louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02303132: Ussing Experiments to Evaluate the Role of Medication-induced Microscopic Colitis
Official title: Ex Vivo Experiments to Evaluate the Role of Medication on the Colon Permeability in Microscopic Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microscopic Colitis
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Medication use, especially NSAIDs and PPIs, prior to diagnosis is considered a risk factor for MC development. However, the exact pathophysiological mechanism is unclear. It is hypothesized that NSAIDs, PPIs, and SSRIs may have an effect on the colon permeability, due to an idiosyncratic reaction which results in a local immune response. MC patients are considered to be susceptible hosts, prone to react on administration of abovementioned drugs. In order to test this hypothesis and to generate new insights in the pathophysiology of MC, we want to perform an Ussing chamber experiment using fresh colon tissue samples. The primary objective is to assess ex vivo the effect of NSAIDs and PPIs on epithelial permeability of colon biopsy specimens of MC and non-MC patients, using the Ussing chamber system


Eligibility criteria: Inclusion Criteria:

* The indication for colonoscopy is a relapse of MC (active) / MC in remission (remission) / no MC (control)
* Patient is not treated with NSAIDs / PPI / SSRI in week before inclusion

Exclusion Criteria:

* Age below 18 years at the time of diagnosis
* Use of anticoagulants or immunosuppressive drugs
* Severe co-morbidities hindering an endoscopic procedure
* A previous history of any type of chronic colitis, IBS, IBD, colon carcinoma or (partial) colectomy
* A recent (last year) diagnosis of infectious diarrhea or radiation proctitis.
* Use of medication known to influence intestinal permeability
* Excessive alcohol usage (\>20 standard units per week)
* Not capable of signing an informed consent

Primary outcomes:
measure: Change in Transepithelial electircal resistance
timeFrame: 2 hours
Secondary outcomes:
measure: Change in permeation of a fluorescent marker
timeFrame: 2 hours
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Maastricht University Medical Center
name: A Masclee, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03261232: Search for Prognostic Factors Associated With Better Survival in Refractory Cardiac Arrest
Official title: Prognostic Factors in Refractory Cardiac Arrest Treated With Extracorporeal Life Support at Dijon CHU
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrest (CA)
ExtraCorporeal Life Support (ECLS)
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with in-hospital or out-of-hospital refractory CA who underwent ECLS

Brief summary: Through this retrospective observational study (over 4 years; period analysed: 1st January 2011 to 31st December 2014), we looked for prognostic factors associated with better survival in refractory cardiac arrest by:

* assessing the overall survival rate
* evaluating the frequency of intra et extra-hospital events and by comparing these with the survival rate
* studying no flow, low flow, rhythm at initial management, troponinemia, lactatemia and blood pH in the different groups.


Eligibility criteria: Inclusion Criteria:

* Patients with in-hospital or out-of-hospital refractory CA who underwent ECLS

Exclusion Criteria:

* CA occurring during cardiac surgery
* Age \> 75 years or \< 18 years

Primary outcomes:
measure: Survival rate
timeFrame: at baseline
measure: Death rate
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT06148532: EnCoRe MoMS:Engaging Communities to Reduce Morbidity From Maternal Sepsis
Official title: EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Maternal Sepsis
Infections
Keywords: Electronic Health Record
Post Partum Period
Pregnancy
Maternal Health
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Northern Manhattan Perinatal Partnership
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-11-28
Enrollment: 400000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Delivery admission records at PRC sites

Brief summary: Sepsis is the second leading cause of maternal death in the U.S. For racial and ethnic minoritized birthing people, especially those who are Black, living in poverty, and from underserved communities, labor and postpartum are particularly vulnerable risk periods. The goal of this multi-center, multidisciplinary observational study is to optimize risk prediction accounting for the social determinants of health, and establish a novel maternal care continuity model to reduce sepsis- related death and disability and increase maternal health equity.

Detailed description: Maternal sepsis is the second leading cause of maternal death, major cause of morbidity, and preventable in most cases. EnCoRe MoMS: Engaging Communities to Reduce Morbidity from Maternal Sepsis will (Aim 2) Develop algorithms to optimize prediction of sepsis around delivery and postpartum.

In the UG3 phase, robust community engagement and research infrastructures were established to: Aim 2a. Create a rich electronic health records (EHR) database from the Perinatal Research Consortium (PRC). Aim 2b. Collate neighborhood-level datasets characterizing social determinants of health (SDOH)

In the UH3 phase, the investigators will Aim 2c. Harmonize patient-level EHR and neighborhood-level SDOH datasets and use machine learning models to analyze the individual and joint contributions of patient and neighborhood factors to optimize sepsis risk prediction within the PRC sample.

Eligibility criteria: Inclusion Criteria:

* Be 18 years or older
* Delivery admission (and) postpartum readmission at one of the Perinatal Research Consortium sites 2014-2021

Exclusion Criteria:

* Under 18 years old
* Delivery admission (and) postpartum readmission at hospital that is not in the Perinatal Research Consortium
* Delivery admission before 2014 or after 2021

Primary outcomes:
measure: Maternal sepsis risk
timeFrame: Delivery hospitalization through 8 weeks postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia Unviersity Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Uma Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02572232: Supraglottic Airway Devices in Pediatric Difficult Airway Situations
Official title: Comparison of Three Different Supraglottic Airway Devices and Endotracheal Intubation in Pediatric Difficult Airway Situations in a Manikin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Morbidity
Emergencies
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare three supraglottic airway devices (Combitube, Easytube, laryngeal mask airway) to endotracheal intubation in a simulated difficult airway scenario in a pediatric manikin.

Detailed description: Supraglottic airway devices (SAD) have been designed for the "cannot intubate, cannot ventilate" scenario in prehospital as well as intrahospital settings and are utilized in medical emergency services and emergency departments all over the world, not only for anticipated and unanticipated difficult airway situations but also as an airway device used by non-anesthesiologists or in situations where only limited practice is possible. Securing an airway in a pediatric emergency situation is crucial. Unfortunately, pediatricians usually lack the required skills and regular practice to perform endotracheal intubation (ETI, which is the gold standard for securing an airway) quickly and safely. SADs would pose a safe and feasible alternative to ETI. However, no studies on this topic are available. The investigators therefore wanted to evaluate three different SADs (Combitube, Easytube, laryngeal mask airway) in simulated difficult airway situations in a pediatric manikin in comparison to ETI.

Eligibility criteria: Inclusion Criteria:

* pediatricians
* residents
* interns
* written informed consent form

Exclusion Criteria:

* none

Primary outcomes:
measure: Time to successful ventilation
timeFrame: 1 min
Secondary outcomes:
measure: Success rate
timeFrame: 1 min
measure: Rating of the device (questionnaire)
timeFrame: 1 min
measure: Re-assessment of success rate after 3 months
timeFrame: 3 months
measure: Re-assessment of time to successful ventilation after 3 months
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Vienna
name: Michael Frass, Prof. Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT06967532: Efficacy of Torque Teno Virus as a Biomarker for Predicting Treatment Response of Immune Checkpoint Inhibitor Therapy and Postoperative Outcome in NSCLC Patients
Official title: Efficacy of Torque Teno Virus as a Biomarker for Predicting Treatment Response of Immune Checkpoint Inhibitor Therapy and Postoperative Outcome in NSCLC Patients - A Prospective Non-interventional Single-arm Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NSCLC (Non-small Cell Lung Cancer)
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 90
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: Male and female patients aged \> 18 years. Women of childbearing potential are eligible and must provide a negative serum or urine pregnancy test and follow instructions for contraception.

Brief summary: First discovered in 1997 the torque teno virus (TTV) can be found in the vast majority of the human population throughout their lifetime. The TTV levels correlate with infectious diseases and organ rejection and are therefore currently being investigated as a tool to optimize the management of patients after solid organ transplantation (SOT). While TTV levels are already tested to guide immunosuppressive therapy its significance for oncologic patients is unclear. In recent years immune checkpoint inhibitors (ICIs) are increasingly implemented in multimodal therapy approaches for patients with non-small-cell lung cancer (NSCLC). Since ICI and TTV levels depend on T-cell function, the TTV load may be a relevant biomarker for the treatment response as well as complication risk after ICI therapy. Current standard imaging using PERCIST and RECIST criteria is prone to misinterpretation of treatment response of ICI therapy due to pseudoprogression and nodal immune flaring. This study aims to prospectively analyze TTV levels in NSCLC patients before, during and after neoadjuvant chemo-immunotherapy and correlate inter- and intraindividual changes in TTV levels with response rates observed on PET/CT restaging and histopathological response rates as well as postoperative outcome.


Eligibility criteria: Inclusion Criteria:

- Histologically or cytologically verified NSCLC stage II-IV (OMD) according to UICC TNM8 edition considered operable in curative intent after neoadjuvant systemic therapy containing immune checkpoint inhibition by local multidisciplinary tumor board (MDT) decision.

ECOG \< or = 1 Staging with PET/CT and cMRI/CCT Written informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: Histopathological response to neoadjuvant chemo-immunotherapy
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT04509752: Dysphagia Management During COVID-19 Pandemic
Official title: Experiences in Dysphagia Management During COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysphagia
Covid19
Keywords: dysphagia
COVID-19
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 23
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinicians who work on a dysphagia clinic will be included.

Brief summary: The current study is aimed to determine the procedures applied in the dysphagia clinics during the COVID-19 pandemic period. A questionnaire consisting of 30 questions will be implemented. Each participant will be asked to answer the questions.

Detailed description: The current study is aimed to understand the current clinical conditions and current practice regarding dysphagia management during the pandemic period/normalization period. It is a cross sectional online survey study. The first part is the survey development and testing, the second part is determination of swallowing centers and last part is survey distribution by google forms. A coordinator will be selected for each center to discuss the survey with the entire team and reply the questions.

Eligibility criteria: Inclusion Criteria:

* Working on a dysphagia clinic from all over the world

Exclusion Criteria:

* Not willing to participate
* Not working on a dysphagia clinic

Primary outcomes:
measure: Online survey
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacetttepe University
Study officials:
affiliation: Hacettepe University
name: SELEN SEREL ARSLAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00196352: A Multicenter Study to Evaluate the Safety of Seasonique, an Oral Contraceptive.
Official title: A Prospective, Multiple Site Study to Evaluate the Safety of an Extended Cycle Combination Oral Contraceptive, Seasonique, Which Utilizes Ethinyl Estradiol During the Pill-free Interval.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: oral contraceptives
birth control
ethinyl estradiol
pregnancy prevention
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is being conducted to evaluate the safety of ethinyl an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years.

Detailed description: This study is being conducted to evaluate the safety of an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years. This is an extension of the Seasonique Phase 3 clinical trial to evaluate long-term safety. Only patients enrolled in the earlier trial are eligible for participation.

Eligibility criteria: Inclusion Criteria:

* Participant in the earlier Phase 3 Seasonique clinical trial

Exclusion Criteria:

* Any contraindication to the use of oral contraceptives

Primary outcomes:
measure: Patient and Investigator reports of adverse events
timeFrame: Duration of Study
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Duramed Investigational Site
state: Arizona
city: Washington
country: United States
facility: Duramed Investigational Site
state: District of Columbia
city: Lincoln
country: United States
facility: Duramed Investigational Site
state: Nebraska
city: Rochester
country: United States
facility: Duramed Investigational Site
state: New York
city: Charlotte
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Duramed Investigational Site
state: Oklahoma
city: Nashville
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: Duramed Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Duramed Investigational Site
state: Virginia
Study officials:
affiliation: Duramed Research, Inc.
name: Duramed Protocol Chair
role: STUDY_CHAIR
References:
Clinical trial NCT02208752: The Effect of a Pre-operative Exercise Program for Patients With Full Thickness Rotator Cuff Tear Waiting for Surgical Repair
Official title: The Effect of a Pre-operative Exercise Program on Pain and Function in Patients With Full Thickness Rotator Cuff Tear Waiting for Surgical Repair.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Tears
Keywords: rotator cuff tears
ultrasound measure
pain
range of motion
muscle force
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomised controlled study involving a group of 20 patients- 10 patients in a control group, 10 patients in treatment group. The treatment group consists of exercises with theraband for the shoulder and exercises of motor control of the scapula. The purpose of the study is to measure the effects of a pre-operative physiotherapy program for patients awaitng for rotator cuff surgery, The duration of the pilot project is 4 weeks.

Detailed description: This study is taken place in a genral hospital using the waiting list in the orthopedic surgery department- only patients awaitng for rotator cuff surgery are included. a randomised process of a block will be used. There will be 2 groups of patients an active comparator and no intervention. All patients at the beginning of the project and after 4 weks will have an evaluation on range of motion, strength, acromial humeral mesurement done by ultrasound and questionnaire on pain(DASH) and quality of life( WORC). At 8 weeks all patients will fill in the 2 questionnaires on DASH and WORC.

Eligibility criteria: Inclusion Criteria:

* Patients waitng for surgery at Cite de la Sante Hospital

Exclusion Criteria:

* Glenohumeral Arthirtis
* Shoulder fracture
* Corticosteriod injections
* Rupture of rotator cuff tear of more than 3 cm
* CSST- Workman's compensation
* Central and peripheral neuropathy

Primary outcomes:
measure: WORC questionnaire
timeFrame: 30 days
Secondary outcomes:
measure: DASH questionnaire
timeFrame: 30 days
measure: Ultrasound measures
timeFrame: 30 days
measure: range of motion
timeFrame: 30 days
measure: strength
timeFrame: 30 days
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Hôpital Cite-de-la-Santé
state: Quebec
Study officials:
affiliation: Université de Montréal
name: François Desmeules, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00904852: Safety Study of the Combination of Tandutinib With Temozolomide and Bevacizumab After Radiation and Temozolomide in Patients With Newly Diagnosed With Glioblastoma Multiforme
Official title: A Phase 1, Multicenter, Open-Label, Dose Escalation Study of Tandutinib (Formerly MLN518) in Combination With Temozolomide and Bevacizumab Following Concurrent Radiation Therapy and Temozolomide in the Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Glioblastoma Multiforme
Lead sponsor: Millennium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2009-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a safety study of tandutinib in combination with temozolomide and bevacizumab after people have received radiation therapy and temozolomide treatment. This study will determine the maximum safe dose of tandutinib when combined with temozolomide and bevacizumab and evaluate the safety of the combination treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of glioblastoma multiforme
* Received radiotherapy for glioblastoma multiforme
* Patients who have not had previous treatments for glioblastoma multiforme (except for surgery, radiation and temozolomide therapy)
* Females that are postmenopausal for at least 1 year prior to screening visit
* 18 years of age and older

Exclusion Criteria:

* Other brain cancers that are not diagnosed as glioblastoma multiforme
* female patients who are lactating or are pregnant
* HIV positive and/or any other active infection requiring therapy
* Known hepatitis B or hepatitis C infection
* Diagnosed or treated any other cancer within 2 years before the first dose
* History of cardiovascular conditions and/or vascular disease
* Allergic to any component of bevacizumab

Primary outcomes:
measure: Maximum tolerated dose of tandutinib, adverse events, serious adverse events and dose limiting toxicities, clinical laboratory values and vital sign measurements
timeFrame: Cycle 1 days 1, 8, 15, and 22. Cycle 2 -6 days 1 and 15
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Millennium Pharmaceuticals, Inc.
name: Sudha Parasuraman, MD
role: STUDY_DIRECTOR
References: