louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00816101: Efficacy Study of a New Antimicrobial Wound Dressing to Treat Wounds Caused by Curettage and Electrodesiccation
Official title: Efficacy of the PROCELLERA™ Wound Dressing in the Healing of Wounds After a Curettage and Electrodesiccation of Skin Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Wounds
Keywords: Curettage and electrodesiccation
acute wounds
partial thickness wounds
Lead sponsor: Vomaris Innovations
Sponsor class: INDUSTRY
First posted: 2008-12-31
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot clinical study is to compare healing rates, pain levels, and incidence of wound complications including infection with the use of a moist PROCELLERA™ Antimicrobial Wound Dressing when compared to a standard dressing, Mepilex® Border Lite, following curettage and electrodesiccation of skin lesions.


Eligibility criteria: Inclusion Criteria:

If female, must either be not of childbearing potential or if they are of childbearing potential must have a negative urine pregnancy test.

* Wound size greater than 1x1 cm
* Wounds must be ≥5 cm away from all other wounds
* Wound size must not be diminished in size greater than 10% between enrollment in study and the prescreening
* Participant agrees to participate in follow-up evaluation
* Participant must be able to read and understand informed consent, and sign the informed consent

Exclusion Criteria:

* Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study
* Participant is to receive another topical antimicrobial agent other than the study dressing
* Participant with sensitivity or adverse reactions to silver or zinc
* Pregnancy or nursing an infant or child
* Immunosuppression
* Active or systemic infection
* Peripheral vascular occlusive disease
* Collagen vascular disease
* Connective tissue disease
* Diabetes
* Venous stasis ulcers
* Participant undergoing active cancer chemotherapy
* Chronic steroid use
* Decision impairment

Primary outcomes:
measure: Number of Patients Who Experienced 50% or Greater Wound Healing
timeFrame: 3 Weeks
Secondary outcomes:
measure: Number of Patients Reporting Pain
timeFrame: 3 Weeks
measure: Erythema at Week 3
timeFrame: 3 Weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Sheftel Associates Dermatology
state: Arizona
Study officials:
affiliation: Sheftel Associates Dermatology
name: Scott N Sheftel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03204201: Validation of ICG to Identify the Urethra During Rectal Surgery
Official title: Validation of ICG to Identify the Urethra During Rectal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Urethra Injury
Rectal Cancer
Surgery
Keywords: Fluorescence
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2017-06-29
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is an open-label feasibility study utilising direct instillation of ICG into the urethra during surgery for low rectal cancers. The trial involves a single intervention taking place during the patient's operation. Participants will be included in the study for around 2 months with time either side of the intervention to collect background data.


Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male, aged 18 years or above.
* Undergoing low rectal surgery where the operating field will be close to the urethra

Exclusion Criteria:

* Participant has an allergy to iodine or ICG
* Known liver failure

Primary outcomes:
measure: Number of urethras identified under white light and fluorescence
timeFrame: 1 day
Secondary outcomes:
measure: Signal to background ratios between cohorts of patients with varying doses of ICG
timeFrame: 1 day
measure: Subjective assessment of usefulness of technology during operative procedure
timeFrame: 1 day
measure: Length of time of interruption in operative procedure to perform trial intervention
timeFrame: 1 day
measure: Number of adverse events related to trial intervention
timeFrame: 30 days
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
state: Oxfordshire
Study officials:
affiliation: Consultant Colorectal Surgeon
name: Roel Hompes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Fellow
name: Thomas Barnes, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02442401: Role of Negative Pressure Wound Therapy in Latissimus Dorsi Flap Donor Site Seroma Prevention
Official title: Role of Negative Pressure Wound Therapy in Latissimus Dorsi Flap Donor Site Seroma Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: NPWT
Latissimus Dorsi Flap
Breast Reconstruction
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Thana Laopiyasakul
name: Pornthep Pungrasmi
name: Poonpissamai Suwajo
First posted: 2015-05-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The use of NPWT as a post-operative dressing significantly reduces the incidence of seroma formation after harvesting LD flap.

Detailed description: NPWT was left in place on donor site with constant pressure between -125 and -80 mmHg to reduce seroma formation

Eligibility criteria: Inclusion Criteria:

* Age between 20-60 years Underwent breast reconstruction with LD Flap

Exclusion Criteria:

* Locally advanced cancer

Primary outcomes:
measure: Incidence of seroma
timeFrame: 3 months
Secondary outcomes:
measure: Aspirated Volume
timeFrame: 3 months
measure: Frequency of Aspiration
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03544801: Renji Cerebral Small Vessel Disease Corhort Study
Official title: Renji Cerebral Small Vessel Disease Corhort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebrovascular Disorders
Cognition Disorders
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 300
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: longitudinal cohort of post stroke CSVD patients

Brief summary: We aim to make clear the impact with the mechanisms of variant pathological injuries on the outcomes of CSVD, to find independent imaging markers and establish prediction model of it.

Detailed description: A cohort of post stroke cerebral small vessel disease (CSVD) patients with different cognitive status are consecutively recruited in this study. Detailed full domain cognitive assessment and multi-modal MRI (including brain morphology , DTI indices, microbleed counts, brain volumes as well as brain network characters, etc.) are performed. Cognitive states(including attention-executive function, memory, language, visuo-spatial and global cognition with the transition to dementia) and the overall prognosis (cardiovascular events, stroke recurrence, death due to cardiovascular event and all cause death) are longitudinally followed up. The correlations between baseline and followed MRI parameters with the outcomes are analyzed in order to make clear the impact with the mechanisms of variant pathological injuries on the outcomes of CSVD, to find independent imaging markers and establish prediction model of it.

Eligibility criteria: Inclusion Criteria:

* ①50-85 years; ② at least 6 years of education; ③ CSVD was defined as patients experienced a clinical lacunar stroke at least 1 months ago, and MRI showed responsible lacunar infarcts and white matter lesions; ④ Cooperate with cognitive tests; ⑤Not accept medications that affect cognition; ⑥. Score of modified Rankin scale ≦3; ⑦. Sign informed consent.

Exclusion Criteria:

* ① Etiology due to cardioembolic or large vessel disease (\>50% stenosis in extra- or intra-cerebral arteries); ② Non vasular white matter lesions(WMLs)；③ Cortical and/or cortico-subcortical non-lacunar infarct; ④ Other cognitive diseases (such as Alzheimer's disease, Parkinson disease or thyroid disease, etc. ) ⑤Severe systemic diseases such as heart, liver and kidney diseases or major psychiatric disorders; ⑥Severe depressive state: Hamilton depression rating scale score \>24; ⑦ MRI contraindications.

Primary outcomes:
measure: a predictive model
timeFrame: 2015,July---
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital,Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: RenJi Hospital
name: qun xu, professor
role: STUDY_CHAIR
References:
Clinical trial NCT00526201: Help Arthritis With Exercise in West Virginia
Official title: Arthritis Benefits of a Physical Activity Program in West Virginia: Evaluation of EnhanceFitness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis
Keywords: Arthritis
Osteoarthritis
Rheumatoid Arthritis
Fibromyalgia
Lupus
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: West Virginia University
First posted: 2007-09-10
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to determine if an evidence-based, community-delivered physical activity program, EnhanceFitness, yields benefits for participants with arthritis. The 3-year project will: 1) conduct a meta-analysis of community-based exercise programs for adults, 2) implement and evaluate the EnhanceFitness program in West Virginia using a randomized, controlled (wait list) design, and 3) disseminate the results to community and public health partners. It is anticipated that participation in the EnhanceFitness program will result in reduced pain, improved physical function and physical activity levels for adults with arthritis.


Eligibility criteria: Inclusion Criteria:

* Age 18 and older
* Any type of self-reported, doctor-diagnosed arthritis

Exclusion Criteria:

* Any co-existing conditions where exercise is a contraindicated
* Impaired cognitive status
* Non-ambulatory

Primary outcomes:
measure: Pain Severity
timeFrame: 8 months
measure: Physical activity level
timeFrame: 8 months
measure: Physical Function
timeFrame: 8 months
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 8 months
measure: Arthritis self-efficacy
timeFrame: 8 months
measure: Self-efficacy for exercise
timeFrame: 8 months
measure: Exercise perceptions
timeFrame: 8 months
measure: Social support
timeFrame: 8 months
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Dina L Jones, PT, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Jennifer M Hootman, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00868101: The Effect of Remote Ischemic Preconditioning Applied in Children the Day Before Open Heart Surgery
Official title: The Use of Remote Ischemic Preconditioning Applied in Child the Day Before Open Heart Surgery With Extracorporeal Circulation to Correct Congenital Heart Diseases (the Second Window Effect)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Congenital Heart Disease
Keywords: ischemic
preconditioning
congenital heart disease
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-03-24
Enrollment: 22
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study research is to analyse brief episodes of limb ischemia applied to children the day before open heart surgery as protection from myocardial injury induced by extracorporeal circulation.

Detailed description: Children undergoing repair of congenital heart defects were randomized to RIPC (remote ischemic preconditioning) or control treatment. RIPC was induced by four 5-minutes cycles of lower limb ischemia and reperfusion using a blood pressure cuff. Measurements of troponin I, brain natriuretic peptide, interleukines 8 and 10, real time PCR to NFKB and clinical parameters were obtained and compared postoperatively (4, 12, 24 and 48 hous after).

Eligibility criteria: Inclusion Criteria:

* 1 month to 2 years age
* waiting for open heart surgery in hospital
* 2008, january to march
* Rachs-1, except the 1 category

Exclusion Criteria:

* genetic syndromes
* infected children
* immunodeficiency
* immunosuppressor use
* no parents permission

Primary outcomes:
measure: IkB-alpha Expression
timeFrame: 24 hours
measure: Interleucine 8
timeFrame: 24 hours
Secondary outcomes:
measure: NT-proBNP
timeFrame: 24 hours
measure: Troponin I
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: General Hospital of Ribeirao Preto, Sao Paulo University
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Ana Paula CP Carlotti, 1
role: STUDY_DIRECTOR
References:
Clinical trial NCT01958801: Clinical Efficacy of Supraclavicular Block for Arthroscopic Shoulder Surgery
Official title: Comparison Between Ultrasound-guided Supraclavicular and Interscalene Brachial Plexus Blocks in the Patients Undergoing Arthroscopic Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Horner's Syndrome
Keywords: Supraclavicular brachial plexus block
Interscalene brachial plexus block
Arthroscopic shoulder surgery
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 104
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study is to compare the efficacy of supraclavicular and interscalene brachial plexus blocks in the patients undergoing arthroscopic shoulder surgery.

Detailed description: This study aims to compare supraclavicular brachial plexus block to interscalene brachial plexus block with regard to degree of sensory and motor blockades, side effects and complications of the blocks, and frequency of intraoperative analgesics or antihypertensives use.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I-II
* Body mass index \< 35 kg/m2

Exclusion Criteria:

* Neurologic deficits on the side to be blocked
* Infection or inflammation at the puncture site for brachial plexus block
* Psychiatric disorders
* Patient refusal
* Difficulty to communicate
* Coagulation deficiencies

Primary outcomes:
measure: Degree of sensory blockade
timeFrame: 20 minutes after the end of local anesthetics injection
Secondary outcomes:
measure: Degree of motor blockade
timeFrame: 20 minutes after the end of local anethetics injection
measure: Side effects
timeFrame: 20 minutes after the end of local anethetics injection
measure: Frequency of intraoperative analgesics or antihypertensives use
timeFrame: At the end of the surgery
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
Study officials:
affiliation: Daegu Catholic University Medical Center
name: JongHae Kim, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu SS, Gordon MA, Shaw PM, Wilfred S, Shetty T, Yadeau JT. A prospective clinical registry of ultrasound-guided regional anesthesia for ambulatory shoulder surgery. Anesth Analg. 2010 Sep;111(3):617-23. doi: 10.1213/ANE.0b013e3181ea5f5d. Epub 2010 Aug 4.
citation: Conroy PH, Awad IT. Ultrasound-guided blocks for shoulder surgery. Curr Opin Anaesthesiol. 2011 Dec;24(6):638-43. doi: 10.1097/ACO.0b013e32834c155f.
Clinical trial NCT05136001: Characterizations of Gut Microbiota and Postoperative Sleep in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass
Official title: Characterizations of Gut Microbiota and Postoperative Sleep in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Valve Surgery
Keywords: Gut Microbiota
polysomnography
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will characterize the gut microbiota and serum metabolites in one group of 36 patients before and after heart valve surgery

Brief summary: The investigators designed a study to assess whether there is any change in gut microbiota and postoperative sleep before and after heart valve surgery with cardiopulmonary bypass.

Detailed description: The investigators designed a study to assess whether there is any change in gut microbiota and postoperative sleep before and after heart valve surgery with cardiopulmonary bypass. Firstly, this study aims to characterize the gut microbiota in patients with valve disease treated with surgery. Secondly, it aims to evaluate microbiota and its influence on postoperative sleep.

Eligibility criteria: Inclusion Criteria:

* Ethnic Chinese;
* Age, 18 to 65 years old;
* Patients undergoing heart valve surgery with cardiopulmonary bypass

Exclusion Criteria:

* Preoperative Pittsburgh Sleep Quality Index global scores higher than 6
* Cognitive difficulties
* Partial or complete gastrectomy
* Previous esophageal surgery
* Previous treated by radiotherapy or surgery
* Inability to conform to the study's requirements
* Body mass index exceeding 30 kg/m2
* Deprivation of a right to decide by an administrative or juridical entity
* Ongoing participation or participation in another study \<1 month ago
* Recent (\< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or traditional Chinese medicine

Primary outcomes:
measure: gut microbiota
timeFrame: from baseline to postoperative 72 hours
Secondary outcomes:
measure: postoperative sleep
timeFrame: on the second postoperative night from 20:00 to 6:00
measure: serum metabolites
timeFrame: from baseline to postoperative 72 hours
Other outcomes:
Locations:
city: Shenyang
country: China
facility: the First Hospital of China Medical University
state: Liaoning
Study officials:
References:
Clinical trial NCT06926101: MARGINAL BONE LEVELS AROUND IMPLANTS PLACED BY PARTIAL OR FULL-THICKNESS FLAP: A 3-YEAR RANDOMIZED CONTROLLED CLINICAL TRIAL
Official title: MARGINAL BONE LEVELS AROUND IMPLANTS PLACED BY PARTIAL OR FULL-THICKNESS FLAP: A 3-YEAR RANDOMIZED CONTROLLED CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Implant
Dental Implant Therapy
Edentulism
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Each enrolled patient received one implant placed with the partial-thickness flap disconnect mode (PT Test Group) or the full-thickness flap disconnect mode (FT Control Group) from the same implant system (Anyridge, MegaGen Implant Co., Gyeongbuk, South Korea). Each implant was placed at 0.5 mm sub-crest as per protocol guidelines. This choice was made according to the current scientific literature. This implant system has specific macrostructural and microstructural techniques that allow high levels of standards. The fixture-abutment connection is internally conical at 2.8 mm with 5° indexing: this feature makes it possible to reduce the prosthetic microgap, move the platform away from the bone margin while maintaining an optimal crestal margin and prevent rotation or unscrewing of the prosthetic component. Each implant was placed at 1 mm sub-crest as per protocol guidelines. This choice was made according to the current scientific literature.


Eligibility criteria: Inclusion Criteria:

* 1. ≥18 years of age; 2. Need for implant placement therapy in the posterior area (from the second premolar to the second molar) due to a failing tooth; 3. Presence of adjacent and opposing natural teeth; 4. Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration; 5. Sufficient apical bone to achieve a minimum primary stability of 30Ncm.

Exclusion Criteria:

* 1. Diagnosis of periodontal disease; 2. Medical or general contraindications for the surgical procedure, such as systemic diseases, history of head and neck radiation therapy, current steroid treatment, neurological or psychiatric conditions affecting oral hygiene, immune-compromised status, severe clenching, or bruxism; 3. Heavy smoking (\>10 cigarettes/day); 4. Active infection at the implant site.

Primary outcomes:
measure: marginal bone levels
timeFrame: each year up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Dental Clinic University of Milan
Study officials:
References: