louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01934530: A Randomized Control Trial Testing Connective Tissue Grafts vs. Allograft on Dental Implants
Official title: Implant Associated Soft Tissue Defects in the Anterior Maxilla: A Randomized Control Trial Between Subepithelial Connective Tissue Graft and Acellular Dermal Matrix Allograft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant Soft Tissue Defects in the Anterior Maxilla
Keywords: implant complications
esthetics
soft tissue grafting
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: BioHorizons, Inc.
First posted: 2013-09-04
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled clinical pilot trial compared the efficacy of two soft tissue grafting methods for correcting esthetic discrepancies associated with non-molar implants in the maxilla. Specifically, it was explored whether defects treated with connective tissue grafts (SCTG) differed in their outcomes from defects treated with acellular dermal matrix allografts (ADM).

Detailed description: Thirteen patients who presented with implants displaying recession, thin biotype, concavity defects or a combination thereof associated with single crowned dental implants participated in this randomized control trial. The control group (N=7) received SCTG and the test group (N=6) received ADM, both under coronally positioned flaps. Data were collected before surgery, and 6 weeks, 3 months, and 6 months after the surgery. Outcome measures included soft tissue, hard tissue, and esthetics parameters and psychosocial data.

Eligibility criteria: Inclusion Criteria:

* Healthy adults of at least 18 years of age
* Maxillary non-molar implant with failing pink esthetic profile
* Implants with adjacent landmarks (only one can be an implant)
* Healthy implants measured by the lack of peri-implantitis and mucositis
* Good oral hygiene.

Exclusion Criteria:

* Unstable systemic diseases, compromised immune system, or unstable bleeding disorders
* History of radiation or cancer in the oral cavity
* Use of IV bisphosphonate or steroid medication
* Use of tobacco products (\>1/2 pack per day)
* Pregnancy
* Mucogingival surgery or implant placement within the past six months

Primary outcomes:
measure: Recession Correction
timeFrame: 6 Months
Secondary outcomes:
measure: Concavity Correction
timeFrame: 6 Months
Other outcomes:
measure: Tissue Thickness
timeFrame: 6 Months
measure: Implant Esthetics
timeFrame: 6 Months
measure: Psychosocial Data
timeFrame: 6 months
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Hom-Lay Wang, DDS, MS, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06652230: Assessment of Treatment Efficacy Using Smile Arc Marginal Ridge Approach Versus MBT Chart Method for Bracket Positioning
Official title: Assessment of Treatment Efficacy Using Smile Arc Marginal Ridge Approach Versus MBT Chart Method for Bracket Positioning: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Class I Malocclusion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 30
Sex: ALL
Minimum age (years): 11
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized clinical trial is to evaluate the effect of Smile Arc Marginal Ridge Approach (SAMRA) versus MBT chart method for bracket positioning on orthodontic treatment results.

The main questions it aims to answer are:

Is there a difference in orthodontic treatment results between smile arc marginal ridge approach (SAMRA) and MBT chart method for bracket positioning?

Does SAMRA provide more accurate orthodontic results and reduce the number of archwire bendings and brackets repositioning needed during finishing?

The investigators will compare Smile Arc Marginal Ridge Approach (SAMRA) with MBT Chart Method (gold standard) to see if SAMRA provides more accurate orthodontic results and reduce the need for archwire bendings and brackets repositioning during finishing.

Participants will:

* Undergo orthodontic treatment and divided into two groups, Group A (SAMRA) and Group B (MBT Chart Method).
* 0.018-inch MBT brackets will be used in both groups.
* Follow ups every 1 month will take place to change the archwires after becoming passive.
* After leveling and alignment is completed, orthodontic treatment results, number of archwire bendings and brackets repositioning needed will be determined to see which type of intervention is better or if both provide similar results.


Eligibility criteria: Inclusion Criteria:

* Orthodontic patients aged 11-30 years old.
* Mild or moderate crowding not requiring tooth extraction.
* Full permanent dentition including fully erupted 7s not necessarily 8s.
* Good oral hygiene.
* Skeletal and dentoalveolar class I malocclusion.

Exclusion Criteria:

* Systemic disease potentially affecting the study outcome.
* Cleft lip and palate/syndromic patients.
* Any signs or symptoms of temporomandibular disorders (TMD).
* Previous orthodontic treatment.
* Pregnant females.
* Chronic use of medications.

Primary outcomes:
measure: Orthodontic treatment results
timeFrame: 6 months
Secondary outcomes:
measure: Number of additional archwire bending and bracket repositioning needed
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Cairo University
state: Manial
Study officials:
References:
Clinical trial NCT00322530: Comparison of Dialysis Strategies in Critically Ill Patients With Acute Renal Failure
Official title: Comparison of Dialysis Strategies in Critically Ill Patients With Acute Renal Failure on the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dialysis
Acute Renal Failure
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2006-05-08
Enrollment: 230
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 goal of the present study is the comparison of different dialysis strategies in critically ill patients with acute renal failure on the intensive care unit. Patients are treated with either continuous dialysis or hemofiltration. Outcome measures are death, restitution of renal function, days on ICU, hemodynamic stability, dialysis efficiency.

Detailed description: The goal of the present study is the comparison of different renal replacement strategies in critically ill patients with acute renal failure on the intensive care unit. In a prospectively randomized clinical study patients are treated with either continuous dialysis (SLED) or continuous hemofiltration (CVVHD). 200 patients should be included in the study (n=100 each). The primary outcome is death at ICU, secondary outcome measures are restitution of renal function, days on ICU, hemodynamic stability, dialysis efficiency.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older
* Written informed consent
* No pre-existing dialysis dependency

Exclusion Criteria:

* Minors / children
* No consent
* Severe electrolyte disturbances which necessitates special dialysis therapy

Primary outcomes:
measure: Death
timeFrame: 90 days
Secondary outcomes:
measure: costs
timeFrame: in hospital
measure: Restitution of renal function
timeFrame: 90 days
measure: days on ICU
timeFrame: in hospital
measure: hemodynamic stability
timeFrame: in hospital
measure: dialysis efficiency
timeFrame: in hospital
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Division of Nephrology, University of Heidelberg
state: Baden-Wurttemberg
Study officials:
affiliation: Division of Nephrology, University of Heidelberg
name: Vedat Schwenger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.
citation: Schwenger V, Weigand MA, Hoffmann O, Dikow R, Kihm LP, Seckinger J, Miftari N, Schaier M, Hofer S, Haar C, Nawroth PP, Zeier M, Martin E, Morath C. Sustained low efficiency dialysis using a single-pass batch system in acute kidney injury - a randomized interventional trial: the REnal Replacement Therapy Study in Intensive Care Unit PatiEnts. Crit Care. 2012 Jul 27;16(4):R140. doi: 10.1186/cc11445.
Clinical trial NCT03056430: Neuroanatomical and Functional Changes in Response to an Intensive Balance Training
Official title: Neuroanatomical and Functional Changes in Response to an Intensive Balance Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spatial Orientation
Balance
Keywords: MRI, Neuroplasticity, Balance, Spatial orientation, Hippocampus, Slacklining
Lead sponsor: German Center for Neurodegenerative Diseases (DZNE)
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Repeated-measures, 2 groups \* 2 timepoints
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether intensive slackline training improves spatial orientation abilities, balancing skills and causes neuroplasticity in related brain cortical regions.


Eligibility criteria: Inclusion Criteria:

* No previous slacklining or related experience, 18-30 years of age, good or corrected to good vision

Exclusion Criteria:

* Musculoskeletal and nervous system injuries/diseases that significantly reduce one's ability to perform slacklining training, systemic diseases (cardiovascular, gastrointestinal, metabolic...)

Primary outcomes:
measure: Change from Baseline at 1 and 3 months in Balance Tests score
timeFrame: Baseline, 1 month post-test, 3 months post-test
measure: Change from Baseline at 1 and 3 months in Spatial Orientation Tests score
timeFrame: Baseline, 1 month post-test, 3 months post-test
measure: Change from Baseline at 1 and 3 months in voxel-wise morphometric brain analysis
timeFrame: Baseline, 1 month post-test, 3 months post-test
Secondary outcomes:
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: DZNE
state: Sachsen-Anhalt
Study officials:
affiliation: German Center for Neurodegenerative Diseases (DZNE)
name: Notger Müller, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04178330: Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases
Official title: Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases:A Single Arm, Single Center,Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Metastases
Keywords: multiple brain metastases
Tomotherapy
fractionated stereotactic radiotheray
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2019-11-26
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases.

Detailed description: This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases(≥3 lesions).

Eligibility criteria: Inclusion Criteria:Histologic or cytologic diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT; the lesion number is no less than 3;KPS ≥60,or KPS ≥40 and the limitation of motion is simply caused by brain tumor that is adjacent to the motor function areas; Age: 18-75 years old; Adequate organ function:WBC≥4.0x109/L, Neu ≥ 1.5x109/L, Hemoglobin ≥ 110 g/L, Platelets ≥100 x109/L, Totalbilirubin ≤ 1.5x ULN, AST and ALT ≤ 1.5x ULN, BUN and Cr: within the normal range.

Exclusion Criteria: Other clinically significant diseases (e.g.myocardial infarction within the past 6 months, severe arrhythmia). Unable or unwilling to comply with the study protocol.The expected survival time is less than 3 months. Patients who are anticipated in other clinical trials of brain metastases. Patients who has been treated with WBRT. Pregnant patients or female patients whose HCG is positive. Unsuitable to participate in study, that in the opinion of the treating physician.

Primary outcomes:
measure: Disease control rate(DCR)
timeFrame: 2-3 month after radiation
Secondary outcomes:
measure: Overall survival
timeFrame: up to 3 years
measure: progress free survival
timeFrame: up to 1 year
measure: local control rate
timeFrame: up to 1 year
measure: intracranial progress free survival rate
timeFrame: up to 1 year
measure: adverse event
timeFrame: from the day of radiation, up to 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Jianping Xiao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01001130: Regulatory AVAMYS Nasal Spray PMS
Official title: An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of Avamys® Administered in Korean Patients According to the Prescribing Information
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis, Allergic, Perennial and Seasonal
Keywords: avamys
Allergic Rhinitis
post marketing surveillance
Seasonal Allergic Rhinitis
Perennial Allergic Rhinitis (PAR)
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-10-23
Enrollment: 3244
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients administrated AVAMYS nasal spray at the site

Brief summary: Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of AVAMYS nasal spray administered in Korean patients according to the prescribing information.

AVAMYS is a registered trademark of the GSK group of companies.


Eligibility criteria: All subjects must satisfy the following criteria.

1. Subject who is treated with AVAMYS nasal spray for the first time.
2. Subject who is treated due to symptoms of seasonal and perennial allergic rhinitis in adults and children ≥2 years.
3. Subject who is considered to follow the PMS protocol by an investigator.
4. Subject who is contactable via telephone.
5. Subject who is treated with AVAMYS nasal spray according to its prescribing information.

As considering the characteristic of the observational post marketing surveillance, the exclusion criteria is not strict. All investigators should prescribe AVAMYS nasal spray according to prescribing information which approved in Korea.

All subjects must not satisfy the following criteria.

1. Subject who has hypersensitivity to its ingredients.
2. As corticosteroids can slow the healing of wounds, if a subject who has surgery on his/her nose recently, or has a sore in his/her nose, or if his/her nose has been injured, the subject does not use AVAMYS nasal spray until his/her nose has healed.

Primary outcomes:
measure: Number of participants with an adverse event
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of participants with a serious adverse event
timeFrame: 2 weeks
measure: Number of participants with an unexpected or expected adverse drug reaction
timeFrame: 2 weeks
measure: Effectiveness after AVAMYS nasal spray administration
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Seongnam-si Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05127330: Pilot RCT of a Video-based Intervention for Suicide Prevention
Official title: Pilot RCT of a Video-based Intervention for Suicide Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Ideation
Suicidal Behaviors
Suicide
Keywords: Psychiatric Hospitalization
Lead sponsor: Butler Hospital
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 40
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 investigators will develop a brief video-based intervention for suicide prevention, called LifePlans. LifePlans will be tested in a pilot randomized controlled trial (n = 40) to examine its feasibility and acceptability. Investigators will recruit patients admitted to a psychiatric hospital for suicidal thoughts and behaviors who will receive the intervention for 4 weeks post-discharge. Patients will be assessed at hospital baseline, 1 month post-discharge, and 6 months post-discharge.

Detailed description: In this project, we propose to develop a new intervention, called LifePlans. LifePlans will consist of brief videos that highlight patients' experiences. Episodes will cover these topics: 1) developing a personalized "Life Plan" to stay safe and restrict means, 2) clarifying valued life domains and related goals to improve hopefulness, 3) using informal problem solving to cope better with illness, 4) improving communication with family/friends to increase social support, and 5) adhering to primary treatments including pharmacotherapy and psychotherapy to promote illness management. LifePlans will be tested in a pilot randomized controlled trial (n = 40) to examine its feasibility and acceptability. Investigators will recruit patients admitted to a psychiatric hospital for suicidal thoughts and behaviors who will receive the intervention for 4 weeks post-discharge. Patients will be assessed at hospital baseline, 1 month post-discharge, and 6 months post-discharge.

Eligibility criteria: Inclusion Criteria:

* current psychiatric hospitalization for suicidal thoughts and behaviors
* 18 years or older
* ability to speak and read English
* access to means for viewing videos (computer, tablet, smartphone)

Exclusion Criteria:

* current psychotic symptoms
* current cognitive impairment

Primary outcomes:
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 1 Month
Secondary outcomes:
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: 1 Month
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Brandon Gaudiano, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Butler Hospital
name: Lisa Uebelacker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05455125: MultiMorbidity Life-Course Approach To Myocardial Health -A Cardiac Sub-Study of the MRC National Survey of Health and Development (NSHD)
Official title: A Cardiac Sub-Study of the MRC National Survey of Health and Development (NSHD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Frailty
Cardiovascular Diseases
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 550
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NSHD cohort

Brief summary: Background The life course accumulation of overt and subclinical myocardial dysfunction contributes to older age mortality, frailty, disability and loss of independence. The Medical Research Council National Survey of Health and Development (NSHD) is the world's longest running continued surveillance birth cohort providing a unique opportunity to understand life course determinants of myocardial dysfunction as part of MyoFit46-the cardiac sub-study of the NSHD.

Methods and expected results The investigators aim to recruit 550 NSHD participants of approximately 75 years+ to undertake high-density surface electrocardiographic imaging (ECGI) and stress perfusion cardiovascular magnetic resonance (CMR). Through comprehensive myocardial tissue characterization and 4-dimensional flow the investigators hope to better understand the burden of clinical and subclinical cardiovascular disease. Supercomputers will be used to combine the multi-scale ECGI and CMR datasets per participant. Rarely available, prospectively collected whole-of-life data on exposures, traditional risk factors and multimorbidity will be studied to identify risk trajectories, critical change periods, mediators and cumulative impacts on the myocardium.

Conclusion By combining well curated, prospectively acquired longitudinal data of the NSHD with novel CMR-ECGI data and sharing these results and associated pipelines with the CMR community, MyoFit46 seeks to transform our understanding of how early, mid and later-life risk factor trajectories interact to determine the state of cardiovascular health in older age.


Eligibility criteria: Inclusion Criteria:

* NSHD study member.
* Who is still alive and agreed to take part in the study.

Exclusion Criteria:

* Pacemaker.
* Implantable cardio defibrillator.
* Atrial fibrillation.
* Complete heart block.
* Severe asthma.

Primary outcomes:
measure: CMR phenotype - T1
timeFrame: Through study completion, an average of 4 years.
measure: CMR phenotype - T2
timeFrame: Through study completion, an average of 4 years.
measure: CMR phenotype - Myocardial blood flow
timeFrame: Through study completion, an average of 4 years.
measure: CMR phenotype - Aortic blood flow
timeFrame: Through study completion, an average of 4 years.
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: UCL Bloomsbury Centre for Clinical Phenotyping
Study officials:
References: