louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05181189: NMDA Enhancement Combined With Omega-3 for Early Dementia
Official title: NMDA Enhancement Combined With Omega-3 Fatty Acids for the Treatment of Early Dementia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Omega 3 Fatty Acids
Dementia
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this 4-year proposed project, we will enroll 140 patients with aMCI or mild AD into a 24-week randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to one of two treatment groups for 24 weeks (n = 70 in each group) in a double-blind manner: \[1\] DAOIB + omega-3; \[2\] DAOIB + placebo. We will assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). We hypothesize that DAOIB combined with omega-3 will yield better efficacy than placebo in improving the cognitive function, global functioning and quality of life in patients with aMCI or mild AD.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Alzheimer's disease or mild cognitive impairment
* MMSE between 10-26
* CDR 1 or 0.5

Exclusion Criteria:

* Hachinski Ischemic Score \> 4
* Substance abuse/dependence
* Parkinson disease, epilepsy, dementia with psychotic features
* Major depressive disorder
* Major physical illnesses
* memantine or special omega-3 fatty acids therapy within 3 months before enrollment
* Severe visual or hearing impairment

Primary outcomes:
measure: Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
Secondary outcomes:
measure: Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24
timeFrame: week 8, 16, 24
measure: Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
measure: Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
measure: Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
measure: Change from baseline in Quality of life score at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
measure: Change from baseline in the composite score of a battery of additional cognitive tests at week 24
timeFrame: week 0, 24
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT05304689: Analysis of the Relationship Between the Quantitative Index of Cytokines in the Oral Fluid and Inflammation
Official title: Analysis of the Interconnection Between the Quantitative Indicators Cytokines in the Oral Fluid and the Local Inflammatory Process at the Stage of Orthopedic Rehabilitation of Patients With Postoperative Jaw Defects.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Inflammation
Keywords: Denture, Removable, Cytokine, Saliva, Jaw
Lead sponsor: Ryazan State Medical University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: two groups of patients
Primary purpose: DIAGNOSTIC

Brief summary: The of study is to increase the effectiveness of orthopedic rehabilitation of patients with postoperative jaw defects using various types of replacement structures, taking into account the clinical and morphofunctional characteristics of oral tissues after surgery.

Detailed description: Formation of three groups of patients Patients with extensive jaw defects after surgery for oncological disease of the middle zone of the face (10 people) Patients with jaw defects after complicated tooth extraction (20 people) Healthy volunteers to determine reference values (5 people) Data on the functional state of the dentoalveolar system in the study groups of patients will be obtained.

An assessment will be made of the rate of formation of a postoperative defect in patients with postoperative jaw defects, depending on the design features of the prosthesis.

Defects of the jaw will be replaced with orthopedic structures, taking into account the individual characteristics of the state of the marginal part of the defect.

Data will be obtained on the rate of adaptation and quality of life in patients using dentures made taking into account the assessment of the state of the marginal part of the defect.

Clinical recommendations for dentists will be proposed, which will optimize the process of orthopedic dental treatment, taking into account the state of the marginal part of the defect in patients with postoperative jaw defects.

Eligibility criteria: Inclusion Criteria:

* Men or women over 30 years of age. The presence of a postoperative defect of the jaw after surgical interventions.

Exclusion Criteria:

* Men or women under 30 years of age. Decompensated somatic pathology. Pregnancy or breastfeeding in women. Participation in another study.

Primary outcomes:
measure: quantitative analysis of cytokines PG/ml
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ryazan
country: Russian Federation
facility: Kseniya
state: Ryazan Region
Study officials:
affiliation: research leader
name: Olga Guiter, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06890689: Effectiveness of Scaling and Root Planing in Deeper Pockets
Official title: Effectiveness of Scaling and Root Planing in Deeper Pockets
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Periodontal Disease
Periodontitis
Lead sponsor: Texas A&M University
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated by dental students at TAMU Collage of Dentistry Predoctoral Clinic

Brief summary: This study will retrospectively evaluate the outcomes of scaling and root planing over a two year time period. The study will focus specifically on the effectiveness of SRP in pockets with an initial pre-treatment pocket probing depth of ≥ 5 mm and ≤ 8 mm. The study will also examine the response to SRP of all initial pocket depths, i.e., those PPD that fall below or above those in the indicated range, to verify the findings of previous studies.


Eligibility criteria: Inclusion criteria:

* All patients treated by dental students who have the required data
* 14 or more permanent teeth
* Have at least 2 molars (excluding third molars)

Exclusion Criteria:

* All third molars and second molars next to a partially impacted third molar
* Smokers
* Diabetes
* Immunocompromised patients (HIV/AIDS; chemotherapy; systemic steroid therapy, etc.)
* Pregnancy during treatment or during the follow-up periods
* Diagnosis of Alzheimer's or dementia
* Diagnosis of oral mucous membrane disease (BMMP, Lupus, erosive lichen planus, etc.)
* Patients that have received periodontal surgery following SRP

Primary outcomes:
measure: Effectiveness of SRP (scaling and root planing) in pockets with an initial (baseline) pre-treatment pocket probing depth of ≥ 5 mm and ≤ 8 mm
timeFrame: From January 2020 to January 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas A&M University Collage of Dentistry,
state: Texas
Study officials:
References:
Clinical trial NCT01981629: The Use of the USCOM Device in Addition to Cardiac Ultrasound in Patients Undergoing Treatment for Undifferentiated Shock
Official title: The Use of the USCOM Device in Addition to Cardiac Ultrasound in Patients Undergoing Treatment for Undifferentiated Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shock
Keywords: Shock
USCOM
Cardiac Ultrasound
Emergency Department
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the emergency department at an urban county hospital.

Brief summary: Currently, bedside ultrasound (US) is performed routinely in emergency department (ED) patients with undifferentiated shock to help guide resuscitation. Previously, it has never been possible to measure cardiac output on patients in the ED. Our clinical question looks at whether the USCOM device gives clinically relevant information in addition to ED cardiac US in patients with shock.


Eligibility criteria: Inclusion Criteria:

* Patients in shock, as defined by systolic blood pressure less than 95 mmHg or shock index (heart rate/systolic blood pressure) greater than 0.9

Exclusion Criteria:

* less than 18 years old
* Pregnant
* Patients in shock due to trauma

Primary outcomes:
measure: Cardiac Output
timeFrame: Twice during ED visit, averaging one hour
Secondary outcomes:
measure: Patient outcomes
timeFrame: After emergency department visit
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin Healthcare Research Institute
name: Johanna C Moore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01174329: Treatment of Salivary Gland Hypofunction With Neuro- Electrostimulation
Official title: Difference in Salivary Flow in Patients With Salivary Gland Hypofunction of the Following Application of Neuro-electrostimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Xerostomia
Polypharmacy
Sjögren's Syndrome
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
First posted: 2010-08-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate with clinical parameters the performance of Saliwell Crown as a neuro-electrostimulator of the submandibular and sublingual salivary glands in hypofunction status due to polypharmacy or Sjögren's Syndrome in patients with symptoms of xerostomia.


Eligibility criteria: Inclusion Criteria:

* Age range between 18 and 75 years of age
* Clinical symptoms of xerostomia
* Difference in whole salivary flow between resting and stimulating conditions
* Patient ASA type I to III
* Absence of at least one mandibular third molar inferior, but at least partially dentated in the mandible

Exclusion Criteria:

* Patients with antimicrobial treatments in the three previous months
* Smokers
* Intake of bisphosphonates
* Limitation of mandibular opening
* Interoclusal distance smaller than 10 millimetres
* Lack of adequate bone availability for implant placement

Primary outcomes:
measure: self-reported xerostomia
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: C.D. Especialidad de Periodoncia
state: Nuevo León
Study officials:
References:
Clinical trial NCT05498129: School Feeding to Improve Cognitive Performance in Disadvantaged Children
Official title: School Feeding to Improve Cognitive Performance in Disadvantaged Children: A Randomized Controlled Trial in in Northwest Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Performance
Lead sponsor: University of Central Lancashire
Sponsor class: OTHER
Collaborators: name: Khyber Medical University
First posted: 2022-08-11
Enrollment: 210
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This trial investigated the impact of providing a regular meal with and without additional multiple micronutrients for children in Northwest Pakistan on their performance at school, in comparison to a local government school that served as a control i.e. no school meal.


Eligibility criteria: Inclusion Criteria:

* Prep or class 1
* Male/ female

Exclusion Criteria:

* Any contraindicating condition

Primary outcomes:
measure: Ravens Colour Matrices test for assessment of Cognitive function
timeFrame: Baseline
measure: Ravens Colour Matrices test for assessment of Cognitive function
timeFrame: 6-months
measure: Ravens Colour Matrices test for assessment of Cognitive function
timeFrame: 12-months
Secondary outcomes:
measure: Height
timeFrame: Baseline
measure: Mass
timeFrame: Baseline
measure: Mid upper arm circumference
timeFrame: Baseline
measure: Height for age
timeFrame: Baseline
measure: Weight for age
timeFrame: Baseline
measure: Haemoglobin
timeFrame: 6-months
measure: Haemoglobin
timeFrame: 12-months
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: Jonathan Sinclair
state: Lancashire
Study officials:
References:
Clinical trial NCT06024629: cOCT Versus LC-OCT for Diagnosing Basal Cell Carcinoma: a Diagnostic Cohort Study
Official title: cOCT Versus LC-OCT for Diagnosing Basal Cell Carcinoma: a Diagnostic Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Basal Cell Carcinoma
Keywords: Optical coherence tomography
Line-field confocal optical coherence tomography
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients visiting the outpatient clinic of Maastricht University Medical Center+ (MUMC+). All included patients (18+) will undergo a punch biopsie for their equivocal BCC lesion conform regular care.

Brief summary: Basal cell carcinoma (BCC) is the most common form of cancer among the Caucasian population. Equivocal BCC lesions are usually diagnosed by means of a punch biopsy, but since the last few decades, non-invasive imaging techniques for the diagnosis of BCC gained popularity within the field of dermatology. Conventional optical coherence tomography (cOCT) is an example of a non-invasive imaging technique. Recent studies revealed that OCT assessors may achieve high diagnostic certainty and accuracy for diagnosing BCC. However, cOCT has a limited axial and lateral resolution and can therefore only visualize the gross architecture of the skin. It has been proposed that the diagnostic certainty and accuracy of cOCT could be optimized by improving the resolution. Line-field confocal optical coherence tomography (LC-OCT) is a new non-invasive imaging technique that provides tridimensional images of the skin with a cellular resolution. Although the resolution of LC-OCT is superior to cOCT, the penetration depth of LC-OCT (500µm) is limited compared to that of cOCT (1.0-1.5mm). In the proposed study, we aim to assess whether LC-OCT is superior to cOCT in terms of diagnostic accuracy for diagnosing BCC in equivocal BCC lesions.


Eligibility criteria: Inclusion Criteria:

* Patients (18+) with equivocal BCC lesions undergoing biopsy conform regular care

Exclusion Criteria:

* Patients unable to sign informed consent
* Patients with clinically evident BCC lesions who do not undergo biopsy

Primary outcomes:
measure: Diagnostic accuracy of cOCT and LC-OCT
timeFrame: Measured before september 1st 2024
Secondary outcomes:
measure: Diagnostic accuracy for BCC subtyping on cOCT and LC-OCT
timeFrame: Measured before september 1st 2024
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
Study officials:
References:
Clinical trial NCT03882229: Middle East MED-EL Observatory Study
Official title: Middle East MED-EL Observatory Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cochlear Implants
Keywords: Registry
Observational Study
Lead sponsor: MED-EL Elektromedizinische Geräte GesmbH
Sponsor class: INDUSTRY
First posted: 2019-03-20
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects of any age and gender who are implanted or will be implanted with a MED-EL CI system.

Brief summary: In the field of cochlear implant research, there are only few data on long-term observational studies available to gain knowledge on clinical effectiveness. Longitudinal comparisons of data collected in different clinics is challenging due to the heterogeneity in measures and procedure.

This Registry represents a non-interventional systematic collection of clinical data in which prospective data from children and adults are collected as anonymized data sets, derived from original clinical records on appropriately informed subjects. Each subject will be treated as per clinical routine.

The Registry will be implemented through a secure, cloud-based, platform that enables collection of anonymized data at consistent time intervals, thus enabling the comparison of repeated measures over time.


Eligibility criteria: Inclusion Criteria:

* Subjects who are implanted or will be implanted with a MED-EL CI system.
* Signed written informed consent for data collection for registry purposes.

Exclusion Criteria:

* Lack of compliance with any inclusion criteria.
* Subjects not receiving a MED-EL CI system due to medical or personal reasons after having consented.
* Anything that, in the opinion of the Investigator would place the subject at increased risk or preclude the subject's full compliance with or completion of the registry procedures.

Primary outcomes:
measure: Hearing threshold level
timeFrame: 5 years
measure: Quality of hearing - adults
timeFrame: 5 years
measure: Auditory development - children (CAP)
timeFrame: 5 years
measure: Auditory development - children (SIR)
timeFrame: 5 years
measure: Auditory development - children (LEAQ)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hearing and Speech Institute
city: Riyadh
country: Saudi Arabia
facility: King Abdullah Ear Specialist Center (KAESC)
city: Riyad
country: Saudi Arabia
facility: King Saud Medical City
Study officials:
affiliation: King Abdullah Ear Specialist Center
name: Abdulrahman Ahmed Alsanosi, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01703429: Complementary and Alternative Care in Multiple Sclerosis
Official title: Complementary and Alternative Medicine (CAM) in Multiple Sclerosis. A Prospective Observational Study of a CAM-using Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
MS
Complementary and Alternative
CAM
Lead sponsor: Bastyr University
Sponsor class: OTHER
First posted: 2012-10-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any individual with multiple sclerosis is invited to participate.

Brief summary: This is a prospective, observational study designed to describe disease progression, symptom change, quality of life, diet and lifestyle habits, and frequency of adverse events among patients with multiple sclerosis (MS) who use complementary and alternative medicine (CAM). In addition to describing the patterns of CAM use, this study will also identify and describe the positive deviants, those individuals with the highest quality of life and least amount of disease activity. Positive deviants will be compared to controls in order to describe medication, diet, and lifestyle patterns associated with a lack of MS disease progression and high quality of life.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of multiple sclerosis (including relapsing remitting MS, secondary progressive MS, primary progressive MS, clinically isolated syndromes (CIS), radiologically-isolated syndromes (RIS), possible MS, or probable MS.
* Age 18-100

Exclusion Criteria:

* Inability to read/write in English
* Inability or unwillingness to complete surveys every six (6) months. (\~ 90 min)

Primary outcomes:
measure: "CAM Therapies" survey
timeFrame: 5 years
Secondary outcomes:
measure: Modified Expanded Disability Severity Score (EDSS)
timeFrame: 5 years
Other outcomes:
measure: PROMIS: Global Health
timeFrame: 5 years
Locations:
city: Kenmore
country: United States
facility: Bastyr University Clinical Research Center
state: Washington
Study officials:
affiliation: Bastyr University
name: Laurie K Mischley, ND, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00656929: Randomized Controlled Trial of Vitamin D3 Supplementation for Viral Upper Respiratory Tract Infections (URI) Prevention
Official title: A Randomized Controlled Trial of Vitamin D3 Supplementation for the Prevention of Viral Upper Respiratory Tract Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Viral Upper Respiratory Tract Infection
Keywords: Vitamin D
Viral URI
Influenza
Colds
Lead sponsor: Winthrop University Hospital
Sponsor class: OTHER
First posted: 2008-04-11
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Vitamin D has been shown to be an important immune system regulator. Vitamin D insufficiency during the winter may cause increased susceptibility to infections, particularly viral upper respiratory tract infections (URIs).

Objective: To determine whether vitamin D supplementation during the winter season prevents or decreases URI symptoms in adults.

Methods: A randomized, double-blind, placebo-controlled trial was conducted in 162 adults. Participants were randomized to receive vitamin D3 50 mcg (2000 IU) daily or matching placebo for 12 weeks from December 2006 to March 2007. A biweekly questionnaire was used to record the incidence and severity of URI symptoms


Eligibility criteria: Inclusion Criteria:

* ambulatory adult age 18-80 and stable medical condition with no change in medications for 6 months prior to study entry.

Exclusion Criteria:

* morbid obesity (body mass index \> 35 kg/m2)
* current tobacco use
* history of hypercalcemia, nephrolithiasis or sarcoidosis
* pregnancy
* recent hospitalization
* current liver or kidney disorders, malignancy and malabsorption
* use of immunosuppressants or medications that interfere with vitamin D metabolism such as phenytoin and carbamazepine.

Primary outcomes:
measure: To see whether vitamin D3 supplementation during the winter prevents viral URI.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Winthrop University Hospital
name: John F Aloia, MD
role: PRINCIPAL_INVESTIGATOR
References: