louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03532516: Compassionate Use Program With Brivaracetam for the Treatment of Patients With Epilepsy
Official title: Compassionate Use Program With Brivaracetam for the Treatment of Patients With Epilepsy
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Epilepsy
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2018-05-22
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This Compassionate Use Program (CUP) is setup to provide study patients with continuous access to Brivaracetam (BRV) for the time period between closures of the long-term follow up studies N01125, N01199, N01372, N01379, and N01315 and when BRV is commercially available.


Eligibility criteria: Inclusion Criteria:

* Patients with epilepsy who are participating in Brivaracetam (BRV) studies N01125, N01199, N01372, N01379 or N01315
* Patients for whom the treating physician believes there is a continued benefit from the long-term administration of BRV and other anti-epileptic therapies might not be suitable for the patient
* Female patients without childbearing potential are eligible
* Female patients with childbearing potential are eligible if they use a medically accepted contraceptive method for the duration of the Compassionate Use Program (CUP) participation. The patient must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive methods, and inform the treating physician of any potential change in status
* Patient is considered reliable and capable of adhering to medication intake.
* Patient is informed of the details of this CUP, is given ample time and opportunity to ask questions and consider his/her participation in this CUP, and the patient or the legally authorized representative (LAR) has provided verbal consent to participate, and, if required under local regulations, has given written informed consent

Exclusion Criteria:

* Severe medical, neurological and psychiatric disorders, including current suicidal ideation or behavior, or laboratory values which may have an impact on the safety of the patient, as determined by the treating physician
* Poor compliance with medication intake in the previous BRV study
* Participation in any clinical study of another investigation drug or device during the CUP
* Pregnant or lactating woman

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
Clinical trial NCT03539016: Observational Study on Pregnant Women With Chronic Hepatitis B and Their Infants
Official title: Epidemiological Study on Clinical Features of Chronic Hepatitis B Virus Infection During Pregnancy and Hepatitis B Virus Mother-to-child Transmission (Shield Study Phase Ⅰ)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B, Chronic
Keywords: Chronic hepatitis B, Mother-to-child transmission
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Tigermed Consulting Co., Ltd
First posted: 2018-05-29
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant woman

Brief summary: The study was conducted to observe the clinical features during pregnancy in women with chronic hepatitis B virus infection and mother-to-child transmission of hepatitis B virus.


Eligibility criteria: Inclusion Criteria:

1. Gestation of 4-32 weeks
2. HBsAg+ \> 6 months, HBeAg+/-
3. Informed consent signed voluntarily
4. Good compliance and able to be followed up as planned

Exclusion Criteria:

1. Coinfection with hepatitis C virus or human immunodeficiency virus;
2. Comorbidities of other severe conditions that hinder compliance with follow ups and because of that, the subjects are anticipated to be unable to complete the project.;
3. Unable or unwilling to use mobile health tools.

Primary outcomes:
measure: Rate of mother-to-child transmission
timeFrame: Infants from 7 to 12 months of age
measure: Rate of hepatitis flare during pregnancy and postpartum
timeFrame: up to postpartum weeks 6-8
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Beijing
country: China
facility: 302 military hospital of China
city: Beijing
country: China
facility: Beijing YouAn Hospital
city: Guangzhou
country: China
facility: Fifth Affiliated Hospital of Southern Medical University
city: Guangzhou
country: China
facility: Guangzhou No. 8 People's Hospital
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Southern Medical University
city: Guangzhou
country: China
facility: Zhujiang Hospital
city: Jiujiang
country: China
facility: Jiujiang Maternal and Child Care Service Centre
city: Jiujiang
country: China
facility: Third Hospital of Jiujiang
city: Nanjing
country: China
facility: Second Hospital of Nanjing
Study officials:
References:
Clinical trial NCT05100316: Screening Protocol for Preliminary Eligibility Determination for Adoptive Cell Therapy Trials
Official title: A Screening Protocol to Support Preliminary Eligibility for Clinical Trials Evaluating Safety and Efficacy of Adoptive Cell Therapies in Participants With Solid Tumors and Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neoplasms
Keywords: Adoptive T-cell therapy
Hematologic Malignancy
Human leukocyte antigen
Screening study
Solid Tumors
T-cell receptors
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2021-10-29
Enrollment: 16
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This screening study is intended to determine preliminary eligibility of participants who may be potential candidates for GlaxoSmithKline's Adoptive T-cell therapy studies by screening for appropriate biomarkers. No treatment intervention will occur as part of this screening study.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of locally advanced high-risk eligible tumor types .
* Participant must be greater than or equal to (\>=)18 years of age (or \>=10 years of age with synovial sarcoma or myxoid/round cell liposarcoma \[MRCLS\])
* Participants with life expectancy of greater than 6 months
* Performance status: Eastern Cooperative Oncology Group 0-1.

Exclusion Criteria:

* Any prior treatment with oncology cell and/or gene therapy (unless agreed in advance with Sponsor)
* Prior malignancy not in complete remission.
* Clinically significant systemic illness
* Serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction,
* Prior or active demyelinating disease
* Previous New-York Esophageal Antigen-1 (NY-ESO-1)-specific T cells, NY-ESO-1 vaccine, or NY-ESO-1 targeting antibody.
* Previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant.

Primary outcomes:
measure: Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status
timeFrame: Up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: GSK Investigational Site
state: Florida
city: Waterloo
country: United States
facility: GSK Investigational Site
state: Iowa
city: Springfield
country: United States
facility: GSK Investigational Site
state: Missouri
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03808116: Evaluation of the SmartBx System for Breast Biopsy
Official title: Evaluation of the SmartBx System for Breast Biopsy Download While Keeping the Orientation, Unfolding and Unity of the Sample
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast biopsy
Lead sponsor: UC Care, Ltd.
Sponsor class: INDUSTRY
First posted: 2019-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Performance evaluation of a novel, semi-automated device and method for needle core biopsy download compared to standard methods in terms of:

3. Biopsy core length obtained (i.e. collecting all tissue fragments) 4. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)

Detailed description: Examination procedure:

* Biopsy cores will be collected from the breast during US guided biopsy procedure.
* The number of cores taken will be decided per the physician discretion according to the clinical demand.
* Additional two biopsy core will be taken the SmartBx cassette. Since the SmartBx cassette holds two biopsies together, two consecutive cores will be collected using the SmartBx.
* samples will be photographed for measurements in 2 steps during the process:

  1. On the needle notch \[A\].
  2. On the glass slide \[B\].
* Standard tissue fixation, processing of the samples in paraffin will be performed unchanged per the pathology laboratory protocols.
* Embedding of the biopsy cores taken with the SmartBx will be embedded using the SmartBx mold and tamper.
* Standard staining and histology analysis will be preformed to the sectioned samples, unchanged per the pathology protocols.

  • Analysis will be preformed to the histological results, and a comparison between the standard procedures samples to the SmartBx samples will be performed in terms of -
* Biopsy core length obtained (i.e. collecting all tissue fragments)
* Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Planned for breast biopsy procedure.
* Signed informed consent.

Exclusion Criteria:

o Patient's unwilling to participate.

Primary outcomes:
measure: biopsy core length
timeFrame: 1 month
measure: biopsy core yield
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek medical center
state: North Region
Study officials:
References:
Clinical trial NCT00981916: Ultrasound Determination of Needle Depth in Epidurals in Adult Patients
Official title: Ultrasound Determination of Needle Depth in Lumbar and Thoracic Epidurals in Adult Non-Parturient Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesia, Epidural
Surgery
Keywords: determination of depth to epidural space using ultrasound
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-09-22
Enrollment: 42
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 patient population will include all non parturients above the age of 18 who are candidates for epidural placement prior to surgery

Brief summary: The introduction of local anesthetics and other medications into the epidural space is a principal technique in provision of anesthesia in many procedures. Typically the anesthetist accesses the epidural space blindly using palpation and visualization of external landmarks and then uses a needle to get to the epidural space. The investigators propose a prospective study of use of ultrasound in a large heterogeneous group of surgical candidates to define the relationship between the actual needle depth (ND) to the epidural space and measured ultrasound depth (UD). Establishing correctly the depth to the epidural space via ultrasound is a component of ultrasound imaging that might improve current technique, and might lead to faster performance of the epidural. Use of ultrasound may also improve the efficacy and safety of epidural placement.

The null hypothesis of this study is that ultrasound depth is similar to the needle depth in adult non parturient patients undergoing lumbar and thoracic epidurals. A parturient in this case is defined as a female currently near or going through labor.


Eligibility criteria: Inclusion Criteria:

* The patient population will include all non parturients above the age of 18 who are candidates for epidural placement prior to surgery.

Exclusion Criteria:

* Parturients, prisoners and patients younger than 18 years old will be excluded from this study.

Primary outcomes:
measure: Ultrasound depth
timeFrame: At time of exam
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
References:
Clinical trial NCT00447616: Prostatectomy Prospective Database
Official title: Prostatectomy Database
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Prostatectomy
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2007-03-15
Enrollment: 896
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having prostatectomy or cryosurgery for the treatment of prostate cancer at William Beaumont Hospital.

Brief summary: The purpose of establishing the database is to evaluate the effects of surgical removal of the prostate (prostatectomy) and cryosurgery on prostate cancer, quality of life, and overall health.

Detailed description: The purpose of establishing the database is to evaluate the effects of surgical removal of the prostate (prostatectomy) and cryosurgery on prostate cancer, quality of life, and overall health. Participation in the study will allow collection of medical information related to prostate cancer treatment from hospital and doctor's office records. Questionnaires will be completed reflecting bladder, bowel, and sexual function, and quality of life at three, six, twelve, eighteen, and twenty-four months after surgery, and yearly thereafter.

Eligibility criteria: Inclusion Criteria:

* males greater than 18 years of age
* patients having prostatectomy or cryosurgery for the treatment of prostate cancer at William Beaumont Hospital.

Exclusion Criteria:

* dementia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Kenneth M Peters, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00237016: Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever
Official title: Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Relapsing Fever, Tick-borne
Jarisch Herxheimer Reaction
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2005-10-12
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Abstract Background Tick-Borne Relapsing Fever (TBRF) is an acute febrile illness. In Israel, TBRF is caused by Borrelia persica and is transmitted by Ornithodoros tholozani ticks. We examined the safety and efficacy of a post exposure treatment policy to prevent TBRF.

Methods In a double blind, placebo controlled trial 93 healthy volunteers with suspected tick exposure (51 with bite signs and 42 contacts) were randomly assigned to receive either Doxycycline (200 mg for the first day and 100mg/d for 4 days) or placebo, approximately 2 days after contact. Blood smears were examined for Borrelia at inclusion and during fever rise. Serology for Lyme disease cross- reactivity and PCR for Borrelia GlpQ gene were also performed. Cases of TBRF were defined as subjects having fever and a positive blood smear.


Eligibility criteria: Inclusion Criteria:

* suspected exposure to tick-borne relapsing fever
* after returning from field exercise in a tick-borne relapsing fever infected area
* having a tick bite or staying in field in close proximity to a subject with tick bite sign

Exclusion Criteria:

* known sensitivity to tetracycline or doxycycline
* febrile illness on recruitment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Israel Defence Forces
Study officials:
affiliation: Medical corps, Israel Defence Forces
name: Tal Hasin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nadelman RB, Nowakowski J, Fish D, Falco RC, Freeman K, McKenna D, Welch P, Marcus R, Aguero-Rosenfeld ME, Dennis DT, Wormser GP; Tick Bite Study Group. Prophylaxis with single-dose doxycycline for the prevention of Lyme disease after an Ixodes scapularis tick bite. N Engl J Med. 2001 Jul 12;345(2):79-84. doi: 10.1056/NEJM200107123450201.
citation: Hasin T, Davidovitch N, Cohen R, Dagan T, Romem A, Orr N, Klement E, Lubezky N, Kayouf R, Sela T, Keller N, Derazne E, Halperin T, Yavzori M, Grotto I, Cohen D. Postexposure treatment with doxycycline for the prevention of tick-borne relapsing fever. N Engl J Med. 2006 Jul 13;355(2):148-55. doi: 10.1056/NEJMoa053884.
Clinical trial NCT00750516: Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet
Official title: Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hypotension
Sepsis
Keywords: Lactic acid
hypotension
sepsis
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2008-09-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypotensive, non pregnant by history, Emergency Medicine patients

Brief summary: This study seeks to determine whether the Lactic Acid blood level in a critically ill patient must be drawn with a non-tourniquet venipuncture. The null hypothesis is that there is no significant difference in Lactic Acid blood level in critically ill patients in a sample taken from either with a tourniquet or a non-tourniquet veni-puncture.

Monitoring of Lactic acid level is helpful in both identifying potentially serious ill patients as well as identifying in the ICU patients with high morbidity and mortality.

When a patient arrives to an Emergency Department and that patient is hypotensive (BP less than or equal to 90 systolic), the nursing staff often starts an IV and if possible draws the patient's initial blood tests off that first IV site; or if the patient has had an IV started in the field by EMS, the nursing staff will draw blood from another site using a tourniquet. This initial work up by the nursing staff takes 15 -20 minutes before a physician may see the patient. Since the present standard Lactic Acid test must be drawn either by arterial puncture or venipuncture without a tourniquet, this test is rarely done as part of their (the RNs) initial blood draws.

This simple impediment of needing to repeat the venipuncture without a tourniquet, especially in patients who often have venous access difficulty, delays the identification of appropriate patients for early and aggressive management- particularly those with sepsis.

Our hypothesis is that this requirement for a non-tourniquet blood draw is unnecessary.


Eligibility criteria: Inclusion Criteria:

* Blood pressure systolic of 90 or less
* Non pregnant by history

Exclusion Criteria:

* Pregnant by history
* Comfort care only

Primary outcomes:
measure: Differences in hypotensive patients between the use of a tourniquet and non tourniquet sampling for Lactic Acid level.
timeFrame: At the initial evaluation of the patient
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Upstate Hospital Emergency Department
state: New York
Study officials:
affiliation: Emergency Medicine Department ofUpstate Hospital
name: Mark Barasz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03065296: Standardized Home Exercise Prescription Education
Official title: Standardized Home Exercise Prescription: Education of Family Medicine Residents
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Behavior
Knowledge, Attitudes, Practice
Keywords: Behavior
education
medical residents
knowledge
confidence
skills assessment
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This project will encompass an evaluation of the educational value of having evidence based home exercise protocols available for family medicine residents in regard to the prescription of home exercise treatment for common musculoskeletal conditions. Investigators will be evaluating resident knowledge on home exercise prescription as well as their level of comfort in educating their patients before and after a series of didactic sessions and implementation of exercise protocols.

Detailed description: This study aims to fill the gap in this area of the literature pertaining to home exercise prescription. The justification of this study's scientific merit comes from the lack of literature and the need for research in this area. There have been multiple studies that have shown different exercise modality treatments for common musculoskeletal (MSK) complaints significantly improve both disability and overall quality of life. Despite the evidence of the short and long term effectiveness of exercise based therapies, there is a general lack of confidence of residents in prescribing and teaching patients rehab exercises.Additionally, many of the patients seen in the University of Florida (UF) Family medicine residency program cannot afford or do not have time to attend physical therapist led rehab sessions. This makes physician led education and the ability of prescribing exercise based treatments for musculoskeletal (MSK) complaints a very important component of patient care.

Eligibility criteria: Inclusion Criteria:

* Resident of the Family Medicine Department at the University of Florida.

Exclusion Criteria:

* None

Primary outcomes:
measure: Improvement in knowledge about Musculoskeletal (MSK) Exercises
timeFrame: at 6 months
measure: Confidence in educating patients about Musculoskeletal (MSK) Exercises
timeFrame: at 6 months
Secondary outcomes:
measure: Confidence in prescribing Musculoskeletal (MSK) Exercises to patients
timeFrame: at 6 months
measure: Improvement in prescribing Musculoskeletal (MSK) Exercises to patients
timeFrame: at 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Charlie Michaudet, MD
role: PRINCIPAL_INVESTIGATOR
References: