louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04145960: Evaluation of Prognostic Monitoring for Women Who Have Completed Standard Treatment for Breast Cancer
Official title: Evaluation of Prognostic Monitoring for Women Who Have Completed Standard Treatment for Breast Cancer Via Analysis of Immunoinflammation-related Protein Complexes in Blood
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 200
Sex: FEMALE
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with high risk of recurrence and metastasis of breast cancer

Brief summary: The relationship between immune inflammation-related protein complexes in blood and recurrence or metastasis of breast cancer will be studied.

Detailed description: 200 patients with breast cancer will be followed up. Peripheral venous blood was collected every 3 to 6 months. Change regularity of breast cancer-specific immune inflammation-related protein complexes in blood at different follow-up time points will be studied. The relationship between disease-specific protein complexes and pathological state of patients will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Female
* Postoperative pathology confirmed invasive breast cancer after surgery for breast tumors
* Breast cancer-related chemotherapy and radiotherapy completed
* axillary lymph node metastasis ≥ 4
* age ≤ 60 years old

Exclusion Criteria:

* Male
* Aged above 60
* Breast Carcinoma in situ
* Women in pregnancy or breastfeeding
* Suffering from other malignant tumors
* Non-compliant patient

Primary outcomes:
measure: immune inflammation-related protein complexes
timeFrame: 2 years
measure: blood markers
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
name: Yali Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02462460: Rapid Pancreatic and Ovarian Screening MR Imaging With Motion Corrected T1, T2, and Advanced Diffusion Weighted Imaging for Patients With BRCA Mutation Who Undergo Screening Breast MRI
Official title: Pilot Study Pancreatic and Ovarian Screening MR Imaging of Rapid With Motion Corrected T1, T2, and Advanced Diffusion Weighted Imaging for Patients With BRCA Mutation Who Undergo Screening Breast MRI
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Screening Breast MRI in Patients Who Are BRCA Mutation Carriers
Keywords: Breast MRI
T1 weighted and diffusion weighted MR
screening pancreatic
screening ovarian
15-120
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 63
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSKCC clinics

Brief summary: The purpose of this study is to create a rapid scan of the pancreas and ovaries that could be used in the future to screen patients at risk for pancreatic or ovarian cancers. Currently, Magnetic Resonance Imaging (MRI) examinations of the pancreas and ovaries can last 30-45 minutes each. The investigators hope to create a rapid pancreatic and ovarian MRI evaluation that can be used as a screening tool that is completed in approximately 15 minutes. They will compare different tools available on modern MRI scanners to see which one reliably offers high quality images of the pancreas and ovaries.


Eligibility criteria: A minimum of 5 and maximum of 60 evaluable patients will be imaged on this study. Description of the subject inclusion and exclusion criteria are listed below.

Inclusion Criteria:

* BRCA 1 or 2 mutation
* Age ≥ 30
* Patients scheduled to undergo screening breast MRI with contrast

Exclusion Criteria:

* Patients with known breast cancer
* Patients unable to complete their scheduled breast MRI
* Patients with prior pancreatic surgery or cancers
* Patients with prior ovarian cancer or surgery involving removal of one or both ovaries
* Patients with prior abdominal or pelvic surgery

Primary outcomes:
measure: define optimized acquisition
timeFrame: 1 year
Secondary outcomes:
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: Peter Sawan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01969760: Pilot-Testing a Family-Based Intervention to Improve Child Outcomes and Increase Family Activity
Official title: Pilot-Testing a Family-Based Intervention to Improve Child Outcomes and Increase Family Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Overweight
Obesity
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2013-10-25
Enrollment: 18
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine the feasibility and acceptability of a family-based program to improve physical activity and tobacco outcomes in a small pilot of middle school students and their families.

Detailed description: Low income ethnic minority youth tend to be at greater risk for obesity, physical inactivity, high risk behaviors such as tobacco and substance use and resulting cardiovascular and chronic disease. In this study we modified a tobacco and substance use risk prevention program to develop a tailored intervention (Healthy Families DC) that also included promotion of physical activity (PA) for DC middle-school students referred by school staff as over-weight and at risk for problem behaviors. The program included an initial family assessment, a family feedback session with family PA goal setting and 6 phone/text based booster sessions. A pilot study with 18 families, comprised of at least one caregiver and target child, was conducted to examine feasibility, acceptability, and trends in preliminary outcomes such as PA via self-report and accelerometry, health risk behaviors (e.g., tobacco use), health goal setting, and changes in family functioning (e.g., youth positive behaviors, parenting).

Eligibility criteria: Inclusion Criteria:

* Students aged 12-16 years
* Attending regular education classes at three urban DC public middle schools. -Students must currently reside with at least one parent or guardian who wishes to also participate in this study.
* Students and at least one guardian must be fluent in English

Exclusion Criteria:

* Adolescents, who are outside the study age range
* Patients/parents unable to speak/read English
* Are wards of the state
* Not attending regular education classes at the public middle schools -Furthermore, adolescents and guardians not assenting/consenting to be in the study will be excluded.

Primary outcomes:
measure: Actigraphy-based changes in physical activity from baseline to 8-weeks post-baseline
timeFrame: 8-weeks
Secondary outcomes:
measure: Smoking Susceptibility Scale changes from baseline to 8-weeks post-baseline
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Cassandra A Stanton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04504760: Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and PK of ONO-2910 in Japanese and Caucasian Subjects
Official title: Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and PK of ONO-2910 in Japanese and Caucasian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2020-08-07
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate safety, tolerability and pharmacokinetics in Japanese and Caucasian subjects when ONO-2910 is administered as single and multiple doses orally.

Detailed description: This study is the First in Human (FIH) study to investigate safety, tolerability and pharmacokinetics in healthy Japanese and Caucasian adult male subjects when ONO-2910 is administered as single and multiple doses orally. Also, the purpose of this study is to evaluate pharmacokinetics of oral single-dose of ONO-2910 in Japanese elderly male and female subjects.

Eligibility criteria: Inclusion Criteria:

1. Japanese healthy adult male subjects (Part A and C)
2. Japanese men or women after menopause aged ≥65 years and ≤74 years (Part B)
3. Caucasian healthy adult male subjects (Part D)
4. Age (at the time of informed consent): ≥20 years, ≤ 45 years (Part A, C and D)

Exclusion Criteria:

1. Subjects currently with or with a history of disease
2. Subjects with current or with a history of severe allergy to drugs or foods
3. Subjects with current or with a history of drug or alcohol abuse

Primary outcomes:
measure: Adverse events [Safety and Tolerability]
timeFrame: Up to 13 days
Secondary outcomes:
measure: Cmax [Pharmacokinetic]
timeFrame: Up to 10 days
measure: Tmax [Pharmacokinetic]
timeFrame: Up to 10 days
measure: AUC24h [Pharmacokinetic]
timeFrame: Up to 10 days
measure: AUClast [Pharmacokinetic]
timeFrame: Up to 10 days
measure: AUCinf [Pharmacokinetic]
timeFrame: Up to 10 days
measure: T1/2 [Pharmacokinetic]
timeFrame: Up to 10 days
measure: CL/F [Pharmacokinetic]
timeFrame: Up to 10 days
measure: fe [Pharmacokinetic]
timeFrame: Up to 4 days
measure: CLr [Pharmacokinetic]
timeFrame: Up to 4 days
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Tokyo Clinical Site 01
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Masaharu Komeno
role: STUDY_DIRECTOR
References:
Clinical trial NCT06814860: Microenvironmental Trial of Classical Hodgkin Lymphoma in Adolescents
Official title: Microenvironmental Trial of Classical Hodgkin Lymphoma in Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Classical Hodgkin Lymphoma
Keywords: Hodgkin Lymphoma
adolescent
microenvironment
immune-check points
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 36
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 12 to 18 years who were histologically diagnosed with Classical Hodgkin lymphoma between 01/01/1996 and 31/12/2020 will be enrolled in the study.

Brief summary: Background. Classical Hodgkin's lymphoma (cHL) in adolescents between 15 and 18 years shows a higher disease-related mortality and the overall prognosis is worse than both children and adults.

Objectives. To investigate the immune checkpoint inhibitors (ICPI) therapeutic targets and specific T-regulatory and cytotoxic T-cell subsets, in the subgroup of adolescent cHL patients and to investigate their prognostic power.

Methods: Retrieved formalin-fixed paraffin-embedded (FFPE) of adolescent patients diagnosed with cHL with available clinical and tested by immunohistochemistry the immune checkpoint molecules CTLA-4, LAG-3, PD-1 and PDL1 and the biological markers FOXP3 and CD8.


Eligibility criteria: Inclusion Criteria:

* Patients aged 12 to 18 years at diagnosis of Classical Hodgkin lymphoma.

Exclusion Criteria:

* Unavailability/insufficiency of histological material for diagnosis.

Primary outcomes:
measure: Characterization of the tumour microenvironment
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Elena Sabattini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06898060: To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture
Official title: A Multicenter, Randomized, Open-label, Parallel Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Postmenopausal Women With Osteoporosis
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-27
Enrollment: 282
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
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 evaluate the efficacy and safety of QLG2128 in the treatment of postmenopausal women with osteoporosis and at high risk of fracture.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women who can walk freely (≥50 and ≤85 years);
* The patient has a body mass index(BMI) of 17.0 kg/m2 to 30 kg/m2；
* The patient has a bone mineral density T-score≤-2.5 and \> -5.0 at the lumbar spine (L1-L4) or femoral neck or total hip by dual energy x-ray absorptiometry (DXA)；
* The patient has at least one of the following high risk factors of fracture: 1) history of previous fragility fractures; 2) family history of hip fragility fracture; 3) age≥70 years; 4) BMI≤19.0 kg/m2；5) Currently smoking.
* The patient with at least 2 consecutive vertebrae(L1 to L4) and at least 1 hip can be evaluated for BMD.

Exclusion Criteria:

* In addition to postmenopausal osteoporosis, the other diseases affecting bone metabolism；
* History of osteosarcoma；
* History of orthostatic hypotension；
* Currently suffering from active urinary calculus；
* Received anti-osteoporosis treatment that does not meet protocol requirements；
* Received medication that affects bone metabolism within 4 weeks prior to screening, or is planned to use prohibited drugs/non-drug therapy under the protocol during the study period.

Primary outcomes:
measure: Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 52 Week
timeFrame: Baseline to 52 Week
Secondary outcomes:
measure: Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 26 Week
timeFrame: Baseline to 26 Week
measure: Percent Change in Bone Mineral Density (BMD) of Total Hip, Femoral Neck From Baseline to 26/52 Week
timeFrame: Baseline to 26/52 Week
measure: Proportion of Subjects With New Fragility Fractures From Baseline to 26/52 Week
timeFrame: Baseline to 26/52 Week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04539860: Comparison of Blood Pressure Measurements Between Transdermal Optical Imaging and Standard of Care
Official title: Comparison of Blood Pressure Measurements Between Transdermal Optical Imaging and Standard of Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Pressure
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Nuralogix Corporation
name: The Affiliated Hospital of Hangzhou Normal University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
First posted: 2020-09-07
Enrollment: 15000
Sex: ALL
Minimum age (years): 13
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only individuals, of any sex, over the age of 13 will be included in the study.

Brief summary: Participants (patients and volunteers) will be recruited to have their blood pressure measured by standard blood pressure assessment methods while having their face video recorded. The data collected will help improve the blood pressure measurement accuracy of Transdermal Optical Imaging, which relies on machine learning to extract physiological information from videos recorded.

Detailed description: There are many ways to measure blood pressure (monitors, mercury sphygmomanometer, aneroid devices), with most relying on a cuff-inflation. Transdermal Optical Imaging measures blood pressure using a video captured by any conventional camera (e.g., those on a phone, tablet, laptop) and advanced machine learning algorithms.

The current study aims to improve the accuracy of Transdermal Optical Imaging algorithms for measuring blood pressure. The investigators will recruit participants (patients with medical problems and healthy volunteers) to have their blood pressure measured in various ways (e.g.,by registered nurses with sphygmomanometer and stethoscope, continuous blood pressure monitor, etc.). Further, participants will have their faces video-recorded intermittently between standard measurements or at the same time as standard measures.

Eligibility criteria: Inclusion Criteria:

* Able and willing to provide written informed consent to participate (including by parent or legal guardian if under 16 years old).

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Blood Pressure Results
timeFrame: Single visit; up to one day
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Hangzhou
country: China
facility: The Affiliated Hospital of Hangzhou Normal University
state: Zhejiang
Study officials:
affiliation: University of Toronto
name: Kang Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03850860: Comparison of Two Empirical Antimicrobial Therapies of Prosthetic Joint Infection
Official title: Comparison of the Tolerance of Vancomycin in Combination With Piperacillin/Tazobactam or Cefepim as Empirical Antimicrobial Therapy of Prosthetic Joint Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone and Joint Infection
Keywords: prosthetic joint infection
empirical antibiotherapy
acute kidney injury
vancomycin
cefepim
Piperacillin/tazobactam
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients having had a prosthetic joint infection and having had a postoperative empirical antibiotherapy with combination of vancomycine and piperacillin-tazobactam or vancomycine and cefepime manage at the croix rousse hospital

Brief summary: The empirical use of vancomycin in combination with a broad-spectrum beta-lactam is currently recommended after the initial surgery of prosthetic joint infection (PJI). However, the tolerability of such high-dose intravenous regimens is poorly known. T

Detailed description: The empirical use of vancomycin in combination with a broad-spectrum beta-lactam is currently recommended after the initial surgery of prosthetic joint infection (PJI). However, the tolerability of such high-dose intravenous regimens is poorly known. The empirical antimicrobial therapy of PJI is associated with an important rate of adverse, linked with the use of the vancomycin and the piperacillin-tazobactam combination. Some studies suggest to use vancomycin-cefepime, which remains to be evaluated in PJI.

Eligibility criteria: Inclusion Criteria:

* patients having had a prosthetic joint infection and having had a postoperative empirical antibiotherapy with combination of vancomycine and piperacillin-tazobactam or vancomycine and cefepime

Exclusion Criteria:

* none

Primary outcomes:
measure: Rate of Treatment Failure
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Secondary outcomes:
measure: rate of adverse events
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
measure: rate of bacteria responsible for infection
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: HCL
name: Florent Valour, Md,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06036160: Feasibility of Integrated Care of Depression in Primary Care Pathways
Official title: Evaluation de Soins Primaires Intégrés en Psychiatrie
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depressive Disorder
Lead sponsor: Association De La Msp Pasteur
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 50
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: This protocol is a feasibility study of an integrated primary care pathway for patients suffering from difficult-to-treat depression. 50 patients will be recruited and followed for two years.


Eligibility criteria: Inclusion Criteria:

* age 18-65 years
* Good understanding of french language
* Major depressive disorder based on DSM-V criteria
* MADRS \> 19
* FAilure of two antidepressants during 6wks at standard minimal dose

Exclusion Criteria:

* Pregnancy or lactating
* People under tutelage
* bipolar disorder
* no health insurance
* neurological disorders
* contra-indication to physical activity
* high suicidal risk
* first degree history of bipolar disorder, schizophrenia, autism spectrum disorder

Primary outcomes:
measure: Percentage of patients completing the study per-protocol
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: