louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00612885: Safety and Efficacy of Mobic Inj. (Meloxicam) for the Patients With OA or RA: Observational Study
Official title: Post Marketing Surveillance to Assess the Safety and Efficacy of Mobic® (Meloxicam) Intramuscular Injection (7.5mg ~ 15mg, q.d.) up to 3 Days (in Case of Need for Prolonged Treatment, Switch to Mobic® Capsule Therapy Was Possible) in Korean Patients With Osteoarthritis and Rheumatoid Arthritis (KFDA Regulatory Requirement PMS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Arthritis, Rheumatoid
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-02-12
Enrollment: 425
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The main objective of this PMS study was to monitor and assess the safety of Mobic® intramuscular injection (7.5mg \~ 15mg, q.d.) up to 3 days (in case of need for prolonged treatment, switch to Mobic® capsule therapy was possible) in Korean patients with osteoarthritis and rheumatoid arthritis.


Eligibility criteria: INCLUSION CRITERIA:

diagnosed as osteoarthritis and rheumatoid arthritis

EXCLUSION CRITERIA:

1. Known hypersensitivity to meloxicam
2. Cross hypersensitivity to aspirin and other non-steroidal anti-inflammatory drugs
3. Symptoms of asthma, rhinitis, angioneurotic edema, or urticaria following the administration of aspirin or other NSAIDs
4. Active peptic ulceration
5. Severe hepatic failure.
6. Non-dialysed severe renal insufficiency
7. Children and adolescents aged 15 years or less
8. Pregnancy or breastfeeding

Primary outcomes:
measure: Efficacy assessment by the treating physician
timeFrame: up to 3 day
measure: Combined efficacy, safety and tolerability assessment by the treating physician
timeFrame: up tp 3 day
measure: Incidence of adverse events
timeFrame: up tp 3 day
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site
city: Chungbuk
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site
city: Daegu
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site
city: Gangwondo
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site
city: Gwangju
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site
city: Gyeongbuk
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site
city: Gyeonggido
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site
city: Gyeongnam
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site
city: Jeonnam
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: B.I. Korea Ltd.
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References:
Clinical trial NCT06707285: MRI Morphology of Femoral Notch in ACL Injury
Official title: MRI Imaging Assessment of Femoral Notch Morphology in Patients With ACL Injury
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: ACL Injury
Keywords: ACL ,femoral notch
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will include adult patients with ACL injury that had previous knee MRI imaging with no history of previous knee surgery or any pathological condition affecting bone health.

Brief summary: This study aims to investigate the association between femoral notch morphology, as assessed by MRI, and the risk of ACL injury


Eligibility criteria: Inclusion Criteria:

* patient aged 18-50 years.
* diagnosed with an ACL injury and confirmed by MRI and age-matched controls.

Exclusion Criteria:

* age \<18 yo and \>50 years
* patients with previous knee surgeries
* congenital knee deformities
* systemic conditions affecting bone health

Primary outcomes:
measure: Correlation between femoral notch morphology and incidence of ACL injury
timeFrame: Base line
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Huang M, Li Y, Li H, Liao C, Xu H, Luo X. Predictive effects of the intercondylar notch morphology on anterior cruciate ligament injury in males: A magnetic resonance imaging analysis. Medicine (Baltimore). 2020 Mar;99(10):e19411. doi: 10.1097/MD.0000000000019411.
citation: Micicoi G, Jacquet C, Khakha R, LiArno S, Faizan A, Seil R, Kocaoglu B, Cerciello S, Martz P, Ollivier M. Femoral and Tibial Bony Risk Factors for Anterior Cruciate Ligament Injuries Are Present in More Than 50% of Healthy Individuals. Am J Sports Med. 2021 Dec;49(14):3816-3824. doi: 10.1177/03635465211050421. Epub 2021 Oct 28.
citation: Gultekin MZ, Dincel YM, Keskin Z, Arslan S, Yildirim A. Morphometric risk factors effects on anterior cruciate ligament injury. Jt Dis Relat Surg. 2023;34(1):130-137. doi: 10.52312/jdrs.2023.910. Epub 2022 Dec 27.
citation: Misir A, Sayer G, Uzun E, Guney B, Guney A. Individual and Combined Anatomic Risk Factors for the Development of an Anterior Cruciate Ligament Rupture in Men: A Multiple Factor Analysis Case-Control Study. Am J Sports Med. 2022 Feb;50(2):433-440. doi: 10.1177/03635465211062594. Epub 2022 Jan 12.
citation: Pradhan P, Kaushal SG, Kocher MS, Kiapour AM. Development of Anatomic Risk Factors for ACL Injuries: A Comparison Between ACL-Injured Knees and Matched Controls. Am J Sports Med. 2023 Jul;51(9):2267-2274. doi: 10.1177/03635465231177465. Epub 2023 Jun 13.
citation: Barnum MS, Boyd ED, Vacek P, Slauterbeck JR, Beynnon BD. Association of Geometric Characteristics of Knee Anatomy (Alpha Angle and Intercondylar Notch Type) With Noncontact ACL Injury. Am J Sports Med. 2021 Aug;49(10):2624-2630. doi: 10.1177/03635465211023750. Epub 2021 Jul 8.
Clinical trial NCT03530085: Dec+Flu+Bu Conditioning Regimen for Elderly AML in CR Undergoing Allo-HSCT
Official title: Decitabine+ Fludarabine+Busulfan Conditioning Regimen for Elderly Acute Myeloid Leukemia in Complete Remission Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Acute Myeloid Leukemia
Allogeneic Hematopoietic Stem Cell Transplantation
Conditioning
Elderly
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Guangzhou First People's Hospital
name: Peking University People's Hospital
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Zhujiang Hospital
First posted: 2018-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is reported to be able to improve the outcomes for elderly acute myeloid leukemia (AML) in complete remission (CR). At present, the best conditioning regimen for elderly AML in CR remains in discussion. In this prospective study, the safety and efficacy of Dec+Flu+Bu myeloablative conditioning regimens in patients with elderly AML in CR undergoing allo-HSCT are evaluated.

Detailed description: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is reported to be able to improve the outcomes for elderly AML(older than 60 years) in complete remission (CR). At present, the best conditioning regimen for elderly AML in CR remains in discussion. Flu+Bu conditioning regimen is the most commonly used regimen for elderly AML in CR undergoing allo-HSCT. However, it appears to have higher relapse rate. To reduce the relapse rate, decitabine is added in the conditioning regimen. In this prospective study, the safety and efficacy of Decitabine+ Fludarabine+Busulfan myeloablative conditioning regimens in patients with elderly AML in CR undergoing allo-HSCT are evaluated.

Eligibility criteria: Inclusion Criteria:

* AML patients older than 60 years, younger than 80 years
* In complete remission before transplantation
* With HLA-matched sibling donors

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)

Primary outcomes:
measure: overall survival (OS)
timeFrame: 2 year
Secondary outcomes:
measure: disease-free survival (DFS)
timeFrame: 2 year
measure: relapse
timeFrame: 2 year
measure: transplant-related mortality (TRM)
timeFrame: 2 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hematology,Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Department of Hematology,Nanfang Hospital
name: Qifa Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06963385: Radiomics and Molecular Classification in Endometrial Cancer
Official title: Correlation Between RadiOmics and Molecular Classification in Endometrial Cancer (the ROME Study): a Step Forward to a Simplified Precision Medicine
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Endometrial Cancer
Uterine Cancer
Endometrium Tumor
Keywords: radiomics
endometrial cancer
molecular/genetic profiling
radiogenomics
ultrasound
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Molecular/genomic profiling is the most accurate method to assess the prognosis of endometrial cancer patients. Interestingly, the adoption of radiomics showed important results, across various oncologic specialties. Radiomic allows extracting mineable high-dimensional data from clinical images, thus providing a number of noteworthy information of the tumor tissues. We aim to correlate radiomic features obtained from ultrasound images with the molecular/genomic profiling to identify new hallmarks for stratification of endometrial cancer patients into different classes of risk The central hypothesis is that combining radiomic features might allow identifying various classes of risk for endometrial cancer. The rationale for the proposed research is that once validated, radiomics applied to ultrasonographic images would be an effective, innovative, and cheap method for tailor operative and postoperative treatment modality in endometrial cancer.


Eligibility criteria: Inclusion Criteria:

(i) preoperative endometrial cancer (any histology); (ii) preoperative ultrasonographic examination; (iii) surgical treatment; (iv) age \>= 18 years; (v) signed informed consent for research purposes.

Exclusion Criteria:

(i) consent withdraw; (ii) lack of available (tumor) tissue for molecular/genomic profiling.

Primary outcomes:
measure: To detail the mechanism by which radiomic features predict the classification of endometrial cancer into various classes of risk.
timeFrame: 1-18 months
measure: Determinate the scaled impact of radiomic features assessed on ultrasonographic images of endometrial tumors.
timeFrame: 1-36 months
Secondary outcomes:
measure: Assess the intraobserver and interobserver reproducibility of radiomic features on ultrasonographic images of endometrial tumors
timeFrame: 19-36 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Study officials:
References:
Clinical trial NCT00502385: Phase I AZD2171 in Patients With Relapsed or Refractory AML and Elderly Patients With DeNovo or Secondary AML
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukaemia
Myelocytic
Acute
Keywords: Phase I
AML
de novo or secondary AML
AZD2171
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-07-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be conducted across multiple European centres to assess the safety and tolerability of multiple doses of AZD2171 in patients with AML.


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent
* Male/female, 18 yrs or over
* WHO performance status 0-2
* Disease not responding to or relapsing after chemotherapy or elderly patients not suited to chemotherapy

Exclusion Criteria:

* Acute myeloid leukaemia arising from previous chronic myeloid leukaemia or acute myeloid leukaemia of type FAB M3
* Previous treatment against new blood vessel formation (anti-angiogenic)
* Chest X-ray showing leukaemia in the lungs

Primary outcomes:
measure: The primary objective is to determine the safety and tolerability of multiple oral doses of AZD2171 in AML patients by assessment of AEs, BP&pulse, heart rate respiration rate, EKG, clinical chemistry
Secondary outcomes:
measure: Efficacy, PK
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Nick Botwood, BSc, MBBS, MRCP, MFPM
role: STUDY_DIRECTOR
affiliation: Frankfurt University Hospital
name: Dieter Hoelzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03025685: "TransRadial Ultra Support Technique" (TRUST)
Official title: "TransRadial Ultra Support Technique" (TRUST Technique) Versus Anchoring Technique to Enhance Guiding Catheter Support: a Prospective Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Arterioscleroses
Coronary Artery Disease
Keywords: Percutaneous Coronary Intervention
Coronary Artery Disease
Wire
Coronary stenting
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2017-01-19
Enrollment: 54
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: Adequate support is required for challenging percutaneous coronary interventions (PCI). The "TransRadial Ultra Support Technique" (TRUST technique) is a new support technique that provides active support by deep pass of the coronary wire into the heart cavities (left ventricle-LV, right ventricle-RV) or aorta.


Eligibility criteria: Inclusion Criteria:

* Subjects singed informed consent form
* Subjects eligible for percutaneous coronary intervention

Exclusion Criteria:

* Age \<18 years or \>75 years
* Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3.
* Known non-adherence to double anti-platelet therapy (DAPT)
* LVEF \<30%
* Continuing bleeding
* Acute coronary syndrome (ST-elevation Myocardial infarction)
* Pregnancy

Primary outcomes:
measure: Procedural success
timeFrame: 1 week after PCI
measure: Device success
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of CIrculation Pathology
Study officials:
References:
Clinical trial NCT03957785: Lower Body Positive Pressure Treadmill Training in Post-Stroke Gait Impairment
Official title: Lower Body Positive Pressure Treadmill Training in Post-Stroke Gait Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait, Hemiplegic
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 75
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lower body positive pressure (LBPP) decreases weight bearing and ground reaction forces, with potentially positive effects on qualitative gait indices. However, which gait features are shaped by LBPP gait training in post-stroke patients is still poorly predictable. A pilot study on the effects of LBPP gait training on qualitative and quantitative gait indices in patients with hemiparesis due to stroke in the chronic phase was carried out. Twenty-five patients who suffered from a first, single, ischemic, supra-tentorial stroke occurred at least 6 months before study inclusion were provided with 24 daily sessions of LBPP treadmill gait training using AlterG device. These patients were compared with 25 age-matched healthy controls (HC), who were formerly provided with the same amount of AlterG training, and 25 patients with the same clinical-demographic characteristics of the first group of patients, who previously underwent conventional treadmill gait training (TGT). Qualitative and quantitative gait features, including Functional Ambulation Categories, gait cycle features, and muscle activation patterns were analyzed before and after the training (AlterG or TGT).


Eligibility criteria: Inclusion Criteria:

* age ≥ 55 years;
* first, single, ischemic supra-tentorial stroke occurred at least 6 months before the study inclusion;
* a Functional Ambulatory Categories (FAC) score of \>2;
* ability to control head and trunk posture;
* no systemic or cardiovascular contraindication to LBPP

Exclusion Criteria:

• Medical and/or psychiatric illness potentially interfering with the treatment.

Primary outcomes:
measure: Functional Ambulatory Categories
timeFrame: 1 month
Secondary outcomes:
measure: gait cycle duration
timeFrame: 1 month
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi Bonino-Pulejo"
Study officials:
References:
Clinical trial NCT01862185: The Effect of Semi-quantitative Procalcitonin Assay to The Adequacy of Empirical Antibiotics and Mortality in Septic Patients
Official title: Pengaruh Pemeriksaan Procalcitonin Semikuantitatif Terhadap Adekuasi Terapi Antibiotik Empirik Awal Dan Mortalitas Pada Pasien Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sepsis
Keywords: semiquantitative
procalcitonin
sepsis
antibiotics
mortality
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Sepsis is a serious clinical condition with a considerable morbidity and mortality. Procalcitonin (PCT) is a good biomarker for early diagnosis and infection monitoring. The present study aimed to investigate the effect of semi-quantitative PCT test to the empirical antibiotic initiation time, the appropriateness of empirical antibiotics and mortality in septic patients.

The hypothesis of the study are :

* There is an effect on mortality between septic patients who do and do not do semi-quantitative PCT examination
* There is an effect on empirical antibiotic initiation time between septic patients who do and do not do semi-quantitative PCT examination
* There is an effect on appropriateness of empirical antibiotic between septic patients who do and do not do semi-quantitative PCT examination

Study design is randomized diagnostic trial which is also a pragmatic trial.


Eligibility criteria: Inclusion Criteria:

* aged more than 18 years old
* have at least two concomitant systemic inflammatory response syndrome criteria
* have focal infection
* with or without sign of organ hypoperfusion or dysfunction

Exclusion Criteria:

* post operative patient
* trauma patient
* have obtained prior antibiotic
* refused to participate

Primary outcomes:
measure: mortality rate
timeFrame: 14 days
Secondary outcomes:
measure: the timing of empirical antibiotic first dose
timeFrame: in 24 hours since the patient was diagnosis as sepsis
measure: the appropriateness of empirical antibiotic
timeFrame: in 24 hours since the patient was diagnosed as sepsis
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Faculty of Medicine, Indonesia University
name: Dana Dharaniyadewi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05326685: The Effect of Visual Video With Korotkoff Sounds on Blood Pressure Measurement Skills and Anxiety Levels
Official title: The Effect of Visual Video With Korotkoff Sounds on Blood Pressure Measurement Skills and Anxiety Levels: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Anxiety
Blood Pressure Measurement Skills
Korotkoff sounds
Nursing students
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Background: The aim of this study was to determine the effect of visual video with korotkoff sounds on nursing students' blood presssure measurement skills and anxiety levels.

Methods: This was a randomized controlled experimental study conducted at the nursing department of the faculty of health sciences of a university. Intervention participants were shown and listened visual video with korotkoff sounds before blood presssure measurement. Aural and visual video containing Korotkoff sounds were shown to the students before the practice.

Detailed description: Background: The aim of this study was to determine the effect of visual video with korotkoff sounds on nursing students' blood presssure measurement skills and anxiety levels.

Methods: This was a randomized controlled experimental study conducted at the nursing department of the faculty of health sciences of a university. Intervention participants were shown and listened visual video with korotkoff sounds before blood presssure measurement. Aural and visual video containing Korotkoff sounds were shown to the students before the practice. The data of the research were collected with the State-Trait Anxiety Inventory short version (STAIS-5, STAIT-5) and the Student introduction form.

Eligibility criteria: Inclusion Criteria:

* Studying in the first year of the nursing department in the 2021-2022 academic year,
* Taking the "pulse and blood pressure measurement" course and laboratory practice
* Students who agree to participate in the study will be included.

Exclusion Criteria:

* Previous manual blood pressure measurement experience,
* Those who do not participate in the theoretical part of the "pulse and blood pressure measurement" course,
* Students who do not attend the lesson on the day of the applications will not be included.

Primary outcomes:
measure: The State-Trait Anxiety Inventory (STAIS-5, STAIT-5)
timeFrame: pre intervention
Secondary outcomes:
measure: State Anxiety Inventory (STAIS-5)
timeFrame: through study completion for each group, an average of 2 hours
measure: Practice Success
timeFrame: through study completion for each participant, an average of 2 hours
Other outcomes:
Locations:
city: Kayseri̇
country: Turkey
facility: Türkan Ülker
Study officials:
affiliation: TC Erciyes University
name: TÜRKAN ÜLKER
role: PRINCIPAL_INVESTIGATOR
References: