louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00746187: Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.
Official title: An Open, Randomized Study to Compare Two Dental Implant Systems With Regard to Changes in Marginal Bone Level.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous, Partially
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2008-09-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 compare marginal bone level changes between ASTRA TECH Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical protocol will be used. Implants will be loaded within 15 weeks from installation. The subjects will be followed for 3 years.


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent
* Age 18 - 75 years
* Partial edentulism, Kennedy class I or II, last natural tooth must be cuspid or first bicuspid
* Edentulous in the area/s if implant placement for more than 2 months

Exclusion Criteria:

* Untreated caries and/or periodontal disease of residual dentition
* Need for pre-surgical bone or soft tissue augmentation in the planned implant area/s.
* Absence of occlusal stability in centric occlusion
* Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
* Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
* Pregnancy
* Present alcohol or drug abuse
* Tobacco smoking during the last 6 months
* Unable or unwilling to return for follow-up visits for a period of 3 years

Primary outcomes:
measure: Marginal Bone Level Changes
timeFrame: 3 years after implant placement (baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Dept. of Implant Dentistry, New York University
state: New York
city: Chapel Hill
country: United States
facility: Dept. of Prosthodontics, School of Dentistry, University of North Carolina
state: North Carolina
Study officials:
affiliation: Dept. of Implant Dentistry, New York University (to March 2011)
name: Dennis P Tarnow, D.D.S. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Implant Dentistry, New York University (from March 2011)
name: Stuart Froum, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01258387: Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure
Official title: A Phase 1, Double-Blind, Placebo-Controlled Study of Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Failure
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-12-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in patients with heart failure.

Detailed description: Phase 1, double-blind, placebo-controlled, dose escalation study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in cohorts of patients with left ventricular dysfunction and symptomatic heart failure.

Eligibility criteria: Inclusion Criteria:

1. Left ventricular ejection fraction (LVEF) between 10% and 40%.
2. Male or female, aged 18 to 75 years, inclusive.

Exclusion Criteria:

1. Received any investigational agent or participation in any clinical study of an investigational agent or investigational therapy up to 30 days prior to the screening visit.
2. Use of any new prescription medication up to 14 days prior to receiving investigational drug.
3. Patients with known specific hepatic disease; bilirubin \>2 mg/dL, SGOT \> 100 IU.
4. Patients with a history of hepatic impairment (hepatitis B and C).
5. Serum creatinine \>2.5 mg/dL.
6. Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment.

Primary outcomes:
measure: Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)
timeFrame: 6 months
Secondary outcomes:
measure: Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF)
timeFrame: Screening, day 8, day 14, day 28, and 3 months post-dose
measure: Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV)
timeFrame: Screening, day 8, day 14, day 28, and 3 months post-dose
measure: Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV)
timeFrame: Screening, day 8, day 14, day 28, and 3 months post-dose
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: The Medical Group of Saint Joseph's
state: Georgia
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Acorda Therapeutics
name: Anthony Caggiano, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05991687: Methods for Effective Disposal of Surplus Analgesics to Facilitate Elimination
Official title: Methods for Effective Disposal of Surplus Analgesics to Facilitate Elimination
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgery
Analgesics, Opioids
Keywords: Opioids
Drug disposal
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Michigan Department of Health and Human Services
First posted: 2023-08-14
Enrollment: 100
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: The primary objective is to evaluate the difference in outcomes for mail-in vs. in-home disposal methods for leftover prescription opioids after discharge from surgery.


Eligibility criteria: Inclusion Criteria:

* Anticipated to be prescribed and use an opioid medication to treat acute pain after elective outpatient surgery
* Opioid-naive

Exclusion Criteria:

* Inability to receive email and/or phone calls for follow up assessment

Primary outcomes:
measure: Use of assigned disposal method
timeFrame: 2 weeks after surgery
Secondary outcomes:
measure: Use of safe disposal method
timeFrame: 2 weeks after surgery
measure: Use of any disposal method
timeFrame: 2 weeks after surgery
measure: Feasibility of Intervention Measure (FIM)
timeFrame: 2 weeks after surgery
measure: Acceptability of Intervention Measure (AIM)
timeFrame: 2 weeks after surgery
measure: Patient-Reported Satisfaction with Use of Disposal Method (study derived question)
timeFrame: 2 weeks after surgery
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Mark Bicket, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04399187: Adjunctive Local Sodium Hypochlorite Gel in Non Surgical Periodontal Debridement
Official title: Clinical Effects of Adjunctive Local Sodium Hypochlorite Gel in Minimally Invasive Non Surgical Debridement (MINSD) of Periodontal Pockets. A 6-month Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 32
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to assess the efficacy of minimally invasive nonsurgical debridement (MINSD) of periodontal pockets with or without local amino acid buffered sodium hypochlorite (NaOCl) gel application after 6 months follow-up.

Detailed description: Forty periodontal compromised patients were randomly allocated in two groups. Periodontal pockets \> 5 mm in patients of test group were treated by MINSD and NaOCl gel application, meanwhile in patients of control group MINSD alone was performed. Full-mouth plaque score (FMPS) , Full-mouth bleeding score (FMBS), probing depth (PD), clinical attachment level (CAL) and gingival recession (GR) were assessed at baseline and after 6 months follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with periodontitis;
* Age \> 18 years old;
* Patients with at least 10 teeth for arch;
* Presence at least of two teeth with PD \> 5 mm for quadrant;
* Single-rooted and multi-rooted teeth;

Exclusion Criteria:

* Patients with systemic diseases;
* Pregnant or lactating;
* Tobacco smokers (\> 10 cigarettes/day);
* Previous periodontal treatment in the last 2 years;
* Prolonged antibiotic treatment or anti-inflammatory treatment within 6 months prior to periodontal therapy;
* Furcation involvement;
* Acute periodontal or endodontic abscess;
* Third molars

Primary outcomes:
measure: Probing depth changes
timeFrame: 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University of Messina
Study officials:
affiliation: University of Messina
name: Gaetano Isola
role: STUDY_CHAIR
References:
Clinical trial NCT04481087: Clinical Comparison of Different Adhesives in NCCLs
Official title: Clinical Comparison of Different Adhesives in NCCLs
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tooth Wear
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 34
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: The aim of this randomized, controlled, prospective clinical trial is to evaluate the performances of a universal adhesive in three different application modes, a self-etch adhesive and an etch\&rinse adhesive in restoration of non-caries cervical lesions. Thirty-four patients will receive restorations. Lesions will be divided into 5 groups according to adhesive systems and application modes: CU-SE: Clearfil Universal Bond Quick in self-etch mode, CU-SLE: Clearfil Universal Bond Quick in selective etch mode, CU-ER: Clearfil Universal Bond Quick in etch\&rinse mode, CSE: Clearfil SE Bond, TB: Tetric N-Bond. Restorations (Tetric N-Ceram composite) will be scored with regard to retention, marginal discoloration, marginal adaptation, recurrent caries and post operative sensitivity using modified USPHS criteria after 48 months. Two examiners who is not involved in the placement of restorations will conduct the evaluations. Descriptive statistics will be performed using Chi-square tests.


Eligibility criteria: Inclusion Criteria:

* being 18 years or older,
* having no medical or behavioral problems preventing then from attending review visits,
* having at least 5 tooth with NCCLs
* having antagonist teeth

Exclusion Criteria:

* poor gingival health,
* uncontrolled, rampant caries,
* bruxism,
* removable partial dentures,
* xerostomia

Primary outcomes:
measure: Clinical performances of different adhesives
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT00418587: Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)
Official title: Phase 1 Study of Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Keywords: Vitamin D
Lupus
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: American College of Rheumatology Research and Education Foundation
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2007-01-05
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the safety and effectiveness of different doses of vitamin D in patients with Systemic Lupus Erythematosus (SLE). A long term goal is to determine if vitamin D could be used as a treatment and/or preventative of SLE.


Eligibility criteria: Inclusion Criteria:

* SLE by ACR criteria (revised 1997)
* African American, participating in the SLE in Gullah Health (SLEIGH) Study
* Outpatient
* Stable disease with no BILAG A or B in any system for the past 4 weeks
* Stable prednisone (or equivalent corticosteroid) dose ≤ 20 mg/day for ≥ 4 weeks prior to study entry
* Baseline 25(OH)D concentration of \< 30 ng/ml
* Willingness to discontinue other vitamin D supplements and/or multivitamins containing vitamin D while participating in the study
* Age 18 - 85 years
* Ability to complete questionnaires in English
* Ability to give informed consent

Exclusion Criteria:

* Presence of hypercalcemia (\>10.4 mg/dL), hypercalcuria (urinary calcium/creatinine ratio ≥ 0.8 mmol/mmol) or known primary hyperparathyroidism
* Liver disease (serum ALT, AST \>2x normal) or total serum bilirubin \>1.5x normal
* History of renal stones
* Current treatment with any dose of cyclophosphamide
* Dialysis or creatinine \> 2.5 mg/dL
* Pregnancy
* Current drug or alcohol abuse
* Anticipated poor compliance

Primary outcomes:
measure: Hypercalcuria
timeFrame: Monthly
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Diane L Kamen, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02399787: Geneexpression as a Marker of Embryo Viability
Official title: Geneexpression as a Marker of Embryo Viability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2015-03-26
Enrollment: 20
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: Infertile women

Brief summary: The aim of the post doc project is investigate which genes regulate implantation in order to analyze specific proteins and microRNA in the spent culture media with the long-term goal of developing a non-invasive method of embryo assessment and selection. This will be achieved by conducting a targeted NGS analysis, based on list obtained from a non-published pilot study. When further validated by q-PCR, the expression of specific microRNAs known to influence the final list of genes will be analyzed in the spent culture media and the protein products of the genes recovered from the media will be quantified. The level of specific microRNAs and proteins will be related to aneuploidy and implantation potential. If the level of specific microRNA and/or proteins correlates with pregnancy, the study will form the basis for developing a clinical applicable precise method of improved embryo selection and thus improved IVF treatment.


Eligibility criteria: Inclusion Criteria:

* \>5 oocytes retrieved

Exclusion Criteria:

* endometriosis

Primary outcomes:
measure: gene expression
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: The Fertility Clinic, Aarhus University Hospital, Skejby
Study officials:
References:
Clinical trial NCT00175487: Comparison of Hip Resurfacing to Large Femoral Head Total Hip Arthroplasty
Official title: Femoral Head Resurfacing Versus a Large Femoral Head (Durom®) Total Hip System: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Avascular Necrosis
Keywords: Osteoarthritis/Avascular Necrosis
Hip
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates femoral head resurfacing versus a large femoral head (Durom®) total hip system. This is a prospective randomized trial.


Eligibility criteria: Inclusion Criteria:

1. Indication for hip resurfacing because of osteoarthritis or avascular necrosis
2. Aged 19 to 65 years old
3. Ability to give informed consent

Exclusion Criteria:

1. Previous fracture requiring internal fixation of the hip
2. Previous hip osteotomy (pelvic or femoral)
3. Dysplasia requiring structural bone graft
4. Inability to respond to questionnaires in English (or French, Montreal centre only)
5. The presence of osteopenia or osteoporosis
6. Evidence of hepatic/renal insufficiency or failure from medical history or laboratory assessment

Primary outcomes:
measure: To estimate the difference in postoperative quality of life between patients with Durom® hip resurfacing versus those with total hip arthroplasty (THA) using a large-head, metal-on-metal articulation
timeFrame: at 2 years
Secondary outcomes:
measure: To estimate the difference in concentrations of cobalt and chromium ions in serum
measure: To estimate the difference in gait (pelvic tilt, forward velocity, and cadence)
timeFrame: at 12 and 52 weeks
measure: To estimate the lower limb functional instability by a test of postural balance
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Donald Garbuz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06169787: Sentinel Lymph Nodes Biopsy in Cervical Cancer
Official title: Sentinel Lymph Nodes Biopsy Versus Lymphadenectomy in Cervical Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sentinel Lymph Node
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 20 and above with early stage cervical cancer, who received surgical treatment

Brief summary: This study aims to compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage cervical cancer who underwent radical hysterectomy.


Eligibility criteria: Inclusion Criteria:

Women aged 20 and above with clinical FIGO stage I-IIA cervical cancer

Exclusion Criteria:

Women did not receive surgical treatment

Primary outcomes:
measure: progression free survival
timeFrame: 5 years
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
measure: Number of dissected lymph node
timeFrame: 5 years
Other outcomes:
measure: Complications
timeFrame: 5 years
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT07012187: The Effect of Using Virtual Reality in Subcutaneous Injection Education on the Knowledge and Skills of Nursing Students
Official title: The Effect of Using Virtual Reality in Subcutaneous Injection Education on the Knowledge and Skills of Nursing Students: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nursing Education
Nursing Education Research
Virtual Goggles
Virtual Reality
Keywords: nursing education
virtual reality
virtual goggles
nursing skill
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study includes experimental and control groups.
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to evaluate whether virtual reality (VR)-based education improves nursing students' knowledge and skill levels related to subcutaneous injection. The study will include first-year nursing students. The main questions it aims to answer are:

Does the use of virtual reality technology increase knowledge about subcutaneous injection compared to traditional education?

Does virtual reality training enhance practical skill performance in subcutaneous injection?

Researchers will compare a VR-based education group (Intervention Group) with a traditional education group (Control Group) to see if VR education leads to greater improvements in knowledge and skill acquisition.

Participants will:

Complete a knowledge test, a skill test, and a demographic data form before and after the training.

In the Intervention Group, watch a video on subcutaneous injection using VR glasses.

In the Control Group, receive standard education using traditional teaching methods.

Undergo knowledge and skill assessment following the educational interventions.


Eligibility criteria: Inclusion Criteria:

* Being a first year student in a nursing undergraduate program.
* Having a health condition and cognitive capacity suitable for using virtual reality technology.
* Having accepted to participate in the study voluntarily.

Exclusion Criteria:

* To give up participating in the study.

Primary outcomes:
measure: Knowledge level about subcutaneous injection
timeFrame: 3 weeks before watching videos with virtual reality glasses and 3 weeks after watching videos with virtual reality glasses.
measure: skill performance level about subcutaneous injection
timeFrame: 3 weeks before watching videos with virtual reality glasses and 3 weeks after watching videos with virtual reality glasses.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
Study officials:
References:
citation: Choi J, Thompson CE, Choi J, Waddill CB, Choi S. Effectiveness of Immersive Virtual Reality in Nursing Education: Systematic Review. Nurse Educ. 2022 May-Jun 01;47(3):E57-E61. doi: 10.1097/NNE.0000000000001117. Epub 2021 Oct 12.