louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06794268: A Study to Patients With Relapsed/Refractory Follicular Lymphoma Treated With Liso-cel (Lisocabtagene Maraleucel) in the Post Marketing Setting
Official title: Non-interventional Cohort Study of Patients Treated With Liso-cel (Lisocabtagene Maraleucel) for Relapsed/Refractory Follicular Lymphoma in the Postmarketing Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Follicular Lymphoma
Keywords: Follicular Lymphoma
Lead sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Sponsor class: INDUSTRY
First posted: 2025-01-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adults with relapsed/refractory follicular lymphoma that are being treated with lisocabtagene maraleucel and are registered within the Center for International Blood and Marrow Transplant Research (CIBMTR) registry.

Brief summary: The purpose of this study is to characterise the long-term safety of lisocabtagene maraleucel, focusing on patients treated in the approved follicular lymphoma (FL) indication, and will be part of post-marketing liso-cel pharmacovigilance activities


Eligibility criteria: Inclusion Criteria:

• Participants must have been treated in the post-marketing setting with at least 1 infusion of lisocabtagene maraleucel (liso-cel) used for the treatment of relapsed/refractory (R/R) follicular lymphoma (FL), including FL Grade 1, Grade 2 and Grade 3a, within the FDA-approved indication and dosage per the United States Prescribing Information (USPI) and product specifications approved for commercial release in the USA

Exclusion Criteria:

* Participants known to be participating in investigational studies at the time of liso-cel, infusion
* Participants treated with liso-cel for the treatment of R/R FL Grade 3b
* Participants treated with non-conforming chimeric antigen receptor (CAR) T-cell product

Primary outcomes:
measure: Incidence of adverse events (AEs) of interest
timeFrame: Up to 15 years
measure: Incidence of other adverse events (AEs) of interest
timeFrame: Up to 15 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 15 years
measure: Overall response rate (ORR)
timeFrame: Up to 15 years
measure: Complete remission rate (CRR)
timeFrame: Up to 15 years
measure: Duration of response (DOR)
timeFrame: Up to 15 years
measure: Progression-free survival (PFS)
timeFrame: Up to 15 years
measure: Time to next treatment (TTNT)
timeFrame: Up to 15 years
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: CIBMTR
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00364468: Dose Finding Study of KRN125 (Pegfilgrastim) for Treatment of Neutropenic Patients
Official title: A Randomized Dose Finding Study of KRN125 (Pegfilgrastim) for the Treatment of Chemotherapy - Induced Neutropenia in Malignant Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neutropenia
Keywords: pegfilgrastim
neutropenia
cancer patients
lymphoma
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 107
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the duration of severe neutropenia in cycle 1 of chemotherapy after treatment with a single injection of KRN125 or multiple daily injections of filgrastim.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed as malignant lymphoma
* patients who were refractory to anthracycline or anthraquinone containing chemotherapy
* patients who are going to receive ESHAP or CHASE treatment regimen
* ECOG performance status =\< 2
* patients who have appropriate bone marrow, hepatic and renal functions
* written informed consent

Exclusion Criteria:

* double cancer
* history of bone marrow transplantation or PBSCT
* more than 2 prior chemotherapy regimens
* primary hematologic disease such as myelodysplastic syndrome
* previous radiotherapy within 4 weeks of enrollment
* woman of childbearing potential who were either pregnant, breast feeding
* patients who participated in other clinical trials within the last 4 weeks of enrollment

Primary outcomes:
measure: To compare the duration of severe neutropenia
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Tokai region
city: Fukuoka, Nagasaki
country: Japan
facility: Kyusyu region
city: Gunma, Saitama, Tokyo, Kanagawa
country: Japan
facility: Kanto region
city: Hokkaido
country: Japan
facility: Hokkaido region
city: Kyoto, Mie, Shiga
country: Japan
facility: Kinki region
city: Miyagi
country: Japan
facility: Tohoku region
Study officials:
affiliation: Nagoya Medical Center
name: Tomomitsu Hotta, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05317468: Assessing Satisfaction With Contraceptive Counseling Using Telephone Versus Video Telehealth Visits
Official title: Pilot Randomized Controlled Trial to Assess Satisfaction With Contraceptive Counseling Using Telephone Versus Video Telehealth Visits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Health Care Utilization
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2022-04-07
Enrollment: 214
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Contraceptive Choice Center (C3) will compare the patient experience between patients receiving contraceptive counseling using a telephone versus video telehealth model.

Detailed description: The Contraceptive Choice Center (C3) will offer contraceptive counseling to patients via telehealth. Participants will be randomized to receive counseling via video or telephone. We will compare patient satisfaction with contraceptive counseling, receipt of desired contraceptive method, and identification of barriers with technology use.

Eligibility criteria: Inclusion Criteria:

* Able to speak and read English
* Access to video-capable technology

Exclusion Criteria:

* Incarceration
* Unable to provide informed consent secondary to language barrier or cognitive limitation

Primary outcomes:
measure: Patient Satisfaction Assessed by IQFP
timeFrame: Baseline
Secondary outcomes:
measure: % of Patients Receiving Desired Contraceptive Method Assessed by Medical Record Review
timeFrame: 30 Days Post Baseline
measure: % of Patients Reporting Barriers to Technology Use Assessed by Baseline Questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jennifer A Reeves, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05641168: A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin
Official title: A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Abnormalities
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2022-12-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The study investigates different adhesive materials on healthy and peristomal skin


Eligibility criteria: Inclusion Criteria:

* Has given written consent
* Be at least 18 years of age and have full legal capacity
* Have had a colostomy/ileostomy/urostomy for more than one year (for stoma patients) Have suitable peristomal skin area (assessed by investigator) (for stoma patients)

Exclusion Criteria:

* Currently receiving or have within the past 2 months received radio- and/or chemotherapy
* Currently receiving or have within the past month received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment
* Are pregnant or breastfeeding
* Having dermatological problems in the abdominal area (assessed by investigator)
* Participate in other clinical investigations. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this protocol

Primary outcomes:
measure: Adherent area
timeFrame: At every material change throughout the study, an average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebaek
country: Denmark
facility: Coloplast Research Unit/Userlab
Study officials:
References:
Clinical trial NCT06815068: Effect of Simplified Implant Placement Protocols on Failure Rate
Official title: Effect of Simplified Implant Placement Protocols on Failure Rate
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dental Implant Failure
Lead sponsor: Chrysalis Dental Center
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 2700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients requiring dental implants

Brief summary: The primary objective of this study is to evaluate the effectiveness of implant treatment in an unselected patient population as measured through implant failure.


Eligibility criteria: Inclusion Criteria:

* edentulism

Exclusion Criteria:

* ASA class 4

Primary outcomes:
measure: Implant failure rate
timeFrame: implant placement between 2011 and 2023
Secondary outcomes:
Other outcomes:
Locations:
city: North York
country: Canada
facility: Chrysalis Dental Center
state: Ontario
Study officials:
References:
Clinical trial NCT00507572: Collection of Outcomes Data for Pregnant Patients With Cancer
Official title: Collection of Outcomes Data for Pregnant Patients With Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-07-26
Enrollment: 500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant patients with cancer and patients known to have been pregnant with a diagnosis of cancer

Brief summary: This study collects treatment and outcomes information on pregnant patients who are or were pregnant with cancer. Gathering and storing health information on pregnant patients with cancer, may provide data for future research studies and improve patient care.

Detailed description: PRIMARY OBJECTIVES:

I. To collect, both prospectively and retrospectively, data on disease characterization, treatment and outcome for pregnant patients with malignancies seen at M. D. Anderson Cancer Center.

II. To organize clinical information in order to support multifaceted queries of patient characteristics, treatment, and pregnancy outcome data and to facilitate correlation of these characteristics with patient outcome.

III. To have a single data repository, kept on a secure platform, that will integrate clinical information and research findings and serve as a secure archive for future research.

OUTLINE:

Patients' medical records are reviewed prospectively and retrospectively.

Eligibility criteria: Inclusion Criteria:

* All pregnant patients with cancer and patients known to have been pregnant with a diagnosis of cancer are eligible, regardless of their diagnosis or treatment plan
* Patients may receive prenatal care from any obstetrician, but a consult with Maternal Fetal Medicine is encouraged

Primary outcomes:
measure: Creation of data repository for patient characteristics, treatment, and pregnancy outcome data
timeFrame: Up to 15 years
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: Andrea M Milbourne
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00195572: Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer
Official title: Post-Approved Phase III Study of 1-LV/5FU Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: Gastric Cancer
Advanced/Recurrent Gastric Cancer
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to verify non-inferiority of survival time between Isovorin/5-fluorouracil (1-LV/5FU) therapy and TS-1 therapy in patients with inoperable advanced or recurrent gastric cancer. Secondary endpoints include response rates, duration of responses, time to progression (TTP) safety and quality of life (QOL).


Eligibility criteria: Inclusion Criteria:

* Gastric cancer diagnosed histologically or cytologically
* Normal organ function of bone marrow, heart, liver and kidney
* Age of 20-77

Other inclusion applies

Exclusion Criteria:

* Serious infection, heart disease, complication or organ disorder
* Ongoing administration of flucytosine
* Pregnant or breastfeeding women

Other exclusion applies

Primary outcomes:
measure: Survival time
Secondary outcomes:
measure: Response rate, duration of response, time to progression, safety, quality of life
Other outcomes:
Locations:
city: Adachi-ku, Tokyo
country: Japan
city: Anjo-city
country: Japan
city: Aomori-shi
country: Japan
city: Chiba-shi
country: Japan
city: Chiba
country: Japan
city: Chikushino-shi
country: Japan
city: Fukuoka
country: Japan
city: Fukuroi-shi
country: Japan
city: Funai-gun
country: Japan
city: Hiroshima-shi
country: Japan
city: Hiroshima
country: Japan
city: Ichihara-shi
country: Japan
city: Kanagawa
country: Japan
city: Kanazawa-shi
country: Japan
city: Kisaradu-shi
country: Japan
city: Kitaadachi-gun
country: Japan
city: Koto-ku, Tokyo
country: Japan
city: Kyoto
country: Japan
city: Misawa-shi
country: Japan
city: Morioka-shi
country: Japan
city: Nagasaki
country: Japan
city: Nagoya City
country: Japan
city: Nagoya
country: Japan
city: Oomura City
country: Japan
city: Osaka-si
country: Japan
city: Osaka-si
country: Japan
city: Sagamiharashi
country: Japan
city: Saga
country: Japan
city: Sapparo City
country: Japan
city: Sapporo City
country: Japan
city: Sapporo-shi
country: Japan
city: Sapporo-shi
country: Japan
city: Sasebo-shi
country: Japan
city: Sendai-shi
country: Japan
city: Sendai-shi
country: Japan
city: Shizuka
country: Japan
city: Shizuoka-shi
country: Japan
city: Sizuoka-shi
country: Japan
city: Takatuki-si
country: Japan
city: Tsuchiura-shi
country: Japan
city: Tsukuba-shi
country: Japan
city: Uji-shi
country: Japan
city: Yamagata-shi
country: Japan
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00792272: Prevalence and Profile of Aspirin Resistance in Hemodialysis Patients
Official title: Prevalence of Aspirin Resistance in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aspirin Resistance
Keywords: aspirin resistance
aspirin resistance in hemodialysis patients
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Staten Island University Hospital
First posted: 2008-11-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: all hemodialysis patients on aspirin

Brief summary: Dialysis patient could be more aspirin resistant than the general population based on data from chronic kidney disease patients

Detailed description: We will try to describe the profile of aspirin resistant patient in hemodialysis patients

Eligibility criteria: Inclusion Criteria:

* all hemodialysis patients on aspirin

Exclusion Criteria:

* low platelets \<100.000
* coagulopathy, bleeding disorders
* patient on plavix

Primary outcomes:
measure: Aspirin Resistance in Hemodialysis patients
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: SIUH
name: Suzanne El-Sayegh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00794872: Chemoreflex Sensitivity in Chronic Kidney Disease
Official title: Hyperoxic Chemoreflex Sensitivity in Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Cardiovascular Morbidity
Keywords: Cardiovascular autonomic neuropathy
Chemoreflex sensitivity
Chronic kidney disease
Sudden cardiac arrest
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: Heinrich-Heine University, Duesseldorf
name: SLK Kliniken Heilbronn GmbH
First posted: 2008-11-20
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: Cardiovascular morbidity and mortality are markedly increased in chronic kidney disease (CKD) and may be explained in part by sympathetic hyperactivity. Impaired hyperoxic chemoreflex sensitivity (CHRS) has been attributed to an increased sympathetic activity. The aim of the present study is to examine whether chemosensor function is altered in patients with stage 3 and stage 4 CKD.

Detailed description: Impaired hyperoxic chemoreflex sensitivity (CHRS) is assessed in patients with stage 3 CKD \[glomerular filtration rate (GFR) 30-59 ml/min/1.73 m2\], in patients with stage 4 CKD \[GFR 15-29 ml/min/1.73 m2\], as well as in patients without any evidence of CKD. CHRS is measured by determination of the venous partial pressure of oxygen and the heart rate before and after deactivation of the chemoreceptors by inhalation of pure oxygen. The difference in the R-R intervals before and after inhalation divided by the difference in the oxygen pressures is calculated as the CHRS. A CHRS below 3.0 ms/mmHg is defined as pathological. It should be shown that using a simple clinical bedside test we provide the first evidence for impaired hyperoxic chemoreflex sensitivity in stage 3 and 4 chronic kidney disease. We thereby may lay the basis for future intervention studies assessing chemosensor function in these patients.

Eligibility criteria: Inclusion Criteria:

* Patients suffering from CDK stage 3 (GFR 30-59 ml/min/1.73 m²) or stage 4 (GFR 15-29 ml/min/1.73 m²)
* For the reference Patients without evidence for CDK

Exclusion Criteria:

* Patients with heart failure, history of myocardial infarction or instable angina pectoris, atrial fibrillation, hyperthyroidism, chronic pulmonary diseases, sleep apnoea syndrome, alcohol abuse and drug induced cardiomyopathy

Primary outcomes:
measure: Hyperoxic chemoreflex sensitivity is impaired in patients with moderate to severe chronic kidney disease
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
state: NRW
Study officials:
affiliation: RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
name: Christian Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05360472: Evaluation of Feconomics for Diagnosis of Intestinal Parasitic Infections
Official title: Evaluation of Feconomics Versus Traditional Techniques for Diagnosis of Intestinal Parasitic Infections
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intestinal Parasitic Infection
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: samples will be collected from school children whose age is between 6-12 from different locations (cities and village).

Brief summary: People of all ages are affected by intestinal parasitic infections(IPIs) ; however, children are the most commonly affected, which is linked to their poor hygienic practices, and weak immune status. In children, IPIs are associated with malabsorption, weight loss, anemia, poor growth rate, learning difficulties, mental retardation and intellectual problems . The difficulty of diagnosis is the main problem in the control of intestinal parasitic infections. The choice of a particular technique is usually influenced by affordability, simplicity, cost, sensitivity in addition to the level of technical skills involved. Microscopic examination remains the cornerstone of parasitological diagnosis which is time consuming and requires an experienced observer to identify the organism. Formalin-ether sedimentation technique is commonly used in laboratories owing to its ability to isolate a large variety of parasites. However, it's a labor intensive procedure and is usually associated with hazards of using the inflammable lipid solvents. The drawbacks of the previous techniques have encouraged the development of commercial products such as Feconomics which is a new ready to use kit for concentration of stool samples in parasitological diagnosis.

The aim of the study is :

evaluation of the efficacy of Feconomics technique in comparison to traditional techniques i.e., direct smear and formalin ethyl acetate sedimentation technique for the diagnosis of intestinal parasites in school children.


Eligibility criteria: Inclusion Criteria:

* school children whose age is between 6-12 years

Exclusion Criteria:

* children taking anti-parasitic drugs within the previous two weeks of stool sample collection .

Primary outcomes:
measure: Evaluation of the efficacy of Feconomics technique which is a new ready to use kit for concentration of stool samples , for diagnosis of intestinal parasitic infections in children
timeFrame: 6 months following the startpoint of the study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: