louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00335712: Pilot Study of ONO-5129 in Patients With Type 2 Diabetes Mellitus
Official title: Phase II Study of ONO-5129 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: ONO-5129
type 2 diabetes mellitus
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2006-06-12
Enrollment: 81
Sex: ALL
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of ONO-5129 in patients with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

1. Fasting Blood Glucose 126-250mg/dL
2. HbA1c 6.5-11%

Exclusion Criteria:

1. Previous treatment with antidiabetic agents equal to or less than 2-3 months prior to randomization
2. History of myocardial infarction, coronary artery surgery
3. Other eligibility criteria as specified in the study protocol

Primary outcomes:
measure: Fasting Blood Glucose at week 8
Secondary outcomes:
measure: Other glycemic control parameters (e.g., HbA1c, glycoalbumin)
Other outcomes:
Locations:
city: Kanto
country: Japan
facility: Kanto Region
city: Kyusyu
country: Japan
facility: Kyusyu Region
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader, Development Planning
role: STUDY_DIRECTOR
References:
Clinical trial NCT02255812: Taste Physiology in Healthy, Normal-weight Volunteers
Official title: Taste Physiology in Healthy, Normal-weight Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exploratory Behavior
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2014-10-03
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Taste physiology describes five main taste qualities in humans: sweet, sour, salty, umami and bitter. The receptors found on the tongue are also found in the entire gut. The correlation of stimulation of these gut receptors and brain activity has not yet been examined. The objectives are to investigate the effect of different taste substances on i) regional brain activity and ii) satiation peptide release.


Eligibility criteria: Inclusion Criteria:

* right-handed healthy males
* Body-mass index of \< 25
* Age 18-45 years
* no drugs
* non-smoking

Exclusion Criteria:

* Smoking
* Substance abuse
* Regular intake of medications (except for oral contraceptives)
* Medical or psychiatric illness, especially: diabetes, pace-maker, claustrophobia
* History of gastrointestinal disorders
* Food allergies, glutamate intolerance
* Body piercings that cannot be removed

Primary outcomes:
measure: regional brain activity assessed by functional Magnetic Resonance Imaging (fMRI)
timeFrame: changes from baseline to one hour after treatment
Secondary outcomes:
measure: gastrointestinal satiation peptide secretion
timeFrame: changes from baseline to one hour after treatment
measure: glucose and insulin secretion
timeFrame: changes from baseline to one hour after treatment
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Christoph Beglinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01689012: The Effect of Facial Exercise on the Appearance of Aging
Official title: A Pilot Study of the Efficacy of a Facial Exercise Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-09-20
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study seeks to evaluate the effects of facial exercises on aging of the face.


Eligibility criteria: Inclusion Criteria:

* Aged 40-65 years
* No significant medical illness
* No chronic smokers
* Subject with mild to moderate facial atrophy
* Subjects who provide and interest and who understand the importance of consistently executing the program daily.
* Subjects with the willingness and ability to understand and provide informed consent.

Exclusion Criteria:

* Under 40 years of age, Over 65 years of age
* Pregnant or lactating
* Subjects who have ever had any invasive cosmetic procedure, including facelifts, neck lifts, laser resurfacing, dermabrasion, or liposuction
* Subjects who have non-invasive or minimally invasive cosmetic procedures, such a non-ablative lasers, medium-depth or deeper chemical peels, injectable neurotoxins or fillers, within the past year.
* Subjects who have used topical or oral retinoids within the past year.

Primary outcomes:
measure: Improvement of face and neck after facial exercise compared to baseline
timeFrame: up to 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03098212: Aromatherapy for Reducing Labor Pain
Official title: Efficacy of Aromatherapy for Reducing Pain During Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 94
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pregnant women who eligible with inclusion criteria are random to two groups. Aromatherapy group will receive the aromatherapy during labor along with standard pain control.

Non-aromatherapy group will receive standard pain control during labor


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Nulliparous
* 37 complete weeks of gestation
* Cephalic presentation
* No emergency obstetric complication
* In labor

Exclusion Criteria:

* Medical or obstetric complication preclude vaginal delivery
* Essential oil allergy
* Side effect of aromatherapy

Primary outcomes:
measure: early active phase pain using Visual Analog Scale
timeFrame: The day of labor
Secondary outcomes:
measure: latent phase pain using Visual Analog Scale
timeFrame: The day of labor
measure: late active phase pain using Visual Analog Scale
timeFrame: The day of labor
measure: analgesic drug
timeFrame: The day of labor
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04029012: Penthrox in Rezūm BPH
Official title: A Pilot Study to Assess Efficacy and Safety of Methoxyflurane for Pain Control During Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
BPH
Lead sponsor: Can-Am HIFU Inc.
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Open-labeled, single-centre study

Detailed description: Patients who have elected Convective Thermal Therapy using Rezūm System for the management of their BPH and fulfilled inclusion and exclusion criteria will sign informed consent form for the study. Patient will use Methoxyflurane inhaler (Penthrox™) on top of standard oral analgesia including oral lorazepam, oral Percocet® (oxycodone and acetaminophen) or oxycodone immediate-release, and intra-urethral lidocaine gel (Xylocaine®). Intravenous propofol will be used as rescue analgesia.

Eligibility criteria: Inclusion Criteria:

* Male subjects of ≥ 18 years of age
* Patient who has elected Convective Thermal Therapy using Rezūm System for the management of their benign prostatic hyperplasia.
* No contra-indication on using Methoxyflurane inhaler (Penthrox™).
* Willing and able to accurately complete the required questionnaires.
* Willing and able to provide signed and dated informed consent.

Exclusion Criteria:

* Ongoing use of analgesic agents for chronic pain.
* Concomitant use of nephrotoxic agents.
* INR \> 4.
* Use of Methoxyflurane inhaler (Penthrox™) within the previous 3 months.
* Known allergy to Lorazepam, Percocet/ Oxycodone, or Xylocaine® gel.
* Known personal or familial hypersensitivity to Methoxyflurane inhaler (Penthrox™) or other halogenated anesthetics.
* Clinically significant respiratory depression, cardiovascular instability, renal or hepatic impairment.
* An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol.
* Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives.
* A history of liver dysfunction after previous Methoxyflurane inhaler (Penthrox™) use or other halogenated anesthetics.

Primary outcomes:
measure: Pain intensity
timeFrame: immediately after final injection of Rezūm treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Can-Am HIFU Inc
state: Ontario
Study officials:
References:
Clinical trial NCT01565512: Dorsal Penile Block for Post-Robotic Prostatectomy Foley Discomfort
Official title: Randomized Trial to Determine the Effect of Dorsal Penile Block on Post-Robotic Prostatectomy Foley Discomfort
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Robotic Prostatectomy
Foley Catheter Discomfort
Keywords: randomized trial
robotic prostatectomy
prostate cancer
foley catheter discomfort
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2012-03-28
Enrollment: 0
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The indwelling urethral foley is a major source of discomfort following radical prostatectomy. Our hypothesis is that intra-operative dorsal penile nerve block with bupivacaine may decrease immediate post-operative foley discomfort.

Detailed description: Patients undergoing robot-assisted radical prostatectomy (RARP) will be randomized in a double-blind placebo controlled manner to undergo penile ring block injection at the time of skin incision closure. A visual analog scale (VAS) based questionnaire including newly developed foley discomfort scores will be administered at various time points post-operatively.

Eligibility criteria: Inclusion Criteria:

* age 40 years and above,
* diagnosis of prostate cancer,
* electing to undergo robot-assisted radical prostatectomy

Exclusion Criteria:

* allergy to bupivacaine or amide-type local anesthetics,
* chronic pain condition,
* recently or currently on narcotics,
* genital abnormalities

Primary outcomes:
measure: Prevalence of pain/discomfort
timeFrame: postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital/Columbia University
state: New York
Study officials:
affiliation: Assistant Professor, Department of Urology, New York Presbyterian Hospital, Columbia University Medical Center
name: Ketan K. Badani, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Urology, New York Presbyterian Hospital, Columbia University Medical Center
name: Chris O. Wambi, M.D.
role: STUDY_CHAIR
affiliation: Professor and Chairman, Department of Urology, New York Presbyterian Hospital, Columbia University Medical Center
name: Mitchell C. Benson, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02287012: Quantification of the Time and Effort Required for Peripheral Blood Stem Cell Collection -The European Perspective
Official title: Quantification of the Time and Effort Required for Peripheral Blood Stem Cell Collection - The European Perspective
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Lead sponsor: Association for Training, Education, and Research in Hematology, Immunology, and Transplantation
Sponsor class: OTHER
First posted: 2014-11-10
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will consist of two parts:

I. Retrospective study:

A medical record review will be conducted covering 200 patients file undergoing peripheral blood stem cell mobilization in different European centers. Patients will be selected from each of centers, evenly divided between two eras: 1) prior to approval of plerixafor= Pre-P era (July 2009); and 2) after approval of plerixafor= P era .

II. Prospective study :Time/Motion evaluation of actual apheresis - 20 events each center

Brief summary: This study aims to observe the effects of the availability of plerixafor on the time and effort associated with autologous peripheral blood stem cell collection.

Detailed description: This non interventional study will consist of two parts:

I. Retrospective study:

A medical record review will be conducted covering 200 patients file undergoing peripheral blood stem cell mobilization in some European centers.

II. Prospective study :Time/Motion evaluation of actual apheresis - 20 events each center The actual apheresis events will be measured in consecutive patients scheduled to be candidates for peripheral blood stem mobilization in the apheresis area of the hospital. Each apheresis will be considered as one event . Should the patient receive more than 1 apheresis, each apheresis will be considered as one different event.

Eligibility criteria: Inclusion Criteria:

Patients must satisfy the following for the part 1

* Oncology patients diagnosed with Non-Hodgkin lymphoma who are candidates for autologous hematopoietic stem cell transplantation (HSCT)
* A patient that fails to achieve a target CD34+\>20 cells/µl, before or on the first day of apheresis
* Age \> 18 years

Exclusion Criteria for the part 1

Patients with:

* Age \< 18 years;
* Primary diagnosis other than Non-Hodgkin lymphoma
* Undergone prior autologous hematopoietic stem cell transplantation (HSCT)

Primary outcomes:
measure: Type, duration and length of administration of mobilizing agents
timeFrame: one week
measure: Number and length of apheresis sessions and number of collected stem cells
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital Saint-Antoine
name: Mohamad Mohty, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02630212: The Relationship Between ALDH2 and Aortic Dissection
Official title: The Relationship Between ALDH2 and Aortic Dissection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Dissection
Keywords: Aortic dissection
Aldehyde dehydrogenase 2 polymorphism
Risk factor
aldehyde dehydrogenase 2
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2015-12-15
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients diagnosed with aortic dissection in Qilu Hospital.

Brief summary: The purpose of this study is to evaluate the impact of ALDH2 Glu504Lys polymorphism on aortic dissection.


Eligibility criteria: Inclusion Criteria:

* Chinese Han people diagnosed with aortic dissection in Qilu Hospital

Exclusion Criteria:

* Aortic dissection based on trauma, connective tissue diseases and pregnancy
* Patients with tumor
* Patients with no written consensus

Primary outcomes:
measure: Number of patients with different ALDH2 genotype
timeFrame: 1-30 days after samples collected
Secondary outcomes:
measure: Concentration of inflammatory factors in blood and aortic specimen
timeFrame: 1-30 days after samples collected
measure: ALDH2 activity
timeFrame: 1-30 days after samples collected
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT02038712: fMRI and Ghlrein in Obesity and Binge Eating Disorder
Official title: fMRI and Ghlrein in Obesity and Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Binge Eating Disorder
Keywords: Obesity
Binge eating disorder
fMRI
gut hormones
Lead sponsor: New York Obesity and Nutrition Research Center
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2014-01-16
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Binge Eating Disorder (BED) may be associated with he development of obesity. However, the pathogenesis of BED is currently unclear, thus making the development of treatment and prevention strategies for BED difficult. Differences in the mechanisms regulating food intake may go some way to reveal potential mechanisms for BED.The purpose of this study is to investigate the responses of key gut-derived hormones that are associated with the regulation of food intake and functional brain activity to food cues using fMRI in BED patients and weight matched controls.

Detailed description: Participants will attend the laboratory on two separate occasions following an overnight fast. Following baseline measures they will be provided wither with a 600mL (600kcal) liquid meal (Fed condition) or a volume matched amount of plain water (Fasted condition) to consume within 15 min in a randomized crossover design. Blood samples will be collected for during the subsequent 120min to measure the glucose, insulin and gut hormone responses, and subjective appetite ratings will be collected. 1500mg of acetaminophen will be added to each of the test drinks so that the appearance in the blood can be used as a proxy measure of gastric emptying. Participants will then undergo a 45min brain scan to assess the responses to visual and auditory food cues.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* BMI 30-50 kg/m2
* Weight stable (\<5% change in body weight during past 3 months)
* Right handed

Exclusion Criteria:

* Smokers
* Regular use of medications
* Current or intended participation in a weight-loss program (diet or exercise)
* Females who are pregnant or lactating

Primary outcomes:
measure: fMRI responses to food cues
timeFrame: 45 min
Secondary outcomes:
measure: Gut hormone responses
timeFrame: 120 min
measure: Subjective appetite ratings
timeFrame: 120 min
Other outcomes:
Locations:
Study officials:
affiliation: New York Obesity Nutrition Research Center
name: Allan Geliebter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00970112: Dexamethasone and Etoricoxib for Pain Prevention Following Periodontal Surgery
Official title: O Uso de Dexametasona e Etoricoxibe Para a prevenção e Controle da Dor pós-operatória após Cirurgia Periodontal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain Control
Keywords: pain
pain assessment
Lead sponsor: Universidade Estadual de Ponta Grossa
Sponsor class: OTHER
First posted: 2009-09-02
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether preemptive medication with dexamethasone or etoricoxib provides better pain management and control than placebo following periodontal surgery.


Eligibility criteria: Inclusion Criteria:

* Patients presenting moderate or severe periodontitis after nonsurgical periodontal treatment with clinical signs of inflammation

Exclusion Criteria:

* Pregnant
* Diabetes mellitus
* Heart diseases
* Allergic to components of the medications
* Risk of endocarditis

Primary outcomes:
measure: pain
timeFrame: up to 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ponta Grossa
country: Brazil
facility: UEPG
state: Paraná
Study officials:
affiliation: UEPG
name: João Paulo Steffens, MSc Student
role: PRINCIPAL_INVESTIGATOR
affiliation: UEPG
name: Fábio André Santos, PhD
role: STUDY_DIRECTOR
affiliation: UEPG
name: Gibson Luiz Pilatti, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04100512: Oscillating Positive Expiratory Pressure (OPEP) Therapy in Trauma Patients With Multiple Rib Fractures
Official title: Oscillating Positive Expiratory Pressure (OPEP) Therapy in Trauma Patients With Multiple Rib Fractures: A Randomized Comparative Trial Against Incentive Spirometry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rib Fractures
Respiratory Complication
Lead sponsor: Poudre Valley Health System
Sponsor class: OTHER
Collaborators: name: Monaghan Medical Corporation
First posted: 2019-09-24
Enrollment: 50
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: To determine the efficacy of oscillatory positive expiratory pressure (OPEP) therapy on patients admitted through the trauma service line for rib fractures, as compared to incentive spirometry (IS).

Detailed description: Patients identified through screening procedures to fit the inclusion criteria will be approached, within 48 hours of floor admission, to participate in the study. Once written informed consent is obtained, participants will be randomized, in a 1:1 ratio, into either the IS or OPEP study group.

Each patient will be instructed on how to use the respiratory therapy device, either IS or OPEP, by research personnel and respiratory therapists. Participants will be instructed to record their compliance with the RT protocol in their respective patient diaries.

Respiratory Therapy will record FVC three times daily on all study participants until stable (FVC \> 1.5L x 4), then daily for up to 7 days or until discharge.

Participants will be contacted on day 30 from discharge, and administered a short questionnaire. All participants will be followed and monitored per standard of care, under the care and supervision of their treating provider teams.

Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 18 years old
* Greater than or equal to 1 Rib Fracture
* Admitted to trauma services at Medical Center of the Rockies (MCR).

Exclusion Criteria:

* Less than 18 years old
* Any physical injury that creates inability to functionally use devices
* Adults unable to consent or cooperate due to
* Dementia
* Confusion
* On ventilator support
* Moderate to severe Traumatic brain injury (Glasgow Coma Scale \< 12)
* Cervical spinal cord injury
* Women who are pregnant

Primary outcomes:
measure: Time (hours) to stable forced vital capacity
timeFrame: 3 times daily, until FVC is >1.5 liters x 4 consecutive tests, or up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
Study officials:
affiliation: Trauma Research Medical Director
name: Julie Dunn, MD
role: PRINCIPAL_INVESTIGATOR
References: