louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06276959: The Effectiveness of iTero Element 5D NIRI System in Early Proximal Caries Detection in Permanent Teeth
Official title: Comparison of Near-infrared Imaging With Cone Beam Computed Tomography for Proximal Caries Detection in Permanent Dentition: An in Vivo Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dental Caries
Lead sponsor: West China College of Stomatology
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent orthodontic treatment at the West China School of Stomatology.

Brief summary: As a new emerging technology for the diagnosis of dental caries, near-infrared imaging requires further research and validation to determine its effectiveness. This study aims to compare near-infrared imaging with cone-beam computed tomography (CBCT) to validate the efficiency of near-infrared imaging in diagnosing proximal caries using large-scale clinical data through retrospective cross-sectional studies.


Eligibility criteria: Inclusion Criteria:

* Permanent dentition
* Participants aged 12 and above
* Patients who have undergone iTero Element 5D oral scanning, as well as CBCT imaging, intraoral photography, and clinical oral examination within 1 week
* CBCT or iTero Element 5D oral scanning indicating proximal caries

Exclusion Criteria:

The following teeth were excluded:

* Third molars
* Teeth with gross loss of tooth structure (cavitated carious lesions extending to the occlusal or buccal/lingual surfaces)
* Teeth with amalgam fillings and their adjacent teeth
* Teeth with crown restorations and their adjacent teeth

Primary outcomes:
measure: positive percent agreement
timeFrame: After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.
measure: negative percent agreement
timeFrame: After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.
measure: overall percent agreement
timeFrame: After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.
Secondary outcomes:
measure: Proximal caries positive site diagnosed by CBCT
timeFrame: Immediately following CBCT image interpretation.
measure: Proximal caries positive site diagnosed by near-infrared imaging (NIRI)
timeFrame: Immediately following NIRI image interpretation.
measure: Proximal caries positive site diagnosed by unaided visual examination (UVE)
timeFrame: Immediately following clinical oral examination.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Stomatology, Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT06062459: Synergistic Benefits of MCE and BT in Sacroiliac Joint Dysfunction: A Randomized Controlled Trial
Official title: Synergistic Benefits of Motor Control Exercises and Balance Training in Sacroiliac Joint Dysfunction: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacroiliac Joint Dysfunction
Lead sponsor: Najran University
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research aimed to ascertain the combined and individual efficacies of MCE and BT in alleviating SIJD symptoms.

Detailed description: The study will be based on a four-arm parallel group randomized control design. one hundred and twenty participants with SIJD will be recruited from the Physiotherapy department, at Integral University, India. Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. All the participants will be randomly divided into four groups A, B, C, and D. Experimental group A will be receiving the hot pack, Stretching exercise, and MCE intervention, group B will receive the hot pack, Stretching exercise, and BT exercise and Group C will be receiving the hot pack, Stretching exercise, and MCE \& BT intervention, control group D will receive the hot pack, Stretching exercise intervention.

Eligibility criteria: Inclusion Criteria:

* Age-30-60 Years
* sacroiliac joint pain (\>3 months)
* Presence of pain exacerbated as a result of bending laterally or backward
* Positive results on at least 2 of the pain-provocation tests \[FABER, Posterior shear and Gaenslen pain provocation tests) and one of the motion palpation tests (ie, Gillet and forward flexion tests)

Exclusion Criteria:

* past or current history of surgery or major trauma to spine, pelvis, lower limb, chest or abdomen in the past 12 months
* lower extremity musculoskeletal disorders; known localized spinal pathology
* known congenital anomalies of hip, pelvis or spine that limits mobility
* known systematic arthropathy, neuropathy or metabolic disorder
* Presence of other causes of LBP such as lumbar discopathy and spinal stenosis discovered via clinical examination and MRI scanning
* pregnancy

Primary outcomes:
measure: Pain Intensity
timeFrame: 6 Weeks
measure: Functional disability
timeFrame: 6 Weeks
measure: self-reported measure of health
timeFrame: 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lucknow
country: India
facility: Integral University Hospital
state: Uttar Pardesh
city: Najrān
country: Saudi Arabia
facility: Hashim Ahmed
state: Najran
Study officials:
affiliation: Najran University
name: Hashim Ahmed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05841459: Spiritual Well-being, Self-compassion, Physical Symptoms Distress and Demoralization Among HD Patients
Official title: Study of Spiritual Well-being, Self-compassion, Physical Symptoms Distress and Demoralization Among Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Demoralization
Keywords: spirituality
self-compassion
demoralization
Lead sponsor: Chang Gung University of Science and Technology
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 156
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hemodialysis patients

Brief summary: To explore the associations between spiritual well-being, self-compassion, physical symptoms distress and demoralization among hemodialysis patients

Detailed description: The aims of this study is to explore the associations between spiritual well-being, self-compassion, physical symptom distress and demoralization in hemodialysis patients.

A cross-sectional correlation design will be used. We use convenient sample to recruit hemodialysis patients in a regional teaching hospital in the southern Taiwan. The research data is collected with a pact of self-administrated questionnaire including Chinese version of the Demoralization Scale , FACITsp-12 Scale, Self-Compassion Scale, and Physical Symptom Distress Scale. SPSS statistical software will be used to data analysis. Analysis methods included descriptive and inferential statistics. Finally, multiple linear regression will be used to test the predictors of demoralization. The research results will offer health providers to identify symptoms related to demoralization earlier and provide appropriate care to patients to adapt the long treatment process and improve their quality of life

Eligibility criteria: Inclusion Criteria:

* hemodialysis patient who agrees to join this study.
* The participant is over 20 years old.
* The participant has a clear consciousness and can communicate in Mandarin and Taiwanese to answer the questionnaire.

Exclusion Criteria:

* The hearing impaired cannot communicate.
* Intensive care unit or inpatients.
* Mental disorders or dementia such as depression, schizophrenia, and anxiety diagnosed by a physician.
* Those who are seriously unwell or have unstable vital signs.

Primary outcomes:
measure: demoralization
timeFrame: during the procedure
Secondary outcomes:
measure: spiritual well-being
timeFrame: during the procedure
measure: self compassion
timeFrame: during the procedure
measure: physical symptom distress
timeFrame: during the procedure
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung University of Science and Technology
state: N/A = Not Applicable
Study officials:
affiliation: Chang Gung University of Science and Technology
name: Ya-Chu Hsiao, EdD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05491759: A Study to Determine Optimal Absorption of Single Dose Omega-3
Official title: A Randomised Three-way Cross Over Study to Determine the Optimal Absorption of an Omega-3 Supplement Administered as a Single Oral Dose to Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Optimal Gastrointestinal Absorption of Omega-3
Lead sponsor: RDC Clinical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2022-08-08
Enrollment: 22
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a randomised three-way cross over study comparing the optimal absorption of a single dose of fish oil using 3 different forms to one another on increasing blood concentrations of fatty acids in 24 healthy adult participants aged 19 years and over.


Eligibility criteria: Inclusion Criteria:

* Male and females over 19 years and otherwise healthy
* Healthy BMI \&gt;18.0 and \&lt;30.0
* Able to provide informed consent
* Agree to arrive fasted on the day of the trial
* Agree to participate in all arms of the study

Exclusion Criteria:

* Unstable or serious illness \[e.g. kidney, liver (including NAFLD), GIT, heart conditions, diabetes, thyroid gland function malignancy\]\*
* Any treatment that included radiation or chemotherapy within the previous 2 years
* Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy.
* Regular use of supplements containing the investigational material (e.g. Omega-3 fatty acids), in the last 3 months, regular consumption of foods containing the investigational material (e.g. fish for omega-3) #
* Active smokers, nicotine, alcohol, drug abuse
* Chronic past and/or current alcohol use (\&gt;14 alcoholic drinks week)
* Allergic to any of the ingredients (i.e., fish oil)
* Pregnant or lactating women
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion

  * An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.

    * Regular use or consumption is considered if participants are consuming omega containing supplements or foods on 3 or more days per week.

Primary outcomes:
measure: Plasma EPA+DHA as measured by AUC0-24
timeFrame: 0, 2, 4, 6, 8, 10, 12 and 24 hours post ingestion
Secondary outcomes:
measure: Cmax
timeFrame: 24 hours post ingestion
measure: Tmax
timeFrame: 24 hours post ingestion
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: RDC Global Pty Ltd
state: Queensland
Study officials:
affiliation: The University of Queensland
name: David Briskey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03705559: Opioid and Cannabinoid Interactions
Official title: Interactions of Marijuana and Opioids: Pharmacodynamic Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Marijuana Usage
Opioid Use
Keywords: marijuana
opioid
opiate
cannabis
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-10-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will examine the effects of doses of marijuana/placebo and doses of opioid/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.


Eligibility criteria: Inclusion Criteria:

* Healthy adults ages 18-50
* Current non-medical use of opioids and marijuana

Exclusion Criteria:

* Physical dependence on opioids, alcohol benzodiazepines/sedative/hypnotics
* Seeking treatment for drug use
* Significant medical problems

Primary outcomes:
measure: Change in Subject-Rated Outcome - VAS Drug Liking
timeFrame: This outcome (visual analog scores, scale of 0-100) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.
Secondary outcomes:
measure: Change in Oxygen Saturation
timeFrame: Oxygen saturation was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals.
measure: Change in Respiration Rate
timeFrame: Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals.
measure: Change in Systolic Blood Pressure
timeFrame: Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.
measure: Change in Diastolic Blood Pressure
timeFrame: Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Shanna Babalonis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06776159: The Effect of Standardizing Procedures for SC Injections of LMWH on Patients with CVD
Official title: The Effect of Standardizing Procedures for Subcutaneous Injections of Low-molecular-weight Heparin on Patients with Cardiovascular Diseases: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: CVD - Cardiovascular Disease
Bruise
Pain
Keywords: LMWH injection
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded, two-armed, clustered randomized controlled trial.
Primary purpose: TREATMENT

Brief summary: Improper subcutaneous administration of LMWH may cause complications at the injection site. Standardized protocol for subcutaneous LMWH injections in patient with cardiovascular diseases is warranted to ensure consistent best practices in clinical settings.

Detailed description: This study examines the effect of standardized protocol in reducing complications for patients with cardiovascular disease.

Eligibility criteria: Inclusion Criteria:

* patients who are in cardiac care units suffering from cardiovascular diseases prescribed with LMWH injections two times per day
* Chinese

Exclusion Criteria:

* cognitively impaired
* unconscious
* refuse to participate

Primary outcomes:
measure: Bruising
timeFrame: 24 hours, 48 hours, 72 hours
measure: Pain
timeFrame: Immediately after injection, 24 hours, 48 hours, 72 hours
Secondary outcomes:
measure: Patient Experience
timeFrame: Immediately after receiving the injection
measure: Communicative Competence
timeFrame: Immediately before and after injection
Other outcomes:
Locations:
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Arkers Wong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05161559: Adhesive Performance of Glass Ionomer and Resin Based Adhesive Systems: A 3 Years Prospective Clinical Evaluation
Official title: Adhesive Performance of Glass Ionomer Versus Resin Based Adhesive Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Leakage
Keywords: Resin Composite
Randomized Clinical Trial
Operative Dentistry
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aimed to clinically evaluate the 3-years clinical performance of glass ionomer and resin based adhesive systems in Class V restorations.

Detailed description: The formulated null hypothesis was that there is no significant difference in the clinical performances between glass ionomer and resin based adhesive systems in Class V restorations for 3-years.

The research question was as follows: Do glass ionomer adhesives in class V restorations present better clinical performances than resin based adhesive systems according to the modified United States Public Health Service (modified-USPHS) criteria?

Eligibility criteria: Inclusion Criteria:

1. Patients with primary caries involving cervical surface only with ICDAS 2 and 3.
2. Patients with normal and full occlusion.
3. Patients with tooth gives positive response to testing with an electric pulp tester.
4. Patients must have a good oral hygiene.
5. Patients with opposing teeth should be natural with no restorations.

Exclusion Criteria:

1. High caries risk patients with extremely poor oral hygiene.
2. Patients involved in orthodontic treatment or periodontal surgery.
3. Patients with periodontally involved teeth (chronic periodontitis).
4. Patients with heavy bruxism habits and clenching.
5. Patients with abutments should be excluded.

Primary outcomes:
measure: Percentage % of patients with marginal staining
timeFrame: 3 years after restoration procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
References:
Clinical trial NCT01518959: The Effect of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases
Official title: Phase III, Controlled, Double-blind, Randomized Study of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Lymphoid Leukemia
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2012-01-26
Enrollment: 31
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: Recent data have shown that the inadequate vitamin D status plays a role in the manifestation of the haematologic tumors and serum vitamin D level has a prognostic role also as it determines the tumor mortality. But data have not proved a causal relationship between the inadequate vitamin D status and the unfavourable outcomes so far. It is also still unknown, whether the normalization of vitamin D status in patient with vitamin D inadequacy is able to improve the prognosis and survival.

In this study the investigators examine the role of the adequate vitamin D substitution in the improvement of the outcomes of haematologic disorders.


Eligibility criteria: Inclusion Criteria:

* at least 18 years old male or female
* chronic lymphoid leukaemia, any Rai stage
* 25-OH-Vitamin-D3 level between 10 and 30 ng/mL

Exclusion Criteria:

* serum calcium \> 2,60 mmol/l
* 24 hour calcium urine excretion \> 0,1 mmol/kg/day
* serum phosphate \> 1,45 mmol/l
* eGFR \< 30 ml/min/1,73m2
* nephrolithiasis
* receiving parenteral vitamin-D3 in past 6 months
* activated vitamin-D3 treatment

Primary outcomes:
measure: Overall survival
timeFrame: up to 5 years
Secondary outcomes:
measure: Time to treatment needed
timeFrame: up to 5 years
measure: Blood lymphocyte count
timeFrame: monthly, up to 5 years
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University - 1st Departement of Internal Medicine
Study officials:
affiliation: Semmelweis University
name: Istvan Takacs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04273659: Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?
Official title: Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unidentified Gastrointestinal Symptoms Following Pulses Consumption
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to compare self-reported gastrointestinal symptoms and intestinal fermentation rates of the study products as measured by breath hydrogen and methane in adult population with self-reported mild abdominal sensitivity to pulses. The study products are a pulse products with two different cereals.

Detailed description: The study is a randomized, controlled, double-blind, cross-over intervention trial. The aim is to recruit 25 subjects to the trial. The study will be conducted with a cross-over setting, where the subjects will go through exposure meals and breath gas measurement two times (two different test products) in a randomized order. The study meals are identical in appearance but differ in fiber content. After study breakfast the breath gases are analyzed every 15 minutes during 8 hours.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects with subjective experience of gut symptoms after consumption of pulses
* Celiac disease and wheat allergy excluded by antigen test
* Age 18-65
* BMI 18,5 - 30
* Normal liver, thyroid and kidney functions

Exclusion Criteria:

* Celiac disease, Crohn's disease, ulcerative colitis or acute diverticulitis
* Any medication affecting the gastrointestinal tract (e.g. laxatives and acid-suppressive drugs)
* Antibiotic treatment within previous 3 months
* Blood donation or participation to another clinical trial within one month prior to study entry

Primary outcomes:
measure: Breath gases
timeFrame: Day 4
Secondary outcomes:
measure: Gastrointestinal symptoms (self-reported)
timeFrame: Day 1-4
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Department of Biochemistry, University of Turku
Study officials:
affiliation: Department of Biochemistry, University of Turku
name: Kaisa Linderborg, PhD
role: PRINCIPAL_INVESTIGATOR
References: