007-12-13
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 1. General: antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery
2. Laparoscopic surgery

   * at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm)
   * with or without anchoring transparietal sutures or double crown technique


Eligibility criteria: Inclusion Criteria:

* written informed consent from the patient or his/her legal representative
* ventral hernia requiring elective surgical repair

Exclusion Criteria:

* no written informed consent
* 'hostile' abdomen; open abdomen treatment
* contraindication to pneumoperitoneum
* emergency surgery (incarcerated hernia)
* parastomal hernia

Primary outcomes:
measure: recurrence rate
timeFrame: after 1 year
Secondary outcomes:
measure: morbidity rate
timeFrame: perioperative
measure: quality of life
timeFrame: after 1 year
measure: postoperative pain
timeFrame: within 1 week
measure: long term complication rate
timeFrame: after 1 year
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Frederik Berrevoet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berrevoet F, Tollens T, Berwouts L, Bertrand C, Muysoms F, De Gols J, Meir E, De Backer A. A belgian multicenter prospective observational cohort study shows safe and efficient use of a composite mesh with incorporated oxidized regenerated cellulose in laparoscopic ventral hernia repair. Acta Chir Belg. 2014 Jul-Aug;114(4):233-8.
Clinical trial NCT02392962: Dynamic and Static Stretching on Postural Stability, Reaction Time and Countermovement Jump of Sprinters
Official title: Efectos de la Fatiga en el Rendimiento físico en el Ejercicio de Sentadillas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Stability
Keywords: proprioception
countermovement jump
postural balance
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
Collaborators: name: University of Jaén
First posted: 2015-03-19
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: All the athletes should perform a warm-up consisting of five minutes of jogging and static stretching (Experimental Group 1) or dynamic stretching (Experimental Group 2). Before the beginning of the study and right after performing the stretching protocol, the investigators evaluated the unipedal postural stability, the acustic reaction time, the joint position sense of the knee and the countermovement jump of the athletes.


Eligibility criteria: Inclusion Criteria:

* National level Sprinters
* Two years or more of experience

Exclusion Criteria:

* Free of injuries in the last six months

Primary outcomes:
measure: Change in the unipedal postural balance of athletes
timeFrame: baseline and 15 minutes
measure: Change in counter-movement jump of athletes
timeFrame: baseline and 17 minutes
measure: Change in Joint Position Sense of the knee of athletes
timeFrame: baseline and 20 minutes
measure: Change in Acustic Reaction Time of athletes
timeFrame: baseline and 22 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: University of Jaén
Study officials:
References:
Clinical trial NCT00184262: Exposure and Response Prevention With Behavioral- Versus Cognitive Therapy Rationale in Obsessive Compulsive Disorder
Official title: Exposure and Response Prevention (ERP) With Behavioral- Versus Cognitive Therapy Rationale in the Treatment of OCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Norwegian Foundation for Health and Rehabilitation
First posted: 2005-09-16
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to determine whether exposure and response prevention (ERP) is more effective when patients are presented with a behavioral therapy versus cognitive therapy rationale in the treatment of obsessive-compulsive disorder (OCD).

Detailed description: The aim of the study is to determine whether exposure and response prevention (ERP) is more effective when patients are presented with a behavioral therapy versus cognitive therapy rationale in the treatment of obsessive-compulsive disorder OCD.

A randomized controlled trial including patients with OCD. 50 patients will receive 15 ERP sessions in 3 months.

Eligibility criteria: Inclusion Criteria:

* Obsessive-compulsive disorder

Exclusion Criteria:

* active thought disorder, uncontrolled bipolar disorder, mental retardation, organic mental disorder, initiation or change in medication three months prior to inclusion in the study

Primary outcomes:
measure: scores on Y-BOCS and SCID-I
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology, INM
Study officials:
affiliation: Norwegian University of Science and Technology
name: K. Gunnar Götestam, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hansen B, Vogel PA, Stiles TC, Gotestam KG. Influence of co-morbid generalized anxiety disorder, panic disorder and personality disorders on the outcome of cognitive behavioural treatment of obsessive-compulsive disorder. Cogn Behav Ther. 2007;36(3):145-55. doi: 10.1080/16506070701259374.
Clinical trial NCT02236962: Enhancement of Brown Adipose Tissue Function Via Chronic Pharmacological Treatment
Official title: Enhancement of Brown Adipose Tissue Function Via Chronic Pharmacological Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Obesity
Cardiovascular Disease
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: Baker Heart and Diabetes Institute
name: The Alfred
First posted: 2014-09-11
Enrollment: 42
Sex: MALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Obesity is epidemic in Australia, and current preventative strategies have had limited success in alleviating this health crisis. While numerous options are available for treatment of obesity, most do not result in sustained weight reduction. Obesity results from an imbalance between energy intake and expenditure, therefore new methods that correct this imbalance are essential for effective long-term treatment. Rodent studies show that brown adipose tissue (BAT) can burn more energy than any other tissue in the body, therefore targeting BAT to increase its activity (energy burning rate) and quantity in humans is potentially a powerful tool for the treatment of obesity and related diseases. BAT has only recently been irrefutably identified in adult humans therefore little is known about how it functions in humans.


Eligibility criteria: Inclusion Criteria:

* Males aged 19 - 35 years
* Free of overt coronary disease (on history, medical examination and ECG)
* Unmedicated
* No major illness
* BMI \<27 kg/m2

Exclusion Criteria:

* Unable to give informed consent
* Smokers
* Participant in research projects involving ionising radiation within the past 5 years.
* Claustrophobia
* Fasting plasma glucose \> 6.0 mmol/L

Primary outcomes:
measure: brown adipose tissue activity
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
References:
citation: Loh RKC, Formosa MF, Eikelis N, Bertovic DA, Anderson MJ, Barwood SA, Nanayakkara S, Cohen ND, La Gerche A, Reutens AT, Yap KS, Barber TW, Lambert GW, Cherk MH, Duffy SJ, Kingwell BA, Carey AL. Pioglitazone reduces cold-induced brown fat glucose uptake despite induction of browning in cultured human adipocytes: a randomised, controlled trial in humans. Diabetologia. 2018 Jan;61(1):220-230. doi: 10.1007/s00125-017-4479-9. Epub 2017 Oct 18.
citation: Carey AL, Pajtak R, Formosa MF, Van Every B, Bertovic DA, Anderson MJ, Eikelis N, Lambert GW, Kalff V, Duffy SJ, Cherk MH, Kingwell BA. Chronic ephedrine administration decreases brown adipose tissue activity in a randomised controlled human trial: implications for obesity. Diabetologia. 2015 May;58(5):1045-54. doi: 10.1007/s00125-015-3543-6. Epub 2015 Mar 1.
Clinical trial NCT03278080: Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #1
Official title: Development of Assessment Method of Driving Ability Using Driving Simulator in Healthy Volunteers #1: Measurement Setup of Assessment Criteria for Driving Ability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Nagoya University
First posted: 2017-09-11
Enrollment: 20
Sex: MALE
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to set an optimal measurement time for assessing driving ability in a driving simulator in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ≥18.5 and \<25.0 kg/m2 at screening inspection
* No visual impairment (enable to correct the vision with eyeglasses or contact lens)
* Receive a prior explanation on the study, able to accept its content, and capable to provide voluntary written consent for participation in this study

Exclusion Criteria:

* History of drug and food allergy
* Routinely drink alcohol before bedtime
* Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator

Primary outcomes:
measure: Standard Deviation of Lateral Position (SDLP)
timeFrame: 60 min.
Secondary outcomes:
measure: Distance Coefficient of Variation (DCV)
timeFrame: 25 min.
measure: Brake Reaction Time (BRT)
timeFrame: 15 min.
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Shigeru Okuyama
role: STUDY_DIRECTOR
References:
Clinical trial NCT03642080: MRI Predictors of Response to Tumor Treating Fields
Official title: Imaging Biomarkers to Predict Responsiveness to Tumor Treating Fields in Patients With High Grade Glioma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioblastoma Multiforme
Lead sponsor: New York Presbyterian Brooklyn Methodist Hospital
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient with newly diagnosed or with recurrent glioblastoma who meet the eligibility criteria of the study.

Brief summary: Patients with glioblastoma, an aggressive brain tumor, are recommended to undergo treatment with tumor treating fields using the Optune device as part of standard of care therapy. While undergoing treatment, patients are monitored regularly with brain MRI scans to look for tumor progression, but there are currently no means to predict which, or when, patients will progress. The purpose of the current study is to prospectively analyze these MRI scans to look for subtle imaging markers that can predict for future brain tumor progression while undergoing tumor treating field therapy.

Detailed description: The proposed trial involves the prospective collection of imaging data at standard clinical time points before and during treatment with TTFields. All patients who are offered treatment with TTFields will also be offered enrollment in this non-randomized, observational study. Imaging data will include the standard battery of MRI sequences, which includes DWI and ADC reconstruction. These data will be collected at standard time points and the proposed study will not rely on any additional imaging or tests outside of the clinical standard of care.

Eligibility criteria: Inclusion Criteria:

* Patients age 18 or older with newly diagnosed WHO grade IV glioblastoma or patients with recurrent glioblastoma not previously treated with TTFields.
* Patients may have undergone surgical resection or biopsy.
* Residual tumor, absence of treatment with temozolomide or radiation therapy will not be an exclusion criteria for the study.

Exclusion Criteria:

* Patients previously treated with TTFields will not be included in the study.
* Patients will also be excluded if they are undergoing active treatment with systemic agents, including bevacizumab, during treatment with TTFields.

Primary outcomes:
measure: Progression of disease
timeFrame: Until discontinuation of tumor treating fields, progression or death. This will be evaluated by imaging and clinical exam from the time of trial enrollment until up to 36 months at approximately three-month intervals.
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: New York Presbyterian - Brooklyn Methodist Hospital
state: New York
Study officials:
affiliation: New York Presbyterian Hospital - Brooklyn Methodist Hospital
name: Adel Guirguis, MD, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT03981380: 11C-PIB PET Study in MESA at Columbia University
Official title: 11C-PIB PET Study in the Multi Ethnic Study of Atherosclerosis at Columbia University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Vascular Diseases
Alzheimer Disease
Atherosclerosis
Keywords: Alzheimer Disease
Cognitive Impairment
11C-PiB
Atherosclerosis
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Wake Forest University
name: National Institute on Aging (NIA)
First posted: 2019-06-10
Enrollment: 59
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current participants in MESA study in New York City

Brief summary: The investigators will conduct a study of brain positron emission tomography (PET) using 11C-PIB for the imaging of brain amyloid in 250 participants in the Multiethnic study of atherosclerosis (MESA) at Columbia University Irving Medical Center in New York City. Participants will be imaged only once with Pittsburgh Compound B (PIB) PET.

Detailed description: This is a single center PET study of 11C-PIB. Eligible participants are current participants in the MESA study in New York City, without contraindications to MRI or PET procedures. Those eligible will have one brain PET scan with 11C-PIB within 12 months of a brain MRI. Vital signs will be checked prior to injection of 11C-PIB, 10 minutes after the injection, and again at the completion of the PET scan. The primary outcome measure for amyloid will be whole brain 11C-PIB SUVR. The relation between exposure groups and amyloid in the brain will be analyzed using linear regression.

Eligibility criteria: Inclusion Criteria:

* Current participants in MESA study at Columbia University
* 60 years or older
* Fluent in English and/or Spanish.
* Able to participate in all scheduled evaluations and to complete all required tests and procedures.

Exclusion Criteria:

* Active treatment for cancer
* Any serious medical condition which would prevent long-term participation
* Pregnancy
* Weight \>300 pounds
* Participants previously diagnosed or adjudicated to have dementia
* Participants unwilling to undergo cognitive testing
* Plans to leave the community within five years
* Language barrier (speaks other than English, Spanish, Chinese)
* Inability to give informed consent or to obtain consent from a Legally Authorized Representative (LAR)

Primary outcomes:
measure: Whole Brain 11C-PIB SUVR
timeFrame: 40 to 90 minutes post injection
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Professor of Medicine and Epidemiology
name: José Luchsinger, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04856280: Kinesiological Taping and Aerobic Exercise in Women With Primary Dysmenorrhea:
Official title: The Effects of Kinesiological Taping and Aerobic Exercise in Women With Primary Dysmenorrhea: A Randomized Single-Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Kinesics
Aerobic Exercise
Keywords: Primary Dysmenorrhea
Kinesiological Taping
Aerobic Exercise
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 45
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dysmenorrhea is defined as the pain and discomfort of women during the menstrual period. Kinesiological taping (KT) and aerobic exercise (AE) are effective methods for dysmenorrhea. The purpose of this study is to investigate the effects of KT and AE on pain, attitude, depression, and quality of life in women with dysmenorrhoea. Forty-five women with dysmenorrhea wıll randomly be divided into three groups as KT group (n=15), AE group (n=15) and control group (n=15). In KT Group, 6 sessions of KT will be applied, starting on the 14th day of the menstrual cycle and 2 times per week for 3 weeks until the end of the cycle. In the AE group, walking and climbing stairs will be given during the menstrual cycle, 3 days a week, 45 minutes. No application will be applied to the control group. All groups will be evaluated with Beck Depression Scale (BDS), Mcgill Pain Questionnaire (MPQ), Menstrual Attitude Scale (MAS), and Short Form- 36 (SF-36) before and after the intervention.


Eligibility criteria: Inclusion Criteria:

* Being in the age range of 15-30
* Not being married
* Women with abdominal pain during menstruation 5 and above according to the Visual Analogue Scale.
* Women whose menstrual cycle has started and those whose cycle continues.

Exclusion Criteria:

* Endometriosis and adenomyosis
* Myoma
* Endometrial polyp
* Previous pelvic infections
* Intrauterine device use
* Venous congestion in the internal genital organs

Primary outcomes:
measure: Mcgill Pain Questionnaire
timeFrame: 4 weeks
measure: Menstrual Attitude Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Beck Depression Scale
timeFrame: 4 weeks
measure: Short Form- 36
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Medipol University
name: Miray BUDAK
role: STUDY_DIRECTOR
References:
Clinical trial NCT00187980: Sleep Disturbance in Lung Cancer Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2005-09-16
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The aim of this study is to 1-evaluate subjectively by questionnaires and objectively by ambulatory actigraphy the quality of sleep in patients with newly diagnosed lung cancer; 2- to correlate sleep quality index with quality of life, daytime alertness, Performans status and lung cancer staging at diagnosis.


Eligibility criteria: Inclusion Criteria:

Newly diagnosed lung cancer age \> 18 yrs Performans status \< 3 Informed consent Life expectancy \> 5 months

Exclusion Criteria:

Psychiatric disease Performans status \> 2 Known sleep disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: UH
Study officials:
affiliation: University Hospital, Angers
name: Yannick Le Guen
role: PRINCIPAL_INVESTIGATOR
References: