louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00958945: Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements
Official title: Retrospective & Prospective Evaluation/Analysis of Hb/Hct in Patients Having Received FloSeal (5ml &10ml) When Undergoing Total Knee or Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Total Knee Arthroplasty
Arthroplasty, Replacement, Hip
Keywords: Postoperative Hematocrit
Postoperative Hemoglobin
Lead sponsor: Desert Orthopedic Center Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2009-08-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Dr. Velyvis's patients that have had a Total Knee or Total Hip after January 1, 2007

Brief summary: The purpose of this analysis is to compare Hemoglobin and Hematocrit levels following total hip or knee arthroplasty. The utilization of FloSeal intraoperatively will improve hemostasis postoperatively. Decreasing bleeding time will decrease the drop in level of Hemoglobin and Hematocrit which usually occurs postoperatively.

Detailed description: Retrospective Analysis of charts on patients having undergone Total Hip or Total Knee Arthroplasty. During the patient's hospitalization, lab values of Hg and Hct will be recorded for further analysis. Preoperative levels will be also noted to establish baselines.

Primary Data interest will be Hemoglobin (Hgb) level documented during hospitalization along with Hematocrit (HCT) and Red Blood Cell (RBC) data also collected.

Secondary Data gathered will consist of the following:

* patient Demographics
* Component Profile
* Length of Stay
* Anesthesia used
* Anesthesiologist
* EBL
* drain type
* Amount of drainage fluid recorded at 12 hour increments until discharge
* Amount of FloSeal used
* Type of Arthroplasty

  500 patients in Total
* 100 Historical Control Patients, knees - no FloSeal (retrospective)
* 100 Patients, knees - 5mL FloSeal (retrospective)
* 100 Patients, knees- 10mL FloSeal (prospective)
* 100 Historical Control patients, hips-no FloSeal (retrospective)
* 100 retrospective patients, hips-5mL of FloSeal (retrospective

Patients scheduled for Total Knee Arthroplasty will be asked if they wish to participate in the part of the study utilizing 10mL of FloSeal. These patient will be consented and the their data will be retrospectively gathered.

Eligibility criteria: Inclusion Criteria:

* Total Knee and Total Hip Patients
* Surgical Time less than 2 hours

Exclusion Criteria:

* Patients who require greater than 2 hour surgeries
* Patients who are undergoing revision arthroplasty
* Patients with known allergies to materials of bovine origin

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rancho Mirage
country: United States
facility: Desert Orthopedic Center
state: California
Study officials:
affiliation: Desert Orthopedic Center
name: John H. Velyvis,, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06831045: Bikini vs Longitudinal Incision in Direct Anterior Approach (DAA) Total Hip Arthroplasty (THA)
Official title: A Clinical Comparison in Wound Healing of Bikini Versus Longitudinal Incision in Direct Anterior Approach Total Hip Arthroplasty in the Obese Patient Population: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: THA
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 110
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 study team is conducting this study to see if there is a difference between the wound healing and participant satisfaction rates between two incision types used during a THA done via the DAA technique.


Eligibility criteria: Inclusion Criteria:

* Patients with body mass index greater than or equal to 30
* Patients undergoing primary unilateral DAA THA
* Patients undergoing primary THA

Exclusion Criteria:

* Patients with body mass index less than 30
* Patients with a history of prior open surgery on the affected hip
* Patients unable/unwilling to undergo spinal anesthesia under monitored anesthesia care (MAC)
* Patients with allergies or absolute contraindication to standardized drugs administered within the University of Miami protocol for total hip replacement
* The following groups will not be included: adults unable to consent, individuals who are not yet adults, pregnant women, prisoners.

Primary outcomes:
measure: Wound Healing measured in number of days
timeFrame: Up to 14 days
measure: Patient satisfaction with scaring as measured by Patient Scar Assessment Scale
timeFrame: Up to to 6 months
measure: Scar cosmesis as measured by Observer Scar Assessment Scale
timeFrame: Up to 6 months
Secondary outcomes:
measure: Number of participants who report lateral femoral cutaneous nerve-related symptoms
timeFrame: Up to 6 months
measure: Patient reported outcomes as measured by Hip Disability and Osteoarthritis Outcomes
timeFrame: Up to 6 months
measure: Number of intraoperative fractures
timeFrame: Up to 3 hours
measure: Length of surgery measured in minutes
timeFrame: Up to 3 hours
measure: Number of postoperative complications
timeFrame: Up to 90 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Victor H Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03175445: Sexual Dimorphism Analysis in Egyptian Population by Locating the Mandibular Canal Using CBCT
Official title: Sexual Dimorphism Analysis in Egyptian Population by Locating the Mandibular Canal Using Cone-beam Computed Tomography: an Observational Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gender Identity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult Egyptian population

Brief summary: Sexual dimorphism analysis in Egyptian population by locating the mandibular canal using cone-beam computed tomography: an observational cross sectional study

Detailed description: Many studies from different countries such as United States, China, Japan, and Europe were done to observe the distinct morphologic and morphometric manifestations of sexual dimorphism. Accordingly, it is mandatory to target a specific population with their unique skeletal features.

Eligibility criteria: Inclusion Criteria:

* 18 years and above.
* Absence of large pathological lesions in mandible.
* Dentulous patients

Exclusion Criteria:

* Patients younger than 18 years old
* Presence of large pathological lesions in mandible
* Completely edentulous patients.

Primary outcomes:
measure: Anterior ramus width , posterior ramus width
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
affiliation: Cairo University
name: Arwa Mousa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01975545: Fluor Varnish With Silver Nanoparticles for Dental Remineralization in Patients With Trisomy 21
Official title: Efficacy of the Addition of Silver Nanoparticles to a Fluor Varnish in the Remineralization of Temporary Teeth in Patients With Trisomy 21. Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Down Syndrome
Keywords: Down syndrome
Caries
Dental varnish
Lead sponsor: Universidad Autonoma de San Luis Potosí
Sponsor class: OTHER
First posted: 2013-11-03
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients with trisomy 21 are in greater danger of developing caries. It has been hypothesized that adding silver nanoparticles to fluor varnishes could promote remineralization of the teeth. A split-plot randomized controlled trial will be performed to address this question.


Eligibility criteria: Inclusion Criteria:

* Patients with trisomy 21 diagnosed through caryotype
* Age 1 to 6 years old
* Any sex
* White spot present in both upper anterior teeth
* Parental agreement to participate in the study

Exclusion Criteria:

* Hypersensibility to any of the substances used
* Non cooperating patients
* Caries in enamel or dentine in the upper anterior teeth
* Leukemia or diabetes
* Dental fluorosis present

Primary outcomes:
measure: Remineralization
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Luis Potosí
country: Mexico
facility: Universidad Autónoma de San Luis Potosí
Study officials:
affiliation: Universidad Autónoma de San Luis Potosí
name: Mauricio Pierdant-Pérez, Md, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT06356545: Phenotype and Multi-omics Analysis of Children With Congenital Diarrhea and Enteropathy in China
Official title: A Case-control Study of Phenotype and Multi-omics Analysis of Children With Congenital Diarrhea and Enteropathy in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diarrhea Infantile
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic diarrhea lasting greater than 2 months or greater than 1 month in patients younger than 2 months of age

Brief summary: This study will establish a clinical cohort of children with congenital diarrhea and enteropathy (CODE), mine biomarkers of CODE through multi-omics technology and construct a clinical risk prediction model.

Detailed description: This study will establish a clinical cohort and a clinical phenotype database of children with congenital diarrhea and enteropathy (CODE), The investigator will mine biomarkers of CODE through multi-omics technology. This study is designed to construct a clinical risk prediction model by combining artificial intelligence technology.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic diarrhea lasting greater than 2 months or greater than 1 month in patients younger than 2 months of age
* Patients with consent from parents or legal guardians

Exclusion Criteria:

* Chronic diarrhea caused by specific infections, i.e. CMV, Clostridioides difficile
* Chronic diarrhea with necrotizing enterocolitis, short bowel syndrome
* Functional diarrhea
* Patients with poor compliance

Primary outcomes:
measure: Clinical phenotype of congenital diarrhea and enteropathy in China
timeFrame: Within approximately 2 years of enrollment
Secondary outcomes:
measure: Biomarkers of congenital diarrhea and enteropathy with diagnostic value through microbiome, metabolome and proteome features
timeFrame: Within approximately 2 years of enrollment
measure: Cinical risk prediction model for congenital diarrhea and enteropathy built by artificial intelligence and machine learning
timeFrame: Within approximately 30 months of enrollment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Yanqiu Wang
state: Shanghai
Study officials:
References:
Clinical trial NCT00067145: Computer Intervention for Prevention of Weight Regain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-08-13
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Many overweight patients are able to lose weight successfully, but then regain their weight. The purpose of this study is to develop and test the efficacy of 2 interventions to prevent weight regain in individuals who have recently lost weight. The two interventions being tested are a face-to-face group maintenance program and an Internet intervention. These interventions will be compared to a no-contact control group that receives quarterly newsletters. The primary outcome measure is weight regain from baseline to 18-months.


Eligibility criteria: 10% weight loss in past 2 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
References:
citation: Wing RR, Tate DF, Gorin AA, Raynor HA, Fava JL. A self-regulation program for maintenance of weight loss. N Engl J Med. 2006 Oct 12;355(15):1563-71. doi: 10.1056/NEJMoa061883.
citation: Marinilli Pinto A, Gorin AA, Raynor HA, Tate DF, Fava JL, Wing RR. Successful weight-loss maintenance in relation to method of weight loss. Obesity (Silver Spring). 2008 Nov;16(11):2456-61. doi: 10.1038/oby.2008.364. Epub 2008 Aug 14.
Clinical trial NCT03002545: Magnesium Supplementation in Type II Diabetes
Official title: Effects of a 12-week Supplementation With 400 mg Magnesium From Magnesium Citrate on Blood Sugar, Blood Pressure and Expression of Magnesium-sensitive Genes in Patients With Type II Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of Magnesium in Diabetes
Keywords: Magnesium
Type II diabetes
magnesium-sensitive genes
Lead sponsor: Protina Pharmazeutische GmbH
Sponsor class: INDUSTRY
First posted: 2016-12-23
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine how a 12-week magnesium supplementation with 400 mg magnesium from organic magnesium citrate affects blood glucose control and insulin resistance within patients with type 2 diabetes (HbA1c\> 6%) and how the expression of certain Mg-sensitive transporting genes is affected .

Detailed description: The examinations are carried out in 50 subjects aged 20-80 years with existing type 2 diabetes (HbA1c\> 6%). The target parameters are determined in the blood. Blood sampling takes place at confinement, after 6 weeks and at the end of the study (week 12). In addition, blood pressure is determined and general health condition of each subject is recorded by a standardized questionnaire (SF-36).

Eligibility criteria: Inclusion Criteria:

* Type II Diabetics (HbA1c \> 6%)

Exclusion Criteria:

* pregnancy, lactation
* persons with severe renal impairment (glomerular filtration rate \<30 ml / min)
* use of insulin, oral antidiabetic drugs, diuretics, antacids or proton pump inhibitors within 4 weeks prior to study start and during the study
* intake of vitamin supplements, dietary supplements, mineral products or possibly enriched foods containing Magnesium within 4 weeks before study start and during the study

Primary outcomes:
measure: blood sampling
timeFrame: 12 weeks
measure: blood pressure measurement
timeFrame: 12 weeks
measure: questionnaire SF-36
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Herne
country: Germany
facility: St. Anna Hospital
Study officials:
References:
Clinical trial NCT00256945: Surface Roughness of a Dental Restorative Material and Biofilm Formation
Official title: In Vivo Study of the Relationship Between Surface Roughness of a Dental Restorative Material and Biofilm Formation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic
Antibiotic Intake
Keywords: biofilm formation
dental plaque
surface roughness
dental restoration
dental materials
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-11-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In this study we intend to find out the pattern of biofilm accumulation in vivo on various surface finishings.

Our intention is to prepare Polymethylmetacrylate squers on orthodontical brackets,then prepare the surface of the sample and measure the surface roughness with a profilimeter and get the mean value in Ra units, then place the brackets on lower premolars and molars for 12 hours, remove them and examine the biofilm formed with confocal scanning microscope.

Detailed description: Several studies in the past to assess the effects of surface roughness on the amount of plaque accumulation in vitro, whereas only few performed a modern in vitro assessment of the plaque accumulation. In this study we intend to find out the pattern of biofilm accumulation in vivo on various surface finishings.

Our intention is to prepare Polymethylmetacrylate squers on orthodontical brackets,then prepare the surface of the sample and measure the surface roughness with a profilimeter and get the mean value in Ra units, then place the brackets on lower premolars and molars for 12 hours, remove them and examine the biofilm formed with confocal scanning microscope.

Statistical evaluation of pilot study determined the need to perform this research on twelve(12) candidates. It is our intention to check two materials in each candidate: composite resin and polymethylmetacrylate.

Eligibility criteria: Inclusion Criteria:

* any patient with intact buccal surfaces of lower molars and premolars

Exclusion Criteria:

* patients that used antibiotics in the three months prior to the experiment

Primary outcomes:
measure: confocal scanning laser microscope evaluation of biofilm formation
Secondary outcomes:
measure: roughness analysis of the samples with profilometer
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Michael M Perez Davidi, DMD
role: STUDY_DIRECTOR
References:
citation: Kawai K, Urano M, Ebisu S. Effect of surface roughness of porcelain on adhesion of bacteria and their synthesizing glucans. J Prosthet Dent. 2000 Jun;83(6):664-7.
Clinical trial NCT05125445: Stability and Crestal Bone Changes Around Implants Placed at Crestal Versus Subcrestal Level in Controlled Type Two Diabetic Patients
Official title: Evaluation of Stability and Crestal Bone Changes Around Implants Placed at Crestal Versus Subcrestal Level in Controlled Type Two Diabetic Patients (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant
Diabetes
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 22
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess clinically the peri implant tissues, the radiological marginal bone loss and the stability around implants placed at the crestal versus the subcrestal level in type 2 controlled diabetic patients using cone beam computed tomography


Eligibility criteria: Inclusion criteria

* Type 2 controlled diabetic patients
* Patients with at least one missing tooth in lower jaw.
* Patients with sufficient alveolar ridge height and width (no need for bone augmentation).
* Patients with sufficient inter-occlusal distance that will allow future restoration.
* Patients with healthy periodontium.

Exclusion criteria

* Smokers.
* Para functional habits.
* Bad oral hygiene measured according to O'Leary plaque index.
* Pregnant women.
* Other local or systemic diseases that may compromise the surgical procedure, healing or osteointegration.

Primary outcomes:
measure: change in Implant stability
timeFrame: at baseline and 3 months
measure: change in margianl bone level
timeFrame: at baseline, 3rd and 6th months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT04166045: Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain
Official title: Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Episodic Migraine
Lead sponsor: Theranova, L.L.C.
Sponsor class: INDUSTRY
First posted: 2019-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Clinical study to determine the responder rate of the TheraNova Migraine Treatment System to that of a sham control treatment.


Eligibility criteria: Inclusion Criteria:

* 18-100 years, inclusive
* Diagnosis of episodic migraine with and without aura per International Headache Society diagnostic criteria
* 4-14 migraine days per month
* Ability to provide informed consent
* Demonstrates no contraindication to the use of electrical nerve stimulation
* Capable and willing to follow all study-related procedures

Exclusion Criteria:

* Currently pregnant or breastfeeding, pregnant within the past 6 months or intends to become pregnant during the enrollment period
* Diagnosis of chronic migraine or other forms of primary or secondary headache disorders, including medication overuse headache per International Headache Society diagnostic criteria
* Any medical condition that would, in the opinion of the investigator, make the subject ineligible
* Has received botulinum toxin injections within the past 3 months
* Is currently implanted with an electrical and/or neurostimulator devic, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, sacral stimulator, bone growth stimulator, or cochlear implant
* Use of investigational drug/device therapy within the past 4 weeks
* Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination (including bleeding disorders, anticoagulant medications and peripheral neuropathy)
* No changes in preventive medications (or other medications determined to potentially interfere with the study) in the previous 30 days and no intent to change it during the study

Primary outcomes:
measure: Mean change in pain score
timeFrame: 4 months
measure: Percent of subjects who are responders
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
References: