louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06890234: Tissue Microdialysis Monitoring of Liver Grafts
Official title: Clinical Applicability of Tissue Microdialysis for Early Assessment of Liver Graft Metabolism in Patients After Orthotopic Liver Transplantation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Liver Transplantation
Liver Graft Dysfunction
Tissue Metabolism
Keywords: microdialysis
liver graft monitoring
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Liver transplant candidates satisfying the inclusion criteria.

Brief summary: This study will investigate the dynamics of metabolic molecules sampled from human liver grafts during the early postoperative period using tissue microdialysis. The obtained tissue samples will be compared with standard liver function tests and dynamic functional liver assessment tests. The primary objective is to evaluate the clinical feasibility, utility, and non-inferiority of tissue microdialysis in comparison to current standard methods for monitoring liver grafts.


Eligibility criteria: Inclusion criteria:

* Adult patients aged between 18 and 65 years.
* Liver transplant candidates on the Slovenian liver transplant waiting list, matched with an available liver graft through the Eurotransplant system, and scheduled for the surgical procedure.
* Signed informed consent to participate in the microdialysis sampling research project, including consent to share the obtained samples with other research studies

Exclusion criteria:

* Patients under 18 or over 65 years of age.
* Refusal to participate in the study.
* Verbal withdrawal of consent at any point during the study, even if informed consent has been previously signed.
* Surgical contraindications preventing the insertion of a microdialysis catheter into the liver graft during the procedure.
* Surgical revision within 48 hours post-transplantation resulting in liver graft loss and removal.
* History of allergic reactions to radiographic contrast media.
* Death during the liver transplant procedure.

Primary outcomes:
measure: The agreement between microdialysis-derived metabolite levels and conventional liver function tests
timeFrame: From the end of liver transplant surgery up to 5 days post-transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
References:
Clinical trial NCT06518434: A Pilot Study on the Effect of Cannabis Oil in Untreatable Liver Cancer Patients
Official title: A Phase 2a Study on the Anti-tumoral Effect of Cannabis Oil (THC 10% / CBD 5%) in Patients With Advanced Untreatable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Cannabis
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria


Eligibility criteria: Inclusion Criteria:

* Age =\>18 yrs
* Histologically proven hepatocellular carcinoma
* Non-cirrhosis or Child Pugh A cirrhosis
* Hepatic encephalopathy grade 0 or 1
* Multidisciplinary treatment (MDT)-advised best supportive care for untreatable advanced HCC or patients unable to undergo or declining treatment for advanced HCC.
* Minimal life expectancy of 3 months
* Willing and able to attend follow-up examinations
* Willing to stop active traffic participation or controlling machinery during the study period if applicable
* Signed informed consent
* Language: Dutch or English

Exclusion Criteria:

* Child Pugh B or C cirrhosis
* Hepatic encephalopathy grade 2 or more
* Previous systemic treatment for HCC
* Mental conditions rendering the subject incapable to understand the nature, scope and consequences of the trial
* Use of medicinal cannabis for other purposes
* Contra-indications for medicinal cannabis oil:

  * Patients who have experienced a myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or have had a cardiac disorder that, in the opinion of the investigator would have put the participant at risk of a clinically significant arrhythmia or myocardial infarction.
  * Patients with known psychotic disorders
  * Female patients who are pregnant or lactating
  * Patients (men or women) intending to start a family
  * Hypersensitivity to cannabinoids or any of the excipients of the cannabis oil

Primary outcomes:
measure: Tumor size
timeFrame: 9 months
Secondary outcomes:
measure: Tumor size
timeFrame: 3 months
measure: Tumor size
timeFrame: 6 months
measure: Tumor markers
timeFrame: 3 months
measure: Tumor markers
timeFrame: 6 months
measure: Tumor markers
timeFrame: 9 months
measure: Quality of Life questionnaires
timeFrame: 3 months
measure: Quality of Life questionnaires
timeFrame: 6 months
measure: Quality of Life questionnaires
timeFrame: 9 months
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: M W Nijkamp, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05271734: Evaluation of the Compatibility of Different Eye Lid Retractors to the Direct Selective Laser Trabeculoplasty (DSLT) Procedure
Official title: Evaluation of the Compatibility of Different Eye Lid Retractors to the Direct Selective Laser Trabeculoplasty (DSLT) Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: OAG - Open-Angle Glaucoma
Lead sponsor: BelkinVision
Sponsor class: INDUSTRY
First posted: 2022-03-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Direct Selective Laser Trabeculoplasty (DSLT) is an emerging therapeutic technology to treat glaucoma. DSLT was previously tested in 2 clinical trials and demonstrated promising safety and efficacy results in reducing the patient's intra ocular pressure.

Experience gained in the previous clinical studies indicates that a full exposure of the limbal area may be a challenge in patients with narrow palpebral fissures, narrow or floppy eyelids, and patients with deep-set eyes.

Detailed description: The DSLT procedure is carried out in the doctor's office while the patient sits in front of the DSLT device (termed the "Eagle" device) for couple of minutes.

In this procedure, 120 laser applications are performed around the full circumference of the ocular limbus, after the system automatically recognizes the limbal target area. It is therefore essential that a full exposure of 3600 limbal area will be achieved, and this is done by placing an eye lid retractor (speculum) in the treated eye at the beginning of the procedure.

The purpose of this study is to evaluate the compatibility of different types of lid retractors. The lid retractors will be tested in adult volunteers visiting the study eye clinic for any reason.

Eligibility criteria: Inclusion Criteria.

* Adult volunteers (age ≥18 years old) of both sexes visiting the study eye clinic for any reason.
* Willing and able to participate in the study and to comply with the study procedures.
* Participant capable of giving informed consent.

Exclusion Criteria:

* Prior incisional ocular surgery or ocular trauma in the tested eye.
* Women who are pregnant.
* Any medical condition that interferes with the subject's ability to sit steady in front of the Eagle device.
* Known allergy to local anaesthesia eye drops.

Primary outcomes:
measure: Limbus Exposure
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Akhali Mzera Eye Clinic
Study officials:
References:
Clinical trial NCT00474734: Intravascular Ultrasound for Hepatocellular Carcinoma Staging
Official title: Intravascular Ultrasound for the Staging of Hepatocellular Carcinoma: a Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
liver transplantation
staging
intravascular ultrasound
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2007-05-17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: To diagnose hepatocellular carcinoma (HCC) and to determine the extent of the disease, a triphasic CT scan or a magnetic resonance imaging are required. The characterization of hepatic nodules is more difficult when the HCC lesions have a diameter of less than 2 cm.

Since accuracy in the assessment of the number and the size of HCC nodules, as well as of the invasion of blood vessels is crucial to determine outcome after liver transplantation due to tumour recurrence, there is a need for techniques with a higher definition potential.

As a consequence, to improve outcome and to optimize organ allocation, patients on the liver transplantation waiting list might benefit from intravascular ultrasound as an additional examination to complete the pre-transplant tumour staging process.


Eligibility criteria: Inclusion Criteria:

* hepatocellular carcinoma nodules
* patient on liver transplantation waiting list
* written informed consent

Exclusion Criteria:

* thrombosis of hepatic veins or vena cava

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital Geneva
Study officials:
affiliation: University Hospital, Geneva
name: Antoine Hadengue, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT02673034: Circadian Variation in Serum-progesterone Levels Following Controlled Ovarian Hyperstimulation.
Official title: Circadian Variation in Serum-progesterone Levels Following Controlled Ovarian Hyperstimulation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing IVF-treatment using either GnRHa long protocol or GnRH antagoinst co-treatment.

Brief summary: The aim of the study is to investigate the circadian variation in serum-progesterone in women undergoing controlled ovarian stimulation.


Eligibility criteria: Inclusion Criteria:

Women undergoing standard IVF/ICSI treatment.

Exclusion Criteria:

Previous participation in the study.

Primary outcomes:
measure: serum progesterone levels
timeFrame: 12 hours
Secondary outcomes:
measure: serum LH levels
timeFrame: 12 hours
measure: serum estradiol levels
timeFrame: 12 hours
measure: 17-OH progesterone
timeFrame: 12-hours
Other outcomes:
Locations:
city: Skive
country: Denmark
facility: The Fertility Clinic Skive
state: Resenvej 25
Study officials:
References:
Clinical trial NCT03013634: Protective Effects of Dexmedetomidine on Myocardial Injury During Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Evidence of Liver Transplantation
Myocardial Injury
Keywords: dexmedetomidine
Lead sponsor: Tianjin First Central Hospital
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to evaluate the protective effect of dexmedetomidine on myocardial injury during liver transplantation

Detailed description: Liver transplantation surgery may lead to myocardial injury. Dexmedetomidine, a highly specific α2-adrenoeptor agonist, has sedative and analgesic properties without significant respiratory depression at the clinically approved dosage. Some investigations indicated that dexmedetomidine was able to protect the myocardium via improving the activity of Na+-K+-adenosine triphosphate enzyme and Ca2+-adenosine triphosphate, alleviating inflammation reaction and avoiding Ca2+ overload. However, the effect and the mechanism of dexmedetomidine on myocardial injury during liver transplantation remain unclear.

Eligibility criteria: Inclusion Criteria:

* End stage liver disease scheduled for liver transplantation in Tianjin First Center Hospital

Exclusion Criteria:

* Pre-existing respiratory failure,renal failure,hepatic encephalopathy

Primary outcomes:
measure: Peri-operative mortality
timeFrame: through study completion, an average of 5 weeks
measure: The incidence of cardiac complications
timeFrame: from anesthesia induction to 24 hours after operation
Secondary outcomes:
measure: Evidences of Clinically Definite Myocardial Injury Confirmed by Electrochemiluminescence
timeFrame: before skin incision, 0.5 hour min after anhepatic, 2 hours of neohepatic stage,the end of surgery,24 hours after operation
Other outcomes:
measure: Length of ICU stay
timeFrame: through study completion, an average of 5 days
measure: length of stay
timeFrame: through study completion, an average of 6 weeks
Locations:
city: Tianjin
country: China
facility: No.24 Fukang Road,Nankai District
state: Tianjin
Study officials:
References:
Clinical trial NCT01714934: The Role of Gastric Content Microaspirations in the Pathogenesis of Idiopathic Pulmonary Fibrosis
Official title: Study of Pepsin Levels in the Broncho-Alveolar-Lavage Fluid of Patients With Idiopathic Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: IDIOPATHIC PULMONARY FIBROSIS
Keywords: IDIOPATHIC PULMONARY FIBROSIS
MICROASPIRATION
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-10-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with IPF versus patients with other interstitial lung disorders (non IPF)

Brief summary: The pathogenesis of idiopathic pulmonary fibrosis (IPF) is debatable. Looking for an insult to lung parenchyma that generates the pathogenesis of the disease is challenging. Pepsin is a proteolytic enzyme present in the gastric juice. Microaspirations of gastric content were described as a potential factor for injury in many chronic lung disorders. Bronchoalveolar lavage (BAL) is a routine investigation technique in interstitial lung diseases. The presence of pepsin in the BAL fluid recovered from patients with IPF may indicate a possible role for gastric microaspirations in the pathogenesis of the disease.


Eligibility criteria: Inclusion Criteria:

* patients with interstitial lung disorders including IPF

Exclusion Criteria:

* patients younger than 18 years or older than 85,
* pregnant women,
* patients that present with medical conditions contra -indicated for performing bronchoscopy including sedation

Primary outcomes:
measure: BAL Pepsin level
timeFrame: 18 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT02956434: An Adjunctive Family Intervention for Individual Posttraumatic Stress Disorder Treatment
Official title: An Adjunctive Family Intervention for Individual PTSD Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Neuroses
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-11-06
Enrollment: 40
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 study aims to test a brief family intervention (the BFI) to enhance individually-delivered PTSD treatment for Veterans.

Detailed description: The investigators will enroll pairs of Veterans and one adult family member who lives with them. Veterans will be beginning a course of PTSD-focused treatment at the Boston VA; Veterans' treatment will not be limited or changed by their participation in this study.

Family members will receive or not receive (depending on which Phase of the study they are recruited in) the BFI. The BFI consists of 2 sessions in which the family member meets one-on-one with a clinician to discuss PTSD, PTSD treatment, and how families can be most helpful to patients in treatment.

Veterans and family members will also be interviewed about their opinions and experiences regarding family-inclusive treatment for PTSD. Clinicians will be recruited and enrolled to obtain their information and feedback (via qualitative interviews), and to deliver the intervention in Phase II.

Eligibility criteria: Inclusion Criteria:

* Veterans must have a diagnosis of PTSD and be beginning a course of Prolonged Exposure (PE) or Cognitive Processing Therapy (CPT) at the Boston VA.
* Must also have an eligible family member who is willing to participate.

Exclusion Criteria:

* Current diagnosis of unstable bipolar disorder, substance dependence, past or present psychosis, or organic mental disorder
* Clear and current suicidal risk
* Current participation in family/couples therapy

Primary outcomes:
measure: Clinician-Administered PTSD Scale, 5th Edition
timeFrame: 16 weeks
measure: Treatment Attendance/Dropout
timeFrame: 16 weeks
Secondary outcomes:
measure: Significant Others' Responses to Trauma Scale (SORTS)
timeFrame: 16 weeks
measure: Revised Dyadic Adjustment Scale
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Johanna Thompson-Hollands, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02631434: Comparison Between Sit-to-stand Test and Six-minute Walk Test in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Comparison between sit-to-stand test and six minutes walking test in chronic obstructive pulmonary disease patients


Eligibility criteria: Inclusion Criteria:

* clinically stable for a minimum of 4 weeks
* no recent infectious exacerbations

Exclusion Criteria:

* musculoskeletal or joint disorders
* contra-indications to perform exercises

Primary outcomes:
measure: number of sit-to-stand movement
timeFrame: 1 minute
measure: walked distance
timeFrame: 6 minutes
Secondary outcomes:
measure: heart rate
timeFrame: 6 minutes
measure: fraction of oxygen-saturated hemoglobin measured by pulsed oximeter
timeFrame: 6 minutes
measure: breathlessness measured by visual analogic scale
timeFrame: 6 minutes
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Clinique universitaire Saint-Luc
Study officials:
References:
Clinical trial NCT01935817: Silybin - Vitamin E- Phospholipids Complex Reduces Liver Fibrosis in Patients With Chronic Hepatitis C Treated With Peg-IFN-a and RBV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Fibrosis
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2013-09-05
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic hepatitis C is both a virologic and a fibrotic disease, with mortality resulting mainly from the complications of cirrhosis and HCC.

The investigators' aim will be to evaluate the impact on of supplementation with a new pharmaceutical complex of silybin-vitamin E-phospholipids in patients with chronic hepatitis C treated with Pegylated-Interferon-α2b plus Ribavirin.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older,
* infection by HCV
* under treatment with pegylated interferon 2 alpha and ribavirin

Exclusion Criteria:

* other liver diseases
* cancer
* severe jaundice
* pulmonary and renal chronic diseases
* prostatic diseases
* autoimmune diseases
* diabetes mellitus

Primary outcomes:
measure: transforming growth factor beta
timeFrame: 12 months
Secondary outcomes:
measure: hyaluronic acid
timeFrame: 12 months
Other outcomes:
measure: metalloproteinase 2
timeFrame: 12 months
measure: amino-terminal pro-peptide of type III procollagen
timeFrame: 12 months
measure: tissue inhibitor of matrix metalloproteinase type I
timeFrame: 12 months
Locations:
city: Catania
country: Italy
facility: Cannizzaro Hospital
state: Sicily
Study officials:
References: