louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05727150: Reliability and Versatility of Supraclavicular Artery Flap in Reconstruction of Head and Neck Soft Tissue Defects
Official title: Reliability and Versatility of Supraclavicular Artery Flap in Reconstruction of Head and Neck Soft Tissue Defects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reconstruction of Head Soft Tissue Defects
Reconstruction of Neck Soft Tissue Defects
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a case series study conducted at plastic surgery department Sohag University including 20 patients The aim of this thesis is to evaluate reliability and versatility of Supraclavicular artery flap in the reconstruction of traumatic and non-traumatic defects of head and neck.With adequate documentation of functional, aesthetic outcome and patient satisfaction through; clinical examination , photographic documentation and doctor and patient satisfaction charts


Eligibility criteria: Inclusion Criteria:

* Patients with head and neck soft tissue defect either traumatic or non-traumatic
* Available healthy donor site

Exclusion Criteria:

* Trauma or conditions affecting donor site or with possible compromise of vascular pedicle.
* Patients with a major uncontrollable medical illness, chronic heavy smokers.

Primary outcomes:
measure: Flap Success
timeFrame: 6 month post-surgery
measure: Flap complications
timeFrame: 6 months post-surgery
measure: patients satisfaction as regard flap color match
timeFrame: 6 months post-surgery
measure: patients satisfaction as regard flap texture match
timeFrame: 6 months post-surgery
Secondary outcomes:
measure: Possible flap lengths
timeFrame: 6 months post-surgery
measure: Possible flap widths
timeFrame: 6 months post-surgery
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag Faculty of Medicine
Study officials:
affiliation: Sohag University
name: Ahmad A Albadry
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00792350: INSIGHT - Post Marketing Surveillance
Official title: International Study With Nexavar About Safety and Efficacy in Carcinoma Hepatocellular Therapy (HCC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Hepatocellular
Keywords: Carcinoma, Hepatocellular
Sorafenib
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-11-17
Enrollment: 791
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In and outpatients with diagnosis of hepatocellular carcinoma (HCC) and decision taken by the investigator to prescribe Nexavar.

Brief summary: In this international non-interventional post-marketing surveillance study we want to evaluate patient characteristics in HCC patients as well as efficacy and safety of Sorafenib (Nexavar®) treatment under daily-life treatment conditions. Specifically investigated are the tumor status, prior and/ or concomitant surgical, radiological and drug treatment and the duration of Sorafenib treatment.


Eligibility criteria: Inclusion Criteria:

* In- and outpatients with diagnosis of hepatocellular carcinoma (HCC) and decision taken by the investigator to prescribe Nexavar

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information

Primary outcomes:
measure: Efficacy: status of tumor, patients performance status
timeFrame: At each follow-up visit, every 2-4 months
Secondary outcomes:
measure: Duration of treatment
timeFrame: At each follow-up visit, every 2-4 months
measure: Time of survival
timeFrame: At each follow-up visit, every 2-4 months
measure: Reports of adverse events
timeFrame: At each follow-up visit, every 2-4 months
Other outcomes:
Locations:
city: Many Locations
country: Austria
city: Many Locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01459250: Pharmacokinetics, Safety and Tolerability of AGO178C in Subjects With Renal Deficiencies Compared With Healthy Subjects
Official title: An Open Label, Non-randomised, Parallel Group Study to Characterise and Compare the Pharmacokinetics, Safety and Tolerability of a Single Dose of AGO178C in Subjects With Mild, Moderate, Severe Renal Impairment and End-stage Renal Disease With That in Healthy Matched Control Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: AGO178C,
renal impairment,
ESRD,
pharmacokinetics
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-10-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will assess the pharmacokinetics, safety and tolerability of a single dose of AGO178C in subjects with mild, moderate, severe renal impairment and end-stage renal disease with that in healthy matched control subjects.


Eligibility criteria: Inclusion Criteria:

* Mild, moderate, severe renally impaired or ESRD patients.
* Healthy male or female subjects to match renally impaired patients in BMI (±15%), age (± 7 years) and gender (in this order). Smoking status (yes or no) will also be used as a final criterion, if deemed feasible by the Investigator.

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless using effective contraception during the study as defined in the protocol.
* Smokers, smoking 10 cigarettes or more per day from screening to study completion
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study
* Co-medication for healthy subjects

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Measure: Composite of AGO178C pharmacokinetics in blood and urine samples.
timeFrame: pre dose, 2 min, 5 min, 10 min, 20 min, 30 min, 45 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h and 36 h post dose
Secondary outcomes:
measure: Measure: Safety and tolerability of AGO178C as assessed by adverse events reports, vital signs, ECGs and safety laboratory tests.
timeFrame: Up to 9 Days post dose
Other outcomes:
Locations:
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Orlando
country: United States
facility: Novartis Investigative Site
state: Florida
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Knoxville
country: United States
facility: Novartis Investigative Site
state: Tennessee
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00502450: Is There Hearing Loss After Acute Mastoiditis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Mastoiditis
Acute Otitis Media
Keywords: Acute mastoiditis
Hearing loss
Mastoidectomy
Audiogram
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2007-07-17
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary care clinic

Brief summary: Following acute mastoiditis there is a possible risk to develop hearing loss. The cause could be either possible involvement of the inner ear, or in cases that underwent surgery, secondary to the effect of the drill's noise. Extended hearing test will be performed for 25 children that suffered acute mastoiditis that resolved with conservative treatment and compared with 25 children that needed surgical intervention.


Eligibility criteria: Inclusion Criteria:

* History of acute mastoiditis 4 years and older

Exclusion Criteria:

* Younger than 4 years old Not cooperative for hearing test Active ear disease Major medical illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Schneider Children'S Hospital
Study officials:
affiliation: Rabin Medical Center
name: Eyal Raveh, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04156750: A Study of LY3556050 in Healthy Participants
Official title: Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study With LY3556050 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-11-07
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part A - Parallel design. Part B - Open label design.
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to learn more about the safety of LY3556050 after it is given by mouth to healthy participants. Blood tests will be performed to check how much LY3556050 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive multiple doses of LY3556050 or placebo and will remain in the study for up to 31 days.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females of nonchild bearing potential, as determined by medical history
* Have safety laboratory results within normal references ranges
* Weight at least 50 kilograms (kg)

Exclusion Criteria:

* Have known allergies to LY3556050, iodine, metformin and related compounds
* Abnormal electrocardiogram (ECG) or blood pressure at screening
* Significant history of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or endocrine disorders
* Show evidence of active renal disease with estimated glomerular filtration rate (GFR) \<90 milliliters per minute per 1.73 meters squared

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Final Follow-up (up to Week 9)]
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3556050
timeFrame: Baseline through Day 17
measure: PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ)
timeFrame: Baseline through Day 17
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02744950: Comparison of Scar Results and Time for Closures of Scalp Defects Via Pulley Sutures or Layered Repairs
Official title: A Prospective, Randomized Study to Evaluate the Efficacy of Pulley Closures Compared to Intermediate or Complex Closures for Reconstruction of Scalp Surgical Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scar
Keywords: pulley
scalp defects
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Surgical defects on the scalp require closure via various techniques of suture placement. A traditional technique requires both dermal (deep) and epidermal (superficial) placement of sutures to close the defect; this is referred to as intermediate or complex linear repair. However, the scalp is a location with high tension, and thus the closures take an hour or longer to perform. A type of suture placement referred to as the "pulley stitch" requires placement of a few stitches along the defect. The pulley stitch can be used in areas of high tension to close a large defect. The purpose of this study is to compare the scar results and time taken to perform scalp closures via only pulley stitches or via intermediate/complex linear repairs.

To my knowledge, no such study has been performed to compare the two techniques. Such a study would be useful in demonstrating comparable scar appearance and reduce the time to perform scalp closures.


Eligibility criteria: Inclusion Criteria:

1. Age greater than 18 years
2. Ability to understand risks, benefits, and alternatives to the study and to be able to give an informed consent
3. Lesions such as skin cancer or benign lesions on the scalp amenable to surgical excision or to MOHS surgical technique
4. Frontal scalp defects defined as frontal hair line to crown of scalp
5. Scalp defect size of 2cm - 8 cm

Exclusion criteria:

1. Patients who tend to form keloids or hypertrophic scars
2. Patients with a history of scleroderma or morphea
3. Pregnant or breast-feeding females
4. Patients whose surgical defects require flap closures

Primary outcomes:
measure: Time to close wound
timeFrame: Depends on case typically 4-10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System- Dermatology
state: Michigan
Study officials:
References:
Clinical trial NCT02001350: Carotid Ultrasound Study
Official title: Carotid Ultrasound Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resistant Hypertension
Lead sponsor: Noblewell
Sponsor class: INDUSTRY
Collaborators: name: Cibiem, Inc.
First posted: 2013-12-04
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 30 patients with longstanding or resistant hypertension

Brief summary: To use carotid ultrasound to screen 20-30 patients with longstanding or resistant hypertension for carotid atherosclerotic disease and bifurcation anatomy. This will establish a screening protocol for Cibiem's eventual endovascular carotid body modulation trial and will give insight into the prevalence and specific location of carotid plaque at the bifurcation in this patient population.


Eligibility criteria: Inclusion Criteria:

* 18-75 years old
* Uncontrolled hypertension on 3 or more medications or longstanding controlled hypertension on 4 or more medications.

Exclusion Criteria:

* Previous stroke
* Carotid endarterectomy or carotid stent procedure
* \>50% stenosis anywhere in carotid arteries

Primary outcomes:
measure: Specific location of carotid plaque at the bifurcation
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: Department of Hypertension and Diabetology, Medical University of Gdansk
Study officials:
affiliation: Cibiem, Inc.
name: Paul A. Sobotka, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05981950: Real-world of AI in Diagnosing Retinal Diseases
Official title: Real-world Application of Using Artificial Intelligence in Diagnosing Retinal Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Artificial Intelligence
Retinal Diseases
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 100000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is derived from an anonymous database that contains health examination results of the general population.

Brief summary: The objective of this study is to apply an artificial intelligence algorithm to diagnose multi-retinal diseases in real-world settings. The effectiveness and accuracy of this algorithm are evaluated by sensitivity, specificity, positive predictive value, negative predictive value, and area under curve.

Detailed description: The objective of this study is to apply an artificial intelligence algorithm to diagnose referral diabetes retinopathy, referral age-related macular degeneration, referral possible glaucoma, pathological myopia, retinal vein occlusion, macular hole, macular epiretinal membrane, hypertensive retinopathy, myelinated fibers, retinitis pigmentosa and other retinal lesions from fundus photography. tic 45-degree fundus cameras, trained operators took binocular fundus photography on participants. Operators were then asked to identify gradable images and unload for algorithm diagnosis. The effectiveness and accuracy of this algorithm are evaluated by sensitivity, specificity, positive predictive value, negative predictive value, area under curve, and F1 score.

Eligibility criteria: Inclusion Criteria:

* fundus photography around 45° field which covers optic disc and macula
* complete identification information

Exclusion Criteria:

* insufficient information for diagnosis

Primary outcomes:
measure: Area under curve
timeFrame: 1 month
measure: Sensitivity and specificity
timeFrame: 1 month
measure: Positive predictive value, negative predictive value
timeFrame: 1 month
measure: F1 score
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Wen-Bin Wei
state: Beijing
Study officials:
References:
Clinical trial NCT00557050: Acute Hamstring Strains in Danish Elite Soccer - Prevention and Rehabilitation
Official title: Acute Hamstring Strains in Danish Elite Soccer - Prevention and Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Strains
Keywords: Hamstring
Muscle
Injury
Prevention
Muscles
Lead sponsor: Amager Hospital
Sponsor class: OTHER
First posted: 2007-11-12
Enrollment: 1000
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: A common soft tissue injury in sports involving sprinting and jumping is the hamstring strain.

Not much evidence-based research has been carried out on prevention of hamstring strains.

Most studies suggest that hamstring strains occur during the later part of the swing phase when the player is sprinting. In this phase the hamstring muscles are working to decelerate knee extension - that is, the muscle develops tension while lengthening. This means that the muscles change from functioning eccentrically to concentrically. We hypothesize that it is during this rapid change from eccentric to concentric function that the muscles are most vulnerable to injuries, and that the injuries can be prevented by increasing the eccentric muscle strength in the hamstring.

This randomized clinical trial will examine the effect of a 10-week preseason strength-training program in Danish elite soccer. The strength-training program focuses on eccentric hamstring training.

60 elite teams (1200 soccer players) will be cluster-randomized to either ordinary training or ordinary training combined with eccentric hamstring strength training. The training group will start the training program in the pre-season (10 weeks) and continue the training once a week during the following season.

Suspected hamstrings strains during the season will be examined within 3 days using ultrasound. Ultrasound verified hamstring strains will be registered, and players will start a standardized rehabilitation program.


Eligibility criteria: Inclusion Criteria:

* Male soccer player in one of the top 4 divisions i Denmark in the 2007/08 season
* Minimum 18 years old at the time for inclusion

Exclusion Criteria:

* Current hamstring strain at the time for inclusion
* Under 18 years old

Primary outcomes:
measure: Number of acute hamstring strains
timeFrame: one soccer season
Secondary outcomes:
measure: Number of ACL-injuries
timeFrame: One soccer season
Other outcomes:
Locations:
Study officials:
affiliation: Department of Orthopaedic Surgery, Amager University Hospital, Denmark
name: Jesper Petersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petersen J, Holmich P. Evidence based prevention of hamstring injuries in sport. Br J Sports Med. 2005 Jun;39(6):319-23. doi: 10.1136/bjsm.2005.018549.
Clinical trial NCT01377350: Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System
Official title: Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
monitoring
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-06-21
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to explore the feasibility of monitoring hemodynamic changes, which result from heart failure exacerbations, by recording the respiratory effort, chest wall dynamics and quantifying the development of dyspnea by using miniature mechanical sensors that are attaches to the chest.

Detailed description: Pulmonary veins congestion and fine changes in alveolar transudative effusion accumulation affect lung mechanics (compliance) and the respiratory effort. Moreover, the associated state of oxygen de-saturation is compensated by an increase in the respiratory effort. These changes in the respiratory effort are reflected in chest wall dynamics and may provide the earliest non-invasive sign for lung congestion and deterioration in the heart failure.

The research system comprises of patches attached to the patients' thorax that include motion sensors (Accelerometers) that measure the chest wall dynamics and the mechanics of lung inflation and deflation. The signals are acquired by a miniaturized device that amplifies and samples the signals, stores and analyzes the data and displays the trends on the screen.

Eligibility criteria: Inclusion Criteria:

* Acute decompensated HF
* Decompensated chronic HF in patients with NYHA class III-IV symptoms
* Age over 20 years
* Ejection fraction reduced below 35% OR doppler evidence of impaired left ventricular diastolic filling

Exclusion Criteria:

* Inability or unwillingness to follow the study protocol

Primary outcomes:
measure: earliest non-invasive signs for lung congestion and deterioration in the heart failure
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Medical Center Haifa Israel
name: Shmuel Rispler, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: