louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04870853: Cardiovascular Events Among Adults Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma Treated With Standard of Care Chimeric Antigen Receptor T Cell Therapy
Official title: Cardiovascular Events Among Adults Patients With Aggressive B-Cell Lymphoma Treated With Standard of Care Chimeric Antigen Receptor T Cell Therapy: A Single-Institution Experience
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Recurrent Aggressive B-Cell Non-Hodgkin Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma
Recurrent High Grade B-Cell Lymphoma
Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma
Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
Refractory Aggressive B-Cell Non-Hodgkin Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Refractory High Grade B-Cell Lymphoma
Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma
Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (\>= 18 years) with a diagnosis of aggressive B-cell lymphoma, who received SOC CAR-T cell therapy at MD Anderson Cancer Center

Brief summary: This study characterizes cardiac events following standard of care chimeric antigen receptor T cell therapy in patients with aggressive B-Cell Lymphoma that has come back (relapsed) or does not respond to treatment (refractory). The results from this study may allow a description of these events, their managements and outcome.

Detailed description: PRIMARY OBJECTIVE:

I. To characterize cardiac events following standard of Care (SOC) chimeric antigen receptor T (CAR-T) cell therapy in adult patients with relapsed/refractory aggressive B-cell lymphoma.

OUTLINE:

Patients' medical records are reviewed retrospectively.

Eligibility criteria: Inclusion Criteria:

* Adults (\>= 18 years) with a diagnosis of aggressive B-cell lymphoma (such as transformed follicular lymphoma, diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and high-grade B-cell lymphoma), who received standard of care (SOC) chimeric antigen receptor T (CAR-T) cell therapy at MD Anderson Cancer Center

Exclusion Criteria:

* None

Primary outcomes:
measure: To characterize cardiac events following standard of care (SOC)
timeFrame: through study completion, an average of 1 year
measure: To characterize cardiac events following chimeric antigen receptor T cell therapy (CAR-T)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Raphael E Steiner
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02949453: ACCeptation and Qualitative Evaluation of Phone-delivered Intervention
Official title: ACCeptation and Qualitative Evaluation of Phone-delivered Intervention To Prevent Suicide Reattempt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Keywords: suicide
prevention
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
First posted: 2016-10-31
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Background: Previous suicide attempt is known to be a strong risk factor for repetition and repetition is common within the first year after an episode of deliberate self-harm (DSH). There has been growing interest in brief interventions for this population that are focused on maintaining long-term contact and/or offering re-engagement with services when needed. Despite telephone-delivered interventions have shown promising results in suicide reattempt prevention, subjective impact of such brief contact interventions and effectiveness mechanisms have never been evaluated.

Detailed description: Semi-structured in-depth interviews with 20 patients previously receiving a telephone-delivered intervention from our team. Six weeks and 3 months after a DSH, people included in telephone-delivered process will be interviewed by a social science researcher. Qualitative analysis using thematic analysis will be independently performed by two researchers.

Eligibility criteria: Inclusion Criteria:

* Deliberate self-harm in the previous week,
* 18 years old and older,
* outpatient care orientation after discharge from emergency department

Exclusion Criteria:

* Difficulties in french language,
* mental retardation

Primary outcomes:
measure: Acceptation of a telephone-delivered intervention after deliberate self-harm(DSH)
timeFrame: change from baseline after the telephone intervention
Secondary outcomes:
measure: Impact of telephone-delivered intervention after a deliberate self-harm (DSH)
timeFrame: 2 years
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Vinatier
Study officials:
affiliation: Centre Hospitalier le Vinatier
name: TERRA JEAN-LOUIS, PUPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05372653: A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis
Official title: A Phase 3, Multicenter, Open-label, Uncontrolled Trial to Evaluate the Efficacy and Safety of OPA-15406 Ointment in Infants Younger Than 2 Years of Age With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis (AD)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-13
Enrollment: 41
Sex: ALL
Minimum age (years): 3
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy of 0.3% OPA-15406 ointment when administered twice daily for 4 weeks in infants younger than 2 years of age with Atopic Dermatitis


Eligibility criteria: Inclusion Criteria:

* Subjects who are diagnosed with AD in accordance with the criteria of the Japanese Dermatological Association
* Subjects whose AD affects 5% to 40% of BSA (excluding scalp) at the screening and baseline examinations
* Subjects who have an IGA score of 2 or 3 at the screening and baseline examinations

Exclusion Criteria:

-Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination

Primary outcomes:
measure: Success Rate in IGA (Percentage of Subjects With an IGA Score of 0 or 1 With Improvement by at Least 2 Grades)
timeFrame: Week 4
Secondary outcomes:
measure: Response Rate in Eczema Area and Severity Index (EASI) 75 (Improvement of ≥75% in EASI)
timeFrame: Week4
Other outcomes:
Locations:
city: Isumi
country: Japan
facility: Sotobo Children's Clinic
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Takehisa Matsumaru
role: STUDY_DIRECTOR
References:
Clinical trial NCT05474053: Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence
Official title: Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence: A Parallel Single-blinded Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Diseases
Acute Coronary Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot study that was conducted to prove the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers. we advocate comparing the clinical efficacy rather than simple bioequivalence comparison.

Detailed description: Cardiovascular diseases are the leading cause of death worldwide. Ticagrelor, is an oral antiplatelet drug used in acute coronary syndrome. Although generic drugs are approved for their bioequivalence to the original product, they are not necessarily to be therapeutically equivalent. This study was conducted to prove the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers. A loading dose of 180 mg ticagrelor named Brilique® or Ticaloguard® followed by a 90 mg twice daily regimen as maintenance dose was given to 14 and 15 volunteers in Ticaloguard and Brilique groups, respectively. The platelet aggregation on adenosine diphosphate (ADP) agonist was assessed at different time intervals .

Eligibility criteria: Inclusion Criteria:

volunteers of both sexes, aged between 18-64 years old

Exclusion Criteria:

* volunteers with any abnormalities in the complete blood count (CBC) at entry time
* those with any medical conditions contraindicated with antiplatelet therapy
* those taking aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), or any over the counter medications (OTC) that contain medication such as, antihistamines, antibiotics in the previous month
* volunteers with history of blood disorders or bleeding diathesis.

Primary outcomes:
measure: testing degree of platelet inhibition of Ticalouguard versus the brand Brilique
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Faculty of pharmacy, Cairo university
name: Nirmeen sabry, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06844253: Comparative Effects of Exergaming Versus Task Oriented Training Among Sub-acute Post-stroke Patients
Official title: Comparative Effects of Exergaming Versus Task Oriented Training Among Sub-acute Post-stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacute Stroke
Keywords: Exergaming
Task-oriented training
Trunk control
sub-acute stroke
TIS
BBS
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized control trail and the purpose of this study is to determine the effects of exergaming versus task oriented training among sub-acute post-stroke patients.

Detailed description: Effects of exergaming training will be assessed for trunk control which includes the parameters of balance and posture.

Sub-acute post stroke patients aged 40-85 years The participants will be assessed through Trunk impairment scale (TIS), Berg Blanace Scale (BBS) and biodex (clinical test for sensory integration in balance).

Informed consent will be taken after which the participants will be recruited into the two groups, where one group will receive intervention through exergaming and other group will receive task oriented trainig.

Baseline and post-treatment measurements will be taken for analysis.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with sub-acute post-stroke.
* Aged 40 years-85 years.
* Mini-mental status examination \>24
* Motor assessment scale (1-5 scoring)

Exclusion Criteria:

* Post-stroke patients with major cognitive deficits.
* Acute infections.
* Patients with any fracture/ MSK disorders.
* Neurological deficits other than stroke

Primary outcomes:
measure: TRUNK CONTROL
timeFrame: 8 weeks
measure: Balance
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University College of Physical Therapy
Study officials:
References:
Clinical trial NCT01639053: Sientra Post-Approval Study
Official title: U.S. Postapproval Study of Sientra Silicone Gel Breast Implants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Augmentation
Breast Reconstruction
Breast Revision
Keywords: Breast Augmentation
Breast Reconstruction
Breast Revision
Silicone breast implants
Lead sponsor: Tiger Biosciences, LLC.
Sponsor class: INDUSTRY
First posted: 2012-07-12
Enrollment: 5498
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who receive Sientra Silicone Gel Breast Implants for augmentation, revision augmentation, reconstruction, and revision reconstruction. Control participants are candidates for and undergo aesthetic surgery other than implantation with Silicone Gel Breast implants.

Brief summary: This is a ten-year postapproval study to evaluate the long-term clinical performance of Sientra Silicone Gel Breast Implants under general conditions of use in the postmarket environment.


Eligibility criteria: Inclusion Criteria:

1. Genetic female with US residency
2. Is at least 18 years old for primary or revision reconstruction or 22 years old for primary or revision augmentation
3. Agrees to Sientra study requirements

Exclusion Criteria:

1. Has an active infection anywhere in body
2. Has active cancer without adequate treatment
3. Currently pregnant or nursing
4. Has any condition or diagnosis that, in the investigator's opinion, would negatively affect ability to complete study requirements
5. If control participant, has undergone breast implant surgery with silicone gel-filled breast implants

Primary outcomes:
measure: Long-term safety of Sientra Silicone Gel Breast Implants in women
timeFrame: 10-years
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Sientra, Inc.
state: California
Study officials:
affiliation: Sponsor GmbH
name: Sientra, Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02812953: Biological Collection and Registry of Patients Who Will Have a TAVR (Transcatheter Aortic Valve Replacement) Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transcatheter Aortic Valve Replacement
Lead sponsor: Action, France
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient undergoing TAVR

Brief summary: A sample of plasma and whole blood will be obtained at 4 time points (pre-procedural, early post-procedural, at hospital discharge and during an eventual visite at 3 or 6 months post-procedural). Test for platelet reactivity (LTA, light transmittance aggregometry and Elisa PRI, Platelet reactivity index), multimeric VWF (von Willebrand factor) and blood level of NET: neutrophil extracellular traps(flow cytometry and ELISA) analyses will be performed at the time of blood sampling. Aliquots of plasma will be stored and frozen for further analyses

Detailed description: There are two major objectives:

* To correlate changes in VWF, platelet reactivity and blood level of NET after TAVR with clinical outcomes
* To correlate changes in VWF, platelet reactivity and blood level of NET with antithrombotic regimens after TAVR (direct anticoagulants apixaban versus standard of care, ie Vitamin K antagonist or antiplatelet therapy).

Eligibility criteria: Inclusion Criteria:

* patient undergoing TAVR intervention
* agreement given

Exclusion Criteria:

* severe thrombopenia ( \<40.10\^9/L)

Primary outcomes:
measure: Major Adverse Cardiac Events
timeFrame: 12 months
measure: Bleeding
timeFrame: 12 months
Secondary outcomes:
measure: mean pressure transprosthetic gradient
timeFrame: within ten days after valve replacement
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Pitie Salpetriere
Study officials:
References:
Clinical trial NCT04761653: Study of the Inflammatory Microenvironment in Atypical Meningiomas
Official title: Prognostic Impact of the Inflammatory Microenvironment in Atypical Meningiomas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atypical Meningioma
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated for a cerebral tumor, with primary diagnosis of atypical meningioma

Brief summary: Atypical meningiomas represent 15% of meningiomas. They present a high rate of recurrence, and therapeutic strategies are limited. There is a need for novel treatment strategies, such as immuotherapy.

This is a retrospective study including 84 patients with primary diagnosis of atypical meningiomas. The presence of T cells (CD4, CD8, Treg and memory T cells) and mature dendritic cells will be quantified on whole tissue sections stained by immunohistochemistry (CD4, CD8, FOXP3, CD45RO and CD208).

This could allow us to identify novel biomarkers for survival, and facilitate the selection of patients who may benefit from immunotherapeutic modalities.


Eligibility criteria: Inclusion Criteria:

* primary diagnosis of atypical meningioma
* surgery

Primary outcomes:
measure: Progression free survival
timeFrame: 2-21 years
Secondary outcomes:
measure: Overall survival
timeFrame: 2-21 years
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: Guillaume GAUCHOTTE
Study officials:
References:
Clinical trial NCT01887353: The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure
Official title: A Randomized, Double-blind, Placebo Controlled Study, Designed to Investigate the Effect of Ranolazine on Left Ventricular Diastolic Function in Patients With Symptomatic AF and Preserved Ejection Function, After the Subject Has Undergone a Successful External Electrical Cardioversion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atrial Fibrillation
Heart Failure
Keywords: atrial fibrillation
heart failure
ranolazine
cardioversion
persistent AF
paroxysmal AF
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2013-06-26
Enrollment: 8
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 purpose of this study is to evaluate the efficacy of ranolazine in the prevention of recurrent atrial fibrillation in post-cardioversion patients with heart failure and preserved ejection fraction.


Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant female \> 18 years of age;
* Documentation of heart failure and who are in NYHA class II or III;
* Documented history of symptomatic AF \< 6 months in duration at the time of presentation, currently in AF at the time of the external electrical cardioversion, and successfully restored to normal sinus rhythm;
* Percutaneous coronary intervention (PCI) patients who can be placed on anticoagulation with warfarin post-cardioversion (and not on rivaroxaban or dabigatran);
* Demonstration of preserved ejection fraction (EF) by echocardiography;
* Echocardiographic evidence of impaired diastolic filling.

Exclusion Criteria:

* Known history of permanent or long-standing AF (\> 6 months);
* Other acutely reversible causes of AF, including but not limited to: hyperthyroidism, pericarditis, myocarditis or pulmonary embolism;
* Known history of cirrhosis;
* NYHA Class IV;
* Myocardial Infarction, unstable angina, or coronary artery bypass graft surgery within three months prior to screening;
* Percutaneous coronary intervention (PCI) within 4 weeks prior to screening, if these patients need to be placed on rivaroxaban or dabigatran post-cardioversion;
* Clinically significant valvular disease;
* Clinically significant pulmonary disease;
* Stroke within 3 months prior to screening;
* Creatinine clearance \< 30 mL/min as calculated by Cockcroft-Gault formula;
* Use of anti-arrhythmic drugs (Class Ia or IIIc) within 3 months prior to screening;
* Concurrent use of drugs considered strong inhibitors of CYP3A;
* Concurrent use of drugs considered as CYP3A inducers;
* Prior treatment with ranolazine.

Primary outcomes:
measure: Time to First Atrial Fibrillation (AF) Recurrence
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Medical Center
name: T. Jared Bunch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01064453: Angeliq Regulatory Post Marketing Surveillance
Official title: Angeliq Regulatory Post Marketing Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postmenopausal Period
Osteoporosis, Postmenopausal
Keywords: Menopause
Menopausal symptoms
Prevention of osteoporosis in menopausal women
Estrogen deficiency symptoms
Hormone replacement therapy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-02-08
Enrollment: 4078
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Korean women who take Angeliq for postmenopausal symptoms or/and prevention of osteoporosis

Brief summary: Angeliq regulatory Post-Marketing Surveillance (PMS) is to get data about safety and efficacy in real practice for the indication approved by Korea Food and Drug Administration (KFDA). This is non-interventional , prospective, multi-center study.Target number of patients is 4500.


Eligibility criteria: Inclusion Criteria:

* Hormone replacement therapy for estrogen deficiency symptoms in postmenopausal women more than 1 year postmenopause
* Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis

Exclusion Criteria:

* Undiagnosed genital bleeding
* Known, past or suspected cancer of the breast
* Known or suspected estrogen-dependent malignant tumors (e.g. endometrial cancer)
* Untreated endometrial hyperplasia
* Previous idiopathic or current venous thromboembolism (e.g. deep venous thrombosis, pulmonary embolism)
* Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)
* Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal
* Porphyria
* Severe renal insufficiency or acute renal failure
* Known hypersensitivity to the active substances or to any of the excipients

Primary outcomes:
measure: Adverse event collection
timeFrame: At each visit of patient during observational period (6 months)
Secondary outcomes:
measure: Improvement of menopausal symptoms
timeFrame: After 6 months or at discontinuation of Angeliq (At earlier point)
Other outcomes:
Locations:
city: Many Locations
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: