louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05617742: Comparison of 68Ga-FAPI-46 PET and 18F-FDG PET in Lung Cancer
Official title: 68Ga-FAPI PET in Evaluation of the Patient With Known or Suspected Lung Cancer: Comparison With Standard 18F-FDG PET
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: 68Ga-FAPI-46
Lung Cancer
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 103
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective, single-center, single arm, open label study to evaluate the performance of 68Ga-FAPI-46 for the diagnosis of primary and metastatic lesions of lung cancer with comparison to 18F-FDG PET.

Detailed description: FDG-PET imaging is recommended by clinical guidelines for staging of lung cancer; however, there are still limitations of FDG-PET in lung cancer staging due to false-positive and false-negative findings. 68Ga-FAPI PET images have shown high diagnostic performance with high tumor-to-background ratio in various cancers. The purpose of this study is head-to-head comparison of 68Ga-FAPI-46 PET and 18F-FDG PET for the diagnosis and staging or re-staging of lung cancer.

Eligibility criteria: Inclusion Criteria:

1. Age \> 20 years
2. Informed consent obtained from patients and families
3. Patients with histology confirmed lung cancer or patients with GGO on chest CT planned to have biopsy or surgery
4. Patients scheduled to undergo FDG-PET examination
5. Performance status: 0, 1, 2, 3

Exclusion Criteria:

1. Contraindication to FAPI-PET and FDG-PET such as pregnant, or lactating patients
2. Patients with mainly malignant pleural effusion without other measurable lesions
3. Undergoing irradiation at accrual
4. Active infection or other serious underlying medical conditions not compatible with study entry
5. History of significant neurological or psychiatric disorders including dementia that would prohibit the understanding and giving of informed consent

Primary outcomes:
measure: To define the diagnostic performance 68Ga-FAPI PET
timeFrame: Through study completion, 2 years
Secondary outcomes:
measure: To determine the safety profile of 68Ga-FAPI PET
timeFrame: Up to 7 days post injection with 68Ga-FAPI-46
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Department of Nuclear Medicine, Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Kung-Chu Ho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00282542: Hepatocyte Transplantation as a Life Support Bridge
Official title: The Use of Human Hepatocyte Transplantation as a Life Support Bridge in Terminal Liver Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fulminant Liver Failure
Keywords: Hepatocytes
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2006-01-26
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to gain knowledge about the result of infusing liver cells, carefully matched to blood type, into a subject's body. The hope is that this procedure will aid functions of the liver and prevent death, enable a transplant procedure to be carried out if a donated liver becomes available, and lessen complications in postoperative recovery. There is no guarantee that any of these benefits will be re eived, but even if they are not, the hope is that knowledge gained by using this procedure will be of future benefit to others who also suffer from liver disease.

Detailed description: Adult and pediatric patients eligible for liver transplantation who require intensive care unit admission for multisystem organ failure in addition to liver failure, without systemic sepsis, are eligible for liver cell transplantation regardless of race, sex or financial support.

Failure of 3 or more organ systems are the criterion used to select patients with as close to 100% mortality as possible without solid organ transplant.

Hepatocytes, isolated from excess liver tissure from reduced liver transplant procedures or from donor livers not used for transplantation, are prepared by a complex process and then are infused, guided by radiology into the splenic artery or portal vein of the patient. Patients must be on immunosuppression therapy for as long as the hepatocytes are living and beneficial to the patient.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to VCU Health System ICU in fulminant Liver Failure in addition to multisystem organ failure

Exclusion Criteria: Patients with Sepsis

-

Primary outcomes:
measure: Survival to liver transplantation
Secondary outcomes:
measure: Liver Function Normalization
Other outcomes:
Locations:
Study officials:
affiliation: VCU Health System
name: Robert A Fisher, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02905942: PEG-rhG-CSF in Lymphoma Patients After Autologous Hematopoietic Stem Cell Transplantation
Official title: A Single Center Randomized Controlled Trial of the Efficacy and Safety of PEG-rhG-CSF After Autologous Hematopoietic Stem Cell Transplantation for Lymphoma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Lymphoma
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF on the recovery of hematopoietic function after autologous stem cell transplantation in patients with lymphoma.

Detailed description: At present, there is few related research of Recombinant Human Granulocyte Colony-stimulating Factor applying to AHSCT in China. The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF in lymphoma patients after autologous hematopoietic stem cell transplantation. Eligible patients were randomly assigned to PEG-rhG-CSF group or rhG-CSF group. Patients in PEG-rhG-CSF group received PEG-rhG-CSF day +1 after transplantation with a dose of 100μg/kg. Patients with the weight more than 45kg were suggested a dose of 6 mg. Patients in control group received rhG-CSF day +1 after transplantation with a dose of 5μg/kg once per day until the recovery of neutrophil.

Eligibility criteria: Inclusion Criteria:

1. Patients with age between 18 and 65 years.
2. Lymphoma patients with the requirement for autologous hematopoietic stem cell transplantation.
3. The collected CD34+ cells≥1×10E6/kg.
4. ECOG score ≤2.
5. Heart and lung is normal.
6. Blood creatinine ≤1.5×ULN.
7. ALT, AST, TBIL ≤2 ×ULN
8. Not in pregnancy.
9. Written informed consent are acquired.

Exclusion Criteria:

1. Had received autologous hematopoietic stem cell transplantation or allogeneic transplantation.
2. Severe or uncontrolled infectious diseases: HIV, HCV, syphilis, ALT, chronic hepatitis B.
3. Serious complications, such as severe infection, heart, lung, liver and kidney dysfunction.
4. LVEF \<55%.
5. Allergic to the product or other biological products from genetically engineered Escherichia coli strains.
6. Refused to take contraceptive measures during the study period and the subsequent 1 years.
7. Severe mental or neurological disorders.
8. Serious heart, lung, central nervous system disorders.
9. Sickle cell anemia, hemolytic anemia and other hematologic diseases.
10. Participate in other drugs clinical trials 30 days before the screening.
11. Other situation that investigators consider as contra-indication for this study.

    -

Primary outcomes:
measure: Time to neutrophil engraftment
timeFrame: 30days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jun Zhu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02306642: Follow-up of AKI in Neonates During Childhood Years
Official title: Long Term Follow-up of Acute Kidney Injury in Very Low Birth Weight Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonatal Acute Kidney Injury
Childhood Chronic Kidney Disease
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children born prematurely less than 1500 grams who stayed in the University of Virginia NICU.

Brief summary: The purpose of this study is to learn more about how to identify signs of early chronic kidney diseases in children who were born prematurely with low birth weight (less than 3 ½ pounds). Researchers plan to compare the kidney function in children who experienced acute kidney injury (AKI) in the Neonatal Intensive Care Unit (NICU) with those who did not experience it. Evidence from several studies and our experience at UVA show that older children who experienced AKI while in the Pediatric Intensive Care Unit (PICU) have increased risk of developing early chronic kidney disease, and they also show early changes in the urine and blood that is consistent with early chronic kidney disease. In this study, the investigators hope to determine if any of these changes can be detected in early childhood, and if so, at what age we can start detecting these changes.


Eligibility criteria: Inclusion Criteria:

* Premature birth for Premature groups
* UVA NICU admission prior to 2 days of life
* Birth weight less than 1500 grams for premature groups
* Premature AKI Study group: Acute Kidney Injury as defined by KDIGO modified criteria during NICU stay at UVA
* Premature no AKI Control group: No AKI during NICU stay
* Term no AKI Control group: No AKI and born at term
* Parental or legal guardian consent obtained

Exclusion Criteria:

- Patients with Congenital Anomalies of the Kidney and Urinary Tract

Primary outcomes:
measure: Composite Abnormality
timeFrame: Age 2-7 years
Secondary outcomes:
measure: Growth
timeFrame: Age 2-6 years
measure: Kidney Size
timeFrame: Age 2-6 years
measure: Urinary Biomarkers
timeFrame: Age 2-6 years
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
Clinical trial NCT01795742: Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer
Official title: Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer in the Treatment of Mild to Moderate Asthma in El Salvador
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Nebulizers
Salbutamol
Developing Countries
Lead sponsor: Marquette University
Sponsor class: OTHER
First posted: 2013-02-21
Enrollment: 110
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an equivalence study comparing an electric nebulizer with a human-powered nebulizer--one that does not need electricity--in the treatment of mild to moderate asthma exacerbations in a regional clinic in San Salvador, El Salvador.

Detailed description: The study design is to treat individuals suffering from mild to moderate exacerbations of asthma with nebulized salbutamol (2.5mg). Subjects will receive nebulization using either an electric nebulizer compressor or a human-powered nebulizer compressor. Improvement in peak expiratory flow will be the primary endpoint. Blood oxygenation levels as measured by pulse oximetry will be a secondary endpoint of the trial.

Eligibility criteria: Inclusion Criteria:

* Suffering from Mild or Moderate Asthma symptoms
* Increased respiratory rate, but not over 30 breaths per minute
* Reduced peak expiratory flow rate, but not less than 60% of normal
* Oxygen saturation levels reduced but greater than 90%

Exclusion Criteria:

* Any other respiratory condition that would interfere with nebulizer treatment
* If any other medication is being taken at the time
* Pregnant women or women who may think they might be pregnant
* Never taken salbutamol before

Primary outcomes:
measure: Improvement in Peak Expiratory Flow
timeFrame: From before to after nebulizer treatment lasting approximately 30 minutes
Secondary outcomes:
measure: Improvement in blood oxygenation as measured by pulse oximetry
timeFrame: From before to after nebulizer treatment lasting about 30 minutes
Other outcomes:
Locations:
city: Ilopango
country: El Salvador
facility: Hospital Nacional San Bartolo
state: San Salvador
Study officials:
affiliation: Marquette University
name: Lars E Olson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hallberg CJ, Lysaught MT, Najarro RA, Cea Gil F, Villatoro C, Diaz de Uriarte AC, Olson LE. Treatment of asthma exacerbations with the human-powered nebuliser: a randomised parallel-group clinical trial. NPJ Prim Care Respir Med. 2014 Jun 26;24:14016. doi: 10.1038/npjpcrm.2014.16.
Clinical trial NCT05730270: Effects of Smartphone-Based Stress Reduction Training on Social Relations
Official title: Effects of Smartphone-Based Stress Reduction Training on Social Relations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotions
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research study is to find out how two different online stress reduction training programs affect people's daily experiences and social relations. The researchers think that people's thoughts, emotions, and behavior toward others may be influenced by stress reduction programs. This study will allow them to study the effectiveness of stress reduction programs for important real-world psychological outcomes.


Eligibility criteria: Inclusion Criteria:

* Virginia Commonwealth University students
* age 18 years or older
* Healthy
* English literate
* non-immigrant
* not practicing stress reduction techniques for more than 60 minutes a week
* ownership of a smartphone

Exclusion Criteria:

* People who are not Virginia Commonwealth University students
* major, uncorrected sensory impairments and cognitive deficits
* psychiatric disorders or history thereof
* new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months
* current drug abuse

Primary outcomes:
measure: Change in state emotion regulation
timeFrame: Baseline to post intervention, approximately 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
References:
Clinical trial NCT03217370: Study on Patient Blood Management in Haematological Patients
Official title: Study on Patient Blood Management in Haematological Patients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Blood Transfusion
Haematology
Keywords: patient blood management
restrictive transfusion
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: observational cross-sectional study with pre and post measurement and in between an interventional phase with education, IT implementations etc.
Primary purpose: TREATMENT

Brief summary: The investigators noticed a variable prescription of blood components to haematological patients in the hospital. This study will analyze the prescription and administration of blood components to Haematological patients (pre measurement). Based on these results guidelines on transfusion triggers will be updated and educated to the physicians and new ICT (information and communications technology) implementations will be added to the electronic order for blood components. The investigators hope to see afterwards (post measurement) a more stable prescription and administration of blood components and a more economic use of blood components.

Detailed description: This study is set up as a first step of implementing patient blood management (PBM) in this hospital. PBM is an evidence-based, multidisciplinary approach to optimizing the care of patients who might need transfusion. Not only in pre/per/postoperative setting but also in haematology PBM guidelines can be implemented. Examples are: use of a restrictive haemoglobin trigger for red blood cells (RBC) transfusion, single use policy for the administration of RBC and platelets, administration only for correct indications (including the introduction of an electronic clinical decision support system for ordering blood components), ...

Eligibility criteria: Inclusion Criteria:

* all adult patients hospitalised at the haematology wards of the University Hospitals of Leuven (UZ Leuven) between 01/08/2017 and 31/07/2018 (pre measurement) and between between 01/08/2019 and 31/07/2020 (post measurement)

Exclusion Criteria:

* ambulatory patients
* patients without blood transfusion administered in their hospitalised period
* patients with no haematological illness that were hospitalised at the haematological wards

Primary outcomes:
measure: how do haematologists prescribe blood components?
timeFrame: up to 1 year pre measurement and up to 1 year post measurement
Secondary outcomes:
measure: what's the effect of the interventional phase?
timeFrame: up to 1 year (post measurement)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: advanced clinical nurse specialist
name: Els Costermans, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01818570: A Study of Local Effect and Safety of a Single PPC-5650 Dose on Reflux Pain During Pain Stimulation in the Esophagus
Official title: A Single-center, Randomized, Double-blind, Cross-over Trial in Healthy Volunteers Investigating the Local Efficacy and Safety of a Single Intra-luminal Administration of PPC-5650 on Reflux Pain and Hyperalgesia During Multimodal Stimulation of the Esophagus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastroesophageal Reflux
Gastroesophageal Reflux Disease
Keywords: Gastroesophageal Reflux
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2013-03-26
Enrollment: 25
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the effect of a single PPC-5650 dose in a human pain model including multimodal (mechanical, thermal, electrical, chemical) stimulations of the esophagus.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent before any study specific procedures
* Able to read and understand Danish.
* Healthy i.e. no history of chronic or recurrent pain rewarding diseases
* Able to co-operate and tolerate the experimental procedures (as assessed in the training visit)
* No over the counter medication 24h before the three visits
* No medications in the study period
* BMI 18.5-35.0
* Caucasian
* No symptoms of Gastroesophageal reflux disease
* All men must use a safe method of contraception during the study period

Exclusion Criteria:

* Any clinically relevant abnormal values from the laboratory tests on hematology, clinical chemistry, and/or urine analyses, as judged by the investigator.
* Participation in any other clinical trial within three months prior to the training day.
* Alcohol or drug abuse.
* Mental illnesses
* Allergic to the active ingredient in the investigational medicinal product

Primary outcomes:
measure: Changes in pain scores recorded after multimodal pain stimulations (mechanical, thermal, electrical, and chemical)
timeFrame: 4 hours
Secondary outcomes:
measure: Number of observed adverse effects (safety profile) and changes in size of referred pain area
timeFrame: 1 month
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Mech-Sense, Department of Medical Gastroenterology, Aalborg University Hospital
state: Jutland
Study officials:
affiliation: Mech-Sense, Department of Medical Gastroenterology, Aalborg Hospital
name: Asbjørn M Drewes, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olesen AE, Nielsen LM, Larsen IM, Drewes AM. Randomized clinical trial: efficacy and safety of PPC-5650 on experimental esophageal pain and hyperalgesia in healthy volunteers. Scand J Gastroenterol. 2015 Feb;50(2):138-44. doi: 10.3109/00365521.2014.966319. Epub 2014 Dec 8.
Clinical trial NCT03736070: Assessment of Routine Oral Screening Programs for New Prisoners
Official title: Assessment of Routine Oral Screening Programs for New Prisoners in France
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Disease
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: General Health Office, France
First posted: 2018-11-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: New prisoners

Brief summary: In 2018, 10 detention centers in France will start organisational programs to improve the quality of screening of oral diseases, relatively to French recommendations, among new prisoners in France. Our study aims 1) to assess the prevalence and nosology of oral diseases ; 2) to describe the care pathway of participants during their stay in the detention center where they were included ; 3) to assess the cost of care per patient, from a societal perspective, using a top-down method.


Eligibility criteria: Inclusion criteria:

* new prisoners
* fluent French language

Exclusion criteria:

* adult guardianship

Primary outcomes:
measure: Description of the oral problems of people entering detention
timeFrame: 1 day
Secondary outcomes:
measure: attending to consultations
timeFrame: The collection of data will end at the discharge of the participant, or at 6 months after inclusion.
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Claire M DUFLOS
role: PRINCIPAL_INVESTIGATOR
References: