louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01575210: Assessment of the Performance of a New Reduced Noise Mask Vent
Official title: Clinical Trial of a New Mask Vent, Designed to Reduce Noise of Mask Venting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnoea (OSA)
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2012-04-11
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As continuous positive airway pressure is the treatment of choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance and usability of the new mask vent. This is done by comparing the apnea-hypopnea index (AHI) of patients, who will apply 2 different washing procedures to the new mask, at the end of the study and their baseline data obtained at the beginning of the study.The study will also assess the breathing comfort as well as obtaining subjective data on the usability of the new mask vent system.


Eligibility criteria: Inclusion Criteria:

* Subjects who are using ResMed mask
* Subjects willing to provide written informed consent
* Subjects who have been treated for OSA \> 6 months
* Subjects who can read and comprehend English
* Subjects ≥ 18 years old
* Subjects who are using a ResMed S8 or S9 device

Exclusion Criteria:

* Patients who are pregnant
* Patient on bi level treatment
* Patients being treated for OSA \< 6 months
* Patients who have a pre-existing lung disease/condition that would predispose them to pneumothorax (for example: COPD; lung cancer, fibrosis of the lungs; recent (\<2 years ago) case of pneumonia or lung infection; lung injury).
* Patients who are deemed unsuitable by the researcher due to the following reasons:

  * They do not comprehend English
  * They are unable to provide written informed consent
  * They are physically unable to comply with the protocol

Primary outcomes:
measure: The apnoea/hypopnoea index (AHI) will be recorded and analysed.
timeFrame: 12 weeks
Secondary outcomes:
measure: The level of comfort patients experience while using the new mask vent
timeFrame: 12 weeks
measure: Patient's and bed partner's perceptions of the mask vent
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: ResMed Centre for Healthy Sleep
state: New South Wales
Study officials:
affiliation: ResMed/ The University of New South Wales
name: Klaus Schindhelm, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03492710: Study of Immune Globulin Intravenous (Human) GC5101F in Subjects With Primary Humoral Immunodeficiency
Official title: Phase III Study of Immune Globulin Intravenous (Human) IGIV-SN in Pediatric Subjects With Primary Humoral Immunodeficiency
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Primary Immune Deficiency Disorder
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2018-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 24
Maximum age (years): 203
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter
Primary purpose: TREATMENT

Brief summary: To assess the safety, efficacy, and pharmacokinetics of IGIV-SN in pediatric subjects with primary immunodeficiency humoral diseases (PHID)


Eligibility criteria: Inclusion Criteria:

* Pediatric subjects with a confirmed clinical diagnosis of a Primary Humoral Immunodeficiency Disease as defined by IUIS (International Union of Immunological Societies) and require treatment with IGIV. Documented agammaglobulinemia or hypogammaglobulinemia
* Subject is willing to comply with all requirements of protocol
* Authorization to access personal health information

Exclusion Criteria:

* Subject has secondary immunodeficiency
* Subject has a history of repeated reactions or hypersensitivity to IGIV or other injectable forms of IgG
* Subject has significant protein loss from enteropathy, nephrotic syndrome or lymphangiectasia

Primary outcomes:
measure: Efficacy: Incidence of Acute SBIs (Serious Bacterial Infections)
timeFrame: 13 months (12 months of treatment + 1 month of Follow-Up)
measure: Safety: Overall Incidence of AEs that occur during 72 hours of following an infusion of test drug
timeFrame: 13 months (12 months of treatment + 1 month of Follow-Up)
Secondary outcomes:
measure: Efficacy: Incidence of Infections other than acute serious bacterial infections
timeFrame: 13 months (12 months of treatment + 1 month of Follow-Up)
measure: Safety: The frequency of all AEs that occuring during the study
timeFrame: 13 months (12 months of treatment + 1 month of Follow-Up)
Other outcomes:
measure: PK Endpoint (1)
timeFrame: 13 months (12 months of treatment + 1 month of Follow-Up)
measure: PK Endpoint (2)
timeFrame: 13 months (12 months of treatment + 1 month of Follow-Up)
Locations:
Study officials:
affiliation: The Hospital for Sick Children
name: Chaim Roifman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03452410: MRIPositive Diagnosis of Vestibular Neuritis Using Fluid Attenuated Inversion Recuperation (FLAIR) Sequence on a 1.5 Tesla
Official title: Positive Diagnosis of Vestibular Neuritis Using Fluid Attenuated Inversion Recuperation (FLAIR) Sequence, One Hour After Intravenous Gadolinium Injection, on a 1.5 Tesla
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vestibular Neuritis
Keywords: Vestibular neuritis
Magnetic resonance imaging (MRI)
Vertigo
Fluid attenuated inversion recuperation (FLAIR)
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with typical unilateral vestibular neuritis during ENT examination with videonystagmograph

Brief summary: Our objective is to allow positive MRI diagnosis of vestibular neuritis by highlighting contrast enhancement of the vestibular nerve on the pathological side of the FLAIR sequence acquired 1h after intravenous gadolinium injection in patients with typical vestibular neuritis. At present, the diagnosis is based on a combination clinical examination / video-head impulse test, and no imaging examination allows the diagnosis to be positive.


Eligibility criteria: Inclusion Criteria:

* Age 18-80 years
* Presence of a typical unilateral vestibular neuritis during the ENT examination with videonystagmography
* Subject having his agreement for the use of his medical data for research purposes.

Exclusion Criteria:

* Special clinical forms of the disease: doubtful or atypical forms, especially the presence of deafness
* Treatments and related interfering diseases, antecedents: antecedents of neuritis for controls, presence of vertigo, bilateral involvement
* Impossibility to give the subject information enlightened (subject in emergency situation, difficulties of understanding the subject, ...)
* Subject under the protection of justice
* Subject under guardianship or curatorship

Primary outcomes:
measure: Diagnosis of vestibular neuritis
timeFrame: one hour after intravenous gadolinium injection
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Imagerie 1
Study officials:
References:
Clinical trial NCT02656810: A Comparison Study of PF708 and Forteo in Healthy Subjects
Official title: A Double-Masked, Randomized, Two-Treatment Cross-over Study Comparing the Pharmacokinetics of PF708 and Forteo Administered by Subcutaneous Injection in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Lead sponsor: Pfenex, Inc
Sponsor class: INDUSTRY
First posted: 2016-01-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pharmacokinetics (blood levels) of two teriparatide products, PF708 and Forteo, in healthy subjects.

Detailed description: This is a double-masked, randomized, two-treatment cross-over study in healthy adult subjects. Half of the subjects will be randomized to receive PF708 first and Forteo second (Sequence A), and the other half will be randomized to receive the drugs in reverse sequence (Sequence B),

Eligibility criteria: Inclusion Criteria:

* Male or female aged 18-50 years at the time of Informed Consent.
* Able to understand and sign the written Informed Consent Form (ICF).

Exclusion Criteria:

* History of or positive test result for human immunodeficiency virus (HIV), hepatitis C virus \[test for hepatitis C virus antibody (HCV Ab)\] or hepatitis B virus \[test for hepatitis B surface antigen (HBsAg)\].
* Female subjects who are pregnant or have a positive pregnancy test result, currently breastfeeding, or planning to become pregnant during the course of the study.
* Blood donation (greater than or equal to 500 mL) within 30 days prior to screening.
* History of Paget's disease of bone.
* History of prior external beam or implant radiation therapy involving the skeleton.
* Active urolithiasis or primary hyperparathyroidism.
* History of alcohol or substance abuse within 3 years prior to screening.
* Previous treatment, including for investigational purposes, with any products (e.g., Forteo, Natpara) derived from human parathyroid hormone (PTH).

Primary outcomes:
measure: Serum area-under-the-curve (AUC) of PF708 and Forteo
timeFrame: 24 hours
measure: Serum maximum concentration (Cmax) of PF708 and Forteo
timeFrame: 24 hours
Secondary outcomes:
measure: Change in serum calcium concentration after a single subcutaneous dose of PF708 and Forteo
timeFrame: 0-24 hours
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Covance Clinical Research Unit
state: Indiana
Study officials:
affiliation: Pfenex, Inc
name: Hubert C Chen, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06179810: Effect of Baduanjin Exercise on Metabolic Syndrome Patients
Official title: Effect of Baduanjin Exercise on Quality of Life in Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pre/posttest randomized control trial
Primary purpose: TREATMENT

Brief summary: Pre/posttest randomized control trial design.

In this study all patients will be randomly assigned into two groups (30 in each group) :

* Group A will do baduanjin exercise in addition to traditional medical treatment.
* Group B will take traditional medical treatment only.


Eligibility criteria: Inclusion Criteria:

* metabolic syndrome patients

Exclusion Criteria:

* patients with Respiratory diseases
* patients with pacemaker patients
* patients with Neurological diseases
* patients with orthopedic diseases

Primary outcomes:
measure: Fasting glucose level
timeFrame: 3 months
measure: Lipids profile
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Mohamed Abdelrahman Eldeeb
state: Qaliop Elbalad
Study officials:
References:
Clinical trial NCT01021410: Acetaminophen-Protein Adduct Resolution
Official title: Serum Acetaminophen-Cysteine (APAP-cys) Adduct Concentrations After 16 Days of Acetaminophen Dosing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acetaminophen-protein Adduct Formation
Keywords: acetaminophen
paracetamol
protein adduct
healthy volunteer
acetaminophen-protein adduct formation
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
First posted: 2009-11-30
Enrollment: 100
Sex: ALL
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: All subjects who have met completion criteria for COMIRB 06-1265 and were assigned to the acetaminophen treatment group for that study.

Brief summary: The purpose of this study is to better understand the pharmacokinetics of acetaminophen and further clinical interpretations of laboratory results that confirm the presence of acetaminophen-cys adducts. This study will determine how long adducts persist in serum after a therapeutic course of acetaminophen as taken in a previous study (COMIRB 06-1265). Subjects will be asked to complete three study visits, each three days apart, following termination of COMIRB 06-1265. Each study visit will include collection of blood samples for batch testing of aminotransferase, serum acetaminophen and protein adducts. No interventions are planned.


Eligibility criteria: Inclusion Criteria:

* Any subject randomized to the acetaminophen arm of COMIRB 06-1265 and meets completion criteria

Exclusion Criteria:

* Subjects who enter the extended dosing period in protocol 06-1265.
* Subjects who were randomized to placebo.

Primary outcomes:
measure: The primary outcome of the proposed study is to determine the proportion of subjects with acetaminophen-cys adduct concentrations above the limit of quantification at day 6 after stopping maximum acetaminophen dosing.
timeFrame: Day 6
Secondary outcomes:
measure: The secondary outcomes of the proposed study are the serum acetaminophen-cys adduct concentrations at 3, 6, 9 days after stopping maximum acetaminophen dosing of the COMIRB 06-1265 study.
timeFrame: Days 3, 6, 9
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital CTRC
state: Colorado
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
Study officials:
affiliation: Denver Health and Hospital Authority
name: Kennon Heard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05990010: OSA Prevalence in Atrial Fibrillation Patients: Jordanian Study
Official title: Prevalence of Obstructive Sleep Apnea Among Atrial Fibrillation Patients: A Cross-sectional Study From Jordan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Obstructive Sleep Apnea
Keywords: AF
OSA
berlin questionnaire
Lead sponsor: King Abdullah University Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 545
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had visited King Abdullah University Hospital cardiology clinics within the timeframe of (2017-2019).

Brief summary: Current Knowledge:

Countless studies have been conducted to study the relationship between OSA and AF, and a significant association has been established between both diseases, owing to the numerous shared risk factors and a wide variety of pathophysiological changes resulting from both diseases being relevant to each other. Our study inspects this relationship from a cardiovascular standpoint, examining the prevalence of OSA in existing AF patients, which could be interpreted as AF being a risk factor for OSA development.


Eligibility criteria: Inclusion Criteria:

* Age 21 or above

Exclusion Criteria:

* Unable to give research consent
* Patients who were unwilling to complete the questionnaires
* Patients who suffer from mental illness

Primary outcomes:
measure: The Berlin Questionnaire survey
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: King Abdullah University Hospital cardiology clinics
state: Ramtha
Study officials:
References:
Clinical trial NCT01731210: Clinical Evaluation Of The Nano Lv Lead System In Chronic Situation (LENEA)
Official title: Clinical Evaluation Of The Nano Lv Lead System In Chronic Situation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: LV Lead
LV Therapy
LV Treatment
LV Microcable
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: NANO LV lead
Primary purpose: TREATMENT

Brief summary: The LENEA study is an international, prospective, open label, non-randomized multicenter clinical research study designed to assess the safety and effectiveness of the NANO LV lead system.


Eligibility criteria: Inclusion Criteria:

* Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or life threatening ventricular tachyarrhythmia(s)
* Receiving a new implant OR undergoing an upgrade from an existing ICD or pacemaker implant with no prior implanted LV lead OR undergoing a new LV implant attempt consecutive to a recent LV lead placement failure not related to coronary sinus cannulation failure
* Patient receiving the PARADYM RF CRT or PARADYM RF CRT SONR devices
* Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

* Ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment;
* Incessant Ventricular tachyarrhythmias;
* Unstable angina, or acute MI , CABG , or PTCA within the past 4 weeks;
* Correctable valvular disease that is the primary cause of heart failure;
* Post heart transplant (patients who are waiting for a heart transplant are allowed in the study);
* Patient who had previously a permanently implanted LV lead;
* Concurrent implant with another pacemaker or ICD (previously implanted pacemaker or ICD devices should be removed prior to implant with the Paradym RF CRT-D or Paradym RF CRT SONR);
* Already included in another clinical study that could confound the results of this study;
* Life expectancy less than 1 year.

Primary outcomes:
measure: Freedom from left ventricular lead related complications through 1 month
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU Charles Nicolle
Study officials:
References:
Clinical trial NCT02051010: ABC Survey - do we Meet the Needs of Patients With Advanced Breast Cancer?
Official title: ABC Survey: Are we Meeting the Needs of Patients With Advanced Breast Cancer (ABC) in Ireland? A Nationwide Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2014-01-31
Enrollment: 500
Sex: FEMALE
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: All patients must have metastatic breast cancer

Brief summary: The study will follow a descriptive design involving a survey. Data collection will involve paper based questionnaires. The questionnaires have been developed in conjunction with breast cancer support groups associated with the Irish Cancer Society and patients.

Detailed description: The purpose of the study is to identify and categorise the need of Metastatic Breast Cancer (MBC) patients in Ireland with particular focus on; quality of life, symptom burden and access to and value of support available.

The study also aims to evaluate future service developments that will provide support to these patients.

Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Clinical diagnosis of MBC
* Female aged 18 years or older
* Able to complete the questionnaires independently

Exclusion Criteria:

* Any patient who does not meet the above mentioned inclusion criteria.

Primary outcomes:
measure: Needs of MBC patients in Ireland
timeFrame: Following analysis of the questionnaires completed by the patients, estimated 24 months
Secondary outcomes:
measure: Future service developments
timeFrame: Following analysis of the questionnaires completed by patients, estimated 24 months
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Bon Secours Hospital
city: Cork
country: Ireland
facility: Cork University Hospital
city: Cork
country: Ireland
facility: South Infirmary - Victoria University Hospital
city: Donegal
country: Ireland
facility: Letterkenny General Hospital
city: Dublin
country: Ireland
facility: Saint Vincent Universtiy Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital and Mater Private Hospital
city: Dublin
country: Ireland
facility: Saint James's Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Galway
country: Ireland
facility: Galway University Hospital
city: Kerry
country: Ireland
facility: Kerry General Hospital
city: Limerick
country: Ireland
facility: Midwestern Regional Hospital
city: Sligo
country: Ireland
facility: Sligo General Hospital
city: Waterford
country: Ireland
facility: Waterford Regional Hospital
Study officials:
References: