louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06741592: Postoperative Pain in Endodontic Therapy
Official title: The Effect of Different Irrigation Activation Methods Preferred During Root Canal Treatment On Postoperative Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endodontic Disease
Postoperative Pain
Keywords: EDDY
Irrigation Activation
Passive Ultrasonic Irrigation
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the change in postoperative pain in mandibular premolar and first molar teeth with asymptomatic apical periodontitis when using EDDY and passive ultrasonic irrigation activation methods.

The null hypothesis is: "There is no difference in postoperative pain after root canal treatment between the irrigation activation systems in mandibular first molars and premolar teeth."


Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 55 years, medically healthy, and free from systemic diseases.
* Patients without pregnancy or breastfeeding status.
* Patients diagnosed with asymptomatic apical periodontitis confirmed through radiographic and clinical examination.
* Patients not having a regular intake of analgesic or anti-inflammatory drugs within the last 12 hours.
* Patients lacking a history of drug allergies.
* Teeth free from calcifications, resorptions, periodontal problems, incomplete root development, a history of endodontic treatment, traumatic occlusion, or severe coronal destruction.
* Teeth with a root canal curvature of 5° or less.
* Mandibular premolars and first molars.

Exclusion Criteria:

* Teeth where the apical area could not be reached with a #8K file.
* Teeth with an apical diameter larger than #20K file.
* Patients with a Periapical Index (PAI) score of 1 or 2.
* Teeth having extra canals.
* Teeth requiring a second local anesthesia during treatment.
* Teeth where a file fractured within the canal during preparation.
* Vital teeth.
* Patients reporting preoperative pain.
* Teeth showing clinical symptoms such as percussion or palpation sensitivity.
* Teeth with persistent purulent discharge.

Primary outcomes:
measure: Postoperative Pain
timeFrame: 8th hour
measure: Postoperative Pain
timeFrame: 12th hour
measure: Postoperative Pain
timeFrame: 24th hour
measure: Postoperative Pain
timeFrame: 48th hour
measure: Postoperative Pain
timeFrame: 7th day
Secondary outcomes:
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Ordu University
state: Karadeniz
Study officials:
affiliation: Ordu University, Faculty of Dentistry, Department of Endodontics
name: Seca MUTLU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01782092: Activator and Type II Diabetics
Official title: Effect of Activator Methods Technique on Lowering A1c Levels in Type II Diabetics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type II Diabetes
Keywords: diabetes
Lead sponsor: Life University
Sponsor class: OTHER
First posted: 2013-02-01
Enrollment: 5
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be eligible to participate in the study if they are between the ages of 30-60 and are clinically diagnosed with Type II diabetes by their primary care providers or endocrinologists (diagnosis usually based on FPG \> 126 mg/dL on two occasions). Participants must have been diagnosed for at least one year and currently be under medical supervision for the disease. They must also have an A1c measurement above 7%, which indicates less than optimal management of the disease.

Brief summary: The purpose of this study (15-subject prospective case series) is to examine the effects of the Activator Methods technique on decreasing A1c levels in patients with type II Diabetes Mellitus (aka adult-onset diabetes).


Eligibility criteria: Inclusion Criteria:

* Subjects will be eligible to participate in the study if they are between the ages of 30-60 and are clinically diagnosed with Type II diabetes by their primary care providers or endocrinologists (diagnosis usually based on FPG \> 126 mg/dL on two occasions).
* Participants must have been diagnosed for at least one year and currently be under medical supervision for the disease.
* They must also have an A1c measurement above 7%, which indicates less than optimal management of the disease.

Exclusion Criteria:

* The study will exclude pregnant women;
* those with co-morbidities affecting life expectancy (e.g. malignancy, CVD); uncontrolled hypertension (\> 150/100 mmHg);
* serious trauma (e.g. MVA) within the previous 12 months;
* diagnosed bleeding/clotting disorders; those currently under chiropractic care or having contraindications to Activator care (e.g. vertebral fracture, infection, active inflammatory arthritis, severe osteoporosis).

The presence of these exclusions will be determined during the history and exam procedures. All female subjects will be asked to take precautions during their participation in the study to avoid becoming pregnant.

Primary outcomes:
measure: Lowered A1C Levels
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marietta
country: United States
facility: Life University
state: Georgia
Study officials:
References:
Clinical trial NCT02142192: Natalizumab Subcutaneous Immunogenicity and Safety Study
Official title: A Multicenter, Open-Label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Relapsing Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2014-05-20
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the immunogenicity of natalizumab (BG00002) 300 mg subcutaneous (SC) administered to participants with relapsing multiple sclerosis (RMS). The secondary objectives of the study are to evaluate the safety of natalizumab SC injections and to evaluate the efficacy of natalizumab SC injections on relapses and on new magnetic resonance imaging (MRI) lesions.


Eligibility criteria: Key Inclusion Criteria:

* Must have documented diagnosis of RMS at screening.
* Must fall within the therapeutic indications stated in the locally approved label for natalizumab.
* Must have an EDSS score from 0 to 6.5, inclusive.

Key Exclusion Criteria:

* Any prior use of natalizumab.
* Positive for anti-natalizumab antibodies at screening.
* Treatment with immunomodulatory injections (including IFN-β and glatiramer acetate) within 2 weeks prior to Screening.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Proportion of participants with persistent anti-natalizumab antibodies
timeFrame: 48 weeks
Secondary outcomes:
measure: Proportion of participants with transient anti-natalizumab antibodies
timeFrame: 48 weeks
measure: Proportion of participants with post-injection adverse events (AEs)
timeFrame: 48 weeks
measure: Proportion of participants with clinical relapse
timeFrame: 48 weeks
measure: Proportion of participants with gadolinium (Gd) enhancing lesion(s) as assessed by MRI.
timeFrame: 48 weeks
measure: Proportion of Participants that experience Adverse Events and Serious Adverse Events
timeFrame: up to 56 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06805292: Evaluation of Acacia Catechu and Low-Level Laser in the Treatmentof Stage II Periodontitis
Official title: Evaluation of Acacia Catechu and Low-Level Laser in the Treatment of Stage II Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Keywords: Chronic periodontitis
Herbal Medicine
Low Level Laser Therapy
Adjunctive therapy
Acacia catechu
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2025-02-03
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of Acacia catechu and Low-Level Laser in the Treatment of Stage 2 Periodontitis.

Detailed description: * Assess the effectiveness of A. catechu gel (local delivery) adjunctive to non surgical therapy in the treatment of stage chronic periodontitis. Clinical and biochemical evaluation.
* Compare the effectiveness of A. catechu gel (local delivery) and low-level laser adjunctive to non-surgical therapy in the treatment of stage chronic periodontitis.

Clinical and biochemical evaluation.

Eligibility criteria: Inclusion Criteria:

1. Motivated patient with good oral hygiene.
2. Age ranges from (30-50) years.
3. Free from any systemic disease according to the Cornell Medical Index (16).

Exclusion Criteria:

1. Patients who received periodontal treatment over the 12 months preceding the study.
2. Patients who consumed antibiotics or anti-inflammatory drugs within the last 3 months.
3. Previous or current radiation or immunosuppressive therapies.
4. Pregnant \& lactating women.
5. Patient with orthodontic appliances. Or having partial dentures.
6. Patient with parafunctional habits.

Primary outcomes:
measure: inflammatory biomarker
timeFrame: 0 and 6 month evaluation
measure: Antioxidant biomarker
timeFrame: 0 and 6 month evaluation
Secondary outcomes:
measure: gingival index
timeFrame: 0,1,3,6 month evaluation
measure: clinical attachment level or loss
timeFrame: 0,1,3,6 month evaluation
measure: plaque index
timeFrame: 0,1,3,6 month evaluation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mona Mansour
city: Cairo
country: Egypt
facility: Mona Mansour
Study officials:
affiliation: Al-Azhar University
name: Abeer Gawish, professor
role: STUDY_DIRECTOR
affiliation: Al-Azhar University
name: mostafa hegazy, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05125692: Vaginal Repair of Post Cesarean Istmocele
Official title: Vaginal Repair of Symptomatic Postcesarean Isthmocele: Evaluating A Simple Novel Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Disease
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: WOMEN IN CHILDBEARING PERIOD WITH SYMPTOMATIC POSTCESAREAN ISTHMOCELE
Primary purpose: TREATMENT

Brief summary: 20 WOMEN WITH SYMPTOMATIC POSTCESAREAN ISTHMOCELE (NICHE) WILL BE RECRUITED EVALUATED AND SUBJECTED TO A VAGINAL REPAIR OF THE DEFECT, RESULTS WILL BE ANALYZED.

Detailed description: METHODS:

* Subjects: women in childbearing period with abnormal uterine bleeding or infertility attributed to post cesarean isthmocele (sample size to be calculated)
* Preoperative evaluation: transvaginal ultrasound to exclude any other uterine or adnexal pathology, and to measure:

  1. Distance from the external cervical os to the lower end of the isthmocele (A)
  2. Distance from the external cervical os to the upper end of the isthmocele(B)
  3. Length of the isthmocele (B-A)
  4. Residual myometrial thickness (the least) of the isthmocele.
* Routine preoperative workup.
* The technique:

  * Postmenstrual
  * Spinal anesthesia
  * Sterilization of the perineum and vagina
  * Cervical dilation up to 8mm using Hegar's dilators
  * Marking the previously measured points A \& B
  * Making 2 transverse incisions, one 5mm below A and the other 5 mm above B.
  * The rectangular area between the 2 incisions is excised while the Hegar's dilator number 8 in in situ.
  * Hemostasis is performed using diathermy.
  * The upper and lower edges of the incision are approximated using number 2/0 vicryl on cutting needle taking 3 to 4 interrupted sutures
* The patients with uneventful postoperative course are discharged from hospital after 8 hours with doxycycline 100 mg bid for 5 days.
* Sexual intercourse is avoided for 4 weeks postoperative
* postoperative transvaginal ultrasound follow up; at 1 month postoperative.
* Data will be statistically analyzed and results will be tabulated.

Eligibility criteria: Inclusion Criteria:

* women diagnosed with symptomatic post cesarean isthmocele.
* should present with abnormal uterine bleeding .

Exclusion Criteria:

* presence of any other uterine pathology,
* presence of adnexal pathology,
* presence of malignancies,
* presence of pregnancy,
* presence of infection in the lower genital tract ,
* general cause of bleeding
* women not accepting the procedure,
* women not consented

Primary outcomes:
measure: myometrial thickness in supracervical area
timeFrame: at 1 month postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals
state: Dakahlya Governorate
Study officials:
References:
Clinical trial NCT00599092: Pituitary Tumor Surveillance: Pathogenic Correlation
Official title: Pituitary Tumor Surveillance: Pathogenetic Correlation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pituitary Tumor
Keywords: pituitary tumor
recurrence
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2008-01-23
Enrollment: 1250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: tertiary referral center

Brief summary: The purpose of this study is to observe predictors of pituitary tumor recurrence and markers of persistent disease activity in patients harboring pituitary mass lesions of all types.

Detailed description: The purpose of this study is to observe predictors of pituitary tumor recurrence and markers of persistent disease activity through computerized collection of comprehensive demographic, therapeutic, pathologic and outcome information on patients harboring pituitary mass lesions of all types.

Eligibility criteria: Inclusion Criteria:

* patients with confirmed pituitary disease

Exclusion Criteria:

* patients who do not have confirmed pituitary disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center, Pituitary Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center, Pituitary Center
name: Shlomo Melmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05730192: EAGLE Trial CADDIE Artificial Intelligence Endoscopy
Official title: Evaluation of Artificial Intelligence for Detection of Gastrointestinal Lesions in Endoscopy (EAGLE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Polyp of Colon
Adenoma Colon
Keywords: Screening
Surveillance
Artificial Intelligence
Colonoscopy
Lead sponsor: Odin Medical
Sponsor class: INDUSTRY
Collaborators: name: Meditrial Europe Ltd.
First posted: 2023-02-15
Enrollment: 985
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel trial design
Primary purpose: DIAGNOSTIC

Brief summary: The EAGLE study is a prospective randomized controlled multicenter parallel design trial, for the assessment of clinical performance of the CADDIE device and to confirm that the device performs as expected.

Detailed description: The EAGLE study will be conducted with a parallel design. Patients who meet the study inclusion/exclusion criteria will be randomized in a 1:1 ratio to receive either computer-aided colonoscopy (CADDIE Arm) using CADDIE or standard colonoscopy without CADe (Control Arm). All resected polyps will be submitted for histologic examination.

Eligibility criteria: Inclusion Criteria:

1. Screening or surveillance colonoscopy
2. Age 40 years or older
3. Informed consent

Exclusion Criteria:

1. Emergency colonoscopies
2. Inflammatory bowel disease (IBD)
3. Colorectal Cancer (CRC)
4. Previous Colorectal Cancer (CRC)
5. Previous colonic resection
6. Returning for a planned elective therapeutic colonoscopy.
7. Polyposis syndromes (familial adenomatous polyposis)
8. Contraindication for biopsy or polypectomy.

Primary outcomes:
measure: Number of Adenoma per colonoscopy (APC)
timeFrame: During the procedure/surgery
measure: Positive percent agreement (PPA)
timeFrame: During the procedure/surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Israeli-Georgian Medical Research Clinic Healthycore
city: Berlin
country: Germany
facility: Sana Klinikum Lichtenberg
city: Castellanza
country: Italy
facility: Humanitas Mater Domini
state: Varese
city: Catania
country: Italy
facility: Humanitas Catania
city: Milan
country: Italy
facility: Humanitas Research Hospital
city: Tychy
country: Poland
facility: H-T. Centrum Medyczne
city: Warsaw
country: Poland
facility: The Maria Sklodowska-Curie National Research Institute of Oncology
city: Warsaw
country: Poland
facility: Przychodnia Polskiej Fundacji Gastroenterologii
city: Zaragoza
country: Spain
facility: University Hospital "Clinico Lozano Blesa" of Zaragoza
Study officials:
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Alessandro Repici, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00333892: Leukapheresis to Obtain Lymphocytes for Studies on Antiretroviral Naive HIV-infected Patients
Official title: Leukapheresis Procedures to Obtain Lymphocytes for Research Studies on Antiretroviral Naive HIV-infected Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Keywords: primary HIV infection
chronic HIV infection
Lead sponsor: Canadian Immunodeficiency Research Collaborative
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2006-06-06
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HIV-infected adults who have a positive ELISA and a confirmatory western blot HIV test.

Brief summary: To further investigate differences in the immunologic function of various lymphocyte subsets in HIV-infected patients who are treated early in their infection and during the chronic phase of the infection. Studies will also be done to further delineate the various antigen-specific and innate immune responses including characterization of soluble factors associated with primary HIV infection.

Detailed description: Primary HIV-1 infected and chronically infected individuals will be recruited and leukapheresis will be performed. This one year study requires that patients be apheresed once before initiating therapy and on two other occasions (at month 6 and month 12) after suppression of plasma viremia. Peripheral blood mononuclear cells will be isolated by sodium diatrizoate density centrifugation and subjected to immunologic and virologic studies.

Eligibility criteria: Inclusion Criteria:

* Adult HIV-1 infected patient
* For primary infected patients anyone with an exposure to a known source of HIV infected material or individual, with symptoms and signs if present consistent with primary HIV infection, a negative ELISA, indeterminate Western blot for HIV and a positive HIV plasma RNA levels \> 10,000 copies/mL by either RT-PCR or bDNA
* Chronic HIV-infected patients should have a positive ELISA and a confirmatory western blot and willingness to give informed consent for the storage of blood.
* Willingness to be able to make follow-up visits for apheresis at 6 and 12 months for those who undergo antiretroviral therapy

Exclusion Criteria:

* Pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Toronto
name: Mario Ostrowski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02484989: UK Surveillance of Treated Retinopathy of Prematurity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinopathy of Prematurity
Lead sponsor: Moorfields Eye Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 270
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Babies with retinopathy

Brief summary: Currently, there is little recent data on regional variations in treatment methods, neonatal units that provide retinopathy (ROP) treatment, facilities for treatment available at each unit including anaesthetic support for such preterm babies, facilities to transfer babies to units that offer treatment etc. While some parts of the UK have established neonatal networks and agreements among units for ROP treatment, in other parts, such arrangements are illdefined.

The number of babies needing ROP treatment may be higher since the introduction of revised guidelines in 2008 as earlier treatment has been shown to be beneficial. Collecting epidemiological data through the British Ophthalmic Surveillance Unit (BOSU) on the incidence of treatable ROP, the treatment methods used and facilities for treatment will provide the foundation for effective planning of resources and manpower to deal with the additional demand.


Eligibility criteria: Inclusion Criteria:

* Any baby with ROP who is treated or referred to another unit for treatment either in the form of laser therapy, cryotherapy, antiVEGF agent or vitrectomy/scleral buckling (or a combination of above treatments)

Exclusion Criteria:

* None; we will monitor data to exclude duplication of cases which may arise from children being transferred between neonatal units or consultants

Primary outcomes:
measure: Incidence of babies requiring treatment for retinopathy of prematurity in the UK
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
Study officials:
affiliation: Moorfields Eye Hospital NHS Foundation Trust
name: Annegret Dahlmann-Noor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adams GG, Bunce C, Xing W, Butler L, Long V, Reddy A, Dahlmann-Noor AH. Treatment trends for retinopathy of prematurity in the UK: active surveillance study of infants at risk. BMJ Open. 2017 Mar 21;7(3):e013366. doi: 10.1136/bmjopen-2016-013366.