louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06476665: A Study to Learn About the Safety of BESPONSA Injection in Pediatric Patients With Acute Lymphocytic Leukemia.
Official title: BESPONSA INJECTION 1MG SPECIAL INVESTIGATION (PEDIATRIC INVESTIGATION)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Lymphocytic Leukemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-06-26
Enrollment: 4
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients with relapsed or refractory CD22-positive ALL receiving BESPONSA

Brief summary: The purpose of this study is to learn about the safety of BESPONSA for pediatric patients. .

BESPONSA is approved for treatment of relapsed or refractory CD22-positive acute lymphocytic leukemia for pediatric patients. A type of leukemia (blood cancer) that comes on quickly and is fast growing. In acute lymphocytic leukemia, there are too many lymphoblasts (early-stage white blood cells) in the blood and bone marrow. Also called ALL.

The registration criteria for this study are:

* Never used BESPONSA before
* \<18 years at the start of treatment with BESPONSA

All patients in this study will receive BESPONSA according to the prescriptions.

Patients will be followed up as follow.

* Treatment phase: From the day of treatment initiation (Day 1) to Day 28 post-treatment to collect information on safety (e.g., adverse events).
* Follow-up phase: From Day 29 post-treatment to Week 52 to collect information on VOD/SOS.


Eligibility criteria: Inclusion Criteria:

1. Patients with relapsed or refractory CD22-positive ALL
2. Patients who have never used BESPONSA before
3. Patients aged \<18 years at the start of treatment with BESPONSA

Exclusion Criteria:

* None

Primary outcomes:
measure: Occurrence of adverse events
timeFrame: Up to 28 days after the last administration
measure: Risk factors related to the onset of venoocclusive liver disease/sinusoidal obstruction syndrome
timeFrame: Up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02093065: Platelet Function in Patients With Hemophilia A
Official title: Decreased Platelet Function as a Cause of Increased Bleeding in Patients With Hemophilia A
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Keywords: severe hemophilia A
coated platelets
bleeding
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2014-03-20
Enrollment: 36
Sex: MALE
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe hemophilia A who do not have inhibitors against FVIII and who have a bleeding history of at least 6 months.

Brief summary: Abnormalities in the gene encoding Factor VIII (FVIII) results in hemophilia A, an X-linked recessive bleeding disorder with a prevalence of 1 in 5000 males. Hemophilia A patients are classified into 3 different categories based on residual FVIII activity compared to normal: mild (6-40%), moderate (1-5%) and severe (\<1%). This categorization correlates to some degree with bleeding phenotype, but does not completely define it. Some patients with hemophilia A bleed less often than others despite identical plasma FVIII levels. The cause(s) of this phenotype heterogeneity in hemophilia A remains largely unknown, despite a number of studies of possible factors.

Activated platelets, in addition to their role in primary hemostasis, play a major role in secondary hemostasis (coagulation) by providing a phospholipid surface to which coagulation factors bind. A role for platelets in the hemorrhagic propensity of hemophilia A has been suggested in the past, but only a small number of studies have been performed with limitations in assays performed and numbers of patients. The purpose of the present study is to determine whether platelet reactivity in severe hemophilia A patients is associated with past bleeding frequency and/or predicts future bleeding frequency.


Eligibility criteria: Inclusion Criteria:

* Patients with severe hemophilia A who are being prophylactically treated with FVIII.
* Age of at least 2 years.
* Bleeding history of at least 6 months.
* IRB-approved informed consent.

Exclusion Criteria:

* Presence of FVIII inhibitors.
* Greater than 7 days since active bleeding.

Primary outcomes:
measure: The percentage of coated platelets.
timeFrame: 2 years
Secondary outcomes:
measure: Platelet reactivity.
timeFrame: 2 years
measure: The number of procoagulant platelet-derived microparticles.
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital, Boston Hemophilia Center
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Alan D Michelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06719765: The Correlation Between Forward Head Posture; Neck Pain, Neck Functional Ability and Deep Neck Core Strength in Jordan
Official title: The Correlation Between Forward Head Posture; Neck Pain, Neck Functional Ability and Deep Neck Core Strength in Jordanian University Students Having Chronic Non-specific Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Forward Head Posture
Keywords: forward head posture
neck pain
Jordanian university
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: We will include 60 Jordanian university students (30 male \& 30 female students)

-Age range will between 18 to 25 years old

Brief summary: Is forward head posture correlated with neck pain, neck functional ability and deep neck core strength in Jordanian university students having chronic nonspecific pain.

Detailed description: The study is an observational cross sectional study considering the effects of one of the most common spinal deformities such as forward head posture on the quality of life regarding Jordanian university students. University students are among the most common populations having these kinds of deformities because of using smart devices and studying for along periods of time in a faulty posture. 60 students "both male and females" having forward head posture with neck pain will be included in the study and different outcome measure as pain , functional ability and deep neck core strength will be measured to define the impact of this faulty posture on them. Pain measurement will be through using numeric rating scale for pain.

Eligibility criteria: Inclusion Criteria:

* The craniovertebral angle is less than 50 degrees .
* Age ranges from 18 to 25 years old
* Forward head is associated with neck pain.
* Studying hours more than 4 hours continuously per day

Exclusion Criteria:

* Previous surgery regarding the spine or shoulders.
* Vertebral fractures regarding the cervical spine or the skull.
* Positive neurological signs or evidence of spinal compression.
* headaches prior to the onset of neck pain and without cervical origin.
* Inner ear or vestibular Problems.

Primary outcomes:
measure: Neck pain
timeFrame: 4 weeks
measure: Neck functional
timeFrame: 4 weeks
measure: Neck Core stability
timeFrame: 4 weeks
measure: Craniovertebral angle
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: AL-Zaytoonah University
Study officials:
References:
Clinical trial NCT06769165: EMDR Treatment of Conditioned Nausea and Vomiting in Cancer Survivors
Official title: EMDR Treatment of Conditioned Nausea and Vomiting in Cancer Survivors - a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer Survivors
Keywords: EMDR
Nausea
Vomiting
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To explore the effectiveness of EMDR therapy treatment in reducing symptoms of chemotherapy-induced conditioned nausea and vomiting in (former) patients with cancer.

Detailed description: Conditioned nausea and vomiting is a common side effect of anti-cancer treatment, and while strategies like antiemetics exist, their effectiveness is limited. Conditioned nausea and vomiting can possibly be addressed through Eye Movement Desensitization and Reprocessing (EMDR) therapy. EMDR therapy is a therapeutic intervention, proven to be effective in the treatment of post-traumatic stress disorder (PTSD), and promising in treating a range of other conditions. At the UMCG, EMDR therapy is used on a small scale to treat conditioned nausea with positive results, although more rigorous research is needed to fully establish its efficacy. This study aims to explore the effectiveness of EMDR therapy treatment in reducing symptoms of chemotherapy-induced conditioned nausea and vomiting in (former) patients with cancer.

Eligibility criteria: Inclusion Criteria:

* Previously pathologically confirmed diagnosis of cancer
* Previously treated with systemic cancer therapy
* Persistent complaints (more than 2 months) of conditioned nausea and/or vomiting
* Able to understand spoken and written Dutch
* 18 years or older

Exclusion Criteria:

* Ongoing psychiatric treatment
* EMDR therapy contraindications (dissociative disorders, personality disorders or severe somatic disorders (e.g. cardiac arrhythmias))
* Complex type 2 trauma
* Known with recent conditions / non-anti-cancer medication which can elicit nausea (e.g. pregnancy or alcohol abuses)

Primary outcomes:
measure: Degree of conditioned nausea and vomiting
timeFrame: Before intake EMDR therapy session and three weeks after last EMDR therapy session
Secondary outcomes:
measure: Impact on QoL of conditioned nausea and vomiting
timeFrame: Before EMDR therapy
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Jacco J de Haan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00916565: Evaluation of Cow Milk-Based Formulas - Functional Proteins
Official title: The Evaluation of Cow Milk-Based Formulas - Functional Proteins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: optimize nutritional content of infant formula
Infant
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2009-06-09
Enrollment: 139
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: formula-fed and breastfed infants

Brief summary: The purpose of this study is to look at the function of infant formula components to optimize the nutritional content and functionality of a marketed routine infant formula.


Eligibility criteria: Inclusion Criteria:

* 10-18 days of age
* 37-42 weeks gestation
* birth weight 2500 g or more
* consuming one source of nutrition

Exclusion Criteria:

* metabolic or chronic disease
* acute infection
* feeding difficulties
* consumed complementary foods or donor milk
* steroid use

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Dr. Claude Ashley
state: Alabama
city: Birmingham
country: United States
facility: William Johnston, MD
state: Alabama
city: Little Rock
country: United States
facility: Lori Montgomery, MD
state: Arkansas
city: Lake Mary
country: United States
facility: Edward Zissman, MD
state: Florida
city: Plantation
country: United States
facility: Harold Deulofeut MD
state: Florida
city: Tamarac
country: United States
facility: Harold Deulofeut MD
state: Florida
city: Kansas City
country: United States
facility: Susan Carlson, Ph.D.
state: Kansas
city: Woburn
country: United States
facility: Joseph Leader, MD
state: Massachusetts
city: Omaha
country: United States
facility: Ann Grandjean, Ed. D
state: Nebraska
city: Clarksville
country: United States
facility: Laurie Harris-Ford, MD
state: Tennessee
city: Austin
country: United States
facility: Beth Nauert, MD
state: Texas
Study officials:
References:
Clinical trial NCT05977465: Empagliflozin in Treatment of Peripheral Diabetic Neuropathy
Official title: Clinical Study to Investigate the Possible Effect of Empagliflozin in Treatment of Peripheral Diabetic Neuropathy in Patients With Diabetes Mellitus Type 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetic Neuropathy Peripheral
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the possible protective effect of empagliflozin in patients with type 2 diabetes mellitus with diabetic peripheral neuropathy and not on SGLT2 inhibitors treatment.


Eligibility criteria: Inclusion Criteria:

Patients with type 2 diabetes mellitus (Hba1c 7 %- 9%). Patients receiving dipeptidyl peptidase-4 inhibitors, metformin ± basal insulin.

Patients with peripheral neuropathy and not on SGLT2 inhibitor treatment. Patients aged between 18 years old to 65 years old.

Exclusion Criteria:

* Breastfeeding female.
* Pregnant female.
* Estimated Glomerular Filtration Rate less than 45 mL/minute/1.73 m2.
* Patients with type 1 diabetes mellitus.
* Patients with diabetic ketoacidosis.
* Patients with urinary tract infections.
* Dehydrated patients till normalized.
* Lower limb amputation patients.
* SGLT2 inhibitors hypersensitivity.
* Severe hepatic patients.
* Patients on neuroprotective drugs.

Primary outcomes:
measure: Change in the electrophysiological assessment of sensory and motor nerve conduction of the lower limb extremities.
timeFrame: change from baseline at three month
measure: Change in HbA1c %
timeFrame: change from baseline at three months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of pharmacy
Study officials:
affiliation: Tanta University
name: Maha Khalifa, Pharm D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05760365: Three-dimensional Printing in Cardiac Catheterization
Official title: The Improvement of Medical Education by Using the Application of Three-dimensional Printing in Cardiac Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satisfaction, Personal
Keywords: 3D printed
medical education
cardiac catheterization
Heart disease
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Our purpose is to use 3D printing technology to make human anatomical cardiovascular model, which could apply in the medical education for medical students, in order to improve the effectiveness of the learning process to access.

Detailed description: Background：

The medical teaching models are expansive and rare. We try to use the 3D printing technology to print cardiovascular model. By using the 3D cardiovascular model, we try to facilitate the leaning curve of understanding the cardiac catheterization.

Study Design：

This is a single-site prospective randomized controlled trial of medical education. We expect to enrolled 50 participants. Both group will receive same teaching program. Traditional education model will be used in control group, and 3D printed model will be used in the experimental group.

Methods：

We use 3D printing technology to create cardiovascular model from the CT scanning, which are drawn by professional 3D drawing staff. The students will be divided into 2 groups: the first group receive lecture/image teaching first then trained by the 3D cardiovascular model; the second group are receiving the reverse order. The satisfaction and the learning outcomes would be evaluated by the questionnaire.

Effect：

We expect the 3D cardiovascular model will bring better learning efficiency and satisfaction. Furthermore, we will construct the individual learning project by using the 3D printing model.

Key words：

3D printing, anatomy instruction, cardiovascular system, cardiac catheterization, high-fidelity simulation.

Eligibility criteria: Inclusion Criteria:

* Medical student, nurse practitioner and Resident in Fu Jen Catholic University Hospital

Exclusion Criteria:

* Refused to participate in the study.

Primary outcomes:
measure: Examination score of pre-intervention
timeFrame: pre-intervention
measure: Examination score of post-intervention
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University
Study officials:
affiliation: Fu Jen Catholic University Hospital
name: Ke-Yun Chao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00681265: Tear Film Break-up Time After Instillation of Artificial Tears
Official title: A Randomized, Masked Exploratory Trial Comparing the Effect of Two Different Over-the-Counter Artificial Tear Preparations on Tear Film Break-up Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratoconjunctivitis Sicca
Keywords: ocular lubricants
Lead sponsor: Calm Water Therapeutics LLC
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an exploratory trial evaluating the tear film break-up time after a single eye drop instillation of over-the-counter artificial tears. The primary hypothesis is that tear film break up time will be greater for test than control eye.

Detailed description: Subjects with varying degrees of dry eye syndrome were enrolled in a randomized, controlled, double masked, single site study. A new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient was compared against a leading commercial product with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent. The primary outcome was a comparison of tear film stability after eye drop instillation.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* symptoms of dry eye
* no other history of ophthalmic problems

Exclusion Criteria:

* Use of any ocular lubricant or ointment in the past 36 hours
* use of contact lenses or excessive eye lid cosmetics on the study day

Primary outcomes:
measure: Noninvasive Tear Film Break-up Time
timeFrame: 15 minutes after eye drop instillation
Secondary outcomes:
measure: Fluorescein Tear Film Break-up Time
timeFrame: 120 minutes after eye drops instillation
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Eye Institute
state: New York
Study officials:
affiliation: University of Rochester Eye Institute
name: James V. Aquavella, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nichols JJ, Nichols KK, Puent B, Saracino M, Mitchell GL. Evaluation of tear film interference patterns and measures of tear break-up time. Optom Vis Sci. 2002 Jun;79(6):363-9. doi: 10.1097/00006324-200206000-00009.
citation: Ousler GW, Michaelson C, Christensen MT. An evaluation of tear film breakup time extension and ocular protection index scores among three marketed lubricant eye drops. Cornea. 2007 Sep;26(8):949-52. doi: 10.1097/ICO.0b013e3180de1c38.
citation: Cho P, Douthwaite W. The relation between invasive and noninvasive tear break-up time. Optom Vis Sci. 1995 Jan;72(1):17-22. doi: 10.1097/00006324-199501000-00004.
Clinical trial NCT06701565: Coronal and Radicular Caries Prevalence and Related Risk Factor in Diabetic Patient
Official title: Coronal and Radicular Caries Prevalence With Related Risk Factors Among Middle Age Type II Diabetic Patients Attending National Institute of Diabetes and Endocrinology: a Hospital Based Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Caries,Dental
Caries Root
Diabetes Mellitus, Type 2
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 265
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Patient whose age between 30-65
2. Diabetic patients
3. Patient consulting in the outpatient clinic
4. Co-operative patient
5. Males \& Females
6. Egyptian

Brief summary: This study aims to investigate the prevalence and risk factors of coronal and radicular caries in middle-aged individuals with Type 2 diabetes. It focuses on how poor blood sugar control, reduced saliva production, increased plaque accumulation, and periodontal disease contribute to a higher risk of dental decay in this population. The study examines the relationship between glycemic control (e.g., HbA1c levels) and the severity of caries, as well as the impact of diabetes-related changes in oral health, such as gum recession and dry mouth, on the development of both coronal and radicular caries. The findings could inform preventive strategies and dental care guidelines tailored for diabetic patients.


Eligibility criteria: Inclusion Criteria:

1. Patient whose age between 30-65
2. Diabetic patients
3. Patient consulting in the outpatient clinic
4. Co-operative patient
5. Males \& Females
6. Egyptian

Exclusion Criteria:

1. Patients under or over this age group
2. Lack of compliance
3. Disabilities
4. Pregnant women

Primary outcomes:
measure: prevalence of coronal caries
timeFrame: One year
measure: prevalence of radicular caries
timeFrame: One year
Secondary outcomes:
measure: Blood Glucose level
timeFrame: One year
measure: Salivary flow
timeFrame: One year
measure: Salivary pH
timeFrame: One year
measure: Caries risk related factors
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References: