louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01640912: Evaluation of the Safety, Pharmacokinetics, and Preliminary Effect on Scar Formation by RXI-109
Official title: A Phase 1 Single Center, Randomized, Double-Blind, Ascending Dose, Within-Subject Controlled Study of RXI-109 for the Treatment of Incision Scars Made in the Pannus of Healthy Women Who Will Later Undergo Elective Abdominoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cicatrix
Scar Prevention
Keywords: Scar
Scar prevention
Fibrosis
Lead sponsor: RXi Pharmaceuticals, Corp.
Sponsor class: INDUSTRY
First posted: 2012-07-16
Enrollment: 15
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the safety and tolerability of a single intradermal administration of RXI-109 at small surgical incisions in the abdominal skin that will later be removed during an elective abdominoplasty. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually and histologically.


Eligibility criteria: Inclusion Criteria:

* Subject must be a female in general good health with normal screening values
* Subject must be a good surgical candidate for an elective abdominoplasty
* Subjects must not be pregnant or lactating and utilize an effective method of contraception (if child-bearing potential exists)

Exclusion Criteria:

* Currently pregnant or lactating
* BMI greater than 35 at screening
* Use of tobacco or nicotine-containing products within the month prior to enrollment and while on study
* Any medical condition or current therapy which would make the subject unsuitable for this study in the opinion of the PI

Primary outcomes:
measure: To assess the safety and tolerability of intradermal administration of RXI-109
timeFrame: 12 weeks
Secondary outcomes:
measure: To assess the effect of RXI-109 on scar formation following small surgical incisions
timeFrame: 12 weeks
Other outcomes:
Locations:
city: St. Louis
country: United States
state: Missouri
Study officials:
References:
Clinical trial NCT04008212: Fusion Imaging for EVAR With Mobile C-arm
Official title: Feasibility of Computer-assisted Aortic and Iliac Endovascular Procedures With Mobile C-arm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fusion Imaging for EVAR
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 59
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients eligible for endovascular treatment of aneurysm disease of the aorta.

Brief summary: Fusion imaging is a technique that facilitates endovascular navigation but is only available in hybrid rooms. The goal of this study is to evaluate the feasibility of fusion imaging with a mobile C-arm in a conventional operating room through the use of an angio-navigation station.

Detailed description: The study include all patients who underwent an aortic stent graft procedure in a conventional operating room with a mobile flat-panel detector (Cios Alpha, Siemens) connected to an angio-navigation station (EndoNaut, Therenva). The intention is to perform preoperative 3D CT/perioperative 2D fluoroscopy fusion Imaging using an automatic registration process. Registration is considered successful when the software was able to correctly overlay preoperative 3D vascular structures onto the fluoroscopy image. For EVAR, contrast dose, operation and fluoroscopy time were compared to those of a control group drawn from the department's database who underwent a procedure with a C-arm image intensifier.

Eligibility criteria: Inclusion Criteria:

Patients eligible for endovascular treatment of aneurysm disease of the aorta. Procedure performed in a conventional operating room equipped with a mobile flat-panel detector (30´30 cm) (Cios-Alpha, Siemens®, Munich, Germany) and a floating table.

Patients who received written and verbal information about the protocol and did not object to participating in the trial.

Exclusion Criteria:

Patients who also required a conventional surgical revascularisation procedure or who required an endovascular revascularisation procedure in another site.

Patients who underwent MR angiography during preoperative evaluation. Non-analysable CT angiogram (no or poor injection). Procedure performed in a hybrid room or in an operating room not equipped with a mobile flat-panel detector.

Primary outcomes:
measure: Feasibility of fusion imaging
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00018512: Biological Specifications for Denture Designs
Official title: Biological Specifications for Denture Designs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tooth Loss
Keywords: dental implant
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary term goal of these research efforts has been to enhance the functional status, comfort and quality of life of edentulous patients by evaluating clinical procedures, denture designs and adjunctive therapies based upon a clear understanding of: (1) oral functional impairments caused by the loss of teeth and subsequent tissue changes; (2) neurophysiological mechanisms associated with oral functions; (3) metabolism of oral tissues; and (4) interactions between biological and psychological processes and denture characteristics. The primary purpose of the proposed clinical outcome study is to compare the relative efficacies of three different combinations of implant-supported maxillary and mandibular prostheses with traditional complete dentures for edentulous patients. Completion of this study will determine the relative cost-effectiveness of the implant-supported denture treatments for use in the general population of edentulous patients.


Eligibility criteria: Inclusion criteria:

* Completely edentulous veterans with clinically acceptable conventional dentures.
* Both male and female applicants will be accepted and the prospective participants will be from 35 to 80 years of age.
* Patients who have been completely edentulous for at least two years and have clinically acceptable conventional dentures, which have been worn for at least 6 months.

Exclusion criteria:

* Verified history of medical conditions such as connective tissue disorders, blood dyscrasias, uncontrolled endocrine disorders, active tuberculosis, AIDS, leukemias, Hodgkins, liver disfunction, osteoporosis, chronic nephritis, any chronic condition with life expectancy of less than five years as well as patients on long-term steroids, anticoagulants, and radiation therapy.
* Extremely poor oral hygiene. Oral hygiene condition will be assessed from the amount of food debris, plaque and calculus in their present dentures.
* Insufficient mandibular or maxillary bone height to accommodate 10 mm long implants in potential implant sites.
* Presence of temporomandibular joint dysfunction and evidence of severe bruxism.
* Physician determines a contraindication for oral surgery.
* Candidate expresses reservations about participating for at least three years.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
Study officials:
References:
Clinical trial NCT02683512: GBE Deficiency (GSD IV and APBD) Natural History Study
Official title: GBE Deficiency (GSD IV and APBD) Natural History Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glycogen Storage Disease Type IV
Adult Polyglucosan Body Disease
GSD4
GSD IV
APBD
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with GBE deficiency, diagnosed as GSD IV or APBD, regardless of gender or ethnicity, are eligible for enrollment.

Brief summary: Collection and review of clinical information related to glycogen branching enzyme (GBE) deficiency, diagnosed as Glycogen Storage Disease Type IV (GSD IV) or Adult Polyglucosan Body Disease (APBD generated during clinic visits.

Detailed description: This natural history study will serve as a repository of clinical, laboratory, and biochemical information on individuals with GBE deficiency, diagnosed as either GSD IV or APBD. This information will allow a more definitive description of GBE deficiency to be developed, which will permit development of treatment strategies for this disease.

Duke will be the only site where this study takes place. However, since this is a rare disorder, participants who receive care for GBE deficiency at other institutions will be included. We will collect retrospective data from patient charts on diagnosed individuals, as far back as necessary to capture the clinical course of the disorder. Prospective data collected from patient charts after enrollment will be captured as well. Participant's medical records will be continually reviewed for the duration of the study.

Data will be collected from medical records and will only pertain to clinically relevant information, including, but not limited to: demographic and diagnostic information, tissue biopsy results, medical and family history, review of systems, imaging studies, results of liver, muscle, and nerve function testing, and urine and blood laboratory results.

Eligibility criteria: * Diagnosis of GSD IV or APBD via:

  * Two variants in the GBE1 gene
  * Deficient GBE activity in liver, muscle, skin fibroblast or other tissue
  * One variant in GBE1 gene with evidence of disease that is pathogenic, per the clinician
* Able to provide informed consent for self (adults) or affected individual (minor or adults with a legally authorized representative)
* Able to provide consent for release of medical records
* Pregnant women with a diagnosis of GSD IV or APBD will be included
* Histology as confirmed by clinician

Primary outcomes:
measure: Progression of disease
timeFrame: Duration of study, approximately 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Priya Kishnani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04478812: Tbit System Precision and Correlation of Different Blood Samples
Official title: A Prospective, Multi-Center, Blood Collection Study to Evaluate TbitTM System Precision and Correlation Between Different Blood Samples Measured With TbitTM System
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Brain Injuries
Traumatic Brain Injury
Lead sponsor: NanoDx
Sponsor class: INDUSTRY
First posted: 2020-07-21
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The Tbit™ System will detect S100B and GFAP concentrations with the blood specimen to produce and compare repeated measures from 3 blood samples from 3 fingersticks from one subject and one 1 venous whole blood sample will be collected from the same subject, on 3 different Tbit™ System by 3 different operators.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Presents to the Emergency Department with suspected traumatic brain injury
* Blood sample collected for Tbit™ System within 12 hours of injury
* Willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)

Exclusion Criteria:

* Suspect of ischemic or hemorrhagic stroke with subsequent incidental trauma based on ED examination
* Subject suspect of need of craniotomy for the acute trauma for this event
* External signs compatible with a depressed skull fracture based on ED exam
* Subject requiring administration of blood transfusion after injury and prior to study blood draw
* Subject for whom timing of injury is unable to be estimated within 1 hour of certainty
* Subject who had neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizures, brain tumors, stroke or TIA within the last 30 days, or history of neurosurgery
* Known or suspected to be pregnant
* Prisoner or under incarceration
* Participating in another clinical research study prior to this study completion

Primary outcomes:
measure: Measurement Repeatability
timeFrame: within 12 hours from injury for Tbit and within 30 min from the sample drawn
measure: Compare Measurements
timeFrame: within 12 hours from injury
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medicept Inc.
name: Jerika Acosta, BSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT01443312: Demographic, Clinical, Laboratory and Genetical Characteristics of Patients With Beta Thalassemia Intermedia
Official title: Demographic, Clinical, Laboratory and Genetical Characteristics of Patients With Beta Thalassemia Intermedia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thalassemia
Keywords: Beta globin gene
Alfa globin gene
xmn1 polymorphism
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2011-09-29
Enrollment: 28
Sex: ALL
Minimum age (years): 1
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with beta Thalassemia Intermedia.

Brief summary: The definition of Thalassemia Intermedia is not generally accepted and the specific clinical and laboratory characteristics varies between patients. Some patients are blood transfusion dependent and others are occasionally transfused. Also the mutations in the beta globin gene are diverse. Another mutations including mutations in the alfa globin gene and in the xmn1 gene can affect the clinical course of this disease. The purpose of this study is to summarize the characteristics of patients with Thalassemia Intermedia treated at the Pediatric Hematology Unit at the HaEmek Medical Center in Israel

Detailed description: The characteristics that will be recorded from the medical files include: demographic data, included gender and ethnic origin, family history, age at diagnosis, number and frequency of blood transfusions including age of first transfusion and physical examination findings.

The laboratory data included iron metabolism parameters, mutation in the alfa and beta gene and the presence of the xmn1 polymorphism.

Eligibility criteria: Inclusion Criteria:

-All patients treated at the Pediatric Hematology Unit

Exclusion Criteria:

* Not enough medical records.
* Patients who refuse to give consent to perform genetic studies will be included in the study but only the retrospective clinical data will be recorded.

Primary outcomes:
measure: The characteristics of patients with thalassemia intermedia
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric Hematology Unit - Ha'Emek Medical Center
Study officials:
affiliation: Ha'Emek Medical Center, Afula, Israel
name: Ariel Koren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04194112: Diagnostic Performance and Predictive Capacity of Immediate Urine Cytology After Transurethral Resection of Non-Muscle Invasive Bladder Cancer; A Prospective Study
Official title: Diagnostic Performance and Predictive Capacity of Immediate Urine Cytology After Transurethral Resection of Non-Muscle Invasive Bladder Cancer; A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The current study aimed at prospectively assessing the performance of IUC as a predictive tool for residual tumor after primary TURBT of NMIBC, and possible future recurrence.

Detailed description: The current study aimed at prospectively assessing the performance of IUC as a predictive tool for residual tumor after primary TURBT of NMIBC, and possible future recurrence.

Eligibility criteria: Inclusion Criteria:

-patients with primary or recurrent NMIBC for whom complete TURBT was done

Exclusion Criteria:

-Patients with concomitant CIS, upper tract urothelial tumors, biopsy proven muscle invasion, or low risk NMIBC (single, primary, Ta, G1 tumor).

Primary outcomes:
measure: Diagnostic performance of IUC
timeFrame: It was assessed 48 hours after primary TURBT
Secondary outcomes:
measure: The secondary outcome included the evaluation of predictive capacity of IUC for tumor recurrence in the study participants.
timeFrame: Within duration of follow up (4 years )
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01629212: Comparison of the Efficacy and Safety of Tiropramide and Octylonium in the Treatment of Irritable Bowel Syndrome
Official title: Comparative and Analytical Study for Effectiveness and Safety of Tiropramide HCl and Octylonium Bromide in the Treatment of Irritable Bowel Syndrome: Mullticenter, Randomized, Double Blind, Active Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2012-06-27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the Efficacy and Safety of Tiropramide HCl and Octylonium bromide in the Treatment of Irritable Bowel Syndrome.


Eligibility criteria: Inclusion Criteria:

1. Adult patients (aged 20-75 years)
2. Patients who had been suffered from IBS as defined by Rome III criteria
3. Patients who had abdominal pain at least 2 days/week, during the run-in period of 2 weeks

Exclusion Criteria:

1. Patients with known intolerance to tiropramide or octylonium
2. Patients with uncontrolled diabetes, uncontrolled hypertension or thyroid dysfunction
3. Patients who had the history of cancer \[However, patients with cancer other than gastrointerstinal cancer, who have not recurr within 5 years after treatment were possible for enrollment\]
4. Patients with hepatic or renal dysfunction
5. Patients with lactose intorelance

Primary outcomes:
measure: Change of abdominal pain VAS scores from baseline to week 4
Secondary outcomes:
measure: Change of abdominal pain VAS scores from baseline to week 2
measure: Change of abdominal discomfort VAS scores from baseline to week 2 and 4
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Han Yang University Hospital
Study officials:
References:
Clinical trial NCT00860912: Veritas Collagen Matrix Cystocele Repair Study - Postmarketing
Official title: Veritas Collagen Matrix Cystocele Repair Study - Postmarketing Protocol #CP1004
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Veritas
Cystocele
Prolapse
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2009-03-13
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: collagen graft reinforcement
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the Veritas Collagen Matrix in treating female patients with documented occurence of Pelvic Organ Prolapse as evidenced by a cystocele.

Detailed description: Surgery for cystocele repair to be performed. Native tissue repair to be randomized versus reinforcement with Collagen matrix

.

Eligibility criteria: Inclusion Criteria:

* Patient is equal or greater than 18 years old
* Female
* Meets follow-up evaluation time frame
* Understands the nature of the procedure and has provided written informed consent
* Is scheduled to undergo vaginal pelvic reconstructive surgery
* Has \> 2nd degree midline cystocele

Exclusion Criteria:

* Presence of severe mucosal ulceration
* Previous pelvic organ prolapse surgery using an implant that will affect the use of the VCM or affect the outcome of the study
* Allergy to bovine material
* Severe mucosal atrophy
* Shortened vaginal length as determined by Investigator
* Pregnant or intends to become pregnant during study
* Has a UTI
* Has vault prolapse \< 2nd degree cystocele

Primary outcomes:
measure: To evaluate the ability of the VCM to treat pelvic organ prolapse as demonstrated by improvement of cystocele as measured by a comparison of POP-Q scores pre and post surgery
timeFrame: 2 years
Secondary outcomes:
measure: To evaluate patient satisfaction as measured by a comparison of Quality of Life questions at baseline and post surgery
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Cleveland Clinic Florida
name: Guillermo W Davila, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guerette NL, Peterson TV, Aguirre OA, VanDrie DM, Biller DH, Davila GW. Anterior repair with or without collagen matrix reinforcement: a randomized controlled trial. Obstet Gynecol. 2009 Jul;114(1):59-65. doi: 10.1097/AOG.0b013e3181a81b41.