louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04633915: Antibody Response in Hemodialysis and Non-dialysis Patients Diagnosed With COVID-19.
Official title: A Comparison of Antibody Response Against SARS-CoV-2 in Hemodialysis and Non-dialysis Patients Diagnosed With COVID-19.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dialysis
Covid19
Keywords: antibodies
IgG
CKD
hemodialysis
Lead sponsor: Saint Petersburg State University, Russia
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient ≥ 18 years old who were diagnosed with SARS-CoV-2 infection confirmed by PCR or strongly suspected on computed tomography within 10 weeks prior enrollment.

Main group include patients with chronic kidney disease stage 5, receiving hemodialysis as a renal replacement therapy.

The another group include volunteers who are not dialysis-dependent.

Brief summary: This is prospective cohort study aimed to compare antibody response against SARS-CoV-2 in dialysis patients and non-dialysis-dependent volunteers.

The research hypothesis is that dynamic of IgG antibodies against SARS-CoV-2 will differ in two groups.

To determine whether there is a statistically significant interaction between factors "group" and "time" on the titer of IgG antibodies against SARS-CoV-2, a two-way repeated measures ANOVA will be used.

Detailed description: In both groups level of IgG antibodies against SARS-CoV-2 will be measured at the Day 1 (10 weeks from the date of first symptoms), Weeks 8 and 16 from the Day 1.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* SARS-CoV-2 infection within 10 weeks prior enrollment, confirmed by PCR or strongly suspected on computed tomography
* Providing informed consent

Exclusion Criteria:

* Refusal to provide informed consent

Primary outcomes:
measure: Anti-SARS-COV-2 IgG level
timeFrame: 16 weeks
Secondary outcomes:
measure: Proportion of people with detectable Anti-SARS-COV-2 IgG in study groups
timeFrame: Day 1, weeks 8, 16
measure: Anti-SARS-COV-2 IgG level
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg State University Hospital
Study officials:
References:
Clinical trial NCT00252915: Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock
Official title: Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock: a Prospective, Randomised, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sepsis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2005-11-15
Enrollment: 38
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: There is basic science evidence that GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can be achieved in patients with severe sepsis and septic shock.

Detailed description: GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can be achieved in patinets with severe sepsis and septic shock.

Eligibility criteria: Inclusion Criteria:

* Severe sepsis or septic shock,
* Presence of infection,
* 2 SIRS criteria,
* Acute organ dysfunction,
* Immunoparalysis,
* Informed consent

Exclusion Criteria:

* Pregnancy,
* Known allergies to study medication or components,
* Moribound patient,
* Autoimmune disease,
* HIV-infection,
* Acute MI or pulmonary embolism,
* Cpr during last 72 hours,
* Patients who participate in a different clinical study

Primary outcomes:
measure: reconstitution of monocytic immunity as defined as a mHLA-DR expression >15,000 molecules per cell at study day 9
timeFrame: after therapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Charite University, Berlin, Germany
name: Hans-Dieter Volk, MD
role: STUDY_CHAIR
affiliation: Charite University Medicine
name: Joerg C Schefold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University Medicine
name: Christian Meisel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meisel C, Schefold JC, Pschowski R, Baumann T, Hetzger K, Gregor J, Weber-Carstens S, Hasper D, Keh D, Zuckermann H, Reinke P, Volk HD. Granulocyte-macrophage colony-stimulating factor to reverse sepsis-associated immunosuppression: a double-blind, randomized, placebo-controlled multicenter trial. Am J Respir Crit Care Med. 2009 Oct 1;180(7):640-8. doi: 10.1164/rccm.200903-0363OC. Epub 2009 Jul 9.
Clinical trial NCT03033615: PixelShine vs. Iterative Reconstruction (IR) Processing of CT Images
Official title: Prospective Review of CT Imaging Data Comparing Quality of Low-Radiation-Dose Images Post-Processed With Iterative Reconstruction Software vs. Machine Learning (AlgoMedica PixelShine) Software
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer, Lung
Cancer Liver
X-rays; Effects
Lead sponsor: AlgoMedica, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cedars-Sinai Medical Center
First posted: 2017-01-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will compare the quality of CT images acquired with very low-dose radiation and processed with commercially available software vs. PixelShine processed images. It would potentially allow imaging facilities to acquire CT scans using lower doses of radiation without sacrificing clarity of CT images. Acquiring high quality CT images with low-dose radiation has the potential to enhance patient safety and has significant implications in imaging practices.

Detailed description: Patients receiving CT scans as part of their standard treatment will be asked to consent to an additional 5 minutes of imaging using very low-dose radiation prior to the conventional-dose CT scan. The prospective review will be performed in two cohorts: Chest CT scans and abdominal CT scans.

Anonymized images will be processed by conventional CT software and compared to the same images processed with machine-learning-based PixelShine. A board-certified radiologist will assess the noise and visual quality of the imaging data.

Study patients will receive approximately 10% more dose than a standard CT scan by participating in the study. There are no known short-term safety issues associated with this study. The study-related very low dose radiation is at a level far below that used for conventional x-ray imaging. The study has been approved by the Radiation Safety Committee as part of the review process.

Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years of age or older
* Patients must be able and willing to consent to participate in this project
* Patients will be scheduled for a standard of care CT scan

Exclusion Criteria:

* This study does not investigate either a specific disease or a specific patient population-it only examines and compares images obtained at low radiation exposure post-processed with Algomedica's PixelShine software with conventionally processed images
* All other patients will be excluded

Primary outcomes:
measure: Visual Image Quality as Assessed by Image Noise Reduction
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
measure: Image Resolution as Assessed by Size of Detected Lesions
timeFrame: Through study completion, an average of 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02547415: Chronic Pain in Children and Adolescents.
Official title: Study of Characteristics of Medically Unexplained Chronic Pain in Children and Adolescents.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Chronic
Keywords: Pain, Chronic
children
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-09-11
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescent with chronic pain

Brief summary: Medically unexplained chronic pain - without identifiable somatic origin - is yet an insufficiently known and explored field in children and adolescents by international clinical works. This research aims to characterize somatic, psychological, psychopathological and environmental (particularly attachment styles and family functioning) processes trough an observational study with three pain management centers.

The study concerns children and adolescents from 7 to 17 years old, suffering of medically unexplained chronic pain and their parents who are referred to a pain center. It is composed of a somatic, psychological and family functioning assessment on the one hand and psychopathological and attachment evaluation on the other hand.

Detailed description: Participation in the study involves an additional visit to 1 day pain center to answer questionnaires about anxiety, family environment, depression and psychological testing

Eligibility criteria: Inclusion Criteria:

* Children and adolescent with chronic pain no proven medical cause, type of painful somatic complaints within the scope of one of the following diagnoses to ICD-10 (International Classification of Diseases) and DSM-IV and DSM-V (Diagnostic and Statistical Manual of Mental Disorders) to somatoform disorders, distinguishing between :

  * pain disorder
  * somatoform disorder
  * undifferentiated somatoform disorder
* Addressed to the pain centers or in pediatric chronic pain services hosting children.
* being fluently French-speaking and French-reading

Exclusion Criteria:

presence of current or past organic pathology including migraines and epilepsy, which may interfere with somatic expression of studied disorder

Primary outcomes:
measure: Explanatory factors for pain
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de LYON
city: Paris
country: France
facility: Hopital TROUSSEAU
city: Paris
country: France
facility: Hopital NECKER
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Anne-Marie PERRIN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02170532: Aerosolized Beta-Agonist Isomers in Asthma
Official title: Aerosolized Beta-Agonist Isomers in Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: asthma
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Dr. MacIntyre and his colleagues are studying inhaled medications in asthma. There are two new medications that have been approved by the United States Food and Drug Administration (FDA): levalbuterol and formoterol. Both of these drugs are similar to standard asthma bronchodilator drugs but offer theoretical advantages in terms of fewer side effects. There are also newer devices to deliver these medications into the lungs: breath actuated nebulizers (BANs) and non-static chambers (Aerochamber-max) that can be used with metered dose inhalers (MDIs or "puffers"). The purpose of this study is to deliver these new medications using several different devices and measuring lung function, heart rate, and sensations of breathlessness.

Detailed description: Patients will be studied on five separate mornings. The duration of the study and frequency of the visits will be solely dependant on the subject availability. Each subject will receive all 5 treatments in the same order.

Eligibility criteria: Inclusion Criteria:

* stable mild to moderate persistent asthma as defined by the National Asthma Education and Prevention Program
* greater than 18 years of age
* requiring bronchodilator therapy either routinely or on a as needed (PRN)basis
* stable with respect to respiratory disease and at least four weeks removed from the most recent acute exacerbation of the disease
* patients may or may not be on inhaled corticosteroids

Exclusion Criteria:

* no unstable cardiovascular symptoms
* no unstable angina
* must be at least four weeks removed from an acute coronary syndrome

Primary outcomes:
measure: Change in Maximum Forced Expiratory Volume at One Second (FEV1)
timeFrame: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment
Secondary outcomes:
measure: Change in 8 Hour Area-under-the-curve FEV1
timeFrame: 0 to 8 hours post dose
measure: Change in Heart Rate
timeFrame: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment
measure: Change in Tremor Assessment Measured by a Scale
timeFrame: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment
measure: Change in Dyspnea Response as Measured by the University of California, San Diego (UCSD) Dyspnea Scale
timeFrame: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Neil MacIntyre, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01850732: Screening of Abdominal Aortic Aneurysms Among Male Patients With TIA Symptoms
Official title: Screening of Abdominal Aortic Aneurysms Among Male Patients With TIA Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: North Karelia Central Hospital
Sponsor class: OTHER
First posted: 2013-05-09
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Primary purpose: SCREENING

Brief summary: The purpose of this study is to investigate the prevalence of abdominal aortic aneurysms (AAA) among male patients with transient ischemic attack (TIA) symptoms. Ethiology of AAA is known to be common with atherosclerotic arterial diseases (coronary artery disease, peripheral artery disease and carotid artery disease), so the hypothesis is that AAA should be more common among these TIA patients, thus making screening of these patients (for AAA) more cost-efficient.

Study will be carried out as a prospective screening study. Data will be collected in North Karelia Central Hospital within one year. All male patients with TIA symptoms will be recruited for the study and screened for AAA with ultrasound.


Eligibility criteria: Inclusion Criteria:

* male patient who has had symptoms of transient ischemic attack (TIA)

Exclusion Criteria:

* Patient's denial to participate
* Female gender
* Already diagnosed or treated abdominal aortic aneurysm

Primary outcomes:
measure: Maximum diameter (mm) of abdominal aorta (outer-to-outer wall) in ultrasound
timeFrame: upon screening (collection of data will take one year)
Secondary outcomes:
Other outcomes:
Locations:
city: Joensuu
country: Finland
facility: North Carelia Central Hospital
state: Pohjois-Karjala
Study officials:
References:
Clinical trial NCT01573832: Integrated Client Care Project Trial: Wound Care Evaluation
Official title: Integrated Client Care Project Randomized Control Trial: Wound Care Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 13999
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will use a randomized control trial design to compare wound care clients who receive "integrated care" versus "usual care" in Community Care Access Centres (CCAC) in Ontario. Data will be collected by existing administrative databases and linked by the Institute for Clinical Evaluative Sciences (ICES). The researchers will analyze these databases and report findings.

Detailed description: The researchers are interested in finding out whether the intervention ("integrated care") helps to improve patient outcomes. A randomized control trial of wound care clients in Ontario CCACs will show the effects of the intervention (integrated care) versus "usual care" clients. The researchers will also examine the financial system costs associated with providing "integrated care" to clients versus "usual care".

The researchers expect to answer the research question of whether there is difference in patient outcomes between "integrated care" versus "usual care clients." The researchers also would like to formulate a response for whether there will be financial system cost difference between "integrated care" and "usual care" clients.

The goal of this evaluation is to help decision-makers in the Ministry of Health and Long Term Care (MOHLTC), in the Community Care Access Centres (CCACs) and among provider organizations to improve the quality of care and patient outcomes for wound care clients, by evaluating innovations in the delivery of care.

Eligibility criteria: Inclusion Criteria:

* receives wound care from Community Care Access Centre provider
* adults over age 18 in Ontario

Exclusion Criteria:

* patients who do not receive wound care from Ontario Community Care Access Centres

Primary outcomes:
measure: percentage of patients whose wound heals within the outcomes benchmark
timeFrame: 1 year
Secondary outcomes:
measure: time to wound healing outcomes
timeFrame: 1 year
measure: total patient length of stay
timeFrame: at patient discharge, up to 365 days
Other outcomes:
Locations:
Study officials:
affiliation: Sunnybrook and Women's Hospital
name: Merrick F Zwarenstein, MB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zwarenstein M, Shariff S, Mittmann N, Stern A, Dainty KN. A large cluster randomized trial of outcome-based pathways to improve home-based wound care. Trials. 2017 Aug 29;18(1):393. doi: 10.1186/s13063-017-2082-5.
Clinical trial NCT03857932: Establishment and Clinical Application of Precise SLNB System in Breast Cancer: a Randomized, Multicenter, Controlled Study
Official title: Clinical Study on Regularity of Lymphatic Drainage and Surgical Treatment of Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigatorsconduct the precise sentinel lymph node biopsy using preoperative computed tomographic lymphography in breast cancer. The investigators aimed to summarize the law of lymphatic drainage of breast, and to conduct the accurate surgical treatment of breast cancer.

Detailed description: AIM:Sentinel lymph node biopsy (SLNB) is the standard technique for patients with early stage breast cancer. The investigators conduct the precise sentinel lymph node biopsy using preoperative computed tomographic lymphography in breast cancer. And The investigators identify the true sentinel lymph nodes(SLNs) followed by lymphatic ducts during operation. The investigators aimed to identify the non-sentinel lymph node, and to investigate the relationship between upper extremity lymphatic drainage. The SLNB procedure could avoid unnecessary lymph node resection and reduce treatment-related sequela.

Arm1：

1. Participants received preoperative computed tomographic lymphography
2. Participants received sentinel lymph node biopsy（SLNB）
3. Participants received stained non-sentinel lymph node resection during SLNB
4. Participants received axillary reverse mapping dissection Arm2： Participants receive sentinel lymph node biopsy

Eligibility criteria: Inclusion Criteria:

1. histologically confirmed primary breast cancer by core needle biopsy or excisional biopsy
2. abnormal para-sentinel lymph node was found by ultrasound examination
3. ultrasound-guided fine needle aspiration cytology of these nodes were performed
4. the result of fine needle aspiration cytology was negative (no tumour cell was found)
5. participants planed to perform SLNB

Exclusion Criteria:

1. pathological diagnosed ductal carcinoma in situ by excisional biopsy
2. the result of fine needle aspiration cytology was positive
3. participants has received neo-adjuvant system therapy

Primary outcomes:
measure: Disease free survival
timeFrame: Up to 10 years
Secondary outcomes:
measure: Overall survival
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qifeng Yang
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Qifeng Yang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00643032: Preoperative Anxiety and Postoperative Pain in Children
Official title: Comparison of 2 Methods to Reduce Postoperative Pain in Children and a Comparison of 3 Methods of Preoperative Education Intervention to Reduce Anxiety in Children and Their Family
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Post-Operative Pain
Pre-Operative Anxiety
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-03-25
Enrollment: 250
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: We wish to study which method of local injection of analgesic (before or during surgery) is the more effective method to reduce post-operative pain in children. In addition, we wish to study which pre-operative educational intervention is more effective in reducing anxiety in children and their family.


Eligibility criteria: Inclusion Criteria:

* Healthy
* ASA I - II
* Undergoing elective day surgery

Exclusion Criteria:

* Known coagulation dysfunction
* Sensitivity to analgesics

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References: