louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03963791: Remineralization Effect of Eggshell Powder on Post-orthodontic White Spot Lesions Compared to CPP-ACP
Official title: Remineralization Effect of Eggshell Powder on Post-orthodontic White Spot Lesions Compared to CPP-ACP: A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 24
Sex: ALL
Minimum age (years): 13
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research is conducted to compare the remineralization efficacy of eggshell powder gel and CPP-ACP (MI paste) on post-orthodontic white spot lesions.


Eligibility criteria: Inclusion Criteria:

* A patient who has just completed a comprehensive orthodontic treatment.
* Presence of at least one WSL, DIAGNOdent score (0-20).
* Age range between 13 and 35years.

Exclusion Criteria:

* Patients are unable to return for recall appointments.
* High caries risk.
* Have plaque accumulation and a periodontal problem
* In progress treatment of chronic disease.
* Presence of abnormal oral, medical, or mental condition (including any milk-related allergies or any medical condition involving kidneys or salivary glands).
* Presence of dentin caries, enamel hypoplasia or restorations on maxillary anterior teeth.

Primary outcomes:
measure: white spot lesion progression.
timeFrame: 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo univercity
Study officials:
References:
Clinical trial NCT03768791: HRV in Patients Treated With Spinal Cord Stimulation
Official title: Heart Rate Variability in Patients With Failed Back Surgery Syndrome, Treated With Spinal Cord Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failed Back Surgery Syndrome
Keywords: Spinal Cord Stimulation
Heart rate variability
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is an observatory single center study investigating heart rate variability during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.


Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years old.
* Diagnosis of FBSS (Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy) and currently being treated with spinal cord stimulation.
* Cognitive and language functioning enabling coherent communication between the examiner and the participant.

Exclusion Criteria:

* The presence of one or more coexisting conditions known to affect HRV analysis (including but not limited to atrial fibrillation, numerous atrial or ventricular extra beats, paced rhythm, left ventricular bundle branch block, cancer, kidney or hepatic failure, and diabetes mellitus (autonomic nervous system dysfunction)).
* The use of medication that directly modifies autonomic control (for example beta-blockers).

Primary outcomes:
measure: Heart rate variability changes
timeFrame: Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.
Secondary outcomes:
measure: Pain intensity scores
timeFrame: Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Maarten Moens, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kalmar Z, Kovacs N, Balas I, Perlaki G, Plozer E, Orsi G, Altbacker A, Schwarcz A, Hejjel L, Komoly S, Janszky J. Effects of spinal cord stimulation on heart rate variability in patients with chronic pain. Ideggyogy Sz. 2013 Mar 30;66(3-4):102-6.
Clinical trial NCT06312891: Value of Heart Rate Lowering Therapy in Acute Myocarditis
Official title: Value of Heart Rate Lowering Therapy in Acute Myocarditis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocarditis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who meet the study's inclusion \& exclusion criteria

Brief summary: To study the value of heart rate lowering therapy "pharmacological rest" on the short term in cases of myocarditis without LV dysfunction.


Eligibility criteria: Inclusion Criteria:

* Adults: ≥18 years of age.
* Presentation: at least one of the following:

  * Myopericarditis/ACS-like
  * MINOCA
  * Arrhythmias: brady or tachyarrhythmias.
  * Unexplained compensated acute cardiomyopathy (excluded ischemic, valvular, hypertensive, metabolic, and toxic causes of cardiomyopathy as indicated clinically).
* TTE: LVEF\>40%
* CMR-confirmed myo(peri)carditis (Lake Louise criteria)

Exclusion Criteria:

* • Rheumatic carditis.

  * Connective tissue diseases (-ve ANA).
  * Cancer chemotherapy.
  * Toxicity from immunotherapy.
  * Vaccine-related myocarditis.
  * Presence of coronary artery disease.
  * Peripartum (occurring during the last month of pregnancy or within 5 months after delivery)
  * ECG: atrial fibrillation/flutter.
  * Resuscitated sudden death.
  * Early/initial phase of decompensated heart failure.
  * Tamponade complicating pericarditis unless successfully managed.

Primary outcomes:
measure: Value of Heart Rate Lowering Therapy in Acute Myocarditis
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Heart Hospital
Study officials:
References:
Clinical trial NCT07026591: Epilepsy and Driving.
Official title: Epilepsy and Driving.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Epilepsy
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2025-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Epileptic patients and healthy volunteers

Brief summary: Epilepsy can lead to cognitive impairments, particularly in attention, which may affect daily activities such as driving. Driving plays a key role in maintaining autonomy and is essential for the social and professional integration of people with epilepsy. Therefore, assessing fitness to drive is a major issue for individuals with epilepsy.

French legislation governing driving for people with epilepsy clearly outlines the periods during which a person is not permitted to drive. However, the means or methods for evaluating driving fitness in these individuals are not well defined. Currently, assessment is based more on a medical consultation than on a comprehensive evaluation of driving ability.

Using a driving simulator in combination with an EEG could be a valuable approach to better assess the impact of epilepsy-related cognitive impairments on driving performance.


Eligibility criteria: Inclusion Criteria

* Aged between 18 and 65 years
* Holder of a category B driving license
* Active driver: drives at least once a month
* No medical condition contraindicating driving, except for epilepsy
* Provides explicit consent to participate in the study
* Affiliated with or a beneficiary of a social security scheme

Exclusion Criteria:

* Subject to legal protection (guardianship and curatorship are accepted for individuals with epilepsy, as this population represents a significant proportion of our institution's patients)
* Pregnant or breastfeeding women
* Known cybersickness (virtual reality or simulator sickness)

Primary outcomes:
measure: Speed
timeFrame: Day 0
measure: Phasic alertness
timeFrame: Day 0
measure: Lane position
timeFrame: Day 0
measure: Braking time
timeFrame: Day 0
measure: Information processing time
timeFrame: Day 0
measure: Sustained attention
timeFrame: Day 0
measure: Divided attention
timeFrame: Day 0
measure: Visual scanning
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04500691: pRedicting the Long-term rEsponse of High Frequency sPinal cOrd sTimulation in Patients With Failed Back Surgery Syndrome.
Official title: pRedicting the Long-term rEsponse of High Frequency sPinal cOrd sTimulation in Patients With Failed Back Surgery Syndrome.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Failed Back Surgery Syndrome
Keywords: High frequency Spinal Cord Stimulation
prediction
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: AZ Nikolaas
First posted: 2020-08-05
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with FBSS treated with high frequency spinal cord stimulation implantation.

Brief summary: The aim of the current retrospective study is to predict responders for HF10-SCS therapy by only using baseline data. Data collected through clinical practice until June 2020 will be used in this retrospective analysis.


Eligibility criteria: Inclusion Criteria:

* FBSS patients treated with high frequency spinal cord stimulation implantation.

Primary outcomes:
measure: Responder status
timeFrame: The difference in pain intensity from the date that a patient was eligible for Spinal Cord Stimulation (i.e. baseline) up to the date of the last routine care visit with Spinal Cord Stimulation with database lock at 15th of June 2020.
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
Study officials:
References:
Clinical trial NCT00575991: Effect of Conjugated Linoleic Acid on Body Fat in Overweight Children
Official title: Effect of CLA Supplementation on Body Fat Accretion Among Children Who Are Overweight or at Risk of Overweight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: conjugated linoleic acid, body fat, children, overweight
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Bunge Loders Croklaan
First posted: 2007-12-18
Enrollment: 62
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The prevalence of overweight children has increased dramatically over the last decade, and many overweight children will remain overweight as adults. Conjugated linoleic acid (CLA), a naturally occurring dietary fatty acid, has shown promising results in reducing body fat among adults, and we propose to test the efficacy of CLA supplementation on body fat accretion in 6 to 10 year old children who are overweight or at risk of overweight.


Eligibility criteria: Inclusion Criteria:

* age 6 to 10 years
* body mass index greater than 85th percentile
* Tanner stage I

Exclusion Criteria:

* medical condition
* dairy allergy

Primary outcomes:
measure: body composition using DXA
timeFrame: 6 months
Secondary outcomes:
measure: blood chemistry variables including fasting glucose and insulin, lipids, and liver enzymes
timeFrame: 6 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Department of Nutritional Sciences
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Dale A Schoeller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00211991: Evaluation of Consistency of StaphVAX Manufacturing Lots
Official title: A Phase 3, Multicenter, Double-Blinded, Randomized, Study to Compare Immunogenicity and Safety Between Three Commercial Lots of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Normal, Healthy, Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Staphylococcal Infections
Lead sponsor: Nabi Biopharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Vanderbilt University
First posted: 2005-09-21
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study answers a U.S. Food and Drug Administration requirement for evaluation in people of the consistency of manufacturing of a vaccine. Subjects are randomized to one of three lots of vaccine. The antibodies in the blood measure the immunogenicity of each lot of vaccine, and typical vaccine safety information is also collected.


Eligibility criteria: Inclusion Criteria:

* healthy,
* written informed consent,
* negative serum pregnancy test if appropriate,
* expect to comply with protocol procedures and schedule

Exclusion Criteria:

* known HIV,
* immunomodulatory drugs,
* malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer),
* active infection in the 2 weeks prior to study injection,
* serious S. aureus infection within the last 3 months prior to injection,
* use of investigational drugs, vaccines or devices within the prior 30 days,
* hypersensitivity to components of StaphVAX

Primary outcomes:
measure: Type-specific antibody concentrations 6 weeks after vaccine dose.
Secondary outcomes:
measure: Antibody concentrations at other time points.
measure: Elicited health events.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbuilt University
state: Tennessee
Study officials:
affiliation: Nabi Biopharmaceuticals
name: Matt Hohenboken, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Creech CB 2nd, Johnson BG, Alsentzer AR, Hohenboken M, Edwards KM, Talbot TR 3rd. Vaccination as infection control: a pilot study to determine the impact of Staphylococcus aureus vaccination on nasal carriage. Vaccine. 2009 Dec 10;28(1):256-60. doi: 10.1016/j.vaccine.2009.09.088. Epub 2009 Sep 30.
Clinical trial NCT00581191: Study Evaluating the Safety and Tolerability of Single Ascending Dose (SAD) SLV-351 in Healthy Subjects
Official title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SLV-351 Administered Orally to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: SAD
Healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Solvay Pharmaceuticals
First posted: 2007-12-27
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Safety and tolerability of single oral doses in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Men, aged 18-50 years.
* Women of nonchildbearing potential, aged 18-50 years.

Primary outcomes:
measure: Safet and tolerability
timeFrame: 35 days
Secondary outcomes:
measure: PK and PD
timeFrame: 35 days
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06792591: Diagnostic Performance of Positron Emission Mammography in Breast Cancer
Official title: Diagnostic Performance of Positron Emission Mammography in Breast Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suspected with breast cancer or pathological proven to have breast cancer, patients underwent breast mammography or breast US and suspected to have breast cancer.

Brief summary: Investigate the accuracy of PEM in detection of breast cancer.

Detailed description: Investigate the accuracy of positron emission mammography as non invasive method for early detection of breast cancer especially small sized cancers.

Eligibility criteria: Inclusion Criteria:

* patients suspected with breast cancer.

Exclusion Criteria:

* patient with glucose level \>200 mg/dl.
* Pregnant patients

Primary outcomes:
measure: Diagnostic performance of positron emission mammography in breast cancer
timeFrame: Base line
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00687791: Oculusgen (Ologen) Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: A Case-Control Study
Official title: Oculusgen (Ologen) Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: A Case-Control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cataract
Glaucoma
Keywords: patients with cataract and glaucoma
ologen
oculusgen
collagen matrix
Phacotrabeculectomy
Aeon Astron
trabeculectomy
tissue engineering
mitomycin-C
Lead sponsor: Pro Top & Mediking Company Limited
Sponsor class: INDUSTRY
First posted: 2008-06-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the safety and effectiveness of the OculusGen™ (ologen) Biodegradable Collagen Matrix Implant in hacotrabeculectomy surgery. The primary endpoint is to prove the effectiveness via the reduction of IOP, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events.

Detailed description: Ologen™ Collagen Matrix is indicated for creating a mature bleb structure to facilitate aqueous outflow for the reduction of elevated intraocular pressure in patients with glaucoma, following traditional filtering surgery (trabeculectomy)

Within 60 days from the time of implantation, ologen™ Collagen Matrix is totally degraded. Postoperatively, mild inflammation may be seen and anti- inflammatory agents are prescribed

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or over.
2. At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy.
3. Visually significant cataract with visual acuity of less than or equal to 6/12.
4. Subject able and willing to cooperate with investigation plan.
5. Subject willing to sign informed consent form.

Exclusion Criteria:

1. Known allergic reaction to collagen.
2. Subject is on Warfarin and discontinuation is not recommended.
3. Subject with normal tension glaucoma or aphakic glaucoma.
4. Subject with corneal disease.
5. Participation in an investigational study during the 30 days proceeding phacotrabeculectomy.
6. Ocular infection within 14 days prior to phacotrabeculectomy.
7. Pregnant or breast-feeding women.
8. Monocular subject.

Primary outcomes:
measure: The primary endpoint is to prove the effectiveness via the reduction of IOP.
timeFrame: 180 days
Secondary outcomes:
measure: the secondary endpoint is to prove the safety via the reduction of complications.
timeFrame: 180 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore Eye Research Institute
Study officials:
affiliation: Singapore Eye Research Institute
name: Aung Tin, PhD MD
role: STUDY_CHAIR
References:
Clinical trial NCT05306691: Remineralizing Efficacy of Giomer Varnish vs. Fluoride Varnish in Management of White Spot Lesions in Adult Patients
Official title: Comparative Remineralizing Efficacy of Giomer Bioactive Barrier Varnish vs. Fluoride Varnish in Management of White Spot Lesions in Adult Patients: Randomized Controlled Tria
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Caries, Dental
Remineralization
White Spot Lesion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the remineralizing capability of biosmart S-PRG barrier coat varnish and its employment in clinical practice


Eligibility criteria: Inclusion Criteria:

* • Age range between 18 and 40 years.

  * Patients with no systemic diseases, syndromic abnormalities, or proven/suspected milk protein allergy and/or sensitivity
  * Patients with fair oral hygiene (mild to moderate plaque accumulation).
  * Patients with non-cavitated initial carious lesions grade 0 or 1 caries in accordance with The Nyvad caries diagnostic criteria.
  * The patient did not receive any remineralizing agent other than the regular toothpaste during the past three months.

Exclusion Criteria:

* • Severe or active periodontal disease.

  * Patients had received therapeutic irradiation to the head and neck region.
  * Patients had participated in a clinical trial within 6 months before commencement of this trial.
  * Patients unable to return for recall appointments
  * Presence of abnormal oral, medical, or mental condition.
  * Presence of dentin caries or enamel hypoplasia on maxillary anterior teeth.
  * Patients with glass ionomer restorations because the glass ionomer restoration release fluoride in the oral cavity, potentially impacting the results.

Primary outcomes:
measure: Change in Remineralization efficacy.
timeFrame: Baseline, 1 month, 3 months
Secondary outcomes:
measure: Change in Caries lesion activity assessment
timeFrame: Baseline, 1 month, 3 months
Other outcomes:
Locations:
Study officials:
References: