louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01757743: Fluid Balance During Closure of Atrial Septal Defect
Official title: Protein Distribution and Colloid Osmotic Pressure in Children With Volume and Pressure Loading Due to Congenital Heart Defects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Defects,Congenital
Heart Septal Defects, Atrial
Keywords: Heart Septal Defects, Atrial
Oedema formation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2012-12-31
Enrollment: 41
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with Atrial Septal Defect scheduled for interventional closure with device or surgical repair

Brief summary: This project will evaluate fluid balance and oedema formation in children with the same congenital heart disease (Atrial Septal Defect) who will either go through heart surgery with the use of Cardio Pulmonary Bypass and hypothermia or through interventional catheterization. The investigators will measure interstitial colloid osmotic pressure, distribution of proteins and cytokines. The study hypothesis is that "Oedema developed during heart surgery is caused by reduced colloid osmotic pressure gradient through the capillary membrane".


Eligibility criteria: Inclusion Criteria:

* The diagnosis of Atrial Septal Defect scheduled for closure
* Informed consent

Exclusion Criteria:

* Renal failure,
* liver failure,
* coexisting cardiac malformations

Primary outcomes:
measure: Interstitial colloid osmotic pressure
timeFrame: During surgery or interventional closure
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Marianne M Indrebo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06851143: 18F-DPA-714 PET/MR in Dysfunctional Brain Diseases
Official title: 18F-DPA-714 PET/MR in Dysfunctional Brain Diseases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Brain Disease
Keywords: 18F-DPA-714 PET/MR
cognitive impairment
dyskinesia
Disorders of consciousness
Autoimmune encephalitis
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: This is a diagnostic pilot study that recruited 25 normal volunteers and 40 patients with dysfunctional brain diseases and performed 18F-DPA-714 PET/MR imaging to evaluate the correlation between the multimodal imaging features of dysfunctional brain diseases, to explore the potential pathological mechanisms of neuroimmune activation, and to further analyse the value of PET/MR-based multimodal imaging in the diagnosis and differential diagnosis of dysfunctional brain diseases. and further analyse the diagnostic and differential diagnostic value of PET/MR-based multimodal imaging in dysfunctional brain diseases.


Eligibility criteria: Inclusion Criteria:

* Dysfunctional disorders diagnosed according to the guidelines include: cognitive disorders, movement disorders, disorders of consciousness-like disorders, and autoimmune encephalitis. Signing the PET/MR informed consent form to volunteer for this study

Exclusion Criteria:

* Minors, pregnant women, nursing mothers, those with severe liver or kidney insufficiency, history of allergy to contrast media or other drugs. Diagnosis of viral encephalitis, acute myelitis, idiopathic epilepsy, antibody-negative AIE; diagnosis of any major disease; history of alcohol or drug abuse/dependence; history of cardiorespiratory disease, oncology, haematological disorders, poorly controlled chronic diseases; contraindications to PET/MR examination. History of head trauma, history of surgery. History of other neurological disorders.

Primary outcomes:
measure: Maximum Standardized uptake value (SUVmax)
timeFrame: 1 day from injection of the tracer
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00404443: Acupuncture for the Treatment of Rheumatoid Arthritis
Official title: Efficacy of Traditional Chinese Acupuncture in the Treatment of Rheumatoid Arthritis: a Double-Blind Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Acupuncture
Electroacupuncture
Rheumatoid arthritis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2006-11-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the efficacy of acupuncture used as an adjunct measure for patients with refractory RA

Detailed description: The study employs a randomized, prospective, double-blind, placebo-controlled trial to evaluate the effect of electroacupuncture, traditional Chinese acupuncture and sham acupuncture in patients with refractory RA. All patients received 20 sessions over a period of 10 weeks. Six acupuncture points were chosen. Primary outcome is the changes in the pain score. Secondary outcomes included the changes in the ACR core disease measures, DAS 28 score and the number of patients who achieved ACR 20 at week 10.

Eligibility criteria: Inclusion Criteria:

* Fulfilled The American College of Rheumatology (ACR)\[10\] criteria of RA
* Active disease affecting the hands and wrists defined as having at least 4 tender joints and 2 swollen joints
* Early morning stiffness of greater than 45 minutes
* ESR \> 28 mmHg or CRP \> 10
* Patients taking disease modifying anti-rheumatic drugs (DMARDs) were eligible if they were on a stable dose for at least 3 months before screening.
* Patients on stable doses of one non-steroidal anti-inflammatory drug (NSAID) or up to 10 mg daily prednisone were also included.

Exclusion Criteria:

* Under the age of 18 years
* Pregnancy
* Previously had acupuncture
* Localized skin infections
* Anticoagulated
* Bleeding diathesis
* Intra-articular corticosteroid within 4 weeks preceding the study
* Any severe chronic or uncontrolled co-morbid disease
* Fear of needles

Primary outcomes:
measure: The changes in the pain score.
timeFrame: wk52
Secondary outcomes:
measure: The ACR core disease measures
timeFrame: wk52
measure: DAS 28 score
timeFrame: wk52
measure: The number of patients who achieved ACR 20 at week 10.
timeFrame: wk52
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Institute of Chinese Medicine
Study officials:
affiliation: Chinese University of Hong Kong
name: Edmund K Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tam LS, Leung PC, Li TK, Zhang L, Li EK. Acupuncture in the treatment of rheumatoid arthritis: a double-blind controlled pilot study. BMC Complement Altern Med. 2007 Nov 3;7:35. doi: 10.1186/1472-6882-7-35.
Clinical trial NCT05107843: Integrated Clinical-radiological Analysis of Hypoxia Markers in Pediatric Osteosarcomas
Official title: Integrated Clinical-radiological Analysis of Hypoxia Markers in Pediatric Osteosarcomas - Single-center Pilot Study of 32 Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteosarcoma in Children
Keywords: Osteosarcoma
Necrosis
Immunohistochemical markers of hypoxia
Hypoxia
Chemotherapy
Metastasis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject ≤ 20 years having been treated for osteosarcoma in the OS2006 protocol or treated according to.

Brief summary: The aim of this pilot study is therefore to retrospectively measure the volume and percentage of necrosis on diagnostic MRI in T1 sequence and in parallel to study the expression of immunohistochemical markers of hypoxia (HIF-1α, CAIX , HIF-2α, pS6, phosphomTor, CD163 and CD68) on diagnostic biopsies of high-grade osteosarcomas from 2007 to 2018 in the Strasbourg center, focusing on the pediatric population. The investigators will systematically carry out a correlation analysis between these different parameters and with the clinical data of these same patients (response to chemotherapy, presence of metastases or not and overall and recurrence-free survival). This will eventually make it possible to highlight new prognostic markers at diagnosis.


Eligibility criteria: Inclusion Criteria:

* Subject ≤ 20 years at diagnosis
* Subject having been treated for osteosarcoma in the OS2006 protocol or treated according to
* Supported at Strasbourg University Hospitals between 05/01/2007 and 10/31/2018
* Availability of its diagnostic tumor material stored in paraffin
* having an MRI diagnostic evaluation comprising the injected T1 sequences necessary for the analysis of the volume / necrotic proportion.

Exclusion Criteria:

* Opposition of the patient (or his legal representatives if he is a minor) to participate in the study
* Diagnosis other than osteosarcoma
* Biological tissue from a patient who does not meet all the inclusion criteria
* Patient under legal protection
* Patient under guardianship or guardianship

Primary outcomes:
measure: Retropsective study of pediatric osteosarcomas
timeFrame: Files analysed retrospectively from January 01, 2007 to December 31, 2018 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Pédiatrie Onco-hématologie - Pédiatrie III - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service Pédiatrie Onco-hématologie - Pédiatrie III - Hôpitaux Universitaires de Strasbourg
name: Natacha ENTZ-WERLE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04050943: A Cohort of Patients With Chronic Pulmonary Disease
Official title: A Long-term, Prospective, Observational Cohort of Patients With Chronic Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Pulmonary Disease
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a longitudinal study of following obstructive pulmonary disease patients from the outpatient clinic.

Brief summary: This is a longitudinal study of following chronic pulmonary disease patients to observe and predict the clinical outcomes of these patients.

Detailed description: In patients with chronic pulmonary disease, impaired pulmonary function and limited exercise capacity, is a complex clinical syndrome with a wide range of underlying causes, which may result in worse quality of life and high economic burden. This is a longitudinal study of following chronic pulmonary disease patients, recording the clinical, pathophysiology, and psychological parameters, to observe and predict the clinical outcomes of these patients.

Eligibility criteria: Inclusion Criteria:

1. Age 18-80, males and females
2. Patients are diagnosed as the obstructive pulmonary disease according to the clinical practice.
3. Willing to participate in the study.
4. Being able to provide informed consent.

Exclusion Criteria:

1. Subjects with severe heart failure, severe arrhythmias, unstable angina, and malignant comorbidities.
2. Subjects with significantly impaired cognitive function and are unable to fulfill the study requirement (unable to provide informed consent)
3. Subjects who participated in another trial within 30 days prior to the planned start of the study
4. Subjects with cancer or have had cancer in the 5 years prior to study entry.

Primary outcomes:
measure: Rate of acute exacerbations
timeFrame: 1 year
Secondary outcomes:
measure: Survival
timeFrame: 1 year
measure: Forced expiratory volume in 1 second
timeFrame: 1 year
measure: Health related quality of life: questionnaires
timeFrame: 1 year
measure: 6-minute walk test
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Institute of Respiratory Disease
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Rongchang Chen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00258843: Safety of Imovax Polio in Chinese Infants and Children
Official title: Clinical Safety Evaluation Study of the Sanofi Pasteur's Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) Administered as a Single Booster Dose at 18 Months of Age in Healthy Chinese Children, and as the First Dose of Primary Vaccination at 2 Months of Age in Healthy Chinese Infants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Poliomyelitis
Keywords: IMOVAX;
poliomyelitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-11-28
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To describe the tolerance in terms of occurrence of serious adverse reactions and severe adverse reactions (injection site and systemic) within eight days after one dose of IMOVAX Polio™ administered in children and infants.


Eligibility criteria: Inclusion Criteria:

* Group 1: Aged 18 months (18-20 months) on the day of inclusion
* Group 2: Aged 2 months (56-70 days) on the day of inclusion

Exclusion Criteria:

* Participation in another clinical trial in the 4 weeks preceding the trial vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
* Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion
* Blood or blood-derived products received in the past 3 months (for Group 1) or since birth (for Group 2)
* Any vaccination in the 4 weeks preceding the trial vaccination (except BCG and Hepatitis B \[Hep B\] for Group 2)
* Vaccination planned in the 4 weeks following the trial vaccination
* Group 1: Previous booster vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine.
* Group 2: Previous vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine.
* History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
* Clinical or serological evidence of systemic illness including Hepatitis B, C and HIV
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
* History of/current seizures
* Febrile illness (axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pingle
country: China
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02052843: Impact Evaluation of the Steps to Success Program
Official title: Impact Evaluation of the Steps to Success Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Lead sponsor: Mathematica Policy Research, Inc.
Sponsor class: OTHER
First posted: 2014-02-03
Enrollment: 595
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The evaluation will examine whether the Steps to Success enhanced home visits are more effective at delaying repeat pregnancies than are traditional Healthy Families home visits.


Eligibility criteria: Inclusion Criteria:

* Female
* Age 14 to 21
* Pregnant, or have delivered a child in the last three months

Primary outcomes:
measure: Subsequent pregnancy
timeFrame: 2-years post random assignment
Secondary outcomes:
measure: Subsequent pregnancy
timeFrame: 1-year post random assignment
Other outcomes:
Locations:
city: San Angelo
country: United States
facility: Healthy Families San Angelo
state: Texas
Study officials:
affiliation: Mathematica Policy Research
name: Robert Wood, p
role: STUDY_DIRECTOR
References:
Clinical trial NCT04178343: Tomotherapy for Leptomeningeal Metastases
Official title: Tomotherapy for Leptomeningeal Metastases: a Single Arm, Single Center, Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leptomeningeal Metastasis
Keywords: tomotherapy
leptomeningeal metastases
fractionated stereotactic radiotherapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2019-11-26
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy for leptomeningeal metastases.

Detailed description: This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy for leptomeningeal metastases, which are defined as leptomeningeal metastases with or without brain metatstases.

Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic diagnosis of primary tumor and conformed meningeal metastases by enhanced MRI; KPS ≥60,or KPS ≥40 and the limitation of motion is simply caused by brain tumor that is adjacent to the motor function areas; Age: 18-75 years old; Adequate organ function:WBC≥4.0x109/L Neu ≥ 1.5x109/L Hemoglobin ≥ 110 g/L Platelets ≥100 x109/L Total bilirubin ≤ 1.5x ULN AST and ALT ≤ 1.5x ULN BUN and Cr: within the normal range.

Exclusion Criteria:

* Other clinically significant diseases (e.g.myocardial infarction within the past 6 months, severe arrhythmia); unable or unwilling to comply with the study protocol; patients who are anticipated in other clinical trials of meningeal metastases; pregnant patients or female patients whose HCG is positive; unsuitable to participate in study, that in the opinion of the treating physician.

Primary outcomes:
measure: overall survival
timeFrame: up to 2 years
Secondary outcomes:
measure: local control
timeFrame: up to 1 year
measure: intracranial progress free survival
timeFrame: up to 1 year
measure: progress free survival rate
timeFrame: up to 1 year
measure: adverse event
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jianping Xiao, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02120443: ivWatch Model 400: Device Validation for Non-Infiltrated Tissues
Official title: ivWatch Model 400: Device Validation for Non-Infiltrated Tissues
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infiltration of Peripheral IV Therapy
Keywords: infiltration
extravasation
peripheral intravenous therapy
Lead sponsor: ivWatch, LLC
Sponsor class: INDUSTRY
First posted: 2014-04-22
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Pass health screen
* 18 years or older

Exclusion Criteria:

* Fail health screen

Primary outcomes:
measure: Normal Tissue Red Notification Rate
timeFrame: 24 hours
Secondary outcomes:
measure: Normal Tissue Yellow Notification Rate
timeFrame: 24 hours
measure: Significant Skin Irritation or Disruption to Skin Integrity
timeFrame: 24 hours
Other outcomes:
Locations:
city: Williamsburg
country: United States
facility: ivWatch, LLC
state: Virginia
Study officials:
References:
Clinical trial NCT00205543: Study of Effects of Sutures on Results of Palate Surgery for Obstructive Sleep Apnea
Official title: Role of Suture Closure in Post-Operative Uvulopalatopharyngoplasty Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
airway obstruction
sleep-disordered breathing
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study we will examine whether suture repair of the palate, or roof of mouth, has any effect on results of palate surgery performed for treatment of obstructive sleep apnea.

Detailed description: Uvulopalatopharyngoplasty, or UPPP, is the most common surgical procedure performed for the treatment of obstructive sleep apnea. The procedure involves removal of redundant tissue from the lower palate (roof of mouth), including the uvula, and then suturing the cut edges of the remaining tissue together. However it is frequently noted by surgeons that sutures placed in the roof of the mouth do not stay intact. Also, in standard tonsillectomy, which involves removal of the tonsils and thus creation of a wound near the palate, no suturing is used, which does not seem to affect how the area heals. Previous studies have shown no significant differences in complication rates, post-operative pain, or symptom outcomes in patients undergoing tonsillectomy either with or without suture repair of the tonsillectomy wound. In this study we will examine whether suture repair following UPPP has any effect on post-operative pain, healing, or treatment success in terms of symptom resolution or post-operative sleep study results.

Eligibility criteria: Inclusion Criteria:

* sleep-study documented obstructive sleep apnea
* sleep apnea refractory to non-surgical treatments including continuous positive airway pressure (CPAP)
* age \> 21

Exclusion Criteria:

* previous palate surgery

Primary outcomes:
measure: sleep study result at 3-6 months; symptom changes at 3-6 months; pain at 0-3 weeks; post-operative complications at any time; post-operative anatomic result/appearance at 3-6 months
timeFrame: 6-12mo
Secondary outcomes:
measure: Operative time
timeFrame: immediate
measure: Procedure cost
timeFrame: immediate
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Department of Otolaryngology - Head & Neck Surgery, Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Evan R Reiter, MD
role: PRINCIPAL_INVESTIGATOR
References: