louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02433951: Exercise Tolerance in Patients With CABG and Sternotomy vs. Patients With Minimally Invasive Coronary Surgery
Official title: Exercise Tolerance in Patients With Coronary Artery Bypass Surgery (CABG) and Sternotomy vs. Patients With Minimally Invasive Coronary Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Bypass Surgery
Keywords: exercise tolerance
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 55
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing CABG surgery or endo-ACAB surgery.

Brief summary: In this study, up to 20 healthy individuals, 20 endo-ACAB patients, and 20 CABG patients undergo a maximal cardiopulmonary exercise test after hospital discharge (for patients only). Exercise tolerance is compared between groups.

Detailed description: In this prospective observational study, up to 20 healthy individuals (no history or presence of any chronic disease, sedentary), 20 endo-ACAB patients, and 20 CABG patients (matched for age, gender and BMI) undergo a maximal cardiopulmonary exercise test after hospital discharge (for patients only).During this exercise test, following parameters are assessed at peak effort and at the second ventilatory threshold (determined by VE/VCO2 slope method): oxygen uptake (VO2), oxygen saturation (SaO2), carbon dioxide output (VCO2), resoiratory gas exchange ratio (RER), expiratory volume (VE), ventilatory equivalent for VCO2 (VE/VCO2), ventilatory equivalent for VO2 (VE/VO2), end-tidal O2 pressure (PETO2), end-tidal CO2 pressure (PETCO2), heart rate (HR), oxygen pulse (VO2/HR), cycling power output (W), tidal volume (Vt), respiratory rate (RR), systolic blood pressure (SBP), diastolic blood pressure (DBP), rate pressure product (RPP). Peak exercise effort is validated by RERpeak.

Eligibility criteria: Inclusion Criteria:

* undergoing this type of surgery. For healthy subjects: must be sedentary.

Exclusion Criteria:

* any neurologic, nephrologic, respiratory disease. For healthy subjects: any chronic disease or condition.

Primary outcomes:
measure: VO2peak (peak oxygen uptake)
timeFrame: At peak exercise, single measurement which is executed between 2-4 weeks after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
Study officials:
affiliation: Jessa Hospital, Stadsomvaart 11, 3500 Hasselt, Belgium
name: Paul Dendale
role: STUDY_DIRECTOR
References:
Clinical trial NCT06583551: Effectiveness of Botox, Dry Needling, Pharmacological Treatment, and Manual Therapy for Bruxism-Induced Myalgia
Official title: Comparison of the Effectiveness of Botox, Dry Needling, Pharmacological Treatment, and Manual Therapy for Bruxism-Induced Myalgia: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myalgia
Bruxism
Quality of Life
Keywords: myalgia
Botulinum toxin
bruxism
Dry needling
manual therapy
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: Botulinum toxin (BTX-A) injection (n=20) Group 2: Dry needling (DN) (n=20) Group 3: Pharmacological therapy (PT) (n=20) Group 4: Manual therapy (MT) (n=20)
Primary purpose: TREATMENT

Brief summary: Eighty individuals (44 female, 36 male), which were randomly divided into 4 groups of 20 patients each, due to the treatment type: Botulinum toxin (BTX); Dry needling (DN); Pharmacological therapy (PT) and Manual therapy (MT). All treatments were carried out by the same maxillofacial surgeon. An informed consent form was obtained from all participants.

Detailed description: The study aimed to assess and compare the effectiveness of 4 different methods in the management bruxism: Botulinum toxin (BTX-A), dry needling (DN), pharmacological therapy (PT), and manual therapy (MT). 80 bruxist patients (44 female, 36 male) were randomly divided into 4 groups of 20 patients each. Botulinum toxin, dry needling, pharmacological therapy and manual therapy were carried out by the same maxillofacial surgeon in all patients. The following measurements were recorded by another investigator in each group, at baseline (before treatment) and at post-treatment intervals of 2nd, 4th, and 12th weeks; Visual Analogue Scale (VAS) for pain, maximum painless mouth opening (mm), Oral Health Impact Profile14 (OHIP-14).

Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18 to 65 years with complete dentition,
* Patients classified as American Society of Anesthesiologists (ASA) physical status ASA I or ASA II
* Patients experiencing moderate to severe pain in the masticatory muscles related to bruxism,
* Patients who had not previously been treated for bruxism
* Patients who were diagnosed with bruxism were excluded from the study.

Exclusion Criteria:

* Presence of temporomandibular joint disorder
* Known allergy to botulinum toxin
* Pregnancy
* Presence of neuromuscular disease
* Chronic use of muscle relaxant medication within the last 3 months.

Primary outcomes:
measure: Pain in at rest and at chewing
timeFrame: 12 weeks
measure: MMO
timeFrame: 12 weeks
measure: OHRQoL questionnaire
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: ALANUR CIFTCI SISMAN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02704351: Suggamadex and Fast-track Cardiac Anesthesia in a Developing Country
Official title: Retrospective Chart Review of Fast-track Cardiac Anesthesia Using Suggamadex for Rapid Reversal of Neuromuscular Blockade Following Cardiac Surgery in a Developing Country
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suggamadex
Surgery for Congenital Heart Disease
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 14
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Last September 2015, patients in Tuxtla, Mexico who underwent cardiac surgery and cardiopulmonary bypass surgery for congenital heart defect where suggamadex was used for reversal of neuromuscular blockade.

Brief summary: The purpose of this study is to retrospectively review our preliminary experience during a surgical trip to Tuxtla, Mexico, using suggamadex to reverse neuromuscular blockade following CPB and cardiac surgery for repair of CHD in infants and children.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent cardiac surgery and cardiopulmonary bypass in Tuxtla, Mexico in September 2015.

Exclusion Criteria:

* None

Primary outcomes:
measure: Clinical effects of the reversal of neuromuscular blockade with suggamadex following surgery for congenital heart disease in infants and children
timeFrame: After cardiac surgery, on average within 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT02370251: Compassionate Use of Omegaven in Children
Official title: Fish Oil Lipid Emulsion for the Treatment of Parenteral-Nutrition-Associated Liver Disease in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Total Parenteral Nutrition-induced Cholestasis
Cholestasis
Short Bowel Syndrome
Gastroschisis
Intestinal Atresia
Infant, Premature, Diseases
Cholestasis of Parenteral Nutrition
Keywords: Fat Emulsions, Intravenous
Parenteral-Nutrition-Associated Liver Disease
Cholestasis
Omegaven
Fish Oil
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: OU Medical Center
First posted: 2015-02-24
Enrollment: 63
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.

Detailed description: Children up to 18 years of age, on parenteral nutrition, with a direct bilirubin level of 2 mg/dL or greater will be eligible to receive Omegaven at a maximum dose of 1 g/kg/day.

Up to 200 children will be eligible for enrollment.

Direct bilirubin levels and other labs will be monitored as well as growth parameters.

Eligibility criteria: Inclusion Criteria:

* Live in or temporarily relocate to Oklahoma
* Age less than 18 years, both sexes, all races
* Have a direct bilirubin level of ≥2 mg/dL for two consecutive weeks after at least 14 days of parenteral nutrition
* Received parenteral lipids at a maximum dose of 1.7 g/kg/day (24 g/kg over the two weeks prior)
* Are not currently enrolled in another lipid emulsion study

Exclusion Criteria:

* Known food allergy to fish
* Known metabolic disorder of lipid metabolism
* Active coagulopathies (active bleeding or requiring blood product treatment in the prior 48 hours)
* Medical condition likely to result in death in the next 30 days

Primary outcomes:
measure: Resolution of Cholestasis for Subjects Who Received Omegaven
timeFrame: Within the first 3 months of sole Omegaven use
Secondary outcomes:
measure: Safety Issues for Infants Who Received Omegaven
timeFrame: Within the first year of use
measure: Essential Fatty Acid Deficiency in Infants Who Received Omegaven
timeFrame: Within the first month of use
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: OU Children's Hospital
state: Oklahoma
Study officials:
affiliation: The University of Oklahoma, Department of Pediatrics
name: Kimberly D Ernst, MD, MSMI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05187351: Native Coronary Artery Instead of SAphenous Vein Graft Intervention for Treatment of Significant Saphenous Vein Graft Lesions
Official title: Native Coronary Artery Instead of SAphenous Vein Graft Intervention for Treatment of Significant Saphenous Vein Graft Lesions
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Target Vessel Failure in Saphenous Vein Grafts
Percutaneous Coronary Intervention
Keywords: Target Vessel Failure (TVF)
Saphenous Vein Graft (SVG)
Lead sponsor: Minneapolis Heart Institute Foundation
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a 50-100% de novo SVG lesion and treated with percutaneous coronary intervention of the corresponding native coronary artery using a SYNERGY stent.

Brief summary: The primary study objective of the NASA registry is to evaluate the 12-month incidence of target vessel failure (TVF) in patients who present with saphenous vein graft (SVG) lesions and undergo percutaneous coronary intervention (PCI) of the corresponding native coronary artery.

Detailed description: This is a phase IV, multi-center, single-arm, observational study evaluating the outcomes of native coronary artery PCI in patients presenting with severe SVG lesions.

Subjects will undergo clinically-indicated PCI of the native coronary artery that supplies the territory subtended by the diseased SVG at the discretion of the treating physicians.

The study team will screen and enroll patients after completion of index procedure.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. Presentation with a 50-100% de novo SVG lesion that is considered to cause clinical symptoms and is treated with percutaneous coronary intervention of the corresponding native coronary artery using a SYNERGY stent.
3. Has provided informed consent and agrees to participate

Exclusion Criteria:

1. Known comorbidities/ conditions that, in the opinion of the investigator, limit life expectancy to less than 1 year

Primary outcomes:
measure: Incidence of TVF in patients who present with SVG lesions and undergo PCI
timeFrame: 12 months
Secondary outcomes:
measure: Evaluate the incidence of various endpoints of patients undergoing PCI of the native coronary artery after SVG lesion development
timeFrame: 12 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: MInneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
Study officials:
References:
Clinical trial NCT00946751: To Demonstrate the Relative Bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam Tablets In Healthy Adults Volunteers Under Fasting Conditions
Official title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam Tablets In Healthy Adults Volunteers Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Seizure
Keywords: Anticonvulsant
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 20
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: To demonstrate the relative bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam tablets in healthy adult volunteers under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MDS Pharma Services
name: Gaetano Morelli, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00386451: Comparing a Closing System Without a Needle With Positive Pressure to a Heparin Lock With Positive Pressure
Official title: Prospective Study Which Compares the Use of a Closing System Without a Needle and With Positive Pressure to a Heparin Lock With Positive Pressure for Patients With a Catheter for Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Keywords: Intravenous chemotherapy
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-10-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective randomized study to compare 2 groups:

* heparine lock with positive pressure
* lock without a needle with positive pressure


Eligibility criteria: Inclusion Criteria:

* Oncological patients who require intravenous chemotherapy

Primary outcomes:
measure: Clinical evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Caren Randon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02879851: Evaluation of the Accuracy of the Elastic Fusion MRI-ultrasound Obtained in Vivo by the Koelis™ System
Official title: Evaluation of the Accuracy of the Elastic Fusion MRI-ultrasound ((Magnetic Resonance Imaging) Obtained in Vivo by the Koelis™ System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer of the Prostate
Keywords: ultrasound
Koelis system
MRI
gold grain
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with prostate cancer referred for placement of intraprostatic fiducials before prostate radiotherapy

Brief summary: The study aims at quantifying the registration error obtained in routine patients in different parts of the prostate and for operators with different experience in order to assess the average precision of the elastic MR-ultrasound fusion obtained by Koelis™ system.

Patients referred for placement of intraprostatic fiducials before radiotherapy for prostate cancer will be prospectively offered to enter the study.

The fiducials will be placed under transrectal ultrasound guidance, in the prostate apex, midgland and base, according to our routine procedure. A 3D Ultrasound acquisition of the prostate will be obtained at the end of the placement. As per our routine procedure, patients will undergo unenhanced prostate MRI to control the position of the fiducials. An elastic fusion of the MR images and the 3D ultrasound acquisitions will be retrospectively performed by operators of varying experience using the Koelis system. The fiducials (visible on MR and ultrasound images) will be used to quantify the registration error.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patient requiring placement of intraprostatic fiducials
* No contra-indication for fiducials placement
* No contra -indication to MRI
* No contra -indication for intravenous injection of gadolinium chelates
* Patient affiliated to the social security system
* Patients who received oral and written information

Exclusion Criteria:

* Patient deprived of liberty as a result of a judicial or administrative decision.
* Patient under guardianship or curatorship.
* Any event preventing or prematurely interrupting the collection of assessment criteria would result in the premature exit of the subject.

Primary outcomes:
measure: Accuracy of the overall registration obtained by the Koelis™ system
timeFrame: 1 month
Secondary outcomes:
measure: Influence on TRE3D of the position of the fiducials (apex, midgland and base)
timeFrame: 1 month
measure: Influence on TRE3D of the experience of the fusion operators
timeFrame: 1 month
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospital of Edouard Herriot
Study officials:
References:
Clinical trial NCT03917251: The Effects of Trans Venous Cardiac Pacing on Coronary Microvascular Function and Hemodynamics
Official title: The Effects of Trans Venous Cardiac Pacing on Coronary Microvascular Function and Hemodynamics
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronary Microvascular Disease
Cardiac Pacemaker Syndrome
Keywords: coronary microvascular dysfunction
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The study will examine role of transvenous pacing on coronary microcirculation.

Detailed description: To study the role of transvenous pacing on the coronary microcirculation. This will be accomplished by gathering data from invasive Fractional Flow Reserve (FFR) and Coronary Flow Reserve (CFR) with and without ventricular pacing.

Eligibility criteria: Inclusion Criteria:

All patients 19 years of age or older with clinical evidence of coronary ischemia undergoing coronary angiogram, and who have a pacemaker.

Exclusion Criteria:

* Acute ST segment myocardial infarction
* Known sensitivity or contraindication to the agents planned for administration during coronary angiography
* Pacemaker dependent patients
* Pregnancy
* Hypotension (a systolic blood pressure lower than 90mmHg) that would preclude the administration of adenosine
* Severe renal dysfunction, defined as a estimated glomerular filtration (eGFR) less than 30ml/min, confirmed by recent testing
* Study subject has any underlying disorder that, in the opinion of the investigator, precludes them from giving informed consent at the time of enrollment

Primary outcomes:
measure: Patients that exhibit coronary microvascular resistance and dysfunction as reflected by FFR
timeFrame: Up to 12 months
Secondary outcomes:
measure: Patients that exhibit coronary microvascular resistance and dysfunction as reflected by CFR
timeFrame: Up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska
name: Nashwa Abdulsalam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05452551: Investigation of Myotonometer Reliability in Evaluation of Plantar Fascia Biomechanical Properties
Official title: Investigation of Myotonometer Reliability in Evaluation of Plantar Fascia Biomechanical Properties in Individuals With Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus
Plantar Fascia
Keywords: Diabetes
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: Bitlis Eren University
name: Medipol University
First posted: 2022-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults between 18-35 years old diagnosed with Type 2 Diabetes

Brief summary: The study aims to examine the intra-rater, inter-rater, and inter-session reliability of MyotonPRO in measuring plantar fascia mechanical properties in adults with diabetes.

Detailed description: Therefore, changes occur in standing weight-bearing points, loading zones, and gait biomechanics. The thickened plantar fascia increases the risk of developing diabetic foot with increased peak-plantar pressure, and therefore, plantar fasciitis is more common in individuals with diabetes than in healthy individuals. The myotonometer studies showed that chronic diabetes history increases dynamic stiffness, which is one of the mechanical properties of the plantar fascia, and that as the severity of the disease increases, fascial stiffness also increases. The aim of the study is to examine the intra-rater, inter-rater, and inter-session reliability of MyotonPRO in measuring plantar fascia mechanical properties in adults with diabetes.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Body mass index \< 30 kilogram/meter square
* Willing to participate in the study
* Diagnosed with Type 2 Diabetes
* HbA1c level ≥ 6.5% mmol/mol
* Fasting plasma glucose ≥126 mg/dl
* Random plasma glucose ≥ 200 mg/d

Exclusion Criteria:

* History of lower extremity injuries
* Ulceration localized on plantar fascia
* Age ≥ 65 years
* Any use of medication that will affect muscle tone

Primary outcomes:
measure: Muscle Tone (Hz)
timeFrame: Day 1
measure: Stiffness (N/m)
timeFrame: Day 1
measure: Logarithmic decrement
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bitlis
country: Turkey
facility: Bitlis Eren University
Study officials:
affiliation: Bitlis Eren University
name: Tülay Çevik Saldıran, PhD
role: STUDY_DIRECTOR
References: