louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05788861: Invasive Group A Streptococcal Infection
Official title: French Pediatric Nationwide Observatory of Invasive Group A Streptococcal Infection (in Childen for 0 to 18 Ages)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis Due to Streptococcus, Group A
Risk Factors
Severe Infection
Medical Care
Medical Complications
Outcome, Fatal
Therapy
Strain
Virulence Factors
Lead sponsor: Association Clinique Thérapeutique Infantile du val de Marne
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatrics patients with documented invasive infection due to Group A Streptococcus

Brief summary: This study is observational, retrospective and prospective study in pediatric patients hospitalized with invasive streptococcal A infection

Detailed description: The main of this study is to identify and record cases of invasive and severe infections due to Streptococcus pyogenes. In order to evaluate the incidence of severe forms of disease and the possible contributing factors, and to optimize their management.

Admitted patients to intensive care or critical care units in reported via Santé Publique France may also be included in this study.

Secondly, epidemiological, clinical, bacteriological data of all severe or not cases, of group A Streptococcal infections will be compiled to describe their characteristics, and try to explain this recrudescence as well as possible.

Eligibility criteria: Inclusion Criteria:

* Age\<18 years
* Documented invasive Group A Streptococcus infection (identification of GAS in a normally sterile site or from another site in case of toxin shock or necrotizing dermo-hypodermatitis)

Exclusion Criteria:

* Opposition of the patient or his/her legal representative

Primary outcomes:
measure: Hospitalisation
timeFrame: 1 year
measure: Treatments provided in intensive care unit
timeFrame: 1 year
measure: Complications
timeFrame: 1 year
measure: Treatments used in routine care unit
timeFrame: 1 year
measure: Risk factors
timeFrame: 1 year
measure: Characterization of Group A Streptococcus strains
timeFrame: 1 year
measure: Death
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Créteil
country: France
facility: ACTIV
Study officials:
affiliation: hôpital Femme-Mère-Enfant, Bron
name: Yves Gillet
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAUX MERE et ENFANTS CHU TOULOUSE
name: Camille Brehin
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Toulouse
name: Lionel Berthomieu
role: PRINCIPAL_INVESTIGATOR
affiliation: Association Clinique Thérapeutique Infantile du val de Marne
name: Corinne Levy
role: STUDY_DIRECTOR
References:
Clinical trial NCT02421861: Critical Care Anxiety and Long-Term Outcomes Management
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Anxiety
Keywords: anxiety
intensive care unit
critical care
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 10
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: The aims of this study are to (1) test the benefits of a non-pharmacologic anxiety management approach with patients who are critically ill and/or traumatically injured during intensive care hospitalization and (2) test whether this approach reduces anxiety and improves engagement in rehabilitation therapies, shortens duration of hospitalization, and improves psychological and quality of life outcomes.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Ability to read, write, and speak English
* Alert (Best RASS ICU sedation score ≥-2)
* Current CAM-ICU test negative
* Expected ICU stay ≥48 hours
* Anxiety Visual Analog Scale (VAS-A) score ≥30
* Prescribed rehabilitation therapy at eligibility

Exclusion Criteria:

* Inability to communicate (verbally, or via hand writing/gestures)
* Greater than 90% probability of mortality in hospital
* Anticipated discharge to hospice or transition to end-of-life care
* Pre-existing cognitive impairment (e.g., dementia, pervasive developmental disorder)

Primary outcomes:
measure: Anxiety (Visual Analog Scale for Anxiety (VAS-A)
timeFrame: Participants will be followed for the duration of hospitalization, an expected average of 13 days and not more than 45 days
Secondary outcomes:
measure: Engagement in rehabilitation therapies (As measured by a 2-item engagement questionnaire)
timeFrame: As measured by a 2-item engagement questionnaire (developed specifically for this study) at the time of hospital discharge (i.e., based on an expected average duration of hospitalization of 13 days and not more than 45 days)
measure: Length of ICU and Hospital Stay
timeFrame: Measured in days (an expected average ICU stay=5 days and average Hospital stay=13 days and not more than 45 days)
measure: Long-Term Anxiety and Depressive Symptoms (as measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 months after enrollment as measured by the Hospital Anxiety and Depression Scale (HADS)
measure: Long-Term Posttraumatic Stress Symptoms (as measured by the PCL-5)
timeFrame: 3 months after enrollment as measured by the PCL-5
measure: Health-Related Quality of Life (as measured by the EQ-5D-5L and SF-36)
timeFrame: 3 months after enrollment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00441961: Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis
Official title: Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasciitis
Keywords: Eosinophilic fasciitis, Shulman's syndrome, methotrexate
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2007-03-01
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the effect of high dose MTX on skin induration in patients with eosinophilic fascia.

Detailed description: Eosinophilic fasciitis (EF)is a fibrosing skin disorder extensively involving the deep fascia. The aim of this pilot study is to evaluate the effect of high dose MTX on skin induration in patients with EF. In addition, we study the effect of this treatment on joint mobility, peripheral blood eosinophilia, functional ability, and pulmonary function. By administering high dose MTX intravenously every four weeks with a Leukovorin rescue, we hope to induce a more pronounced and sustained effect on the involved skin with less (long-lasting) side effects.

Eligibility criteria: Inclusion Criteria:

* Eosinophilic fasciitis as defined by clinical judgement of an expert,
* Histologically confirmed with a skin-fascia-muscle biopsy, and in additon:

  * Either the presence of a modified skin score according to Zachariae of 8 or higher (0-18), regarded as a generalised eosinophilic fasciitis or the presence of severe contractures due to eosinophilic fasciitis lesions.

Exclusion Criteria:

* Age \< 18 yrs
* Contraindications to MTX: AST/ALT level \> 2 times upper limit of normal, WBC count \< 3.5 x 109/l or platelet count \< 150 x 109/l, serum creatinine \> 130 micromol/l or clearance \< 50 ml/min, confirmed by two repeated tests within one month.
* Chronic liver disease, insulin dependant diabetes mellitus, alcohol abuse
* Restrictive pulmonary disease (total lung capacity or vital capacity \< 40% of predicted) or interstitial lung disease (KCO \< 60% of predicted)
* Pregnancy or child bearing potential without adequate contraception
* The presence of any serious co-morbidity or malignancy
* Use of other anti-folate drugs than MTX

Primary outcomes:
measure: Efficacy is evaluated after 6 months.
timeFrame: December 2008
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: H. Knaapen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mertens JS, Zweers MC, Kievit W, Knaapen HK, Gerritsen M, Radstake TR, van den Hoogen FH, Creemers MC, de Jong EM. High-Dose Intravenous Pulse Methotrexate in Patients With Eosinophilic Fasciitis. JAMA Dermatol. 2016 Nov 1;152(11):1262-1265. doi: 10.1001/jamadermatol.2016.2873.
Clinical trial NCT02692261: Hyaluronic Matrix Efficacy for Maxillary Sinus Augmentation
Official title: Evaluation of Hyaluronic Matrix, Used With Xenograft, Efficacy in Sinus Augmentation by Histomorphometry and Micro Computed Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinus; Dental
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 13
Sex: ALL
Minimum age (years): 33
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sinus augmentation is a predictable method when alveolar bone height is not sufficient for dental implant placement in posterior maxillary alveolar region..The aim of this prospective, randomized, controlled clinical study is comparison of hyaluronic acid originated matrix and equine derived xenograft with only xenograft use in sinus augmentation by micro computed tomography and histomorphometry.


Eligibility criteria: Inclusion Criteria:

* Systemically healthy patients
* Requiring bilateral maxillary sinus augmentation (residual crest height ≤ 4 mm)

Exclusion Criteria:

* Advanced systemic diseases
* Chronic medication use
* Maxillary sinus disease
* Current pregnancy
* Lactation
* Smoking habit

Primary outcomes:
measure: Percentage of newly formed bone calculated from bone biopsises by Micro-CT and Histomorphometry
timeFrame: 4 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hacettepe University
name: Feriha Caglayan, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00471861: Inflammatory Markers in Patients With Active Migraine Headaches
Official title: Does Migraine As A Partly Inflammatory Disease Increase The Inflammatory Markers Of The Patient When Actively Having a Migraine?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: Inflammatory Markers
Migraine
Lead sponsor: Westside Family Medical Center, P.C.
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2007-05-10
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Migraine

Brief summary: The purpose of this study is to determine whether C-Reactive Protein (CRP) is elevated in patients with active migraine headaches. Secondary goal is to determine whether other inflammatory markers, such as Calcitonin Gene Peptide (CGRP), Vasoactive Intestinal Polypeptide (VIP) or Substance P (SP) are elevated in patients having a migraine headache.

Detailed description: A random selection of patients both male and female from a primary care practice with a diagnosis of having migraine headaches will be enrolled. Thirty (30) patients will be recruited mainly from the primary care practice. Recruitment will include males and females aged 21-65. The patients who meet the inclusion criteria will be enrolled. The patients who do not have migraine headaches will also be enrolled and function as controls. Non-migraine patients will meet inclusion criteria 1, 2 and 3 and all of the exclusion criteria.

Eligibility criteria: Inclusion Criteria:

1. Subjects must sign a written informed consent.
2. Enrollment population would include males and females 21 years of age to 65 years of age.
3. Non-migraine subjects will be allowed in the control group
4. Have episodic migraine headaches
5. Patients to satisfy the diagnosis of migraine headaches with aura, without aura or mixed.
6. Must be able to differentiate migraine headaches from other headaches

Exclusion Criteria:

1. Any medical condition in the opinion of the investigator that would make the subject unsuitable for enrollment.
2. Basilar or hemiplegic migraine headaches.
3. Pregnant woman or a nursing mother
4. History (within 1 year) or current evidence of drug or alcohol abuse.
5. More than 15 migraine headaches per month
6. Chronic daily headaches
7. Chronic use of NSAIDs
8. Current participation in a research study or within the last 30 days.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Westside Family Medical Center, P.C.
state: Michigan
Study officials:
affiliation: Westside Family Medical Center, P.C.
name: Gary E Ruoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03304561: The Effect of Contralateral Limb Training on Functional Outcomes in Patients With ACL Reconstruction
Official title: Contralateral Strength Training Effects on Functional Outcomes in Patients Who Had Undergone ACL Reconstruction: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: knee
rehabilitation
ACL
Contralateral training
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL reconstruction and one of the main focus of rehabilitation is to improve strenght of these muscles. With the strenghtening of the contralateral limb (cross-over training) we aimed to improve the strenght of the quadriceps

Detailed description: Returning to sport after ACL reconstruction is not at desired level among athletes. Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL reconstruction. Cross-over training is recomended during rehabilitation after ACL reconstrucion. Yet duration of the training, frequancy and type of exercise interention are not clear for the cross-over training. Ain of the study is to investigate the effects of cross-over training on muscle strenght

Eligibility criteria: Inclusion Criteria:

* having surgery of ACL reconstruction on one side
* having no problem at least six month on the nonsrgical side
* recieving the rehabilitation programme at hacettepe university, physiotherapy department

Exclusion Criteria:

* refusing to include to the study
* having revision ACL surgery
* addition of PCL or cartilage surgery addition to the ACL surgery
* not participating to the rehabilidation program regularly over 3 month after sugery

Primary outcomes:
measure: quadriceps and hamstring muscle strenght
timeFrame: 6 month
Secondary outcomes:
measure: functional outcomes
timeFrame: 6 month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Sports Physiotherapy Unit
Study officials:
affiliation: volgamel@yahoo.com
name: volga tunay, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03049761: Water Flosser vs String Floss vs Manual Toothbrush Safety
Official title: Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Injuries
Lead sponsor: All Sum Research Center Ltd.
Sponsor class: OTHER
Collaborators: name: Water Pik, Inc.
First posted: 2017-02-10
Enrollment: 105
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a examiner-masked, 3-treatment, randomized clinical trial comparing the safety of different oral hygiene regimens.
Primary purpose: OTHER

Brief summary: Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings

Detailed description: This study is designed to add to the safety data by measuring, Oral Soft tissue, Clinical Attachment Levels and Probing Pocket Depths on different pressure settings at different time points over a 6 week period. Data will be collected at Baseline, 2 week, 4 week and 6 week time frames.

Eligibility criteria: Inclusion Criteria:

* Written consent prior to participation
* Good general health and non smoker
* Have scorable Ramfjord's teeth

Exclusion Criteria:

* Probing depth \>4mm on Ramfjord's teeth
* Moderate to severe gingivitis
* Advanced periodontitis
* Medications that impact soft tissue.

Primary outcomes:
measure: Clinical Attachment Levels
timeFrame: 6 weeks
Secondary outcomes:
measure: Probing pocket depth
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06217783: Ultrasound-guided Peripheral Intravenous Catheter Placement in an Oncologic Emergency Department - a Prospective, Randomized Controlled Trial of Catheter Lengths
Official title: Ultrasound-guided Peripheral Intravenous Catheter Placement in an Oncologic Emergency Department - a Prospective, Randomized Controlled Trial of Catheter Lengths
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oncologic Complications and Emergencies
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To learn about the effects of the length of the catheter on the failure and success rate of USIV placement.

Detailed description: Primary Objectives:

- The rate of catheter failure, defined as removal of the catheter for any reason other than "Care Complete" (i.e. a composite of removal due to "infiltration," "leaking," "catheter damage," "occlusion"), by day 10.

Secondary Objectives:

1. Time from catheter placement to removal (i.e. survival or dwell time).
2. Per catheter length rate of failure analysis
3. Rate of repeat catheterization
4. Rate of infection
5. Rate of thrombosis

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years old.
2. Provision of signed and dated informed consent form.
3. Predetermined to have difficult IV access necessitating USIV placement
4. Expected admission to hospital with anticipated stay \> 48 hours (per discussion with treating physician).

Exclusion Criteria:

1. Expected/anticipated discharge disposition from the ACCC (per discussion with treating physician).
2. Inability to give informed consent.
3. Pregnant women.
4. Non-English speaking participants.

Primary outcomes:
measure: Safety and adverse events (AEs)
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jonathan Rowland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05247983: Tension-free Repair of Inguinal Hernia With "Undissociate Spermatic Cord"
Official title: The First Affiliated Hospital of Harbin Medical Uniersity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia, Without Mention of Obstruction or Gangrene
Keywords: Undissociate Spermatic cord
Inguinal hernia
Hernia exclusion
Hernial sac
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: inguinal hernia patients

Brief summary: The theory of "undissected Spermatic cord (US)" only transected the hernia ring ends in the abdominal cavity, the hernia ring, hernia sac and spermatic cord will not be dissected. Its significance lies in that inguinal hernia repair can get rid of the "entanglement" of hernia sac and spermatic cord and fundamentally change the treatment mode of hernia ring and hernia sac.

Detailed description: In recent years, with the deepening of the anatomical cognition of the inguinal region and the renewal of the hernia repair concept, inguinal hernia repair has become increasingly mature surgical approach. However, no matter how the hernia repair modes change, the treatment and repair of the hernia ring has always been the focus, so that the treatment of the hernia sac has been neglected. From March 2014 to May 2019, there were 132 patients underwent inguinal hernia repair with "Undissociate Spermatic cord" theory (Undissected Spermatic cord and hernia sac, hernia ring and sac exclusion). All the patients were followed up for 18\~63 months (mean of 41.5 months) without recurrence. Its significance lies in that inguinal hernia repair can get rid of the "entanglement" of hernia sac and spermatic cord and fundamentally change the treatment mode of hernia ring and hernia sac.

Eligibility criteria: Inclusion Criteria:

* Inguinal hernia patients who can tolerate surgery

Exclusion Criteria:

* Patients who cannot tolerate surgery

Primary outcomes:
measure: surgery time
timeFrame: 0-120minutes
measure: Bleeding
timeFrame: surgery
measure: hospital stay
timeFrame: 1-30days
measure: Does it recur
timeFrame: 18-63months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03006783: Assessment of the Cross-face Nerve Graft in the Treatment of Facial Paralysis
Official title: Assessment of the Cross-face Nerve Graft in the Treatment of Facial Paralysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Facial Palsy
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective cohort of people treated with a cross-face nerve graft or other nerve transfer

Brief summary: A retrospective and cross-sectional analysis of standard of care for facial paralysis involving the cross-face nerve graft in the past 20 years.

* Imagery analysis
* Questionnaires

Detailed description: The investigators will retrospectively and cross sectionally analyze all patients treated with a cross-face nerve graft and another nerve transfer in our institution by image analysis and sending out quality of life questionnaires.

Eligibility criteria: Inclusion Criteria:

* Treated with one of the described procedures

Exclusion Criteria:

* Evaluation material present

Primary outcomes:
measure: Symmetry of the mouth
timeFrame: March 2016 - October 2016
measure: Excursion of the mouth
timeFrame: March 2016 - October 2016
measure: Disease-specific quality-of-life
timeFrame: March 2016 - October 2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: