louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07004465: Effectiveness of Vitamin b12 Versus Kenalog on Traumatic Ulcer Associated With Orthodontic Treatment
Official title: Effectiveness of Vitamin b12 Versus Kenalog in Orabase on Traumatic Ulcer Associated With Orthodontic Treatment: Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mouth Ulcer
Lead sponsor: Karbala University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a randomized controlled trial. the participants will be equally divided into two groups to compare the clinical effectiveness of vitamin b12 versus kenalog in treatment of traumatic ulcers associated with orthodontic treatment during

Detailed description: Recurrent aphthous stomatitis (RAS), commonly called "canker sores," is a perplexing oral condition characterized by the recurrent development of painful aphthous ulcers on non-keratinized oral mucous membranes. Recurrent aphthous stomatitis is a relatively common condition, affecting up to 25% of the worldwide population. Certain factors predispose to RAS, including local trauma, stress, smoking cessation, anemia, and hematinic deficiency. In the patient who undergoes orthodontic management, there is improvement in the dental and facial aesthetics and development of self-confidence. Data also supports the prevalence of traumatic ulcers in the oral cavity and periodontal diseases. Ulcerations can happen due to brackets, bands, arch wires and long unsupported stretches of wire resting against the lips.

Vitamin B12, also known as Cobalamin, is a water-soluble vitamin primarily found in animal products; plays a vital role in the formation of hematopoietic stem cells and vitaminB12 deficiency may play a role in the pathogenesis of recurring aphthous (RAS). TRIAMCINOLONE (Kenalog in Orabase) treats and relieves discomfort caused by mouth sores. It works by decreasing inflammation in the mouth. It belongs to a group of medications called topical steroids.

Eligibility criteria: Inclusion Criteria:

* Orthodontic adult patients older than 18 years.
* Ulcer due to trauma not more than 10 mm in size.

Exclusion Criteria:

* Patients who had known systemic diseases.
* Concurrent with lesions in the mouth (Bechet's disease, rheumatoid. arthritis, lupus, and acquired immune deficiency syndrome).
* A patient who had received other concurrent treatment for aphthous ulcers.
* Patients with chronic diseases such as liver diseases, rheumatoid arthritis, diabetes, cancer, and renal diseases.
* Pregnant or nursing women.
* Patient who had a known vitamin B12 deficiency.

Primary outcomes:
measure: pain reduction
timeFrame: 8 days
Secondary outcomes:
measure: ulcer size
timeFrame: 8 days
Other outcomes:
Locations:
city: Karbala
country: Iraq
facility: Karbala university
Study officials:
References:
Clinical trial NCT00000265: Subjective Effects of Nitrous Oxide in Dental Patients - 17
Official title: Subjective Effects of Nitrous Oxide in Dental Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: nitrous oxide
anxiety
subjective effects
dental
patients
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study was to characterize mood changes during nitrous oxide inhalation in patients with different levels of preoperative dental anxiety.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Anxiety scale
timeFrame: Before, during, after dental procedure
measure: Mood scale
timeFrame: Before, during, after dental procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago, Anesthesia & Critical Care
state: Illinois
Study officials:
affiliation: University of Chicago
name: James Zacny, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01630265: Caregivers' Knowledge of Emergency Department Discharge Instructions Improves With the Use of Video
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaluation of Video Discharge Instructions in Improving Understanding
Keywords: Discharge Instructions
Video Discharge Instructions
Video
Emergency Department Discharge Instructions
ED Discharge
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 436
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Previous studies demonstrate that patients often have difficulty understanding their discharge instructions. Video discharge instructions have the potential to mitigate factors such as illiteracy and limited physician time, which may affect comprehension. Our goal is to determine if adding video discharge instructions affects caregivers' understanding of their child's emergency department (ED) visit, plan and follow-up.

Detailed description: Caregivers of patients, age 29 days to 18 years, with a diagnosis of fever, vomiting or diarrhea, and wheezing or asthma were randomized into written or video discharge instruction groups. In the ED, caregivers read standard written discharge instructions or watched a 3-minute video based on their child's diagnosis. They were then asked questions regarding information covered in these instructions. After completing the 20-point questionnaire, standard discharge procedure was followed. Caregivers were contacted by phone 2-5 days after discharge for a follow-up questionnaire. Usefulness of the discharge instructions was also assessed.

Eligibility criteria: Inclusion Criteria:

* caregivers of pediatric patients age 29 days to 18 years old diagnosed with wheezing or asthma exacerbation, fever, or vomiting and/or diarrhea.

Exclusion Criteria:

* Caregivers of patients who were critical in the ED,
* Admitted to the hospital, or given an alternate diagnosis prior to discharge were excluded from the study.
* Also, non-English speaking caregivers were excluded.

Primary outcomes:
measure: Knowledge about the child's diagnosis, treatment and follow-up care.
timeFrame: up to 5 days
Secondary outcomes:
measure: Caregiver satisfaction with their discharge instructions
timeFrame: Satisfaction will be assessed at two time points within 5 days of being evaluated in the Emergency Department
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
Study officials:
affiliation: Augusta University
name: Scott A Bloch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bloch SA, Bloch AJ. Using video discharge instructions as an adjunct to standard written instructions improved caregivers' understanding of their child's emergency department visit, plan, and follow-up: a randomized controlled trial. Pediatr Emerg Care. 2013 Jun;29(6):699-704. doi: 10.1097/PEC.0b013e3182955480.
Clinical trial NCT03224065: NTM-LD Treatment Based on GenSeizer Characteristic Gene Capture Strategy
Official title: Randomized, Controlled Clinical Study of Non-tuberculosis Mycobacteria Lung Disease Treatment Based on GenSeizer Characteristic Gene Capture Strategy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non - Tuberculosis Mycobacteria Lung Disease
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 246
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of non - tuberculosis mycobacteria lung disease is challenging. The current treatment used is from 2007 American Thoracic Society guidelines recommended antibiotic combination therapy, which is lack of validation of clinical studies. More and more studies have confirmed that NTM antibiotic resistant gene will affect the efficacy, such as erm(41), rrl to clarithromycin, rrs to amikacin and so on. This study aimed to compare the efficacy of guideline recommended therapy and optimized therapy according to antibiotic susceptibility - related genotype.Genetic testing is accomplished through GenSeizer's high-throughput gene capture technique.


Eligibility criteria: Inclusion Criteria:

* Patients met diagnostic criteria of NTM lung disease by ATS/IDSA on 2007
* non-CF Bronchiectasis

Exclusion Criteria:

* Already on treatment for NTM lung disease
* Appropriate exclusion of other lung diagnosis
* Patients with severe organ dysfunction

Primary outcomes:
measure: Culture conversion rate
timeFrame: up to 18 months
Secondary outcomes:
measure: Initial time of sputum culture conversion
timeFrame: up to 18 months
measure: Chest CT
timeFrame: up to 18 months
measure: Blood routine test
timeFrame: every month, up to 18months
measure: liver function test
timeFrame: every month, up to 18months
measure: kidney function test
timeFrame: every month, up to 18months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Haiqing Chu
Study officials:
References:
Clinical trial NCT03868865: Effects of an Integrative Day-care Clinic Program for Breast Cancer Patients During Chemotherapy
Official title: Effects of an Integrative Day-care Clinic Program for Breast Cancer Patients During Chemotherapy: an Observational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Chemotherapy
Mind-Body-Medicine
Acupuncture
Quality of Life
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study was to evaluate a new integrative day-care clinic concept for breast cancer patients receiving chemotherapy. This is an explorative pilot study. Therefore, all outcomes are analyzed exploratively.


Eligibility criteria: Inclusion Criteria:

* curative malignancy (breast cancer of TNM (T: primary tumor, N: regional nodes, M: metastasis) staging I-III)
* receiving chemotherapy
* at least 18 years old
* written informed consent
* willing and physically/mentally able to participate in a six hours day care clinic program eleven times during chemotherapy.

Exclusion Criteria:

* insufficient knowledge of the German language
* physical or mental disabilities resulting in ineligibility for participation in the program or filling out the questionnaires.

Primary outcomes:
measure: European Organization for Research and Treatment of Cancer (EORTC) QoL questionnaire (QLQ-C30)
timeFrame: up to 26 weeks (depending on chemotherapy regime)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: up to 26 weeks (depending on chemotherapy regime)
measure: Brief Fatigue Inventory (BFI)
timeFrame: up to 26 weeks (depending on chemotherapy regime)
measure: Perceived Stress Scale (PSS)
timeFrame: up to 26 weeks (depending on chemotherapy regime)
measure: Satisfaction with the program
timeFrame: up to 26 weeks (depending on chemotherapy regime)
measure: Patients and numbers of adverse events
timeFrame: up to 26 weeks (depending on chemotherapy regime)
Secondary outcomes:
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
state: NRW
Study officials:
References:
Clinical trial NCT03663465: The Effect of Hawthorn on Lipoprotein Cholesterol Ratio in Schizophrenics With Antipsychotics
Official title: The Disparity of Hawthorn Effects to Triglyceride/High-density Lipoprotein Cholesterol Ratio in Schizophrenics With Antipsychotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Hawthorn
TG/HDL ratio
dyslipidemia
schizophrenia
antipsychotics
Lead sponsor: Calo Psychiatric Center
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 135
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: case control study
Primary purpose: PREVENTION

Brief summary: Importance: The problems of side effects of metabolic disturbances in schizophrenic patients have been of worldwide concern for some time. Patients with dyslipidemia have an increased risk of cardiovascular diseases. A Chinese herb, Hawthorn, is widely used for the treatment of dyslipidemia.

Objective: Therefore, this study aimed to investigate the effect of Hawthorn on lipid profile levels in schizophrenic patients treated with antipsychotics.

Design, Setting, and Participants: A longitudinal case-control study was used in a general hospital in Taiwan. A total of 59 schizophrenics treated with antipsychotics, and 76 healthy adult subjects, who were all hospital workers, were enrolled in this study.

Main outcomes and measures: All participants received Hawthorn at a dose of 3 gm/day for six months.

Detailed description: The problem of metabolic disturbances in schizophrenic patients who take antipsychotics has always been a cause for global concern and discussion. Although Hawthorn is widely used in the treatment of heart problems and the lowering of blood lipid levels, it is unknown whether Hawthorn has an effect in schizophrenic patients treated with antipsychotics. Hence, there are several areas of interest in the present study: 1) the effect of Hawthorn on lipid profile levels in schizophrenic patients treated with antipsychotics; 2) a comparison of lipid profile levels between schizophrenic patients and healthy adults; 3) the contributing factors that relate to changes in lipid profile levels in patients who take Hawthorn.

Eligibility criteria: Inclusion Criteria:

* Patients in case group who had to meet the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
* All participants in the case group had previously received antipsychotic treatment for a period of time.

Exclusion Criteria:

* Patients who had comorbid serious medical illnesses, and may therefore present substantial clinical risk due to pharmacotherapy, were excluded from the sample
* Participants were pregnant and lactating women in both group, were excluded.

Primary outcomes:
measure: lipid profiles
timeFrame: three days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01225965: Efficacy and Feasibility of Ectoin® Inhalation Solution in Inflammatory Obstruction and Ageing of the Lung
Official title: An Efficacy and Feasibility Study to Investigate the Effect of Ectoin® Inhalation Solution (EIL) in Subjects With Inflammation and Airway Obstruction Followed by a Long Term Study Extension on the Prevention of Lung Function Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Particulate Matter Induced Inflammation of the Lung
Keywords: Particulate Matter induced inflammation of the lung
Lead sponsor: Bitop AG
Sponsor class: INDUSTRY
First posted: 2010-10-21
Enrollment: 36
Sex: FEMALE
Minimum age (years): 75
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the physical inflammation inhibition effects of EIL (Ectoin-Hydro-Complex) in subjects of the established SALIA-cohort and the preventive effects on lung function decline.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal females (75 - 80 years)
* FEV1/FVC \< 0,77 (in the investigation 2007/2008)
* Inflammatory markers TFN-alpha \> median or neutrophilic granulocytes \> median (investigation 2007/2008)
* Non smokers or ex smokers who have stopped smoking for longer than 6 months

Exclusion Criteria:

* Participation in another clinical study in the previous month
* Severe concomitant disease which may have an impact on the study participation
* Hypersensitivity against Ectoin
* Myocardial infarction or apoplexy within the last year
* Uncontrolled hypertension: systolic blood pressure \>200 mmHg or diastolic pressure \>120 mmHg
* Known aortic aneurysm
* Other respiratory diseases (e.g. cystic fibrosis, alpha-1-Antitrypsin deficiency, sarcoidosis, allergic alveolitis, tuberculosis, etc.)
* Patients who have had treatment with live attenuated vaccinations within 14 days prior to screening visit (Inactivated influenza vaccination is acceptable, provided it is not administered within 7 days prior to screening visit)
* on investigators decision

Primary outcomes:
measure: Reduction of inflammatory markers considered to be indicative for the protective efficacy of EIL in pulmonary inflammation in COPD
timeFrame: Baseline and 28 days after treatment start
Secondary outcomes:
measure: Vital signs
timeFrame: Baseline and 28 days after treatment start
measure: Reduction of lung function decline
timeFrame: Baseline and 28 days after treatment start
measure: Quality of life
timeFrame: Baseline and 28 days after treatment start
measure: Need for rescue medication
timeFrame: 28 days (during treatment phase)
measure: Occurence of adverse events
timeFrame: 28 days (during treatment phase)
measure: Lung function parameters
timeFrame: 28 days (during treatment phase)
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Institut für umweltmedizinische Forschung
Study officials:
References:
Clinical trial NCT03685565: Facial Lacerations Repaired With Dermabond Compared With Dermabond With Underlying Steristrips in Pediatric Patients
Official title: Cosmetic Outcomes of Simple Facial Lacerations Repaired With Dermabond Compared With Dermabond With Underlying Steristrips: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Laceration
Keywords: facial laceration
pediatric
dermabond
skin glue
steristrips
skin adhesive
scar
cosmesis
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 120
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group: Dermabond with underlying steristrips. Control group: Dermabond alone
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare cosmetic outcomes of simple facial lacerations in children repaired with Dermabond (skin glue) compared with Dermabond (skin glue) with underlying steristrips (skin adhesive strips).


Eligibility criteria: Inclusion Criteria:

* Age ≤17 years old
* Presents with simple, linear facial laceration requiring repair
* English or Spanish speaking parents or guardians

Exclusion Criteria:

* Laceration to lips, nose, ear, eyelids, eyebrows
* Laceration requiring multi-layer closure
* Laceration requiring sub-specialty care
* Laceration that has previously been repaired
* Animal/human bites
* Lacerations \>5cm in length
* Allergy to adhesive

Primary outcomes:
measure: Cosmesis
timeFrame: 2 months after repair
Secondary outcomes:
measure: Time to repair laceration
timeFrame: Day 0 (physician will complete just after the repair)
measure: Ease of repair of laceration
timeFrame: Day 0 (physician will complete just after the repair)
measure: Type of analgesia & sedation required
timeFrame: Day 0 (physician will complete just after the repair)
measure: Wound dehiscence
timeFrame: 1 week
measure: Wound infection
timeFrame: 1 week
Other outcomes:
Locations:
city: Austin
country: United States
facility: Dell Children's Hospital
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Erin Munns, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Munns E, Kienstra AJ, Combs PD, Gabriele G, Wilkinson M. Cosmetic Outcomes of Simple Pediatric Facial Lacerations Repaired With Skin Adhesive Compared With Skin Adhesive With Underlying Adhesive Strips: A Randomized Controlled Trial. Pediatr Emerg Care. 2022 Oct 1;38(10):477-480. doi: 10.1097/PEC.0000000000002837. Epub 2022 Aug 26.
Clinical trial NCT02652065: Cutaneous Microcirculation and Nervous Sensitivity in Psoriasis
Official title: Cutaneous Microcirculation and Nervous Sensitivity in Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Keywords: Psoriasis
Microcirculation
TRPV1
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Psoriasis is a chronic inflammatory cutaneous disease, affecting 3% of the French population. Among psoriatic patients, 80% feel pain or cutaneous discomfort related to their pathology.

Neurogenic inflammation's role in psoriasis has recently been put forward by a study showing that TRPV1 ion channels are necessary to establish psoriasiform inflammation in mice.

The investigators hypothesize that there is a link between cutaneous sensory neuropathies and altered cutaneous microcirculation during psoriasis.

In order to test this hypothesis, local vasodilators will be delivered to patients by iontophoresis and their skin blood flow in response to these molecules will be followed by laser Doppler recordings. Two recordings will be performed for each patient, both on a psoriasis plaque and on uninvolved skin, in order for the patient to be his own internal control.


Eligibility criteria: Inclusion Criteria:

* Type I psoriasis
* Psoriasis plaques on the patient's back

Exclusion Criteria:

* BMI \> 25
* Diabetic patient
* Arteriovenous disease history
* Ongoing anti-inflammatory treatment
* Major cardiovascular history (\<3 months)
* Hypertension
* Topical treatment on the back skin (\<7 days)
* Systemic treatment (steroids, methotrexate, retinoids, cyclosporine) or phototherapy (\<1 month)
* Pregnant women
* Subject within exclusion period following a previous or ongoing biomedical study

Primary outcomes:
measure: skin blood flow variation
timeFrame: at the latest 3 months after inclusion
Secondary outcomes:
measure: Sensory detection threshold
timeFrame: at the latest 3 months after inclusion
measure: Potential discomfort sensation thresholds
timeFrame: at the latest 3 months after inclusion
measure: Heat sensitivity
timeFrame: at the latest 3 months after inclusion
Other outcomes:
Locations:
city: LYON cedex 03
country: France
facility: Hôpital Edouard Herriot - Service de Dermatologie et Vénéréologie
Study officials:
References: