louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03078504: Hemodynamic Effects of Blood Flow Variation in Continuous Renal Replacement Therapy
Official title: Hemodynamic Effects of Blood Flow Variation in Continuous Renal Replacement Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Kidney Injury
End-stage Renal Disease
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose of this study is to evaluate the short-term hemodynamic effects of changes in blood flow rates in critically ill patients receiving continuous renal replacement therapy.


Eligibility criteria: Inclusion Criteria:

* Age 18-89
* Acute renal failure or end-stage renal disease necessitating CRRT
* Admitted to the MICU service
* If on vasopressor/inotropic agent, norepinephrine as only intravenous pressor
* If on vasopressor/inotropic agent, at stable pressor dose for at least four hours
* If on IV fluids, stable dose of crystalloids \<= 100cc/hour and is not receiving colloids for 4 hours or more prior to initiation of CRRT
* Mean arterial pressure (MAP) \>= 65
* Arterial catheter present for continuous blood pressure monitoring
* CRRT duration of 48 hours or less using NxStage System One dialysis system
* successfully tolerated CRRT for at least 4 hours without clotting or hemodynamic instability
* no other procedures, blood products transfusion, or additional medication administration are anticipated during the study period

Exclusion Criteria:

* listed for organ transplant
* atrial fibrillation, other irregular heart rhythm, unstable arrhythmia
* need for more than one intravenous vasopressor agent
* intravenous vasopressor/inotropic agent other than norepinephrine (ie dobutamine, dopamine, vasopressin, epinephrine)
* therapeutic anticoagulation being administered
* known acute myocardial infarction as defined by elevated troponin along with a documented clinical diagnosis during current hospitalization
* known acute stroke, intracerebral hemorrhage, intracranial mass effect, or elevated intracranial pressure within the last 30 days.
* dialysis catheter malfunction and unable to maintain target blood flow rate
* fluid removal (ultrafiltration) rate \> 100mL/hour

Primary outcomes:
measure: Blood Pressure Change
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
Study officials:
affiliation: Associate Professor
name: Zafar Jamkhana, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01453504: Everolimus in Combination With DHAP in Patients With Relapsed or Refractory Hodgkin Lymphoma
Official title: A Prospective, Randomized, Placebo-controlled, Multicenter, International Phase I/II Trial of RAD001 (Everolimus) in Combination With DHAP as Induction Therapy in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hodgkin Lymphoma
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2011-10-18
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is

1. to determine the recommended dose of everolimus for a subsequent Phase II trial
2. to determine the efficacy of everolimus plus DHAP


Eligibility criteria: Inclusion Criteria:

* relapsed or refractory Hodgkin Lymphoma
* age 18-60
* histology confirmed relapse

Exclusion Criteria:

* previous therapy with mTOR inhibitor
* current CNS involvement
* other primary malignant disease within the last 3 years

Primary outcomes:
measure: Dose Limiting Toxicity Rate (DLT)
timeFrame: 4 weeks
measure: Complete Remission Rate (CR)
timeFrame: 4 weeks
Secondary outcomes:
measure: Adverse event rate
timeFrame: 4 weeks
measure: Tumor status (assessed by CT) after chemotherapy
timeFrame: 4 weeks
measure: Tumor status (assessed by PET) after chemotherapy
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: 1st Dept. of Medicine, Cologne University Hospital
Study officials:
affiliation: University of Cologne, German Hodgkin Study Group
name: Peter Borchmann, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT05499104: A Trial Comparing a Cellulose Dressing to Two Standard of Care Dressings in Treating Split Thickness Donor Sites in Burn and Wound Patients.
Official title: A Prospective, Randomized, Controlled Trial Comparing a Cellulose Dressing to Two Standard of Care Dressings in Treating Split Thickness Donor Sites in Burn and Wound Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Donor Sites
Wound Heal
Wound Drainage
Pain Management
Lead sponsor: Joseph M. Still Research Foundation, Inc.
Sponsor class: OTHER
Collaborators: name: Innovatech Engineering, LLC
First posted: 2022-08-12
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a three arm study, comparing the Novadress, Mepilex Ag, and Xeroform Occlusive dressings for healing, drainage, and pain management. NovaDress is constructed of pure cellulose derived from tree pulp. Mepilex Ag is a antimicrobial foam dressing that absorbs low to moderate exudate and maintains a moist wound environment. Xeroform Occlusive Dressing is a fine-mesh gauze impregnated with a petrolatum blend, 3% bismuth tribromophenate.


Eligibility criteria: Inclusion Criteria:

* Is ≥18 years of age.
* Has been admitted to the Joseph M. Still Burn Center at Doctors Hospital Augusta or The Advanced Wound Clinic, needing a split-thickness skin graft and will undergo a subsequent donor site harvest.
* Subject is able to provide informed consent.
* Has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) if available or if stated by patient.

Exclusion Criteria:

* Has a Baux Score of ≥130.
* Subject is intubated, unable to state pain levels.
* Has active diagnosis of any autoimmune process, cancer, or organ failure that in the opinion of the investigator would prevent the subject from successfully participating in the study,
* Has coagulopathy that in the opinion of the investigator, would place subject at an increased risk for bleeding.
* Vulnerable subjects who, in the opinion of the Investigator, present with poor skin integrity (i.e. Elderly), is a prisoner, non-English speaking, or is without means of follow-up or return to clinic (i.e. homeless).
* Is pregnant, plans to become pregnant, or is actively breastfeeding.
* Active illicit drug use.
* Is moribund, or in the opinion of the investigator is not expected to survive.

Primary outcomes:
measure: Pain and Healing
timeFrame: 14 days
Secondary outcomes:
measure: Absorbent ability
timeFrame: 14 days
measure: Conformability
timeFrame: 14 days
measure: Adherence
timeFrame: 14 days
measure: Management of bloody exudate
timeFrame: 14 days
measure: Ease of removal
timeFrame: 14 days
measure: Cost
timeFrame: 14 days
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Joseph M. Still Research Foundation
state: Georgia
Study officials:
References:
Clinical trial NCT04539704: Assessing Impacts of Static Magnetic Fields on Peripheral Pulses and Skin Blood Flow
Official title: Assessing Impacts of Static Magnetic Fields on Peripheral Pulses and Skin Blood Flow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Stiffness
Magnetic Field Exposure
Peripheral Arterial Disease
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research study is to investigate and determine the effects of static magnetic fields produced by a small magnet on peripheral pulses and skin blood flow.

Detailed description: A specific neodymium magnet and sham device will be placed on certain sites near the ulnar and medial arteries and the effect of such placement on peripheral pulses assessed via PPG on fingers and on skin blood flow via laser Doppler perfusion determined. These assessments will be made while healthy subjects are lying supine on a padded examination table over a time interval of about 45-60 minutes. In addition to the impact that either the magnet or the sham devices have, the pulse and skin blood flow patterns and features will be analyzed from the point of view of sequential variability with and eye toward developing related parameters to potentially improve such variability.

Eligibility criteria: Inclusion Criteria:

1. Age between 18-35 years
2. No known neurological deficit
3. No known cardiovascular condition

Exclusion Criteria:

1. Unable or unwilling to lie reasonably still for about 55 minutes
2. Known to have diabetes of any type
3. Having any metallic or wire implant

Primary outcomes:
measure: Effect of magnet on skin blood flow
timeFrame: one hour
measure: Effect of magnet on arterial pulses
timeFrame: one hour
measure: Characterization of temporal pattern of pulse changes and their amelioration
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Davie
country: United States
facility: Nova Southeastern University
state: Florida
Study officials:
References:
citation: Mayrovitz HN, Astudillo A, Shams E. Finger skin blood perfusion during exposure of ulnar and median nerves to the static magnetic field of a rare-earth magnet: A randomized pilot study. Electromagn Biol Med. 2021 Jan 2;40(1):1-10. doi: 10.1080/15368378.2020.1856682. Epub 2020 Dec 5.
Clinical trial NCT00950404: Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet
Official title: An Open-Label, Crossover Study In Healthy Volunteers To Evaluate The Pharmacokinetics Of Sildenafil Following Administration Of Three Orally Disintegrating Tablet Formulations Of Sildenafil Without Water Relative To Viagra Conventional Oral Tablet With Water.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Bioavailability Pharmacokinetic Formulation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-07-31
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The bioavailability of the oral disintegrating tablet formulations given without water will be similar to an equivalent dose of the standard oral tablet given with water.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Weight: BMI from 17.5 to 30.5

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.

Primary outcomes:
measure: AUC0-T and Cmax of sildenafil
timeFrame: 1 month
Secondary outcomes:
measure: AUC0-Tmax and AUCinf of sildenafil
timeFrame: 1 month
measure: Tmax and half-life of sildenafil
timeFrame: 1 month
measure: adverse events
timeFrame: 3 weeks
measure: vital signs
timeFrame: 3 weeks
measure: laboratory parameters
timeFrame: 3 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05737004: Effects of Prostate Cancer on Brain Function
Official title: The Effects of Prostate Cancer on Brain Function: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: prostate cancer
functional magnetic resonance imaging(fMRI)
Brain function
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 250
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient coming to our hospital for prostate biopsy and fully understand the clinical trial protocol and sign informed consent

Brief summary: To explore whether the patients with prostate cancer have functional changes in specific brain areas and changes in psychological and mental characteristics compared with the patients without prostate cancer.

Detailed description: This study was intended to observe the functional changes of brain fMRI in patients with and without prostate cancer enrolled in the cohort of patients who planned to undergo prostate biopsy, in an attempt to discover specific brain region changes in patients with prostate cancer, and lay a foundation for further clarifying the relationship and mechanism between brain region function changes and prostate cancer.

Eligibility criteria: Inclusion Criteria:

1. Between the ages of 18 and 80
2. Patients with prostate biopsy;
3. No history of other malignant tumors;
4. Exclude other malignant tumors;
5. Fully understand the clinical trial protocol and sign informed consent;

Exclusion Criteria:

1. magnetic resonance contraindications;
2. symptomatic acute or chronic inflammation of the prostate;
3. Patients with brain trauma or brain disease;
4. Patients who have died of other malignancies in the past or are currently suffering from other malignancies;
5. Patients judged by the investigator to be unfit to participate in the clinical trial;

Primary outcomes:
measure: The evaluation of Magnetic Resonance(MR)
timeFrame: Within 1 week before biopsy
Secondary outcomes:
measure: Assessment of anxiety status
timeFrame: Within 1 week before biopsy
measure: Assessment of depressive status
timeFrame: Within 1 week before biopsy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital, Tongji University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai East Hospital,Tongji University School of Medicine
name: Haifeng Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01037504: AZD5423 Multiple Ascending Dose Study
Official title: Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled AZD5423 After Administration of Multiple Ascending Doses for 14 Days in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: safety
tolerability
healthy
inhalation
Healthy volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-12-23
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following multiple ascending dose administrations in healthy male and female subjects


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically significant abnormalities at screening examination
* Use of any prescribed or non-prescribed medication

Primary outcomes:
measure: Safety variables: adverse events
timeFrame: Assessment taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up visit. Volunteers will be monitored throughout the study for adverse events.
Secondary outcomes:
measure: Pharmacokinetics profile: concentration of AZD5423 in plasma
timeFrame: Samples taken at defined timepoints pre-dose and post-dose during treatment periods. Samples taken at approx. 39 timepoints.
measure: Investigation of PD effects
timeFrame: Samples taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up.
Other outcomes:
Locations:
city: London Bridge
country: United Kingdom
facility: Research Site
state: Greater London
Study officials:
affiliation: Quintiles Drug Research Unit at Guy's Hospital, London, UK
name: Darren Wilbraham
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D, Lund, Sweden
name: Jorup Carin
role: STUDY_DIRECTOR
References:
Clinical trial NCT01496404: Electrocautery Versus Scalpel for Skin Incisions
Official title: A Randomized Controlled Trial Comparing the Cosmetic Outcome of Electrocautery Versus Scalpel for Surgical Skin Incisions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Complication
Surgical Wound Infection
Post-operative Pain
Keywords: Electrocautery
Lead sponsor: St. Paul's Hospital, Canada
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 66
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this research project is to compare electrocautery to scalpel for laparotomy skin incisions, with the following objectives:

1. To investigate whether electrocautery produces a cosmetically inferior surgical scar.
2. To compare the rates of wound infection with each technique.
3. To determine if electrocautery results in less postoperative pain. Our null hypothesis is that electrocautery is equivalent to scalpel for creating skin incisions; with respect to wound cosmesis, wound infection rate, and post-operative pain.


Eligibility criteria: Inclusion Criteria:

* Patients over 19 years old
* bowel resection surgery
* incision is 3cm or larger

Exclusion Criteria:

* Diagnosed with a connective tissue disease (e.g. Systemic lupus, scleroderma, polymyositis, dermatomyositis, Marfan syndrome, Ehler's Danlos, etc.)
* The site of planned surgery has a previous surgical scar.

Primary outcomes:
measure: Scar Cosmesis
timeFrame: 6 months
Secondary outcomes:
measure: Wound Infection Rate
timeFrame: within 6 months post-operatively
measure: Post-operative wound pain
timeFrame: within 5 days post-operatively
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St Paul's Hospital
state: British Columbia
Study officials:
affiliation: Providence Health, University of British Columbia
name: Carl J Brown, MD MSc FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Lisa NF Aird, BSc MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aird LN, Bristol SG, Phang PT, Raval MJ, Brown CJ. Randomized double-blind trial comparing the cosmetic outcome of cutting diathermy versus scalpel for skin incisions. Br J Surg. 2015 Apr;102(5):489-94. doi: 10.1002/bjs.9751. Epub 2015 Feb 18.
Clinical trial NCT03891004: Skin Closure With Tissue Adhesives vs. Subcuticular Suture After Robotic Urogynecologic Procedures
Official title: Skin Closure With Tissue Adhesives vs. Subcuticular Suture After Robotic Urogynecologic Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound
Tissue Adhesion
Lead sponsor: St. John Hospital & Medical Center
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a randomized controlled trial comparing skin closure after robotic urogynecologic surgery with tissue adhesive versus subcuticular suture.
Primary purpose: TREATMENT

Brief summary: To compare skin closure via subcuticular suture versus tissue adhesive (Dermabond) in urogynecological robotic surgeries. The primary outcome is incision cosmesis at the 12 week follow up visit. Secondary outcome is the operative time between the two methods of closure.

Detailed description: The purpose of this study is compare skin closure via suture versus tissue adhesive (Dermabond) in urogynecological robotic surgeries. The primary outcome is incision cosmesis. Therefore, if the tissue adhesive is cosmetically comparable to that of sutures, that will be reason to use tissue adhesives over traditional sutures. In these surgeries, there are five to six port sites (compared to fewer for usual laparoscopic procedures) and the procedures are lengthy procedures (average duration about 300 minutes as per recent AUGS/ACOG committee opinion), so if the investigators can show significant time reduction for closure, that should reduce operative time and costs. To the investigators' knowledge, this will be the first study of its kind to make this comparison for urogynecologic robotic procedures.

Eligibility criteria: Inclusion Criteria:

* Women, ages 18 years and older, undergoing any urogynecologic robotic procedure at St. John Hospital and Medical Center from March 19, 2018 - November 30, 2018.

Exclusion Criteria:

* We will exclude women with active skin infections as they may contribute to poor wound healing and infections. We will also exclude procedures that are converted to laparotomy.

Primary outcomes:
measure: Incision Cosmesis
timeFrame: 12 weeks
Secondary outcomes:
measure: Incision closure time
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Detroit
country: United States
facility: St. John Hospital & Medical Center
state: Michigan
Study officials:
References: