louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05528432: ANKLE TRAUMA Diagnostic Value of Ultrasound Compared to Standard Radiography in the Detection of Fractures
Official title: ANKLE TRAUMA Diagnostic Value of Ultrasound Compared to Standard Radiography in the Detection of Fractures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fractures Bone
Keywords: Fracture ankle
Fracture foot
Frature metatarsus
Ultrasound
X-ray
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any adult patient presenting to the emergency services of the CHU Saint Pierre

Brief summary: To investigate the diagnostic value of ultrasound performed by a lay experimenter compared to standard radiographic imaging (or standard x-ray) in the detection of fractures in patients with closed acute ankle trauma and positive Ottawa ankle rules

Detailed description: Selection of patients is according to the criteria detailed below. If the patient is deemed eligible for the study, he will be asked to read and sign the informed consent. Besides standard history taking, physical examination and radiographic imaging, a standardized ultrasound examination of the ankle joint will be performed by a lay experimenter.

Care will be provided by the attending physician and, according to "standard of care", treatment decisions will be based on history taking, physical examination and conventional ankle x-ray series. Sonographic results will not be used for this purpose. All ankle x-ray series will be reviewed by a senior resident radiologist.

Eligibility criteria: Inclusion Criteria:

Any adult patient with acute ankle trauma

+ one or more criteria of the Ottawa ankle rules :

* Inability to walk 4 steps immediately after the trauma or in the emergency room,
* pain at the level of the internal or external malleolus (the distal 6 cm) or the base of the 5th metatarsal bone.

Exclusion Criteria:

* Any patient under the age of 18 years
* Any patient unable to sign the informed consent
* Skin lesions contraindicating sonography (e.g. open fracture wound, ... )
* An unstable patient whose inclusion in the study would delay vital treatment

Primary outcomes:
measure: Negative predictive value
timeFrame: at inclusion
Secondary outcomes:
measure: Sensitivity
timeFrame: at inclusion
measure: Specificity
timeFrame: at inclusion
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: FREZALS Laeticia Vaiana
Study officials:
affiliation: Centre Hospitalier Universitaire Saint Pierre
name: Laeticia Vaiana FL Frezals, Médecin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bozkurt O, Ersel M, Karbek Akarca F, Yalcinli S, Midik S, Kucuk L. The diagnostic accuracy of ultrasonography in determining the reduction success of distal radius fractures. Turk J Emerg Med. 2018 Aug 10;18(3):111-118. doi: 10.1016/j.tjem.2018.04.001. eCollection 2018 Sep.
Clinical trial NCT04431232: Endo-Band: Endoscopic Band Ligation for Weight Loss
Official title: Endoscopic Band Ligation for Weight Loss
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Obesity
BMI
Lead sponsor: El Katib Hospital
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To the best of our knowledge, this is the first study to use endoscopic band ligation for weight loss. All ligatures will be performed in the gastric body starting at the distal body; 5 parallel rows, with the last one in the proximal body.The entire procedure can be completed in 30 min. Oxygen is used for endoscopic air insufflation.Endoscopy is performed using propofol for sedation.

Detailed description: The idea of band ligation of the gastric body is to induce multiple gastric ulcers that forms a fibrotic scars which can lead to marginal narrowing of the lumen; same as that occurred in the esophagus following band ligation of esophageal varices or in the antrum following band ligation of GAVE.

Eligibility criteria: Inclusion Criteria:

* BMI \> 27

Exclusion Criteria:

* Any contraindication for endoscopy
* Any gastric bleeding lesions
* Uncontrolled use of anticoagulants or NSAID's

Primary outcomes:
measure: Weight Loss
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: El Katib Hospital (Celopatra Group)
state: Dokki
Study officials:
affiliation: Endoscopy Unit Faculty of Medicine Cairo University
name: Mohamed Abeid, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keohane J, Berro W, Harewood GC, Murray FE, Patchett SE. Band ligation of gastric antral vascular ectasia is a safe and effective endoscopic treatment. Dig Endosc. 2013 Jul;25(4):392-6. doi: 10.1111/j.1443-1661.2012.01410.x. Epub 2012 Dec 17.
citation: Jirapinyo P, Thompson CC. Endoscopic gastric body plication for the treatment of obesity: technical success and safety of a novel technique (with video). Gastrointest Endosc. 2020 Jun;91(6):1388-1394. doi: 10.1016/j.gie.2020.01.030. Epub 2020 Jan 28.
citation: Abeid M, Miller KA, Kaddah T, Zaitoun N. Outcome of Primary Obesity Surgery Endolumenal Procedure as Obesity Treatment in Private Practice Setting: an Intervention Study. Obes Surg. 2019 Apr;29(4):1364-1366. doi: 10.1007/s11695-018-03698-z. No abstract available.
Clinical trial NCT00483132: Study of Treatment High Risk and/or Low Risk Acute Lymphoblastic leukémia(ALL) Adults Stage III
Official title: Study of Treatment High Risk and/or Low Risk Acute Lymphoblastic leukémia(ALL) Adults Stage III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Leukemia, Lymphocytic, Acute
Lead sponsor: French Innovative Leukemia Organisation
Sponsor class: OTHER
First posted: 2007-06-06
Enrollment: 232
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Improved outcome of high risk lymphoblastic leukemia (ALL) with laite high dose therapy.

High dose versus conventional therapy for adult low risk T-ALL and Lymphoblastic lymphoma (LBL).

Detailed description: Comparison between two autograf therapeutic strategies in high risk patients Ramdomised comparison between maintenance treatment with or not interferon alpha 2 a

Eligibility criteria: Inclusion Criteria

* ALL high risk or low risk or lymphoblastic lymphoma
* age 15-55 years old
* informed consent signed

Exclusion Criteria:

* patients previously treated with a chemotherapy or alpha-interferon
* ALL 3 (burkitt like)

Primary outcomes:
measure: overall survival
timeFrame: time to death
Secondary outcomes:
measure: Efficacy of study treatments
timeFrame: time to end of treatment
Other outcomes:
Locations:
city: Angers
country: France
facility: INorbert IFRAH
state: chu ANGERS
Study officials:
affiliation: French Innovative Leukemia Organisation
name: Norbert IFRAH, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: French Innovative Leukemia Organisation
name: Noël MILPIED
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hunault M, Harousseau JL, Delain M, Truchan-Graczyk M, Cahn JY, Witz F, Lamy T, Pignon B, Jouet JP, Garidi R, Caillot D, Berthou C, Guyotat D, Sadoun A, Sotto JJ, Lioure B, Casassus P, Solal-Celigny P, Stalnikiewicz L, Audhuy B, Blanchet O, Baranger L, Bene MC, Ifrah N; GOELAMS (Groupe Ouest-Est des Leucemies Airgues et Maladies du Sang) Group. Better outcome of adult acute lymphoblastic leukemia after early genoidentical allogeneic bone marrow transplantation (BMT) than after late high-dose therapy and autologous BMT: a GOELAMS trial. Blood. 2004 Nov 15;104(10):3028-37. doi: 10.1182/blood-2003-10-3560. Epub 2004 Jul 15.
Clinical trial NCT06363032: Elastography in Predicting Renal Outcome
Official title: Application of Transthoracic Shear-wave Ultrasound Elastography in the Evaluation of Renal Function and Diagnosis of Renal Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Disease
Keywords: elastography
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients receiving scheduled renal biopsy and scheduled renal sonography

Brief summary: There are two types of elastography: strain elastography assesses the degree of strain when applying a given amount of force to the skin. Shear-wave elastography assesses the velocity of shear wave propagation within the target lesion. A part of the tissue is deformed by a "push pulse", the velocity of the shear waves propagating within the tissue is detected, and the stiffness of the tissue is assessed based on the detected shear velocity. Shear-wave elastography has been intensively studied in thyroid, breast, liver, cervical lymph nodes, and musculoskeletal diseases with promising result.

Transthoracic shear-wave ultrasound is also used for the prediction of lung malignancy.

In progressive renal disease, renal function decline correlates with the extent of interstitial fibrosis, irrespective of the original pathology. Experience and research in using shear-wave elastography to study the stiffness of renal parenchyma and renal fibrosis are scanty. The investigators will conduct a prospective observational study. This study aims to provide the information of tissue elasticity in different etiologies of renal diseases and to validate the predictive value of shear-wave elastography in predicting renal function and renal fibrosis.

By assuming a power of 0.8, a two-side p value of 0.05, a ratio of 0.2 (sample sizes in negative/positive groups) to detect the difference between area under ROC curve and null hypothesis value (0.8 and 0.7), a target sample of 273 (with a 5% cushion, 260\~290) patients is required.


Eligibility criteria: Inclusion Criteria:

* patients receiving scheduled renal biopsy and scheduled renal sonography

Exclusion Criteria:

* age \< 20 y/o, patients who can't hold their breath for at least 5 seconds

Primary outcomes:
measure: collect medical record of blood urea nitrogen and Creatinine
timeFrame: 3 months and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT02529332: Omega-3 Supplementation for Smell Dysfunction
Official title: Effect of Omega-3 Supplementation in Patients With Smell Dysfunction Following Endoscopic Pituitary Tumor Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sellar/Parasellar Tumor
Smell Dysfunction
Keywords: Endoscopic Sellar/Parasellar Tumor Resection
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2015-08-20
Enrollment: 110
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: Omega-3 supplementation has been shown to have neuroprotective and potentially anti-inflammatory properties in both central and peripheral nerve injuries. The investigators are studying to see if omega-3 supplementation will affect olfactory (smell) function in patients with olfactory dysfunction following endoscopic removal of pituitary tumors.


Eligibility criteria: Inclusion Criteria:

* sellar/parasellar tumor scheduled to undergo endoscopic transnasal transsphenoidal resection
* 18 years of age or older
* English speaking

Exclusion Criteria:

* Currently using blood thinning agents (aside from NSAIDs or cardioprotective ASA)
* elevated AST, ALT, or alk phos \>10% outside of normal range, if randomized to omega-3 group
* diabetes, if randomized to omega-3 group and not already on omega-3 prescribed by another provider
* unable to provide informed consent due cognitive deficiencies

Primary outcomes:
measure: Difference in Olfactory Function at baseline, based upon tumor type (i.e. functional vs. non-functional tumor)
timeFrame: Baseline (pre-tumor resection)
measure: Change in Olfactory Function over 6-month post-op period
timeFrame: Baseline (pre-tumor resection), at 6 months (post-tumor resection)
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Stanford University
name: Zara M Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03415932: Health Group Intervention Among Refugees in Sweden
Official title: Health Group Intervention Among Refugees in Sweden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migration Stress
Lead sponsor: Region Östergötland
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: baseline and follow up in one population
Primary purpose: SUPPORTIVE_CARE

Brief summary: This prospective intervention study evaluates whether health education and basic body awareness training reduces health care consumption and improves movement quality among refugees in Sweden.

Detailed description: Migration is well known to be stressful and to have a negative impact on Health. Multidisciplinary health-promoting group interventions have significantly improved self-rated health. Further, symptom improvement was shown after implementation of physical activity in form of basic body awareness training. In this study a multimodal team consisted of a physiotherapist, nurse, psychologist, dietician, and physician held sessions of three hours weekly for a period of nine weeks. The sessions started with basic body awareness training, followed by theme discussions on symptoms and health strategies. A total of 54 participants completed the intervention. Health care consumption and movement quality were measured before and after the intervention.

Eligibility criteria: Inclusion Criteria: Refugees seeking primary care consultation or rehabilitation unit aged 18-65 years were candidates for inclusion. Based on the health care provider's assessment, patients whose health symptoms could be connected to or increased by the migration process were eligible for inclusion -

Exclusion Criteria:

-

Primary outcomes:
measure: Health care consumption
timeFrame: three months before and after intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01787032: Drug-drug Interaction Trial of BI 113608 in Combination With Ketoconazole and Voriconazole in Healthy Male Subjects
Official title: Relative Bioavailability of Single Oral Dose of BI 113608 When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole or Voriconazole in Healthy Male Subjects (an Open-label, Randomised, Three-period Cross-over Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-02-08
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to investigate the relative bioavailability of a single oral dose of BI 113608 without and with ketoconazole and voriconazole at steady state. The assessment of safety and tolerability of BI 113608 administered alone and upon co-administration will be an additional objective of this trial.


Eligibility criteria: Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions.

Primary outcomes:
measure: Area Under the Concentration-time Curve of BI 113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
timeFrame: 1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.
measure: Maximum Measured Concentration of BI 113608 in Plasma (Cmax)
timeFrame: 1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.
Secondary outcomes:
measure: Area Under the Concentration-time Curve of BI 113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
timeFrame: 1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.
measure: Time From Dosing to Maximum Measured Concentration of BI 113608 in Plasma (Tmax)
timeFrame: 1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.
measure: Terminal Half-life of BI 113608 in Plasma (t1/2)
timeFrame: 1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.
Other outcomes:
Locations:
city: Ingelheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT03027232: Control of Leukocyte Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammation, Brain
Keywords: infection
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal healthy volunteers

Brief summary: The protocol is to draw peripheral blood from healthy volunteers for in vitro studies. The aims of these in vitro studies are to determine the cellular and intracellular mechanisms by which hypertonic saline and ATP release regulate neutrophil and lymphocyte functions.

Detailed description: The proper regulation of leukocyte function is critical for immune defense and to prevent autoimmune diseases. Many aspects of immune cell regulation are unknown. A better understanding could lead to novel therapeutic approaches to improve immune function in patients suffering from various diseases.

The investigators have found that hypertonic conditions regulate leukocyte functions through feedback mechanisms involving ATP release and purinergic receptors. The purpose of the proposed protocol is to obtain access to peripheral blood from healthy volunteers to study these complex regulatory mechanisms in more detail.

Eligibility criteria: Inclusion Criteria:

* any healthy volunteer

Exclusion Criteria:

* pregnancy
* needing/using drugs
* inflammatory or infectious complications

Primary outcomes:
measure: Immune cells will be studied in vitro to learn about basic mechanisms of immune cell signaling.
timeFrame: Blood is collected as needed; time frame: indefinitely. Blood used between 1-7 days after blood draws.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: BIDMC
state: Massachusetts
Study officials:
References:
Clinical trial NCT03174132: Pain and Safety of Restylane Perlane With and Without Lidocaine for Correction of Moderate and Severe Nasolabial Folds
Official title: A Randomised, Multi-center, Subject and Evaluator-blinded Study Comparing the Pain and the Safety Profile Associate With Correction of Moderate to Severe Nasolabial Folds Using Restylane Perlane Lidocaine Compared to Restylane Perlane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasolabial Fold
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2017-06-02
Enrollment: 70
Sex: ALL
Minimum age (years): 20
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 pain and safety in associated with injection of Restylane Perlane Lidocaine compared to Restylane Perlane using VAS scale


Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent to participate in the study.
* Men or women aged 20 years or older of Chinese origin.
* Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study.
* Intent to undergo correction of both nasolabial folds (NLF) with a wrinkle severity in Wrinkle Severity Rating Scale (WSRS) of either grade 3 on both NLFs or grade 4 on both NLFs.

Exclusion Criteria:

* Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the lower orbital rim.
* Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months before treatment.
* Previous tissue revitalization treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling or dermabrasion in the midface within 6 months before treatment.
* Scars or deformities, active skin disease, inflammation or related conditions near or in the area to be treated.
* Other condition preventing the subject from entering the study in the Investigator's opinion

Primary outcomes:
measure: Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS)
timeFrame: At the time of injection
Secondary outcomes:
measure: Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS)
timeFrame: 15, 30, 45, and 60 minutes after injection
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Galderma R&D
name: Q-Med AB
role: STUDY_DIRECTOR
References: