louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00691327: Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Official title: Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Reconstruction
Keywords: Revision of augmentation or reconstruction
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-06-05
Enrollment: 84329
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.


Eligibility criteria: Inclusion Criteria:

* Females of any age for which breast reconstruction is considered appropriate (Patients under 18 years old require parental/legal guardian consent to participate.
* Females seeking revision augmentation or revision reconstruction, where problems exist
* Have any of the following conditions or situations present:
* Post mastectomy surgical removal of the breast for cancer or other disease;
* Post trauma or post surgery where there was total or partial removal of the breast resulting in significant deformity;
* Severe ptosis requiring reconstruction;
* Any congenital or acquired discrepancy in breast size such as to represent a significant physical deformity.
* Adequate tissue available to cover implants.
* Saline-filled implants are not an appropriate choice.

Exclusion Criteria:

* Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy.
* Existing carcinoma of the breast, without mastectomy.
* Abscess of infection in the body at the time of enrollment.
* Pregnant or nursing.
* Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.
* Show tissue characteristics which are clinically incompatible with mammaplasty.
* Have, or under treatment for any condition which, in the opinion of the surgeon, may constitute an unwarranted surgical risk.
* Are not willing to undergo further surgery for revision, if medically required.
* Diagnosis of lupus or scleroderma.

Primary outcomes:
measure: Local Complications
timeFrame: 5 years
Secondary outcomes:
measure: Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale
timeFrame: 5 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
state: Indiana
Study officials:
References:
Clinical trial NCT02417727: Feasibility Study of Deep Brain Recordings for Learning and Memory
Official title: A Feasibility Study of Deep Brain Recordings for Learning and Memory
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Movement Disorders
Keywords: MEMORY TESTING
Biomarkers
Learning
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2015-04-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: Background:

- Some people with movement disorders are in another NIH protocol. They will have electrodes placed in deep brain areas. They may do tasks before, during, and after surgery. Researchers want to learn more about how brain cells and networks work while people learn and remember. They want to use the data from the other NIH study to do this.

Objective:

- To share data from before and during deep brain stimulation surgery. The data will be used in a study of how the brain learns and remembers.

Eligibility:

- People at least 18 years old who are in protocol 11-N-0211 and have certain movement disorders.

Design:

* As part of protocol 11-N-0211, data on participants brainwave activity is collected. In this protocol, they will have that data stored and shared.
* Researchers will access imaging data from deep brain stimulation surgery.
* Researchers will access other medical records.

Detailed description: OBJECTIVES:

The purpose of this protocol is to share neural data collected before and during deep brain stimulation surgery with the University of Pennsylvania to identify biomarkers of successful learning and memory.

STUDY POPULATION:

Up to twenty (20) adult subjects who are participating in NIH protocol 11-N-0211 Deep Brain Stimulation Surgery for Movement Disorders who provide written informed consent for sharing and the additional use of their data.

STUDY DESIGN:

This protocol only involves providing consent to share learning and memory data collected under Protocol 11-N-0211. There are no separate or additional participant procedures involved in this protocol.

Eligibility criteria: * INCLUSION CRITERIA:

Adults at least age 18

Currently enrolled in 11-N-0211

EXCLUSION CRITERIA:

Unable to provide own informed consent

Primary outcomes:
measure: Permission to share data from partiicpation on NIH protocol #11-N-0211
timeFrame: ongoing
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Institute of Neurological Disorders and Stroke (NINDS)
name: Kareem A Zaghloul, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06541327: Cellular Immunotherapy for Relapsed or Refractory Lymphoma Data Collection
Official title: Cellular Immunotherapy for Relapsed or Refractory Lymphoma Data Collection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma, Non-Hodgkin
Keywords: CAR-T
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with relapsed or refractory lymphoma receiving cellular immunotherapy

Brief summary: This study aims to collect clinical data from adult patients with relapsed or refractory non-Hodgkin's lymphoma (r/r NHL) receiving cellular immunotherapy to establish a large database of cellular immunotherapy for Chinese patients.

Detailed description: This study aims to collect efficacy and safety data from adult patients with r/r NHL who received cellular immunotherapy between January 2017 and December 2040. Study investigators will determine the most appropriate diagnostic and treatment plans for patients based on clinical practice, without any intervention due to the existence of this study. No grouping will be conducted, and subgroup analyses will be performed based on the collected data.

Data collection process:

Clinical data will be collected from patients before cellular immunotherapy, before immune cell infusion, on the day of infusion, and at the last visit or follow-up within 24 months post-infusion. This includes collecting efficacy data, adverse events related to cellular immunotherapy, and survival data. Additionally, any new tumors, pathological findings, and other relevant laboratory or auxiliary examination data will be collected.

Eligibility criteria: Inclusion Criteria:

* Adult patients with a confirmed diagnosis of r/r B-NHL (including r/r DLBCL, r/r FL, r/r MCL, HGBL-NOS, FL3b, r/r MZL, transformed lymphomas such as MCL) and r/r T-cell lymphoma, who have received informed consent waivers;
* Patients who have received or are receiving cellular immunotherapy, with cellular immunotherapy products including the following categories: cytokine-induced killer cell therapy (CIK), tumor-infiltrating lymphocytes (TIL), cytokine-induced killer cell-dendritic cell mixed therapy (DC-CIK), chimeric antigen receptor T cells, NK cells or macrophage therapy (CAR-T, CAR-NK, CAR-M), T-cell receptor chimeric T cell therapy (TCR-T), dendritic cell therapy.

Exclusion Criteria:

* NA

Primary outcomes:
measure: Complete Response (CR) Rate in 3 months
timeFrame: 3 months post CAR-T infusion
Secondary outcomes:
measure: Objective remission rate (ORR) in 3months
timeFrame: 3 months post CAR-T infusion
measure: Overall Survival (OS)
timeFrame: 2 years post CAR-T infusion
measure: Adverse events (AEs)
timeFrame: 2 years post CAR-T infusion
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Hematology, Shanghai Institute of Hematology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
References:
Clinical trial NCT05193773: Effects of a Multifactorial Intervention to Reduce Physical Restraints for Care Providers in Nursing Homes
Official title: The Effects of a Multifactorial Intervention to Reduce Physical Restraints for Care Providers in Nursing Homes: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Homes
Intervention
Older People
Keywords: care providers
restraints
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 354
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Scholars from around the world have been strongly advocating restraint-free care in long-term care institutions. Therefore, the aim of this study was to evaluate the effects of a multifactorial intervention to reduce physical restraints for care providers in nursing homes.

Detailed description: In Taiwanese nursing homes, the use of physical restraints on residents as a protective measure is fairly common. However, physical restraints can be seen as a violation of human rights, and there is no guarantee of the effectiveness or safety of such physical restraints.This study was to evaluate the effects of a multifactorial intervention to reduce physical restraints for care providers in nursing homes. A cluster randomized controlled trial was conducted using pretest-posttest control group design. A purposive sampling of participants was chosen from care providers of 6 nursing home institutions in Taiwan, who were then randomly assigned to the experimental group (3 nursing homes) or the control group (3 nursing homes). The experimental group underwent multifactorial interventions to reduce physical restraint.

Eligibility criteria: Inclusion Criteria:

* A full-time care provider
* Worked in a nursing home for more than three months
* Care providers have imposed physical restraints on elderly residents aged 60 or above Within the last month.

Exclusion Criteria:

• can't speak or read chinese, Vietnamese, Indonesian

Primary outcomes:
measure: knowledge
timeFrame: 8 minutes
measure: Attitudes
timeFrame: 8 minutes
measure: Behavior
timeFrame: 4 minutes
measure: physical restraint use
timeFrame: 1 minutes
Secondary outcomes:
measure: Restraint types
timeFrame: 1 minutes
measure: Multiple restraints
timeFrame: 1 minutes
measure: agitated and inappropriate behavior
timeFrame: 1 minutes
measure: Extubation rate
timeFrame: 1 minutes
measure: falls rate
timeFrame: 1 minutes
measure: psychotropic medication prescriptions
timeFrame: 1 minutes
measure: fall-related fractures
timeFrame: 1 minutes
Other outcomes:
Locations:
city: Miaoli
country: Taiwan
facility: Nursing Homes
Study officials:
name: Su-Hua Liang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05442073: Effect of Initial Empirical PEEP Setting on the Esophageal Pressure-guided PEEP Titration in ARDS
Official title: Effect of Initial Empirical Positive End-Expiratory Pressure (PEEP) Setting on the Esophageal Pressure-guided PEEP Titration in Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS, Human
PEEP, Occult
Esophageal and Pleural Pressure
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients all the moderate to severe ARDS with P/F\<200 no contraindication to esophageal catheter

Brief summary: Esophageal manometry was used as surrogate of pleural pressure to titrate positive end-expiratory pressure (PEEP) in ARDS patients. However, Absolute values of esophageal pressure (Pes) could be affected by the PEEP setting. In moderate to severe ARDS patients, the end-expiratory Pes changed differently with PEEP adjustment. and the esophageal phenotypes could be divided into type I and type II. with Type I （ΔPes≥30%ΔPEEP）and Type II（ΔPes\<30%ΔPEEP）.


Eligibility criteria: Inclusion Criteria:

- aged over 18 all the moderate to severe ARDS patients invasive mechanical ventilation

Exclusion Criteria:

* aged\<18 contraindication to esophageal catheter

Primary outcomes:
measure: the changes of esophageal pressure during the PEEP titration
timeFrame: March 1st to May 31st, 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Shuyang Zhang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01233973: Using Videos to Improve Understanding of the Delivery of End-of-life Medical Care in Non-hospital Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Keywords: nursing home
advance care planning
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2010-11-04
Enrollment: 101
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To compare the decision making of elderly subjects having a verbal advance care planning discussion compared to subjects using a video.

Detailed description: A.1. Aim 1: To recruit 101 subjects over the age of 64 who are newly admitted to a nursing home facility and randomly assign these subjects to one of two advance care planning (ACP) modalities: 1. a video visually depicting the Goals of Care (Life Prolonging Care, Limited Care, and Comfort Care) (intervention) or 2. a verbal narrative describing the Goals of Care (control) encountered if the subject becomes very ill.

Hypothesis 1: It is feasible to recruit and randomize newly admitted elderly subjects to each of the ACP modalities.

A.2. Aim 2: To compare the care preferences for their primary goal of care (i.e., life-prolonging care, limited care, or comfort care) among 101 subjects randomized to video vs. verbal narrative intervention for ACP.

Hypothesis 2: Subjects randomized to the video intervention will be significantly more likely to opt for comfort care (vs. life-prolonging or limited care) as the primary goal of care compared to those randomized to the verbal narrative.

A.3. Aim 3: To compare knowledge assessment of the Goals of Care of 101 subjects randomized to video vs. verbal narrative intervention for ACP.

Hypothesis 3: When compared to subjects randomized to the verbal narrative arm, subjects in the video group will have higher knowledge assessment scores when asked questions regarding their understanding of the Goals of Care.

Eligibility criteria: Inclusion Criteria:

* over age of 64
* have decision making capacity

Exclusion Criteria:

* do not speak English

Primary outcomes:
measure: preference for medical care
timeFrame: 5 minutes after the survey
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH
state: Massachusetts
Study officials:
affiliation: MGH
name: Angelo Volandes
role: PRINCIPAL_INVESTIGATOR
References:
citation: Volandes AE, Brandeis GH, Davis AD, Paasche-Orlow MK, Gillick MR, Chang Y, Walker-Corkery ES, Mann E, Mitchell SL. A randomized controlled trial of a goals-of-care video for elderly patients admitted to skilled nursing facilities. J Palliat Med. 2012 Jul;15(7):805-11. doi: 10.1089/jpm.2011.0505. Epub 2012 May 4.
Clinical trial NCT01635673: Effects of Whole Body Vibration Exercise on Metabolic Systems in Latino Boys
Official title: Effects of Whole Body Vibration Exercise on Metabolic Systems in Latino Boys
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of Whole Body Vibration Exercise on Metabolic Systems
Keywords: Exercise
Latino
Hispanic
Boys
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2012-07-09
Enrollment: 20
Sex: MALE
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if whole body vibration exercise improves insulin/glucose dynamics and bone metabolism in Latino Boys.


Eligibility criteria: Inclusion Criteria:

* Boy 8-10 years of age
* Tanner Stage I
* Age and gender BMI \> 85th percentile
* Hispanic descent( all four grandparents of Hispanic descent)

Exclusion Criteria:

* Acute or chronic illness
* Any condition known to influence body composition, or insulin/glucose dynamics
* Musculoskeletal disease, injury, or orthopedic condition that would prevent exercise

Primary outcomes:
measure: Blood insulin
timeFrame: Baseline and week 10
Secondary outcomes:
measure: Bone Density
timeFrame: Baseline and week 10
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Biokinesiology and Physical Therapy, Clinical Exercise Research Center
state: California
Study officials:
affiliation: University of Southern California
name: Todd Schroeder, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01410773: User Performance Evaluation of an Investigational Blood Glucose Monitoring System
Official title: Ninja 2 User Performance Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2011-08-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to demonstrate that untrained subjects with diabetes can use an investigational Blood Glucose Monitoring System (BGMS) with capillary blood obtained from fingerstick and from Alternative Site (AST) Palm .


Eligibility criteria: Inclusion Criteria:

* Males and females, 18 years of age and above
* Diagnosed as having type 1 or type 2 diabetes
* Currently self-testing blood glucose at home
* Able to speak, read, and understand English
* Willing to complete all study procedures

Exclusion Criteria:

* Blood Borne infections like hepatitis or HIV or infections such as tuberculosis
* Hemophilia or any other bleeding disorder
* Employee of competitive medical device company,immediate family member of such, or living within the household of such
* Pregnancy

Primary outcomes:
measure: Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL(<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
Secondary outcomes:
measure: Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
Other outcomes:
Locations:
city: Mishawaka
country: United States
facility: Bayer HealthCare LLC, Diabetes Care
state: Indiana
Study officials:
affiliation: Ascensia Diabetes Care
name: David Simmons, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00520273: A Prospective Study to Evaluate the Specificity of the Cobas TaqScreen MPX Test for Use on the Cobas s 201 System for Screening Plasma Pools From Source Plasma Donors for the Presence of HBV DNA, HCV RNA, and HIV-1 RNA
Official title: A Prospective Study to Evaluate the Specificity of the Cobas TaqScreen MPX Test for Use on the Cobas s 201 System for Screening Plasma Pools From Source Plasma Donors for the Presence of HBV DNA, HCV RNA, and HIV-1 RNA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-08-23
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will evaluate the specificity of the cobas TaqScreen MPX Test for the simultaneous detection of HBV DNA, HCV RNA and HIV-1 Group M in a minimum of 100,000 individual donor samples in 96-unit pools.


Eligibility criteria: Inclusion Criteria:

* Healthy adults 18-65 years of age
* Fulfil criteria for plasma donation

Exclusion Criteria:

* Do not fulfil criteria for plasma donation

Primary outcomes:
measure: Source plasma donors were screened for the presence of HIV-1 RNA, HBV DNA, and/or HCV RNA
timeFrame: Study duration
Secondary outcomes:
Other outcomes:
Locations:
city: Boca Raton
country: United States
state: Florida
city: Raleigh
country: United States
state: North Carolina
city: Memphis
country: United States
state: Tennessee
Study officials:
affiliation: Roche Molecular Systems, Inc
name: Rainer Ziermann
role: STUDY_DIRECTOR
References:
Clinical trial NCT02623673: Simultaneous Therapy With Intravitreal Dexamethasone Implant and Bevacizumab for the Treatment of Macular Edema
Official title: Simultaneous Therapy With Intravitreal Dexamethasone Implant and Bevacizumab for the Treatment of Macular Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Edema
Lead sponsor: Retina Clinic, Sao Paulo, Brazil
Sponsor class: OTHER
First posted: 2015-12-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with macular edema

Brief summary: Retrospective cases series is a non-randomized, open-label, single-center investigation (Retina Clinic, São Paulo, Brazil) of patients diagnosed with macular edema secondary to diabetic retinopathy (DME) and retinal vein occlusions who underwent to simultaneous treatment with intravitreal injection of bevacizumab 1.25mg and implant of dexamethasone 0.7mg.

Detailed description: This retrospective cases series is a non-randomized, open-label, single-center investigation (Retina Clinic, São Paulo, Brazil) approved by the Institutional Review Board of Hospital Oftalmológico de Sorocaba/SP, and adhered to the tenets of the Declaration of Helsinki. Were included patients older than 18 years, treated between April 2014 and July 2015, diagnosed with macular edema secondary to diabetic retinopathy (DME) and retinal vein occlusions who underwent to simultaneous treatment with intravitreal injection of bevacizumab 1.25mg (Avastin; Genentech, South San Francisco, CA) and intravitreal implant of dexamethasone 0.7mg (Ozurdex; Allergan, Inc, Irvine, CA).

Eligibility criteria: Inclusion Criteria:

* central macular thickness \> 300 µm on optical coherence tomography (OCT)
* macular edema secondary to diabetic retinopathy (DME) and retinal vein occlusions

Exclusion Criteria:

* intravitreal anti-VEGF within 6 weeks
* treatment with laser or intravitreal corticosteroids within 3 months of study entry.

Primary outcomes:
measure: Improvement in BCVA
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Retina Clinic / UNIFESP
Study officials:
References: