louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03255213: Lingual Muscle Training in Late-Onset Pompe Disease (LOPD)
Official title: Lingual Muscle Training in Late-Onset Pompe Disease (LOPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycogen Storage Disease
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 5
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being done to test the effects of Lingual Muscle Therapy (LMT) in patients with Late-Onset Pompe Disease (LOPD) who have tongue weakness. The results of this study will help design future research studies about LMT in LOPD.


Eligibility criteria: Inclusion criteria:

* Age ≥ 12 years
* Lingual weakness as measured by quantitative muscle testing (≤ 5% lower limit of normal for stratified age)
* Confirmed diagnosis of LOPD
* On enzyme replacement therapy for ≥ 26 weeks at pretest
* Able to follow directions for study participation
* Able to complete a home-based LMT regimen
* Access to reliable internet connection
* Access to use of electronic device that allows for FaceTime, Jabber, or WebEx use

Exclusion Criteria:

* Neurodegenerative conditions (e.g. stroke, dementia) or other serious neurologic condition that would prevent meaningful study participation as determined at the discretion of the principle investigator
* Any current or past history of seizures.
* Head and neck cancer or radiation treatment to head/neck
* Inability to tolerate IOPI device tongue bulb
* Inability to give legally effective consent
* Inability to read and understand English

Primary outcomes:
measure: Safety of lingual muscle training
timeFrame: 13 weeks
measure: Feasibility of lingual muscle training as measured by questionnaires
timeFrame: 13 weeks
Secondary outcomes:
measure: Change in lingual strength
timeFrame: baseline, 13 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center and affiliated practices
state: North Carolina
Study officials:
affiliation: Duke University
name: Jones Harrison, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06979713: Yoga, Education, and Nidra (YEN) for Chronic Low Back Pain: A Pilot Study on Pain Modulation, Well-Being, and Sleep
Official title: Yoga, Education, and Nidra (YEN) for Chronic Low Back Pain: A Pilot Study on Pain Modulation, Well-Being, and Sleep
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 24
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 purpose of this study is to compare the impact of yoga, pain education, and yoga nidra with pain acceptance intention to yoga, pain education, and relaxing music on pain intensity, well-being, and sleep quality. This is a pilot study trial of individuals with chronic low back pain. Participants will attend two sessions in the laboratory (week 1 and week 8) and complete their assigned intervention 2 x per week for 6 weeks at home. Participants will be randomized to either receive yoga postures targeting the low back, pain education, and yoga nidra with pain acceptance intention and motor imagery or yoga postures targeting the low back, pain education, and relaxing music.


Eligibility criteria: Inclusion Criteria:

* Chronic pain in lower back that has lasted for over three months
* Pain intensity rated as 3/10 or higher in the past 24 hours (0=no pain, 10=worst pain imaginable)

Exclusion Criteria:

* non-English speaking
* systemic medical conditions that affect sensation (such as uncontrolled diabetes)
* History of surgery or fracture within the past six months
* any blood clotting disorders (such as hemophilia)
* any contraindication to the application of ice (blood pressure \> 140/90 mmHg, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise)
* Exceed pressure and heat sensory thresholds
* Unable to access the internet or email
* Pregnant
* Unable to exercise without medical clearance (assessed on PAR-Q+ on first visit)

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: Completed on week one and week eight
measure: Warwick-Edinburgh Mental Well-Being Scale
timeFrame: Completed on week one and week eight
measure: Pittsburgh Sleep Quality Index
timeFrame: Completed on week one and week eight
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
References:
Clinical trial NCT04607213: Effectiveness of Rotation-advancement and Straight-line Surgical Approaches in Repairing Unilateral Cleft Lip Defect
Official title: Comparison of Rotation- Advancement and Straight-line Methods for Repairing of Unilateral Cleft Lip (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unilateral Cleft Lip
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: compare different effects of Rotation-advancement based on the Millard technique and Straight-line based on Fisher modification as surgical approaches in repairing lip defect of unilateral cleft lip patients.

Detailed description: Twelve participants with unilateral cleft lip equally divided into two groups. Both groups were photographed preoperative and postoperative. The Control group treated using (Rotation-advancement) based on the Millard technique; and the test group treated using (Straight-line) technique based on Fisher modification.

Eligibility criteria: Inclusion Criteria:

* Have complete unilateral cleft lip
* from birth to 4 years old

Exclusion Criteria:

* syndromic cleft patient

Primary outcomes:
measure: change in vertical and horizontal lip length
timeFrame: at 3rd, 6th months
measure: change in lip defect
timeFrame: at 1st, 3rd and 6th months
Secondary outcomes:
measure: change in degree of labial scaring
timeFrame: at 3rd, 6th months
measure: change in nasal symmetry
timeFrame: at 3rd, 6th months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
state: Azarita
Study officials:
References:
Clinical trial NCT03966313: Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation
Official title: Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: End-stage Heart Failure
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with end-stage heart failure (acute or chronic) under surgery for implantation of a ventricular assist device.

Brief summary: Implanting a ventricular assist device (VAD) is a promising therapy for end-stage cardiac failure. However, the implantation of these devices is associated with a high risk of severe hemorrhages and massive blood product transfusion in the first 48 hours following the implantation. The primary purpose of this study is to assess the functionality of the von Willebrand Factor (vWF) which is essential for hemostasis. The hypothesis is that the high shear stress generated by these VAD expose ADAMTS13 cleaving site on the vWF. This result in a loss of high molecular weight vWF and an acquired von Willebrand syndrome.

The secondary purpose of the protocol is to assess platelet function after the implantation of VAD. Indeed, platelet function might be affected shortly after the implantation of the device.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years old
* Who gave his consent to the study
* With an end-stage heart-failure
* Under surgery for a ventricular assist device implantation
* Scheduled or in emergency

Exclusion Criteria:

* Preoperative anemia less than 7 g/dL
* Subject under the protection of justice
* Subject under guardianship or curatorship
* Pregnancy
* Breastfeeding

Primary outcomes:
measure: Von Willebrand Factor activity
timeFrame: From Baseline to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hopitaux Universitaire de Strasbourg
Study officials:
References:
Clinical trial NCT06129513: The Effect of a Plant-blend Protein Isolate on Post-exercise Myofibrillar Protein Synthesis
Official title: The Effect of a Novel Plant-blend Protein Isolate on Post-exercise Myofibrillar Protein Synthesis When Compared to Whey Protein in Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Metabolism
Keywords: Myofibrillar Protein Synthesis
Resistance Exercise
Plant Protein
Stable Isotopes
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Dietary protein ingestion is required to maximise the anabolic response during the recovery from resistance exercise. Whey protein is considered the optimal dietary strategy to maximise post-exercise muscle protein synthesis, but animal-protein production and consumption is associated with growing environmental and ethical concerns. Plant-based protein sources are considered of lesser anabolic quality than isonitrogenous boluses of animal-derived protein attributed to, at least in part, deficiencies in key essential amino acid. Blending different protein sources may overcome amino acid deficiencies and potentiate the post-exercise anabolic response. In the present study the investigators assessed the post-exercise muscle protein synthetic response following the ingestion of a novel plant-based protein isolate when compared with an isonitrogenous bolus of whey protein in healthy young, resistance trained women and men.


Eligibility criteria: Inclusion Criteria:

* BMI between 18 - 30
* Resistance trained (\>3 times per week structured resistance exercise training for at least 3 months)

Exclusion Criteria:

* Any metabolic impairment
* Any cardiovascular impairment
* Smoking
* Lactose intolerance
* Allergies to products containing dairy, meat or nuts
* Prescribed intake of over the counter pharmaceuticals

Primary outcomes:
measure: Post-exercise myofibrillar protein synthesis following protein ingestion
timeFrame: 4 hours
Secondary outcomes:
measure: Post-exercise myofibrillar protein synthesis during the early postprandial period
timeFrame: 2 hours
measure: Post-exercise myofibrillar protein synthesis during the late postprandial period
timeFrame: 2 hours
measure: Plasma amino acid response
timeFrame: 4 hours
measure: Serum insulin response
timeFrame: 4 hours
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
Study officials:
References:
Clinical trial NCT01303913: Predicting Oxygen Desaturation in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: Composite Analysis on Factors That Predict Oxygen Desaturation During Walking in COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: COPD
Oxygen desaturation
Walking test
Lead sponsor: Villa Pineta Hospital
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients

Brief summary: Oxygen desaturation (SO2 \< 88-90%) during walking is a common clinical feature of Chronic Obstructive Pulmonary Disease (COPD) patients. By a predicted analysis our study is aimed to evaluate anthropometric and functional characteristics of COPD patients correlated with oxygen desaturation during Six-minute walking test (6MWT).


Eligibility criteria: Inclusion Criteria:

* COPD patients
* Ability to perform 6MWT
* Normal oxygen saturation at rest and at the begin of 6MWT

Exclusion Criteria:

* No-COPD patients
* Chronic Respiratory Failure patients in Long-term oxygen therapy (LTOT)
* Any co-morbidities

Primary outcomes:
measure: Oxygen saturation nadir (SO2 nadir)
timeFrame: Measured at the end of 6MWT
Secondary outcomes:
Other outcomes:
Locations:
city: Pavullo nel Frignano
country: Italy
facility: Villa Pineta Hospital
state: Modena
Study officials:
affiliation: Villa Pineta Hospital
name: Ernesto Crisafulli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crisafulli E, Iattoni A, Venturelli E, Siscaro G, Beneventi C, Cesario A, Clini EM. Predicting walking-induced oxygen desaturations in COPD patients: a statistical model. Respir Care. 2013 Sep;58(9):1495-503. doi: 10.4187/respcare.02321. Epub 2013 Jan 29.
Clinical trial NCT05220813: Ilioinguinal Nerve Block in Transcatheter Aortic Valve Implantation
Official title: Does Ilioinguinal Block Provide Satisfactory Analgesia During Transcatheter Aortic Valve Implantation Procedure? A Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 88
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: To assess the effect of iliohypogastric and ilioinguinal nerve block on the hemodynamic stability ,narcotic consumption and the rate of conversion to general anesthesia in patients undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI).


Eligibility criteria: Inclusion Criteria:

* • Patients undergoing TF-TAVI.

  * Both sexes.
  * Age 18 and above

Exclusion Criteria:

* • Inability to tolerate supine position as in patients with musculoskeletal disease or back pain, OR in patients with congestive heart failure or with obstructive sleep apnea.

  * Patients with severe pulmonary hypertension (PAP\>60 mmhg)
  * Barrier to communications as language barrier or dementia.
  * Patients' preference of general anesthesia.
  * Surgical consideration as transapical, subclavian approach, extensive TEE requirements.
  * Patients with history of allergy to any drugs used.
  * Patients with psychiatric disease.
  * Patients with neurocognitive or neurodegenerative disease.
  * Secondary exclusion criteria include abortion of the procedure, perioperative emergency conversion to general anesthesia and the need to cardiopulmonary resuscitation so the primary endpoint couldn't be detected in these conditions.

Primary outcomes:
measure: conversion to general anesthesia.
timeFrame: during the procedure (intraoperatively)
Secondary outcomes:
measure: propofol dose
timeFrame: during the procedure (intraoperatively)
measure: fentanyl dose
timeFrame: during the procedure (intraoperatively)
measure: sedation score
timeFrame: during the procedure (intraoperatively)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ismail Mohammed Ibrahim
Study officials:
References:
Clinical trial NCT06990113: Three-dimensional Lumbar Myofascial Release and Motor Control in Lumbar Radiculopathy
Official title: Effect of Three-dimensional Lumbar Myofascial Release With Motor Control Training on Back Perception and Pain in Patients With Lumbar Radiculopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lumbar Radiculopathy
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 32
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients were randomly divided into two equal groups; Study group (16 patients): received three dimensional lumbar myofascial release with motor control training, and conventional treatment. Control group (16 patients): received conventional treatment.
Primary purpose: TREATMENT

Brief summary: to investigate The Efficacy of three-dimensional lumbar myofascial release with motor control training on back perception and pain in lumbar radiculopathy Patients with lumbar radiculopathy demonstrate impairments in function and range of motion to deficits in patient's quality of life.

Detailed description: PURPOSE: to investigate The Efficacy of three-dimensional lumbar myofascial release with motor control training on back perception and pain in lumbar radiculopathy Patients with lumbar radiculopathy demonstrate impairments in function and range of motion to deficits in patient's quality of life.

HYPOTHESES: It will be hypothesized that there will be no statically Effect of three dimensional lumbar myofascial release with motor control training on back perception and pain in lumbar radiculopathy RESEARCH QUESTION: Is there an Effect of three-dimensional lumbar myofascial release with motor control training on back perception and pain in lumbar radiculopathy

Eligibility criteria: Inclusion Criteria:

* Their ages range from 35 to 50 years.
* Both sex
* Unilateral lumbar radiculopathy for more than 6 months.
* Normal body mass index (18.5 - 24.99Kg/m2).

Exclusion Criteria:

* • Any other musculoskeletal disorders of the spine or upper extremity

  * Patients with any other Neurological deficits, psychiatric disease lumbar myelopathy, Cognitive problems, vertebral fractures and previous history of spine or lumbar surgery.
  * Clinical instability, recent trauma
  * Structural abnormalities of the spine, osteoporosis, and spasmodic torticollis.
  * Inflammatory or other specific disorders of spina such as ankylosing spondylitis and rheumatoid arthritis

Primary outcomes:
measure: Fremantle Back Awareness Questionnaire
timeFrame: four weeks
measure: Oswestry Low Back Pain Disability Questionnaire
timeFrame: four weeks
Secondary outcomes:
measure: pressure pain algometer
timeFrame: four weeks
measure: visual analog scale
timeFrame: four weeks
Other outcomes:
Locations:
city: Al Jīzah
country: Egypt
facility: Lama Saad El-Din Mahmoud
state: Select State
Study officials:
References:
Clinical trial NCT02226913: Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of IAN Block of Teeth With Irreversible Pulpitis
Official title: Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of Inferior Alveolar Nerve Block for Teeth With Symptomatic Irreversible Pulpitis: A Prospective, Randomized Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Local Anesthesia
Keywords: Buffered
inferior alveolar nerve block
irreversible pulpitis
local anesthesia
sodium bicarbonate
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-08-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Buffering of local anesthetics (alkalinization) has been suggested in achieving pain control. The purpose of this prospective, randomized, double-blind study was to evaluate the effect of adding 0.6 mL 8.4% sodium bicarbonate to 3.0 mL 2% lidocaine with 1: 80,000 epinephrine on the success rate of IAN block for endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.

Detailed description: Some studies have been shown buffering of local anesthetics reduce pain of injection, hasten the onset of anesthesia, and improved success rate of anesthesia. Others reported buffering of local anesthetics cannot reduce pain of injection, hasten the onset of anesthesia, and improve success rate of anesthesia. There are no studies evaluating a sodium bicarbonate-buffered lidocaine formulation for IAN block for teeth with irreversible pulpitis.

Eligibility criteria: Inclusion Criteria:

* vital mandibular molar tooth
* diagnosis of symptomatic irreversible pulpitis

Exclusion Criteria:

* younger than 18 years old
* history of significant medical conditions
* allergies to local anesthetics or sulfites
* pregnancy
* taking any medications that might influence anesthetic assessment
* active sites of pathosis in area of injection
* inability to give informed consent

Primary outcomes:
measure: Percentage of the success of IAN Block anesthesia with a buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block
timeFrame: Baseline
Secondary outcomes:
measure: Heft-Parker visual analog scale recording of a non-buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Masoud Saatchi, DDS MSc
role: STUDY_CHAIR
References: