louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02799550: Allogeneic CART-19 for Elderly Relapsed/Refractory CD19+ ALL
Official title: Treatment of Elderly Relapsed and/or Refractory CD19-positive Acute Lymphoblastic Leukemia by Infusions of Allogeneic CART-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Leukemia
Keywords: CART
ALL
Relapsed
Refractory
CD19+
Lead sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2016-06-15
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 19 (CD19)-directed chimeric antigen receptor modified T cells (CART-19) infusions in patients with relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL)

Detailed description: The relapsed and/or refractory B-ALL patients will receive infusions of allogeneic CART-19 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily vindesine, mitoxantrone, cyclophosphamide, pegaspargase and dexamethasone, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 60 years
* Patient with relapsed and/or refractory CD19 positive B-cell acute lymphoblastic leukemia (B-ALL)
* Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

* Previous treatment with investigational gene or cell therapy medicine products
* CD19 negative B-cell leukemia
* Any uncontrolled active medical disorder that would preclude participation as outlined

Primary outcomes:
measure: Occurrence of study related adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Overall response rate of allogeneic CART-19
timeFrame: up to 24 weeks
measure: Disease-free survival
timeFrame: up to 24 weeks
measure: Overall survival
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Affiliated Hospital of Academy of Military Medical Sciences ,
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Affiliated Hospital of Academy of Military Medical Sciences
name: Huisheng Ai, MD
role: STUDY_CHAIR
References:
citation: Cai B, Guo M, Wang Y, Zhang Y, Yang J, Guo Y, Dai H, Yu C, Sun Q, Qiao J, Hu K, Zuo H, Dong Z, Zhang Z, Feng M, Li B, Sun Y, Liu T, Liu Z, Wang Y, Huang Y, Yao B, Han W, Ai H. Co-infusion of haplo-identical CD19-chimeric antigen receptor T cells and stem cells achieved full donor engraftment in refractory acute lymphoblastic leukemia. J Hematol Oncol. 2016 Nov 25;9(1):131. doi: 10.1186/s13045-016-0357-z.
Clinical trial NCT06876350: Woodcasting Versus Thermoplast Splint in CMC Arthroplasty
Official title: Patient Satisfaction for Post-Operative Carpometacarpal Arthroplasty: Wood Casting Versus Thermoplastic Splint
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpometacarpal (CMC) Joint Arthritis
Keywords: Randomized
Hand and Upper Extremity
Lead sponsor: Foundation for Orthopaedic Research and Education
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 26
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: This study is a prospective, randomized, nonblinded trial to evaluate patient preference in splints after having a carpometacarpal arthroplasty.

Detailed description: Patients undergoing carpometacarpal arthroplasty will be randomized into the woodcast or thermoplast splint after their surgery to see which is preferred using compliance and surveys.

Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 years old.
* Intact Medical Decision Making
* Eligible for Surgical Intervention
* Willing to comply with all aspects of the treatment and evaluation schedule over 6 weeks

Exclusion Criteria:

* Pregnant Women
* Deemed Unsuitable by Principal Investigator

Primary outcomes:
measure: Patient Satisfaction Score
timeFrame: 6 Weeks
Secondary outcomes:
measure: Waste
timeFrame: 2 Weeks
measure: Splint Satisfaction
timeFrame: 6 Weeks
measure: Splint Issues
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Florida Orthopaedic Institute
state: Florida
Study officials:
affiliation: Florida Orthopaedic Institute
name: Michael Doarn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00616850: Treatment of Postoperative Pain After Total Knee Arthroplasy Using Intravenous Lidocaine Infusion
Official title: Treatment of Postoperative Pain After Total Knee Arthroplasty Using Intravenous Lidocaine Infusion in Combination With Patient Controlled Analgesia Versus Continuous Femoral Block Catheter in Combination With Patient Controlled Analgesia: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Total Knee Arthroplasty
Intravenous Lidocaine Infusion
Femoral Block Catheter
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2008-02-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Total knee replacement is often associated with severe postoperative pain, especially in the first 24 hours. Patient controlled analgesia (PCA) and continuous femoral block with PCA are commonly used to treat postoperative pain after total knee arthroplasty. However, PCAs use opioids. Opioids are excellent painkillers but their use is hampered by side effects such as nausea, vomiting, bowel dysfunction, urinary retention, pruritus, sedation and respiratory depression. We propose to test the hypothesis that adding a low dose lidocaine infusion to PCAs will lower the amount of opioids that these patients receive, thereby improving patient safety while still providing adequate analgesia. In addition, continuous femoral block has been shown to provide superior postoperative pain control when compared to morphine PCA. Therefore, postoperative pain levels of study subjects will be compared to those subjects who receive a combination of a continuous femoral block catheter with a PCA.


Eligibility criteria: Inclusion Criteria:

1. Undergoing a total knee arthroplasty
2. Be American Society of Anesthesiologist physical status 1,2, or 3
3. Be willing and capable of providing informed consent
4. Be English speaking

Exclusion Criteria:

1. Age greater than 80 years old or younger than 18 years old
2. Congestive hear failure
3. Hepatic insufficiency
4. Neurological disorders
5. Psychiatric disorders
6. Steroid treatment
7. History of atrial fibrillation
8. Chronic pain disorder with opioid treatment

Primary outcomes:
measure: Total PCA opioid consumption
timeFrame: 72 hours
Secondary outcomes:
measure: Time to first flatus
timeFrame: 72 hours postoperatively
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Loma Linda University Medical Center
name: Michelle Schlunt, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02241850: Genetic Polymorphisms Affecting Effect of High Intensity Training
Official title: Assessment of Genetic Polymorphisms Affecting Effect of High Intensity Training in Korean Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: High Intensity Training
Genetic Polymorphisms
Genome Wide association study
Single Nucleotide Polymorphism genotype
Subjects
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Daewoong Pharmaceutical Co. LTD.
First posted: 2014-09-16
Enrollment: 110
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of the study is to investigate the effect of high intensity training on maximal oxygen uptake according to the genetic polymorphisms in healthy Korean volunteers.


Eligibility criteria: Inclusion Criteria:

* Age between 30 to 60, healthy male subjects (at screening)
* Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

* Volunteer who has past or present history of any diseases following below; liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder
* Subject who already participated in other trials in 30 days
* Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
* Subject who smokes an average of 20 cigarettes/day or drink \> 5 cups of coffee

Primary outcomes:
measure: Change of maximal oxygen uptake
timeFrame: Baseline and after 6, 9 weeks of training
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kyung Hee University Hospital
name: Sung-Vin Yim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yoo J, Kim BH, Kim SH, Kim Y, Yim SV. Genetic polymorphisms to predict gains in maximal O2 uptake and knee peak torque after a high intensity training program in humans. Eur J Appl Physiol. 2016 May;116(5):947-57. doi: 10.1007/s00421-016-3353-7. Epub 2016 Mar 21.
Clinical trial NCT00384150: Retreatment Study of Galiximab + Rituximab in Follicular Non-Hodgkin's Lymphoma (NHL)
Official title: A Phase III, Open-Label, Multicenter, Single-Arm, Retreatment Study of Galiximab in Combination With Rituximab for Subjects With Relapsed, Follicular Non-Hodgkin's Lymphoma Who Previously Responded on Study 114-NH-301
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lymphoma, Non-Hodgkin's
Keywords: galiximab
antibody
refractory
follicular
relapsed
NHL
rituximab
retreatment
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2006-10-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase III, multicenter, global, open-label, single-arm, retreatment study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with relapsed or refractory, follicular NHL who demonstrated a response on Study 114-NH-301 with a time-to-progression \>=6 months.


Eligibility criteria: Key Inclusion Criteria:

* Demonstrated a response (CR, CRu, or PR) on Study 114-NH-301 (Galiximab in combination with Rituximab compared with Rituximab in combination with Placebo) and then relapsed or progressed with a TTP \>=6 months. Relapsed disease is defined as documented disease progression using the International Workshop Response Criteria (IWRC).
* Bidimensionally measurable disease with at least 1 lesion \>=2.0 cm in a single dimension.
* Acceptable hematologic, hepatic, and renal function.

Key Exclusion Criteria:

* Any lymphoma therapy between Final Visit on Study 114-NH-301 and Study Day 1 of this retreatment study.
* Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to Study Day 1.
* Transfusion-dependent subjects.
* Presence of central nervous system (CNS) lymphoma.
* Histologic transformation.
* Presence of pleural or peritoneal effusion with positive cytology for lymphoma.
* Another primary malignancy requiring active treatment.
* Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions that would compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
* New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to Study Day 1.

Primary outcomes:
measure: Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies
timeFrame: Study period is approx. 2 years
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: Study period is approx. 2 years
measure: To further characterize the efficacy profile of galiximab in combination with rituximab
timeFrame: Study period is approx. 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00758550: Visual Function After Bilateral Implantation of AcrySof® Toric
Official title: Visual Function After Bilateral Implantation of AcrySof® Toric
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Visual Function
Keywords: Visual function;
Refractive cylinder;
AcrySof® Toric;
AcrySof® Natural
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.


Eligibility criteria: Inclusion Criteria:

* Bilateral cataracts
* 40\~80 years of age
* 4 Days - 1 Week interval between a single patient's surgery
* dilated pupil size (in dim light) ≥ 4.0 mm
* Anticipated correction with an IOL of +10 Diopters \~ +25 Diopters
* 0.75 - 2.0 Diopters of astigmatism preoperatively as measured by Keratometry readings

Exclusion Criteria:

* Preoperative ocular pathology
* Previous intraocular or corneal surgery
* An increased risk for complications which could require vitreoretinal surgery
* Corneal irregularities
* Corneal opacities
* Current contact lens usage(within 6 months prior to first surgery)

Primary outcomes:
measure: Uncorrected Visual Acuity (UCVA)
timeFrame: 6 Months after surgery
Secondary outcomes:
measure: Questionnaire Results
timeFrame: 6 Months
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center
state: Texas
Study officials:
References:
Clinical trial NCT03666650: NOAC Plasma Concentration and Blood Coagulation in Healthy Volunteers
Official title: Relationship of Edoxaban Plamsa Concentration and Blood Coagulation in Healthy Volunteers Using Standard Laboratory Tests and Viscoelastic Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Coagulation Disorder
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Helsinki University Central Hospital
First posted: 2018-09-12
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Relationship of edoxaban plasma concentration and blood coagulation in healthy volunteers using standard laboratory tests and viscoelastic analysis


Eligibility criteria: Inclusion Criteria:

healthy

Exclusion Criteria:

intolerance of the study drug history of bleeding disorder or similar

Primary outcomes:
measure: correlation of edoxaban peak plasma concentrations and viscoelastic analysis
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
state: Varsinais-Suomi
Study officials:
References:
Clinical trial NCT01381250: Effects of Internet-based Treatment of Pathological Gambling
Official title: Prediction and Treatment Outcome of Internet-based Treatment of Pathological Gambling With Three-year Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pathological Gambling
Keywords: Pathological gambling according to DSM and having gambled at least once the past month.
Being atleast 18 years old
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2011-06-27
Enrollment: 284
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 trial testing the outcome of an Internet-based treatment of pathological gambling with the hypothesis that there will be improvements both immediately and up to 36 months. It is also hypnotized that treatment response can be predicted from background variables.


Eligibility criteria: Inclusion Criteria:

* Pathological gambling according to DSM and having gambled at least once the past month
* Being atleast 18 years old
* Living in Sweden

Exclusion Criteria:

Primary outcomes:
measure: The National Opinion Research Center DSM Screen for Gambling Problems (NODS)
timeFrame: 1 month
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: 1 week
measure: Quality of Life Inventory
timeFrame: Present moment
Other outcomes:
Locations:
city: Umea
country: Sweden
facility: University
Study officials:
affiliation: Umeå University
name: Per Carlbring, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06968650: Cocooned Moms Study
Official title: Efficacy of a Culturally-sensitive Telehealth Platform in Fostering Community-based Care Coordination for Respectful Maternal Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress
Depression
Pregnancy
Blood Pressure
Lead sponsor: InovCares Connected Comprehensive Healthcare Corporation
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: National Institute of Nursing Research (NINR)
First posted: 2025-05-13
Enrollment: 384
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The Cocooned Moms Study is a pre- and post-design study primarily aimed at reducing stress, depressive symptoms, and blood pressure among expectant Black women by providing them with free access to the InovCares mobile app. InovCares is a culturally-sensitive telehealth platform designed for community-based care coordination in maternal care. It also offers a culturally tailored maternal mental health program, which provides access to resources addressing social determinants of health, cognitive behavioral therapy (CBT), interpersonal therapy, and compassion-focused therapy (CFT), along with peer-to-peer support and gamification. The study will evaluate the impact of these interventions on reported stress levels, depressive symptoms, sleep quality, and blood pressure (BP) among Black pregnant women.


Eligibility criteria: Inclusion Criteria:

- Black Women ages 18 + with confirmed pregnancy of at least eight or up to 28 weeks, with no known fetal or genetic abnormalities (with the exception of abnormal amniotic fluid volume; Women who have the developmental or legal capacity to consent; Able to speak English

Exclusion Criteria:

* Exclusion criteria

  1. Psychosis diagnosis
  2. Does not speak or understand English
  3. Participants who are not pregnant
  4. Non-Black
  5. Significant vision impairment.

Primary outcomes:
measure: Change in depression, anxiety, and stress as measured by Depression Anxiety Stress Scales- Short Form (DASS-21)
timeFrame: Up to 7 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Up to 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University Of Miami
state: Florida
city: Tampa
country: United States
facility: Dr.Traci's House
state: Florida
Study officials:
References:
citation: DeNicola N, Grossman D, Marko K, Sonalkar S, Butler Tobah YS, Ganju N, Witkop CT, Henderson JT, Butler JL, Lowery C. Telehealth Interventions to Improve Obstetric and Gynecologic Health Outcomes: A Systematic Review. Obstet Gynecol. 2020 Feb;135(2):371-382. doi: 10.1097/AOG.0000000000003646.
citation: Blanc J, Scaramutti C, Carrasco M, Dimanche S, Hollimon L, Moore J, Moise R, Gabbay V, Seixas A. I am Lifted Above the World: utilizing VR for stress reduction among perinatal women of color. Front Psychiatry. 2024 Apr 23;15:1377978. doi: 10.3389/fpsyt.2024.1377978. eCollection 2024.
Clinical trial NCT01959750: Psychological Intervention on Burnout in ICU Caregivers
Official title: Psychological Intervention on Burnout in ICU Caregivers: a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout
Anxiety
Depression
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2013-10-10
Enrollment: 166
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: ICU caregivers face up to a demanding job with a high level of technical skills, a stressful environment, and a heavy work load. They run a high risk of developing burnout that can impact on their welfare, performance, and patient care. Burnout favours absenteeism and staff quitting their jobs, whereas the shortage of ICU caregivers already started. No randomised controlled intervention aimed at reducing such distresses had been run until now.

This study allowed finding a new method of psychological support applicable in the special environment of ICU. Our findings suggest that psychologists specifically assigned to treat ICU caregivers might be beneficial on their burnout.


Eligibility criteria: Inclusion Criteria:

* all ICU caregivers rrom the University Hospital of Geneva

Exclusion Criteria:

* refusals

Primary outcomes:
measure: Measurement of the changes in the levels of anxiety, depression, and burnout in nurses and nursing auxiliaries.
timeFrame: At the beginning , at the end and 6 months after the end of the intervention.
Secondary outcomes:
measure: Composite measurement of the changes of ICU activity and absenteeism before, during, just after and six months after the intervention.
timeFrame: 4 three-months time periods (cf. Description).
Other outcomes:
measure: Measurement of staff quitting their jobs
timeFrame: At the end of the intervention
Locations:
city: Geneva
country: Switzerland
facility: University Hopitals of Geneva
Study officials:
affiliation: University Hospitals of Geneva
name: Bara Ricou, Professor
role: STUDY_DIRECTOR
References: