louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00606151: PeriOperative Bridging - Perioperative Anticoagulation in the Setting of Recent Intracoronary Drug Eluting Stents
Official title: Short-Term Outcomes of Perioperative Anticoagulation in the Setting of Recent Intracoronary Drug Eluting Stents
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stent Thrombosis
Keywords: drug eluding stents
perioperative bridging
Stents
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-02-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We intend to assess, in a prospective observational manner, the clinical course of patients who have undergone stent implantation less than 6 months prior to a surgical procedure requiring discontinuation of clopidogrel therapy and the efficacy of intravenous antiplatelet therapy to prevent morbidity related to stent thrombosis.

Brief summary: The purpose of this study is to determine if an intravenous (IV) antiplatelet medication is as safe and effective at preventing clot formation in your stented artery as compared in people who have stopped clopidogrel prior to surgery.

Detailed description: Stent thrombosis continues to be associated with a high rate of death or myocardial infarction. While this risk has been ameliorated through the use of the oral antiplatelet agent clopidogrel, there is a small but important subset of patients who will require discontinuation of clopidogrel due to unplanned or emergency surgery. These patients are exposed to a high risk of stent thrombosis during this time period. It is not known whether a strategy of intravenous antiplatelet therapy to "bridge" these patients is effective at preventing the morbidity related to stent thrombosis in the perioperative period. We intend to assess, in a prospective observational manner, the clinical course of patients who have undergone stent implantation less than 6 months prior to a surgical procedure requiring discontinuation of clopidogrel therapy and the efficacy of intravenous antiplatelet therapy to prevent morbidity related to stent thrombosis.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or greater, able to give consent
* DES implantation \< or = 6 months prior to admission
* Undergoing an invasive surgical procedure that will require cessation of clopidogrel therapy for \>48 hours

Exclusion Criteria:

* Age \< 18 years
* Refusal to give consent
* Surgical procedure performed without discontinuation of clopidogrel therapy (or \< 48h of clopidogrel cessation)
* Ongoing anticoagulant therapy other than aspirin (i.e. warfarin, ticlopidine)

Primary outcomes:
measure: stent thrombosis
timeFrame: hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Matthew (Casey) Becker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00729651: Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)
Official title: A Prospective, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Fosamax Plus D in Postmenopausal Osteoporotic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis Postmenopausal
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-08-07
Enrollment: 343
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate the efficacy/safety of Fosamax Plus D


Eligibility criteria: Inclusion Criteria:

* Patient agrees to apply sunscreen and limit sunlight-exposure to 1 hour per day during the study
* Patient has been diagnosed with osteoporosis
* Patient has been postmenopausal for more than 6 months
* Patient has no contraindication to taking oral bisphosphonates
* Patient is eligible for dual energy x-ray absorptiometry in spine or hip

Exclusion Criteria:

* Patients with esophageal dysfunction
* Patients who can not sit or stand at least 30 minutes
* Patients who had a malignant disease or active systemic disease 5 years prior to participating in this trial
* Patients with diseases of bone or mineral metabolism besides osteoporosis or receiving therapies which affect bone metabolism or calcium metabolism
* Patients with history of major gastrointestinal disease (peptic ulcer, malabsorption, esophageal disease, gastritis, gastroduodenitis, etc.) within the last 6 months

Primary outcomes:
measure: Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment
timeFrame: 16 weeks
Secondary outcomes:
measure: Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment
timeFrame: Baseline and 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Kim KJ, Min YK, Koh JM, Chung YS, Kim KM, Byun DW, Kim IJ, Kim M, Kim SS, Min KW, Han KO, Park HM, Shin CS, Choi SH, Park JS, Chung DJ, Mok JO, Baek HS, Moon SH, Kim YS, Lim SK; VALUE study group. Efficacy and safety of weekly alendronate plus vitamin D(3) 5600 IU versus weekly alendronate alone in Korean osteoporotic women: 16-week randomized trial. Yonsei Med J. 2014 May;55(3):715-24. doi: 10.3349/ymj.2014.55.3.715. Epub 2014 Apr 1.
Clinical trial NCT02482051: Ultra Rapid Culture Independent Detection of High-Priority Carbapenem Resistant Enterobacteriaceae Directly From Blood
Official title: Ultra Rapid Culture Independent Detection of High-Priority Carbapenem Resistant Enterobacteriaceae Directly From Blood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia
Enterobacteriaceae Infections
Keywords: Carbapenem-resistant Enterobacteriaceae
Accelerate ID/AST
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Accelerate Diagnostics, Inc.
First posted: 2015-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients with bacterial blood infections.

Brief summary: The purpose of this study is to develop a new and very rapid diagnostic test for identifying a certain type of bacteria called Enterobacteriaceae in blood. Rapid identification of bacteria will assist in decreasing the use of antibiotics and help more patients survive bacterial infections of the blood.

Detailed description: It is our overall goal to develop a new diagnostic technology that will facilitate antibacterial stewardship to reduce selective pressure and improve patient outcomes. The Institute of Medicine has identified antibiotic resistance as one of the key microbial threats to health in the United States and has prioritized decreasing inappropriate use of antimicrobials as the primary solution to address this threat. The emergence of carbapenem resistance among Enterobacteriaceae (CRE) in the United States represents a recent and severe byproduct of excessive antimicrobial use with a high mortality rate in bacteremia. A major barrier toward decreasing use of antimicrobials is lack of sensitive and accurate rapid diagnostic tests for identifying bacterial etiologies of infection.

Eligibility criteria: Inclusion Criteria:

* Laboratory confirmed gram negative bacilli blood culture

Exclusion Criteria:

* Pregnancy
* Prisoner

Primary outcomes:
measure: Bacteria identification
timeFrame: 3 hours
measure: Accuracy of carbapenem susceptibility testing
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
affiliation: Denver Health Medical Center
name: Connie S Price, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01945151: Analysis of the Electrical Muscle Activity and Resistance to Movement in Spastic Hemiparetic Patients.
Official title: Analysis of the Electrical Muscle Activity and Resistance to Movement After Pplication Neuromuscular Electrical Stimulation (EENM) in Patients With Hemiparesis Spastic.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: spastic hemiparesis
Lead sponsor: Universidade do Vale do Paraíba
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 15
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate and compare the effects of Neuromuscular Electrical Stimulation when applied in the agonist and antagonist muscles of spastic hemiparetic patients.

The specific objectives are:

* Evaluate the resistance movement, strength and muscle electrical activity before and after application of Neuromuscular Electrical Stimulation in spastic muscle (gastrocnemius).
* Evaluate the resistance movement, strength and muscle electrical activity before and after application of Neuromuscular Electrical Stimulation in the spastic antagonist muscle (tibialis anterior).
* Compare the risk of falls after application of Neuromuscular Electrical Stimulation in both muscles studied.

Detailed description: Most hemiparetic patients can develop spasticity, characterized by neuronal hyperexcitability, increased resistance to passive stretch, Babinski sign, clonus, reflexes and involuntary spasms skin.

As a consequence, there may be contractures and muscle shortening, generating functional limitations. Neuromuscular Electrical Stimulation feature that can control the spasticity through reciprocal inhibition, muscle relaxation and sensory stimulation. The goal will be to evaluate and compare the effects of neuromuscular electrical stimulation when applied in the agonist and antagonist muscles of spastic hemiparetic patients.

Eligibility criteria: Inclusion Criteria:

* involve patients who have spasticity grade 1, 1 + and 2 of the gastrocnemius muscle, which ambulate with or without assistance devices, patients who tolerate the stimulus and have preserved cognition.

Exclusion Criteria:

* involve patients who have severe shortening, joint stiffness, cognitive deficits and patients with hypersensitivity.

Primary outcomes:
measure: Analysis of the electrical muscle activity and resistance to movement after application of neuromuscular electrical stimulation (NMES) in patients with spastic hemiparesis.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: São José dos Campos
country: Brazil
facility: Laboratório de Engenharia de Reabilitação Sensorio Motora
state: São Paulo
Study officials:
affiliation: Universidade do Vale do Paraíba
name: Sergio ST Takeshi, pesquisador
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00503451: A Study to Investigate the Effects of Ketoconazole on LBH589 in Patients With Advanced Solid Tumors
Official title: A Phase IB, Study to Investigate the Effect of Ketoconazole, a CYP3A4 Inhibitor, on Oral LBH589 and to Assess the Efficacy and Safety of Oral LBH589 in Patients With Advanced Solid Tumors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Hodgkin Lymphoma
Neoplasms
Keywords: Advanced cancer
solid tumors
lymphoma
HDAC
LBH589
adults
non-Hodgkin's lymphoma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this open-label study is to investigate the interaction of ketoconazole, a liver enzyme inhibitor, on oral LBH589 in adult patients with advanced solid tumors. The extension phase of the study will evaluate the safety and efficacy of LBH589 in patients with advanced solid tumors.


Eligibility criteria: Inclusion criteria:

* Patients with histologically confirmed solid tumors or non-Hodgkin's lymphoma with progression on prior standard therapies.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* Adequate kidney function and laboratory values

Exclusion criteria:

* Patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago
* Patients who had a heart attack or have unstable angina within past 6 months
* Heart disease including congestive heart failure and uncontrolled high blood pressure
* Liver disease, abnormal gastrointestinal (GI) function or ongoing diarrhea
* Use of any anti-cancer therapy, including radiation therapy, or certain drugs while on study
* Female patients who are pregnant or breast feeding.

Other protocol inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Levels of LBH589 in the blood on days 1, 5, 8, 9 and 10 of first cycle
timeFrame: 2 weeks
Secondary outcomes:
measure: Safety, tolerability and efficacy of oral LBH589 throughout the study
timeFrame: at least every 2 months
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Hamberg P, Woo MM, Chen LC, Verweij J, Porro MG, Zhao L, Li W, van der Biessen D, Sharma S, Hengelage T, de Jonge M. Effect of ketoconazole-mediated CYP3A4 inhibition on clinical pharmacokinetics of panobinostat (LBH589), an orally active histone deacetylase inhibitor. Cancer Chemother Pharmacol. 2011 Sep;68(3):805-13. doi: 10.1007/s00280-011-1693-x. Epub 2011 Jun 26.
Clinical trial NCT00194051: Symptomatic, Biomechanical and Radiographic Outcomes in Knee Osteoarthritis Following Gastric Bypass Surgery
Official title: Symptomatic, Biomechanical and Radiographic Outcomes in Knee Osteoarthritis Following Gastric Bypass Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Osteoarthritis
Keywords: obesity
gait biomechanics
knee osteoarthritis
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Elizabeth Severance Prentiss Foundation
First posted: 2005-09-19
Enrollment: 35
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Weight is a risk factor for knee osteoarthritis

Knee osteoarthritis is associated with abnormal gait biomechanics

Gait biomechanics are evaluated in gastric bypass patients before and after losing 100 pounds.

Detailed description: Weight is a major risk factor for development of knee osteoarthritis, but not hip or ankle arthritis. One possible mechanism for this is the generation of abnormal gait biomechanics secondary to obesity that are conducive to the development of knee osteoarthritis.

We evaluate gait biomechanics, knee symptoms and knee radiographs in 35 obese patients before and after gastric bypass surgery to determine the effect of significant weight loss on gait biomechanics, knee symptoms and knee radiographs.

Eligibility criteria: Inclusion Criteria:

Undergoing gastric bypass surgery At least 35 years old

-

Exclusion Criteria:

Inability to walk unassisted Pain affecting gait in any lower extremity joint

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Michele M Hooper, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01917851: Evaluate the Accuracy of the NBM200 for Noninvasive Hemoglobin Measurements on Obstetric/Gynecological Patients
Official title: Evaluate the Accuracy of the NBM200 for Noninvasive Hemoglobin Measurements on Obstetric/Gynecological Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anemia
Keywords: Accurate
Hb
noninvasive measurement
Lead sponsor: OrSense, Ltd.
Sponsor class: INDUSTRY
First posted: 2013-08-07
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: The purpose of the study is to define the precision, accuracy and variability of the NBM-200 system in non invasive blood Hemoglobin (Hb) measurements relative to the laboratory blood analyzer by comparing two consecutive Hb values obtained by the NBM system to venous values.

Detailed description: Each subject will be placed in a comfortable position in a temperature regulated room. Participants will have two consecutive non invasive (NBM) measurements taken which involves inserting the thumb into a ring shaped sensor. After each non invasive measurement the sensor will be removed. Each measurement takes approximately 85 seconds and involves the finger cuff inflating (to over systolic pressure) and deflating several times in quick successions in order to measure and calculate the Hb values. The two non invasive measurements will be performed using the same finger. After the NBM system testing is complete and recorded, the subject will have a venous (venipuncture) blood sample collected in order to provide two blood tests performed on two different models of routine automated CBC or Hb blood analyzers.

Eligibility criteria: Inclusion Criteria:

* Female volunteers aged 18 years and over.
* Any patient subject to CBC testing according to OBGYN standard care and clinical judgment.

Exclusion Criteria:

* Participants under the age of 18 years
* Significant deformity, degenerative changes or edema of the thumb or index fingers
* Localized infection, ulceration or skin breaks involving the fingers
* Low peripheral body temperature (tissue perfusion) \<36.0˚C
* Vascular disease or Raynaud's phenomenon affecting the fingers
* Participants who are unable to give informed written consent

Primary outcomes:
measure: Compare the Hb values from the NBM200 series against the Hb from the lab blood analyser on obstetric/gynecological patients.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rabin Medical Center
name: Eran Hadar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05771051: Australian University of California San Francisco (UCSF) Concussion in Athletes (AUSSIE-2)
Official title: Australian UCSF Concussion in Athletes Studied With Cranial Accelerometry Part 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Concussion, Mild
Keywords: headpulse
mTBI
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recently concussed athletes playing Australian rules football. Controls are athletes of Australian Football or other sports without concussion for more than 1 year.

Brief summary: Analysis of cardiac induced brain forces using cranial accelerometry has been shown to diagnose concussion in high school athletes. This trial expands on this observation by recording headpulse signals in a recently concussed athletes playing Australian rules football.

Detailed description: Recently concussed athletes will have headpulse measurements obtained as soon after the clinically identified concussion as is feasible and at 1-3 day intervals over the course of a month. These recordings will pair with a self administered neurological symptom inventory (NSI) to track the athletes subjective concussion symptoms. Data from the prior study (AUSSIE-1) will be used to confirm the predictive value of the established algorithm

Eligibility criteria: Concussion Subjects:

Inclusion Criteria:

* Diagnosed with sport related concussion
* first recording obtained within one week
* willingness to have multiple recordings in the month following concussion

Exclusions:

- head laceration

Control subjects:

Inclusion Criteria

* athletes without concussion over the last year
* willingness to have single or multiple recordings

Exclusion Criteria:

* head laceration

Primary outcomes:
measure: Accuracy of model for the detection of concussion
timeFrame: 1 month
Secondary outcomes:
measure: Time to recovery of headpulse following concussion
timeFrame: 1 Month
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Wade S Smith, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05785351: Swedish National Benchmarks in Laparoscopic Bariatric Surgery
Official title: Bariatric Surgery Benchmarks - How Much Do We Bench?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery
Keywords: Obesity
Bariatric Surgery
Laparoscopy
Benchmarking
Lead sponsor: Region Östergötland
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 55372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with obesity undergoing elective bariatric surgery in order to achieve weight loss.

Brief summary: The aim of this observational study is to define national reference values, according to the achievable benchmarks of care method (ABC™), for laparoscopic bariatric surgery in Sweden. The primary outcome is to identify the best possible, yet achievable, results during and after bariatric surgery. The second outcome to investigate if there are risk groups for complications, and if so perform risk-adjusted benchmark-calculations.

Detailed description: The data source will be the Scandinavian Obesity Surgery Registry (SOReg), a prospective quality registry for obesity surgery. The time frame will be 2012-2021. The techniques to be investigated are laparoscopic roux-en-y gastric bypass and laparoscopic gastric sleeve respectively. Register variables related to surgical quality will be analyzed, and related to risk of peroperative and postoperative complications. The study will analyze data for the time of surgery and up to one year after surgery.

Eligibility criteria: Inclusion Criteria:

* adults ≥ 18 years of age
* primary laparoscopic gastric sleeve or primary laparoscopic roux-en-y gastric bypass

Exclusion Criteria:

* other organ surgery at the time of the index operation
* no data about surgery
* no data about follow-up

Primary outcomes:
measure: Benchmark values of variables related to surgical quality
timeFrame: Surgical intervention and up to one year after surgery
measure: Number of participants with severe postoperative complications
timeFrame: Within 30 days and one year after surgery
Secondary outcomes:
measure: Potential risk groups for complications
timeFrame: Within 30 days and one year after surgery
measure: Risk-adjusted benchmark values
timeFrame: Within 30 days and one year after surgery
Other outcomes:
Locations:
Study officials:
References: