louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03466814: Study of the Safety of Orencia in Japanese Children and Adolescents With Active Juvenile Arthritis of Unknown Origin
Official title: ORENCIA Safety Surveillance in Japanese Children and Adolescents With Active Juvenile Idiopathic Arthritis (JIA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Undifferentiated Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2018-03-15
Enrollment: 82
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study is a local, prospective, non-interventional, non-controlled, multicenter, observational study for authorization of abatacept in the treatment of JIA

Brief summary: Observational study of abatacept in the treatment of JIA in Japan.


Eligibility criteria: Inclusion Criteria:

* All JIA participants who initiate treatment with Orencia in accordance with the prescribing information

Exclusion Criteria:

* Participants receiving Orencia for an off-label indication

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Number of adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Safety measured by number of participants who receive at least 1 dose of Orencia
timeFrame: 1 year
measure: Efficacy measured by number of participants who receive at least 1 dose of Orencia
timeFrame: 1 Year
Other outcomes:
Locations:
city: Shinjuku-ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT07022314: Urine Output Response to Fluid and Diuretic Therapy in Cardiac ICU Patients Monitored With FIZE kUO®
Official title: FIZE kUO® Real-Time Measurement of Urine Output Response to Fluid Therapy and Diuretics in Cardiovascular Surgery Patients: A Prospective Post-Market Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: AKI - Acute Kidney Injury
Cardiac Surgery
Fluid Therapy
Hemodynamic Instability
Postoperative Complications
Keywords: FIZE kUO
Urine Output
Fluid Management
Diuretics
Cardiothoracic Surgery
Lead sponsor: FIZE Medical ltd
Sponsor class: INDUSTRY
First posted: 2025-06-15
Enrollment: 45
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: Adult cardiac surgery patients in the cardiothoracic ICU who require continuous urine output monitoring and are connected to the FIZE kUO® device as part of routine clinical care.

Brief summary: This prospective observational study evaluates the real-time urine output response to fluid therapy and diuretics in cardiothoracic intensive care unit (CTICU) patients monitored with the FIZE kUO® device. The study aims to assess how continuous urine output monitoring can inform fluid management and improve patient outcomes post-cardiac surgery.

Detailed description: The study involves adult patients undergoing coronary artery bypass graft (CABG) or valve replacement/repair surgeries. Utilizing the FIZE kUO® device, continuous urine output data will be collected to analyze responses to hemodynamic interventions, including fluid boluses and diuretics. Secondary objectives include assessing urine output differences in patients with and without postoperative acute kidney injury (AKI), responses to vasopressors, and capturing real-time urine output data from FIZE kUO® for observational analysis.

Eligibility criteria: Inclusion Criteria:

1. Adults aged 18 years and older scheduled for CABG or valve surgery and expected postoperative admission to CTICU
2. Ability to provide informed consent

Exclusion Criteria:

1. Pregnancy
2. Preoperative dialysis (chronic or acute)
3. Enrollment in other interventional trials assessing urine output or AKI

Primary outcomes:
measure: Urine output response to fluid boluses and diuretics
timeFrame: 4 hours (2 hours before and 2 hours after intervention)
Secondary outcomes:
measure: Difference in urine output during surgery between patients with and without AKI
timeFrame: Perioperative/Periprocedural
measure: Urine output response to vasopressors
timeFrame: 4 hours (2 hours before and 2 hours after intervention)
measure: Evaluation of FIZE kUO® Urine Output Monitoring Compared to Manual Measurement
timeFrame: Through ICU stay, up to 5 days
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
References:
Clinical trial NCT00788814: Study of Pathways Curriculum for Use With WPD
Official title: Women Physical Disability and Depression: Communities Responding Now!
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Portland State University
First posted: 2008-11-11
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to assess the efficacy of a modified Pathways curriculum in treating depressive symptoms in women with physical disabilities.


Eligibility criteria: Inclusion Criteria:

* Women with physical disability requiring accommodation for major mobility limitations
* CES-D score of 16 or higher -

Exclusion Criteria:

* Active suicidality
* Diagnosis of Schizophrenia, Schizoaffective D/O, Psychosis NOS
* Currently receiving other psychotherapy -

Primary outcomes:
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: pre-test, post-test weeks, 12, 18, 24
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Dena M Hassouneh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04668014: The Characteristics and Role of Mucosal Microbiome After Treatment of Clostridioides Difficile Infection
Official title: The Characteristics and Role of Mucosal Microbiome After Treatment of Clostridioides Difficile Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clostridioides Difficile Infection
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 20
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: Adults undergoing screening colonoscopy who have no history of C. difficile infection

Brief summary: This research is being done to study the ability of C. difficile to colonize the colonic mucosa of individuals with no prior history of C. difficile infection.

Detailed description: The ability of C. difficile to colonize the mucosa of the colon will be studied in healthy individuals with no history of C. difficile infection who are undergoing colonoscopy for colon cancer/polyp screening purposes.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 and over
* No history of C. difficile infection
* Undergoing clinically indicated colonoscopy for colon cancer screening or colon polyp surveillance purposes in the absence of active GI symptoms.

Exclusion Criteria:

* Known active pregnancy
* Other known active gastrointestinal infectious process
* Inflammatory gastrointestinal conditions (microscopic colitis, inflammatory bowel disease, Celiac disease)
* Vulnerable adults
* Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes

Primary outcomes:
measure: Presence of C. difficile within the sigmoid colonic mucosal tissue
timeFrame: 1 day (At time of biopsy)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Purna Kashyap, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01307514: Effects of Heating Massaging Vibrating Vicinity of the Insulin Delivery Site
Official title: Protocol for Evaluation of the Effects of Heating Massaging Vibrating or Application of Topical Agent on the Vicinity of the Insulin Delivery Site
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: DIABETES
Keywords: DIABETES
PHARMACOKINETICS
PHARMACODYNAMICS
INSULIN
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-03-03
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants will be patients with insulin dependent diabetes using standard insulin injections or continuous insulin infusion pumps.

Brief summary: The aim of this experiment is to test the pharmacodynamics and pharmacokinetics of insulin analogs and their dependence on external and physiological alterations. The investigators plan compare the pharmacodynamics of insulin analog delivery in regular conditions and in the presence of increased perfusion of the delivery site, achieved by way of local warming, movement and topical application of Capsaicin cream. The investigators will also test the effect of local heating and topical application of Capsaicin cream on the post prandial glucose levels following a bolus.


Eligibility criteria: Inclusion Criteria:

1. Participant age between 18- 65 years old
2. Type I or Type II diabetes
3. HbA1c 6-12%
4. Does not suffer from sever hypertension, kidney, liver or heart disease
5. Does not suffer from active Ischemic heart disease
6. Is willing to sign the consent form

Exclusion Criteria:

1. Participants age \< 18 or \> 65
2. Pregnancy
3. Breast feeding women
4. Un-controlled diabetes, HbA1c values \> 12% range
5. Suffers from active Ischemic heart disease
6. Alcohol addiction
7. Is not prepared to signed the informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization,
Study officials:
References:
Clinical trial NCT01078714: Efficiency of Bumetanide in Autistic Children
Official title: Study of the Efficiency of a Treatment by Bumetanide in a Population of Autistic Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autistics Children
Keywords: Autism
Bumetanide
GABA
NKCC1
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2010-03-02
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a treatment by bumetanide presents an efficiency at the level of the neuronal maturation in the autism


Eligibility criteria: Inclusion Criteria:

* Children from 3 to 10 years old, answering the diagnosis of typical autism according to the diagnostic criteria of autism of the classification of the WHO ( CIM-10) and the parents of which gave a free, enlightened and written consent.

Exclusion Criteria:

* Patients epileptic autistics treated by anticomitiaux or having hurts of the central nervous system
* Patients autistics receiving a psychotropic treatment
* Patients presenting disorders electrolytes
* Patients presenting a hypersensibility known about sulpha drugs
* Presenting patients against indications relative to the treatment by bumetanide
* Patients already treated by diuretics
* Patients presenting a hepatic or renal incapacity
* Patients presenting an elongation of the QT to the electrocardiogram.
* Patients autistics of CARS sore is lower than 30.

Primary outcomes:
measure: Child Autism Rating Scale score
timeFrame: day 0 to day 90
Secondary outcomes:
measure: Clinical global impressions score
timeFrame: day 0 to day 90
measure: Repetitive end restricted behavior score
timeFrame: day 0 to day 90
measure: GRAM score
timeFrame: day 0 to day 90
Other outcomes:
Locations:
city: Brest
country: France
facility: Lemonnier
city: Rennes
country: France
facility: Chevreuil
city: Vannes
country: France
facility: DUPIN
Study officials:
affiliation: CHRU de Brest
name: Eric LEMONNIER, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lemonnier E, Degrez C, Phelep M, Tyzio R, Josse F, Grandgeorge M, Hadjikhani N, Ben-Ari Y. A randomised controlled trial of bumetanide in the treatment of autism in children. Transl Psychiatry. 2012 Dec 11;2(12):e202. doi: 10.1038/tp.2012.124.
Clinical trial NCT01726114: A Clinical Study of the C8 MediSensors Optical Glucose Monitor™
Official title: A Clinical Study to Evaluate the Performance of the C8 MediSensors Optical Glucose Monitor™ During On-Site Testing and Real Time Use Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes
Diabetes Mellitus
continuous Glucose Monitor
Lead sponsor: C8 MediSensors, Inc.
Sponsor class: INDUSTRY
First posted: 2012-11-14
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to compare glucose measurements from the C8 MediSensors non-invasive Optical Glucose Monitor™ System to blood glucose measurements from the Yellow Springs Instrument(YSI) blood glucose analyzer.

Detailed description: This is a prospective, non-randomized, open label study to evaluate the performance of the C8 MediSensors non-invasive Optical Glucose Monitor™ on individuals with diabetes mellitus. Capillary blood samples will be obtained throughout a daily study session; the study session may last for up to 12 hours. Blood glucose will be measured on a YSI blood glucose analyzer. Subjects may adjust food intake and insulin administration so device performance is evaluated across a broad range of glucose concentrations. Glucose measurements will be time matched and paired for comparison. Skin effects and adverse events will be evaluated.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older.
2. Understands and agrees to comply with study instructions.
3. Read, understood, signed and dated the Informed Consent Form.

Exclusion Criteria:

1. Pregnancy.
2. Extensive skin changes or diseases that preclude wearing the test device at the proposed wear site(s) (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
3. Employed by a company within the diabetes field other than the study sponsor.
4. Medical history or any condition that may, in the opinion of the investigator, compromise the subject's ability to participate.

Primary outcomes:
measure: Performance of the test device in comparison to the reference device
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Jose
country: United States
facility: C8 MediSensors, Inc.
state: California
Study officials:
affiliation: C8 MediSensors, Inc.
name: Vice President, Clincal, Regulatory, Quality
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05427214: Imaging Study on Halcyon 4.0 System for Patients Receiving Radiation Therapy
Official title: A Prospective Imaging Study of Target Definition and Simulation-free Planning Workflows on the Halcyon 4.0 System for Patients Receiving Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Cancer
Head and Neck Cancer
Lung Cancer
Gastric Cancer
Ovarian Cancer
Colon Cancer
Keywords: radiation therapy
halcyon
brain radiation
thoracic radiation
abdominal radiation
pelvic radiation
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems
First posted: 2022-06-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This prospective imaging study is evaluating the feasibility of using the Halcyon 4.0 radiotherapy system for radiation therapy planning in patients with cancer. The Halcyon 4.0 system has been engineered to decrease the image acquisition time and the radiation exposure, but the system has not yet been clinically validated for use in radiation planning. This pilot study will evaluate images obtained on the Halcyon 4.0 system to assess if the quality is sufficient for radiation treatment plan construction.


Eligibility criteria: Eligibility Criteria:

* Planning to receive radiation therapy to one of the following sites:

  * Head and neck/brain (n=10)
  * Thorax (n=10)
  * Abdomen (n=10)
  * Pelvis (n=10)
* At least 18 years of age
* If the patient will be receiving IV contrast on study: Adequate renal function as defined by a serum creatinine \< 1.4, or, for patients with chronic kidney disease, a stable serum creatinine \< 2.0. Note: if no IV contrast will be administered on study, patient may enroll without creatinine level documented.
* If the patient is a woman of childbearing potential, a negative pregnancy test must be obtained. Contraceptive use is not an adequate documentation of no chance of pregnancy.
* Able to understand and willing to sign an IRB approved written informed consent document.

Primary outcomes:
measure: Percentage of images that are of sufficient quality for patient primary treatment plan construction
timeFrame: At 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Pamela Samson, M.D., MPHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06277414: a Prediction of Post-Endoscopic Retrograde Cholangiopancreatography Complication
Official title: Machine Learning for the Prediction of Post-Endoscopic Retrograde Cholangiopancreatography Complication Risk
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endoscopic Retrograde Cholangiopancreatography
Lead sponsor: The First Affiliated Hospital of University of South China
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Routine ERCP patients

Brief summary: To develop effective preoperative and postoperative prediction models for postoperative complications of ERCP

Detailed description: To develop effective preoperative and postoperative prediction models for postoperative complications of ERCP based on machine learning

Eligibility criteria: Inclusion Criteria:

* Routine ERCP patients

Exclusion Criteria:

* Unwillingness or inability to consent for the study
* Pregnant women or breastfeeding
* current acute pancreatitis

Primary outcomes:
measure: Number of Participants with Pancreatitis
timeFrame: 1 month
Secondary outcomes:
measure: Number of Acute PEC(post-ERCP-cholecystitis )
timeFrame: 1 month
measure: Number of Participants with Cholangitis
timeFrame: 1 month
measure: Number of Participants with Perforation
timeFrame: 1 month
measure: Number of Participants with bile duct stents
timeFrame: 1 month
Other outcomes:
Locations:
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
Study officials:
References:
Clinical trial NCT00164814: The Role of Visceral Hyperalgesia, Gastroesophageal Reflux Disease (GERD) and Esophageal Motility Disorder (EMD) in NCCP Patients
Official title: Is Visceral Hyperalgesia the Culprit of Noncardiac Chest Pian in Chinese? Part I: The Role of Visceral Hyperalgesia, Gastroesophageal Reflux Disease (GERD) and Esophageal Motility Disorder (EMD) in NCCP Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-Cardiac Chest Pain
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Noncardiac chest pain (NCCP) is a common clinical problem worldwide. In Hong Kong, it has been estimated that about 20% of patients with chest pain are misdiagnosed to have coronary heart disease. Despite its benign nature, this condition causes anxiety, impairs quality of life and consumes a substantial amount of healthcare resources. While acid reflux and motility disorder in the esophagus are often attributed as the cause of NCCP, visceral hyperalgesia of esophagus is now recognized to play a central role in the pathogenesis of this condition. This research project aims to evaluate the role of visceral hyperalgesia in Chinese patients with NCCP. NCCP patients will be evaluated for the prevalence of gastroesophageal reflux disease and esophageal motility disorder by endoscopy, manometry and pH study. The visceral sensory and pain thresholds of these patients will be compared with asymptomatic controls.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients with monthly angina-like chest pain and negative coronary angiogram or scintigraphy
* Age between 18-70

Exclusion Criteria:

* Gastroesophageal reflux disease
* Psychiatric illness
* Cerebrovascular accident
* Active peptic ulceration
* Heart failure or cardiac bradyarrhythmia
* Epilepsy
* Pregnancy or lactating female
* Previous hypersensitivity to muscle relaxant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Endoscopy Centre, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Justin CY WU, MD
role: PRINCIPAL_INVESTIGATOR
References: