louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01398709: Effect of Rewarming Rate During Cardiopulmonary Bypass on Clinical Prognosis of Infants Undergoing Cardiac Surgery
Official title: Study of the Relationship Between Rewarming Rate During Cardiopulmonary Bypass and Clinical Prognosis in Infants Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cardiac Surgery
Cardiopulmonary Bypass
Rewarming Rate
Keywords: Cardiopulmonary Bypass
Prognosis
Cardiac Surgery
Rewarming Rate
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2011-07-20
Enrollment: 100
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to investigate the relationship between rewarming rate during cardiopulmonary bypass and clinical prognosis in infants undergoing cardiac surgery.

Detailed description: There have been many studies indicating that rewarming management plays an important role in cardiac surgery. The purpose of this study is to investigate the relationship between rewarming rate during cardiopulmonary bypass and clinical prognosis in patients undergoing cardiac surgery. Infants undergoing cardiac surgery with cardiopulmonary bypass are randomly assigned to either a slow rewarming strategy (0.24 degrees C/min) or a fast rewarming strategy (0.5 degrees C/min).

Eligibility criteria: Inclusion Criteria:

* Infants who had underwent cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Preoperative liver or kidney disease or dysfunction
* Preoperative coagulation disorder
* Palliative operation or a second operation
* Above 3 years

Primary outcomes:
measure: all cause mortality
timeFrame: one year
Secondary outcomes:
measure: Acute renal failure
timeFrame: one month
measure: Respiratory failure
timeFrame: one month
measure: ICU and hospital length of stay, and ICU readmissions
timeFrame: one month
measure: Stroke and reversible ischemic neurologic deficit
timeFrame: one month
measure: Measures of inflammation
timeFrame: one month
measure: Biochemical markers of myocardial necrosis
timeFrame: one month
measure: Perioperative complications
timeFrame: one month
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shannxi
Study officials:
affiliation: Xijing Hospital
name: Dinghua Yi, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06538909: Steps Against the Burden of Parkinson's Disease - StepuP
Official title: Steps Against the Burden of Parkinson's Disease - StepuP
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-08-06
Enrollment: 21
Sex: ALL
Minimum age (years): 25
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goals of our StepuP project are:

1. To understand the kinematic and neural mechanisms underlying walking improvements due to treadmill training with and without VR-enabled gait adaptations in people with PD;
2. To assess to what extent improvements in walking due to treadmill training, as measured in the laboratory, transfer to improvements in daily life mobility;
3. To understand the mechanisms underlying the transfer from improvements in walking to improvements in mobility in daily life in people with PD;
4. To understand for whom treadmill training improves walking characteristics in the laboratory and for whom it does not, and to understand for whom treadmill training improves mobility in daily life and for whom it does not.


Eligibility criteria: Inclusion Criteria:

Specific criteria for Parkinson's disease - PD

* Diagnosis of Parkinson's disease according to the MDS World Movement Disorders Society criteria Disease severity H\&Y I-III
* Score section 3.10 (ability to walk) MDS-UPDRS 3.10 ≥ 1
* MoCA cognitive assessment \> 15
* Stable cardiovascular condition, ability to perform aerobic activity at low to moderate intensity
* Without orthopedic diseases and other diseases that affect the quality of walking, at the decision of the researcher.

Exclusion Criteria:

* Moderate or severe depression (BDI-II ≥18)
* Orthopedic diseases and other diseases that affect the quality of walking, at the decision of the researcher

Primary outcomes:
measure: motion capture
timeFrame: 13 months
measure: describe brain activity by EEG cap
timeFrame: 13 months
measure: describe muscles activity by EMG electrodes
timeFrame: 13 months
Secondary outcomes:
measure: clinical trial TUG
timeFrame: 13 months
measure: clinical trial walk test
timeFrame: 13 months
measure: clinical trial MiniBESTest
timeFrame: 13 months
measure: mGES questionnaire
timeFrame: 13 months
measure: FES-i questionnaire
timeFrame: 13 months
measure: FACIT-F questionnaire
timeFrame: 13 months
measure: EQ-5D questionnaire
timeFrame: 13 months
measure: Frailty questionnaire
timeFrame: 13 months
measure: Fall questionnaires
timeFrame: 13 months
measure: MDS-UPDRS test
timeFrame: 13 months
measure: NFOGQ questionnaires
timeFrame: 13 months
measure: aids questionnaires
timeFrame: 13 months
measure: cognition questionnaires
timeFrame: 13 months
measure: Demographics questionnaire ( descriptive measures)
timeFrame: 13 months
measure: Fracture history questionnaire
timeFrame: 13 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06442709: Combined Anti-IL6R and Anticoagulation Therapy in Advanced NPC Patients
Official title: Combined Anti-IL6R and Anticoagulation Therapy Improves Prognosis in Patients With Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nasopharyngeal Carcinoma
Keywords: nasopharyngeal narcinoma
metastasis
extracellular vesicles
organ-organ crosstalk
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators have demonstrated the crucial role of the liver-lung axis in the distant metastasis of NPC. Furthermore, the investigators have identified a potential therapeutic approach to improve outcomes in NPC patients by identifying those most suitable for anticoagulant therapy. Further, the combination of anticoagulant therapy and anti-IL6R therapy has shown promising results in enhancing the prognosis of NPC patients. These findings highlight the significance of targeting the liver-lung axis and utilizing personalized treatment strategies for NPC.

Detailed description: Distant metastasis accounts for nasopharyngeal carcinoma (NPC)-related mortalities. Recently, extracellular vesicles (EVs) have been widely explored as key mediators of bidirectional tumor-host cell interactions by mediating pre-metastatic niche (PMN) formation. However, considering the complexity of the human body, multiple organ studies of tumor metastasis remain poorly understood. Here, the investigators have demonstrated the crucial role of the liver-lung axis in the distant metastasis of NPC. The investigators demonstrated mechanistically that hepatocellular derived EVs can be specifically taken up by the lung to form a hypercoagulable pre-metastatic microenvironment associated with IL6.Furthermore, the investigators have identified a potential therapeutic approach to improve outcomes in NPC patients by identifying those most suitable for anticoagulant therapy. Further, the combination of anticoagulant therapy and anti-IL6R therapy has shown promising results in enhancing the prognosis of NPC patients. These findings highlight the significance of targeting the liver-lung axis and utilizing personalized treatment strategies for NPC.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of NPC with distant metastasis
* Must be able to swallow tablets

Exclusion Criteria:

* Liver disease
* Blood disease
* Long-term use of anticoagulants

Primary outcomes:
measure: Tumor progression and metastasis
timeFrame: Five to Ten years
Secondary outcomes:
Other outcomes:
Locations:
city: Nantong
country: China
facility: Bo You
state: Jiangsu
Study officials:
affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Affiliated Hospital of Nantong University
name: Bo You, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04684407: C-reactive Protein Levels in Acute Apical Abscess Due to Root Canal Infection
Official title: Assessment of C-reactive Protein Levels in Acute Apical Abscess Due to Root Canal Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dentoalveolar Abscess
Lead sponsor: CSI College of Dental Sciences and Research, Madurai
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: C-reactive protein levels of patients with acute apical abscess are evaluated before and after root canal treatment

Detailed description: In patients with acute apical abscess C-reactive proteins are evaluated before and after root canal treatment. In this intra-canal medications calcium hydroxide and triple antibiotic paste are compared. PAI score of the corresponding tooth is noted .

Eligibility criteria: Inclusion Criteria:

patient with acute apical abscess

Exclusion Criteria:

* Teeth with evidence of previous initiated root canal treatment
* History of myocardial infarction, coronary heart disease
* Patients allergic to local anesthetic
* Patients under steroid medication
* Patients who are immunocompromised

Primary outcomes:
measure: Post root canal C reactive protein level
timeFrame: 2 weeks
Secondary outcomes:
measure: pain and swelling assessment
timeFrame: 6 months
Other outcomes:
Locations:
city: Madurai
country: India
facility: Csi College of Dental Sciences and Research
state: Tamil NADU
Study officials:
References:
Clinical trial NCT05819307: Structural Imaging Assisted Retinal Fluorescence Lifetime Imager (STARFLI)
Official title: Structural Imaging Assisted Retinal Fluorescence Lifetime Imager (STARFLI) Using a High-speed Fluorescence Lifetime Measurement Scheme
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Retinal Disease
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Haag-Streit AG
name: University of Bern
First posted: 2023-04-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retina healthy subjects

Brief summary: To investigate the feasibility of a combined OCT/FLIM device

Detailed description: To investigate the feasibility of a combined Optical coherence tomography/ Fluorescence Lifetime Measurement (OCT/FLIM) device.

Eligibility criteria: Inclusion Criteria:

* Subject must be willing to give written informed consent
* Age: Patients and Probands 18 years or greater
* Both eyes will be assessed in the study

Exclusion Criteria:

* Patients not willing or able to sign informed consent
* Patients younger than 18 years
* Patients with epilepsy

Primary outcomes:
measure: Feasibility of device
timeFrame: 1 year
Secondary outcomes:
measure: To provide two key technology aspects of the project:
timeFrame: 1 year
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Ophthalmology, Bern University Hospital, Bern, 3010 Bern, Switzerland
Study officials:
affiliation: Clinic director
name: Martin S. Zinkenagel, Prof.Dr.Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT05767307: Danish Prostate Cancer Consortium Study-1
Official title: Danish Prostate Cancer Consortium Study-1 (DPCC-1): Multicenter Development of Liquid Biopsy Biomarkers for Early Detection of Prostate Cancer.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: Odense University Hospital
name: Herlev and Gentofte Hospital
First posted: 2023-03-14
Enrollment: 2500
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males referred to "MRI-first" due to suspicion of PC (elevated PSA and/or suspect DRE) at one of the following three major urology/uroradiology centers in Denmark: Aarhus University Hospital (AUH), Herlev \& Gentofte Hospital (HGH), and Odense University Hospital (OUH).

Brief summary: The purpose of the study is to investigate if a new promising microRNA-based urine biomarker test for prostate cancer, called uCaP, is better than the current standard test (PSA) to identify men who would benefit from an MRI scan of the prostate. The study will include 2,500 men referred to MRI of the prostate at three major hospital centers in Denmark (Aarhus, Odense, and Herlev) and compare the accuracy of uCaP to PSA. Based on preliminary data it is expected that uCaP will be \>20% better than PSA at identifying treatment-requiring cancer. Hence, uCaP could help to better pre-select men for MRI and thereby reduce unnecessary MRI scans, unnecessary prostate biopsies, as well as overdiagnosis and overtreatment of indolent PCs, while maintaining high sensitivity for aggressive PC that needs early detection and early treatment.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Understand oral and written Danish.
* Referred to MRI (multi or bi-parametric) due to suspicion of PC at AUH, OUH, or HGH.

Exclusion Criteria:

* Previously diagnosed with PC or other urogenital cancers.
* Has one or more contraindications for MRI.
* Have had gender reassignment treatment.
* Blood PSA levels \> 20 μg/l.

Primary outcomes:
measure: Number of MRI scans used to detect clinically significant PCs.
timeFrame: At recruitment completion, at year 3 in 2025
measure: Clinically significant PC diagnoses compared to benign biopsies.
timeFrame: At recruitment completion, at year 3 in 2025
measure: Clinically significant PC diagnoses compared to clinically insignificant PC diagnoses.
timeFrame: At recruitment completion, at year 3 in 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
state: Aarhus
city: Hellerup
country: Denmark
facility: Herlev & Gentofte University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
References:
Clinical trial NCT01139307: Biomarkers in Samples From Patients With Down Syndrome and Acute Megakaryoblastic Leukemia
Official title: Development of Novel Therapeutics for AMKL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: adult acute megakaryoblastic leukemia (M7)
childhood acute megakaryocytic leukemia (M7)
recurrent adult acute myeloid leukemia
recurrent childhood acute myeloid leukemia
untreated adult acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-06-08
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of acute megakaryoblastic leukemia or diagnosis of Down syndrome when cryopreserved specimens are available.

Brief summary: RATIONALE: Studying samples of blood or tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in samples from patients with Down syndrome and acute megakaryoblastic leukemia.

Detailed description: OBJECTIVES:

* Determine whether megakaryocyte differentiation agents comprising a Rho kinase inhibitor and a JAK3 inhibitor can lead to proliferation arrest, polyploidization, and terminal differentiation of blasts in specimens from patients with Down syndrome and acute megakaryoblastic leukemia.

OUTLINE: Cryopreserved specimens are cultured and treated in vivo (in mice) and in vitro with megakaryocytic differentiation agents comprising a Rho kinase inhibitor and a JAK3 inhibitor.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of acute megakaryoblastic leukemia
* Diagnosis of Down syndrome
* Cryopreserved specimens available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Proliferation arrest
measure: Polyploidization
measure: Terminal differentiation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: John Crispino, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02727907: Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment of Patients With Multiple Sclerosis
Official title: International, Multicenter, Double-blinded, Placebo-controlled, Randomized Study of the Efficacy and Safety of Drugs BCD-033 and Rebif for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Multiple Sclerosis
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2016-04-05
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Study design is double-blind, randomized, placebo-controlled study in 3 parallel groups with the use of active comparator and placebo. Total duration of therapy of about 2 years. Study hypothesis is equivalence of efficacy and safety of the investigational drug BCD-033 original drug Rebif®.


Eligibility criteria: Inclusion Criteria:

1. Age 18-55
2. Patients of both genders with Multiple Sclerosis (McDonald criteria 2010)
3. No relapses 28 days before randomisation
4. Expanded Disability Status Scale score 0-5,5

Exclusion Criteria

1. Primary or secondary progression of Multiple Sclerosis
2. Expanded Disability Status Scale score more then 5,5
3. Severe depression, suicide ideas and/or attempts
4. Systemic corticosteroid application in 30 days before randomisation

Primary outcomes:
measure: Number of Combined Unique Active Lesions
timeFrame: 52 weeks
Secondary outcomes:
measure: Annual Relapse Rate
timeFrame: 52 weeks
measure: Proportion of Subjects Without Confirmed Relapse
timeFrame: 16, 52 weeks
measure: Relapse Free Time
timeFrame: 96 weeks
measure: Number of Combined Unique Active Lesions
timeFrame: 96 weeks
measure: Annual Relapse Rate
timeFrame: 96 week
measure: Relapse Free Time
timeFrame: 16, 52 weeks
measure: Number of Combined Unique Active Lesions
timeFrame: 16 weeks
Other outcomes:
measure: Adverse Events/Serious Adverse Events
timeFrame: 96 weeks
measure: Severe Adverse Events Frequency
timeFrame: 52 weeks
measure: Withdrawal
timeFrame: 16, 52 weeks
measure: Immunogenicity
timeFrame: 16, 52 weeks
measure: Adverse Reaction/Serious Adverse Reactions
timeFrame: 16, 52 weeks
measure: Severe Adverse Events Frequency
timeFrame: 96 weeks
measure: Withdrawal
timeFrame: 96 weeks
measure: Immunogenicity
timeFrame: 96 weeks
measure: Serious Adverse Events
timeFrame: 52 week of study
Locations:
city: Moscow
country: Russian Federation
facility: Scientific neurology center, RAS
Study officials:
References:
Clinical trial NCT00488007: Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids
Official title: Clinical Trial on Cognitive, Behavioural, Quality of Life and Medico-economic Benefits of Hearing Aids in Alzheimer Disease Patients Suffering From Presbycusis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Presbycusis
Keywords: Alzheimer disease
Cognitive impairment
Sensorineural hearing loss
Hearing aids
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2007-06-19
Enrollment: 51
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 12-months' randomized clinical trial that aims at studying the benefit of bilateral hearing aids in hearing impaired patients suffering from a slight to moderate stage Alzheimer disease.

The benefit of this intervention will be studied in the cognitive, behavioural, quality of life and economic fields.

2groups are involved in this trial: Intervention group: 12 months' treatment with active hearing aids, fitted hearing impairment Control group: 6 months' treatment with placebo hearing aids, followed with 6 months' active hearing aids, fitted hearing impairment


Eligibility criteria: Inclusion Criteria:

* \> 65 year-old
* Medical diagnosis of Alzheimer disease
* 15 ≤ MMSE ≤ 25
* No hearing aids in the last 2 years
* Motivated caregiver living with the patient
* Sensorineural hearing loss

Exclusion Criteria:

* Beginning of an anticholinesterasic treatment in the last 6 months
* Change in the anticholinesterasic treatment in the last 2 months

Primary outcomes:
measure: Cognitive benefit evaluated thanks to the ADAS-Cog scale
timeFrame: Times of measurements: 0, 6th and 12th month
Secondary outcomes:
measure: Cognitive scales: MMSE, Grober and Buschke, Digit symbol test
timeFrame: 0, 6th and 12th month
measure: Behavioural scales: IADL, NPI
timeFrame: 1st week, 3rd 6th 9th and 12th month
measure: Quality of life scales: Zarit scale and ADRQL
timeFrame: Zarit scale(every 2 months during the study time), ADRQL (0, 6th and 12th month)
measure: Consumption questionnaire
timeFrame: monthly
Other outcomes:
Locations:
city: Lyon
country: France
facility: Xavier PERROT
Study officials:
affiliation: Hospices Civils de Lyon
name: Marc BONNEFOY, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen MF, Bonnefoy M, Adrait A, Gueugnon M, Petitot C, Collet L, Roux A, Perrot X; ADPHA study group. Efficacy of Hearing Aids on the Cognitive Status of Patients with Alzheimer's Disease and Hearing Loss: A Multicenter Controlled Randomized Trial. J Alzheimers Dis. 2017;58(1):123-137. doi: 10.3233/JAD-160793.
citation: Adrait A, Perrot X, Nguyen MF, Gueugnon M, Petitot C, Collet L, Roux A, Bonnefoy M; ADPHA study group. Do Hearing Aids Influence Behavioral and Psychological Symptoms of Dementia and Quality of Life in Hearing Impaired Alzheimer's Disease Patients and Their Caregivers? J Alzheimers Dis. 2017;58(1):109-121. doi: 10.3233/JAD-160792.