louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01137786: Kidney Damage in Patients With Normal eGFR
Official title: A Phase IV Pilot Study to Evaluate Kidney Damage Measured by Neutrophil Gelatinase-Associated Lipocalin (NGAL) as a New Bio-Marker in Patients With Normal eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Stenosis
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2010-06-04
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a pilot study, randomized, double-blind, parallel group comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have normal eGFR. Statistical summaries will be presented to analyse the various laboratory tests for the two groups.


Eligibility criteria: Inclusion Criteria:

* Provides written Informed Consent and is willing to comply with protocol requirements;
* Is at least 18 years of age;
* Is scheduled to undergo a percutaneous coronary intervention and/or diagnostic coronary angiography.
* Has documented estimated glomerular filtration rate \[eGFR\] ≥60 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior to enrollment.

Exclusion Criteria:

* Is a pregnant or lactating female.
* Has a history of severe congestive heart failure
* Has a history of hyperthyroidism
* Has a history of hypersensitivity to iodinated contrast agents
* Has unstable renal function

Primary outcomes:
measure: Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media.
timeFrame: Baseline and 2, 4, 6, 24, 48, and 72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Prairie Cardiovascular Consultants, Ltd.
state: Illinois
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Maria Luigia Storto, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00212186: Selenium Supplementation of Patients With Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Liver Cirrhosis
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2005-09-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether patients with liver disease can improve their nutritional selenium status by taking supplemental selenium.

Detailed description: Selenium is an essential nutrient. Selenium carries out its biological functions through selenoproteins. The most abundant selenoprotein in the plasma is selenoprotein P, which is largely synthesized in the liver. Patients with liver disease often have less than half the selenoprotein P levels of normal individuals. This suggests that people with liver disease are not meeting their selenium requirements and may benefit from additional selenium.

We proposed to compare the effects of two different forms of supplemental selenium on plasma selenium levels among patients with severe liver cirrhosis and healthy individuals (controls). Patients and controls were randomly assigned to one of 3 treatment groups: 200 µg selenium per day as selenate, 200 µg selenium per day as selenomethionine, or a placebo. The intervention lasted 8 weeks. Blood was measured initially and after 2 and 4 weeks of supplementation. Selenium, selenoprotein P and glutathione peroxidase were measured in the plasma. We compared changes in selenium and selenoprotein levels between liver cirrhosis patients and healthy controls.

Eligibility criteria: Inclusion Criteria:

* Healthy Adults
* Adults with Child-Pugh Class C liver cirrhosis

Exclusion Criteria:

* Diagnosis of renal failure
* Urgent need of liver transplant
* Selenium supplements of \>25 µg per day during the past year

Primary outcomes:
measure: Plasma Selenium Biomarkers
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Raymond F Burk, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05016986: Penetrating Gunshot Injuries at a Single Johannesburg Centre
Official title: Penetrating Gunshot Cardiac Injuries: Single Centre Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Keywords: cardiac
penetrating
GSW
Lead sponsor: University of Witwatersrand, South Africa
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Trauma patients who sustained GSW to chest with cardiac injuries in a sigle centre

Brief summary: A retrospective audit of cardiac penetrating cardiac injuries with specific reference to GSW

Detailed description: A descriptive retrospective study looking at the outcomes in patients with penetrating cardiac injuries especially following gunshot injuries. The physiology on presentation, the ISS, the RTS, the clinical injuries confirmed, the type of investigations conducted, the length of hospital stay, the in-hospital mortality will all be collected. Descriptive study statistics will be utilized and a p-value of \<0,05 will be considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* all adult Priority 1 patients with GSW cardiac injuries seen at a Johannesburg Trauma facility

Exclusion Criteria:

* Incomplete data or dead on arrival

Primary outcomes:
measure: Injury patterns (check list)
timeFrame: 01 Jan 2008 till 31 December 2018
measure: The number of in-hospital patients who survive the injury
timeFrame: 01 jan 2008 till 31 December 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Charlotte Maxeke Johanneburg Academic Hospital
state: Gauteng
city: Johannesburg
country: South Africa
facility: Charlotte Maxeke Johanneburg Academic Hospital
state: Gautheng
Study officials:
affiliation: University of Witwatersrand, South Africa
name: Maeyane Moeng, MBBCH, FCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01470586: Surgical Resection Lowers Oxidative Stress Markers in Patients With Colorectal Cancer
Official title: Surgical Resection Lowers Oxidative Stress Markers in Patients With Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Colon Rectal Resection
Oxidative Stress
Keywords: Colorectal cancer
Surgical resection
Oxidative Stress Markers
Controls
Lead sponsor: G. Hatzikosta General Hospital
Sponsor class: OTHER
Collaborators: name: University of Ioannina
First posted: 2011-11-11
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: Study of Oxidative stress Markers (F2 Isoprostanes for lipid peroxidation, Carbonyl groups for protein peroxidation, 3 Nitrotyrosine for damage by nitrogens, and 8-Hydroxyguanosine for RNA peroxidation)in patients with colorectal cancer undergo surgical treatment (preoperatively during the intervention and postoperatively) and controls.

Detailed description: Study of the impact of surgery on Lipid peroxidation, Protein peroxidation, damage by nitrogens, and RNA peroxidation, in patients undergo surgical resection for colorectal cancer and compared with controls, and validation of the responsiveness of oxidative stress markers on surgery

Eligibility criteria: Inclusion Criteria:

* Patients with colorectal cancer
* Controls

Exclusion Criteria:

* ASA\>3
* Metastatic Disease
* Acute bowel obstruction
* Acute bowel perforation
* BMI\<30
* Chronic Systemic or Autoimmune Diseases
* Smokers
* Alcohol consumers

Primary outcomes:
measure: Comparison of Oxidative stress markers in patients with colorectal cancer and controls
timeFrame: up to 2 years
Secondary outcomes:
measure: Validation of oxidative stress markers in patients with colorectal cancer undergo surgical resection
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: G. Hatzikosta General Hospital
state: Epirus
Study officials:
affiliation: G. Hatzikosta General Hospital
name: George Pappas-Gogos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05191186: Documentation of Efficacy of Intralymphatic Allergen Immunotherapy
Official title: Documentation of Efficacy of Intralymphatic Allergen Immunotherapy in a Phase III Randomized, Parallel Group Placebo Controlled Double Blind Multisite Field Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Allergic Rhinitis Due to Grass Pollen
Allergic Conjunctivitis of Both Eyes
Allergic Asthma
Keywords: Allergen immunotherapy
Allergic rhinoconjunctivitis
grass pollen allergy
intralymphatic immunotherapy
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: University Hospital, Linkoeping
First posted: 2022-01-13
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel group, double blind placebo controlled multi site
Primary purpose: TREATMENT

Brief summary: Investigation of the clinical efficacy of 3 intralymphatic injections with grass pollen extract into inguinal lymph nodes on combined symptom-medication scores during grass pollen season in grass pollen allergic patients compared to placebo

Detailed description: A double-blind, parallel group, placebo controlled multi-site trial of the clinical efficacy of 3 intralymphatic injections with a low dose of grass pollen extract into inguinal lymph nodes in grass pollen allergic subjects.

Primary endpoint is the difference in combined symptom and medication score during grass pollen seasons following treatment compared with patients receiving placebo.

Injections are giving ultrasound-guided with at least 4 weeks intervals.

Eligibility criteria: Inclusion Criteria:

* moderate-severe grass pollen allergic rhinoconjunctivitis
* positive skin prick test for grass pollen extract

Exclusion Criteria:

* significant mugwort allergy
* previous AIT for grass pollen allergy
* uncontrolled non-allergic upper airways disease
* uncontrolled asthma
* planned depot steroid injections during season
* uncontrolled autoimmune diseases
* active malignancies
* uncontrolled other severe condition, including psychiatric diseases

Primary outcomes:
measure: Combined symptom and medication score, cSMS
timeFrame: 2 years
Secondary outcomes:
measure: side-effects
timeFrame: 3 months
measure: correlation of CSMS to pollen count
timeFrame: 2 years
measure: combined symptom and medication score, cSMS
timeFrame: 2 years
measure: Rhinitis related quality of life, RQLQ
timeFrame: 2 years
measure: Airwave oscillometry system(AOS), asthma
timeFrame: 2 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Central Region
city: Linkoeping
country: Sweden
facility: Lars University Ahlbeck
state: Oestergotland
Study officials:
affiliation: Aarhus University Hospital/Aarhus University
name: Johannes M Schmid, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06745986: Ultrasound-Guided Fascia Iliaca Compartmental Block Versus Spinal Anesthesia in Femoral Thrombectomy
Official title: Ultrasound-Guided Fascia Iliaca Compartmental Block Versus Spinal Anesthesia in Femoral Thrombectomy: a Randomized Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fascia Iliaca Compartmental Block
Femoral Thrombectomy
Spinal Anesthesia
Keywords: Visual Analogue Score
UltraSound Guided
Fascia Iliaca Compartmental Block,
Spinal Anesthesia,
Femoral Thrombectomy
Lead sponsor: Port Said University hospital
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 84
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eighty-four cases were scheduled for femoral thrombectomy and classified into tw0 equal groups (n=42 each), spinal group received spinal anesthesia with 0.5% hyperbaric bupivacaine in a total volume in a total volume 2.5ml and fascia iliaca group received ultrasound guided fascia iliaca block with 40ml of 0.25% bupivacaine for each block. Data collected for each block were onset and duration of sensory and motor block, visual analogue scale, analgesic duration and analgesic consumption, hemodynamics and complications.
Primary purpose: TREATMENT

Brief summary: This study aims to assess the efficiency of Fascia Iliaca Compartmental Block in patients undergoing femoral thrombectomy versus spinal anesthesia.

Detailed description: Anesthesia for lower limb revascularization consists of general anesthesia, neuraxial anesthesia and peripheral regional block. Fascia iliaca compartment block (FICB) is an anterior approach to the lumbar plexus and it blocks femoral nerve, LFCN, and limited numbers of nearby nerves such as ilioinguinal, genitor femoral.

Eligibility criteria: Inclusion Criteria:

* scheduled femoral thrombectomy,
* both sexes,
* aged between 40-65 years,
* American Society of Anesthesiologists (ASA) II-III. Patients Criteria:

Exclusion Criteria:

* ASA status Grade IV, patient
* refused to participate,
* patients with contraindications to neuraxial anesthesia, such as systemic infection or history of allergy to anesthetic drugs
* infection at the site of injection.

Primary outcomes:
measure: pain score postoperative
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New Damietta
country: Egypt
facility: Mansoura university hosbital
Study officials:
References:
Clinical trial NCT01782586: Validation of Gene Expression Markers of Renal Allograft Functional Decline
Official title: Multicenter Validation of Gene Expression Markers of Renal Allograft Functional Decline (GEN-04)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant Recipients
Keywords: kidney transplant
gene expression markers
renal allograft function
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Genomics of Transplantation Cooperative Research Program
First posted: 2013-02-04
Enrollment: 499
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney transplant recipients

Brief summary: The purpose of this study is to determine if certain genes found in a kidney biopsy performed at one-year post transplant can predict which transplanted kidneys will have decreased kidney function within five years post-transplant.

Detailed description: Gene expression profiling is used to study the activity of genes. Each gene has an "on/off" switch that controls how they are expressed in a cell, as well as a "volume control" that increases or decreases the level of expression of a particular gene as necessary. Researchers want to see if the presence and abundance of certain transcripts in a kidney biopsy at one year after transplant can predict which kidneys will have reduced function over time.

Eligibility criteria: Inclusion Criteria:

* Adult (≥18 years) conventional renal transplant recipient.
* Patients who have given informed consent and are willing to comply with the protocol.

Exclusion Criteria:

* ABO incompatible kidney transplants.
* Positive crossmatch kidney transplants (T cell crossmatch \>100, B flow cytometric crossmatch \>150).
* Simultaneous kidney and extra-renal organ transplants including pancreas, liver, heart, lung, etc. Subjects who had previous extra renal transplants may be included in the study.
* Patients taking chronic anticoagulation, which includes Coumadin, Plavix and any type of heparin. Aspirin is acceptable but must be stopped 5 days prior to the renal biopsy.
* An inability to have the 1-year renal biopsy performed within the acceptable protocol window (Months 11-14 \[Days 301-420\] post-transplant).

Primary outcomes:
measure: Renal Function Decline
timeFrame: Baseline to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic, Rochester, MN
name: Mark D. Stegall, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01870986: Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)
Official title: Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study Of PF-06410293 and Adalimumab Sourced From US And EU Administered To Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
Phase 1
PK
adalimumab
Single-dose
Immunology
Bioequivalence
Biosimilarity
Similarity.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-06-06
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This healthy volunteers study will evaluate 210 subjects who will receive a single sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European Union). This study will involve sampling and pharmacokinetics evaluation of drug levels following administration of PF-06410293 and the licensed adalimumab products.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female (non-childbearing potential). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure, pulse, ECG, and laboratory testing.

Exclusion Criteria:

* Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary gastrointestinal, cardiovascular, hepatic psychiatric, neurologic, autoimmune, or allergic disease.

Primary outcomes:
measure: Maximum Observed Serum Concentration (Cmax)
timeFrame: Day 1 - Day 43
measure: Area Under the Curve From Time Zero to Last Time Point with Quantifiable Concentration (AUClast)
timeFrame: Day 1 - Day 43
measure: Area under the Concentration-Time Curve (AUC) from Time Zero extrapolated to infinity (AUCInf)
timeFrame: Day 1 - Day 43
Secondary outcomes:
measure: Incidence of anti-adalimumab antibodies (ADA) and neutralizing antibodies (Nab)
timeFrame: Day 1 - Day 71
measure: Time to Reach Maximum Observed Serum Concentration (Tmax)
timeFrame: Day 1- Day 43
measure: Area under the Concentration-Time Curve (AUC) time Zero to 2 weeks after Dosing
timeFrame: Day 1- Day 43
measure: Systemic Clearance (CL)
timeFrame: Day 1- Day 43
measure: Serum Decay Half-Life (t1/2)
timeFrame: Day 1- Day 43
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04987086: 68Ga-PSMA PET in the Renal Cell Carcinoma
Official title: A Single Center Prospective Study of Diagnostic Efficiency of 68Ga-PSMA PET in the Patients With Locally Advanced and Advanced Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Cancer
Metastases
PSMA PET
Keywords: advnaced renal cancer
PSMA PET
metastases
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary research purpose is to evaluate the diagnostic efficacy of 68Ga-PSMA PET in metastatic lesions of locally advanced and advanced renal cell carcinoma, and to compare with that of enhanced CT. The second purpose is to evaluate whether 68Ga-PSMA PET can change the treatment decision of patients with locally advanced and advanced renal cell carcinoma


Eligibility criteria: Inclusion Criteria:

* 2017 AJCC renal cell carcinoma TNM stage III, IV lesions;
* In contrast-enhanced CT staging, suspicious metastases were found;
* There were no known peripheral or central venous problems;
* 68Ga PSMA PET / CT imaging can be performed within 6 weeks after the diagnosis of renal cell carcinoma;
* Signed the informed consent form of voluntary participation in clinical trials.

Exclusion Criteria:

* Age ≤ 18 years old;
* Can't stand lying flat in PET / CT examination;
* There are contraindications for 68Ga PSMA ligands;
* In the past two years, there was a history of other malignant tumors, or according to the doctor's research judgment, complications may occur and affect the normal operation of the test;
* Renal function is impaired or hemodialysis is in progress.

Primary outcomes:
measure: Additional diagnostic value of 68Ga PSMA PET / CT compared with CT in patients with locally advanced and advanced renal cell carcinoma
timeFrame: 2 years
Secondary outcomes:
measure: The changes of treatment decision-making in patients with locally advanced and advanced renal cell carcinoma by 68Ga PSMA PET / CT.
timeFrame: 2 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
References: