louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01797705: Revised Algorithm for Next Generation DeVilbiss Healthcare AutoAdjust Continuous Positive Airway Pressure (CPAP)
Official title: Revised Algorithm for Next Generation DeVilbiss AutoAdjust CPAP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: DeVilbiss Healthcare LLC
Sponsor class: INDUSTRY
First posted: 2013-02-22
Enrollment: 33
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this protocol is to improve the current FDA-approved continuous positive pressure auto-titration algorithm, including treatment precision, residual disease detection characteristics and phenotyping with the DeVilbiss brand AutoAdjust CPAP device.


Eligibility criteria: Inclusion Criteria:

* Apnea hypopnea index ≥ 15 / hour of sleep on the diagnostic polysomnogram, or diagnostic component of a split night polysomnogram
* Sleep efficiency reported on CPAP titration night PSG should be \> 78%
* Diagnosis of moderate to severe obstructive sleep apnea (AHI ≥15) or central/complex sleep apnea
* On stable CPAP or APAP \[Automatic Positive Airway Pressure\] therapy, with compliant use averaging 4 or more hours nightly
* Age 21-75 years
* Predominately central sleep apnea for up to 10 subjects only
* Willingness to give written informed consent and ability to adhere to visit schedule

Exclusion Criteria:

Diagnosis of mild sleep apnea

* CPAP naïve patients
* Co-morbid conditions which render participation to be at risk. These may include patients with congestive heart failure, COPD \[Chronic Obstructive Pulmonary Disease\] or psychiatric illness
* Allergies to mask materials
* Evidence of another primary sleep disorder
* Evidence of arousing periodic limb movements during titration
* Contraindications as listed on product labeling
* Pregnant
* Currently diagnosed with depression if symptomatic
* Deemed medically unsuitable by investigator
* Evidence of any type of infection or treatment of an infectious condition during the period of research participation
* Have a bi-level requirement, or prescribed a bi-level therapy device
* CPAP pressure \>15cmH2O
* Subjects with tracheotomy
* Uncontrolled hypertension
* Require supplemental oxygen
* Stimulants, major tranquillizers or antipsychotics
* Restless Leg Syndrome or Periodic Leg Movement Index of \> 5 per hour

Primary outcomes:
measure: % Agreement Between Reviewer and Machine Pressure Settings During Sleep Study
timeFrame: 1 night
Secondary outcomes:
Other outcomes:
Locations:
city: Newton
country: United States
facility: NeuroCare, Inc.
state: Massachusetts
Study officials:
References:
Clinical trial NCT04223505: Left Atrial Imaging Prior to Cardioversion: Leveraging Computed Tomography to Rule Out Thrombus
Official title: Left Atrial Imaging Prior to Cardioversion: Leveraging Computed Tomography to Rule Out Thrombus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Evaluating contrast enhanced ECG-gated cardiac CT (CCT) as an alternative to transesophageal echocardiography (TEE) to expedite cardioversion of atrial fibrillation (AF), improve patient care and reduce hospital admissions for AF and atrial flutter.


Eligibility criteria: Inclusion Criteria:

1. Admitted patients who require LA imaging prior to cardioversion
2. Age ≥18 years old
3. Able and willing to comply with the study procedures

Exclusion Criteria:

1. Indication for acute cardioversion (e.g. hemodynamic instability, acute coronary syndrome (ACS), or pulmonary edema)
2. Unwillingness or inability to provide informed consent
3. Contraindication to Cardiac CT

   * Severe renal insufficiency(GFR\< 45ml/min)
   * Allergy to intravenous contrast agents
   * Contraindications to radiation exposure (for example, pregnancy)
   * Inability to perform 20-second breath-hold
4. Contraindication to TEE

   * Unrepaired tracheoesophageal fistula
   * Esophageal obstruction or stricture
   * Perforated hollow viscus
   * Poor airway control
   * Severe respiratory depression
   * Uncooperative, unsedated patient

Primary outcomes:
measure: Time to Imaging
timeFrame: From admission to imaging/spontaneous cardioversion, up to approximately 30 days.
Secondary outcomes:
measure: Time to Cardioversion
timeFrame: From admission to cardioversion, up to approximately 30 days
Other outcomes:
measure: Time to Hospital Discharge
timeFrame: From admission to hospital discharge, up to approximately 90 days.
measure: QoL
timeFrame: At hospital discharge
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: UOHI
name: Benjamin Chow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02956005: Envarsus XR in African American Renal Transplant Recipients
Official title: Envarsus XR in African American Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Renal Transplant Recipients
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2016-11-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 collect data prospectively on African American patients who are taking the immunosuppressant Envarsus post kidney transplant. We are looking to see if African American renal transplant recipients that receive Envarsus will have less tubular injury and calcenurin inhibitor toxicity compared with patients that receive tacrolimus IR.

African americans have the higher rates of CYP3A5 which is associated with the need of higher tacrolimus dose to achieve an adequate level and this many times is associated with signs and symptoms of tacrolimus toxicity such as tremors, headaches and neuropathies.

The retrospective cohort will be African American patients that will be matched by age, gender, type of kidney transplant (living vs deceased) and level of sensitization


Eligibility criteria: Inclusion Criteria:

1. African American race
2. Adult renal transplant recipients (\>18 y/o)
3. Previous adverse reaction or contraindication to the use of tacrolimus

Exclusion Criteria:

1. Non African American race
2. Less than 18 y/o (pediatric patients)
3. Recipients of liver and small bowel transplants
4. Adverse reaction to tacrolimus

Primary outcomes:
measure: Primary Endpoint is to Determine the Rate of Calcineurin Inhibitor Toxicity as Measured by Surveillance Kidney Biopsies.
timeFrame: 1 year
Secondary outcomes:
measure: Renal Function After Transplantation
timeFrame: 1 year
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Georgetown Transplant Institute
state: District of Columbia
Study officials:
References:
Clinical trial NCT03964298: Study of the Activity of PD-1 Inhibitors in Metastatic Uveal Melanoma
Official title: Study of the Activity of PD-1 Inhibitors in Metastatic Uveal Melanoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uveal Melanoma
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with metastatic uveal melanoma.

Brief summary: Study of the activity of PD-1 inhibitors in metastatic uveal melanoma

Detailed description: The aim of the research is to study the activity of PD-1 inhibitors in patients with metastatic uveal melanoma and treated by Nivolumab and Pembrolizumab. These molecules have already received the authorities approvals. The data collected will be crucial for the understanding of the mechanism of PD-1 inhibitors and also for the futures studies.

Eligibility criteria: Inclusion Criteria:

* Patients with metastatic uveal melanoma
* Patients who received at least once injection of Nivolumab or Pembrolizumab in the case of the disease's treatment

Exclusion Criteria:

* Antecedent of another evolutionary tumor pathology

Primary outcomes:
measure: Response rate Data collection of the efficacity of PD-1 inhibitors
timeFrame: December 2019
measure: Progression Free Survival Data collection of the efficacity of PD-1 inhibitors
timeFrame: December 2019
measure: Global Survival Data collection of the efficacity of PD-1 inhibitors
timeFrame: December 2019
measure: Stability Data collection of the efficacity of PD-1 inhibitors
timeFrame: December 2019
measure: Objective response Data collection of the efficacity of PD-1 inhibitors
timeFrame: December 2019
Secondary outcomes:
measure: Exploration of PD-1 inhibitors biomarkers
timeFrame: December 2019
Other outcomes:
Locations:
city: Paris
country: France
facility: Rodrigues
state: Ile-de-France
Study officials:
affiliation: Institut Curie
name: Manuel Rodrigues, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04876898: High Body Mass Index and Severity of Coronavirus
Official title: High Body Mass Index and Severity of Coronavirus Disease 2019 (Covid-19): a Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pneumonia
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 114 adult patients with confirmed COVID-19 were categorized by BMI levels on admission: overweight (25-29.9 kg/m2), and obesity (four categories: 30-34.9 kg/m2, 35-39.9 kg/m2, 40-44.9 kg/m2, and ≥45 kg/m2). Pneumonia, severe pneumonia, and ICU admission rate were our primary outcomes, complications, and length of hospital stay was the secondary outcome.

Brief summary: A cohort study included 114 adult patients with confirmed COVID-19 were categorized by BMI levels on admission: overweight (25-29.9 kg/m2), and obesity (four categories: 30-34.9 kg/m2, 35-39.9 kg/m2, 40-44.9 kg/m2, and ≥45 kg/m2).


Eligibility criteria: Inclusion Criteria:

* patients older than 18 years
* confirmed COVUID 19 infection
* body mass index more than 25kg/m2

Exclusion Criteria:

-

Primary outcomes:
measure: pneumonia
timeFrame: 30 days
measure: sever pneumonia
timeFrame: 30 days
measure: ICU admission
timeFrame: 30 days
Secondary outcomes:
measure: length of hospital stay
timeFrame: 30 days
measure: clinical complication
timeFrame: 30 days
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Gad sayed Gad
state: Qena
Study officials:
affiliation: ass prof ,anesthesia and ICU ,south valley university,Qena .Egypt
name: Gad S Gad, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02371798: Unilateral Meniere Disease: Can Double Dose Gadolinium and Delayed Imaging Make the Diagnosis?
Official title: Diagnosing Endolymphatic Hydrops in Patients With Meniere Disease Using Magnetic Resonance Imaging With Intravenous Gadolinium Administration
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Meniere Disease
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research study is to see if magnetic resonance imaging (MRI) with a double dose of contrast, or dye, and delayed imaging with MRI can help to diagnose Meniere Disease.

Detailed description: Meniere's disease (MD) is a medical condition causing attacks of vertigo, ringing in the ears, hearing loss and often a fullness in the ear. Currently there is no definitive test to diagnose the problem. It is believed to be caused by inner ear abnormalities, specifically of an over-collection of lymphatic fluid.The goal of this trial is to determine if an MRI with double dose of IV gadolinium can be diagnostic.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of unilateral Meniere Disease (MD) per the Committee on Hearing and Equilibrium of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS)
* Glomerular filtration rate (GFR) \> 90 mls/min/1.73 m2
* Creatinine (Cr) level serum \< 1.6 mg/dl

Exclusion Criteria:

* Age \< 18 years
* Diagnosis of bilateral MD
* History of prior temporal bone surgery
* History of cochlear implant placement
* Pacemaker, cardiac implantable electronic device, shrapnel, aneurysm clips or other metal objects that are prohibited in the MR suite
* GFR \< 90 mls/min/1.73m2
* Cr level \> 1.6 mg/d
* Lack of IV access
* Contrast allergy to gadolinium agent
* Pregnancy
* Claustrophobia necessitating parenteral anxiolytics
* Patients who are unable to provide informed consent for themselves

Primary outcomes:
measure: Grade of endolymphatic hydrops (EH) in the cochlea and vestibule
timeFrame: 6 hours after intravenous contrast injection
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Department of Otolaryngology Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Patricia Hudgins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04390698: Opioid Free Anesthesia in Breast Cancer Surgery
Official title: Opioid Free Anesthesia in Breast Cancer Surgery: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Free Anesthesia
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A comparison of incidences of postoperative nausea and vomiting (PONV) , postoperative pain severity and recovery parameters in breast cancer patients receiving opioid or opioid-free general anesthesia.

Detailed description: Breast cancer is one of the most common oncologic diagnosis in women. Surgery is traditionally performed under general anesthesia with opioid-based analgesia. It is associated with higher incidences of PONV, more severe acute postoperative pain and increased incidences of chronic pain. The possibility of higher risk of metastasis has also been reported.

The purpose of our study is to compare the opioid-free general anesthesia with the opioid-based general anesthesia with respect to the quality of recovery, postoperative pain and cancer recurrence and metastasis.

Eligibility criteria: Inclusion Criteria:

1. first diagnosis of histologically confirmed primary breast cancer without known extension beyond the breast and axillary nodes;
2. ASA physical statue I-II;

Exclusion Criteria:

1. chronic pain and opioid administration history;
2. allergy to local anesthetics or NSAIDs;
3. coagulation disorders;
4. local infection at regional block site;
5. unable to comply to study protocol schedule for logistic or other reasons;
6. refusal to participate to the study；
7. breast reconstruction with implants or latissimus dorsi flap

Primary outcomes:
measure: quality of recovery
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: health related quality of life
timeFrame: up to 3 months after surgery
measure: postoperative pain
timeFrame: up to 3 months after surgery
measure: cancer recurrence and metastasis
timeFrame: up to 12 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Yi Feng, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tripathy S, Rath S, Agrawal S, Rao PB, Panda A, Mishra TS, Nayak S. Opioid-free anesthesia for breast cancer surgery: An observational study. J Anaesthesiol Clin Pharmacol. 2018 Jan-Mar;34(1):35-40. doi: 10.4103/joacp.JOACP_143_17.
Clinical trial NCT05847998: Second Generation DICART Prototype Validation
Official title: Second Generation DICART Prototype Validation for Patients With Acute Circulatory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Circulatory Failure
Shock
Keywords: Acute Circulatory Failure
Shock
capillary refill time (CRT)
prognosis
diagnostic
evaluation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Capillary refill time (CRT) is a clinical sign for diagnosis of acute circulatory failure and response to treatment but is also associated with prognosis in patient with shock.

CRT is clinically evaluated by physician with a high risk of inter and intra evaluator variations, depending, for example, on measurement site, pressure applicated or visual evaluation.

The investigator hypothesizes that CRT measurement with second generation DICART prototype will be well correlated with clinical measurement.


Eligibility criteria: Inclusion Criteria:

-\>18 years old

* Acute circulatory failure
* Written informed consent given by patient or its relatives

Exclusion Criteria:

* Pregnant women, breastfeeding women, childbearing age women without oral contraception
* Cutaneous lesion at measurement site
* Patient under legal protection
* Patient already included in another interventional clinical trial

Primary outcomes:
measure: clinical capillary refill time measurement.
timeFrame: during procedure
measure: automatic DICART capillary refill time measurement.
timeFrame: during procedure
Secondary outcomes:
measure: ROC curve with DICART device
timeFrame: during procedure
measure: Inter-operator reproducibility in CRT measurement with DICART device
timeFrame: during procedure
measure: Inter-operator reproducibility in CRT measurement with clinical method
timeFrame: during procedure
measure: Intra-operator reproducibility in CRT measurement with DICART device
timeFrame: during procedure
measure: Intra-operator reproducibility in CRT measurement with clinical method
timeFrame: during procedure
measure: vital status
timeFrame: 30 days
measure: survival rate without renal replacement therapy
timeFrame: 30 days
measure: skin lesion assessed by clinical examination
timeFrame: during procedure
measure: rash assessed by clinical examination
timeFrame: during procedure
measure: pain evaluation by numerical rating scale
timeFrame: during procedure
Other outcomes:
Locations:
city: Bron
country: France
facility: Louis Pradel Cardiologic Hospistal
Study officials:
affiliation: Hospices Civils de Lyon
name: Matthias JACQUET-LAGREZE, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04332198: Neurobiological and Immunological Mechanisms of Dyspnea in ALS (BIOPNEA)
Official title: Neurobiological and Neuro-immunological Mechanisms of Dyspnea in Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shortness of Breath
Dyspnea
Amyotrophic Lateral Sclerosis
Lead sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 30
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: Dyspnea; subjective experience of respiratory discomfort; which produces negative emotional experience, is the most common symptom of patients afflicted with chronic respiratory failure and its treatments are limited. Amyotrophic Lateral Sclerosis (ALS) related - dyspnea, due to diaphragmatic dysfunction, is similar to dyspnea during mechanical inspiratory load (activation of the supplementary motor area, SMA). The perception of pain and dyspnea is processed in similar brain areas (insula, dorsal anterior cingulate cortex, amygdala and medial thalamus) and in ALS; relieving dyspnea by noninvasive ventilation (NIV) is associated with decreased pain thresholds. Otherwise, it is reported systemic elevations of pro-inflammatory cytokines in chronic pain patients, correlating with intensity of pain, and during respiratory load in healthy volunteers.

The objectives are to evaluate the cytokines and endorphins rates variations after initiation of NIV in ALS patients, and to correlate cytokines and endorphins rates with the intensity of the affective component and the intensity of the sensory component of dyspnea.

The investigators will perform a prospective, experimental study, including 30 ALS patients. Dyspnea, ventilatory and cardiac settings, electromyographic recording of the scalene muscle and biological assays (ACTH, endorphin, Neuropeptide P, BDNF, IL1, IL6, IL8, IL10, TNF), will be measured during spontaneous breathing and during NIV at different times after initiation.

The investigators expect a reduction of immunological and neurobiological markers after relieving dyspnea by NIV. This work could lead to the development of new treatments for dyspnea.


Eligibility criteria: Inclusion Criteria:

- Patients with chronic respiratory failure with diaphragmatic dysfunction linked to amyotrophic lateral sclerosis and requiring long-term NIV

Exclusion Criteria:

* Other respiratory disease (COPD, asthma, obstructive sleep apnea)
* Alcohol or psychotropic drug the lasts 24 hours
* Cognitive impairment
* Smoking \> 10 PA
* Exacerbation or infection 6 weeks earlier
* Endstage of illness
* Chronic or acute pain (VAS \> 3)

Primary outcomes:
measure: the cytokines and endorphins rates variation after initiation of NIV in ALS patients
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: