louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01411228: A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
Official title: A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gaucher Disease
Keywords: Gaucher disease
pediatrics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-08-08
Enrollment: 15
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A protocol to extend the assessment of the safety and efficacy of taliglucerase alfa in pediatric subjects (2 to \<18 years old) with symptoms and clinical manifestations of Gaucher disease who completed treatment in Protocols PB-06-002 (switchover study from imiglucerase) or PB-06-005 (naïve treatment with taliglucerase alfa).


Eligibility criteria: Inclusion Criteria:

* Successful completion of Protocol PB-06-002 or PB-06-005
* The subject, parent(s) or legal guardian(s) signs an informed consent and/or assent

Exclusion Criteria:

* Currently taking another investigational drug for any condition.
* Presence of neurological signs and symptoms characteristic of Gaucher disease with complex neuronopathic features other than longstanding oculomotor gaze palsy.
* Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the subject's compliance with the requirements of the study.

Primary outcomes:
measure: Hemoglobin
timeFrame: Baseline, months 9, 12 and 24
Secondary outcomes:
measure: Chitotriosidase
timeFrame: Baseline, months 9, 12 and 24
measure: Spleen Volume
timeFrame: Baseline, months 12 and 24
measure: Platelet Count
timeFrame: Baseline, months 9, 12, 24 and 33-36
measure: Liver Volume
timeFrame: Baseline, months 12 and 24
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Barrio Asuncion
country: Paraguay
facility: Instituto Privado de Hematologia E Investigacion Clinica (I.P.H.I.C)
city: Morningside
country: South Africa
facility: Morningside Medi-Clinic
Study officials:
References:
citation: Zimran A, Gonzalez-Rodriguez DE, Abrahamov A, Cooper PA, Varughese S, Giraldo P, Petakov M, Tan ES, Chertkoff R. Long-term safety and efficacy of taliglucerase alfa in pediatric Gaucher disease patients who were treatment-naive or previously treated with imiglucerase. Blood Cells Mol Dis. 2018 Feb;68:163-172. doi: 10.1016/j.bcmd.2016.10.005. Epub 2016 Oct 20.
citation: Abbas R, Park G, Damle B, Chertkoff R, Alon S. Pharmacokinetics of Novel Plant Cell-Expressed Taliglucerase Alfa in Adult and Pediatric Patients with Gaucher Disease. PLoS One. 2015 Jun 8;10(6):e0128986. doi: 10.1371/journal.pone.0128986. eCollection 2015.
Clinical trial NCT04779528: Awake Nasal Fiber-optic Intubation of Severely Obese Patients in Lateral Position
Official title: Awake Nasal Fiber-optic Intubation of Severely Obese Patients in Lateral Position: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Intubation;Difficult
Intubation; Difficult or Failed
Anesthesia Intubation Complication
Keywords: Anesthesia
Intubation
obesity
fiberoptic
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 60
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: Airway management in severely obese patients remains a challenging issue for anesthetists and may lead to life-threatening situations. Awake Fiber-Optic Bronchoscopy Intubation (FOBI) technique is considered as the gold standard when a difficult airway is anticipated to secure the airway and to facilitate the surgery. FOBI is usually done in supine position, while (in conscious patients) lateral position is the most recommended position to keep the upper airway patent. This prospective clinical trial study will test whether awake FOBI in Lateral position will provide a safe profile or a significant advantage over FOBI in supine position, in morbidly obese patients undergoing elective bariatric surgery.

Detailed description: Airway management in severely obese patients remains a challenging issue for anesthetists and may lead to life-threatening situations. Awake Fiber-Optic Bronchoscopy Intubation (FOBI) technique is considered as the gold standard when a difficult airway is anticipated to secure the airway and to facilitate the surgery. FOBI is usually done in supine position, while (in conscious patients) lateral position is the most recommended position to keep the upper airway patent.

This prospective clinical trial study will test whether awake FOBI in Lateral position will provide a safe profile or a significant advantage over FOBI in supine position, in morbidly obese patients undergoing elective bariatric surgery. The main outcome is success rate and duration of the procedure. Secondary outcomes are oxygenation maintenance, hemodynamic stability, airway complication, sedation score, and postoperative airway morbidity in 6 hours after surgery.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status classification two and three.
* Patients scheduled for elective bariatric surgeries under general anesthesia.

Exclusion Criteria:

* Refusal of fiberoptic intubation.
* Allergy to local anesthetics.
* Coagulopathy.
* Raised intracranial or intraocular pressure.

Primary outcomes:
measure: Duration of fiberoptic intubation.
timeFrame: 5 minutes
Secondary outcomes:
measure: Complications during airway manipulation.
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
Study officials:
References:
Clinical trial NCT01625728: Vocal Demands Among Classroom Teachers
Official title: A Comparison of Vocal Demands With Vocal Performance Among Classroom Teachers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Voice Disorders
Keywords: Voice
aerodynamics
acoustics
Lead sponsor: Southern Illinois University Carbondale
Sponsor class: OTHER
First posted: 2012-06-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants in the experimental group: student teachers enrolled in teaching education programs and active teachers. Participants in the control group: not enrolled in teaching education programs and are not active teachers.

Brief summary: The purpose of the study "A comparison of vocal demands with vocal performance among classroom teachers" is to gather information about the voice production of teachers using three separate strategies: (a) measures of voice assessed with the Computerized Speech Lab (CSL) and the Phonatory Aerodynamic System (PAS) instruments in the SIUC Voice Lab.

Detailed description: (a) measures of voice assessed with the Computerized Speech Lab (CSL) and the Phonatory Aerodynamic System (PAS) instruments in the SIUC Voice Lab

Eligibility criteria: Inclusion Criteria:

* Enrollment in teaching education programs; active teachers.

Exclusion Criteria:

* Current diagnosed with voice disorder.

Primary outcomes:
measure: Acoustic measures of voice.
timeFrame: 1 year
Secondary outcomes:
measure: Identify changes in aerodynamic measures of voice.
timeFrame: 1 year
Other outcomes:
Locations:
city: Carbondale
country: United States
facility: Southern Illinois University Carbondale
state: Illinois
Study officials:
affiliation: Southern Illinois University Carbondale
name: Maria Claudia Franca, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01251328: Near INfrared Spectroscopy in Aortic valvE ReplacemenT
Official title: Near Infrared Spectroscopy in Aortic Valve Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Transcatheter Aortic Valve Implantation
Eligibility for Both Anaesthetic Methods
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2010-12-01
Enrollment: 62
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: Transcatheter aortic valve implantation (TAVI) is an alternative for patients, that are considered to be too sick for conventional aortic valve replacement. There is no conclusive opinion about the best anesthesiologic management of these patients. Sedation and general anaesthesia are both adequate and the current literature shows no benefit towards one of these methods.

This study wants to investigate the influence of these two anesthesiologic managements on the cerebral oxygen saturation during the "rapid pacing"-period during valvuloplasty. The patients are randomised allocated to one of these two anaesthesiological managements. The investigators use the Near-Infrared Spectroscopy (NIRS) to measure the cerebral oxygen saturation. Parallel there will be a measurement of cerebral biomarkers to monitor cerebral hypoxia.


Eligibility criteria: Inclusion Criteria:

* informed consent
* transcatheter aortic valve implantation

Exclusion Criteria:

* denial by patient
* denial by screening anaesthesist
* active neurodegenerative disease

Primary outcomes:
measure: Cerebral oxygen desaturation during the "rapid pacing" period and periprocedural
timeFrame: up to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
state: Bavaria
Study officials:
affiliation: Deutsches Herzzentrum München, Department of Anaesthesiology, Technische Universität München
name: Patrick N Mayr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mayr NP, Hapfelmeier A, Martin K, Kurz A, van der Starre P, Babik B, Mazzitelli D, Lange R, Wiesner G, Tassani-Prell P. Comparison of sedation and general anaesthesia for transcatheter aortic valve implantation on cerebral oxygen saturation and neurocognitive outcomedagger. Br J Anaesth. 2016 Jan;116(1):90-9. doi: 10.1093/bja/aev294. Epub 2015 Sep 29.
Clinical trial NCT06851728: Immediate Skeletal and Dento-alveolar Effects of Two and Four Mini-screw Supported Hyrax for Maxillary Expansion in Non-growing Patients
Official title: Immediate Skeletal and Dento-alveolar Effects of Two and Four Mini-screw Supported Hyrax for Maxillary Expansion in Non-growing Patients: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transverse Maxillary Deficiency
Posterior Crossbite, Upper Airway
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two experimental groups ,two screw supported and four screw supported hyrax
Primary purpose: TREATMENT

Brief summary: transverse malocclusion is very common in adult ,using conventional hyrax expander has many limitations and side effects, therefore ,recently A minis crews assisted rapid expansion is recently introduced to overcome hence complications

Detailed description: transverse malocclusion is very common in adult ,using conventional hyrax expander has many limitations and side effects such as buccal tipping, marginal bone loss, dento aloveolar expansion.

in such cases , surgically assisted rapid palatal expansion used to be the option of choice ,due to the invasiveness of the procedure and co-morbidity associated with it ,minis crews assisted rapid expansion is recently introduced to overcome the complications of both convectional and surgically assisted rapid palatal expansion

Eligibility criteria: Inclusion Criteria:

* adults male or female aged from 18-30 years with skeletal Maxillary constriction
* unilateral or bilateral Dental posterior cross-bite
* mid-palatal suture maturation (Grade C, D) according to F Angileri classification
* good oral hygiene

Exclusion Criteria:

* no functional crossbite due to premature contacts
* no previous orthodontic treatment
* no buccal crossbite
* no craniofacial anomalies or syndromes.

Primary outcomes:
measure: Skeletal effects
timeFrame: the outcome will be assessed immediate post expansion (one month-tow month)
Secondary outcomes:
measure: Dento-alveolar effects
timeFrame: 1-2 months
measure: Dento-alveolar effects
timeFrame: 1-2 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: 11,ElSaraya street ,Almanyal ,CAIRO ,EGYPT
Study officials:
affiliation: Associate proff
name: fady hussein fahim, PhD
role: STUDY_DIRECTOR
affiliation: lecturer
name: nada Omer elzawahry, PhD
role: STUDY_DIRECTOR
affiliation: MSc degree candidate
name: elzubair osman salih, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT02898428: Continuous Glucose Monitoring in New Mothers With Type 1 Diabetes
Official title: Continuous Glucose Monitoring During Breastfeeding or Formula Feeding in New Mothers With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoglycemia
Breastfeeding
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: New mothers with type 1 diabetes

Brief summary: With appropriate day-time carbohydrate intake and insulin dose, the 24 hour glucose levels and prevalence of night-time hypoglycaemia are comparable in breastfeeding new mothers and formula feeding new mothers with type 1 diabetes at the second after delivery diabetes control compared with the first after delivery diabetes control at Steno Diabetes Center.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 45 years.
* Delivery of a single infant.
* Proficiency in Danish to read and understand the patient information sheet, questionnaires and to converse with the diabetes caregivers.

Exclusion Criteria:

* A diagnosis with severe mental or psychiatric barriers or a concurrent disease on the decision of the principal investigator

Primary outcomes:
measure: Hypoglycemia
timeFrame: Night-time 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center Copenhagen
Study officials:
References:
citation: Ringholm L, Roskjaer AB, Engberg S, Andersen HU, Secher AL, Damm P, Mathiesen ER. Breastfeeding at night is rarely followed by hypoglycaemia in women with type 1 diabetes using carbohydrate counting and flexible insulin therapy. Diabetologia. 2019 Mar;62(3):387-398. doi: 10.1007/s00125-018-4794-9. Epub 2019 Jan 3.
Clinical trial NCT00510328: Vibration Therapy Effects on Muscle Firing Patterns
Official title: Vibration Therapy Effects on Muscle Firing Patterns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: whole body vibration
muscle physiology
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2007-08-02
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the effects of whole body vibration therapy on muscle firing patterns as measured by EMG analysis.

Detailed description: Proprioception is the specialized sensory modality that informs the body as to movement, position, and spatial orientation through mechanisms that track sensations accompanying joint movement and position. Mechanoreceptors in joints, along with vestibular, visual, muscle spindle, Golgi tendon organ, ligament and tendon sensory receptors, comprise the propriosensory system, which conveys information to the motor system to maintain equilibrium on a reflexive, automatic basis. Alterations in somatosensory input from mechanoreceptors have been identified as causing aberrant muscle firing patterns.

Eligibility criteria: Inclusion Criteria:

* Logan student, staff, or faculty with no history of ankle injury
* Ages 18 - 60 years old
* Logan student, staff, or faculty with no history of ankle surgery
* No visual or vestibular condition that would affect balance

Exclusion Criteria:

* Systemic illnesses that have an adverse effect on balance
* Local infection, injury, or other malignancy affecting the lower extremity
* Any unstable joints of the lower extremity
* Any spinal manipulation within 48 hours
* Prescription or herbal muscle stimulants, relaxants, etc. that could affect balance
* Pregnancy

Primary outcomes:
measure: Electromyographic analysis of the gastrocnemius muscle
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan University, College of Chiropractic
state: Missouri
Study officials:
affiliation: Logan College of Chiropractic
name: Dennis E. Enix, DC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06771128: Ginkgo Biloba Vs Desmopressin in Treatment of Children with Monosymptomatic Nocturnal Enuresis
Official title: Ginkgo Biloba Versus Desmopressin in Treatment of Children with Monosymptomatic Nocturnal Enuresis: a Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nocturnal Enuresis in Children
Desmopressin
Monosymptomatic Nocturnal Enuresis
Keywords: monosymptomatic nocturnal enuresis
nocturnal enuresis
desmopressin
Ginkgo Biloba
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 90
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the efficacy of Ginkgo Biloba versus desmopressin in treatment of children with monosymptomatic nocturnal enuresis

Detailed description: Bedwetting among children is a common disorder, affecting 30% at age 4, 10% at age 6, 3% at age 12, and 1% at age. Untreated, the spontaneous cure rate is about 15% a year. Treatment is dominated by two approaches, enuresis alarm and drugs.

Treatment with drugs has largely been focused on tricyclic antidepressants especially imipramine or, more recently, antidiuretic agents such as desmopressin. For imipramine the proportion of total remission is 10-50% during treatment and a long term cure in 5-40%. However, numerous reports of side effects, some lethal, have led to a decline in its use.

One of theory of nocturnal enuresis is deep sleep in children, this the main cornerstone in using Alarm as line of management.

On the other hand drugs used in re-habitation of sleep rhythm seems to be with great benefits in management as GINKGO BILOBA.

Ginkgo biloba leave extract is among the most widely sold herbal dietary supplements in the United States. Its purported biological effects include: scavenging free radical; lowering oxidative stress; reducing neural damages, reducing platelets aggregation; anti-inflammation; anti-tumor activities; anti-aging, and improve night sleep rhythm.

the aim of this study is to evaluate the effect of Ginkgo Biloba versus desmopressin in treatment of children with monosymptomatic nocturnal enuresis.

Eligibility criteria: Inclusion Criteria:

* all children with monosymptomatic nocturnal enuresis.

Exclusion Criteria:

* children with day and night wetting.

Primary outcomes:
measure: Night wetting frequency
timeFrame: 1, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shebin El-Kom
country: Egypt
facility: Menoufia Faculty of Medicine
state: Menoufia
Study officials:
References:
Clinical trial NCT04441528: Lid Wipes Versus Baby Shampoo in Patients With Seborrehic Blepharitis
Official title: Randomized Double-Blind Trial of Lid Wipes Containing Terpinen-4-ol and Sodium Hyaluronate Versus Baby Shampoo in Patients With Seborrheic Blepharitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seborrheic Blepharitis
Keywords: seborrheic blepharitis
terpinen-4-ol
baby shampoo
lid wipes
sodium hyaluronate
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Koç University
First posted: 2020-06-22
Enrollment: 48
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 investigate the efficacy of lid wipes containing terpinen-4-ol and sodium hyaluronate (Hy-ter®) for the treatment of seborrheic blepharitis compared to baby shampoo.

Detailed description: After being informed about the study and potential risks, all patients giving written consent will have a complete ophthalmological examination to determine eligibilty for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double blind manner (participant and investigator) in a 1:1 ratio to lid wipes containing terpinen-4-ol and sodium hyaluronate (Hy-ter®) or baby shampoo (twice daily).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of seborrheic blepharitis

Exclusion Criteria:

* Patients with ophthalmological pathologies that may affect the tear film functions including ocular rosacea, contact lens use, history of any ocular surgery, or patients with systemic pathologies or those using systemic medications that may affect the tear film functions
* Patients younger than 18-year-old
* Patients who used any treatment for blepharitis within the 6 months prior to the examination

Primary outcomes:
measure: Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score
timeFrame: 0-4-8-12 weeks
Secondary outcomes:
measure: Efficacy of the treatment assessed by the change in Demodex mite count by light microscopy
timeFrame: 0-4-8-12 weeks
measure: Efficacy of the treatment assessed by the change in the Schirmer test results
timeFrame: 0-4-8-12 weeks
measure: Efficacy of the treatment assessed by the change in the tear breakup time
timeFrame: 0-4-8-12 weeks
measure: Efficacy of the treatment assessed by the change in the ocular surface disease index score
timeFrame: 0-4-8-12 weeks
measure: Efficacy of the treatment assessed by the change in the non-invasive tear breakup time
timeFrame: 0-4-8-12 weeks
measure: Efficacy of the treatment assessed by the change in the meibomian gland loss
timeFrame: 0-4-8-12 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References: