louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00026026: Linkage and Identification of (a) Candidate Gene(s) for Tooth Disorders
Official title: Linkage and Identification of (a) Candidate Gene(s) for Tooth Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anodontia
Keywords: Human tooth agenesis
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2001-11-07
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL

Brief summary: The congenital absence of teeth, commonly referred to as hypodontia or tooth agenesis, is a common developmental anomaly of human dentition that affects approximately 20% of the population. Although new genetic and molecular approaches in humans and mice have increased our understanding of the molecules that control tooth patterning (number, position, shape and size), the precise nature of the genes involved in hypodontia in humans is poorly understood. Hence, understanding the molecular basis for missing teeth is an issue of paramount importance that is both timely and significant to the practice of dentistry. So far, only two genes have been associated with non-syndromic familial tooth agenesis: MSX1 and PAX9. Substitution mutations in the homeodomain region of MSX1 were linked to premolar agenesis while an insertion mutation in the paired box domain of PAX9 was shown to be responsible for molar oligodontia.

The long-term goals of this research are to elucidate the molecular pathology of human tooth agenesis, in particular, to evaluate whether genes other than MSX1 and PAX9 (locus heterogeneity) are involved. Alternatively, as in the case of MSX1, it will be interesting to know whether allelic variations, different mutations in these genes, are associated with tooth agenesis. We propose to study a potentially large kindred that report the developmental absence of several posterior teeth. The fundamental hypothesis to be tested states that the gene responsible for the congenital absence of molar teeth in this kindred is a critical element in the genesis of molars. The specific goals are to perform linkage analysis followed by direct sequencing of PCR products to identify the gene and to characterize the nature of the underlying defect. Identifying the underlying gene defect in this family affected by tooth agenesis will add new knowledge to our understanding of the pathogenesis of this defect and will provide the basis for future studies.


Eligibility criteria: * Patients affected with non-syndromic tooth agenesis and non-affected family members

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
References:
Clinical trial NCT00438126: Family-Centered Diabetes Project - Sharing Wisdom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Metabolic Syndrome
Overweight
Obesity
Keywords: diabetes
Prevention
American Indian
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2007-02-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a randomized trial of an educational intervention to reduce the risk of diabetes among urban American Indian women

Detailed description: Two hundred American Indian women aged 18 to 40 years were recruited from a large Southwest city to participate in a type 2 diabetes prevention intervention. Half of the women were randomized to participated in the educational intervention and half were assigned to a delayed intervention. Measures were obtained at baseline, 6-months,12-months and 18-months.

Eligibility criteria: Inclusion Criteria:

* American Indian women
* Aged 18-40 years
* Living in Albuquerque area
* Not having diabetes

Exclusion Criteria:

* Pregnancy
* Planning to become pregnant within 2 years
* Diagnosed with diabetes fasting blood glucose \> 126 planning to move out of town in next 2 years

Primary outcomes:
measure: decreased dietary fat intake
measure: increased vegetable consumption
measure: increased self-reported leisure physical activity
Secondary outcomes:
measure: fasting glucose
measure: HOMA
measure: serum free insulin
measure: Body Mass Index
measure: waist circumference
measure: decreased dietary intake of total sugar
measure: decreased time watching television
measure: resting blood pressure
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico School of Medicine
state: New Mexico
Study officials:
affiliation: Univeristy of New Mexico
name: Carla J Herman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Willging CE, Helitzer D, Thompson, J 'Sharing Wisdom': Lessons learned during the development of a diabetes prevention intervention for urban American Indian women Evaluation and Program Planning 29 (2006) 130-140
citation: Helitzer D, Peterson AB, Thompson J, Fluder S. Development of a planning and evaluation methodology for assessing the contribution of theory to a diabetes prevention lifestyle intervention. Health Promot Pract. 2008 Oct;9(4):404-14. doi: 10.1177/1524839906289076. Epub 2006 Jul 21.
citation: Thompson JL, Allen P, Helitzer DL, Qualls C, Whyte AN, Wolfe VK, Herman CJ. Reducing diabetes risk in American Indian women. Am J Prev Med. 2008 Mar;34(3):192-201. doi: 10.1016/j.amepre.2007.11.014.
Clinical trial NCT04045626: Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns
Official title: Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Progressive Keratoconus
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess depth of demarcation line in transepithelial versus epithelium-off accelerated cross-linking in keratoconus patients

Detailed description: Anterior segment optical coherence tomography "OCT" will be performed to evaluate the corneal stroma for the presence of demarcation line 1 month postoperatively by an independent observer unware of purpose of study

Eligibility criteria: Inclusion Criteria:

* progressive keratoconus stage 1-2

Exclusion Criteria:

* any concomitant ocular disease

Primary outcomes:
measure: evaluation of depth of demarcation line
timeFrame: 1 month postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al Ainy teaching hospital
Study officials:
affiliation: Kasr Al Ainy, cairo university
name: Sarah Azzam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salah Y, Omar K, Sherif A, Azzam S. Study of Demarcation Line Depth in Transepithelial versus Epithelium-Off Accelerated Cross-Linking (AXL) in Keratoconus. J Ophthalmol. 2019 Sep 26;2019:3904565. doi: 10.1155/2019/3904565. eCollection 2019.
Clinical trial NCT01843426: Aortic Stenosis Pre-Transcatheter Aortic Valve Replacement (TAVR) Procedure CT Scan
Official title: Diagnostic Image Quality and Safety of Low-Volume, Low-Concentration, Iso-Osmolar Contrast Medium in the Computed Tomographic Workup of Patients Considered for TAVR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Comorbidity
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: General Electric
First posted: 2013-04-30
Enrollment: 40
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: The purpose of this study is to evaluate contrast media volume, safety and 30-day outcome of patients after a computed tomography (CT) scan. The results of this study will help to determine the minimum volume of contrast material that can be used to ensure patient safety while not compromising diagnostic image quality in high-risk patients.

Detailed description: The scholarly rationale for the study is to determine the feasibility of restricting the contrast media volume to 60ml of 270mg Iodine (mgI)/ml iodixanol or less to accomplish sufficient intravascular attenuation for comprehensive CT assessment prior to TAVR. The study will also evaluate the effects of contrast media administration on our subjects' kidney function by performing serum creatinine measurements at baseline, as well as at three days and thirty days after contrast media administration.

Eligibility criteria: Inclusion Criteria:

1. Subject must be 18-90 years of age.
2. Subject must have been referred for a clinically indicated CT prior to TAVR.
3. Subject must provide written informed consent prior to any study-related procedures being performed.
4. Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria:

1. Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:

   * By testing (serum or urine βHCG) within 24 hours before contrast agent administration, or
   * By surgical sterilization, or
   * Post menopausal, with minimum one (1) year history without menses.
2. Subject has an acute psychiatric disorder or is cognitively impaired.
3. Subject is using or is dependent on substances of abuse.
4. Subject is unwilling to comply with the requirements of the protocol.
5. Subject has previously entered this study.
6. Subject has an allergy against iodinated contrast agents.
7. Subject is in acute unstable condition.

Primary outcomes:
measure: Clinically Diagnostic CT Assessments
timeFrame: up to 2 years
Secondary outcomes:
measure: Image Quality
timeFrame: up to 2 years
measure: Safety
timeFrame: up to 2 years
measure: Long-term Follow-Up
timeFrame: up to 4 years
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Joseph Schoepf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01684826: X-ray Dose Reduction Study for Cardiac Angiography and Intervention
Official title: Clinical Validation and Evaluation of ClarityIQ Cardiac Image Processing for Cardiac Angiography and Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Diseases
Keywords: X-rays
Image processing
Cardiovascular procedure
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2012-09-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose significantly. This is realized by anatomy-specific optimization of the full acquisition chain (grid switch, beam filtering, pulse width, spot size, detector and image processing engine) for every clinical task individually. Furthermore, smaller focal spot sizes and shorter pulses are used, which are known to positively influence image quality . The final effect on the clinical image quality is investigated in this study.

Detailed description: Fluoroscopically guided procedures are associated with a risk of radiation injury to the skin, caused by high peak skin dose. The increasingly complex nature of many of the interventions performed requires the use of significant amounts of radiation for their completion. Of particular relevance to dose reduction concerns are obese patients, for whom additional radiation is often necessary to obtained sufficient diagnostic quality, as well as patients suffering from chronic total coronary occlusions (CTO), for whom long procedures with extended radiation time and contrast usage are common.

In order to introduce a dose reduction technology the most important aspect is to validate the diagnostic image information. Philips has developed a new algorithm that is capable to process images with similar image quality but acquired at lower dose.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years of age undergoing coronary angiography

Exclusion Criteria:

* Patients not willing or unable to give consent to participate
* Patients already involved in a clinical trial
* Patients under the age of 18
* Pregnant women and breastfeeding women
* Patients with severe kidney disease (eGFR \< 60)

Primary outcomes:
measure: Image Quality
timeFrame: 1 day
Secondary outcomes:
measure: Radiation Dose Measurements: Dose Area Product (DAP)
timeFrame: Participants were followed for the duration of the procedure
Other outcomes:
measure: Radiation Dose Measurements: Air Kerma (AK)
timeFrame: Participants were followed for the duration of the procedure
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
Study officials:
affiliation: Radboud University Nijmegen Medical Center
name: Harry Suryapranata, Prof Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04856826: Placement of Peripheral Venous Catheters Under Echo Guidance in a Post-emergency Medical Service
Official title: Placement of Peripheral Venous Catheters Under Echo Guidance in a Post-emergency Medical Service
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Catheterization, Peripheral
Echography
Hospital Units
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 276
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: Compare the number of attempts to place a peripheral venous catheter in the group of patients hospitalized in the post-emergency unit and benefiting from echo guidance and therapeutic communication, to the group of patients hospitalized on the post-emergency unit using traditional technique.


Eligibility criteria: Inclusion Criteria:

* Hospitalized in the post-emergency unit
* Requiring the placement of a venous catheter in the post-emergency unit
* Affiliation to social security or benefiting from such a scheme
* Informed and written consent signed

Exclusion Criteria:

* Protected person (art. L1121-5 to L1121-8 of the CSP)
* Patient included in another interventional study
* Patient already included for a first catheter placement in the post-emergency unit.

Primary outcomes:
measure: successful placement of a venous catheter on the first attempt
timeFrame: within the hour after insertion of peripheral venous catheter
Secondary outcomes:
measure: patient experience
timeFrame: within the hour after insertion of peripheral venous catheter
measure: number of attempts to insert a peripheral venous catheter
timeFrame: within the hour during insertion of peripheral venous catheter
measure: number of calls for a second nurse in the service
timeFrame: within the hour during insertion of peripheral venous catheter
measure: number of calls to a nurse anesthetist
timeFrame: within the hour during insertion of peripheral venous catheter
measure: location of the final placement site
timeFrame: within the hour during insertion of peripheral venous catheter
measure: the caliber of the catheter placed
timeFrame: within the hour during insertion of peripheral venous catheter
measure: infectious or thromboembolic events
timeFrame: 4 days
measure: duration of catheter placement
timeFrame: within the hour during insertion of peripheral venous catheter
measure: functional life of the catheter
timeFrame: 4 days
measure: Satisfaction of nursing staff
timeFrame: at the end of study inclusion, at 6 month
Other outcomes:
Locations:
city: La Tronche
country: France
facility: CHU Grenoble Alpes
Study officials:
affiliation: University Hospital, Grenoble
name: Perrine Dumanoir
role: STUDY_CHAIR
References:
Clinical trial NCT05427526: Outcome of Zeiss AT LARA EDOF Lens Implantation in Vitrectomized Eyes
Official title: Outcome of Zeiss AT LARA EDOF Lens Implantation in Vitrectomized Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitreous Disorder
Cataract
Keywords: LARA EDOF lens
Intra ocular lensimplantation
cataract
vitrectomy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group 1: patients that had a LARA IOL implanted in combination with vitrectomy group 2: patients that had a LARA IOL implanted in during surgery for cataract secondary to vitrectomy
Primary purpose: DIAGNOSTIC

Brief summary: To determine the surgical outcome and patient satisfaction in patients who underwent AT LARA lens implantation during or after vitrectomy at a relatively young age (around 55 years of age), mostly to treat (urgent) retinal detachment.

Detailed description: The surgical outcome is defined as the patient satisfaction determined by patient questionnaires.

* Visual quality: CatQuest questionnaire
* Near vision: NAVS questionnaire
* Glare: APPLES questionnaire

These questionnaires are standardized and validated, although no cut-off values have been determined. Hence, the results drawn from these questionnaires are descriptive only.

Eligibility criteria: Inclusion Criteria:

* patients that had a LARA IOL implanted in combination with vitrectomy.
* patients that had a LARA IOL implanted in during surgery for cataract secondary to vitrectomy.

Exclusion Criteria:

* Patients with a LARA IOL implanted without concomitant or earlier vitrectomy

Primary outcomes:
measure: visual quality
timeFrame: 2 weeks
measure: near vision
timeFrame: 2 weeks
measure: glare
timeFrame: 2 weeks
Secondary outcomes:
measure: Binocular performance
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Peter Stalmans, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00808626: Phase II Investigation of 99mTc-rBitistatin for Imaging Venous Thrombosis
Official title: Phase II Investigation of 99mTc-rBitistatin for Imaging Venous Thrombosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Venous Thrombosis
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2008-12-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 99mTc-rBitistatin is a radiolabeled polypeptide which is designed to stick to blood clots so that the blood clots can be detected by imaging. The purpose of this trial is to evaluate in patients the safety of 99mTc-rBitistatin and its ability to locate blood clots in the arms and legs.


Eligibility criteria: Inclusion Criteria:

* peripheral acute venous thrombosis diagnosed by vascular ultrasound
* is able to give informed consent
* is likely to complete the study

Exclusion Criteria:

* is pregnant
* is lactating
* has a history of prior severe allergic reactions (anaphylactic response)
* prior use of GP IIb/IIIa antagonist (e.g., abciximab, eptifibatide)
* has a platelet count \<100,000 or history of thrombocytopenia
* has a history of stroke
* has a history of recent bleeding documented by decreasing hemoglobin (\>1 gm) in last 7 days

Primary outcomes:
measure: Establish the proof of concept that 99mTc-rBitistatin enables imaging of peripheral venous thrombi
timeFrame: 1-4 hours after administration
Secondary outcomes:
measure: Continue to evaluate the safety of 99mTc-rBitistatin administered intravenously
timeFrame: 0-4 hr, 6 hr, 3-4 weeks, 3-4 months after administration
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Temple University Hospital
name: Alan H Maurer, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04644926: The Effect of Remote Ischemic Conditioning on the Microcirculation in Sepsis
Official title: Effects of Remote Ischemic Conditioning on Microcirculatory Alterations in Patients With Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Septic Shock
Sepsis
Keywords: Microcirculation
Remote ischemic conditioning
Sepsis
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an evaluation of the effect of Remote ischemic conditioning on sublingual microcirculation in patients with sepsis.

Detailed description: This prospective open-label trial is performed in mixed ICU in a tertiary teaching hospital. Investigators include patients with sepsis or septic shock within the first 24 h after ICU admission. Remote ischemic conditioning (RIC) procedure comprise three repetitions of brachial cuff inflation to 200 mmHg for five minutes following deflation to 0 mmHg for another five minutes. The procedure overall took 30 minutes. RIC is performed at inclusion and repeated 12 h and 24 h later. Sublingual microcirculatory measurements are obtained before and after each RIC procedure, using incidence dark field (IDF) device.

Eligibility criteria: Inclusion Criteria:

* Patients with sepsis or septic shock within the first 24 h after ICU admission.

Exclusion Criteria:

* age \< 18 years,
* pregnancy,
* advanced malignancy,
* peripheral artery disease affecting both arms,
* oral mucosal inflammation or injury or technical difficulties in obtaining sublingual images.

Primary outcomes:
measure: Microvascular flow index (MFI) and Proportion of perfused small vessels (PPV)
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian university of health sciences
Study officials:
References:
citation: Kiudulaite I, Belousoviene E, Vitkauskiene A, Pranskunas A. Effects of remote ischemic conditioning on microcirculatory alterations in patients with sepsis: a single-arm clinical trial. Ann Intensive Care. 2021 Apr 7;11(1):55. doi: 10.1186/s13613-021-00848-y.