louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04722926: Lyon PJI Retrospective Cohort Study
Official title: Lyon Prosthetic Joint Infection Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone and Joint Infection
Keywords: prosthesis joint infection
relapse
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients having had a PJI between 2018 and 2020 managed at the CRIOAc Lyon

Brief summary: Bone and joint infections (BJI), although infrequent (prevalence of 70 per 100,000 in France), have a significant economic and clinical impact. Between 2008 and 2013, the prevalence of BJI increased and infections involving joint prosthesis (PJI) represent a third of BJI in France. They are most often post-operative and more expensive than native IOAs.

This study aims to describe PJI and understand the failure mechanisms of PJI in order to improve their management.


Eligibility criteria: Inclusion Criteria:

* patients having had a PJI between 2018 and 2020

Exclusion Criteria:

-

Primary outcomes:
measure: rate of PJI
timeFrame: between 2018 and 2020
measure: Description of PJI
timeFrame: between 2018 and 2020
measure: Description of type of prosthesis PJI
timeFrame: between 2018 and 2020
measure: Description of patients having had a PJI
timeFrame: between 2018 and 2020
measure: Description of comorbidities of patients having had a PJI
timeFrame: between 2018 and 2020
measure: rate of bacteria
timeFrame: between 2018 and 2020
measure: description of antibiotic used
timeFrame: between 2018 and 2020
measure: description of antibiotic treatment
timeFrame: between 2018 and 2020
measure: description of surgical treatment
timeFrame: between 2018 and 2020
Secondary outcomes:
measure: rate of failure
timeFrame: between 2018 and 2020
measure: description of the failure
timeFrame: between 2018 and 2020
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT05206526: Dragonboat Activity for Breast Cancer
Official title: DRagonboat Activity for CAncer RecoverY and Self-efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 32
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to determine how a structured and supervised physical activity program linked to Dragon Boat practice can improve motivation to participate in physical activity sessions. It is also the purpose of this study to evaluate the improvement in body composition, body image perception and physical function.

For this purpose, a group of women operated on for breast cancer was recruited and divided into two experimental groups: one group participated in a structured program of Dragon Boat while the other followed a home-based program of exercises independently in the home environment.

Anthropometric measures (weight, height, BMI) and arm circumference, data on lifestyle and psychological well-being were evaluated by means of questionnaires. Tests were also performed to assess shoulder strength, aerobic capacity and mobility.

The results of this study will (a) identify the strategies used that make Dragon Boat activity effective in ensuring quality participation in physical activity, (b) define the physiological effects of Dragon Boat activity on physical functionality and (c) correlating objective measures with subjective perceptions thanks to the integration of new body composition analysis techniques (regional BIA) and validated questionnaires on the perception of body image.


Eligibility criteria: Inclusion Criteria:

* age 45-70 years
* Body mass index: \<18 and \<30 kg / m2
* Diagnosis and treatment for breast cancer

Exclusion Criteria:

* Other corneal diseases (cardiovascular, hepatic, respiratory)
* Participation in other structured exercise programs

Primary outcomes:
measure: Lean body mass
timeFrame: Change from baseline to up to 3 months
measure: cardiovascular fitness
timeFrame: Change from baseline to up to 3 months
measure: body appreciation
timeFrame: Change from baseline to up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Nutrition and Exercise Lab, DSB, University of Padova
Study officials:
References:
Clinical trial NCT01133626: Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Adult and Adolescent Subjects With Perennial Allergic Rhinitis (PAR)
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, 6-Week Study Designed to Investigate the Effects of BDP HFA Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA) Axis When Administered in Adolescent and Adult Subjects (12 to 45 Years of Age) With Perennial Allergic Rhinitis (PAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perennial Allergic Rhinitis
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-31
Enrollment: 107
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis function.


Eligibility criteria: Inclusion Criteria:

* Informed Consent
* Male or female subjects 12-45 years of age
* Documented history of perennial allergic rhinitis
* General good health
* Other criteria apply

Exclusion Criteria:

* History of physical findings of nasal pathology (within 60 days prior to Screening Visit 1)
* Participation in any investigational drug study 30 days preceding Screening Visit 1
* History of respiratory infection/disorder with 14 days preceding Screening Visit 1
* Use of any prohibited concomitant medications

Primary outcomes:
measure: The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment
timeFrame: Day 0 (Baseline), Day 42
Secondary outcomes:
Other outcomes:
Locations:
city: North Dartmouth
country: United States
facility: Teva Clinical Study Site
state: Massachusetts
city: New Braunfels
country: United States
facility: Teva Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: Teva Clinical Study Site
state: Texas
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Sudeesh K. Tantry, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Hampel FC, Ratner PH, Miller SD, Melchior A, Dunbar SA, Tantry SK, Dorinsky PM. Once-daily treatment with beclomethasone dipropionate hydrofluoroalkane nasal aerosol (320 mcg/d) is not associated with hypothalamic-pituitary-adrenal axis suppression in adolescent subjects with perennial allergic rhinitis. J Allergy Clin Immunol 2012; 129:AB188
citation: Ratner PH, Miller SD, Hampel FC, A, Dunbar SA, Tantry SK, Dorinsky PM (2011). BDP HFA Nasal Aerosol 320 μg Once Daily g Once Daily Is Not Associated with HPA-Axis Suppression in Subjects With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol. 107(11):A118.
citation: Ratner PH, Miller SD, Hampel FC Jr, Melchior A, Dunbar SA, Tantry SK. Once-daily treatment with beclomethasone dipropionate nasal aerosol does not affect hypothalamic-pituitary-adrenal axis function. Ann Allergy Asthma Immunol. 2012 Nov;109(5):336-41. doi: 10.1016/j.anai.2012.08.005.
Clinical trial NCT05250726: Use of a Treated, Devitalized and Sterile Meniscus Segment (MENISC-T) in the Treatment of Scaphotrapeziotrapezoid Osteoarthritis
Official title: Evaluation of the Treatment of Symptomatic Scaphotrapeziotrapezoidal (STT) Osteoarthritis with a Treated, Devitalized and Sterile Meniscus Segment (MENISC-T) Placed in Joint Interposition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis Hand
Keywords: ScaphoTrapezioTrapezoid OsteoArthritis (STT OA)
Lead sponsor: TBF Genie Tissulaire
Sponsor class: INDUSTRY
First posted: 2022-02-22
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this open, prospective and multi center trial is to evaluate the use of a treated, devitalized and sterile meniscus implant placed in joint interposition in the treatment of STT osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Male or female; age between 18 and 75 years.
* Patient with symptomatic STT OA.
* Patient treated medically for functional signs for more than 3 months, without improvement, justifying a surgical intervention.
* Patient with a QuickDash score \> 33 points (converted to 50%).
* Patient with wrist pain (VAS) in front of the STT joint at rest \> 4/10.
* Patient who received the study information and provided consent.
* Member or beneficiary of a national health insurance plan.

Exclusion Criteria:

* Pregnant or breastfeeding woman; woman without effective contraception.
* Patient with functional rhizarthrosis that has not been stabilized or treated medically or surgically.
* Patient with signs of neuropathy with functional disorders such as hyperesthesia.
* Patient with uncontrolled epilepsy or neuropathy that contraindicates locoregional anesthesia.
* Person confined by a judicial or administrative decision.
* Adult subjected to legal protection measures or unable to provide his/her consent.

Primary outcomes:
measure: Decrease of the symptomatology related to the STT OA
timeFrame: 12 months
Secondary outcomes:
measure: Absence of toxicity
timeFrame: Through study completion - average of 12 months
measure: Increase of thumb strength
timeFrame: 1 month, 3 months, 6 months, 12 months
measure: Decrease of pain related to STT OA
timeFrame: 1 month, 3 months, 6 months, 12 months
measure: No apparent anomaly of joint space
timeFrame: 12 months
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Institut Chirurgical de la Main et du Membre Supérieur
Study officials:
References:
Clinical trial NCT01228526: A Multicenter, Prospective, Observational Study With PriMatrix for the Treatment of Neuropathic Diabetic Foot Ulcers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Foot Ulcers, Diabetic
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
name: Samuel Merritt University
name: New York College of Podiatric Medicine
name: Temple University
name: Circleville Foot & Ankle LLC
First posted: 2010-10-26
Enrollment: 22
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: Patients with a diabetic foot ulcer and meet the inclusion/exclusion criteria

Brief summary: To evaluate the effectiveness of PriMatrix in the treatment of DFUs in subjects without significantly compromised arterial circulation.


Eligibility criteria: Inclusion Criteria:

* Type I or Type II diabetes with investigator-confirmed reasonable metabolic control
* Peripheral neuropathy
* A full thickness diabetic plantar foot ulcer of at least 1 cm2 but not exceeding 10 cm2 in area
* An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening

Exclusion Criteria:

* Suspected or confirmed signs/symptoms of wound infection
* Wounds with exposed bone or tendon
* Hypersensitivity to bovine collagen

Primary outcomes:
measure: Percent of study ulcers healed
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: California School of Podiatric Medicine at Samuel Merritt University
state: California
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: New York College of Podiatric Medicine
state: New York
city: Circleville
country: United States
facility: Circleville Foot & Ankle
state: Ohio
city: Philadelphia
country: United States
facility: Temple University School of Podiatric Medicine
state: Pennsylvania
Study officials:
affiliation: Mayo Clinic
name: Steven Kavros, DPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02282865: The Relationship Between the Surgery-related Anxiety and HRV: Prediction for Aggressive Emergence Behavior
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Closed Reduction Surgery for Nasal Bone Fracture
Keywords: Emergence agitation, Heart rate variability (HRV)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20-60 years old male, ASA 1-2, scheduled for elective closed reduction for nasal bone fracture.

Brief summary: Heart rate variability (HRV) is known to reflect the balance of autonomic nervous system. Anxiousness, which tend to result from the deficient action of parasympathetic nervous system, likely to show low HRV. This study is to investigate the relationship between the surgery-related anxiety and the HRV which is known to reflect the balance of autonomic nervous system. Furthermore, this study also focuses on HRV's role as a predictor for aggressive emergence behavior, which might also be considered as partially related to imbalance of autonomic nervous system.


Eligibility criteria: Inclusion Criteria:

1. 20-60 years old male, ASA 1-2
2. scheduled for elective closed reduction for nasal bone fracture

Exclusion Criteria:

1. Patients having hearing difficulties, Foreigner, taking any CNS related medication, history of any adverse drug reaction, Glasgow coma scale \< 15
2. patients with severe cardiopulmonary dysfunction
3. patients taking any neurologic medication (anti-depressant, anti-convulsant, etc)
4. patients taking any cardiovascular medication
5. patients taking medications affecting the autonomic nervous system (a-blocker, b-blocker, etc)
6. patients refusal

Primary outcomes:
measure: High frequency (HF) of Heart Rate Variability (HRV)
timeFrame: from immediately after tracheal intubation to 5 min after tracheal intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT00336765: Study of XL647 Administered Orally Daily to Patients With Solid Tumors
Official title: A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally Daily to Subjects With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: solid tumors
Lead sponsor: Kadmon Corporation, LLC
Sponsor class: INDUSTRY
First posted: 2006-06-14
Enrollment: 31
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: The purpose of this study is to assess the safety and tolerability of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR, VEGFR2, ErbB2, and EphB4) XL647 when given orally daily to adults with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Subject has histologically confirmed malignancy that is metastatic or unresectable
* Subject has disease that is assessable by tumor marker, physical, or radiologic means
* Subject is at least 18 years old
* Subject has an ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
* Subject has a life expectancy ≥ 3 months
* Subject has normal organ and marrow function
* Subject gives written informed consent
* Subject must use an accepted method of contraception during the study
* Female subjects of childbearing potential must have a negative pregnancy test

Exclusion Criteria:

* Subject has received anticancer treatment within 30 days of first dose of XL647
* Subject has received another investigational agent within 30 days of first dose of XL647
* Subject has known brain metastases
* Subject has corrected QT interval (QTc) of \> 0.45 seconds
* Subject is currently receiving anticoagulation therapy with warfarin
* Subject has uncontrolled intercurrent illness
* Subject is pregnant or breastfeeding
* Subject has known HIV

Primary outcomes:
measure: Evaluate safety, tolerability, and maximum tolerated dose of XL647
timeFrame: Inclusion until 30 days post last treatment
Secondary outcomes:
measure: Characterize pharmacokinetics and pharmacodynamic effects of XL647
timeFrame: At various time points from pre-dosing until post dosing
measure: Evaluate preliminary tumor response
timeFrame: Inclusion until disease progression
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
citation: Das M, Padda SK, Frymoyer A, Molina J, Adjei A, Lensing JL, Miles D, Sikic BI, Wakelee HA. A safety, tolerability, and pharmacokinetic analysis of two phase I studies of multitargeted small molecule tyrosine kinase inhibitor XL647 with an intermittent and continuous dosing schedule in patients with advanced solid malignancies. Cancer Chemother Pharmacol. 2018 Sep;82(3):541-550. doi: 10.1007/s00280-018-3646-0. Epub 2018 Jul 20.
Clinical trial NCT01267565: Tracheal Dosage of Amylase : a New Surrogate for Microaspirations in Ventilated ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilated-acquired Pneumonia
Keywords: ventilator-acquired pneumonia
prevention
amylase
tracheal aspiration
microaspiration
Lead sponsor: Université Victor Segalen Bordeaux 2
Sponsor class: OTHER
First posted: 2010-12-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Microaspirations of the oropharyngeal ± gastric contents through the endotracheal tube cuff contribute to the constitution of VAP. The pepsin has been recently proved effective as a surrogate of gastric content and was assessed in tracheal secretions. However, the pepsin dosage is fastidious, expensive and only characterizes aspirations from gastric origin. The aim of our study is to asses whether the value of amylase, which is mostly secreted by salivary glands, may turn out to be a new and simpler surrogate for microaspirations in ventilated ICU patients. Thirty patients ventilated for an anticipated length \> 48h whose endotracheal tube includes a subglottic secretion device and producing sufficient endotracheal aspirations will be included. From H48, 4 sets of 3 aspirations each (oral, subglottic, tracheal) will be performed during one ventilation day for amylase dosage purpose. In ten of these patients, a comparison between pepsin and amylase will be assessed. In addition, 10 non intubated patients with an indication to bronchoscopy and necessitating a tracheal aspiration during the procedure will be included as a control group. The primary assessment criteria will be the oral/tracheal amylase ratio.


Eligibility criteria: Inclusion Criteria:

* intubated and ventlated patients group: patients ventilated with a tube including a subglottic secretion device for an anticipated length \> 48h and producing sufficient endotracheal aspirations
* non intubated patients group: patients with an study-independant indication to bronchoscopy and necessitating a tracheal aspiration during the procedure

Exclusion Criteria:

* patients ventilated for less than 48h
* patients developing ventilated-acquired pneumonia or bronchitis before potential inclusion
* paralysed patients
* patients requiring a closed suction device
* patients with relative contraindications to endotracheal aspiration (status asthmaticus, severe ARDS with PF ratio \< 100, hemorragic risk, brochopleural fistula)
* bronchiectasis, cystic fibrosis
* moribund patient or ethical decision to withhold or withdraw intensive care.

Primary outcomes:
measure: oral/tracheal amylase ratio
timeFrame: up to 24h after bronchoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References:
Clinical trial NCT03533465: Understanding the Role of Sleep in Complicated Grief
Official title: Understanding the Role of Sleep in Complicated Grief: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep
Grief
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 5
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The first aim of this study will involve a comparison of baseline psychiatric symptoms and subjective and objective measures of sleep, with specific attention to REM, in adults with CG compared to 25 healthy controls. 10 of these adults with CG who complete AIM 1 will participate in Complicated Grief Treatment (CGT).
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn more about the causes of Complicated Grief (CG) in those who experience the loss of a loved one. This study aims at learning more about the sleep patterns and emotions in participants with CG as compared to those who have lost a loved one but do not have CG.

This study will consist of two aims:

Aim 1: Approximately 10 complicated grief (CG) patients and 10 controls (without a current psychiatric diagnosis) will complete a 3-day home polysomnography (PSG) sleep assessment in addition to several self-report sleep and psychiatric measures.

Aim 2: Approximately 10 CG patients (subsample from Aim 1) will complete 16 weekly sessions of complicated grief therapy (CGT) in addition to completion of repeated PSG assessments and self-report sleep and psychiatric measures.


Eligibility criteria: Inclusion Criteria:

* Bereaved due to death of a loved one \>= 6 months prior (for both CG and control groups)
* For CG participants: grief is primary psychiatric problem with ICG \>= 30 (threshold symptoms; for CG group only). Controls will be free of current psychiatric disorders with the exception of specific phobia.
* Normal or corrected vision

Exclusion Criteria:

* Psychiatric or sleep medications in the past 4 weeks (past 6 weeks for fluoxetine)
* Concurrent grief or exposure based therapy
* Lifetime bipolar, psychosis, significant neurological disorders
* Past 6 months of alcohol/substance use disorder
* Unstable medical illness
* Serious safety concerns of suicide or homicide
* Pregnant or nursing
* Overnight shift work
* \> 4 caffeinated or \> 11 alcoholic beverages per week
* Screening reveals OSA defined as an apnea hypopnea index with 4% desaturation (AHI4%) ≥15 or an AHI4% ≥ with an Epworth \>10

Primary outcomes:
measure: Clinical Global Impression Scales
timeFrame: 16 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Naomi Simon, MD
role: PRINCIPAL_INVESTIGATOR
References: