louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00991159: A Study To Access The Safety And Tolerability Of RN316 (PF-04950615) When Administered To Healthy Adult Subjects
Official title: A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Escalating, Intravenous Doses Of RN316 (PF-04950615) In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Endocrinology; Hypercholesterolemia; Hyperlipidemia; Lipid Metabolism Disorders RN316 PF-04950615
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-07
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is designed to determine the safety and tolerability of RN316 when administered intravenously to healthy adult subjects. This is the first time RN316 has been given to humans.


Eligibility criteria: Inclusion Criteria:

* Healthy, ambulatory men and women (of non-childbearing potential) ages 18 -70 inclusive.
* Baseline total cholesterol ≥ 200 mg/dl, baseline LDL ≥ 130 mg/dl.
* BMI 18.5 to 35, and body weight ≤150 kg, inclusive.

Exclusion Criteria:

* Evidence of clinically significant disease that may increase the risk to the subject of study participation or interfere with interpretation of results.
* Secondary hyperlipidemia.
* Subjects who have taken lipid lowering compounds within the past 12 months prior to dosing.

Primary outcomes:
measure: Safety and tolerability of single, escalating, intravenous infusions of RN316 administered to healthy adult subjects
timeFrame: Entire duration of study
Secondary outcomes:
measure: pharmacokinetics of RN316 in plasma after administration of single, escalating, intravenous infusions of RN316 to healthy adult subjects
timeFrame: Entire duration of study
measure: pharmacodynamic effect (lipid-lowering) of single, escalating, intravenous doses of RN316 administered to healthy adult subjects
timeFrame: Entire duration of study
measure: single dose immunogenicity
timeFrame: Entire duration of study
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Miami Gardens
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Udata C, Garzone PD, Gumbiner B, Joh T, Liang H, Liao KH, Williams JH, Meng X. A Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for Bococizumab, a Humanized Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, and Its Application in Early Clinical Development. J Clin Pharmacol. 2017 Jul;57(7):855-864. doi: 10.1002/jcph.867. Epub 2017 Feb 9.
Clinical trial NCT05602259: PROspective Trial on EOsinophilia in Non-Small Cell Lung Cancer (NSCLC).
Official title: PROspective Trial on EOsinophilia in Non-Small Cell Lung Cancer (NSCLC) (PROTEON).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Centre Hospitalier Universitaire de Liege
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 200
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: This prospective study will examine eosinophils in various biological materials to compare the detection in those materials and ascertain the prognostic and predictive role of eosinophils in untreated non-small cell lung cancer patient.


Eligibility criteria: Inclusion Criteria:

* o All stages of NSCLC

  * Stage III-IV NSCLC eligible for ICI treatment
  * 18 years or older; non pregnant women
  * in stage III-IV: no previous ICI and before ICI (mono- or combination therapy) initiation
  * Signed informed consent
  * Clinical, biological and radiological evaluation at the CHU de Liège for at least 6 months following treatment initiation

Exclusion Criteria:

* Probable noncompliance with the follow-up requirements of the study (psychiatric condition, socio-economic factors)
* Inclusion in a clinical study contraindicating the enrolment in the PROTEON study

Primary outcomes:
measure: Detection of eosinophils in untreated non-small cell lung cancer patients
timeFrame: Baseline (pre-treatment)
Secondary outcomes:
measure: Prognostic and predictive value of eosinophils in non-small cell lung cancer patients
timeFrame: Baseline (pre-treatment) and, if immunotherapy, after 3 months of treatment
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU de Liège
Study officials:
References:
Clinical trial NCT01391559: Efficacy of Inhaling Bronchodilator Medications in Chronic Obstructive Pulmonary Disease
Official title: Efficacy of Inhaling Bronchodilator Medications in Patients With Chronic Obstructive Pulmonary Disease Who Have a Low Peak Inspiratory Flow Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: breathing difficulty
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Sumitomo Pharma America, Inc.
First posted: 2011-07-12
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Some patients with Chronic Obstructive Pulmonary Disease (COPD) report that they are uncertain whether they achieve clinical benefit using a dry-powder inhaler (DPI). One possible explanation is that the patient is unable to inhale the dry powder bronchodilator medication into the lower respiratory tract due to a low peak inspiratory flow rate (PIFR). A PIFR \< 60 l/min is considered to be suboptimal flow for a DPI, including the Diskus device. The hypothesis of the study is that the forced expiratory volume in 1 second (FEV1) measured at two hours after inhalation of the study medication will be higher with arformoterol solution (15 mcg) from a nebulizer compared with salmeterol dry powder (50 mcg) inhaled from the Diskus.


Eligibility criteria: Inclusion Criteria:

* male or female patient 60 years of age or older; diagnosis of COPD; current or former smoker; previous or current use of Diskus device; PIFR \< 60 l/min using the In-check DIAL against the resistance of the Diskus device; clinically stable.

Exclusion Criteria:

* any patient who has a concomitant disease that might interfere with study procedures or evaluation; inability to withhold short-acting and long-acting bronchodilators on the days of testing

Primary outcomes:
measure: Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline at Two Hours After Inhalation of the Study Medication
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Donald A Mahler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Janssens W, VandenBrande P, Hardeman E, De Langhe E, Philps T, Troosters T, Decramer M. Inspiratory flow rates at different levels of resistance in elderly COPD patients. Eur Respir J. 2008 Jan;31(1):78-83. doi: 10.1183/09031936.00024807. Epub 2007 Sep 26.
citation: Mahler DA, Waterman LA, Ward J, Gifford AH. Comparison of dry powder versus nebulized beta-agonist in patients with COPD who have suboptimal peak inspiratory flow rate. J Aerosol Med Pulm Drug Deliv. 2014 Apr;27(2):103-9. doi: 10.1089/jamp.2013.1038. Epub 2013 Jun 8.
Clinical trial NCT04416659: Flow Arrest Safety and Technical Success With Balloon Guide Catheters
Official title: Flow Arrest Safety and Technical Success With Balloon Guide Catheters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 52
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 acute ischemic stroke

Brief summary: The objective of this post-market registry is to assess technical efficacy and safety associated with the use of the BOSS Balloon Guide Catheter during neuro-vascular procedures while providing temporary arrest of blood flow.

Detailed description: This is a prospective, multi-center, non-randomized observational registry evaluating use of BOSS balloon guide catheters in patients diagnosed with an acute ischemic stroke due to large intracranial vessel occlusion.

Eligibility criteria: Inclusion Criteria:

* Acute ischemic stroke vessel occlusion (ICA, M1 or M2) of the anterior circulation with associated symptoms
* Adult patient willing to provide Informed Consent
* Pre-treatment National Institutes of Health Stroke Scale (NIHSS) ≥ 6

Exclusion Criteria:

* Posterior circulation stroke
* Tandem occlusions
* Cervical carotid stenosis
* Participating in another clinical trial

Primary outcomes:
measure: Safety Evaluation
timeFrame: Hospital discharge or 7 days
measure: Performance Evaluation
timeFrame: Completion of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: BNI (St. Joseph's Hospital-Dignity Health)
state: Arizona
city: Englewood
country: United States
facility: Swedish-RIACO
state: Colorado
city: Jacksonville
country: United States
facility: Baptist Health Jacksonville
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Kansas City
country: United States
facility: KUMC
state: Kansas
city: Worcester
country: United States
facility: UMass Medical School
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Knoxville
country: United States
facility: Ft Sanders Regional Medical Center
state: Tennessee
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Biraj Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03047759: Comparison of Two Interdental Cleaners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Lead sponsor: All Sum Research Center Ltd.
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 70
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparison of Two interdental cleaning devices on plaque removal, gingivitis and bleeding.

Detailed description: This study measured plaque accumulation, bleeding on probing and gingivitis using the Rustogi Modification of the Navy Plaque Index, BOP and Modified Gingival Index at baseline, 2-weeks and 4-weeks.

Eligibility criteria: Inclusion Criteria:

* Healthy adult
* Non smoker
* Available for 4-weeks
* Able to provide written informed consent.
* Minimum of 20 natural teeth.
* Minimum requirement for plaque, gingivitis and bleeding.

Exclusion Criteria:

* Medical condition
* No antibiotics within 6 months of study start
* Not on any medication (impact oral health).

Primary outcomes:
measure: Bleeding upon probing
timeFrame: 4 weeks
Secondary outcomes:
measure: Gingivitis
timeFrame: 4 weeks
measure: Plaque
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03501459: Lymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome
Official title: Lymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Nephrotic Syndrome
Lead sponsor: National University Health System, Singapore
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
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 investigate if lymphocyte markers predict response to rituximab among patients with idiopathic nephrotic syndrome


Eligibility criteria: Inclusion Criteria:

* Age 1-18 years old at the time of diagnosis of nephrotic syndrome
* Steroid-dependent (SDNS) or steroid-resistant nephrotic syndrome (SDNS)

Exclusion Criteria:

* eGFR \<60 ml/min per 1.73m2
* infantile onset of nephrotic syndrome
* nephrotic syndrome secondary to chronic infections such as hepatitis B, hepatitis C or human immunodeficiency virus, systemic lupus erythematosus, Henoch-Schönlein purpura, IgA nephropathy, membranoproliferative glomerulonephritis or membranous nephropathy
* current or previous therapy for tuberculosis
* presence of mutations in WT1, NPHS1, NPHS2 and TRPC6.

Primary outcomes:
measure: Response
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
Clinical trial NCT04150159: Evaluation of a Fasting Mimicking Diet
Official title: Evaluation of a Fasting Mimicking Diet and the Effect on Endothelial Function, Body Composition and Vascular Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Hypertension Institute, Nashville
Sponsor class: OTHER
Collaborators: name: L-Nutra Inc
First posted: 2019-11-04
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, open-label, 7-month trial in eighty (80) adult subjects. Forty (40) subjects will be randomized to the intervention FMD arm with a 5 day meal program every month for four (4) months. Forty subjects will be randomized to a follow a Mediterranean diet plan for four months.
Primary purpose: PREVENTION

Brief summary: Randomized, open-label, 7-month trial in eighty (80) adult subjects. Forty (40) subjects will be randomized to the intervention FMD arm with a 5 day meal program every month for four (4) months. Forty subjects will be randomized to a follow a Mediterranean diet plan for four months. Both arms will have a final study visit at month 7.

Detailed description: Determine the effects of the FMD on cardiovascular (CV) biomarkers, coronary heart disease (CHD) risk factors (body weight, body mass index (BMI), body composition, blood pressure, serum lipid levels and dysglycemia blood measurements), noninvasive cardiovascular testing for endothelial function, arterial stiffness of large and small arteries and autonomic function testing in adult subjects over a seven-month study period.

Eligibility criteria: Inclusion Criteria:

* Body mass index equal to or greater than 28
* EndoPAT® Score for endothelial function of less than or equal to 2.0 or AC 2 small resistance artery compliance by computerized arterial pulse wave analysis (CAPWA) of less than or equal to 5.0.
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Individuals who are allergic to tree nuts (macadamia, cashew, almond, pecan), soy, oats, sesame, or celery/celeriac
* Pregnant females
* Any cancer within the past 5 years
* Documented myocardial infarction within past 5 years
* Documented cerebrovascular accident within past 5 years
* Chronic steroid use (longer than 45 consecutive days
* Type I insulin-dependent diabetes mellitus

Primary outcomes:
measure: Change from Baseline to End of Study in endothelial function
timeFrame: 7 months
Secondary outcomes:
measure: Change from Baseline to End of Study in cardiovascular biomarkers
timeFrame: 7 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Hypertension Institute
state: Tennessee
Study officials:
References:
Clinical trial NCT03097159: Comparison of Costoclavicular Brachial Plexus Block and Supraclavicular Brachial Plexus Block
Official title: Comparison of Costoclavicular Brachial Plexus Block and Supraclavicular Brachial Plexus Block
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Phrenic Nerve Paralysis
Keywords: costoclavicular block
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for surgery of hand or forearm

Brief summary: The investigator will compare Costoclavicular approach of infraclavicular block and supraclavicular block. Especially, the incidence of phrenic nerve palsy and the quality of block.

Detailed description: Costoclavicular brachial plexus block is a recently developed approach of infraclavicular brachial plexus block. Using ultrasound, all of 3 cords are well visible in single plane. Compared to conventional infraclavicular block, it needs smaller amount of local anesthetics.

Supraclavicular brachial plexus block is known as spinal anesthesia of upper extremities. It provides fast and good quality of anesthesia and analgesia. But some studies showed that there are over 50% of phrenic nerve palsy in supraclavicular block.

In this study, the investigator will compare phrenic nerve palsy incidence and block quality between Costoclavicular block and supraclavicular block using ultrasound.

Eligibility criteria: Inclusion Criteria:

* ASA I or II
* Scheduled for surgery of hand or forearm

Exclusion Criteria:

* Patient refusal
* Neuromuscular disease
* Pregnancy
* Previous history of surgery of periclavicular region
* Nerve injury history
* Bleeding tendency
* Allergy to local anesthetics
* Other contraindication of regional anesthesia

Primary outcomes:
measure: Diaphragm palsy
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou university school of medicine
state: Gyeonggi-do
Study officials:
affiliation: Ajou University School of Medicine
name: In Kyong Yi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06089200: TAP Block vs Spinal Orphine for Postoperative Caesarean Section Analgetics
Official title: Comparison of Post-operative Analgetics With Transversus Abdominis Block and Spinal Morphine for Post-Caesarean Section: A Randomised Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post Operative Pain
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled trial is to compare the effect of TAP block vs spinal morphine for post caesarean section analgesics. The main questions it aims to answer are:

* Which post op analgesic method works better for patients who underwent caesarean section
* The number of additional opioid needed


Eligibility criteria: Inclusion Criteria:

* Indicated for caesarean section as assessed by Obstetricians
* ASA II
* Consented to be included in the study

Exclusion Criteria:

* Allergy history
* Spinal converted to general anesthesia

Primary outcomes:
measure: Length of time the patient needed the first additional opioid analgesics
timeFrame: 24 hours post operative
measure: Total need for additional opioids
timeFrame: 24 hours post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Hasan Sadikin General Hospital
state: Jawa Barat
Study officials:
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Mohammad F Maulana, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Suwarman, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Osmond M Pison, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Prapanca Nugraha, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00972400: Fatigue in Breast Cancer Survivors
Official title: Biological Mechanisms of Fatigue in Breast Cancer Survivors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Cancer Survivor
Fatigue
Psychosocial Effects of Cancer and Its Treatment
Keywords: psychosocial effects of cancer and its treatment
fatigue
cancer survivor
breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-09-04
Enrollment: 96
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: Gathering information over time from blood samples and measurements of activity, sleep, mood, and cognition may help doctors learn more about fatigue in breast cancer survivors and plan the best treatment.

PURPOSE: This clinical trial is studying fatigue in breast cancer survivors.

Detailed description: OBJECTIVES:

* To investigate the relationship between fatigue severity; protein biomarkers; and measures of activity, sleep, mood, and cognition in breast cancer survivors.
* To identify and quantify serum biomarkers and underlying biological pathways unique to cancer-related fatigue syndrome in these survivors.
* To map changes over time in order to explore the inter-relationships between these variables.

OUTLINE: Participants undergo fatigue assessment by the Diagnostic Interview for Cancer Related Fatigue and the FACT-Fatigue questionnaire; psychological symptoms assessment by the Structured Clinical Interview for DSM-IV, Hospital Anxiety and Depression Scale, and the Insomnia Severity Index questionnaires; and quality of life assessment by the EORTC-QLQc30 and EORTC-QLQ-BR23 questionnaires twice approximately 3 months apart.

Participants also undergo activity level, circadian rhythm, and sleep measurements by the Micro-mini® Motionlogger actigraphy and measurement of cognitive disturbances by the Cantabeclipse™ technology.

Participants undergo blood sample collection for protein analysis by 2D gel electrophoresis and mass spectrometry.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Disease-free breast cancer survivors between 3 months and 2 years after completion of primary treatment
* Recruited from the nurse-led breast cancer follow-up clinic at St George's Hospital

PATIENT CHARACTERISTICS:

* Sufficient English language skills
* No significant cognitive impairment
* No concurrent severe combined immunodeficiency disease

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Relationship between fatigue severity; protein biomarkers; and measures of activity, sleep, mood, and cognition
measure: Identification and quantification of serum biomarkers underlying biological pathways unique to cancer-related fatigue syndrome
measure: Inter-relationships between variables
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St. Georges, University of London
state: England
Study officials:
affiliation: St George's, University of London
name: Ollie Minton, MD
role: PRINCIPAL_INVESTIGATOR
References: