louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04624022: AS OCT Evaluation for Perforated Punctual Plugs
Official title: Evaluation of Implanted Perforated Lacrimal Punctal Plugs Using Anterior Segment Optical Coherence Tomography.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Punctal Stenosis
Keywords: Punctual stenosis
Perforated Lacrimal Punctal Plugs
AS-OCT
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with epiphora will be evaluated to exclude other causes than punctal stenosis. Perforated punctal plugs were implanted under topical anaesthesia. patients follow up and AS-OCT

Brief summary: Evaluation of the perforated punctal plugs after implantation in cases of punctal stenosis regarding position and patency in the early postoperative period (during the first operative weak)

Detailed description: Prospective non randomized case series study included 50 eyes. The study is conducted on patients attending to the oculoplastic unit of ophthalmology department of Minia university hospital. Informed consents were obtained from the participants in this study. The study was adherent to the tenets of declaration of Heleniski.

Anterior segment optical coherence tomography(AS-OCT) was performed for the included patients after perforated plug implantation (during the first operative weak)

Eligibility criteria: Inclusion Criteria:

* Patients with punctal stenosis who will be treated by implantation of perorated punctal plugs

Exclusion Criteria:

* Patients who are not willing to participate in the study

Primary outcomes:
measure: Evaluation of the fitting of implanted perforated lacrimal plugs
timeFrame: first week post-operatively
measure: Evaluation of the patency of the plugs
timeFrame: first week post-operatively
measure: Evaluation any contents within the plugs
timeFrame: first week post-operatively
measure: Evaluation of the lower tear film height
timeFrame: first week post-operatively
measure: Evaluation of the tear level within the plug
timeFrame: first week post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Ophthalmology department/ Minia University Hospital/Minia University
Study officials:
affiliation: Faculty of Medicine, Minia University
name: Heba AttaAllah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdallah RMA, Elshafei AMK, AttaAllah HR. Evaluation of implanted perforated lacrimal punctal plugs using anterior segment optical coherence tomography. Eye Vis (Lond). 2021 Oct 3;8(1):36. doi: 10.1186/s40662-021-00259-x.
Clinical trial NCT00004422: Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pertussis
Whooping Cough
Keywords: bacterial infection
immunologic disorders and infectious disorders
pertussis
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 1999-10-19
Enrollment: 174
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

Assess the efficacy of a single infusion of a high titer pertussis immune globulin for the treatment of severe pertussis in children.

Detailed description: PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive an infusion of either pertussis immune globulin or placebo (0.9% saline).

Patients are followed every 2 weeks for up to 6 months.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: * Documented infection with Bordetella pertussis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: IWK Health Centre
name: Scott A. Halperin
role: STUDY_CHAIR
References:
Clinical trial NCT00471822: Nasopharyngeal Streptococcus Pneumoniae Carriage
Official title: An Evaluation of Streptococcus Pneumoniae Serotype Carriage Rate for Nasopharyngeal Carriage in Taiwanese Children Attending Pediatric Clinics in Hospitals, Day Care Centers, or Kindergartens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Streptococcus Pneumoniae Infections
Keywords: Streptococcus pneumoniae nasopharyngeal carriage
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-10
Enrollment: 9707
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects aged between 2 months and 5 years attending pediatric clinics in hospitals, daycare centers, and kindergartens

Brief summary: Primary Objective: Evaluation of the

- Carriage rate of Streptococcus pneumoniae in the nasopharynx of children

Secondary Objective:

* Carriage rate and distribution of Streptococcus pneumoniae serotypes
* Estimation of prevalence rate of antibiotic-resistant Streptococcus pneumoniae strains
* Distribution of Staphylococcus aureus strain
* The influence of risk factors in the Streptococcus pneumoniae carriage rate in children


Eligibility criteria: Inclusion Criteria:

1. Children aged between 2 months and 5 years attending pediatric clinics in hospitals, day care centers or kindergartens.
2. Informed consent obtained from parents or legal guardian.

Exclusion Criteria:

1. Children younger than 2 months of age.
2. Children with following serious diseases: immunological disease, neoplastic disease, renal, cardiac or hematological disease, bronchodysplasia, Down's syndrome.

Primary outcomes:
measure: Percentage of Participants With Carriage of Streptococcus Pneumoniae in Nasopharynx
timeFrame: Day 1
Secondary outcomes:
measure: Serotype Distribution of Streptococcus Pneumoniae Isolates
timeFrame: Day 1
measure: Antibiotic-Resistant Streptococcus Pneumoniae Strains
timeFrame: Day 1
measure: Percentage of Participants With Carriage of Staphylococcus Aureus in Nostril
timeFrame: Day 1
measure: Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors
timeFrame: Day 1
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00401622: Clinical Benefits of a Blood Glucose Monitoring System in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: LifeScan
Sponsor class: INDUSTRY
Collaborators: name: Synexus(UK)
name: CPS(UK)
name: Battelle CRO(US)
name: RPS CRO(US)
name: Robertson Centre For Biostatistics (UK)
First posted: 2006-11-20
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Clinical benefits of the OneTouch® Ultra®2 BGMS versus standard BGMS during 52 weeks of use.


Eligibility criteria: Inclusion Criteria:·

* Current diagnosis of type 2 diabetes
* Diagnosed at least 3 months prior to the start of the study but not more than 15 years from the start of the study
* Stable regimen (i.e., no changes in therapeutic regimen) for the past three months
* Baseline HbA1c of 7.0 to 8.9%, inclusive

Exclusion Criteria:

* Using insulin
* Using oral agents that target post-prandial hyperglycemia (Note: These medications may be added during the study)
* Known history of anemia or disorders associated with anemia
* Has previously used the devices being tested in the study

Primary outcomes:
measure: Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS.
timeFrame: From baseline to 52 wks
Secondary outcomes:
measure: Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS.
timeFrame: 52 wks
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: San Diego
country: United States
state: California
city: Wilmington
country: United States
state: Delaware
city: Hollywood
country: United States
state: Florida
city: Dawsonville
country: United States
state: Georgia
city: Whitehouse Station
country: United States
state: New Jersey
city: East Syracuse
country: United States
state: New York
city: Endwell
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: San Antonio
country: United States
state: Texas
city: Oshawa
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Reading
country: United Kingdom
state: Berkshire
city: Llanishen
country: United Kingdom
state: Cardiff
city: Buckshaw Village
country: United Kingdom
state: Chorley
city: Lloyd Street North
country: United Kingdom
state: Manchester
city: Glasgow
country: United Kingdom
state: Scotland
city: Claygate
country: United Kingdom
state: Surrey
Study officials:
References:
Clinical trial NCT01457222: Cognition and Health in Adolescents, Mindfulness as Prevention of Stress.
Official title: Mindfulness as a Method of Improving Mental Health and Cognitive Results and Decreasing Stress in Secondary School Students; a Prospective Randomised Controlled Single-blinded Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Complete Psychological Check Up
Sleep
Cognition - Other
Personality
Keywords: Mindfulness
Stress
Cognition
Psychological health
Primary prevention
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2011-10-21
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether mindfulness is useful as primary prevention for psychological health in highschool students, primarily related to stress, and whether mindfulness can improve cognitive function.

Detailed description: There is a general suspicion that stress and stress-related psychological disorders is growing in highschool students in Sweden. Mindfulness is a well researched therapeutical method for treating stress-related disorders. This study will first collect data on stress-related psychological symptoms by several well-validated surveys. The surveys will be made twice with 8 weeks in between to examine variability. After the second survey the population of highschool students will be randomly assigned to web-based mindfulness intervention, music relaxation intervention or control group. A third survey will be conducted after eight weeks of intervention and before and after an external stressor.

Eligibility criteria: Inclusion Criteria:

* High school student from designated school

Exclusion Criteria:

* None Swedish-speaking

Primary outcomes:
measure: Better mental health
timeFrame: Baseline to Eight weeks
Secondary outcomes:
measure: Better sleep quality
timeFrame: Baseline to Eight weeks
measure: Lower degree of perceived stress
timeFrame: Baseline to Eight weeks
measure: Cognitive enhancement
timeFrame: Baseline to Eight weeks
measure: Higher grades
timeFrame: Baseline to 6 months
measure: Lower sick leave
timeFrame: Baseline to 6 months
measure: Lower Neuroticism
timeFrame: Baseline to Eight weeks
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Centrum för Primärvårdsforskning, Lunds Universitet
Study officials:
affiliation: Centrum för Primärvårdsforskning
name: Jan Sundquist, Professor/MD
role: STUDY_CHAIR
References:
Clinical trial NCT04169022: AML Cell Immunotherapy Using Chimeric Antigen Receptor T-cells
Official title: Targeting Interleukin 1 Receptor Accessory Protein (IL1RAP) Expressing Acute Myeloid Leukemic (AML) Cells by Chimeric Antigen Receptor (CAR) Engineered T-cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myeloid Leukemia
Keywords: AML
Chimeric Antigen Receptor T Cells
Immunotherapy
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Dijon
name: Etablissement Français du Sang
First posted: 2019-11-19
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: AML is one of the most aggressive forms of leukemia, where bone marrow transplantation remains the gold standard treatment, with its known associated toxicities and related mortality. Despite progress in the treatment of leukemic malignancies, especially the emergence of targeted- and immuno-therapies arising from biological genomic knowledge, there remains a need to provide additional strategies for refractory/relapsing (R/R) patients

Aim of this study is to collect biological samples of AML patients in order to validate our Chimeric Antigen Receptor T-cells immunotherapy approach


Eligibility criteria: Inclusion Criteria:

* AML patients adults and pediatrics

Exclusion Criteria:

* AML3

Primary outcomes:
measure: IL1RAP protein expression
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
Study officials:
References:
Clinical trial NCT00479622: Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus
Official title: A Randomized, Two-Arm, Parallel Group Study of the Safety, Pharmacokinetics, and Pharmacodynamics of TRU-015 Added to Standard Therapy in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Keywords: Membranous Nephropathy
Systemic Lupus Erythematosus
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Emergent Product Development Seattle LLC
First posted: 2007-05-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how the body absorbs and chemically changes a single infusion of TRU-015 in subjects with kidney disease caused by lupus.


Eligibility criteria: Inclusion Criteria:

* Man or nonlactating and nonpregnant woman, aged 18 to 70 years, inclusive, at the screening visit.
* Diagnosis of systemic lupus erythematosus more than 6 months before study day 1.
* History of positive antinuclear antibody titer of \>1:160 or equivalent.
* Biopsy-proven class V lupus nephritis within the last 2 years.
* Have been on a stable dose of oral corticosteroids (\<20 mg/day prednisone or equivalent) for 2 months before study day 1.

Primary outcomes:
measure: To evaluate the pharmacokinetics of TRU-015 after a single administration in subjects with membranous nephropathy secondary to systemic lupus erythematosus.
timeFrame: 6 months
Secondary outcomes:
measure: To evaluate the safety, immunogenicity, and pharmacokinetic/pharmacodynamic relationship of TRU-015 in subjects with membranous nephropathy secondary to systemic lupus erythematosus.
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Lake Success
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05137522: Chidamide Combines With VP-16 and Methylprednisolone in the Treatment of HLH
Official title: Chidamide Combines With Etoposide and Methylprednisolone in the Treatment of Hemophagocytic Lymphohistiocytosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chidamide
Hemophagocytic Lymphohistiocytosis
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chidamide combines with VP-16 and methylprednisolone in HLH

Detailed description: This study aimed to investigate the efficacy and safety of Chidamide together with Etoposide and methylprednisolone for hemophagocytic lymphohistiocytosis

Eligibility criteria: Inclusion Criteria:Meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria; patients were diagnosed with EBV associated HLH (EBV-HLH) and lymphoma associated HLH.Age ≥18 years old, gender is not limited. Serum creatinine ≤ 1.5 times normal；NT-proBNP ≤ normal；Informed consent obtained.

-

Exclusion Criteria: Active bleeding of the internal organs or patients with new thrombotic diseases；Allergic to Chidamide and etoposide；Participate in other clinical research at the same time；HIV , HBV and HCV infected patients (HIV antibody positive)；History of QT interval prolongation, atrioventricular block, ventricular tachycardia, coronary atherosclerotic heart disease；Pregnant or lactating women and patients of childbearing age who refuse to take appropriate contraceptive measures during this trial. If the patient was male, he refused to use adequate contraceptive methods or donate semen during the study period and within 3 months after receiving the last cycle of drug study；patients judged by the investigator to be unsuitable to participate in this study.

-

Primary outcomes:
measure: Evaluation of treatment response
timeFrame: 4 weeks after Chidamide combines with VP-16 and methylprednisolone was used
Secondary outcomes:
measure: EBV-DNA copies
timeFrame: 4 weeks after Chidamide combines with VP-16 and methylprednisolone was used
measure: relapsed rate of HLH
timeFrame: 4 weeks after Chidamide combines with VP-16 and methylprednisolone was used
measure: the response rate of lymphoma
timeFrame: 4 weeks after Chidamide combines with VP-16 and methylprednisolone was used
Other outcomes:
measure: treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: 4 weeks after Chidamide combines with VP-16 and methylprednisolone was used
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Wang Zhao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01398722: Effect of Intensive Insulin Therapy on Clinical Prognosis of Infants Undergoing Cardiac Surgery
Official title: Study of the Relationship Between Intensive Insulin Therapy and Clinical Prognosis in Infants Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cardiac Surgery
Keywords: cardiac surgery
prognosis
intensive insulin therapy
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2011-07-20
Enrollment: 800
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators sought to determine whether intensive insulin therapy can improve prognosis of infants undergoing cardiac surgery.

Detailed description: Previous studies showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical and medical intensive care patients. Blood sugar control with intravenous insulin may improve prognosis of patients undergoing cardiac surgery. It is not clear what the best insulin regimen is or what is the best blood sugar target in these patients. So far, most of researches have focused on adult patients but little on infants. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of infants undergoing cardiac surgery. On admission, patients will be randomly assigned to either strict normalization of blood glucose ( 110-150 mg/dl) with intensive insulin therapy or the conventional approach, in which blood glucose levels are maintained between 150 and 180 mg/dl.

Eligibility criteria: Inclusion Criteria:

* Infants underwent cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Therapy restricted upon admission
* Preoperative liver or kidney disease or dysfunction
* Preoperative coagulation disorder
* Palliative operation or a second operation
* Type 1 diabetes
* Type 2 diabetes

Primary outcomes:
measure: All cause mortality
timeFrame: one year
Secondary outcomes:
measure: Biochemical markers of myocardial injury(troponin and creatine kinase MB)
timeFrame: average 1 month during the hospitalization
measure: Acute renal failure
timeFrame: average 1 month during the hospitalization
measure: Respiratory failure
timeFrame: average 1 month during the hospitalization
measure: ICU and hospital length of stay, and ICU readmissions
timeFrame: average 1 month during the hospitalization
measure: Stroke and reversible ischemic neurologic deficit
timeFrame: average 1 month during the hospitalization
measure: Cardiac Index
timeFrame: average 1 month during the hospitalization
measure: Inotropic Scores
timeFrame: average 1 month during the hospitalization
measure: Perioperative complications
timeFrame: average 1 month during the hospitalization
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Dinhhua Yi, MD
role: STUDY_CHAIR
References: