louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04497207: Deep Learning for Classification of Scheimpflug Corneal Tomography Images
Official title: Classification of Color-Coded Scheimpflug Camera Corneal Tomography Images Using Deep Learning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Diseases
Keywords: Keratoconus
Deep learning
Scheimpflug camera
Corneal tomography
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 1669
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with keratoconus, subclinical keratoconus \& normal individuals from refractive surgery candidates.

Brief summary: Keratoconus is a common disorder. An early diagnosis influences the disease prognosis in the affected patients and prevents postoperative complications in patients with keratoconus considering refractive surgery. Machine learning approaches have been widely used for image classification. Here, we will assess the ability of deep learning to enable high-performance image classification of the color-coded corneal maps obtained by Scheimpflug camera in patients with keratoconus, subclinical keratoconus, and normal individuals.


Eligibility criteria: Inclusion Criteria:

Keratoconus group:

* Presence of a central protrusion of the cornea with Fleischer ring, Vogt striae, or both by slitlamp examination.
* irregular cornea determined by distorted keratometry mires and distortion of retinoscopic red reflex or both in addition to the following topographic findings as summarized by Pińero and colleagues :
* focal steepening located in a zone of protrusion surrounded by concentrically decreasing power zones
* focal areas with diopteric (D) values \>47.0D
* inferior- superior(I-S) asymmetry measured to be \> 1.4 D
* Angling of the hemimeridians in an asymmetric or broken bowtie pattern with skewing of the steepest radial axis(SRAX) .

Suspicious group:

• Defined as subtle corneal tomographic changes as the aforementioned keratoconus abnormalities in the absence of slit- lamp or visual acuity changes typical of keratoconus (forme fruste keratoconus).

Normal group:

* Refractive surgery candidates
* Refractive error of less than 8.0 D sphere
* Less than 3.0 D of astigmatism
* without clinical, topographic or tomographic signs of keratoconus or suspect keratoconus.

Exclusion Criteria:

* Systemic disease
* Other corneal disease such as pellucid marginal degeneration
* History of trauma
* Corneal surgery such as corneal cross- linking for progressive keratoconus.

Primary outcomes:
measure: Croppedm denoised, and resized to obtain four separate image stacks of 256×256 pixels
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT00159107: Integrative Therapy in Alcoholism
Official title: Acamprosate and Integrative Behavior Therapy in the Outpatient Treatment of Alcohol Dependents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Keywords: alcoholism
abstinence enhancement
psychotherapy
cognitive behavior therapy vs. supportive counseling
Acamprosate vs. Placebo
multi-center study
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: German Addiction Research Network
name: Merck Sharp & Dohme LLC
name: University of Bonn
name: Universität Duisburg-Essen
name: University of Homburg
name: Psychosomatic Clinic of Bergisch Gladbach
First posted: 2005-09-12
Enrollment: 371
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of this project consists in the investigation of the interaction of behavior therapy and Acamprosate in the outpatient treatment of alcoholic patients in a randomized, prospective and (regarding study medication Acamprosate vs. Placebo) double blind design. A total of 371 patients has been randomly assigned immediately after detoxification to one of three different outpatient treat-ment conditions.

Detailed description: The objective of this multi-center study is to optimize the long-term treatment of patients with alcohol dependence. This investigation should contribute to the issue of effective relapse prevention. Each treatment condition is lasting 6 months: a) Behavior Group Therapy + Acamprosate, b) Behavior Group Therapy + Placebo and c) support and counseling + Acamprosate. Follow-up examinations carried out 3 and 6 months after the end of treatment.

Eligibility criteria: Inclusion Criteria:

* DSMIV criteria of alcoholism
* Age between 25 and 60
* Informed consent

Exclusion Criteria:

* Residence outside of the catchment area
* Legal reasons
* Insufficient knowledge of the German language
* Substance abuse or addiction other than alcohol or nicotine
* Pregnancy
* Serious physical illness
* Organic brain disease
* Contraindication to Acamprosate treatment

Primary outcomes:
measure: Abstinence
timeFrame: 3,6,12 months
Secondary outcomes:
measure: Social functioning
timeFrame: 12 months
measure: Cognitive functioning
timeFrame: 12 months
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf, Germany
state: North Rhine-Westfalia
Study officials:
affiliation: Department of Psychiatry and Psychotherapy, University of Düsseldorf
name: Wolfgang Gaebel, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT02812407: HRIM vs Mucosal Impedance in GERD Participants
Official title: Baseline Impedance Measured on High Resolution Esophageal Impedance Manometry to Discriminate GERD From Non GERD Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastro-esophageal Reflux Disease (GERD)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 0
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: DIAGNOSTIC

Brief summary: Does baseline impedance measured during the landmark phase of esophageal High resolution impedance manometry HRIM correlates with direct mucosal impedance measurement and discriminates GERD from non GERD patients?

Detailed description: Patients referred to the Mayo Clinic Rochester for a clinically indicated high resolution impedance manometry (HRIM), 24 hour impedance pH (MII-pH) study, and esophagogastroduodenoscopy (EGD) will be recruited. Gastroesophageal reflux will be defined as a total 24 hour esophageal acid exposure time ≥5% regardless of concomitant Proton Pump inhibitor (PPI) use. A negative 24 hour MII-pH study will be defined as an acid exposure time ≤2% off PPI therapy or ≤1% if on PPI therapy.

Eligibility criteria: Patients being seen at Mayo clinic Rochester having a clinically indicated endoscopy, a high resolution impedance manometry and a 24 hour pH impedance study.

Inclusion criteria:

* Adults ages 18-90
* Patients scheduled for or have completed a HRIM ( within 5 days)
* Patients scheduled for or recently have completed a MII-pH studies ( within 5 days)
* Patients scheduled for EGD

Exclusion criteria:

* Technically limited esophageal HRIM or MII-pH study
* Patients with HRIM and MII-pH studies not performed within 5 days of each other
* Patients with EGD not performed within 30 days of HRIM and MII-pH studies
* Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy
* Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy

Primary outcomes:
measure: The mean impedance
timeFrame: 2 years
Secondary outcomes:
measure: Maximal impedance measured on HRIM in GERD patients compared to minimal impedance in patients without GERD to determine a potential diagnostic cutoff value
timeFrame: 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Karthik Ravi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02804607: Children Severe Traumatic Skin Lesions and Functional Outcome
Official title: Children Severe Traumatic Skin Lesions and Functional Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns
Keywords: burn
child
graft
development
complications
autonomy
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 51
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children who were hospitalized for an extensive and deep skin lesion on at least one joint, at CHU Amiens, from April 1999 to December 2014, in the Physical and Rehabilitation Pediatric activity center.

Brief summary: Traumatic skin lesions require an adapted and early patient care management

Detailed description: Traumatic skin lesions and in particular the burns which happen to growing children are complex and require an adapted and early patient care management. A child presents physical, psychological, and physiological characteristics which involve a specific functional prognosis. The aim of the study was to evaluate the functional outcome after a mid-term period from a severe skin traumatism occurring during childhood and which had required an initial graft.

Eligibility criteria: Inclusion Criteria:

* children who were hospitalized for an extensive and deep skin lesion on at least one joint, at CHU Amiens, from April 1999 to December 2014, in the Physical and Rehabilitation Pediatric activity center.
* And with a serious skin lesion:

  * What the total dermal area is estimated to be less than 25%
  * Taking at least one articulation
  * Dont a part is at least 2nd degree deep or third degree

Exclusion Criteria:

* First degree burns or superficial second degree Burns resulting in death in the acute phase
* A history of pre-burn disorders affecting growth
* Escarres

Primary outcomes:
measure: autonomy
timeFrame: 5 years
Secondary outcomes:
measure: appearance of contractures
timeFrame: 5 years
measure: limited joint mobility
timeFrame: 5 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Séverine FRITOT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00131807: A Study to Explore the Association Between Blood Pressure, HIV and Antiretroviral Therapy
Official title: A Study to Explore the Association Between Blood Pressure, HIV and Antiretroviral Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Blood Pressure
HIV
Antiretroviral therapy
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: The Hypertension Trust
First posted: 2005-08-19
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to explore the association between blood pressure, HIV and/or its treatment in a cross sectional observational study.

Detailed description: Deaths from AIDS have declined dramatically since the introduction of highly active antiretroviral therapy in HIV infected patients. However the incidence of heart disease has increased four-fold and is now one of the major causes of death in HIV infected patients. While HIV drugs are known to adversely affect serum lipids, the evidence concerning the association between raised blood pressure (a major risk for cardiovascular disease) HIV and/or its treatment is limited and conflicting. The researchers believe it of interest to study heart disease risk factors in patients with HIV infection to avoid one premature cause of death (AIDS) being replaced with another potentially preventable cause of death and disability (heart disease). In this cross sectional observational study the researchers will systematically measure blood pressure and other cardiovascular risk factors in HIV positive patients on and off antiretroviral therapy. These individuals will be matched for age, sex and ethnic group with HIV negative individuals.

Eligibility criteria: Inclusion Criteria:

* Attending St. Mary's sexual health outpatient department
* Patients willing to give written informed consent
* Ability to communicate in English

Exclusion Criteria:

* Failure to give written informed consent in English

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paddington
country: United Kingdom
facility: St. Mary's Hospital
state: London
Study officials:
affiliation: Imperial College London
name: Neil R Poulter
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06856707: MIRA Registry Study
Official title: MIRA Surgical System Registry Study (MIRA Registry)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Colon Procedures
Bowel Resection
Lead sponsor: Virtual Incision Corporation
Sponsor class: INDUSTRY
First posted: 2025-03-04
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients indicated for minimally invasive surgery using the MIRA Surgical System.

Brief summary: The purpose of the MIRA Surgical System Registry is to accumulate and evaluate real world evidence experience as part of post-market surveillance using the MIRA Surgical System.

The studies primary goals are to:

* To evaluate the performance of the MIRA Surgical System
* To evaluate the Device Safety profile


Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery using the MIRA Surgical System
* Subject is able to provide informed consent
* Subject is available for post operative follow up visit through 30 days

Exclusion Criteria:

* Has or is participating in another clinical trial which may confound study results
* In the opinion of the investigator, patient is not likely to complete post-operative care and/or return for standard follow-up.

Primary outcomes:
measure: Performance of MIRA Surgical System
timeFrame: From time of procedure through completion of the surgical procedure
measure: Device Safety
timeFrame: From time of surgery using the MIRA Surgical System through 30 days following surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Bryan Medical Center
state: Nebraska
Study officials:
affiliation: Virtual Incision Corporation
name: Piet Hinoul, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04402307: Effect of Training of Patients With Dysphagia
Official title: Effect of Training of Patients With Dysphagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Keywords: Training
Effect
Elderly
Lead sponsor: Regionshospital Nordjylland
Sponsor class: OTHER_GOV
First posted: 2020-05-26
Enrollment: 93
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: Effect of training of patients with dysphagia

Detailed description: A randomised controlled study in the effect of training in patients with dysphagia.

The patients are randomised for training or for usual care.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with dysphaigia
* Patients living in the participating locations

Exclusion Criteria:

* Patients who are linguistically or cognitively unable to participate
* Patients who are unable to collaborate about the training
* Palliative patients
* Patients with a probe

Primary outcomes:
measure: Readmission
timeFrame: 6 months
Secondary outcomes:
measure: Change in Quality of life
timeFrame: 3 months
measure: Cost effectiveness
timeFrame: 6 months
measure: Mortality
timeFrame: 6 months
measure: Swallowing function
timeFrame: 3 months
Other outcomes:
Locations:
city: Brovst
country: Denmark
facility: Jammerbugt municipality
city: Brøndby
country: Denmark
facility: Brøndby municipality
city: Frederikshavn
country: Denmark
facility: Frederikshavn municipality
city: Hjørring
country: Denmark
facility: Hjørring municipality
city: Kolding
country: Denmark
facility: Kolding municipality
city: Odense
country: Denmark
facility: Odense municipality
city: Slagelse
country: Denmark
facility: Slagelse municipality
city: Tønder
country: Denmark
facility: Tønder municipality
Study officials:
affiliation: Regionshospital Nordjylland
name: Dorte M Kristiansen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05729607: Vertical Soft Tissue Augmentation With CTG vs ADM
Official title: Vertical Soft Tissue Augmentation With Dermal Matrix and Enamel Matrix Derivative vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences in the Esthetic Zone: A Randomized, Controlled, Clinical, Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Implant Complication
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel-arm
Primary purpose: TREATMENT

Brief summary: The study aims at comparing two different approaches for vertical soft tissue augmentation at implant sites exhibiting soft tissue dehiscences: autogenous connective tissue graft vs acellular dermal matrix + enamel matrix derivative

Detailed description: The present randomized clinical trial aims at investigating two approaches (autogenous connective tissue graft vs acellular dermal matrix + enamel matrix derivative) when performed for vertical soft tissue augmentation at sites with peri-implant soft tissue dehiscences. Clinical, volumetric, ultrasonographic, and patient-reported outcomes will be evaluated at different time points up to 1 year.

Eligibility criteria: Inclusion criteria:

* Age ≥ 18 years
* Periodontally and systemically healthy
* Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)
* Presence of single functional dental implant in the anterior with a PSTD
* Implants diagnosed as healthy (Berglundh et al., 2018)

Exclusion criteria are:

* Contraindications for surgery
* Systemic condition (e.g. diabetes mellitus, HIV, cancer, etc) that could compromise wound healing
* Patients pregnant or attempting to get pregnant (self-reported)
* Untreated periodontitis
* Untreated peri-implant mucositis or peri-implantitis (Berglundh et al., 2018)
* Smoking, defined as self-reported daily habit. Occasional smokers won't be excluded
* History of soft tissue grafting at the implant site within the last 6 months

Primary outcomes:
measure: Change in Soft tissue dehiscence depth
timeFrame: 12 months
Secondary outcomes:
measure: Complete peri-implant soft tissue dehiscence (PSTD) coverage
timeFrame: 12 months
measure: mean peri-implant soft tissue dehiscence (PSTD) coverage
timeFrame: 12 months
measure: Mucosal thickness changes
timeFrame: 3, 6, and 12 months
measure: 3D Volumetric changes
timeFrame: 3, 6, and 12 months
measure: Post-operative pain
timeFrame: 14 days after the surgery
measure: Professional esthetic assessment (IDES)
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Harvard School of Dental Medicine, Boston, USA
name: Lorenzo Tavelli, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05628207: Evaluation of the SCALED (SCaling AcceptabLE cDs)
Official title: Evaluation of the SCALED (SCaling AcceptabLE cDs) Approach for the Implementation of Interoperable CDS for Venous Thromboembolism Prevention - CDS Data
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Venous Thromboembolism
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2022-11-28
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients age 18 and older admitted with a TBI will be eligible for inclusion.

Brief summary: This project will adapt a currently deployed Clinical Decision Support (CDS) system to deliver a VTE prevention guideline for adult patients with traumatic brain injury (TBI). We believe this is an ideal PCOR use case given PCORI's continued effort to combat VTE in trauma and our experience previously implementing this guideline. The Our overall goal is to successfully scale, evaluate, and maintain an interoperable TBI CDS across 7 total institutions.


Eligibility criteria: Inclusion Criteria:

* age 18 and older
* admitted with a TBI

Exclusion Criteria:

* Patients who die within 24 hours of hospital admission and patients documented as "comfort cares" during the first 72 hours of hospitalization or with mild TBI will be excluded from final analysis.

Primary outcomes:
measure: primary effectiveness outcome
timeFrame: 2 years and a half
measure: Evaluate implementation strategy guided by the EPIS Implementation
timeFrame: 2 years and a half
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References: