louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04826783: Use of Various Laser Systems in Peri-implatit
Official title: Effect of Various Laser Systems in Smokers and Nonsmokers With Peri-implantitis: A Randomized, Prospective, Single-Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peri-Implantitis
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: In recent years, a new field of work has been created with the use of laser beam to provide titanium surface decontamination. The aim of this study was to evaluate the effect of various laser systems in smokers and non-smokers with peri-implantitis.

Materials and Methods: According to the study protocol, patients, who were diagnosed with peri-implantitis based on the clinical and radiographic evaluations, were divided into six groups: Group 1: smokers undergoing diode laser application; Group 2: smokers undergoing Erbium, chromium: yttrium, scandium, gallium, garnet (Er, Cr:YSGG) laser application; Group 3: smokers undergoing Erbium:yttrium-aluminum-garnet (Er:YAG) laser application; Group 4: non-smokers undergoing diode laser application; Group 5: non-smokers undergoing Er, Cr:YSGG laser application; and Group 6: non-smokers undergoing Er:YAG laser application. Peri-implant sulcus depth (SD), clinical attachment level (CAL), suppuration, modified plaque index (mPI), gingival index (GI), and modified sulcus bleeding index (mSBI) were recorded and peri-implant sulcus fluid (PISF) was collected to evaluate osteocalcin.


Eligibility criteria: Inclusion Criteria:

1. Presence of pocket in probing depth of ≥4 mm in at least one implant
2. No mobility in implant
3. Implants with bridge foot and opposite occlusion
4. Having no systemic disease that may affect the outcome of treatment
5. No systemic use of antibiotics for the last six months
6. Not receiving peri-implantitis treatment for the last three months
7. Individuals at the 30-60 years of age.

Exclusion Criteria:

1. Individuals who did not agree to participate in the study
2. Individuals receiving radiation therapy
3. Individuals using alcohol
4. Presence of pregnancy and lactation period
5. Individuals with parafunctional habits such as clenching or bruxism.

Primary outcomes:
measure: Sulcus depth
timeFrame: basaline - six month
Secondary outcomes:
Other outcomes:
Locations:
city: Yahşihan
country: Turkey
facility: Kırıkkale University faculty of Dentistry
state: Kırıkkale
Study officials:
References:
Clinical trial NCT03882983: Stromal Vascular Fraction From Lipoaspirate to Treatment of Chronic Non-healing Wound
Official title: A Phase I Safety Study Using Stromal Vascular Fraction From Lipoaspirate in the Treatment of Chronic Non-healing Wounds
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Chronic Wounds
Keywords: Autologous Adult Stem Cell
Lipoaspirate
Non-healing Wounds
Stomal Vasular Fraction
Lead sponsor: Antria
Sponsor class: INDUSTRY
First posted: 2019-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase I, open-label, single arm study to demonstrate the safety of Antria Cell Preparation Process during fat grafting augmented with autologous adipose derived stromal vascular fraction to demonstrate the safety and efficacy of administration of SVF enriched fat grafting in chronic wounds

Detailed description: This is a Phase I, open-label, single arm study to demonstrate the safety of Antria Cell Preparation Process during fat grafting augmented with autologous adipose derived stromal vascular fraction to demonstrate the safety and efficacy of administration of SVF enriched fat grafting in chronic wounds.

Eligibility criteria: Inclusion Criteria:

1. Female or Male, Age 18 years or older
2. Subjects that are diagnosed with one or more chronic wounds.
3. Able to understand and provide written and verbal informed consent

Exclusion Criteria:

1. Currently taking or have taken NSAIDs within last two weeks or corticosteroids within the last six weeks prior to screening.
2. Diagnosis of any of the following medical conditions:

   * Active malignancy (diagnosed within 5 years), except for treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm (e.g. cervical cancer)
   * Active infection (other than their wound)
3. Subjects who are unlikely to comply with the protocol (e.g., uncooperative attitude, inability to return for subsequent visits, dementia, and/or otherwise considered by the Investigator to be unlikely to complete the study)
4. Subjects with a known drug or alcohol dependence within the past 12 months as judged by the Investigator
5. Any other disease condition or laboratory results that in the opinion of the investigator may be clinically significant and render the subject inappropriate for the study procedure(s), may alter the accuracy of study results, or increase the risk for subjects.
6. Subjects with life-expectancies less than 12 months
7. Subjects with known collagenase allergies
8. Pregnant females On radiotherapy or chemotherapy agents

Primary outcomes:
measure: Bates-Jensen Wound Assessment
timeFrame: 1 year
Secondary outcomes:
measure: Digital Picture of wound
timeFrame: 1 year
Other outcomes:
Locations:
city: Indiana
country: United States
facility: Indiana Regional Medical Center
state: Pennsylvania
Study officials:
affiliation: Antria Inc.
name: Leonard E Maliver, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04765683: Video, Telephone or Face-to-face Surgical Consultations: a Survey of Patients' and Surgeons' Views
Official title: Video, Telephone or Face-to-face Surgical Consultations: a Survey of Patients' and Surgeons' Views
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery
Keywords: outpatient consultation
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 260
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General surgical outpatients General surgeons

Brief summary: This study will send out questionnaires to surgical outpatients and surgeons to gather their views on the appropriate type of surgical outpatient consultation in different clinical scenarios, in order to establish a guideline for surgical outpatient planning.

Detailed description: As above - this study will send out questionnaires to surgical outpatients and surgeons to gather their views on the appropriate type of surgical outpatient consultation in different clinical scenarios, in order to establish a guideline for surgical outpatient planning.

Eligibility criteria: Inclusion Criteria:

PATIENTS

Adults attending general surgical outpatients in Aberdeen Royal Infirmary during the study period presenting with:

* lumps and bumps
* hernias
* biliary problems
* jaundice
* abdominal pain/mass/weight loss
* gastro-oesophageal reflux
* dysphagia
* change in bowel habit
* anorectal problems
* thyroid nodules
* parathyroid disease
* adrenal masses

SURGEONS

Consultant General Surgeons in NHS Grampian / Tayside and Highlands

Exclusion Criteria:

PATIENTS

* lacking capacity
* without language skills to answer questionnaires or ability to understand questionnaires
* children \< 16yrs (No upper age limit)
* patients presenting as emergencies
* patients unwilling to complete questionnaires.

SURGEONS

- trainee surgeons.

Primary outcomes:
measure: appropriate type of surgical outcome
timeFrame: June 2021
Secondary outcomes:
measure: Are there any new surgical patients that can be seen or assessed by video or telephone consultation? Do remote consultations improve efficiency?
timeFrame: June 2021
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
Study officials:
References:
Clinical trial NCT03626883: Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction
Official title: Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction. Clinical, Laboratory, Radiographic and Patient-reported Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Keywords: arthroscopy
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to examine the influence of number of the harvested hamstring tendons on subjective and objective outcomes of primary anterior cruciate ligament reconstruction.

Detailed description: The aim of the study is to examine the influence of number of the harvested hamstring tendons on subjective (patient-reported outcome measures) and objective (instrument-tested and imaging studies) outcomes of primary anterior cruciate ligament reconstruction.

The study will recruit 60 patients per each of two arms.

Eligibility criteria: Inclusion Criteria:

* chronic anterior knee instability with MRI-confirmed anterior cruciate ligament tear

Exclusion Criteria:

* revision anterior cruciate ligament surgery
* other lower limb injuries

Primary outcomes:
measure: Knee stability (KT1000 assessment), pivot shift at 2,4 and 5yrs time-points
timeFrame: up to 5yrs
Secondary outcomes:
measure: Change from baseline International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at 104 weeks
timeFrame: up to 5yrs
measure: Change from baseline Knee injury and Osteoarthritis Outcome Score at up to 5yrs
timeFrame: up to 5yrs
measure: Change from baseline Lysholm Knee Questionnaire at 104 weeks
timeFrame: up to 5yrs
measure: Change from baseline Visual Analog Scale for Pain at 104 weeks
timeFrame: up to 5yrs
measure: Change from baseline tunnel volume at 104 weeks
timeFrame: 104-weeks postop
measure: Change from baseline tunnel diameter at 104 weeks
timeFrame: 104-weeks postop
measure: Need for arthrocentesis, revision surgery, additional procedures up to 104 weeks
timeFrame: up to 5yrs
Other outcomes:
Locations:
city: Otwock
country: Poland
facility: Prof. A. Gruca Teaching Hospital, Centre for Postgraduate Medical Education
state: Woj. Mazowieckie
Study officials:
affiliation: Centre for Postgraduate Medical Education in Warsaw
name: Marcin K Wasko, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05676983: Investigation of the Effects of Balance Discs With Different Surfaces Used in Balance Education in Children With Cerebral Palsy on Proprioceptive Sense and Balance.
Official title: Investigation of the Effects of Balance Discs With Different Surfaces Used in Balance Education in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 16
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a non-invasive prospective study investigating the effects of balance discs with different surfaces used in balance education in children with cerebral palsy on proprioceptive sense and balance.

Detailed description: Many methods are used for balance training. One of them is balance discs. Balance discs consist of smooth and rough surfaces. Balance training is given to children with cerebral palsy on these two surfaces. Thanks to its balance disc structure, it plays an active role in the development of balance, but there is a need for evidence about whether rough or smooth surfaces and training have superiority over each other. Knowing the difference between the two surfaces will help the staff about which surface to use in the treatment and will be beneficial for the children.

The aim of this study is to determine whether there is a difference between a rough and smooth surface in terms of improving proprioceptive sense and balance.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with cerebral palsy
* Diagnosed with motor developmental delay
* 0-12 years old
* Levels 1 and 2 according to GMFCS
* Having bilateral and unilaterally affected spastic type CP
* Cooperate with assessments

Exclusion Criteria:

* Botulinum toxin administration in the last 6 months
* Having had any surgical operation in the last 6 months
* Having dyskinetic, ataxic and hypotonic type CP
* Unable to cooperate with assessments

Primary outcomes:
measure: Change in Pediatric Berg balance test:
timeFrame: baseline and week 10
measure: Change in Functional reach test
timeFrame: baseline and week 10
measure: Change in One-leg standing test
timeFrame: baseline and week 10
measure: Change in Proprioceptive sensory test:
timeFrame: baseline and week 10
Secondary outcomes:
Other outcomes:
measure: height
timeFrame: baseline
measure: weight
timeFrame: baseline
measure: body mass index
timeFrame: baseline
Locations:
city: Antakya
country: Turkey
facility: Hatay Mustafa Kemal Üniversitesi
state: Hatay
Study officials:
References:
Clinical trial NCT02173483: Anterior Cruciate Ligament-reconstruction: Quadriceps Tendon or Hamstrings Tendon? A Prospective Trial
Official title: Anterior Cruciate Ligament-reconstruction: Quadriceps Tendon or Hamstrings Tendon? A Prospective Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ligament; Laxity, Knee
Rupture of Anterior Cruciate Ligament
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 100
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: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether there is a difference in muscle strength after anterior cruciate ligament comparing 2 surgery technics. Using either autograft hamstrings tendon or a autograft quadriceps tendon.


Eligibility criteria: Inclusion Criteria:

* Anterior cruciate ligament rupture

Exclusion Criteria:

* current malignant disease
* Rheumatoid arthritis
* Other knee ligament instability
* Obesity BMI \>30
* Morbus Bechterew

Primary outcomes:
measure: Patient reported outcome score - IKDC
timeFrame: 12 month
Secondary outcomes:
measure: Knee laxity
timeFrame: 12 month
measure: Patient reported outcome score - KOOS
timeFrame: 12 month
measure: TEGNER
timeFrame: 12 month
measure: Anterior knee pain scale
timeFrame: 12 month
measure: Donor Site morbidity score
timeFrame: 12 month
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Division of Sports Trauma, Tage-Hansens Gade 2b
Study officials:
References:
citation: Sinding KS, Nielsen TG, Hvid LG, Lind M, Dalgas U. Effects of Autograft Types on Muscle Strength and Functional Capacity in Patients Having Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Sports Med. 2020 Jul;50(7):1393-1403. doi: 10.1007/s40279-020-01276-x.
citation: Lind M, Nielsen TG, Soerensen OG, Mygind-Klavsen B, Fauno P. Quadriceps tendon grafts does not cause patients to have inferior subjective outcome after anterior cruciate ligament (ACL) reconstruction than do hamstring grafts: a 2-year prospective randomised controlled trial. Br J Sports Med. 2020 Feb;54(3):183-187. doi: 10.1136/bjsports-2019-101000. Epub 2019 Nov 8.
Clinical trial NCT00453583: Evaluation of Treatment Satisfaction in Children With an Allergy and Who Received an Antihistamine
Official title: Evaluation of the Treatment Satisfaction in Children Suffering From an Allergy and Who Received an Antihistamine Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergies
Keywords: Pediatric
Allergies
Antihistamines
Non-interventional
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-03-29
Enrollment: 4581
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care

Brief summary: This is a non-interventional retrospective data collection study from children aged from 2 to 12 years old diagnosed with an allergy and who received a treatment consisting of an H1-antihistamine. The period of last taken medication will be observed to evaluate the global satisfaction of the parents and physician for this last treatment.


Eligibility criteria: Inclusion Criteria:

* Children from 2-12 included
* History of allergy
* Used an Antihistamine within market authorization

Exclusion Criteria:

* Child not yet treated for the presented allergy

Primary outcomes:
measure: Parent satisfaction on a 11-point scale
timeFrame: duration of the study
Secondary outcomes:
measure: Physician satisfaction on an 11-point scale
timeFrame: duration of the study
measure: Efficacy, tolerability and global satisfaction
timeFrame: duration of the study
Other outcomes:
Locations:
city: Smyrna
country: United States
facility: UCB Pharma
state: Georgia
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02589483: Reinforcement of Rectal Anastomosis-RORA
Official title: RORA (Reinforcement of Rectal Anastomosis(<10cm) With HemoPatch - Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Capio Sankt Görans Hospital
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The anastomotic leaks are multivariable in its origin. The incidence varies among different centers between 4% and as high as 25%. The impact of leakage in a rectal anastomosis can be devastating for the patient and very costly for the health care system.

Prolonged hospital stay (LOS), invasive treatment and intensive care are the consequences.

The future of colorectal surgery will increasingly include older patients with increased preoperative morbidity and probably even higher risk for anastomotic leaks. which makes it suitable for reinforcing a rectal anastomosis. The goal is to shift the clinical leaks spectrum into a subclinical and therefore self-healing one.

Detailed description: The rationale is to explore if the procedure of reinforcement with HemoPatch and bringing more mechanical strength over an extended area around the anastomosis thus lowers the incidence of clinical anastomotic leaks.

The characteristics of HemoPatch, with its structural properties such as flexibility and tissue adhesion are suitable for this purpose.

Eligibility criteria: Inclusion Criteria:

* Rectal surgery with anastomosis below 10 cm from anal verge

Exclusion Criteria:

* none

Primary outcomes:
measure: Evidence of clinical anastomotic leak( elevated C reactive protein and white blood corpuscles, fever, nausea). Suspicion of a leak will be investigated with a Ct scan.
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Dan Kornfeld
city: Stockholm
country: Sweden
facility: Dan Kornfeld
Study officials:
affiliation: Capio Sankt Görans Hospital
name: Dan Kornfeld, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bruce J, Krukowski ZH, Al-Khairy G, Russell EM, Park KG. Systematic review of the definition and measurement of anastomotic leak after gastrointestinal surgery. Br J Surg. 2001 Sep;88(9):1157-68. doi: 10.1046/j.0007-1323.2001.01829.x.
citation: Daams F, Luyer M, Lange JF. Colorectal anastomotic leakage: aspects of prevention, detection and treatment. World J Gastroenterol. 2013 Apr 21;19(15):2293-7. doi: 10.3748/wjg.v19.i15.2293.
citation: Dekker JW, Liefers GJ, de Mol van Otterloo JC, Putter H, Tollenaar RA. Predicting the risk of anastomotic leakage in left-sided colorectal surgery using a colon leakage score. J Surg Res. 2011 Mar;166(1):e27-34. doi: 10.1016/j.jss.2010.11.004. Epub 2010 Dec 1.
Clinical trial NCT04100928: Evaluating the Well-being Among Dental Students With Warwick-Edinburg Mental Well-Being Scale
Official title: Evaluating the Well-being Among Dental Students With Warwick-Edinburg Mental Well-Being Scale and the Relationship Between Mental Well-being and Socio-demographic Findings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Well Being
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All students in the faculty of dentistry, Baskent University

Brief summary: The present study was conducted to measure the mental well-being amongst dental students by using Warwick-Edinburg Mental Well-being Scale (WEMWBS) and investigate factors affecting well-being among dental students.

Detailed description: The survey schedule was planned to be independent of the students' assessment period and the questionnaire was administered to the students when they were attending a lecture together. After the lecture, a researcher explained to the students the purpose of this survey and assured them of confidentiality. Participation in this study was also voluntary, and all participants remained anonymous. The questionnaire was given to all participants after explaining the purpose of the study. The questionnaire included demographic details (age, gender, year of study), social background (parents' education levels, family income, first choice for admission, living accommodation) and lifestyle behaviors (smoking status, presence of regular sport activity and hobby). In addition, Warwick-Edinburg Mental Well-Being Scale was applied to the participants of this study.

Eligibility criteria: Inclusion Criteria:

to be officially registered in the faculty of dentistry, Baskent University

Exclusion Criteria:

unwilling to participate

Primary outcomes:
measure: Warwick-Edinburg Mental Well-being Scale
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Yasemin Sezgin
Study officials:
affiliation: Dr.
name: yasemin sezgin
role: STUDY_DIRECTOR
References: