louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02904135: Collection of Circulating Tumor Cells From the Peripheral Blood of Metastatic Breast Cancer Patients
Official title: Collection of Circulating Tumor Cells From the Peripheral Blood of Metastatic Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Circulating Tumor Cells (CTCs)
Keywords: Circulating Tumor Cells
Lead sponsor: MiCareo Taiwan Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-09-16
Enrollment: 141
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: metastatic breast cancer (mBC) patients

Brief summary: To address the challenges of isolating and analyzing rare cells, this study aims to validate the instrumentation, the test protocols, and the analysis of patient's outcome to show the instrument's capability to reproducibly and accurately detect CTCs in cancer patients. In order to facilitate the validation process, investigators will only focus on metastatic patients for whom CTCs supposedly present at higher abundance. Investigators propose to enroll cohorts of metastatic breast cancer patients. Blood samples will be collected from these patients before they start any new line of therapy as determined by their doctors. The specific aims are to isolate, enumerate and analyze the number and/or molecular information of circulating tumor cells in patient blood using microfluidic chip-based sorting, imaging, and molecular profiling techniques. Investigators will use this study to optimize diagnostic instrumentation, test blood processing protocols and CTC analysis algorithm. During this study investigators will collect patients' clinical information related to cancer, as well as the patients' survival status to validate the system's prognosis ability.


Eligibility criteria: Inclusion Criteria:

1. Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
2. Progressive and measurable metastatic breast cancer.
3. Commencement of new anti-cancer chemotherapy or palliative care.
4. ECOG performance status equal or less than grade 2.

Exclusion Criteria:

1. Subject has received any investigational agent, not explicitly approved by MiCareo, within last one year.
2. Subject being identified with any blood borne infectious disease.
3. Subject has received anticancer chemotherapy within last one month. (not including hormone therapy, or target therapy)
4. Pregnancy.

Primary outcomes:
measure: Overall survival(OS)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Keelung City
country: Taiwan
facility: Keelung Chang Gung Memorial Hospital
Study officials:
affiliation: CEO
name: Chen Jui-Lin
role: STUDY_DIRECTOR
References:
Clinical trial NCT05389735: Evaluation of Postoperative Ventilation Distribution With Electrical Impedance Tomography
Official title: Evaluation of Ventilation Distribution With Electrical Impedance Tomography in Mechanically Ventilated Patients After Surgery: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Electrical Impedance Tomography
Lead sponsor: Osaka University
Sponsor class: OTHER
Collaborators: name: Nihon Kohden
First posted: 2022-05-25
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: postoperative patients

Brief summary: Postoperative patients require respiratory management . It is known that the intrapulmonary ventilation distribution becomes uneven due to dorsal atelectasis and ventral hyperinflation during mechanical ventilation management, but the incidence in postoperative patients is unknown. EIT is a device that can monitor the ventilation distribution in the lungs over time without being exposed to the bedside. Therefore, for patients at risk of postoperative respiratory complications, use EIT to 1) evaluate the pulmonary ventilation distribution during postoperative ventilation management, 2) pulmonary ventilation distribution and postoperative respiratory organs. The purpose of this study is to clarify the relationship with the severity of complications.

A prospective observational study to investigate the relationship between ventilation distribution and prognosis using EIT in patients undergoing mechanical ventilation after adult surgery.


Eligibility criteria: 1. Patients aged 18 years or older who have undergone surgery
2. Patients undergoing mechanical ventilation management when returning to the ICU after surgery
3. High-risk patients with postoperative respiratory complications

Exclusion Criteria:

1. the EIT belt is worn Patients with unstable spine or pelvis due to fractures, etc. Patients with implantable defibrillation and implantable pacemaker Patients with skin lesions such as blisters between the 4th and 5th intercostal spaces where
2. Patients with DNR (do-not-resuscitate)
3. Patients undergoing home ventilator management before surgery
4. Preoperative, hypocardiac function patients (echocardiography shows left ventricular ejection fraction of 40% or less, or NYHA III degree or more +)
5. Patients with a ventricular assist device
6. Patients with extracorporeal membrane oxygenation (VV or VA)
7. History of neuromuscular disease

Primary outcomes:
measure: Association the dorsal fraction of ventilation in EIT and postoperative respiratory complication score
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Department of Anesthesiology and Intensive Care Medicine, Osaka University
Study officials:
References:
Clinical trial NCT01552135: Pilot Study - Putative Penetration of Nanoparticles in Sunscreen in Intact or Sunburned Skin
Official title: Pilot Study - Does Nanoparticles in Sunscreen Penetrate Intact or Sunburned Skin?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Skin
Sunburned Skin
Titanium Dioxide
Nanoparticles
Penetrate Skin
Keywords: titanium dioxide
nanoparticles
skin
penetrate
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Occupational Health, Norway
name: University Hospital of North Norway
First posted: 2012-03-13
Enrollment: 2
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 2 healthy males older than 50 years

Brief summary: The investigators want to study if nanoparticles of titaniumdioxide are penetrating skin when the skin is intact and when the skin is sunburned. The hypothesis is "Does nanotitandioxide penetrate intact or sunburned skin?"

Detailed description: In this pilotstudy there are two human volunteers. The study comprises two phases. The first phase: The volunteers are applying a commercially available sunscreen lotion containing titanium dioxide nano particles 6 times a day for one week in an area of the back that is 30x20 cm. Before the first application a 2mm punch biopsy is to be taken and examined by scanning electron microscopy. After applying sunscreen lotion for a week, a new biopsy will be taken in order to see how far down in the skin the particles have penetrated. In the second phase: An artificial sunburn will be induced in the same area of the back. They will thereafter apply the sunscreen lotion 6 times a day like in the first phase. After two days (estimated time of maximum skin irritation) a biopsy will be taken in order to see if the nanoparticles have penetrated down in the layers of the skin, and the investigators will also take a biopsy after a full week of applying the sunscreen lotion. The investigators will also examine the urine, before and after the use of sunscreen, to see if the investigators can find the particles there.

Eligibility criteria: Inclusion Criteria:

* Healthy men above 50 years old

Primary outcomes:
measure: Depth of penetration of nano particles in skin
timeFrame: One Week
Secondary outcomes:
measure: Occurrence of nano particles in urine
timeFrame: Two weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Dept. of Environmental and Occupational Medicine
Study officials:
affiliation: University Hospital of North Norway
name: Marit Gulbrandsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Jan-Oivind Holm, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Occupational Health, Norway
name: Vidar Skaug, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Elise Naess, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01819935: Clinical Outcomes of Methicillin Resistant Staphylococcus Aureus (MRSA) Hospital-Based Pneumonia
Official title: Clinical Outcomes Among a National Veterans Affairs Methicillin Resistant Staphylococcus Aureus (MRSA) Pneumonia Cohort Treated With Linezolid Or Vancomycin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Keywords: MRSA. pneumonia
outcomes
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-03-28
Enrollment: 5271
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: National database of inpatient admissions between January 1, 2002 and Septmeber 30, 2010

Brief summary: The purpose of this non-interventional, retrospective study of existing data is to evaluate clinical outcomes related to Methicillin-resistant Staphylococcus aureus hospital based pneumonia by treatment and among subpopulations.

Detailed description: All patients meeting inclusion/exclusion criteria from inpatient database from 1/1/02-9/30/10.

Eligibility criteria: Inclusion Criteria:

* MRSA and pneumonia cases by ICD-9 code identification.
* Diagnosis included during inpatient stay.
* Treatment initiation in hospital.

Exclusion Criteria:

* Death of discharge within 3 days of treatment initiation.
* Exposure to other treatments with MRSA activity.

Primary outcomes:
measure: Time to 30-day Mortality
timeFrame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Secondary outcomes:
measure: Time to Therapy Change
timeFrame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
measure: Time to Discharge From the Hospital
timeFrame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
measure: Time to Transfer Out From the Intensive Care Unit (ICU)
timeFrame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
measure: Time to Intubation
timeFrame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
measure: Time to 30-day Re-admission
timeFrame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
measure: Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection
timeFrame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
measure: Clinical Success
timeFrame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04494035: AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System
Official title: AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arteriovenous Graft Thrombosis
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2020-07-31
Enrollment: 7
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 prospective, single-arm, non-blinded study, intending to treat and collect and evaluate data in up to ten (10) human subjects who are currently being treated with hemodialysis and who present with acute thrombosis in their arteriovenous (AV) grafts, treated with the CAPERE® Thrombectomy System.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: A prospective, single-arm, non-blinded study, intending to treat and collect and evaluate data in up to ten (10) human subjects who are currently being treated with hemodialysis and who present with acute thrombosis in their arteriovenous (AV) grafts, treated with the CAPERE® Thrombectomy System.


Eligibility criteria: Inclusion Criteria:

* Dialysis patients who are ≥ 18 years of age
* Dialysis patients with clinical signs, symptoms and presentation consistent with acute thrombosis; onset of symptoms ≤ 14 days

Exclusion Criteria:

* Dialysis patients who are ≤ 18 years of age.
* Grafts with aneurysmal degeneration
* Central venous occlusion
* Patients with infection of the vascular access
* Patients with active cancer under current therapy, myeloproliferative syndromes, hyperhomocysteinemia, and heparin-induced thrombocytopenia.
* Patients with pulmonary embolism (PE) with hemodynamic compromise
* Any contraindication to systemic or therapeutic doses of heparin or anticoagulants
* Known anaphylactic reaction of radiographic contrast agents that cannot be pre- treated
* Imaging evidence or other evidence that suggests the participant is not appropriate for mechanical thrombectomy intervention (e.g. recent access site creation where there are concerns of leak or disruption of the suture line)
* Female who is pregnant or nursing
* Concurrent participation in another investigational drug or device treatment study

Primary outcomes:
measure: Primary Endpoint (Effectiveness)
timeFrame: Intraoperative
measure: Safety Evaluation
timeFrame: 24 Hours
Secondary outcomes:
measure: Device Safety
timeFrame: Intraoperative
measure: Technical Success
timeFrame: Intraoperative
measure: Thrombus Removal Rate
timeFrame: Post-procedure
measure: 30-Day Patency Rate
timeFrame: 30-days
measure: Clinical Success
timeFrame: Open
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network Toronto General
state: Ontario
Study officials:
affiliation: University Health Network Toronto General
name: Sebastian Mafeld, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04066335: Study to Evaluate the Safety of Nanoxel M Inj.
Official title: An Observational Study to Evaluate the Safety of Nanoxel M (Docetaxel-PM) Inj.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Non-small Cell Lung Cancer
Prostate Cancer
Ovarian Cancer
Head and Neck Cancer
Gastric Cancer
Esophageal Cancer
Keywords: Observational Study, Safety, Nanoxel M, Docetaxel
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2019-08-26
Enrollment: 1498
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 who are assessed as adequate to administer Nanoxel M inj.

Brief summary: Study to evaluate the safety of Nanoxel M inj. administration in patients.

Detailed description: This is a multi-center, prospective observational study to observe the incidence of adverse events under actual clinical settings to test the safety of Nanoxel-M inj. administration in patients with breast cancer, non-small cell lung cancer, prostate cancer, ovarian cancer, head \& neck cancer, gastric cancer or esophageal cancer.

Eligibility criteria: Inclusion Criteria:

1. Adults ≥18 years old
2. Patients who have signed written consent form prior to participating in the clinical trial
3. Patients who are assessed as adequate to administer Nanoxel M injection.

Exclusion Criteria:

1) Patients who have shown severe hypersensitivity to Docetaxel and concomitant drugs

Primary outcomes:
measure: Safety of Nanoxel M inj.
timeFrame: through study completion, an average of 6cycles(each cycle is 3weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samyang Biopharmaceuticals
Study officials:
References:
Clinical trial NCT01184235: Multidimensional Measurement of Psychopharmacological Treatment Response
Official title: Actigraphic, Observational, Psychometric and Biological Measurement of Psychopharmacological Treatment Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorders
Mood Disorders
Sleep Disorders
Attention Deficit Disorders
Keywords: Circadian Disorders
Autism Spectrum Disorders
Mood Disorders
Executive Functioning
Pediatric Mood Disorders
Lead sponsor: Child Psychopharmacology Institute
Sponsor class: OTHER
First posted: 2010-08-18
Enrollment: 44
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adults, male or female receiving or anticipating pharmacological intervention and their non-affected first degree relatives will be invited to participate based on institutional actiwatch availability. Since children are the focus of the Child Psychopharmacology Institute they will be the primary recruitment focus, however, adult subjects may include non-affected first degree relatives or others who represent designated cohort groups and will be accepted based on actiwatch availabilty.

Brief summary: The study examines actigraphic, observational, psychometric and associated repeated measurements obtained prior to and during psychopharmacological treatment.

Detailed description: Baseline actigraphic measurements, multi-symptom operationally defined observations and psychometric data will be established and repeated to measure treatment response. Additional biological and biometric measures that have potential to further characterize the cohorts under study or treatment response will be collected as practical and when possible.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of:
* Autism Spectrum Disorder
* Mood Disorder
* Attention Deficit Hyperactivity Disorder
* Unaffected First Degree Relative of Study Subject
* Anticipation of pharmacological intervention or current pharmacological intervention

Exclusion Criteria:

Inability to wear an actigraphy watch

Primary outcomes:
measure: Actigraphic Measurement
timeFrame: Three week actigraphic measurement periods
Secondary outcomes:
measure: Operationally Defined Observations
timeFrame: Randomly repeated treatment course observational measurements during actigraphic measurement periods
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Child Psychopharmacology Institute
state: North Dakota
Study officials:
affiliation: Child Psychopharmacology Institute
name: Bill J Duke, M.A., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Child Psychopharmacology Institute
name: Robert D Staton, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: B. Duke and D. Staton,
Clinical trial NCT06555835: Effect of Flexibility on Postural Stability
Official title: Effect of Lower Extremity Flexibility on Postural Stability
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
Collaborators: name: Atlas University
First posted: 2024-08-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will consist of healthy young adults who meet inclusion criteria.

Brief summary: Postural stability has an important role for functional movements, injury prevention and the performance of many athletic skills. Therefore, it is very important to understand the factors that affect postural stability. The aim of this study is to investigate the effect of lower extremity flexibility on postural stability in healthy individuals.

Detailed description: Postural stability provides the relationship between the body's center of gravity and the base of support using somatosensory information. Postural stability is a very important determinant for functional movements. It is known that postural stability plays an important role in the performance of many sports skills, protection from injuries and daily life activities. Therefore, it is very important to understand the factors affecting postural stability well.

Joint range of motion, muscle strength and flexibility are among the factors affecting postural stability. Hip, knee and ankle joint movements controlled along the kinetic chain are important in providing postural stability. The aim of the study is to evaluate the effect of lower extremity flexibility on dynamic postural stability in healthy individuals. Healthy volunteers between the ages of 18-25 will be included in the study and flexibility and postural stability assessments will be performed.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-25
* Volunteering to participate in the study

Exclusion Criteria:

* Having a diagnosis of neurological, orthopedic, vestibular, rheumatological disorder
* Having a history of musculoskeletal injury or surgery within the last year
* Participating in a regular exercise program

Primary outcomes:
measure: Passive straight leg raise test
timeFrame: Baseline
measure: Passive ankle dorsiflexion range of motion
timeFrame: Baseline
measure: Postural stability
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Vakif University
name: Kubra Alpay, PhD
role: PRINCIPAL_INVESTIGATOR
References: