louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05352048: MMG vs. EMG for Cortical Breach Detection
Official title: Prospective Evaluation of Mechanomyography Versus Triggered Electromyography for Intraoperative Assessment of Cortical Breaches During Instrumented Lumbar Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Disorder
Keywords: Lower back surgery
Lumbar fusion
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: DePuy Synthes
First posted: 2022-04-28
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine how well mechanomyography (MMG) and electromyography (EMG) prevent cortical bone breaches, or the pinching of a nerve from screw placement, in patients having lower back surgery requiring hardware. Both MMG and EMG are devices approved by the FDA to detect the location of nerves during surgery so they can be avoided. The results from both tests will be compared to one another to determine if one is better at accurately locating nerves than the other.


Eligibility criteria: Inclusion Criteria:

* scheduled to undergo a one-, two-, or three-level posterolateral spinal fusion surgery using Depuy Synthes Expedium pedicle screw instrumentation.
* over the age of 18 years old
* unresponsive to conservative care for a minimum of 6 months
* psychosocially, mentally, and physically able to fully consent and comply with this protocol

Exclusion Criteria:

* preexisting medical condition or comorbidity that makes them a poor candidate
* open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis
* requires medications that may interfere with bone or soft tissue healing
* active local or systemic infection
* metal sensitivity/foreign body sensitivity
* implanted pacemaker
* morbidly obese, defined as a body mass index (BMI) greater than 45
* osteoporosis
* involved in or planning to engage in litigation or receiving Workers Compensation related to neck or back pain.

Primary outcomes:
measure: Success of Pedicle Screw Trajectories
timeFrame: 1 hour
Secondary outcomes:
measure: Change in the Numeric Rating Scale (NRS) Questionnaire for pain.
timeFrame: 6 weeks and 3 months after surgery
measure: Change in the Oswestry Disability Index version 2.1A
timeFrame: 6 weeks and 3 months after surgery
measure: Change in the PROMIS Global-10
timeFrame: 6 weeks and 3 months after surgery
measure: Change in the Short-From (SF-36) Health Survey
timeFrame: 6 weeks and 3 months after surgery
measure: Hospital Readmission at 30 days
timeFrame: 30 days
measure: Hospital Readmission at 90 days
timeFrame: 90 days
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: H. Francis Farhadi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00848848: Safety, Tolerability, and Immunogenicity of Different Combinations of Trivalent Influenza Vaccine Varying Influenza Antigen Dose, Adjuvant Dose, and Route of Administration in Healthy Elderly Individuals Ages 65 Years and Older
Official title: A Phase Ib, Multi-Center, Randomized, Observer-Blind, Proof of Concept, Dose- and Formulation-Ranging Study to Evaluate Safety, Tolerability, and Immunogenicity of One Dose of Trivalent Inactivated Influenza Vaccine in Different Presentations (Intramuscular and Intradermal Delivery), Dosages (Regular or Higher A/H3N2 Content) and Doses of Adjuvant Administered to Healthy Elderly Aged ≥ 65 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: Influenza
Flu
Vaccine
Intradermal
Adjuvant
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2009-02-20
Enrollment: 450
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The study will evaluate the safety, tolerability and immunogenicity of different doses and types of Influenza Vaccine in healthy elderly subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects 65 years or older generally in good health as determined by medical history, physical assessment and clinical judgment of the investigator.

Exclusion Criteria:

* Subjects who have received influenza vaccine within the past 6 month and who have received adjuvanted vaccine in the past two years.
* Subjects with hypersensitivity to vaccine components. Subjects who are on or were recently on immunosuppressive therapy.

Primary outcomes:
measure: Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.
timeFrame: 21 days
Secondary outcomes:
measure: Strain-specific influenza antibody titers will be used to assess Immunogenicity
timeFrame: 21 days
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Center For Vaccinology
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Della Cioppa G, Nicolay U, Lindert K, Leroux-Roels G, Clement F, Castellino F, Galli C, Groth N, Levin Y, Del Giudice G. A dose-ranging study in older adults to compare the safety and immunogenicity profiles of MF59(R)-adjuvanted and non-adjuvanted seasonal influenza vaccines following intradermal and intramuscular administration. Hum Vaccin Immunother. 2014;10(6):1701-10. doi: 10.4161/hv.28618. Epub 2014 Apr 14.
citation: Della Cioppa G, Nicolay U, Lindert K, Leroux-Roels G, Clement F, Castellino F, Galli G, Groth N, Del Giudice G. Superior immunogenicity of seasonal influenza vaccines containing full dose of MF59 ((R)) adjuvant: results from a dose-finding clinical trial in older adults. Hum Vaccin Immunother. 2012 Feb;8(2):216-27. doi: 10.4161/hv.18445. Epub 2012 Feb 1.
Clinical trial NCT03370848: Effects of Psyllium on Niacin Tolerability
Official title: A Prospective Randomized, Open-Label, Crossover Study on the Effects of Psyllium on Niacin Tolerability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Flushing
Hyperlipidemias
Dyslipidemias
Keywords: Niacin
Psyllium
Dietary fiber
Lead sponsor: VA Greater Los Angeles Healthcare System
Sponsor class: FED
First posted: 2017-12-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether psyllium is effective in reducing flushing due to niacin and also to measure the effect of niacin on cholesterol levels.


Eligibility criteria: Inclusion Criteria:

* Patients who are starting ER niacin for clinical indication by a healthcare provider
* No prior use of psyllium for the past 2 months
* No prior use of niacin for the past 3 months
* Ability to give informed consent
* Must be reachable by telephone

Exclusion Criteria:

* Known contraindications to ER niacin, aspirin or psyllium (including: presence of nausea, vomiting, abdominal pain, intestinal obstruction, or fecal impaction; known hypersensitivity to ER niacin, aspirin or psyllium; severe hepatic dysfunction, transaminitis; history of gastrointestinal bleed attributable to aspirin induced gastritis)
* Patient who are unable to perform assessment of flushing using the standardized scales or questionnaires
* Patients who are pregnant

Primary outcomes:
measure: Global Flushing Severity Score
timeFrame: up to 6 weeks
Secondary outcomes:
measure: HDL
timeFrame: Baseline, & end of week 6
measure: LDL
timeFrame: Baseline, & end of week 6
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA West Los Angeles Medical Center
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System
name: Freny V Mody, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05453448: The Renal Safety of Tenofovir Alafenamide in HBV-related Acute-on-chronic Liver Failure: Real-World Study
Official title: Higher Risk of Kidney Function Decline With Entecavir Than Tenofovir Alafenamide in Patients With HBV Related Acute-on-chronic Liver Failure: Real-World Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antiviral Drugs
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 272
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tenofovir alafenamide (TAF) and entecavir (ETV) are the preferred agents in patients with predisposing factors for nephrotoxicity, but few studies to date have directly compared the renal safety of the two antiviral drugs in patients with acute-on-chronic liver failure (ACLF). Hence, the investigators compared the risk of kidney function decline among patients with HBV related acute-on-chronic liver failure (HBV-ACLF) treated with ETV or TAF.From April 2020 to June 2021, a total of 272 HBV-related ACLF hospitalized patients in the Xiangya Hospital of Central South University were enrolled in this prospective study. Chronic hepatitis B was diagnosed by hepatitis B surface antigen and/or hepatitis B virus deoxyribonucleic acid (HBV-DNA) positivity for ≥6 months. ACLF was diagnosed based on the criteria proposed by the APASL Working Party. All patients received antiviral therapy with TAF (25 mg QD, n=100) or ETV (0.5mg QD, n=172), and comprehensive medical treatments. Clinical and laboratory data were collected to evaluate the progression of chronic kidney disease (CKD) .


Eligibility criteria: Inclusion Criteria:

* the presence of hepatitis B surface antigen (HBsAg) in the serum for at least 6 months.
* evidence of active viral replication as documented by measurable HBV DNA in the serum (≥2000IU/mL).

Exclusion Criteria:

* Less than 18 years old.
* history of ESKD or kidney transplantation.
* unknown baseline estimated glomerular filtration rate (eGFR).
* coexistence with other liver diseases such as alcoholic liver disease, autoimmune hepatitis, drug-induced liver injury, or other viral infections(hepatitis A, C, and E virus or HIV infection).
* concomitant with malignant tumor or other serious diseases affecting survival time.
* patients with missing data. follow-up period of \<48 weeks.

Primary outcomes:
measure: the survival rates without transplantation
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Wenting Peng
Study officials:
References:
Clinical trial NCT01358448: A Pilot Study of the Efficacy and Program Cost-effectiveness of Prevention Plus for Childhood Obesity
Official title: A Pilot Study of the Efficacy and Program Cost-effectiveness of Prevention Plus for Childhood Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Treatment of childhood obesity
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
First posted: 2011-05-23
Enrollment: 22
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In 2007 the Expert Committee published recommendations on the prevention and treatment of childhood obesity. These recommendations outlined four interventions intended for advancement based on the child's age, body mass index (BMI), and response to treatment. The initial stage, Prevention Plus, is to be implemented in the primary care setting and focuses on primary care providers monitoring growth monthly and delivering intervention messages that target dietary and leisure-time behaviors that most contribute to energy imbalance in children. Little research has evaluated the efficacy of these recommendations. Thus the primary goal of the proposed pilot study is to test the feasibility of the Prevention Plus stage for treating childhood overweight and obesity in a primary care setting. As the cost of interventions is a large barrier to the translation of evidence-based research into primary care settings, a second goal of the project is to evaluate program cost-effectiveness.


Eligibility criteria: Inclusion Criteria:

* between 4 to 8 years of age at the start of the intervention
* overweight or obese (≥85th BMI-for-age percentile)
* have no medical conditions that effect growth, intake or physical activity (e.g., Prader Willi Syndrome, type 2 diabetes, etc.)
* not currently participating in a weight loss program and/or taking weight loss medication
* have a primary caretaker willing to participate in the research study, receive monthly newsletters and be randomized to one of the three conditions
* caretaker must be able to read, speak and understand English and the child speak English
* have transportation to their child's primary care provider office
* family does not plan to move out of the area before March 2012

Primary outcomes:
measure: Weight Status
timeFrame: Baseline and 6-month
measure: Dietary Intake
timeFrame: baseline and 6-months
measure: Leisure-time Behaviors
timeFrame: Baseline and 6-months
measure: Caretaker Feeding Behaviors
timeFrame: Baseline and 6-months
Secondary outcomes:
measure: Cost Effectiveness
timeFrame: 6-months
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: Knoxville Pediatric Associates
state: Tennessee
city: Knoxville
country: United States
facility: Healthy Eating and Activity Laboratory
state: Tennessee
Study officials:
References:
Clinical trial NCT00868348: A Comparison of Naropin and Ketorolac for Postoperative Analgesia After Total Knee Arthroplasty
Official title: Local Infiltration Analgesia for Total Knee Arthroplasty: Should Ketorolac be Added
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Total Knee Arthroplasty
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2009-03-25
Enrollment: 60
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: The purpose of this study is to determine wether ketorolac is effective in the treatment of postoperative pain after total knee arthroplasty


Eligibility criteria: Inclusion Criteria:

* Total knee arthroplasty
* Age \> 18
* Tolerance for study drugs
* Written informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: Morphine Consumption
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request
timeFrame: within 48 hours after surgery
measure: Pain Intensity Scores During Walking
timeFrame: 6-24 hours postoperatively
measure: Home Readiness
timeFrame: time to fulfilment of discharge criteria
measure: Length of Hospital Stay
timeFrame: From the day of surgery until discharge
measure: Pain Intensity During Daily Activity
timeFrame: 16 weeks after surgery
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
Study officials:
affiliation: Aarhus University Hospital
name: Kjels Søballe, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04452448: Analysis of I-Trace High Order Aberrations Induced by Wavefront Optimized Ablation Profiles
Official title: Analysis of I-Trace High Order Aberrations Induced by Wavefront Optimized Ablation Profiles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Myopia
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective clinical study including 20 eyes of 10 cases undergoing LASIK with wave front optimized ablation profile
Primary purpose: TREATMENT

Brief summary: This work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles WFO using I-Trace aberrometer (Ray -Tracing)

Detailed description: The iTrace (Tracey Technologies, Houston, Tx) is uniquely designed to combine Placido corneal topography with a ray tracing aberrometer to measure quality of vision in a patient. This work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles WFO using I-Trace aberrometer (Ray -Tracing)

Eligibility criteria: Inclusion Criteria:

1. Myopia up to -8.0 D and astigmatism up to -2.0D.
2. Cases above 18 years of age with a stable refraction for at least one year.

Exclusion Criteria:

1. Keratoconus.
2. Patients with collagen diseases.
3. Previous LASIK or any other refractive surgery.
4. Severe dry eye syndrome.

Primary outcomes:
measure: Evaluation of ocular aberrations
timeFrame: 3 months
measure: Visual acuity
timeFrame: 3 months
measure: Manifest refraction
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Medicine
Study officials:
affiliation: Alexandria Faculty of Medicine
name: Ehab Mossallam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03723148: Individual Patient Compassionate Use of Fedratinib
Official title: Compassionate Use of Fedratinib for Patients Who Have Previously Received TG101348, SAR302503 or Fedratinib
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Myelofibrosis
Keywords: Expanded Access
Compassionate Use
Lead sponsor: Celgene
Sponsor class: INDUSTRY
Collaborators: name: Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation
First posted: 2018-10-29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an expanded access program (EAP) for eligible participants designed to provide access to fedratinib.

Expanded access is only available in markets where fedratinib is not yet approved.

Detailed description: This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee and Single Patient IND approval.

Eligibility criteria: Inclusion Criteria:

Subjects will be considered if they received TG101348, SAR302503 or Fedratinib as a participant on a clinical trial prior to 31 Jan 2018.

Exclusion Criteria:

Subject is eligible for enrollment in an ongoing clinical trial using Fedratinib or has been treated with Fedratinib after 31 Jan 2018.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Summit
country: United States
facility: Celgene
state: New Jersey
Study officials:
References:
Clinical trial NCT05418348: Relative Bioavailability of Intravenous GTX-104 Compared to Oral Nimodipine Capsules in Healthy Subjects
Official title: A Phase 1, Randomized, Two-Period Crossover Study to Evaluate the Relative Bioavailability of Intravenous GTX-104 Compared to Oral Nimodipine Capsules at Steady State in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Aneurysmal Subarachnoid Hemorrhage
Lead sponsor: Grace Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-14
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, single center, randomized, two-period crossover study in healthy male and female subjects designed to evaluate the relative bioavailability (BA) and safety at steady state of two formulations of nimodipine: GTX 104 (nimodipine for intravenous \[IV\] infusion; test formulation) and nimodipine oral capsules, RS (reference formulation).


Eligibility criteria: Inclusion Criteria:

* Subject had a body mass index between 18 and 32 kg/m2, inclusive.
* Subject was in good general physical health as determined by absence of clinically significant (CS) medical or psychiatric history, physical examination findings, vital signs, clinical laboratory evaluations, and 12-lead ECG measurements.

Exclusion Criteria:

* History or presence of clinically significant medical illness, including, but not limited to, cardiovascular, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, psychiatric, renal, hepatic, chronic respiratory, or gastrointestinal disease, that could have interfered with the interpretation of the study.
* Had current or recent (within 6 months) history of gastrointestinal disease or any surgical or medical condition (eg, Crohn's or liver disease) that could potentially alter the absorption, metabolism, or excretion of the study drug.

Primary outcomes:
measure: Cmax Day 1
timeFrame: Day 1 for the first dose (8:00 AM dose)
measure: AUC (AUCDay 3, 0-24hr)
timeFrame: Day 3 from 8:00 AM to 8:00 AM from 0 to 24 hr
Secondary outcomes:
measure: Cmax Day 3 across all 6 doses
timeFrame: Day 3
measure: Absolute bioavailability (F) Day 3
timeFrame: Day 3
measure: Total body clearance of the drug from plasma after IV infusion (CL) Day 3
timeFrame: Day 3 from 8:00 AM to 8:00 AM from 0 to 24 h
measure: Apparent total body clearance of the drug from plasma after oral administration (CL/F) Day 3
timeFrame: Day 3 from 8:00 AM to 8:00 AM from 0 to 24 h
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Clinical Research Unit
Study officials:
affiliation: Clinical Research Unit
name: Eric Sicard, MD
role: PRINCIPAL_INVESTIGATOR
References: