louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04691349: CAR-T for r/r Malignant Tumors in Children
Official title: Chimeric Antigen Receptor T Cells Therapy for r/r Malignant Tumors in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: CAR-T
Child, Only
Malignant Tumor
Lead sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-31
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a clinical study of CAR-T treatment of patients with relapsed/refractory malignant tumors in children. The purpose is to evaluate the safety and effectiveness of chimeric antigen receptor T cells in the treatment of relapsed/refractory malignant tumors in children.


Eligibility criteria: Inclusion Criteria:

* Age 3-18
* Expected survival time ≥ 12weeks
* ECOG 0-2
* At least second-line or above chemotherapy failed
* Liver and kidney function, heart and lung function meet the following requirements:

Creatinine is within the normal range; Left ventricular ejection fraction ≥ 45%; Baseline blood oxygen saturation\>91%; Total bilirubin≤1.5×ULN; ALT and AST≤2.5×ULN

* Understand the trial and have signed the informed consent

Exclusion Criteria:

* Those who have graft-versus-host disease (GVHD) or need to use immunosuppressive agents
* Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer test is not within the normal reference range; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) Antibody positive; CMV DNA test positive; Syphilis test positive
* Severe heart disease
* Systemic diseases judged by the investigator to be unstable: including but not limited to severe liver, kidney or metabolic diseases that require medication
* Within 7 days before screening, there are active infections or uncontrollable infections that require systemic treatment (except for mild urogenital infections and upper respiratory tract infections)
* Those who have received CAR-T therapy or other genetically modified cell therapy before screening
* According to the researcher's judgment, it does not meet the situation of cell preparation
* Situations that other researchers think are not suitable for inclusion

Primary outcomes:
measure: ORR3
timeFrame: Three months after CAR T cell infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Chilren's Hospital of Soochow University
state: Jiangsu
Study officials:
References:
Clinical trial NCT04556149: imPulse™ Una Full-spectrum, Over Clothing E-stethoscope
Official title: SARS-CoV-2/COVID-19 Study of the Audible and Inaudible Vibroacoustic E-stethoscope - imPulse™ Una
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corona Virus Infection
Coronavirus
Keywords: infrasound
e-stethoscope
biosignature
SARS-CoV-2/COVID-19
Lead sponsor: Level 42 AI, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Schmidt Futures
name: Johns Hopkins University
First posted: 2020-09-21
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult men and women will be recruited from among hospitalized patients with symptomatic COVID-19 infection who are not receiving ventilator support. One hospitalized control without lung disease or pulmonary symptoms will be selected for each case.

Brief summary: This study generates robust clinical data to train ML/AI algorithms of the Sponsor's imPulse™ Una full-spectrum e-stethoscope for digital diagnostic feature synthesis of symptomatic SARS-CoV-2/COVID-19 biosignatures for rapid and accurate mass screening.

Detailed description: This study is designed to evaluate the ability of the imPulse™ Una e-stethoscope to differentiate vibroacoustic signals in inpatients with and without confirmed COVID-19 as the first step to establish the performance characteristics - sensitivity, specificity, positive and negative predictive value - of the imPulse™ Una device for early and rapid, point-of-care diagnosis of COVID-19. This will inform the utility and design of further larger-scale studies using the device.

Eligibility criteria: Inclusion Criteria

* Individuals hospitalized within a Johns Hopkins-affiliated hospital
* Able to understand and willingness to comply with study procedures
* Cases - inpatients with positive COVID-19 PCR test, collected from a respiratory sample within the last 7 days, AND pulmonary symptoms within 72 hours of enrollment
* Controls - inpatients without COVID-19 diagnosis and no pulmonary diagnosis or symptoms
* Cases or Control not able to sit or stand will be allowed to participate in just the parts of the staircase exam they're capable of doing.

Exclusion Criteria

* Assisted ventilation, including high flow nasal cannula, or ventilator support
* Unable to comply with study procedures, defined at investigator's discretion
* Participants with any visible skin infections or open wounds in areas where the imPulse™ Una device would be applied

Primary outcomes:
measure: Diagnostic performance characteristics
timeFrame: through study completion, an average of 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Kelly Dooley, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins School of Medicine
name: Ed Fuchs, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT00744549: Study of Antioxidants on MRI Detectable Early Stage Prostate Cancer Among Men on Active Surveillance
Official title: The Impact of Antioxidants on MRI Markers of Cell Proliferation and Hypoxia Among Men on Active Surveillance With Early Stage Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer of the Prostate
Prostate Cancer
Prostatic Neoplasms
Keywords: Male Urogenital Diseases
Antioxidants
Vitamin E
Vitamin D
Lycopene
Selenium
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: The Prostate Cancer Research Foundation of Canada
First posted: 2008-09-01
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether antioxidants (vitamin E, selenium and lycopene)can change(reduce)prostate tumor size or blood flow to the prostate as determined by MRI imaging among men on Active Surveillance.


Eligibility criteria: Inclusion Criteria:

* MRI detectable prostate cancer
* PSA less than 15 ng/ml
* Gleason score \<= 7
* Prostate cancer staging T1c or T2a

Exclusion Criteria:

* Concurrent use of high-dose vitamins which include selenium, lycopene, vitamin D or vitamin E
* Other malignancies diagnosed or requiring treatment within the past 5 years (except superficial bladder cancer or basal cell carcinoma)
* Current use of Proscar or Avodart

Primary outcomes:
measure: To determine the impact of combination vitamin E, lycopene, and selenium on MRI detected prostate tumor size and/or tumor blood flow among me on active surveillance
timeFrame: At baseline MRI compared to 1-year MRI compared to 2-year MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network - Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Neil Fleshner
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01849549: Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage
Official title: Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damaged Subjects.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebrovascular Disorders
Brain Lesions
Degenerative Diseases
Developmental Pathology
Keywords: neuropsychological Study
brain Imaging
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Two groups of subjects will be constitute: (i) patients with circumscribed brain injury (including stroke, vascular malformations, tumor or circumscribed infectious lesions) or degenerative disorders and selective cognitive disorders; (ii) healthy control subjects.

The objective of this project is to evaluate specific neuropsychological deficits and apply current brain imaging techniques (anatomical, diffusion, functional) to patients suffering from these cognitive deficits due to brain damage, in order to elucidate the brain mechanisms underlying these deficits.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 80 years
* french language
* effective contraception for women during the study
* informed consent
* no alcohol intake the day before the exam
* for patients only, focal cerebral lesion (stroke, malformation, tumor, inflammatory, infectious, traumatic), neonatal pathology or degenerative disease with cognitive deficit

Exclusion Criteria:

* for healthy volunteers: previous neurological history (except non complicated migraine), previous psychiatric history (except depression with good evolution or anxiety with maximum one anxiolytic treatment), or severe cranial traumatism
* for patients: vigilance disorders, severe depression or anxiety.
* for both: psychotropic medication other than a hypnotic or an anxiolytic at low doses without dose modification for at least one month, severe visual or auditory impairment, patient without judicial or administrative liberty, measure of legal protection or no capable to express their consent, pregnancy or breastfeeding, contraindication for MRI, participation in another trial or former involvement in another trial within one month

Primary outcomes:
measure: Cognitive deficit
timeFrame: 3 to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU - Hôpitaux de Rouen
Study officials:
affiliation: service de Neurologie
name: Olivier MARTINAUD, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01783249: Influence of Exercise on Anemia in MDS Patients
Official title: The Influence of Exercise on Anemia in MDS Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Feasibility Pilot Study
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: That exercise will reduce anemia and fatigue, while improving aerobic capacity, strength and hematopoietic stem and progenitor cell mitochondrial function.


Eligibility criteria: Inclusion Criteria:Have a confirmed diagnosis of MDS, Have approval of the study medical monitor, be able to read English, be 21 years of age or older, give informed consent -

Exclusion Criteria: Have physical limitations, be identified in the active or maintenance stage of exercise behavior

-

Primary outcomes:
measure: Feasibility data on the effect of a stationary cycling program
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center, University of Rochester
state: New York
Study officials:
References:
Clinical trial NCT03973749: Effects of a High or Low Salycilate Diet on Urinary LTE4 and Clinical Features in AERD
Official title: Effects of a High or Low Salycilate Diet on Urinary Leucotriene E4 Levels and Clinical Features in Patients With Aspirin Exacerbated Respiratory Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aspirin-exacerbated Respiratory Disease
Aspirin-Sensitive Asthma With Nasal Polyps
Samter's Syndrome
Widal Syndrome
Lead sponsor: Instituto Nacional de Enfermedades Respiratorias
Sponsor class: OTHER_GOV
First posted: 2019-06-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: On day one, two groups of nine patients each will respectively recieve the tree daily meals (breakfast, Lunch and dinner) in a controled clinical setting. Group 1 will recieve a low-salycilate diet, and group 2 a high-salycilate diet. Two hours after each meal, urinary Leucotriene E4, FEV1, FVC, FEV1/FVC and total nasal resistance will be measured. On day 7, after clearance time, group 1 will recieve high-salycilate diet and group 2 low salycilate diet and the same measurements will be obtained.


Eligibility criteria: Inclusion Criteria:

* Confirmed Aspirin exacerbated respiratory disease.
* Controled asthma
* No actual systemic corticosteroid treatment
* No antileucotriene treatment.

Exclusion Criteria:

* Patients who do not complete both phases of the study
* Patients unable to perform adecuate spyrometric testing
* Patients who present severe asthmatic reactions with high salycilate foods

Primary outcomes:
measure: Change from baseline in Urinary concentration of Leucotriene E4 (LTE4)
timeFrame: Baseline-4-8-12 hours in day one and Baseline-4-8-12 hours in day 7
Secondary outcomes:
measure: Change from baseline in Expiratory Volume in 1 second (FEV-1)
timeFrame: Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
measure: Change from baseline in Vital Capacity (FVC)
timeFrame: Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
measure: Change from baseline in the Relationship between FEV1/FVC
timeFrame: Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
measure: Change from baseline in the total nasal resistance obtained by rhinometry
timeFrame: Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias
state: Ciudad DE Mexico
Study officials:
References:
Clinical trial NCT03139149: Comparison of Early Operative Treatment and 48 h Conservative Treatment in Small Bowel Obstruction
Official title: Comparison of Early Operative Treatment (12 h) and 48 h Conservative Treatment in Acute Small Bowel Obstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Small Bowel Obstruction
Small Bowel Adhesion
Strangulation of Ileum
Keywords: conservative treatment
laparoscopic adhesiolysis
strangulation
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 200
Sex: ALL
Minimum age (years): 17
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the results of early surgery after 12 h conservative treatment and 48 h conservative treatment of adhesive small bowel obstruction.

Detailed description: At the admission patients undergo abdomen x-ray, general and biochemical blood test and computer tomography (CT). After exclusion of indications for an emergency operation, patients are given a water-soluble contrast. Conservative treatment is carring out to 12 hours from admission. All patients with resolution of small bowel obstruction in 12 hours will be excluded from the research. Criteria for obstruction release of conservative treatment 1. No pain 2. Appearance of gas in the colon 3. Decrease of bloating 4. Contrast in the colon. After that, if obstruction is not resolved, randomization is performed. First group undergo surgery. Second group undergo conservative treatment with water-soluble contrast evaluation until 48 hours. In the second group surgery is performed if the conservative treatment is not effective. The results of early and late surgery and the results of conservative treatment in groups will be compared.

Eligibility criteria: Inclusion Criteria:

Patients with adhesive small bowel obstruction

Exclusion Criteria:

Early postoperative small bowel obstruction Irreducible hernia Strangulation or peritonitis symptoms Impairment of consciousness Unstable hemodynamics

Primary outcomes:
measure: Quantity of patients with obstruction release after conservative treatment
timeFrame: in the 2nd group - 48 hours
Secondary outcomes:
measure: Readmission rate in conservative treatment and surgery
timeFrame: 12 months
measure: 30 days mortality
timeFrame: 30 days
measure: Complications rate
timeFrame: 30 days
measure: Quantity of bowel resection
timeFrame: 156 hours
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Clinical Hospital 1
Study officials:
References:
Clinical trial NCT03232749: Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint
Official title: Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis of the Glenohumeral Joint
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will examine the effectiveness of a single cortisone injection in patients with shoulder osteoarthritis over a 6-month period, and identify clinical and radiographic factors to help predict how a patient with shoulder osteoarthritis will respond to a cortisone injection utilizing ultrasound guidance.

Detailed description: The purpose of this study is to assess the effectiveness of intraarticular corticosteroid injections (IACSI) for glenohumeral arthritis by 1) through patient-reported outcomes and 2) identifying clinical and radiographic predictors of IACSI success.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of symptomatic primary osteoarthritis of the shoulder will be recruited from the patient population seeking treatment at the Orthopaedics Sports Medicine Institute.
* those who have failed previous treatment including over-the-counter analgesics and activity modification
* have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder.

Exclusion Criteria:

* Patients will be excluded from the study for any of the following reasons:
* Post traumatic osteoarthritis
* Inflammatory osteoarthritis
* Imaging confirmed rotator cuff tear
* Prior ipsilateral shoulder surgery
* Memory loss or inability to complete study measures
* History of allergy to injection medications
* Diabetic patients with patient-reported fasting blood glucose \>200
* Prior injection in the ipsilateral shoulder within three months

Primary outcomes:
measure: ASES Scores at Each Time Point
timeFrame: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months
measure: Visual Analog Scale Scores at Each Time Point.
timeFrame: Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months
measure: SST (Simple Shoulder Test) Scores at Each Time Point
timeFrame: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF and Shands Orthopaedics and Sports Medicine Institute
state: Florida
city: Gainesville
country: United States
facility: UF Health Orthopaedics and Sports Medicine Institute
state: Florida
Study officials:
affiliation: Faculty
name: Bradley Schoch, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04092049: Lollipop on Gastric Emptying
Official title: Effect of Chewing Lollipop on Gastric Emptying
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Emptying
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the effect of chewing lollipop on gastric volume and gastric emptying in healthy volunteers drinking water.


Eligibility criteria: Inclusion Criteria:

* volunteer aged 18 years-45 years old
* volunteer with a body mass index between 18 and 28 kg/m2

Exclusion Criteria:

* those with history of diabetes mellitus
* those with gastric diseases
* those with history of gastro-intestinal surgery
* those with history of smoking
* those with use of gastric mobility medicines
* those with pregnancy or breeding

Primary outcomes:
measure: half time of gastric emptying
timeFrame: from drinking water to gastric volume return to half of top volume before drinking water,on an average of 2 hours
Secondary outcomes:
measure: time of gastric emptying
timeFrame: from drinking water to gastric volume return to baseline before drinking water,on an average of 2 hours
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
References:
citation: Bouvet L, Loubradou E, Desgranges FP, Chassard D. Effect of gum chewing on gastric volume and emptying: a prospective randomized crossover study. Br J Anaesth. 2017 Nov 1;119(5):928-933. doi: 10.1093/bja/aex270.