louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06251648: Acute Lymphoblastic Leukaemia Related to Lenalidomide (LenALL)
Official title: Acute Lymphoblastic Leukaemia Related to Lenalidomide in Patients With Cancer: an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients treated with LEN and experiencing ALL

Brief summary: Although lenalidomide (LEN) have proved effective in treating many cancers, few patients receiving LEN may experience rare but life-threatening adverse events such as Acute Lymphoblastic Leukaemia (ALL). Today, data about ALL are scarce.

The objective was to investigate reports of ALL adverse events related to LEN in patients with cancer using the World Health Organization (WHO) pharmacovigilance database.


Eligibility criteria: Inclusion Criteria:

* Case reported in the World Health Organization (WHO, also called VigiBase) at the time of the extraction
* Patients treated with at least LEN (L04AX04)

Exclusion Criteria:

-Chronology not compatible between LEN and ALL

Primary outcomes:
measure: ALL reports related to LEN (from WHO database).
timeFrame: From inception to February, 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
Study officials:
References:
Clinical trial NCT06128148: Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of JYP0322 in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Protein Kinase Inhibitors
Other Protocol Specified Criteria
Lung Neoplasms
Brain Neoplasms
Keywords: ROS1 Fusions
ROS1 Gene Rearrangements
Primary brain tumors
ROS1
Lead sponsor: Guangzhou JOYO Pharma Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open, non-randomized, multicenter, single-arm dose-escalation design, phase 1 trial to study the safety, tolerability, pharmacokinetics and efficacy of JYP0322 in patients with ROS1+ locally advanced/metastatic solid tumors .

Detailed description: JYP0322 is an orally available inhibitor of ROS1 (coded by the gene ROS1). Molecular fusions are present in several different tumor types, including non-small cell lung cancer (NSCLC), glioma, etc. Patients with locally advanced or metastatic cancer with a detectable molecular fusion in targets of interest may be eligible for enrollment.

Phase 1 will assess safety and tolerability of JYP0322 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and efficacy will be assessed in the dose expansion portion of the study.

Eligibility criteria: Key Inclusion Criteria

* Adult patients age 18 years or older.
* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors that have a ROS1 molecular fusion.
* Measurable disease according to RECIST version 1.1
* Life expectancy of at least 3 months
* Other protocol specified criteria

Key Exclusion Criteria:

* Current participation in another therapeutic clinical trial.
* Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.
* A history of severe allergies, or a history of severe allergy, hypersensitivity or other hypersensitivity to any active or inactive ingredient of the study drug.
* Known active infections (bacterial, viral including HIV positivity).
* Other protocol specified criteria

Primary outcomes:
measure: Dose-Limiting Toxicity (DLT)
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes:
measure: Plasma Concentrations of JYP0322
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
measure: Disease Control
timeFrame: Approx. 2 years
measure: Duration of Response
timeFrame: Approx. 2 years
measure: Progression-Free Survival (PFS)
timeFrame: Approx. 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Li Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02211248: Cardiovascular Autonomic Control Evaluation Through Cardiac Frequency Variability in Hypertensive Patients
Official title: Cardiovascular Autonomic Control Evaluation Through Cardiac Frequency Variability in Hypertensive Patients Subjected to Distinct Interventions: Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Cardiac Frequency Variability
multidisciplinary care
clinical trial
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2014-08-07
Enrollment: 36
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: Analyzing cardiovascular evaluation measures in the multidisciplinary and in the conventional treatment of hypertensive patients will provide better parameters for comparing the two approaches.


Eligibility criteria: Inclusion Criteria:

* Above 18 years of age
* Diagnosis of primary hypertension

Exclusion Criteria:

* Neurological condition
* Cardiac condition
* Renal condition
* Congenital conditions
* Previous myocardial revascularization surgery

Primary outcomes:
measure: Change from Baseline in Cardiac Frequency Variability at 1 year
timeFrame: Measured at the first appointment and 1 year later
Secondary outcomes:
measure: Change from Baseline in Systolic and Diastolic Blood pressure
timeFrame: Measured at the first appointment and 1 year later
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia do Rio Grande do Sul
state: RS
Study officials:
References:
Clinical trial NCT00934648: A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate
Official title: An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-07-08
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: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who have had an inadequate response or were intolerant to treatment with methotrexate. Eligible patients will receive MabThera (1000mg by intravenous infusion) on days 1 and 15, and background methotrexate (oral or subcutaneous dose of 10-25mg weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* receiving out-patient treatment;
* experienced an inadequate response to previous or current treatment with methotrexate.

Exclusion Criteria:

* rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA;
* history of, or current, inflammatory joint disease other than RA;
* previous treatment with any cell-depleting therapies.

Primary outcomes:
measure: Percentage of Participants With an Adverse Event (AE)
timeFrame: Week 104
Secondary outcomes:
measure: Disease Activity Score Based on 28-Joint Count (DAS28)
timeFrame: Day 1 and Week 24
measure: Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category
timeFrame: Screening, Day 1, and Weeks 24 and 104
measure: Percentage of Participants With Changes in Bone Density
timeFrame: Screening, Weeks 48 and 104
Other outcomes:
Locations:
city: Casablanca
country: Morocco
city: Casablanca
country: Morocco
city: Marrakech
country: Morocco
city: Rabat
country: Morocco
city: Salé
country: Morocco
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00457548: Phone Intervention for Alcohol (ETOH) Use in Emergency Department Motor Vehicle Crash (ED MVC) Patients
Official title: Study of Effectiveness of BI Given to Injured MVC ED Patients Who Use Alcohol Harmfully and Hazardously
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Alcoholic Intoxication
Wounds and Injuries
Keywords: Alcohol use
Brief Interventions
Injuries
Emergency Department Patients
Harmful and hazardous alcohol use among ED injured patients
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2007-04-06
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to determine if a brief counseling intervention, delivered by telephone, is more effective than standard ED care, to reduce future alcohol related injuries and alcohol related negative consequences, among patients treated in the ED for injuries from an MVC and other injury mechanisms.

Detailed description: Alcohol related motor vehicle crashes (MVC) continue to be a substantial public health problem. Brief interventions for alcohol (BI) for injured ED patients have been demonstrated to be effective, and perhaps more so for MVC patients.

Telephone interventions have been utilized in varying ways in health care. We compared the delivery of two brief interventions by telephone against an assessment only condition. Participants who received the BI and the assessment only condition were contacted 3 and 12 months after recruitment. Data about alcohol use, injuries and high risk behaviors, including drinking and driving behaviors were collected at the 3 and 12 month follow-up assessments.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Emergency department patient
* Subacute injury
* Motor vehicle crash or other injury
* Alcohol use at harmful and hazardous levels

Exclusion Criteria:

* Younger than 18 years old
* Does not meet alcohol use criteria
* Non-English speaker
* In police custody
* Suicidal
* Psychiatric diagnosis
* No locator
* Injury occurred \> 72 hours prior to ED visit

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Mello MJ, Longabaugh R, Baird J, Nirenberg T, Woolard R. DIAL: a telephone brief intervention for high-risk alcohol use with injured emergency department patients. Ann Emerg Med. 2008 Jun;51(6):755-64. doi: 10.1016/j.annemergmed.2007.11.034. Epub 2008 Apr 23.
Clinical trial NCT00583648: Does Implementing a Urinanylsis Protocol Based on Symptoms Decrease Length of Stay in the Emergency Department?
Official title: A Randomized Controlled Trial Showing the Effect of Patient Lenght of Stay in the Emergency Department Through Utilizing a Urinalysis Nursing Protocol.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Urinary Tract Infections
Keywords: urinary tract infections
urine
urinalysis
urine protocols
urinalysis protocols
nursing protocols
Emergency Department
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2007-12-31
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The implementation of nursing urinanlysis protocols based off of symptoms of urinary infections will significantly decrease the length of a patient's stay in the Emergency Department.


Eligibility criteria: Inclusion Criteria:

* patients between 16 and 65 years of age complaining of any of the following: dysuria, hematuria, urinary frequency, urinary urgency

Exclusion Criteria:

* any person less than 16 or greater than 65 years of age, history of kidney disease or transplant, foley catherization within the last 30 days, on immuno-suppresent and/or receiving chemotherapy

Primary outcomes:
measure: Length of Stay in the Emergency Department
timeFrame: 1 hour
Secondary outcomes:
measure: Physician decision making on ordering urinalysis based off of chief complaints
timeFrame: 1 hour
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Andrew W Seefeld, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05667948: Molecular Analysis and Treatment Options of Thymic Malignancies
Official title: Molecular Landscape Analysis and Treatment Options for Thymic Epithelial Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thymic Epithelial Tumor
Thymic Carcinoma
Thymic Cancer
Keywords: thymic malignancy
thymoma
chemotherapy
targeted therapy
immunotherapy
molecular landscape
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2022-12-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with thymic malignancies are with the standard treatment and/or are enrolled in the clinical trials.

Brief summary: Thymic malignancies are the most common tumors of the anterior mediastinum, though surgery and radiation often effectively treat thymic carcinomas, a minority continue to progress and eventually lead to death. Therefore, there is an unmet need for more effective therapies for thymic malignancies. Considering the role of molecular alterations has yet to be defined in the treatment of thymoma and thymic malignancies, there is an urgent recognition that molecular alterations in the thymic malignancies are important to predict response and survival for novel targeted therapies.

In summary, identification of genetic alterations in thymic malignancies is increasingly essential to perform molecular diagnostics and individualized treatments. This project aims to create a registry of patients with thymic malignancies to further the characterization of molecular alterations and develop (novel) treatments based on the detection.


Eligibility criteria: Inclusion Criteria:

* Histologically proven diagnosis of thymic malignancies
* 18 years of age or older
* Ability to understand and the willingness to sign a written informed consent document

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 20 years
measure: Disease control rate (DCR)
timeFrame: 20 years
measure: Progression-free survival (PFS)
timeFrame: 20 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 20 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xiaomin Niu
state: Shanghai
Study officials:
References:
Clinical trial NCT05625048: Urinary Incontinence After Radical Prostatectomy
Official title: Urinary Incontinence After Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Incontinence, Urinary
Radical Prostatectomy
Lead sponsor: Regional Hospital West Jutland
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 66
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of this project are; 1) To examine the efficacy of ultrasound-guided pelvic floor muscle training compared to standard care on urinary incontinence in patients undergoing robot assisted radical prostatectomy and 2) To compare physical function, incontinence, and QoL in two groups of patients with low or high function of the pelvic floor muscles respectively before the surgery.

This study consists of two parts. The first part is a randomized controlled trial where 44 patients with weak pelvic floor muscle function are randomized to either treatment as usual (control group 1) or ultrasound-guided pelvic floor muscle training (Intervention group). In the second part the patients in control group 1 will be compared with 22 patients with normal/strong pelvic floor muscle function (control group 2).

Patients not able to perform the pelvic floor muscle test consisting of 8 repetitions of 4-seconds pelvic floor muscle contraction and 1 repetition of 15-seconds pelvic floor muscle contraction will be randomized to either intervention group or control group 1. Patients able to perform the pelvic floor muscle test will be included in control group 2.


Eligibility criteria: Inclusion Criteria:

* Men aged 18 and above
* Diagnosis of prostatic adenocarcinoma and referred to robot assisted radical prostatectomy
* No comorbidity that prevents pelvic floor training or effects the function of the pelvic floor
* Adequacy in written and spoken Danish Performance status 0-1
* Able to understand the study procedures and willing to provide written informed consent

Exclusion Criteria:

* Major surgery within the last month that may affect pelvic floor function.
* Urinary incontinence prior to surgery

Primary outcomes:
measure: 24-hour pad weigh test
timeFrame: 12 month after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Regional Hospital Goedstrup
Study officials:
References:
Clinical trial NCT00924248: Primovist Regulatory Post Marketing Surveillance (PMS)
Official title: Primovist Regulatory Post Marketing Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver
Keywords: Liver MRI
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-06-18
Enrollment: 4358
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: Korean who take Primovist for liver MRI

Brief summary: The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice


Eligibility criteria: Inclusion Criteria:

* Patient who take Primovist for liver MRI

Exclusion Criteria:

* Patients who belong to the contraindication on the product label

Primary outcomes:
measure: Safety evaluation in real practice (SAE/AE/ADR collection)
timeFrame: After administration
Secondary outcomes:
measure: Assessment of contrast effect by imaging after administration
timeFrame: Before administration
measure: Overall contrast effects by combining individual assessment
timeFrame: Before administration
measure: Assessment of contrast enhancement effect
timeFrame: After administration
Other outcomes:
Locations:
city: Many Locations
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02100748: A Study of TRV130 for the Treatment of Pain After Bunionectomy
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Multiple-dose, Adaptive, Placebo- and Active-controlled Study of TRV130 for the Treatment of Acute Postoperative Pain After Bunionectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Pain
Keywords: moderate to severe acute pain
bunionectomy
Lead sponsor: Trevena Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-01
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy.

Detailed description: The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy. The results section also includes data from the morphine arms.

Eligibility criteria: Inclusion Criteria:

* Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures.
* Experiences a pain intensity rating of ≥ 4 on an 11 point NRS
* Able to provide written informed consent before any study procedure.

Exclusion Criteria:

* ASA Physical Status Classification System classification of P3 or worse
* Has surgical or post-surgical complications.
* Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs.
* Has previously participated in another TRV130 clinical study.

Primary outcomes:
measure: Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Premier Research
state: Arizona
city: Pasadena
country: United States
facility: Chesapeake Research Group
state: Maryland
city: Austin
country: United States
facility: Premier Research
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Trevena Inc.
name: Franck Skobieranda, MD
role: STUDY_DIRECTOR
References: