louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04905758: Soft and Hard Tissues Evaluation Around Immediately Placed New Implant Design
Official title: Soft and Hard Tissues Evaluation Around Immediately Placed New Implant Design: Randomised Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Mucositis
Dental Implant Failed
Keywords: platform switched implants
platform matched implants
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Maxi-Z plus dental implant
Primary purpose: PREVENTION

Brief summary: patients were randomly divided into Maxi-Z plus dental implant group versus Maxi-Z implant group

Detailed description: after tooth extraction implants will be placed immediately and provisional restoration will be placed in both groups to detect the advantaged and drawbacks of newly designed Maxi-Z plus dental implant versus Maxi-Z dental implant

Eligibility criteria: Inclusion Criteria:

* good health
* unrestorable, periodontal healthy teeth

Exclusion Criteria:

* systemic disease
* periodontal disease
* presence of abscess

Primary outcomes:
measure: Implant mobility using Periotest M
timeFrame: 12 months
measure: marginal bone level
timeFrame: 12 months
Secondary outcomes:
measure: pink estheic score
timeFrame: 12 months
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: faculty of dentistry, kafrelsheikh University
state: Kafrelsheikh
Study officials:
References:
Clinical trial NCT01707758: Detection of Cancer-Specific Active Proteases in Blood Via Fluorescence
Official title: Detection of Cancer-Specific Active Proteases in Blood Via Fluorescence
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer
nanoparticle
proteases
cell survival
tumor progression
angiogenesis
tissue remodeling/invasion
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited from the University of Kansas Cancer Center prior to any treatment for their pancreatic cancer. Final histology and staging will be recorded and correlated with protease concnentration. Healthy subjects will be recruited from the University of Kansas and Kansas State community.

Brief summary: The primary objective is to develop a rapid in vitro screening assay for detection of pancreatic cancer biomarkers in blood of patients with pancreatic cancer.

Detailed description: The goal of the project is to develop a rapid in vitro screening assay for detection of cancer biomarkers in blood. The aim is testing and optimization of nanoparticle sensors, based on cyanine dyes that are chemically linked to Fe/Fe3O4 nanoparticles via protease-selective consensus (cleavage) sequences. The focus is on the quantitative determination of active cancer-specific proteases in blood via simple fluorescence measurements. The matrix metalloproteinases, urokinase-type plasminogen activator, and cathepsins, are up-regulated in the vast majority of progressing cancers and can, therefore, serve as markers for cell survival/tumor progression, angiogenesis, and tissue remodeling/invasion

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria for Pancreatic Cancer Patients:

* Patients will either have a histologic diagnosis of pancreatic carcinoma or a clinical picture consistent with pancreatic cancer and will be undergoing surgery or a diagnostic procedure to confirm the diagnosis.
* Patients will have had no prior treatment or surgery

Inclusion Criteria for Healthy Subjects:

* Subjects will have no prior history of any cancer

Exclusion Criteria:

Exclusion Criteria for Pancreatic Cancer Patients

* Any prior treatment for pancreatic cancer
* Poorly controlled diabetes

Exclusion Criteria for Healthy Subjects

* Poorly controlled diabetes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Kansas Medical Center Cancer Center
name: Stephen Williamson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06660758: Pilot Study of the Entarik System With Advanced Functionality in Health Adults
Official title: Pilot Study of the Entarik System With Advanced Functionality in Health Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Adults
Lead sponsor: Gravitas Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Theranova, L.L.C.
First posted: 2024-10-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In this single-site study, data will be recorded during nasogastric or orogastric placement (and post-pyloric placement) and removal of the Entarik Feeding Tube. Data will also be collected prior to, during, and following the delivery of a meal through the feeding tube.


Eligibility criteria: Inclusion Criteria:

1. At least 18 years old
2. Able to provide informed consent
3. Capable and willing to follow all study-related procedures
4. Confirmed fasted state for a minimum of 8 hours prior to study initiation

Exclusion Criteria:

1. Inability to receive a feeding tube
2. Known self-reported history of hiatal hernia, esophagitis, esophageal strictures or gastric ulcers
3. Has a basilar skull fracture
4. Self-reports pregnancy
5. Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: From enrollment to end of study (1 day)
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Gravitas Medical, Inc.
state: California
Study officials:
name: Thomas Sorrentino, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03614858: CD19/CD22-targeted Chimeric Antigen Receptor Engineered T Cell (CART) in B-Cell Acute Lymphoblastic Leukemia.
Official title: Pilot Study of the Efficacy and Safety of Cluster of Differentiation Antigen 19 (CD19) /Cluster of Differentiation Antigen 22 (CD22) CART in the Treatment of Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Leukemia, B-cell
Keywords: CD19
CD22
Lead sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital of Soochow University
First posted: 2018-08-03
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single center, open-label ,phase 1/2 study to evaluate the safety and efficacy of targeted CD19/CD22 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19/CD22 positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Detailed description: The patients will receive infusion of CART cells targeting CD19 and CD22 to confirm the safety and efficacy of CD19/CD22 CART Cells in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Eligibility criteria: Inclusion Criteria:

* Male or female patients with CD19+/CD22+ relapsed/refractory B-cell acute lymphoblastic leukemia who have a dismal prognosis (estimated survival from several months to \<2 year). The study will enroll 20 evaluable patients as follows:
* Age 6-65 years.
* Left ventricular ejection fractions≥ 0.5 by echocardiography.
* Creatinine \< 1.6 mg/dL.
* Aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal.
* Bilirubin \<2.0 mg/dL.
* Karnofsky performance status ≥ 60
* Expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion Criteria:

* Pregnant or lactating women.
* Uncontrolled active infection.
* Active hepatitis B or hepatitis C infection.
* Class III/IV cardiovascular disability according to the New York Heart Association Classification.
* HIV infection.
* Patients with history of seizure
* Active central nervous system leukemia

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Xiaowen Tang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03035396: Clinical Performance of the Diassess Influenza A and B Test
Official title: Clinical Performance of the Diassess Influenza A and B Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza, Human
Influenza
Flu
Lead sponsor: Diassess Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-30
Enrollment: 567
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The primary objective of this study is device feasibility of the Diassess Influenza A and B Test


Eligibility criteria: Inclusion Criteria:

* Subject currently has a fever (≥37.8°C/100°F), or self-reports having had or is currently treating a fever ≥37.8°C/100°F with onset within the previous 72 hrs
* Subject has at least one additional flu-like symptom including fever or feeling feverish/chills, runny or stuffy nose, muscle or body aches, fatigue (very tired), sore throat, headaches, or cough

Exclusion Criteria:

* Subject received nasal vaccine (e.g. FluMist) within the past 10 days
* Subject has been taking or took any antivirals for influenza in the past 30 days
* Subject enrolled in any drug trials

Primary outcomes:
measure: Diassess test measurement agreement with Polymerase Chain Reaction (PCR)
timeFrame: One (1) patient visit which is a time frame of one (1) hour
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: University Health Care Center
state: New York
Study officials:
affiliation: Diassess Inc.
name: Carol Chen, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00003796: Irofulven in Treating Patients With Metastatic Breast Cancer
Official title: Phase II Study of MGI-114 in Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage IV breast cancer
recurrent breast cancer
male breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase II trial to study the effectiveness of irofulven in treating patients who have metastatic breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Detailed description: OBJECTIVES:

I. Evaluate the response rate and time to treatment failure in patients with refractory metastatic adenocarcinoma of the breast treated with irofulven.

II. Assess the qualitative and quantitative toxic effects of this drug in these patients.

III. Determine the population pharmacokinetics and the pharmacokinetics-pharmacodynamic relationships of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive irofulven IV over 30 minutes on days 1 and 15. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic adenocarcinoma of the breast
* Measurable disease outside previously irradiated area or occurred/progressed after completion of radiotherapy
* Must have received 1 or 2 prior chemotherapy regimens for metastatic disease

  * More than 3 prior regimens allowed
* No active brain metastases or meningeal breast cancer involvement

PATIENT CHARACTERISTICS:

Sex:

* Male or female

Performance status:

* SWOG 0-2

Hematopoietic:

* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 3 times ULN (5 times ULN for liver metastases)

Renal:

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min

Cardiovascular:

* No history of myocardial infarction or unstable angina within the past 6 months
* No uncontrolled congestive heart failure

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Prior diagnosis of cancer allowed (must be off cancer therapy and have no evidence of disease)
* No history of retinopathy and/or macular degeneration

PRIOR CONCURRENT THERAPY:

Chemotherapy:

* No prior irofulven

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Lisa Hammond, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04018196: Effects of Motor Imagery on Motor Learning and Motor Retention in Octogenarian.
Official title: Effects of Motor Imagery on Motor Learning and Motor Retention in Octogenarian "IMAge-8".
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aging
Keywords: Very old adults
Memorizing
Motor imagery
Motor learning
Upper limb
Lower limb
Motor task
Manual task
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 84
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Aging is associated with impairments in cognitive function, particularly motor learning and memorizing, impacting functional capacities. Older adults are still able to learn new skills but at a slower rate, and they forget quickly the new-learned skill because of an alteration in motor memory. Motor imagery, which is a mental simulation of an action without actual execution, has been demonstrated to improve performance in young adults and stabilize performance after a short break in older adults. However, in very old adults (\>80 years old) for whom the decline in motor and cognitive functions is greater, it is unknown whether motor imagery training during a short break is still efficient. Previous studies on old adults were performed on upper limb muscles. Because aging differentially affects upper and lower limb muscles, the present study will aim to explore the effects of motor imagery on motor memorizing in both upper and lower limb muscles.

Detailed description: The primary purpose is to evaluate the effectiveness of motor imagery to improve the performance of very old people (\> 80 years) through learning a task of the upper limbs.

Eligibility criteria: Inclusion Criteria:

* Being part of the Proof cohort
* Signed written consent form
* Affiliated to social security

Exclusion Criteria:

* Pathology or chirurgical intervention causing locomotor disorder
* Neurological or psychic pathology
* Use psychotropic drugs
* Mini-Mental State Examination (MMSE) \< 20

Primary outcomes:
measure: Performance at the manual task (Nine Hole Peg Test (NHPT)) (s)
timeFrame: Day: 0
Secondary outcomes:
measure: Performance at the motor task (s)
timeFrame: Day: 7
measure: Learning capacity of manual task (Nine Hole Peg Test (NHPT))
timeFrame: Day: 0
measure: Learning capacity of motor task (hopscotch)
timeFrame: Day: 7
measure: Test of 6 minutes walking (m)
timeFrame: Day: 0
measure: Test of Get-up-and-Go (s)
timeFrame: Day: 0
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Léonard FEASSON, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02465996: Gastric Barrier Dysfunction of Functional Dyspepsia and Therapeutic Response to Puyuanhewei Detected by Endomicroscopy
Official title: Gastric Barrier Dysfunction of Functional Dyspepsia and Therapeutic Response to Puyuanhewei Detected by Endomicroscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dyspepsia
Keywords: barrier dysfunction
functional dyspepsia
Confocal Laser Endomicroscopic
therapeutic response
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Functional dyspepsia might have impaired gastric mucosal dysfunction and Puyuanhewei may be helpful to improve the symptoms of FD.

Detailed description: This study aimed to investigate the gastric mucosal dysfunction in functional dyspepsia (FD) and verify the efficacy of Puyuanhewei for treating FD and assess the relationship between gastric microalterations and therapeutic response by endomicroscopy.

Eligibility criteria: Inclusion Criteria:

1. Consecutive outpatients aged 18 to 75 years old.
2. FD patients defined by the Rome III classification.
3. Willing to choose pCLE and no organic diseases.

Exclusion Criteria:

1. Severe liver, heart, or kidney diseases.
2. Current or past evidence of uncontrolled diabetes mellitus, psychosomatic disorders, such as depressive and anxiety disorders, and drug or alcohol abuse.
3. Pregnant or breastfeeding women.
4. Inability to give informed consent.
5. Use of nonsteroidal anti-inflammatory drugs, proton pump inhibitors, H2-receptor antagonists, antacids, prokinetics, or other injurious drugs (antibiotics, and steroids) in the prior two weeks.

Primary outcomes:
measure: pCLE score
timeFrame: within 1 hour after pCLE examination
Secondary outcomes:
measure: Leeds dyspepsia questionaire
timeFrame: baseline and 4th week
measure: Main dyspepsia symptom score
timeFrame: baseline and 4th weeks
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yanqing Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04921696: Association of Red Blood Cell Transfusion, Anemia, and Necrotizing Enterocolitis
Official title: Association of Red Blood Cell Transfusion, Anemia, and Necrotizing Enterocolitis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Necrotizing Enterocolitis
Anemia
Red Blood Cell (RBC) Transfusion
Keywords: necrotizing enterocolitis
anemia
red blood cell (RBC) transfusion
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Chongqing Medical University
First posted: 2021-06-10
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The level of blood bilirubin of the included neonatal infants reached the cirteria of transfusion therapy. Whether or not the transfusion therapy was dicided according to the parents' decision.

Brief summary: Necrotizing enterocolitis (NEC) is a leading cause of mortality among preterm infants.The pathogenesis of NEC remains unclear with conflicting data regarding the role of red blood cell (RBC) transfusion and anemia. A meta-analysis of retrospective studies demonstrated an association between exposure to RBC transfusion and NEC(adjusted odds ratio, 2.0 \[95% confidence interval, 1.6-2.5\]). However, recent observational studies have found no association between RBC transfusion and NEC or have found RBC transfusion to be protective.

Detailed description: Improving understanding of the role of RBC transfusion and anemia in the development of NEC is important. Several studies characterizing the associations between transfusion, anemia, and NEC were potentially limited by small sample size, study design. As such, researchers have underscored the need for prospective study in which each RBC exposure, episode of anemia, and outcome of NEC can be systematically and consistently evaluated.

This prospective study examined whether RBC transfusion and anemia were associated with the rate of NEC. The primary objective was to test whether NEC was increased in infants receiving RBC transfusion compared with non transfused infants. Further, exposure to severe neonatal anemia was examined as an independent risk factor for NEC.

Eligibility criteria: Inclusion Criteria:

* age between 1 min and 28 days
* the level blood bilirubin reached the criteria of transfusion therapy

Exclusion Criteria:

* congenital abnormalities
* receipt of transfusion before enrollment
* parents' decision not to participate
* infant not expected to survive beyond 7 days of life based on the assessment by the treating neonatologist

Primary outcomes:
measure: Necrotizing enterocolitis
timeFrame: within 28 days
Secondary outcomes:
measure: death
timeFrame: within 28 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT00032396: A Study to Evaluate Retisert in the Treatment of Patients With the "Wet" Form of Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Macular Degeneration
Keywords: AMD
ARMD
Age-Related Macular Degeneration
Subfoveal Choroidal Neovascularization
CNV
Lead sponsor: Control Delivery Systems
Sponsor class: INDUSTRY
Collaborators: name: Bausch & Lomb Incorporated
First posted: 2002-03-22
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: A study evaluating Retisert in patients with age-related macular degeneration



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Watertown
country: United States
facility: Control Delivery Systems, Inc.
state: Massachusetts
Study officials:
References: