louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06477874: Assessment of Implants Placed in Consolidated Graft With Different Bone Drills.
Official title: ASSESSMENT OF DENTAL IMPLANTS PLACED IN MANDIBULAR CONSOLIDATED ILIAC-CREST BONE GRAFTS USING DENSAH BURS VERSUS THE STANDARD DRILLS (A Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Implant Complication
Bone Graft; Mechanical Complications
Keywords: Bone graft
Iliac crest
Implant stability
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The anterior iliac crest is a popular source of bone harvest. However, when fused to the intramembranous jaw bones, it yields low-density bones that qualitatively and quantitatively endanger the fixture's stability.

In 1994, Summers first documented using the bone-condensing approach to improve the primary stability of dental implants.

This study aims to determine whether osseodensifying the consolidated mandibular bone grafts will improve implant stability and marginal bone loss


Eligibility criteria: Inclusion Criteria:

1. Patients of both sexes with an age range of 18-55 years.
2. Patients subjected to a successful iliac crest mandibular bone graft after segmental mandibular resection.
3. A minimal ridge height of ten millimeters and a ridge width of seven millimeters.
4. Healthy soft tissue coverage, with a reasonable interaction space.

Exclusion Criteria:

1. Clinical or radiographic signs of graft infection, rejection, or massive resorption.
2. The previous exposure to radiotherapy or chemotherapy.
3. Any systemic disease that would affect bone healing or implant osseointegration.

Primary outcomes:
measure: Radiographic bone loss
timeFrame: 6 months osseointegration period
Secondary outcomes:
measure: Implant stability
timeFrame: 6 months osseointegration period
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Modern University for Technology & Information.
Study officials:
References:
Clinical trial NCT06423274: Comparing Artificial Intelligence for Assisted Diagnosis of Diabetic Retinopathy
Official title: A Comparative Analysis of the Diagnostic Outcomes of Artificial Intelligence-assisted Fundus Photography for Diabetic Retinopathy and Diabetic Macular Edema Versus Other Imaging Devices in Ophthalmology: A Controlled Trial
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetic Retinopathy
Diabetic Macular Edema
Keywords: diabetic retinopathy
diabetic macular edema
artificial intelligence
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: It is planned to include 1,000 participants in the study, all of whom will undergo fundus photography, 500 additional patients will undergo fundus fluorescence angiography, and 500 additional patients will undergo optical coherence tomography.

All participants met inclusion and exclusion criteria.

Brief summary: This study plans to compare the accuracy of artificial intelligence (AI)-assisted fundus images with other ophthalmic devices such as optical coherence tomography (OCT) and fundus fluorescence angiography (FFA) in the diagnosis of diabetic retinopathy and diabetic macular edema.

Detailed description: This study plans to compare the accuracy of artificial intelligence (AI)-assisted fundus images with other ophthalmic devices such as optical coherence tomography (OCT) and fundus fluorescence angiography (FFA) in the diagnosis of diabetic retinopathy and diabetic macular edema.

This study was conducted as a prospective study. Participants meeting eligibility criteria will be recruited from sites staffed by trained photographers. After assessing eligibility and obtaining informed consent, fundus photographs will be taken using a non-dilated fundus camera. And optical coherence tomography or fundus fluorescence angiography will be performed.

Eligibility criteria: Inclusion Criteria:

1. Diagnostic for diabetes: Type 1 diabetes of a lest 5 years of evolution; or Type 2 diabetes;
2. Obtaining informed consent;
3. Patient age 18 or above.

Exclusion Criteria:

1. Patients under 18 years of age;
2. Failure to Obtain informed consent;
3. Presence of other retinal diseases;
4. A patient who has already undergone the treatment.

Primary outcomes:
measure: The accuracy
timeFrame: Baseline-Month 12
Secondary outcomes:
measure: The accuracy
timeFrame: Baseline-Month 12
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT05809674: Polarization Sensitive Optical Coherence Tomography
Official title: Polarization Sensitive Optical Coherence Tomography - Phase II: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Lead sponsor: Singapore Eye Research Institute
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 178
Sex: ALL
Minimum age (years): 10
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult and children cohorts

Brief summary: The purpose of the study is to use the polarization sensitive optical coherence tomography (PS-OCT) developed by Singapore Eye Research Institute, to evaluate the potential OCT scleral biomarkers capable of predicting risk of myopia progression.


Eligibility criteria: Inclusion Criteria:

(Adult Cohort)

* Aged 21 and above
* Ability to provide informed consent
* 42 normal controls: No diabetes and free from clinically relevant eye disease that interferes with the aim of the study i.e. glaucoma, diabetic retinopathy, age-related macular degeneration, uveitis, or vascular occlusive diseases
* 76 subjects with pathological myopia (up to -12 dioptres) or staphyloma

(Children Cohort)

* Aged 10 to 18
* 23 subjects with low to moderate myopia (-0.75 to -6 dioptres)
* 23 subjects with high myopia (more than -6 dioptres)
* Ability of legal representative and subject to provide informed consent

Exclusion Criteria:

(Adult Cohort)

* Unable to give consent
* Subjects with visual acuity worse than 6/12
* Diagnosis of clinically relevant eye disease that interferes with the aim of the study (e.g. diabetic retinopathy, hereditary macular disease, glaucoma, uveitis, or vascular occlusive diseases) or conditions that may potentially result in poor quality imaging scans (severe cataract, corneal haze/opacity)

Primary outcomes:
measure: Primary Aim
timeFrame: 1.5 years
Secondary outcomes:
measure: Secondary Aim
timeFrame: 1.5 years
Other outcomes:
measure: Tertiary Aim
timeFrame: 1.5 years
Locations:
city: Singapore
country: Singapore
facility: Singapore National Eye Centre
Study officials:
References:
Clinical trial NCT00547274: Dyslipidemia in Type 2 Diabetes (0767-034)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type II
Dyslipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-22
Enrollment: 111
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the lipid-altering effects of MK0767, glipizide, and pioglitazone after 12 weeks of treatment.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility criteria: Inclusion Criteria:

* Men and non-pregnant females
* Age greater than or equal to 21 years
* Stop current diabetes therapy (if applicable)
* Stop current statin therapy (if applicable)

Exclusion Criteria:

* History of type 1 diabetes mellitus or ketoacidosis who are currently being treated with insulin
* Patients on a weight loss program with ongoing weight loss, or starting an intensive exercise program within the last four weeks
* Patients requiring treatment with corticosteroids for more than 14 consecutive days
* Patients taking warfarin or warfarin-like anti-coagulants
* Patients undergoing surgery within 30 days of Visit 1
* Patients with Hepatitis B, Hepatitis C, active liver or gallbladder disease
* Patients with history of pancreatitis or uncontrolled high blood pressure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03996174: Palliative Care Needs Assessment of the Population Living in Mayotte (French Island of Comoros)
Official title: What Are the Palliative Care Needs of the Mahoran Population Take Into Consideration the Socio-anthropological Specificities of This Population, But Also the Demographic, Social, Health and Geographical Characteristics of Mayotte Island
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Palliative Therapy
Keywords: Palliative care
needs assessment
Mayotte
terminal care
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3 studies will be conducted: one with "palliative patients" identified by their care workers, one with their family or caregivers, and one with their care workers.

.

Brief summary: This qualitative study aims to explore the assessment of palliative care needs of the population living in Mayotte, French territory of the Comoros.

The aim is to offer a palliative care service tailored to the needs of the population in this area.


Eligibility criteria: Inclusion Criteria:

* patients study: to be at the palliative stage of his illness, informed consent
* family study: being a family or caregiver of a patient in palliative care, informed consent
* care workers study: being a care worker of a patient in palliative care, informed consent

Exclusion Criteria:

* 0

Primary outcomes:
measure: individual semi-structured interviews
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHRU Besançon
Study officials:
affiliation: Service douleur, soins palliatifs
name: Régis Aubry, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03100474: Global Registry: ExAblate Neuro MR Guided Focused Ultrasound (MRgFUS) of Neurological Disorders:
Official title: Global Registry: ExAblate 4000 Transcranial MR Guided Focused Ultrasound (TcMRgFUS) of Neurological Disorders:
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Essential Tremor
Parkinson's Disease
Movement Disorders
Neuropathic Pain
Keywords: tremor
Parkinson's
movement
neuropathic
pain
Lead sponsor: InSightec
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patients suffering from clinically diagnosed neurologic disorders that can be

Brief summary: A global post approval study to collect safety and effectiveness data related to ExAblate Neuro for the treatment of certain disorders such as Essential Tremor, Parkinson's Movement Disorders, or Neuropathic Pain within the thalamus and/or pallidum.

Detailed description: A global, multi-center, open-label, observational registry to capture safety and effectiveness data related to ExAblate Neuro, an MRI guided focused ultrasound device designed to lesion tissue deep within the brain using sound waves without the need for craniotomy. This registry includes certain regional and country specific approved thalamotomy and pallidotomy procedures using ExAblate Neuro for the treatment of various neurologic disorders such as essential tremor, Parkinson's movement disorders, and neuropathic pain. Treatment targets/indications are country/region dependent based on approved labeling within that region.

Eligibility criteria: Inclusion Criteria:

* Meets labeling indication for use per information for prescribers
* Target is accessible by Focused Ultrasound per treatment planning parameters

Exclusion Criteria:

* Do not agree to participate or who are unlikely to participate over an extended period of time

Primary outcomes:
measure: Clinical Rating Scale for Tremor
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: Swedish Neuroscience Institute
state: Washington
city: Toronto
country: Canada
facility: Sunnybrook
state: Ontario
city: Haifa
country: Israel
facility: Rambam Healthcare Campus
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Chang Hua
country: Taiwan
facility: Chang Bing Show Chwan Memorial Hospital
Study officials:
affiliation: University of Maryland
name: Howard Eisenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00750165: Auto Continuous Positive Airway Pressure (CPAP) Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
Official title: Auto CPAP Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: Obstructive Sleep Apnea
Humidification
Continuous Positive Airway Pressure
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2008-09-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Nasal Continuous Positive Airway Pressure (CPAP) is the standard therapy for obstructive sleep apnea hypopnea syndrome (OSAHS). This is most commonly administered as a single positive pressure that has been individualized for the patient to prevent obstructive respiratory events. However, the therapeutic pressure may vary by sleep stage and body position within a single night and may change over the course of several nights. One approach to dealing with this variability is the use of automatically adjusting CPAP that responds to patient breathing patterns with alterations in the delivered pressure. This study is designed to determine the effectiveness of using the energy spectrum analysis of flow signals to automatically adjust CPAP pressure and improve sleep variables. Thirty subjects who require CPAP will be recruited from the NYU sleep disorders center. Following diagnostic studies (either split night or full night) the subject will undergo a night of treatment with the Fisher and Paykel Healthcare AutoPAP. Efficacy of treatment will be evaluated based on normalization of sleep disordered breathing while treated with the AutoPAP.


Eligibility criteria: Inclusion Criteria:

* AHI \>15 on the diagnostic portion of the study
* \>18 years of age

Exclusion Criteria:

* Significant Central Apnea
* Congestive Heart Failure
* Inability to give informed consent
* Patient intolerance to CPAP
* Anatomical or physiological conditions making CPAP therapy inappropriate

Primary outcomes:
measure: Apnea Hypopnea Index (AHI)
timeFrame: 1 night
Secondary outcomes:
measure: Percent of Time With Less Than 90% Oxygen Saturation
timeFrame: 1 Night
measure: Respiratory Disturbance Index (RDI)
timeFrame: 1 Night
measure: Arousal Index (AI)
timeFrame: 1 Night
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Sleep Disorders Center
state: New York
Study officials:
affiliation: NYU School of Medicine
name: David M Rapoport, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Norman RG, Rapoport DM, Ayappa I. Detection of flow limitation in obstructive sleep apnea with an artificial neural network. Physiol Meas. 2007 Sep;28(9):1089-100. doi: 10.1088/0967-3334/28/9/010. Epub 2007 Sep 5.
Clinical trial NCT03716765: Locally Injected Vit D as a Non-surgical Modality for Periodontal Regeneration of Infrabony Defects
Official title: Locally Injected Vitamin D as a Non-surgical Modality for Periodontal Regeneration of Infrabony Defects: Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Bone Loss
Periodontal Pocket
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: vitamin D has great role in bone regenration and soft tissue health. in the past periodontal regeneration was performed using bone graft and barrier membrane

Detailed description: there was no previous studies used the locally injected vitamin d in periodontal regeneration. therefore, we intended to study the effect of locally injected vitamin D in peridoontal regerneration in comparison with the conventional surgical technique

Eligibility criteria: Inclusion Criteria:

* patients with infrabony vertical defects
* systemically free patients
* periodontally affected patients

Exclusion Criteria:

* patients with systemic diseases
* smokers
* pregnency

Primary outcomes:
measure: radiographic interproximal bone level
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: october university of modern sciences and arts
name: nermin yussif
role: STUDY_DIRECTOR
References:
Clinical trial NCT05274620: Integrating a Suite of Mental Health Apps for Depression in a Healthcare Setting
Official title: Integrating a Suite of Mental Health Apps for Depression in a Healthcare Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: Adaptive Health, Inc
Sponsor class: INDUSTRY
First posted: 2022-03-10
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the implementation of IntelliCare as a frontline intervention within health care settings.

Detailed description: This study will evaluate the implementation of IntelliCare in two settings: Primary care in the McLeod Health system, serving a rural population where mental healthcare workers are scarce, and Northwestern Medicine's Department of Psychiatry, which currently has a 9-month waitlist for psychological services.

Eligibility criteria: Inclusion Criteria:

* Patient who have been identified as depressed or anxious by a care provider in one of the participating healthcare organizations.

Exclusion Criteria:

* None

Primary outcomes:
measure: Reach
timeFrame: 5 months
measure: Cost
timeFrame: 7 months
Secondary outcomes:
measure: Depression
timeFrame: Administered weekly over 8 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine Dept of Psychiatry
state: Illinois
city: Florence
country: United States
facility: MacLeod HealthCare
state: South Carolina
Study officials:
affiliation: Adaptive Health, Inc
name: Carolyn MacIver
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01573520: Treatment Adhesion in Dialysis Patients Treated With Cinacalcet
Official title: A Randomized Trial Comparing an Integrated Care Approach Using Electronic Cinacalcet Adherence Data Versus Usual Care to Improve Secondary Hyperparathyroidism in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperparathyroidism
Chronic Kidney Disease
Keywords: compliance
dialysis
hyperparathyroidism
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2012-04-09
Enrollment: 50
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: Controlling secondary hyperparathyroidism (sHPT) in maintenance hemodialysis (MHD) patients is cumbersome, partly due to patient's non-adherence to prescribed drugs.

The main objective of this study was to assess whether an integrated care (IC) approach, in which adherence data are integrated in the decisional process, led to improved therapeutic control of secondary hyperparathyroidsm and higher percentages of bone metabolism targets as compared to a usual care (UC) approach, in which biological values represent the main stem of the decisional process.

The predefined hypothesis was that patients of the IC group should reach the iPTH targets using 25% less doses of cinacalcet at 6 months than those of the UC group.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Patients on hemodialysis since more than 3 months
* Patients with secondary hyperparathyroidism treated with Cinacalcet-HCl at a stable dose (30mg/day or more) for at least 1 month before enrolment and indication to Cinacalcet-HCL therapy (iPTH in target values or over target values)
* Patients with secondary hyperparathyroidism with indication to be treated with Cinacalcet-HCL (iPTH ≥ locally pre-defined targets). In this case, patients should be treated at least 1 month with stable dose Cinacalcet-HCL before enrolment

Exclusion Criteria:

* Intolerance to Cincalcet-HCL
* Inability to understand the protocol
* Mental diseases
* Patients suffering from cancer or having a short life expectancy (\<6 months)
* Patients planned for a parathyroidectomy
* Patients having had a parathyroidectomy
* Patient already enrolled in a Cinacalcet-HCL protocol
* Symptomatic hypocalcaemia or total serum calcium \< 1.87 mmol/l

Primary outcomes:
measure: Relative change from baseline in cinacalcet dose at 6 months
timeFrame: baseline and 6 months
Secondary outcomes:
measure: absolute change from baseline in iPTH at 6 months
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Michel Burnier, MD
role: PRINCIPAL_INVESTIGATOR
References: