louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05594862: Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue.
Official title: Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue. Multicenter Randomized Controlled Prospective Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Lipogems International spa
Sponsor class: INDUSTRY
First posted: 2022-10-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: multicentre randomized controlled prospective study aimed at evaluating the efficacy of the infiltration of microfractured adipose tissue in the healing of perianal fistulas not-responding to treatment with biologics, in order to improve the quality of life and significantly reduce the risk of definitive ostomy.


Eligibility criteria: Inclusion Criteria:

* The patient's age is over 18 at the time of surgery.
* The patient suffers from Crohn's disease confirmed by instrumental and histological methods.
* The patient presents with complex perianal fistulising disease refractory to standard treatment (combination of surgical drainage of sepsis and local / systemic administration of anti-TNF-α for at least 1 year)
* The patient received, understood and signed informed consent for active participation in the study.
* The patient is able to understand the conditions of the study and to participate throughout the duration.

Exclusion Criteria:

* Patients with more than 1 internal and 3 external openings.
* Patients with ileus / colo ostomy.
* Patients with anus / rectum-vaginal fistulas.
* Patients with active HIV infections, hepatitis C (HCV), hepatitis B (HBV), tuberculosis.
* Patients with abdominal localization of Crohn's disease who may require general surgery during the study.
* Patients with active oncological or lymphoproliferative diseases from which it was not possible to safely withdraw an adequate quantity of lipoaspirate (at least 60 cc).
* Patients with clinical conditions that may compromise the success of the surgery or the follow-up.
* Pregnant or breastfeeding women.

Primary outcomes:
measure: Number of participants with Combined remission
timeFrame: 24 weeks
Secondary outcomes:
measure: Number of participants with Clinical remission
timeFrame: 2-4-8-12-24 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS S Orsola Malpighi
Study officials:
References:
Clinical trial NCT00002262: A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma
Official title: A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sarcoma, Kaposi
HIV Infections
Keywords: Skin Neoplasms
Tumor Necrosis Factor
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate tolerance, toxicity, and preliminary evidence of antitumor efficacy of intralesionally administered tumor necrosis factor (TNF) and to define a maximum tolerated dose (MTD) for single intralesional injections. In addition, to assess the effects of TNF injections on Kaposi's sarcoma (KS) lesions as measured by P-32 magnetic resonance spectroscopy.


Eligibility criteria: Inclusion Criteria

Patients must have:

* Biopsy-proven Kaposi's sarcoma (KS) with multiple cutaneous lesions.
* Minimum life expectancy of 3 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Clinically significant cardiac disease.
* Known hemorrhagic diathesis or active bleeding disorder.
* Clinically apparent vascular disease.
* Known lipoprotein disorders.
* History of seizure disorder or central nervous system (CNS) metastasis.
* Additional malignancy.

Concurrent Medication:

Excluded:

* Cardiac agents.
* Anticoagulants.
* Thrombolytic agents.
* Nonsteroidal anti-inflammatory drugs.
* Corticosteroids.
* Aspirin.
* Vasodilators.

Patients with the following are excluded:

* Additional malignancies or other conditions listed in Patient Exclusion Co-Existing Conditions.

Prior Treatment:

Excluded within 4 weeks of study entry:

* Chemotherapy.
* Radiotherapy.
* Immunotherapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco AIDS Clinic / San Francisco Gen Hosp
state: California
Study officials:
References:
Clinical trial NCT02116062: Robotic Surgery of the Ocular Surface
Official title: Robotic Microsurgery of the Ocular surfaceProspective Human Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Keratitis
Pterygium
Corneal Opacity Corneal Thinning
Corneal Perforation
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The introduction of surgical robots in the OR revolutionized a number of specialties (i. e. urology, gynecology, digestive surgery). Robots are currently used in many situations and the list of appropriate indications is growing rapidly. There are many potential advantages of robotics in eye surgery such as increased precision and maneuverability, better ergonomics, improved patient access to surgeons and surgical training. As a result, robotics might improve patient care. The Da Vinci© robot has been used for 10 years in experimental conditions to suture corneal lacerations, to perform corneal grafts, to remove ocular foreign bodies, lens capsules and vitreous. The authors reported a lack of precision resulting from poor visualization and the absence of microsurgical instruments. These elements were considered to be hurdles to further clinical investigation. The new Da Vinci Si HD© robot has been available since 2009 at the IRCAD center and more recently in Strasbourg University Hospital. It provides greater magnification and better resolution of the operative field than the previous model. We performed since 2012 various ocular surface surgeries on porcine eyes at the IRCAD center. The aim of the present trial is to perform the same procedures (amniotic membrane transplantations, pterygium surgeries, corneal grafts) in a clinical setting with the Da Vinci Si HD© system.


Eligibility criteria: Inclusion Criteria:

* Adult patient \> 18 year-old suffering :

symptomatic pterygium

* chronic corneal ulceration resistant to medical treatment
* corneal opacity involving corneal stroma and corneal endothelium
* corneal thinning
* corneal perforation

Exclusion Criteria:

* History of eye surgery
* psychiatric disease
* mental deficiency
* pregnancy
* nursing mother

Primary outcomes:
measure: Respect for different phases of the operating procedure of each intervention.
timeFrame: At the end of the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Les Hôpitaux Universitaires de Strasbourg
name: Bourcier Tristan, PHMD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bourcier T, Chammas J, Becmeur PH, Danan J, Sauer A, Gaucher D, Liverneaux P, Mutter D. Robotically Assisted Pterygium Surgery: First Human Case. Cornea. 2015 Oct;34(10):1329-30. doi: 10.1097/ICO.0000000000000561.
Clinical trial NCT01363362: Selective Lasertrabeculoplasty and Ocular Hemodynamics in Glaucoma
Official title: Effect of Selective Lasertrabeculoplasty (SLT) on Ocular Hemodynamics in Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Selective Laser Trabeculoplasty
pulsatile ocular blood flow
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2011-06-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Selective Laser Trabeculoplasty (SLT) is known to reduce intraocular pressure in glaucoma patients. This study investigates, if there are changes in different ocular hemodynamic parameters prior and after SLT.

Detailed description: Ocular blood flow, ocular pulse amplitude and ocular pulse volume are measured with the Blood Flow Analyzer (Paradigm Medical Industries, Inc.) prior and 3 month after SLT.

Eligibility criteria: Inclusion Criteria:

* glaucoma patient
* over 18 years
* needs further intraocular pressure regulation

Exclusion Criteria:

* age under 18 years
* debilitated
* no glaucoma

Primary outcomes:
measure: Change in ocular hemodynamics after Selective Laser Trabeculoplasty (SLT)
timeFrame: baseline and 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Eye Clinic Dresden
state: Saxony
Study officials:
affiliation: University Eye Clinic Dresden
name: Lutz E Pillunat, Prof. MD
role: STUDY_CHAIR
References:
Clinical trial NCT02598362: Pharmacokinetics of Ciprofloxacin in Pediatric Patients
Official title: Pharmacokinetics of Ciprofloxacin in Pediatric Patients With Emphasis on Renal Excretion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Tract Infection
Pyelonephritis
Keywords: ciprofloxacin
pharmacokinetics
excretion
clearance
infant
children
adolescent
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Universitair Ziekenhuis Brussel
First posted: 2015-11-05
Enrollment: 22
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Measuring serum and urine concentrations of ciprofloxacin after IV and oral administration in children aged 3 months - 17 years who are treated for urinary tract infections.


Eligibility criteria: Inclusion Criteria:

* age between 3 months and 17 years of age
* confirmed diagnosis of febrile urinary tract infection (a rectal body temperature of 38.5 °C.in combination with either significant leukocyturia or a positive urine nitrite test in a reliable urine sample.
* indication for treatment or uroprophylaxis with ciprofloxacin at discretion of the treating physician.

Exclusion Criteria:

* pregnancy
* impaired renal function as defined by 2x serum creatinine level for age and sex
* epilepsy
* myasthenia gravis
* long QT-syndrome
* glucose 6 phosphatase deficiency (G6PD)
* allergy to one of the substances of cipro
* concomitant use of corticosteroids
* for the oral group: co medication of antacidic drugs, ferrofumarate, calcium, magnesium or Zinc supplements.

Primary outcomes:
measure: Serum concentrations
timeFrame: 12 hours
Secondary outcomes:
measure: Urine concentrations
timeFrame: 12 hours
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Johan Vande Walle, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meesters K, Michelet R, Mauel R, Raes A, Van Bocxlaer J, Vande Walle J, Vermeulen A. Results of a Multicenter Population Pharmacokinetic Study of Ciprofloxacin in Children with Complicated Urinary Tract Infection. Antimicrob Agents Chemother. 2018 Aug 27;62(9):e00517-18. doi: 10.1128/AAC.00517-18. Print 2018 Sep.
Clinical trial NCT04452162: Physiologic MR Imaging of Salivary Gland Tumors
Official title: Physiologic MR Imaging in Distinguishing Benign From Malignant Salivary Gland Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Salivary Gland Tumor
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: McCabe Fund
First posted: 2020-06-30
Enrollment: 30
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 goal of this study is to use advanced Magnetic Resonance Imaging (MRI) techniques to help identify the difference between cancerous and non-cancerous salivary gland tumors for improving treatment strategies and to aid in the prediction of disease progression.

Detailed description: The goal of this proposed study is to investigate the potential utility of combined analysis of parameters (Ktrans, ti and ADC) in discriminating benign from malignant salivary glands tumors (SGTs). A total of 30 treatment naïve patients suspicious of SGT as observed on clinical evaluation and prior routine CT, MRI, Ultrasound, FNAC and/or PET will undergo 3T MRI. The MRI protocol will include acquisition of anatomical images with and without contrast agent injection, diffusion imaging and dynamic contrast enhanced-MRI.

Eligibility criteria: Inclusion Criteria:

* Possess a salivary gland lesion of 1cm3 size
* Have no prior history of treatment for salivary gland lesion

Exclusion Criteria:

* Has any prior history of cancer other than SGT
* Has any MRI contra-indications
* Has a history of known renal disease.
* Has history of prior radiation to head and neck region
* Is pregnant

Primary outcomes:
measure: Differentiation and Progression Free
timeFrame: 6 Month after the end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Professor
name: Sanjeev Chawla
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03007862: Bronchial Alpha Amylase as a Marker for Early Aspiration Pneumonia in Therapeutic Hypothermia.
Official title: Salivary Alpha Amylase Bronchial Measure for Early Aspiration Pneumonia Diagnosis in Patients Treated With Therapeutic Hypothermia After Out-of-hospital Cardiac Arrest.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Aspiration Pneumonia
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Early Aspiration Pneumonia after out-of-hospital cardiac arrest treated with Therapeutic Temperature Management

Brief summary: Early Aspiration Pneumonia is a frequent and dreadful complication in survivors of cardiac arrest. Therapeutic Hypothermia widely used in Intensive Care Unit for its benefice on post cardiac arrest syndrome may otherwise hide signs of early pneumonia that may occur without use of a reliable screening biological marker. The goal is to assess the diagnostic accuracy of bronchial alpha amylase measure to predict a risk of early aspiration pneumonia in patients successfully resuscitated after out-of-hospital cardiac arrest.

In this prospective non interventional study we included patients resuscitated after cardiac arrest and treated with Targeted Temperature Management (TTM). A distal bronchoalveolar lavage using specific display (Combi-Cath) was executed immediately after admission for each patient with both biochemic and bacteriological analysis including dosage of bronchial salivary alpha amylase. Urea was used as a marker of dilution in the measure of bronchial and plasmatic alpha amylase. Aspiration pneumonia diagnosis was established with clinical and biological criteria. On this basis we intended to determine a threshold measure of alpha amylase predicting occurrence of aspiration pneumonia and allowing a guidance in antibiotherapy prescription. Sensibility and Specificity of this technique were determined.


Eligibility criteria: Inclusion Criteria:

* Well resuscitated patients after out-of-hospital cardiac arrest
* Indication of Therapeutic Temperature Management
* Patients aged over 18 years
* Immediate or deferred acceptation of study

Exclusion Criteria:

* Patients aged under 18 years.
* Pregnant women.
* Against indication to therapeutic hypothermia.
* Active therapeutic limitation after admission.
* Patient without social security.

Primary outcomes:
measure: Early Aspiration Pneumonia
timeFrame: Within 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle Desalbres
role: STUDY_DIRECTOR
References:
Clinical trial NCT04528862: Reducing Error in ER Settings Through Attention Restoration Theory
Official title: RESTART Trials: Reducing Error in ER Settings Through Attention Restoration Theory
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Attention Fatigue, Attention Restoration
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this research study is to find out about how looking at different types of pictures can affect people's attention spans. Attention Restoration Theory (ART) suggests that there are two types of attention. One type (directed attention) can become tired and cause people to make mistakes. The other type (involuntary attention) gives directed attention a chance to rest, so people make less mistakes. Certain types of pictures are good at capturing involuntary attention. We think that capturing involuntary attention will help emergency physicians make less mistakes on tests of attention. This study will allow us to learn more about it.

Detailed description: In this study, participants will be asked to do the following things:

1. Before their usual shift in the emergency department, arrive ten minutes early to rate their mood and complete a Digit Span Backwards (DSB) task that tests their memory of different sets of numbers.
2. Five hours into their shift, they will take a ten minute break.
3. During this break, they will be randomly assigned to view either a picture presentation of nature slides or urban slides.
4. After the presentation, they will complete the Digit Span Backwards task again, they will rate their mood again, then return to their shift.

Participation in this study will last up to 30 minutes. Approximately fifty individuals will participate in this study.

Eligibility criteria: Inclusion Criteria:

• Emergency Medicine Resident of any PGY level. (1-5)

Exclusion Criteria:

* Anybody under the age of 18
* Pregnancy

Primary outcomes:
measure: Working memory
timeFrame: 5 hours
measure: Positive mood
timeFrame: 5 hours
measure: Negative mood
timeFrame: 5 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Virginia Commonwealth University
name: Stephen Miller, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06143462: Vestibular Rehabilitation for Unsteadiness After Intratympanic Gentamicin in Patients With Meniere's Disease
Official title: The Effect of Vestibular Rehabilitation Treatment (VRT) on Patients With Unsteadiness After Intratympanic Gentamicin in Meniere's Disease: Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vestibular Disorder
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy of vestibular rehabilitation treatment on unsteadiness after intratympanic gentamicin in patients with Meniere's disease.

Detailed description: Previous studies have generally focused on the efficacy of VRT for Meniere's disease, with little attention paid to the effect of VRT on MD patients who still have vestibular dysfunction even after intratympanic gentamicin treatment.

The aim of this study is to compare the efficacy of VRT with usual care in MD patients who experience persistence of unsteadiness 1 month after intratympanic gentamicin treatment, in order to understand whether VR has a positive impact on balance maintenance and vertigo control in MD patients.

Eligibility criteria: Inclusion Criteria:

1. Adults aged between 18 and 75 years old;
2. Complained of persistent unsteadiness 1 month after intratympanic gentamicin treatment;
3. Be willing to sign the informed consent of the study.

Exclusion Criteria:

1. Conformed to neuromuscular disease;
2. Conformed to severe cervical spine disease;
3. Conformed to congenital inner ear disease (except vestibular migraine(VM))
4. Concurrent manifestation of psychiatric or psychological disorders.

Primary outcomes:
measure: Functional Gait Assessment (FGA)
timeFrame: Change from baseline, at 8 weeks and 6 months post-randomization
Secondary outcomes:
measure: Sensory Organization Test (SOT)
timeFrame: Change from baseline, at 8 weeks and 6 months post-randomization
measure: Meniere's Disease Outcomes Questionnaire (MDOQ)
timeFrame: Change from baseline, at 8 weeks and 6 months post-randomization
measure: Visual Vertigo Analogue Scale (VVAS)
timeFrame: Change from baseline, at 8 weeks and 6 months post-randomization
measure: Vestibular Activities and Participation Measure (VAP)
timeFrame: Change from baseline, at 8 weeks and 6 months post-randomization
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Eye and ENT Hospital of Fudan University
name: Huiqian Yu
role: PRINCIPAL_INVESTIGATOR
References: