louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03679377: Mandibular Slotplates
Official title: Mandibular Slotplates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Craniofacial Abnormalities
Keywords: Orthognathic surgical procedures
Osteosynthesis
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 9
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mandibular slotplates are placed during the osteosynthesis phase of the BSSO surgery. After clinical testing during the surgery the plates are removed and the osteotomy is fixated with bicortical screws.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: A new osteosynthesis system for orthognathic surgery was proposed.This system allows small intra-operative adjustments of the bone fragments during the osteosynthesis phase of the operation (also known as the slot principle). Another possible advantage are the slant screw holes with chamfered ridges allowing easy placements of the screws via the small incision wound without undercuts in between the plate and the screwheads.

Detailed description: Initial slotplates were developed for Le Fort I osteotomies, zygoma 'sandwich 'osteotomies and genioplasties. Those plates allowed for the slot principle to be performed during orthognathic surgery. Mandibular slotplates for bilateral sagittal split osteotomy (BSSO) were recently designed. The aim of the study is to evaluate their clinical usefulness and the applicability of the slot principle with these plates in BSSO.

Eligibility criteria: Inclusion Criteria:

• Patients undergoing single osteotomy BSSO surgery

Exclusion Criteria:

• Concomitant surgeries at the same time.

Primary outcomes:
measure: Feasebility of the slotprinciple
timeFrame: during surgery
measure: Inclination of the screws
timeFrame: during surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: universitair Ziekenhuis Brussel
state: Vlaams Brabant
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Brandaan Zigterman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Maurice Mommaerts, Prof Mult
role: STUDY_DIRECTOR
References:
Clinical trial NCT03613077: A Non-Interventional Study to Document the Use of Straumann BLX Implants in Daily Dental Practice
Official title: A Non-Interventional Study to Document the Use of Straumann BLX Implants in Daily Dental Practice
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Surgical Operation With Implant of Artificial Internal Device
Keywords: Survival rate
Success rate
Straumann® BLX Implant Roxolid® SLActive®,
Lead sponsor: Institut Straumann AG
Sponsor class: INDUSTRY
First posted: 2018-08-02
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients seeking an implant supported restoration

Brief summary: Prospective, multi-center, non-interventional observation to document the success and survival rates of Straumann BLX Implants used for tooth replacement in cleared indications up to 1 year after implant placement

Detailed description: Objective of the study is to confirm the safety and performance of Straumann BLX Implants used for tooth replacement in cleared indications up to 12 months after implant placement. Implants used are Straumann® BLX Implant Roxolid® SLActive®. Regular Base (3.5 mm): implant diameters 3.75 and 4.5mm, in lengths 6, 8, 10, 12,14, 16 and 18 mm Wide Base (4.5 mm): diameter 5.5 mm in lengths 6, 8, 10 and 12 mm

Eligibility criteria: Inclusion Criteria:

* Patients seeking an implant supported restoration
* all patients with conditions that are in accordance with the IFU
* Patients must provide their informed consent for study participation and must be willing and able to attend control visits
* Patients need to be at least 18 years old

Exclusion Criteria:

-

Primary outcomes:
measure: Implant success rate at one year post implant placement
timeFrame: 12 months follow-up period after implantation
measure: Implant survival rate at one year post implant placement
timeFrame: 12 months follow-up period after implantation
Secondary outcomes:
measure: Prosthetic success at 12 months post implant placement
timeFrame: 12 months follow-up period after implantation
measure: Prosthetic survival at 12 months post implant placement
timeFrame: 12 months follow-up period after implantation
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Mediplus Praxisklinik
Study officials:
affiliation: Mediplus Praxisklinik
name: Christian Walter, Prof. Dr.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05708677: A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB
Official title: A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: RDEB
Lead sponsor: Abeona Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2023-02-01
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with previous EB-101 treatment

Brief summary: A Long-Term Extension Study for Participants Previously Treated with EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Detailed description: This is an open-label, long-term, follow-up study in participants from prior interventional trials involving surgical application of gene-corrected keratinocyte sheets (EB-101) for the treatment of RDEB wound sites. Up to 22 participants will be enrolled in this study, with follow-up through at least 5 years post treatment. Patient-reported outcomes and safety will be assessed throughout the study, and where applicable, compared to Baseline of the preceding interventional EB-101 trial. Upon completion, participants will transfer to an annual monitoring program for additional 10 years of phone visits.

Eligibility criteria: Inclusion Criteria:

* Willing and able to give consent/assent;
* If under the age of 18, guardian(s) is/are willing and able to give consent;
* Prior study treatment with EB-101.

Exclusion Criteria:

* Inability to properly follow protocol as determined by the Principal Investigator

Primary outcomes:
measure: Wound Closure
timeFrame: 5 years
measure: Pain Reduction
timeFrame: 5 years
measure: Itch Severity
timeFrame: 5 years
measure: Zarit Burden Interview
timeFrame: 5 years
measure: Quality of Life
timeFrame: 5 years
measure: Caregiver Global impression of Pain
timeFrame: 5 years
measure: Wound Infection and Adverse Events
timeFrame: 5 years
measure: The number of treatment-emergent adverse events.
timeFrame: 5 years
measure: Serious Adverse Events
timeFrame: 5 years
measure: Incidence of squamous cell carcinoma.
timeFrame: 5 years
measure: Replication-competent retrovirus (RCR) status
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University
state: California
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: Abeona Therapeutics, Inc
name: Angela Iheanacho, MS
role: STUDY_DIRECTOR
affiliation: Abeona Therapeutics, Inc
name: Sarah Abdelwahab, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01627977: Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy
Official title: A Descriptive Study to Evaluate the Effectiveness of the Dye Compound of the Combination of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epiretinal Membrane
Macular Hole
Proliferative Diabetic Retinopathy
Keywords: chromovitrectomy
epiretinal membrane
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-06-26
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to test the efficacy of the combination of dye Lutein, Zeaxanthin and brilliant blue to stain the internal limiting membrane as well as the epiretinal membranes during the Vitrectomy surgery.

Detailed description: Twenty five patients with epiretinal membrane, macular hole or proliferative diabetic retinopathy and indication of vitrectomy surgery will be selected to participate in this study.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years, both gender
* Diagnosis of epiretinal membrane OR macular hole OR proliferative diabetic retinopathy
* Indication of surgical treatment for removal of the epiretinal membrane

Exclusion Criteria:

* Any history of eye disease
* glaucoma
* Eye infection affecting any structure provided eye

Primary outcomes:
measure: Visibility of the membrane after injection of the dye
timeFrame: during the surgery
Secondary outcomes:
measure: Degree of impregnation of the dye
timeFrame: during the surgery
measure: Usefulness of the dye
timeFrame: at the end of surgery
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Depto. of Ophthalmology - Hospital São Paulo - UNIFESP
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Rubens Belfort, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Badaro E, Furlani B, Prazeres J, Maia M, Lima AA, Souza-Martins D, Muccioli C, Lucatto LF, Belfort R Jr. Soluble lutein in combination with brilliant blue as a new dye for chromovitrectomy. Graefes Arch Clin Exp Ophthalmol. 2014 Jul;252(7):1071-8. doi: 10.1007/s00417-013-2539-5. Epub 2014 Jan 19.
Clinical trial NCT00837577: MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104)
Official title: A Phase III, Randomized, Placebo-controlled, Double-blind Clinical Trial and Subsequent Open-label, Extension Clinical Trial to Study the Efficacy and Safety of Addition of Sitagliptin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Voglibose Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-02-05
Enrollment: 133
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The phase III clinical trial examines the efficacy, safety, and tolerability of the addition of MK0431/ONO-5435 to Japanese patients with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on diet/exercise therapy and voglibose monotherapy


Eligibility criteria: Inclusion Criteria:

* Japanese Patients With Type 2 Diabetes Mellitus, Who Have Inadequate Glycemic Control On Diet/Exercise Therapy And Voglibose Monotherapy

Exclusion Criteria:

* Patients Have A History Of Type 1 Diabetes Mellitus

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in 2-hour Postprandial Glucose at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Tajima N, Kadowaki T, Okamoto T, Sato A, Okuyama K, Minamide T, Arjona Ferreira JC. Sitagliptin added to voglibose monotherapy improves glycemic control in patients with type 2 diabetes. J Diabetes Investig. 2013 Nov 27;4(6):595-604. doi: 10.1111/jdi.12116. Epub 2013 Jul 21.
Clinical trial NCT02398877: HPA Axis Activity Due To Early Traumatic Stress and Metabolic Symptoms
Official title: Altered Hypothalamic-Pituitary-Adrenal Axis (HPA-Axis) Activity Due To Early Traumatic Stress and Its Relevance for Metabolic Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Trauma
Major Depressive Disorder
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the association between early trauma, depression and metabolic symptoms.

Detailed description: Early traumatic stress is associated with alterations of the hypothalamic-pituitary-adrenal axis (HPA-axis) indicated by an increased response to stress, a diminished negative feedback and alterations in expression of glucocorticoid receptors. Patients with a history of childhood trauma are more likely to develop metabolic disorders such as diabetes mellitus type 2 or metabolic syndrome.

The investigators will examine participants with and without early life stress and with and without major depression. The investigators assume that traumatized study participants (1) show an increased endocrine stress reaction to psychosocial stress, (2) display an altered sensitivity of GR, and (3) therefore suffer from an adverse cardiovascular risk profile in comparison to not-traumatized participants.

The investigators study will increase current knowledge on possible sequel of early traumatic stress. The results will lead to a more comprehensive understanding of stress-related eating behaviour and its implications.

Eligibility criteria: Inclusion Criteria:

* diagnosis of MDD and/or experience of early trauma

Exclusion Criteria:

* severe illness,
* control group: no diagnosis of MDD and experience of early trauma

Primary outcomes:
measure: Endocrine response to stress (salivary cortisol)
timeFrame: 2 hours
measure: glucose to oral glucose tolerance test (plasma insulin)
timeFrame: 2 hours
measure: insulin to oral glucose tolerance test (plasma insulin)
timeFrame: 2 hours
measure: cortisol to corticotropin releasing factor (salivary cortisol)
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University
Study officials:
affiliation: Charite University
name: Katja Wingenfeld, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01838577: Genetics of EGFR (Epidermal Growth Factor Receptor) Mutation Study
Official title: Genetics of EGFR Mutation Study (GEM): a Translational Study of the EORTC Lung Group.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: EGFR Mutation Positive Non Small Cell Lung Cancer
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2013-04-24
Enrollment: 2000
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: Case cohort: Patients with proven EGFR mutation in exons 18-21 from tumor material.

Control cohort: Patients known to be somatic EGFR "wild-type," i.e. no mutation detected in exons 18-21 from tumor material.

Brief summary: The investigators wish to document the distribution of EGFR somatic mutations, and assess the relationship between specific genotype, clinical demographic, therapy, and survival, in a large cohort of EGFR mutant NSCLC.

The investigators also wish to comprehensively investigate the relationship between germline DNA and risk of EGFR mutant NSCLC developing, through a GWAS (Genome-Wide Association Studies) and candidate gene approach, and explore the relationship between germline DNA and clinical outcome, in order to potentially identify germline genetic modifiers of EGFR TKI (Tyrosine Kinase Inhibitor) outcome.

Detailed description: Objective 1: To identify germline allelic DNA variation associated with somatic EGFR mutation in NSCLC, Objective 2: Correlation between germline allelic variants and survival in EGFR somatic mutant NSCLC.

Objective 3: Study germline allelic DNA variation associated with never /ex light smoking NSCLC.

Objective 4: Catalogue distribution of somatic EGFR mutant genotypes in 1,000 EGFR mutant NSCLC cases and describe their relationship to clinical outcome.

Eligibility criteria: * Histologically or cytologically diagnosed NSCLC, all histologies are acceptable.
* Patients can be included in the study with any disease stage and at any time during the disease course.
* Any type (surgery, RadioTherapy, chemotherapy, targeted agents) of previous treatment and any line of treatment are eligible.
* Age ≥18 years.

Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol; those conditions should be discussed with the patient before registration in the trial.

Before patient registration, written informed consent must be given according to ICH/GCP (International Conference on Harmonisation/Good Clinical Practice), and national/local regulations.

Primary outcomes:
measure: For the second objective, the primary endpoint is Overall survival (OS)
timeFrame: 5 years from FPI
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden
Study officials:
affiliation: Royal Marsden Hospital, Chelsea, London, UK
name: Sanjay Popat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01421277: Study of Treatment Used for Migraine Headaches (MK-0974-076)
Official title: Migraine Attack Study of Treatment, Efficacy and Resource Use (MASTER) - McKesson Substudy (MK-0974-076)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Migraine
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-08-22
Enrollment: 216
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: Participants with physician-diagnosed migraine (with or without aura) who have had at least two, but not more than 8 moderate to severe migraines during the 30 days prior to screening. Participants must have received a triptan prescription 3 months (± 2 weeks) prior to being identified by the physician, must have been triptan-naïve prior to that initial prescription, and must have taken triptan medication at least once within 6 months prior to the date of informed consent for screening.

Brief summary: This study will describe the reasons for triptan utilization patterns (continuation and discontinuation) in triptan-naïve participants and assess the stability of treatment utilization patterns over time according to standard medical guidelines or clinical practice standards of the investigating physician.

Detailed description: After study start, the Protocol was amended to clarifiy that the first triptan prescription must have been received by the participant within a time window of 3 months (± 2 weeks) prior to the participant being identified by the Investigator, and could be enrolled into the study within 6 months of taking the prescribed triptan medication for the first time and that use of a sample triptan would not disqualify a participant as long as the sample was of the same triptan that was eventually prescribed.

Eligibility criteria: Inclusion criteria:

* At least 18 years of age in the United States at the time of consent
* Physician-diagnosed migraine with or without aura
* At least two and up to a maximum of 8 moderate to severe migraine attacks during the 30 days prior to screening
* Initial triptan prescription 3 months (± 2 weeks) prior to being identified as eligible for this study, and triptan-naïve before that initial prescription
* Used triptan medication at least once within 6 months prior to the date of informed consent for screening
* Internet access and able to complete online surveys via electronic data entry

Exclusion criteria:

* Treated with triptans prior to this study
* In active litigation and compensation issues including disability dispute cases with a Government agency
* Participation in a clinical trial within the last 90 days

Primary outcomes:
measure: Number of Participants Using a Triptan for Migraine Attacks
timeFrame: Up to 3 months
measure: Number of Participants Continuing Triptan Therapy
timeFrame: Up to 3 monoths
measure: Main Reason for Stopping Triptan Use
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05543577: Assessing the Preparedness and Knowledge of Pharmacists in the Current Monkeypox Outbreak
Official title: Comparative Study of the Preparedness and Knowledge of Pharmacists Versus Intern Physician in the Current Monkeypox Outbreak
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Monkey Pox
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: community, hospital and clinical pharmacists, Medical interns of both sexes and any age

Brief summary: General objective: to measure the preparedness of pharmacists and medical interns about monkeypox

Specific objectives: to evaluate the level of knowledge among pharmacists and medical interns about monkeypox treatment and nature of disease

Detailed description: Globally, the ongoing outbreak was declared as a public health emergency. After the first laboratory-confirmed case of monkeypox was reported in Singapore on May 2019, countries all over the world started to strengthen disease surveillance systems. One challenge in preventing monkeypox is a lack of knowledge, particularly among healthcare workers.

Study significance: to examine in detail the preparedness and the perception of pharmacists and medical interns about monkeypox and to evaluate the level of knowledge about monkeypox management and nature of disease.

Eligibility criteria: Inclusion Criteria:

- community, hospital and clinical pharmacists, Medical interns of both sexes

Exclusion Criteria:

* any other healthcare professional

Primary outcomes:
measure: the level of knowledge among pharmacists and medical interns about monkeypox treatment and nature of disease using an online Questionnaire
timeFrame: 2 months
measure: Direct interviews with the pharmacists and medical interns to assess their knowledge and attitudes about diagnosing and dealing with the Monkeypox infected cases
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: BeniSuefU
Study officials:
affiliation: 6october University
name: Engy Wahsh, Ph.D.
role: STUDY_DIRECTOR
References: