louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05102318: Clinical and Radiographic Evaluation of Mineral Trioxide Aggregate and Biodentine as Pulp Medicaments in Primary Molars
Official title: Clinical and Radiographic Evaluation of Mineral Trioxide Aggregate and Biodentine as Pulp Medicaments in Primary Molars
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulp Disease, Dental
Keywords: Direct pulp capping, Partial Pulpotomy, and Pulpotomy
Lead sponsor: British University In Egypt
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2021-11-01
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to evaluate Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars.

Detailed description: Screening of patients will continue until the target population is achieved. Identifying and recruiting potential subjects is achieved through patient database in Pediatric Dentistry department.

A total of 150 primary molars from healthy subjects will be selected from the Pediatric Dentistry and Dental Public Health outpatient clinic, Faculty of Dentistry, Ain shams University.

Subjects will be assigned randomly into two different treatment groups as follows:

MTA Group (1):

1. Group 1(A): MTA Direct Pulp Capping. (n=25)
2. Group 1 (B): MTA Partial Pulpotomy. (n=25)
3. Group 1 (C): MTA Complete Pulpotomy. (n=25)

BiodentineTM Group (2):

1. Group 2(A): BiodentineTM Direct Pulp Capping. (n=25)
2. Group 2 (B): BiodentineTM Partial Pulpotomy. (n=25)
3. Group 2 (C): BiodentineTM Complete Pulpotomy. (n=25)

Eligibility criteria: Inclusion Criteria:

* No clinical symptoms or history implying irreversible pulpitis such as spontaneous pain, or pain persisting after stimuli removal.
* Absence of periapical or interadicular radiolucencies, inflammatory root resorption, sinus tract or gingival abscess.

Exclusion Criteria:

* Children who are extremely uncooperative and difficult to manage.
* Children suffering from any physically or mentally disability that will complicate the treatment: Special Health Care needs (SHCN).
* Teeth of poor prognosis due to presence of an abscess or a sinus, mobility, advanced bone or root resorption or Non-Restorable teeth.

Primary outcomes:
measure: Is to evaluate the clinical and radiographic success rates of Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: British University In Egypt
name: Noha Kabil, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00476918: Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema
Official title: Dosage Dependency of Intravitreal Triamcinolone Acetonide for Treatment of Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diabetic Retinopathy
Diabetic Macular Edema
Keywords: diabetic macular edema
triamcinolone acetonide
intravitreal
steroid
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2007-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Efficacy duration of triamcinolone acetonide (steroid) for treatment of diabetic macular edema. Furthermore, dosage dependency of triamcinolone acetonide comparing a high dosage versus a low dosage.

Detailed description: Patients with diabetic retinopathy suffer from visual acuity loss caused by diabetic macular edema. Intravitreal injected Triamcinolone Acetonide (steroid) reduces macular edema and increases visual acuity. The duration of its effect is however limited. Therefore, several injections are necessary.

In this study a dosage dependency of triamcinolone acetonide (high dosage vs low dosage) is performed. The primary outcome parameters are the number of treatments and the efficacy of each injection.

Eligibility criteria: Inclusion Criteria:

* diabetic macular edema and visual acuity between 20/200 and 20/40 age over 18 years

Exclusion Criteria:

* recent treatment with laser photocoagulation or intravitreal drugs

Primary outcomes:
measure: Visual acuity, no of treatments, duration of efficacy
timeFrame: 12 months
Secondary outcomes:
measure: intraocular pressure, retinal thickness
timeFrame: 12 months
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Dep of Ophthalmology, University of Mannheim
Study officials:
affiliation: Dep of Ophthalmology, University of Mannheim
name: Jost Jonas, PhD MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00319618: Combination Weekly Taxotere™ With Iressa™ /Placebo in Metastatic Breast Cancer
Official title: A Randomised Phase II Study: Treatment With Daily p.o. Iressa™ (ZD1839) or Placebo in Combination With Weekly IV Infusion of Docetaxel in Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if combination therapy of weekly Taxotere™ with Iressa™ will increase the objective responses in measurable leasions in metastatic breast cancer


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed mammary carcinoma

Exclusion Criteria:

* prior taxane chemotherapy for metastatic disease or prior treatment with tyrosine kinase inhibitors inhibiting the EGF receptor.
* Prior hormone treatment or one type of anthracycline based treatment regimen without taxane for metastatic disease is allowed prior to inclusion.
* If the patient has been treated in the adjuvant or neoadjuvant setting with taxanes, inclusion is allowed when the first cycle of trial medication is started 12 months after the last course of adjuvant treatment

Primary outcomes:
measure: Objective tumour response (CR + PR) per RECIST criteria
Secondary outcomes:
measure: Time to progression and response duration
measure: Exploratory outcomes: Objective tumour response in relation to ER, PgR, erb-B1 and erb-B2 receptor status and reduction in the number of malignant cells present in bone marrow
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Norway Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04627818: Diagnostic, Therapeutic and Reproductive Aspects of Patients with Mullerian Anomalies
Official title: Diagnostic, Therapeutic and Reproductive Aspects of Patients with Mullerian Anomalies: a Prospective Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mullerian Anomaly of Uterus, Nec
Mullerian Anomaly of Vagina
Mullerian Anomaly of Cervix
Keywords: Mullerian anomaly
Diagnostic tools
Surgical treatment
Reproductive function
Obstetric complications
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 1500
Sex: FEMALE
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diagnosed and/or treated in the Ghent University Hospital

Brief summary: The purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian anomalies.

Detailed description: Mullerian anomalies are rare, therefore they are not well known and not often considered as differential diagnosis. This causes a delay in the diagnosis with risk of long lasting symptoms and adverse effects on the reproductive function. However, the diagnosis can be made more accurately with improved diagnostic tools. Moreover, minimally invasive surgery allows for preservation and potential improvement of fertility in these women.

The purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian anomalies.

Eligibility criteria: Inclusion Criteria:

* women with a uterus
* presence of a mullerian variation
* Maximum age 45y

Exclusion Criteria:

* women without a uterus
* aged \>45y

Primary outcomes:
measure: Fertility
timeFrame: 10 years after trying to conceive
measure: Fertility
timeFrame: 18 weeks after conception
measure: Surgical approach
timeFrame: During surgery
measure: Surgical success
timeFrame: 15 years after surgery
Secondary outcomes:
measure: Diagnostic accuracy
timeFrame: at the time of diagnostic workup
measure: Obstetric complications
timeFrame: 1 year after conception
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University hospital
Study officials:
affiliation: University Hospital, Ghent
name: Tjalina Hamerlynck
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01514318: Encore Revelation Hip Stem
Official title: A Long-term Follow Up Study of the Revelation™ Hip Stem
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Hip
Complications; Arthroplasty
Lead sponsor: Encore Medical, L.P.
Sponsor class: INDUSTRY
Collaborators: name: DJO Incorporated
First posted: 2012-01-23
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include only subjects who received the Revelation Hip Stem prior to 2002 and who voluntarily consent to take part in this study.

Brief summary: The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the Revelation Hip Stem prior to 2002.


Eligibility criteria: Inclusion Criteria:

* Subjects must have received the Revelation™ Hip Stem as part of a total hip arthroplasty prior to 2002.
* Surgery must have been a primary total hip replacement
* Subject must have received only one primary hip replacement per hospitalization
* Subject must have had a diagnosis of inflammatory tissue disorder, osteoarthritis, post-traumatic arthritis/secondary arthritis or avascular necrosis
* Subject must be willing and able to sign the informed consent document

Exclusion Criteria:

* Subject must not have had any previous hip implants (hemi or total joint)
* Subject has a mental condition that may interfere with the ability to give an informed consent (i.e., severe mental retardation such that the subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
* Subject is a prisoner
* Subject is pregnant

Primary outcomes:
measure: Survivorship of the Device
timeFrame: 10 year
Secondary outcomes:
measure: Western Ontario McMaster Arthritis Index (WOMAC)
timeFrame: 10 year
measure: Harris Hip Score
timeFrame: 10 year
Other outcomes:
Locations:
city: Austin
country: United States
facility: Westlake Orthopaedics Spine & Sports
state: Texas
Study officials:
affiliation: Westlake Orthopaedics Spine & Sports
name: Frosty Moore, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05232318: Root Resorption Accompanied Clear Aligners and Fixed Orthodontic Appliance
Official title: Apical Root Resorption Accompanied Orthodontic Treatment Using Clear Aligners Versus Fixed Appliances: A CBCT Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Root Resorption
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare apical root resorption accompanied orthodontic treatment using clear aligners vs fixed appliances.

Detailed description: by using pretreatment and posttreatment CBCT, root resorption will be measured using a 3D imaging software.

Eligibility criteria: Inclusion Criteria:

* Healthy systemic condition/no systemic illness, as reported by patients.
* No use any form of anti - inflammatory drugs the at beginning of study.
* Good oral hygiene.
* Cooperative and motivated.
* In the permanent dentition with all teeth present ( except third molars).
* Minimum to moderate anterior crowding.
* No previous orthodontic treatment.

Exclusion Criteria:

* Previous upper removable orthodontic treatment.
* Patients who required surgery to correct skeletal discrepancies.
* Patients with hyperdontia, hypodontia, or syndromic diseases (e.g. cleft lip and palate).
* Uncooperative patients.
* Patients with poor oral hygiene.

Primary outcomes:
measure: Amount of Root resorption
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AlAzhar Azhar University
state: Or
city: Cairo
country: Egypt
facility: Al Azhar university
Study officials:
affiliation: Lecturer, Department of Orthodontics
name: Ahmed M Abouelnour, Lecturer
role: STUDY_DIRECTOR
affiliation: Associate professor, Department of Orthodontics
name: Ramadan Y Aboushahba, Associate professor
role: STUDY_CHAIR
References:
Clinical trial NCT03381118: Haploidentical Lymphocytes With Nivolumab/Ara-C as Consolidation in Elderly AML Patients
Official title: A Randomized Study of Haploidentical Lymphocytes With Nivolumab and Intermediate Dose Cytarabine Versus Nivolumab and Intermediate Dose Cytarabine as Consolidation Treatment in Older Adults With Acute Myeloid Leukemia.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 16
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A phase II trial to compare the efficacy and safety of nivolumab and intermediate dose cytarabine with or without haploidentical lymphocyte infusion. To identify the role of haploidentical lymphocytes in the treatment of acute myeloid leukemia in older adults. The patients will be stratified based on the remission number (first or second)


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of acute myeloid leukemia with the confirmed first or second complete remission
* ≥ 55 years of age
* Not candidates for allogeneic stem cell transplantation as decided by the panel of hematologists at the transplant center
* Patients with a HLA-haploidentical donor who should be able to provide informed consent for peripheral blood apheresis
* No severe concurrent illness that limits life expectancy to less than 2 years

Exclusion Criteria:

* Uncontrolled bacterial or fungal infection at the time of enrollment
* Karnofsky index \<70%
* Acute promyelocytic leukemia
* Other tumor requiring treatment at the time of enrollment
* Active or prior documented autoimmune disease requiring systemic treatment
* Somatic or psychiatric disorder making the patient unable to sign informed consent

Primary outcomes:
measure: Disease-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Incidence of graft-versus-host disease
timeFrame: up to 12 months
measure: Treatment-related adverse events as assessed by CTCAE v4.03
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Boris V Afanasyev, MD, Prof.
Study officials:
References:
Clinical trial NCT04196218: Driving After Shoulder Surgery
Official title: Driving After Arthroscopic Rotator Cuff Repair or Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Shoulder
Lead sponsor: The Hawkins Foundation
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patients undergoing a shoulder arthroplasty or rotator cuff repair will be enrolled in the study. Patients will be asked to undergo driving simulator assessments post-operatively in ATI Physical Therapy for up to 12 weeks after surgery in order to determine when it may be safe for them to return to driving. Additional assessments include patient-reported outcomes, range of motion, and strength measures, which are all standard of care. Study participation concludes when the patient passes the driving simulator test.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing either Rotator Cuff Repair or Shoulder arthroplasty from participating surgeon
2. Patients receiving physical therapy from ATI Patewood clinic
3. Must be able and willing to complete all study assessments and to be followed for the full course of the study.
4. Must be able to read, write and follow instructions in English.
5. In the opinion of the investigator, is that they subject is competent to participate in study activities
6. Prior to injury, patient was routinely driving.

Exclusion Criteria:

1. Prior shoulder surgery in the last 90 day
2. Individuals with a history of any underlying neurological conditions

Primary outcomes:
measure: Driving Assessment
timeFrame: surgery through 12 weeks post-op
Secondary outcomes:
measure: Range of Motion
timeFrame: surgery through 12 weeks post-op
measure: Strength
timeFrame: surgery through 12 weeks post-op
measure: Visual Analog Pain Score
timeFrame: surgery through 12 weeks post-op
measure: Single Alpha Numeric Evaluation of the shoulder
timeFrame: surgery through 12 weeks post-op
measure: Veterans Rand 12 Item Health Survey
timeFrame: surgery through 12 weeks post-op
measure: Brief Resilience Scale
timeFrame: surgery through 12 weeks post-op
measure: Shoulder function
timeFrame: surgery through 12 weeks post-op
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00673218: The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils
Official title: The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Allergy
Keywords: IL13
Cytokines
Basophil stimulation
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2008-05-07
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: If you are allergic to ragweed, and not taking certain medications, you will be asked to have blood drawn. We will perform experiments on your blood cells.

Detailed description: Adult ragweed allergic subjects will have blood drawn. Basophils will be enriched and stimulated with allergen and controls. Supernatants from these stimulations will be assayed for cytokines and histamine.

Eligibility criteria: Inclusion Criteria:

* Ages 19 to 50
* At least 2 year history of ragweed allergic rhinitis
* Positive skin prick tests to ragweed \>5 mm wheal diameter
* IgE \<700 iU/m

Exclusion Criteria:

* Use of prohibited medications (e.g. antihistamine in past 7 days and topical or oral corticosteroids in past 1 month, beta-agonist or theophylline for 2 days.
* History of immunotherapy in the past 2 years
* Exposure to Omalizumab in the past 2 years
* Clinically significant non-allergic or perennial rhinitis to avoid mediator release due to environmental allergens
* Asthma other than mild intermittent
* Women of childbearing potential who are not on an accepted form of birth control, as well as women who are breastfeeding
* Known sensitivity to study drug Xolair
* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
* Patients with a previous history of cancer
* Use of any other investigational agent in the last 30 days

Primary outcomes:
measure: Basophil histamine release
timeFrame: After 4 weeks treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Robert G Townley, MD
role: PRINCIPAL_INVESTIGATOR
References: