louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02244788: Humanitarian Use of AVANTA Orthopaedics Proximal Interphalangeal Joint
Official title: Humanitarian Use of AVANTA Orthopaedics Proximal Interphalangeal Joint
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Arthroplasty of the PIP Joint
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2014-09-19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to allow patients to undergo surgery with the SR™ PIP (Proximal Interphalangeal) Implants for finger arthritis. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device

Detailed description: The purpose of this IRB approved study is to allow patients to undergo surgery with the SR™ PIP (Proximal Interphalangeal) Implants. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device. Use of the SR™ PIP is approved for humanitarian use by the FDA when either the patient is in need of a revision of failed PIP prothesis(es) or the patient expects to place his/her hand under loading situation which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic PIP joint.

Eligibility criteria: Inclusion Criteria:

* patient is in need of a revision of failed PIP prosthesis(es)
* patient expects to place his/her hands under loading situations which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic PIP joint

Exclusion Criteria:

* patient is not in need of a revision of a failed PIP prothesis(es)
* patient is eligible to use an alternative implant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Edward Athanasian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06772688: Custom Made Plate in Orthognathic Surgery
Official title: Evaluation of the Accuracy of Custom-made Plate in Maxillary Repositioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Prognathism
Maxillary Retrusion
Keywords: Orthognathic surgery
Virtual planning
custom made plate
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2025-01-13
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Fixation of maxilla with custom made plate designed by 3D virtual planning
Primary purpose: TREATMENT

Brief summary: Orthognathic surgery has traditionally been used to correct dentofacial deformities. Conventional methods rely on 2D radiographic images, occlusal splints, and dental casts, but these approaches have limitations, such as errors during face-bow transfer. Technological advancements, including 3D imaging, virtual surgical planning (VSP), and computer-aided design and manufacturing (CAD/CAM), have improved the precision and outcomes of orthognathic surgery.

Detailed description: This study included one group of patients need orthognathic surgery and fixation of maxilla using custom made plate designed by 3D virtual planning using Materialize mimic soft ware

Eligibility criteria: Inclusion Criteria:

* Patients with skeletal class II or class III who need orthognathic surgery.
* Patients who suffer from clinical facial asymmetry.
* Patients with occlusal plane canting.
* Age range of patients 18-40 years old, with no gender prediction, able to read and sign the informed consent.

Exclusion Criteria:

* Maxillofacial trauma
* Patients who suffer from maxillofacial tumors
* Segmental maxillary surgery.
* Oral soft tissues defects, infections and bone metabolism disturbance.
* Allergy to titanium implant.
* Patient with systemic disease and immunocompromised patient.

Primary outcomes:
measure: Evaluation of the accuracy of custom-made plate
timeFrame: immediate postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dental medicine Azhar university
Study officials:
affiliation: professor of oral and maxillofacial surgery
name: fatma ibrahim
role: STUDY_DIRECTOR
References:
Clinical trial NCT00437788: The Effect of a Digital Photograph of the Patient in a CT Scan Examination on the Quality of Diagnosis by the Radiologist
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: imaging
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2007-02-21
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Whenever a scan is accessed through the PACS system a scanned document or digital picture may be displayed automatically. In this study the technician will take a digital picture of the patient who will be undergoing the CT scan. This way the radiologist will be able to view the patient's face before viewing the scan.

The hypothesis is that viewing a digital picture of the patient before viewing the CT scan will improve the quality of diagnosis.


Eligibility criteria: Inclusion Criteria:

* Patient who are to be scanned by ct

Exclusion Criteria:

* Disabled

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shaheed Ziaur Rahman Medical College
name: yonatan turner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00988988: The Effects of Ethyl-Alpha-Guanido-Methyl Ethanoate on Skin Reactions From Glatiramer Acetate Injections
Official title: The Effects of Ethyl-alpha-Guanido-methyl Ethanoate on Skin Reactions Form Glatiramer Acetate
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
AGEE
histamine response
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Teva Branded Pharmaceutical Products R&D, Inc.
First posted: 2009-10-02
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants with multiple sclerosis that are currently treated with glatiramer acetate (GA, Copaxone®) injections and have redness, pain, swelling, itching or a lump at the injection site will be recruited to examine histamine response of three topical treatments to reduce these symptoms.

Detailed description: Participants are asked to be in this study because they have multiple sclerosis, are currently treated with glatiramer acetate (GA, Copaxone®) injections and have redness, pain, swelling, itching or a lump at the injection site.

The purpose of this study is to determine if the use of ethyl-a-guanida-methyl ethanoate (AGEE) will decrease histamine response measured by redness, swelling, and itch response following subcutaneous injection of glatiramer acetate (GA) for the treatment of Multiple Sclerosis (MS).

Eligibility criteria: Inclusion Criteria:

* Able to give informed consent
* Between ages 19-65
* Laboratory supported diagnosis of multiple sclerosis
* Currently treated with injectable GA, experiencing wheal and flare after injection

Exclusion Criteria:

* Unable to give informed consent
* Treated with any other therapy for Multiple Sclerosis

Primary outcomes:
measure: Histamine response after ethyl-α-guanida-methyl ethanoate (AGEE) and subcutaneous injection of glatiramer acetate
timeFrame: Three weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska
name: Mary Filipi, PhD, APRN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04488588: Survival and 30-days Hospital Outcome in COVID-19 Patients in Upper Egypt
Official title: Survival and 30-days Hospital Outcome in Hospitalized COVID-19 Patients in Upper Egypt: Multi-center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Coronavirus Disease
SARS-CoV-2
Keywords: COVID-19
Survival
30- Days Hospital outcome
outcome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 1064
Sex: ALL
Minimum age (years): 36
Maximum age (years): 63
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cases had confirmed COVID-19 infection (based on PCR, chest HRCT, CBC, CRP, Ferritin levels) and received standardized treatment protocols of Ministry of Health and Population based on disease severity.

Brief summary: Through history, there have been plenty of pandemics however; the social response to corona virus disease (COVID-19) is unparalleled. It is assessed that almost four billion individuals are living in social segregation during this mother of all pandemics.

Initially described in China in December 2019, severe acute respiratory syndrome caused by corona virus 2 (SARS-CoV-2) has spread all over the world and by 18th July 2020- there was an emergent figure of 13,824,739 confirmed cases and 591.666 losses reported to the WHO. To date, Egypt reported slightly over 82,000 confirmed COVID-19 cases with 3858 deaths. The new pandemic is injuring not only health organizations of several countries but also the financial prudence universal.

Defining the clinical features and associated outcomes of patients diagnosed with coronavirus disease (COVID-19) is fundamental to improving our understanding and adequate management of this illness. Several articles have recently been published, describing the clinical features and outcomes of retrospective individuals with COVID-19


Eligibility criteria: Inclusion Criteria:

* This study included 1064 patients consecutively admitted to isolation hospitals in Upper Egypt during the period from 22 March to 23 June 2020

Exclusion Criteria:

* only hospitalized confirmed cases of COVID-19 were included.

Primary outcomes:
measure: number of co-morbidities in hospitalized patients with COVID-19
timeFrame: one month
measure: causes of ICU admission
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: AssiutU
city: Assiut
country: Egypt
facility: Aliae Mohamed-Hussein
Study officials:
affiliation: Assiut University
name: Aliae Mohamed-Hussein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05516888: Comparison of the Radiofrequency Treatments for the Treatment of Trigeminal Neuralgia.
Official title: A Prospective, Randomized Comparison of the Radiofrequency of Gasserian Ganglion Versus Peripheral Branches of the Trigeminal Nerve for the Treatment of Trigeminal Neuralgia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigeminal Neuralgia
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the efficacy of radiofrequency of the Gasserian ganglion versus peripheral branches of the trigeminal nerve for the treatment of trigeminal neuralgia.

Detailed description: Trigeminal neuralgia (TN) is defined as sudden, severe, short-term, stabbing and recurrent pain in the distribution of one or more branches of the trigeminal nerve. Many invasive treatments are available for patients who respond poorly to medical therapy. Among them, radiofrequency therapy is a viable option with a reliable initial and long-term clinical efficacy.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Primary Trigeminal Neuralgia meets the criteria of the International Classification of Headache Disorders.
* Suffering from severe trigeminal neuralgia that cannot be alleviated effectively with conservative therapy.
* Agree to participate in the study

Exclusion Criteria:

* Infection at the puncture site.
* Coagulation disorder.
* Abnormal blood test (hepatic or renal function)
* History of receiving invasive treatment (glycerol rhizolysis, radiofrequency thermocoagulation, balloon compression, gamma knife treatment, microvascular decompression)

Primary outcomes:
measure: The modified Barrow Neurological Institute Pain Intensity Score
timeFrame: six months
Secondary outcomes:
measure: Numeric rating scale
timeFrame: baseline to six months
measure: Patient satisfaction
timeFrame: six months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Training and Research Hospital
Study officials:
References:
Clinical trial NCT03692988: Dignity Therapy for Patients With Early Dementia and Their Family
Official title: Dignity Therapy: a Brief Psychological and Existential Intervention for Patients With Early Dementia and Their Family. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia, Mild
Depressive Disorder
Keywords: Psychotherapy
Dignity
Family
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Waid City Hospital, Zurich
First posted: 2018-10-02
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Developed by Harvey M. Chochinov in 2005, Dignity Therapy (DT) invites individuals with life-limiting illnesses to reflect on matters of importance to them and compiles them in a narrative document for the patient to share. DT has shown to improve quality of life and a sense of dignity, as well as supporting relatives in the process of grievance. Featuring a gradual loss of memories of the past, decline of cognitive functions and awareness of self, dementia can be regarded as a life-limiting or life-changing illness, which is often accompanied by significant psychological stress. DT may help patients and their relatives reduce this stress. Yet, no studies have been conducted to determine the benefits of DT in patients with early stage dementia (ESD). This study investigates the feasibility and acceptance of DT by patients with (very) mild dementia (CDR: 0.5 - 1.5) and their relatives, as well as their overall satisfaction. This study further seeks to determine the effects of DT on sense of dignity, quality of life, dyadic coping, and levels of anxiety and depression in a randomized controlled design.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent
* Diagnosis of very mild dementia
* older 18 years of age
* Study partner (life partner, relative, close friend) available

Exclusion Criteria:

* Unable to speak and read German
* Physical or cognitive incapacity to participate

Primary outcomes:
measure: Participation and refusal rate of Dignity Therapy among Patients with an early stage dementia
timeFrame: 10 days post randomization
measure: Overall satisfaction of patients and their relatives
timeFrame: 10 days post randomization
Secondary outcomes:
measure: Psychological distress
timeFrame: 10 days post randomization
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University of Zurixh
Study officials:
References:
Clinical trial NCT00804388: Wear Measurements of E-Poly in an Uncemented THA With Either 32 or 36 mm Caput of Ceramics.
Official title: Comparing Polyethylene Wear Using 3. Generation Highly Crosslinked Polyethylene in an Uncemented Total Hip Prostheses With Either 32 mm or 36 mm Caput of Ceramics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Arthrosis
Osteoarthritis
Keywords: Vitamine E
E-poly
Hip
Degenerative joint disease
Lead sponsor: Lovisenberg Diakonale Hospital
Sponsor class: OTHER
Collaborators: name: Helse Sor-Ost
name: Zimmer Biomet
name: Ullevaal University Hospital
First posted: 2008-12-08
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare polyethylene wear in an uncemented total hip prosthesis with 3rd. generation highly cross-linked polyethylene with a 32 mm ceramic femoral head compared to a 36 mm ceramic head. Using X-ray, RSA and DEXA.

The polyethylene to be used is E-Poly (Biomet).

The H0 hypothesis is that there is no difference with regard to polyethylene wear and bone loss between the two groups.

Detailed description: Uncemented THA, 32 mm or 36 mm caput of ceramics, E-Poly inserts. Measure wear with RSA, X-Ray and bone mineral density with DEXA.

Eligibility criteria: Inclusion Criteria:

* 50-65 years old
* Primary or secondary osteoarthritis

Exclusion Criteria:

* Significant anatomical divergence are excluded
* Rheumatoid arthritis
* Fracture sequelae
* Dysplasia
* Immune suppression or grave systemic illness

Primary outcomes:
measure: Measure polyethylene wear and bone mineral density between the two groups
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Lovisenberg Diakonale sykehus
Study officials:
affiliation: Ullevål Univeristy Hospital Norway
name: Stephan M. Røhrl, MD,PhD
role: STUDY_CHAIR
affiliation: Lovisenberg Diakonale sykehus
name: Einar Lindalen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05706688: Effect of Regional Versus General Anesthesia on Thirty-day Outcomes Following Carotid Endarterectomy: a Matched-pairs Cohort Study.
Official title: Effect of Regional Versus General Anesthesia on Thirty-day Outcomes Following Carotid Endarterectomy: a Matched-pairs Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Regional Anesthesia Morbidity
Carotid Artery Diseases
Perioperative/Postoperative Complications
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 37204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elective carotid endarterectomy patients, ACS-NSQIP 2015-2019

Brief summary: The goal of this observational study is to assess the effect of regional versus general anesthesia on carotid endarterectomy thirty-day outcomes. The main questions it aims to answer are:

* Is regional anesthesia associated with lower incidence of major morbidity and mortality?
* Is regional anesthesia associated with lower incidences of secondary adverse events?

Participants will be sampled from the 2015-2019 American College of Surgeons National Surgical Quality Improvement Program


Eligibility criteria: Inclusion Criteria:

* Elective, non-emergent cases
* Regional anesthesia
* General anesthesia

Exclusion Criteria:

* Concurrency in procedures
* Acute kidney injury (preoperative)
* End-stage renal disease (preoperative)
* Metastatic disease (preoperative)
* Wound infection (preoperative)
* Sepsis (preoperative)
* ASA 5

Primary outcomes:
measure: Major morbidity and mortality
timeFrame: Thirty days
Secondary outcomes:
measure: Minor morbidity
timeFrame: Thirty days
measure: Bleeding events
timeFrame: Thirty days
measure: Unplanned resource utilization
timeFrame: Thirty days
measure: Mortality
timeFrame: Thirty days
Other outcomes:
Locations:
Study officials:
affiliation: University of Virginia
name: Zhiyi Zuo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05938088: Mirogabalin for Total Hip Arthroplasty
Official title: Mirogabalin and Pain After Total Hip Arthroplasty: a Double-blind, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Osteoarthritis
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm the analgesic effect of mirogabalin in patients undergoing unilateral hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

1. Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty
2. American Society of Anesthesiologists class 1-3

Exclusion Criteria:

1. Major prior ipsilateral open hip surgery
2. Allergies to drugs used in research
3. Difficult to manage diabetes mellitus (including insulin dependence)
4. Chronic use of gabapentin or pregabalin (regular use for more than 3 months)
5. Patients taking cimetidine, probenecid, or lorazepam
6. Patients with moderate or severe hepatic impairment (AST/ALT 2.5 times or more of the upper limit of normal)
7. Estimated glomerular filtration rate \< 60 mL/min/1.73m2
8. Dependence on opioids
9. In the case of subjects who cannot read the consent form (e.g. illiterate, foreigners, etc.)

Primary outcomes:
measure: numeric rating scale at flexion
timeFrame: postoperative day 1
Secondary outcomes:
measure: numeric rating scale at flexion
timeFrame: up to 3 month after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
References:
Clinical trial NCT02046109: Study of the Success and Survival of Dental Composite Restorations Being Repaired Instead of Being Replaced
Official title: Replacement Versus Repair of Composite Restorations, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Failing Dental Composite Restorations
Keywords: Repair
Replace
Composite
restoration
failing dental restoration
filling
dental
dentistry
Lead sponsor: Dalhousie University
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this trial is to compare the success (as assessed by a pre-defined set of outcome) of failing composite resin restorations that are repaired using diamond bur induced surface abrasion, to those that are completely replaced.

It is hypothesized that both treatment will have comparable success rate.

Detailed description: This study is a single-blind randomized non-inferiority trial using parallel groups.

Patients recruited into the study will be randomly assigned to one of two treatment groups. Subjects allocated to Group 1 will have their defective restoration completely replaced while subjects allocated to Group 2 will have their defective restoration repaired.

The success of the treatments will be assessed immediately following the intervention (baseline) and 12 months later.

Eligibility criteria: Inclusion Criteria:

* Patients of the Dalhousie University Dental Clinic who are:
* Age 18 and over
* Capable of providing informed consent
* Asymptomatic permanent teeth with class III, IV, V or veneer composite restorations on the facial/buccal surface, requiring treatment (e.g. stain, chipping or color discrepancy).
* Restoration must present with a portion (mesial, distal, gingival or occlusal) that can be completely retained to allow repair.

Exclusion Criteria:

* Patients with contra-indications for regular dental treatment based on their medical history
* Teeth with active caries
* Teeth with multiple overlapping composite restorations
* Patients with uncontrolled periodontal disease
* Restorations smaller than 3mm diameter

Primary outcomes:
measure: Success rate
timeFrame: 12-month
Secondary outcomes:
measure: Survival
timeFrame: 12-month
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Dalhousie University Faculty of Dentistry
state: Nova Scotia
Study officials:
References: