louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01202578: Evaluation of the Tympanostomy Tube Delivery System
Official title: A Clinical Study of the Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Otitis Media With Effusion
Acute Otitis Media
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Acclarent
First posted: 2010-09-16
Enrollment: 53
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with either chronic otitis media with effusion or acute otitis media and scheduled to undergo tympanostomy tube insertion

Exclusion Criteria:

* Reaction to anesthesia
* Markedly atrophic, bimeric, severely retracted, atelectatic or perforated tympanic membrane
* Otitis externa
* Active acute otitis media
* Otitis media pathology requiring T-tubes
* Stenosed ear canal
* Anatomy that precludes visualization and access to tympanic membrane
* Anatomy that necessitates tympanostomy tube placement in posterior half of membrane

Primary outcomes:
measure: Safety of Tympanostomy Tube (TT) Delivery System
timeFrame: 7 days
measure: Device Success
timeFrame: 0 days
Secondary outcomes:
measure: Proportion of Subjects With Procedure Success
timeFrame: 0 days
measure: Tube Retention
timeFrame: 7 days
Other outcomes:
Locations:
city: Port Saint Lucie
country: United States
facility: South Coast ENT
state: Florida
city: Louisville
country: United States
facility: Advanced ENT and Allergy
state: Kentucky
city: San Antonio
country: United States
facility: Ear Medical Group
state: Texas
city: Kirkland
country: United States
facility: Evergreen Sinus Center
state: Washington
Study officials:
affiliation: Evergreen Sinus Center
name: Kenneth Faw, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Advanced ENT and Allergy
name: Andrew Gould, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ear Medical Group
name: Charles Syms, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: South Coast ENT
name: Jacob Zeiders, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03029078: FEcal Transplant, a Hope to Eradicate Colonization of Patient Harboring eXtreme Drug Resistant Bacteria?
Official title: FEcal Transplant, a Hope to Eradicate Colonization of Patient Harboring eXtreme Drug Resistant Bacteria?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Microbial Colonization
Bacterial Peritonitis
Faeces Smearing
Keywords: XDR
fecal microbiota transplant
eradicate
colonization
CRE
GRE
bacteria
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2017-01-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study of patients colonized by either CRE or GRE will be enrolled in order to evaluate the impact of fecal microbiota transplant on the eradication of XDR bacteria colonization
Primary purpose: TREATMENT

Brief summary: Our trial try to eradicate digestive tract colonization of patient harboring Extreme Drug Resistant (XDR) bacteria by performing a fecal transplantation.

Detailed description: Main objective:

Evaluate the eradication of the colonization of patient harboring XDR bacteria after a fecal transplantation from a healthy donor.

Secondary objectives:

English Evaluate the side effects of this procedure and tolerability. Evaluate the efficacy of the transplant if the patient is harboring glycopeptid resistant enteroccus (GRE) or carbapenem resistant enterobacteriae (CRE)

Eligibility criteria: Inclusion Criteria:

* Patient harboring a VRE or CRE bacteria
* Colonization confirmed by our microbiology department, including at least 3 positives swabs in the last month

Exclusion Criteria:

* Pregnant woman or breastfeeding
* immunosuppression including AIDS, corticosteroids over 60mg/day
* ongoing antibiotic treatment at the day of inclusion
* impossibility to obtain a signed consent form.

Primary outcomes:
measure: Negativation of digestive tract colonization
timeFrame: At one week, 2 weeks, one month up to 6 months
Secondary outcomes:
measure: Metagenomics profile between donor and recipient depending on decolonization
timeFrame: At one week, 2 weeks, one month up to 3 months
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincaré
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Benjamin Davido, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06185478: Prostate Diffusion Imaging With Distortion Correction
Official title: Prostate Diffusion Imaging With Distortion Correction
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of East Anglia
First posted: 2023-12-29
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: There has been literature demonstrating the effectiveness of correcting these MRI images by using an additional measurement of the magnetic field, but the implied improvement in lesion detection in these common distorted regions in the prostate has yet to be shown.

We propose that introducing this distortion correction would greatly improve the DWI images used for tumour detection. For this study we propose testing this hypothesis as a primary objective, and as a secondary objective including additional b-values to further refine the ADC value. The study involves adding one additional distortion correcting scan to the standard clinical study, adding approximately 2 minutes to the study.


Eligibility criteria: Inclusion Criteria:

* Male
* Aged 18 and over
* No contraindication to MR scanning
* Smokers and non-smokers
* Patients who have had a complete scan on the 3T scan MRI at Norfolk and Norwich University Hospital and have gone on to have a biopsy at the Norfolk and Norwich University Hospital

Exclusion Criteria:

* Previous diagnosis of prostate cancer, prostatic biopsy or treatment for prostate cancer

Primary outcomes:
measure: MRI image quality
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
state: Norfolk
Study officials:
affiliation: Norfolk and Norwich University Hospitals NHS Foundation Trust
name: Paul Malcolm
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03900078: Incisional Negative Pressure Wound Therapy for Resection of Soft Tissue Tumors
Official title: Inzisionelle Negative Drucktherapie Nach Resektion Von Weichteiltumoren - Eine Prospektive, Randomisierte, Kontrollierte Klinische Studie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Sarcoma
Lipoma
Tumor
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT with two therapy arms.
Primary purpose: TREATMENT

Brief summary: This study is aimed to examine the value of incisional negative pressure therapy after resection of soft tissue tumors. Its a prospective randomized trial comparing incisional negative pressure to standard wound dressings.

Detailed description: Wound healing after resection of large soft tissue tumors is often impaired by large dead space and fluid collection, potentially resulting in seroma formation and infection. Aim of the study is to compare negative pressure wound therapy to standard wound dressing in terms of quantity of drainage fluid and wound healing complications.

Eligibility criteria: Inclusion Criteria:

* Soft tissue tumor of extremities or trunk with expected resection of \>10cm tissue in any dimension.

Exclusion Criteria:

* No primary skin closure.
* Skin infection in area of operation (e.g. acne inversa).

Primary outcomes:
measure: Amount of drainage fluid
timeFrame: up to 14 days postoperatively
Secondary outcomes:
measure: Wound complications
timeFrame: 3 months
measure: Wound margin perfusion
timeFrame: 5 days postoperatively
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
state: NRW
Study officials:
affiliation: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
name: Björn Behr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
name: Mehran Dadras, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01614678: A Comparison of Manufacturing Processes for AIR OPTIX® COLORS Contact Lens
Official title: AIR OPTIX® COLORS: Automated vs Semi-automated Manufacturing Processes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-06-08
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this feasibility study was to compare AIR OPTIX® COLORS contact lenses manufactured using an automated process to AIR OPTIX® COLORS contact lenses manufactured using a semi-automatic process.


Eligibility criteria: Inclusion Criteria:

* Able and willing to sign a written Informed Consent form.
* Cylinder ≤ -0.75 diopter (D).
* Able to achieve visual acuity (VA) of at least 20/30 Snellen in each eye at distance with contact lenses (CLCVA) and best corrected visual acuity (BCVA) ≥ 20/25.
* Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses.
* Successful daily wear of single-vision spherical soft contact lenses in both eyes during the past 3 months for a minimum of 8 hours/day, 5 days/week.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks immediately prior to enrollment in this trial.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in an ophthalmic clinical trial.
* Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions, as determined by the investigator.
* Pathologically dry eye.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Overall satisfaction
timeFrame: Week 2
Secondary outcomes:
measure: Overall lens fit
timeFrame: Dispense (Day 0)
measure: Overall lens fit
timeFrame: Week 2
measure: Contact Lens Corrected Visual Acuity (CLCVA)
timeFrame: Dispense (Day 0)
measure: Corrected distance monocular visual measurement in normal illumination reported as Contact Lens Corrected Visual Acuity (CLCVA)
timeFrame: Week 2
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Sharon Holden Thomas, O.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05766878: The Rehabilitation of Atrophic Jaws Using Short Implants With Different Surface Characteristics
Official title: The Rehabilitation of Atrophic Jaws Using Short Implants With Different Surface Characteristics: Multicentric RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-Implantation Loss
Periodontal Bone Loss
Periimplantitis
Gingival Inflammation
Implant Complication
Osseointegration Failure of Dental Implant
Keywords: short implants
surface treatment
Lead sponsor: University of Foggia
Sponsor class: OTHER
Collaborators: name: Universita degli Studi di Genova
name: University of Turin, Italy
First posted: 2023-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the research is to evaluate the clinical outcome of short dental implants, characterized by a new macro-structural design and inserted in the upper or lower jaw in patients with reduced bone volume. The clinical outcomes will be compared for different surface treatments of implant neck and those of prosthetic components.


Eligibility criteria: Inclusion Criteria:

* healthy patients, with edentulous maxillary or mandibular ridge, requiring rehabilitation with two adjacent implants;
* at least 6 month after extraction;

Exclusion Criteria:

* post-extractive implants;
* sites requiring bone regeneration or maxillary sinus lift;
* general health problems that contraindicate implant treatment.

Primary outcomes:
measure: Marginal Bone remodeling around the implant
timeFrame: 0-4-12 months after implant placement
Secondary outcomes:
measure: Periodontal indexes: Probing Depth
timeFrame: The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.
measure: Implant Stability evaluation
timeFrame: 0-4 months.
measure: Bleeding on Probing
timeFrame: The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.
measure: Suppuration on probing
timeFrame: The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.
measure: Plaque index of peri-implant tissues
timeFrame: The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.
Other outcomes:
Locations:
city: Foggia
country: Italy
facility: Clinica Odontoiatrica, University of Foggia
city: Genova
country: Italy
facility: University of Genoa
city: Torino
country: Italy
facility: University of Turin
Study officials:
affiliation: University of Foggia
name: Giuseppe Troiano, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turin, Italy
name: Francesco Pera, DDS, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01631578: Improving the Reproductive Outcome of Poor Quality Ova by Injection of Autologous Somatic Mitochondria
Official title: Phase 1 Study of the Impact of Injecting an Autologous Somatic Mitochondrial Concentrate Into Poor Quality Ova.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Low Ovarian Reserve
Poor Quality Oocytes
Keywords: mitochondrial injection
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective randomized controlled trial (RCT) to determine the effect of injecting an autologous somatic mitochondria concentrate, together with the spermatozoon during ICSI, into oocytes of older and or poor prognosis in vitro fertilization (IVF) patients.

Detailed description: Maternal age at first delivery constantly rises in developed countries. Oocyte quality decreases with advanced age, thus the rate of age-related infertility continuously increases. Presently oocyte donation is the only prompt solution for this widespread problem. Deterioration of mitochondrial function was suggested as one of the explanations for the age-related deterioration of oocyte quality. The supplementation of the ageing oocyte with autologous mitochondria from dividing somatic cells can be a possible solution for energetic enrichment, without introducing foreign mtDNA.

We established a non-hazardous clinical grade system to prepare functional autologous mitochondria concentrate from the granulosa cells aspirated during oocyte pick up. The mitochondrial preparation was examined and found to be non-toxic. The activity of the respiratory chain was constant and unaffected by age or ovarian response. Moreover, the mtDNA in the mitochondrial preparation was found to be intact in all samples examined, including those from older and low responding patients.

Eligibility criteria: Inclusion Criteria:

* Adequate sperm source and uterine cavity. And one or more of the following:
* Age \> 40
* 3 unsuccessful IVF cycles or
* \> 75% of embryos in previous cycles with \> 20-50% fragments or
* \< 50% fertilization rate in previous cycles

Exclusion Criteria:

* Inadequate sperm source. Inadequate uterine cavity.

Primary outcomes:
measure: Oocyte fertilization rate
timeFrame: one day
measure: The rate pace and quality of the early embryonic development
timeFrame: up to 6 days
Secondary outcomes:
measure: Clinical pregnancy
timeFrame: within 2 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
Study officials:
affiliation: Hadassah
name: Yoel Shufaro, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05795478: Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery
Official title: Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery: a Randomized Control, Double-blinded, Factorial Design Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Post Operative Pain
Oxycodone
Pregabalin
Postoperative Complications
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Chronic postoperative pain is one of the common perioperative complications, which seriously affects the prognosis of patients. Currently, no specific perioperative pain management strategy has been found to be effective in preventing and treating chronic postoperative pain in patients undergoing spinal surgery. At present, oxycodone has been widely recognized in different surgical populations for the control of acute postoperative pain, but its contribution to chronic postoperative pain remains unknown. Meanwhile, whether pregabalin can reduce the occurrence of chronic postoperative pain remains controversial, and whether the combination of the two drugs can control the occurrence of chronic postoperative pain in a more comprehensive way remains unknown. Therefore, we intend to conduct this randomized-controlled, factorial design study to determine the efficacy and safety of oxycodone combined with pregabalin in the treatment of chronic postoperative pain in patients undergoing spinal surgery.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing elective spinal surgery
* Ages equal to or more than 18 years old
* ASA I-III
* Signed informed consent

Exclusion Criteria:

* Previous allergic history to gabapentinoids or oxycodone;
* Patients with aphasia or inability to cooperate with scales assessments;
* Patients with a diagnosed history of psychiatric disorder;
* Known severe insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure);
* Patients treated with gabapentin/pregabalin in the last three months;
* History of drug abuse;
* Body Mass Index more than 35 kg/㎡;
* Pregnant or breastfeeding woman.

Primary outcomes:
measure: the incidence of CPSP
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
affiliation: Beijing Tiantan Hospital
name: Ruquan Han, M.D., Ph D.
role: STUDY_CHAIR
References:
Clinical trial NCT01235078: Observation of Intraosseous Vascular Access in the Emergency Department
Official title: An Observational Study of Intraosseous Vascular Access Compared to Central Venous Catheters in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Requiring Urgent Vascular Access
Lead sponsor: Vidacare Corporation
Sponsor class: INDUSTRY
First posted: 2010-11-05
Enrollment: 105
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 requiring urgent vascular access

Brief summary: The purpose of this study is to evaluate the use of powered intraosseous vascular access (EZ-IO by Vidacare) in the emergency department for patients requiring urgent vascular access. Data collected will be compared to historical data on central venous catheter use in the emergency department. The primary hypothesis is that powered intraosseous vascular access will decrease the amount of time needed to obtain vascular access.


Eligibility criteria: Inclusion Criteria:

* Patients requiring vascular access who would otherwise receive a central venous catheter due to lack of other options.

Exclusion Criteria:

* Fracture in target bone, or significant trauma to the site
* Excessive tissue and/or absence of adequate anatomical landmarks in target bone
* Infection in target area
* IO insertion in past 24 hours, prosthetic limb or joint or other significant orthopedic procedure in target bone

Primary outcomes:
measure: Time to vascular access
timeFrame: at time of patient's arrival to emergency department, average within 10 minutes
Secondary outcomes:
measure: Incidence of complications with intraosseous device
timeFrame: time subject has intraosseous vascular access, an average of 24 hours
Other outcomes:
Locations:
city: Gulf Breeze
country: United States
facility: Gulf Breeze Hospital
state: Florida
city: Pensacola
country: United States
facility: Baptist Hospital Pensacola
state: Florida
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: Omaha
country: United States
facility: Omaha Children's Hospital and Medical Center
state: Nebraska
city: Memphis
country: United States
facility: Methodist Healthcare, University Hospital
state: Tennessee
city: El Paso
country: United States
facility: Texas Tech University Medical Center
state: Texas
Study officials:
References: