louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01333319: The Role of Biomarkers in the Early Detection of Acute Kidney Injury Induced by Liver Transplantation
Official title: The Role of Biomarkers in the Early Detection of Acute Kidney Injury Induced by Liver Transplantation : an Observational Analysis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: liver transplantation
acute kidney injury
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-04-11
Enrollment: 80
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: Patients of the University Hospitals Leuven listed on the Eurotransplant waiting list for liver transplantation and undergoing a liver transplantation

Brief summary: Renal dysfunction is a major risk factor for poorer outcome after liver transplantation. Nevertheless, mechanisms of renal dysfunction in liver transplant recipients are not clearly understood. Calcineurin inhibitors are generally perceived as the most important cause; however the liver transplant procedure itself represents a major surgical / hemodynamic / inflammatory trauma that - on its own - can cause renal dysfunction. Creatinine and creatinine clearance are late markers of acute kidney injury and changes in these parameters occur only after substantial injury has already occurred. Even a stable creatinine does not exclude structural kidney damage.

A series of new markers of tissue injury have been identified and have the potential to identify acute kidney injury better and earlier than creatinine and creatinine clearance. The aim of this study is to determine whether and how liver transplantation affects these urinary and plasma biomarkers and to study whether the changes in these biomarkers may predict later changes in standard functional parameters (creatinine and creatinine clearance). For this purpose, the urinary and plasma biomarkers, together with creatinine, will be determined serially during the different phases of the liver transplant process and daily until day 5 after transplantation.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years

Exclusion Criteria:

* Younger than 18 years old
* Combined organ transplants
* Dialysis dependent prior to liver transplantation

Primary outcomes:
measure: Biomarkers in urine and plasma
timeFrame: First 5 days post transplantation
Secondary outcomes:
measure: Creatinine change
timeFrame: First 5 days post transplantation
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Abdominal Transplant Surgery, University Hospitals Leuven, KULeuven
name: Jacques Pirenne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06550219: Evaluation of Nasal Non Invasive Ventilation in Management of Neonates With Respiratory Distress Using Lung Ultrasound
Official title: Evaluation of Nasal Non Invasive Ventilation Modalities in Management of Neonates With Respiratory Distress Using Lung Ultrasound
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preterm
Ventilator Lung; Newborn
Keywords: preterm infants
non-invasive ventilation
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effect of non-invasive ventilation (nIPPV)

, (nCPAP), and nasal high flow cannula (NHFC) as a primary mode of ventilation in preterm neonates \<37 gestational week with moderate to severe RD using LUS as regard: I. Primary outcomes: Duration of non-Invasive ventilation. II. Secondary outcomes: Evaluation LUS over the 1 st 7 days of life or weaning from ventilation. Need for intubation and invasive ventilation. Duration of respiratory support. Need for surfactant. Oxygen saturation index and oxygen index. Broncho-pulmonary dysplasia; grade. Duration of hospital stay


Eligibility criteria: Inclusion Criteria: Preterm \<37 wk. gestational age admitted to the NICU with spontaneous breathing and clinical manifestations of RD (tachypnea, nasal flaring, intercostal and subcostal retraction and or grunting).

Exclusion Criteria:

1. Obvious major congenital abnormalities.
2. Any of the baby intubated for resuscitation or for other reasons.
3. Neonates need invasive mechanical ventilation.
4. Pulmonary hemorrhage.
5. Severe cardiovascular instability.
6. Cardiopulmonary arrest needing prolonged resuscitation.
7. Birth asphyxia (one-minute Apgar score ≤ 3).
8. Major cardiac diseases (not including patent ductus arteriosus).

Primary outcomes:
measure: Duration of non-Invasive ventilation (NIV)
timeFrame: First two weeks of life.
Secondary outcomes:
measure: Oxygen saturation index (OSI).
timeFrame: first one weeks of life.
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university, Elshattbi hospital
Study officials:
References:
Clinical trial NCT06389019: Whole-slide Image and CT Radiomics Based Deep Learning System for Prognostication Prediction in Bladder Cancer
Official title: Whole-slide Image and CT Radiomics Based Deep Learning System for Prognostication Prediction in Bladder Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Keywords: deep learning
Radiomics
Histopathological tissue slides
Tomography
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We included patients who had surgery only or who had neoadjuvant chemotherapy before surgery. We excluded patients with a postoperative diagnosis of non-urothelial carcinoma.

Brief summary: Bladder cancer (BLCA), with its diverse histopathological features and varying patient outcomes, poses significant challenges in diagnosis and prognosis. Postoperative survival stratification based on radiomics feature and whole slide image feature may be useful for treatment decisions to improve prognosis. In this research, we aim to develop a deep learning-based prognostic-stratification system for automatic prediction of overall and cancer-specific survival in patients with BLCA.

Detailed description: Bladder cancer can be difficult to diagnose and predict outcomes for, as the disease can vary greatly between patients. This research aims to develop a new system that uses artificial intelligence to analyze patient information, including images from surgery and scans. This system could then automatically predict a patient\&#39;s overall survival and how likely they are to survive specifically from bladder cancer. This information could be used by doctors to make better treatment decisions for each patient.

Eligibility criteria: Inclusion Criteria:

* patients with bladder cancer who had surgery like radical cystectomy or transurethral resection of bladder tumour (TURBT)
* contrast-CT scan less than two weeks before surgery
* complete CT image data and clinical data
* complete whole slide image data

Exclusion Criteria:

* patients with a postoperative diagnosis of non-urothelial carcinoma
* poor quality of CT images
* incomplete clinical and follow-up data

Primary outcomes:
measure: Overall survival
timeFrame: up to 10 years
Secondary outcomes:
measure: Recurrence free survival
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Urology, The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT02853019: Emotion and Motivation in Patients With Psychosis
Official title: Influence of Emotion and Motivation on Behaviour and Neural Activity in Patients With Psychosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Keywords: Emotion
motivation
cognition
schizophrenia
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2016-08-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Anhedonia and avolition reflect emotional and motivational disorders, respectively. However, if these disorders play a major role in the symptomatology of schizophrenia, their mechanisms remain poorly understood, and existing treatments are inefficient on these symptoms. The literature suggests that the impairment does not concern emotion or motivation per se, but rather their influence on cognition. This project aims at using recent advances in the fundamental domain to better understand the cognitive and neuronal mechanisms of the patients' alterations, and especially how emotion and motivation influence cognition in schizophrenia.


Eligibility criteria: Inclusion Criteria:

* diagnostic and Statistical Manual of Mental Disorders criteria for schizophrenia

Exclusion Criteria:

* addiction problem
* invalidating visual sensory problems
* neurological history
* for the healthy volunteers: psychiatric history

Primary outcomes:
measure: Change in the amplitude of the CNV (Contingent Negative Variation) as a function of the primer displayed on the screen
timeFrame: During EEG sessions, at experimental session 1 (Day 0) and experimental session 2 (up to Day 120)
Secondary outcomes:
measure: Change in the amplitude of the LPP (Late Positive Potential) as a function of the primer displayed on the screen
timeFrame: During EEG sessions, at experimental session 1 (Day 0) and experimental session 2 (up to Day 120)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Unité INSERM 1114
Study officials:
References:
Clinical trial NCT05035719: Comparison Studies Comparing Hemodynamic Parameters Provided by the Caretaker Against Respective Gold Standard References
Official title: Comparison Studies Comparing Hemodynamic Parameters Provided by the Caretaker
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Output, Low
Lead sponsor: CareTaker Medical LLC
Sponsor class: INDUSTRY
Collaborators: name: The Cooper Health System
First posted: 2021-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cardiac patients

Brief summary: Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.

Detailed description: Comparison study comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.

Specifically, continuous beat-by-beat blood pressure readings against arterial catheter readings and cardiac output (CO) and stroke volume (SV) measures against thermo-dilution measurements

Eligibility criteria: Inclusion Criteria:

* 18 years of age
* able and willing to participate
* provide written consent

Exclusion Criteria:

* Unable to give written consent
* \<18 years of age
* No or poor finger pulse, as determined through visual inspection for ischemic hands

Primary outcomes:
measure: Cardiac output performance comparison
timeFrame: Change between several paired readings over the course of cardiac surgery (typically 2-4 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
Study officials:
References:
Clinical trial NCT05208619: Comparison of Different Methods for Intra- and Postoperative Pain Therapy in Thoracic Surgery
Official title: Comparison of Different Methods for Intra- and Postoperative Pain Therapy in Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracic Surgery
Keywords: Thoracic surgery
paravertebral block
epidural analgesia
Thoracic anaesthesia
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
Collaborators: name: HELIOS Klinikum Bonn/Rhein-Sieg
First posted: 2022-01-26
Enrollment: 118
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: The aim of the study is to determine which regional anaesthesiological technique (thoracic epidural analgesia or paravertebral block) is more suitable for thoracic surgery

Detailed description: Thoracic interventions (lung operations) are associated with considerable postoperative pain, whereby an open surgical procedure via a skin incision (thoracotomy) is more painful than a minimally invasive endoscopic intervention (thoracoscopy). In order to reduce pain, a regional anaesthetic is administered during the induction of anaesthesia, which reduces pain both intraoperatively and postoperatively. In thoracic surgery, thoracic epidural analgesia (PDA) and paravertebral block (PVB) are the main regional anaesthesiological measures used, although it is unclear which of the two procedures is superior in terms of efficiency and effectiveness. Particularly intraoperatively, but also to some extent postoperatively, regional anaesthesia alone is usually not sufficient for pain management. Rather, additional systemic (i.e. intravenous) analgesics (especially opioids) are administered. Therefore, the amount of these additionally administered analgesics is a measure of the efficiency of the regional anaesthesia procedure.

Eligibility criteria: Inclusion Criteria:

* elective thoracic surgery
* American Society of Anaesthesiologists (ASA) 1-3 status
* written informed consent

Exclusion Criteria:

* pregnancy
* adipositas (bmi \> 30)
* cardiac arrhythmia
* coagulation abnormalities
* chronic pain
* opiate abuses

Primary outcomes:
measure: Opiate consumption
timeFrame: intraoperative
Secondary outcomes:
measure: pain score
timeFrame: from admission to post-anaesthesia care unit (PACU) until discharge from PACU (up to 1 hour after admission)
measure: postoperative pain
timeFrame: up to day 2 after surgery
measure: anaesthetic depth
timeFrame: intraoperative
measure: intraoperative nociception
timeFrame: intraoperative
measure: Patient recovery
timeFrame: at day 1 after surgery
measure: Patient satisfaction
timeFrame: at day 2 after surgery
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn
city: Bonn
country: Germany
facility: Helios Klinikum Bonn/Rhein-Sieg
Study officials:
References:
Clinical trial NCT04463719: AIM2: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid
Official title: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Nodules
Thyroid Cancer
Keywords: thyroid nodules
shared decision making
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-07-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: There is an epidemic of thyroid cancer that is harmful to patients and the medical system. The study hypothesizes that the use of an electronic conversation aid during clinical visits can help patients and clinicians collaborate. The study aims to update a conversation aid prototype that was developed to support shared decision making in the diagnosis of thyroid cancer and conduct a pilot clinical trial to evaluate the feasibility of conducting a larger efficacy study.


Eligibility criteria: Inclusion Criteria:

* Adults \>18 years old presenting for evaluation of a thyroid nodule

Exclusion Criteria:

* Patients with hyperthyroidism
* Patients with previous biopsy of the nodule of interest
* Pregnant patients
* Prisoners

Primary outcomes:
measure: Proportion of eligible patients for feasibility
timeFrame: at 6 months of follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: University of Florida
name: Naykky Singh Ospina
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01462019: Photobiomodulation as a New Approach for the Treatment of Nipple Traumas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Injuries to the Nipple (Fissures and Cracks) Resulting Breastfeeding
Keywords: nipple trauma
breast feeding
phototherapy
wound healing
Lead sponsor: Pontifícia Universidade Católica de Minas Gerais
Sponsor class: OTHER
First posted: 2011-10-28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Inadequate care during pregnancy and postpartum are predisposing factors for the emergence of nipple fissures. The therapeutic approach of nipple trauma care guidelines aimed at the breast and the appropriate techniques for breastfeeding. These measures, however, have a much more preventive than curative, it is not, in most cases, sufficient to power the closing of nipple trauma. The objective of this study was to evaluate the effectiveness of a phototherapy device designed specifically for the treatment of nipple trauma.


Eligibility criteria: Inclusion Criteria:

* women should have a medical diagnosis of nipple trauma were not infected and aged 18 to 35 years

Exclusion Criteria:

* previous history of cancer; use of other therapeutic modalities that might interfere with the healing of the lesions; presence of infected wounds; history of photosensitivity to light; cognitive deficits that undermine the understanding and implementation of guidelines of care for breast

Primary outcomes:
measure: Size and classification of injuries
Secondary outcomes:
measure: Pain:
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Pontifícia Universidade Católica de Minas Gerais
state: Minas Gerais
Study officials:
References:
Clinical trial NCT02517619: Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Non-Infectious Anterior Uveitis
Official title: A Prospective, Multi-Center, Randomized, Double-Masked, Positive Controlled, Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspension (1%) in Patients With Non-Infectious Anterior Segment Uveitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anterior Uveitis
Keywords: Iontophoresis
Ophthalmology
Non-Infectious Anterior Segment Uveitis
Lead sponsor: Eyegate Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-07
Enrollment: 251
Sex: ALL
Minimum age (years): 12
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis.

Detailed description: This will be a Phase 3, randomized, double-masked, parallel arm, positive-controlled non-inferiority study, in which up to 250 subjects (approximately 125 subjects per treatment arm) will be enrolled at up to 60 clinical sites. Patients with non-infectious anterior segment uveitis who are interested in participating in the study will be provided an informed consent form prior to screening. Screening/Baseline procedures which include BCVA, slit lamp examination, fundus exam, IOP by tonometry will be used to determine eligibility.

Eligibility criteria: Inclusion Criteria:

1. Age 12 to 85 years with a diagnosis of non-infectious anterior segment uveitis defined as an AC cell count of ≥ 11 cells
2. Receive, understand, and sign a copy of the written informed consent form
3. Be able to return for all study visits and willing to comply with all study-related instructions

Exclusion Criteria:

Primary outcomes:
measure: Proportion of subjects with an AC cell count of zero at Day 14
timeFrame: Day 14 ± 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
affiliation: Study Principal Investigator
name: John D. Sheppard, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03724019: Impact of the Use of Ketamine in Laparoscopic Surgery.
Official title: Evaluation of the Impact of the Use of Ketamine in Laparoscopic Surgery, Using the Quality of Recovery 15 Questionnaire.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Quality of Recovery
Keywords: Ketamine
QoR-15
Laparoscopic surgery
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2018-10-30
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: In order to improve the postoperative period (namely pain control), several drugs can be used. For instance, ketamine is a general anesthetic that holds strong analgesic properties, yet also owns undesirable effects, in which hallucination phenomena is one the most common indicator. However, slight information is available about the real implication in the quality of the recovery on the use of ketamine for postoperative pain treatment. The quality of the recovery includes several health conditions, such as pain, physical comfort, physical independence, psychological support and emotional state. In recent years, investigations in this field has been attracted the attention by the health professionals, since is an indicator of the quality of post-operative care. To evaluate these parameters, questionnaires have been developed, in which the Portuguese version of Quality of Recovery 15 (QoR-15) is include. This questionnaire evaluates five psychometric dimensions. Therefore, the present study has the main goal, the evaluation of the effect of using ketamine in laparoscopic surgery and the quality of the recovery using the QoR-15 questionnaire.


Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 65 years age, with an American Society of Anesthesiology physical status I, II or III.
* Laparoscopic surgery (sleeve gastrectomy, salpingectomy, or cholecystectomy)

Exclusion Criteria:

* patient refusal, the incapacity of providing informed consent, drug abusers (current or past history) or alcohol abuse, medication with benzodiazepines, inability to give informed consent, pregnant, emergency surgery, psychiatric pathology, existence of surgical complications in the recovery and admission to a level II or III unit ( for any reason).

Primary outcomes:
measure: Impact in QoR-15 score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: CHU São João
Study officials:
References: