louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04893148: Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes
Official title: Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes Insufficiently Controlled by Insulin Glargine and Metformin Combination Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Glucose, High Blood
Keywords: IGlarLixi
Dulaglutide
Continuous glucose monitoring system
Type 2 diabetes mellitus
Lead sponsor: Chungbuk National University Hospital
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aimed to compare efficacy and safety of IGlarLixi and insulin glargine plus dulaglutide as intensification from basal insulin with metformin, in the absence of head-to-head trials.

Detailed description: Fixed-dose combinations of insulin glargine/lixisenatide (IGlarLixi) or insulin glargine plus dulaglutide constitute treatment intensification in type 2 diabetes mellitus (T2D). The investigators aimed to compare efficacy and safety of IGlarLixi and insulin glargine plus dulaglutide as intensification from basal insulin with metformin, in the absence of head-to-head trials. Treatments were compared in terms of glycated hemoglobin (HbA1c), fasting plasma glucose (FPG) change from baseline, and variables from continuous glucose monitoring (CGM) system; in addition to safety issues on hypoglycemia and changes in weight.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Patient with type 2 diabetes, treated with basal insulin plus metformin (maximum tolerated dosage) for at least 12 weeks
* Patient accepting to participant to this study

Exclusion Criteria:

* Pregnant or breastfeeding woman
* severe renal dysfunction (eGFR \<60 ml/min/1.73m2)
* chronic or acute hepatic disorder (HBV or HCV hepatitis, liver cirrhosis etc.) (AST/ALT \> 2.5\*ULN)
* Prescription such as immunosuppressant agents, glucocorticoids
* Active anti-cancer treatment

Primary outcomes:
measure: Changes in glycated hemoglobin (HbA1c)
timeFrame: Baseline, week 12
Secondary outcomes:
measure: Changes in fasting plasma glucose (FPG)
timeFrame: Baseline, week 12
measure: Changes in glucose time in range (TIR)
timeFrame: Baseline, week 12
measure: Changes in glucose time above range (TAR)
timeFrame: Baseline, week 12
measure: Changes in glucose time below range (TBR)
timeFrame: Baseline, week 12
measure: Incidence of hypoglycemia
timeFrame: Baseline, week 12
measure: Changes in weight
timeFrame: Baseline, week 12
Other outcomes:
Locations:
city: Cheonju
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
Study officials:
affiliation: Chungbuk National University Hospital
name: Eu Jeong Ku, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02666248: Long-term Follow-up of Subjects Exposed to Lentiviral-based CART-EGFRvIII Gene-modified Cellular Therapy Products in Cancer Studies
Official title: Long-term Follow-up of Subjects Exposed to Lentiviral-based CART-EGFRvIII Gene-modified Cellular Therapy Products in Cancer Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subjects Entering Into This Protocol Will be Followed for up to 15 Years After Initial CART-EGFRvIII Infusion
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who have participated in a lentiviral vector study and have received CART-EGFRvIII cells.

Brief summary: This is a non-therapeutic, long-term follow-up (LTFU) study of subjects who have received retroviral-based gene therapy products in cancer studies. All subjects in this LTFU protocol have received lentiviral modified T cells engineered to express an anti-EGFRvIII scFv Chimeric Antigen Receptor (CAR).

Detailed description: The primary objective of this study is to monitor adult subjects, who as participants of a clinical trial, received T cells modified by a lentiviral vector encoding a chimeric antigen receptor specific for EGFRvIII, for adverse events that may be associated with lentiviral vector gene transfer such as insertional oncogenesis.

Eligibility criteria: Inclusion Criteria:

* Subjects will be enrolled into this destination protocol because they have received CART-EGFRvIII cells that were genetically modified with a lentiviral vector. All subjects who have participated in a lentiviral vector study under IND 15968 and have received CART-EGFRvIII cells will be asked to participate in this protocol.
* Subjects 18 years of age and older
* Subjects who have provided informed consent prior to their study participation.

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of adverse events
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Donald O'Rourke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03452748: Fourier Transformed Infrared Spectroscopy in Macular Surgery
Official title: Fourier Transformed Infrared Spectroscopy in Macular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epiretinal Membrane
Macular Hole
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all excised membranes will be examined with FTIR spectroscopy, there will be no control group
Primary purpose: DIAGNOSTIC

Brief summary: Epiretinal membranes (ERM) are disorders leading to vision loss and metamorphopsia. Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of ERM. ERM can be well visualized with spectral domain optical coherence tomography (SD-OCT).

The aim of the study is to examine ERM and internal limiting membranes (ILM) exzised during routine macular surgery with fourier transformed infrared spectroscopy (FTIR) and compare results to optic coherence tomography (OCT) findings.

Detailed description: Purpose of the present study is to analyse components of ERM and ILM, giving hints for the origin of cells producing ERM. In contrast to electron microscopy, FTIR spectroscopy does not need any chemical fixation of the membranes and therefore structure of components of ERM and ILM are not changed by fixation.

In total, 20 eyes with idiopathic ERM, 10 eyes with lamellar macular hole, 10 eyes with full thickness macular hole and 10 eyes with diabetic ERM will be examined. To our knowledge there are no previous reports about FTIR spectroscopy of ERM and ILM, therefore the study will be performed as an exploratory pilot study.

Eligibility criteria: Inclusion Criteria:

* Idiopathic ERM, lamellar macular holes, full thickness macular holes, diabetic ERM and the indication for surgery (visual symptoms)
* Age 21 and older
* written informed consent for surgery and participation in the study prior to surgery

Exclusion Criteria: - Macular edema due to other reasons than ERM

* Hereditary macular disorders
* In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Primary outcomes:
measure: collagen
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Study officials:
affiliation: VIROS at Hanuschkrankenhaus
name: Oliver Findl, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02594930: Comparison of Two Different Techniques of Synovial Biopsy and Resistances of Cutaneous Smears in Suspected PPI
Official title: Comparison of Directed Versus Undirected Synovial Biopsy in Culture-negative Periprosthetic Joint Infections (With Preoperative Smears From the Skin) of the Knee and Evaluation of Outcome After Revision Joint Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infection of Total Knee Joint Prosthesis
Keywords: synovial biopsy
knee arthroplasty
infection
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether an undirected synovial biopsy technique has the same accuracy in detecting periprosthetic joint infection in the knee as an arthroscopic assisted directed synovial biopsy technique.

Detailed description: Successful treatment of an infected joint arthroplasty depends on correctly identifying the responsible pathogens. The value of a preoperative biopsy remains controversial. We compared the sensitivity and specificity of two techniques of synovial biopsy of knee joint arthroplasties suspicious for infection and asked whether the results correlate with intraoperative findings at revision.

Eligibility criteria: Inclusion Criteria:

* Chronic painful knee prosthesis planned for synovial biopsy to detect infection
* Culture-negative joint aspiration

Exclusion Criteria:

* Co-morbidities: Tumour disease, immune suppression

Primary outcomes:
measure: Correlation of microbiological and histological results of undirected and directed synovial biopsies
timeFrame: within the first 14 days after surgery
Secondary outcomes:
measure: Correlation of microbiological results from synovial biopsy with intraoperative findings at revision
timeFrame: within the first 14 days after surgery
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar
state: Bavaria
Study officials:
affiliation: Klinikum rechts der Isar, TU Munich
name: Ruediger Eisenhart-Rothe, Prof.
role: STUDY_CHAIR
References:
citation: Scheele C, Krauel I, Pohlig F, Muehlhofer H, Gerdesmeyer L, Lasic I, Prodinger PM, Banke I, von Eisenhart-Rothe R, Harrasser N. Guided and Unguided Biopsy in the Diagnostic of Periprosthetic Infections of the Knee - Evaluation of an Evidence-based Algorithm. Z Orthop Unfall. 2019 Dec;157(6):684-694. doi: 10.1055/a-1034-0923. Epub 2019 Oct 28. English, German.
Clinical trial NCT01188330: Program of Evaluation and Geriatric Intervention on the Functional Status, Quality of the Life, and Survival
Official title: Randomized Study Comparing the Interest of a Program of Evaluation and Geriatric Intervention on the Functional Status, Quality of the Life, and Survival of Elderly Patients With Acute Myeloid Leukaemia. MLSP/IPC 2009-003
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myeloid Leukemia
Keywords: acute myeloid leukemia
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2010-08-25
Enrollment: 100
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Acute myeloid leukaemia (AML) is a disease of the elderly, with a median age at diagnosis of 65. A poor outcome in this population has been well established, with very short overall survival (OS) and disease free survival (DFS).There are numerous bad prognostic factors related to the disease itself or to the patient's medical condition.

This study will evaluate the impact of a Comprehensive Geriatric assessment (CGA) performed at diagnosis with planned interventions according to disabilities and monthly follow-up by a nurse practitioner during 6 months on functional status of older cancer patients treated for Acute myeloid leukaemia. Functional status will be assessed with the Lawson Instrumental Activities of Daily Living (IADL) scale at diagnosis and 6 months after randomisation.


Eligibility criteria: Inclusion Criteria:

* Patients aged 70 years and older
* Referred for treatment following a diagnosis of acute myeloid leukaemia.
* signed informed consent

Exclusion Criteria:

* Terminal patients, with a life expectancy estimated to be less than 3 months, will be excluded from the study, due to ethical issues and the fact that they are unlikely to benefit from this evaluation.
* Patients unable to give informed consent.

Primary outcomes:
measure: functional status
timeFrame: 6 months
Secondary outcomes:
measure: nutritional status
timeFrame: 6 months
measure: quality of life
timeFrame: 6 months
measure: survival
timeFrame: 6 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Aude CHARBONNIER, MD
city: Toulouse
country: France
facility: Christian RECHER
Study officials:
affiliation: Institut Paoli-Calmettes
name: Aude CHARBONNIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06015230: Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GR1603 in SLE
Official title: A Phase Ⅰb/Ⅱ, Randomized, Double-blind, Placebo-controlled Study to Investigate the Tolerability, Safety,Pharmacokinetics and Efficacy of an Intravenous Treatment Regimen of GR1603 in Subjects with Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Lupus Erythematosus, Systemic
Keywords: IFNR
Autoimmune Diseases
SLE
Lead sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-29
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Study to Investigate the Tolerability, Safety,Pharmacokinetics and efficacy of GR1603 in subjects with Systemic Lupus Erythematosus ； GR1603 injection is a monoclonal antibody targeting IFNAR1, which can block IFNAR binding to type I interferons such as IFNα and be used to treat systemic lupus erythematosus.

Detailed description: This is a Phase Ib/Ⅱ,double blind, multiple-dose study to evaluate the pharmacokinetics (PK), safety，tolerability and efficacy of intravenously administered GR1603 in participants with active SLE despite receiving standard of care .

Phase Ib is a multi-dose escalation phase in which 16 subjects are scheduled to enroll.

A total of 120 subjects were randomly assigned to GR1603 injection low dose group, high dose group or placebo group in phase Ⅱ.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of SLE according to the ACR 1997 ≥24 weeks
* Active moderate to severe SLE
* At least one of these antibodies positive: ANA, anti-dsDNA and anti-Smith.

Exclusion Criteria:

* Active severe or unstable neuropsychiatric SLE
* Clinically significant laboratory test
* Clinically significant active infection

Primary outcomes:
measure: Adverse events(phase Ib)
timeFrame: up to week 16
measure: Number of participants who achieved BICLA response (phase Ⅱ)
timeFrame: week 24
Secondary outcomes:
measure: Cmax(phaseⅠb）
timeFrame: up to week 16
measure: AUC0-t(phaseⅠb）
timeFrame: up to week 16
measure: AUC0-∞(phaseⅠb）
timeFrame: up to week 16
measure: AUCss(phaseⅠb）
timeFrame: up to week 16
measure: Tmax(phaseⅠb）
timeFrame: up to week 16
measure: t1/2z(phaseⅠb）
timeFrame: up to week 16
measure: Vz(phaseⅠb）
timeFrame: up to week 16
measure: CLz(phaseⅠb）
timeFrame: up to week 16
measure: Number of participants who achieved SRI (4)(phase Ⅱ)
timeFrame: up to week 28
measure: Number of participants who achieved BICLA response(phase Ⅱ)
timeFrame: up to week 28
measure: Number of participants with a ≥50% reduction in CLASI activity score (phase Ⅱ)
timeFrame: up to week 28
measure: Flare rate(phase Ⅱ）
timeFrame: up to week 28
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking union Medical Hosipital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: xiaofeng zeng, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01151748: Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma
Official title: Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Retinoblastoma
Eye Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-06-28
Enrollment: 0
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase II study of selective intra-arterial infusion of chemotherapy for intraocular retinoblastoma


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with advanced intraocular retinoblastoma (International Retinoblastoma Classification group D or E\*).
2. Patients with tumor recurrence or vitreous seeding following completion of systemic chemotherapy or previous radiation therapy.

Exclusion Criteria:

1. Congenital brain anomaly identified on MRI.
2. History of systemic coagulopathy.
3. Evidence of extra ocular retinoblastoma on clinical examination or neuroimaging.

Primary outcomes:
measure: Response: Globe salvage rate (Eyes saved/Eyes treated). This will be determined by clinical ocular examination.
timeFrame: Follow-up will be performed for one year from treatment date.
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Jonathan W Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05638048: Effect of Precise Grip Strength Training on PICC Catheter-Related Thrombosis in Cancer Patients
Official title: Effect of Precise Grip Strength Training on PICC Catheter-Related Thrombosis in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Stomach Cancer
Breast Cancer
Liver Cancer
Colon Cancer
Rectal Cancer
Keywords: PICC；Cancer patients；Grip strength training
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, color Doppler ultrasound diagnostic instrument and electronic grip device were used to determine the best grip strength of patients with tumor PICC catheterization, formulate precise and standardized grip strength training guidance for them, provide personalized functional exercise health education, and observe the impact of precise grip strength training guidance on Peripheral central venous catheter-associated thrombosis. To provide a reference for clinical prevention of Peripheral central venous catheter-associated thrombosis in the future.


Eligibility criteria: Inclusion Criteria:

* Cancer patients undergoing chemotherapy throughout their treatment in our hospital
* Patients with PICC implanted for the first time and maintained at our hospital;
* Age 18-60 years;
* Normal cognitive function;
* the clenching movement is barrier-free;
* The material and performance of PICC catheter are silicone three-way valve catheter;
* Catheter placement under the guidance of portable color Doppler ultrasound diagnostic instrument;
* Voluntarily participate and sign the informed consent form.

Exclusion Criteria:

* Patients treated with combined radiotherapy;
* Patients with coagulation dysfunction;
* Patients who need to use anticoagulant drugs due to underlying diseases;
* Puncture times more than 1 time;
* The blood flow velocity of catheterization vessel in calm state was less than 4.78cm/s.

Primary outcomes:
measure: Incidence of Peripheral central venous catheter-associated thrombosis in patients with PICC tube
timeFrame: 8 weeks
Secondary outcomes:
measure: Hemodynamic changes of the patient
timeFrame: 8 weeks
measure: Analysis of the influencing factors of Peripheral central venous catheter-associated thrombosis formation
timeFrame: 8 weeks
measure: Patients' satisfaction with health education after PICC catheterization
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital
name: Junyan Zhao, Master
role: STUDY_DIRECTOR
affiliation: Shandong University of Traditional Chinese Medicine
name: Yuanjing Qiao, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06927648: CAPIVASERTIB REGULATORY POSTMARKETING SURVEILLANCE IN KOREA
Official title: CAPIVASERTIB REGULATORY POSTMARKETING SURVEILLANCE IN KOREA
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-04-15
Enrollment: 130
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients currently treated with or initiating the study drug under approved local label and conditions of routine daily medical practice in South Korea will be included in the study. This study will be conducted using a total surveillance method to investigate the safety and effectiveness of all patients being treated with the study drug.

Brief summary: To fulfil the post-approval commitment of MFDS to conduct post-marketing surveillance, this study is designed to assess the known safety profile, identify previously unsuspected adverse reactions and to evaluate the effectiveness of Capivasertib under conditions of routine daily medical practice in Korea.

Detailed description: The objectives of this study are to assess the safety and effectiveness of Capivasertib (hereinafter "the study drug") in a real-world practice setting for patients prescribed with the study drug under the approved local label in South Korea.

Primary Objective To assess the safety of the study drug in patients prescribed with the study drug under the approved label(s) in South Korea

Secondary Objective To assess effectiveness of the study drug in patients prescribed with the study drug under the approved label(s) in South Korea

Eligibility criteria: Inclusion Criteria:

* Patients eligible for and treated with the study drug according to the approved label in South Korea
* Patients who provide signed and dated written informed consent, either personally or through a legally acceptable representative.

Exclusion Criteria:

* Participation in any interventional trial during the treatment of the study drug
* Other off-label indications according to the approved label in South Korea

Primary outcomes:
measure: Adverse Events (AEs)·Adverse Drug Reactions (ADRs) Serious Adverse Events (SAEs)·Adverse Drug Reactions (SADRs) Unexpected Adverse Events (AEs)·Adverse Drug Reactions (ADRs)
timeFrame: For about 12 months from the first dose of the study drug unless they withdraw consent, are lost to follow-up, experience disease progression, or die. 30 days addtional follow up in case of not completing 12 months.
Secondary outcomes:
measure: Real-world progression free survival (rwPFS)
timeFrame: For about 12 months from the first dose of the study drug unless they withdraw consent, are lost to follow-up, experience disease progression, or die
Other outcomes:
Locations:
Study officials:
References: