louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05724407: Molecular Signature for Breast Cancer
Official title: Evaluation of the Use of a Diagnostic Assistance Tool of Prognostic and Predictive Marker Scoring System in Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female breast cancer patient

Brief summary: The main objective of this study is to evaluate and compare the diagnostic performance of a diagnostic assistance tool for analysis of 5 prognostic and predictive markers of breast cancer (HER2, Ki67 Index, Mitoses, Estrogen Hormone Receptor, Hormone Progesteron receptors hormone of Progesteronereceptor) integrating an automatic analysis algorithm compared to a reference (gold standard defined as the rereading by at least two different anatomopathologists according to the standard method of care) in order to show the non-inferiority of the automatic analysis algorithm compared to this gold standard.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Understanding French
* With symptoms of breast cancer that required a biopsy (microbiopsy or macrobiopsy or surgical biopsy) and pathological examination diagnosing breast cancer
* First diagnosis of invasive breast cancercarcinoma
* Affiliated to a social security system
* Agreeing to participate in the study

Exclusion Criteria:

* Refusal to participate in the study
* Not affiliated to the social security system
* Minor or under legal protection
* Patient with a history of breast cancer
* Patient previously treated for breast cancer
* Patient who has relapsed from breast cancer treatment
* Non ductal or non lobular invasive breast cancer carcinoma

Primary outcomes:
measure: Diagnostic performances
timeFrame: at inclusion
Secondary outcomes:
measure: Duration of procedure
timeFrame: at inclusion
measure: Cognitive savings
timeFrame: at inclusion
measure: General comfort of use
timeFrame: at inclusion
measure: Organizational constraints
timeFrame: at inclusion
measure: inter-rater agreement
timeFrame: at inclusion
measure: Diagnostic performances
timeFrame: at inclusion
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06499207: Advanced Coronary Plaque Morphology Assessment Using Photon-counting Detection and Invasive Coronary Imaging
Official title: Advanced Coronary Plaque Morphology Assessment Using Photon-counting Detection and Invasive Coronary Imaging
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Coronary Disease
PCI
Stent Restenosis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial aims to compare non-invasive photon-counting detector computed tomography (PCD-CT) with invasive intravascular imaging (IVI) for post-interventional follow-up in patients with coronary artery disease (CAD).

Participants will undergo post-interventional follow-up using both PCD-CT and coronary angiography with IVI. Researchers will test qualitative and quantitative PCD-CT results for non-inferiority to IVI regarding stent evaluation and detection of in-stent restenosis and plaque morphology.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* DES in proximal coronary vessel segments

Exclusion Criteria:

- Any conditions that may interfere with the safety or efficacy of CCTA

Primary outcomes:
measure: Quantitative comparison of PCD-CT and IVI in stent evaluation
timeFrame: Within 1 year
measure: Qualitative comparison of PCD-CT and IVI in stent evaluation
timeFrame: Within 1 year
Secondary outcomes:
measure: Quantitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis
timeFrame: Within 1 year
measure: Quantitative comparison of PCD-CT and IVI for the evaluation of plaque morphology
timeFrame: Within 1 year
measure: Qualitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis and plaque morphology
timeFrame: Within 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03325907: Transthoracic Needle Biopsy Using 3D Printed Navigational Template: A Phase I Feasibility Trial
Official title: Transthoracic Needle Biopsy for the Diagnosis of Pulmonary Nodule Using Three-dimensional Printed Navigational Template: A Phase I Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasms
Keywords: Biopsy, Needle
Printing, Three-Dimensional
Image-Guided Biopsy
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-armed feasibility trial
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study evaluates the feasibility of three-dimensional printed template in transthoracic pulmonary nodule biospy. Investigator planned to include 20 patients with lung nodule biopsy schedule to receive template-guided transthoracic needle aspiration.

Detailed description: In previous study,a navigational template has been created to simplify the procedure of preoperative lung nodule localization. It was reported that localizer deviation was 10(0-20)mm.In this trial,Investigator explores the utility of this navigational template in transthoracic lung nodule biopsy.

Eligibility criteria: Inclusion Criteria:

CT confirmed peripheral lung nodule; Nodule size larger than or equal to 3 cm; ECOG Performance Status 0-2 ; Informed consent.

Exclusion Criteria:

Nodule located in the scapula region wherein biopsy needle is impeded; Nodule within 3 cm above diaphragmatic dome.

Primary outcomes:
measure: Success rate of needle insertion
timeFrame: 15 minutes
Secondary outcomes:
measure: procedural length
timeFrame: 1 hour
measure: radiation dosage
timeFrame: 1 hour
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Chang Chen, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang L, Li M, Li Z, Kedeer X, Wang L, Fan Z, Chen C. Three-dimensional printing of navigational template in localization of pulmonary nodule: A pilot study. J Thorac Cardiovasc Surg. 2017 Dec;154(6):2113-2119.e7. doi: 10.1016/j.jtcvs.2017.08.065. Epub 2017 Sep 1.
citation: E H, Chen J, Sun W, Zhang Y, Ren S, Shi J, Wen Y, Su C, Ni J, Zhang L, He Y, Chen B, Casal RF, Kheir F, Ishiwata T, Zhang J, Zhao D, Chen C. Three-dimensionally printed navigational template: a promising guiding approach for lung biopsy. Transl Lung Cancer Res. 2022 Mar;11(3):393-403. doi: 10.21037/tlcr-22-172.
Clinical trial NCT01317407: Automated Visual Monitoring for Improving Patient Safety (VIPSafe)
Official title: Automatisierte Optische Überwachung Mittels Videosensorik Zur Verbesserung Der Patientensicherheit Auf Intensivstation (Automated Visual Monitoring for Improving Patient Safety (VIPSafe))
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Confusion
Keywords: postoperative delirium
Lead sponsor: Staedtisches Klinikum Karlsruhe
Sponsor class: OTHER
Collaborators: name: Karlsruhe Institute of Technology
First posted: 2011-03-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a planned or not-planned stay at the intensive care unit after an operation

Brief summary: After an operation many patients are in a confused mental status at the intensive care unit. In this status they possibly fall out of their bed or pull out endotracheal tubes or central venous catheters accidentally. For this, they need permanently monitoring and control through intensive care personnel.

The goal of the VIPSafe project is to develop robust techniques for automated patient monitoring, that rely on data from a small number of untethered sensors, which are nonetheless flexible enough to cope with a large variety of demands.


Eligibility criteria: Inclusion Criteria:

* patients with planned postoperative stay at intensive care unit after previous written consent to the study
* patients with not-planned postoperative stay at intensive care unit with written consent after admission to intensive care unit
* patients unfit to plead with admission to intensive care unit with written consent of the officially appointed agent

Exclusion Criteria:

* absent written consent
* age \< 18 years old

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Karlsruhe
country: Germany
facility: Klinik für Anästhesie und Intensivmedizin, Städtisches Klinikum Karlsruhe
Study officials:
References:
Clinical trial NCT06026007: Efficacy of Acupressure Versus Traditional Treatment on Reducing Ankle Edema During Pregnancy
Official title: Efficacy of Acupressure Versus Traditional Treatment on Reducing Ankle Edema During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Edema
Keywords: Edema Leg
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sixty pregnant women aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will participate in this study. They will be assigned into three equal groups, Group A will receive only traditional physical therapy protocol in the form of advice including elevation, wearing supportive stocking, and avoiding standing in one position for extended periods, and Group B will receive the same traditional treatment as group A in addition to circulatory exercises, 3times per week for 4 weeks; while Group C will receive the same conventional physical therapy protocol in addition to foot acupressure 3times per week for 4 weeks.
Primary purpose: TREATMENT

Brief summary: Incidence of ankle edema is high during pregnancy, If left untreated, it may lead to difficulty walking; stiffness; stretched skin which can become itchy and uncomfortable. Acupressure promotes the condition of the circulatory and lymphatic system leading to the elimination of edema. The aim of this study is to investigate the efficacy of acupressure versus traditional physical therapy treatment on ankle edema during pregnancy.

Detailed description: Sixty pregnant women aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will participate in this study. They will be assigned into three equal groups, Group A will receive only traditional physical therapy protocol in the form of advice including elevation, wearing supportive stocking, and avoiding standing in one position for extended periods, and Group B will receive the same traditional treatment as group A in addition to circulatory exercises, 3times per week for 4 weeks; while Group C will receive the same conventional physical therapy protocol in addition to foot acupressure 3times per week for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* pregnant women in their third trimester,
* age ranged from 25-35 years and
* BMI was ≥30Kg/m2.

Exclusion Criteria:

* Pregnant women with skin diseases
* irremovable bracelet,
* decreased functional active range of motion in the affected lower extremity
* any mental or physical disorders.

Primary outcomes:
measure: change in foot and ankle edema during pregnancy
timeFrame: Before starting study and after four weeks of intervention
Secondary outcomes:
measure: level of swelling
timeFrame: Before starting study and after 4 weeks of intervention
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: faculty of physical therapy Cairo university
Study officials:
affiliation: BUC
name: noha abd el rhaman, doctoral
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06800807: Metacognitive Beliefs in Adolescents With Eating and Nutrition Disorders
Official title: Metacognitive Beliefs and Eating and Nutrition Disorders in Adolescents With Eating and Nutrition Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Feeding and Eating Disorders
Keywords: metabeliefs
metacognition
brooding
rumination
anorexia nervosa
bulimia nervosa
binge eating disorder
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 72
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 36 patients aged between 12 and 17 years, females, of Italian nationality, who present a diagnosis relating to the END framework according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

These patients will be compared with a control group made up of 36 subjects of the same sex, age, and nationality, belonging to the general population.

Brief summary: The present study aims to study the presence of metacognitive beliefs in adolescent subjects with eating and nutrition disorders (END) compared with a control group composed of subjects of the same sex and age belonging to the general population.


Eligibility criteria: Eating and nutrition disorders (END)

Inclusion Criteria:

* Female sex
* Age: 12 to 17 years
* Italian nationality
* Diagnosis relating to the END framework according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

Exclusion Criteria:

* Absence of signed Informed Consent

Control group

Inclusion Criteria:

* Female sex
* Age: 12 to 17 years
* Italian nationality

Exclusion Criteria:

* Absence of signed Informed Consent

Primary outcomes:
measure: Metacognitive beliefs
timeFrame: Baseline
measure: Brooding
timeFrame: Baseline
measure: Rumination
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Oggebbio
country: Italy
facility: Istituto Auxologico Italiano IRCCS, Site Piancavallo
state: Verbania
Study officials:
References:
Clinical trial NCT03431207: Behavioral Dynamics Between Infants With Visual Loss and Healthy Controls
Official title: Comparison of the Behavioral Dynamics Between Visually Impaired Infants and Healthy Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Behavioral Dynamics
Visual Impairment
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 4196
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators focused on thousands of human infants who suffered varying degrees of visual stimuli deficiency in early stages, while their behavioral systems remained sensitive and thus retained high behavioral plasticity. Having access to this unique population provides an unprecedented opportunity to investigate the effect of diverse visual conditions on the behavioral system.

Brief summary: An individual senses the world and reflects feedbacks via independent behaviors. Such precise collaboration of the sensory and behavioral systems is fundamental to survival and evolution. When a sensory modality is altered, the behavioral system has the potential to fit in a substitute modality. However, the specific dynamics of human behaviors in response to sensory loss remain largely unknown due to the paucities of representative situations and large-scale samples.

Here, the investigators focused on thousands of human infants who suffered varying degrees of visual stimuli deficiency in early stages, while their behavioral systems remained sensitive and thus retained high behavioral plasticity. Having access to this unique population provides an unprecedented opportunity to investigate the effect of diverse visual conditions on the behavioral system.


Eligibility criteria: Inclusion Criteria:

* Younger than 3 years of age

Exclusion Criteria:

* Any brain and mental illnesses, or other known illnesses that may affect the behavioral patterns

Primary outcomes:
measure: Behavioral dynamics
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
name: Yizhi Liu, Ph.D
role: STUDY_CHAIR
References:
citation: Long E, Lin Z, Chen J, Liu Z, Cao Q, Lin H, Chen W, Liu Y. Monitoring and Morphologic Classification of Pediatric Cataract Using Slit-Lamp-Adapted Photography. Transl Vis Sci Technol. 2017 Nov 2;6(6):2. doi: 10.1167/tvst.6.6.2. eCollection 2017 Nov.
citation: Japyassu HF, Malange J. Plasticity, stereotypy, intra-individual variability and personality: handle with care. Behav Processes. 2014 Nov;109 Pt A:40-7. doi: 10.1016/j.beproc.2014.09.016. Epub 2014 Sep 18.
Clinical trial NCT05455307: Efficacy and Safety of Allium Ureteral Stent for Treating Refractory Ureteral Stricture
Official title: Efficacy and Safety of Self-expanding Ureteral Stent for Treating Refractory Ureteral Stricture: Results of a Multicenter Experience
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ureteral Stenosis
Hydronephrosis
Ureteral Stent Occlusion
Keywords: ureteral stone
ureteral stricture
hydronephrosis
Lead sponsor: En Chu Kong Hospital
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single group without control
Primary purpose: TREATMENT

Brief summary: To conduct a prospective, multi-center study to observe the long-term efficacy and safety of self expanding ureteral stent for treating participants with refractory ureteral stricture.

Detailed description: The aim of the study is to conduct a prospective, multi-center study to observe the long-term efficacy and safety of self expanding ureteral stent for treating participants with refractory ureteral stricture.

About 200 participants with refractory ureteral stricture will be enrolled in four hospitals. After the allium ureteral stents are placed, renal function, renal echo, images and associated complications will be recorded.

Eligibility criteria: Inclusion Criteria:

* refractory ureteral stricture after at least two times of ureteral dilation

Exclusion Criteria:

* poor cardiovascular function for anesthesia unwilling to accept the long-term placement of ureteral stent uncontrolled urinary tract infection

Primary outcomes:
measure: Renal function test
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months
Secondary outcomes:
measure: Complications
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months
measure: Renal structure
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: En Chu Kong Hospital
Study officials:
affiliation: En Chu Kong Hospital
name: Chung Cheng Wang, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Avitan O, Bahouth Z, Shprits S, Gorenberg M, Halachmi S. Allium Ureteral Stent as a Treatment for Ureteral Stricture: Results and Concerns. Urol Int. 2022;106(5):482-486. doi: 10.1159/000522174. Epub 2022 Mar 1.
citation: Sampogna G, Grasso A, Montanari E. Expandable metallic ureteral stent: indications and results. Minerva Urol Nefrol. 2018 Jun;70(3):275-285. doi: 10.23736/S0393-2249.18.03035-7. Epub 2018 Mar 28.
Clinical trial NCT06110507: Chronic Anergic-anhedonic Depression Open Trial
Official title: Chronic Anergic-anhedonic Depression Open Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depressive Disorder, Treatment-Resistant
Keywords: Depressive Disorder
Treatment-Resistant
Anergic-anhednic
TRD
TRAD
MAOI
dopamine D2 receptor agonists
D2RAG
dopamine-sensitive
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major patient (≥18 years old) covered for consultation at the Expert Resistant Depression Center of Alsace (CEDRA) (CHU-Strasbourg branch) for TRAD between 01 January 2013 and 31 March 2023

Brief summary: A form of depression called 'dopamine-sensitive anergic-anhedonic syndrome is usually resistant to standard therapies (TRAD). On the other hand, they respond to dopaminergic approaches for which recommendations have been developed: DATA ('Dopaminergic Antidepressant Therapy Algorithm'). These are two stages starting with non-selective monoamineoxidase inhibitors (MAOI) or dopamine D2 receptor agonists (D2RAG) in 'monotherapy' (DATA1) and proposing to combine them in the event of a partial response (DATA2).

The effectiveness of this approach in the management of TRAD has not yet been evaluated in routine care.

The aim of this study is to evaluate the feasibility and effectiveness in routine care of the DATA recommendations in the management of TRAD presenting to a specialized consultation for resistant depression (short and long-term results).


Eligibility criteria: Inclusion Criteria:

* Major patient (≥18 years old)
* Man or woman
* Patient covered for consultation at the Expert Resistant Depression Center of Alsace (CEDRA) (CHU-Strasbourg branch) for TRAD between 01 January 2013 and 31 March 2023
* Patient not opposing to the reuse of their data for the purposes of this research

Exclusion Criteria:

* Patient having expressed opposition to participating in the study
* Patient under judicial protection
* Patient under guardianship or curatorship

Primary outcomes:
measure: Proportion of patients in remission; Remission time; Survival curves for remissions and responses
timeFrame: 3 months after the patient was taken care of at the Strasbourg University Hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: CENTRE DE NEUROMODULATION NON INVASIVE DE STRASBOURG (CEMNIS) - CHU de Strasbourg - France
Study officials:
References: