louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03048188: Manuka Honey in Second- and Grafted Third-degree Burns
Official title: Clinical Application Observation of Manuka Honey in Second- and Grafted Third-degree Burns
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Second-degree Burn
Third-Degree Burn
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: University of Luebeck
First posted: 2017-02-09
Enrollment: 10
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: Treatment strategies of II. degree burn wounds and split-skin grafted III. degree burn wounds aim at reducing infection and improving reepithelialization. The aim of this study is to evaluate time to reepithelialization, pain, microbiology and handling of manuka honey dressings with second-degree burn wounds and split-skin grafted burn wounds.

Detailed description: In plastic and reconstructive surgery, treatment strategies of second-degree burn wounds and split-skin grafted third-degree burn wounds aim at reducing infection and improving reepithelialization. Although previous studies indicate that burn patients benefit from wound dressings containing manuka honey, only a few studies can be found. Therefore, the aim of this study is to evaluate time to reepithelialization, pain, microbiology and handling of manuka honey dressings with second-degree burn wounds and split-skin grafted burn wounds.

Eligibility criteria: Inclusion Criteria:

* Consent-capable male and female patients (or guardian)
* ≥18 years of age
* ability to asses pain

Exclusion Criteria:

* Immunosuppressive Therapy
* Clinical wound infection
* Allergy against honey
* Relationship to someone who is involved in the study design or assessment
* Participation in other clinical trials

Primary outcomes:
measure: Epithelialization
timeFrame: Up to 1 year
Secondary outcomes:
measure: Pain
timeFrame: Up to 1 year
measure: Microbiology
timeFrame: Up to 1 year
measure: Handling
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: University Hospital Schleswig-Holstein
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: University of Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
affiliation: University of Lübeck, University Hospital Schleswig-Holstein
name: Tobias Kisch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02915588: Early Active Rehabilitation After Arthroscopic Rotator Cuff Repair
Official title: Early Active Rehabilitation After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Full Thickness Rotator Cuff Tear
Lead sponsor: Johannes Kepler University of Linz
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare two different rehabilitation protocols after arthroscopic rotator cuff surgery.


Eligibility criteria: Inclusion Criteria:

* surgery of the rotator cuff after full thickness tear
* informed consent
* understanding german language

Exclusion Criteria:

* previous surgery of the shoulder
* neurological or systemic diseases with impairment of shoulder function

Primary outcomes:
measure: Change of Constant Murley Score
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Change of DASH Score
timeFrame: up to 24 weeks
measure: Change of Active range of Motion (Flexion, Extension, Abduction, Internal Rotation, External Rotation)
timeFrame: up to 24 weeks
measure: Change of Pain (max; average; rest)
timeFrame: up to 24 weeks
measure: Change of Strength (abduction; external Rotation)
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler University Hospital
Study officials:
affiliation: Institute of physical medicine and rehabilitation
name: Christian Mittermaier, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01012388: Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color
Official title: Post-Marketing Study of Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nasolabial Folds
Keywords: Moderate to severe wrinkles and folds such as nasolabial folds
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Post marketing study to assess the likelihood of hypertropic scarring, keloid formation and hyper- or hypopigmentation in patients with Fitzpatrick Skin Types IV, V, and VI receiving nasolabial fold treatment with Radiesse® Injectable Dermal Filler


Eligibility criteria: Inclusion Criteria:

* Is at least 18 years of age.
* Has Fitzpatrick Skin Type IV, V, or VI.
* Understands and accepts the obligation not to receive any other procedures or treatments in the nasolabial fold for 6 months.

Exclusion Criteria:

* Has history of hyper- or hypo-pigmentation in the nasolabial folds, keloid formation, or hypertrophic scarring.
* Has a known bleeding disorder or is receiving drug therapy that could increase the risk of bleeding.
* Has nasolabial folds that are too severe to be corrected in one treatment session.
* Has received any dermal filler or other injections, grafting or surgery in either nasolabial fold.
* Is pregnant, lactating, or not using acceptable contraception.

Primary outcomes:
measure: Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment
timeFrame: 3 months
measure: Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Chevy Chase
country: United States
state: Maryland
city: Ypsilanti
country: United States
state: Michigan
city: New York
country: United States
state: New York
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
References:
citation: Marmur ES, Taylor SC, Grimes PE, Boyd CM, Porter JP, Yoo JY. Six-month safety results of calcium hydroxylapatite for treatment of nasolabial folds in Fitzpatrick skin types IV to VI. Dermatol Surg. 2009 Oct;35 Suppl 2:1641-5. doi: 10.1111/j.1524-4725.2009.01311.x. Epub 2009 Aug 25.
Clinical trial NCT05636488: Determination of the Effects of Noise Level in the Operating Room
Official title: Determination of the Effects of Noise Level in the Operating Room on the Anesthesiologist, Patient, and Environment During the Induction Phase and Investigation of the Effect of Staff Training
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Noise; Adverse Effect
Noise Induced Hearing Loss
Keywords: noise induced hearing loss
operatin room's noise
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over the age of 18 without hearing loss who will undergo elective surgery under general anesthesia

Brief summary: The goal of this observational study is to learn about effects of noise in healthy patients undergoing elective surgery.

Detailed description: There are many factors that can negatively affect surgical performance in operating rooms. Noise is the most striking of these factors. Excessive noise can cause hearing loss, cognitive dysfunction, anxiety, stress-induced increases in cortisol levels, and an increased risk of cardiovascular disease. Noise can have negative effects on concentration and performance. At the same time, workplace noise is one of the most important causes of fatigue. One of the anesthesia phases where the sound level reaches the highest levels is the induction phase. With this study, the investigators want to examine the effects on the anesthesia team, the patient and the environment by measuring the noise levels during the induction period, and then train the operating room personnel to examine the effects on this issue. The investigators aim to raise awareness about the development of procedures and training programs for operating room personnel.

Eligibility criteria: Inclusion Criteria:

* patients over the age of 18,

  * Elective cases to be taken under general anesthesia,
  * Those who do not have a psychiatric disease,
  * Patients without hearing loss

Exclusion Criteria:

* patients under the age of 18
* Patients who have psychiatric disease
* Patients who has hearing loss

Primary outcomes:
measure: assessing effect of noise level on fatigue with questionnaire
timeFrame: postoperative 24 hours
measure: assessing effect of noise level on anxiety with questionnaire
timeFrame: postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05009888: COVID-19 SARS-CoV-2 Antibody Testing Study
Official title: COVID-19 SARS-CoV-2 Antibody Testing Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Staff members based at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN).

Brief summary: SATS is a single site feasibility study to assess the practical and psychological feasibility of using rapid COVID antibody testing of blood obtained from fingertip pin-pricks.

Detailed description: SATS is a feasibility study conducted at a single site - King's College London and South London and Maudsley staff working at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN) at Denmark Hill, London, England. The practical and psychological feasibility of using rapid COVID antibody testing of blood obtained from fingertip pin-pricks will be assessed.

Eligibility criteria: Inclusion Criteria:

* King's College Staff member
* Aged 18 years or over
* Able to freely give informed consent

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

* known to have an infectious disease including a current SARS-CoV-2 infection.
* Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the research study, or may influence the result of the research study, or the participant's ability to participate in the research study. Examples of disorders or diseases which would be excluded include:

  * Medically diagnosed bleeding disorder;
  * Medically diagnosed platelet disorder;
  * Anticoagulant medication.

Primary outcomes:
measure: Acceptability of performing antibody testing procedures involving a capillary blood sample collected via finger-prick
timeFrame: 1 Year
measure: Test validity of the antibody tests that are performed
timeFrame: 1 Year
Secondary outcomes:
measure: o Representativeness of participants psychological and behavioural reaction to the testing procedure, their test results, and their willingness to be re-tested.
timeFrame: 1 Year
measure: o Representativeness of participants sampled
timeFrame: 1 Year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01198288: Effects of Home-based Pulmonary Rehabilitation in Patients With Severe or Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Official title: Randomised Controlled Trial on the Effects of Home-based Pulmonary Rehabilitation in Patients With Severe or Very Severe COPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Respiratory Physiotherapy
Lead sponsor: Associazione Riabilitatori Insufficienza Respiratoria
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 182
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate if adding a domiciliary respiratory physiotherapy treatment to standard care in patients with chronic obstructive pulmonary disease (COPD) can improve physical function (walking test) and quality of life.


Eligibility criteria: Inclusion Criteria:

* Severe COPD (FEV1/FVC \< 70% and FEV1 \< 50% pred.) associated to hypoxaemic chronic respiratory insufficiency (PaO2 \< 60mmHg) or
* Very severe COPD (FEV1/FVC \< 70% and FEV1 \< 30% pred.)

With the following characteristics:

* no signs of lung restriction (TLC≥80%)
* clinically stable for at least the last four weeks
* MRC ≥ 2
* no participation to PR programmes in the last year

FEV1= Forced expiratory volume in the 1st second FVC= Forced vital capacity TLC= Total Lung Capacity PaO2= Partial pressure of arterial oxygen

Exclusion Criteria:

* - Muscular-skeletal impairment that could limit the patient's participation to the exercise programme;
* Cognitive impairment that could limit the patient's participation to the activities of education and exercise, as assessed by the Mini Mental State (MMS) test \<26;
* Malignancies

Primary outcomes:
measure: meters as per walking test performance
timeFrame: 8 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 8 weeks
measure: Bode index
timeFrame: 8 weeks
measure: dyspnea
timeFrame: 8 weeks
measure: relapses
timeFrame: 8 weeks
measure: services utilization
timeFrame: 8 weeks
measure: meters as per walking test performance
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Bode index
timeFrame: 6 months
measure: dyspnea
timeFrame: 6 months
measure: relapses
timeFrame: 6 months
measure: services utilization
timeFrame: 6 months
measure: meters as per walking test performance
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
measure: Bode index
timeFrame: 12 months
measure: dyspnea
timeFrame: 12 months
measure: relapses
timeFrame: 12 months
measure: services utilization
timeFrame: 12 months
Other outcomes:
Locations:
city: Busto Arsizio
country: Italy
facility: Unità di pneunologia, Ospedale di Busto Arsizio
state: Varese
Study officials:
References:
Clinical trial NCT02638688: Measurement of Fibroid Volume and 2D, 3D US
Official title: Uterine Fibroid Volume After Myomectomy Compared to Pre-operative Measurement by Two and Three-dimensional Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecology
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2015-12-23
Enrollment: 3
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 44

Brief summary: Objective: To compare 2-dimensional and 3-dimensional ultrasound measurements with the actual myomas volume after surgical removal, to clinically test the validity and usability of 3D ultrasound technology as opposed to conventional 2D real-time ultrasound and to assess the reliability of different ultrasound methods to measure volume of uterine fibroids.


Eligibility criteria: Inclusion Criteria:

* surgical intervention

Exclusion Criteria:

* unfit for surgery

Primary outcomes:
measure: measuring fibroid volumes
timeFrame: 2012-2015
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04374188: Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy
Official title: Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nephrolithiasis
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Efficacy of ciprofloxacin therapy in sepsis avoidance.
Primary purpose: TREATMENT

Brief summary: Efficacy of ciprofloxacin therapy in avoidance of sepsis in patient undergoing percutanous nephrolithotomy. A randomized controlled trial.

Detailed description: To figure out the value of oral ciprofloxacin medication in ameliorate the outcome of renal nephrolithiasis extraction via the endoscope as regard the sepsis.

Eligibility criteria: Inclusion Criteria:

* 1. Patient 18 years or older
* Stones ≥ 2 cm and/or mild to moderate hydronephrosis
* Sterile mid urine stream

Exclusion Criteria:

* Patients with a stent, nephrostomy tube or indwelling catheter
* Renal failure
* Fever before surgery
* Previous manipulation/procedure
* Concomitant bladder stone or tumour
* Patients with active UTI
* Contralateral renal/ureteric stone

Primary outcomes:
measure: Effect of ciprofloxacin versus levofloxacin duration before PCNL
timeFrame: 12 months
Secondary outcomes:
measure: differences between Culture and sensitivity (C&S) of Preoperative urine (MSU) and intraoperative renal pelvic urine
timeFrame: 12 months
measure: predictors of systemic inflammatory response syndeome (SIRS) and sepsis post PCNL.
timeFrame: 12 months
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh faculty of medicine
state: Kafrelsheikh
Study officials:
affiliation: Lecturer of urology
name: Diaa Eldin Taha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04584788: Validation of the O3 Regional Somatic Tissue Oxygenation Monitor
Official title: A Single-Center, Prospective Study in Healthy Volunteers for Validation of the O3 Regional Somatic Tissue Oxygenation Monitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxygen Deficiency
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
Collaborators: name: University Medical Center Groningen
First posted: 2020-10-14
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Testing the absolute accuracy of the Masimo O3 regional oximeter in reading somatic tissue oxygenation in healthy volunteers under controlled hypoxia.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 45 years, inclusive
* Willing and able to provide written informed consent
* Healthy subjects

Exclusion Criteria:

* Pregnant women
* Presence of any cardiovascular or pulmonary disease
* Exposure to high altitude(s) (\>2000 m) within 30 days prior to the study
* Known allergy to intravenous contrast medium or heparin
* Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent monitoring of SpO2 levels during the study
* Patients deemed not suitable for the study at the discretion of the Investigator

Primary outcomes:
measure: Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2
timeFrame: 1 visit up to 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Site 1
Study officials:
References:
Clinical trial NCT00712088: Project ICARE: Intervening for Community Awareness, Respect, & Empowerment
Official title: Project ICARE: Intervening for Community Awareness, Respect, & Empowerment - Behavioral Intervention to Reduce Sexual Risk Behavior of African American Men Who Have Sex With Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
Unsafe Sex
High Risk Sex
HIV Prevention
African-American
gay
bisexual
intervention trial
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Howard Brown Health Center
name: University of Illinois at Chicago
name: South Side Help Center
name: Chicago Department of Public Health
First posted: 2008-07-09
Enrollment: 275
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project will test the efficacy of a behavioral intervention to reduce sexual risk for HIV infection among African American Men who Have Sex with Men (MSM).


Eligibility criteria: Inclusion Criteria:

* Be 18 years of age or older;
* Self-identify as African American
* Understand and read English;
* Live within the Chicago area;
* Report at least two (male or female) sex partners in the past three months, and unprotected anal sex with at least one male sex partner in the past three months.

Exclusion Criteria:

* Have been diagnosed with HIV within the past three months (to allow for psychological and behavioral adjustment following an initial HIV diagnosis);
* Have a specific plan to move from the Chicago area within the next nine months;
* Report active injection drug use other than hormones or steroids.
* Participated in the intervention video or the pilot phase of this study.

Primary outcomes:
measure: Unprotected Sex
timeFrame: past three months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Howard Brown Health Center
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: David McKirnan, PhD
role: PRINCIPAL_INVESTIGATOR
References: