louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01452425: In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome
Official title: In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Volunteers
Keywords: Human volunteers
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2011-10-14
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Muscular compartment syndrome (MCS) is consecutive to an increase in intramuscular compartment pressures, and is a rare but serious postoperative complication.

The INVOS (In Vivo Optical Spectroscopy) monitors tissular oxygenation continuously and non-invasively.

The objective is to develop a model mimicking the physiopathology of MCS to assess the interest of the INVOS in this case.

Detailed description: After inflation of a tourniquet (pressure equal to the mean arterial pressure, we will obtain a model of slight venous congestion and arterial hypoperfusion. A comparison will be made between INVOS monitoring, sensory deficits, pain, electromyography and invasive pressure.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* \>18yr
* Informed consent
* Male

Exclusion Criteria:

* Neuropathies
* Vascular pathology
* Actual pain
* Anti-platelet or anticoagulant therapy
* Ipsilateral history of fracture

Primary outcomes:
measure: Comparison Between INVOS Monitoring and Electromyography
timeFrame: 45 minutes
measure: Intracompartmental Pressure (ICP)
timeFrame: 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: UCL
name: Patrice Forget, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02645825: Predictive Character Analysis of Ganglionic Echography for the Diagnostic of Benin or Malignant Superficial Adenopathy
Official title: Analyse du caractère prédictif de l'échographie Ganglionnaire Pour le Diagnostic de bégninité ou malignité d'Une adénopathie Superficielle
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Superficial Adenopathy
Keywords: superficial adenopathy - echography
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-01-05
Enrollment: 300
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: Patient from ambulatory medicine consultation with superficial adenopathy

Brief summary: Investigators need to establish a formal diagnostic of superficial adenopathy through complementary investigations to find etiologic diagnostic ( Echography, adenogram).

Echography examination should be a guide to take in charge the adenopathy and to predict presence of malignant (primitive) or benin (reactional) character of adenopathy. The aim of this study is to codify the management of adenopathic patient with a diagnostic in 48 hours after examination. This fast diagnostic helps to prevent unnecessary biopsy, to avoid wasting time in case of a serious pathology.


Eligibility criteria: Inclusion Criteria:

- superficial adenopathy

Exclusion Criteria:

- obvious adenopathy

Primary outcomes:
measure: Parameter of echography
timeFrame: inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Cabinet Brest
city: Brest
country: France
facility: Cabinet Brest
city: Brest
country: France
facility: Cabinet Brest
city: Brest
country: France
facility: Caninet Brest Centre
city: Brest
country: France
facility: CHRU de Brest
city: Ergue Gaberic
country: France
facility: Cabinet Ergue Gaberic
city: Ergue Gaberit
country: France
facility: Cabinet Ergue Gaberic
city: Ergue Gaberit
country: France
facility: Cabinet Ergue Gaberit
city: Lanmeur
country: France
facility: Cabinet Lamneur
city: Lanmeur
country: France
facility: Cabinet Lanmeur
city: Lanmeur
country: France
facility: Cabinet Lanmeur
city: Lanmeur
country: France
facility: Cabinet Lanmeur
city: Lanmeur
country: France
facility: Cabinet Lanmeur
city: Le Guilvinec
country: France
facility: Cabine Le Guivinec
city: Le Guilvinec
country: France
facility: Cabinet Le Guilvinec
city: Le Guilvinec
country: France
facility: Cabinet Le Guilvinec
city: Le Relecq Kerhuon
country: France
facility: Cabinet Brest Centre
city: Lesconil
country: France
facility: Cabinet Lesconil
city: Penmarch
country: France
facility: Cabinet Penmarch
city: Plouegat Guerrand
country: France
facility: Cabinet Plouegat Guerrand
city: Quimper
country: France
facility: Cabinet Quimper
city: Quimper
country: France
facility: CHIC Quimper
Study officials:
affiliation: CHRU de Brest
name: Christian Berthou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03841825: Effects of Active Reminders and Motivational Techniques on Oral Hygiene and Gingival Health in Orthodontic Patients
Official title: Effects of Active Reminders and Motivational Techniques on Oral Hygiene and Gingival Health in Orthodontic Patients: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Hygiene
White Spot Lesion
Gingivitis
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 67
Sex: ALL
Minimum age (years): 11
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This study will compare the use of text message reminders versus multiple in-person sessions of oral hygiene instructions and motivation on improving oral hygiene measurements.

Detailed description: Orthodontic treatment (i.e. braces) makes it hard to keep good oral hygiene. The purpose of this research study is to compare the use of text message reminders versus multiple in-person sessions of oral hygiene instructions and motivation on improving oral hygiene measurements. Participation in this study will last up to 6 months and will consist of 4 study visits to the VCU Orthodontic clinic which are also regular visits for treatment. Measurements to assess participant's oral health will be taken during these visits. Participants will be randomly assigned to 1 of 4 groups which may include receiving different types of text messages, repeated in-person oral hygiene instructions, or both, or neither.

Eligibility criteria: Inclusion Criteria:

1. Age 11-20 that have their own mobile device
2. Patients have cellular plan that allows them to receive text messages at no extra cost
3. Patients that will undergo treatment with full fixed appliances

Exclusion Criteria:

1. patients with significant medical or dental history, including patients with bleeding disorders that would require antibiotic prophylaxis
2. Pregnant women

Primary outcomes:
measure: Change in 3-item Bleeding Index (BI)
timeFrame: Initial visit to 4 - 6 weeks
measure: Change in 3-item Bleeding Index (BI)
timeFrame: 4 - 6 weeks to 8 - 12 weeks
measure: Change in 3-item Bleeding Index (BI)
timeFrame: 8 - 12 weeks to 12 - 18 weeks
Secondary outcomes:
measure: Change in 5-item Modified Gingival Index (MGI)
timeFrame: Initial visit to 4 - 6 weeks
measure: Change in 5-item Modified Gingival Index (MGI)
timeFrame: 4 - 6 weeks to 8 - 12 weeks
measure: Change in 5-item Modified Gingival Index (MGI)
timeFrame: 8 - 12 weeks to 12 - 18 weeks
measure: Change in 6 item Plaque index (PI)
timeFrame: Initial visit to 4 - 6 weeks
measure: Change in 6 item Plaque index (PI)
timeFrame: 4 - 6 weeks to 8 - 12 weeks
measure: Change in 6 item Plaque index (PI)
timeFrame: 8 - 12 weeks to 12 - 18 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Shroff Bhavna, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06460025: Compare Wound Sampling Methods Efficacy in Microbiology Culture
Official title: Slough in Acute or Chronic Wounds for the Diagnosis of Microbiology Cultivation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Microbial Colonization
Infected Wound
Slough
Keywords: Microbial Colonization
Infected Wound
Slough
Biofilm
Sampling
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This was a single-center, retrospective, cross-sectional study, including 131 patients with acute or chronic wounds treated in Wound Healing Center of Peking University Third Hospital from October 2022 to October 2023

Brief summary: Slough was a visible indicator of biofilm, which was the most available specimen from acute and chronic wounds. However, studies believed that slough were poorly accurate, and that the Levine swab was more recommended for sampling bacterial culture. This study aimed to compare slough with swab sample and analyze the consistency.


Eligibility criteria: Inclusion Criteria:

1. Patients with acute and chronic wounds who were first seen at the Wound Care Centre of Peking University Third Hospital from October 2022 to October 2023;
2. Patients who have followed the wound sample collection SOP to simultaneously take wound swabs and putrefactive samples and send them for bacterial culture;;
3. Patients aged 18 years or older;

Exclusion Criteria:

1. Patients who had been taken only one of the wound samples, either swab or slough;
2. The swab collection did not meet the deifinitions for the exudate method or the Levine technique；
3. Bacterial culture profile was incomplete didn't meet the requirement of the trial.

Primary outcomes:
measure: cohen's k coefficient of Gram Stain between Slough and Swap Specimens
timeFrame: Day 0, patients' the first site in wound healing center
Secondary outcomes:
measure: cohen's k coefficient of Common pathogens between Slough and Swap Specimens
timeFrame: Day 0, patients' the first site in wound healing center
measure: agreements in microbiology cultivation between slough and swap
timeFrame: Day 0, patients' the first site in wound healing center
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University 3rd Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05607225: Deep Learning-based Classification and Prediction of Radiation Dermatitis in Head and Neck Patients
Official title: Deep Learning-based Classification and Prediction of Radiation Dermatitis in Head and Neck
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Radiation Dermatitis
Head and Neck Cancer
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 300
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: patients with head and neck cancer who will receive radical radiotherapy

Brief summary: to develop a deep learning-based model to grade the severity of radiation dermatitis (RD) and predict the severity of radiation dermatitis in patients with head and neck cancer undergoing radiotherapy, so as to provide support for doctors' diagnosis and prediction.

Detailed description: 1. Image acquisition The images of the neck area were collected from the enrolled patients one week before and every week during radiotherapy. The photographs were taken from three angles (front, left and right oblique) of the neck area.
2. Grading evaluation Each image was individually graded by three experienced radiotherapy experts according to the RD criteria of RTOG
3. Data analysis Construct a dermatitis grading model basing on deep learning. Evaluate the performance of model using accuracy, precision, recall, F1-measure, dice value.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old.
* Histologically or cytologically confirmed head and neck carcinoma confirmed by pathology.
* Receive radical radiotherapy including neck area
* Informed consent.

Exclusion Criteria:

* unable to cooperate with image acquisition

Primary outcomes:
measure: Accuracy
timeFrame: July 1, 2022 to June 30, 2025
measure: Precision
timeFrame: July 1, 2022 to June 30, 2025
measure: Recall
timeFrame: July 1, 2022 to June 30, 2025
measure: F1-measure
timeFrame: July 1, 2022 to June 30, 2025
measure: ROC curve
timeFrame: July 1, 2022 to June 30, 2025
Secondary outcomes:
measure: dice value
timeFrame: July 1, 2022 to June 30, 2025
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Cancer Hospital, Chinese Academy of Medical Sciences
state: Guangdong
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
Study officials:
affiliation: Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
name: Ye Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenzhen Cancer Hospital, Chinese Academy of Medical Sciences
name: Li Ma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05313425: Effect of Ectoine After Photorefractive Keratectomy (PRK).
Official title: Effect of Ectoine on Stromal Haze, Wound Healing and Pain After Photorefractive Keratectomy.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Photorefractive Keratectomy
Corneal Haze
Keywords: PRK, surface ablation, corneal haze
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient enrolled for photorefractive keratectomy for correction of myopia and myopic astigmatism.

Brief summary: This is a comparative, open label, parallel group, non interventional study aims to assess the effect of Ectoine containing eye drops on stromal haze, pain and epithelial healing after Photorefractive keratectomy (PRK). The patient apply Ectohylo eye drops (Ectoine +Sodium Hyauronate) in the right eye and Polyfresh Extra eye drops (Carboxymethyl cellulose + Sodium Hyauronate ) in the left eye plus the routine post PRK treatment in both eyes. Post operative pain , epithelial healing and corneal densitometry is observed in both eyes.

Detailed description: Photorefractive keratectomy (PRK) is a commonly used operation for laser vision correction. The main fears of this type of laser vision correction is corneal haze, delayed epithelial healing and postoperative severe pain. Ectoine is a natural compound that has the ability to protect biological membranes from damage and environmental effects. This study assess the use of Ectoine containing eye drops to protect the bare ocular surface and reduce inflammation after PRK that will inturn is expected to affect the post operative corneal haze, pain, and epithelial healing .

Eligibility criteria: Inclusion Criteria:

* Patient undergoing PRK for myopia and myopic astigmatism when astigmatism is 2.5 diopters or less and myopia with spherical equivalent -4 or less.

Exclusion Criteria:

* patient spherical equivalent more myopic than -4 diopters
* Patients with astigmatism more than 2.5 diopter
* Patients with anisometropia ( difference \> 2 diopters)
* Patient with previous ocular surgery
* Patients with chronic systemic disease that can affect results of laser vision correction (e.g. rheumatoid arthritis)
* Pregnant and lactating females

Primary outcomes:
measure: Corneal Densitometry (assesed by Pentacam).
timeFrame: 3 months post operative
Secondary outcomes:
measure: Pain score (0 -10)
timeFrame: 2 days
measure: Time of Epithelial healing (days)
timeFrame: 2-7 days
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El Gharbia
Study officials:
affiliation: Tanta University
name: Mohamed Elkadim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02660125: Endometrial Injury and Implantation Rates Before First ICSI Cycle
Official title: Does Local Endometrial Injury Improve Implantation Rates in Women Undergoing Their First ICSI Cycle.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Invitro Fertilization
Keywords: ICSI
endometrial injury
implantation rate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-01-21
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Midluteal single endometrial strip will be taken using a Novak curett under general anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of forbidden cervix, the step that will be beneficial to embryo transfer procedure.

Controller ovarian hyperstimulation; will be done using the long luteal phase agonist protocol and the short protocol(as judged by patient,s age ovarian reserve judged by day 3 FSH and antral follicular count and previous history of ovarian response).

Ovarian response will be monitored by vaginal ultrasound and HCG will be given when when there is \>=1 follicle \>=18 mm. and \>=3 follicles \>=16 mm. Ultasound guided oocyte retrieval will be carried out 35 hours later. Embryo transfer will be performed on day 2 or day 3 after oocyt retrieval according to number and quality of embryos.

Embryo transfer will be carried out under trans-abdominal ultrasound guidance pregnancy test will be done using qualitative blood HCG detection 2 weeks after the embryo transfer.


Eligibility criteria: Inclusion Criteria:

1. subfertile women indicated for ICSI.
2. normal uterine cavity demonstrated by transvaginal ultrasound and hystrogram.
3. FSH\<10mIU/mL on day 3 of her cycle.

Exclusion Criteria:

1. presence of endometrial polyp or fibroid distorting the uterine cavity.
2. hydrosalpinx.
3. ICSI carried out for preimplantation genetic diagnosis.
4. FSH\>10mIU\\mL.

Primary outcomes:
measure: implantation rate
timeFrame: 14 days after embryo transfer
measure: clinical pregnancy rate
timeFrame: 4 weeks after embryo transfer
Secondary outcomes:
measure: multiple pregnancy rate
timeFrame: 4 weeks after embryo transfer
measure: abortion rate
timeFrame: 12 weeks of gestational age
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Kasr Alainy medical school
name: Ahmed Maged
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maged AM, Rashwan H, AbdelAziz S, Ramadan W, Mostafa WAI, Metwally AA, Katta M. Randomized controlled trial of the effect of endometrial injury on implantation and clinical pregnancy rates during the first ICSI cycle. Int J Gynaecol Obstet. 2018 Feb;140(2):211-216. doi: 10.1002/ijgo.12355. Epub 2017 Nov 18.
Clinical trial NCT00381225: Feasibility of Ultra-sound Guided Radiofrequency Ablation in the Management of Head and Neck Neoplasia.
Official title: Feasibility of Ultra-sound Guided Radiofrequency Ablation in the Management of Head and Neck Neoplasia.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Head and Neck Neoplasia
Keywords: Radio-frequency ablation; Head and Neck neoplasia.
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2006-09-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To study the feasibility of Radiofrequency ablation (RFA) via ultrasound guidance in the management of head and neck neoplasia.

Detailed description: The study evaluates the feasibility of radio-frequency ablation in the management of head and neck neoplasia.

Eligibility criteria: Inclusion Criteria:

* Patients with head and neck neoplasia.

Exclusion Criteria:

* When the patient does not meet the inclusion criteria.
* When the patient has a contra-indication of surgery or anesthesia.
* If the patient refuses involvement in the study.

Primary outcomes:
measure: Technical success
timeFrame: Length of the procedure, up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine, Department of Otolaryngology-Head and Neck Surgery
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kieran Murphy, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000225: Alternate-Day Buprenorphine Administration. Phase VI - 7
Official title: Alternate-Day Buprenorphine Administration. Phase VI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Vermont
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if four times a subject's daily maintenance dose will hold for 96 hours without changes in agonist and antagonist effects.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Drug use
measure: Opioid withdrawal
measure: Opioid agonist effects
measure: Dose identification
measure: Pupil diameter
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Treatment Research Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: Warren Bickel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: patry, Bickel, Tzanis, Badger (in preparation). Every fourth day dosing with buprenorphine (1) A comparison of four schedules under blind-dosing procedures.. Patry, Bickel, Tzanis, Badger (in preparation). Every fourth day dosing with buprenorphine (1) A comparison of four different dosing schedules under blind-dosing procedures.