louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02133235: The Need of Fiberoptic Bronchoscopy for Placing an Endobronchial Blocker
Official title: The Need and the Effectiveness of Fiberoptic Bronchoscopy for Better Lung Collapse in Vedio-assisted Thoracic Operations Using Endobronchial Blockers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms, Pulmonary
Thoracic Diseases
Keywords: endobronchial blocker
lung separation
vedio-assisted thoracic operation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-05-07
Enrollment: 112
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The need of fiberoptic bronchoscopy for placing an endobronchial blocker. Endobronchial blockers (EBB) have been presented effective and safe alternative for lung separation in vedio-assisted thoracoscopic (VATS) operations. In this study, the investigators will randomize the patients receiving VATS operation with EBB into two groups: one group will receive the conventional bronchoscopic guided EBBs placement, the other group receive two step procedure without confirmation by fiberoptic bronchoscopy.

Detailed description: The need of fiberoptic bronchoscopy for placing an endobronchial blocker. Endobronchial blockers (EBB) have been presented effective and safe alternative for lung separation in vedio-assisted thoracoscopic (VATS) operations. However, there were previous reports showed that it takes longer time to position the EBB versus the double lumen tubes. Placing EBBs need three-step procedure (one is placing an endotracheal tube, the second is inserting the EBB, the third is confirmation of the position by fiberoptic bronchoscopy). In this study, the investigators will randomize the patients receiving VATS operation with EBB into two groups: one group will receive the conventional 3-step procedure, the other group receive two step procedure without confirmation by fiberoptic bronchoscopy.

Eligibility criteria: Inclusion criteria:

Lung separation by endobronchial blockers

Exclusion criteria:

Lung separation by conventional double lumen tube Lung separation with endobronchial blockers through

Primary outcomes:
measure: Surgical Grading for Lung Isolation
timeFrame: 10-15 minutes
measure: Time Required for Proper Placement of the Endobronchial Blocker
timeFrame: 10-15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ya-Jung Cheng
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang ML, Wang YP, Hung MH, Hsu HH, Chen JS, Yang FS, Cheng YJ. Is fibre-optic bronchoscopy necessary to confirm the position of rigid-angled endobronchial blockers before thoracic surgery? A randomized controlled trial. Eur J Cardiothorac Surg. 2018 Jan 1;53(1):241-246. doi: 10.1093/ejcts/ezx260.
Clinical trial NCT00854035: MK-0431/ONO-5435 Phase III Clinical Trial - Insulin Add-on Study for Patients With Type 2 Diabetes Mellitus
Official title: A Phase III, Randomized, Placebo-Controlled, Double-Blind Clinical Trial and Subsequent Open-Label, Extension Clinical Trial to Study the Efficacy and Safety of Addition of MK-0431/ONO-5435 in Japansese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Insulin Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: MK-0431/ONO-5435
Type 2 diabetes mellitus
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2009-03-02
Enrollment: 266
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase III clinical trial will examine the efficacy, safety, and tolerability of the addition of MK-0431/ONO-5435 to Japanese patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and insulin monotherapy.


Eligibility criteria: Inclusion Criteria:

* Japanese Patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and insulin monotherapy

Exclusion Criteria:

* Patients with Type 1 Diabetes Mellitus

Primary outcomes:
measure: HbA1c
timeFrame: 16 weeks
measure: Safety and Tolerability
timeFrame: 16 weeks and 52 weeks
Secondary outcomes:
measure: 2 hour post-meal glucose
timeFrame: 16 weeks
measure: Fasting plasma glucose
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Chubu Region
city: Chugoku
country: Japan
facility: Chugoku Region
city: Hokuriku
country: Japan
facility: Hokuriku Region
city: Kanto
country: Japan
facility: Kanto Region
city: Kinki
country: Japan
facility: Kinki Region
city: Kyushu
country: Japan
facility: Kyushu Region
city: Tohoku
country: Japan
facility: Tohoku Region
Study officials:
affiliation: First Division Clinical Development Planning I
name: Seki Akiteru
role: STUDY_CHAIR
References:
Clinical trial NCT04930835: Treatment Outcomes With Full Arch Rehabilitations Retained by Immediate or Conventionally Loaded Implants
Official title: Treatment Outcomes With Full Arch Rehabilitations Supported by Immediate or Conventionally Loaded Implants: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Jaw
Missing Teeth
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 20
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: This study aims to assess the treatment outcomes (clinical, functional and subjective) of full arch rehabilitations supported by implants with or without an immediate loading protocol. In this randomized clinical trial 20 fully edentulous patients were treated with full arch rehabilitations on dental implants. In half of the sample, the implants were loaded immediately by means of abutments after emplacement of the implant; but in the counterparts these abutments were connected to implants two months after the surgery (conventional protocol), and until that time the dentures were retained by healing abutments. Treatment outcomes were assessed at 2, 6 and 12 months after surgery. Clinical outcomes were quantified on the basis of implant failure rate, marginal bone loss and the peri-implant gingival index. Functional outcomes were calculated according to masticatory performance, estimated by the mixed fraction of a two-coloured chewing gum after 5, 10 and 15 chewing strokes, by the occlusal force recorded by pressure-sensitive sheets and by the bioelectrical muscular activity. The subjective outcomes of the treatment were assessed using both the oral satisfaction scale (visual analogue scale) and the Spanish version of the Oral Health Impact Profile (OHIP-20).


Eligibility criteria: Inclusion Criteria:

* completely edentulous individuals who had lacked teeth for more than 10 years, routine users of conventional complete prostheses.
* sufficient amount of remaining bone to receive the implants in the region of the mandibular canines (minimum height=15 mm/minimum ridge width= 5mm)
* no evidence of systemic or psychic pathology that might contraindicate the implant treatment.

Exclusion Criteria:

* Those in which oral surgery or cognitive evaluations are contraindicated

Primary outcomes:
measure: Clinical Performance of Dental implants
timeFrame: One year after treatment
measure: Oral health-related quality of life
timeFrame: One year after treatment
measure: Mastication
timeFrame: One year after treatment
measure: Area of Occlusal Occlusion
timeFrame: One year after treatment
measure: Occlusal Load
timeFrame: One year after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Clinica Odontológica de la Universidad de Salamanca
Study officials:
References:
Clinical trial NCT05674435: Clinical Utility of Neuromodulation on Tinnitus
Official title: Clinical Utility of Neuromodulation on Tinnitus: A Systematic Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tinnitus
Lead sponsor: Hearing and Language Healthcare Center, China Medical University Hsinchu Hospital, Taiwan
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tinnitus patients

Brief summary: The aim of the present narrative review is to one of the first to critically evaluate the clinical effectiveness of neuromodulation as a therapeutic option for patients with tinnitus. Our method involves conducting a systemic review and the findings reported following PRISMA statement. Pubmed, Cochrane database and Google Scholar databases literature search was conducted for articles reporting the use of neuromodulatory interventions on tinnitus patients. Each article was evaluated using the Cochrane risk of bias tool.


Eligibility criteria: Inclusion Criteria:

* Tinnitus patients
* At least one of the neurofeedback methods
* Single and multi-center
* Randomized control trials and observational studies

Exclusion Criteria:

* Non-peer-reviewed papers, letters, editorials
* Not English language

Primary outcomes:
measure: Tinnitus severity scores
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: Hearing and Language Healthcare Center, China Medical University Hsinchu Hospital, Taiwan
Study officials:
References:
Clinical trial NCT06432335: E-Socket, Diagnostic Monitoring
Official title: E-Socket, Diagnostic Monitoring
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trans-Tibial Amputation
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The long-term goal of this research is a socket-embedded prosthesis use and socket fit monitor (E-Socket) that facilitates clinical decision-making in the diagnosis and prognosis of health issues faced by people with transtibial amputation. The overall strategy is to enhance the E-socket to include additional metrics that we identified needed from studies to date (Aim #1). Then we conduct a randomized control trial testing the diagnostic utility of the E-socket data in clinical care (Aim #2). From the data collected in that study, we develop the prognostic capability of the system (Aim #3).

Aim 3 will not involve human subject testing as it will focus on the development of the system in preparation for a future aim involving participants' own clinicians.

Note: we use the term "diagnostic" throughout our application in a general sense. The device will not be diagnosing specific diseases or medical conditions.


Eligibility criteria: Inclusion Criteria:

-

Prosthesis Users:

Aims 1 and 2

* Over 18 years of age
* Unilateral or bilateral trans-tibial amputation at least 12 months prior
* Have a limb of length 9 cm or greater
* Are capable of at least 5 minutes of continuous walking
* Regularly use a definitive prosthesis
* Do not regularly use assistive devices (e.g., cane, walker) for ambulation
* Do not have open wounds on their residual limb at the time of enrollment

Aim 2

-Regularly visit their prosthetist at least twice a year,

Exclusion Criteria:

-

Prosthesis Users:

Aims 1 and 2

* Reduced skin sensation
* Presence of skin breakdown
* Regular use of an assistive device
* Persons with trans-femoral amputation

Aim 1 Only

-Vacuum suspension users

Primary outcomes:
measure: Anterior-Distal Limb Motion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Joan Sanders
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05626335: Does Double With Regular Monitoring Prevent Undesired Tooth Movement?
Official title: Does Double (Fixed and Removable Orthodontic Retention) With Regular Monitoring Prevent Undesired Tooth Movement?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malocclusion
Keywords: retention
stability
orthodontic treatment
3D analysis
intraoral scan
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
Collaborators: name: 3Shape Poland Sp.z.o.o.
name: Koszalin University of Technology
First posted: 2022-11-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study group comprised 300 patients adult patients (age 18 to 41) who have completed fixed orthodontic treatment between (1st January 2021 - 9th September 2022).

Brief summary: The goal of observational study is to learn about the stability of orthodontic treatment results in orthodontic patients during retention phase of treatment.

Detailed description: The aim of the present study was to three-dimensionally analyze tooth movement in retention phase of treatment and wherever double effectively retention prevents it.

Eligibility criteria: Inclusion Criteria:

* Non-extraction treatment
* No hypodontia
* Normal occlusion after treatment (Class I occlusion), perfect alignment
* Normal overjet and overbite
* Double retention including fixed retainer bonded from canine to canine in both dental arches and thermally formed removable splint

Exclusion Criteria:

* Fixed orthodontic treatment in one dental arch
* Extraction cases
* Patient treated with orthognathic surgery
* Imperfect treatment result due to treatment cessation on patients demand or health issues
* Craniofacial disorders

Primary outcomes:
measure: Tooth displacement in mm
timeFrame: One month after debonding
measure: Tooth displacement in mm
timeFrame: Three months after debonding
measure: Tooth displacement in mm
timeFrame: Six months after debonding
Secondary outcomes:
measure: Failure rate
timeFrame: Six months of observation
measure: Compliance rate
timeFrame: Six months of observation
Other outcomes:
Locations:
city: Szczecin
country: Poland
facility: Department of Interdisciplinary Dentistry, Pomeranian Medical Univeristy in Szczecin
state: Zachodniopomorskie
Study officials:
References:
Clinical trial NCT03242135: Role of RDW as Anon Invasive Index for Predicting Liver Cell Failure and Portal Hypertension in Cirrhotic Patient
Official title: Role of Red Cell Distribution Width as Anon Invasive Index for Predicting Liver Cell Failure and Portal Hypertension in Cirrhotic Patient
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Predicting Liver Cell Failure & Portal Hypertension in LC
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 100
Sex: ALL
Minimum age (years): 17
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include a total of 100 patient in Assiut university hospital diagnosed to be cirrhotic by abdominal US

Brief summary: role of RDW as anon invasive method for predicting liver cell failure \& portal hypertension in cirrhotic patient

Detailed description: Red blood cell distribution width (RDW) is a measure of the range of variation of red blood cell (RBC) volume. The RDW-SD (Standard deviation ) is an actual measure of size. Normal reference range of RDW-SD in adult human is 39-46 fL .Liver plays an important role in removing body toxins which affects RBCs ,so liver cirrhosis may affects the RDW. Cirrhosis is a chronic degenerative disease in which irreversible scarring of the liver occurs. It leads to liver failure. Child's score is used as an indicator for liver cell function Portal hypertension is an increase in the blood pressure within the portal venous system .Obstruction to blood flow that occurs in liver due to fibrosis and regenerating nodules reduce flow from the portal veins into the hepatic veins. It also impedes hepatic artery flow from the branches that feed into the sinusoids. This increase in arterial resistance leads to an increase in arterial flow into the portal vein via producing a new anastamosis. The net result of that is an increase in portal vein pressure and dilatation of portal vein. Direct measurement of portal pressure is invasive, inconvenient, and clinically impractical. The Hepatic Venous Pressure Gradient (HVPG) is used to measure portal pressure .Recently, portal vein diameter is used as indicator for portal hypertension .

Eligibility criteria: Inclusion Criteria:

The study will include a total of 100 patient in Assiut university hospital diagnosed to be cirrhotic by abdominal US. They will be divided into 3 groups according to Child's score (A,B,C)

Exclusion Criteria:

* Evidence of iron deficiency anaemia
* Patients within one month of hematemesis
* Thalassaemia

Primary outcomes:
measure: Role of RDW (red cell distribution width) as a non invasive index for predicting liver cell failure and portal hypertension in cirrhotic patient
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Marina Atef
Study officials:
affiliation: Assiut University
name: marina Atef, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06064786: Fetuin A Association in Periodontal Disease and Diabetes Mellitus
Official title: Evaluation of Fetuin-A and hsCRP Levels in Gingival Crevicular Fluid in Periodontitis Diabetic and Non-Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis, Adult
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: individuals recruited from outpatient clinic of periodontology department

Brief summary: Aim: The aim of the current study was to compare and correlate gingival crevicular fluid (GCF) fetuin-A levels and high sensitivity C-reactive protein (hs-CRP) levels in non-diabetic periodontitis patients and type 2 diabetic periodontitis patients with healthy subjects and revealing its possible role in diagnosis of periodontal disease.

Methodology: Forty-five periodontitis stage III patients categorized into 3 groups according to whether having type II diabetes mellitus or not were compared to systemically and periodontally healthy participants in this investigation. Clinical parameters for all groups were recorded. Assessment of GCF levels of fetuin A and hs-CRP were done to all enrolled participants utilizing an enzyme linked immune-sorbent assay (ELISA) kit. Receiver operating characteristic (ROC) curve was performed to reveal sensitivity, specificity, predictive value and diagnostic accuracy of the markers used.


Eligibility criteria: Inclusion Criteria:

* both gender periodontitis stage III

Exclusion Criteria:

1. Smoking,
2. Systemic diseases (except DM in group B),
3. Periodontitis patients having periodontal treatment recently (past 6 months),
4. Pregnancy, lactation, contraceptive pills,
5. Anti-inflammatory/ immunosuppressive drugs.

Primary outcomes:
measure: GCF levels of fetuin A and hsCRP evaluation in all groups
timeFrame: levels of fetuin A and hsCRP are measured at baseline after the completion of all GCF sample collection carried at the day of enrollment of subjects in the investigation after diagnosis confirmation
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: faculty of dentistry, Fayoum university
Study officials:
References:
Clinical trial NCT00551486: Pyrosequencing of the BRAFV600E Mutation
Official title: Diagnostic Value of Pyrosequencing for the BRAFV600E Mutation in Ultrasound-Guided Fine-Needle Aspiration Biopsy Samples of Thyroid Incidentalomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Neoplasms
Keywords: Pyrosequencing
BRAFV600E mutation
Thyroid incidentaloma
Ultrasound-guided fine-needle aspiration biopsy
Lead sponsor: Chungnam National University
Sponsor class: OTHER
First posted: 2007-10-31
Enrollment: 101
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Patients with thyroid nodule larger than 1 cm, or nodule smaller than 1 cm that required further evaluation because of suspicious ultrasound findings
2. The average size of the nodules was 1.0 cm.

Brief summary: To investigate the diagnostic efficiency of pyrosequencing for the mutant BRAF allele in ultrasound (US)-guided fine needle aspiration biopsies (FNAB) of thyroid incidentalomas.


Eligibility criteria: Inclusion Criteria:

* Patients with thyroid nodule larger than 1 cm, or nodule smaller than 1 cm that required further evaluation because of suspicious ultrasound findings

Exclusion Criteria:

* Patients who refuse participation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
Study officials:
affiliation: Chungnam National University
name: Minho Shong, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06422286: Efficacy of Low-level Laser Acupuncture and Microcurrent Electrical Stimulation on Gag Reflex on Children
Official title: Efficacy of Low-level Laser Acupuncture and Microcurrent Electrical Stimulation on Gag Reflex on Children During Taking Dental Impression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gagging
Keywords: gag reflex
dental anxiety
low-level laser
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 63
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of the current study is to evaluate the effectiveness of the laser acupuncture in comparison to the electroacupuncure for controlling gag reflex in children

Detailed description: the study will select children who are suffering from gag reflex that can affect their dental appointments negatively. they will be diagnosed then randomly distributed to one of the 3 groups of the study gag reflex and anxiety will be measured before and after the intervention then the results will be compared.

Eligibility criteria: Inclusion Criteria:

* children free of any systemic disease or special health care needs
* children with score 2 or 3 according to the frankle behavioral rating scale
* a full arch maxillary alginate impression is needed
* moderate to severe gagging according to the gagging severity index
* written informed consent of the legal guardian

Exclusion Criteria:

* children taking anti-emetic drugs
* children sensitive to alginate

Primary outcomes:
measure: gagging prevetive index
timeFrame: immediately after the intervention
Secondary outcomes:
measure: anxiety
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
affiliation: Alexandria University
name: sawsan hafez, PHD
role: STUDY_CHAIR
References: