louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03589001: 24 Month Follow-up of Patients With Osgood Schlatter (OSD)
Official title: A Prospective Investigation of Osgood Schlatter With 24 Month Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osgood-Schlatter Disease
Apophysitis
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 51
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents aged 10-14 years old diagnosed with Osgood Schlatter

Brief summary: Osgood Schlatter is a common knee condition, affecting approximately 10% of adolescents. OSD is thought to be a growth related pain conditon, and thus resolve after maturation. Despite this, there a lack of prospective data investigating whether this is in fact the case.

Detailed description: This is a prospective cohort study of 51 adolescents (aged 10-14 at baseline) with Osgood schlatter. Participants are followed for two years.

Eligibility criteria: Inclusion Criteria:

* 10-14 years of age
* Pain at tibial tuberosity during two or more of the following activities: Sitting with a bent knee, squatting, running, jumping or stair ambulation
* Pain during palpation of tibial tuberosity
* Knee pain for 6 weeks or more

Exclusion Criteria:

* Other knee conditions that may manifest as anterior knee pain (Patellofemoral pain, iliotibial band syndrome, sinding-larson-johanson disease).
* Previous surgery
* Pain from the hip or back that interferes with activities of daily living.
* Habitual patella luxations
* Clinical suspicion of meniscal lesion

Primary outcomes:
measure: Current knee pain
timeFrame: 24 months
Secondary outcomes:
measure: Pain intensity
timeFrame: 24 months
measure: Pain frequency
timeFrame: 24 months
measure: Duration of being pain-free
timeFrame: 24 months
measure: Medical attention
timeFrame: 24 months
measure: Use of pain killers
timeFrame: 24months
measure: knee injury and osteoarthritis outcomes score (KOOS) sport and activity subscale
timeFrame: 24 months
measure: Sports participation
timeFrame: 24 months
measure: Health Related quality of life
timeFrame: 24 months
measure: Sleep
timeFrame: 24 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Research Unit for General Practice in Aalborg
Study officials:
References:
Clinical trial NCT04739501: Trans-arterial Chemoembolization in Patients With Hepatocellular Carcinoma: A Study of Different Outcomes and Their Predictive Factors
Official title: Trans-arterial Chemoembolization in Patients With Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HCC with TACE

Brief summary: Radiological response after trans arterial chemoembolization (TACE) is classified according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) to: complete response (CR) (disappearance of arterial enhancement), partial response (PR) ( at least a 30% decrease in the sum of diameters of viable enhancement), progressive disease (PD) (an increase of at least 20% in the sum of the diameters of viable enhancement, or appearance of new lesions), and stable disease (any cases that do not qualify for either partial response or progressive disease

Detailed description: POST-TACE response of treatment for cases of hepatocellular cancer

Eligibility criteria: Inclusion Criteria:

Clinical history and examination with special stress on symptoms and signs of chronic liver disease with or without evidence of hepatic decompensation e.g. the presence of ascites and with or without evidence of complications e.g. jaundice spider naevi, bleeding varices, ascites, and lower limb edema.

Laboratory findings in the form of raised bilirubin and liver enzymes, impaired coagulation profile, and/or low serum albumin.

Abdominal ultrasonography revealing liver cirrhosis (coarse echopattern, attenuated hepatic veins, irregular outlines, hypertrophy of caudate lobe and/or shrunken liver, presence of focal hepatic) and presence of splenomegaly, ascites, or portal vein thrombosis (PVT).

Exclusion Criteria:

A patient who had surgical resection or liver transplantation Patients refuse to participate Hepatic focal lesion other than HCC

Primary outcomes:
measure: Post_TACE hepatic cell failure
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut
Study officials:
References:
Clinical trial NCT00084201: Interactions Between Cranberry Juice and Antibiotics Used to Treat Urinary Tract Infections
Official title: Cranberry: Interactions With Anti-Infectious Agents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Keywords: Vaccinium macrocarpon
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-06-09
Enrollment: 18
Sex: ALL
Minimum age (years): 6
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of study is to determine whether cranberry juice interacts with antibiotics used to treat urinary tract infections (UTIs).

Detailed description: Although evidence of its effectiveness is limited, cranberry juice is widely used to prevent urinary tract infections (UTIs). However, recent studies have shown that cranberry juice may affect the way the body absorbs and metabolizes antibiotics used to treat UTIs. This study will determine whether concurrent cranberry juice administration lowers the urinary concentrations of two commonly used antibiotics, amoxicillin and cefaclor.

This study will involve children being treated for UTIs and adults without UTIs. All of the children will continue their prescribed amoxicillin/cefaclor treatment. After 7 to 10 days of antibiotic treatment, the children will be assigned to receive either cranberry juice for 2 days or no additional treatment. Urine samples will be collected from all child participants before and after the administration of cranberry juice to examine the excretion of the antibiotics.

Adult participants will receive two different doses of amoxicillin, with or without cranberry juice. Blood and urine samples will be collected to evaluate the effect of cranberry juice on the absorption and elimination of amoxicillin.

Eligibility criteria: Inclusion Criteria for Children:

* Urinary tract infection (UTI) treated with cefaclor or amoxicillin

Inclusion Criteria for Adults:

* No UTI

Exclusion Criteria:

* Allergies to antibiotics
* Use of medications other than oral contraceptives
* Pregnancy or breast-feeding
* Smoker

Primary outcomes:
measure: Drug Elmination
Secondary outcomes:
measure: Drug absorption
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Gail D Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01112501: SPECT/CT in the Diagnosis of Dementia
Official title: SPECT/CT in the Diagnosis of Dementia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Keywords: Diagnosis
Dementia
Imaging
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2010-04-28
Enrollment: 82
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with possible/suspected early dementia

Brief summary: Aim of the study is to evaluate whether Tc-99m-ECD-SPECT/CT enhances early diagnosis of dementia in two specific patient groups: (1) patient with mild cognitive impairment, and (2) patient with possible symptoms and signs of frontotemporal dementia. Evaluation of SPECT/CT data is performed both by visual and quantitative voxel-based analyses (Statistical Parametric Mapping). The final diagnosis is based on up to four years clinical follow-up.


Eligibility criteria: Inclusion Criteria (one of these):

* healthy control
* mild cognitive impairment (recruited from a population based data)
* clinically suspected frontotemporal dementia (unset diagnosis)

Exclusion Criteria:

* unable to be scanned with SPECT/CT

Primary outcomes:
measure: Final diagnosis
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
References:
Clinical trial NCT05123001: Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events
Official title: Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hodgkin Lymphoma
Non Hodgkin Lymphoma
Leukemia
Multiple Myeloma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to monitor physiological and molecular changes during and following CAR-T cancer cell therapy, towards improved management of adverse events including Cytokine Release Syndrome and neurotoxicity.

Our study aims are to improved early detection and precise management of adverse events for patients receiving Chimeric antigen receptor T- cell (CAR-T):

1. To assess the feasibility, including accuracy, usability, and usefulness of wearable sensors in CAR-T patients.
2. To generate comprehensive multiomic profile analysis following CAR-T therapy.
3. To perform integrated analysis of wearables sensor data, omics data, and symptom/clinical data.


Eligibility criteria: Inclusion Criteria:

* Participant must be in the process of undergoing cancer cell therapy at Stanford University.

  * Adults \> 18 years
  * Any cell target may be used. (e.g. CD19, CD22, Bispecific CD19/22, Bispecific CD19/20, etc.)
  * English speaking
  * Assessed ability for caregiver/patient to use wearable devices and independently perform blood microsample collection

Exclusion Criteria:

* In the investigator's judgment, the subject is unlikely to comply with all protocolrequired study visits or procedures.

Primary outcomes:
measure: Monitoring heart rate data
timeFrame: 28 days
measure: Monitoring temperature data
timeFrame: 28 days
Secondary outcomes:
measure: Microsampling
timeFrame: 28 days
measure: Safety of wearable devices
timeFrame: 28 days
measure: Safety of the microsampling device
timeFrame: 28 days
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Surbhi Sidana
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06667401: Exploring the Efficacy of Assistive Artificial Intelligence for Ultrasound Guided Regional Anesthesia in Residency Training
Official title: Exploring the Efficacy of Assistive Artificial Intelligence for Ultrasound Guided Regional Anesthesia in Residency Training
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Regional Anesthesia
Keywords: Regional anesthesia
Artificial Intelligence
Resident training
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The student population includes anesthesia residents in training, and experienced regional anesthesia providers.

Brief summary: The purpose of this study is to investigate the efficacy of a novel artificial intelligence (AI) device designed to assist in Ultrasound guided regional anesthesia (ScanNav Anatomy Peripheral Nerve Block; ScanNav), in the teaching and training of anesthesiology residents in the subspecialty of regional anesthesia.

Detailed description: Ultrasound-guided regional anesthesia (UGRA) relies on the precise acquisition and interpretation of ultrasound images. The necessary skills to attain this is dependent on the knowledge of the underlying anatomy. Notwithstanding, even experienced anesthesiologists can find this challenging, especially in the setting of anatomical variation, obesity and other potential confounders. This study aims to clarify if The ScanNav, a novel artificial intelligence device designed to assist in UGRA, when utilized with trainees, improves their uptake and training. We also aim to see the relationships of how it enhances teaching and training of residents by experienced regional anesthesia providers.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria include any anesthesia resident with no prior experience with UGRA.

Exclusion Criteria:

* Exclusion criteria include any anesthesia resident who has undergone the regional elective service prior to the inception of the study.

Primary outcomes:
measure: Qualtric questionaire of participants
timeFrame: From enrollment to the end of device use at 2 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
citation: Bowness JS, El-Boghdadly K, Woodworth G, Noble JA, Higham H, Burckett-St Laurent D. Exploring the utility of assistive artificial intelligence for ultrasound scanning in regional anesthesia. Reg Anesth Pain Med. 2022 Jun;47(6):375-379. doi: 10.1136/rapm-2021-103368. Epub 2022 Jan 28.
Clinical trial NCT00639301: Retinoblastoma Survivor Study: Assessment of General Health and Quality of Life
Official title: Retinoblastoma Survivor Study: Assessment of General Health and Quality of Life
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retinoblastoma
Keywords: Survivor
Quality of Life
Eye
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: St. Jude Children's Research Hospital
First posted: 2008-03-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Long term survivors of retinoblastoma will be identified via the NCI and New York (MSKCC) databases and offered participation in the study.

Brief summary: The purpose of this study is to find out about the quality of life and health in a group of adults who had retinoblastoma when they were children. By quality of life, we mean how you are feeling about being satisfied with things in your life, including your physical health, your emotional health, and your ability to carry out daily activities. We hope that this information will help us provide better care to future children with retinoblastoma and better follow-up care for survivors of retinoblastoma.


Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with retinoblastoma at any age
* At least five years from completion of all retinoblastoma-directed therapy
* Able to provide informed consent and/or assent, if indicated

Primary outcomes:
measure: To describe the long-term health status of long term survivors of childhood retinoblastoma, General medical outcomes, vision status, Rates of second cancer
timeFrame: conclusion of study
Secondary outcomes:
measure: To describe the quality of life and psychosocial functioning of long term survivors of childhood retinoblastoma Fear of disease recurrence/development of other cancers, Health behaviors, Body image, etc.
timeFrame: conclusion of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Danielle Novetsky Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02035501: Treatment of TNNT1-Myopathy With L-Tyrosine.
Official title: Treatment of TNNT1-Myopathy With L-Tyrosine. A Double-blind, Placebo-controlled Crossover Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nemaline Myopathy
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 10
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate if treatment with L-Tyrosine improves selected outcome measures of TNNT1 myopathy.


Eligibility criteria: Inclusion Criteria:

* Male or female patients
* any age with TNNT1-related myopathy

Exclusion Criteria:

* Patients who are non-cooperative or parents/ legal guardians who are unwilling to sign consent form

Primary outcomes:
measure: 1. goal attainment score
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
References:
Clinical trial NCT05199701: Prospective Case Collection Study for New Mammography Technologies
Official title: Prospective Case Collection Study for New Mammography Technologies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mammography
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 7500
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: To evaluate the safety and efficacy of the proposed investigational device and assess its clinical utility in breast cancer screening and diagnosis to support continuing technology development of the investigational technology.


Eligibility criteria: Inclusion Criteria:

* Subject is female of any race and ethnicity
* Subject is at least 35 years old
* Subject is indicated for a screening or diagnostic mammogram or breast biopsy

Exclusion Criteria:

* Subject is pregnant or thinks she may be pregnant
* Subject has breast implants, cardiac pacemakers, nipple piercings, or IV ports in the mammography field of view
* Subject previously participated in the study

Primary outcomes:
measure: Clinically acceptable image quality of the Investigational Device.
timeFrame: 4 years
measure: Mammograms can be safety acquired on the Investigational Device.
timeFrame: 4 years
Secondary outcomes:
measure: The ease of positioning and usability of the Investigational Device.
timeFrame: 4 years
measure: Subject assessment of comfort of the Investigational Device.
timeFrame: 4 years
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Gilbert
country: United States
facility: Southwest Medical Imaging
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Medical Imaging LTD
state: Arizona
city: Coral Gables
country: United States
facility: Miami Breast Institute
state: Florida
city: Palm Beach Gardens
country: United States
facility: Diagnostic Centers of America Palm Beach Gardens
state: Florida
city: West Palm Beach
country: United States
facility: Diagnostic Centers of America West Palm Beach
state: Florida
city: Louisville
country: United States
facility: Baptist Health
state: Kentucky
city: Bel Air
country: United States
facility: Progressive Radiology
state: Maryland
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Rochester
country: United States
facility: Elizabeth Wendy Breast Care
state: New York
city: Greensboro
country: United States
facility: Solis Mammography Greensboro
state: North Carolina
city: Columbus
country: United States
facility: Solis Mammography Columbus
state: Ohio
city: Burleson
country: United States
facility: Solis Mammography Burleson
state: Texas
city: Arlington
country: United States
facility: Washington Radiology
state: Virginia
city: Sterling
country: United States
facility: Washington Radiology
state: Virginia
Study officials:
References:
Clinical trial NCT01042301: Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes
Official title: Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2010-01-05
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The "Lymphoscreen" study aims to characterize precisely (phenotypes/cytokines/functions) CD8+ T cell responses in type 1 Diabetes to identify biomarkers of the disease. Such markers are needed for refine type 1 Diabetes diagnosis/prognostic, and to design new therapeutic approaches targeting autoreactive CD8+ T cells. An original approach using DNA immunization of humanized mice allowed us to identify relevant CD8 epitopes derived from GAD65 and IA-2 beta cell autoantigens. The aims are: (i) identifying exhaustively epitopes recognized by autoreactive CD8+ T lymphocytes in type 1 Diabetes and following islet or pancreas graft in humans; (ii) identifying pathogenic CD8+ T cell patterns or profiles related to type 1 Diabetes pathogenesis and evolution; (iii) correlating CD8+ autoreactive T cell responses and autoantibody responses to new cellular (such as CD4+ T cells or peripheral cell miRNA) or humoral markers of the disease (such as serum miRNA).


Eligibility criteria: Inclusion criteria:

* at least, 50 patients with "recent" type 1 diabetes,
* 30 patients with long-term type 1 diabetes,
* 10 patients with Latent Autoimmune Diabetes,
* 10 subjects with a risk for diabetes,
* 20 type 1 diabetic patients with pancreatic graft or Langerhans islet graft.
* 50 healthy subjects paired to HLA class I and to the age

Those subjects have to respect the following criteria :

* Age from 7 to 70 -Caucasian
* Affiliated to a national insurance scheme
* Written informed consent obtained For children, written informed consent is required from the two parents.

Non-inclusion criteria :

* Age strictly inferior to 7 or strictly superior to 70 years old
* Pregnancy
* Secondary diabetes
* No written informed consent

Primary outcomes:
measure: Identification and characterization of new CD8+ T lymphocytes related to type 1 diabetes and its evolution (2009-2012)
timeFrame: 3 years
Secondary outcomes:
measure: Identification and characterization of new profiles of humoral and cellular markers (including T cell reactivity and miRNA) related to type 1 diabetes (2010-2014).
timeFrame: 3 years
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Lucy Chaillous
role: PRINCIPAL_INVESTIGATOR
References: