louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02224287: Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control
Official title: Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urolithiasis
Kidney Stones
Keywords: Urolithiasis
Kidney Stones
Ureteroscopy
Fluoroscopy
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2014-08-25
Enrollment: 74
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized trial to study the effect of assigning the control of the fluoroscopic x-ray activation to the surgeon as compared to the radiation technologist. Radiation exposure will be assessed from the collected data, fluoroscopy time, and dose parameters (cumulative absorbed dose and dose area product). From exposure data, entrance skin dose (ESD) and midline absorbed dose (MLD) will be calculated. The primary outcome in this study will be total fluoroscopy time for the procedure. A secondary outcome will be the ESD. The investigators will further analyze the contribution of clinical predictors (e.g. stone size/location) and procedural predictors on fluoroscopy times and ESD.

It is hypothesized that a 30% reduction in fluoroscopy time will occur when the operating surgeon is controlling the activation of the x-ray beam.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing ureteroscopy for urolithiasis
* 5 years to 25 years old

Exclusion Criteria:

* Pregnant
* Less than 5 years old or older than 25 years old

Primary outcomes:
measure: The primary outcome in this study will be total fluoroscopy time for the procedure.
timeFrame: 1-5 hours
Secondary outcomes:
measure: A secondary outcome will be the entrance skin dose (mGy). We will further analyze the contribution of clinical predictors (e.g. stone size/location) and procedural predictors on fluoroscopy times and entrance skin dose.
timeFrame: 1-5 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Caleb Nelson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kokorowski PJ, Chow JS, Cilento BG Jr, Kim DS, Kurtz MP, Logvinenko T, MacDougall RD, Nelson CP. The effect of surgeon versus technologist control of fluoroscopy on radiation exposure during pediatric ureteroscopy: A randomized trial. J Pediatr Urol. 2018 Aug;14(4):334.e1-334.e8. doi: 10.1016/j.jpurol.2018.04.035. Epub 2018 Jun 27.
Clinical trial NCT00479687: SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder
Official title: A Multi-center, Randomized, Double-blind, Placebo Controlled Trial of SUPARTZ (Sodium Hyaluronate) for the Treatment of Chronic Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Shoulder
Keywords: Osteoarthritis
Shoulder
Hyaluronic Acid (HA)
Lead sponsor: Bioventus LLC
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 300
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial is to determine the safety and effectiveness of three injections of SUPARTZ (sodium hyaluronate) compared with phosphate buffered saline (PBS) for the treatment of glenohumeral osteoarthritis of the shoulder. The trial contains two phases. Phase I is 26 weeks, double blinded, and subjects are randomized to either SUPARTZ or PBS treatment. Phase II is 26 weeks (total 52 weeks) and open-label so all subjects will receive SUPARTZ injections only.

Detailed description: Phase 3 Study: Multi-center, randomized, double blinded, two phase study to determine the safety and efficacy of 3 injections of SUPARTZ for Osteoarthritis of the Shoulder

Eligibility criteria: Inclusion Criteria:

* Glenohumeral Osteoarthritis (OA) confirmed by radiograph
* Limitation of shoulder motion in at least one direction
* Retained active range of motion of at least 30% in all directions

Exclusion Criteria:

* Full thickness rotator cuff tear or rotator cuff tendinopathy
* Frozen shoulder
* Female who is pregnant or lactating

Primary outcomes:
measure: Visual Analogue Scale (VAS: 0-100) for Pain on Movement
timeFrame: Ph1: weeks 7 - 26
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northeast Orthopedics - Unlimited Research
name: Scott Sledge, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Pharmacology Study Group
name: Charles Birbara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004987: Treatment of Advanced AIDS Patients With Dextrin Sulfate
Official title: Intraperitoneal Dextrin Sulfate in Patients With Advanced HIV Disease: A Phase I Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: HIV Infections
Keywords: Anti-HIV Agents
Viral Load
dextrin 2-sulfate
Infusions, Parenteral
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to look at the safety and effectiveness of dextrin sulfate in AIDS patients who have failed conventional anti-HIV treatment.

Detailed description: Patients have intraperitoneal (IP) catheter placement done at study entry. Infusion with the carrier vehicle (icodextrin 4%) begins 2 weeks later, and 2 days after that, treatment with dextrin sulphate (DS) commences. DS is given three times per week. A nurse delivers initial treatments and the patient and caregiver will be trained to give subsequent treatments until DS has been given a total of 8 weeks. Patient evaluations are done regularly during treatment and observation continues for 24 weeks.

Eligibility criteria: Inclusion Criteria

Patients may be eligible for this trial if they:

* Are HIV-positive.
* Have been diagnosed with AIDS and are under treatment to prevent opportunistic (AIDS-related) infection.
* Have had a CD4 cell count greater than 50 microL for at least the past 3 months.
* Have had a viral load of at least 50,000 copies/ml for at least the past 3 months.
* Have used up all other treatment options.
* Are able to understand and give written consent.

Exclusion Criteria

Patients may not be eligible for this trial if they:

* Have been in any other study in the 6 weeks before beginning this study.
* Have an active, opportunistic infection or other infection.
* Have any other long-term medical condition or nervous disorder that might make it difficult for them to finish the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Steinhart Medical Associates
state: Florida
Study officials:
References:
Clinical trial NCT02885987: Use of Accessory Device AmplifEYE During Average Risk Screening Colonoscopy to Increase Adenoma Detection Rate
Official title: Use of Accessory Device AmplifEYE During Average Risk Screening Colonoscopy to Increase Adenoma Detection Rate
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colonic Polyps
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this investigator-initiated study is to determine whether the use of an accessory device called AmplifEYE can improve colonoscopy quality in patients who are undergoing average risk colorectal cancer screening. Primary end point is adenoma detection rates.


Eligibility criteria: Inclusion Criteria:

* All adult patients greater than or at 50 years of age who are referred for average risk screening colonoscopy.

Exclusion Criteria:

* Any pregnant patient
* Patient's that are unable to provide consent for themselves
* Any patient undergoing diagnostic colonoscopy (IBD, rectal bleeding, recent change in bowel habits, etc.)
* Any patient undergoing surveillance (prior history of polyps or colorectal cancer)
* Any patient undergoing high risk screening colonoscopy (family history of colon cancer in first degree family member \<65 years of age, or co-existing conditions that pre-dispose to colon cancer such as polyposis syndromes, PSC or IBD)
* Prior history of any cancer
* Current or past immunosuppression (due to either infection or medications)
* Coagulation disorder OR use of anti-coagulation or anti-platelet therapy other than aspirin within 5-7 days of procedure
* Colonic strictures
* suspected intestinal obstruction or colonic pseudo-obstruction
* history of colon resection
* active infection
* active inflammation (including diverticulitis)

Primary outcomes:
measure: Difference in adenoma detection rate (ADR), with and without use of AmplifEYE.
timeFrame: 1 week
Secondary outcomes:
measure: ADR will be differentiated according to morphology
timeFrame: 1 week
measure: ADR will be differentiated according to final pathology
timeFrame: 1 week
measure: ADR will be differentiated according to location
timeFrame: 1 week
measure: Advanced ADR
timeFrame: 1 week
measure: Mean total number of polyps detected
timeFrame: 1 week
measure: ADR-plus
timeFrame: 1 week
measure: APP (adenomas per positive participant)
timeFrame: 1 week
measure: APC (adenomas per colonoscopy)
timeFrame: 1 week
measure: Quality metrics: time of colonoscopy
timeFrame: 1 hour
measure: Quality metrics: prep quality
timeFrame: 1 hour
measure: Sedative Medications used
timeFrame: 1 hour
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Loma Linda University
name: Alexander Jahng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05485987: A Study of Vatiquinone for the Treatment of Participants With Friedreich Ataxia
Official title: An Open-Label Study to Evaluate Pharmacokinetics, Safety, and Efficacy of Vatiquinone in Children With Friedreich Ataxia Younger Than 7 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Friedreich Ataxia
Lead sponsor: PTC Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-08-03
Enrollment: 5
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to assess the pharmacokinetics (PK) and safety of vatiquinone administered in participants with Friedreich ataxia (FA) younger than 7 years.


Eligibility criteria: Inclusion Criteria:

* Friedreich ataxia diagnosis (homozygous for GAA repeat expansion in intron-1 of FXN gene), confirmed by clinical genetic testing.
* Must be able to abstain from anticoagulants and any aspirin (including 81 mg) for 30 days before the Baseline Visit and for the duration of the study; any possible discontinuation of anticoagulants should be monitored and indicated by a specialist (for example, cardiologist, neurologist, or hematologist), and discontinuation will be noted by the prescribing physician.
* Must be able to abstain from strong cytochrome P450 (CYP) 3A4 inducers/inhibitors (for example, ketoconazole, rifampin, St. John's wort, grapefruit juice, or any grapefruit product) for at least 30 days prior to enrollment and for the duration of the study.
* Must be able to take vatiquinone oral solution with food.

Exclusion Criteria:

* Previous treatment with vatiquinone.
* Allergy to vatiquinone or sesame oil.
* Ejection fraction \<50%.
* Participation in any other interventional clinical trial or receipt of any study drug in any other clinical trial within 60 days prior to the Baseline Visit. Participants may be rescreened after the exclusionary period of 60 days has passed.
* Concomitant use of interventional CoQ10, vitamin E, or any approved or non-approved medication for FA within 30 days prior to the Baseline Visit. These prohibited medications can be discontinued at the Screening Visit.

Note: Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Plasma Concentration of Vatiquinone
timeFrame: Pre-morning dose (0 hour) at Week 4; 1 to 3 hours and 3 to 6 hours post-morning dose at Weeks 4, 12, and 24
measure: Area Under the Curve (AUC) of Vatiquinone
timeFrame: Pre-morning dose (0 hour) at Week 4; 1 to 3 hours and 3 to 6 hours post-morning dose at Weeks 4, 12, and 24
measure: Number of Participants With Adverse Events
timeFrame: Baseline up to Week 76
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02601287: A Safety and Efficacy Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in Korean Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Incontinence
Overactive Bladder
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-11-10
Enrollment: 168
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: This is a safety and efficacy study of BOTOX® (Botulinum Toxin Type A) in the Treatment of Adult Korean Patients with Urinary Incontinence due to Neurogenic Detrusor Overactivity or Overactive Bladder.


Eligibility criteria: Inclusion Criteria:

* Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
* Symptoms of urge urinary incontinence, urgency, and frequency due to overactive bladder

Exclusion Criteria:

* Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
* Use of botulinum toxin therapy of any serotype in the 3 months prior to screening
* Has acute urinary retention who do not routinely perform clean intermittent self-catheterization (CIC)

Primary outcomes:
measure: Change from the baseline in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) total score
timeFrame: Baseline, Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Korea
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea Bucheion St. Mary Hospital
state: Korea
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Korea
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Korea
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Korea
Study officials:
affiliation: Allergan
name: Medical Contact
role: STUDY_DIRECTOR
References:
Clinical trial NCT00751387: Study Evaluating Epidemiology of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis in Australia
Official title: Australian Descriptive Epidemiology Study of Severity of Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS) and Exposure to Biological Disease Modifying Anti-rheumatic Drugs (bDMARDs)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Psoriatic Arthritis
Rheumatoid Arthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-12
Enrollment: 559
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care

Brief summary: The study is a cross sectional, epidemiology study of disease severity for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in four geographic regions in Australia (Illawarra, Sutherland, Hunter Urban and Hunter Rural).


Eligibility criteria: Inclusion criteria include:

Adult patients with a diagnosis of rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who have visited a primary care centre within one of the specified catchment areas for their condition within the last 24 months.

Primary outcomes:
measure: Proportion of rheumatoid arthritis/psoriatic arthritis/ankylosing spondylitis patients in defined disease severity categories
timeFrame: Single visit
Secondary outcomes:
measure: Proportion of patients exposed to biological disease modifying antirheumatic drugs
timeFrame: Single visit
Other outcomes:
Locations:
city: Georgetown
country: Australia
city: Miranda
country: Australia
city: Newcastle
country: Australia
city: Wollongong
country: Australia
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03665987: The Effect of Preoperative Assessment Clinic on Prognosis and Economic Results of Patients With Coexisting Disease.
Official title: The Effect of Preoperative Assessment Clinic on Prognosis and Economic Results of Patients With Coexisting Diseases.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Length of Stay
Postoperative Complications
Morality
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 250
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population will be selected from outpatient surgery department in Shanghai Zhongshan Hospital.

Brief summary: To assess the effect of preoperative assessment clinic on prognosis and economic results of patients with coexisting diseases, the investigators designed a prospective cohort study. The investigators will recruit 250 patients preparing to undergo a selective epigastrium surgery with coexisting medical diseases which need an anesthetic consultation. The patients will be randomly assigned into two groups. The intervention group will be seen in the preoperative clinic before hospitalization, while the control group will get anesthetic consultation after hospitalization without clinic service. No additional interventions will be given during and after surgery. The length of stay, hospitalization expense, postoperative complication rate and mortality rate of the two groups will be compared. The investigator assume that consultation in preoperative assessment clinic will improve the prognosis and decrease the hospitalization expenses.


Eligibility criteria: Inclusion Criteria:

* patients preparing to undergo a selective epigastrium surgery
* patients with coexisting medical diseases needing an anesthetic consultation
* over 60 years old
* ASA II-III
* patients with good compliance

Exclusion Criteria:

* patients ubdergoing emergency operation
* ASA I, IV
* patients under 60 years old
* patients with bad compliance

Primary outcomes:
measure: length of stay
timeFrame: an average of 5 days
Secondary outcomes:
measure: hospitalization expense
timeFrame: an average of 5 days
Other outcomes:
measure: postoperative complication rate
timeFrame: an average of 5 days
measure: mortality rate
timeFrame: an average of 5 days
Locations:
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Jing Cang, Doctor
role: STUDY_CHAIR
References:
citation: van Klei WA, Moons KG, Rutten CL, Schuurhuis A, Knape JT, Kalkman CJ, Grobbee DE. The effect of outpatient preoperative evaluation of hospital inpatients on cancellation of surgery and length of hospital stay. Anesth Analg. 2002 Mar;94(3):644-9; table of contents. doi: 10.1097/00000539-200203000-00030.
citation: Ferschl MB, Tung A, Sweitzer B, Huo D, Glick DB. Preoperative clinic visits reduce operating room cancellations and delays. Anesthesiology. 2005 Oct;103(4):855-9. doi: 10.1097/00000542-200510000-00025.
Clinical trial NCT00691587: Pilot Trial of KB001 in Mechanically-Ventilated Patients Colonized With Pseudomonas Aeruginosa
Official title: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial of KB001 in Mechanically-Ventilated Patients Colonized With Pseudomonas Aeruginosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pseudomonas Aeruginosa
Ventilator Associated Pneumonia
Keywords: mechanical ventilation
mechanically ventilated
Pseudomonas aeruginosa
ventilator associated pneumonia
Lead sponsor: Humanigen, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pseudomonas aeruginosa is an opportunistic pathogen that rarely causes disease in healthy people, but is a significant problem for critically ill or immunocompromised individuals. Experts estimate that there are greater than 100,000 patients in the United States, Europe and Japan where Pseudomonas pneumonia occurs. Patients with Pseudomonas pneumonia currently represent only about 20% of the patients in the hospital who get Pseudomonas infections.

Detailed description: This trial will evaluate KB001 in patients in the intensive care setting who are receiving ventilator therapy and who have Pseudomonas infections. They will receive either placebo, or one of two dose levels of KB001, a Humaneered™, high-affinity antibody fragment that KaloBios is developing for the treatment of Pseudomonas aeruginosa (Pa) infections. This trial will evaluate the ability of KB001 to protect host epithelium and immune cells, and evaluate reduction of pulmonary Pa burden.

Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent obtained from patient or patient's surrogate if unconscious or altered sensorium
* Age \>18 years
* On mechanical ventilation and expected to remain mechanically ventilated for at least 3 days
* Documented pulmonary Pa colonization

Exclusion Criteria:

* Patients with known chronic pulmonary infection with Pa (i.e., patients with cystic fibrosis)
* Patient currently diagnosed with Pa VAP
* Change in systemic antibiotic therapy active against Gram negative bacteria within 72 hours
* Use of an investigational medication within 4 weeks prior to randomization

Primary outcomes:
measure: The safety and tolerability of a single dose of KB001.
timeFrame: Day 28
Secondary outcomes:
measure: To measure the pharmacodynamic effects of a single-dose of KB001.
timeFrame: Day 28
Other outcomes:
Locations:
city: Multiple Cities
country: France
Study officials:
affiliation: Hopital La Pitie Salpetriere
name: Prof. Jean Chastre
role: PRINCIPAL_INVESTIGATOR
References: