louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01286636: Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea
Official title: Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Sleep Apnea
Keywords: artificial neural network
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: VA Office of Research and Development
First posted: 2011-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators have developed a simple, accurate, and a point-of-care, computer-based clinical decision support system (CDSS) not only to detect the presence of sleep apnea but also to predict its severity. The CDSS is based on deploying an artificial neural network (ANN) derived from anthropomorphic and clinical characteristics.

The investigators hypothesize that patients with severe OSA defined as AHI≥30 can be diagnosed with the use of ANN without undergoing a sleep study, and that empiric management with auto-CPAP has similar outcomes to those who undergo a formal sleep study.


Eligibility criteria: Inclusion Criteria:

* Must be an adult (≥18 years old)
* Must have symptoms suggestive of OSA, and be considered for sleep study by the sleep specialist provider.

Exclusion Criteria:

* Pregnancy or breast feeding
* Patients with severe congestive heart failure (eg, NYHA Class IV, ejection fraction \< 35%).
* Patients with end-stage renal disease on hemodialysis
* Patients with CVA, Parkinson, neuromuscular degenerative disease.
* Patient on narcotics.
* Patients with severe lung disease requiring oxygen at night and/or during the day.
* Patient with predominant insomnia or sleep hygiene problems, and who are not considered for PSG by the sleep specialist.

Primary outcomes:
measure: To demonstrate that using an ANN directed management of OSA is not inferior to PSG directed management of OSA in terms of sleepiness related functional outcome
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Veterans Affairs Medical Center in Buffalo
state: New York
Study officials:
affiliation: State University of New York at Buffalo
name: Ali El-Solh, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02080936: Does Muscle Wasting Always Mean Muscle Weakness? A Prevalence Study in COPD
Official title: Does Muscle Wasting Always Mean Muscle Weakness? A Prevalence Study in COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: Experimental approaches
Peripheral muscle Keyword
Rehabilitation
Lead sponsor: 5 Santé
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 138
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients from "Clinique du Souffle La vallonie" and "Clinique du Souffle La Solane"

Brief summary: Peripheral muscle mass and strength are relevant indicators of COPD survival. Current guidelines recommend to assess muscle strength only in muscle wasted patients. However, a recent study reported quadriceps weakness without muscle wasting (Menon, M et al. Resp. Res.2012, 13:119). Thus, these guidelines raise the risk to miss out some weak patients. In clinical settings, fat-free-mass index (FFMI) is indicated as a simple index to assess muscle wasting. We aimed at determining the prevalence of patients entering in pulmonary rehabilitation (PR) a priori not eligible for muscle strength evaluation given the lack of muscle wasting clinical signs.


Eligibility criteria: Inclusion Criteria:

* Patients who have got FFMI (bioimpedance)
* Patients who have done quadriceps muscle strenght evaluation

Exclusion Criteria:

* Patients without FFMI
* Patients without quadriceps muscle strenght

Primary outcomes:
measure: Muscle wasting in COPD patient
timeFrame: baseline
Secondary outcomes:
measure: Muscle weakness in COPD patient
timeFrame: baseline
Other outcomes:
Locations:
city: Lodeve
country: France
facility: Clinique du Souffle La Vallonie
Study officials:
References:
Clinical trial NCT03470636: Clinical Study of the HeartLight X3 Endoscopic Ablation System With Excalibur Balloon
Official title: Clinical Study of the HeartLight X3 Endoscopic Ablation System (EAS) With Excalibur Balloon Compared to HeartLight System in the Treatment of Symptomatic Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: CardioFocus
Sponsor class: INDUSTRY
First posted: 2018-03-20
Enrollment: 60
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 objective of the study is to demonstrate the improved ablation and procedure times of the HeartLight X3 compared to the current HeartLight catheter in the treatment of atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* paroxysmal atrial fibrillation failure of at least one AAD others

Exclusion Criteria:

* overall good health as established by multiple criteria

Primary outcomes:
measure: Ablation time
timeFrame: Acute - at the end of the index procedure
Secondary outcomes:
measure: Procedure time
timeFrame: Acute - at the end of the index procedure
measure: PV Isolation
timeFrame: Acute - at the end of the index procedure
measure: PAE Rate
timeFrame: 30 Days
measure: AF Free Rate
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Nemocnice Na Homolce
Study officials:
affiliation: CardioFocus, Inc.
name: Burke T. Barrett
role: STUDY_DIRECTOR
References:
citation: Schmidt B, Petru J, Chun KRJ, Sediva L, Bordignon S, Chen S, Neuzil P. Pivotal Study of a Novel Motor-Driven Endoscopic Ablation System. Circ Arrhythm Electrophysiol. 2021 Mar;14(3):e009544. doi: 10.1161/CIRCEP.120.009544. Epub 2021 Feb 11.
Clinical trial NCT01000636: Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)
Official title: Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® PDT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Actinic Keratosis
Keywords: Renal transplant patients
Actinic Keratoses
Metvix PDT
Field cancerisation
Gene expression
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2009-10-23
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to determine possible molecular changes on large scale gene expression profiling after treatment with Metvix photodynamic therapy (PDT) of actinic keratoses (AK) and cancerised field in renal transplant recipients.

Detailed description: In this study, the whole target area defined by the investigator will be treated by Metvix PDT: this means that both lesions and sub-clinical lesions will be exposed to Metvix PDT. Biopsies will be performed in both regions: lesional and peri-lesional ones. This will allow us to compare pre and post treatment molecular changes that occurred in these regions and so to evaluate if Metvix PDT acts on the sub-clinical lesions.

Eligibility criteria: Inclusion Criteria:

* Renal transplant with an history of immunosuppression from 5 to 15 years,
* Presenting at least 4 discrete AK lesions, mild or moderate, either on the face, the scalp, forearms or the chest.

Exclusion Criteria:

* At risk in terms of precautions, warnings, and contra-indication referred in the package insert of Metvix®,
* AK lesions clinically atypical or suspicious for malignancy on the target field,
* Any of the following topical treatments within the specified washout period at Screening:

  * 5-FU, Imiquimod, Diclofenac sodium: 3 months,
  * Cryotherapy: 3 months,
  * PDT: 3 months,
  * Other less common AK treatments: 3 months.
* Systemic retinoids within the last month prior to Screening visit.

Primary outcomes:
measure: Percent Change From Baseline in Lesion Count at Week 18
timeFrame: Baseline and Week 18.
Secondary outcomes:
measure: Global Percent Change From Baseline in AK Lesion Count in the Target Field (Including New and Recurrent Lesions) at Month15
timeFrame: Baseline and Month15
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Department of Dermatology of Manchester Royal Infirmary
Study officials:
affiliation: Manchester Royal Infirmary
name: John T. Lear, MB,Ch.B,M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00156936: ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])
Official title: An Open-Label, Multi-Center Study to Evaluate the Long-Term Safety of Medisorb® Naltrexone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alcoholism
Opiate Dependence
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to assess the long-term safety of repeat monthly doses of naltrexone long-acting injection. All subjects received open-label Medisorb® naltrexone 380 mg (VIVITROL®).

Planned treatment duration was up to 3 years. Alkermes terminated the study for business purposes in December 2006. The median duration of treatment among all subjects in this extension study was 43 weeks.

Detailed description: From the date of successful completion of Study ALK21-006 (base study \[NCT01218997\])), all subjects, including those who received oral naltrexone during the base study, were given the option to enroll in this extension study.

Study investigators ensured that subjects were opioid-free and did not demonstrate evidence of withdrawal prior to administration of VIVITROL therapy. If the investigator suspected recent clinically significant opioid use, a naloxone challenge test was performed. The naloxone challenge was not performed in a subject presenting clinical signs or symptoms of opioid withdrawal or in a subject whose urine contained opioids.

Eligibility criteria: Primary Inclusion Criteria:

* Adults with a diagnosis of alcohol and/or opioid dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) who had satisfactorily completed Alkermes' Study ALK21-006 or other qualifying Medisorb naltrexone study
* Willing and able to return for scheduled clinic visits and study assessments
* Had a stable address
* Agreed to use a contraception for the duration of the study and for 1 month following the last dose if of childbearing potential
* Written informed consent

Primary Exclusion Criteria:

* Pregnancy or lactation
* Terminated early from study drug in a previous Medisorb naltrexone clinical trial
* Any finding that, in the view of the investigator, would compromise the ability to fulfill the protocol visit schedule and/or visit requirements

Primary outcomes:
measure: Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alkermes, Inc.
name: Bernard L. Silverman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00600236: HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population
Official title: HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2
Proliferative Diabetic Retinopathy
Keywords: Diabetes mellitus type 2 with 10 years of diagnosis and no diabetic retinopathy
Diabetes mellitus type 2 with 10 years of diagnosis and proliferative diabetic retinopathy
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Referencia Epidemiológica (INdRE)
First posted: 2008-01-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: One of the first causes of irreversible blindness in mexican population is diabetic retinopathy which is clearly diferent between patients the time of evolution and development of retinopathy and complications. The aim of this study is to explore the inmunogenetic profile and the influence of HLA in this variations of the sickness to predict the severity of diabetic complications.


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus type 2 with 10 years of diagnosis and no diabetic retinopathy
* Diabetes mellitus type 2 with 10 years of diagnosis and proliferative retinopathy

Exclusion Criteria:

* Systemic hipertension
* Cardic disease
* Lupus
* Any kind of artritis
* Allergies
* Optic Neuritis
* VKH
* Cancer
* Inmunological diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Asociación para Evitar la Ceguera en México, Hospital "Luis Sanchez Bulnes"
state: Mexico DF
Study officials:
affiliation: Asociación para Evitar la Ceguera en México, Hospital "Luis Sánchez Bulnes"
name: Hugo Quiroz-Mercado, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01575236: A Randomized Non Crossover Study of the GuardianTM Versus SupremeTM Laryngeal Mask Airway
Official title: A Randomized Non Crossover Study of the GuardianTM Versus SupremeTM Laryngeal Mask Airway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adverse Anesthesia Outcome
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
Collaborators: name: Medical University Innsbruck
First posted: 2012-04-11
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the LMA SupremeTM in paralyzed, anesthetized patients.

Detailed description: The GuardianTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). In the following randomized, non-crossover study, the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the LMA SupremeTM in paralyzed, anesthetized patients.

Eligibility criteria: Inclusion Criteria:

* ASA 1 or 2
* Age 18-75 yr
* Written informed consent

Exclusion Criteria:

* Difficult airway
* Non fasted
* BMI \> 35

Primary outcomes:
measure: efficacy of oropharyngeal seal pressure
timeFrame: 5 min
Secondary outcomes:
measure: anatomic position
timeFrame: 5 min
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Universitätsklinik für Anästhesie
state: Tirol
Study officials:
affiliation: Anästhesie Schulthess Klinik
name: Christian Keller, MD MSc
role: STUDY_CHAIR
References:
Clinical trial NCT04319536: Integrated Genetic and Functional Analysis of the Female Microbiome in a Flemish Cohort
Official title: Integrated Genetic and Functional Analysis of the Female Microbiome in a Flemish Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vaginal Microbiome
Skin Microbiome
Saliva Microbiome
Keywords: Metagenomic sequencing
vaginal microbiome
skin microbiome
saliva microbiome
large-scale self-sampling cohort
Microbiota
Probiotics
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study populations involves healthy women from 18 years and older.

Brief summary: The aim of the project is to improve our knowledge on the stability and temporal dynamics of the Flemish female microbiome (vagina, skin and saliva) in relation to different lifestyle factors and environmental conditions and to establish certain individual and social risk factors that can influence the healthy microbiome. Therefore, microbial DNA from swabs will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq sequencing in order to identify the microbial species present in these samples. Special attention will go to microbial species that are overrepresented in the healthy populations as potential health promoting microbes (i.e. probiotics).


Eligibility criteria: Inclusion Criteria:

* none

Exclusion Criteria:

* none

Primary outcomes:
measure: Differences in microbial communities colonizing the vagina, skin and saliva between healthy individuals measured with Illumina MiSeq
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University of Antwerp and University Hospital Antwerp
Study officials:
References:
Clinical trial NCT03419936: Distribution of Helicobacter Pylori After Gastrectomy
Official title: Distribution of Helicobacter Pylori in Remnant Stomach After Subtotal Gastrectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Helicobacter Pylori Infections
Keywords: Stomach Neoplasms
Helicobacter pylori
Subtotal gastrectomy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sample size will be determined based on the analysis the distribution rate of Helicobacter pylori at first 60 patients.

Brief summary: The purpose of this study is to know the distribution of Helicobacter pylori in stomach before subtotal gastrectomy and after subtotal gastrectomy.

Detailed description: Endoscopy and biopsy will be performed to investigate the distribution of Helicobacter pylori before and after subtotal gastrectomy.

Eligibility criteria: Inclusion Criteria:

1. Patients who are indicated to subtotal gastrectomy due to gastric neoplasm
2. Aged between 19 to 75 years
3. Informed consent

Exclusion Criteria:

1. Previous history of Helicobacter pylori eradication
2. Previous history of proton pump inhibitor use within 6 months

Primary outcomes:
measure: Distribution of Helicobacter Pylori After Gastrectomy
timeFrame: Change in the distribution of Helicobacter Pylori at 2 years
Secondary outcomes:
measure: Change of atrophy after gastrectomy
timeFrame: Change in the atrophic status at 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
affiliation: Study Principal Investigator Asan Medical Center
name: Ji Yong Ahn, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01433536: Evaluation of Circulating Osteogenic Factors in Trauma Patients
Official title: Evaluation of Circulating Osteogenic Factors in Trauma Patients (BMP-9)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Healthy
High Velocity Fracture
Cranial Trauma
Spinal Trauma
Keywords: cranial trauma with or without high velocity fracture to inferior limb
spinal trauma with or without high velocity fracture to inferior limb
high velocity fracture to inferior limb
Lead sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Université de Sherbrooke
name: Canadian Institutes of Health Research (CIHR)
First posted: 2011-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients arriving at the emergency room at the CHUS that present pathologies associated with the different cohorts described and responding to inclusion criteria.

Brief summary: Bone fractures in traumatic brain-injured and spinal cord-injured patients often heal faster than in other patients. However, such patients are also occasionally prone to bone formation in soft tissues such as muscle. This process is called heterotopic ossification and tends to occur around joints. Patients with heterotopic ossification often suffer from complications such nerve compression, ankylosis, chronic pain, osteoporosis, and infections. Loss of movement can also interfere with function and the quality of life of patients already experiencing difficulties associated with their trauma. Positioning, transfers, and hygiene become difficult and even impossible, which worsens the loss of autonomy.

Previous research has suggested that an osteoinductive factor (which has the capacity to induce the formation of bone) may be released into the bloodstream following a head or spinal cord injury. The investigators laboratory has shown that a growth factor called BMP-9, when injected into a damaged mouse muscle, has the ability to cause strong ossification in damaged muscle. The investigators would like to find out whether the levels of BMP-9 and/or its receptor (which is called ALK1) increase after traumatic brain and spinal cord injuries that occur at the same time as serious orthopaedic traumas.

The main goal of the investigators study is thus to determine whether BMP-9 levels increase in the serum of trauma patients.


Eligibility criteria: Inclusion Criteria:

* cranial trauma with Glasgow =\< 8
* spinal trauma with ASIA A, B, C
* high-velocity fracture of femur, tibia, pelvis

Exclusion Criteria:

* brain dead
* pathological fractures (cancer, osteoporosis)
* blood transfusion received
* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Guillaume Grenier, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: