louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04375540: Vertical Gingival Display Changes Associated With Upper Premolars Extraction
Official title: Vertical Gingival Display Changes Associated With Upper Premolars Extraction Orthodontic Treatment in Gummy Smile Patients: A Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gummy Smile
Orthodontic Treatment
Keywords: Gingival display
Tooth extraction
Dental esthetics
Corrective orthodontics
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 76
Sex: ALL
Minimum age (years): 17
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: upper first premolars extraction (24 patients) Group 2: upper second premolars extraction (26 patients) and Group 3: no orthodontic intervention was performed (happy with their teeth) (26 subjects).
Primary purpose: TREATMENT

Brief summary: To investigate and compare vertical gingival display (VGD) changes associated with upper premolars extraction during orthodontic treatment.

Detailed description: Seventy-six subjects who met the inclusion criteria were divided into one of 3 groups according to their treatment modalities as follows: group 1: upper first premolars extraction (24 patients, aged 21.56±3.19 years); group 2: upper second premolars extraction (26 patients, aged 22.16±3.59 years) and group 3: no orthodontic intervention was performed (happy with their teeth) (26 subjects, aged 20.45±3.29 years).

Initial records (radiographs, study casts and clinical photographs) were taken for all subjects. The same records were taken post treatment for treated subjects only. The Pre- and post- treatment VGD and lip length in static and dynamic positions and the amount of upper teeth retractions were recorded.

The paired t-test and ANOVA test were used to detect treatment changes and differences between studied groups, respectively. Factors affecting VGD were investigated using backward stepwise linear regression analysis.

Eligibility criteria: Inclusion Criteria:

* age 17 years or more
* skeletal class I or class II malocclusion
* upper premolars extraction treatment plan
* high smile line 2mm or more
* no previous orthodontic treatment.

Exclusion Criteria:

* poor oral hygiene
* lower arch extraction treatment plan
* smoking
* Any systemic or periodiontal disease.

Primary outcomes:
measure: The amount of pre- and post-treatment vertical gingival display in static and dynamic positions.
timeFrame: 2 years
measure: Pre- and post treatment Nose-U-lip-length
timeFrame: 2 years
measure: Upper anterior teeth retraction
timeFrame: 2 years
measure: Upper incisors extrusion
timeFrame: 2 years
Secondary outcomes:
measure: Upper molars protraction
timeFrame: 2 years
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Faculty of Dentistry/ Jordan university of Science and Technology Dental Teaching cliniucs
Study officials:
affiliation: Jordan University of Science and Technology
name: Elham Abu Alhaija, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01961440: Prognosis Scoring System for Acute-on-Chronic Liver Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Failure
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2013-10-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population from large hospitals will be selected.

Brief summary: This research is to establish a simple and practical system to predict the prognosis of sever hepatitis B.Seven factors (level of serum total bilirubin, prothrombin time, severity of hepatic encephalopathy, hepatorenal syndrome,ascites ,infection and size of liver) which were easier to evaluate and more influential， were included to establish a prognosis scoring system．The scorings of a new score system and MELD were graded at the same time in the patients with sever hepatitis B. And then the distribution figures of survival rates and mortality rates were done according to the scores from low to high. The features of distribution figures of two score system in survival rates and mortality rates and significances of clinical application in certain score were interpreted.


Eligibility criteria: Inclusion Criteria:

* serum hepatitis B surface antigen(HBsAg) positive for at least 6 months;
* All patients had a poor general condition, manifested as general malaise, fatigue, jaundice and so on;
* serum T-Bil of 171 mmol/L or more; or serum T-Bil rises 17.1 mmol/L or more per day;

Exclusion Criteria:

* superinfection or co-infection with hepatitis A, C, D, E, cytomegalovirus and HIV, or Epstein-Barr virus;
* other liver diseases such as alcoholic liver disease, drug-induced hepatitis, Wilson disease and autoimmune hepatitis;
* ascites or gastrointestinal bleeding or peptic ulcer or esophageal varix by electronic gastroscope examination;
* decompensated liver cirrhosis;
* severe bacterial or fungal infections;
* a history of diabetes or cardiac disease or hypertension or nephrosis.

Primary outcomes:
measure: survival rate
timeFrame: twelve weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02471040: Brain Ketone Metabolism in Type 1 Diabetes
Official title: Impact of Recurrent Hypoglycemia on Brain Ketone Metabolism in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes
Hypoglycemia
Keywords: brain metabolism
cognitive function
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-06-12
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The added 3rd arm does not apply to the crossover design.
Primary purpose: DIAGNOSTIC

Brief summary: This study is designed to examine the value of infusing BHB in type 1 diabetic subjects during experimentally induced hypoglycemic episode in conjunction with testing of cognitive function. This will lay the basis for subsequent trials exploring the novel use of therapeutic doses of oral ketone formulations that are currently under commercial development, which could serve as adjunct therapies to protect the brain from hypoglycemia in type 1 diabetic subjects experiencing recurrent hypoglycemia.

Detailed description: Healthy controls as well as type 1 diabetic subjects will undergo a hyperinsulinemic-hypoglycemic clamp with concomitant BHB or saline (control) infusion in random order. During each experimental condition the participants will complete a battery of validated cognitive tests that are sensitive to the cognitive impairment typically caused by hypoglycemia. An additional healthy control arm was added to the study design after the initial registration as a 2 arm study, to provide imaging results of normal healthy responses to hypoglycemia.

Eligibility criteria: Inclusion Criteria:

1. Type 1 diabetes mellitus of \> 5 years (C-peptide negative, age 18-60 years, on intensive insulin therapy (HbA1c \<7.5%)
2. Non-diabetic volunteers, age 18-65 years that do not meet any of the exclusion criteria.

Exclusion Criteria:

1. Pregnancy
2. Significant baseline anemia (hemoglobin \<11.0 or hematocrit \< 33%)
3. A history of liver cirrhosis or porto-caval shunt surgery.
4. Any contraindications for MRI scanning.
5. Subjects that follow a vegetarian diet
6. Subjects that exercise heavily on a regular basis (i.e. marathon runners, body builders or other forms of excessive exercise as determined by the PI)
7. Subjects with a history of anxiety/ panic attacks

Primary outcomes:
measure: Cognitive Function
timeFrame: Under clamped hypoglycemia (50 min from start)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Raimund Herzog, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05574140: BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders
Official title: BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders (B-GLAD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Generalized Anxiety Disorder
Oxygenation Sensitive CMR
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will recruit patient participants who are identified as having Generalized Anxiety Disorder (GAD), as well as age-similar healthy volunteer participants.

Brief summary: This study aims to view variations in MRI measurements of the heart and the brain in people with anxiety versus healthy volunteers. The MRI measurements used will be Oxygenation-Sensitive Cardiac MRI (OS-CMR), a recent type of MRI which is safe, fast, and non-invasive.

Detailed description: The investigators will prospectively analyze OS-CMR data from patients with a generalized anxiety disorder from one site. The investigators will observe how an anxiety disorder affects the OS-CMR data. In a follow-up MRI scan, the investigators will look at the OS-CMR of a subgroup who have anxiety disorder and are also undertaking cognitive behavioural therapy to asses how and if this therapy affects the OS-CMR data.

Eligibility criteria: Inclusion Criteria:

Patient population:

Age 18-55,

* Confirmation of an anxiety disorder as identified by the PSWQ,
* No known, current or history, of significant medical conditions that may affect or directly involve the neurological, cardiovascular or respiratory system (except anxiety and depression)
* Non-smoker

Healthy Volunteers:

* Age 18-55
* No known, current or history, of significant medical conditions that may affect or directly involve the neurological, cardiovascular or respiratory system
* Non-smoker

Exclusion Criteria:

* General MRI contraindications: pacemakers, defibrillating wires, implanted defibrillators, intracranial aneurysm clips, metallic foreign bodies in the eyes, pregnancy
* History of significant neurological disease or illness that is not anxiety (e.g. Dementia, stroke)
* Hemodynamically unstable conditions
* Significant or uncontrolled arrhythmias
* Severe pulmonary disease
* Recent (\<90 days) myocardial infarction
* Recent (\<90 days) surgery or coronary intervention
* Consumption of caffeine (caffeinated beverages, coffee, tea, cocoa, chocolate) within 12h of the exam
* Use of benzodiazepines or other short-acting anxiety medications (\<1 day)

Primary outcomes:
measure: Change in Signal Intensity
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Emotional Health CBT Clinic
state: Quebec
Study officials:
References:
Clinical trial NCT01750840: A Clinical Registry to Collect Patient Outcome Date for the BIOMET® Stimulator Systems
Official title: A Clinical Registry to Collect Patient Outcome Data for the BIOMET® EBI Bone Healing System, BIOMET® OrthoPak® Non-invasive Bone Growth Stimulator System, and the BIOMET® SpinalPak® Non-Invasive Spine Fusion Stimulator System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Fusion of Spine (Disease)
Fractures, Ununited
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2012-12-17
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This clinical registry will be a prospective, multi-center study. Subjects will undergo treatment with Biomet's BHS or OrthoPak devices for non-spinal applications.

Subjects will undergo treatment with Biomet's SpinalPak for spinal applications

Brief summary: The purpose of this clinical registry is to capture data on an ongoing basis from a population of patients who will use Biomet's BHS, OrthoPak and SpinalPak devices.

Detailed description: The purpose of this clinical registry is to capture current, real-world, bone specific healing data from the medical records of patients being treated with a Biomet® EBI Bone Healing System (BHS), the Biomet® OrthoPak® Non-Invasive Bone Growth Stimulator System, or the Biomet® SpinalPak® Non-Invasive Spine Fusion Stimulator System. This study will provide current data on the effectiveness of these electrical stimulation devices.

Eligibility criteria: Inclusion Criteria:

1. Subject has agreed to undergo electrical stimulation therapy as prescribed by their physician.
2. Subject has agreed to return to the physician for their physician required follow up visits.
3. Subject will undergo treatment with Biomet's BHS, OrthoPak or SpinalPak devices.
4. Subject has agreed to complete QoL questionnaires prior to starting treatment and at the follow up visit when the physician has determined the subject to be either healed or failed.

Exclusion Criteria:

1. Any subject not willing to comply with the physician prescribed treatment program and follow up visit schedule.
2. Any subject not willing to complete the QoL questionnaires.

Primary outcomes:
measure: Radiographic Assessment of Healing
timeFrame: The time frame for healing determination was not pre-specified. Patients were evaluated at regular doctors' visits for up to 12 months. The physician determined the time point at which healing occurred for each patient at their regular visits.
Secondary outcomes:
measure: Quality of Life Assessment
timeFrame: The quality of life assessment was to be completed at the regular doctor's visit at which the physician determined the patient to be healed. No quality of life data was collected.
Other outcomes:
Locations:
city: Vineland
country: United States
facility: Cumberland Orthopedics
state: New Jersey
Study officials:
affiliation: Zimmer Biomet
name: Randy Graham
role: STUDY_DIRECTOR
References:
Clinical trial NCT05448040: Clinical and Histological Assessment of Free Gingival Graft or Collagen Matrix for Socket Sealing After Bone Grafting
Official title: Clinical and Histological Assessment of Free Gingival Graft or Collagen Matrix for Socket Sealing After Bone Grafting: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Socket Sealing
Free Gingival Graft
Collagen Membrane
Keywords: Alveolar sealing
Free gingival graft
Autogenous graft
Collagen matrix
Lead sponsor: Universidade Salgado de Oliveira
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study was to compare, clinical and histologically, the use of the suine collagen matrix (Mucograft Seal \[MS\], Geisthlich®) and the free gingival graft (FGG) for the alveolar sealing after inserted bone graft biomaterial. It was included 18 patients with tooth referred to extraction (maxilar incisives, canines, or pre-molars) which were randomly divided in 2 groups, according to the material for alveolus sealing: control (FGG) and test (MS). After the minimally traumatic extraction, all the alveoli were filled with bovine mineral matrix (Bio-Oss®), and the material for alveolar sealing were positioned and stabilized with sutures. The follow-up (clinical and photographic) happened on the immediate post-operatory period, and with 3, 7, 15, 30, 60, 90, and 120 days. After 120 days, before implant placement, tissues samples were obtained with a 3.5mm punch scalpel for histological analysis. Qualitative information related to the patient's perception considering the treatment were collected.


Eligibility criteria: Inclusion criteria

* patients ASA I
* patients requiring single tooth extraction in the site between #4 to #13
* patients without enough bone volume for immediate implant placement.

Exclusion criteria

* patients with general contraindications for implant surgery
* pregnant or lactating women
* patients with untreated periodontitis
* bruxism or severe clenching
* immunosuppressed
* patients with a previous history of irradiation of the head and neck area
* uncontrolled diabetes
* heavy smoker (\>10 cigarettes/day)
* poor oral hygiene and low motivation
* use of bisphosphonates
* substance abuse such as alcohol or drugs and psychiatric disorders.

Primary outcomes:
measure: Radiographic and clinical analysis
timeFrame: 6 months
Secondary outcomes:
measure: Histological analysis - Gingiva
timeFrame: 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: UM - POM Dpt
state: Michigan
Study officials:
affiliation: Sao Leopoldo Mandic
name: Joly, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02711540: Retrospective Analysis of Procedural Aspects of Transcatheter Aortic Valve Implantation (TAVI) on Peri-procedural Stroke
Official title: Retrospective Analysis of Procedural Aspects of Transcatheter Aortic Valve Implantation (TAVI) on Peri-procedural Stroke Rates in the United Kingdom
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Stenosis
Lead sponsor: Royal Sussex County Hospital
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who had TAVI in the UK

Brief summary: Retrospective analysis of all patients receiving TAVI in the United Kingdom (UK). Stroke rates following TAVI are roughly 3%. There are several device and procedure related characteristics which may increase the risk of stroke. We will examine if there is a signal in the UK registry. This will be important is TAVI is to be extended down to lower risk patient cohorts.

Detailed description: Retrospective analysis of all patients receiving TAVI in the UK. Stroke rates following TAVI are roughly 3%. There are several device and procedure related characteristics which may increase the risk of stroke. We will examine if there is a signal in the UK registry. This will be important is TAVI is to be extended down to lower risk patient cohorts.

Factors to be examined include (but not limited to):

need for Pre-procedure Balloon aortic Valvuloplasty (BAV) Need for two valves need for post-dilatation need for rapid ventricular burst pacing

Eligibility criteria: Inclusion Criteria:

* Had TAVI procedure in UK

Exclusion Criteria:

* Nil

Primary outcomes:
measure: Stroke
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04426240: The Effect of Cyclosporin Before Cataract Surgery
Official title: A Comparative Study of Use of Cyclosporin Eye Before Cataract Surgery for the Prevention of Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the effect of cyclosporine eye drop before cataract surgery for the prevention of post cataract surgery dry eye syndrome.


Eligibility criteria: Inclusion Criteria:

1. 21+ adult men and women
2. Those who are scheduled to undergo cataract surgery due to a diagnosis of cataract
3. Corneal fluorescein staining score (Oxford) is II or less
4. Preoperative MMP-9 positive
5. Those who have not used the trial and the test (cyclosporine) for at least 1 month before surgery.
6. Those who have voluntarily written consent to participate in this clinical trial

Exclusion Criteria

1. Those who have used systemic or topical cyclosporine within 4 weeks
2. Use of eye drops for more than 4 weeks (disorders, allergies, eye inflammation / infection, etc.) other than the current dry eye syndromes
3. Patients who have systemic or ocular disorders or conditions (eye surgery, trauma, disease) that can influence the results of this trial.
4. Abnormal eyelid function
5. An eye disease that can impair the function of the corneal sensation: herpes keratopathy, conjunctival wounds due to scarring conjunctivitis, pterygium, pinguecula, diabetic keratitis, keratoconus , corneal transplant status
6. Patients with active eye infections
7. Patients with conflicts with this clinical trial
8. Pregnant and lactating mothers
9. Patients who are determined to be inappropriate by other investigators

Primary outcomes:
measure: Corneal florescence staining score
timeFrame: 1 month
Secondary outcomes:
measure: tear break-up time
timeFrame: 1 month
measure: Schirmer test
timeFrame: 1 montn
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Tae-Young Chung
role: PRINCIPAL_INVESTIGATOR
References: