louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06420570: Sensory Changes Associated With Thoracic Surgery
Official title: Dysaesthesia Associated With Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Surgery
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2024-05-20
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be identified from the thoracic surgery operative list at the Royal Infirmary of Edinburgh.

Brief summary: Many patients experience chronic pain after thoracic surgery and this is caused by nerve damage during surgery. Changes in skin sensation (dysaesthesia) is typically associated with chronic nerve pain.

We hypothesise that thoracic surgery causes sensory changes. Another hypothesis is that minimally invasive thoracic surgery using video cameras results in less nerve damage and so a smaller area of altered skin sensation, when compared to the traditional method of chest surgery using a large surgical incision. A final hypothesis is that the extent of nerve damage during surgery is associated with the severity of pain early after surgery.

This study is designed to compare the total areas of sensory changes after thoracic surgery on the operated side of the chest with that on the non-operated side of the chest. We also aim to identify the type, pattern, location and area of sensory changes associated with thoracic surgery, comparing the operated with the non-operated side of the chest. In addition, we aim to compare the total area of sensory changes between the traditional method of chest surgery and the minimally invasive method of chest surgery. We would also like to determine whether the severity of pain early after surgery is associated with the area of sensory changes.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years old or older admitted for elective thoracic surgery

Exclusion Criteria:

* Emergency thoracic surgery
* Thoracic surgery involving sternotomy
* Damage to the spinal cord and/ or intercostal nerves prior to surgery
* Neurological diseases that may alter the skin sensation to the chest wall such as multiple sclerosis and neuropathies, previous surgery of chest wall, a history of chronic pain

Primary outcomes:
measure: Area of dysaesthesia on a patient's chest wall
timeFrame: Days after thoracic surgery (at least 3 hours after chest drain removal)
Secondary outcomes:
measure: Acute post-operative pain experienced by the patient
timeFrame: Days after thoracic surgery (at least 3 hours after chest drain removal)
Other outcomes:
measure: The patient's mood
timeFrame: Days after thoracic surgery (at least 3 hours after chest drain removal)
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
Study officials:
affiliation: University of Edinburgh
name: R Peter Alston
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04496570: Resolvin D1 Levels in Patients With Periodontitis
Official title: The Role of Resolvin D1 in Maintaining Oral Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: gingival crevicular fluid
resolvin D1
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 26
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study was to determine the levels of Resolvin D1 (RVD1) in the gingival crevicular fluid (GCF) and saliva of the patients with periodontitis (P) and also to investigate the effects of non-surgical periodontal treatments (NSPTs) on its levels.

A total of 26 subjects (15 P, 11 healthy) were included. Clinical periodontal measurements, GCF and saliva samples were collected from each individual at baseline and 1 month after NSPTs in P group. RVD1 levels were determined by enzyme-linked immunosorbent assay (ELISA) method.


Eligibility criteria: Inclusion Criteria:

* Stage 3, Grade B and generalized periodontitis patients

Exclusion Criteria:

* excessive forces;
* presence of systemic diseases
* administration of non-steroidal and anti-inflammatory drugs or antibiotic therapies within the previous 6 months
* having received non-surgical periodontal treatment within the past 6 months
* allergy or sensitivity to any drug,
* pregnancy, lactation
* current and former use of tobacco.

Primary outcomes:
measure: Biochemical parameter (resolvin D1)
timeFrame: Baseline and 1 month after NSPT
Secondary outcomes:
measure: Probing pocket depth
timeFrame: Baseline and 1 month after NSPT
measure: Clinical attachment level (CAL)
timeFrame: Baseline and 1 month after NSPT
measure: Plaque index (PI)
timeFrame: Baseline and 1 month after NSPT
measure: Gingival index (GI)
timeFrame: Baseline and 1 month after NSPT
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Ordu University
Study officials:
References:
Clinical trial NCT00853970: Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Inflammation
Keywords: Pain and Inflammation as a function of cataract surgery
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2009-03-02
Enrollment: 299
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: Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery


Eligibility criteria: Inclusion Criteria:

* Male or female at least 18 years of age who are scheduled for unilateral cataract surgery

Exclusion Criteria:

* Have known hypersensitivity to bromfenac or to any component of the investigational product

Primary outcomes:
measure: Summed Ocular Inflammation Score (SOIS) of Zero
timeFrame: Day 15 (Primary Endpoint)
Secondary outcomes:
measure: Pain Free
timeFrame: Day 1
Other outcomes:
Locations:
city: Irvine
country: United States
facility: ISTA Pharmaceuticals, Inc.
state: California
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Tim McNamara, PharmD
role: STUDY_DIRECTOR
References:
citation: Silverstein SM, Cable MG, Sadri E, Peace JH, Fong R, Chandler SP, Gow JA, Klier SM, McNamara TR; Bromfenac Ophthalmic Solution Once Daily (Bromday) Study Group. Once daily dosing of bromfenac ophthalmic solution 0.09% for postoperative ocular inflammation and pain. Curr Med Res Opin. 2011 Sep;27(9):1693-703. doi: 10.1185/03007995.2011.597663. Epub 2011 Jul 14.
Clinical trial NCT01347775: Inspiratory Muscle Training in Patients With End Stage Renal Failure
Official title: Inspiratory Muscle Training in Patients With End Stage Renal Failure: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Renal Failure
Chronic Renal Insufficiency
Keywords: Renal failure
Respiratory muscles
Resistance training
Lead sponsor: The University of Queensland
Sponsor class: OTHER
First posted: 2011-05-04
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: This study will investigate whether inspiratory muscle training in patients with end stage renal failure can improve strength and function.

Detailed description: Patients with chronic renal failure commonly have weak respiratory muscles leading to problems in everyday activities and respiratory infections.

This project aims to investigate if threshold inspiratory muscle training improves the strength, everyday function and participation of patients on haemodialysis. Forty eight patients will be recruited in a randomized controlled trial of inspiratory muscle training vs sham training.

Outcome measures include the maximal inspiratory pressure and the Frenchay activities index. Initial data will be collected by a blinded assessor; the patients will train at 40 % of initial maximal inspiratory pressure for six weeks and be reassessed. If the inspiratory muscle training is effective, it will improve both the physical and functional components of the patient's lives and be recommended for all renal patients.

Eligibility criteria: Inclusion Criteria:

* documented chronic renal failure
* attending either haemodialysis or pre-dialysis clinic
* age 18
* English speaking
* no prior experience with inspiratory training devices.

Exclusion Criteria:

* lung collagen disorders
* renal diseases associated with autoimmune pulmonary diseases
* current pleural effusion
* pulmonary oedema
* decreased conscious level
* behavioural disturbances
* unable or refused to give consent
* taking medications that influence respiratory muscle function (e.g. steroids or cyclophosphamide)

Primary outcomes:
measure: Maximal inspiratory pressure (MIP)
timeFrame: Change between baseline (enrolment) and 6 weeks
Secondary outcomes:
measure: Frenchay activities index
timeFrame: Change between baseline (enrolment) and 6 weeks
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Royal Brisbane & Womens Hospital
state: Queensland
Study officials:
affiliation: The University of Queensland
name: Jennifer D Paratz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05035875: Evaluation of Diaphragm in Chronic Obstructive Pulmonary Disease Patients by Ultrasound in Relation to Severity
Official title: Evaluation of Diaphragm in Chronic Obstructive Pulmonary Disease Patients Using Ultrasonography in Relation to Disease Severity in Fayoum University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: ultrasonography, diaphragm, COPD, Fayoum
Lead sponsor: Fayoum University Hospital
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 80
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 40 COPD patients and 40 age matched healthy control

Brief summary: The study of the diaphragm is an important point in the assessment of COPD patients.

Ultrasonographic evaluation of the diaphragm is considered a simple, non-invasive, available bedside technique. Ultrasonography can be used for evaluation of the site, structure, and motion of the diaphragm, assessment of excursion, and thickness.

The aim of the study is ultrasonographic assessment of the diaphragm in COPD patients and its relation to disease severity

Detailed description: The study was conducted on eighty patients, forty COPD patients who were diagnosed and classified into four groups according as following: The first group: included 10 patients with a mild stage. The second group: included 10 patients with a moderate stage. The third group: included 10 patients with a severe stage. The fourth group: included 10 patients with a very severe stage. The study also included forty healthy individuals of the same age and sex as COPD patients. All participants gave their informed consent for inclusion before sharing in the study. Every person was submitted to: Full medical history, Clinical examination,Chest x-ray, spirometry and ultrasonographic assessment of diaphragm function (thickness and excursion)

Eligibility criteria: Inclusion Criteria:

* • Stable COPD patients aged more than 40 years who were diagnosed and classified into four groups of severity according to GOLD 2020.

  * Age and sex-matched healthy controls

Exclusion Criteria:

* • Patient with a known neuromuscular disorder.

  * Patient with known anatomical malformation of the diaphragm.
  * Post abdominal or thoracic surgery.

Primary outcomes:
measure: measure diaphragmatic thickness by ultrasound
timeFrame: 1 year study
measure: measure diaphragm excursion by ultrasound
timeFrame: 1 year study
Secondary outcomes:
measure: spirometry assessment
timeFrame: 1 year study
measure: questionnaires
timeFrame: 1 year study
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University Hospital
Study officials:
affiliation: Fayoum University Hospital
name: Enas S Farhat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05260775: Intelligent Evaluation and Supervision of Cataract Surgery
Official title: Intelligent Evaluation and Supervision of Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: cataract surgery
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 344
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants who had senile cataracts and phacoemulsification and IOL implantation in the Zhongshan Ophthalmic Centre (ZOC, Guangzhou, Guangdong, China) and Shenzhen Eye Hospital (Shenzhen, Guangdong, China)

Brief summary: Research purpose: intelligent identification and evaluation of cataract surgery steps Research methods: A total of 9 items (such as gender, age, visual acuity, etc.) were extracted from the surgical videos of senile cataract patients and the clinical data recorded by the electronic medical record system. The machine learning algorithm 3D-CNN was applied to identify the 11 steps in cataract surgery and the pictures (blank pictures) without instrument manipulation on the eyeball during the operation. Six key cataract surgery steps were scored using deep learning algorithms (probability smoothing window and softmax). We employ precision, precision, recall, and F1-score to evaluate the model's performance for recognizing surgical steps. To evaluate the reliability of the model's scoring of surgical steps, we used a human-machine comparison method to calculate the agreement (kappa value) between machine and expert scores.


Eligibility criteria: Inclusion Criteria:

-Videos of phacoemulsification and IOL implantation for senile cataracts will be included

Exclusion Criteria:

-The peak signal-to-noise ratio (PSNR) is utilized to assess whether a video was blurred. If the PSNR of a video was less than 20 decibels (dBs), the whole video was discarded.

Primary outcomes:
measure: Accuracy
timeFrame: baseline
Secondary outcomes:
measure: kappa
timeFrame: baseline
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi Liu, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03055975: Prevalence of Bacteria Following Endodontic Treatment
Official title: Prevalence and Phenotype of Oral Enterococcus Faecalis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Root Canal Infection
Keywords: Bacteria
Root canal treatment
Endodontics
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
First posted: 2017-02-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The source population are adults aged 18-65, referred by their general dental practitioner into specialist endodontic clinics of Guy's Hospital, King's College London Dental Institute. Both single- and multi-rooted non-vital teeth are included in the study

Brief summary: Sampling of accessed root canals with endodontic paper points during treatment and immediately pre-obturation of endodontic root canals was carried out.

Detailed description: Following ethical approval (REC ref: 05/Q0705/051), informed consent was obtained from patients undergoing root canal treatment.The teeth included in the study had been referred to a specialist centre for the treatment of endodontic infection. They all responded negatively to vitality tests and presented pre-operative apical radiolucencies. The source population were referred by their general dental practitioner into specialist endodontic clinics of Guy's Hospital, King's College London Dental Institute.Treatments on the teeth were carried out by a total of 19 postgraduate endodontic students.

Eligibility criteria: Inclusion Criteria:

* Patients with single or multi-rooted teeth undergoing root canal treatment.

Exclusion Criteria:

* For certain aspects of the study secondary treatments and vital teeth are excluded.

Primary outcomes:
measure: Detection of residual bacteria during and post root canal treatment
timeFrame: June 2016
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London, Dental Institute, Floor 22, Endodontics
Study officials:
affiliation: King's College London
name: Federico Foschi, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herzog DB, Hosny NA, Niazi SA, Koller G, Cook RJ, Foschi F, Watson TF, Mannocci F, Festy F. Rapid Bacterial Detection during Endodontic Treatment. J Dent Res. 2017 Jun;96(6):626-632. doi: 10.1177/0022034517691723. Epub 2017 Feb 1.
Clinical trial NCT03661775: Serum Magnesium Level Administration in Severe Pre-eclampsia Obese Pregnancy
Official title: Serum Magnesium Level Between Administered Rate of 2 g/hr Versus 2.5 g/hr in Severe Pre-eclampsia Obese Pregnancy, Multicentered Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Pre-eclampsia
Magnesium Level
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2018-09-07
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Factorial 2-by-2 open labeled randomised controlled trial
Primary purpose: PREVENTION

Brief summary: Comparison of the magnesium level in difference continuous rate in women who were diagnosed severe pre-eclampsia obese

Detailed description: Magnesium sulfate is, generally, applied in order to alleviate or to avoid seizures. It can be administered according to many medical approaches. Nevertheless, at Rajavithi Hospital, the recommended administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2 grams for maintenance dose per hour (Zudpan regimen). The therapeutic index of magnesium is in the range of 4.8-8.4 mg/dL. After that, the level of magnesium sulfate will be evaluated every 4 or 6 hours.

At Rajavithi Hospital, there are a lot of patients having pre-eclampsia symptom and many patients, who were received magnesium sulfate in the treatment, having the level of magnesium sulfate lower than the therapuetic level and needed to increase the maintenance dose to 2.5 grams/hour. Therefore, this work aims to studying the amount of magnesium sulfate administered to pregnant woman with pre-eclampsia symptom who possess high body mass index (BMI), especially for BMI greater than or equal to 30 kg/m2.

Eligibility criteria: Inclusion Criteria:

* Pregnancy women who have MBI ≥ 31kg/m2
* Pregnancy women who were diagnosed severe pre-eclampsia at gestational age 24 weeks more.
* Pregnancy women who were diagnosed eclampsia at gestational age 24 weeks more.

Exclusion Criteria:

* Pregnancy women who were chronic kidney disease or have serum creatinine more than 1.1 mg/dl
* Pregnancy women who have contraindication to use magnesium sulfate

Primary outcomes:
measure: therapeutic level
timeFrame: 4 hours after infusion magnesium sulfate
Secondary outcomes:
measure: Outcome of pregnancy
timeFrame: 24 hours after delivery
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
References:
Clinical trial NCT00077675: Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
Official title: A Phase 2, Randomized, Double-Blind, Multinational Trial of Intravenous Telavancin Versus Standard Therapy for Treatment of Complicated Gram-Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Gram-positive Bacterial
Keywords: Abscess
Burns
Cellulitis
Ulcer
Wound infections
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2004-02-13
Enrollment: 201
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: Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. This study will measure how well TD-6424 (Telavancin) can control infections and whether the drug is safe to give to patients.


Eligibility criteria: Inclusion Criteria:

* Patients must have a diagnosis of one of the following complicated skin and soft tissue infections and either a suspected or confirmed Gram positive organism

  * major abscess requiring surgical incision and drainage
  * infected burn (see exclusion criteria for important qualifications)
  * deep/extensive cellulitis
  * infected ulcer (see exclusion criteria for important qualifications)
  * wound infection
* Patients must be expected to require at least 4 days of intravenous (IV) antibiotic treatment

Exclusion Criteria:

* Previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for \> 24 hours within 7 days prior to the first dose of study drug unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days)
* Burns involving \> 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis

Primary outcomes:
measure: Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
timeFrame: 7 to 14 days following completion of antibiotic treatment
Secondary outcomes:
Other outcomes:
Locations:
city: National City
country: United States
facility: Paradise Valley Hospital, 2400 E. 4th Street
state: California
Study officials:
affiliation: Duke University
name: G. Ralph Corey, MD
role: PRINCIPAL_INVESTIGATOR
References: