louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02465398: Anatomical Shoulder™ Fracture PMCF Study
Official title: Anatomical Shoulder™ Fracture Post-Market Surveillance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fracture
Keywords: Fracture shoulder arthroplasty
Three or four part fracture
Hemiarthroplasty
Multi-center
Europe
Non-controlled
Anatomical reconstruction
Proximal
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2015-06-08
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to obtain outcomes data on the Anatomical Shoulder Fracture System by analysis of standard scoring systems and radiographs.

Outcome data will be collected using the following standard scoring systems:

- Constant and Murley Score

Detailed description: This is a multi-centre, non-comparative, prospective post-market surveillance study involving surgeons skilled in shoulder replacement surgery. Each case enrolled will receive an Anatomical Shoulder Fracture implant. All system components are CE (Conformité Européenne)-marked and commercially available. Patients will be selected according to the subject selection criteria.

All patients will undergo pe-operative, intra-operative and post-operative physical examination, radiographic evaluation according to the hospital's routine procedure and collection of quality of life metrics. Follow-up evaluations are to be conducted at 6-12 weeks (x-rays only), at 6 months and annually thereafter for a minimum period of 5 years post hospital discharge. Follow-up evaluation at 10 years post hospital discharge is optional.

Eligibility criteria: Inclusion Criteria:

* Age - 18 years minimum.
* Sex - male and female.
* General Health - the patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history.
* Informed Consent - patient or patient's legal representative has signed a 'Patient Informed Consent form'.
* Indications - Diagnosis of trauma in the affected joint with the indication for shoulder hemiarthroplasty.

Exclusion Criteria:

* Patient is skeletally immature.
* Patient is pregnant.
* Patient is unwilling or unable to cooperate in a follow-up program.
* Patient is planned for a bilateral shoulder replacement.
* Patient shows one or more of the following medical conditions:

  * Pathological Fracture
  * Active Infection
* Patient requires one or more of the following medical interventions:

  * Revision surgery (non-union)
  * Inverse fracture prosthesis

Primary outcomes:
measure: Functional Performance
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Zürich
country: Switzerland
facility: Uniklinik Balgrist
city: Manchester
country: United Kingdom
facility: The Pennine Acute Hospital NHS Trust
Study officials:
affiliation: Zimmer Biomet, Jr. Clinical Project Lead
name: Elliott Goff, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01443598: Pulmonary Hypertension in Interstitial Lung Disease
Official title: Observational Study of Patients With Pre Capillary Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Diffuse Interstitial Lung Disease
Keywords: Pulmonary arterial hypertension,
Interstitial lung disease at HRCT
Lead sponsor: Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
First posted: 2011-09-29
Enrollment: 224
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 with pre capillary pulmonary hypertension and interstitial lung disease at HRCT

Brief summary: HYPID study is an observational and prospective study of patients with interstitial lung disease and pre capillary hypertension diagnosed by right heart sided catheterization. The primary aim of the study is to identify prognostic factors.

Detailed description: Pre capillary pulmonary hypertension (PH) may be present in patients with diffuse interstitial lung disease.

In this context, PH represents an important factor of morbidity and mortality for these patients.

One of the purposes of HYPID is to determine predictive factors of mortality within this cohort of patients.

In order to reach that aim,the study includes an evaluation based on exams conducted for the routine follow-up of patients. Each patient will be followed during 2 years at least.

Eligibility criteria: Inclusion Criteria:

* pre capillary pulmonary hypertension at right heart sided catheterization with: mPAP \> or = 25 mmHg,PCWP \< or = 15 mmHg
* interstitial lung disease with diffuse infiltrative opacities on chest CT scan

Exclusion Criteria:

* pulmonary hypertension related to a thromboembolic disease
* respiratory disease other than diffuse interstitial lung disease
* any etiological factor of pulmonary arterial hypertension based on DANA POINT classification other than diffuse interstitial lung disease
* any progressive disease associated to a life expectancy less than 6 months other than pulmonary hypertension, diffuse interstitial lung disease and respiratory insufficiency

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free survival (1)
timeFrame: 2 years
measure: Progression-free survival (2)
timeFrame: 2 years
measure: Progression-free survival (3)
timeFrame: 2 years
measure: Progression-free survival (4)
timeFrame: 2 years
measure: Progression-free survival (5)
timeFrame: 2 years
measure: Progression-free survival (6)
timeFrame: 2 years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Louis Pradel Hospital (Bâtiment A4)
state: Bron
Study officials:
affiliation: Hospices Civils de Lyon / University Lyon I
name: Vincent Cottin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06431698: CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS
Official title: CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ear Malformation
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 134
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the non-inferiority of the custom-made device developed in the maxillofacial surgery department of Caen University Hospital compared to the device from the EarWell™ group


Eligibility criteria: Inclusion Criteria:

* Newborn, age between 8 days and 1 month
* newborn with ear malformation

Exclusion Criteria:

* Total chondrocutaneous agenesis of the ear
* polymalformative syndrome
* age greater than 4 weeks
* parental refusal

Primary outcomes:
measure: Subjective ear deformation score
timeFrame: baseline and 1 year after
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
state: N
Study officials:
References:
Clinical trial NCT05397028: Weight Management for the Remission of Type 2 Diabetes Using a Proprietary Meal Replacement System- Diabetes Remission Study (DRS)
Official title: Weight Management for the Remission of Type 2 Diabetes Using a Proprietary Meal Replacement System- Diabetes Remission Study (DRS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Diabetes Mellitus, Type 2
Keywords: obesity
Diabetes, Type 2
meal replacement
diabetes remission
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 3
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A three month meal replacement dietary system which combines meal replacements and self-prepared meals which hypothetically will result in Diabetes remission in \>30% of intervention subjects

To assess the efficacy of which patients with Type 2 Diabetes (non insulin dependent) can be brought into a optimal A1C remission state without the use of medications by achieving clinically significant weight loss (\>20-30 pounds) using a proprietary meal replacement system associated with a 3-month intensive lifestyle program.


Eligibility criteria: Inclusion Criteria:

* Men and Women
* Ages 25-65
* Have been diagnosed with non-insulin dependent diabetes for less than five years
* Are taking at least one oral agents for diabetes
* English speaking

Exclusion Criteria:

* Individuals currently being treated for cancer
* Had a myocardial infarction in the previous 3 months
* Have uncontrolled persistent hypertension - diastolic \>90 systolic \>160
* Individuals with established eating disorder diagnoses
* Individuals who have recent weight loss attempt in the last 3 months with \> 5-pound loss
* Use of anti-obesity medications in the last three months
* Individuals who have had bariatric surgery
* Individuals taking medications that are known to cause weight gain including but not limited to insulin, steroids, haloperidol clozapine, risperidone, olanzapine, amitriptyline imipramine, paroxetine, and lithium
* Individuals who are pregnant or planning to become pregnant in the next 6 months

Primary outcomes:
measure: Efficacy of plant-based meal replacement system on A1-C levels
timeFrame: Change between baseline and six month visit.
Secondary outcomes:
measure: Efficacy of plant-based meal replacement system on insulin levels
timeFrame: Change between baseline and six month visit.
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
Study officials:
affiliation: Loma Linda University Health
name: Warren Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01920828: Gait Analysis in MPS IVA
Official title: Gait Analysis in Patients With MPS IVA Treated With Enzyme Replacement Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: MPS IVA
Morquio Syndrome
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: University of Utah
name: BioMarin Pharmaceutical
First posted: 2013-08-12
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of MPS IVA

Brief summary: The purpose of this study is to learn about gait (walking) characteristics in MPS IVA and possible changes in gait with enzyme replacement therapy.

Detailed description: The purpose of this 3-year study is to conduct a longitudinal investigation using motion analysis of gait to objectively and quantitatively assess gait characteristics of MPS IVA patients. Data documenting gait characteristics and abnormalities will be gathered in patients initiating enzyme replacement therapy.

Inclusion criteria Individuals with MPS IVA diagnosed by enzyme or molecular studies Exclusion Criteria Individual with MPS IVA previously enrolled in BMN-110 Individual is non-ambulatory The individual is unable to complete longitudinal study visits at least yearly

Eligibility criteria: Inclusion Criteria:

-Diagnosis of MPS IVA

Exclusion Criteria:

Non-ambulatory

* Previous enrolled in clinical trial BMN-110

Primary outcomes:
measure: Measurable changes in gait
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
References:
Clinical trial NCT02659228: Assessing Covert Consciousness in Unresponsive Patients
Official title: Assessing the Potential for 'Covert Consciousness' in Unresponsive Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Consciousness Disorders
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: McGill University
name: McMaster University
First posted: 2016-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, the investigators explore anesthesia as a tool for providing further insight into the level of consciousness of individuals with a clinical diagnosis of unresponsive wakefulness syndrome (UWS), but who possess some neurophysiological signatures of conscious awareness. This group, who could potentially be conscious, will herein be referred to as the target population. Our goal is to assess whether or not neurological patterns of consciousness in the target population respond to anesthesia in a similar manner to neurologically compromised individuals with known consciousness (e.g. those in minimally conscious state (MCS). In healthy controls, propofol-induced unconsciousness results in an elimination of the mismatch negativity event-related brain potential (ERP) and a diminished directed connectivity. The investigators hypothesize that at doses well below those required for surgery, anesthesia will have similar effects on these neural patterns in neurologically compromised patients with the potential for conscious awareness, but will not affect these patterns in those who lack consciousness.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the intensive care unit at Hamilton General Hospital who:

  * Clinical status consistent with UWS (no responsiveness to commands)
  * Clinical status consistent with MCS (minimal response to at least one command)
  * Presence of an endotracheal tube (ETT) or a tracheostomy tube
  * Between 18 and 50 years of age

Exclusion Criteria:

* • Elevated intracranial pressure (ICP)

  * Hepatic or renal failure
  * Hemodynamic instability
  * Active vasopressor therapy
  * Previous open-head injury
  * Previous intracranial pathology requiring neurosurgical interventions in the past 72 hours
  * Anticipated ICU stay \< 24 hours
  * Documented allergy to propofol
  * Pregnancy
  * BMI \> 35 kg/m2
  * Anyone who is deemed medically unsuitable for this study by the attending intensivist
  * Patients who are already in a medically-induced coma for intracranial hypertension or status epilepticus

Primary outcomes:
measure: Asymmetry in feedback vs. feedforward network connectivity
timeFrame: 3 hours
Secondary outcomes:
measure: Presence of P300 and N400 event-related potentials
timeFrame: 3 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01720628: The Relationship Between Serum Levels of Angiogenin, bFGF, VEGF and Ocular Involvement in Patients With Behçet's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Behçet's Disease
Keywords: Angiogenin, Behçet's disease, bFGF, VEGF
Lead sponsor: Turkish Ophthalmology Society
Sponsor class: OTHER
First posted: 2012-11-02
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Turkish patients fulfilling the international diagnostic criteria for Behçet's disease

Brief summary: Objectives: Behçet's disease (BD) is a systemic vasculitis. Since vascular endothelial dysfunction plays a prominent role in the pathogenesis of the disease, we considered angiogenic cytokines as an interesting target for investigation in BD. The aim of this study was to investigate the possible role of angiogenin, vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) in the pathogenesis of BD.

Design and Methods: Sixty five patients with BD and 21 healthy control subjects were included in the study. Serum angiogenin, bFGF and VEGF concentrations were determined by using in vitro enzyme immunoassay (ELISA) kits according to the manufacturer's instructions.


Eligibility criteria: Inclusion Criteria:

* age between 18-65
* fulfilling the international diagnostic criteria for Behçet's disease

Exclusion Criteria:

* to have another systemic disease

Primary outcomes:
measure: Serum levels of angiogenin in Behçet's patients with or without ocular involvement
timeFrame: 1 year
Secondary outcomes:
measure: Serum levels of bFGF in Behçet's patients with or without ocular involvement
timeFrame: 1 year
Other outcomes:
measure: Serum levels of VEGF in Behçet's patients with or without ocular involvement
timeFrame: 1 year
Locations:
city: Ankara
country: Turkey
facility: Ankara University, Faculty of Medicine, Department of Ophthalmology
Study officials:
affiliation: * Dışkapı Yıldırım Beyazıt Training and Research Hospital, Department of Clinical Biochemistry
name: ali yalçındağ
role: STUDY_DIRECTOR
References:
Clinical trial NCT03145428: Evaluation of Monocyte Volume Distribution Width (MDW) for Early Detection of Sepsis
Official title: Evaluation of Monocyte Volume Width Distribution (MDW) for Early Detection of Sepsis or Developing Sepsis on the UniCell DxH800 Hematology Analyzer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Severe Infection
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-09
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients with suspicion who present to ED and for whom CBC with Diff is performed upon ED presentation.

Brief summary: The measurement of monocyte volume width distribution (MDW) is intended for use with adult patients presenting to the emergency department (ED), where a CBC with Differential has been ordered, as an aid in the early detection of patients with or developing sepsis. The study will establish the clinical performance of MDW for detection of sepsis in the ED.

Detailed description: A prospective multi-center study to establish the clinical utility of the measurement of monocyte volume width distribution, a cell population parameter of the CBC-Differential, on the Beckman Coulter Unicel DxH analyzers. The study will validate the cut-off for the early detection of sepsis in an adult emergency room population where the standard of care included a CBC with Differential and will evaluate the diagnostic performance of the parameter.

Eligibility criteria: Inclusion Criteria:

* Adults (18-89 years) presenting to ED
* All races \& ethnicities
* CBC with Differential performed upon presentation
* Subjects with at least 12 hours of follow-up in ED (or in-patient if admitted)

Exclusion Criteria:

* Previously enrolled
* Subjects discharged \<12 hours form ED presentation

Primary outcomes:
measure: Identification of sepsis vs. non-sepsis, including SIRS and infection (non-SIRS) by adjudication based on the 2001 SCCM sepsis definition (sepsis-2)
timeFrame: 12 hours after presentation to the ED
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
References:
citation: Crouser ED, Parrillo JE, Martin GS, Huang DT, Hausfater P, Grigorov I, Careaga D, Osborn T, Hasan M, Tejidor L. Monocyte distribution width enhances early sepsis detection in the emergency department beyond SIRS and qSOFA. J Intensive Care. 2020 May 5;8:33. doi: 10.1186/s40560-020-00446-3. eCollection 2020.
Clinical trial NCT06443528: Comparison of Lung Ultrasound Scores With Clinical Models for Predicting Bronchopulmonary Dysplasia：A Multi-center Prospective Cohort Study
Official title: Comparison of Lung Ultrasound Scores With Clinical Models for Predicting Bronchopulmonary Dysplasia：A Multi-center Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Ultrasound
Bronchopulmonary Dysplasia
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 1620
Sex: ALL
Minimum age (years): 0
Maximum age (years): 32
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants who meet all of the inclusion and exclusion criteria will be included

Brief summary: This study aimed to fill this knowledge gap and designed a multicentre cohort study to verify the hypothesis that LUS has good reliability to predict BPD in China and to compare the predictive value of LUS and clinical models for the development of BPD at different time points in infants born before and after 28 weeks.


Eligibility criteria: Inclusion Criteria:

1. Preterm infants with GA \<32 weeks.
2. Infants with enrollment within 24 hours from birth
3. Parental written consent is obtained.

Exclusion Criteria:

1. Complex congenital malformations or chromosomal abnormalities
2. Congenital lung diseases or congenital heart defects
3. Infants with enrollment after 24 hours from birth

Primary outcomes:
measure: bronchopulmonary dysplasia
timeFrame: 2024.06.01-2027.06.30
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: