louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06798298: A Safety and Efficacy Long-Term Follow-up Study of Adult Participants Treated With Gene Modified T Cells
Official title: A Long-Term Follow-up Protocol for Participants Treated With Gene Modified T Cells
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Long Term Safety Following GM T Cell Therapy
Keywords: GM T cell therapy
Replication Competent Lentivirus (RCL)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2025-01-29
Enrollment: 50
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: Enrolled participants will be determined by the number of participants participating in GM T cell 2seventy bio (prior to April 2024) and Regeneron Pharmaceuticals sponsored studies consenting to participate in the LTFU study.

Brief summary: This is a prospective study for the Long-Term Follow-Up (LTFU) of safety and efficacy of all participants exposed to gene modified (GM) T cell therapy in accordance with Health Authorities' guidance for participants treated with gene therapy products.

Participants who received at least one infusion of gene modified T cells in a 2seventy bio (prior to April 2024) or Regeneron Pharmaceuticals sponsored study will be asked to participate in this LTFU protocol, upon either premature discontinuation from, or completion of the parent treatment protocol.

Participants enrolled in this LTFU protocol will have safety assessments, laboratory evaluations, and complete patient-reported outcome (PRO) questionnaires at scheduled intervals as applicable.


Eligibility criteria: Inclusion Criteria:

1. All participants who received at least one GM T cell infusion in a previous 2seventy bio (prior to April 2024) or Regeneron Pharmaceuticals sponsored study, and have completed the post-treatment follow-up period on the parent treatment protocol, or discontinued follow-up on the parent protocol after completing at least 6 months of safety monitoring, as applicable.
2. Participant (and legal representative, when applicable) must understand and voluntarily sign an Informed Consent Form (ICF)/Informed Assent Form (IAF) prior to any study related assessments/procedures being conducted.

Exclusion Criteria:

Not applicable.

Primary outcomes:
measure: Incidence of delayed adverse events considered at least possibly related to prior gene modified T cell therapy
timeFrame: Up to 15 years
measure: Persistence of gene modified T cells
timeFrame: Up to 15 years
measure: Analysis of vector integration sites
timeFrame: Up to 15 years
measure: Incidence of RCL
timeFrame: Up to 15 years
measure: Disease progression status
timeFrame: Up to 15 years
measure: Date of disease progression
timeFrame: Up to 15 years
measure: Survival status
timeFrame: Up to 15 years
Secondary outcomes:
measure: Health-Related Quality of Life (HRQoL) Changes
timeFrame: Up to 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT00711698: Comparison of Patient Controlled Analgesia (PCA) Versus Bolus Narcotic Therapy for the Treatment of Vaso-Occlusive Crisis (VOC)
Official title: PCA for Pain Control in Adults With Sickle Cell Disease in the Emergency Department (ED) Decreases Admission Rates Over Standard Bolus Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Sickle Cell Disease
Vaso-occlusive Crisis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2008-07-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research is being done to find out the best way to give narcotics for pain relief in adults with sickle cell disease and painful crisis. This study is a comparison of two ways of giving narcotics. The first way is what occurs now in the Emergency Acute Care Unit (EACU) where patients are given a single intravenous (iv) dose of a narcotic which is repeated by the nurse as needed to control the pain. The second way is to provide a single iv dose of narcotic and then allow the patient to push a button and receive one or more additional doses of narcotic when he/she thinks it is needed. Our hypothesis is that PCA will be a more effective way of controlling pain.


Eligibility criteria: Inclusion Criteria:

* Documented sickle cell disease
* Signed consent in outpatient clinic or during a prior hospitalization
* 18+ years of age
* Seen in the ED with sickle cell pain crisis - this will be based on patients chief complaint that they are in a VOC.
* Requires IV administration of narcotics (has failed oral narcotic therapy at home)
* Must be 2 weeks since their last randomization on this study.

Exclusion Criteria:

* Contraindication to the use of IV narcotics
* Hypotension with systolic blood pressure (SBP) ≤ 90
* Respiratory rate ≤9
* Altered mental status
* Patient unable to understand how to use the PCA device
* Patient unwilling to use PCA device
* Pulse oximeter reading of ≤ 94% on room air
* Patient is allergic to IV morphine \& hydromorphone \& fentanyl.
* Patient is allergic to oral hydromorphone \& morphine \& oxycodone
* Patient has been randomized on this study 3 times before

Primary outcomes:
measure: Decrease in admissions for those treated with a PCA in the ED v those that are given bolus narcotic dosing
timeFrame: Measured at time of discharge from ED
Secondary outcomes:
measure: Length of stay
timeFrame: Endpoints will be the time at which the decision for discharge from the EACU or transfer from the EACU to inpatient admission to the hospital is made
measure: Total narcotic used
timeFrame: Endpoints will be the time at which the decision for discharge from the EACU or transfer from the EACU to inpatient admission to the hospital is made
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Sophie Lanzkron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00215098: Chylothorax Following Heart Surgery
Official title: Chylothorax in Children Following Congenital Heart Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chylothorax
Keywords: pediatric health
cardiac
congenital heart surgery
post-operative chylous effusions
heart defects
children
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the congenital surgery database

Brief summary: The purpose of this study is to determine at risk populations for certain congenital heart defects or certain operative procedures and to define the associated morbidity secondary to chylothorax - prolonged chest tube drainage, prolonged hospital stay, need for central access and hyperalimentation, subsequent infection.

Detailed description: Chylothorax is not uncommon following congenital heart surgery. It often results in prolonged chest tube drainage and hospital stays. Due to the feeding difficulties, it often results in malnutrition and the need for central hyperalimentation. In addition, it results in a depressed immune system with the possibility of subsequent infection. Chylothorax can be a significant contributor to post-operative morbidity and mortality.

The primary aims are to determine at risk populations - certain congenital heart defects or certain operative procedures, to define the associated morbidity secondary to chylothorax - prolonged chest tube drainage, prolonged hospital stay, need for central access and hyperalimentation, subsequent infection and to review our current treatment methods - change formulas, hyperalimentation, somatostatin. The secondary aims are to determine ways to prevent chylothorax, determine the most successful treatment method, and to discover better treatment methods. This study will be conducted through a retrospective chart review.

Eligibility criteria: Inclusion Criteria:

* Patients in the congenital surgery database
* patients have developed post-operative chylous effusions

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Egleston
state: Georgia
Study officials:
affiliation: Emory University
name: Brian Kogon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06996145: Study of the Isometry of the Anterior Cruciate Ligament From the Center of the Native MRI Insertion Reported on Dynamic Scanner
Official title: Study of the Isometry of the Anterior Cruciate Ligament From the Center of the Native MRI Insertion Reported on Dynamic Scanner
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament (ACL)
Reconstruction
Software
Keywords: anterior cruciate ligament
reconstruction
software
planning
tunnel
isometry
navigation
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In anterior cruciate ligament (ACL) reconstruction, navigation and robotic assistance now provide the possibility of precise positioning of the tunnels.

The challenge is therefore to carry out isometric preoperative planning which can be carried out with robotic or navigation assistance.

In the classic reconstruction technique this isometry is assumed by positioning the tunnels on the center of the native ACL footprints. However, studies cast doubt on this hypothesis.

In this work, the investigators will study the isometry of the center of the native footprints on a dynamic 4D scanner in order to obtain the variation in the distance between the centers of the native footprints during a knee flexion cycle.

This study is part of a larger project. the objective is, if the absence of isometry of the center of the native impressions is confirmed, to develop software assistance which will help the surgeon plan preoperatively an isometric reconstruction. The hypothesis is that the techniques based on the center of the native footprints does not allow isometric reconstruction.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers aged 18 or older
* Signed informed consent
* Affiliation to a social security system
* Negative pregnancy test for women of childbearing age

Exclusion Criteria:

* Volunteer having already undergone knee ligament reconstruction or having peri- or intra-articular knee fractures
* Volunteers for whom ligamentoplasty would not have been the therapeutic option chosen in the event of an ACL rupture
* Pregnant woman
* Volunteer under guardianship or curators, under the protection of justice or deprived of public law.
* Minor volunteer
* Contraindication to MRI or scanner

Primary outcomes:
measure: variation in length of the ACL
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHRU Amiens
Study officials:
References:
Clinical trial NCT02871245: Clinical Trial on Acupuncture Therapy in Patients With Gastrointestinal Neoplasms Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Neoplasms
Keywords: Acupuncture Therapy
Laparoscopic Surgery
Gastrointestinal Tract Recovery of Function
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients accepted laparoscopic radical operation for carcinoma of colon and upper middle section of the rectum will be as the research object. Cancer patients are diagnosed based on pathology or cell biology. The trial is randomized, parallel and open. They are randomized into 2 groups: both groups receive surgery. The experimental group receives conventional treatment combine with electroacupuncture Zusanli point .etc finish operation and the contrast receives the same conventional treatment with experimental group. Clinical evaluation includes gastrointestinal tract recovery of function, pain relief, life quality improvement. Blood biochemistry tests mainly include gastrin(GAS), stress related hormone, peroxidatic reaction and the ratio of immune cells.


Eligibility criteria: Inclusion Criteria:

* Weight: 40kg-90kg, male and female.
* Diagnosis: imaging, cell and pathology report.
* Brain, heart, lung, liver, kidney are at good condition in 2 weeks before surgery.
* No conscious obstacle and limbs disability.

Exclusion Criteria:

* Fainting during acupuncture.
* Electrolyte imbalance.
* Serious and life-threatening complications after surgery.
* In addition, patients taking part in other clinical trials, being treated with other biotherapy or immunotherapy and researchers consider not suitable for clinical subjects for other reasons will be excluded.

Primary outcomes:
measure: Number of participants and classification with operation-related adverse events as assessed by CTCAE v4.03.
timeFrame: day 1, day 3, day 5, day 7 after surgery
Secondary outcomes:
measure: The quality of life questionnaire(QLQ).
timeFrame: day 1, day 3, day 5, day 7 after surgery
measure: Stress hormone in blood.
timeFrame: day 2, day 7 after surgery
measure: Immune cell number ratio in blood.
timeFrame: day 2, day 7 after surgery
Other outcomes:
Locations:
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
Study officials:
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Xiaonan Cui, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01913145: Comparison Study of Lay Person Finger Stick Versus Blood Draw
Official title: Usability and HbA1c Method Comparison Study Using Lay Person Micro-Blood Specimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Lead sponsor: Home Access Health Corporation
Sponsor class: INDUSTRY
First posted: 2013-07-31
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood taken from the arm vein).

Detailed description: This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood taken from the arm vein). The information and data obtained will be used to finish development of a convenience kit that allows doctors to provide their patients a method to have their blood tested for clinical laboratory tests in the convenience of their home without having to visit the doctor's office or clinic.

Eligibility criteria: Inclusion Criteria:

1. Ability to understand and follow verbal and written instructions in English
2. Demonstrate a willingness to participate by providing a written informed consent
3. Aged between 18 to 80 years of age with no obvious signs of illness (e.g. fever, vomiting)
4. Diabetics who were diagnosed 6 months ago or longer are preferred. However, non-diabetics will be accepted into the study.

Exclusion Criteria:

1. Withdrawn informed consent
2. Mental or physical impairment which would preclude participation
3. Any condition which, in the opinion of the Principle Investigator or site or study coordinator, makes the participant unsuitable for this study. This includes but is not limited to any mental or physical impairment, which would preclude provision of adequate and knowledgeable consent.

Primary outcomes:
measure: Usability and HbA1c Method Comparison Study Using Lay-Person Micro-Blood Specimens
timeFrame: Outpoint measured within 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: Mills-Peninsula Health Services
state: California
city: Louisville
country: United States
facility: L-MARC
state: Kentucky
Study officials:
affiliation: Mills-Peninsula Health Services Dorothy L. and James E. Frank Diabetes Research Institute 100 South San Mateo Drive San Mateo, California 94401
name: David Klonoff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: L-MARC, 3288 Illinois Ave., Louisville, KY
name: Harold E. Bayes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03202745: The Effect of Informative Letters on the Prescription and Receipt of Opioids
Official title: The Effect of Informative Letters on the Prescription and Receipt of Opioids
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Economics
Fraud
Delivery of Health Care
Health Expenditures
Prescribing
Centers for Medicare and Medicaid Services (U.S.)
Lead sponsor: Abdul Latif Jameel Poverty Action Lab
Sponsor class: OTHER
Collaborators: name: Centers for Medicare and Medicaid Services
name: General Services Administration (GSA)
First posted: 2017-06-29
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Inappropriate prescribing exposes patients to health risks and results in wasteful public expenditures. This study will evaluate an approach to fighting abusive prescription: sending letters to suspected potentially inappropriate prescribers warning them that they are outliers compared to their peers and have been flagged for review. The study will target high prescribers of opioids in the Schedule II controlled substances class. Two types of letters will be tested: one focusing on the health consequences of inappropriate prescribing for patients, and the other focusing on the consequences for prescribers including e.g. potential administrative actions. Using claims data, the investigators will assess the effect of the letters on prescribing of opioids, receipt of opioids by patients, substitution behavior by prescribers and patients, and health outcomes of patients.


Eligibility criteria: Inclusion Criteria:

* Outlier with respect to prescribing of Schedule II opioids relative to peers, measured in prescription drug events (PDE), in 2014Q3-2015Q2 and 2015Q3-2016Q2
* Outlier with respect to prescribing of Schedule II opioids relative to peers, measured in 30-day equivalents, in 2014Q3-2015Q2 and 2015Q3-2016Q2

Exclusion Criteria:

* Deceased
* Fewer than 75 Schedule II Opioid PDE in 2015Q3-2016Q2
* Specialty listed as "Student in an Organized Health Care Education/Training Program"

Primary outcomes:
measure: Morphine Milligrams Equivalent (MME)
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University
name: Adam Sacarny, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04648345: Efficacy and Safety of Erector Spinal Plane Block (ESPB) for Analgesia in Laparoscopic Cholecystectomy
Official title: Efficacy and Safety of Erector Spinal Plane Block (ESPB) for Intraoperative and Postoperative Analgesia in Laparoscopic Cholecystectomy : A Randomized, Single-blind，Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia
Keywords: erector spinal plane block
analgesia
laparoscopic cholecystectomy
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, single-blinded, controlled clinical trial
Primary purpose: TREATMENT

Brief summary: Purpose: to evaluate the efficacy and safety of erector spinal block (ESB) for analgesia in laparoscopic cholecystectomy（LC）.

Method: This study is a randomized, single-blind, controlled clinical trial. Pre-operative ultrasound-guided bilateral erector spinae plane block will be performed in the ESPB group. Vertebral side block will be performed in the VSB group. And the control group will receive local anaesthesia after the surgery. Intraoperative and postoperative analgesia effect and side effects will be compared between the three groups.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1-3
* Scheduled for elective laparoscopic cholecystectomy surgery under general anesthesia

Exclusion Criteria:

* patient refusal
* pregnancy
* history of allergy to study drugs
* neurological and cognitive disorders
* coagulopathy
* chronic pain disorders
* infections at the injection site
* history of abdominal surgery

Primary outcomes:
measure: Pain intensity at rest(Hour 2)
timeFrame: Hour 2
measure: Pain intensity at rest (Hour 6)
timeFrame: Hour 6
measure: Pain intensity at rest (Hour 24)
timeFrame: Hour 24
Secondary outcomes:
measure: The overall dose of remifentanil
timeFrame: During the surgery
Other outcomes:
Locations:
Study officials:
References: