louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01612117: Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) in Invasive Cardiology
Official title: Is Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) the "Renal Troponin" in Invasive Cardiology?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Failure
Keywords: renal failure
cardiology
contrast-induced nephropathy
Lead sponsor: University of Freiburg
Sponsor class: OTHER
First posted: 2012-06-05
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all consecutive patients

Brief summary: Diagnosis of acute kidney injury (AKI) relies on a late marker, namely serum creatinine (SCr). New biomarkers are considered for early and sensitive detection of CIN. In particular, uNGAL has been used for early detection of AKI in the emergency department, after cardiopulmonary bypass or following CM administration.

This study will be conducted to assess the possible value of urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) as an early detector of contrast-induced nephropathy (CIN) in a large sized cohort of patients undergoing percutaneous coronary procedures (PCP) and whether or not uNGAL correlates with the volume of contrast medium (CM) used.

Detailed description: Methods. We will enroll all consecutive patients undergoing PCP with iomeprolum during a 3-month period at our institution. CIN will be defined as a ≥25% increase in SCr from baseline when measured 2-4 days after PCP. uNGAL will be measured at its peak with the Abbott ARCHITECT assay.

Eligibility criteria: Inclusion Criteria:

* All except patients with exclusion criteria

Exclusion Criteria:

* dialysis-dependent chronic kidney disease
* lack of written consent

Primary outcomes:
measure: to assess the value of uNGAL measurement 4 to 6 hours after PCP as a possible early detector of CIN
timeFrame: 4-6 hours after PCP
Secondary outcomes:
measure: to study the relationship between the volume of contrast medium used for PCP and the uNGAL levels measured 4 to 6 hours thereafter
timeFrame: 4-6 hours after PCP
Other outcomes:
Locations:
city: Freiburg
country: Switzerland
facility: Department of Cardiology
state: Fribourg
Study officials:
affiliation: University Fribourg
name: Stephane Cook, MD
role: STUDY_CHAIR
References:
citation: Perrin T, Descombes E, Magnin JL, Gachet M, Hemett OM, Hayoz D, Stolt V, Baeriswyl G, Stauffer JC, Goy JJ, Togni M, Cook S. Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) and contrast-induced acute kidney injury after coronary angiogram. Swiss Med Wkly. 2013 Aug 27;143:w13853. doi: 10.4414/smw.2013.13853. eCollection 2013.
Clinical trial NCT02223117: Evaluation of the Safety and Immunogenicity of Autologous Thrombosomes® in Healthy Human Subjects; A Microdose Escalation Study (Cohorts 1 - 4) and Repeat Microdose Immunogenicity Study (Cohort 5)
Official title: Evaluation of the Safety and Immunogenicity of Autologous Thrombosomes® in Healthy Human Subjects; A Microdose Escalation Study (Cohorts 1 - 4) and Repeat Microdose Immunogenicity Study (Cohort 5)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: Cellphire Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
First posted: 2014-08-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This "first-in-human" exploratory IND, single-center study will assess the safety, toxicity, hematology, and immunogenicity of sub-therapeutic "microdoses" of autologous Thrombosomes® in healthy human subjects.


Eligibility criteria: Inclusion Criteria:

1. Minimum weight 110 pounds (50 kg)
2. Age 18-45 years
3. Able and willing to provide informed consent
4. Has permanent address and phone/e-mail for contact and notification, and able to come to the research site for scheduled study visits for up to 60 days after their last study infusion
5. Understands, speaks and reads standard English language
6. Normal healthy subject able to pass the universal blood donor history questionnaire and screen

Exclusion Criteria:

1. Breast-feeding female
2. At any time, previously pregnant female
3. Participation in an experimental drug/device study within the past 30 days.

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety Evaluation
timeFrame: 60 days
Secondary outcomes:
measure: Standard Hematology, Coagulation and Platelet Immunology Assessment
timeFrame: 60 Days
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Bloodworks Northwest
state: Washington
Study officials:
affiliation: Cellphire Therapeutics, Inc.
name: Michael Fitzpatrick, PhD
role: STUDY_DIRECTOR
affiliation: Bloodworks Northwest
name: Sherrill Slichter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03481517: Wound Infiltration With Local Anesthetic Agent for Laparoscopic Appendectomy in Adult
Official title: The Interest of Wound Infiltration With Local Anesthetic Agent for Laparoscopic Appendectomy in Adult: a Double Blind, Prospective, Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Appendicitis Acute
Keywords: adult
appendectomy
appendicitis
local anesthesia
pain
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 47
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute appendicitis is one of the most common acute abdomens that need surgical intervention. Laparoscopic surgery much decreases postoperative pain of wound, however, pain remains an important determinant of recovery after surgery. Intraoperative local anesthetic agent infiltrated locally into surgical wound to relieve postoperative pain is a feasible and safe method suggested in some literature. However, there is no routine use of this method in clinical practice because its benefit is still unknown. Besides, very few evidence could be found in literature review. To date, there is still no double blinded, prospective, randomized control trial addressing in evaluation of its interest. In this study, the investigators aim at investigating the benefit of wound infiltration with local anesthetic agent (bupivacaine) for laparoscopic appendectomy in adult. The study design is a double blind, prospective, randomized control trial with a 1:1 allocation ratio. Fifty adult patients with appendicitis will be included. The control group undergo laparoscopic appendectomy without wound infiltration with local anesthetic agent, the intervention group undergo laparoscopic appendectomy with wound infiltration with local anesthetic agent intraoperatively. The clinical characteristics, outcomes, and patient's satisfaction will be recorded and analyzed. The investigators hope this study can provide a high level evidence in pain management of patient undergo laparoscopic surgery.


Eligibility criteria: Including criteria:

1. Clinical diagnosis of appendicitis and undergo laparoscopic appendectomy
2. Age more than 20 years
3. Well comprehensive in speaking Chinese

Exclusion criteria:

1. Age no more than 20 years
2. Pregnancy
3. Can not cooperate with evaluation
4. Convert to open surgical method, resect more organs than appendix
5. Using patient control analgesia
6. Allergy to local anesthetic agent

Primary outcomes:
measure: Pain score of surgical wound of the patient
timeFrame: within 24 hours after surgery
Secondary outcomes:
measure: Satisfaction of the patient
timeFrame: up to one month after surgery
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chih-Yang Hsiao, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06366217: Efficacy of the MydCombi on Pupillary Dilation in Pediatric and Adult Patients
Official title: Efficacy of the MydCombi on Pupillary Dilation in Pediatric and Adult Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Dilation
Pupil Reaction Absent
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To raise the standard of care, improve the overall patient experience and streamline practice flow, Eyenovia has developed an innovative mydriatic to be delivered as a microdose by a specialized dispenser. While still achieving effective pupil dilation, MydCombi has the potential to increase patient throughput at practicing offices by decreasing time spent eye dropping patients, eliminating time wasted waiting between drop instillations and ensuring more accurate drug delivery. The proposed study hopes to demonstrate the non-inferiority of using MydCombi to achieve pupillary dilation in patients compared to standard of care eye drops.

Detailed description: The proposed study strives to demonstrate the non-inferiority of using MydCombi to achieve pupillary dilation in patients compared to standard-of-care (SOC) eye drops in a randomized trial.

Primary Aim: Demonstrate non-inferiority of using MydCombi to achieve pupillary dilation compared to standard-of-care eye drops in patients.

Participants 2 years or older undergoing standard pupillary dilation will be randomized to use MydCombi in one eye and standard of care pupillary dilation in another eye.

Eligibility criteria: Inclusion Criteria:

* Receiving pupillary dilation in both eyes as part of the participant's standard of care.

Exclusion Criteria:

* Pupillary or anterior segment abnormality
* Participants with pre-existing health conditions that would prevent pupillary dilation.

Primary outcomes:
measure: Percent change in Spherical equivalent
timeFrame: Before dilation and 30 minutes after dilation
measure: Percent Change in maximum pupil diameter
timeFrame: Before dilation and 30 minutes after dilation
measure: Percent Change in pupil constriction percentage
timeFrame: Before and 30 minutes after dilation
Secondary outcomes:
measure: Percent Change in Intraocular Pressure
timeFrame: Before and 30 minutes After Dilation
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Julius Oatts, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03430817: Citicholine-Amantadine Trial in Traumatic Brain Injury
Official title: Citicholine-Amantadine Trial in Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intensive Care Unit
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 45
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized study aims at comparing between the effects of amantadine, citcholine and its combinations on arousal and behavioral consequences in early phase of moderate Traumatic Brain injury (TBI).

Detailed description: As both agents amantadine and citcholine showed considerable effects on neuro-recovery from TBI, The investigators hypothesized that combination therapy of both drugs will have significant effect as it simultaneously will target multiple mechanisms of injury. So, this randomized study aims at comparing between the effects of amantadine, citcholine and their combinations on arousal and behavioral consequences in early phase of moderate TBI

Eligibility criteria: Inclusion Criteria:

* Sustained moderate non-penetrating TBI with GCS of 9-12

Exclusion Criteria:

* Patients with mild (GCS \> 12) or severe TBI (GCS \< 9)
* Patients suffering from any central nervous system disability prior to the traumatic brain injury
* Major medical problems as; major cardiovascular disease or heart failure, renal insufficiency (creatinine clearance, less than 60 ml per minute), liver impairment,
* Pregnancy,
* More than one seizure in the previous month,
* Prior treatment with amantadine,
* Allergy to the study drugs.

Primary outcomes:
measure: Galsgow coma scale
timeFrame: 30 days
Secondary outcomes:
measure: disability rating scale (DRS)
timeFrame: 30 days
measure: Mini Mental scale (MMS)
timeFrame: 30 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
References:
Clinical trial NCT02775617: Azithromycin - Ivermectin Mass Drug Administration for Skin Disease
Official title: Impact of Combined Azithromycin and Ivermectin Mass Drug Administration for Yaws and Scabies - Impact on Impetigo and Skin Microbiology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Scabies
Yaws
Impetigo
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Atoifi Adventist Hospital, Solomon Islands
name: Kirby Institute
name: Murdoch Childrens Research Institute
First posted: 2016-05-17
Enrollment: 1291
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label prospective community intervention trial to assess the impact of community mass treatment with azithromycin for yaws and ivermectin for scabies, on non-yaws bacterial skin infections.

Communities will be randomised to receive standard treatment for both yaws and scabies either in parallel (site 1) or in sequence (site 2).

Treatment of yaws:

Single dose of Azithromycin (30mg/kg, max 2G).

Treatment of scabies:

Either an oral dose of Ivermectin (200μg/kg) or permethrin cream for those with a contraindication to Ivermectin (WT\<15kg, pregnant or breastfeeding women) given in 2 doses 7-14 days apart.

Investigators will complete a clinical and microbiological assessment of bacterial skin disease at baseline and at 12 months to assess the impact of treatment on the prevalence of bacterial infection and the emergence of antimicrobial resistance.

Primary Outcome

1. Difference in the change in prevalence of impetigo between baseline and 12- months between the parallel and the sequential treatment arms.

   Secondary Outcomes
2. Change in the proportion of swab samples from which S. pyogenes is cultured between baseline and follow-up in the two arms
3. The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms


Eligibility criteria: Inclusion Criteria:

* All community members are able to be included in the study.

Exclusion Criteria:

* Allergy to any of the components of the allocated drug regimen

Primary outcomes:
measure: Impetigo Prevalence at 12 Months
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Group A Streptococcus at 12 Months
timeFrame: 12 Months
measure: Antimicrobial Resistance in Culture Isolates
timeFrame: 12 Months
Other outcomes:
Locations:
city: Atoifi
country: Solomon Islands
facility: Atoifi Adventist Hospital
state: Malaita
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Michael Marks
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marks M, Toloka H, Baker C, Kositz C, Asugeni J, Puiahi E, Asugeni R, Azzopardi K, Diau J, Kaldor JM, Romani L, Redman-MacLaren M, MacLaren D, Solomon AW, Mabey DCW, Steer AC. Randomized Trial of Community Treatment With Azithromycin and Ivermectin Mass Drug Administration for Control of Scabies and Impetigo. Clin Infect Dis. 2019 Mar 5;68(6):927-933. doi: 10.1093/cid/ciy574.
Clinical trial NCT00712517: Propofol Versus Volatile Anesthesia in Post Operative Pain Management
Official title: Do Patients Anesthetized With Propofol Have Less Pain Than Those Anesthetized With Volatile?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Varicose Vein
Postoperative Pain
Keywords: postoperative pain
Piritramid
propofol
sevoflurane
varicose vein
Anesthesia
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-07-10
Enrollment: 90
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: The study will test the hypothesis that patients anesthetized with propofol suffer less postoperative pain than those anesthetized with sevoflurane.

Detailed description: Patients undergoing s stripping operation for varicose veins will be randomized to one of two groups. Group 1 patients will receive propofol anesthesia. Group 2 patients will receive sevoflurane anesthesia. Intraoperative measurements including mean-arterial pressure, heart rate, propofol infusion rate, remifentanil infusion rate, and end-tidal sevoflurane concentration will be taken at 15 minute intervals. Patients in both groups will receive Piritramid as necessary to control pain either intravenously or through patient controlled pump. VAS pain score, mean-arterial pressure, heart rate, nausea will be evaluated at 30 minute intervals during the first four postoperative hours. Piritramid dosage and vomiting will be recorded through the first postoperative morning. Patients will rate pain based on the VAS score for the period between leaving the recovery room and the first postoperative morning

Eligibility criteria: Inclusion Criteria:

* Participants will undergo a stripping operation for varicose veins
* Surgery will be performed by one physician only
* Written informed consent

Exclusion Criteria:

* Any contraindications to the proposed interventions
* Procedures done under regional anesthesia

Primary outcomes:
measure: The primary outcome is morphine-equivalent use from the end of surgery until the first post-operative morning.
timeFrame: first post operative morning
Secondary outcomes:
measure: To determine the average pain score for each group during the first four hours of recovery after surgery.
timeFrame: 30 minute intervals for first 4 hours post operatively
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Olga Plattner , MD
Study officials:
affiliation: Medical University of Vienna
name: Olga Plattner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Windpassinger M, Plattner O, Gemeiner J, Bohler K, Luntzer R, Klimscha W, Yang D, Mascha EJ, Sessler DI. Opioid use after propofol or sevoflurane anesthesia: a randomized trial. Can J Anaesth. 2016 Nov;63(11):1258-65. doi: 10.1007/s12630-016-0728-5. Epub 2016 Sep 14.
Clinical trial NCT04212117: CALS Patient Activated Learning System (PALS)
Official title: Can the Digital Patient Activated Learning System Increase Racial Minority Engagement With Health Information? A Multi-Site Pilot Examination in New York State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Trust
Health Knowledge, Attitudes, Practice
Lead sponsor: Cornell University
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall goal in this line of inquiry is to test whether the Patient Activated Learning System (PALS) is effective in reducing disparities in access to reliable, easily understood health information, and whether this increased understanding has downstream consequences such as increases in trust in the medical system and self-management behaviors.

Detailed description: Participants will view, in randomized order, PALS or WebMD content on hypertension and on high cholesterol. This study will test knowledge uptake across topics as well as attitudes toward and trust in the information and information providers.

Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years of age.
* Self-reported hypertension diagnosis.
* English speaking
* Passing the cognition screener
* Able to read in English
* Patient at designated recruitment clinics

Exclusion Criteria:

* Non-English speakers
* Not having self-identified as having hypertension
* Inability to read in English
* Being younger than 18
* Not passing the screener
* Not being a patient on the participating clinics

Primary outcomes:
measure: Knowledge
timeFrame: Day 1, Immediately after reading article
measure: Trust in eHealth
timeFrame: Day 1, Immediately after reading article
measure: E-health usability
timeFrame: Day 1, Immediately after reading article
measure: Physician trust
timeFrame: Day 1, Immediately after reading article
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Cornell University
name: Neil Lewis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01630317: Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.
Official title: Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 33
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: Slow continuous ultrafiltration using central vs peripheral line: feasibility of implementation, safety and efficacy in acute heart failure syndromes.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years
* Patients hospitalized with primary diagnosis of acute heart failure defined as ≥ 2 of the following criteria:
* Peripheral or sacral edema
* Jugular venous distension or venous central pressure \> 10 mmHg
* Hepatomegaly or ascites
* Pulmonary edema or pleural effusion on x-ray or pulmonary wedge pressure or end-diastolic pressure \> 20 mmHg.
* High pro-BNP
* Randomization during first 24 hours
* Serum creatinine levels \< 3mg/dL, and K \< 6 mmol/L
* The patient should be able to communicate with research staff and meet with study procedures.
* The patient will signed informed consent.

Exclusion Criteria:

* Diagnosis of severe aortic stenosis or severe obstruction to the LVOT, tamponade, cardiac hypertrophic or restrictive cardiomyopathy.
* Impossibility of venous catheterization
* Acute coronary syndrome
* Creatinine greater than 3.0 or K greater than 6 mmol/L.
* Systolic blood pressure less than or equal to 100 mmHg
* Hematocrit greater than 45%
* Prior administration of IV vasoactive drugs in the emergency room (ER)
* Clinical instability requiring pressors during hospitalization
* Sepsis
* On or requires renal dialysis.

Primary outcomes:
measure: Efficacy
timeFrame: 48 hours after initiation of scuf therapy
Secondary outcomes:
measure: Security
timeFrame: 5th day of the study
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Cardiology Service, Hospital del Mar. Passeig Maritim 25-29,
Study officials:
References: