louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00717873: Evaluation of High-Frequency Chest Wall Oscillation
Official title: Evaluation of High-Frequency Chest Wall Oscillation Using the Vest Airway Clearance System Compared to Conventional Chest Physical Therapy at Barnes-Jewish Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Secretion Clearance
Keywords: Mucus Clearance
Secretion Clearance
HFCWO
Lead sponsor: Hill-Rom
Sponsor class: INDUSTRY
First posted: 2008-07-18
Enrollment: 105
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 compare the outcomes of patients treated with the Vest and conventional chest physiotherapy to determine if the Vest provides equivalent therapy


Eligibility criteria: Inclusion Criteria:

* Acute or chronic disease requiring secretion mobilization as per hospital protocol

Exclusion Criteria:

* Absolute contraindications for positional changes
* Absolute contraindications for chest percussion
* Women visibly pregnant
* Previous enrollment in study
* Previous CPT or Vest treatment

Primary outcomes:
measure: Hospital Length of Stay
timeFrame: Admission to Discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
Study officials:
affiliation: Barnes-Jewish Hospital
name: Darnetta Clinkscale, RRT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morrison L, Milroy S. Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Apr 30;4(4):CD006842. doi: 10.1002/14651858.CD006842.pub5.
citation: Clinkscale D, Spihlman K, Watts P, Rosenbluth D, Kollef MH. A randomized trial of conventional chest physical therapy versus high frequency chest wall compressions in intubated and non-intubated adults. Respir Care. 2012 Feb;57(2):221-8. doi: 10.4187/respcare.01299. Epub 2011 Jul 12.
Clinical trial NCT03512873: A Clinical Study of Tranilast in the Treatment of Scleredema Diabeticorum
Official title: A Clinical Study of Tranilast in the Treatment of Scleredema Diabeticorum
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Scleredema Adultorum
Keywords: Scleredema Diabeticorum
Tranilast
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 56 patients with scleredema diabeticorum will be selected to receive treatment of tranilast. After a period of time ,we can determine the efficacy of the drug by detecting the the thickness of skin before and after treatment.

Detailed description: 56 patients with Scleredema Diabeticorum will be selected. After the signing of the informed consent ,they will be collected the initial lesions photos,the thickness of skin lesions by ultrasound and magnetic resonance,and chemical examinations including blood routine examination, routine urine test, liver function, renal function.During tranilast (0.1g each time, three times a day,6 months) treatment, patients need regular follow-up (1 per month) including liver and kidney function, blood glucose level monitoring, and every three months to retest lesion thickness.With 3 month as a time point, they were observed for two points.After the experiment, the experimental data will be arranged and the data of the thickness change of skin lesions will be statistically processed (t test) to determine whether it is meaningful.

Eligibility criteria: Inclusion Criteria:

* (1)Clinical and histopathological examination has been proved to be scleredema diabeticorum; (2)Ultrasound and magnetic resonance detection found that the thickest skin of the back was more than 5mm.

Exclusion Criteria:

* (1)with a liver or kidney disease, or accompanied by a tumor or a severe infection ; (2)Poor blood sugar control; (3)with mental disease.

Primary outcomes:
measure: Measure the volume change of skin lesions by ultrasound
timeFrame: This experiment will last for 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05881473: Clavipectoral Fascial Plane Block Versus Superficial Cervical Block in Fracture Clavicle
Official title: Ultrasound-guided Clavipectoral Fascial Plane Block Versus Ultrasound-guided Superficial Cervical Plexus Block in Patients Undergoing Fracture Clavicle Operation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fracture Clavicle
Keywords: fracture clavicle
clavipectoral block
superficial cervical block
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 84
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ultrasound-guided Clavipectoral fascial plane block versus ultrasound-guided superficial Cervical plexus block in patients undergoing fracture clavicle operation

Detailed description: The clavipectoral fascial plane block (CPB) is a novel regional anesthesia technique that has been utilized for clavicular fracture surgery. It has been hypothesized that the CPB is an effective regional anesthesia technique for peri-operative analgesia since the terminal branches of many of the sensory nerves like suprascapular, subclavian, lateral pectoral, and long thoracic nerves pass through the plane between the clavipectoral fascia and the clavicle itself.

The ultrasound-guided superficial cervical plexus (SCP) block may be useful for providers in emergency care settings who care for patients with ear, neck, and clavicular region injuries, including clavicle fractures and acromioclavicular dislocations. The SCP originates from the anterior rami of the C1-C4 spinal nerves and gives rise to 4 terminal branches (greater auricular, lesser occipital, transverse cervical, and suprascapular nerves) that provide sensory innervation to the skin and superficial structures of the anterolateral neck and sections of the ear and shoulder.

Eligibility criteria: Inclusion Criteria:

1. Age from 21 to 60 years
2. Both gender
3. Isolated fracture clavicle.
4. ASA classification 1 \& 2

Exclusion Criteria:

1. Polytrauma patients with multiple fractures.
2. Hemodynamically unstable patients.
3. Patients with infection at the injection site.
4. Refusal of patients.
5. Patients with disturbed anatomical plane.
6. Patients with a known history of allergy to local anesthetic will be used.

Primary outcomes:
measure: visual analogue score (VAS score) post operative
timeFrame: starting at the recovery room then every 2 hours for 8 hours post operatively
Secondary outcomes:
measure: hemodynamics
timeFrame: every 2 hours for 8 hours
measure: hemodynamics
timeFrame: every 2 hours for 8 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT06085573: A Study to Learn About the Study Medicine - Precedex in Children From Japan.
Official title: Precedex Intravenous Solution Special Investigation (Sedation of Non-intubated Pediatric Patients for Non-invasive Procedures and Tests)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sedation
Keywords: Precedex;
Dexmedetomidine Hydrochloride;
Sedation;
non-intubated;
pediatric;
non-invasive procedures and tests
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-10-17
Enrollment: 43
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients (1 month to \< 18 years old) administered Precedex for "sedation of non-intubated pediatric patients for non-invasive procedures and tests"

Brief summary: The purpose of this study is to look at the safety of Precedex when it was used to calm children at procedures or tests under actual medical practice in Japan.

This study is seeking for children who are 1 month to less than 18 years old.

The patients are planned to be looked over:

* From the time of patient check before receiving Precedex
* To 1 hour after the completion or stop of using Precedex.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients (1 month to \< 18 years old) administered Precedex for "sedation of non-intubated pediatric patients for non-invasive procedures and tests"

Exclusion Criteria:

* No exclusion criteria is set out in this study.

Primary outcomes:
measure: Number of participants with adverse drug reactions (ADRs)
timeFrame: From the time of patient assessment before the start of administration of Precedex to 1 hour after the completion or discontinuation of administration
Secondary outcomes:
Other outcomes:
Locations:
city: Toykyo
country: Japan
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04650373: Durability of Weight Loss After Bariatric Surgery
Official title: Long-term Durability of Weight Loss After Bariatric Surgery; A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Bariateric surgery
Durability
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in Al-Azhar University hospital for overweight or obesity problems

Brief summary: The present study is a retrospective cohort study. Patients older than 18 years of age and underwent Roux-en-Y gastric bypass (RYGB) surgical treatment during the period from 2014 to 2019 and paired severely overweight controls who had no longer gone through bariatric surgery. Patients having BMI (Body Mass Index) much lower than 35 (calculated as the weight (kilograms) / length2 (meters)), a base line diagnosis taken into consideration a medical exclusion for surgical treatment died in one year of surgical operation and missed statistics at scientific information had been excluded from the study. The primary final results of the study was the weight-change percentage at follow-up in comparison with baseline one and the clinical events after surgery.

Detailed description: This is a retrospective cohort study. The sample size of our study includes one hundred case older than 18 years of age and underwent RYGB surgical treatment during the period from 2014 to 2019 and paired severely overweight controls who had no longer gone through bariatric surgery. Patients having BMI (Body Mass Index) much lower than 35 (calculated as the weight (kilograms) / length2 (meters)), a base line diagnosis taken into consideration a medical exclusion for surgical treatment, died in one year of surgical operation and missed statistics at scientific information had been excluded from the study. Data was collected taking in to account each patient history (age, sex, length, weight, BMI, occupation, marital status, and comorbidities) and weight record in every visit from measurements statistics. Outcomes: The primary final results of the study was the weight-change percentage at follow-up in comparison with baseline one. The secondary effects including the clinical events after surgery, micronutrient levels, incidence of diabetes, hypertension, and dyslipidemia.

Eligibility criteria: Inclusion Criteria:

* Patients equal or over 18 years old
* BMI more than 40
* Complete follow up

Exclusion Criteria:

* No complete follow up
* Age less than 18 or more than 80

Primary outcomes:
measure: weight-change percentage at follow-up
timeFrame: 1 year
measure: Clinical Events, Diabetes Miletus
timeFrame: 1 year
measure: Clinical Events, Hypertension
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Abdulkarim Hasan
Study officials:
affiliation: Al-Azhar University
name: Mohamad Baheeg
role: STUDY_CHAIR
References:
Clinical trial NCT02190773: Effect of Surgical Therapy on RANKL/OPG (Osteoprotegerin) System
Official title: Effect of Surgical Periodontal Therapy on the RANKL/OPG System : Do we Need Osteo-immune Modulation Targeting RANKL?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Periodontitis
Aggressive Periodontitis
RANKL/OPG Ratio
Gingival Crevicular Fluid
Keywords: Chronic Periodontitis, Aggressive Periodontitis, RANKL/OPG ratio, Gingival crevicular fluid
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individulas that applied to periodontology clinic in faculty of dentistry, Hacettepe University.

Brief summary: In the present clinical study including chronic, aggressive periodontitis and healthy individuals, the investigators aimed to determine the RANKL, osteoprotegrin (OPG), Interleukin-1 (IL-1β), IL-10, IL-1β levels in gingival crevicular fluid(GCF) before and after surgical periodontal treatment and search out the relationship of clinical parameters with these cytokine levels.


Eligibility criteria: Inclusion Criteria:

* Chronic periodontitis having at least 5mm or more probing depth and aggressive periodontitis patients.

Exclusion Criteria:

* Any known systemic disorder, used antibiotics and/or anti-inflammatory medications, had periodontal treatment in the last 3 months and all of them were non smokers. Subjects who were lactating and pregnant were also excluded.

Primary outcomes:
measure: RANKL (pmol) level in GCF
timeFrame: Baseline-3 months
measure: OPG level (pg) in GCF
timeFrame: Baseline-3 months
measure: RANKL/OPG ratio
timeFrame: Baseline - 3months
Secondary outcomes:
measure: IL-1β (pg) levels in GCF
timeFrame: Baseline, 3 months after treatment
measure: Il-10 (pg) levels in GCF
timeFrame: Baseline-3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT02000973: Effects of Epidural Local Anesthetics on Propofol Induction
Official title: Effects of Thoracic Epidural Anesthesia With Different Local Anesthetics on Propofol Induction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: General Anesthesia
Propofol Target-controlled Infusion
Thoracic Epidural Anesthesia
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 80
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators designed a prospective, randomized, placebo-controlled study to determine whether thoracic epidural anesthesia(TEA) with different local anesthetics has different influences on the propofol dose during induction.


Eligibility criteria: Inclusion Criteria:

Surgery for thoracotomies, BMI: 18-25 Kg/m2, American Society of Anesthesiologists(ASA) classification I or II.

Exclusion Criteria:

liver or kidney disease, alcohol dependence, take sedative recently, contraindications for epidural anesthesia.

Primary outcomes:
measure: Propofol Effect-site Concentration
timeFrame: Before starting anesthesia to finishing endotracheal intubation
Secondary outcomes:
measure: Mean Arterial Pressure
timeFrame: Before starting anesthesia to finishing endotracheal intubation
measure: Heart Rate
timeFrame: Before starting anesthesia to finishing endotracheal intubation
measure: Bispectral Index Score
timeFrame: Before starting anesthesia to finishing endotracheal intubation
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Anesthesiology, First Hospital of China Medical University
name: Jun Wang
role: STUDY_CHAIR
References:
Clinical trial NCT03609073: Endomina Diverticulum
Official title: A Prospective Study to Evaluate the Safety and Feasibility of an Endoluminal-suturing Device (Endomina TM) as an Aid for Diverticulum Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Oesophageal Disease
Keywords: endoscopy
mini invasive
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Esophageal diverticulum is a rare disease. Majority comes form the pharyngo-esophageal junction (70 % Zenker's Diverticulum), 10% are mediothoracic and 20% epiphrenic. Zenker's diverticulum is well treated with endoscopy (efficacy around 80%, complications around 5%) (1). For medio or epihrenic diverticulum, the classic treatment is surgery (diverticulectomy with or without anti-reflux surgery) but is associated with 33% morbidity and 9% mortality (2). Recently another technique involving magnet was described (3). Five patients were treated with success.

Considering the surgical risk, other techniques need to be evaluated. Using the Endomina device, sutures can be apposed between the foot of the diverticulum and the esophageal lumen. If necessary the bridge between the diverticulum and the esophagus can be cut with needle knife as described in Zenker's diverticulum treatment.


Eligibility criteria: Inclusion Criteria:

1. Symptomatic medio or epiphrenic diverticulum.
2. Age between 18-80 years;
3. Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: clinical assessment, endoscopy, radiography, as well as laboratory investigations;
4. Must be able to understand and be willing to provide written informed consent;
5. Must live within 75 km of the treatment site;

Exclusion Criteria:

1. Achalasia and any other esophageal motility disorders.
2. Severe esophagitis
3. Gastro-duodenal ulcer
4. Severe renal, hepatic, pulmonary disease or cancer;
5. GI stenosis or obstruction;
6. Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months;
7. Anticoagulant therapy;
8. Currently participating in other study

Primary outcomes:
measure: Incidence of all Adverse Device Effects
timeFrame: one year from procedure
Secondary outcomes:
measure: Dysphagia
timeFrame: one year from procedure
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Gastroenterology Department Erasme Hospital
Study officials:
References:
Clinical trial NCT00252473: S-Frame CT Immobilization Masks For Patients Undergoing Radiation Therapy For Head and Neck Cancer
Official title: Evaluation of Setup Accuracy in Med Tec S-Frame Immobilization Masks For Patients Undergoing Radiation Therapy For Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Neoplasms
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2005-11-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Immobilization devices such as thermoplastic masks are used routinely in the radiation treatment of head and neck cancer patients. It is important to assess how well they function at preventing patient motion while the radiation treatment is being delivered. (i.e. isocentre set-up margins, patient motion with the mask). If these new thermoplastic masks such as MedTec S-frame allow less movement, then smaller margins are needed during radiation therapy which, in turn, would decrease side effects from the treatment.


Eligibility criteria: Inclusion Criteria:

* Histological confirmation of mucosal malignancy in the head and neck (H\&N) region
* Undergoing radiotherapy (RT) with curative intent using a lateral parallel pair treatment with an anterior or anterior/posterior low neck filed technique using a MedTec S-frame mask

Primary outcomes:
measure: Measurement of the accuracy of MedTec S-frame head and neck immobilization system (isocentre set-up accuracy, patient movement margins and movement of the normal tissue critical structures and planning target volumes)
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Andrew Bayley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04196673: Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses
Official title: Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses: Vivinex iSert P261 vs. Acrysof SN60WF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age Related Cataracts
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved Investigational Plan on subjects and includes: visual acuity, slitlamp examination, fibrosis, posterior capsule opacification (PCO) score and YAG capsulotomy rate.
Primary purpose: DIAGNOSTIC

Brief summary: On the day of surgery, the first eye to be operated is randomised to receive a Vivinex , HOYA Surgical Optics GmbH or an SN60WF, Alcon, Fort Worth, Texas. The second eye to be operated receives the other IOL type.

A complete biomicroscopic examination, visual acuity testing using autorefractometer, contrast sensitivity testing, and standardised retroillumination photography for PCO evaluation, will be performed 6 month (30-60 days), 1.5 years (± 3 months) and 3 (± 3 months) years postoperatively.


Eligibility criteria: Inclusion Criteria:

* Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
* Age 50 and older
* Visual potential in both eyes of 20/30 or better as determined by investigators estimation
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* Preceding intraocular surgery or ocular trauma
* Relevant other ophthalmic diseases (such as pseudoexfoliation, glaucoma, uveitis, retinal degenerations, etc.)
* Laser treatment
* Uncontrolled systemic or ocular disease
* Infectious disease
* Pregnancy/Nursing

Primary outcomes:
measure: PCO score
timeFrame: 3 years
Secondary outcomes:
measure: Visual Acuity
timeFrame: 3 years
measure: Fibrosis
timeFrame: 3 years
measure: Subjective glistening score
timeFrame: 3 years
measure: YAG capsulotomy rate
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Vienna
name: Rupert Menapace, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: