louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06073873: A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea
Official title: Post-Marketing Surveillance (PMS) Study on Zeposia® (Ozanimod) Use Among Moderate to Severe Active Ulcerative Colitis Patients in Korea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ulcerative Colitis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-10-10
Enrollment: 3000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of participants with moderately to severely active ulcerative colitis who will receive at least 1 dose of ozanimod according to local product label. Moderate to severe disease will be defined as a Mayo score of 6 to 12 and an endoscopic sub-score of 2 or higher. Participants will be eligible if they had an inadequate response, lost response, or were intolerant to conventional therapy (5-aminosalicylic acid, corticosteroids, immunosuppressants) or biologic agents.

Brief summary: The purpose of this observational study is to assess the real-world safety of ozanimod in Korean participants with moderate to severe active ulcerative colitis.


Eligibility criteria: Inclusion Criteria:

* Adult participants 19 years of age or older
* Participants who will receive ozanimod according to the approved label after enrollment
* Participants who sign the informed consent form voluntarily

Exclusion Criteria:

* Participants who are prescribed ozanimod for therapeutic indications not approved in Korea
* Participants for whom ozanimod is contraindicated as clarified in Korean prescribing information approved by Ministry of Food and Drug Safety

Primary outcomes:
measure: Adverse events
timeFrame: Up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Bristol-Myers Squibb YH
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02259673: Effects of Fun Physical Activity on the Interest to Daily Physical Activity and Sarcopenia of Elderly People
Official title: Mashhad University Medical of Sciences
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Activity
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Grudzen, Corita, M.D., MSHS
First posted: 2014-10-08
Enrollment: 63
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this research, the elderly living in nursing homes were selected in two group control and intervention.

Intervention group 3 times a week for 20 minutes during 2 months, fun physical exercises (including activities carried out with the use of sports equipment such as beach ball, stretch, bird toys, etc).

Detailed description: Have of a healthy life with minimal complications in this period. Most important issue in improving the health and quality of life of the elderly is maintain their independence in physical activity. World Health Organization (WHO) is believed that, the first indicator of the health of a society is physical activity of the society.

The studies show that sarcopenia leads to a decrease in the function and increase of disability 2/1 male and 3/1 are older women. sarcopenia leads to some perturbation such as, movement disorders, impaired balance, the incidence of inflammatory disease and dementia. In this reserch, the elderly living in nursing homes were selected in two group control and intervention.

Intervention group 3 times a week for 20 minutes during 2 months, fun physical exercises.

(including activities carried out with the use of sports equipment such as beach ball, stretch, bird toys, etc).

Eligibility criteria: Inclusion Criteria:

* age more than 60 year

Exclusion Criteria:

* absence more than 3 session training

Primary outcomes:
measure: interest of daily physical activity
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad University Medical of siences
Study officials:
affiliation: Msc student, Mashhad University Medical of Siences
name: Mohammad rajabpoor, Msc student
role: STUDY_DIRECTOR
References:
citation: Canga L, Gorelik G, Sterin-Borda L. Diabetes alters the reactivity of myocardium to a thromboxane analogue. Can J Physiol Pharmacol. 1987 Apr;65(4):499-503. doi: 10.1139/y87-085.
Clinical trial NCT01141673: Development of a Diagnostic Kit for FLT3-ITD in Acute Myeloid Leukemia
Official title: Development of a Diagnostic Kit for FLT3-ITD in Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myeloid Leukemia
Keywords: FLT3-ITD
acute myeloid leukemia
FLT3
D835
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-06-10
Enrollment: 100
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: acute myeloid leukemia patient in wanfang hospital

Brief summary: FLT3 overexpression in acute myeloid leukemia (AML) is often caused by mutations in this gene. These mutations cause constitutive phosphorylation of FLT3 proteins leading to increased proliferation and survival, decreased apoptosis and resistance to chemotherapeutic agents in AML cells. There are two major types of FLT3 mutations- internal tandem duplication (ITD) and point mutation at 835th amino residue. AMLs with FLT3 mutations have worse prognosis and are often resistant to conventional chemotherapy. Several small molecule compounds targeting FLT3 have been in the market or in clinical trials. Therefore, identification of these mutations at the time of diagnosis will provide a better prognostic prediction, might guide the treatment selection and follow-up strategies. In this study, the investigators will develop a sensitive molecular assay to detect FLT3 mutations for future clinical application. The investigators will collect 100 AML samples with at least 20 samples with known FLT3 mutations. The investigators will compare this assay with commonly used methods and standardize the procedure to meet the requirement of clinical pathology laboratory with reasonable cost.


Eligibility criteria: Inclusion Criteria:

* Patients with confirmed diagnosis of acute myeloid leukemia

Exclusion Criteria:

* non

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University - WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Hsin-Gjin Eugene Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05612373: Message Offering Free Round Trip Ride-Share Ride to Pharmacy
Official title: Message Offering Free Round Trip Ride-Share Ride to Pharmacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
behavioral science interventions
vaccination promotion
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 300000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to the different arms.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This experiment is part of a megastudy with a total of ten experimental conditions and a holdout control condition to which patients will be randomly assigned. The focal comparison in this experiment is between a message encouraging vaccination that provides patients with a free round trip ride-share ride to and from any pharmacy near them and a control message telling patients that an updated COVID booster vaccine is waiting for them.


Eligibility criteria: Exclusion Criteria:

1. The patient unsubscribed from texts before the send date and time of the patient's SMS/MMS message
2. The patient received a bivalent COVID booster before the send date and time of the patient's SMS/MMS message.

Primary outcomes:
measure: COVID bivalent booster receipt
timeFrame: During the 30 days after receiving the SMS/MMS intervention
Secondary outcomes:
measure: COVID bivalent booster receipt
timeFrame: 60 days after receiving the SMS/MMS intervention
measure: COVID bivalent booster receipt
timeFrame: 90 days after receiving the SMS/MMS intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06813573: Prospective Analysis of Circulating Nucleosomes in Patients Receiving a First Line Treatment for a Non-Hodgkin Lymphoma
Official title: Prospective Analysis of Circulating Nucleosomes in Patients Receiving a First Line Treatment for a Non-Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Follicular Lymphoma
Diffuse Large B-Cell Lymphoma
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this study is to prospectively follow the level of circulating nucleosomes in patients treated for a non-Hodgkin lymphoma and determine whether it correlates with the clinical response.


Eligibility criteria: Inclusion Criteria:

* Histologically proven diagnosis of diffuse large B cell lymphoma or follicular lymphoma, according to the WHO 2016 classification, requiring a first line of treatment with a RCHOP 21 regimen
* Agreement to participate after receiving oral and written information on the study

Exclusion Criteria:

* History of previous treatment for lymphoma (excluding localized low dose radiotherapy in the case of follicular lymphoma)
* Treatment with a chemotherapy regimen different from RCHOP21

Primary outcomes:
measure: Prospective quantitative analysis of the level of circulating nucleosomes at baseline and during treatment in patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL)
timeFrame: From enrollment to the end of the study (24 months of follow-up from beginning of treatment for each patient)
Secondary outcomes:
measure: Correlation between the level of circulating nucleosomes (number of cells) and the response to treatment as defined by international response criteria
timeFrame: From enrollment to the end of the treatment (6 cycles of 21 days)
measure: Comparison between the results of molecular analysis of ctDNA and DNA extracted from nucleosomes
timeFrame: From enrollment to the end of the study (24 months of follow-up from beginning of treatment for each patient)
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
References:
Clinical trial NCT02424773: Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients
Official title: Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Respiratory Failure
Immunocompromised Host
High Flow Oxygen Cannula
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-04-23
Enrollment: 100
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: In immunocompromised patients, Acute Respiratory Failure (ARF) is associated with a high case-fatality, particularly when invasive Mechanical Ventilation (MV) is required. In the most hypoxemic patients, oxygen administration through High Flow Nasal Cannula (HFNC) has been reported as an alternative to the venturi mask. The aim of this study is to compare HFNC and venturi mask on early respiratory deterioration and patient's comfort in that setting. The investigators planned a prospective randomized study in 4 Intensive Care Units (ICUs). As respiratory deterioration occurs early after ICU admission, patients are randomized to receive two hours of oxygen therapy either through HFNC or venturi mask. The primary endpoint is defined as the need for invasive or noninvasive MV in the 2-hour period. Secondary endpoints include comfort, dyspnea and thirst.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years.
* Admission to ICU for ARF. ARF was defined with the need of oxygen over 6l/min to maintain SpO2 over 95% or symptom of respiratory distress (intercostal recession or tachypnea \>30/min or dyspnea at rest).
* Immunosuppression. Immunosuppressed conditions were solid tumor, hematological malignancy, steroid treatment or other immunosuppressive treatment, or HIV infection.

Exclusion Criteria:

* Hypercapnia (above 47 mmHg)
* Chronic respiratory failure
* Previous mechanical ventilation in the days before admission
* Need of immediate NIV or intubation
* Refusal
* Pregnancy

Primary outcomes:
measure: Oxygenation failure
timeFrame: 2 hours
Secondary outcomes:
measure: comfort (0-10 Visual analog Scale)
timeFrame: 1 hour
measure: comfort (0-10 Visual analog Scale)
timeFrame: 2 hours
measure: dyspnea (0-10 Visual analog Scale)
timeFrame: 1 hour
measure: dyspnea (0-10 Visual analog Scale)
timeFrame: 2 hour
measure: thirst (0-10 Visual analog Scale)
timeFrame: 1 hour
measure: thirst (0-10 Visual analog Scale)
timeFrame: 2 hour
Other outcomes:
Locations:
Study officials:
affiliation: DRCD APHP Paris
name: Sophie COURTIAL DESTEMBERT
role: STUDY_DIRECTOR
References:
citation: Lemiale V, Mokart D, Mayaux J, Lambert J, Rabbat A, Demoule A, Azoulay E. The effects of a 2-h trial of high-flow oxygen by nasal cannula versus Venturi mask in immunocompromised patients with hypoxemic acute respiratory failure: a multicenter randomized trial. Crit Care. 2015 Nov 2;19:380. doi: 10.1186/s13054-015-1097-0.
Clinical trial NCT02858973: A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of Q203 in Normal Healthy Male and Female Volunteers
Official title: A Phase 1B, Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Q203 When Administered Orally to Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Qurient Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-08-08
Enrollment: 47
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is randomized, double-blind, placebo-controlled, multiple ascending dose study of Q203 in healthy volunteers conducted at one study center in the United States

Detailed description: Six (6) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive multiple oral doses of Q203 or placebo for 14 days QD with a standard meal. Subjects will participate in only one cohort.

Safety (i.e., physical examinations, vital signs, ECGs, clinical laboratory tests, and adverse events \[AEs\]) will be assessed throughout the study; serial blood and urine samples will be collected for these assessments. Blood samples will also be collected for the PK assessment of Q203.

Escalation to the next dose level (i.e., initiation of the next cohort) will not take place until the Principal Investigator (PI), medical monitor, and representatives of the Sponsor have reviewed all available safety and tolerability from the previous cohorts and agree to the initiation of the next cohort.

Eligibility criteria: Inclusion Criteria:

1. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
2. Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age, inclusive, at screening.

Exclusion Criteria:

1. Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
3. History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.

Primary outcomes:
measure: Safety assessment through adverse event, vital signs, ECG, laboratory results, and telemetry monitoring
timeFrame: 16 days post dose
Secondary outcomes:
measure: Pharmacokinetic analysis: Area under the curve
timeFrame: 16 days post dose
measure: Pharmacokinetic analysis: Maximum observed plasma drug concentration
timeFrame: 16 days post dose
measure: Pharmacokinetic analysis: Time of maximum observed concentration
timeFrame: 16 days post dose
Other outcomes:
Locations:
city: Lincoln
country: United States
state: Nebraska
Study officials:
References:
Clinical trial NCT05998473: Characterization of Dynamic Stability in Normal Pressure Hydrocephalus and Parkinson's Disease
Official title: Characterization of Dynamic Stability in Normal Pressure Hydrocephalus and Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hydrocephalus
Parkinson Disease
Walking, Difficulty
Movement Disorders
Gait Ataxia
Diagnoses Disease
Lead sponsor: Henri Mondor University Hospital
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with normal pressure hydrocephalus or Parkinson's disease.

Brief summary: This study aims to characterize dynamic stability disorders in two conditions mainly affecting the elderly and with similar walking deficits: hydrocephalus at normal pressure and Parkinson's disease, to provide the most relevant monitoring criteria in usual care.

Detailed description: Walking disorders in normal pressure hydrocephalus are manifested by slowing and ataxic gait, similar to disorders in Parkinson's disease. No studies in the literature have focused on advanced measures of dynamic stability in hydrocephalus at normal pressure, compared to Parkinson's disease, on large samples. The Laboratory of Analysis and Restoration of Movement, located in a Neurorehabilitation Department, provides quantitative data on gait and in particular dynamic stability as part of additional assessments to help patients follow up. Since 2010, people with normal pressure hydrocephalus or Parkinson's disease regularly benefit from these assessments. Retrospective analysis of all these data would help to better characterize motor disorders in hydrocephalus at normal pressure, by discriminating them from those associated with Parkinson's disease. It would lead to the definition of relevant indices to be used for patient follow-up.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Patient who performed a walking test in the Laboratory Analysis and Restoration of Movement
* Diagnosis of normal pressure hydrocephalus or Parkinson's disease

Exclusion Criteria:

* Levodopa drugs administrated during a delay of 12 hours before walking test
* Presence of an other neurologic disease or of any disease associated with motor disorders in lower limb.

Primary outcomes:
measure: Coefficient of variation in step length
timeFrame: 30 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Créteil
country: France
facility: Laboratoire Analyse et Restauration du Mouvement
Study officials:
affiliation: Henri Mondor University Hospital
name: Emilie Hutin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04636073: The Leaflex™ Early Feasibility Study
Official title: A Prospective, Multicenter, Non-randomized, Single-arm, Open-label Clinical Study to Demonstrate the Safety and Performance of the Leaflex™ Performer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Aortic Valve Stenosis
Lead sponsor: Pi-cardia
Sponsor class: INDUSTRY
First posted: 2020-11-19
Enrollment: 0
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: A prospective, multicenter, single-arm, early feasibility study aimed to assess safety and performance of the Leaflex™ Performer in the treatment of patients with symptomatic, severe aortic stenosis.

Subjects will be seen at pre- and post procedure, discharge, 30 days and at 3, 6, 9 and 12 months post procedure.


Eligibility criteria: Inclusion Criteria:

* Patient with symptomatic, severe aortic stenosis who are operable, but not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement.
* Patient is willing to comply with scheduled visits and tests and is able and willing to provide informed consent.

Exclusion Criteria:

* Inoperable for emergency surgery.
* Moderate or greater aortic regurgitation.
* Anatomic contraindications.
* Coronary, carotid, or vertebral artery disease that, in the opinion of the heart team, should be treated; or treatment of coronary artery disease ≤ 1 month prior to index procedure.
* Aortic balloon valvuloplasty ≤ 3 months prior to index procedure.
* Stroke ≤ 12 months prior to index procedure.
* History of a myocardial infarction ≤ 6 weeks prior to index procedure.
* Patients with clinically significant abnormality in cell blood count, history of bleeding diathesis or coagulopathy.
* Hemodynamic instability.
* Hypertrophic cardiomyopathy with obstruction.
* Left ventricle ejection fraction \<30%.
* Ongoing severe infection, including endocarditis, or sepsis.
* Life expectancy ≤ 12 months.

Primary outcomes:
measure: Change in aortic valve area
timeFrame: Baseline to 3 days
Secondary outcomes:
measure: Rate of all-cause mortality and all-cause stroke (VARC 2)
timeFrame: 30 days post procedure
measure: Rate of worsening of aortic regurgitation
timeFrame: Baseline to 30 days
measure: Rate of worsening of aortic regurgitation
timeFrame: Discharge to 30 days
measure: Rate of device related adverse events
timeFrame: 12 months
measure: Change in 6 minute walk test
timeFrame: 1, 6 and 12 months
measure: Quality of Life Improvement
timeFrame: 1, 6 and 12 months
measure: Quality of Life Improvement
timeFrame: 1, 6 and 12 months
measure: Change in aortic valve area
timeFrame: 30 day, 3, 6, 9, 12 months
measure: Change in pressure gradients
timeFrame: 30 day, 3, 6, 9, 12 months
Other outcomes:
Locations:
Study officials:
References: