louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06333912: Accuracy of Guided Ridge Splitting With Simultaneous Implant Placement
Official title: Accuracy of Novel Ridge Splitting Guide Design in Comparison to Freehand With Simultaneous Implant Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant
Keywords: guided ridge splitting, atrophic maxilla, osseodensification drills.
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessing whether is there a difference between computer-guided ridge splitting and conventional technique with simultaneous implant placement in patients with maxillary width deficiency.

Detailed description: Two groups one treated with ridge splitting using guided surgery and the other one treated with freehand surgery and both groups had simultaneous dental implants the first one had guided placement and the other one was freehand.

Eligibility criteria: Inclusion Criteria:

* Patient with missing maxillary anteriors or premolars teeth.
* Tooth extraction at the implant sites was performed at least 4 months before the surgery.
* The bone width of the crestal one -third (3-5 mm) with sufficient bone height allowing for simultaneous implant placement.
* Free from any systemic disease or local pathological lesions that may affect bone healing or contraindicate implant placement.
* With no history of any previous grafting surgeries at the area of interest.

Exclusion Criteria:

* Sever concavity of the alveolar ridge.
* Bad oral hygiene ( Silness-Löe index (score 2-3).
* Heavy smoker (smoke greater than or equal 25 cigarettes per day).
* Presence of acute infections or periapical lesions in adjacent teeth.
* Parafunctional habits.
* Pregnant females.

Primary outcomes:
measure: Assessing the accuracy of guided surgery
timeFrame: one week
Secondary outcomes:
measure: the bone-width increase between control and study group.
timeFrame: 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University, Faculty of dentistry
Study officials:
affiliation: Alexandria University
name: Mahmoud Elbayaa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04363112: Association Between a Biological Pattern of Dysregulation of the HPA Axis and Mental Disorders in Children Exposed to Early Life Stress
Official title: Association Between a Biological Pattern of Dysregulation of the HPA Axis and Mental Disorders in Children Exposed to Early Life Stress
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mental Disorder, Child
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 8
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is an monocentric, interventional, comparative uncontrolled study
Primary purpose: OTHER

Brief summary: The purpose of this study is to demonstrate an association between a biological pattern of dysregulation of the HPA axis and mental disorders in children exposed to early life stress.

Detailed description: The purpose of this study is to demonstrate an association between a biological pattern of dysregulation of the HPA axis and mental disorders in children exposed to early life stress.

Cortisol secretion lead to define two groups : pathologic versus normal cortisol secretion.

Mental disorders is evaluate with Mini-Kids II (a mental health questionary) and lead to define two groups : mental disorders versus no mental disorders

Eligibility criteria: Inclusion Criteria:

* Aged 8 to over 10 years
* To be entrust to ASE of Finistère in stable environment (the same place of residence since 6 months or more)
* French speaking
* Oral consent by children
* Informed and signed consent by tenured of parent authority

Exclusion Criteria:

* Don't want to participate
* To have chronic neurologic or endocrinal pathology or don't have access to verbal language.

Primary outcomes:
measure: Mini Kid II : Mini International Neuropsychiatric Interview
timeFrame: Day 10 to the study
Secondary outcomes:
measure: CBCL score : Child Behaviour Check List
timeFrame: Day 10 to the study
measure: BRIEF : Behavrioral Rating Inventory of Executive Function
timeFrame: Day 10 to the study
Other outcomes:
Locations:
city: Brest Cedex
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT05282212: Point of Care, High Resolution and 3-Dimensional Ultrasonography
Official title: Point of Care, High Resolution and 3-Dimensional Ultrasonography for Diagnosing Peri-Implant Bone Loss
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Loss in Jaw
Dental Diseases
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2022-03-16
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at the University of Michigan School of Dentistry who are scheduled for dental implant revision surgery as standard of care in the Graduate Periodontics department.

Brief summary: The overall purpose of this study is to establish an ultrasound technique to aid in oral and dental examination of soft and hard tissues. Ultrasound is currently not used in Dentistry and associated oral examinations and we are exploring its usefulness for clinical practice. This study will investigate the use of ultrasonic imaging for planning and placing dental implants, as well as evaluate the use of ultrasonic imaging for monitoring marginal bone loss around dental implants.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* • Have a dental implant infection (bleeding on probing/exudate and probing depths of at least 5 mm) and are or will be scheduled for revision surgery within 90 days of the screening visit.
* Willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria:

* Unwilling or unable to read and sign informed consent form.
* Pregnancy or unsure of their pregnancy status (self-reported)

Primary outcomes:
measure: Dental Implant bone level
timeFrame: Within 90 days before dental surgery
measure: Dental implant radicular bone thickness
timeFrame: Within 90 days before dental surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Hsun-Liang Chan, DDS, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan, Radiology
name: Oliver Kripfgans, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan HL, Misch K, Wang HL. Dental imaging in implant treatment planning. Implant Dent. 2010 Aug;19(4):288-98. doi: 10.1097/ID.0b013e3181e59ebd.
citation: Lindhe J, Meyle J; Group D of European Workshop on Periodontology. Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology. J Clin Periodontol. 2008 Sep;35(8 Suppl):282-5. doi: 10.1111/j.1600-051X.2008.01283.x.
citation: Peri-implant mucositis and peri-implantitis: a current understanding of their diagnoses and clinical implications. J Periodontol. 2013 Apr;84(4):436-43. doi: 10.1902/jop.2013.134001. No abstract available.
Clinical trial NCT05330546: Evaluation of Implant Stability in Low Quality Bone Following the Use of Osseodensifiers Versus Ridge Expanders
Official title: Evaluation of the Stability of Implants Placed in Low Quality Bone Following the Use of Osseodensification Technique Versus Ridge Expanders: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Bone Density
Keywords: osseodensification
ridge expansion screw
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the use of osseodensification technique compared to ridge expansion screws in low bone quality

Detailed description: using Densah burs in preparation of implant osteotomy compared to ridge expansion screws in low quality bone

Eligibility criteria: Inclusion Criteria:

* • Single tooth missing in the maxillary region with D3 (350-850 HU) and D4 (150-350 HU) bone (Sultana et al., 2020).

  * A minimum of 4 mm residual buccolingual bone width at site of implant placement (Koutouzis et al., 2019).

    * The recipient site of the implant should be free from any pathological conditions.
    * No diagnosed bone disease or medication known to affect bone metabolism.
    * Patients who are cooperative, motivated and hygiene conscious.
    * Patients having adequate inter-occlusal space of 8-10 mm (Fernández et al., 2017)

Exclusion Criteria:

* Systemic conditions/diseases that contraindicate surgery (Jarikian et al., 2021).

  * Patients who have any habits that might jeopardize the osseointegration process, such as current smokers (Vollmer et al., 2020).
  * Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching (Sultana et al., 2020).
  * Alcohol or drug abuse (Ibrahim et al., 2020).
  * Pregnant and lactating women.

Primary outcomes:
measure: Implant stability
timeFrame: change from baseline at 3 month
measure: Implant stability
timeFrame: change from baseline at 6 month
Secondary outcomes:
measure: Radiographic bone density
timeFrame: change from baseline at 3 month
measure: Radiographic bone density
timeFrame: change from baseline at 6 month
measure: Change in crestal bone level
timeFrame: change from baseline at 3 month
measure: Change in crestal bone level
timeFrame: change from baseline at 6 month
measure: Change in buccolingual bone width
timeFrame: change from baseline at 3 month
measure: Change in buccolingual bone width
timeFrame: change from baseline at 6 month
measure: Patient reported outcomes
timeFrame: at time of surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Main supervisor
name: Ahmed El Barbary, Assis. prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05566912: Practices Made by Patients to Avoid Insulin Injection Pain
Official title: AVOIDING PAIN CAUSED BY INSULIN INJECTION Patients Using Insulin With Diabetes Seek For Painless Injection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Insuline injection pain
lipohypertrophy
nursing care
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with diabetes between the ages of 18-65

Brief summary: Abstract Objective: This study was conducted to determine the knowledge levels of DM patients about the disease and insulin use, and their practices to avoid insulin injection pain.

Methods: Data were collected from 399 patients who administered insulin injections in the study. Patient identification form, disease and treatment compliance form, Morisky-8 Treatment Adherence Scale (MMAS-8), and Visual Analog Scale were used for data collection. The data were collected by the same researcher by face-to-face interview technique.

Detailed description: The face-to-face interview technique was applied to all patients who met the inclusion criteria and accepted to participate in the study, in the waiting area of the internal medicine outpatient clinic. Data were collected by the same researcher. Questionnaire forms were filled in the form of questions and answers in 10-15 minutes.

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18-65, diagnosed with diabetes mellitus at least 1 year ago, injecting themselves with insulin.

Exclusion Criteria:

* Having no communication problems, and having no mental illness were included in the study.

Primary outcomes:
measure: Completing the surveys
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Akşehir
Study officials:
References:
Clinical trial NCT04150146: To Evaluate Food Effect on the Pharmacokinetics of Rebamipide in Healthy Volunteers
Official title: A Randomized, Open Label, Single Dose, Crossover Study to Evaluate the Food Effect on the Pharmacokinetics of "Rebamipide Sustained Release (SR) 150mg" in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-11-04
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a randomized, open label, single dose, crossover study to evaluate the food effect on the pharmacokinetics after single oral dose of "rebamipide SR 150 mg" in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

1. Subjects who give consent to voluntary participation by signing the informed consent form
2. Healthy adult males aged ≥19 and ≤45 years at screening
3. Subjects with weight ≥50 kg AND body mass index (BMI) ≥18.0 and ≤27.0

Exclusion Criteria:

1. Subjects with hypersensitivity to the active ingredient of the IP or other anti-ulcer agents or history of clinically significant hypersensitivity
2. Subjects with any past history of gastrointestinal diseases which can affect the absorption of the IP
3. Subjects who have participated in other clinical trial and received any other investigational products within 6 months before the expected date of IP administration
4. Subjects who have taken any inducers or inhibitors of drug metabolism enzyme
5. Subjects who have been on diets that may affect the absorption, distribution, metabolism, and excretion of a drug
6. Subjects who donated whole blood within 2 months or underwent apheresis within 1 month prior to obtaining informed consent or who did not agree to prohibit blood donation
7. Smokers who have smoked \>10 cigarettes per day within the last 6 months
8. Subjects with any positive result on HBsAg, hepatitis C virus (HCV) Ab, HIV Ab, and (venereal disease research laboratory) VDRL tests

Primary outcomes:
measure: Cmax
timeFrame: From Period1/ Day1 to Period2/Day9
measure: AUClast of Rebamipide
timeFrame: From Period1/ Day1 to Period2/Day9
Secondary outcomes:
measure: t1/2 β of Rebamipide
timeFrame: From Period1/ Day1 to Period2/Day9
measure: Tmax of Rebamipide
timeFrame: From Period1/ Day1 to Period2/Day9
measure: AUCinf of Rebamipide
timeFrame: From Period1/ Day1 to Period2/Day9
Other outcomes:
Locations:
city: Bundang
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT01832246: Endoscopic Ultrasonographic Staging and Conventional Endoscopic Staging for Depth of Invasion for Early Gastric Cancer
Official title: Prospective Study of Endoscopic Ultrasonographic Staging and Conventional Endoscopic Staging for Depth of Invasion and Endoscopic Tumor Size Estimation for Early Gastric Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Tumor
Early Gastric Cancer
Keywords: endoscopy
endosonography
stomach cancer
tumor staging
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 560
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with early gastric adenocarcinoma is prospectively enrolled at Seoul National University Hospital.

Brief summary: The accurate prediction of depth of tumor invasion in early gastric cancer is essential for the proper selection of candidates for endoscopic resection. Conventional endoscopy and endoscopic ultrasonography have been useful diagnostic method for depth of invasion in early gastric cancer. However, there has been no prospective comparative study on the accuracy between the 2 methods. Therefore, the investigators prospectively compare the accuracy between the 2 methods regarding prediction of depth of invasion.


Eligibility criteria: Inclusion Criteria:

* Patients with early gastric adenocarcinoma undergo both endoscopic staging and endoscopic ultrasonographic staging for depth of invasion

Exclusion Criteria:

* patients had previously received neoadjuvant chemotherapy or chemoradiotherapy
* patients with obviously advanced gastric cancer by endoscopy
* the evidence of distant metastasis or extensive adjacent organ invasion on abdominal CT scan

Primary outcomes:
measure: diagnostic accuracy between endoscopic ultrasonographic staging and conventional endoscopic staging
timeFrame: up to 2.5 years (end of study, December 2014)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Gastroenterology, Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital
Study officials:
affiliation: Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine
name: Sang Gyun Kim, M.D.
role: STUDY_DIRECTOR
affiliation: Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine
name: Jeongmin Choi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06436846: Genomic Risk in Retroperitoneal Sarcoma
Official title: Characterization of the Genomic Risk Underlying Retroperitoneal Liposarcoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retroperitoneal Liposarcoma
Soft Tissue Sarcoma
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (age 18 years or older) with retroperitoneal tumors suspicious for liposarcoma.

Brief summary: The protocol intends to explore the biology which may underlie recurrences of retroperitoneal liposarcoma. Surgery remains the only curative intent intervention for this disease. Often, tumors recur in locations within the retroperitoneum remote from the original primary tumor. This study hypothesizes that normal appearing retroperitoneal fat actually harbors underlying genetic changes which predispose to development of future liposarcoma. To accomplish this goal, retroperitoneal fat is sampled from quadrants within and remote from the primary tumor and is subsequently subjected to genetic analyses looking for such predisposing factors.


Eligibility criteria: Inclusion Criteria:

* Adult patients (age ≥18 years).
* Histologically confirmed retroperitoneal liposarcoma via preoperative biopsy, or cross-sectional imaging suspicious for liposarcoma with planned surgical resection
* Will be undergoing surgical resection for treatment of primary or recurrent disease
* Have provided informed consent to participate in this study

Exclusion Criteria:

• Prior surgical anatomy which makes sampling of remote areas of the retroperitoneum technically impossible or clinically undesirable for safety reasons

Primary outcomes:
measure: Presence of MDM2 amplification in "normal" retroperitoneal fat
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06747546: Research on Circulation Management Strategy Based on Oxygen Metabolism Balance After CHD Surgery
Official title: Research on Circulation Management Strategy Based on Oxygen Metabolism Balance After Congenital Heart Disease Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Congenital Heart Disease (CHD)
Cardiopulmonary Bypass
Children
Oxygen Delivery
Oxygen Consumption
Oxygen Saturation
Goal-directed Therapy
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to investigate a goal-oriented postoperative circulation management strategy centered on "oxygen metabolism balance". This strategy is independent of the absolute metrics of oxygen supply and consumption, and aims to enhance oxygen consumption and uptake within the critical "golden 8 hours" following pediatric cardiopulmonary bypass, thereby preventing severe hypotension, cardiopulmonary arrest, and other adverse events.

Detailed description: This study firstly offered a specialized treatment strategy for children, particularly those who have undergone cardiopulmonary bypass surgery, that uses tailored parallel control and is independent of absolute oxygen supply and consumption characteristics.In addition, this study seeks to investigate the correlation between oxygen supply and consumption following pediatric cardiopulmonary bypass surgery and to assess the clinical utility of a goal-directed strategy concerning cardiac function recovery (ICON, echocardiography, myocardial markers) and outcomes (incidence of low cardiac output, duration of endotracheal intubation, length of CCU stay, and mortality). This strategy is of great significance to improve the surgical outcomes and prognoses for children.

Eligibility criteria: Inclusion Criteria:

* 1.Body weight \> 2.5kg;
* 2.Preoperative oxygen saturation \>80%;
* 3.Biventricular radical surgery with cardiopulmonary bypass.

Exclusion Criteria:

* 1. Complicated with functional single ventricle and atrial isomerism;
* 2.Complicated with liver, kidney, lung, brain and other vital organ diseases;
* 3.History of rescue before operation;
* 4.Palliative surgery;
* 5.Residual deformities that significantly affected hemodynamics after operation;
* 6.Guardians did not provide the bundle of informed consent.

Primary outcomes:
measure: Number of participants with low cardiac output syndrome
timeFrame: 72 hours after surgery
Secondary outcomes:
measure: Number of death
timeFrame: 1 month after surgery
Other outcomes:
Locations:
city: Minhang
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Ping Ya Mi
role: STUDY_DIRECTOR
References: