louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05495763: The Ultrasonographic Changes of Intercostal Muscles and Diaphragm in Mechanically Ventilated Preterm Neonates
Official title: The Ultrasonographic Changes of Intercostal Muscles and Diaphragm in Mechanically Ventilated Preterm Neonates
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mechanical Ventilation Complication
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 28
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be conducted on neonates admitted to NICU.

Brief summary: Invasive mechanical ventilation induces ventilator induced diaphragmatic dysfunction particularly when used for long time and Intercostal muscles as well contribute to the important work of respiratory movement by expanding the thorax , and determining the thickness of them would be a useful parameter in evaluating respiratory muscle activity.

This study will add the impact of mechanical ventilation on the diaphragm and intercostal muscles in preterm infants using ultrasound.


Eligibility criteria: Inclusion Criteria:

1. Preterm infants from 28-36 weeks gestation
2. In need for invasive mechanical ventilation according to work of breathing, oxygen saturation and blood gases .

Exclusion Criteria:

* 1) Significant congenital anomalies including cardiac, abdominal or respiratory.

  2) Congenital anomalies involving the diaphragm. 3) Phrenic nerve paralysis. 4) Congenital muscular dystrophies. 5) Major upper or lower airway anomalies. 6) Storage diseases.

Primary outcomes:
measure: The impact of mechanical ventilation on diaphragm and intercostal muscles using ultrasound
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT04016363: Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations
Official title: Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations: a Prospective, Randomized Controlled Open Label Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Pharmacological stress-echocardiography examinations are routinely performed in daily clinical practice. Usually, the echo probe is manually placed on the patient's thorax by the physician. The ProbeFix is a novel device, enabling the fixation of the ultrasound probe on the patient's thorax. Therefore, there is no need to manually hold the probe. This may improve the standardization of the examination and my reduce its duration. The present trial will investigate, whether the utilization of the ProbeFix reduces the duration of stress-echocardiography examinations and improves standardization of image acquisition.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing clinically indicated pharmacological stress-echocardiography
* Willingness to participate

Exclusion Criteria:

* Pharmacological stress echocardiography indication other than evaluation of stress induced ischemia (e.g. Low-Flow-Low-Gradient aortic valve stenoseis)
* poor image quality
* Early termination of the stress-echocardiography examination for clinical reasons

Primary outcomes:
measure: Duration of stress-echocardiography examination
timeFrame: During the examination
Secondary outcomes:
measure: Echocardiography axis deviation in 4 chamber view
timeFrame: During the examination
Other outcomes:
measure: Cost-effectiveness
timeFrame: During the examination
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
state: NRW
Study officials:
References:
Clinical trial NCT04279886: Three-dimensional Scanning of the Chest: a Comparison Between Three Different Imaging Modalities
Official title: Three-dimensional Scanning of the Chest: a Comparison Between Three Different Imaging Modalities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Wall Disorder
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
First posted: 2020-02-21
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All included healthy volunteers received 6 three-dimensional scans, utilizing 3 different scanning systems (2 scans per system)
Primary purpose: DIAGNOSTIC

Brief summary: Recently, three-dimensional scanning of the torso has been proposed as an alternative for two-view chest radiographies and computed tomography to determine the severity of pectus excavatum without exposure to ionizing radiation. The range of three-dimensional scanning systems is broad with even varying systems being used within hospitals. Most of these scanning systems have been validated for accuracy and reproducibility, no comparison between these systems is known. In addition, severity measures of pectus excavatum, as well as other research outcomes, surgical planning techniques, and analysis methods are based on a single imaging system. It is subsequently essential to determine whether different imaging systems can be used interchangeably regarding accuracy and reproducibility.

The aim of this study was to assess the reproducibility and accuracy between three commonly used three-dimensional scanning systems.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers only

Exclusion Criteria:

* none

Primary outcomes:
measure: Reproducibility
timeFrame: 1 month
measure: Accuracy
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Zuyderland Medical Centre
state: Limburg
Study officials:
References:
Clinical trial NCT03501186: Effects of Backward Gait on Sand on Improving the Gait Parameters of Patients With Chronic Stroke.
Official title: Effects of Backward Gait on Sand on Improving the Gait Parameters of Patients With Chronic Stroke: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Stroke
Keywords: Backward walking, stroke, gait training
Lead sponsor: Majmaah University
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gait training in stroke is a complex process of motor learning although restoring patients ability to walk would not prepare the individual with the challenges faced in the real environment. The aim is not simply walking in controlled environment, but to achieve dynamic walking. Dynamic walking is the ability of an individual to adjust to the changing surfaces and terrains. thereby returning to achieve active participation in the community. Hence, recovery of walking ability is the primary goal when planning treatment for patients with stroke.


Eligibility criteria: Inclusion criteria:

* Had experienced stroke for the first time.
* Unilateral involvement.
* Demonstrate motor stage 3 or 4 on Brunnstrom motor recovery.
* Able to walk 12 m with or without assistive devices.
* Medically stable.
* Able to follow simple commands.

Exclusion criteria:

* Patient exhibits comorbid disease other than stroke that may affect gait.
* Any conditions contra indicated to exercises
* Any other cardio-pulmonary or orthopedic disorders that affects walking ability of the participant.

Primary outcomes:
measure: Gait velocity (m/s)
timeFrame: 10-15 mins
measure: Cadence (Number of steps per min)
timeFrame: 10-15 mins
measure: Stride length in meters
timeFrame: 10-15 mins
measure: Gait cycle in seconds
timeFrame: 10-15 mins
Secondary outcomes:
measure: Barthel index
timeFrame: 45 Mins
Other outcomes:
Locations:
city: Al Majma'ah
country: Saudi Arabia
facility: King Khalid Hospital
state: Riyadh
Study officials:
References:
citation: Makino M, Takami A, Oda A. Comparison of forward walking and backward walking in stroke hemiplegia patients focusing on the paretic side. J Phys Ther Sci. 2017 Feb;29(2):187-190. doi: 10.1589/jpts.29.187. Epub 2017 Feb 24.
citation: Kim CY, Lee JS, Kim HD. Comparison of the Effect of Lateral and Backward Walking Training on Walking Function in Patients with Poststroke Hemiplegia: A Pilot Randomized Controlled Trial. Am J Phys Med Rehabil. 2017 Feb;96(2):61-67. doi: 10.1097/PHM.0000000000000541.
Clinical trial NCT00413686: Study to Assess Safety of AZD7762 Administered Alone and in Combination With Gemcitabine in Patients With Advanced Solid Malignancies
Official title: A Phase I Open Label Multi Center Dose Escalation Study to Assess Safety, Tolerability, and Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose Gemcitabine in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: Mixed solid tumors
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-12-20
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, multi-center, dose-escalation, Phase I study to evaluate the safety, tolerability, and pharmacokinetics and to investigate biomarker changes of AZD7762 administered as a single intravenous unit and in combination with gemcitabine. The study is sponsored by AstraZeneca.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
* ECOG performance status of 0 or 1
* Patient and tumor type must be suitable for treatment with weekly standard gemcitabine.

Exclusion Criteria:

* Inadequate bone marrow reserve, inadequate liver function or impaired renal function
* Any troponin elevation (above normal range)
* Stage II, III, or IV cardiac status, according to New York Heart Association (NYHA) classification; recent history (ie, within 6 months) of coronary artery disease or arteriosclerotic cardiovascular disease (angina, myocardial infarction \[MI\])
* Any prior anthracycline treatment

Primary outcomes:
measure: To assess the safety and tolerability of AZD7762 alone and in combination with Gemcitabine
timeFrame: Assessed after each course of treatment
Secondary outcomes:
measure: To determine the single-dose (after the first single-agent dose) and combination-dose (afer the 2nd combination dose) pharmacokinetics (PK) of AZD7762.
timeFrame: Assessed after each course of treatment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Detroit
country: United States
facility: Research Site
state: Michigan
Study officials:
affiliation: AstraZeneca
name: Peter Langmuir, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00520286: Phase 2, Multi-Center Trial of Modafinil for Methamphetamine Dependence
Official title: Phase2, Double-blind, Placebo-controlled Trial of Modafinil for the Treatment of Methamphetamine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Methamphetamine Dependence
Keywords: Methamphetamine Dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: VA Office of Research and Development
First posted: 2007-08-24
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study will be to examine the safety and efficacy of modafinil in increasing number of methamphetamine non-use weeks in subjects with methamphetamine dependence.

Detailed description: To evaluate the efficacy and safety of modafinil in reducing methamphetamine use in subjects with methamphetamine dependence. It is hypothesized that modafinil, compared to placebo, will be associated with an increase in the number of methamphetamine non-use weeks over time as measured by quantitative urine analysis for methamphetamine.

Eligibility criteria: Inclusion Criteria:

* Must be between the ages of 18 and 65
* Methamphetamine dependent as defined by DSM-IV criteria
* Must be in good general heath with a history of methamphetamine use at screening
* Must be able to provide written informed consent
* If female and of child bearing potential, must agree to use birth control.

Exclusion Criteria:

* Please contact site for more information

Primary outcomes:
measure: Abstinence (Week 1 - 12)
timeFrame: Weeks 1 - 12
Secondary outcomes:
measure: Reduction of Craving
timeFrame: 21 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: South Bay Treatment Center
state: California
city: Tarzana
country: United States
facility: Matrix Institute on Addictions
state: California
city: Torrance
country: United States
facility: Torrance Site
state: California
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Honolulu
country: United States
facility: John A. Burns School of Medicine
state: Hawaii
city: Des Moines
country: United States
facility: Powell Chemical Dependency Center
state: Iowa
city: Kansas City
country: United States
facility: START Research and Treatment
state: Missouri
city: Salt Lake City
country: United States
facility: Salt Lake City VA Medical Center
state: Utah
Study officials:
affiliation: National Institute on Drug Abuse (NIDA)
name: Ahmed Elkashef, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson AL, Li SH, Biswas K, McSherry F, Holmes T, Iturriaga E, Kahn R, Chiang N, Beresford T, Campbell J, Haning W, Mawhinney J, McCann M, Rawson R, Stock C, Weis D, Yu E, Elkashef AM. Modafinil for the treatment of methamphetamine dependence. Drug Alcohol Depend. 2012 Jan 1;120(1-3):135-41. doi: 10.1016/j.drugalcdep.2011.07.007. Epub 2011 Aug 12.
Clinical trial NCT06523686: Lateral Ridge Augmentation Using Two Graft Combination and a Cross-linked Collagen Membrane
Official title: Lateral Ridge Augmentation Using Autogenous-xenogeneic or Allogeneic-xenogeneic Graft Mix With a Cross-linked Collagen Membrane: a Randomized Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Alveolar Bone Resorption
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 4
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To treat resorbed alveolar ridges, many surgical procedures are available in the literature such as ridge splitting, distraction osteogenesis, block grafting techniques and guided bone regeneration, which is the most documented technique. Various grafting materials are available but there is a lack of evidence on the superiority of a material or a combination of materials.

Detailed description: Bone width at the implant site is an important prerequisite for a predictable and long-term prognosis in implant dentistry. Different types of membranes and bone grafts are used in the GBR procedure. However, there is a lack of studies in the literature about the combination allograft/xenograft. The aim of the present trial is to compare two different bone graft combinations (autogenous-xenogeneic and allogeneic-xenogeneic) covered with a cross-linked collagen membrane in a horizontal alveolar ridge augmentation (without simultaneous implant placement).

Eligibility criteria: Inclusion Criteria:

* Healthy patients, non-smokers or smokers \<10 cigarettes/day.
* Age between 20 and 75.
* Full mouth bleeding score (FmBS) \<20 %.
* Full mouth plaque score (FmPS) \<15%.
* Residual bone width \< 5 mm and adequate bone height in the maxilla and the mandible.
* Tooth extraction performed at least 6 weeks before surgery.
* Presence of enough teeth to support an occlusal stent/radiographic guide.

Exclusion Criteria:

* Systemic diseases.
* Heavy smokers (\> 10 cigarettes/day).
* History of radiotherapy in the head and neck region in the last 5 years.
* Active periodontitis on the remaining teeth.
* Pregnancy.
* Intake of medications that may have an effect on bone turnover and mucosal healing (i.e., tetracycline within the last month, steroids within the last 6 months, bisphosphonates or fluorides at bone therapeutic levels, vitamin D and metabolites at therapeutic levels within the last 6 months).

Primary outcomes:
measure: Linear bone width changes
timeFrame: 6 months
measure: Volumetric bone changes
timeFrame: 6 months
Secondary outcomes:
measure: Clinical Ridge Height gain
timeFrame: 6 months
measure: Probe penetration
timeFrame: 6 months
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Saint Joseph university
Study officials:
affiliation: Saint-Joseph University
name: Celine Rassi, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01579786: Treatment of Post Operative Pain in Thyroid Surgery Patients: Perspective Study Acupuncture Versus Drugs
Official title: The Treatment of Post Operative Pain in Thyroid Surgery Patients: Perspective Study Acupuncture Versus Pharmacological Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Operative Pain
Keywords: post operative pain
acupuncture
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2012-04-18
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to evaluate if acupuncture may reduce intraoperative ULTIVA (remifentanil) consumption and post operative pain measured with VAS, italian version Mc Gill Questionnaire Pain and drug consumption (acetaminophen daily consumption).

Detailed description: The aim of the study was to evaluate if acupuncture may reduce intraoperative ULTIVA (remifentanil) consumption and post operative pain measured with VAS, italian version Mc Gill Questionnaire Pain and drug consumption (acetaminophen daily consumption). The study involve patients who underwent thyroid surgery randomised in two groups. A group patients treated with drugs and B group patients treated with drugs and acupuncture.Acupuncture related risk are pain, faint and haematoma.The study will be done in Padova University Hospital (Endocrine Unit.Primary end point will be VAS pain and secondary end points ULTIVA consumption, post operative pain measured with italian version of Mc Gill Questionnaire Pain and acetaminophen daily intake

Eligibility criteria: Inclusion Criteria:

* thyroid surgery patients

Exclusion Criteria:

* back severe arthritis
* osteoporosis
* myofascial pain
* rheumatic disease
* fibromyalgia
* systemic cardiovascular and respiratory disease
* hypertension
* drug or alcohol consumption
* mental disease
* cervical trauma
* chronic use of antidepressant
* hypnotic and antihypertensive drugs

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: within the 3rd postoperative day
Secondary outcomes:
measure: Mc Gill Questionnaire pain
timeFrame: within the 3rd postoperative day
Other outcomes:
measure: Remifentanil consumption
timeFrame: Intraoperative
measure: Acetaminophen
timeFrame: within 7 days after surgery
Locations:
city: Padova
country: Italy
facility: Endocrine Unit, Padova Universitary Hospital
Study officials:
affiliation: University of Pdova
name: Professor Nitti, Donato
role: STUDY_DIRECTOR
References:
Clinical trial NCT01638286: Study to Evaluate a Pharmacokinetic Drug Interaction Between Eperisone Hydrochloride and Aceclofenac in Healthy Male Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Low Back Pain
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2012-07-11
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Acute low back pain

Brief summary: A randomized, open label, single-dose, 6-sequence, 3-period, crossover study to evaluate a pharmacokinetic drug interaction between eperisone hydrochloride and aceclofenac in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* BMI : 20.0 - 28.0 kg/m2 willingness to sign the written informed consent form(ICF)

Exclusion Criteria:

* Evidence of clinically relevant pathology within 30 days prior to drug administration History of relevant drug and/or food allergies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05998486: Detecting the Rest Tremor Associated With Parkinson's Disease Using Analysis of the Muscle Contractions Rhythmicity
Official title: Detecting the Rest Tremor Associated With Parkinson's Disease Using Analysis of the Muscle Contractions Rhythmicity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson
Cerebellar Tumor
Rest Tremor
Diagnoses Disease
Movement; Abnormal, Involuntary
Lead sponsor: Henri Mondor University Hospital
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease or cerebellar tremor diagnosis.

Brief summary: Resting tremors associated with Parkinson's disease (PD) remains difficult to quantify and track during disease progression. This study propose to explore the rhythmicity of distal muscle contractions in the upper limb to characterize resting tremor and discriminate it from cerebellar tremor (CT) based on the frequency spectrum of the EMG signal.

Detailed description: This retrospective study analyzed surface EMG recordings of wrist flexor-pronators and extensor-supinators from patients with PD or CT bilaterally in five 10-second conditions: rest with contralateral motor distraction, symmetrical arms extended forward posture with hands pronated, semi-pronation, supination, and elbows flexed with hands pronated. The rhythmicity index (RI) is calculated from the ratio of the area of the maximum power peak to the total area of the spectrum between 1.5-12Hz.

Eligibility criteria: Inclusion Criteria:

* patient who performed surface EMG recordings of wrist flexor-pronators and extensor-supinators in Laboratories;
* diagnosis of Parkinson's disease or cerebellar tremor.

Exclusion Criteria:

* Botulinium toxin injection in upper limb during a delay of 3 months before surface EMG recordings;
* Levodopa drugs administrated during a delay of 12 hours before surface EMG recordings;
* Tremor-favour drugs administrated during a delay of 30 days before surface EMG recordings;
* Presence of an other neurologic disease or of any disease associated with motor disorders in upper limb.

Primary outcomes:
measure: rhythmicity index
timeFrame: 10 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Créteil
country: France
facility: Laboratoire Analyse et Restauration du Mouvement
Study officials:
affiliation: Henri Mondor University Hospital
name: Emilie Hutin
role: PRINCIPAL_INVESTIGATOR
References: