louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04535999: Open Label Study of the Effects of Secukinumab on Nail Psoriasis and Non-Invasive Measures of Enthesitis (Phase IV)
Official title: Phase IV Open Label Study of the Effects of Secukinumab on Nail Psoriasis and Non-Invasive Measures of Enthesitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Psoriasis
Keywords: Psoriasis
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2020-09-02
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention-Secukinumab
Primary purpose: TREATMENT

Brief summary: This study will be an open label study of secukinumab for the treatment of nail psoriasis. Secukinumab is an FDA-approved treatment for psoriasis. We will examine time to response and different methods of defining nail disease response.

Detailed description: This study will be an open label study of secukinumab for the treatment of nail psoriasis. Secukinumab is an FDA-approved treatment for psoriasis. This is a single arm trial - all patients will receive the study drug. We will examine time to response and different methods of defining nail disease response.

Eligibility criteria: Inclusion Criteria:

* Active psoriatic nail disease defined as a Minimum 4 or more fingernails OR NAPSI\>20
* Active skin psoriasis currently (no minimum PASI or BSA) or skin psoriasis in the past documented by a dermatologist
* Age 18-85

Exclusion Criteria:

* History of IL-17 inhibitor use (other therapies including TNF inhibitors or non- biologics DMARDS in the past are acceptable)
* Inflammatory bowel disease
* Metal implants or other concerns for use of MRI
* Active infection
* Patients may have a history of self-reported psoriatic arthritis but may not have active PsA at the time of screening.
* We will exclude patients with onychomyosis of the fingernails on clippings

Primary outcomes:
measure: NAPSI
timeFrame: Baseline to 24 Weeks
Secondary outcomes:
measure: PASI
timeFrame: Baseline to 24 Weeks
measure: Physician Global Assessment of Nail Disease
timeFrame: Baseline to 24 Weeks
measure: DLQI
timeFrame: Baseline to 24 Weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital at the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Alexis Ogdie-Beatty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00707499: A Phase I Study in Healthy Volunteers to Assess Safety of BMS747158
Official title: A Single-Dose, Phase I, Dosimetry, Biodistribution, and Safety Trial of BMS 747158 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Lantheus Medical Imaging
Sponsor class: INDUSTRY
First posted: 2008-07-01
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this clinical research study is to learn the safety and biodistribution of BMS747158 in normal, healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* age 18-40
* BMI 18-30 kg/m2
* No active or chronic illnesses
* If female: not pregnant, use of birth control or not of child-bearing potential

Exclusion Criteria:

* Significant active or chronic illness
* Any neurological disorder
* GI disease within 3 months
* Recent infection
* Major surgery within 4 weeks
* Donation of blood within 4 weeks
* Blood transfusion within 4 weeks
* Recent history drug/alcohol abuse
* Head trauma
* Significant screening ECG, EEG, lab tests, physical exam and vital signs abnormalities
* Prescription or OTC drugs within 2 weeks
* Exposure to any other investigational drug/device within 6

Primary outcomes:
measure: Dosimetry analysis following whole body imaging after resting injection
timeFrame: Imaging takes place 0 - 310 minutes post injection
Secondary outcomes:
measure: Safety analysis following vital signs, ECGs, EEG, neuro and physical exams, telephone and visit follow up, and blood draws for chemistry and hematology post injection of BMS747158 at rest
timeFrame: Screening (14 days prior to dosing) through 14 days post dose administration
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Jamshid Maddahi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04395599: Risk of Air Contamination During Visceral Surgery in COVID19 Patients
Official title: Assessment of Air Contamination Risk by Sars-Cov2 During Visceral Surgery in COVID19 Patients: Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sars-CoV2
Surgery
COVID
Keywords: COVID-19
visceral surgery
air contamination
laparoscopy, prevention
prevention
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: COVID19 patients undergoing visceral surgery
Primary purpose: PREVENTION

Brief summary: Sars-Cov2 has been found in the digestive tract, as well as the respiratory tract. Protection of health care workers during surgery has been increased and some guidelines advocate for abandoning laparoscopy in COVID19 patients for fear of contamination, evenghtough this does not benefit the patient. However, Sars-Cov2 contamination risk during visceral surgery remains unknown. Inadequate protection is unnecessary costful and can be inefficient if too binding. Our hypotheses are that 1) Sars-Cov 2 can travel through droplet and air during visceral surgery. 2) Laparoscopy, because of the pneumoperitoneum and its leaks, warrant more air contamination whereas laparotomy warrant more droplet contamination, which would justified increased protection.


Eligibility criteria: Inclusion Criteria:

* Documented Sars-Cov2 infection (nasopharyngeal swab, tracheal sampling, thoracic CT, serology)
* Need of visceral surgery (laparoscopy or laparotomy)
* Signed informed consent
* Social coverage
* Patient who agrees to be included in the study and who signs the informed consent form
* Patient affiliated to a healthcare insurance plan
* Patient willing to comply with study's requirements

Exclusion Criteria:

* Need of another type of surgery during the same procedure
* Mentally unbalanced patients, under supervision or guardianship
* Patient who does not understand French/ is unable to give consent
* Patient not affiliated to a French or European healthcare insurance
* Patient incarcerated

Primary outcomes:
measure: Air contamination
timeFrame: 10 minutes after incision if no opening of the digestive lumen, or 10 minutes after opening of the digestive tract
Secondary outcomes:
measure: Environment contamination
timeFrame: At the end of surgery, an average 1 hour 30 min
measure: Surgical approach
timeFrame: At the end of the intervention, an average 2 hours
measure: Opening of the digestive tract
timeFrame: At the end of the intervention,an average 2 hours
measure: Biological fluids
timeFrame: During the procedure, an average 2 hours 30 min
measure: Pneumoperitoneum
timeFrame: At the end of the procedure,an average 2 hours 30 min
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Robert CAIAZZO, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00816699: Effects of Providing Preprint Preoperative Anesthetic Risk Information
Official title: Effects of Providing Preprint Preoperative Anesthetic Risk Information
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Preoperative Anxiety
Keywords: Anxiety
preprint anesthetic risk information
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2009-01-05
Enrollment: 103
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Proportion of patients in study group(preprint preoperative anesthetic risk should have more anxiety, more knowledge, and more cancellation than controlled group


Eligibility criteria: Inclusion Criteria:

* Inpatients scheduled for surgery under general anesthesia with or without regional anesthesia
* Low to moderate risk surgery

Exclusion Criteria:

* Patient's refusal
* Patients scheduled for cardiovascular surgery and neurosurgery
* Patients with consciousness change following surgery
* Emergency case
* CNS or psychological diseases

Primary outcomes:
measure: Spielberger State Trait Anxiety Inventory Scale
timeFrame: 5 days
Secondary outcomes:
measure: Knowledge, proportion of patients who cancel surgery, proportion who refuse regional anesthesia
timeFrame: 5 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Siriraj Hospital, Mahidol Unversity
Study officials:
affiliation: Department of Anesthesiology, Siriraj Hospital
name: Suwannee Suraseranivongse
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology, Siriraj Hospital
name: Suwannee Suraseranivongse, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01128699: Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma
Official title: Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Refractory Glaucoma
Keywords: Ahmed valve
Neovascular Glaucoma
Uveitic glaucoma
Failed glaucoma
VEGF-A
Intraocular pressure
Subconjunctival Avastin
Lead sponsor: Vanak Eye Surgery Center
Sponsor class: OTHER
First posted: 2010-05-24
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aim to demonstrate the efficacy and safety of subconjunctival injection of Avastin as an adjunctive therapy for Ahmed valve glaucoma implant in patients with refractory glaucoma.

Detailed description: Several studies have revealed evidences on the substantial role of Vascular endothelial growth factor-A (VEGF-A) in enhancing neovascularization processes. Some studies have shown the efficacy of intravitreal Avastin in reducing level of VEGF-A to improve NVG. On the other hand, recent pathological studies demonstrated that neutralization of VEGF reduced vascularity and decreased scar formation during wound healing, showing that VEGF strongly influence scar tissue formation. This may reduce the formation of encapsulated cyst after glaucoma surgeries and thus might improve the surgical success rate. The effect of subconjunctival bevacizumab as an adjunctive therapy in filtering glaucoma surgeries has been recently illustrated.

We aim to demonstrate the efficacy and safety of subconjunctival injection of Avastin as an adjunctive therapy for Ahmed valve glaucoma implant in patients with refractory glaucoma.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of refractory glaucoma defined as uncontrolled IOP (\> 21 mm Hg) despite maximal antiglaucoma medication, previously failed surgical treatment, or a combination thereof

Exclusion Criteria:

* No light perception
* elevated IOP associated with silicone oil
* previous glaucoma drainage device implantation in the same eye
* previous cyclodestructive treatment
* increased risk of endophthalmitis (e.g., active adnexal and ocular surface infection, immunosuppression, or immunodeficiency, including the use of systemic steroids)
* posterior segment disorders, or pre-existing ocular comorbidities (e.g., pterygium, phacodonesis, corneal opacity, or corneal endothelial dystrophies).

Only 1 eye per patient was included in this trial.

Primary outcomes:
measure: Change in intraocular pressure (IOP)
timeFrame: 12 months
Secondary outcomes:
measure: Surgical failure
timeFrame: 12 months
measure: Change in intraocular pressure
timeFrame: day 1, week 1, and months 1, 3, 6, 9
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Vanak Eye Surgery Center
Study officials:
References:
Clinical trial NCT02215499: A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
Official title: A Double-Blind, Phase 1, Single-Center, Single-Ascending Dose Study of JZP-386 Compared to Xyrem® vs. Placebo to Evaluate the Safety and Pharmacokinetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Narcolepsy, Excessive Daytime Sleepiness
Keywords: JZP-386, Xyrem, sodium oxybate
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-08-13
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is being conducted to evaluate the safety, tolerability, blood distribution and effectiveness single ascending doses of JZP-386 compared to doses of Xyrem® and placebo.

Detailed description: This is a Phase 1, single center, single-ascending dose, sequential, randomized, and crossover study.

Following a Screening period of up to 21 days, eligible subjects will be randomized different dosing sequences, with approximately 4 subjects allocated to each dosing sequence. The total in-clinic duration for each subject will be 24 days (including the admission day prior to the first dosing period).

Eligibility criteria: Inclusion Criteria:

* Healthy male and female volunteer subjects, 18 to 50 years of age, inclusive.

Exclusion Criteria:

Clinically significant history of unstable medical abnormality. Inability to cooperate with study procedures. Female subjects with a positive pregnancy test result, nursing or lactating. Participation in any other investigational drug trial within 90 days prior to screening. A history of prescription drug abuse, or illicit drug or known drug dependence within last 5 years prior to screening. Use of any prescription medication within 14 days prior to dosing. A history of alcohol abuse or dependence.

Primary outcomes:
measure: safety
timeFrame: 3 days
Secondary outcomes:
measure: pharmacokinetics
timeFrame: 12 hours
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Clinical Ltd.
state: Nottingham
Study officials:
affiliation: Concert Pharmaceuticals
name: LuAnn Sabounjian
role: STUDY_DIRECTOR
References:
Clinical trial NCT03280199: The Impact of Different Simulator Characteristics on Transfer of Learning
Official title: The Impact of Different Simulator Characteristics on Transfer of Learning
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Simulation-based Medical Education
Ultrasound Simulation
Education, Professional
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: This study aims to explore the impact of different simulator characteristics on transfer of learning.

Detailed description: During an ISUOG basic training course, participants will be randomly assigned to 30 minutes of simulator training during which time they will practice the 2nd trimester US scan. A total of four different simulators are being used for training. After completing the practical basic training session, they shift the type of simulator that they trained on to one of the remaining three simulators. On this simulator, they are required to perform selected planes for the 2nd-trimester scan. The planes produced are recorded and evaluated by fetal medicine specialists using the ISUOG 20 planes checklist. The performances of participants coming from each of the four simulators are examined and the role of 1) type of simulator interaction (physical mannequin vs. virtual abdomen vs. fixed-point scan) and 2) the type of image acquisition (real US images vs. computer-generated images) are examined.

Eligibility criteria: Inclusion Criteria:

ISUOG course participants

Exclusion Criteria:

More than 50 independent 2nd trimester US scan before attending the course.

Primary outcomes:
measure: Correct planes
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00648999: Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients
Official title: Phase IV, Non Randomized Study in ARV Experienced Patients Under Switch Therapy With Kaletra
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Human Immunodeficiency Virus
Keywords: Kaletra
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 207
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate that patients treated with Kaletra have an improvement in their quality of life compared to the quality of life they had with their previous NRTI therapy.


Eligibility criteria: Inclusion Criteria:

* HIV Infected subjects
* Subjects failing in current HIV treatment, or
* Subjects with a viral load \< 400 copies/mL and not tolerating their current HIV treatment.

Exclusion Criteria:

* Subject is currently participating in another clinical study or has participated in another clinical study within 30 days prior to screening visit
* Subject is pregnant

Primary outcomes:
measure: Quality of Life
timeFrame: Baseline, Week 4, Week 24 and Week 48
measure: CD4
timeFrame: Baseline, Week 24 and Week 48
Secondary outcomes:
measure: Adverse Event Monitoring
timeFrame: Baseline, Week 4, Week 24 and Week 48
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Site Ref # / Investigator 4049
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Site Ref # / Investigator 4050
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Site Ref # / Investigator 4051
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Site Ref # / Investigator 4077
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Site Ref # / Investigator 4056
state: Distrito Federal
city: Leon
country: Mexico
facility: Site Ref # / Investigator 4074
state: Guanajauto
city: Morelia
country: Mexico
facility: Site Ref # / Investigator 4054
state: Michoacan
city: Tepic
country: Mexico
facility: Site Ref # / Investigator 4072
state: Nayarit
city: Culiacan
country: Mexico
facility: Site Ref # / Investigator 4055
state: Sinaloa
city: Merida
country: Mexico
facility: Site Ref # / Investigator 4075
state: Yucatan
city: Chihuahua
country: Mexico
facility: Site Ref # / Investigator 4073
city: Oaxaca
country: Mexico
facility: Site Ref # / Investigator 4052
city: Puebla
country: Mexico
facility: Site Ref # / Investigator 4053
Study officials:
affiliation: AbbVie
name: Jose Canadas, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04207099: Comparing Wound Area Reduction of Non-healing DFUs Using MolecuLight i:X Versus Standard of Care
Official title: A 12-week, Prospective, Parallel Arm, Randomized Controlled Trial (RCT) Comparing Wound Area Reduction of Non-healing Diabetic Foot Ulcers With MolecuLight i:X Used in Standard of Care Compared to Standard of Care Alone
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Healing Diabetic Foot Ulcer
Lead sponsor: MolecuLight Inc.
Sponsor class: INDUSTRY
First posted: 2019-12-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female subjects presenting with non healing diabetic foot ulcer

Brief summary: This is a 12 week, randomized controlled trial. There are 2 arms and 20 patients with non healing diabetic foot ulcer allocated in each arm. One arm receives i:X guided treatment and the other arm receives standard of care treatment. Our primary objective is to compare the wound area reduction in both arms.


Eligibility criteria: Inclusion Criteria:

* Male or female patients presenting with chronic DFU
* The chronic DFU has a surface area that has reduced \<25% in the previous 4 weeks1 prior to first study visit
* Patient has been receiving treatment for their DFU for less than 12 weeks.
* The chronic DFU is \> 1 cm2 in area and less than 15 cm in length (max. diameter)
* 18 years or older
* Willing and able to make all required study visits

Exclusion Criteria:

* • Patients categorized as having a maintenance wound

  * Use of skin substitutes or hyperbaric oxygen therapy or surgical intervention
  * Treatment with an investigational drug within 1 month of enrolment
  * Presents with chronic (\>10 mg/kg for \>30 days) systemic corticoids before enrolment
  * Has ABI \<0.5 (measured within 3 months of randomisation)
  * Undergoing chemotherapy or is immunocompromised
  * Diagnosed with Charcot disease or ulcers from electrical, chemical or radiation burns, or presents with collagen vascular disease, ulcer malignancy, untreated osteomyelitis or cellulitis
  * Recombinant or autologous growth factors or skin/dermal substitutes within 30 days of enrollment
  * Inability or unwillingness to consent

Primary outcomes:
measure: Rate of change in wound area of diabetic foot ulcers in ARM 2 vs ARM 1
timeFrame: 5 months
Secondary outcomes:
measure: Wound Healing Rate
timeFrame: 5 months
Other outcomes:
Locations:
city: Vista
country: United States
facility: ILD Research Centre
state: California
city: Lake Success
country: United States
facility: Northwell Comprehensive Wound Healing Center and Hyperbarics
state: New York
Study officials:
References: