louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00529555: Periocline as an Adjunct to Scaling and Root Planing for Adult Periodontitis
Official title: A 9 Month,3-arm Multicenter Clinical Trial of Treatment With Periocline Gel (2.1% Minocycline HCl) for Adjunctive Use to Scaling and Root Planing (SRP) in Adults With Periodontal Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adult Periodontitis
Lead sponsor: Sunstar Americas
Sponsor class: INDUSTRY
First posted: 2007-09-14
Enrollment: 602
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: Periodontal disease (commonly called gum disease) is generally treated by deep cleaning of the root surfaces of the teeth. This is also called scaling and root planing. Placing a topical antibiotic into the periodontal pocket at the time of scaling and root planing may help reduce pocket depth and thus help the periodontal disease. Periocline (minocycline HCl) 2.1% gel is a topical antibiotic approved in a number of countries for this use, and is now being tested in the US.


Eligibility criteria: Inclusion Criteria:

* moderate to severe periodontitis

Exclusion Criteria:

* recent periodontal therapy
* certain medical or dental conditions
* pregnancy
* allergy to active drug or related drugs

Primary outcomes:
measure: Change in Pocket Depth.
timeFrame: baseline & 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: Gainsville
country: United States
facility: University of Florida
state: Florida
city: Baltimore
country: United States
facility: University of Maryland - Dental School
state: Maryland
city: Boston
country: United States
facility: Boston University Dental School
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Oral Health Research Center
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Buffalo
country: United States
facility: State University of New York at Buffalo, Dental Medicine
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania Dental School
state: Pennsylvania
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: State University of New York at Buffalo
name: Robert Genco, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05460455: A Study to Evaluate Multi-dose of HB0034 in Healthy Adult Participants
Official title: A Phase Ic, Randomized, Double-blind, Placebo-controlled, Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0034 in Adult Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following multiple-dose.

Detailed description: This is a multi-dose escalation study of HB0034 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects age ≥ 18 and ≤ 55 years.
* Body Mass Index (BMI) ≥ 17.5 and ≤ 32 kg/m².
* Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant.
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

Exclusion Criteria:

* History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.
* Current or history of malignancy. • Family history of premature Coronary Heart Disease (CHD)
* History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
* Pregnant or Breasting feeding subject. Women with a positive pregnancy test .
* Further exclusions criteria apply.

Primary outcomes:
measure: Percentage of subjects with drug related adverse events (AEs)
timeFrame: up to 2000 hours
Secondary outcomes:
measure: Cmax
timeFrame: up to 2000 hours
measure: AUC0-infinity
timeFrame: up to 2000 hours
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: New zealand Clinical Research
Study officials:
affiliation: NZCR OpCo limited AKL
name: Christian Schwabe
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05712655: Masticatory Muscles Electromyography in Post-pubertal Females With Forward Head Posture and Temporomandibular Disorders
Official title: Electromyographic Activity of Masticatory Muscles in Post-pubertal Females With Forward Head Posture and Temporomandibular Disorders: An Observational Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head Pain
TMJ Disorder
Keywords: Forward head posture
Temporomandibular disorders
Masticatory muscles
Electromyography
post-pubertal females
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 61
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 22
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: They were invited to participate in the study through flyers and social media invitations

Brief summary: The aim of this study was to evaluate masticatory muscle electrical activity in post-pubertal females with forward head posture (FHP) and temporomandibular disorders (TMD) as well as in post-pubertal females with neutral head posture and with no temporomandibular disorders.

Detailed description: It has been demonstrated by a previous study that a strong relationship exists between forward head posture and temporomandibular disorders and that individuals with forward head posture and temporomandibular disorders exhibit alterations in masticatory muscle electromyographic activity either as a result of the disorder itself or due to a compensatory mechanism associated with the symptoms of temporomandibular disorders . As a consequence, the aim of the study was to evaluate the electromyographic activity of the masticatory muscles in post-pubertal females with forward head posture and temporomandibular disorders as well as in post-pubertal females with neutral head posture and with no temporomandibular disorders.

Eligibility criteria: Inclusion Criteria:

* Age ranging from 17 to 22 years.
* Body mass index ranging from 18 to 25 kg/m2.
* Having a normal menstrual cycle.
* Spending four to six hours per day with bad posture on computer, laptop or smart phones.
* Fully dentate subjects.

Exclusion Criteria:

* Having dental loss, acquired dental anomalies, current use of dental prostheses, malocclusion, sleep bruxism.
* Having inflammatory diseases of the face or jaw, fibromyalgia, or any fractures or surgeries in the orofacial or neck areas.

Primary outcomes:
measure: Electromyographic (EMG) activity of masticatory muscles
timeFrame: 8 months
Secondary outcomes:
measure: Measurement of cranivertebral angle (CVA)
timeFrame: 8 months
measure: Assessment of research Diagnostic criteria for temporomandibular Disorders (RDC/TMDS)
timeFrame: 8 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Nasser Institute for research and treatment
Study officials:
affiliation: Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
name: Amel M Yousef, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04099355: Investigating the Effect of Dronabinol on Post-surgical Pain
Official title: Investigating the Effect of Dronabinol on Post-surgical Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Knee Replacement
Arthropathy of Knee
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 0
Sex: ALL
Minimum age (years): 21
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 is designed to investigate the effect of dronabinol on post operative pain in patients undergoing total knee replacement (for their own clinical care).

Detailed description: Total knee replacement is a common surgical procedure that restores function to the damaged joint. Recovery from this procedure takes weeks and requires opioids to manage post-surgical pain. The goal of this study is to investigate whether dronabinol (synthetic THC) can reduce pain and the need for opioid medication following this particular surgery.

Subjects will be recruited from the Department of Orthopedic Surgery. All subjects will undergo total knee replacement as part of their clinical care (the surgery itself is not part of this study). The study begins following discharge from the hospital. They will be asked to take dronabinol or placebo as they recover from surgery. During this time they will be given their usual pain medications at discharge which includes opioids for pain. The opioids are to be taken if the subject is experiencing pain. The investigator's hypothesis is that subjects taking dronabinol will need fewer doses of opioids to control pain.

Eligibility criteria: Inclusion Criteria:

* Participants undergoing total knee arthroplasty (TKA) at the CUIMC department of orthopedic surgery as part of their clinical care.
* Able to give informed consent and comply with study procedures in English

Exclusion Criteria:

* Meet DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, or psychosis. Subjects with a current substance use disorder will be excluded. Subjects with a past cannabis use disorder are excluded.
* Diagnosis of a major medical or neurological disorder, including orthostatic hypertension, cardiovascular disease (congestive heart failure, unstable angina, or a history of cardiac infarction), hypotension, or neurodegenerative disorders.
* Subjects taking medications that can lead to a drug interaction.

Primary outcomes:
measure: Brief Pain Inventory-Short Form
timeFrame: 2 weeks
Secondary outcomes:
measure: opioid medication log
timeFrame: two weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: 1051 Riverside Drive
state: New York
Study officials:
affiliation: NYSPI
name: Diana Martinez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05582655: Leveraging Autism Intervention for Families Using Telehealth (LIFT)
Official title: Leveraging Autism Intervention for Families Using Telehealth (LIFT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Early intervention
Autism Spectrum Disorder
Caregiver Implemented
Adaptive Intervention
Lead sponsor: University of Oregon
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 80
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the LIFT study is to develop a technology-assisted adaptation of the JASPER (Joint Attention, Symbolic Play, Engagement, and Regulation: Kasari et al., 2021) social communication intervention for young children with autism spectrum disorder (ASD). In partnership with community early intervention (EI) and early childhood special education (ECSE) practitioners in Oregon, implementation strategies to help caregivers learn to the use the intervention strategies with their young children will delivered in a pilot randomized trial. The pilot trial will compare primarily self-directed learning through online materials and brief practitioner support (ONLINE) with the addition of live synchronous coaching (ONLINE + COACH) on caregivers' strategy use (primary) and children's joint engagement and social communication (secondary).


Eligibility criteria: Inclusion Criteria:

* Receiving Early Intervention (EI) or Early Childhood Special Education (ECSE) services from partnered providers in Southern Oregon Education Service District (SOESD).
* Child has received or is awaiting a diagnosis of autism spectrum disorder (ASD)

Exclusion Criteria:

* Child is not receiving services from a partnered educational service district

Primary outcomes:
measure: Change in Acceptability: Caregiver Diary
timeFrame: Entry, Early Response (6 weeks), Exit (12 weeks), Follow up (24 weeks)
measure: Change in Adoption: Caregiver Involvement Scale
timeFrame: Entry, Early Response (6 weeks), Exit (12 weeks), Follow up (24 weeks)
measure: Change in Fidelity: JASPER Coaching Fidelity
timeFrame: Coaching session 1 (week 1), last session of phase 1 (week 6), last session of phase 2 (week 12)
Secondary outcomes:
measure: Change in Caregivers' JASPER Strategy Use: JASPER Implementation Fidelity
timeFrame: Entry, Early Response (6 weeks), Exit (12 weeks), Follow up (24 weeks)
measure: Change in Children's Time in Child Initiated Joint Engagement (Caregiver Child Interaction)
timeFrame: Entry, Early Response (6 weeks), Exit (12 weeks), Follow up (24 weeks)
Other outcomes:
measure: Change in Initiations of Joint Attention (Short Play and Communication Evaluation)
timeFrame: Entry, Exit (12 weeks), Follow up (24 weeks)
measure: Change in Play diversity (Short Play and Communication Evaluation)
timeFrame: Entry, Exit (12 weeks), Follow up (24 weeks)
Locations:
Study officials:
affiliation: University of Oregon
name: Stephanie Y Shire, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01917955: Cardiac MRI in Ischemic Stroke Study
Official title: Cardiac MRI in Ischemic Stroke Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: MRI
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Center for Stroke Research Berlin
name: Cardiology and Angiology, Elisabeth Hospital, Essen, Germany
First posted: 2013-08-07
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overall, 103 patients with acute ischemic stroke detected by brain magnetic resonance imaging will be enrolled.

Brief summary: The purpose of this prospective single-center trial is to compare the safety and diagnostic value of contrast medium-enhanced cardiac magnetic resonance imaging and transesophageal echocardiography in patients with acute ischemic stroke.

Detailed description: Primary safety objective: Contrast medium-enhanced cardiac magnetic resonance imaging is safe in patients with acute ischemic stroke. Primary outcome: The diagnostic value of contrast medium-enhanced cardiac magnetic resonance imaging is comparable to transesophageal echocardiography in patients with acute ischemic stroke.

Eligibility criteria: Inclusion Criteria:

* Patients with acute ischemic stroke detected by brain magnetic resonance imaging.

Exclusion Criteria:

* Known atrial fibrillation or cardiac source of embolism
* Severe aphasia
* Acute infection or chronic inflammation
* Severe arteriosclerosis or stenosis of brain-supplying arteries
* Contraindications for magnetic resonance imaging or transesophageal echocardiography.

Primary outcomes:
measure: Sensitivity and specificity of contrast medium-enhanced cardiac magnetic resonance imaging to detect echocardiography-proven cardiac sources of embolism in patients with acute ischemic stroke.
timeFrame: < 1 week after ischemic stroke
Secondary outcomes:
measure: Rate of unrecognised myocardial infarction detected by late gadolinium-enhanced cardiac MRI in patients with acute ischemic stroke.
timeFrame: < 1 week after ischemic stroke
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité, Universitätsmedizin Berlin, Campus Benjamin Franklin
city: Essen
country: Germany
facility: Elisabeth Hospital
Study officials:
affiliation: Center for Stroke Research Berlin
name: Prof. Matthias Endres, MD
role: STUDY_CHAIR
affiliation: Center for Stroke Research Berlin
name: Karl Georg Haeusler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haeusler KG, Wollboldt C, Bentheim LZ, Herm J, Jager S, Kunze C, Eberle HC, Deluigi CC, Bruder O, Malsch C, Heuschmann PU, Endres M, Audebert HJ, Morguet AJ, Jensen C, Fiebach JB. Feasibility and Diagnostic Value of Cardiovascular Magnetic Resonance Imaging After Acute Ischemic Stroke of Undetermined Origin. Stroke. 2017 May;48(5):1241-1247. doi: 10.1161/STROKEAHA.116.016227. Epub 2017 Apr 14.
Clinical trial NCT05006014: Immediate Implant With Provisionalization
Official title: Primary Versus Secondary Implant Stability in Relation to Gap Distance of Immediate Implant With Immediate Loading by Provisional Restoration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Maintain the Esthetic
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult with non restorable dental unit seeking for immediate implantation with provisionalization

Brief summary: Prospective observational clinical study conducted to evaluate the success of graftless immediate implantation with provisionalizaion

Detailed description: In this study 35 graftless immediately placed implant in smile line loaded by provisional office made restoration, the primary and secondary stability measured and compared in addition to evaluation of pink esthetic score

Eligibility criteria: Inclusion Criteria:

1. Medical and psychological fitness for minor oral surgery.
2. Age 20-60 years.
3. medium to thick gingival biotype.
4. buccal plate thickness more than (1mm).

Exclusion Criteria:

1. Smoking habit.
2. Diabetes mellitus.
3. A systemic disorder that is contraindicated for the minor surgical procedure.
4. Pregnancy or lactation.
5. Any irradiation in head and neck area.
6. Need for bone augmentation procedure.
7. Clinical signs of bruxism or other severe functional disorders.
8. patient with periodontal disease.

Primary outcomes:
measure: Implant primary stability
timeFrame: 0 day
measure: Jumping gab
timeFrame: 0 day
measure: Pink esthetic score
timeFrame: 0 day, before extraction and implant placement
Secondary outcomes:
measure: Implant secondary stability
timeFrame: Up to 16 weeks
measure: Ridge reduction
timeFrame: Up to 16 weeks
measure: Pink esthetic score
timeFrame: after implantation By 4 months
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: College of dentistry
state: Bab Al Moatham
Study officials:
References:
Clinical trial NCT03154814: Ulinastatin Improves Postoperative Oxygenation After Cardiopulmonary Bypass
Official title: High-dose Ulinastatin Improves Postoperative Oxygenation in Patients Undergoing Aortic Valve Surgery With Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiopulmonary Bypass
Cardiac Surgery
Keywords: ulinastatin
cardiopulmonary bypass
cardiac surgery
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Retrospective cohort study
Primary purpose: TREATMENT

Brief summary: Retrospective study determine whether ulinastatin enhances postoperative pulmonary oxygenation after cardiopulmonary bypass (CPB).

Detailed description: This retrospective study evaluate patients who underwent aortic valvular surgery under moderate hypothermic CPB. The patients were classified into two groups: patients in whom high-dose ulinastatin (10,000 U/kg and 5,000 U/kg/h) was administered during CPB (Group-U); and patients in whom ulinastatin was not administered (Group-C). We measured PaO2/FiO2 at the following time points: before CPB (Pre-CPB), 2 hours after weaning from CPB (Post-CPB) and within 6 hours after admission to the ICU. The lengths of ventilator care and ICU stay were also reviewed.

Eligibility criteria: Inclusion Criteria:

* patients who underwent aortic repair or replacement under moderate hypothermic CPB

Exclusion Criteria:

* Preoperative:

\< 19 years old, \> 85 years old, emergency operation, reoperation, left ventricular ejection fraction \< 50%, arrhythmia, ischaemic myocardial disease, uncontrollable hypertension or hypotension, pericardial disease, pre-existing hepatic dysfunction, pre-existing renal dysfunction or underlying lung disease.

* Intraoperative:

intraoperative application of an intra-aortic balloon pump, administration of steroids or tranexamic acid, and transfusion of fresh frozen plasma or platelet concentrates during CPB.

* Postoperative:

reoperation for surgical correction of intractable postoperative bleeding within 2 hours after the end of surgery and transfusion of any banked blood products.

Primary outcomes:
measure: change of arterial oxygen partial pressure (PaO2)/fraction of inspired oxygen (FiO2) during CPB
timeFrame: before CPB (Day 0), 2hours after CPB(Day 0), within 6hour after admission to intensive care unit(Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University Medical Center
name: Tae-yop Kim
role: PRINCIPAL_INVESTIGATOR
References: