louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03177798: Mitochondria and Chronic Kidney Disease
Official title: Mitochondrial Dysfunction in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hemodialysis-Induced Symptom
Mitochondrial Diseases
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The overarching goal of this study is to determine the role of chronic kidney disease and the activation of the kallikrein-kinin system during hemodialysis on the development of mitochondrial dysfunction; the investigators will measure mitochondrial function using the gold standard method, 31-phosphorus magnetic resonance spectroscopy.

The investigators will test the hypothesis that endogenous bradykinin promotes mitochondrial dysfunction in patients undergoing hemodialysis. The investigators will first perform a randomized, placebo-controlled, double-blind, cross-over study measuring the effect of Icatibant (HOE-140), a bradykinin B2 receptor blocker, on mitochondrial function.


Eligibility criteria: Inclusion Criteria:

* Adult patients who have been on maintenance hemodialysis for at least 6 months

Exclusion Criteria:

* History of functional transplant less than 6 months prior to study
* Use of immunosuppressive drugs within 1 month prior to study
* History of active connective tissue disease
* History of acute infectious disease within one month prior to study
* AIDS (HIV seropositivity is not an exclusion criteria)
* History of myocardial infarction or cerebrovascular event within 3 months
* Advanced liver disease
* Gastrointestinal dysfunction requiring parental nutrition
* Active malignancy excluding basal cell carcinoma of the skin
* Ejection fraction less than 30%
* Anticipated live donor kidney transplant
* Pregnancy, breast-feeding or child-bearing potential
* History of poor adherence to hemodialysis or medical regimen
* Subjects with cardiac pacemaker, artificial heart valve, any metallic implant, permanent tattoo, or any retained foreign metallic bodies that are contraindicated in magnetic resonance imaging.
* Inability to provide consent

Primary outcomes:
measure: Phosphocreatine (PCR) Recovery Time After Knee Extension Assessed by 31 Phosphorus Magnetic Resonance Spectroscopy (31P-MRS)
timeFrame: Up to 2 hours after completion of drug infusion
Secondary outcomes:
measure: Systolic Blood Pressure
timeFrame: 30 minutes before hemodialysis, during dialysis, and up to 1 hour after hemodialysis
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT00038298: A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving Methotrexate
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy, Safety and Tolerability of AMG 719 in Subjects With Rheumatoid Arthritis Receiving Methothrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2002-05-31
Enrollment: 53
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: This clinical study is investigating AMG 719, an investigational drug, for the treatment of patients who have Rheumatoid Arthritis and who are taking Methotrexate. AMG 719 is a drug which is self-injected beneath the skin (similarly to the way insulin is self-injected by diabetics). Patients on this study are on study for 28-weeks. They visit the study facility at least 11 times while participating in the study.


Eligibility criteria: * Men or women, at least 18 years of age at screening
* Diagnosed with Rheumatoid Arthritis, with a disease duration of at least 24 weeks, receiving methotrexate, and having no recent history of substance or alcohol abuse

Primary outcomes:
measure: AMG 719 has a favorable safety profile in subjects with RA receiving methotrexate.
timeFrame: Week 24
Secondary outcomes:
measure: To assess the effects of multiple doses of AMG 719 relative to placebo on signs and symptoms of RA
timeFrame: Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00736398: Fusion Assessment Clinical Trial
Official title: Fusion Assessment Clinical Trial (FACT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Lead sponsor: Flexuspine, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring spinal fusion

Brief summary: This is an observational study to assess clinical outcomes in patients who undergo spinal fusion. Patients who are already scheduled for spinal fusion will enroll in the study. Information about prior therapies will be collected, and then patients will be followed to see how they do after spinal fusion. This study will help researchers better understand the natural course of patients who patients who undergo spinal fusion surgery.


Eligibility criteria: Inclusion Criteria:

* Lumbar DDD
* Candidate for spinal fusion
* Provide written informed consent

Exclusion Criteria:

* Prior lumbar spinal fusion
* Metabolic bone disease
* Morbid obesity
* Systemic infection or active malignancy
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Florida Spine Institute
state: Florida
city: Temple Terrace
country: United States
facility: Foundation for Orthopaedic Research and Education
state: Florida
city: Baltimore
country: United States
facility: Greater Baltimore Medica Center
state: Maryland
city: Washington
country: United States
facility: The Washington Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC
state: South Carolina
city: Tyler
country: United States
facility: Guy Danielson, M.D.
state: Texas
Study officials:
References:
Clinical trial NCT05222698: Free Neurovascularized Muscle Transfer in Facial Reanimation of Long-standing Facial Palsy Patients
Official title: Segmental Free Latissimus Versus Free Gracillis Muscles Powered by Hypoglossal Nerve in Facial Reanimation of Long-standing Facial Palsy Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Facial Paralysis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of free Neurovascularized muscles like free latissimus and gracillis muscles for reanimation of long-standing facial palsy patients using the hypoglossal nerve for innervating these muscles

Detailed description: The investigators need to know which of the two muscles is better functionally and aesthetically in facial reanimation of patients with facial paralysis of more than one year duration.

Eligibility criteria: Inclusion Criteria:

* All patients with facial paralysis more than one year what ever the cause.

Exclusion Criteria:

* patients with uncontrolled diabetes.

Primary outcomes:
measure: Change in smile excursion with the two muscles in the paralyzed side from the pre operative state.
timeFrame: One year post operatively.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sohag faculty of medicine
name: Ahmed Saber, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01685398: Topical Timolol for Superficial Infantile Hemangioma
Official title: Treatment of Cutaneous Hemangioma of Infancy With Topical 0.5% Timolol Maleate Eye Drop Compared With Placebo in Pediatric Patients, Siriraj Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemangioma
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2012-09-14
Enrollment: 48
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population. The characteristic natural history of this tumor is rapid growth in the first year of life and follows by spontaneous involution. However, it may cause cosmetic unacceptable. Early intervention in superficial IH may help to minimize the risk of residual aesthetic problems. Topical timolol, a non selective beta-blocker, is an emerging treatment which has been reported in efficacy and safety for the treatment of IH. However, the reported studies were case-series or small study. This study is a prospective double-blind,randomized-controlled study to evaluate the efficacy and safety of 0.5% timolol maleate solution for treatment in superficial IH. The patient will be treated with topical timolol for at least 6 months and instructed to 4 times daily apply 1-2 drop of timolol solution on the lesion and rub over the entire lesion with a finger. Photographs of the lesion will be taken at the baseline and every 1-month visit. Clinical evaluation of the treatment efficacy is carried out by 2 investigators independently to determine the change in lesion size and visual analogue scale of the lesion color. The main outcome is to evaluate the efficacy of 0.5% timolol maleate solution in treatment of infantile hemangioma compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Patient who is less than 2 years
* Patient who has been diagnosed with superficial infantile hemangioma
* The tumor which has been in proliferative or plateau phase
* There is no indication for systemic treatment
* Informed consent is obtained from the parent of the patient

Exclusion Criteria:

* Patient who has the indication for systemic therapy
* Patient who is treated by the other modality such as laser treatment
* Patient who has underlying disease treated by beta blocker, corticosteroids, interferon, cyclophosphamide or vincristine
* Patient who has history of hypersensitivity reaction to beta blocker, asthma, cardiac condition prove to heart block

Primary outcomes:
measure: Efficacy of the topical 0.5% timolol maleate solution in treatment of infantile hemangioma compared to placebo
timeFrame: 6 months
Secondary outcomes:
measure: Side effects of the topical 0.5% timolol maleate solution in treatment of infantile hemangioma
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital Mahidol University
state: Bangkok
Study officials:
References:
Clinical trial NCT05183698: Point-spectroscopy Trial
Official title: Spectroscopic Assessment of Autofluorescent Signatures of Tissue in and Around Wounds Identified by MolecuLight i:X Imaging Device
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wound
Wound of Skin
Lead sponsor: MolecuLight Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic and/or acute wound

Brief summary: Evaluation and characterization of autofluorescence signals of tissue in and around wounds as identified by MolecuLight fluorescence image.

Detailed description: Evaluate and characterize autofluorescence signals of tissue components in and around wounds identified by MolecuLight FL images using a point spectrometer. The fluorescence spectroscopy data will yield quantitative spectral information, including the relative intensity and emission peak of the biological autofluorescence signatures.

Eligibility criteria: Inclusion Criteria:

* Patients presenting with acute or chronic wounds
* 18 years or older
* Willing to consent

Exclusion Criteria:

* Treatment with an investigational drug within 1 month of enrolment
* Any contra-indication to regular wound care
* Inability or unwillingness to consent

Primary outcomes:
measure: Spectra of autofluorescent signatures of tissue in and around the wounds
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04137198: Sufentanil Intranasal
Official title: The Effect of Intranasal Sufentanil on Acute Posttraumatic Pain. A Randomized Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Emergencies
Pain, Acute
Analgesia
Sufentanil
Keywords: emergency
pain
analgesia
intranasal
sufentanil
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized trial
Primary purpose: TREATMENT

Brief summary: Study of the effects of intranasal sufentanil on patients presenting to the emergency department with acute post-traumatic pain.

Detailed description: In this study, patients presenting to the emergency department with post-traumatic pain of 7 or more on the visual analog pain scale, since less than 24 hours, in the limbs, spine or thorax are randomized in a control arm or an interventional arm.

The patients in the control arm will receive the institution's classical analgetic protocol level 1 and 3, the patients in the intervention arm are given classical level 1 medication as well as intranasal Sufentanil.

Pain is then measured using the Visual Analogue Pail Scale at 15-20 minutes and at 60 minutes. At both these time points, adverse effects and vitals are also assessed.

Eligibility criteria: Inclusion Criteria:

* posttraumatic pain + lasting for less than 24 hours + with an analog visual pain scale of 7/10 or more

Exclusion Criteria:

* pregnant
* \<18 years
* prisoners
* lesions of head, face or abdomen
* no consent given or possible
* pain not scorable
* known drug abuse or substitution therapy
* chronic level 3 pain medication
* intake of level 3 \< 8 hours
* intoxicated patient
* allergy or intolerance to opiates
* renal or hepatic insufficiency
* \< 50kg body weight
* hemodynamic instability

Primary outcomes:
measure: change in pain score
timeFrame: 15-20 minutes after first administration of Sufentanil
Secondary outcomes:
measure: change in pain score
timeFrame: 60 minutes after first administration of Sufentanil
Other outcomes:
measure: number of participants with adverse effects
timeFrame: at 15-20 and at 60 minutes
Locations:
city: Bruxelles
country: Belgium
facility: CHU Saint Pierre
Study officials:
References:
Clinical trial NCT01596998: Plasma Concentrations of Levobupivacaine With and Without Epinephrine in Transversus Abdominis Plane Blocks
Official title: Comparison of Plasma Concentrations of Levobupivacaine With and Without Epinephrine for Transversus Abdominis Plane Block Under Ultrasound.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Transversus Abdominis Plane Block
Keywords: anesthesia, conduction
transversus abdominis plane block
Vasoconstrictor Agents
Ultrasonography
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2012-05-11
Enrollment: 11
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine the effect of the addition of vasoconstrictor in the plasma concentrations achieved and the extent of the transversus abdominis plane block in healthy male volunteers.

Detailed description: Use of TAP blocks, decreases use of opioids and reduces pain scores during the postoperative period after surgeries involving the anterior abdominal wall. However, the information regarding the sensitive range of the blockade and its duration is still limited. Since that the area of administration is an intermuscular plane, it is possible to infer a large area of absorption. Knowing plasma concentrations is essential to balance the usefulness of this technique with potential systemic toxicity associated with its use.

As an additional effect, clinically, the use of vasoconstrictors may prolong the duration of the blockade significantly, depending on the drug used and site of administration. To date, no studies evaluating the effect of the addition of vasoconstrictor both in the plasma concentrations achieved, and the quality, extent and duration of the TAP block.

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers
* ASA I-II

Exclusion Criteria:

* BMI \> 30kg m-2
* Patients with allergy to study drugs

Primary outcomes:
measure: Effect of the addition of vasoconstrictor in the plasma concentrations achieved
timeFrame: Since the beginning of the block up to 90 minutes after
Secondary outcomes:
measure: Determine the mapping of sensory block in the abdominal wall after the completion of a U.S. guided TAP Block in healthy volunteers.
timeFrame: Since the beginning of the block up to 4 hours after
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clinico Universidad Catolica
state: Region Metropolitana
Study officials:
affiliation: Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile
name: Fernando R Altermatt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02036398: Tubeless Versus Standard Upper Pole Percutaneous Nephrolithotomy
Official title: Comparison of Complications Between Patients Undergoing Standard Percutaneous Nephrolithotomy With Nephrostomy Tube Placement and Tubeless Percutaneous Nephrolithotomy With Double J Stent Only Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleural Effusion
Keywords: Percutaneous Nephrolithotomy (PCNL)
Nephrostomy
Double J stent
PleuraL Effusion
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 75
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: Comparison of complications between standard upper pole percutaneous nephrolithotomy (PCNL) with nephrostomy placement and double J stent and PCNL with double J placement only without nephrostomy.

Detailed description: Measurement of complications in and comparison between two groups of patients undergoing upper pole PCNL. First group consists of patients left with nephrostomy and double J stent and the second group includes patients left with double J stent only without nephrostomy.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing upper pole percutaneous nephrolithotomy older than 18 years of age and willing to participate

Exclusion Criteria:

* Patients younger than 18 years of age
* Patients unwilling to participate in the study
* Patients that nephrostomy tube placement was a prerequisite at the end of the procedure

Primary outcomes:
measure: Number of Participants with pleural effusion
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tiqva
country: Israel
facility: Urology department, Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Hanan Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goldberg H, Nevo A, Shtabholtz Y, Lubin M, Baniel J, Margel D, Ehrlich Y, Lifshitz D. Tubeless supra-costal percutaneous nephrolithotomy is associated with significantly less hydrothorax: a prospective randomized clinical study. BJU Int. 2020 Feb;125(2):276-283. doi: 10.1111/bju.14950. Epub 2019 Dec 3.
Clinical trial NCT05294198: Beetroot Extract and Its Influence on Cardiovascular and Autonomic Recovery From the Effort in Healthy Males
Official title: Beetroot Extract and Its Influence on Cardiovascular and Autonomic Recovery From the Effort in Healthy Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Males
Lead sponsor: University of Pernambuco
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: There is no evidence that beetroot extract (Beta vulgaris L.) is advantageous for the recovery of cardiovascular parameters and the autonomic nervous system (ANS) after submaximal aerobic exercise. The objective of this study is to evaluate the effect of beetroot extract supplementation on the recovery of cardiorespiratory and autonomic parameters after a submaximal aerobic exercise session. Healthy male adults will perform a cross-over, randomized, double-blind, and placebo-controlled trial. Beetroot extract (600mg) or placebo (600mg) will be ingested 90 minutes before evaluation in randomized days. Systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse pressure (PP), mean arterial pressure (MAP), heart rate (HR), and HR variability (HRV) indexes will be recorded at Rest and during 60 minutes of recovery from exercise.


Eligibility criteria: Inclusion Criteria:

* Healthy males;
* Physically active according to International Physical Activity Questionnaire (IPAQ);
* 18 to 30 old years.

Exclusion Criteria:

* Body mass index BMI \<18.5kg/m² and \>29.9kg/m²;
* Smokers;
* Subjects undergoing pharmacotherapies;
* Musculoskeletal, metabolic, renal diseases;
* Root mean squared standard deviation of R-R intervals \<15 milliseconds.

Primary outcomes:
measure: Heart rate variability values (milliseconds)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Systolic and diastolic blood pressure values (mmHg)
timeFrame: Through study completion, an average of 1 year
measure: Heart rate values (beats per minute)
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Petrolina
country: Brazil
facility: University of Pernambuco
state: Pernambuco
Study officials:
affiliation: University of Pernambuco
name: Cicero Benjamim, nutricionist
role: PRINCIPAL_INVESTIGATOR
References: