louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03875937: The Trauma INtramuscular Tranexamic Acid Clinical Trial
Official title: Pharmacokinetics of Intramuscular Tranexamic Acid in Trauma Patients: a Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Traumatic Haemorrhage
Keywords: tranexamic acid
pharmacokinetic
intramuscular
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Barts & The London NHS Trust
name: St George's University Hospitals NHS Foundation Trust
name: University of Versailles
name: JP Moulton Charitable Foundation
First posted: 2019-03-15
Enrollment: 31
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, open-label, multicentre, pharmacokinetic study.
Primary purpose: OTHER

Brief summary: Intramuscular injection of tranexamic acid (TXA) would increase its use in situations where administration of intravenous drugs is difficult. The investigators aim to assess the population pharmacokinetics of intramuscular TXA in trauma patients.

Primary endpoint: Serum TXA concentrations over time. Secondary endpoints: Local reactions at injection sites and adverse events

Detailed description: A prospective, open-label, multicentre, pharmacokinetic study conducted in the UK hospital. Potential eligible patients will have received a 1 gram IV dose of TXA at the scene of the injury or on arrival in hospital and a second dose is clinically indicated.

Eligibility criteria: Inclusion Criteria:

* Adult (appear to be at least 16 years old) trauma patients who have received 1 gram of intravenous TXA for the management of haemorrhage in whom a second dose is clinically indicated are eligible.

Exclusion Criteria:

* none

Primary outcomes:
measure: Concentration of serum TXA concentrations over time.
timeFrame: Blood samples will be taken pre-dose and up to 11 hours after IM TXA
Secondary outcomes:
measure: Number of participants with Injection sites reactions
timeFrame: death, discharge or day seven (whichever comes first)
measure: Number of adverse events reported by type
timeFrame: death, discharge or day 7 (whichever comes first)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal London Hospital
city: London
country: United Kingdom
facility: St George's Hospital
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Haleema Shakur-Still
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Ian Roberts
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grassin-Delyle S, Shakur-Still H, Picetti R, Frimley L, Jarman H, Davenport R, McGuinness W, Moss P, Pott J, Tai N, Lamy E, Urien S, Prowse D, Thayne A, Gilliam C, Pynn H, Roberts I. Pharmacokinetics of intramuscular tranexamic acid in bleeding trauma patients: a clinical trial. Br J Anaesth. 2021 Jan;126(1):201-209. doi: 10.1016/j.bja.2020.07.058. Epub 2020 Sep 30.
Clinical trial NCT00160537: POPULAR (Preference Of Patient Using Levocetirizine in Allergic Rhinitis)
Official title: A Monocenter, Double-blind, Randomized Trial, With Two Parallel Groups Comparing the Clinical Efficacy of Levocetirizine 5 mg Capsules and Desloratadine 5 mg Capsules Taken Once a Day Over 3 Weeks of Treatment in Adult Subjects Suffering From Seasonal Allergic Rhinitis (SAR) Due to Grass Pollen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seasonal Allergic Rhinitis
Keywords: Seasonal Allergic Rhinitis (SAR), Grass pollen, SAR Symptoms (sneezing, rhinorrhea, nasal / ocular pruritus, nasal congestion)
POPULAR, Xyzal, Levocetirizine
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Comparative study on clinical efficacy and safety of levocetirizine and desloratadine as measured by the subject's satisfaction/dissatisfaction after one week of treatment


Eligibility criteria: Inclusion Criteria:

* Clinical history of SAR known and treated since 2 years.
* Positive skin prick test (wheal \> 3 mm larger than the diluent control) or RAST (≥3.5 IU/ml) to grass pollen (less than 1 year).
* Minimum mean T5SS of 8 during the baseline period.

Exclusion Criteria:

* Have an associated asthma requiring a daily treatment other than β2 short acting agonist prn
* Have atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids and any other disease requiring the administration of oral or topical corticosteroids

Primary outcomes:
measure: Subjects' satisfaction / dissatisfaction after the first week of treatment.
Secondary outcomes:
measure: allergic rhinitis symptoms scores over the first week of treatment , subject's satisfaction / dissatisfaction of their choice of treatment after the first week of treatment, time to first feeling of (sufficient) symptom improvement during the first we
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06703437: Long Acting Neuraxial Peri-prostatic Block in Cancer
Official title: A Phase I Open Label Peri-prostatic Neuraxial Block with Lidocaine and Ethanol in High-risk Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 12
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Disease progression after definitive therapy for prostate cancer is a major source of morbidity and mortality. Adrenergic/sympathetic innervation of the prostate is essential for prostate cancer progression, and abrogation of these signals by blocking adrenergic innervation halts disease progression. Long-acting neuraxial block of the sympathetic nerves that innervate the pelvis with dehydrated alcohol (\>98% Ethanol) is a safe and effective tool in the treatment of chronic pelvic pain and cancer- induced pelvic pain. Furthermore, ultrasound guided periprostatic neuraxial block at the time of prostate biopsy with short-acting lidocaine is standard of care. Herein the research team proposes to administer a long-acting periprostatic neuraxial block with dehydrated alcohol and lidocaine under trans rectal ultrasound guidance in patients with high-risk clinical features for prostate cancer at the time of prostate biopsy.


Eligibility criteria: Inclusion Criteria:

* PSA \>10
* PSAD \>0.15
* PI-RADS 5 lesion on MRI
* Karnofsky performance status \>80
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Prior or concomitant treatment for prostate cancer, including radiation therapy, focal therapy, cryo therapy, androgen deprivation therapy.
* Imaging or clinical evidence of metastatic disease.
* PSA \> 100ng/mL

Primary outcomes:
measure: Dose-Limiting Toxicity (DLT)
timeFrame: At week 2
measure: Maximally Tolerated Dose (MTD)
timeFrame: At week 2
Secondary outcomes:
measure: Time to biochemical recurrence
timeFrame: at month 6 and at year 2
measure: Response Rate
timeFrame: at week 8
measure: Tumor immunogenicity
timeFrame: at week 8
measure: Degree of neural inhibition
timeFrame: at week 8
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Ali Zahalka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Ash Tewari
role: STUDY_DIRECTOR
References:
Clinical trial NCT04602637: Training Load Management in Three Professional Tennis Players During COVID-19 Lockdown: a Case Series Study
Official title: Training Load Management in Three Professional Tennis Players During COVID-19 Lockdown: a Case Series Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Monitor Training Load
Keywords: training load
tennis
covid
Lead sponsor: Kine Kinesiologia Deportiva y Funcional
Sponsor class: NETWORK
First posted: 2020-10-26
Enrollment: 3
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tennis players training in argentina

Brief summary: Research describing training load management during COVID-19 enforced home training in professional tennis players is lacking. Therefore, the main objective of this case series is to describe in detail the training load management and progression of three professional tennis players before, during and after COVID-19 pandemic lockdown.

Detailed description: Research describing training load management during COVID-19 enforced home training in professional tennis players is lacking. Therefore, the main objective of this case series is to describe in detail the training load management and progression of three professional tennis players before, during and after COVID-19 pandemic lockdown.

Eligibility criteria: Inclusion Criteria:

* tennis players training in argentina

Exclusion Criteria:

-

Primary outcomes:
measure: Training load
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: KINÉ kinesiología deportiva y funcional
Study officials:
affiliation: Kine Kinesiologia Deportiva y Funcional
name: Diego Mendez, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00155337: Photodynamic Therapy for Oral Leukoplakia and Erythroleukoplakia
Official title: Photodynamic Therapy for Oral Leukoplakia and Erythroleukoplakia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oral Leukoplakia
Keywords: leukoplakia
erythroleukoplakia
photodynamic therapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Photodynamic therapy for oral leukoplakia and erythroleukoplakia

Detailed description: Photodynamic therapy for oral leukoplakia and erythroleukoplakia

Eligibility criteria: Inclusion Criteria:

* patients with leukoplakia or erythroleukoplakia

Exclusion Criteria:

* oral cancers

Primary outcomes:
measure: End of 8 treatments
Secondary outcomes:
measure: Regression of lesions
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chun-Pin Chiang, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01262937: A Study to Examine the Human Gastrointestinal Tract Using the Confocal Endomicroscope
Official title: A Pilot Study to Examine the Human Gastrointestinal Tract Using the Confocal Endomicroscope
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Digestive System Diseases
Keywords: confocal, biliary, esophagus
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2010-12-20
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with long-standing reflux symptoms, undergoing surveillance for Barrett's esophagus, or scheduled for endoscopic therapy with esophageal dysplasia. Also, patients undergoing ERCP for known or suspected biliary strictures.

Brief summary: The goal of the project is to determine whether confocal endomicroscopy can be used to identify and discriminate among dysplastic, neoplastic, and nonneoplastic tissue, as compared with histologic specimens as a reference. The project will evaluate those at risk for or with known Barrett's esophagus, and those with known or suspected biliary strictures. It is our hypothesis that we will be able to identify between neoplastic and nonneoplastic tissue.

Detailed description: This study was amended from it's initial design to increase the number of patients to 200. The study was terminated in July 2016 after 106 patients were enrolled and had completed the study.

Eligibility criteria: Inclusion Criteria:

* Patients with long-standing reflux symptoms, undergoing surveillance for Barrett's esophagus, or scheduled for endoscopic therapy with esophageal dysplasia
* Patients undergoing ERCP for known or suspected biliary strictures.

Exclusion Criteria:

* have a known allergy or have had a prior adverse reaction to fluorescent contrast agents or chromoendoscopy stains
* are younger than age 18 or who are mentally or legally incapacitated or unable to give informed consent
* are pregnant or breastfeeding
* patients with advanced esophageal cancer
* acute gastrointestinal bleeding
* coagulopathy
* impaired renal function

Primary outcomes:
measure: To compare confocal image characteristics between benign and malignant tissue.
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Michael Nathanson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02546037: Clotting With Different Dialyzer Membranes
Official title: Pilot Study to Determine the Effect of Different Dialyzer Membranes on Clotting During Haemodiafiltration Treatments in Patients With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Failure
Keywords: coagulation
haemodialysis
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2015-09-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: attending RFH kidney care centre for routine outpatient HDF treatments for chronic kidney disease

Brief summary: Primary Objective:

The purpose of this study is to measure the amount of convection achieved with two different haemodiafilters designed for haemodiafiltration and clotting during haemodiafiltration treatment.

Detailed description: This is a prospective observational cohort pilot study of patients under the care of the Royal Free Hospital with chronic kidney disease who have been established on regular thrice weekly haemodiafiltration treatments in a dialysis centre. Information on the study will be disseminated to the Royal Free consultant nephrologists at the dialysis centre with primary responsibility for the individual patient.

Eligibility criteria: Inclusion Criteria:

* Patients age 18 years and older up to 80 years
* Under the care of the Royal Free Hospital with chronic kidney disease and established on regular thrice weekly haemodiafiltration.
* Able to provide written informed consent obtained

Exclusion Criteria:

* Patients scheduled for a kidney transplant
* Patients taking concomitant systemic anticoagulants
* Patients with known prothrombotic or bleeding disorders
* Patients with abnormal platelet counts
* Patients unable to provide written informed consent
* Patients not fulfilling inclusion criteria

Primary outcomes:
measure: convective volume exchanged
timeFrame: day 1
Secondary outcomes:
measure: platelet and coagulation pathway activation
timeFrame: day 1
measure: visual coagulation
timeFrame: day 1
measure: small and middle sized solute clearances
timeFrame: day 1
Other outcomes:
Locations:
Study officials:
affiliation: UCL centre for nephrology, Royal Free Hospital
name: andrew davenport
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06677437: Endovascular Preparation for Kidney Tranplantation
Official title: Endovascular Preparation for Kidney Tranplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Failure Chronic
Kidney Transplant
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study concerns adult patients with chronic renal failure who are all awaiting a kidney transplant, whether or not they are treated by extra-renal purification.

These patients are contraindicated for transplantation due to their anatomical constraints: major arterial calcifications, iliac dissections, iliac stenoses and They can only receive the kidney transplant after arterial preparation.

Brief summary: This national study is a feasibility study. It wants to validate all stages of the endovascular preparation of the iliac axis up to the kidney transplant for patients in whom the installation of a tailor-made endoprosthesis was necessary beforehand.

These patients are currently at a therapeutic impasse. This strategy of renal transplantation on an iliac artery endoprosthesis could ultimately give them access to the transplant with an improvement in quality of life and survival, for lower costs of care for the hospital and safety. less social than treatment by hemodialysis


Eligibility criteria: Inclusion Criteria:

1. Patient from 18 to 85 years old (beyond 85 years old, guidance must remain exceptional)
2. Patients with chronic renal failure
3. Waiting for a kidney transplant
4. Who have a vascular contraindication to renal transplantation because of their anatomical constraints.

Exclusion Criteria:

1-All criteria contraindicating kidney transplant other than for arterial anatomical problems: All criteria contraindicating kidney transplant other than for arterial anatomical problems:

* A progressive cancer, which is not cured,
* An uncontrolled infectious disease,
* Severe cardiovascular or respiratory disease making general anesthesia impossible,
* Unstabilized psychiatric disorders or illness,
* Dementia proven to have progressed after specialist advice
* Major obesity, with a body mass index greater than 50 kg/m2
* Patient refusal 2. Patient under curatorship 3. Pregnant woman 4. Patients for whom it will not be possible to organize regular medical follow-up

Primary outcomes:
measure: Evaluate the success of endovascular arterial preparation for grafting Renal.
timeFrame: "From enrollment to the end of treatment at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: HCL Hopital Louis Pradel
Study officials:
References:
Clinical trial NCT06130137: Gut Microbiome in People Living With HIV and HBV
Official title: Genome-based Multiomics Analysis on Gut Microbiome in People Living With HIV and HBV
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Human Immunodeficiency Virus
Chronic Hepatitis b
Gut Microbiome
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
Collaborators: name: Kyunghee University Medical Center
name: Hanyang University
First posted: 2023-11-14
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with chronic viral diseases will be evaluated.

Brief summary: Building a Microbiome Data Platform and Conducting Clinical Evidence Research in Individuals Infected with the Human Immunodeficiency Virus (HIV) and Hepatitis B virus.

Detailed description: Chronic HIV infection, which often results in metabolic disorders, leads to shifts in the gut microbiota, contributing to immune activation and chronic inflammation. This study seeks to compare the gut microbiota in individuals with chronic HIV infection and chronic hepatitis B patients. The objective is to identify specific gut bacterial strains and metabolic pathways linked to the metabolic disorders commonly observed in HIV patients.

Eligibility criteria: Inclusion Criteria:

1. HIV patients

   * Inidividuals over 19 years old
   * HIV patients on antiretroviral therapy (ART)
2. HBV patients

   * Individuals over 19 years old
   * Chronic hepatitis B patients with either chronic hepatitis, liver cirrhosis or hepatocellular carcinoma

Exclusion Criteria:

1. Patients with indeterminate colitis
2. Individuals who have used antibiotics or steroids within 24 hours of the microbiome sample collection (excluding antiviral treatments for hepatitis B and HIV)
3. Individuals who have used vaginal or external medications, including antifungal agents, within 24 hours of microbiome sample collection
4. Those with acute illnesses, with or without fever, of moderate or severe severity; however, sampling may be postponed until the subject recovers.
5. Individuals with gastrointestinal disorders that may impact microbiome analysis and are currently medically uncontrolled or under treatment for the respective condition
6. Individuals with a positive result in a urine pregnancy test, pregnant, or breastfeeding at the time of microbiome sample collection
7. Individuals for whom medical opinions suspect that they may have an impact on the sample collection at the time of microbiome collection.

Primary outcomes:
measure: Collect clinical information data and stool from HIV and HBV patients
timeFrame: 2 years
Secondary outcomes:
measure: Shotgun metagenomic sequencing will be done with stool collected from HIV and HBV patients
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Eunjeong Joo, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: