louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00056368: The Safety and Efficacy of Anidulafungin Versus Comparator in Patients With Candidemia and Invasive Candidiasis
Official title: A Phase III, Double-Blind, Randomized, Multi-Center, Study of the Safety and Efficacy of Anidulafungin vs. Fluconazole in the Treatment of Patients With Candidemia and Other Forms of Invasive Candidiasis and Prevention of Complications.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Candidiasis
Keywords: Candida blood stream infections
Candida infections
Candidemia
Invasive Candidiasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Vicuron Pharmaceuticals
First posted: 2003-03-12
Enrollment: 256
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Anidulafungin is a medicine being developed for treatment of patients with certain kinds of fungal infections. These infections due to yeast (a type of fungus) in the mouth/esophagus, in the blood or in other areas within the body.

Detailed description: Anidulafungin is an investigational drug being developed as an intravenous treatment for esophageal candidiasis, candidemia and other invasive fungal infections. Anidulafungin is an antifungal agent of the echinocandin class, which targets the fungal cell wall of yeast and other filamentous fungi.

Eligibility criteria: * Diagnosis of candidemia and/or other forms of invasive candidiasis.
* Should not have received greater than 48 hours of systemic antifungal therapy.
* Life expectancy should be greater than 72 hours.
* Should not have received greater than one week of prophylactic azole therapy 30 days prior to enrollment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: King of Prussia
country: United States
facility: Versicor, Inc.
state: Pennsylvania
Study officials:
References:
citation: Reboli AC, Rotstein C, Pappas PG, Chapman SW, Kett DH, Kumar D, Betts R, Wible M, Goldstein BP, Schranz J, Krause DS, Walsh TJ; Anidulafungin Study Group. Anidulafungin versus fluconazole for invasive candidiasis. N Engl J Med. 2007 Jun 14;356(24):2472-82. doi: 10.1056/NEJMoa066906.
Clinical trial NCT04922268: External Focus of Attention Posttraumatic Osteoarthritis
Official title: External Focus of Attention Feedback to Mitigate Posttraumatic Osteoarthritis Risk After ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Anterior Cruciate Ligament Rupture
Anterior Cruciate Ligament Tear
Osteo Arthritis Knee
Lead sponsor: University of North Carolina, Charlotte
Sponsor class: OTHER
Collaborators: name: Arthritis Foundation
First posted: 2021-06-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Knee injuries, especially those to the ACL, are common among physically active people. These injuries are frequently treated with surgical reconstruction (ACL reconstruction; ACLR). While ACLR restores stability it does not protect against future injury, long-term pain, disability, and arthritis associated with these injuries. Our study is going to examine new ways to provide feedback about the way people move to determine if these are better at modifying movement patterns that are known risk factors of posttraumatic osteoarthritis development than current standard treatments. If you participate, you will be asked to undergo a movement analysis in a research laboratory while you perform tasks such as walking and hopping. After this initial assessment, you will be randomly allocated to one of 2 treatment groups. Each treatment group will perform 4 weeks (3x/week) of exercises to change the way people walk. Participants will then report for follow-up movement analysis testing 1- and 4-weeks after completing the intervention.


Eligibility criteria: Inclusion Criteria:

* history of primary, unilateral ACL reconstruction 6-24 months prior to enrollment
* cleared to return to full activity by treating orthopedic surgeon

Exclusion Criteria:

* Body mass index \>35 kg/m2
* History of musculoskeletal injury sustained 3 months prior to enrollment
* Current participation in formal post-operative rehabilitation

Primary outcomes:
measure: Changes from baseline in lower extremity biomechanics during walking
timeFrame: 1-week post-intervention, 4-weeks post-intervention
measure: Knee cartilage health
timeFrame: 1-week post-intervention, 4-weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: UNC Charlotte
state: North Carolina
Study officials:
References:
Clinical trial NCT02028468: Anterolateral Watson Jones Approach Versus Transgluteal Approach for Uncemented Hemi- Arthroplasty in Displaced Femoral Neck Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Neck Fracture
Keywords: Femoral Neck Fracture
Anterolateral approach
Trans-gluteal approach
Watson Jones approach
Hardinge approach
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2014-01-07
Enrollment: 150
Sex: ALL
Minimum age (years): 70
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hemiarthroplasty is a well established treatment of Femoral Neck Fractures in the Elderly. During the last decade the use of Minimal Invasive Surgical( MIS) approaches have been increasing. Our hypothesis is that Patients with a Femoral Neck Fracture may benefit from a MIS approach.

Detailed description: The study's main objective: The purpose of the study is to test the following hypothesis. Patients 70 to 90 years with a displaced femoral neck fracture, operated with a hemiarthroplasty through an anterolateral approach, have less pain and better patient satisfaction as measured by PROMs than patients operated through the lateral approach.

The study's subsidiary objectives. We aim to shed light on the following subsidiary hypotheses.

1. A hemiarthroplasty inserted through an anterolateral approach gives less bone resorption, as measured by DEXA around the stem, than a hemiarthroplasty inserted via a direct lateral approach.
2. A hemiarthroplasty inserted through an anterolateral approach causes lesser degree of muscle damage, as measured by CK, than a direct lateral approach

Eligibility criteria: Inclusion Criteria: Patients 70- 85 Years of Age -

Exclusion Criteria:

Dementia, Infection Not Suitable for Hemiarthroplasty

-

Primary outcomes:
measure: Visual Analogue Scale Pain and Patient Satisfaction
timeFrame: Pre and postoperative, 3 and 12 Months
Secondary outcomes:
measure: Timed up and go
timeFrame: postoperative, 3 and 12 Monthes
measure: Harris Hip Score
timeFrame: Pre / Postoperative, 3 and 12 Months
measure: Hip Osteoarthritis Disability Score
timeFrame: Postoperative, 3 and 12 Months
measure: EuroQol
timeFrame: Postoperative, 3 and 12 Months
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sorlandet Hospital
Study officials:
affiliation: University of Oslo Ullevål
name: Lars Nordsletten, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ugland TO, Haugeberg G, Svenningsen S, Ugland SH, Berg OH, Pripp AH, Nordsletten L. Biomarkers of muscle damage increased in anterolateral compared to direct lateral approach to the hip in hemiarthroplasty: no correlation with clinical outcome : Short-term analysis of secondary outcomes from a randomized clinical trial in patients with a displaced femoral neck fracture. Osteoporos Int. 2018 Aug;29(8):1853-1860. doi: 10.1007/s00198-018-4557-y. Epub 2018 May 22.
Clinical trial NCT04417868: Evolution of Cochleovestibular Schwannomas
Official title: Evolution of Cochleovestibular Schwannomas in the Internal Auditory Canal by Volume Measering With aTeslas MRI 3
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schwannoma
Keywords: schwannoma
cochleovestibular schwannomas
cochleovestibular
intra labyrinthine schwannoma
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having a typical vestibular schwannoma diagnosis during the first MRI, having a minimum of 3 internal auditory canal MRIs on the same machine (Signa HDxt, General Electric, Strasbourg, France) ) at the Hôpitaux Universitaires de Strasbourg

Brief summary: Investigators want to know the natural history of the vestibular schwannomas: increasing, decreasing or stability, by monitoring more than 3 MRIs during a span of more than 2 years. They will obtain 3 groups: the volume increasing schwannomas which will be the most important group, the schwannomas that will be stable and a small group where the schwannomas will decrease.

The secondary purpose is that the investigators want to know the threshold values: a minimum volume under which we are sure that the schwannoma will not increase, a maximum value where it will increase and if its evolution can be correlated to clinical or radiological criteria.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* having a typical vestibular schwannoma diagnosis during the first MRI, having a minimum of 3 internal auditory canal MRIs on the same machine (Signa HDxt, General Electric, Strasbourg, France) ) at the Hôpitaux Universitaires de Strasbourg
* patients consenting to participate

Exclusion Criteria:

* intra-labyrinthical extension
* treatment before the 3 MRIs
* no injection of gadolinium
* atypical diagnosis

Primary outcomes:
measure: Presence or absence of intra labyrinthine vestibular nerve tumor using T2 FIESTA
timeFrame: 1 hour after the realization of the MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Srtrasbourg
country: France
facility: Service Imagerie 1
state: Strasbourg
Study officials:
References:
Clinical trial NCT06257368: TFL Driven Urinary System Treatment Study
Official title: TFL-DUST Study TFL Driven Urinary System Treatment Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urologic Diseases
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2024-02-13
Enrollment: 373
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients, male and female with an urological disease for which TFL treatment is indicated.

Brief summary: The goal of this observational study is:

To assess the use of Coloplast TFL Drive in daily practice

To confirm:

* the safety and efficacy of the Coloplast TFL Drive and its GUI (Graphical User Interface) with pre-embedded settings in Laser lithotripsy
* the safety and efficacy of the Coloplast TFL Drive and its GUI with pre-embedded settings for enucleation of prostate as treatment of benign prostate hyperplasia
* the safety and efficacy of the Coloplast TFL Drive and its GUI with pre-embedded settings for ablation of urological tumors


Eligibility criteria: Inclusion Criteria:

* Any adult patient, for which TFL laser is indicated for treating a urological disease (e.g. kidney or ureteral stones, urological tumor, BPH (Benign Prostate Hypertrophy...)

Exclusion Criteria:

* Any condition when TFL laser should not be indicated as per the TFL user manual (untrained surgeon on laser use, patient's conditions)
* Patients with no signed consent form
* Patients \<18 years old
* Patients under tutorship or guardianship
* Patients who already took part in the study
* Pregnant or breastfeeding women
* Patient undergoing 2nd step laser procedure at inclusion
* Subject already included in another study

Primary outcomes:
measure: Time in Laser ON
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Nantes
country: France
facility: Clinique Jules Verne
city: Paris
country: France
facility: Hôpital Tenon
city: Périgueux
country: France
facility: Hôpital Privé Francheville
city: Madrid
country: Spain
facility: HM Hospital Sanchinarro
Study officials:
affiliation: Coloplast Manufacturing France
name: Isabelle D de Berny
role: STUDY_DIRECTOR
References:
Clinical trial NCT01808768: Ocular Allergy Treatment Practical Impact Trial
Official title: To Assess the Impact of Ocular Allergy Treatment on Patients Using an Opthalmic Agent (or no Treatment) Versus Alcaftadine(Lastacaft™)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Allergic Conjunctivitis
Rhinoconjunctivitis
Lead sponsor: Starx Research Center, LLC
Sponsor class: INDUSTRY
First posted: 2013-03-11
Enrollment: 50
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: To study the impact of alcaftadine in patients treated with other opthalmic ocular agents (or specific topical opthalmic treatment) in an allergy subspecialist outpatient setting.

Detailed description: To assess the impact of ocular allergy treatment on patients using an ophthalmic agent (or no treatment) versus alcaftadine(Lastacaft™)

Eligibility criteria: Inclusion Criteria:

1. patients age 18 and older with a history of seasonal or perennial forms of allergic conjunctivitis and skin test positive reactivity to seasonal aeroallergens
2. Total Ocular Symptom Score (TOSS) on the day of enrollment of 4 or more.
3. have allergic ocular symptoms for the past week for which they are either treating with ophthalmic agents or have had no treatment.
4. Are willing/able to follow instructions from the study investigator and his/her study staff.
5. Have signed infromed consent approved by Institutional Review Board or Independent Ethics Committee.

   -

Exclusion Criteria:

1. Active ocular infection;
2. History of retinal detachment, diabetic neuropathy, or any progressive retinal disease;
3. Ocular surgical intervention within three (3) months prior to visit 1 or scheduled during the study.
4. History of unstable, or uncontrolled disease of any nature.
5. Pregnancy or lactation;
6. Have a known hypersensitivity tp LASTACAFT™ (alcaftadine) -

Primary outcomes:
measure: Quality of Life- Eye Allergy Patient Impact Questionnaire
timeFrame: 4 months
Secondary outcomes:
measure: Ocular Surface Disease Index Pollen Count correlation of symptoms
timeFrame: 6 months
Other outcomes:
Locations:
city: Edison
country: United States
facility: STARx Research Center
state: New Jersey
city: Springfield
country: United States
facility: STARx
state: New Jersey
Study officials:
affiliation: Starx Research Center, LLC
name: Jayesh Kanuga, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03670368: Interpersonal Relationships Intervention and Cardiovascular Health
Official title: An Interpersonal Relationships Intervention for Improving Cardiovascular Health in Youth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Health
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: DePaul University
name: University of Illinois at Chicago
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-09-13
Enrollment: 500
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether random assignment to a mentor-mentee relationship is associated with beneficial cardiovascular health effects in both mentors and mentees.

Detailed description: Participants will be undergraduate students randomly assigned to either being in the mentor or comparison group. A second set of participants will be randomly assigned to either being in the mentee or comparison group. These participants will come from Chicago Public School elementary schools. In total, there will be 125 mentors, 125 comparators, 125 mentees, and 125 comparators. Participants will come for a laboratory visit in which cardiovascular health measures will be taken (details below). Visits will occur once at baseline (before the intervention starts), and once post-intervention. There will be a mid-point assessment of questionnaires. Participants in the intervention group will engage in one-on-one mentoring sessions (mentors together with mentees) once a week after school for the school year. Participants in the comparator group will receive written versions of all materials covered in the mentoring sessions.

Eligibility criteria: Inclusion Criteria:

* undergraduate students for mentors
* Chicago Public School students for mentees

Exclusion Criteria:

-

Primary outcomes:
measure: Metabolic symptoms
timeFrame: Change in metabolic symptoms from baseline to approximately 1 year later
measure: Flow-mediated vasodilation
timeFrame: Change in flow-mediated vasodilation from baseline to approximately 1 year later
measure: HOMA-IR
timeFrame: Change in HOMA-IR score from baseline to approximately 1 year later
Secondary outcomes:
measure: Pro-inflammatory cytokines
timeFrame: Change from baseline to approximately 1 year later
measure: Stimulated cytokine production
timeFrame: Change from baseline to approximately 1 year later
measure: Glucocorticoid sensitivity
timeFrame: Change from baseline to approximately 1 year later
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Northwestern
state: Illinois
Study officials:
References:
Clinical trial NCT04517968: Immediate Implant With Cusomized Healing Abutment
Official title: Evaluation of Immediate Implant Placement Using Customized Healing Abutment (Clinical Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Osteogensis
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: evaluate clinically and radiographically the effect of customized healing abutment on peri-implant osteogenesis following immediate implant placement.

Detailed description: Now a day most people want to make immediate implant after extraction, which save them time and eliminates the need of second surgery. The problem is that the jummping gap between the implant and the bone that needs bone graft, this increase the cost on the patient. In this experiment we tend to evaluate this technique which may help us in growing autogenous bone and stop the need for bone grafting.

The aim of this study is to evaluate clinically and radiographically the effect of customized healing abutment on peri-implant osteogenesis following immediate implant placement.

A clinical trial was carried out on 8 patients (20-40 years old) with freshly extracted mandibular molars. Implants were placed immediately after extraction and a customized healing abutment will be fabricated. Patients were followed up clinically and radio graphically for 6 months.

Eligibility criteria: Inclusion criteria:

* Age range: 20 - 40 years
* Good oral hygiene
* A freshly extracted socket in the mandibular molar area.
* The gap between the implant and the bone will be at least 3-4 mm.

Exclusion criteria:

* Acute infection (periodontitis or mucosal infection)
* Patients on radiotherapy or chemotherapy.
* Alcohol or drug abuse.
* Patient with the systemic disorder (uncontrolled Diabetes mellitus, autoimmune diseases, bone diseases, etc.)
* Smokers.
* Parafunctional habits.

Primary outcomes:
measure: change in bone density
timeFrame: at 3rd, 6th months
Secondary outcomes:
measure: Change in pain
timeFrame: 1st day, 1 week, 4 weeks, 6 weeks, 12 weeks and after 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
Clinical trial NCT04238468: Scar Tissue Analysis After Intraoperative Application of Stromal Vascular Fraction Cells Into Suture Line
Official title: Scar Tissue Analysis After Intraoperative Intradermal Application of Stromal Vascular Fraction Cells Into Suture Line
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wound Heal
Scar
Hypertrophic Scar
Delayed Wound Healing
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will evaluate the effect of intradermal injection of stromal vascular fraction into suture line on wound healing and scarring.

Detailed description: Patients undergoing primary or secondary Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction will be included in this monocentric, randomised, controlled, double-blinded study.

After bilateral flank liposuction, the fat will be processed by a special protocol with enzymatic digestion. Stromal vascular fraction will be isolated and injected intradermally just after wound closure into one site of surgical wound (most lateral 5 cm) at the DIEP flap donor site. The other site of DIEP flap donor site (most lateral 5 cm) will serve as a control. Part of stromal vascular fraction will be analysed by flow cytometry for the viability and cell specification. Ten months after DIEP flap surgery the scars at both sites (control and injected site) will be excised and analysed histologically. At that time photographs will be taken and scars will be analysed by Patient and Observer Assesment Scale (POSAS).

Eligibility criteria: Inclusion Criteria:

* breast cancer patients scheduled for primary or secondary DIEP flap breast reconstruction

Exclusion Criteria:

* BMI
* age
* immunosuppressive disease

Primary outcomes:
measure: Analysis of stromal vascular fraction by flow cytometry
timeFrame: 2 hours
measure: Histological analysis of epidermal thickness of scar tissue
timeFrame: 10 months
measure: Histological analysis of rete ridges of scar tissue
timeFrame: 10 months
measure: Histological quantification of elastin of scar tissue.
timeFrame: 10 months
measure: Histological quantification of vascularity in scar tissue
timeFrame: 10 months
measure: Histological quantification of inflammatory cells in scar tissue
timeFrame: 10 months
measure: Clinical outcome by the use of Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Katarina Zivec
role: PRINCIPAL_INVESTIGATOR
References: