louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01050283: A Study to Evaluate [18F]-FDG PET (Fluorodeoxyglucose-positron) in Patients With Pancreatic Cancer (MK-0000-144)
Official title: A Multicenter Trial to Evaluate 18F-FDG Uptake by PET in Patients With Advanced Pancreatic Adenocarcinoma as an Early Indicator of Drug Activity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Pancreatic Adenocarcinoma
Keywords: Advanced pancreatic adenocarcinoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-01-15
Enrollment: 15
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will determine whether \[18F\]-fluorodeoxyglucose-positron emission tomography (FDG-PET) can be used to screen for the activity of novel pancreatic cancer treatments.


Eligibility criteria: Inclusion Criteria:

* Patient has a diagnosis of Stage IV pancreatic adenocarcinoma with distant metastases
* Patient is scheduled to receive standard chemotherapy containing gemcitabine
* Patient has not received prior systemic therapy for advanced pancreatic adenocarcinoma
* Patient must be available for periodic blood sampling, study-related assessments, and management at the treating institution

Exclusion Criteria:

* Patient has had open abdominal surgery within 6 weeks of the screening visit
* Patient has had radiotherapy to the thorax, abdomen, or pelvis within 6 months of the screening visit
* Patient has an active infection, inflammation, or unresolved bowel obstruction
* Patient has poorly controlled diabetes

Primary outcomes:
measure: Association of changes in FDG uptake with overall survival (OS)
timeFrame: Week 3 and at least 7 months after the last patient is treated
Secondary outcomes:
measure: Association of metabolic response with OS
timeFrame: Baseline, Week 3, and at least 7 months after the last patient is treated
measure: Correlation between FDG standardized uptake values (SUV) at Week 3 and Week 6-7
timeFrame: Week 3 and Week 6-7
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02047383: Hospital Stay and Respiratory Infection
Official title: Repercussion of Hospital Stay in Patients With Respiratory Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Infection
Keywords: respiratory infection
physical variables
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 116
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients with an acute respiratory infection

Brief summary: The acute respiratory infection is the fourth most common cause of hospital stay between elderly people. The purpose of this study is to evaluate the repercussion of hospital stay in hospitalized patients with a respiratory infection.

Detailed description: Acute respiratory infection is a serious infection that prevents normal breathing function. It refers to any of a number of infectious diseases involving the respiratory tract. Health conditions that increase the risk of a respiratory infection include: another lung condition, a heart condition, a kidney or liver condition and a lowered immune system. The hospital stay of this patients is approximately 7-10 days and it is important to study the effects of this stay in the physical and psycho-emotional characteristics of patients.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of respiratory infection
* Age: more than 50 year.
* Signed written consent.

Exclusion Criteria:

* Heart disease and concomitant neurological condition.

Primary outcomes:
measure: Strength in upper and lower limbs
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
Secondary outcomes:
measure: Quality of life
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
measure: Lung function
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
measure: Activity monitoring
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
measure: Quality of sleep
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
measure: Mood
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Faculty of health Sciences. University of Granada
Study officials:
affiliation: Universidad de Granada
name: Marie Carmen Valenza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martin-Salvador A, Torres-Sanchez I, Saez-Roca G, Lopez-Torres I, Rodriguez-Alzueta E, Valenza MC. Age group analysis of psychological, physical and functional deterioration in patients hospitalized for pneumonia. Arch Bronconeumol. 2015 Oct;51(10):496-501. doi: 10.1016/j.arbres.2014.11.009. Epub 2015 Jan 17. English, Spanish.
Clinical trial NCT04991883: Analysis of the Molecular Profile of the Mixofibrosarcoma of the Extremities
Official title: Analysis of the Molecular Profile of the Mixofibrosarcoma of the Extremities: Diagnostic and Prognostic Impact
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma,Soft Tissue
Keywords: Mixofibrosarcoma
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of Mixofibrosarcoma treated at the Rizzoli Institute from 1 January 1993 up to 01 December 2017

Brief summary: Single institution case series review with a histological diagnosis of mixofibrosarcoma of the extremities from 01 Jan 1993 to 01 Dec 2017.

The study will exam all the clinical, radiological, histological and immunohistochemical features of this tumour in all samples and in a limited serie of cases the presence of mutation of 50 genes cancer related.


Eligibility criteria: Inclusion Criteria:

1. Male and female patients treated at Rizzoli Institute from 01 Jan 1993 to 01 Dec 2017
2. Diagnosis of mixofibrosarcoma of extremities
3. Histological slides/formalin-fixed paraffin-embedded tissue tumor (FFPE) blocks from archive available to perform the histology analysis and molecular analysis
4. Enough tumor biobanked material available for molecular analysis
5. Presence of the biobank signed informed consent
6. Written informed consent prior to any study-specific analysis and/or data collection

Exclusion Criteria:

1) Patients with histological diagnosis different from mixofibrosarcoma of extremities

Primary outcomes:
measure: disease-free survival
timeFrame: at baseline (Day0)
measure: overall survival
timeFrame: at baseline (Day0)
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: BO
Study officials:
References:
citation: Mentzel T, Calonje E, Wadden C, Camplejohn RS, Beham A, Smith MA, Fletcher CD. Myxofibrosarcoma. Clinicopathologic analysis of 75 cases with emphasis on the low-grade variant. Am J Surg Pathol. 1996 Apr;20(4):391-405. doi: 10.1097/00000478-199604000-00001.
citation: Gronchi A, Lo Vullo S, Colombo C, Collini P, Stacchiotti S, Mariani L, Fiore M, Casali PG. Extremity soft tissue sarcoma in a series of patients treated at a single institution: local control directly impacts survival. Ann Surg. 2010 Mar;251(3):506-11. doi: 10.1097/SLA.0b013e3181cf87fa.
citation: Kaya M, Wada T, Nagoya S, Sasaki M, Matsumura T, Yamaguchi T, Hasegawa T, Yamashita T. MRI and histological evaluation of the infiltrative growth pattern of myxofibrosarcoma. Skeletal Radiol. 2008 Dec;37(12):1085-90. doi: 10.1007/s00256-008-0542-4. Epub 2008 Jul 16.
Clinical trial NCT03091283: Time Management in Nurse Anaesthetist Students
Official title: A Survey Study of Time Management in Nurse Anaesthetist Students
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Educational Problems
Keywords: time management, anaesthesia training program
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: nurse anaesthetist students

Brief summary: Nurse anaesthetist student is a registered nurse who spends 1- year training in anaesthesia, has to work laboriously to cope with all assigned activities day and night. Time management, therefore, becomes a practical tool for nurse student to reach her goal. However, many factors act as barriers to nurse students' attaining and maintaining a high grade point average (GPA). Investigators would like to determine the effect of skills in time management on GPA amongst faculty nursing students.

Detailed description: Skills in time management are crucial for academic success. It can be defined as clusters of behavioural set that are essentials in the organisation of learning load. These are comprised of activities such as planning, prioritising, preparation, and following schedules. Consequently, it yields an impact on students' achievement.

Nurse anaesthetist student is a registered nurse who spends 1- year training in anaesthesia. She has to work laboriously to cope with all assigned activities day and night. Time management, therefore, becomes a practical tool for nurse student to reach her goal. It has many good aspects; namely, problem analysis, target determination, planning, implementation, evaluation and revision for improvement .

However, many factors act as barriers to nurse students' attaining and maintaining a high grade point average (GPA) at their training. Faculty members target all these issues in developing strategies to improve students' academic performance and learning achievement. As a result, time management would be a solution to solve these problems.

Investigators would like to determine the effect of skills in time management on GPA amongst faculty nursing students. The research questions are as follows:

1. What is the nurse student's competency on Time management?
2. What is the relationship between GPA and Time management skills among faculty nursing students?

Eligibility criteria: Inclusion Criteria:

* volunteered nurse anaesthetist students in 1-year training program

Exclusion Criteria:

* none

Primary outcomes:
measure: nurse student's competency on Time management
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Suchittra Bumrongsawa
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Suchittra Bumrongsawa, BNS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00001183: Evaluation of the Causes and Disease Processes of Chronic Lung Disease
Official title: Comprehensive Evaluation of the Etiology and Pathogenesis of Chronic Lung Disease (Screening Protocol)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease
Keywords: Computed Tomography
Fiberoptic Bronchoscopy
Pulmonary Function Testing
Cardiopulmonary Exercise Testing
Allergen Skin Testing
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 6564
Sex: ALL
Minimum age (years): 7
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients being screened for lung disease

Brief summary: Chronic lung diseases are disorders associated with abnormalities in any of the structures involved in the process of breathing and bringing oxygen into the lungs and blood. This includes abnormalities in the airways, lungs, blood vessels in and around the lungs, and the tissue covering the lungs (pleura).

The purpose of this research study is to evaluate patients referred to the Cardiovascular and Pulmonary Branch of the National Heart, Lung, and Blood Institute (NHLBI) in order to;

1. Develop a better understanding of the causes and disease processes involved in disorders of the lungs
2. Identify patients eligible to participate in other P-CCMB research studies

Detailed description: The chronic lung diseases are those disorders associated with functional and/or structural derangement to the alveolar structures, airways, pulmonary blood vessels, pleura and/or mediastinum. The purpose of this project is to permit the comprehensive evaluation of patients referred to the Pulmonary Branch of the National Heart, Lung, and Blood Institute (NHLBI) in order to: (1) develop an understanding of the etiology and pathogenesis of these disorders; and (2) identify individuals who will be suitable candidates for other NHLBI protocols. Testing and procedures will only be performed when medically indicated for the purposes of making a diagnosis or obtaining information likely to be useful in the management of the subjects' disease or condition.

Eligibility criteria: * INCLUSION CRITERIA:

Symptoms consistent with pulmonary disease.

May have family history of lung disease.

Patients with diseases of organs with known association with lung disease.

Ranging in age from 7 to 90 years old.

Pregnant and nursing women may participate in minimal risk procedures

EXCLUSION CRITERIA:

Persons with no clinical evidence of lung disease.

Primary outcomes:
measure: N/A-screening protocol
timeFrame: 1 Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Joel Moss, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01511783: Evaluation of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of E2609 in Healthy Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of E2609 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2012-01-19
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this single-center, randomized, double-blind, placebo-controlled, study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when administered to healthy elderly subjects.


Eligibility criteria: Key Inclusion Criteria:

* Healthy males and females
* Female subjects must be of non-childbearing potential
* Aged 50 to 85 years, inclusive BMI of 18 to 32 kg/m2 at screening
* Thyroid function tests within normal rangeMini-Mental State Examination score of 28-30, inclusive

Key Exclusion Criteria:

* History of neurological abnormalities, including seizures
* Any clinically significant abnormality of the ECG at Screening and Baseline including QTc prolongation
* History of ischemic heart disease, cardiac arrhythmias, cerebrovascular diseases
* Other medical conditions that are not stably controlled
* Presence of orthostatic hypotension

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 19 days
Secondary outcomes:
measure: Plasma Cmax and AUC (0-24h) of E2609 on Day 1 and Day 14
timeFrame: 20 days
measure: Plasma Aβ(1-x) Amax (defined as maximum change (%) of E2609 levels compared to time-matched baseline at a single time point within 24 hours postdose) in plasma and cerebrospinal fluid, plasma and CSF
timeFrame: 20 days
measure: Time at which Amax occurs for plasma Aβ(1-x)
timeFrame: 20 days
measure: Area under the plasma Aβ(1-x) concentration, AUAC(0-24h), by time curve from time 0 to time 24 hours on Day -1, Day 1, and Day 14
timeFrame: 20 days
measure: Change (%) in plasma Aβ(1-x) AUAC within 24 hours comparing Day 1 to Day -1 and Day 14 to Day -1
timeFrame: 20 days
measure: Percent change of Aβ(1-x) in CSF from Day -2 to Day 14
timeFrame: 20 days
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Compass Research Phase 1, LLC
state: Florida
Study officials:
affiliation: Compass Research Phase 1, LLC
name: Craig Curtis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02069483: Testing Methods of Self-persuasion Involving Cigarette Smoking
Official title: Testing Methods of Self-persuasion Involving Cigarette Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: smoking
smoker
text
smartphone
motivation
quitting
cessation
feedback
messages
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-02-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Smokers who are not actively engaged in quitting will participate in a study using self-generated text and audio text messages containing reasons to quit smoking.

Detailed description: Participants must have a smartphone that can accept text messages from an email address and link to a study related website to hear audio recordings, and be willing to receive a text message each weekday for two weeks between 8-9am as part of the study. After completing a phone screener, participants will complete a baseline phone survey. Within two weeks of the baseline survey, participants will come to an in-person session. At that time they will be randomized with equal probability to one of two conditions: 1) Motivational Interviewing (MI), or 2) tailored feedback on reasons for quitting. After undergoing MI or receiving tailored feedback, participants will be asked to generate message that they feel would motivate them to quit. These messages will be both text and audio. After generating and reviewing these messages, participants will then evaluate these messages before ending the laboratory session. Starting two days after their laboratory session, between 8:00am and 9:00am, staff will send participants one of the self-generated text messages with a link to also hear the message; this process will last for two weeks. Within a week of stopping sending messages, participants will be asked to complete a final phone survey to elicit smoking behaviors and provided feedback on the messaging.

Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* not actively engaged in trying to quit smoking
* must have smoked 100 cigarettes to date
* must smoke at least 1 cigarette per day
* must own smartphone capable of receiving messages from study email
* must agree to receive text messages between 8-9am each weekday for 2 weeks

Primary outcomes:
measure: Number of messages generated during in-person visit
timeFrame: one hour
Secondary outcomes:
measure: Quality of messages
timeFrame: before and after completion of the trial, approximately 3 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Isaac Lipkus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06863428: Mymobility Knee ROM
Official title: Concordance Between an App-based Range of Motion Measurement and Standard Goniometer.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Knee Range of Motion
Keywords: mymobility
range of motion
goniometer
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2025-03-07
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of a minimum of 41 patients who meet all the inclusion criteria and none of the exclusion criteria.

Brief summary: This prospective study aims to evaluate the agreement, also referred as concordance, of the mymobilty knee ROM with a clinician's assessment of knee ROM via goniometer.


Eligibility criteria: Inclusion Criteria:

* Patient is a minimum of 18 years of age
* Patient is willing and able to provide written Informed Consent by signing and dating the IRB-approved Informed Consent form

Exclusion Criteria:

* The patient is currently participating in any other study that would hinder the assessor's ability to measure knee ROM
* Complex primary knee pathology with significant restrictions on the range of motion per surgeon discretion
* Patient is pregnant or considered a member of a protected population (e.g. prisoner, mentally incompetent, etc.)

Primary outcomes:
measure: Active knee flexion
timeFrame: Day 1 (Single Visit)
measure: Active knee extension
timeFrame: Day 1 (Single Visit)
measure: Passive knee extension with overpressure
timeFrame: Day 1 (Single Visit)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: