louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07007962: Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
Official title: A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Immune Thrombocytopenia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2025-06-06
Enrollment: 60
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: This is a multinational, open label, single arm study that will evaluate the impact of early multi-immune modulation with rilzabrutinib in adult ITP patients who failed first-line treatment. The study includes a screening period (up to 8 weeks), a primary analysis period (up to 28 weeks), a long-term extension period for selected participants (28 weeks) and a 24-week follow-up period only for eligible participants.


Eligibility criteria: Key Inclusion Criteria:

* Male or female participants aged 18 years and older with primary ITP
* Participant received at least a first line therapy and had a history of response while on treatment
* Participant has loss of response, relapse or steroid dependency

Key Exclusion Criteria:

* Participants with Secondary ITP
* Participants with Evans syndrome or history of myelodysplastic syndrome
* Participants with history of lymphoma, leukemia, or any malignancy within the past 5 years except for non-melanoma skin malignancy.
* Participants with history of solid organ transplant
* Participants with history of coagulation or bleeding disorders other than ITP
* Participant received advanced therapy for ITP or was splenectomized
* Pregnancy or nursing The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcomes:
measure: Durable platelet response
timeFrame: Until Week 28
Secondary outcomes:
measure: Overall platelet response
timeFrame: Until Week 28
measure: Duration of platelet response
timeFrame: Until Week 28
measure: Change from baseline in the immune thrombocytopenia bleeding scale (IBLS) score at the end of week 28
timeFrame: Until Week 28
measure: Percentage of participants able to discontinue or reduce CS dose by 50% or to <5 mg from baseline at the end of week 28
timeFrame: Until Week 28
measure: Frequency and severity of treatment emergent adverse events (TEAEs, including serious adverse events [SAEs], bleeding TEAEs, adverse event of special interest [AESI] and adverse events leading to discontinuation)
timeFrame: Until Week 80
measure: Percentage of participants with potential clinical significant abnormal (PCSA)
timeFrame: Until Week 80
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00264862: DynaCT Imaging in EVAR: Comparing Clinical Benefit of DynaCT to Multidetector CT as the Current Gold Standard.
Official title: Use of DynaCT in Endovascular Treatment of Abdominal Aortic Aneurysm. Evaluation of Image Quality.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2005-12-13
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate a new way to create CT-like images during intra-operative procedures. We want to prove that the quality and information received from DynaCT is satisfactory in implementing stent-graft in abdominal aortic aneurysm.

Detailed description: The study will compare images from the new modality (DynaCT) with the present modality (Multi detectorCT). We make three different set of images from each modality.

Eligibility criteria: Inclusion Criteria:

* Age over 65,
* Satisfactory renal function

Primary outcomes:
measure: Evidence og clinical benefit of new imaging functionality.
timeFrame: 3 days (pluss or minus 3 days).
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hosptial
Study officials:
affiliation: NTNU/St.Olavs Hospital
name: Kari R Eide, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan Normal University
name: Olav Haraldseth, PhD MD
role: STUDY_CHAIR
References:
citation: Eide KR, Odegard A, Myhre HO, Lydersen S, Hatlinghus S, Haraldseth O. DynaCT during EVAR--a comparison with multidetector CT. Eur J Vasc Endovasc Surg. 2009 Jan;37(1):23-30. doi: 10.1016/j.ejvs.2008.09.017. Epub 2008 Nov 17.
Clinical trial NCT00541762: Regulation of Fat-stimulated Neurotensin Secretion in Healthy Subjects
Official title: Mechanistic Study (Physiology)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Neurotensin
Human
Physiology of neurotensin
fat perfusion
healthy subjects
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2007-10-10
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Context: Cholecystokinin (CCK) and neurotensin are stimulated during meal intake by the presence of fat in the small intestine. The sequence of events suggests that fat hydrolysis is crucial for triggering the release.

Objectives: The aim of this study was therefore to investigate whether CCK mediated the effect of intraduodenal (ID) fat on neurotensin secretion via CCK-1 receptors.

Detailed description: Setting: Single center study; 34 male volunteers were studied in consecutive, randomized, double blind, crossover studies.

Subjects and Methods: CCK and neurotensin release were quantified in: 1) 12 subjects receiving an ID fat infusion with or without 60 mg orlistat, an irreversible inhibitor of gastrointestinal lipases, in comparison to vehicle. 2) 12 subjects receiving ID long chain fatty acids (LCF), ID medium chain fatty acids (MCF) or ID vehicle. 3) 10 subjects receiving ID LCF with and without the CCK-1 receptor antagonist dexloxiglumide (DEXLOX) or ID vehicle plus IV saline (placebo). Hormone concentrations were measured by specific RIA systems.

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects

Primary outcomes:
measure: Neurotensin plasma concentrations
timeFrame: Change in plasma cocnentrations over 2-3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Clinical Research Center, University Hospital
Study officials:
affiliation: University Hospital, 4031 Basel, Switzerland
name: Juergen Drewe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Research and Clinical Pharmacology, University Hospital, Basel Switzerland
name: Christoph Beglinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferris CF, Carraway RE, Hammer RA, Leeman SE. Release and degradation of neurotensin during perfusion of rat small intestine with lipid. Regul Pept. 1985 Oct;12(2):101-11. doi: 10.1016/0167-0115(85)90191-0.
Clinical trial NCT04444362: Protective Effect of Probacine Against Negative Gut Metabolism and Organ Dysfunction After Cardiovascular Surgery (PANDA IV)
Official title: Protective Effect of Probacine Against Negative Gut Metabolism and Organ Dysfunction After Cardiovascular Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cardiovascular Disease
Cardiopulmonary Bypass
Keywords: Gut microbiota
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Anzhen Hospital
name: Shanghai East Hospital of Tongji University
name: West China Hospital
name: The First Affiliated Hospital of Guangzhou Medical University
First posted: 2020-06-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cardiovascular diseases (CVDs) continue to be the primary cause of illness and death globally, emphasizing the pressing requirement for efficient prevention methods. Recent studies indicate that the gut microbiome plays a vital role in maintaining cardiovascular health, affecting the pathophysiological mechanisms related to CVDs. The potential therapeutic strategies for primary care practitioners included the modulation of the gut microbiome through dietary changes, prebiotics, and probiotics. The aim of this study was to investage the effect of gut microbiome modulation on clinical outcomes after cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Adult men and women;
* Cardiovascular surgery;
* Agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

* Pregnant women;
* Patients with preexisting psychotic disorders;
* Decline to participate in the study.

Primary outcomes:
measure: Systemic inflammatory response syndrome
timeFrame: 7 days after surgery
Secondary outcomes:
measure: ΔSOFA
timeFrame: 7 days after surgery
measure: 30-day mortality rate
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Shanghai
country: China
facility: Shanghai East Hospital, Tongji University
Study officials:
References:
Clinical trial NCT06396962: Survival and Prognostic Factors of Primary Retroperitoneal Sarcomas After Surgery: a Single-center Experience
Official title: Survival and Prognostic Factors of Primary Retroperitoneal Sarcomas After Surgery: a Single-center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Retroperitoneal Sarcoma
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (1) diagnosis of primary retroperitoneal sarcoma, (2) pathological conformity, (3) no prior surgical resection, (4) complete clinicopathological data, and (5) age of ≥18.

Brief summary: he percentage of retroperitoneal sarcomas (RPS) among all soft tissue sarcomas ranges from 10%-15%. Surgery remains the gold standard for RPS. In this study, we analyzed the impact of surgical treatment for primary RPS on recurrence and overall mortality at a Chinese institution and identified and evaluated prognostic variables.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria were as follows: (1) diagnosis of primary retroperitoneal sarcoma, (2) pathological conformity, (3) no prior surgical resection, (4) complete clinicopathological data, and (5) age of ≥18.

Exclusion Criteria:

* Patients with benign retroperitoneal tumors, gastrointestinal stromal tumors, Ewing, desmoid-type fibromatosis, pheochromocytomas/paragangliomas, or any other subtypes other than RPS were not included. The ethics committee of the Northern Jiangsu People's Hospital approved the study.

Primary outcomes:
measure: Overall survival
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT00788762: Myocilin Variations and Familial Glaucoma in Taxiarchis
Official title: Myocilin Variations and Familial Glaucoma in Taxiarchis, A Small Greek Village.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Keywords: glaucoma
myocilin
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2008-11-11
Enrollment: 840
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Villagers from Taxiarchis

Brief summary: Taxiarchis, a small village in Northern Greece with 1060 inhabitants, was considered to have a surprisingly high incidence of glaucoma. This isolated population located on Mount Holomondas appeared to be enriched for familial glaucoma. Based upon the high reported incidence of glaucoma in Taxiarchis and previous findings of the Thr377Met myocilin mutation in the Greek population,the investigators undertook a community-based study to determine if this variant was present in this village.


Eligibility criteria: Inclusion Criteria:

* Individuals born in Taxiarchis

Exclusion Criteria:

* Individuals that have not been born in Taxiarchis

Primary outcomes:
measure: Examining all of the villagers to determine the actual incidence of glaucoma in Taxiarchis and identify the Thr377Met myocilin mutation in glaucoma patients.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Polygyros
country: Greece
facility: Taxiarchis village
state: Halkidiki
Study officials:
affiliation: Glaucoma Unit, 1st University Dept
name: Anastasios G Konstas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00138255: Responses of Premature Infants to Measles-Mumps-Rubella (MMR) and Varicella Vaccines
Official title: MMR and Varicella Vaccine Responses in Extremely Premature Infants
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Measles
Mumps
Rubella
Varicella
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2005-08-30
Enrollment: 32
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to see if the MMR and chickenpox vaccines work as well in premature infants as in children that were carried to full term. A group of children who were carried full-term will be matched for age, sex, and race and will be used for comparison.

Detailed description: The purpose of this study is to see if the MMR and chickenpox vaccines work as well in premature infants as in children that were carried to full term. A group of children who were carried full-term will be matched for age, sex, and race and will be used for comparison. Extremely premature infants (born at \<28-30 weeks gestation) have lower antibody responses than full-term infants to several vaccines given at the postnatal ages recommended for full term infants. We propose to evaluate the immunogenicity of varicella and mumps-measles-rubella (MMR) vaccines in relatively healthy 15 month-old children born at \<29 weeks gestation. This is a phase IV, observational study with 2 study arms having 16 infants each. The first group will enroll infants 9-12 months old that were born premature (\<29 weeks gestation). The second group will be matched for sex, race, and postnatal age, but will have been full term (\>= 37 weeks gestation) at birth. Infants will be vaccinated at visit 1 and post-vaccine serology will drawn at visit 2 (4 to 6 weeks after visit 1).

Eligibility criteria: Inclusion Criteria:

1. Premature infant \< 29 weeks gestation at birth or term infant \>= 37 weeks gestation at birth.
2. Postnatal age \< 16 months, 0 days.
3. Has not yet received MMR or varicella vaccines. (There are no restrictions on the administration of other vaccines at the time of MMR/varicella vaccination.)
4. Parental permission.
5. Agreement of primary care pediatrician/ health care provider.
6. Receives primary pediatric care within an approximate 25-mile radius of the University of Rochester.
7. Healthy status at enrollment.

Exclusion Criteria:

1. Known immunodeficiency.
2. Systemic corticosteroid therapy at the time of MMR/varicella vaccination.
3. Requiring oxygen therapy.
4. Clinically significant findings on review of medical history and physical exam determined by the investigator or sub-investigator to be sufficient for exclusion.
5. Any condition determined by the investigator that would interfere with the evaluation of the vaccine or be a potential health risk to the subject.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester School of Medicine and Dentistry
state: New York
Study officials:
References:
Clinical trial NCT04022655: Predictors of Mortality in Patients With Autoimmune Diseases Admitted to the Intensive Care Unit
Official title: Predictors of Mortality in Patients With Autoimmune Diseases Admitted to the Intensive Care Unit - Retrospective Analysis at a Single Tertiary Care Center
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vasculitis
Systemic Lupus Erythematosus
Myositis
Keywords: Intensive Care Unit
Mortality
Autoimmune Diseases
Lead sponsor: University of Göttingen
Sponsor class: OTHER
Collaborators: name: University Medical Center Goettingen
First posted: 2019-07-17
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with systemic autoimmune diseases admitted to the ICU at the University Medical Center Göttingen

Brief summary: Autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, myositis, or anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, may affect multiple organ systems. Occasionally, patients deteriorate acutely requiring advanced care in an intensive care unit (ICU). In an ICU setting, mortality is estimated with scoring systems, such as APACHE or SAPSII. Since there are limited data available on their use in autoimmune diseases, with the current study, we aim to assess the usefulness of these ICU scores and analyze predictors of mortality in this particular group of patients.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the ICU at the University Medical Center Göttingen

Exclusion Criteria:

* Patients with incomplete or missing data

Primary outcomes:
measure: In-hospital mortality
timeFrame: From date of admission to the ICU until the date of death from any cause assessed up to 52 weeks
Secondary outcomes:
measure: Risk of renal replacement therapy
timeFrame: From date of admission to the ICU until the date of event assessed up to 52 weeks
measure: Need for catecholamines
timeFrame: From date of admission to the ICU until the date of event assessed up to 52 weeks
measure: Need for ventilation
timeFrame: From date of admission to the ICU until the date of event assessed up to 52 weeks
measure: Need for cardiopulmonary resuscitation
timeFrame: From date of admission to the ICU until the date of event assessed up to 52 weeks
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medical Center Göttingen
Study officials:
affiliation: University Medical Center Göttingen
name: Peter Korsten, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04216355: Low-dose AZA Combined With Short Term CAG Derived Regimen as a Bridging Treatment in Patients With Advanced MDS Prior to Allo-HSCT
Official title: The Feasibility of a Bridging Treatment With Low-dose Azacitidine (AZA) in Combination With Short Term CAG Derived Regimen Prior to Allogeneic Stem Cell Transplantation (Allo-HSCT) in Patients With Advanced Myelodysplastic Syndromes (MDS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: MDS-EB
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 20
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm, prospective study on the feasibility of a bridging treatment with low-dose azacitidine (AZA) in combination with short term CAG derived regimen prior to allogeneic stem cell transplantation (allo-HSCT) in patients with advanced myelodysplastic syndromes (MDS) .


Eligibility criteria: Inclusion Criteria:

* New Diagnosed advanced myelodysplastic syndrome (MDS) for whom an allogeneic hematopoietic stem cell transplant is planned
* Recipient of an allogeneic hematopoietic stem cell transplantation
* Age \< 65 years
* ECOG performance status ≤2
* Written informed consent
* No psychological, familial, social, or geographic reason that would compromise clinical follow up

Exclusion Criteria:

* Relapsed or refractory advanced MDS
* Severe pshyciatric or organic disorder, supposed to be independent from advanced MDS, that would contraindicate treatment
* Known allergic or hypersensitivity to azacitidine, aclarubicin or cytarabine or to any of the test compounds, materials
* Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk
* A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications

Primary outcomes:
measure: Mean Time to Engraftment
timeFrame: Baseline to engraftment, assessed minimally 28 days post transplant
Secondary outcomes:
measure: Cumulative Incidence of Graft-versus Host Disease
timeFrame: Up to 2 years
measure: Incidence of systemic infections
timeFrame: Up to 2 years
measure: Overall survival
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References: