louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00368186: Immunogenicity and Safety Study of Pneumococcal 7-Valent Conjugate Vaccine in Sickle Cell Disease Infants.
Official title: An Open, Multicenter Clinical Trial to Investigate the Immunogenicity and Safety of the Pneumococcal 7-Valent Conjugate Vaccine (PREVENAR) in Sickle Cell Disease Infants.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pneumococcal Infections
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-24
Enrollment: 51
Sex: ALL
Minimum age (years): 57
Maximum age (years): 112
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The primary objectives of this study were to assess the immunogenicity and the tolerance of the heptavalent pneumococcal conjugate vaccine (Prevenar) in young infants (2 months of age) with sickle cell disease when administred at 2,3, and 4 months of age.


Eligibility criteria: Inclusion Criteria

Infants with neonatal diagnosis of sickle cell disease and confirmed hemoglobin status by hemoglobin electrophoresis.

Exclusion Criteria

Previous immunization with pneumococcal-containing vaccines.

History of pneumococcal invasive disease (meningitis, bacteremia, pneumonia).

Known or suspected impairments of the immune system (including HIV infection) or recipients of immuno-suppressant agents.

Other Exclusions apply.

Primary outcomes:
measure: Antibody responses to pneumococcal capsular polysaccharides antigens contained in PCV7 vaccine; local and systemic reactions.
Secondary outcomes:
measure: Opsonophagocytic activity; S. pneumoniae nasopharyngeal carriage.
Other outcomes:
Locations:
city: Paris
country: France
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03679286: Comparative Analysis of PCM With ROTEM in the Measurement of Viscoelastic Coagulation Parameters
Official title: Comparative Analysis of the Entegrion Point of Care Coagulation Monitor (PCM) With ROTEM in the Measurement of Viscoelastic Coagulation Parameters
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemostasis Monitoring
Keywords: Coagulation
Lead sponsor: Entegrion, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-20
Enrollment: 120
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: Male and female patients who have a medical management need that requires measurement of their hemostasis status or are at risk of being hypocoagulable or hypercoagulable

Brief summary: To determine if PMC viscoelastic coagulation parameters correlate with those generated by a marketed device in adult patients who require hemostasis monitoring or who are at risk of bleeding or thrombotic indications

Detailed description: The primary aim of this study is a performance evaluation of the PCM coagulation monitor in comparison to the ROTEM thromboelastometry system.

To include a measurement of the entire range of the test system, subjects with a medical management need that requires the measurement of their hemostasis status (such as PT/PTT, INR) or are at risk for being hypo-coagulable or hyper-coagulable will be included in this study.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* In opinion of investigator, absence of anything that precludes subject from being good study candidate
* Informed consent
* Order for measurement of hemostasis status of patients who are at risk for being hyper-coagulable or hypo-coagulable due to clinical diagnosis or medical need

Exclusion Criteria:

* Previous enrollment in study
* Incarcerated
* Heparin infusion in prior 24 hours

Primary outcomes:
measure: Method comparison: Deming regression analysis (PCM and ROTEM NATEM)
timeFrame: Parameter differences assessed at time of blood sampling
Secondary outcomes:
measure: Method comparison: Deming regression analysis (PCM and ROTEM INTEM, EXTEM)
timeFrame: Parameter differences assessed at time of blood sampling
measure: Correlation between abnormalities
timeFrame: Parameter differences assessed at time of blood sampling
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01933386: Evaluation of Benefit for Treatment of Single Sided Deafness (SSD) Between Two Bone Conduction Prosthetic Devices; Osseointegrated Implant Versus Maxilla Anchored Removable Oral Appliance ("SoundBite")
Official title: Evaluation of Benefit for Treatment of Single Sided Deafness (SSD) Between Two Bone Conduction Prosthetic Devices; Osseointegrated Implant Versus Maxilla Anchored Removable Oral Appliance ("SoundBite")
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Single Sided Deafness
Keywords: Single Sided Deafness
SSD
Unilateral hearing loss
Lead sponsor: Sonitus Medical Inc
Sponsor class: INDUSTRY
First posted: 2013-09-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.


Eligibility criteria: Inclusion Criteria:

* Must be current users of a surgically implanted digitally programmable surgically implanted bone conduction device
* Must be \>18, \<80 years old
* Must be fluent in English, as determined by the PI
* Must have diagnosis of SSD, time since onset (≥3 months)
* Must have at least two contiguous molar or premolar teeth with no untreated tooth decay. Patients with tooth decay present are to first have restorations before being fitted for SoundBite
* Healthy attachment to those teeth with tooth pockets limited to no more than 5mm

Exclusion Criteria:

* Subjects with known hypersensitivity to any of the components including allergies to polymers.
* Subjects that are unable to use their hands such as quadriplegics or others that are unable to comply with the warnings in the product's labeling.
* Subjects with known or active secondary medical conditions associated with variable sensorineural hearing loss

Primary outcomes:
measure: APHAB Questionnaire
timeFrame: 30 days
Secondary outcomes:
measure: Single Sided Deafness Questionnaire
timeFrame: 30 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Ear Center
state: Arizona
city: Novi
country: United States
facility: Michigan Ear Institute
state: Michigan
city: San Antonio
country: United States
facility: Ear Medical Group
state: Texas
Study officials:
affiliation: Ear Medical Group
name: Charles Syms, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00153686: Capsule Endoscopy or Mesenteric Angiogram in Patients With Overt Gastrointestinal Bleeding (GIB) of Obscure Origin
Official title: Capsule Endoscopy or Mesenteric Angiogram in Patients With Overt Gastrointestinal Bleeding of Obscure Origin: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Hemorrhage
Keywords: Capsule Endoscopy
Mesenteric angiogram
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To compare the diagnostic yield of mesenteric angiogram with CE in patients with active obscure GIB.

Detailed description: Gastrointestinal bleeding (GIB) of obscure origin is a common conditions resulting in recurrent hospitalization and extensive investigations. Mesenteric angiogram is one of the standard radiological investigations for GIB of obscure origin, and its diagnostic yield ranged from 40-80%. Capsule endoscopy (CE) is a newly available investigation for small bowel examination, especially in bleeding of obscure origin. The diagnostic yield is particularly high in patients with ongoing bleeding. This is a prospective randomized study to compare the diagnostic yield of mesenteric angiogram with CE in patients with overt GIB of obscure origin. The results will help to define the optimal management strategy for this group of patients.

Eligibility criteria: Inclusion Criteria:

* All patients admitted to PWH medical or surgical wards with melena or hematochezia in whom OGD and colonoscopy fail to identify site of bleeding.
* Normal or non-diagnostic OGD and colonoscopy
* Informed consent
* Patients presented with shock will be resuscitated for urgent endoscopy

Exclusion Criteria:

* Patients remained in shock despite resuscitation.
* Moribund patients
* Terminal malignancy
* Presence of pacemaker or ICD
* Suspected or confirmed intestinal obstruction
* Swallowing difficulties
* Renal failure that preclude angiographic examination
* Pregnancy
* Age \<18
* Refused consent

Primary outcomes:
measure: Diagnostic yield of CE and mesenteric angiogram as the primary investigation after negative EGD and colonoscopy.
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of patients with definitive diagnoses achieved;Length of stay (days) ;Transfusion requirements;No. of additional investigations (endoscopies, radiological investigation, CE etc);No. of patients requiring surgery ;12-month rebleeding rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong(SAR)
country: China
facility: Endoscopy Center, Prince of Wales Hospital
Study officials:
affiliation: CUHK
name: Wai K Leung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00235586: Vitamin D Deficiency: Bone Loss and Vascular Dysfunction
Official title: Vitamin D Deficiency: Bone Loss and Vascular Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopausal Women
Keywords: vitamin D deficiency postmenopausal women
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Osteoporosis Foundation
First posted: 2005-10-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To learn if there is a connection between low vitamin D level and hardening of the arteries.

Detailed description: Osteoporosis and vascular disease are two of the most common disorders affecting postmenopausal women. A potential association, beyond aging, has long been speculated. Our previous study revealed evidence of loss of vascular compliance in postmenopausal women with lower bone density, suggesting women with lower bone density had "stiffer" blood vessels. This proposal further investigates that association and a potential role of vitamin D deficiency as a possible common link between both bone loss and "hardening of the arteries".

Eligibility criteria: Inclusion Criteria:

* Females ages 50-70 with ability to give informed consent
* One year past last menstrual period
* 20 women with Vitamin D levels \< 15 mg/ml
* 20 women with Vitamin D levels \> 30 mg/ml

Exclusion Criteria:

* women receiving hormone replacement therapy
* women receiving medication known to effect vascular compliance, including anti-hypertension medications
* subjects receiving therapy for osteoporosis
* hyperthyroidism
* untreated hypothyroidism
* history of metabolic bone disease
* current or previous use of medications known to accelerate bone loss
* chronic liver disease
* chronic renal disease
* diabetes mellitus
* obesity, BMI \> 24

Primary outcomes:
measure: to determine if differences exist in vascular compliance and carotid artery intima media thickness between individuals with normal and low vitamin D levels
measure: to evaluate correlation of markers of vascular disease and boen disease between individuals with normal and low vitamin D
measure: to quantify the effect of Vitamin D replacement on vascular compliance and markers of bone loss and vascular disease.
Secondary outcomes:
measure: Vitamin D at the end of 3 months of supplementation.
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Leland Graves, III, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01539486: Relationship of Preoperative Parathyroid Hormone (PTH) and Ex-Vivo Gamma Counts in Minimally Invasive Parathyroidectomy
Official title: Relationship of Preoperative PTH and Ex-Vivo Gamma Counts in Minimally Invasive Parathyroidectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parathyroid Disease
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2012-02-27
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: An estimated 200 patient charts will be reviewed.

Brief summary: The intent for this study is to do a retrospective chart review of all patients who have undergone minimally invasive parathyroidectomy for primary hyperthyroidism. All data collected will be recorded under assigned identification numbers that will have no association with medical record or hospital numbers. Identifying characteristics will include age and sex. Anonymity will be upheld. The patient/family will not be contacted directly. All information will be obtained from the medical chart. Demographics, location, preoperative PTH levels and intraoperative Ex-Vivo gamma counts, co-morbid conditions, and the outcome based on the hospital notes will be obtained from patients' charts and will be transferred to a secure database. It is our hypothesis that there is a linear relationship between immediate preoperative parathyroid hormone (PTH) levels and Ex-Vivo gamma counts and the aim of this study is to better describe this relationship.


Eligibility criteria: Inclusion Criteria:

* Patients must be between the ages of 18 and 90 years old who have documented primary hyperparathyroidism and have undergone minimally invasive parathyroidectomy.

Exclusion Criteria:

* Patients who have not had both intraoperative parathyroid hormone (PTH) levels and Gamma counts during their parathyroidectomy
* Patients who have parathyroidectomies for reasons other than primary hyperparathyroidism.

Primary outcomes:
measure: Retrospective Chart Review
timeFrame: Retrospective Chart Review
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Deanne King, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01288586: Post-Approval Study to Investigate the Long Term (8 Year) Survivorship of STAR Ankle Among Continued Access Study Patients
Official title: Post-Approval Study to Investigate the Long Term (8 Year) Survivorship of Scandinavian Total Ankle Replacement (STAR) Ankle Among Continued Access Study Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Arthrosis
Keywords: Post Traumatic Arthritis
Rheumatoid Arthritis
Osteoarthritis
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2011-02-02
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of all living subjects who participated in the continued access study.

Brief summary: The purpose of this study is to examine the long term survivorship of the Scandinavian Total Ankle Replacement (STAR). Specifically, this study focuses on the revision and/or removal rate of any component of the STAR ankle.


Eligibility criteria: The study population consists of all living subjects who participated in the continued access arm of the IDE clinical trial.

Inclusion Criteria:

* Only patients that participated in the continued access study make up the patient cohort for this long-term follow-up study.
* Willing and able to give informed consent.

Exclusion Criteria:

* Subjects who were withdrawn or withdrew consent to participate in the investigation
* Subjects who do not consent to participate in long-term or provide personal contact information to the sponsor(solely for the purposes of tracking subjects to help ensure follow-up compliance)

Primary outcomes:
measure: The primary objective for this study is to examine the long-term survivorship of the STAR Ankle
timeFrame: 8 year
Secondary outcomes:
measure: American Orthopaedic Foot and Ankle Society questionnaire will be used to evaluate and monitor the progress of patients following foot and ankle surgery.
timeFrame: 8 year
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Oakland Bone & Joint Specialists
state: California
city: Temple Terrace
country: United States
facility: Foundations of Orthopedic Research and Education
state: Florida
city: Boise
country: United States
facility: St. Alphonsus Medical Group, Coughlin Foot & Ankle Clinic
state: Idaho
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Stryker Nordic
name: Richard Jay, DPM
role: STUDY_DIRECTOR
References:
Clinical trial NCT01656486: Stereotactic Radiation to Decrease Pancreatic Secretions
Official title: Utilization of Stereotactic Radiation in Patients With Pancreatic Fistula to Decrease Pancreatic Secretions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Fistulae
Keywords: Pancreas
Pancreatic fistula
Stereotactic radiation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2012-08-03
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients that have undergone pre-operative radiation for pancreatic carcinoma, that upon pathologic examination of the normal portion of the pancreatic gland that was in the radiation field showed acute and chronic changes in the pancreatic cells. The hypothesis for utilizing stereotactic radiation on pancreatic fistulae is that the treatment will decrease pancreatic secretions, thus decreasing autodigestion.

Detailed description: Stereotactic radiation for cancer has been utilized to successfully treat the head of the pancreas, which is generally a well-tolerated procedure with minimal complications. Upon further investigation under the microscope, after resection during a complex Whipple operation, it is noted that particularly the exocrine glandular tissue atrophied substantially. Based on this information, the hypothesis for utilizing stereotactic radiation on the remaining pancreas is production of a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland. The use of stereotactic radiation will be performed on individuals that are non-surgical candidates.

Eligibility criteria: Inclusion Criteria:

* Pancreatic fistula
* Non-surgical candidate

Exclusion Criteria:

* Surgical candidate

Primary outcomes:
measure: Decreased Secretions
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: David Sindram, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03739086: Retrospective Evaluation of Erector Spinae Plane Blocks
Official title: Evaluation of Erector Spinae Plane Block; Indications, Complications and Analgesic Effects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 182
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all of the patients performed erector spinae plaen block

Brief summary: Retrospective Evaluation of Erector Spinae Plane Blocks

Detailed description: in our institue; we use erector spinae plane block as a part of multimodal analjesia. we want to evaluate block failures and complications related erector spinae plane block. In all patients performed regional anesthesia techniques, we use a regional anesthesia follow chart.

Eligibility criteria: Inclusion Criteria:

* patient performed erector spinae plane block

Exclusion Criteria:

-

Primary outcomes:
measure: complication rate
timeFrame: 14 months
Secondary outcomes:
measure: block failure rate
timeFrame: 14 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Maltepe University faculty of medicine
Study officials:
References:
citation: Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
citation: Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.