louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06562647: SY001 Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors
Official title: An Exploratory Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of SY001 Injection Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Treatment Related Cancer
Ovarian Cancer
Lead sponsor: Cell Origin Biotech (Hangzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-20
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Single-arm, dose-increasing setting study of CAR macrophages in Mesothelin overexpressing solid tumors.

Detailed description: This study was a single-arm, single-center, dose-increasing design, using the "3+3" approach for dose escalation, to evaluate the safety, tolerability and initial effectiveness of SY001, and to evaluate the pharmacokinetic characteristics, cytokines and the correlation between the efficacy of SY001.

Eligibility criteria: Inclusion Criteria:

1. Patients with pathologically diagnosed advanced ovarian cancer/pancreatic cancer who have failed at least 1 prior lines treatment, and tumor tissue samples were positive for mesothlin IHC staining;
2. According to the RECIST 1.1, there is measurable tumor lesions (non-lymph node lesion 10mm in length or lymph node lesion 15mm in diameter measured by CT or MRI, with scan layer thickness 5mm);
3. Eastern Cooperative Oncology Group (ECOG) score of 2 and satisfactory major organ functions;
4. Estimated life expectancy \>3 months;
5. Female patients of childbearing age must undergo a serum pregnancy test at screening and prior to pretreatment and the results must be negative, and are willing to use a very effective and reliable method of contraception within 1 year after the last study treatment.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Any uncontrollable active infection, including but not limited to active tuberculosis, HBV infection;
3. Patients who have a history of other mesothelin-targeting therapy;
4. Patients who have a history of autoimmune disease;
5. The investigator assessed that the patient was unable or unwilling to comply with the requirements of the study protocol.

Primary outcomes:
measure: Identification of Maximum Tolerated Dose (MTD)
timeFrame: up to 28 days after SY001 infusion.
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: 3 months
measure: Time to Peak (Tmax)
timeFrame: 1 month
measure: Area Under the Plasma Concentration Versus Time Curve (AUC)
timeFrame: 1 month
measure: Maximum Plasma Concentration of cytokines (Cmax)
timeFrame: 1 month
Other outcomes:
Locations:
city: Linyi
country: China
facility: Linyi Cancer Hospital
Study officials:
References:
Clinical trial NCT03208647: Multi Center Case Control Study on Multiple Risk Factors of Aplastic Anemia
Official title: Multi Center Case Control Study on Multiple Risk Factors of Aplastic Anemia Based on EDC Data Management Platform
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aplastic Anemia
Keywords: case-control study
Multiple risk factors
Lead sponsor: Zhejiang Provincial Hospital of TCM
Sponsor class: OTHER
First posted: 2017-07-05
Enrollment: 1802
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the patients of AA group met a AA diagnostic criteria；The control group were chosen from other departments who were under acute infection (such as pneumonia), acute abdominal emergency (such as appendicitis), cataract surgery; All cases had no history of tumor and radiation and chemotherapy, without receiving the immunological therapy; the control group cases without hematological diseases, autoimmune diseases, Fanconi anemia, congenital diseases, etc.

Brief summary: To ascertain the risk factors of AA in ZheJiang Province of China at the moment, especially the comprehensive multiple factors risks. The author conducted a case-control research included 338 AA cases and 1464 controls. Subjects were surveyed using same standard questionnaire including personal data, past histories of diseases, family history and histories of occupational and daily exposure to harmful substances. Single and multiple Logistic regression analyses were made using SPSS17.0 on the dates to study potential factors in the development of AA.


Eligibility criteria: Inclusion Criteria:

* All the patients of AA group met a AA diagnostic criteria；The control group were chosen from other departments who were under acute infection (such as pneumonia), acute abdominal emergency (such as appendicitis), cataract surgery;
* 1-65 years old, male or female;
* Sign the informed consent.

Exclusion Criteria:

* With myelodysplastic syndrome, leukaemia, multiple myeloma,megaloblastic anaemia, paroxysmal sleep hemoglobinuria disease blood disease, etc.
* History of tumor, radiation or chemotherapy, once accept the immunological therapy, autoimmune diseases or allergic disease patients;
* Patients with neurological diseases.

Primary outcomes:
measure: the items about daily Exposures
timeFrame: January 2014
Secondary outcomes:
measure: Individual Behaviours
timeFrame: January 2014
measure: Occupational Exposures
timeFrame: January 2014
measure: Individual Health Status
timeFrame: January 2014
measure: Family disease history
timeFrame: January 2014
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00171847: Study of the Efficacy and Safety of Letrozole Combined With Trastuzumab in Patients With Metastatic Breast Cancer
Official title: An Open Label, Randomized Comparison of Femara® 2.5mg Once Daily With or Without Weekly Herceptin® Until Disease Progression as First-line Treatment in Postmenopausal Women With Advanced Breast Cancer.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Metastatic Breast Cancer
Keywords: Breast cancer
Metastatic
Trastuzumab
Letrozole
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Roche - Prof. Dr. Jens Huober et al.
First posted: 2005-09-15
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase IV trial to investigate the effect of the combination of Letrozole with trastuzumab in metastatic breast cancer patients


Eligibility criteria: Inclusion Criteria:

* Postmenopausal
* Her-2 overexpression and ER and/or PgR positive
* Metastatic Breast Cancer

Exclusion Criteria:

* Previous treatment with trastuzumab
* Significant Liver or renal impairment
* Erbb2 negative and/or ER and PgR negative

Other protocol-defined inclusion / exclusion criteria may apply.

Primary outcomes:
measure: Time to progression as assessed by clinical palpation and radiologic imaging every 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Objective response rate/Clinical Benefit rate
timeFrame: 3 months
measure: Time to treatment failure
timeFrame: 3 months
measure: Duration of response/clinical benefit during treatment
timeFrame: 3 months
measure: Overall survival
timeFrame: 3 months
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00902447: Human Blood Cell Disorders Tissue Bank
Official title: Human Blood Cell Disorders Tissue Bank
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Human Blood Cell Disorders
Lymphoid, Myeloid and Erythroid Proliferative Disease
Keywords: Human Blood Cell Disorders
lymphoid, myeloid and erythroid proliferative disease
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2009-05-15
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The Human Blood Cell Disorder Tissue Bank will provide a convenient, comprehensive source of tissue containing populations of human blood cells from patients with various types of lymphoid, myeloid, and erythroid proliferative diseases as well as other associated conditions. The tissue bank will continue to be an invaluable asset for understanding of the biology of multiple blood cell disorders involving several cell types as well as the physiology of normal cellular counterparts affected in these disorders. Internal and external investigators will be able to utilize this tissue to test hypotheses relating to the immunologic, virologic, genetic, and molecular properties of these abnormal cells as well as normal cells from normal unaffected family members or normal aged matched subjects to provide better comparisons.


Eligibility criteria: Inclusion Criteria:

* Participants or participant's Legally Authorized Representatives (LAR) must be able to understand and render voluntary, written informed consent.
* Patients must be able to contribute the required amount of blood and/or tissue without compromising their well-being or care.
* Participants must be willing to be contacted again for consideration of additional studies in the future, such as a blood draw or another action (e.g., bone marrow aspiration and/or biopsy) that would be done as part of their standard of care.

Exclusion Criteria:

* Patients who are known to be anemic, with hemoglobin \<8.0g/dl.
* Patients who are known to be infected with HIV.

Primary outcomes:
measure: Accumulate tissue from patients with various blood disorders, including but not restricted to lymphoproliferative, myeloproliferative, and erythroproliferative conditions.
timeFrame: Indefinite
Secondary outcomes:
measure: Develop a database of at least 10,000 subjects who have donated samples for research as well as DNA banking, and who are willing to be contacted again for consideration of additional studies in the future.
timeFrame: Indefinite
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: The Feinstein Institute for Medical Research
state: New York
Study officials:
affiliation: Northwell Health
name: Nicholas Chiorazzi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01136447: Continuous Infraclavicular Blocks: Neurostimulation Versus Ultrasound
Official title: Success Rate of Infra-clavicular Blocks: Comparison of Ultrasound Versus Neurostimulation Guided Catheter Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Upper Extremity
Keywords: Brachial plexus
Ultrasound
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2010-06-03
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 whether ultrasound guidance or nerve stimulation is the best option for placing continuous peripheral nerve block catheters for upper limb surgery.

Detailed description: In a multidisciplinary, observer blinded, prospective, single center, randomized study, success rate of US guided versus neurostimulation guided catheter placement for continuous infraclavicular block in patients scheduled for upper limb surgery will be studied. Block effectiveness, time taken, discharge from recovery, postoperative pain and disability and patient acceptance will be studied in 210 patients.

Eligibility criteria: Inclusion Criteria:

* Age 18-80 yrs
* Weight 40-100 kg
* Either sex
* Height \>150 cm
* American Society of Anesthesiologists physical status 1-3
* Scheduled for hand or elbow surgery under regional anesthesia

Exclusion Criteria:

* Inability to give informed consent
* Refusal of treatment randomization
* Language barrier
* Allergy to any medications being used in the study protocol
* Ongoing major medical or psychiatric problems
* Chronic pain or narcotic use/abuse
* Peripheral neuropathy or major neurological problems
* Scarring in area of blockade
* Inability to co-operate with post-operative evaluation
* Major coagulopathy
* Pregnancy and breast feeding
* Patients requiring anesthesia of other surgical sites
* Obese patients (i.e. BMI \>40)
* Postoperatively, patients will be excluded if they have had additional operative procedures requiring a change in the usual protocol of care

Primary outcomes:
measure: Neurostimulation versus ultrasound guided infraclavicular catheter placement
timeFrame: 14 days
Secondary outcomes:
measure: Time taken for complete nerve block
timeFrame: 14 days
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Hospital
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Shalini Dhir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00151047: Docetaxel Plus Capecitabine in Newly Diagnosed Localized or Locally Advanced Prostate Cancer
Official title: Evaluation of Primary Chemotherapy With Docetaxel Plus Capecitabine in Selected Patients With Newly Diagnosed Localized or Locally Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2005-09-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose: The purpose of this clinical trial is to look at the chemotherapy combination of docetaxel and capecitabine in the treatment of newly diagnosed or locally advanced prostate cancer, and to determine if this treatment is an acceptable, effective and a safe treatment option. In addition, this clinical trial will evaluate how this treatment affects chemicals (enzymes), and other cancer related genetic changes in the tumor. Optional: This clinical trial will conduct extra imaging studies for research purposes including combined endorectal prostate magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRSI) and diffusion weighted imaging (DWI) to evaluate prostate cancer and response to study treatment.


Eligibility criteria: Patients must have newly diagnosed prostate cancer with at least one of the following criteria:

* Clinical Stage \> T2
* PSA \> 15 ng/ml
* Biopsy Gleason's sum \> 8
* All patients must have a minimum PSA value of \> 5 ng/ml.
* Patients may not have evidence of distant systemic metastasis.
* Patients may not undergo concurrent hormonal, biologic, or chemotherapy.
* Patients may not have prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil.
* Patients with a history of severe reaction to docetaxel or other drugs formulated with polysorbate 80 will not be eligible.
* Patients may not have an underlying cardiac disease.

Primary outcomes:
measure: The percentage of patients who respond to treatment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: The University of Michigan Comprehensive Cancer Center
name: Maha Hussain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02687347: Efficacy and Safety of Ultra-low Dose Methadone as Adjuvant Analgesic in Cancer Patients With Pain
Official title: A Double Blind Randomized Clinical Trial to Investigate the Efficacy and Safety of Ultra-low Dose Methadone as Adjuvant Analgesic Therapy in Cancer Patients With Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pain, Intractable
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The research hypothesis of this study is: In patients with moderate to severe cancer related pain, the addition of low dose methadone to an existing opioid significantly reduces pain severity compared to low doses morphine.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed of cancer-related pain of more than 3 months duration
* Pain relief during the last week rated unsatisfactory by the patient
* Pain severity during the last week rated moderate (between 4 and 7/10)
* Analgesic therapy must have been stable for 7 days
* Able to understand English or French
* Willing and able to give written informed consent

Exclusion Criteria:

* Patients who are currently receiving or have received methadone as analgesic in the last 6 months
* Contraindication to receive methadone (allergy, QTc segment on the ECG\>450msec, concurrent treatment with medication that could increase methadone's effects)
* Patients presenting with changes in their cancer status/treatment with potential effects on their pain severity, during the duration of the trial (eg: new metastasis, indication for radiotherapy)
* Patients whose life expectancy is shorter than 2 months
* Patients with cognitive impairment presenting with difficulties understanding the trial and completing the research questionnaires
* Pregnant or lactating women (women of childbearing potential must have negative pregnancy test)

Primary outcomes:
measure: pain relief
timeFrame: 2 months
measure: pain relief
timeFrame: 2 months
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".
timeFrame: 2 months
Other outcomes:
measure: pain interference
timeFrame: 2 months
Locations:
city: Montreal
country: Canada
facility: Alan Edwards Pain Management Unit. Mcgill University Health Centre
state: Quebec
Study officials:
References:
Clinical trial NCT00986947: Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates
Official title: Phase 2 Study of IVIg and Rituximab for Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Kidney Failure
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2009-09-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Some patients who need kidney transplants have high levels of antibodies that make them incompatible with most potential deceased donor kidney offers. These patients are considered highly-sensitized and are very difficult to transplant because the likelihood that they will receive a compatible organ is very low. There are some medications and procedures that can decrease the antibody levels and this can increase the chance of finding a compatible donor for these patients. In this study the investigators will give two medications (IVIg and Rituximab) to highly-sensitized patients who are on the waiting list for a deceased donor kidney transplant. After the investigators administer these medications, the investigators will continue to check for compatibility as organ offers are received. If a compatible organ offer is received, the investigators will perform the transplant using that organ. The investigators hypothesize that these medications will lower antibody levels and increase the chance that a these patients are able to receive a compatible kidney transplant.


Eligibility criteria: Inclusion Criteria:

* Ages 18-75
* End-stage renal disease on dialysis
* Panel Reactive Antibody (PRA) \> 60%
* Have been evaluated for and are currently listed for deceased donor renal transplantation

Exclusion Criteria:

* Have contraindication to transplantation
* Have contraindication to receiving IVIG
* Have allergy to IVIG
* Have received IVIG for desensitization previously without effect
* Pregnant women or those intending to become pregnant

Primary outcomes:
measure: Time to Kidney Transplantation
timeFrame: 4 months
Secondary outcomes:
measure: Decrease in Panel Reactive Antibody
timeFrame: 4 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
Study officials:
References:
Clinical trial NCT02835547: Evaluation and Management of Cardiovascular Risk Factors in Inflammatory and Acquired Dysimmune Diseases (CARMIN)
Official title: Evaluation and Management of Cardiovascular Risk Factors in Inflammatory and Acquired Dysimmune Diseases (CARMIN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory and Acquired Dysimmune Diseases
Keywords: cardiovascular event
risk factors
inflammatory diseases and acquired dysimmune
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-18
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with systemic lupus erythematosus, rheumatoid arthritis, psoriasis, scleroderma, kidney transplants, or hematopoietic stem cells transplants

Brief summary: The hypothesis is that chronic inflammatory dysimmune state promotes the development of cardiovascular complications. The biological assumption is based on the fact that chronic inflammation promotes lesions of the vessel wall (endothelial alterations, calcification, atherosclerosis). The clinical aim is to allow to identify high-risk patients and to act in prevention.

The project CARMIN involves the assessment of cardiovascular risk factors, their management, and their influence on cardiovascular prognosis in patients with autoimmune diseases and immunodeficiencies acquired. It is based on the creation and monitoring of a cohort of patients with different types of dysimmune disorders: systemic lupus erythematosus, rheumatoid arthritis, psoriasis, scleroderma, systemic vasculitis ANCA, kidney transplants, and hematopoietic stem cells transplants.


Eligibility criteria: Inclusion Criteria:

* Patients followed in the various services of medical specialties pole of the Edouard Herriot hospital
* The diagnosis of the pathology selected for this study based on a clear clinical and biological evaluation supported by criteria specific to each pathology and compatible with international standards.
* Date of diagnosis should not be less than 5 years (+/- 1 year), except for scleroderma patients where it has been extended to 10 years.
* For kidney transplant patients the investigators take into account only patients with a maximum of 2 years of dialysis before graft.

Exclusion Criteria:

* Diabetic patients
* HIV seropositive
* Patients with multiple pathologies

Primary outcomes:
measure: The occurrence of any cardiovascular event (will be recorded from the patient files and/or phone calls to patient")
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: