louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06632301: DEXA Bone Density Analysis of the CoreHip® Prosthesis System
Official title: DEXA Bone Density Analysis to Analyze the Loading Concept of the CoreHip® Prosthesis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Primary Osteoarthritis
Cartilage Degeneration
Osteoarthritis, Hip
Inflammatory Arthritis
Osteonecrosis of Femoral Head
Traumatic Disorder
Keywords: Total Hip Arthroplasty
DEXA Bone Density Analysis
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2024-10-09
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this interventional post-market follow-up study is to evaluate radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4) within 24 months postoperative in patients treated with CoreHip® primary cementless stem. The DEXA bone density analysis is used.

Detailed description: Additional diagnostic examination: DEXA-Analysis. A DEXA scan is an imaging test that measures bone density (strength). The results can provide helpful details about risk for osteoporosis (bone loss) and fractures. Furthermore we would like to find out more about stress shielding processes around our prosthesis.

Eligibility criteria: Inclusion Criteria:

* Unilateral hip osteoarthritis
* Indication for CoreHip Standard hip stem according to preoperative planning
* Written Informed Consent
* Age 35-85 years
* According to the assessment of the study doctor, the patient is therapy compliant and able to attend the follow-up visits

Exclusion Criteria:

* Femoral neck fractures
* Pregnancy
* BMI \> 35
* History of femoral fracture or previous surgery on the same hip
* Metabolic bone disease, use of steroids or other drugs affecting bone metabolism
* Intraoperative bone cracks
* Severe osteoarthritis of the contralateral hip
* THA of the contralateral side or other event leading to restricted weight bearing during the study period

Primary outcomes:
measure: Radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4)
timeFrame: within 24 months postoperative
Secondary outcomes:
measure: Clinical Results: Joint Function (Harris Hip Score)
timeFrame: preoperative, at discharge (1 week postop) and 12 months postoperative
measure: Development of Quality of Life (EQ-5D-5L)
timeFrame: preoperative, at discharge (1 week postop) and 12 months postoperative
measure: Development of Forgotten Joint Score
timeFrame: preoperative, at discharge (1 week postop) and 12 months postoperative
measure: Development of Pain
timeFrame: preoperative, at discharge (1 week postop) and 12 months postoperative
measure: Development of Pain
timeFrame: preoperative, at discharge (1 week postop) and 12 months postoperative
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
Study officials:
affiliation: Orthopädische Kliniken im Annastift, MHH
name: Henning Windhagen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01861704: Post-market Study to Capture Information Regarding Performance of Lyric2
Official title: Post-market Study to Capture Information Regarding Performance of Extended Wear Hearing Aid Lyric2 Compared to Lyric
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: Mild to moderate hearing loss
Lead sponsor: Phonak AG, Switzerland
Sponsor class: INDUSTRY
First posted: 2013-05-24
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Randomized post market study comparing Lyric to Lyric2 capturing information regarding comparative performance and safety.

Detailed description: Randomized post market study comparing extended wear hearing aids Lyric to Lyric2 capturing information regarding comparative performance and safety.

Eligibility criteria: Inclusion Criteria:

* Aged 18-90 years at the time of enrollment in the study
* Mild to moderately-severe hearing loss bilaterally, or unilaterally if normal hearing in other ear
* Fluent in English
* Willingness to comply with all study requirements

Exclusion Criteria:

* Scuba dives or sky dives
* Underwater swimming or dives into the water
* Handicaps that would restrict participation in all the evaluations
* Hearing loss of neural or central origin
* Unrealistic expectations regarding benefits and limitations inherent in the devices
* Chemotherapy within the last six months
* Compromised immune system
* Radiation to head or neck
* Perforated tympanic membrane
* History of cholesteatoma
* Active outer or middle ear pathology
* High levels of anticoagulant therapy
* Insulin-dependent and/or uncontrolled diabetes
* Contact dermatitis
* Bleeding disorder
* Unwillingness or inability to comply with all study requirements

Primary outcomes:
measure: Immediate Refit Upon Device Removal
timeFrame: Following device removal at the same appointment (Up to 24 hours after removal)
Secondary outcomes:
measure: Device Comfort
timeFrame: During useful lifespan of device
measure: Gain, Speech Understanding and Sound Quality
timeFrame: During useful lifespan of device
Other outcomes:
Locations:
city: Newark
country: United States
facility: InSound Medical
state: California
Study officials:
affiliation: Employee
name: Tanya Arbogast
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02754804: Claudication, Systematic Evaluation of Limp on Treadmill
Official title: Claudication et Fatigue Musculaire de l'artériopathe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-04-28
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients complaining claudication and referred for a treadmill test

Brief summary: Vascular claudication is a common cause of functional limitation. This painful condition is a source overall muscle deconditioning in the peripheral arterial diseased (PAD) patient leading gradually to a state accented inactivity. The characterization of the claudication as it results from a proximal or distal ischemia has never carried out. Investigators will analyze dynamic pedometer parameter throughout walking tests in PAD patients with claudication

Detailed description: Patients referred for exercise tests on treadmill for the quantification of walking ability will gave a recording of their walking parameters through an instrumented treadmill recording biomechanic parameters (surface electromyography, walking pace; force of the foot/treadmill interface, length of the step.. etc.) Analysis will be performed until walking is stopped due to usual claudication during a constant load 2 miles per hour 10% slope treadmill procedure.

Eligibility criteria: Inclusion Criteria:

* Referred for treadmill testing
* Age \> 18
* Claudication
* Covered by the French Healthcare system
* Consent to participate

Exclusion Criteria:

* Unstable angina
* History of lower limb osteo articular rheumatologic disease
* Lower limb amputation
* Cardiac or respiratory failure
* Neurologic disease

Primary outcomes:
measure: Root mean square (RMS) of the electromyogram signal
timeFrame: Evaluation is complete immediately at the end of each walking test. (The end of the walking period is the end of participation of each patient, no follow up of patients)
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre hospitalier universitaire
Study officials:
affiliation: University Hospital, Angers
name: pierre Abraham, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04542304: Efficacy of Diuretics in Kidney Disease
Official title: Efficacy of Diuretics in Kidney Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Kidney Disease
End Stage Renal Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study will determine the efficacy of diuretics in patients with chronic kidney disease.

Detailed description: Participants with chronic kidney disease will undergo two 1-week study periods (single-dose diuretic versus single-dose placebo) separated by 1-2 weeks of washout in a cross-over design. Blood and urine samples will be collected at the end of each study period to determine the effect on urine output and to assess the kidney clearance and levels of uremic solute. Participants will weigh themselves daily.

Eligibility criteria: Inclusion Criteria:

* stable chronic kidney disease patients able to provide consent
* stable dialysis patients who produce urine and able to provide consent

Exclusion Criteria:

* use of antibiotics for last two months or expected antibiotic use
* recent hospitalization or other event resulting in instability of food intake

Primary outcomes:
measure: Change in Urine Output
timeFrame: Change from baseline urine output at 1 week for each study arm
Secondary outcomes:
measure: Kidney Clearance of Uremic Solutes
timeFrame: Kidney clearance of uremic solutes at 1 week for each study arm
measure: Change in Quality of Life Questionnaire Score
timeFrame: Change from baseline quality of life score at 1 week for each study arm
measure: Plasma Urea
timeFrame: Week 1
measure: Blood Pressure
timeFrame: Week 1
measure: Weight Change
timeFrame: Baseline, Week 1
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
References:
Clinical trial NCT01812304: Theoretical Compared With hands-on Training of Vaginal Breech Management
Official title: Objective Structured Assessment of Technical Skills Evaluation of Theoretical Compared With hands-on Training of Shoulder Dystocia Management: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaginal Abnormality - Baby Delivered
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This trial aims to assess the hypothesis that hands-on training of vaginal breech delivery on a pelvic model is significantly better in terms of a technical skills scoring system compared to frontal teaching.

Detailed description: Primary endpoint is a score describing technical proficiency, ie the OSATS score, consisting of 25 items. Each item, if done correctly, is awarded one point. The maximum OSATS score is 25.

Secondary endpoints are performance time in seconds, cinfidence using a scale from 1-5 with one being very confident and 5 having no confidence when performing the procedures, and self-assessment using a scale of 1-5 with 1 being the optimal grade.

This is a two-arm study. The experimental arm uses a hands-on training and the control arm a frontal teaching approach. The allocation is randomized and single-blinded.

Eligibility criteria: Inclusion Criteria:

* informed consent
* able to understand German
* Medical student

Exclusion criteria:

* significant language barrier
* previous experience with vaginal breech training

Primary outcomes:
measure: OSATS Score
timeFrame: probands are tested after training within an hour
Secondary outcomes:
measure: OSATS Scores
timeFrame: 72 Hours after training
Other outcomes:
measure: confidence, speed, self assessment
timeFrame: immediately after training and 72 hours later
Locations:
city: Bochum
country: Germany
facility: Ruhr University Bochum
state: NRW
Study officials:
affiliation: Ruhr University Bochum
name: Clemens Tempfer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buerkle B, Rueter K, Hefler LA, Tempfer-Bentz EK, Tempfer CB. Objective Structured Assessment of Technical Skills (OSATS) evaluation of theoretical versus hands-on training of vaginal breech delivery management: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2013 Dec;171(2):252-6. doi: 10.1016/j.ejogrb.2013.09.015. Epub 2013 Sep 25.
Clinical trial NCT01991704: Incubation of Alcohol Craving During Abstinence
Official title: The Neural Mechanisms of the Incubation of Cue-induced Craving in Alcohol Dependence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Dependence
Keywords: incubation
Craving
alcohol dependence
Lead sponsor: National Institute on Drug Dependence, China
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2013-11-25
Enrollment: 99
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: alcohol dependence

Brief summary: In order to determine whether the 'incubation of craving' phenomenon also occurred in alcoholics, investigators employed an experimental approach to investigate the time course of cue-induced craving in alcoholism. Eighty male participants were randomly divided into Four groups, and they were assessed at 7, 14, 30, and 60 days of abstinence for cue-induced alcohol craving . Another group including 19 patients was repeatedly tested for the cue-induced alcohol craving at the above abstinence days. Other psychological and physiological measures were administered at the four abstinence time points.

Detailed description: All subjects provided written informed consent after a full explanation of the protocol design.

Eligibility criteria: Inclusion Criteria:

* met the criteria of DSM-IV for alcohol dependence
* aged 18-60 years,male

Exclusion Criteria:

* current or past history of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) axis I disorders
* with other serious physical diseases (respiratory disorders, cardiovascular disease and so on)
* other drug abuse except for nicotine

Primary outcomes:
measure: changes of alcohol craving measured with visual analogue scales
timeFrame: abstained from alcohol for 7 days, 14 days, 30 days and 60 days
Secondary outcomes:
measure: heart rate changes
timeFrame: 7, 14, 30 and 60 days after abstained
measure: blood pressure changes in different abstinence days
timeFrame: 7, 14, 30 and 60 days after abstained
measure: skin conductance changes in different abstinence days
timeFrame: 7, 14, 30 and 60 days after abstained
measure: changes of Alcohol Urge Questionnaire
timeFrame: 7, 14, 30 and 60 days after abstained
Other outcomes:
Locations:
Study officials:
affiliation: National Institute on Drug Dependence, China
name: Lin Lu, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00240604: Prevention of Corticosteroid-induced Glucose Intolerance
Official title: Treatment With Rosiglitazone for the Prevention of Glucose Intolerance in Patients Treated With Corticosteroids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Glucose Intolerance
Keywords: corticosteroid treatment
inflammatory diseases
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-10-18
Enrollment: 100
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: Glucose intolerance is frequent and serious complication of corticosteroid therapy. the aim of the study is to examine the hypothesis that co treatment with rosiglitazone can prevent glucose intolerance in patients treated with corticosteroids.

Detailed description: Glucose intolerance is frequent and serious complication of corticosteroid therapy. the aim of the study is to examine the hypothesis that co treatment with rosiglitazone can prevent glucose intolerance in patients treated with corticosteroids.

Eligibility criteria: Inclusion Criteria:

* corticosteroid treatment

Exclusion Criteria:

* congestive heart failure pedal edema

Primary outcomes:
measure: plasma glucose concentration
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah University Hospital
name: Arie BenYehuda, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04791904: Predictive Factors for Cranioplasty Complications - A Decade Experience
Official title: Predictive Factors for Cranioplasty Complications - A Decade Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Decompressive Craniectomy and Cranioplasty
Keywords: Cranioplasty
Surgery Complications
Decompressive Craniectomy
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 168
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients submitted to cranioplasty after decompressive craniectomy between 1 of January of 2008 and 21 of December of 2019.

Brief summary: This is a single-center, observational retrospective study. This study aims to identify predictive factors of complications for patients submitted to cranioplasty after decompressive craniectomy for all types of etiologies.

All patients submitted to cranioplasty since 2008 will be analyzed.

Detailed description: Patients submitted to cranioplasty since 2008 to 2019 will be retrospectively analyzed.

Will be considered for analysis all cases treated after decompressive craniectomy. Will be excluded patients with incomplete clinical or imaging records.

Main factors determined as a possible influence on complications after cranioplasty will be recorded focusing on patients characteristics, craniectomy characteristics, surgical timing, and cranioplasty materials.

Patients' records will be review by two investigators and data will be verified by a third investigator. records will be anonymously recorded.

Eligibility criteria: Inclusion Criteria:

* Cranioplasty surgery
* Previous decompressive craniectomy

Exclusion Criteria:

* Incomplete records (Clinical and Imaging) since craniectomy to 6 months after cranioplasty.
* More than one decompressive craniectomy

Primary outcomes:
measure: Surgical Complications
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário de São João
Study officials:
affiliation: University of Porto, Medicine Faculty
name: Pedro Silva, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00283504: A Description of Inflammatory Cell Types In Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy
Official title: A Description of Inflammatory Cell Types in Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy (Xolair)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ALLERGIC ASTHMA
Lead sponsor: Children's Hospital of The King's Daughters
Sponsor class: OTHER
Collaborators: name: Novartis
name: Genentech, Inc.
First posted: 2006-01-30
Enrollment: 13
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The researcher proposes to assess levels of sputum inflammatory markers (eosinophils, eosinophil cationic protein (ECP), neutrophils IL-8) before and while on anti-IgE therapy in a pediatric population of moderate to severe asthmatics who have ongoing persistent asthma symptoms despite on moderate to high doses of inhaled corticosteroids (ICS).

Associations will be assessed between the types of sputum inflammatory markers and the patient's atopic status and level of asthma control as indicated by the following measures:

1. pulmonary function test (PFT)
2. asthma symptoms based on the Asthma Control Test (ACT)

Detailed description: Objectives:

Primary: Describe inflammatory cell types in study patients and compare changes in inflammatory cell patterns before and during anti-IgE therapy.

Secondary:Describe patterns of sputum eosinophilia and neutrophilia in relation to asthma symptom improvement based on ACT and PFT

Hypotheses:

Differences in inflammatory response after the addition of anti-IgE therapy can be described in neutrophilic, eosinophilic and neutrophilic/eosinophilic asthmatics.

Neutrophilic asthmatics patients will fail to respond when placed on anti-IgE while eosinophilic asthmatics will respond well.

Sputum inflammatory markers are sensitive markers of inflammation and can predict response to new asthma treatment modalities such as anti-IgE therapy.

Eligibility criteria: Inclusion Criteria:

* Moderate to severe allergic asthma, uncontrolled on conventional therapy

Exclusion Criteria:

* History of systemic illness, currently on other immune modulators like immunotherapy, IVIg
* Pregnancy
* IgE level \>1300

Primary outcomes:
measure: Number of Participants With Change in Sputum Markers by End of Study
timeFrame: 32 weeks
Secondary outcomes:
measure: Number of Participants With Response to Therapy Based on Clinical Parameters Such as ED Visits, Hospitalizations, Systemic Steroid Use and Symptom Control
timeFrame: 32 weeks
measure: Number Participants for Whom Sputum Induction Was Safe
timeFrame: every 4 weeks up to 32 weeks
Other outcomes:
Locations:
Study officials:
affiliation: CHILDREN'S HOSPITAL OF KING'S DAUGHTERS/EASTERN VIRGINIA MEDICAL SCHOOL
name: MARIPAZ B MORALES, MD
role: PRINCIPAL_INVESTIGATOR
References: