louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02364375: Usability Evaluation of Menai CPAP Masks
Official title: Menai Mask Systems - Clinical Study 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: sleep
apnea
OSA
CPAP
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2015-02-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective of this study is to evaluate the subjective performance of the Menai mask systems (full face, nasal, and pillows variants), compared against Comparison mask systems.

Detailed description: The study will evaluate the subjective seal, comfort, stability, usability, and humidification performance of the prototype mask systems in CPAP established patients. The performance of the prototype Menai mask systems (full face, nasal, and pillows variants) will be subjectively assessed through user questionnaires based on an 11-point Likert scale, and will be compared against Comparison masks.

The prototype masks share the same parts (cushion, frame, headgear), with the difference being that the Menai masks feature a novel vent and humidification system.

Eligibility criteria: Inclusion Criteria:

* Participants willing to provide written informed consent
* Participants who can read and comprehend written and spoken English
* Participants who are over 18 years of age
* Participants who have been diagnosed with OSA
* Participants who have been established on CPAP for ≥ 6 months
* Participants who are currently using the same mask type/variant as the interventional mask system to be evaluated

Exclusion Criteria:

* Participants who are not able to provide written informed consent
* Participants who are unable to comprehend written and spoken English
* Participants who are pregnant
* Participants who are unsuitable to participate in the study in the opinion of the researcher
* Participants with a pre-existing lung disease or a condition that would predispose them to pneumothorax (e.g. COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection, lung injury)
* Participants who cannot participate for the duration of the trial
* Participants who are established on bi-level support therapy
* Participants who are not currently using the same mask type/variant as the interventional mask system to be evaluated

Primary outcomes:
measure: Usability Performance Evaluation
timeFrame: 2 weeks
Secondary outcomes:
measure: Humidification Performance Evaluation
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: ResMed Sleep Research Centre
state: New South Wales
Study officials:
affiliation: Graduate School of Biomedical Engineering, University of New South Wales, Sydney Australia and Applied Research, ResMed Ltd Sydney Australia
name: Klaus Schindhelm, BE PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01137175: Laboratory Diagnosis of of Rickettsial and Rickettsia-like Diseases
Official title: Laboratory Diagnosis of of Rickettsial and Rickettsia-like Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rickettsioses
Keywords: Rickettsioses
Scrub Typhus
Q fever
Typhus fever
Spotted fever
Rickettsioses reported cases
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2010-06-04
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients suspect to be infected by Rickettsia pathogen

Brief summary: The low confirmed rickettsioses cases rate may indicate the presence of rickettsiosis other than scrub typhus, murine typhus, and Q fever. The clinical presentation of rickettsiosis is variable and atypical that laboratory confirmation is necessary. This project is aimed to set up the laboratory to diagnose rickettsial and rickettsial like disease, which could help in develop rapid diagnostic kits, epidemiologic surveillance and prognostic factor.


Eligibility criteria: Inclusion Criteria:

* Rickettsioses reported cases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
References:
Clinical trial NCT04125875: Gastric Slow Wave and Autonomic Nervous Function in Cirrhotic Patients With Esophageal Varices After Ligation-A Clinical Research
Official title: Gastric Slow Wave and Autonomic Nervous Function in Cirrhotic Patients With
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Varices in Cirrhosis of the Liver
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20 patients with cirrhotic esophageal varices who were admitted to the First Affiliated Hospital of Nanjing Medical University since May 2019. Eight patients with gastric polyps were randomly selected as controls.

Brief summary: This study is intended to include 20 patients with esophageal varices caused by liver cirrhosis who were admitted to the first affiliated hospital of nanjing medical university from May 2019, and randomly select 8 patients with gastric polyps as the control group.General clinical data, imaging data, endoscopic data and laboratory indicators were collected.Electrogastrogram (EGG) and Heart Rate Variability (HRV) were performed before and 24 hours after operation in patients with cirrhotic esophageal varices, and the dyspepsia scale was filled out.Electrogastrogram (EGG) and cardiac variability (HRV) were performed in patients with gastric polyps 24 hours before and after surgery, and the dyspepsia scale was filled.EGG uses the surface electrode to record gastric myoelectric activity, and evaluates the patient's gastric rhythm by normal slow wave ratio, overspeed ratio, overslow ratio, and rhythm disorder ratio.The HRV evaluates the balance state of the patient's autonomic nervous system with High Frequency (HF)/Low Frequency (LF).SPSS software was used for paired sample analysis of experimental results.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old with cirrhosis of esophageal varices who underwent endoscopic ligation
* Signed informed consent

Exclusion Criteria:

* Hemorrhage in the digestive tract, unstable vital signs
* Hepatic encephalopathy
* Unwilling to cooperate with the examiner
* Skin allergies

Primary outcomes:
measure: Gastric Slow Wave of patients before the surgery, Change from Baseline Gastric Slow Wave 1 day after the surgery ,Change from Baseline Gastric Slow Wave 5 days after the surgery
timeFrame: before the surgery, 1 day after the surgery, and 5 days after surgery
Secondary outcomes:
measure: LF/HF of patients before the surgery, Change from Baseline LF/HF 1 day after the surgery ,Change from Baseline LF/HF 5 days after the surgery
timeFrame: before the surgery, 1 day afterthe surgery, and 5 days after surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: First Affiliated Hospital of Nanjing Medical Universit
state: Jiangsu
Study officials:
References:
Clinical trial NCT04604275: Functional Sucrase Deficiency in Short Bowel Syndrome Patients with Intestinal Failure
Official title: Functional Sucrase Deficiency in Short Bowel Syndrome Patients with Intestinal Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Short Gut Syndrome
Keywords: Intestinal failure
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: QOL Medical, LLC
First posted: 2020-10-27
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Short gut syndrome with intestinal failure patients may have decreased production of disaccharidases, like sucrase, an enzyme responsible for digesting sugar in foods. This can happen due to loss of bowel length from surgery or from loss of cellular function in the intestines due to use of parenteral nutrition intravenously. Therefore, patients with these conditions may not be able to digest sucrose (sugar) fully. Patients might experience abdominal distension/pain, vomiting and diarrhea when sugar is taken in orally or through the g-tube, which can limit patients' ability to increase oral or g-tube feeds in short gut syndrome patients with intestinal failure.

In patients with short gut syndrome and intestinal failure, the administration of exogenous sucrase (enzyme) may improve sucrose (sugar) digestion and thus the ability to tolerate more oral or g-tube feeds.


Eligibility criteria: Inclusion Criteria:

* Short bowel syndrome, of all ages, with dependence on parental support to provide at least 50% of fluid or caloric needs.
* Must be on diet containing sucrose.
* Must be willing and able to sign informed consent
* Adult and Pediatric patients (all ages)

Exclusion Criteria:

* Current IV antibiotic administration for confirmed bout of bacteremia.
* No enteral nutrition
* Any condition, disease, illness, or circumstance that in the investigator's opinion puts the subject at any undue risk, prevents completion of the study, or interferes with analysis of the study results

Primary outcomes:
measure: Change in Carbohydrate Malabsorption
timeFrame: baseline, up to 9 weeks
measure: Change in Carbohydrate Malabsorption as measured by patient symptom survey
timeFrame: baseline, up to 9 weeks
measure: Change in Carbohydrate Malabsorption as measured by growth velocity
timeFrame: baseline, up to 9 weeks
measure: Change in Carbohydrate Malabsorption as measured by enteral nutrition tolerance
timeFrame: baseline, up to 9 weeks
Secondary outcomes:
measure: Change in digestion
timeFrame: baseline, up to 9 weeks
measure: Change in digestion as measured by amount of emesis
timeFrame: baseline, up to 9 weeks
measure: Change in digestion as measured by stool consistency
timeFrame: baseline, up to 9 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Amanda Fifi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00992875: Does Mindfulness Training Change the Processing of Social Threat?
Official title: Does Mindfulness Training Change the Processing of Social Threat?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Stress
Keywords: Healthy but stressed individuals
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Mind and Life Institute, Hadley, Massachusetts
name: European Commission
First posted: 2009-10-09
Enrollment: 28
Sex: ALL
Minimum age (years): 22
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Training in mindfulness, the non-judgmental observation of experiences as they arise in the present moment, has been increasingly and successfully applied to the treatment of normative stress conditions and mental disorders. Yet, the neurological mechanisms that underlie the reported improvements are still largely unknown. This longitudinal study will investigate the influence of mindfulness training on a key underpinning of mental health, namely emotion regulation, and its associated brain activity. Healthy participants will be randomly assigned to either a validated eight week Mindfulness-based stress reduction (MBSR) program or to a control condition. In a pre-post investigation, participants' subjective reactions to aversive emotional stimuli (affective facial expressions) will be assessed, as will the associated brain activation using functional magnetic resonance imaging (fMRI). The investigators hypothesize that after the training the MBSR participants will rate the pictures as less aversive compared to control participants. Furthermore, the MBSR participants will show a patter of brain activation indicative of improved emotion regulation, relative to control participants. Finally, the effect of MBSR on the gray matter structure of the brain will be investigated.


Eligibility criteria: Inclusion Criteria:

* no previous significant meditation or yoga experience
* eligible for MRI scanning (no metallic implants, not pregnant, not claustrophobic)
* no significant previous meditation or yoga experience

Exclusion Criteria:

* DSM-IV diagnosis for depression, manic episodes, GAD, social phobia, anorexia, bulimia, schizophrenia, ADHD, substance dependency/abuse, suicidality
* ineligible for MRI scanning (metallic implants, pregnant, claustrophobic)

Primary outcomes:
measure: BOLD signal on a 1.5T MRI scanner
timeFrame: the second time-point will take place eight weeks after the first data collection
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sara W Lazar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04833075: Real World Pharmacokinetics of Immune Checkpoint Inhibitors
Official title: Real World Pharmacokinetics of Immune Checkpoint Inhibitors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Keywords: Immune Checkpoint Inhibitor
Pharmacokinetics
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A low-interventional cross-sectional pharmacokinetic study.
Primary purpose: OTHER

Brief summary: Rationale: Real-world pharmacokinetic data from cancer patients treated with immune checkpoint inhibitors (ICIs) are sparse. Moreover, pharmacokinetic parameters may be associated with response to ICI treatment and may act as a predictive or early response biomarker.

Objective: To describe the real-world pharmacokinetics of ICIs in patients eligible for ICI treatment or already treated with ICIs.

Study design: A low-interventional cross-sectional pharmacokinetic study. Study population: Patients treated with ICIs. Intervention: A maximum of 13 blood samples (39 mL) will be derived from subjects on treatment. After discontinuation of ICI treatment, a maximum of 7 blood samples (21 mL) will be derived.

Main study parameters: Real- world pharmacokinetic parameters of ICIs: clearance, volume of distribution, serum exposure (serum concentration - time curve).


Eligibility criteria: Inclusion Criteria:

* Treatment with immune checkpoint inhibitors (atezolizumab (Tecentriq®), avelumab (Bavencio®), cemiplimab (Libtayo®), durvalumab (Imfinzi®), ipilimumab (Yervoy®), nivolumab (Opdivo®) and pembrolizumab (Keytruda®))
* Willingness and ability to provide written informed consent
* Age 18 years or older

Exclusion Criteria: n/a (real-world)

Primary outcomes:
measure: Real-world pharmacokinetic parameters --> clearance
timeFrame: t=0 until t=12 months or end-of-treatment, whichever comes first (on-treatment) and t=0 until max. t=26 weeks (after discontinuation)(depends on ICI used)
measure: Real-world pharmacokinetic parameters --> volume of distribution
timeFrame: t=0 until t=12 months or end-of-treatment, whichever comes first (on-treatment) and t=0 until max. t=26 weeks (after discontinuation)(depends on ICI used)
measure: Real-world pharmacokinetic parameters --> exposure
timeFrame: t=0 until t=12 months or end-of-treatment, whichever comes first (on-treatment) and t=0 until max. t=26 weeks (after discontinuation)(depends on ICI used)
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
References:
Clinical trial NCT04817475: Live Stream of Prehospital point-of Care Ultrasound During Cardiopulmonary Resuscitation
Official title: Live Stream of Prehospital point-of Care Ultrasound During Cardiopulmonary Resuscitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiopulmonary Resuscitation
Echocardiography
Ultrasound
Keywords: Ultrasound diagnstics
Prehospital emergency medicine
Telemedicine
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 44
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: 30 critically ill patients suffering from acute cardiopulmonary resuscitation will be included in this study. POCUS will be performed with tele-supervision.

Brief summary: Background: Point-of-care ultrasound (POCUS) has been suggested as a useful tool in out-of-hospital cardiac arrest (OHCA) for diagnosis and treatment of reversible causes. However, in prehospital emergency medicine performing ultrasound and the translation of the findings can be challenging. As new prehospital ultrasound devices offer the possibility for remote supervision, the impact of tele-supervision on the performance of POCUS during OHCA is unclear.

Aims: This prospective observational study aims to evaluate if POCUS with tele-supervision can be performed during CPR without any additional hands-off periods longer than 5 seconds.

Methods: In total 30 patients with OHCA, where POCUS is considered, will be included in this study.


Eligibility criteria: Inclusion Criteria:

Patients with prehospital cardiac arrest, where POCUS is considered during cardiac pulmonary resuscitation, will be included.

Exclusion Criteria:

* under the age of 18,
* if POCUS is not considered or if POCUS will lead to a delay of live-saving treatment or transportation.
* pregnant patients
* patients with a body-mass-index (BMI) above 35 kg/m2

Primary outcomes:
measure: Hands-off time during prehospital cardiopulmonary resuscitation
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Impact of real-time supervision of POCUS during cardiopulmonary resuscitation on the duration time of POCUS
timeFrame: through study completion, an average of 1 year
measure: Impact of real-time supervision of POCUS during cardiopulmonary resuscitation on changing of diagnosis of suspected cause of out-of-hospital cardiac arrest.
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Anaesthesia & General Intensive Care
Study officials:
affiliation: Medical University of Vienna
name: Department of Anaesthesia & General Intensive Care
role: STUDY_CHAIR
References:
Clinical trial NCT02402075: Spinal Motor Evoked Potentials in Brain Surgery
Official title: Spinal Motor Evoked Potentials During Neurosurgical Procedures Within the Central Region
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Tumor
Glioma
Keywords: muscle motor evoked potentials
spinal motor evoked potentials
D-wave
brain tumor surgery
intraoperative neuromonitoring
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: Johann Wolfgang Goethe University Hospital
First posted: 2015-03-30
Enrollment: 40
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 glioma

Brief summary: During neurosurgical resection of brain tumors within brain areas for motor control, it is important to monitor motor function. For this muscle motor evoked potentials are used. Those are elicited by transcranial and direct cortical stimulation. Motor responses are recorded from muscles. In neurosurgical procedures for spinal cord tumors, the same methods are used, but additionally motor activity is recorded from the spinal cord. This is called spinal motor evoked potentials. It is known that the relation between spinal and muscle motor evoked potentials helps to extent the resection of spinal cord tumors. This study implements the spinal motor evoked potential into brain tumor surgery and analyses the relationship between spinal and muscle motor evoked potentials. With this, detection of injury to the brain area for motor control might be discovered earlier and thus tumor resection can be performed safely.


Eligibility criteria: Inclusion Criteria:

* \> 18 years
* tumor location adjacent to the motor cortex and corticospinal tract

Exclusion Criteria:

* minor
* neurological degenerative diseases
* neurological immunological diseases
* drug abuse
* implanted medical devices such as cardiac pacemaker
* spine deformation

Primary outcomes:
measure: D-wave measurement
timeFrame: 24 hours
measure: Clinical motor status according to the MRC scheme
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Neurosurgical Department
city: Frankfurt
country: Germany
facility: Department of Neurosurgery
Study officials:
affiliation: Neurosurgical Department, Heinrich Heine University
name: Andrea Szelenyi, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: