louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05193487: Intraosseous Anesthesia Versus Mandibular Nerve Block in Children
Official title: Influence Of Computerized Intraosseous Anesthesia On Children's Behaviour In Comparison To Traditional Mandibular Nerve Block Technique: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Anaesthesia
Keywords: intra-osseous anesthesia
inferior alveolar nerve block
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 88
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to compare a new computerized intra-osseous injection system to the conventional inferior alveolar nerve block in children

Detailed description: Patients will be randomly allocated to one of the experimental groups.: Conventional (Inferior alveolar nerve block) and Computerized intraosseous anesthesia administration using the Quick Sleeper 5TM system (Dental Hi TecTM, Cholet, France). Both techniques will be performed by a single trained operator.

Articaine 4% with 1/200000 Adrenaline will be used for both techniques.

Eligibility criteria: Inclusion criteria

1. Children aging between 6-9 years with no history of previous local dental anesthesia experience.
2. American society of anesthesiologists score equal to or less than II
3. Lower 2nd primary molars requiring pulpotomy

Exclusion criteria:

1. American society of anesthesiologists Score more than II
2. Uncompliant, Uncooperative children
3. Children turning non-compliant during procedure
4. Patients taking analgesics and anti-inflammatory
5. Un-restorable teeth, teeth near exfoliation, teeth with gingival abscess/fistula, pathological mobility, pain on percussion, radiographic evidence of internal or external pathological root resorption, periapical/furcation radio-lucencies, widened periodontal membrane space.

Primary outcomes:
measure: Patient's level of cooperation
timeFrame: directly after anesthetic injection while providing the dental treatment
Secondary outcomes:
measure: Heart Rate
timeFrame: before injection, during injection and directly after injection.
measure: Anesthesia success or failure
timeFrame: directly after anesthetic injection while providing the dental treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Ain Shams University
Study officials:
affiliation: Faculty of Dentistry, Ain Shams University, Cairo, Eypt
name: Mohamed Zayed, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03556787: An Evaluation of a Gender Specific Insole to Provide Relief From Knee Pain Due to Osteoarthritis or General Anterior Knee Pain in Male Subjects When Used in Foot Wear Over a Period of Four Weeks
Official title: An Evaluation of a Gender Specific Insole to Provide Relief From Knee Pain Due to Osteoarthritis or General Anterior Knee Pain in Male Subjects When Used in Foot Wear Over a Period of Four Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-06-14
Enrollment: 89
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to demonstrate the ability of a full length foam insole to provide relief from pain due to osteoarthritis of the knee or general knee pain when used in foot wear for a 4-week period of time.

The secondary objectives comprise the evaluation of the insole's ability to provide appropriate shoe fit and comfort as well as relief from osteoarthritis/ general knee pain after short-term use. The safety and tolerability of the test articles in terms of adverse events (AE) will also be investigated.


Eligibility criteria: Inclusion Criteria:

* Male subjects with age 18 to 70 years and a self-reported foot size between 8 and 14
* Subjects with regular knee pain
* Subjects with a baseline pain level of pain of ≥20 mm to ≤90 mm on 100 mm VAS scale at baseline (Visit 1)
* Subjects must be able to walk unaided by cane or walker.

Exclusion Criteria:

* Subjects with knee pain which is due to a recent injury

Primary outcomes:
measure: Osteoarthritis knee pain according to Visual Analog Scale
timeFrame: Up to 4 weeks
measure: General anterior knee pain according to Visual Analog Scale
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Foot Comfort according to Likert scale
timeFrame: Up to 4 weeks
measure: Shoe Fit according to Likert scale
timeFrame: Up to 4 weeks
measure: Number of subjects with adverse events
timeFrame: Up to 4 weeks
measure: Number of subjects with serious adverse events
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Calabasas
country: United States
facility: Focus & Testing, Inc.
state: California
city: Cincinnati
country: United States
facility: The Wolf Group
state: Ohio
Study officials:
References:
Clinical trial NCT01106287: Single Doses of MK-0941 in Type 2 Diabetics (MK-0941-027)
Official title: A Study of Higher Single Doses of MK-0941 in Type 2 Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-04-19
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and tolerability of single doses of MK-0941 based on assessment of clinical and laboratory adverse experiences


Eligibility criteria: Inclusion Criteria:

* Female participants of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control
* Diagnosis of Type 2 Diabetes and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent
* No treatment with three of more anti-hyperglycemic agents or any treatment regimen that includes insulin
* In good health (except for Type 2 Diabetes)
* Willingness to follow a specific diet throughout the study (consisting of 50% carbohydrates, 20%protein and 30% fat)
* Nonsmoker

Exclusion Criteria:

* History of stroke, chronic seizure or major neurological disorder
* History of cancer
* History of Type 1 Diabetes
* Recent history of eye infection
* Glaucoma or blindness
* Eye surgery (by incision or laser) within the past three months

Primary outcomes:
measure: Number of Participants Who Experienced One or More Adverse Events During the Study
timeFrame: Up to 30 days after the last dose of study drug
measure: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
timeFrame: Up to 6 weeks after the first dose of study drug
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03186287: Effectiveness of Eccentric and Concentric Strength Training in Patients With Subacromial Impingement Syndrome
Official title: Effectiveness of Eccentric and Concentric Strength Training in Patients With Subacromial Impingement Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Impingement Syndrome
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 45
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 purpose of this study is to investigate and compare the effects of eccentric and concentric strength training on pain, strength, joint position sense and function in patients with subacromial impingement syndrome.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of subacromial impingement syndrome
* Complaints associated with subacromial impingement syndrome for at least 3 months
* No extra pain with 90 degree abduction-90 degree external rotation position of the shoulder
* Ability to complete the entire study procedure

Exclusion Criteria:

* Severe pain; shoulder pain is \> 7/10
* History of upper extremity fracture
* History of shoulder, cervical and thoracic surgery
* Having shoulder instability or frozen shoulder diagnosis
* History of shoulder injuries, trauma and / or shoulder symptoms requiring treatment during the last 1 year (except than subacromial impingement syndrome)
* Full-thickness rotator cuff tear
* Systemic musculoskeletal disease
* Neck and shoulder pain with cervical spine movement
* Chest deformity or scoliosis diagnosis

Primary outcomes:
measure: Shoulder Function
timeFrame: Baseline, 12 weeks and 24 weeks
Secondary outcomes:
measure: Pain intensity
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Upper extremity function
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Isometric strength
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Eccentric strength
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Joint position sense
timeFrame: Baseline, 12 weeks and 24 weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University, School of Physical Therapy and Rehabilitation
state: Balçova
Study officials:
affiliation: Izmir Katip Celebi University
name: Damla KARABAY, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: Sevgi Sevi YESILYAPRAK, PhD
role: STUDY_DIRECTOR
affiliation: Dokuz Eylul University
name: Mehmet ERDURAN, MD
role: STUDY_DIRECTOR
affiliation: Izmır Katip Celebi University Atatürk Training and Research Hospital
name: Cem OZCAN, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04711187: Study of AT-527 in Healthy Subjects (R07496998)
Official title: A Phase I Study Assessing the Safety and Pharmacokinetics of Multiple Doses of AT-527 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer Study
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hoffmann-La Roche
First posted: 2021-01-15
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Other clinically significant medical conditions or laboratory abnormalities

Primary outcomes:
measure: Proportions (active vs. placebo) of subjects experiencing treatment-emergent adverse events.
timeFrame: Day 10
Secondary outcomes:
measure: Pharmacokinetics (PK) of AT-527
timeFrame: Days 1 and 5
measure: Pharmacokinetics (PK) of AT-527
timeFrame: Days 1 and 5
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Atea Study Site
state: Quebec
Study officials:
References:
Clinical trial NCT00139087: Mother-Infant Rapid Intervention at Delivery Telephone Outreach for Neonatal Therapy (TOT) Trial.
Official title: Mother-Infant Rapid Intervention at Delivery Telephone Outreach for Neonatal Therapy (TOT) Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-08-31
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The Telephone Outreach for Therapy Trial was designed to test an intervention to assist new mothers or caregivers of HIV-exposed children with administering medication for the first 6 weeks of life to prevent mother-to-child HIV infection in the infants. To be eligible, mothers of infants were identified as HIV-infected in the Mother-Infant Rapid Intervention at Delivery Study. Mothers or caregivers of infants were randomized into two groups: the intervention group received a cellular phone and scheduled twice daily calls to assure infant medications were given, and the other group received the current standard of care. Enrollment into the study was completed and analysis of the study data is underway.

Detailed description: The Telephone Outreach for Therapy Trial was designed to test an intervention to assist new mothers or caregivers of HIV-exposed children with administering medication for the first 6 weeks of life to prevent mother-to-child HIV infection in the infants. To be eligible, mothers of infants were identified as HIV-infected in the Mother-Infant Rapid Intervention at Delivery Study. Mothers or caregivers of infants were randomized into two groups: the intervention group received a cellular phone and scheduled twice daily calls to assure infant medications were given, and the other group received the current standard of care. Enrollment into the study was completed and analysis of the study data is underway.

Eligibility criteria: Inclusion Criteria:

* Mother-infant pairs in which the mother was identified as HIV-infected in the MIRIAD Study

Exclusion Criteria:

* Mother-infant pairs in which the infant is expected to be hospitalized for \>2weeks after birth

Primary outcomes:
measure: Neonatal adherence to zidovudine syrup measured as self report of the mother or caregiver AND drug level measured in heel stick specimens collected at 2, 4 and 6 weeks of life.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Susan P Danner, BA
role: STUDY_DIRECTOR
References:
Clinical trial NCT00909454: Vitamin D Supplement Study for Adolescents
Official title: V.I.P. Feasibility Study (Vitamin D Intake Project)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Overweight
Obesity
Keywords: Vitamin D deficiency
Adolescents
African Americans
Overweight
Obesity
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2009-05-28
Enrollment: 45
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if 14-19 year old African American adolescents are able to take a daily vitamin D supplement daily for about 4 months and how well a daily dose of 400 IU or 2000 IU vitamin D supplement raises their vitamin D blood level.

Detailed description: To determine the feasibility of African American teenagers taking a daily vitamin D supplement over a 4 month period in terms of compliance and practical implementation.

To determine the differences in response in blood 25-OH D level between those randomly assigned to taking a 400 IU supplement versus 2000 IU per day and to determine if there are differences in blood 25-OH D level response depending on subject gender and overweight/obese versus healthy-weight status.

Eligibility criteria: Inclusion Criteria:

* Healthy African American Adolescents

Exclusion Criteria:

* Hypertension
* Pregnancy
* Medications that affect study outcome measures
* Use of other vitamin and/or mineral supplement or herbal supplements
* Individuals of other races

Primary outcomes:
measure: Plasma 25-OH D level
timeFrame: 3-4 months from baseline to post-testing
Secondary outcomes:
measure: Blood pressure
timeFrame: 3-4 months from baseline to post-testing
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Prevention Institute at Medical College of Georgia
state: Georgia
Study officials:
affiliation: Augusta University
name: Yanbin Dong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dong Y, Stallmann-Jorgensen IS, Pollock NK, Harris RA, Keeton D, Huang Y, Li K, Bassali R, Guo DH, Thomas J, Pierce GL, White J, Holick MF, Zhu H. A 16-week randomized clinical trial of 2000 international units daily vitamin D3 supplementation in black youth: 25-hydroxyvitamin D, adiposity, and arterial stiffness. J Clin Endocrinol Metab. 2010 Oct;95(10):4584-91. doi: 10.1210/jc.2010-0606. Epub 2010 Jul 21.
Clinical trial NCT05138354: Standard Care With LLLT & Myofascial Release Versus Standard Care Alone in Pregnant Women With Temporomandibular Disorder
Official title: Standard Care Combined With Low-Level Laser Therapy and Myofascial Release Versus Standard Care Alone in Pregnant Women With Temporomandibular Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorder
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate a novel approach to treat pregnant women with tempromandibular disorder using a combined method of low level laser therapy, myofascial release and standard care versus standard care alone. It's hopeful that the results of this study can fill the gap of knowledge surrounding the conservative treatment options for TMD in order to help patients restore their oral function properly and promote new ways of addressing TMD.


Eligibility criteria: Inclusion Criteria:

* Pregnant women diagnosed with myofascial TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders

Exclusion Criteria:

* facial neuro-musculoskeletal pathologies (i.e., facial trauma and/or fractures, and bell's palsy)
* acute infections or systemic disorders
* osteoporosis
* cervical spine or upper limb dysfunction
* steroid infiltration4
* any recent dental treatment taken or surgery over TMJ
* hypermobile joint
* neurological impairments

Primary outcomes:
measure: Changes in visual analogue scale
timeFrame: Baseline and after 4 weeks
measure: Changes in pain pressure threshold (PPT)
timeFrame: Baseline and after 4 weeks
Secondary outcomes:
measure: Limitations of daily function in temporomandibular disorder questionnaire
timeFrame: Baseline and after 4 weeks
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: October 6 University Hospital
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, October 6 University
name: Radwa M Yehia, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT00568854: Immunobiology of Diabetes and Tuberculosis
Official title: Converging Epidemics: Immunobiology of Diabetes Mellitus and Tuberculosis Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tuberculosis
Diabetes Mellitus
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2007-12-06
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study hypothesis is that type 2 diabetics have abnormal cell-mediated immunity to tuberculosis manifesting as altered cytokine responses by peripheral blood mononuclear cells (PBMCs). This hypothesis will be tested using the live tuberculosis vaccine, Bacille Calmette-Guerin (BCG), in U.S.-born type 2 diabetics and nondiabetics. The investigators will control for potential confounding by age, sex, race, comorbidities, and select medications. Expression of key cytokines will be measured with real-time polymerase chain reaction.

Detailed description: The project has three specific aims:

Specific Aim 1: To assess differences between the study groups in cytokine expression before and after BCG vaccination. The investigators will determine within-individual variability in cytokine measurements and describe the kinetics of cytokine response to BCG. Peak response levels, time to peak, and patterns of cytokines expressed will be compared.

Specific Aim 2: To evaluate the effect of hyperglycemia on the cytokine response of type 2 diabetics. The investigators will evaluate whether levels of hemoglobin A1C (HbA1C) are associated with degree of cytokine response and test if type 2 diabetics who have good glucose control are different from nondiabetics.

Specific Aim 3: To evaluate the effect of testing PBMCs from diabetics outside of their diabetic milieu. Investigators will compare the BCG-specific cytokine responses of PBMCs stimulated in normal medium, PBMCs stimulated in glucose correlating to the person's most recent HbA1C, and whole blood samples.

Eligibility criteria: Inclusion Criteria:Type 2 diabetes or healthy individual Able to give consent US-born Age 30-65 Exclusion Criteria:\* Immunosuppressive disease

* Immunosuppressive medications
* Pregnancy
* Renal failure
* Advanced pulmonary disease
* Prior BCG vaccination
* Prior TB infection
* Type 1 diabetes

Primary outcomes:
measure: Antigen-specific Immune Response Measured by Reaction to Tuberculin Skin Test
timeFrame: 5 months
measure: Kinetics of Mycobacterial-specific Immune Response After BCG Vaccination
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Alicia Hsin-Ming Chang
role: SUB_INVESTIGATOR
affiliation: Stanford University
name: Julie Parsonnet
role: PRINCIPAL_INVESTIGATOR
References: