louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04895878: Patients With Co-occurrence of ANCA Vasculitis and Sjögren Syndrome
Official title: Patients With Co-occurrence of ANCA Vasculitis and Sjögren Syndrome : a Case Series and Systematic Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ANCA Associated Vasculitis
Sjogren's Syndrome
Keywords: Overlap syndrom
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated in internal medicine services in secondary care centers of Languedoc-Roussillon region.

Brief summary: ANCA vasculitis and Sjögren syndrome are two rare diseases, and even more rarely associated. These two conditions have specific organ involvements, and specific follow-up.

The Investigators hypothesise that patients with co-occurrence of these two diseases may have a singular clinical course.


Eligibility criteria: Inclusion criteria:

* Diagnosis of ANCA vasculitis based on clinical, immunological and histopathological features.
* Diagnosis of Sjögren syndrom based on ACR/EULAR 2016 criteria.

Exclusion criteria:

* Age \< 18 years
* Insuffisant data during follow-up

Primary outcomes:
measure: Severity of Sjögren disease
timeFrame: day 1 (Upon diagnosis)
Secondary outcomes:
measure: Sjögren extra-glandular complications
timeFrame: day 1 (Upon diagnosis)
measure: severity of ANCA vasculitis
timeFrame: day 1 (Upon diagnosis)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Philippe GUILPAIN, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Guellec D, Cornec-Le Gall E, Groh M, Hachulla E, Karras A, Charles P, Dunogue B, Abad S, Alvarez F, Gerard F, Devauchelle-Pensec V, Pers JO, Puechal X, Guillevin L, Saraux A, Cornec D; CRI (Club Rhumatismes et Inflammation) and the French Vasculitis Study Group. ANCA-associated vasculitis in patients with primary Sjogren's syndrome: detailed analysis of 7 new cases and systematic literature review. Autoimmun Rev. 2015 Aug;14(8):742-50. doi: 10.1016/j.autrev.2015.04.009. Epub 2015 Apr 24.
citation: Lee SB, Choi H, Kim MK, Jung SM, Song JJ, Park YB, Lee SW. Can antineutrophil cytoplasmic antibody positivity at diagnosis predict the poor outcomes of Sjogren's syndrome? Rheumatol Int. 2020 Jul;40(7):1063-1070. doi: 10.1007/s00296-019-04476-5. Epub 2019 Nov 12.
citation: Ramos-Casals M, Brito-Zeron P, Font J. The overlap of Sjogren's syndrome with other systemic autoimmune diseases. Semin Arthritis Rheum. 2007 Feb;36(4):246-55. doi: 10.1016/j.semarthrit.2006.08.007. Epub 2006 Sep 22.
Clinical trial NCT01882478: Cryotherapy -BEATS-RF Ablation Trial
Official title: CryoSpray Ablation for Barrett's Esophagus After Treatment Failure With Serial RadioFrequency Ablation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett's Esophagus With Persistent Dysplasia or
Early Esophageal Adenocarcinoma Post Radio Frequency Ablation
Keywords: Barrett's esophagus
Early esophageal adenocarcinoma
Radio Frequency Ablation
Cryotherapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-06-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with persistent BE with HGD or IMCA despite 2 or more serial RF ablation treatment sessions in a cohort of patients undergoing endoscopic therapy.

Brief summary: The purpose of this study is to determine whether cryotherapy is effective in the treatment of persistent high grade dysplasia (HGD) or early esophageal adenocarcinoma (IMCA) in patients who have not responded to radiofrequency ablation (RFA).


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Able to provide informed consent
* Patients with unifocal or multifocal BE with HGD or IMCA who have failed at least 2 serial RFA therapy.
* Patients who refused esophagectomy or deemed inoperable or whose BE dysplasia is not amenable to endoscopic mucosal resection (EMR) treatment alone due to: (1) extensive multifocal lesions (2) severe coagulopathy or any medical condition deemed high risk for EMR (3) patient refuses EMR
* Patients with a nodular BE lesions may undergo clinically-indicated EMR and still be eligible for enrollment as long as they have BE-HGD lesion/s that are still candidate for ablative treatment

Exclusion Criteria:

* Age younger than 18 years old
* Life expectancy less than 12 months
* Pregnancy
* Presence of esophageal varices
* Esophageal stricture precluding passage of an endoscope and suction tubing
* Any procedure that has impeded normal gastric emptying or limited gastric volume distention, including but not limited to gastric bypass, stomach stapling, gastrojejunostomy or any disease state has significantly reduced the elasticity in the GI tract (e.g. Marfan's syndrome, Scleroderma or any Connective Tissue Disease)
* Esophageal cancer (T2 and above)

Primary outcomes:
measure: Response
timeFrame: 2 years
Secondary outcomes:
measure: Predictors of response
timeFrame: 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kenneth K Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06414278: Evaluation of Early Identification of Cognitive Side Effects of Immunotherapy
Official title: Early Identification of Cognitive Side-Effects of Immunotherapy
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-05-16
Enrollment: 38
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 planning to undergo CAR-T therapy for primary malignancy recruited through the University of Minnesota.

Brief summary: This clinical trial evaluates the use of a tool kit, Stress, Affect, Language and Speech Analysis (SALSA), for early identification of cognitive side effects of immunotherapy compared to the standard of care assessment.

Detailed description: PRIMARY OBJECTIVES:

I. To investigate the use of a toolkit for automated administration and scoring of cognitive tests (Stress, Language and Speech Analysis, or SALSA) in adult cancer patients who are treated with commercial chimeric antigen receptor T cell therapy (CAR-T) products at University of Minnesota and are at risk of developing immune effector cell-associated neurotoxicity syndrome (ICANS).

OUTLINE: This is an observational study.

Patients complete SALSA assessment and ICE assessments on study. Patients also have their medical records reviewed on study.

Eligibility criteria: Inclusion Criteria:

* \* ≥ 18 years of age at initiation of therapy

  * Planning to undergo inpatient CAR-T therapy for primary malignancy
  * Fluent in English (written or spoken)

Exclusion Criteria:

* \* Subjects with speech or hearing impediment that would make them unable to be assessed with SALSA

  * Subjects with diagnosed cognitive impairment prior to CAR-T therapy
  * Unwilling or unable to sign voluntary written consent

Primary outcomes:
measure: Proportion of patients completing at least 80 percent of planned SALSA administrations during post CAR-T hospitalization
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota/Masonic Cancer Center
state: Minnesota
Study officials:
affiliation: University of Minnesota Masonic Cancer Center
name: Veronika Bachanova
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02332278: Early Oral Feeding Versus Traditional Postoperative Care After Cesarean Section.
Official title: Early Oral Feeding Versus Traditional Postoperative Care After Uncomplicated Cesarean Section. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications; Cesarean Section
Keywords: Cesarean section
Early feeding
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 444
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine the effect in the post operative period of early feeding (4 hours after surgery) vs. traditional management (feeding 12 hours after surgery) in uncomplicated cesarean section.


Eligibility criteria: Inclusion Criteria:

* Cesarean section with regional anesthesia, regardless of gestational age.

Exclusion Criteria:

* Use of magnesium sulphate
* General anesthesia
* Pre gestational or gestational diabetes
* Bowel injury during surgery

Primary outcomes:
measure: Adynamic ileus
timeFrame: 72 hours
Secondary outcomes:
measure: Post operative pain
timeFrame: 72 hours
measure: Satisfaction
timeFrame: 72 hours
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas H
Study officials:
affiliation: Saint Thomas Hospital, Panama
name: Ana Lia Becerra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Thomas Hospital, Panama
name: Osvaldo Reyes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01066078: Echocardiography and Peak Endocardial Acceleration (PEA) Measurements in Cardiac Resynchronization Therapy (CRT)
Official title: Echocardiography and PEA Measurements in CRT Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure
Keywords: heart failure - congestive
Cardiovascular imaging agents/Techniques]
Echocardiography
Other diagnostic testing
Other Treatment
Recipients of cardiac resynchronization therapy systems
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2010-02-10
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CRT recipients

Brief summary: This study used an external endocardial acceleration sensor (sonR sensor), placed on the patient's chest, to time the closure of aortic and mitral valves, and compared its performance with echocardiography.


Eligibility criteria: Inclusion Criteria:

* Every patient coming in the participating centers for an echocardiographic exam and implanted with a pacemaker or an implantable cardioverter defibrillator (ICD) can be included in the study.

Exclusion Criteria:

* Inability to understand the patient information sheet.
* Minor patient or pregnant woman.

Primary outcomes:
measure: The timings of mitral (tMC) and aortic (tAC) valves closure by echocardiography and sonR
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Paris
country: France
facility: Clinique Bizet
city: Rennes
country: France
facility: CHU Pontchaillou
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: CHU Rennes
name: Erwan DONAL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01366378: Effect of Cimetidine on the Single-Dose PK of IV- Administered MNTX
Official title: A Phase 1, Open-Label, Study of the Effect of Cimetidine, a Known Inhibitor of Active Renal Secretion, on the Single-Dose Pharmacokinetics of Intravenously-Administered Methylnaltrexone in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Subjects
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label study assesses the single-dose pharmacokinetics of intravenously-administered MNTX in healthy adult male and female subjects in the absence of, and in the presence of, orally-administered cimetidine.


Eligibility criteria: Inclusion Criteria:

1. Healthy males and females between the ages of 18 and 45
2. Subjects who are non-smokers
3. Subjects with body weights with range of 154-220 lbs.

Exclusion Criteria:

1. Females who are pregnant or lactating
2. Subjects with a history of any clinically significant disease or condition affecting a major organ system
3. Subjects with ECG abnormalities
4. Subjects who have tested positive for hepatitis B, hepatitis C or HIV
5. Subjects who have had a diagnosis of alcohol or substance dependence with the past 12 months
6. Subjects with positive urine results for drugs of abuse.

Primary outcomes:
measure: Peak plasma concentration (Cmax) of MNTX prior to and following multi-dose cimetidine regimen
timeFrame: 7 days
Secondary outcomes:
measure: Area under the plasma concentration (AUC) of MNTX prior to and following a multi-dose cimetidine regimen
timeFrame: 7 days
measure: Half-life of MNTX prior to and following a multi-dose cimetidine regimen
timeFrame: 7 days
measure: Clearance (both total and renal)of MNTX prior to and following a multi-dose cimetidine regimen
timeFrame: 7 days
measure: Volume of distribution of MNTX prior to and following a multi-dose cimetidine regimen
timeFrame: 7 days
measure: Number of subject with adverse events as measured before, during, and after administration of cimetidine
timeFrame: 7 days
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals, Inc.
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Tage Ramakrishna, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00204178: The Role of Reactive Oxygen Species in Ischaemia-Reperfusion Injury of the Transplanted Kidney
Official title: The Role of Reactive Oxygen Species in Ischaemia-Reperfusion Injury of the Transplanted Kidney
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Transplantation
Keywords: Kidney transplantation
Reperfusion injury
Lead sponsor: Uniwersytet Mikolaja Kopernika w Toruniu
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Measurement of reactive oxygen species production and antioxidant system status before and directly after reperfusion of the transplanted kidney and influence of oxidant stress on kidney function in 2 and 6 weeks.

Detailed description: Oxidative stress is one of the most important factors in ischaemia-reperfusion injury to the transplanted organ. In kidney transplant recipients following factors were measured: glutathione level, activities of glutathione peroxidase (GSH-PX), catalase (CAT) and superoxide dismutase (SOD) and superoxide anion production by granulocytes in whole blood without and after the stimulation with zymosan.

Blood was sampled from peripheral vein (before reperfusion) and directly from renal vein (5 and 15 minutes after reperfusion).

Transplanted kidney function was evaluated by the incidence and length of Delayed Graft Function and serum creatinine level in 2 and 6 weeks after transplantation.

Eligibility criteria: Inclusion Criteria:

* consecutive patients accepted for and undergoing cadaveric kidney transplantation

Exclusion Criteria:

* no informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Klinika Transplantologii, Szpital Uniwersytecki, ul. M. Sklodowskiej-Curie 9
Study officials:
affiliation: Klinika Transplantologii Collegium Medicum UMK w Toruniu
name: Zbigniew Wlodarczyk, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01067378: Peer Debriefing Versus Instructor Debriefing for Interprofessional Simulation Based Education
Official title: Peer Debriefing Versus Instructor Debriefing for Interprofessional Simulation Based Education (PICS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crisis Resource Management
Keywords: Interdisciplinary Health Team
Training
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2010-02-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Crisis management is important for operating room practice and non-technical skills are acknowledged as key to ensure patient safety in these situations. Unfortunately, it can be difficult to find instructors with appropriate experience. A peer-led team debriefing is led by the team it self rather than an external expert instructor but remains a reflective process. Incorporating peer-led debriefing compared to expert-led debriefing may increase access to an interprofessional crisis resource management course using simulation.

The goals of the study are to observe the effect of an interprofessional peer-led team debriefing in the change in performance of non-technical skills of team performance and to compare it with the "gold standard" of expert-led debriefing on the performance of non-technical skills during a simulated operating room crisis.

The investigators hypothesize that interprofessional peer-led debriefing will improve the performance of non-technical skills of the team during simulated intraoperative crisis management and that this improvement will be equivalent to the "gold standard" expert-led debriefing.


Eligibility criteria: Inclusion Criteria:

* Operating room (OR) nurses from St. Michael's Hospital and University of Toronto Anesthesia and Surgery Residents/Fellows

Exclusion Criteria:

* OR nurses from other hospitals and Residents/Fellows from other programs

Primary outcomes:
measure: Performance of non-technical skills of the teams.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Allan Waters' Family Patient Simulation Centre
state: Ontario
Study officials:
References:
citation: Boet S, Bould MD, Sharma B, Revees S, Naik VN, Triby E, Grantcharov T. Within-team debriefing versus instructor-led debriefing for simulation-based education: a randomized controlled trial. Ann Surg. 2013 Jul;258(1):53-8. doi: 10.1097/SLA.0b013e31829659e4.
Clinical trial NCT02098278: Pilot Study To Assess CAT-2003 in Patients With Chylomicronemia
Official title: A Phase 2 Pilot Study to Assess the Safety and Efficacy of CAT-2003 in Patients With Chylomicronemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lipoprotein Lipase Deficiency, Familial
Hyperlipoproteinemia Type I
Chylomicronemia, Familial
Hypertriglyceridemia
Lead sponsor: Catabasis Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-03-28
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess safety and efficacy of CAT-2003 in patients with chylomicronemia. The study will evaluate the effects of CAT-2003 on fasting total and chylomicron triglyceride levels, as well as postprandial total and chylomicron triglyceride clearance.

This is a single-blind study. All patients will receive placebo for 1 week, and CAT-2003 for 12 weeks during the 13 week treatment period.


Eligibility criteria: Key Inclusion Criteria:

* Familial Chylomicronemia (Fasting triglycerides ≥ 880 mg/dL at Screening and documented history of plasma post-heparin LDL activity \< 20% of normal or genetic confirmation of homozygosity or compound heterozygosity for loss-of-function mutations in familial chylomicronemia-causing genes) OR
* Non-familial Chylomicronemia (Fasting triglycerides ≥ 440 mg/dL at Screening and documented history of fasting triglycerides ≥ 880 mg/dL)

Key Exclusion Criteria:

* History of any major cardiovascular event within 6 months of Screening
* Type I diabetes mellitus or use of insulin
* History of pancreatitis within 3 month of Screening

Primary outcomes:
measure: Percent change from baseline in fasting triglycerides in patients with chylomicronemia
timeFrame: 12 Weeks
Secondary outcomes:
measure: Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels
timeFrame: 12 Weeks
measure: Absolute and percent change from baseline on chylomicron triglyceride clearance
timeFrame: 12 Weeks
measure: Absolute and percent change from baseline in plasma non-HDL-C
timeFrame: 12 Weeks
measure: Frequency of adverse events
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Chicoutimi
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
Study officials:
References:
Clinical trial NCT02025478: Human Breastmilk in Children Receiving a Bone Marrow Transplant
Official title: A Pilot Study of Enteral Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Marrow Transplant- Autologous or Allogeneic
Keywords: children
bone marrow transplant
autologous
allogeneic
breastmilk
hematopoietic stem cell transplantation (HSCT)
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Mothers' Milk Bank Northeast
First posted: 2014-01-01
Enrollment: 11
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators hypothesize that children receiving human milk will maintain a greater diversity of helpful bacteria in their gut and have lower levels of inflammatory proteins in the blood compared with children not receiving human milk.

Detailed description: The investigators hypothesize that the gut microbiota during bone marrow transplant could be influenced by administration of enteral donor breast milk. This study will attempt to address this hypothesis, by feeding donor breast milk to young children undergoing transplant, and serially comparing the gut micobiota in children receiving human milk, with those receiving conventional feeding.

Eligibility criteria: Inclusion Criteria:

* Children less than 5 years old receiving transplant (autologous or allogeneic)
* Parents must give informed consent

Exclusion Criteria:

- Failure to meet inclusion criteria

Primary outcomes:
measure: Percentage of lactobacillales
timeFrame: 21 days after transplant
Secondary outcomes:
measure: Levels of pro-inflammatory cytokines
timeFrame: Weekly during study course; up to approximately one year
measure: Incidence of bacteremia
timeFrame: through day 14 post transplant
measure: Incidence of graft versus host disease (GVHD)
timeFrame: through study course; approximately one year
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Stella Davies, MBBS, PhD, MRCP
role: PRINCIPAL_INVESTIGATOR
References: