louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06346756: Clinical Evaluation of Class II Restorations
Official title: Clinical Evaluation of Class II Restorations Performed With High-fill Injectable Composite and Condensable Universal Composites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Dental Caries Class II
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the one-year clinical performance of Class II restorations made with high-filling injectable and condensable universal composite resins.

The study included 71 patients and 140 restorations. It used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), Filtek Ultimate (FU) composites, and the Clearfil SE Bond adhesive system. Restorations were evaluated and scored according to modified USPHS criteria at seven days, six months, and one year. Chi-square and Cochran Q tests were used for statistical analysis (p\<0.05).


Eligibility criteria: Inclusion Criteria:

A patient presenting with;

1. over 18 years of age
2. a normal periodontal status and good general health
3. proximal caries that are similar in size to premolar and molar teeth
4. vital teeth
5. teeth in contact with the opposing tooth and subjected to normal occlusal forces
6. attend follow-up appointments

Exclusion Criteria:

1. poor oral hygiene status
2. those with severe or chronic periodontitis
3. absence of adjacent and antagonist teeth
4. potential behavioral problems (e.g. bruxism)
5. allergy to any product used in the study
6. exposure of the pulp during cavity preparation
7. systemically unhealthy
8. pregnant and lactating women

Primary outcomes:
measure: Retention
timeFrame: seventh day, sixth month, twelfth month
Secondary outcomes:
measure: color match
timeFrame: seventh day, sixth month, twelfth month
measure: marginal adaptation
timeFrame: seventh day, sixth month, twelfth month
measure: marginal discoloration
timeFrame: seventh day, sixth month, twelfth month
measure: surface texture
timeFrame: seventh day, sixth month, twelfth month
measure: anatomical form
timeFrame: seventh day, sixth month, twelfth month
measure: secondary caries
timeFrame: seventh day, sixth month, twelfth month
measure: postoperative sensitivity
timeFrame: seventh day, sixth month, twelfth month
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University, Faculty of Dentistry
Study officials:
affiliation: Selcuk University, Faculty of Dentistry
name: Merve Gürses
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05808556: Sticker Pad Containing Essential Oil in Volunteer With High Blood Pressure
Official title: Efficacy and Safety of Sticker Pad Containing Essential Oil in Volunteer With High Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Blood Pressure
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 34
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: The aims of the study were to evaluate efficacy and safety of the sticker pads containing lavender and ylang ylang oil in high blood pressure volunteers

Detailed description: High blood pressure volunteers were divided into the sticker group or the placebo group. The volunteers attached the pad to their shirt for 3, 7, 10, and 14 days. Blood pressure, pulse rate, adverse reactions, and satisfaction were investigated.

Eligibility criteria: Inclusion Criteria:

* age more than 18 years
* systolic blood pressure of more than 130 mmHg but less than 160 mmHg or diastolic blood pressure more than 80 mmHg but less than 100 mmHg
* no hypertensive medicine
* no dermatological diseases, immunocompromised diseases, seizures, asthma, or respiratory diseases

Exclusion Criteria:

* an unstable condition of other diseases
* olfactory problems
* pregnancy
* lactation

Primary outcomes:
measure: Systolic blood pressure
timeFrame: 14 days
measure: Diastolic blood pressure
timeFrame: 14 days
measure: Pulse rate
timeFrame: 14 days
Secondary outcomes:
measure: adverse reactions of the respiratory tract, skin, gastrointestinal tract, eye, and central nervous system
timeFrame: 14 days
measure: Satisfaction of the product
timeFrame: 14 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
Study officials:
References:
Clinical trial NCT06926556: Different Microlenses Array for Controlling Myopia Progression in Children and Adolescents
Official title: Different Microlenses Array for Controlling Myopia Progression in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia Progressing
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 134
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the effectiveness of lenses with different defocused microlens array in controlling the progression of myopia in children and adolescents, and to explore the feasibility of effective defocus microlens design, and apply personalized defocus frame lenses for myopia prevention and control.


Eligibility criteria: Inclusion Criteria:

1. Age: 6-14 years old;
2. After using 1% cyclohexanone hydrochloride eye drops (Saifeijie) for ciliary muscle paralysis, binocular spherical power were within -0.50D\~-4.00D, binocular cylinder power ≤ 1.50D, the anisometropia is less than 1.50D, and the best corrected visual acuity was above 5.0;
3. Within 30 days, the myopia prevention and control methods such as multifocal glasses, orthokeratology, defocusing flexible glasses, progressive glasses, atropine eye drops, red light and acupuncture and moxibustion treatment were not used;
4. The subject has a willingness to receive treatment and an informed consent form is signed by their legal guardian.

Exclusion Criteria:

1. Diagnosed constant strabismus;
2. Diagnosed pathological myopia;
3. Other congenital eye diseases;
4. Researchers believe that the patients have other reasons that are not suitable for inclusion in the project.

Primary outcomes:
measure: Subjective refraction equivalent spherical
timeFrame: 2 years
Secondary outcomes:
measure: Axial length
timeFrame: 2 years
Other outcomes:
measure: Other biological parameters
timeFrame: 2 years
measure: Best corrected visual acuity
timeFrame: 2 years
measure: questionnaires of daily eye habits and wearing time of subjects collected
timeFrame: 2 years
Locations:
city: Shanghai
country: China
facility: Shanghai Eye Diseases Prevention &amp;Treatment Center/ Shanghai Eye Hospital, School of Medicine, Tongji University
state: Shanghai
Study officials:
References:
Clinical trial NCT01304056: How to Study Ventilatory Physiology With the Help of Surface Electromyography (EMG) Recordings
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ventilatory Physiology
Keywords: Ventilatory physiology
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult population \> 18 years of age

Brief summary: Respiratory muscles seem to be activating differently in critically ill patients than in healthy persons. Needle electrodes would provide artefact-free signal information about muscle activation. However, needle recordings are an invasive technique which limits its feasibility in clinical setting. Intention of this study is to investigate if surface electromyography could be used to measure recruitment patterns of ventilatory muscles.


Eligibility criteria: Inclusion Criteria:

* \> 18 years of age

Exclusion Criteria:

* brain death of injury
* high spinal cord injury
* severe ARDS (static compliance below 40, PFI below 150)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Critical Care Medicine Research Group, Tampere University Hospital
name: Jyrki Tenhunen, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04862156: WP02 Continued Access Study
Official title: Continued Access Protocol Study for the Use of the OrganOx Metra Normothermic Machine Perfusion Device in Human Liver Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Transplantation
Lead sponsor: OrganOx Ltd.
Sponsor class: INDUSTRY
Collaborators: name: North American Science Associates Ltd.
First posted: 2021-04-27
Enrollment: 19
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: The single-arm continued access phase will be used to collect additional effectiveness and safety data to support the objectives and outcomes of the original IDE pivotal study.


Eligibility criteria: Inclusion Criteria:

* Subject is 18 years of age or greater
* Subject is registered as an active recipient on the UNOS waiting list for liver transplantation
* Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization
* Subject is able and willing to comply with all study requirements

Exclusion Criteria:

* Subject requiring all of the following at the time of transplantation:

  1. Oxygen therapy via a ventilator/respirator
  2. Inotropic support
  3. Renal replacement therapy
* Subject has acute/fulminant liver failure (UNOS status 1A)
* Subject undergoing simultaneous transplantation of more than one organ (e.g., liver and kidney)
* Subject is pregnant (as confirmed by urine or serum pregnancy test) or nursing
* Concurrent enrollment in another clinical trial. Subjects enrolled in clinical trials or registries where only measurements and/or samples are taken (NO TEST DEVICE or TEST DRUG USED) are allowed to participate.

Primary outcomes:
measure: Incidence of Early Allograft Dysfunction (EAD)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Maywood
country: United States
facility: Loyola University Chicago
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
References:
Clinical trial NCT04504656: Comparison of Early Outcomes of Minimally Invasive Surgery for Oesophageal Replacement Versus Open Surgery in Children
Official title: Comparison of Early Outcomes of Minimally Invasive Surgery for Oesophageal Replacement Versus Open Surgery in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post-Op Complication
Anastomosis; Complications
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 20
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children up to 18 years

Brief summary: a comparative prospective study of postoperative between minimally invasive and open surgery complications for esophageal replacement in children

Detailed description: Esophageal replacement in childhood is indicated in esophageal atresia patients with long-gap defects or following complications of primary esophageal anastomosis, as well as in patients with trauma and scarring to the esophagus following caustic ingestion. It is widely accepted that the ideal esophageal replacement is one that resembles the function of the native esophagus with minimal deterioration over time. Several techniques of esophageal replacement have been developed. These have focused mainly on the use of native tissues (including the stomach, jejunum, and colon) as conduits (1), attempts to use a synthetic prosthesis have been largely unsuccessful. In an attempt to reduce the trauma and morbidity associated with laparotomy and thoracotomy incisions, minimally invasive techniques are increasingly used. (2-4). Meta-analyses of adult esophagectomy for the treatment of esophageal cancer support the use of minimally invasive surgery (5) however, equivalent comparative studies in the pediatric population are lacking. As such, it is unclear whether minimally esophageal replacement is as safe as the open procedure in children. The present study aims to address this question by comparing the postoperative outcomes of children who underwent minimally invasive versus open esophageal replacement procedures at single-center and multicenter levels.

Eligibility criteria: Inclusion Criteria:

All children undergoing oesophageal replacement aged one to 18 years. Due to

1. long gap esophageal atresia
2. caustic ingestion
3. congenital esophageal stenosis or strictures

Exclusion Criteria:

* patient who underwent previous esophageal replacement operations.

Primary outcomes:
measure: Anastamotic leaks
timeFrame: 2 years
Secondary outcomes:
measure: Anastamotic stricture
timeFrame: 2 years
measure: Mortality
timeFrame: 2 years
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Children Hospitals
Study officials:
affiliation: Assiut University
name: Ahmed Eltayeb, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05596656: IgE-mediated Allergies Among Type 1 Diabetes Mellitus Children, Single Centre Observational Study
Official title: IgE-mediated Allergies Among Type 1 Diabetes Mellitus Children, Single Centre Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Children
Lead sponsor: Mansoura University Children Hospital
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children with at least 2 years' duration of Type 1 Diabetes Mellitus. Participants: among 200 cases with Type 1 DM children following up at endocrinology unit

Brief summary: an interviewer-administrated questionnaire was designed to take history of allergy in diabetic child come to outpatient clinic fulfilling inclusion criteria and used to collect data. Skin prick testing was performed to all diabetic children with history of allergy. Laboratory assessment of Serum Total IgE, IL5 and eosinophils%.


Eligibility criteria: Inclusion Criteria:

* Children with at least 2 Years duration of diabetes diagnosed by Criteria for the diagnosis of diabetes mellitus (ISPAD 2018) that include:
* Classic symptoms of diabetes or hyperglycemic crisis, with plasma glucose concentration ≥11.1 mmol/L (200 mg/dL).
* Fasting plasma glucose ≥7.0 mmol/L (≥126 mg/dL). Fasting is defined as no caloric intake for at least 8 hours.
* Two-hour post load glucose ≥11.1 mmol/L (≥200 mg/dL) during an oral glucose tolerance test (OGTT).
* HbA1c ≥6.5%.

Exclusion Criteria:

* presence of other chronic disease associated with DM.

Primary outcomes:
measure: positive skin prick test
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Children Hospital
state: None Selected
Study officials:
affiliation: assistant Professor, Pediatrics Department, Faculty of Medicine, Mansoura University, Egypt.
name: Engy Osman, MD
role: STUDY_DIRECTOR
References:
citation: Heinzerling L, Mari A, Bergmann KC, Bresciani M, Burbach G, Darsow U, Durham S, Fokkens W, Gjomarkaj M, Haahtela T, Bom AT, Wohrl S, Maibach H, Lockey R. The skin prick test - European standards. Clin Transl Allergy. 2013 Feb 1;3(1):3. doi: 10.1186/2045-7022-3-3.
Clinical trial NCT01773356: Effect of Dihydrocapsiate on Energy Expenditure in Women
Official title: Randomized, Controlled, Parallel Trial to Evaluate the Effects of Dihydrocapsiate on Energy Expenditure in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Body Weight
Body Composition
Metabolism
Resting Energy Expenditure
Lead sponsor: University of Georgia
Sponsor class: OTHER
Collaborators: name: Kellogg Company
First posted: 2013-01-23
Enrollment: 126
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to test the effect of dihydrocapsiate on energy expenditure in women.

Detailed description: Capsaicin, a substance found in chili pepper, is known to stimulate thermogenesis. Dihydrocapsiate, a capsinoid, found in the non-pungent CH-19 sweet pepper has similar thermogenic effects without the gastrointestinal side effects. The objective of this project is to test the effect of 12 weeks of daily consumption of 9 mg dihydrocapsiate on resting energy expenditure relative to baseline when compared to a control group consuming products without DCT.

Eligibility criteria: Inclusion Criteria:

* BMI: 18.5-34.5 kg/m2
* Good general health
* Low to mild physical activity
* Willing to maintain habitual diet and physical activity patterns throughout the study period
* Premenopausal and cycling regularly or using oral contraceptives
* Willing to attend study visits only during the follicular phase or bleed phase of their menstrual cycle
* Understands study procedures and signs forms providing informed consent to participate in the study
* Have spoken and written English literacy

Exclusion Criteria:

* Diabetes mellitus or any conditions that might affect energy metabolism
* Weight change ±2 kg over previous three months
* Known sensitivity or allergy to ingredients of the study products
* Non-breakfast eater
* Recent use of antibiotics
* History of smoking during the six months prior to study
* Recent signs or symptoms of infection, including cold or flu-like symptoms
* Concurrent or recent intervention study participation
* Instability in breathing patterns or energy expenditure measures
* History of drug or alcohol abuse
* Lipid-lowering, anti-hypertensive or anti-inflammatory steroid medication use
* Weight loss medication
* Pregnant or lactating
* Unwilling to be randomized to any experimental group and unable to meet all requirements of the study

Primary outcomes:
measure: Resting Energy Expenditure
timeFrame: Change from Baseline at 12 weeks
Secondary outcomes:
measure: Thermic effect of feeding
timeFrame: Change from baseline at 12 weeks
measure: Body Composition
timeFrame: Change from baseline at 12 weeks
Other outcomes:
Locations:
city: Athens
country: United States
facility: University of Georgia, Department of Kinesiology
state: Georgia
Study officials:
affiliation: University of Georgia
name: Ellen M Evans, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05040256: Neurologic and Immunologic Characteristics of CTLA-4 and LRBA Hereditary Deficiency
Official title: Neurologic and Immunologic Characteristics of CTLA-4 and LRBA Hereditary Deficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CTLA4 Haploinsufficiency
Keywords: LRBA deficiency
Primary immunodeficiency
Neuroinflammation
Genetic diseases
Autoimmune diseases
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients listed with CTLA4 or LRBA deficiency in the register of the national reference center for primary immunodeficiencies.

Brief summary: CTLA4 and LRBA deficiencies are rare genetic disorders, recently described, and associated with multiple clinical features. It ranges from recurrent infections, auto-immunity, and organ infiltration with lymphocytes. Neurologic syndroms are described in up to 30% of patients, yet they are poorly defined to date. Early recognition of a specific pattern can be important, given that there is a targeted therapy in this situation.


Eligibility criteria: Inclusion criteria:

- Patients diagnosed with CTLA4 or LRBA mutation

Exclusion criteria:

- Age \< 12 years

Primary outcomes:
measure: Number of Neurologic impairment
timeFrame: 1 day
Secondary outcomes:
measure: Presence of reccurent infections
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Xavier Ayrignac, MD
role: STUDY_DIRECTOR
References:
citation: Schindler MK, Pittaluga S, Enose-Akahata Y, Su HC, Rao VK, Rump A, Jacobson S, Cortese I, Reich DS, Uzel G. Haploinsufficiency of immune checkpoint receptor CTLA4 induces a distinct neuroinflammatory disorder. J Clin Invest. 2020 Oct 1;130(10):5551-5561. doi: 10.1172/JCI135947.
citation: Ayrignac X, Goulabchand R, Jeziorski E, Rullier P, Carra-Dalliere C, Lozano C, Portales P, Vincent T, Viallard JF, Menjot de Champfleur N, Rieux-Laucat F, Besnard C, Koenig M, Guissart C, Labauge P, Guilpain P. Two neurologic facets of CTLA4-related haploinsufficiency. Neurol Neuroimmunol Neuroinflamm. 2020 Jun 4;7(4):e751. doi: 10.1212/NXI.0000000000000751. Print 2020 Jul.
citation: Schubert D, Bode C, Kenefeck R, Hou TZ, Wing JB, Kennedy A, Bulashevska A, Petersen BS, Schaffer AA, Gruning BA, Unger S, Frede N, Baumann U, Witte T, Schmidt RE, Dueckers G, Niehues T, Seneviratne S, Kanariou M, Speckmann C, Ehl S, Rensing-Ehl A, Warnatz K, Rakhmanov M, Thimme R, Hasselblatt P, Emmerich F, Cathomen T, Backofen R, Fisch P, Seidl M, May A, Schmitt-Graeff A, Ikemizu S, Salzer U, Franke A, Sakaguchi S, Walker LSK, Sansom DM, Grimbacher B. Autosomal dominant immune dysregulation syndrome in humans with CTLA4 mutations. Nat Med. 2014 Dec;20(12):1410-1416. doi: 10.1038/nm.3746. Epub 2014 Oct 20.