louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06670417: Low-level Laser Therapy Versus Offloading Exercises on Foot Ulcer Healing in Patients with Type 2 Diabetes
Official title: Low-level Laser Therapy Versus Offloading Exercises on Foot Ulcer Healing in Patients with Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer (DFU)
Keywords: Low level laser
Diabetic Foot Ulcer
Blood glucose level
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the effect of extravascular Low-level laser therapy (LLLT) versus offloading exercises on foot ulcers healing (DFUs) in type 2 diabetic patients. could include sixty patients with type 2 diabetes associated with diabetic foot ulcer as a complication, their ages ranging from 45 - 55 years. Patients will be selected from Faculty of Medicine (Kasr Al-Aini) Cairo University. They will be referred by the physician after a complete medical evaluation. . The main question it aims to answer is there any significant difference between extravascular low-level laser therapy and offloading exercise on diabetic foot ulcer healing in type 2 diabetic patients ?

After clinical assessment patients will be randomly allocated into three groups equal in number:

Group (A) (Experimental A): will receive extravascular low level laser therapy LLLT (laser watch device) combined with their prescribed hypoglycaemic medications(oral and insulin) and usual wound care for 12 weeks (3 sessions/ week).

Group (B) (Experimental B): will receive Offloading exercise inform of burger allen exercise combined with their prescribed hypoglycaemic medications(oral and insulin) and usual wound care for 12 weeks (3 sessions/ week).

Group (C) Control group will receive their prescribed hypoglycaemic medications(oral and insulin) and usual wound care only for 12 weeks (3 sessions/ week).


Eligibility criteria: Inclusion Criteria:

* Body mass index of 25-34.9 kg/m2.
* Glycated hemoglobin (HbA1c) \&gt;7 %.
* ABP index absolute normal (1-1.3)
* Patient with polyneuropathy.
* Patient suffer from diabetes more than 5 years.
* Patient has chronic unhealed diabetic ulcer from 4 weeks up to 6 weeks.

Exclusion Criteria:

* Patients with history of hypo- hyperglycemic coma.
* Uncontrolled cardiovascular complications.
* Malignancy, Anemia, Hemorrhagic diseases.
* Cardiac peace maker.
* Deep venous thrombosis.
* Osteomyelitis.
* Patients with Monckeberg sclerosis.
* Photosensitivity to laser.

Primary outcomes:
measure: wound surface area
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Glycated hemoglobin HbA1c
timeFrame: From enrollment to the end of treatment at 12weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
state: Dokki
Study officials:
References:
Clinical trial NCT05529017: Post Injury Performance Deficits in Rink Hockey
Official title: Performance Characteristics and Post-injury Deficits in Rink Field Hockey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Injuries
Sports Physical Therapy
Non Contact Injury
Performance
Lead sponsor: University of Oviedo
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: rink hockey players (male and female) from spanish senior leagues only outfield players irrespective of category

Brief summary: Rink Hockey is a sport played on a 40\*20 metres rink characterized by combined periods of high intensity and short breaks, there´s a lack of epidemiological studies in this field. In line with the well-established model of sports injury prevention research proffered by van Mechelen, the first stage in this process is establishing the extent of the problem i.e. injury incidence, severity and burden.

Detailed description: This study will assess performance metrics from rink hockey athletes and injury epidemiology. 4 tests (to be specified yet) will evaluate players fitness during preseason and when a player suffers a non-contact injury during the season, the player will be retested to assess variability and performance deficits.

injury characteristics and exposure time will be recorded too

Eligibility criteria: Inclusion Criteria:

* Compete in senior league
* be uninjured during preseason

Exclusion Criteria:

* not signing the participation consent
* no participation in the performance assessment during preseason

Primary outcomes:
measure: Maximal strength capacity
timeFrame: september 2022 to june 2023
measure: injury incidence
timeFrame: september 2022 to june 2023
measure: Explosive strength test (Countermovement jump test)
timeFrame: september 2022 to june 2023
measure: Agility test (5-10-5 test)
timeFrame: september 2022 to june 2023
measure: cardiovascular fitness test (30-15 test)
timeFrame: september 2022 to june 2023
Secondary outcomes:
measure: region injured
timeFrame: september 2022 to june 2023
measure: tissue affected
timeFrame: september 2022 to june 2023
measure: injury burden
timeFrame: september 2022 to june 2023
measure: mechanism of injury
timeFrame: september 2022 to june 2023
Other outcomes:
Locations:
Study officials:
affiliation: Universidad de Oviedo
name: Hugo Olmedillas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04180917: Current Trends and Future Perspectives Regarding Elective Rotations
Official title: Current Trends and Future Perspectives Regarding Elective Rotations Abroad Within Italian Surgical Residency Training: Is the Glass Half Empty or Half Full?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2019-11-29
Enrollment: 116
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: resident

Brief summary: Surgical resident elective rotation abroad give different opportunity such experience a different teaching and training, acquire more and new operative experience, experience living and working in a different cultural environment. Furthermore, the growing process of globalization that involves the nations themselves in different sectors, should also lead to a homogeneity of training on a global level, in order to be able to guarantee adequate assistance to different types of patients at the same time, and the possibility for doctors themselves of working abroad. the objective of the study is to provide the first overview of what is the current Italian scenario concerning abroad elective rotations during surgical training


Eligibility criteria: Inclusion Criteria:

* working as short-term supernumerary registrars in a foreign surgical department during the academic year 2017-2018

Exclusion Criteria:

* Surgeons/residents who have not been abroad for training

Primary outcomes:
measure: Satisfaction grade of actual elective rotation abroad in Italy
timeFrame: 1 years
Secondary outcomes:
measure: Gender
timeFrame: 1 year
measure: Age at time of elective training
timeFrame: 1 year
measure: Year of residency at the time of elective training
timeFrame: 1 year
measure: Institution visited
timeFrame: 1 year
measure: Global surgical exposure
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04593017: On Probiotic, Dental Caries, and Orthodontic Patients
Official title: Effect of Drops Containing Lactobacillus Reuteri (DSM 17938 and ATCC PTA 4659) on Plaque Acidogenicity and Other Caries Related Variables in Orthodontic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 28
Sex: ALL
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups matched in age and gender
Primary purpose: PREVENTION

Brief summary: To investigate the short term effect of probiotic oil on plaque acidogenicity among orthodontic patients. Shortage on testing the effect of probiotic on Orthodontic patients can be seen on litterateurs making a gap of whether is product of help in preventing dental caries or not ?

Detailed description: To investigate the short term effect of probiotic oil on plaque acidogenicity among orthodontic patients and to investigate the effect of probiotics on mutan streptococci and lactobacilli in plaque and saliva.

The null-hypothesis is that: The effect of probiotics would not differ from placebo-treated control group.

This product might decrease the chance of getting caries but also cooperation and cost effectiveness should be considered

Eligibility criteria: Inclusion Criteria:

* Subjects undergoing bimaxillary fixed orthodontic treatment
* Number of S. mutans counts (\>10.000 CFU/ml)
* Permanent dentition
* 3-12 months into the treatment (study from Sweden by Andrea)
* Medically healthy
* Not taking any medication
* Ability to understand the nature of the study and sign the consent form

Exclusion Criteria:

* Cleft lip and palate patients as well as handicapped and patients with mental impairments
* Systemic diseases or conditions that could interfere with our study (diabetes, immunosuppression diseases, pregnancy or ongoing therapy).
* History of probiotics/anti-inflammatory drugs taken during the last 4 weeks prior to baseline examination
* Local or general antimicrobial substances taken during the last 4 prior weeks prior to baseline examination
* Habitual consumers of xylitol chewing gums
* No active or untreated carious lesions and reported daily tooth brushing habit using fluoridated toothpaste

Primary outcomes:
measure: Effect of Probiotic oil (drops) on plaque acidogenicity (pH) among orthodontic patients.
timeFrame: 3 weeks
Secondary outcomes:
measure: Effect of Probiotics on Dental plaque
timeFrame: 3 weeks
measure: Effect of Probiotics on Saliva
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Gothenburg university
Study officials:
References:
citation: Alforaidi S, Bresin A, Almosa N, Lehrkinder A, Lingstrom P. Effect of drops containing Lactobacillus reuteri (DSM 17938 and ATCC PTA 5289) on plaque acidogenicity and other caries-related variables in orthodontic patients. BMC Microbiol. 2021 Oct 6;21(1):271. doi: 10.1186/s12866-021-02310-2.
Clinical trial NCT02696317: Clinical Evaluation of ACUVUE® OASYS® 1-Day and ACUVUE® OASYS®
Official title: Clinical Evaluation of ACUVUE® OASYS® 1-Day Daily Disposable Silicone Hydrogel Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2016-03-02
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the performance of two commercially-available silicone hydrogel contact lenses in normal and low humidity environments after at least 7 days of wear.

Detailed description: After randomization to lens order, subjects attended study visits that included a 3 hour exposure to reduced humidity environment (20% relative humidity) and subsequent tear film assessments for each study lens.

Eligibility criteria: Inclusion Criteria:

* Must sign an informed consent form;
* Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months;
* Prescription within power range of both study contact lenses, as stated in the protocol;
* Cylinder equal or lower than -0.75 diopter (D) in both eyes;
* Willing to wear lenses every day or at least a minimum of 5 days per week, 6 hours per day;
* Willing to discontinue artificial tears and rewetting drops on the days of study visits;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* History of herpetic keratitis, ocular surgery, or irregular cornea;
* Pregnant or lactating;
* Current AO1D or AO lens wearer;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Tear Film Evaporation Rate in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)
timeFrame: Day 10 ± 3 days, each product
Secondary outcomes:
measure: Tear Film Evaporation Rate After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)
timeFrame: Day 10 ± 3 days, each product
measure: Pre-Lens Tear Film Minimum Protected Area (MPA) in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)
timeFrame: Day 10 ± 3 days, each product
measure: Pre-Lens Tear Film MPA After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)
timeFrame: Day 10 ± 3 days, each product
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Senior Clinical Manager, GCRA Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT05400317: A Study to Evaluate the Efficacy and Safety of AD-218
Official title: A Randomized, Double-blinded, Active-controlled, Multicenter Phase 3 Clinical Trial and Open-label, Extension Study to Evaluate the Efficacy and Safety of AD-218 in Patients with Mixed Dyslipidemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Mixed Dyslipidemia
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-01
Enrollment: 520
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of AD-218

Detailed description: Condition or disease : Mixed Dyslipidemia Treatment Drug : AD-218, AD-218A, Placebo of AD-218, Placebo of AD-218A

Eligibility criteria: Inclusion Criteria:

* A man or woman over 19 years old.
* Sign on ICF prior to study participation

Exclusion Criteria:

* History of Fibromyalgia, Myopathy etc (CK ≥ 2 X ULN)
* Other exclusions applied

Primary outcomes:
measure: Percent change (%) of non-HDL-C from baseline at week 12
timeFrame: from baseline at 12 weeks
Secondary outcomes:
measure: Percent change (%) of non-HDL-C from baseline at week 4, 8
timeFrame: from baseline at week 4,8
measure: Percent change (%) of Lipid panel from baseline at week 4, 8, 12
timeFrame: from baseline at week 4, 8, 12
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Yeongnam University Hospital
state: Nam-gu
Study officials:
affiliation: Yeungnam University Hospital
name: Kyu Chang Won, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03491917: Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer
Official title: A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Fujifilm Medical Systems USA, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This clinical research is a retrospective, pilot, multi-reader, multi-case (MRMC) study with an enriched sample of 100 breast screening or diagnostic cases which were selected from the library of mammograms collected under Fujifilm protocol FMSU2013-004A (all subjects previously provided written informed consent agreeing their image data and supporting documentation could be used for future research and investigations).

Brief summary: The purpose of this pilot is to provide credible performance estimate information in order to conduct a subsequent pivotal reader study.

Detailed description: This clinical research is a retrospective, pilot, multi-reader, multi-case (MRMC) study with an enriched sample of 100 breast screening or diagnostic cases which were selected from the library of mammograms collected under Fujifilm protocol FMSU2013-004A (all subjects previously provided written informed consent agreeing their image data and supporting documentation could be used for future research and investigations). Approximately 6 qualified radiologists will independently perform two reads on all (approximately 100) cases. Each reader will read each case both as a FFDM (Full Field Digital Mammography) read, and a DBT (Digital Breast Tomosynthesis) plus S-View (Synthesized View) read on the ASPIRE Bellus II workstation.

Eligibility criteria: Inclusion Criteria:

* Female subjects participating in FMSU2013-004A protocol with known clinical status

Exclusion Criteria:

* Female subjects that did not have known clinical status in FMSU2013-004A

Primary outcomes:
measure: Compare Per Subject Average Area Under the ROC (Receiver Operating Characteristic) Curve (AUC)
timeFrame: 2 visits with 4 week washout period
Secondary outcomes:
Other outcomes:
Locations:
city: Norwalk
country: United States
facility: International HealthCare, LLC
state: Connecticut
Study officials:
affiliation: independent contractor
name: Laurie L. Fajardo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04741217: Aerosolisation During Respiratory Procedures
Official title: A Proof of Concept Study to Evaluate Aerosol Generation During Non-Invasive Positive Pressure Respiratory Procedures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Respiratory Tract Infections
Lung Infection
Droplet Spread
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects

Brief summary: Currently, a major issue within respiratory medicine is undertaking procedures that generate aerosolisation with the concern of spreading infection, such as the SARS-COV-2/COVID-19 virus. It is anecdotally reported that lung function testing and positive airways pressure devices used in clinical practice are aerosol generating procedures however the data to support this is limited. With the advent of high-speed imaging systems that can capture and quantify particle size and velocity we aim to investigate the aerosol generation in routine non-invasive positive pressure respiratory procedures.


Eligibility criteria: Inclusion Criteria:

* Age 18-80 years
* Healthy subjects with no active medical conditions or previous pneumothorax
* Cognitively and linguistically able to follow instructions given in English and provide informed consent

Exclusion Criteria:

* Significant respiratory, cardiac or neurological conditions or previous pneumothorax
* Smoking history greater than 10 pack years
* Acute illness at the time of assessment
* Allergies to latex, metals or local anaesthetic agents

Primary outcomes:
measure: Characterisation of aerosolised respiratory droplets
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00196417: The HIT-TRAP Trial
Official title: Randomized-Double Blind Trial to Assess the Incidence and Clinical Relevance of Heparin-Induced Thrombocytopenia (HIT) Antibodies in Trauma Patients Treated With Unfractionated or Low-Molecular Weight Heparin, the HIT-TRAP Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heparin-Induced Thrombocytopenia
Keywords: heparin-induced thrombocytopenia
HIT
unfractionated heparin
UFH
low-molecular-weight heparin
LMWH
thrombosis prophylaxis
HIT-antibody
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2005-09-20
Enrollment: 600
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: Randomised, double blind trial in non-intensive care trauma patients comparing unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH) in heparin-induced thrombocytopenia (HIT).

Detailed description: This is a randomised, double blind trial including trauma patients with need for thrombosis prophylaxis with heparin. Patients receive either unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH).

Heparin-induced thrombocytopenia (HIT) antibodies are measured on days 1 and 10. There are daily platelet counts. On discharge an ultrasound doppler of the lower extremities is performed to rule out deep vein thrombosis (DVT).

Three months after discharge every patient is answering a questionnaire about thromboembolic complications following discharge.

The key questions of the study are whether the two heparins cause HIT-antibodies in differing frequencies, and if yes, whether these differences lead to different clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* trauma-surgical patient
* consent given
* minimum age 18
* expected inpatient period at least 7 days
* need for thrombosis prophylaxis with heparin

Exclusion Criteria:

* intolerance of one of the study drugs
* malignancy with life expectancy \< 3 months
* pregnancy/lactation
* drug or alcohol abuse
* fibrinolytic therapy
* need for extracorporal circulation (e.g. cardiopulm. bypass, hemodialysis) at study entry
* participation in another clinical trial within 30 days prior to intended inclusion

Primary outcomes:
measure: Frequency of formation of HIT-antibodies during prophylactic treatment with UFH or LMWH in trauma-surgical patients
Secondary outcomes:
measure: Thromboembolic complications (TECs) during inpatient period in relation to heparin received and HIT-antibody status
measure: TECs during 3 months following discharge in relation to heparin received and HIT-antibody status
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Ernst-Moritz-Arndt University, Depts. of Transfusion Medicine / Trauma surgery
Study officials:
affiliation: Ernst-Moritz-Arndt University Greifswald, Germany
name: Andreas Greinacher, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: