louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00313183: A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus
Official title: A Randomized, Single-Blind, Dose-Rising, Placebo-Controlled, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of SYMLIN in Adolescent Subjects With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes
pediatric
pramlintide
Symlin
Amylin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-04-12
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will be the first evaluation of Symlin in adolescent subjects with type 1 diabetes mellitus and is designed to evaluate the blood levels (pharmacokinetics), biochemical and physiological effects (pharmacodynamics), and safety and tolerability of Symlin in these subjects.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 1 diabetes mellitus for at least 1 year prior to screening
* Be on a stable regimen requiring multiple daily injections of basal and mealtime insulin or continuous subcutaneous insulin infusion for at least 2 weeks prior to screening
* HbA1c between 6.0% and 10.0%, inclusive, at screening
* Body weight \>=50 kg at screening

Exclusion Criteria:

* Currently being treated with the following medications: \*Any oral antihyperglycemic agent; \*Drugs that directly affect gastrointestinal motility
* Has been previously treated with Symlin/pramlintide (or has participated in a Symlin/pramlintide clinical study)
* Has received any investigational drug within 1 month of screening

Primary outcomes:
measure: To evaluate the pharmacokinetics of Symlin in adolescent subjects with type 1 diabetes
timeFrame: single doses
measure: To assess the safety and tolerability of Symlin in adolescent subjects with type 1 diabetes
timeFrame: single doses
Secondary outcomes:
measure: To evaluate the effects of Symlin compared to placebo in adolescent subjects with type 1 diabetes on various pharmacodynamic endpoints
timeFrame: single doses
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: New York
country: United States
facility: Research Site
state: New York
Study officials:
affiliation: Amylin Pharmaceuticals, LLC.
name: Lisa Porter, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05101083: Speech Intelligibility in Quiet and Noise for New vs. Legacy Hearing Aids
Official title: Speech Intelligibility in Quiet and Noise for New Versus Legacy Hearing Aids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Hearing Loss
Lead sponsor: Starkey Laboratories, Inc
Sponsor class: INDUSTRY
First posted: 2021-11-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment - Each participant will experience both test conditions (counterbalanced)
Primary purpose: TREATMENT

Brief summary: This clinical investigation is designed to compare audiological performance (i.e., measurements of sound quality and speech understanding) between Starkey's new receiver-in-canal device and a commercially available legacy receiver-in-canal device.

Detailed description: Starkey is investigating a new hearing aid with several new audiological features. These features have been assessed for benefit, individually, but this clinical investigation will serve as a test for safety and efficacy with all hearing aid features, together. The design of this study is a single-blinded, crossover design and will be conducted at Starkey's headquarters in Eden Prairie, MN.

Eligibility criteria: Inclusion Criteria:

* Adults, minimum age of 18
* Native English speakers
* Ability to complete questionnaires and laboratory assessments
* Symmetric, mild to moderately-severe sensorineural hearing loss
* Informed consent completed with signature

Exclusion Criteria:

* Inability to visit the Starkey Headquarters building for testing
* Central or middle ear hearing problems
* Medical contraindications to wearing hearing aids
* Learning disability, major cognitive handicap, or serious neurological or psychiatric disease that would prevent or restrict participation, as determined by the PI or designee

Primary outcomes:
measure: Speech intelligibility (% words repeated back correctly) in quiet and noise for new vs. legacy hearing aids
timeFrame: Four weeks
Secondary outcomes:
measure: First fit ratings of sound quality on subjective questionnaires for the new vs. legacy hearing aids
timeFrame: Four weeks
measure: Safety of the new, receiver-in-canal devices through tracking of adverse events
timeFrame: Four weeks
Other outcomes:
Locations:
city: Eden Prairie
country: United States
facility: Starkey
state: Minnesota
Study officials:
References:
Clinical trial NCT01381783: Phacoemulsification Under Topical Anesthesia and Its Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Phacoemulsification
Keywords: topical anaesthesia
Phacoemulsification
Lead sponsor: Instituto de Oftalmologia Ivo Correa-Meyer
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 111
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if topical anesthesia is safe for phacoemulsification in eyes with comorbidities.


Eligibility criteria: Inclusion Criteria:

* patients with cataract with a visual acuity less than 0.8

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of Postoperative events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04344483: Effect of Lidocaine and Adrenaline Soaked Gauze Versus Normal Saline Soaked at Skin Graft Donor Site of Thigh
Official title: Effect of Lidocaine and Adrenaline Soaked Gauze Versus Normal Saline Soaked at Skin Graft Donor Site of Thigh: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-healing Wound
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients with non healing wound who will otherwise be healthy will be recruited in the study and will randomly assign groups. One group will receive Adrenaline and Lidocaine soaked gauze and the second group will be a control group who will receive normal saline soaked gauze.
Primary purpose: TREATMENT

Brief summary: Investigator is studying the effects of Lidocaine and Adrenaline Soaked Gauze vs Normal Saline Soaked Gauze at Skin Graft Donor Site of Thigh.

Haemostatic effect, epithelization and post operative pain will be assessed on follow up.

Detailed description: After admission participants will be randomized either to be in Group A or Group B. Closed envelop technique will be used for random assignment of the patients.

Group A will be receiving 2% lidocaine and 1:100,000 adrenaline soaked gauze while group B will be given only normal saline soaked gauze at donor-site for ten minutes.

The primary end point of study is intraoperative bleeding. The secondary end points of study include no. of dressings required in first 24 hours after surgery, donor site epithelization at 14th post-operative day, post-operative pain in first 24 hours after surgery along with systemic analgesia requirement after surgery.

Eligibility criteria: Inclusion Criteria:

* • Patients of both the gender of age \> 15 years

  * Multiple donor-sites

Exclusion Criteria:

Bleeding disorder

* Concomitant injuries
* Donor site other than thigh
* Previously harvested donor-site
* Patients on antiplatelet medications

Primary outcomes:
measure: Intra operatieve bleeding
timeFrame: per operative
measure: Post operative bleeding
timeFrame: 24 hours
measure: Post operative pain
timeFrame: 24 hours
measure: Analgesia requirement
timeFrame: 24 hours
Secondary outcomes:
measure: Epithelization of donor site
timeFrame: 14 days
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Zaara Zahid
state: Sindh
Study officials:
References:
citation: Gacto P, Miralles F, Pereyra JJ, Perez A, Martinez E. Haemostatic effects of adrenaline-lidocaine subcutaneous infiltration at donor sites. Burns. 2009 May;35(3):343-7. doi: 10.1016/j.burns.2008.06.019. Epub 2008 Oct 23.
Clinical trial NCT01429883: Extracorporeal Shock Wave Treatment - Can the Pain be Reduced?
Official title: Extracorporeal Shock Wave Treatment - Can the Pain be Reduced?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fasciitis, Plantar
Achillodynia
Periarthritis Calcarea
Epikondylopathia Humeri /Radii
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2011-09-07
Enrollment: 36
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: Patients with Fascititis plantaris, Achillodynie, Periarthropathia humerosacpularis calcarea or Epikondylopathia humeri /radii, who got the shock wave therapy.

Brief summary: Patients with Fascititis plantaris, Achillodynie, Periarthropathia humerosacpularis calcarea or Epikondylopathia humeri /radii get the shock wave therapy in our clinic as planned. During our study the investigators want to ask for pain, pain reduction and function.

Detailed description: Patients with either Fascititis plantaris, Achillodynie, Periarthropathia humerosacpularis calcarea or Epikondylopathia humeri /radii get a shock wave therapy in our clinic of rheumatology as planned. During our study the investigators ask for pain, pain reduction and function (all questionnaires).

Eligibility criteria: Inclusion criteria:

-Patients with:

* Fascititis plantaris,
* Achillodynie,
* Periarthropathia humerosacpularis calcarea or
* Epicondylopathia humeri /radii, who got the shock wave therapy.

Exclusion criteria:

* Anticoagulation,
* Sepsis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
affiliation: University Hospital Zurich, Division of Rheumatology
name: Sandra Blumhardt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06493383: Lotrafilcon B Plano Cosmetic Contact Lenses Study
Official title: Lotrafilcon B Plano Cosmetic Contact Lenses Post-Market Clinical Follow-Up Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cosmetic Appearance
Keywords: Eye color
Colored contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to gather long-term performance and safety data on AIR OPTIX™ COLORS (lotrafilcon B) plano cosmetic contact lenses in subjects 12 years of age and older. AIR OPTIX™ COLORS plano contact lenses do not contain visual correction and are worn for cosmetic purposes only.

Detailed description: Eligible participants will receive the contact lens color of their choice (if available) to be used as intended by the manufacturer for the duration of their participation in the study, approximately 1 year.

Eligibility criteria: Key Inclusion Criteria:

* Subject and/or parents/legally authorized representative must be able to understand and sign an approved informed consent form.
* Has never worn contact lenses before, with or without refractive error correction.
* Willing to wear cosmetic contact lenses and who have expressed interest in 1 to 3 color variants of lotrafilcon B plano cosmetic contact lenses.
* Willing to wear the study lenses at least 5 hours per day for at least 2 days a week during the study.
* Best Corrected Visual Acuity (BCVA) of 20/25 or better in each eye at screening.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Any ocular disease or condition that would contraindicate contact lens wear.
* Pregnant and lactating women.
* Any use of systemic or ocular medications that would contraindicate contact lens wear.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Incidence of corneal infiltrative events
timeFrame: Up to Year 1
measure: Incidence of microbial keratitis
timeFrame: Up to Year 1
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT01971983: Effect of Two Osteopathic Techniques on Thickness of Paravertebral Muscles of the Lumbar Spine
Official title: Effect of Two Osteopathic Techniques on Thickness of Paravertebral Muscles of the Lumbar Spine: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Spinal manipulation
Osteopathy
Muscle energy technique
Muscle thickness
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2013-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this randomized controlled trial is to describe the effect of two osteopathic techniques - "high velocity, low amplitude" (HVLA) and muscle energy (ME) - on thickness, activation, strength, pressure pain threshold (PPT) of the paravertebral muscles at the lumbar spine, as well as the peak plantar pressures immediately and after a two-day follow-up.

The muscle thickness of the paravertebral muscles at the lumbar spine, namely internal oblique, external oblique and transversus abdominis can be altered after the application of 'high-velocity low-amplitude'(HVLA)and 'muscle energy' (ME)techniques immediately and after a two-day follow-up.


Eligibility criteria: Inclusion Criteria:

* At least one episode of low back pain over the last three months; confirmation of lumbar spine dysfunction by an experienced osteopath; age between 18 and 40 years; do not have performed physical stress activities over the last 24 hours; do not be physically active (physical activity for at least three times a week); fulfill the orientations to the follow-up assessment.

Exclusion Criteria:

* History of surgery, fracture or fixation on the lumbar spine and/or the pelvis; being pregnant; signs of radiculopathy; disc herniation at the lumbar spine; degenerative process at the lumbar spine; have received any kind of manipulative treatments over the past four weeks;

Primary outcomes:
measure: Muscle thickness
timeFrame: immediate
measure: Muscle thickness
timeFrame: Two days
Secondary outcomes:
measure: Pressure pain threshold
timeFrame: Immediate
measure: Pressure pain threshold
timeFrame: Two days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Laboratory of Physiotherapy - The Federal University of Health Sciences of Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: The Federal University of Health Sciences of Porto Alegre
name: Rodrigo F Angellos, Physiotherapis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03282383: Identification of Biomarkers for Severe Pneumonia
Official title: Shanghai Changhai Hospital,Second Military Medical University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biomarkers
Keywords: biomarkers pneumonia severity
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: collection the blood from 600 patients

Brief summary: To identify the potential serum biomarkers with regard to the severity of pneumonia, and to further evaluate the prognostic value of these markers.

Detailed description: First, we will collect serum samples from patients with pneumonia. Then we will identify biomarkers differentially expressed between non-severe pneumonia and severe pneumonia. We will further evaluate the prognostic value of these markers for pneumonia.

Eligibility criteria: Inclusion Criteria:

- under 18 years old

Exclusion Criteria:

* over 80 years old

Primary outcomes:
measure: microRNA
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Changhai Hospital
name: Xiangyu Kong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05275283: Efficacy Evaluation of Positive End-expiratory Pressure in Children Undergoing Mechanical Ventilation Using Supraglottic Airway Device
Official title: Efficacy Evaluation of Positive End-expiratory Pressure in Children Undergoing Mechanical Ventilation Using Supraglottic Airway Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Positive End Expiratory Pressure
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 94
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to determine whether application of positive end-expiratory pressure (PEEP) improves respiratory data including respiratory compliance in children who receive positive pressure ventilation using supraglottic airway device (SAD).


Eligibility criteria: Inclusion Criteria:

* Pediatric patients under 6 years of age who are scheduled simple operation under general anesthesia
* SAD was used for mechanical ventilation

Exclusion Criteria:

* Abdominal distension, risk of pulmonary aspiration
* Bronchopulmonary dysplasia/respiratory distress syndrome
* Pneumothorax
* Airway surgery
* Thoracic surgery or laparotomy
* Surgery under prone position

Primary outcomes:
measure: Respiratory system compliance
timeFrame: at the end of surgery, about 2 hours after starting of mechanical ventilation
Secondary outcomes:
measure: Respiratory system compliance
timeFrame: 10 minutes, 30 minutes, 60 minutes after starting of mechanical ventilation
measure: oropharyngeal leak pressure
timeFrame: immediate after SAD insertion
measure: Electrical impedance tomography parameter - dynamic compliance
timeFrame: throughout anesthesia (about during 1-3 hours)
measure: Electrical impedance tomography parameter - regional ventilation delay
timeFrame: throughout anesthesia (about during 1-3 hours)
measure: Electrical impedance tomography parameter - pulmonary opening pressure
timeFrame: throughout anesthesia (about during 1-3 hours)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hee-Soo Kim
Study officials:
References:
Clinical trial NCT05209997: Observational, Real-life, Retrospective, Data Collection, Use Sibutramine/topiramate in Overweight Comorbidities/obesity
Official title: An Observational, Multicenter, National Study with Real-life Retrospective Data Collection on the Combined Use of Sibutramine and Topiramate As Anti-obesity Treatment in Overweight Patients with Comorbidity(ies) or Obesity.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Overweight
Obesity
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2022-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients, of both sexes, for whom combination treatment with sibutramine and topiramate, both at any dose/dosage, with prescribed treatment between the year 2011 and the beginning of the study

Brief summary: An observational, multicenter, national study with retrospective real-life data collection on the combined treatment of sibutramine and topiramate (off-label use) for the treatment of overweight with comorbidity(ies) or obesity. Data from all adult patients, of both sexes, for whom combination treatment with sibutramine and topiramate, both at any dose/dosage, were prescribed between the year 2011 and the beginning of the study will be included in the study.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Both sexes
* Diagnose of overweight with comorbidity(ies) or obesity
* Treatment use of sibutramine combined with topiramate
* Treatment prescription between 2011 and the beginning of the study

Exclusion Criteria:

* Use of topiramate for other condition besides overweight with comorbidity(ies) or obesity
* Individual use of one of the medications (sibutramine or topiramate)

Primary outcomes:
measure: The percentage of patients who achieved a weight loss greater than 5%
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: HC-FMUSP
state: SP
city: São Paulo
country: Brazil
facility: Eurofarma Laboratórios S.A
Study officials:
References: