louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00981071: The Time of Positive Conversion of Interferon-γ Releasing Assay After Tuberculosis Exposure
Official title: The Time of Positive Conversion of Interferon-γ Releasing Assay After Tuberculosis Exposure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: Tuberculosis
QuantiFERON
Outbreak
Conversion
Lead sponsor: Armed Forces Capital Hospital, Republic of Korea
Sponsor class: OTHER_GOV
First posted: 2009-09-22
Enrollment: 32
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A military unit in South Korean Army

Brief summary: The aim is to evaluate the time of positive conversion after exposure to smear positive pulmonary tuberculosis (TB) in a platoon of Korean military, a closed communal setting.

Detailed description: In a platoon where TB outbreak occurred, we performed low dose chest CT (LDCT), QuantiFERON-TB gold in tube (QFT) and two-step (0, 4weeks) TST for outbreak investigation. We perform QFT at 0, 2, 4, 8 and 12 weeks after initial investigation for soldiers with negative QFT results, and soldiers with positive QFT and normal LDCT took isoniazid and rifampin for 3 months as treatment of latent TB.

Eligibility criteria: Inclusion Criteria:

* All soldiers who assigned to the military platoon where a tuberculosis outbreak occurred

Exclusion Criteria:

* Soldiers who could not complete study or refused the study protocol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Jae-Joon Yim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00935571: Incidence of Postthoracotomy Pain Following General Anesthesia: A Comparison Between TIVA and Inhalation Anesthesia
Official title: Incidence of Postthoracotomy Pain Following General Anesthesia: A Comparison Between TIVA and Inhalation Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Neoplasms, Lung
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2009-07-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
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 to undergo elective thoracotomy of lung surgery

Brief summary: The purpose of this study is to evaluate the incidence of postthoracotomy pain between total intravenous anesthesia (TIVA)and inhalation anesthesia after lung surgery.

Detailed description: Thoracotomy is one of the most painful surgical incisions. It has been shown that 5-80% of patients still suffer from thoracic pain 2-3 months after surgery and the international association for the study of pain (IASP) defines postthoracotomy pain syndrome (PTTS)as pain that recurs or persists at least 2 months after surgical procedure. Previous reports have shown that the incidence of PTTS varies according to preoperative pain, pain intensity, sex, and types of procedure. However, little is known about the effect of the type of anesthesia to postthoracotomy pain.

Eligibility criteria: Inclusion Criteria:

* patients undergo elective thoracotomy of lung surgery

Exclusion Criteria:

* emergency operation age under 18 years patients with unstable hemodynamics

Primary outcomes:
measure: Incidence of pain
timeFrame: 3 and 6 months later after operation
Secondary outcomes:
measure: pain characters
timeFrame: 3 and 6 months later after operation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, University of Ulsan College of Medicine, Asan Medical Center
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine
name: In Cheol Choi, MD, PhD
role: STUDY_CHAIR
References:
citation: Gotoda Y, Kambara N, Sakai T, Kishi Y, Kodama K, Koyama T. The morbidity, time course and predictive factors for persistent post-thoracotomy pain. Eur J Pain. 2001;5(1):89-96. doi: 10.1053/eujp.2001.0225.
Clinical trial NCT03981471: Fall Prevention in Elderly: Mechanisms and Strategies
Official title: STrategies and mechAnisms of Community-Based falL Prevention in Elderly
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Elderly
Lead sponsor: National Research Center for Rehabilitation Technical Aids
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2019-06-10
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: In communities with over 100,000 residents, to investigate the incidence and mechanisms of fall in elderly, and strategies of fall prevention.


Eligibility criteria: Inclusion Criteria:

* community dwelling adults without medical conditions to impair walking ability

Exclusion Criteria:

* cognitively or physically unable to cooperate with the examiner to finish the test

Primary outcomes:
measure: Incidence of fall
timeFrame: From date of recruitment until the end of the study, assessed up to 42 months (reported once per year)
Secondary outcomes:
measure: Kinematics test
timeFrame: From date of recruitment until the end of the study, assessed up to 42 months
measure: Kinetics test
timeFrame: From date of recruitment until the end of the study, assessed up to 42 months
measure: EEG test
timeFrame: From date of recruitment until the end of the study, assessed up to 42 months
measure: fNIRS test
timeFrame: From date of recruitment until the end of the study, assessed up to 42 months
measure: MRI assessments
timeFrame: From date of recruitment until the end of the study, assessed up to 42 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Research Center for Rehabilitation Technical Aids
state: Beijing
city: Beijing
country: China
facility: National Research Center for Rehabilitation Technical Aids
Study officials:
References:
Clinical trial NCT02507778: Circulating Tumor Cells Spillage After Pulmonary Biopsy
Official title: Circulating Tumor Cells Spillage After Pulmonary Biopsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: Lung
Cancer
Biomarkers
Early detection
Circulating tumor cell
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2015-07-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to quantify the spillage of tumor cells after biopsy in early lung cancer.

Detailed description: Introduction:

Lung cancer (NSCLC) is a common malignancy with a high recurrence rate even when diagnosed at early stages. Biopsy is currently the procedure of choice for the investigation of pulmonary lesions, yet it is unclear whether the biopsy itself releases tumor cells into the circulation and attributes to the late distal recurrence.

Studies of various malignancies show the ability to identify circulating tumor cells (CTCs) even in early stage cancer. The number of CTCs correlates with disease outcome. Dynamics of CTCs after CT or bronchoscopy guided biopsy has not been evaluated so far. In the metastatic setting, the number of CTCs correlates to tumor response to chemotherapy in both small and non-small lung cancer (SCLC and NSCLC, respectively).

The aim of this study is to quantify the spillage of tumor cells after biopsy in early lung cancer.

Patients with suspected pulmonary lesions undergoing CT or bronchoscopy guided biopsy will be enrolled into the study. The CellCollectorTM will be used for CTCs detection before and after the procedure. These patients will be their own controls.

In this study the investigators will use the CellCollectorTM (Gilupi, Germany) needle that isolates CTCs of epithelial origin using a needle coated with antibodies directed against the epithelial cell adhesion molecules (EpCAM). This technology enables high quality immunohistochemical and molecular testing of the acquired cells as needed for treatment planning, and even allows cell culture growth from the live CTCs. This device is certified for use throughout Europe, with no adverse events noted with its usage .

Eligibility criteria: Inclusion Criteria:

* A diagnosis of lung cancer
* Patients are designated to undertake biopsy
* Able and willing to participate in this study
* Availability of a signed informed consent

Exclusion Criteria:

* Any recent non-lung cancer in the recent 2 years.

Primary outcomes:
measure: Circulating tumor cells (CTCs) before and after the procedure.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: nirp@clalit.org.il
name: Nir Peled, MD PhD FCCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02024178: Ultrasound Imaging in Finding Prostate Cancer in Patients Undergoing Surgery
Official title: A Pilot Evaluation of the Efficacy of HistoScanning™ in Predicting the Presence and Location of Prostate Cancer in Men Undergoing Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Radical Prostatectomy
Ultrasound Imaging
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 34
Sex: MALE
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 pilot clinical trial studies ultrasound imaging in finding prostate cancer in patients undergoing surgery. Diagnostic procedures, such as ultrasound imaging, may help find and diagnose prostate cancer. This study will serve as an analysis of the Histo-Scanning technology for the purpose of determining its ability to identify sites of prostate cancer at the time of prostate ultrasound.


Eligibility criteria: Inclusion Criteria:

* Patients who have completed a staging multiparametric MRI at New York University (NYU)
* Patients who plan to undergo radical prostatectomy by open or robotic approach

Exclusion Criteria:

* Previous History of Prostate Cancer Radiation Treatment
* Focal Ablation of the prostate for cancer treatment
* Men receiving hormonal ablation within 6 months prior to undergoing radical prostatectomy

Primary outcomes:
measure: Correlation of Histoscan findings with Radical Prostatectomy Pathology
timeFrame: up to 3 years
Secondary outcomes:
measure: Extent of tumor and grade in treatment planning
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Smilow Comprehensive Prostate Cancer Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Samir Taneja, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03758378: Evaluation of Food Additive Contributions to Obesity - Feasibility Study 2
Official title: Evaluation of Food Additive Contributions to Obesity - Feasibility Study 2
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: dietary modification
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 2
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The effects of food additives on body weight in humans are largely unknown. This is a before-and-after feasibility study in 5 obese adults who will be followed for 5 months. Eligible participants with meet with the study team and will be taught how to limit the exposure to the studied food additives in their diet. Participants will also be asked to limit eating out to a maximum of 2 days per week. Primary outcomes in this study are recruitment rate, retention rate and adherence to the proposed dietary intervention.


Eligibility criteria: Inclusion Criteria:

* BMI\>/=30 kg/m2
* routine consumption/use of (i) \>/=250 ml of artificially-sweetened beverages per day and/or (ii) \>/=1 gum per day
* willingness and ability to follow the proposed dietary intervention
* informed consent

Exclusion Criteria:

* previous or planned bariatric surgery in the next 1 year
* current or planned participation in any structured weight-loss programs in the next 6 months
* current or recent (within the last 6 months) use of weight-loss-inducing drugs or systemic steroids
* bipolar disorder or attention deficit hyperactivity disorder
* current use of anti-depressant or anti-psychotic medications
* eating disorder or any other active disorder that may lead to significant weight changes
* working night shifts
* pregnancy or planned pregnancy in the next 1 year
* uncontrolled diabetes mellitus or diabetes requiring treatment with \>2 oral diabetes medications or with insulin

Primary outcomes:
measure: Recruitment rate
timeFrame: Baseline
measure: Retention rate
timeFrame: 5 months
measure: Proportion of meals/beverages suspected to contain the studied food additives on 3 unannounced 24-hour dietary recalls
timeFrame: 2 to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
References:
Clinical trial NCT02299778: Bacterially-synthesized Folate Absorption Across the Large Intestine
Official title: Is Bacterially-Synthesized Folate Absorbed Across the Colon of Humans?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether folate produced by bacteria that live in our colon can be absorbed in human colon using a stable isotope method. This study would lead a better understanding of the bioavailability of colonic bacterially-synthesized folate and its quantitative contribution to whole body folate homeostasis.


Eligibility criteria: Inclusion Criteria:

1. 18-65 years;
2. overall healthy

Exclusion Criteria:

1. \<18 years or \>65 years
2. chronic disease (eg. history of hepatic, gastrointestinal, renal, vascular, haematological or neuropsychiatric disease) or surgery affecting gastrointestinal motility, pH or folate absorption/metabolism
3. regular use of medications affecting gastrointestinal pH, motility or folate absorption/metabolism (eg. antiacids, laxatives, phenytoin, sulfasalzine, phenobarbital, primidone, cimetidine, proton pump inhibitors \[such as Nexium\] and antibiotics \[such as Sulfonamides\] or nonsteroidal anti-inflammatory drugs \[NSAIDS, such as aspirin/ibuprofen\])
4. consumption of \>1 drink/day of alcohol on a regular basis or current smoking (last 6 months)
5. planning a pregnancy, pregnant, breast feeding or the use of high-dose estrogen oral contraceptives/hormone replacement therapy
6. known sensitivity to sunscreens containing ultraviolet B filters and/or PABA
7. difficulty with swallowing large pills or providing venous blood samples

Primary outcomes:
measure: Change in isotopic folate overtime in blood
timeFrame: Baseline (day 1), Days 2-4 ( 0h,1h,2h,3h,4h,5h,6h,7h,8h,9h,10h,11h,12h,24hr,48hr)
measure: Change in isotopic folate overtime in urine
timeFrame: Day 1 (0-24hr), Day 2 (25-48hr), Day 3 ( 49-72hr), Day 4 (73-96hr)
Secondary outcomes:
measure: Folate intake
timeFrame: Day1-4
measure: Fiber intake
timeFrame: Day1-4
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto, ON, Canada
name: Deborah L O'Connor, RD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05181878: AcQMap 2.1 With Electro-Magnetic Tracking System Feasibility Study (EMT Feasibility Study)
Official title: AcQMap 2.1 With Electro-Magnetic Tracking System Feasibility Study (EMT Feasibility Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Catheter Ablation
Keywords: localization
Lead sponsor: Acutus Medical
Sponsor class: INDUSTRY
First posted: 2022-01-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any participant 18 years of age or older. Currently scheduled for an ablation of an arrhythmia utilizing the diagnostic AcQMap 2.1 System.

Brief summary: Non-Significant Risk Clinical Study

Clinical Investigational Use Only for the purposes of collecting electromagnetic tracking data to validate the use of the device in a clinical setting.

Detailed description: The EMT Feasibility Study is a prospective, multi-center, feasibility study designed to demonstrate the feasibility of EMT solution in conjunction with the AcQMap 2.1 System's existing capabilities.

The objective of the study is to demonstrate the ability of the AcQMap 2.1 System to support EMT in conjunction with the existing impedance localization capabilities. The new EMT technology is expected to continuously provide fully synchronized and similar localization information to the impedance-based localization information associated with the location of the catheter's magnetic sensor position.

Eligibility criteria: Inclusion Criteria:

1. Male or female 18 years of age or older.
2. Currently scheduled for the ablation of an atrial arrhythmia utilizing the diagnostic AcQMap 2.1 System.
3. Willing and able to give written informed consent.

Exclusion Criteria:

1. In the opinion of the investigator, any contraindication to the planned ablation, including anticoagulation contraindications, atrial thrombus, renal failure, or sepsis.
2. Current enrollment in any study protocol sponsored by Acutus Medical
3. Any other condition that, in the judgment of the investigator, makes the participant a poor candidate for this procedure, the study, or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, extensive travel away from the research center, etc.).

Primary outcomes:
measure: Successful recording of continuous and synchronized impedance and magnetic localization information.
timeFrame: Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute
state: Kansas
city: Las Vegas
country: United States
facility: Nevada Heart and Vascular
state: Nevada
Study officials:
References:
Clinical trial NCT03988478: Inpatient Alcohol Detox & Psychotherapy
Official title: Effectiveness of Inpatient Alcohol Detoxification and Psychotherapeutic Support Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: Tribhuvan University, Nepal
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate effectiveness of inpatient detoxification and psycho-therapeutic support, measured in terms of readiness to change and abstinence maintenance. The study participants will be the patients admitted for alcohol use disorder (age: 18 years above) at a tertiary level hospital in Kathmandu. Baseline assessments on readiness to change will be done during admission, and compared prior to and after discharge. Percentage of participants maintaining abstinence in 3 months after discharge will be another outcome to be analysed.


Eligibility criteria: Inclusion Criteria:

* Diagnosed as ADS according to ICD 10

Exclusion Criteria:

* Major Psychiatric or medical comorbidity

Primary outcomes:
measure: Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) Short Form
timeFrame: Change from baseline at discharge, an average of 2 weeks
measure: Percentage of participants staying abstinent
timeFrame: Three month follow up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00945178: Double-blind Placebo-controlled 2-part Study Assessing the Safety, Tolerability and PK of AZD1386 in Healthy Volunteers
Official title: A Single-centre, Randomised, Double-blind, Placebo-controlled, Two-part Study to Assess Safety, Tolerability, Pharmacokinetics of Orally Administered AZD1386
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Safety
Tolerability
Healthy
Pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-07-24
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study will investigate how a new formulation of the study drug is absorbed, metabolised and distributed through the body, as well as its safety and tolerability in higher doses when given as single and multiple doses and as a single dose in the presence and absence of naproxen.


Eligibility criteria: Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedures
* Healthy male and female (of non childbearing potential)
* Body Mass Index (BMI) of ≥19 to ≤28 kg/m2 and a weight of ≥50 to ≤100 kg

Exclusion Criteria:

* History or presence of any clinically significant disease or disorder in the opinion of the investigator.
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.

Primary outcomes:
measure: Safety variables (adverse events, vital signs, ECG, safety lab)
timeFrame: Assessments performed at frequent timepoints (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 3 (Part A: treatment period 1 and Part B) or Day-1 to Day 9 (Part A: treatment period 2) and at follow-up 4-14 days after discharge.
Secondary outcomes:
measure: To characterize the pharmacokinetics of AZD1386 in plasma
timeFrame: Assessments performed at frequent timepoints (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 3 (Part A: treatment period 1 and Part B) or Day-1 to Day 9 (Part A: treatment period 2).
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca Pharmaceuticals, Wilmington, UK
name: Richard Leff
role: STUDY_DIRECTOR
affiliation: PAREXEL Early Phase Clinical Unit, London UK.
name: Dr. Tania Hugo
role: PRINCIPAL_INVESTIGATOR
References: