louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01483404: Identification of the Microcirculation of the Caput Femoris After Fracture of the Femoral Neck
Official title: Identification of Microcirculation in Fracture of the Femural Neck: How Does the Intracapsular Hematoma Affect the Capillary Bloodflow in the Caput Femoris?
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Microcirculation of the Caput Femoris
Keywords: microcirculation
caput femoris
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2011-12-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with fracture of the femural neck, who are treated in the University Hospital Aachen

Brief summary: This project investigates wether the intra-capsular hematoma, that often occurs after fracture of the femural neck, decreases the capillary blood flow of the caput femoris.

During operation the measuring device of the O2c-machine in placed on the joint capsula first and afterwards, after surgical opening of the capsula, on the femur directly. The integral of the microcirculation of both parts of the femur is measured in both settings. So the capillary blood flow is measured with the hematoma still in situ, eventually putting pressure on the caput femoris and after the capsula has been opened, the pressure relieved and the hematoma removed. Both measurements are compared for each patient.

The O2c-machine measures non-invasive with light waves and laser-doppler. The sounding rod is packed in a sterile tube to prevent any contamination of the operation site.


Eligibility criteria: Inclusion Criteria:

* medial fracture of the femural neck
* surgical treatment (hip replacement)

Exclusion Criteria:Polytrauma

* pathologic fracture
* conservative treatment
* soft tissue damage
* delay of surgery more than 3 days
* Immune default
* polytrauma

Primary outcomes:
measure: Microcirculation of the caput femoris befor the capsula of the joint is opend
Secondary outcomes:
measure: Microcirculaiton of the caput femoris after the capusla of the joint has been surgically opened and the hematoma has been removed
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: RWTH Aachen University Hospital
state: NRW
Study officials:
affiliation: Chief of medicine
name: Hans-Christoph Pape, Univ-prof.MD
role: STUDY_CHAIR
References:
Clinical trial NCT04955704: Performance Study for InferRead CT Pneumonia.AI
Official title: Performance Study for InferRead CT Pneumonia.AI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pneumonia
Lead sponsor: Infervision
Sponsor class: INDUSTRY
Collaborators: name: University of Maryland, College Park
First posted: 2021-07-09
Enrollment: 423
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This retrospective study will be used to assess the performance of the subject device. The principal investigator will collect DICOM data and relevant clinical information based on the selection criteria. DICOM will be de-identified of PHI and stored in a secure location.

The validation dataset will contain non-contrast chest CT scans from patients in the United States that are either negative or have confirmed pneumonia (viral or bacterial). Data will come from at least 3 hospitals and cover a variety of data attributes.

Brief summary: A retrospective, blineded, multicenter study of the InferRead CT Pneumonia.AI to evaluate the performance in identifying non-contrast chest CT scans containing pneumonia findings.

Detailed description: This is a retrospective, blinded, multicenter study for the InferRead CT Pneumonia.AI. The primary endpoint will evaluate the software's performance in identifying non-contrast chest CT scans containing pneumonia. It will evaluate InferRead CT Pneumonia.AI in terms of sensitivity and specificity with respect to a ground truth, as established by trained thoracic radiologists, in the detection of penumonia. In addition, the study will compare time to notification for the InferRead CT Pneumonia.AI software with respect to the time to notification for the standard of care as established from available radiological reports.

1. To evaluate the performance of InferRead CT Pneumonia.AI.
2. To evaluate the effect of different factors such as CT manufacturer, CT scanning protocols and patient characteristics on the performance of InferRead CT Pneumonia.AI

Eligibility criteria: Inclusion Criteria:

1. Non-contrast chest CT DICOM scans
2. Contains both lung lobes
3. Slice thickness is less than 3 mm.

Exclusion Criteria:

1. Incomplete scan or corrupted scan
2. Irregular scanning, increased intrapulmonary density due to insufficient inspiration, and respiratory artifacts affecting the physician's judgment.
3. Altered or absent lung morphology in the postoperative patient.

Primary outcomes:
measure: Primary Endpoint
timeFrame: 1/1/2022 - 2/28/2022
Secondary outcomes:
measure: Secondary Endpoint
timeFrame: 1/1/2022 - 2/28/2022
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01855204: Low Tube Voltage Computed Tomographic (CT) Urography Using Low Concentration Iodine Contrast Agent
Official title: Low Tube Voltage Computed Tomographic (CT) Urography Using Low Concentration Iodine Contrast Agent: a Comparison Study With Conventional CT Urography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exposure to Medical Diagnostic Radiation
Keywords: Computed Tomography, Spiral
Urography
Radiation dosage
Contrast media
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Computed Tomographic (CT) urography is the best imaging modality to evaluate obstructing lesions of urinary tract such as urinary stone, tumor and inflammatory lesion. The purpose of our study is to compare images of CT urography performed by low voltage and low concentrated iodine CT contrast with them of conventional CT urography.

Detailed description: Computed Tomographic (CT) urography is the best imaging modality to evaluate obstructing lesions of urinary tract such as urinary stone, tumor and inflammatory lesion. It is needed that CT urography should have the high contrast between target lesion described as filling defect and adjacent contrast filled urinary tract. For the implementation of high contras, conventional CT urography has been performed with higher voltage and higher concentrated CT contrast than another CT protocols. The higher voltage results in the more radiation exposure. And the intravenous injection of higher concentrated CT contrast results in the increase of the prevalence of contrast induced nephrotoxicity.

The purpose of our study is to compare images of CT urography performed by low voltage and low concentrated iodine CT contrast with them of conventional CT urography.

Eligibility criteria: Inclusion Criteria:

* Patients to perform Computed Tomographic (CT) urography
* Patients without diminish of renal function (serum creatinine: more than 1.4 mg/dl \& glomerular filtration rate: more than 34 mL/min/1.73 m2)

Exclusion Criteria:

* patients to have operations and/or injuries of urinary system
* patients to have the histories of anaphylaxis or allergic reaction about intravenous iodine contrast material

Primary outcomes:
measure: Measurement of Radiation Dose
timeFrame: The day of admission (within 24hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Departement of Radiology, Seoul National University Hospital
name: Jeong Yeon Cho, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02038504: Investigating the Role of EN in NTIS Among Fistula Patients
Official title: a Prospective Study to Investigate the Role of Enteral Nutrition in Nonthyroidal Illness Syndrome Among Fistula Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Fistula
Keywords: gastrointestinal fistula
enteral nutrition
thyroid function
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Department of general surgery in Jinling hospital

Brief summary: The purpose of this study is to investigate whether enteral nutrition are effective in the treatment of nonthyroidal illness syndrome among fistula patients.

Detailed description: Nonthyroidal illness syndrome (NTIS) is a common alterations in thyroid function observed in about 70% of hospitalized patients, with or without acute systemic illnesses. Mechanisms in the pathogenesis of NTIS are not yet well understood. Our previous study demonstrated that NTIS occurred frequently with a prevalence of 57.5% in gastrointestinal fistulas patients. In recent study, it has been shown that early enteral nutrition decreases the duration of hospitalization and mortality in the burn population, indicating a potential role of enteral nutrition in NTIS.In addition, the management of fistula patients requires bundle therapy including Nutrition therapy, especially enteral nutrition.The purpose of this study is to investigate whether enteral nutrition are effective in the treatment of nonthyroidal illness syndrome among fistula patients.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of gastrointestinal fistula
* Clinical diagnosis of nonthyroidal illness syndrome
* Using enteral nutrition for fistula management

Exclusion Criteria:

* patients who were prescribed drug which may affect thyroid function before or in our study
* patients who were diagnosed as primary thyroid disease

Primary outcomes:
measure: Thyroid function
timeFrame: Changes of thyroid function from baseline at 1 week,2 week, 3 week and 4 week after enrolled.
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of General Surgery, Jinling Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT03443804: To Evaluate the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients
Official title: A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase 3 Clinical Trial to Evaluated the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastritis Acute
Gastritis Chronic
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-02-23
Enrollment: 462
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the Efficacy and Safety of DW1401 versus Stillen tab. in Patients with Acute or Chronic Gastritis


Eligibility criteria: Inclusion Criteria:

* Patients who were diagnosed with acute or chronic gastritis in a gastroscopy performed within 7 days prior to administration of this trial.
* At least one or more erosions have been identified on gastroscopy.
* Patients who decided to voluntarily participate in this trial and agreed in writing.

Exclusion Criteria:

* Patients who can not undergo gastroscopy
* Peptic ulcer (except scarring) and reflux esophagitis
* Patients who have had gastric acid suppression surgery or stomach/esophagus surgery (except for simple perforation surgery and appendectomy)
* Patients with a history of gastrointestinal malignancies
* Zollinger-Ellison syndrome patients
* Patient with spontaneous coagulation disorder
* Patients with an allergic or hypersensitive response to a study drug
* Patients with a potential pregnancy.
* Patients who had clinically significant abnormalities in the screening test. (ALT, AST, BUN, Serum creatinine is more than twice the upper limit)
* Pregnant and lactating women
* Those currently taking other study drugs
* patients who were judged to be ineligible for the trial by the principle investigator and the person in charge.

Primary outcomes:
measure: The efficacy rate on gastroscopy
timeFrame: 0, week 2
Secondary outcomes:
measure: Cure rate on gastroscopy
timeFrame: 0, week 2
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03880604: Triple Tourniquets With or Without Tranexamic Acid for Reducing Blood Loss at Open Myomectomy
Official title: Triple Tourniquets With or Without IV Tranexamic Acid for Reducing Blood Loss at Open Myomectomy: A Double-blinded Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myoma
Keywords: Haemostatic tourniquets
tranexamic acid
myomectomy
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double-blinded randomized placebo-controlled trial
Primary purpose: PREVENTION

Brief summary: In this study, the investigators will investigate the effectiveness of an intravenous tranexamic acid plus triple tourniquets compared with triple tourniquets alone for the reduction of blood loss at the time of myomectomy

Detailed description: An RCT investigated the efficacy of intravenous tranexamic acid (TA) during abdominal myomectomy. The study was unable to demonstrate any significant impact on blood loss, duration of surgery or need for blood transfusionHemostatic tourniquets to reduce intra-operative bleeding have long been available, but data on their efficacy from controlled trials are lacking. The investigators set out to evaluate the use of triple tourniquets plus tranexamic acid in controlled conditions and for the first time to investigate the hypothesis that adding tranexamic acid to tourniquet around the uterine artery reduces postoperative bleeding from the uterine incisions, a well-recognized sequel to surgery

Eligibility criteria: Inclusion Criteria:

* Patients presenting for abdominal myomectomy with documented uterine fibroids on ----pelvic imaging
* Age ≥ 18 years and ≤ 50 years
* Pre-operative hemoglobin \>8 g/dl
* Ability to understand and the willingness to sign a written informed consent.
* Admissible medical/surgical history
* Five or less symptomatic uterine myomas
* All myomas are subserous or intramural.
* Uterine size less than 24 weeks of pregnancy

Exclusion Criteria:

* Patients who have had a prior abdominal myomectomy
* Post-menopausal women
* Patients with known bleeding/clotting disorders
* Patients with a history of gynecologic malignancy
* Hypertension.
* Cardiac and Pulmonary Diseases.
* Obesity (body mass index \> 30 kg/m2).
* History of allergic reactions attributed to misoprostol
* Cases that will require intraoperative conversion of myomectomy to hysterectomy

Primary outcomes:
measure: Mean amount of intraoperative blood loss
timeFrame: intraoperative
Secondary outcomes:
measure: The number of patients needs for blood transfusion
timeFrame: 24 hours post delivery
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan University Hospital
name: hany f sallam, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06077604: Influence of Air Pollution on SPondyloarthritis Flare-ups and Resistance to Treatment
Official title: Influence of Air Pollution on SPondyloarthritis Flare-ups and Resistance to Treatment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Spondyloarthritis, Axial
Keywords: Air pollution
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of Axial Spondyloarthritis, received in rheumatology consultation/hospitalization over the period 2019-2022 and living in Franche-Comté over the same period.

Brief summary: The relationship between exposure to air pollution and spondyloarthritis (SpA) has been poorly studied. Based on data from the literature on other inflammatory pathologies such as rheumatoid arthritis, we hypothesize that there is a relationship between exposure to air pollution and the risk of presenting a flare-up in SpA patients following and living in Franche-Comté (France).

Primary objective:The potential relationship between exposure to air pollution (nitrogen dioxide, fine particles with a diameter of less than 10 or 2.5 microns and Ozone) and the onset of a spondyloarthritis flare-up will be explored in patients with this pathology.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Axial Spondyloarthritis (radiographic or non-radiographic) according to Assessment of SpondyloArthritis international Society (ASAS) criteria
* Patient having received a consultation / hospitalization during the period 2019-2022
* Patient enrolled in the MISTIC cohort
* Having lived in Franche-Comté during the 2019-2022 period.

Exclusion Criteria:

* Other chronic inflammatory rheumatism (rheumatoid arthritis according to ACR 2010 criteria or psoriatic arthritis according to ClASsification criteria for Psoriatic ARthritis criteria)
* No inflammatory rheumatic disease

Primary outcomes:
measure: Occurrence of a SpA flare-up
timeFrame: 6 to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Besançon University Hospital
state: Bourgogne Franche Comté
Study officials:
References:
Clinical trial NCT00933504: Dermacyd Silver Floral (Lactic Acid) - Compatibility - Stay on Floral
Official title: Study for Dermatological Evaluation of Topic Compatibility. Primary and Accumulated Dermical Irritability and Dermical Sensitivity for the Product Dermacyd PH_DESILSTY_FL (Lactic Acid).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-07-07
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDESILSTYFL.


Eligibility criteria: Inclusion criteria:

* Phototype Skin I,II, III e IV Integral skin test in the region
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

* Lactation or pregnancy
* Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection
* Disease which can cause immunosuppresion, such as diabetes, HIV
* Use of Antihistamines 30 days before selection
* Personnel history of atopy
* History of sensitivity or irritation for topic products
* Cutaneous active disease (local and/or general) which can modify the study results
* Use of new drugs and/or cosmetics during the study
* Cutaneous reactive
* Previous participation in studies using the same product in test
* Volunteer which has immunodeficiency congenital or acquired
* Relevant history or confirmation of alcohol or other drugs abuse
* Intolerance detected or suspected for some component of the sample tested
* Medecin or sponsor employees or their close family

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Evaluation of the absence of primary and accumulated dermical irritability and dermical sensitivity by using International Contact Dermatitis Research Group (ICDRG) scale
timeFrame: from the treatment start to the end of the study (treatment duration 6 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT02134704: MOUVSCO: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis
Official title: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Scoliosis
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: TIMC-IMAG
name: Clinical Investigation Centre for Innovative Technology Network
First posted: 2014-05-09
Enrollment: 48
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The hypothesis of this study is that moderate scoliosis patients have postural and kinematic differences (static and dynamic) compared with healthy volunteers and it is possible to characterize and quantify.

The aim of this study is the detailed analysis of postural anomalies in moderate scoliosis patients compared with healthy volunteers

Detailed description: Subjects participating in the study must wear sensors that will be arrange at the shoulders, spine, pelvis and legs. Subjects will perform under the direction of the investigator, different tasks of a total duration of 45 minutes.

During the period of experimentation, the data collected will be:

* the positions of each one of the sensors in all three planes of space,
* the ground support forces

Eligibility criteria: Scoliosis Group - Inclusion Criteria:

* female children patients from 9 to 16 years old,
* patients with idiopathic scoliosis lumbar left and / or right thoracic,
* patients with moderate scoliosis: Cobb angle measured on a radiograph between 10 ° and 25°,
* both parents of patients must be affiliated to social security or similarly regime.

Healthy Volunteers Group - Inclusion Criteria:

* female children from 9 to 16 years old, matched in age and size with scoliosis patients,
* children with no neuromuscular disease that may have an influence on the required tasks,
* both parents of children must be affiliated to social security or similarly regime,

Exclusion Criteria:

* refusal to consent: from child's in age to consent or from both parents

Primary outcomes:
measure: Relative movements, in mm, of the spinous processes in the three planes of space
timeFrame: 2 hours
Secondary outcomes:
measure: Relative rotations of the bi-acromial line, thoracic and pelvic plan.
timeFrame: 2 hours
measure: Walking speed, step length and single stance time.
timeFrame: 2 hours
measure: The surface of displacement of the center of plantar pressure, static relative orientation of the bi-acromial line, thoracic and pelvic plan.
timeFrame: 2 hours
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Émilie Chipon
state: Isère
Study officials:
affiliation: University Hospital, Grenoble
name: Aurelien Courvoisier, Pr
role: PRINCIPAL_INVESTIGATOR
References: