louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02473198: Femoral Nerve Block Compared to Exparel in Total Knee Replacement
Official title: A Prospective Randomized Trial Comparing Femoral Nerve Black to Intraoperative Local Anesthetic Injection of Liposomal Bupivacaine (Exparel) in Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Osteoarthritis
Pain
Keywords: Total Knee Arthroplasty
Amide Local Anesthetic
Lead sponsor: The New England Baptist Hospital
Sponsor class: OTHER
First posted: 2015-06-16
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to determine if intrarticular injection with liposomal bupivicaine (Exparel) provides better postoperative pain relief and functional outcome following total knee replacement (TKR) than the current standard New England Baptist Hospital regimen of femoral nerve block combined with intraarticular injection of a standard bupivicaine solution.

Detailed description: A prospective, single blind study comparing femoral nerve blockade and intraarticular posterior capsular injection to interarticular injection of bupivicaine and liposomal bupivicaine (Exparel) alone.

Eligibility criteria: Inclusion Criteria:

• Patients between the ages of 18 - 73 who are undergoing primary, unilateral, Total Knee Replacement at the New England Baptist Hospital in Boston, Massachusetts are eligible to participate.

Exclusion Criteria:

* Patients with Revision or Complex Total Knee Replacements and are under the age of 18, or over the age of 73 will be excluded.
* Patients with an ASA 4 level will be excluded.
* Patients with a Body Mass Index of less than 20, and over 40, will be excluded.
* Patients taking preoperative narcotics, patients with extreme sensitivity or allergy to narcotics or local anesthetics, and patients using opioid medications for at least 3 months leading up to surgery, will also be excluded.

Primary outcomes:
measure: Pain Relief measured by VAS Questionnaire
timeFrame: One Year
Secondary outcomes:
measure: Functional Ability measured by the KSS Questionnaire Score
timeFrame: One Year
Other outcomes:
Locations:
city: Boston
country: United States
facility: New England Baptist Hospital
state: Massachusetts
Study officials:
affiliation: New England Baptist Hospital
name: Carl Talmo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00192998: The Serotonergic Transmitter System in Dementia and Affective Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mood Disorders
Alzheimer Disease
Keywords: Affective disorder
Alzheimer dementia
healthy controls
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The aim of this project is to examine the serotonergic transmitter system using functional imaging of the brain (positron emission tomography \[PET\]) to gain knowledge about early pathophysiological changes in Alzheimer's dementia and mood disorders.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe Alzheimer's disease
* Individuals genetically predisposed to affective disorder
* Healthy gender and age matched controls

Exclusion Criteria:

* Contraindications to magnetic resonance imaging (MRI)
* Use of psychoactive drugs
* Past or present affective disorder
* Other systemic diseases that may affect brain function

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Neurobiological Research Unit
Study officials:
affiliation: Neurobiological Research Unit, Copenhagen University Hospital, Denmark
name: Vibe G. Frokjaer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02833545: Safety and Efficacy of Intra-articular Ozone Injections for Knee Osteoarthritis
Official title: Safety and Efficacy of Intra-articular Ozone Injections for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis Knee
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A sequential series of patients receiving steroid injections was compared to a sequential series of patients receiving ozone injections
Primary purpose: TREATMENT

Brief summary: Prospective, Interventional, Non-Randomized, Open Label, Single Group Assignment, Single Center.


Eligibility criteria: Inclusion Criteria:

* 55 to 79 years of age
* Symptomatic Knee osteoarthritis
* VAS pain intensity is at least 40 mm on a 100 mm scale
* Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely schedule clinical and radiographic visits.

Exclusion Criteria:

* Any known tumor of the ipsilateral knee.
* Any known infection of the treated knee.
* Osteoarthritis of the operated knee Kelgren Lawrence \< grade 2.
* Chemotherapy treatment in the past 12 months.
* Patients who are sensitive to ozone.
* Pregnant women, or breastfeeding women.
* Evidence of any significant systemic disease (such as but not limited to HIV infection, hepatitis infection or HTLV infection), known coagulopathies, that might compromise the Subject's welfare.
* Substance abuse or alcohol abuse.
* Participation in other clinical trials in parallel to this study.

Primary outcomes:
measure: Improvement in VAS Pain intensity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01328145: Acetylic Salicylic Acid for the Treatment of Chronic Obstructive Pulmonary Disease
Official title: Acetylic Salicylic Acid for the Treatment of Chronic Obstructive Pulmonary Disease (COPD). A Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COPD
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-04-04
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The pathomechanisms of COPD are still not fully understood, and up to now there is no satisfying causal treatment inhibiting the progress of the disease. Available therapy is in most cases symptomatic. Experimental and clinical observations suggest that treatment with ASA might be beneficial in the treatment of COPD in terms of respiratory and lung-functional improvement.

To evaluate the efficacy of ASA as add-on therapy in COPD in comparison to placebo a prospective, randomized, double-blind, placebo controlled study will be conducted. Adult male and female patients (n=74) with proven COPD GOLD grade II-III will be randomized to 2 groups (i.e. 37 patients per group, stratification according to smoking status and gender). They will receive either 500 mg ASA per day or matching placebo over 12 weeks. Primary efficacy endpoints are changes in the lung-functional parameter FEV1 (forced expiratory 1-second volume) after 12 weeks of treatment. Secondary endpoints are the health score of the St. Georges respiratory questionnaire (SGRQ) and Peak-flow (PEF).


Eligibility criteria: Inclusion Criteria:

* COPD GOLD II or III

Exclusion Criteria:

* Long term NSAIDS, pregnancy et al.

Primary outcomes:
measure: Change in FEV1 (forced expiratory volume in 1 second) after 12 weeks of treatment
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Rolf Ziesche, MD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02044445: Is the IVF Outcome Dependent on the Time Interval Between hCG Administration and Oocyte Retrieval?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subfertility
Keywords: IVF, hCG, oocyte retrieval, time interval
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 154
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During controlled ovarian hyperstimulation (COH), human chorionic gonadotrophin (hCG) is administered to trigger the final follicular maturation before oocyte retrieval, in an attempt to mimic the physiologic effects of LH. The hCG is administered when more than three follicles ≥17mm in mean diameter have developed.

The time interval between hCG administration and oocyte retrieval is of critical importance since the time after luteinizing stimulus is a period of intense processes including the start of luteinization, expansion of cumulus cells and oocyte meiotic maturation.

The commonly practiced hCG administration time of 33 to 36 h in most IVF cycles aims to avoiding spontaneous ovulation before oocyte retrieval. However, several studies have shown that significantly more high quality embryos have been obtained with a prolonged hCG-to-oocyte interval of 38 h. It has been hypothesized that longer interval would be beneficial in improving oocyte quality and achieving optimal maturation.

Currently there are no data on the effect of the time interval between hCG administration and oocyte retrieval on IVF outcome in GnRH antagonist cycles. The aim of this study is to determine whether there is any difference in in vitro fertilization outcome when oocyte retrieval takes place at 36 h or 38 h following hCG administration


Eligibility criteria: Inclusion Criteria:

* women undergoing fresh IVF cycle with recombinant FSH and GnRH antagonists
* regular spontaneous menstrual cycle (24-35 days)
* age ≤ 43 years
* FSH ≤ 20 IU/L

Exclusion Criteria:

* History of previous ovarian surgery
* Women with Stage III-IV Endometriosis
* Women undergoing natural cycle IVF

Primary outcomes:
measure: retrieval rate (cumulus-oocyte complexes/ follicles> 11 mm)
timeFrame: up to 38 h after hCG administration
Secondary outcomes:
measure: Clinical pregnancy rate (evidence of intrauterine sac with fetal heart activity at 6-8 weeks of gestation)
timeFrame: At 6-8 weeks of gestation
measure: Total number of oocytes retrieved
timeFrame: up to 38 h after hCG administration
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Unit for Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
Study officials:
References:
Clinical trial NCT03513445: Peri-Incisional Drug Injection in Lumbar Spine Surgery
Official title: Efficacy of Peri-Incisional Multimodal Drug Injection in Reducing Post-Operative Pain Following Lumbar Spine Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Lumbar Disc Herniation
Degenerative Disc Disease
Spondylolisthesis
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized prospective study that will compare the use of narcotics in a control group of non-injected patients with a treatment arm of patients injected intra-operatively with a ropivacaine, morphine, and epinephrine cocktail. The investigators hypothesize that this treatment will reduce narcotic use in patients during their hospital stay, and possibly decrease the length of their stay in the hospital.The investigators also hope their pain will be decreased as displayed by their multi-daily Clinically Aligned Pain Assessment (CAPA) score.


Eligibility criteria: Inclusion Criteria:

* Any adult patient 18 years of age and older who is undergoing surgery for a lumbar spine problem. Common diagnoses in this category would include lumbar disc herniations, spinal stenosis, and spondylolisthesis, but this is not an exhaustive list.

Exclusion Criteria:

* Patients with comorbidities excluding use of proposed injection.
* Patients with major head trauma such that they cannot provide consent or describe their post-operative pain.
* Patients with other surgical treatment during study treatment (i.e. more than 1 surgery during the study period or within 30 days prior to surgery).
* Pregnant women (as assessed by pre-operative pregnancy test, which is standard of care).
* Patients with dementia such that they cannot provide consent or describe their post-operative pain.
* Patients with an allergy to study medications.
* Patients with previous drug dependencies.
* Any patient that refuses to be randomized or does not wish to enroll.
* Vulnerable populations, such as prisoners.
* Patients with a fracture, tumor, or infection as their primary diagnosis.
* Patients undergoing a deformity correction.
* Patients with surgeries extending more than 4 levels, with surgeries that extend to the pelvis, or with surgeries that cross the thoracolumbar junction.

Primary outcomes:
measure: Post-operative narcotic use
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Patients' self-reported pain (CAPA) scores
timeFrame: Up to 6 weeks
measure: Length of hospital stay
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT04800445: Salivary C- Reactive Protein, Mean Platelet Volume and Neutrophil Lymphocyte Ratio as Diagnostic Markers for Neonatal Sepsis
Official title: Salivary C-reactive Protein,Mean Platelet Volume and Neutrophil Lymphocyte Ratio as Diagnostic Markers for Neonatal Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonatal Sepsis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Full term neonates of both genders from birth to the 28th day of life who were admitted to Cairo University NICU with clinical features of either early- or late-onset neonatal sepsis diagnosed by culture, CRP more than 10 ,and has three or more the clinical findings of sepsis were enrolled in this study.

Neonates with no symptoms or signs suggestive 0f sepsis who had been hospitalized In Cairo University Nicu . Serum CRP level for neonates in this group was negative (CRP \< 10 mg/L) as control group.

Brief summary: To evaluate reliability of salivary C-reactive protein ,mean platelet volume , neutrophil -lymphocyte ratio , and platelet lymphocyte ratio in diagnosis of neonatal sepsis


Eligibility criteria: Inclusion Criteria:

* - Full term neonates of both genders from birth to the 28th day of life diagnosed with sepsis by history, clinical findings, laboratory findings, and blood culture. The clinical findings included the presence of three or more of the following:
* (1) temperature instability (hypothermia, hyperthermia) .
* (2) respiratory alterations (grunting, intercostal retractions, apnea, tachypnea, cyanosis) .
* (3) cardiovascular alterations (bradycardia, tachycardia, poor perfusion, hypotension) .
* (4) neurologic alterations (hypotonia, lethargy, seizures)
* (5) gastrointestinal alterations (feeding intolerance, abdominal distension). CRP values \>10 mg/L were considered to be positive.

Exclusion Criteria:

* - Preterm neonates .
* Neonates with CNS malformations, metabolic disorders, chromosomal abnormalities, intrauterine growth restriction, or birth asphyxia were excluded from the study

Primary outcomes:
measure: Salivary c reactive protein in neonatal sepsis
timeFrame: 28 days
Secondary outcomes:
measure: Mean platelet volume
timeFrame: 28 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine
state: Almanyal
Study officials:
References:
Clinical trial NCT03453645: Modification of Rhythmic Risk Assessment by Ventricular Tachycardia Ablation
Official title: Modification of Rhythmic Risk Assessment by Ventricular Tachycardia Ablation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventricular Tachycardia
Keywords: ablation
sudden death
signal averaged ECG
T wave alternans
heart rate variability
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people wich an Ventricular Tachycardia Ablation necessary and programed

Brief summary: Sudden cardiac death is a frequent cause of cardiovascular mortality. Numerous rhythmic risk assessment criterion have been described targeting the substratum, the cardiac nervous tone or the trigger of arrhythmias. Development of ventricular tachycardia ablation in the past few years show interesting results preventing the recurrence of ventricular arrhythmias.

Detailed description: Sudden cardiac death is a frequent cause of cardiovascular mortality. Numerous rhythmic risk assessment criterion have been described targeting the substratum, the cardiac nervous tone or the trigger of arrhythmias. Development of ventricular tachycardia ablation in the past few years show interesting results preventing the recurrence of ventricular arrhythmias.

Rhythmic risk assessment criterions have never been studied in relation with ventricular tachycardia ablation. The purpose of this study is to explore the modifications of these criterions after ventricular tachycardia ablation.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing ventricular tachycardia,
* patients with ischemic cardiomyopathy according to European Society of Cardiology Guidelines,
* patients with implanted cardiac defibrillator.

Exclusion Criteria:

* Contra-indication to stress test,
* permanent atrial fibrillation,
* permanent ventricular pacing,
* left bundle block.

Primary outcomes:
measure: measure assessing change before and after Ventricular Tachycardia Ablation of the non-invasive parameters analysis of the rhythmic risk before and after Ventricular Tachycardia Ablation
timeFrame: 10 minutes and 60 minutes after the Ventricular Tachycardia Ablation
Secondary outcomes:
measure: Assessing the correlations of the modifications of the risk criterion after ablation with the recurrences of arrhythmias at one year follow-up
timeFrame: 3 months, 6 months and 12 months after the Ventricular Tachycardia Ablation
measure: Study of the correlation between the modifications of non-invasive parameters analysis of the rhythmic risk and the success of the ablation procedure
timeFrame: 3 months, 6 months and 12 months after the Ventricular Tachycardia Ablation
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital of Toulouse
name: Philippe MAURY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01131845: The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil
Official title: An Evaluation of the Pharmacokinetics and Safety of a Single Dose of UT-15C SR (Treprostinil Diethanolamine) in Subjects With Renal Impairment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Arterial Hypertension
Renal Dysfunction
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-05-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-center, open-label, single-dose evaluation of 1 mg UT-15C SR pharmacokinetics, safety, and tolerability in subjects with normal, mild, moderate and end stage renal disease (ESRD; on dialysis).

Subjects in the ESRD group will receive 2 doses of UT-15C SR, separated by 14 days. One dose will be given 4 hours prior to dialysis, the other dose will be given at the end of dialysis.

Pharmacokinetic samples will be taken immediately prior to dosing and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 30, 36, 42 and 48 hours post dose. Additionally, subjects with ESRD will have a sample taken at 60 hrs post dose.


Eligibility criteria: Male and female volunteers with ESRD (requiring dialysis), moderate (creatinine clearance; CrCL = 30-50 mL/min), mild (CrCL = 50-80 mL/min) and normal renal function (control group; (CrCL \>80 mL/min)) may be enrolled. Eligible subject will be 18-79 years of age with a BMI between 18 - 40 kg/m2 and not taking chronic nonsteroidal antiinflammatory drugs (NSAIDs)

Primary outcomes:
measure: Treprostinil pharmacokinetics in volunteers with varying degrees of renal function following a single oral dose of a 1 mg treprostinil diethanolamine sustained release.
timeFrame: 48hrs post dose (60 hours for ESRD)
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
Study officials:
affiliation: Orlando Clincal Reserach Center
name: Thomas Marbury, MD
role: PRINCIPAL_INVESTIGATOR
References: