louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01154517: Utility of the History and Physical Exam in the Emergency Department
Official title: Utility of the History and Physical Exam in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Pain
Back Pain
Dyspnea
Headache
Weakness
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2010-07-01
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency Department Patients

Brief summary: The study is trying to prove that the history and physical exam (H\&P) in the emergency department is the most important tool in exam of patients. The investigator is attempting to correlate the time of the H\&P of residents and attendings to the accuracy of diagnosis.

Detailed description: The purpose of the study is to examine the utility of the history and physical exam in the emergency room towards obtaining a diagnosis. The goal of this observational study is to correlate physician level of experience and time spent on history and physical exam, to the correct diagnosis.

The aim of this study is:

1. To draw a connection between time and accuracy of the history and physical exam.
2. To draw a connection between time and level of experience as a physician based on post-graduate level.
3. To assess the number of laboratory and radiographic studies and the post-graduate level.
4. To assess the relevance of the labs and radiographs ordered. (Relevance is defined as something that changes plan of care.)

Time is a critical component of the ED physician. Our study will analyse if modern medicine has created a more laboratory/image based need to ascertain a diagnosis or if history and physical examination alone can predict the ultimate diagnosis.

Eligibility criteria: Inclusion Criteria:

* Anyone over the age of 18 with a generalized complaints able to provide consent

Exclusion Criteria:

* Anyone under 18 yrs and anyone with a very specific, system based complaint.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Clinton Township
country: United States
facility: Henry Ford Macomb Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Macomb
name: Jennifer Stevenson, DO
role: STUDY_DIRECTOR
References:
Clinical trial NCT03295617: Management of Giant Thoracic Disc Hernias by Thoracoscopy: Experience of 52 Cases
Official title: Management of Giant Thoracic Disc Hernias by Thoracoscopy: Experience of 52 Cases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Giant Thoracic Herniation
Myelopathy
Keywords: spinal thoracic herniation
surgery
endoscopic approach
thoracic spine
minimal invasive access
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient operated on giant thoracic thoracic disc herniation between May 2001 and October 2016

Brief summary: Introduction: Giant thoracic disc herniation is a rare condition for which surgical treatment is indicated when there are signs of spinal cord injury. To date, several surgical techniques have been described in the treatment of this condition on small patient series. The main objective is to evaluate the long-term results of a series of 53 patients treated with a minimally invasive endoscopic procedure. The secondary objective is to explain our pre-operative planning and the technical details of our procedure. METHOD: Retrospective monocentric study on a cohort of patients treated in our department. The following medical data from our database are analyzed: Morbidity of operative gesture (duration of procedure, bleeding, postoperative complications), clinical results at the last follow-up visit (thoracic Japanese Orthopedic Association (JOA) score, Frankel score, parietal pain , ability to walk, wish to carry out the same intervention again if necessary). On the radiological level, we evaluated the quality of the resection (total, subtotal, incomplete and impossible), the reappearance of a border of cerebrospinal fluid perimedullary and the presence of an intramedullary T2 hyperintense signal MRI post- operative. All these data are collected and analyzed anonymously. Expected Results: We believe we can demonstrate that thoracoscopy is a valid therapeutic option in the treatment of thoracic disc herniation responsible for spinal cord compression. This with a low morbidity given the minimally invasive nature of the approach.


Eligibility criteria: Inclusion Criteria:

* Patient operated on giant thoracic thoracic disc herniation between May 2001 and October 2016

Exclusion Criteria:

* none

Primary outcomes:
measure: Japanese Orthopedic Association Score
timeFrame: 30 minutes
Secondary outcomes:
measure: Frankel score
timeFrame: 30 minutes
measure: Parietal pain measured by visual analogic scale
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: David Brauge, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00235417: Stem Cell Therapy in Chronic Ischemic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Ischemia
Heart Failure, Congestive
Keywords: Bone Marrow Transplantation
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2005-10-10
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether intracoronary bone marrow transplantation can improve left ventricular ejection fraction in patients with severe ischemic heart failure and no other option for standard therapies (revascularization and drugs).

Detailed description: Despite standard therapies (revascularization and drugs), patients with severe ischemic heart failure have a high morbidity and mortality.

The purpose of this study is to determine whether intracoronary transfer of autologous bone marrow cells can induce angiogenesis, subsequently improving regional myocardial perfusion, and finally resulting in improved systolic and diastolic left ventricular function in patients with severe ischemic heart failure.

35 patients with stable left ventricle function will - with four months interval - receive two treatments with bone marrow transplantation intracoronary in vessels supplying dysfunctional myocardial territories. Echocardiography is performed three times prior (four and two months and just before) and two times after (four and eight months after) therapy. It is a non-randomised trial, patients will enter as their own control.

Eligibility criteria: Inclusion Criteria:

1. Severe ischemic heart failure and no other other option for standard therapies (revascularization and drugs),
2. Stable left ventricular ejection fraction \< 40%,
3. CCS class 2-3 and/or NYHA class 2-3, and
4. Signed informed consent.

Exclusion Criteria:

1. Implantation of pacemaker (including implantable cardioverter defibrillator \[ICD\] and biventricular pacing),
2. Acute myocardial infarction within 3 months,
3. Atrial fibrillation, or
4. Severe comorbidity that could impact the patient's short-term survival (including primary hematologic disorders)

Primary outcomes:
measure: Changes in left ventricular ejection fraction from baseline to 12 months' follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Cardiology, Odense University Hospital
state: Odense C
Study officials:
affiliation: Department of Cardiology, Odense University Hospital
name: Per Thayssen, MDSci
role: STUDY_DIRECTOR
affiliation: Department of Cardiology, Odense University Hospital
name: Axel CP Diederichsen, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diederichsen AC, Moller JE, Thayssen P, Videbaek L, Saekmose SG, Barington T, Kassem M. Changes in left ventricular filling patterns after repeated injection of autologous bone marrow cells in heart failure patients. Scand Cardiovasc J. 2010 Jun;44(3):139-45. doi: 10.3109/14017430903556294.
Clinical trial NCT02334917: Comparison of Fast-Absorbing Sutures for Mohs Surgery
Official title: Comparison of Fast-Absorbing Sutures for Mohs Surgery Repair on the Face (ComFAS): a Randomized Controlled Split-scar Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Cicatrix
Keywords: Suture Comparison
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2015-01-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being carried out to assess equivalence of scar outcome for two absorbable sutures used for wound closure on the face in dermatologic surgery: rapidly absorbable polyglactin 910 (VicrylRapide™) and fast-absorbing plain gut (5-0 fast). This is important because absorbable sutures are commonly used in Mohs surgery for epidermal closure, yet there is no evidence indicating if any of the sutures above allow for a better cosmetic outcome (less erythema, edema, and scarring).

Detailed description: Prospective randomized controlled split-scar observer-blinded study.

After dermatologic surgery on the face, surgeons have a choice between using non-absorbable or absorbable sutures for skin closure. A dermatologic surgeon favoring absorbable sutures for wound closure will consider many factors in material selection, including ease of manipulation, cost, and absorption time. However, there have been no randomized trials comparing the most important measure: aesthetic/cosmetic outcome.

Study endpoint/outcome: use three validated scar assessment tools.

Eligibility criteria: Inclusion Criteria:

* Patients who are over 18 years and are having Mohs surgery on the face.

Exclusion Criteria:

* Patients with surgical wounds less than 4cm in length
* Patients requiring full thickness skin grafts for reconstruction
* Patients who are unable to attend routine postoperative follow-up appointments
* Patients who are receiving radiation therapy after surgery.

Primary outcomes:
measure: The Stony Brook Scar Evaluation Scale (SBSES) score (cosmetic outcome)
timeFrame: 6 months
measure: The Wound Evaluation Scale (WES) score (cosmetic outcome)
timeFrame: 6 months
measure: The Visual Analogue Scale (VAS) score (cosmetic outcome)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of British Columbia
name: David M Zloty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00761917: Diagnostic Evaluation of the Tear Film
Official title: Analysis of the Tear Film Lipid Layer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndromes
Lead sponsor: TearScience, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing routine eye examination in ophthalmic practices

Brief summary: The objectives of this study are to assess for a difference between normal and dry eye subjects in tear film quality using a diagnostic interferometry device and to determine whether there are associations between tear film quality and dry eye symptoms and signs.


Eligibility criteria: Inclusion Criteria:

* Adults 18 year of age or older
* Willing and able to comply with study exam procedure

Exclusion Criteria:

* Eyelid abnormality or ocular surface condition affecting ability to visualize tear film
* Women who are pregnant or nursing
* Any of the following conditions within specified timeframe prior to study participation:

  1. Instillation of eye drops
  2. Contact lens wear
  3. Use of oil-based facial cosmetics
  4. Swimming in chlorinated pool
  5. Eye examination procedures that may affect the tear film
  6. Participation in another ophthalmic clinical trial

Primary outcomes:
measure: Tear film analysis of lipid layer quality
timeFrame: upon enrollment
Secondary outcomes:
measure: Dry Eye Symptoms
timeFrame: upon enrollment
measure: Tear Film Break-Up Time
timeFrame: upon enrollment
measure: Corneal and Conjunctival Staining
timeFrame: upon enrollment
measure: Meibomian Gland Assessment
timeFrame: upon enrollment
measure: Schirmer Test
timeFrame: upon enrollment
Other outcomes:
Locations:
city: Fayetteville
country: United States
state: Arkansas
city: Morrow
country: United States
state: Georgia
city: Oak Lawn
country: United States
state: Illinois
city: Edgewood
country: United States
state: Kentucky
city: Bloomington
country: United States
state: Minnesota
city: Chesterfield
country: United States
state: Missouri
city: Charlotte
country: United States
state: North Carolina
city: Henderson
country: United States
state: North Carolina
Study officials:
affiliation: Kolis Scientific
name: Christy Stevens, OD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01998217: Combination of Remifentanil and Flurbiprofen in Sedation and Analgesia for ESWL of Pancreatic Stone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pancreatic Stone Disease
Keywords: extracorporeal shock wave lithotripsy
remifentanil
flurbiprofen
pancreatic stone
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 60
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: TREATMENT

Brief summary: Extracorporeal shock wave lithotripsy (ESWL) of pancreatic stones has been described as an effective approach for stone drainage and pain relief, and general or epidural anesthesia has been reported for such procedure. Single infusion of remifentanil has been described in ESWL of urinary stones, but it has never been described in ESWL of pancreatic stones. Moreover, single infusion of remifentanil might induce several complications, such as postoperative nausea and vomiting. The investigators attended to investigated whether combination of flurbiprofen with remifentanil reduced remifentanil dose and attenuated the complications.


Eligibility criteria: Inclusion Criteria:

* aged 18-65 years
* ASA I-II
* ESWL indication was met

Exclusion Criteria:

* patients with hypertension
* patients compromised in cardiopulmonary function
* patients undergoing ESWL for the second or more times

Primary outcomes:
measure: Visual analogue score of pain
timeFrame: During ESWL procedure
Secondary outcomes:
measure: Cardiovascular responses including blood pressure and heart rate
timeFrame: During ESWL procedure
Other outcomes:
measure: Side effects
timeFrame: within 24 hours after ESWL procedure
Locations:
city: Shanghai
country: China
facility: Department of Anesthesiology, Changhai Hospital
state: Shanghai
Study officials:
References:
citation: Yang YG, Hu LH, Chen H, Li B, Fan XH, Li JB, Wang JF, Deng XM. Target-controlled infusion of remifentanil with or without flurbiprofen axetil in sedation for extracorporeal shock wave lithotripsy of pancreatic stones: a prospective, open-label, randomized controlled trial. BMC Anesthesiol. 2015 Nov 7;15:161. doi: 10.1186/s12871-015-0141-6.
Clinical trial NCT01037517: Trial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for Poor Stem Cell Mobilization
Official title: Open Label Phase II Trial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for Poor Stem Cell Mobilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Lymphoma
Keywords: Myeloma
Multiple Myeloma or Lymphoma Patients undergoing
mobilization for the purpose of autologous stem cell collection
Lead sponsor: CancerCare Manitoba
Sponsor class: OTHER
First posted: 2009-12-23
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Poor mobilization of hematopoietic progenitors needed to support autologous transplantation is a serious clinical problem. We are investigating the role of plerixafor administered in an at risk population to augment successful stem cell collection.

OBJECTIVES

To determine if plerixafor when administered on the day prior to planned autologous collection on first mobilization attempt in those with a peripheral blood CD34 ≤ 10X106/L will:

* increase the number of patients successfully collected in one day
* increase the number of patients successfully mobilized on first collection attempt
* is cost neutral within a Canadian setting


Eligibility criteria: Inclusion Criteria:

1. Participants must be 18 years of age or older
2. Patients must be able to provide written consent
3. Participants must have a diagnosis of lymphoma or multiple myeloma and be undergoing autologous stem cell mobilization for the purposes of ASCT
4. Females of child bearing age will be asked to use an approved form of contraception

Exclusion Criteria:

1. Patients who are pregnant or breastfeeding
2. Patients whose creatinine ≥ 250 μM
3. Serum AST, ALT or total bilirubin \>5X upper limit of normal
4. Acute infection

Primary outcomes:
measure: To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected in one day. The anticipated proportion increase is from 30%-60%.
timeFrame: within 1-2 days after commencing therapy
Secondary outcomes:
measure: To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected on first mobilization attempt rather than requiring a second mobilization.
timeFrame: After therapy
measure: To describe the kinetics of platelet and neutrophil recovery post ASCT in those treated and not treated with plerixafor
timeFrame: After therapy
measure: To examine the immune recovery at day 100 post ASCT in those treated and not treated with plerixafor
timeFrame: After therapy
measure: To undertake a pharmacoeconomic evaluation to examine the impact of plerixafor on resource utilization in a population at risk for poor mobilization
timeFrame: After therapy
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
Study officials:
References:
Clinical trial NCT02338817: Clinical Evaluation of a Non-Invasive Hypoglycemia Detector in a Glycogen Storage Disease Population
Official title: Clinical Evaluation of a Non-Invasive Hypoglycemia Detector in a Glycogen Storage Disease Population
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Glycogen Storage Disease
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Diabetes Sentry
First posted: 2015-01-14
Enrollment: 9
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed and clinically treated at the University of Florida with any of the glycogen storage diseases

Brief summary: Glycogen storage disease (GSD) patients frequently experience periods of hypoglycemia, putting them at risk for several complications, such as hepatomegaly, adenomas, and cirrhosis. As of now, glycogen storage disease patients are limited to using finger stick glucose meters to monitor their glycemia at home. Diabetes Sentry, a non-invasive hypoglycemia detector designed like a watch, has been available for diabetic patients to non-invasively alert for hypoglycemia, but has never been tested in a GSD population. The investigators propose to test the accuracy of the Diabetes Sentry on patients with GSD types 0, I, III, VI, and IX, by measuring their metabolic markers every two hours, as well as whenever the device alerts for hypoglycemia. If accurate, it could be a useful tool for GSD patients in managing hypoglycemia, both clinically and at home.

Detailed description: As a participant the following will take place:

The Diabetes Sentry device, which is non-invasive and is worn on the wrist will be used while an inpatient at the University of Florida Health \& Shands Hospital. Participants will be monitored for the duration of the observational period on the unit, an expected average will be 24 hours. The device is designed to alarm during periods of perspiration and drops in body temperature. When this occurs, a blood draw will be taken to test for glucose, lactate, and ketone values at those times if there is not an already scheduled clinical care blood draw for normal clinical care.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed and clinically treated at the University of Florida with any of the glycogen storage diseases I, III, VI, IX, 0 will be asked to participate in this study.

Exclusion Criteria:

* Patients not clinically treated at the University of Florida.

Primary outcomes:
measure: Blood Glucose
timeFrame: At time of alarm (Average of 24 hours)
measure: Blood Lactate
timeFrame: At time of alarm (Average of 24 hours)
measure: Blood Ketones
timeFrame: At time of alarm (Average of 24 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: Univeristy of Florida
name: David A Weinstein, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References: