louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04780815: An Exploratory PET-study of Deposition, Disposition and Brain Uptake of [11C]Nicotine After Inhalation of 2 Nicotine Formulations Via the myBluTM E-cigarette in Smokers
Official title: An Exploratory PET-study of Deposition, Disposition and Brain Uptake of [11C]Nicotine After Inhalation of 2 Nicotine Formulations Via the myBluTM E-cigarette in Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Imperial Brands PLC
Sponsor class: INDUSTRY
Collaborators: name: Nerudia Ltd
First posted: 2021-03-04
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a single-center, exploratory positron emission tomography (PET) study of deposition, disposition and brain uptake \[11C\]nicotine when given to smokers as two different formulations via mybluTM e-cigarette system.


Eligibility criteria: Inclusion Criteria:

* Body mass index ≥18.0 and ≤ 30.0 kg/m2
* Habitual daily cigarette smoker
* Women have to be of non-child bearing potential

Exclusion Criteria:

* History of any clinically significant disease
* Relevant concomitant medication
* Any clinically significant condition
* Malignancy within the past 5 years
* Positif for HIV, hepatitis B or C
* Untreated hypertension
* Previous participation to a PET-study or other nuclide medical study
* Previous exposure to significant radiation
* Negative results of the modified Allen test on both arms at screening
* Alcohol or drug abuse

Primary outcomes:
measure: Lung PET
timeFrame: 40 minutes
measure: Oral Cavity PET
timeFrame: 40 minutes
measure: Brain PET
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: PET Centre, Uppsala University Hospital
Study officials:
References:
Clinical trial NCT02288715: Relationship of Cerebral Perfusion Pressure Variability to Sepsis-associated Encephalopathy
Official title: Relationship of Cerebral Perfusion Pressure Variability to Sepsis-associated Encephalopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: cerebral perfusion pressure
septic encephalopathy
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients admit to the general ICU of an academic teaching hospital

Brief summary: The purpose of the study is to evaluate whether variability of CPP (cerebral perfusion pressure) is related to sepsis-associated encephalopathy and outcomes of patients with sepsis.

Detailed description: Encephalopathy is a common complication of sepsis, impaired cerebrovascular autoregulation (AR) in patients with sepsis is considered related to Sepsis-associated encephalopathy (SAE). As AR is important in stabilizing the cerebral perfusion pressure, whether greater variability of CPP is related to SAE and mortality or not remains unclear. We conduct this study to evaluate the relationship between them.

Eligibility criteria: Inclusion Criteria:

* clinical symptoms of sepsis, severe sepsis and septic shock
* age over 18 years

Exclusion Criteria:

* preexisting Neurological diseases
* traumatic brain injury
* intracranial infectious disease
* severe hepatic or renal dysfunction
* ICU discharge Within 72 hours
* pregnancy

Primary outcomes:
measure: relationship between cerebral perfusion pressure variability and sepsis-associated encephalopathy
timeFrame: cerebral perfusion pressure is assessed up to 72 hours
Secondary outcomes:
measure: Duration of mechanical ventilation
timeFrame: All the participants will be followed up until discharge or death, assessed up to 24 months
measure: Time of ICU stay
timeFrame: All the participants will be followed up until discharge or death, assessed up to 24 months
measure: Time of hospital stay
timeFrame: All the participants will be followed up until discharge or death, assessed up to 24 months
measure: 90-day mortality rate
timeFrame: All the participants will be followed up until 90 days after their enrollment or death
measure: 1-year mortality rate
timeFrame: All the participants will be followed up until 1 year after their enrollment or death
measure: 2-year mortality rate
timeFrame: All the participants will be followed up until 2 years after their enrollment or death
measure: 1-year quality of life of survivors
timeFrame: All the participants will be followed up until 1 year after their enrollment or death
measure: 2-year quality of life of survivors
timeFrame: All the participants will be followed up until 2 year after their enrollment or death
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Kang Yan
state: Sichuan
Study officials:
References:
Clinical trial NCT04389515: Postoperative Recovery Index, Patient Expectations and Satisfaction With Prenatal Care Instrument in Pregnant Patients With COVID-19
Official title: Evaluation of Pregnant Women Diagnosed With COVID-19 With "Post-operative Recovery Index" and "Prenatal Care Satisfaction and Patient Expectations Scale"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Prenatal Care
Postoperative Care
Keywords: COVID-19
Prenatal Care
Postoperative Care
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As the patient group, two groups of 75 persons, each of whom are between the ages of 18-45 and who are diagnosed with COVID-19 in reproductive age and healthy pregnant women, will be selected. Patients diagnosed with COVID-19 giving birth with cesarean at term and patients who are followed up with COVID-19 diagnosis before the prenatal period will be selected.

Brief summary: The aim of this study is to provide optimum care to postoperative patients diagnosed with COVID-19 (after cesarean) and to help them with recovery, to determine and assist the expectation and satisfaction of pregnant women with COVID-19 regarding prenatal care.


Eligibility criteria: Inclusion Criteria:

* Pregnant patients with COVID-19

Exclusion Criteria:

* Patient giving Preterm Labor

Primary outcomes:
measure: Evaluation of pregnant women diagnosed with COVID-19 with "Post-operative Recovery Index" and "Prenatal Care Satisfaction and Patient Expectations Scale"
timeFrame: 3 Months
Secondary outcomes:
measure: Evaluation of pregnant women diagnosed with COVID-19 with "Post-operative Recovery Index" and "Prenatal Care Satisfaction and Patient Expectations Scale"
timeFrame: 3 Months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
state: Halkali
Study officials:
References:
citation: Omar MA, Schiffman RF, Bingham CR. Development and testing of the patient expectations and satisfaction with prenatal care instrument. Res Nurs Health. 2001 Jun;24(3):218-29. doi: 10.1002/nur.1024.
citation: Cengiz H, Aygin D. Validity and reliability study of the Turkish version of the Postoperative Recovery Index of patients undergoing surgical intervention. Turk J Med Sci. 2019 Apr 18;49(2):566-573. doi: 10.3906/sag-1806-33.
Clinical trial NCT02930915: Acquisition of 3D Facial Geometry of Patients' Scheduled for Radiotherapy Treatment
Official title: Feasibility Study: Acquisition of Three Dimensional Facial Geometry of Patients' Scheduled for Head and Neck Radiotherapy Treatment.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer
Radiotherapy
Lead sponsor: University of East Anglia
Sponsor class: OTHER
Collaborators: name: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
First posted: 2016-10-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort of patients who have a Head-and-neck cancer and receiving radiotherapy treatments in the Norfolk and Norwich University Hospital.

Brief summary: This study investigates the feasibility of using 3D-Printing to manufacture masks used to immobilize patients undergoing radiotherapy treatment for tumors affecting the head and neck.

Detailed description: The current types of masks that are used in radiotherapy treatment sessions for those patients who have head-and-neck cancer are 'made to measure' and the methods currently employed to make them are invasive and in some cases patients' have found this to be particularly unpleasant. Their experience motivates research into less invasive and potentially more accurate techniques for their manufacture.

To effectively develop an automatic manufacturing pipeline, and to assess the accuracy of the approach we need access to CT data from a cohort of patients for which we also have an accurate (ground truth) 3D facial model. Such a model can be acquired in a few minutes using a hand-held laser scanner.

Eligibility criteria: Inclusion Criteria:

* Have a Head-and-neck cancer
* Receiving radiotherapy treatments (CT images)

Exclusion Criteria:

* Children (age less than 18)

Primary outcomes:
measure: 3D facial geometry of patient's head
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: School of Computing Sciences, University of East Anglia
state: Norfolk
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich Univeristy Hospital NHS foundation Trust
state: Norfolk
Study officials:
affiliation: University of East Anglia
name: Mark Fisher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fisher, Mark, Christopher Applegate, Mohammad Ryalat, Stephen Laycock, Mark Hulse, Daniel Emmens, and Duncan Bell. Evaluation of 3-d printed immobilisation shells for head and neck IMRT. Open Journal of Radiology 4, no. 04 (2014): 322.
citation: Laycock, S. D., M. Hulse, C. D. Scrase, M. D. Tam, S. Isherwood, D. B. Mortimore, D. Emmens, J. Patman, S. C. Short, and G. D. Bell. Towards the production of radiotherapy treatment shells on 3D printers using data derived from DICOM CT and MRI: preclinical feasibility studies. Journal of Radiotherapy in Practice 14, no. 01 (2015): 92-98.
Clinical trial NCT01584115: Clinical Trial of a Therapeutic Vaccine With NY-ESO-1 in Combination With the Adjuvant Monophosphoryl Lipid A (MPLA)
Official title: Phase I Clinical Trial of a Therapeutic Vaccine for Malignancies, Comprising the Tumor Antigen NY-ESO-1 in Combination With the Adjuvant MPLA of Bordetella Pertussis. Evaluation of Toxicity and Immunogenicity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cancer.
Melanoma.
Ovarian Cancer.
Lung Cancer.
Keywords: Cancer.
Melanoma.
Ovarian cancer.
Lung cancer.
NY-ESO-1.
MPLA (monophosphoryl lipid A).
Tumor antigen.
Bordetella pertussis.
Lead sponsor: Instituto de Investigação em Imunologia
Sponsor class: OTHER
Collaborators: name: Butantan Institute
First posted: 2012-04-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a clinical trial phase I/II. Its goal is to determine the safety, tolerability, immunogenicity and efficacy of a therapeutic vaccine with the tumor antigen NY-ESO-1 combined with the adjuvant MPLA from B. pertussis in cancer patients.

Detailed description: The safety and immunogenicity of the vaccine with the antigen NY-ESO-1 in combination with the MPLA will be evaluated in a phase 1 clinical trial conducted in patients with malignancies that express the antigen (lung, ovarian and melanoma). This study will involve 15 patients, who will receive 250 mcg of NY-ESO-1 and 100 mcg of MPLA.

Eligibility criteria: Inclusion Criteria:

* In this study, will be included fifteen patients aged over 18 years, with a confirmed diagnosis of malignant neoplasms, which have proven NY-ESO-1 expression by immunohistochemistry and have undergone the standard treatment.

Exclusion Criteria:

* Will be excluded from the study patients with continuous use of systemic steroids, immunosuppressive agents and antibiotics, and with severe chronic systemic disease.

Primary outcomes:
measure: Safety
timeFrame: Six months after immunization.
Secondary outcomes:
measure: Immunogenicity
timeFrame: Six months after immunization.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clinicas da FMUSP
Study officials:
affiliation: University of Sao Paulo
name: Pedro Giavina-Bianchi, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03794115: Immune Repertoire of Ovarian HGSC
Official title: Differential Expression of Immune Repertoire of T/B Lymphocytes in Ovarian High Grade Serous Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian High Grade Serous Carcinoma
Immune Repertoire
T Lymphocyte Receptor
B Lymphocyte Receptor
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 40
Sex: FEMALE
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 confirmed of primary ovarian high grade serous carcinoma, aged 18 years or older and accept systematic treatment including debulking surgery and platinum-based chemotherapy.

Brief summary: In this preliminary study, peripheral blood and carcinoma tissue with pericarcinomatous tissue are taken from the patients with ovarian high grade serous carcinoma at several points: before any treatment, after the debulking surgery, and after all the proposed chemotherapy. The differential expression of the T/B lymphocyte receptors in these samples will be analyzed with the platinum-based treatment and survival outcomes of the patients. The primary objective is the expression rates of T/B lymphocyte receptors in different stages of checking points.


Eligibility criteria: Inclusion Criteria:

* Confirmed of primary ovarian high grade serous carcinoma
* Aged 18 years or older
* No immunosuppressive disease
* Signed an approved informed consents

Exclusion Criteria:

* Not meeting all of the inclusion criteria

Primary outcomes:
measure: Expression rates of T lymphocyte receptors
timeFrame: One year
measure: Expression rates of B lymphocyte receptors
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
References:
Clinical trial NCT05451615: Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
Official title: Clinical Efficacy and Safety of Real-world Patients With Refractory Rheumatoid Arthritis (D2TRA) Receiving Abatacept in Combination With a Janus Kinase (JAK) Inhibitor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Abatacept
Treatment Compliance
Rheumatoid Arthritis
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to observe the clinical efficacy and safety of abatacept combined with JAK inhibitor in the treatment of D2TRA patients


Eligibility criteria: Inclusion Criteria:

1. Meet the above diagnostic criteria for refractory rheumatoid arthritis
2. The traditional disease-improving rheumatic drug treatment is ineffective, and the use of two or more biological/targeted disease-improving anti-rheumatic drugs is ineffective, and abatacept combined with a JAK inhibitor is required treated patients

Exclusion Criteria:

1. Patients with tumors, hematological diseases, and other autoimmune diseases
2. Those who have a history of allergies to the drugs selected in this study
3. Those who cannot adhere to abatacept combined with JAK inhibitor therapy, or who have serious adverse reactions and did not complete the observation period prescribed by the study

Primary outcomes:
measure: Efficacy of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
timeFrame: maximum 1 years
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse EventsArthritis
timeFrame: maximum 1 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
References:
citation: Iglesias M, Khalifian S, Oh BC, Zhang Y, Miller D, Beck S, Brandacher G, Raimondi G. A short course of tofacitinib sustains the immunoregulatory effect of CTLA4-Ig in the presence of inflammatory cytokines and promotes long-term survival of murine cardiac allografts. Am J Transplant. 2021 Aug;21(8):2675-2687. doi: 10.1111/ajt.16456. Epub 2021 Feb 18.
Clinical trial NCT02962115: Development and Pilot Testing of a Clinical Informatics Lung Cancer Screening Intervention
Official title: Development and Pilot Testing of a Clinical Informatics Lung Cancer Screening Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasms
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 55
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study evaluates the feasibility of a clinical informatics system-based approach to lung cancer screening. Patients of a large academic medical center who may qualify for lung cancer screening will be sent an electronic invitation to complete an online lung cancer screening decision aid.

Detailed description: The Center for Medicaid and Medicare Services (CMS) recently approved the use of low-dose chest CT scans for lung cancer screening in patients who meet specific criteria. However, many individuals who meet these criteria do not realize they qualify for screening. This study will determine the feasibility of using a clinical informatics approach to systematically identify potential candidates for LDCT screening, reach out to them via the patient portal, and use a web app to provide them with a personalized LDCT screening decision aid and facilitate the ordering of screening tests.

Eligibility criteria: Inclusion Criteria:

* Has an active patient portal account
* Scheduled to see a Wake Forest primary care provider within the next 4 weeks

Exclusion Criteria:

* Never smokers
* Current or former history of lung cancer
* Receipt of chest CT scan within last 12 months
* Need for a language interpreter
* Presence of disease predicting short life-expectancy

Primary outcomes:
measure: Receipt of LDCT screening
timeFrame: 120 days
Secondary outcomes:
measure: Read portal invitation
timeFrame: 120 days
measure: Visit web decision aid
timeFrame: 120 days
measure: Complete web decision aid
timeFrame: 120 days
measure: Eligible for LDCT
timeFrame: 120 days
measure: Interest in LDCT screening
timeFrame: 120 days
measure: Appointment for LDCT visit
timeFrame: 120 days
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: David P Miller, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dharod A, Bellinger C, Foley K, Case LD, Miller D. The Reach and Feasibility of an Interactive Lung Cancer Screening Decision Aid Delivered by Patient Portal. Appl Clin Inform. 2019 Jan;10(1):19-27. doi: 10.1055/s-0038-1676807. Epub 2019 Jan 9.
Clinical trial NCT00570115: Left Atrial Volume and Function Evaluation in Patients With Obstructive Sleep Apnea
Official title: Left Atrial Volume and Function in Patients With Obstructive Sleep Apnea Assessed by Real Time Three Dimensional Echocardiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea Syndromes
Keywords: Sleep Apnea Syndromes diastolic disfunction left atrium
Lead sponsor: Associação Fundo de Incentivo à Pesquisa
Sponsor class: OTHER
First posted: 2007-12-10
Enrollment: 106
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators recruited 56 recently diagnosed OSA patients, confirmed by full polysomnography (PSG), referred to Sleep Laboratory of Psychobiology Department of Federal University of Sao Paulo, Brazil, according to the following inclusion criteria: both genders aging from 29 to 70 years old, with apnea-hypopnea index (AHI) \>5 events/hour of sleep. Control group comprised 50 healthy community subjects without OSA confirmed by full PSG, matched by age, gender, and BMI.

Brief summary: The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in left atrial morphology and function evaluated by echocardiography three dimensional

Detailed description: Several studies have been suggesting that Obstructive Sleep Apnea contributes to deterioration of left ventricular diastolic function . It may lead to atrial myocardium stretching and enlargement which may be associated to increased risk of cardiovascular events. We hypothesized that morphological and functional LA changes might be found using three dimensional echo, and that such alterations are related to obstructive sleep apnea presence.

Eligibility criteria: Inclusion Criteria:

* Age from 30 to 70
* Apnea-hypopnea index \> 5 by polysomnography

Exclusion Criteria:

* Any cardiac disease
* Poor imaging quality by mean of echocardiography
* non-sinusal Rhythm

Primary outcomes:
measure: Left Atrial enlargement
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Sono/Federal University of Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Sergio Tufik, PhD,MD.
role: STUDY_DIRECTOR
References:
citation: Anwar AM, Soliman OI, Geleijnse ML, Nemes A, Vletter WB, ten Cate FJ. Assessment of left atrial volume and function by real-time three-dimensional echocardiography. Int J Cardiol. 2008 Jan 11;123(2):155-61. doi: 10.1016/j.ijcard.2006.12.017. Epub 2007 Apr 17.