louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06754397: Diagnostic Accuracy of Magnetic Resonance Cholangiopancreatography in Patients With Obstructive Jaundice
Official title: Diagnostic Accuracy of Magnetic Resonance Cholangiopancreatography as Compared to Ultrasound and Computed Tomography in Patients With Obstructive Jaundice
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obstructive Jaundice
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male and female patients clinically diagnosed obstructive jaundice are included in the study with positive laboratory tests.

Brief summary: Evaluate the diagnostic accuracy of Magnetic Resonance Cholangiopancreatography (MRCP) compared with Ultrasound and Computed Tomography (CT) in patients with obstructive jaundice taking findings of ERCP/ PTC and histopathology as gold standard.

Detailed description: MRCP as a diagnostic role to determine the presence and severity of biliary and pancreatic ductal dilatation. It can also detect the length of the stricture as well as the exact cause and location of the obstructing lesion in comparison to other modalities.

Eligibility criteria: Inclusion Criteria:

Adult male and female patients clinically diagnosed obstructive jaundice are included in the study with positive laboratory tests.

Exclusion Criteria:

Patients with non-obstructive (prehepatic/hepatic) cause of jaundice. Patients having contraindications to perform MRI (Patients with any electrically, magnetically or mechanically activated implants, pacemaker, cochlear implants or any metallic orthopedic implants and claustrophobic patients).

Primary outcomes:
measure: Diagnostic accuracy of Magnetic Resonance Cholangiopancreatography in patients with obstructive jaundice according to the findings
timeFrame: Within twelve months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical research ethics committee - Sohag university
name: Magdy M Amin, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06845397: Chuvashia Inappropriate Prescribing Study
Official title: Chuvashia Inappropriate Prescribing Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multimorbidity, Cardiovascular Diseases
Keywords: multimorbidity
self-medication
drugs
over-the-counter (OTC) drugs
prescription drugs
adherence
inappropriate prescribing
Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine
Sponsor class: OTHER_GOV
Collaborators: name: BU "Respublikanski Kardiologicheski Dispanser" Minzdrava Chuvashii, Cheboksary
First posted: 2025-02-25
Enrollment: 300
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a cross-sectional study based on an outpatient registry. All medical therapy will be registered in order to assess inappropriate prescribing's, in accordance with the criteria PROMPT and BEERS, also in accordance with the officially approved instructions for the use of this medicinal product.

Brief summary: This is a cross-sectional study based on an outpatient registry. All medical therapy will be registered in order to assess inappropriate prescribing's, in accordance with the criteria PROMPT and BEERS, also in accordance with the officially approved instructions for the use of this medicinal product.


Eligibility criteria: Inclusion Criteria:

* Age \> 50 years old, multimorbidity, signed Patients' Informed Consent

Exclusion Criteria:

* Age \< 50 years, presence of mental illnesses, oncological diseases detected less than 5 years ago, acute cardiovascular pathology within 6 months prior to inclusion.

Primary outcomes:
measure: frequency of inappropriate drug prescriptions
timeFrame: Assessed at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cheboksary
country: Russian Federation
facility: Respublikanski Kardiologicheski Dispanser Minzdrava Chuvashii
Study officials:
affiliation: National Medical Research Centre for Therapy and Preventive Medicine, Moscow, Russia
name: Sergey Martsevich, M.D., Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01187797: Effects of Emotional Stimulation on the Stress Levels of Healthy Persons
Official title: Evaluation of the Effects of a Body-centered Emotional Stimulation in Healthy Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Depression
Somatization Disorder
Anger
Anxiety
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2010-08-24
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of a short-term emotional stimulation on the mood of healthy persons.

Detailed description: The trial assesses the effects of a emotion-centered stimulation on the mood of healthy persons. The outcomes will be evaluated with standard questionnaires.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 45
* Ability to speak German

Exclusion Criteria:

* Physical or psychiatric disorders
* Consume of drugs or alcohol 24 previous to the test

Primary outcomes:
measure: Depression
timeFrame: After 10 days
measure: Somatization
timeFrame: After 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: fernando Dimeo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00647205: Evaluation of 2 Interferon γ Assays in the Diagnosis of Latent Tuberculosis in HIV-infected Patients.ANRS EP 40 QUANTI SPOT
Official title: Evaluation of 2 Interferon γ Assays (QuantiFERON TB Gold In-Tube® and T-SPOT.TB®) in the Diagnosis of Latent Tuberculosis in HIV-infected Patients.ANRS EP 40 QUANTI SPOT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Tuberculosis
Keywords: Interferon, gamma
HIV Infections
Tuberculosis
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
First posted: 2008-03-31
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to estimate the usefulness of QuantiFERON TB Gold In-Tube® and T-SPOT.TB® for the diagnosis of latent tuberculosis in HIV infected antiretroviral naive patients: 80 originated from low TB prevalence countries, without any active TB; 80 HIV infected antiretroviral naïve patients originated from high TB prevalence countries, without any active TB, 40 HIV infected patients with active TB and 40 HIV negative patients with active TB.

Detailed description: The aim of this study is to estimate the usefulness of QuantiFERON TB Gold In-Tube and T-SPOT.TB for the diagnosis of latent tuberculosis in this population. Concordance between TST, QuantiFERON TB Gold and T-SPOT.TB will be assessed in patients with different risks of TB, in a transversal study. This study will include 240 patients during 2 years: 80 HIV infected antiretroviral naïve patients originated from low TB prevalence countries, without any active TB (40 patients with CD4 cell count \> 350/mm3, 40 with CD4 \< 350/mm3), 80 HIV infected antiretroviral naïve patients originated from high TB prevalence countries, without any active TB, 40 HIV infected patients with active TB and 40 HIV negative patients with active TB. TST and the 2 blood interferon gamma assay will be compared according to the level of risk. The improvement of latent TB diagnosis in HIV infected patients may lead to the initiation of TB prophylaxis and decrease the incidence of this life threatening disease.

Eligibility criteria: Inclusion Criteria:

* sign an informed consent
* to be adult
* not to be pregnant
* to have a clinical examination and a medical questionnaire

Exclusion Criteria:

-

Primary outcomes:
measure: Intradermal Tuberculin Tests QuantiFERON TB Gold In-Tube® T-SPOT.TB®
timeFrame: 48 to 72 hours after the injection
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Service des Maladies Infectieuses B Hopital Bichat
Study officials:
affiliation: AP-HP Paris
name: Daniel Bonnet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: France Mentre, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06735105: Study on the Value of Three DWI Scanning Sequences in Staging of Gastric Cancer
Official title: Comparative Study on the Value of Three DWI Scan Sequences of 3.0T Magnetic Resonance in Staging of Gastric Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Yunnan Cancer Hospital
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Accurate staging is critical for effective gastric cancer treatment planning. Conventional DWI (C-DWI) has limitations in image quality due to magnetic field inhomogeneity, which hampers precise T staging.

This study aims to compare the image quality and T staging accuracy of C-DWI, TSE-DWI, and ZOOMit-DWI (Z-DWI) sequences in MRI examinations of gastric cancer patients.

A prospective study plan to enroll 72 gastric cancer patients undergoing preoperative MRI with C-DWI, TSE-DWI, and Z-DWI sequences using a 3.0 T scanner. Quantitative metrics (ADC, SNR, CNR) and image quality were evaluated. T staging accuracy was assessed by comparing MRI results with postoperative pathological staging using ROC analysis.


Eligibility criteria: Inclusion Criteria:

1. The patient was diagnosed with gastric cancer by pathological biopsy
2. No biopsy was taken within 1 week before MR Examination to rule out the effect of bleeding on the image
3. No contraindications for MRI examination; And exclude serious heart, liver, kidney, cerebrovascular diseases.

Exclusion Criteria:

1. The image quality cannot meet the diagnostic criteria;
2. Patients could not tolerate MRI examination, resulting in incomplete MR-related sequence image data.

Primary outcomes:
measure: T staging of gastric cancer
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Kunming
country: China
facility: Yunnan Cancer Hospital
Study officials:
affiliation: Ethics Committee of Yunnan Provincial Cancer Hospital
name: Lianhua Ye
role: STUDY_DIRECTOR
References:
Clinical trial NCT01139905: Lopinavir/Ritonavir (LPV/r) Tablet in HIV Infected Children
Official title: Pharmacokinetics of Low- Dose Lopinavir/Ritonavir Tablet Formulation HIV-1 Infected Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV-1 Infections
Keywords: Lopinavir/ritonavir
pharmacokinetic
low dose
HIV-infected children
pharmacokinetics of low-dose lopinavir/ritonavir in HIV-1 infected Thai children.
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: Chulalongkorn University
name: Radboud University Medical Center
First posted: 2010-06-09
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To study the pharmacokinetics of low-dose lopinavir/ritonavir tablet in HIV-1 infected Thai children.

Detailed description: This is an open-label, single arm study to compare standard dose with a new tablet formulation of a lower dose of lopinavir/ritonavir in HIV-1 infected children.

Eligibility criteria: Inclusion Criteria:

1. HIV infection
2. Age \< 18 years old
3. BW \> 25 kg
4. HIV RNA viral load \< 50 copies within 6 months
5. Written informed consent

Exclusion Criteria:

1. Active opportunistic infection
2. Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
3. Use of concomitant medications that may interfere with the pharmacokinetics of lopinavir/ritonavir

Primary outcomes:
measure: assess the level of lopinavir trough level >1 mg/L in low dose lopinavir (reduction by 70%)
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: HIV-NAT
Study officials:
affiliation: The HIV Netherlands Australia Thailand Research Collaboration
name: Kiat Ruxrungtham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klinklom A, Puthanakit T, Gorowara M, Phasomsap C, Kerr S, Sriheara C, Ananworanich J, Burger D, Ruxrungtham K, Pancharoen C. Low dose lopinavir/ritonavir tablet achieves adequate pharmacokinetic parameters in HIV-infected Thai adolescents. Antivir Ther. 2012;17(2):283-9. doi: 10.3851/IMP1958. Epub 2011 Nov 10.
Clinical trial NCT06073405: Colonic Polyp Size Measurement With Artificial Intelligence
Official title: MEasuring the Accuracy of an Artificial Intelligence Tool That Establishes Polyp Size in Real-time
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Polyp
Artificial Intelligence
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 225
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 aged 18 years or older undergoing colonoscopy

Brief summary: Primary objective of the study is to evaluate if the novel virtual polyp sizing tool accuracy in determining the size class of polyps among diminutive (0-5 mm), small (6-9 mm) and large (10 mm and above).


Eligibility criteria: Inclusion criteria:

* Patients aged 18 years or older undergoing colonoscopy
* Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation.

Exclusion criteria:

* Patients with known contra-indications to colonoscopy
* Patients who perform an emergency colonoscopy.

Primary outcomes:
measure: Accuracy for categorical distribution of polyp size
timeFrame: at study completion (this outcome is not an outcome measured from Time A to Time B but an outcome measured in one time point for all the colonoscopies performed in the study.
Secondary outcomes:
measure: Accuracy for continous determination of polyp size
timeFrame: at study completion (this outcome is not an outcome measured from Time A to Time B but an outcome measured in one time point for all the colonoscopies performed in the study.
Other outcomes:
Locations:
city: Ariccia
country: Italy
facility: Ospedale dei Castelli
state: Rome
Study officials:
References:
Clinical trial NCT06553105: Diagnosis and Clinical Presentation of Iliac Graft-Enteric Fistula: A Case Report
Official title: Department of Radiology, School of Medicine, 5th Azar Hospital, Gorgan, Golestan, Iran
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Case-report
Diagnosis
Digestive System Fistula
Gastrointestinal Hemorrhage
Iliac Graft-Enteric Fistula
Keywords: case-report; CT scan; Diagnosis; Digestive System Fistula; Gastrointestinal Hemorrhage; Iliac Graft-Enteric Fistula.
Lead sponsor: Golestan University of Medical sciences
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 1
Sex: MALE
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: one man

Brief summary: Abstract

Introduction:

Aorto-enteric fistula (AEF) is a life-threatening complication arising from abnormal connections between the gastrointestinal tract and major arteries. One uncommon type, iliac artery-enteric fistula (IEF), can occur following vascular interventions such as arterial stent-graft placement.

Case Presentation:

We report the case of a 47-year-old male presenting with hematemesis and abdominal pain, who was diagnosed with an iliac graft-enteric fistula. Timely recognition and management were crucial for a favorable outcome.

Clinical Discussion:

Diagnosing AEFs remains challenging, requiring a multidisciplinary approach and high clinical suspicion. While computed tomography angiography (CTA) is commonly used for diagnosis, its sensitivity may be limited, emphasizing the importance of integrating clinical history and findings. Management strategies vary based on etiology and patient status, with surgery being pivotal.

Conclusion:

Aorto-enteric fistula, which can arise from a thrombosed graft, presents diagnostic challenges due to its rare formation. In patients with a history of vascular interventions and gastrointestinal bleeding, AEF should be considered. This case underscores the need for heightened awareness among healthcare professionals regarding AEF diagnosis and management to reduce severe morbidity, mortality, and prolonged hospital stays.


Eligibility criteria: Inclusion Criteria:

n/a

Exclusion Criteria:

n/a

Primary outcomes:
measure: diagnosis of fistula by ct scan
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04270305: Study of Navigation Skills in Cerebral Palsy for Assessment and Rehabilitation in Immersive Virtual Reality
Official title: Study of Navigation Skills in Cerebral Palsy for Assessment and Rehabilitation in Immersive Virtual Reality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 48
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Spatial navigation refers to the ability to maintain a sense of direction/location while moving around the environment so to find one's way. It includes abilities such as orienting in complex environments,perceiving distance and planning routes to distant locations as well as mentally representing the reciprocal relations of landmarks in space (Lawton, 2010; Wolbers \& Hegarty 2010. Spatial navigation involves the precision in encoding multisensorial (visual, vestibular, proprioceptive)experiences, as well as to form mental representations to be used to guide behavior (Bianchini et al.,2014).

Cerebral Palsy (CP) is a neurodevelopmental disorder characterized by movement and posture disorders causing activity limitation. Impairment in many other functions is common in CP including visual spatial competences and spatial organization. In this study the investigators meant to explore the navigation and learning strategies in children with CP.


Eligibility criteria: Inclusion Criteria:.

* diagnosis of bilateral CP;
* age between 8 and 14 years old;
* severity of motor impairment classified in levels I, II and III, according to the Gross Motor Function Classification System (GMFCS) (Palisano et al., 1997)
* or according to the Manual Ability Classification System (MACS) (Eliasson et al., 2006);
* ability to follow instructions.

Exclusion Criteria:

* severe muscle spasticity and/or contracture,
* a diagnosis of severe learning disability,
* behavioral problems,
* visual or hearing difficulties that would affect the feasibility of proposed activities and/or compliance

Primary outcomes:
measure: The Corsi Block Test
timeFrame: 1 month
measure: The Labyrinth subtest of the WISC-III
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS Medea
state: LC
Study officials:
References:
Clinical trial NCT02537405: Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects
Official title: Randomized, Non-blinded, Two-way Crossover Study to Establish the Bioequivalence Between a Rivaroxaban Tablet 10 mg and a Rivaroxaban Granule 10 mg in Japanese Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Embolism, Atrial Fibrillation and Venous Thrombosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-09-01
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 10mg and rivaroxaban granule formulation 10mg, and to assess the safety and tolerability of rivaroxaban 10mg in healthy adult male subjects.


Eligibility criteria: Inclusion Criteria:

* Japanese healthy male subjects
* 20 to 40 years of age
* 17.6 to 26.4 kg / m² of body mass index (BMI)

Exclusion Criteria:

* Subject with incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Subject with a history of relevant diseases of vital organs, of the central nervous system or other organs, eg instable coronary heart disease, heart failure, liver failure, kidney failure, hypotension, or history of stroke or myocardial infarction
* Subject with known coagulation disorders (eg von Willebrand's disease, hemophilia)
* Subject with known disorders with increased bleeding risk (eg periodontosis, hemorrhoids, acute gastritis, peptic ulcer)
* Subject with known sensitivity to common causes of bleeding (eg nasal)

Primary outcomes:
measure: Cmax (maximum observed drug concentration in measured matrix after single dose administration)
timeFrame: Multiple time point up to 3 day
measure: AUC(0-tlast) (AUC from time 0 to the last data point > LLOQ (lower limit of quantitation))
timeFrame: Multiple time point up to 3 day
Secondary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Up to 30 day
Other outcomes:
Locations:
city: Kumamoto
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: