louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03013413: Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy
Official title: Evaluation of the Aixplorer Ultrasound System for Evaluation of the Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 99
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 clinical trial studies an ultrasound-based imaging procedure called elastography using the Aixplorer system in diagnosing prostate cancer in patients undergoing biopsy. Ultrasound is a non-invasive imaging technique that uses high-frequency sound waves to produce images of internal structures. Elastography uses ultrasound imaging techniques to examine the stiffness or elasticity of a tissue and may enhance the detection of prostate cancer. It is not yet known whether elastography imaging using the Aixplorer system works better than standard ultrasound imaging in detecting prostate cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate the detection of prostate cancer with elastography using the Aixplorer scanner.

SECONDARY OBJECTIVES:

I. To obtain quantitative data on the elastic properties of normal and malignant tissue in the prostate of patients referred for ultrasound guided biopsy.

II. To compare the Gleason grade of prostate cancers detected with elastography to the Gleason grade of tumors detected by conventional systematic biopsy.

Eligibility criteria: Inclusion Criteria:

* Be scheduled for a clinically indicated biopsy of the prostate
* Agree to an ultrasound examination using the Aixplorer system
* Sign an institutional review board (IRB) approved informed consent prior to any study procedures

Exclusion Criteria:

• Recent prostate biopsy within 90 days

Primary outcomes:
measure: Frequency of diagnosis of prostate cancer using elastography using the Aixplorer scanner
timeFrame: At the time of prostate biopsy
Secondary outcomes:
measure: Gleason scores of the cores detected with targeted biopsy versus those of the cores of systematic biopsy
timeFrame: At the time of prostate biopsy
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Ethan Halpern, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05054413: Formulating Expert Consensus Guidelines in Cancer Care Using the Delphi Method
Official title: Key Elements for Standardized Reporting in Prostate Cancer Management: An Expert Delphi Consensus Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with board certification in Radiation Oncology, Radiation Physics, Urology, and/or Medical Oncology

Brief summary: This study formulates consensus agreement on clinical key elements related to prostate cancer care that are critical for standardization and global reported using a robust Delphi technique, completely remote and electronic. The goal of this survey study is to have a panel of specialty-specific experts create a consensus agreement on a minimum set of key data elements for use in standardized reports. These recommendations would be used to develop standardized methods to report key data in electronic health records to better manage cancer patients at time of diagnosis, treatment, follow up, and into survivorship.

Detailed description: PRIMARY OBJECTIVE:

I. To formulate consensus agreement on a minimum set of clinical key elements that should be included in standardized reports in electronic health records when managing patients with prostate cancer.

OUTLINE:

Participants complete 3-4 rounds of questionnaires over 20-30 minutes each over 2 weeks.

Eligibility criteria: Inclusion Criteria:

* Age 21 and above
* Board certification in Radiation Oncology, Radiation Physics, Urology, and/or Medical Oncology
* Maintenance of an active practice that includes prostate cancer patients
* English speaking

Exclusion Criteria:

* Medical providers that are not board certified in the professions and/or those who do not treat prostate cancer
* Prisoners, children, and adults unable to consent to participation will also be excluded
* No exclusions were made based on sex, age, racial/ethnic background, or pregnancy status

Primary outcomes:
measure: To establish a standardized methods to report key data in electronic health records to better manage cancer patients at time of diagnosis, treatment, follow up, and into survivor-ship.
timeFrame: through study completion, an average of a year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Amy C Moreno
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06587113: An Investigation of Attentional and Inhibitory Processes During Active Visual Search in Humans
Official title: Contributions of Attentional and Inhibitory Functioning to Saccadic Decisions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Eye Movements
Attention
Executive Function
Keywords: Individual differences
Eye movements
Perception
Attention
Inhibition
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2024-09-19
Enrollment: 75
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
Intervention model description: Basic Experimental Studies Involving Humans (BESH)
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to investigate the finding that there are large individual differences in how participants move their eyes during active visual search. For example, some individuals tend to fixate, that is point their eyes steadily at a single location, for longer than other individuals before moving to another location. This experiment will use behavioral tasks to measure an individual's attentional and inhibitory functioning, and then see how each of these contributes to between-participant variability in eye movement behavior during visual search.

Detailed description: To accomplish the goal of understanding the source of individual variability in eye movement patterns, each participant will complete three separate tasks. The first task will require participants to find a target and eye movements will be measured to assess individual differences in fixation duration and other types of eye movement behavior. A second task will evaluate attentional functioning over the visual field by requiring participants to detect briefly-presented targets using their peripheral vision. Finally, a third task will assess inhibitory functioning by having participants attempt to stop eye movements after they have been programmed.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old

Exclusion Criteria:

* Self-reported history of neurological illness
* Uncorrected vision problems

Primary outcomes:
measure: First fixation duration during visual search
timeFrame: During visual search task
measure: Fixation count during visual search
timeFrame: During visual search task
measure: Stop signal reaction time
timeFrame: During inhibitory task
measure: Useful field of view thresholding
timeFrame: During attention task
measure: Useful field of view dual task performance
timeFrame: During attention task
Secondary outcomes:
measure: Average fixation duration during visual search
timeFrame: During the visual search task
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado enver
name: Carly J Leonard, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02579213: Electronic Nose and Fetal Chromosomal Disorders
Official title: Examining the Ability of Electronic Nose in Detecting Fetal Chromosomal Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Detecting Abnormal Fetal Karyotype by the Electronic Nose
Keywords: electronic nose
abnormal fetal karyotype
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 500
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A prospective study that includes pregnant women candidates for amniocentesis between 17-33 gestational weeks

Brief summary: "electronic nose"- the tiny sensors, will smell and detect the changes in the sample of abnormal fetal karyotype, and fluid that will be confirmed by amniocentesis.

Detailed description: The biochemical engineering department had developed a device called "electronic nose" that can detect various diseases Including cancer and asthma on basis of evaporable substances. The device simulates the human nose ", which includes an array of tiny sensors connected to nanometric sizes electronic calculating unit.. Thanks to their small size, electrical, physical and chemical properties, the sensitive sensors smell and identified changes in composition of the materials that characterize various diseases including kidney disease and asthma.

The electronic nose was developed by Professor Haick from the Technion. The main concept of the device is testing and characterization a trace amounts of substances in the air with the help of nana-technology sensors the idea is revolutionary and would allow the diagnosis of different diseases, like cancer, by exhaling air into the device.

The test is simple and not complicated to perform ,the examiner inhale air into a bag which connected to the "electronic nose". The molecules of the patient's breath will be tied to sensors and transmit an electrical signal to computer chip.

After processing the data the "electronic nose "can distinguish between normal cells and pathological cells.

Hypothesis: the tiny sensors ("electronic nose") will smell and detect the changes in the sample of abnormal fetal karyotype, and fluid that will be confirmed by amniocentesis.

Eligibility criteria: Inclusion Criteria:

* Pregnant women candidates for amniocentesis
* 17-33 gestational weeks

Exclusion Criteria:

* women that refuse to participate in the research
* women older than 45 or less than 16

Primary outcomes:
measure: Examining the ability of the electronic nose in detecting abnormal fetal karyotype
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06120413: 18F-LN1 PET/CT in Urothelial Carcinomas
Official title: Clinical Evaluation of 18F-LN1 PET/CT for Imaging of Nectin-4 in Urothelial Carcinomas
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urothelial Carcinoma
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 30
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 clinically suspected or diagnosed urothelial carcinomas

Brief summary: The clinical feasibility of 18F-LN1 PET/CT will be evaluated in 30 patients with urothelial carcinoma, and the results will be compared with those of 18F-FDG.

Detailed description: This study aims to evaluate the recognition efficiency of 18F-LN1 and 18F-FDG PET imaging for tumor target Nectin-4 in patients with urothelial carcinoma. The main method is to compare the results of visually interpreted PET images with histopathological results (through surgery or biopsy), which are the gold standard for final diagnosis.

Eligibility criteria: Inclusion Criteria:

* Age 18 and above
* No gender difference
* Patients who have been diagnosed with, or are clinically highly suspected of, urothelial carcinomas and have had no other treatment within 3 months

Exclusion Criteria:

* Hypertension that is difficult to control with medication, and systolic blood pressure exceeding 160mmHg
* Complicated with chronic liver disease, myocardial infarction, stroke
* Female patients who are pregnant (or attempting to become pregnant within six months), breastfeeding, or unwilling to use contraception
* Abnormal cardiopulmonary function or mental state, unable to tolerate prone lying for 20 minutes

Primary outcomes:
measure: Comparison of 18F-LN1 and 18F-FDG Uptake in Patients with urothelial carcinoma
timeFrame: 1 mouth
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Departments of Nuclear Medicine, Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
affiliation: Sichuan Provincial People's Hospital
name: Hao Wang
role: STUDY_DIRECTOR
References:
Clinical trial NCT00960713: The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders
Official title: The RITAI Cohort. An Observational Study on Serious Adverse Events Occuring After Rituximab Off-label Use for Auto-immune Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pemphigus
Auto-immune Thrombocytopenic Purpura
Hemolytic Auto-immune Anaemia
Cold Agglutinin Disease
Cryoglobulinemia
Keywords: observational cohort
rituximab
off-label use
auto-immunity
cytopenia
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2009-08-18
Enrollment: 35
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: Every patient treated by rituximab off -label for auto-immune diseases in the public hospitals of the Midi-Pyrénées County (in the South of France) is eligible for the study

Brief summary: The primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for various auto-immune diseases.

Detailed description: Every patient treated by rituximab off -label for auto-immune diseases in the public hospitals of the Midi-Pyrénées County (France) is eligible for the study, whatever the dose and the number of planned infusions. The enrollment is definitive at the time the first rituximab infusion begins. Follow-up visits are planned at months 1, 3, 6, 12 and 18 after the first infusion. At each visit, the investigators will record the adverse events that have occurred since the last visit. Serious or unexpected adverse events will be systematically monitored and declared to the Pharmacovigilance. Imputability will be quoted according to the French method. A biological collection will be constituted to allow pharmaco- immunological studies.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* rituximab is prescribed off-label for an auto-immune disorder
* rituximab prescription is validated by an institutional board
* Patients have given their informed consent to be included in the cohort

Exclusion Criteria:

* Follow-up for 6 months presumably doubtful
* Rituximab is prescribed for rheumatoïd arthritis
* Rituximab is prescribed for lymphoma
* Pregnant or breath feeding women

Primary outcomes:
measure: Occurrence of a serious adverse events
timeFrame: Day 14, Week 6, Month 6, Month 12 and Month 18
Secondary outcomes:
measure: Type, severity and frequency of all other adverse events occurring in the year following rituximab
timeFrame: Day 14, Week 6, Month 6, Month 12 and Month 18
measure: Factors that may influence the occurrence of infectious adverse events
timeFrame: Day 14, Week 6, Month 6, Month 12 and Month 18
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Service de médecine interne, hôpital Purpan, place du Dr Baylac
Study officials:
affiliation: University Hospital, Toulouse
name: Laurent Sailler
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01270113: Improving Methadone Maintenance Treatment Compliance and Outcomes in China
Official title: Improving Methadone Maintenance Treatment Compliance and Outcomes in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methadone
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-01-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: China faces the challenge of dual epidemics of drug use and HIV/AIDS. In responding to concerns of high rates of HIV/AIDS and other medical consequences among heroin users, China has recently implemented methadone maintenance treatment (MMT) programs nationwide. One problem noted with this rapid expansion is that the dropout rates from MMT have been high. The proposed study will adapt a motivational incentives (MI) intervention developed in the United States for use in Chinese MMT settings and will pilot test its effectiveness in improving treatment compliance and outcomes. The study's primary aims are: 1. to adapt a motivational incentives intervention in MMT in China, and 2. to experimentally pilot test the motivational incentives intervention. A secondary aim is to explore factors that may influence the outcomes of MMT that incorporates a motivational incentives intervention. It is hypothesized that the MI intervention can be adapted to Chinese settings and that it will optimize the positive outcomes of MMT in reducing HIV risks among heroin abusers. The collaborative team includes researchers in American and Chinese institutes (UCLA/Johns Hopkins/Washington, Shanghai Mental Health Center, Yunnan Institute for Drug Abuse), officials from national and local Chinese Centers for Disease Control and Prevention, and providers in local MMT clinics in Shanghai and Yunnan.


Eligibility criteria: Inclusion Criteria:adult patients entering the participating MMT clinics during the recruitment period who are dependent on heroin and who are willing to participate in the study.

Exclusion Criteria:Patients who are diagnosed with severe mental illness will not be eligible to participate.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04082013: Effect of Opposite Leg Position on Hamstring Flexibility in Patients With Mechanical Low Back Pain
Official title: Effect of Opposite Leg Position on Hamstring Flexibility in Patients With Mechanical Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Flexibility
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Male and female
* Age range from 18-40 years old
* With previous mentioned inclusion criteria

Brief summary: PURPOSE: this study aimed to investigate the effect of opposite knee position on hamstring flexibility BACKGROUND Hamstrings tightness is one of the most common findings in patients with LBP. It is thought that, due to the attachments of hamstrings to the ischial tuberosity, hamstrings tightness generates posterior pelvic tilt and decreases lumbar lordosis, which can result in LBP.

HYPOTHESES There will be significant difference in the hamstring flexibility with changing position of opposite knee (flexed or extended) in patients with mechanical low back pain.

RESEARCH QUESTION: Will changing position of opposite knee (flexed or extended) affect the hamstring flexibility in patients with mechanical low back pain?

Detailed description: * The subject will be instructed to maintain 90° hip flexion in the supine position.
* Then asked to actively extend the knee joint.
* The degree of achieving active knee extension will be measured using a universal goniometer.
* The average of three active knee extension measurements will be recorded used as the hamstring muscle length for the data analysis (Dong-Kyu Lee, et al., 2018).
* This test will be done for the same limb with opposite leg extended and with opposite flexed.

Eligibility criteria: Inclusion Criteria:

* Patients with history of back pain and assessed with Mechanical inflammatory low back pain index and have very high grade for mechanical component.
* Age ranges from 18-40 years.
* The body mass index of the subject is ≤25 kg/meter square.

Exclusion Criteria:

1. Previous trauma, fractures or surgery of the back.
2. Malignancy of the back.
3. Rheumatoid arthritis
4. Spondylolysis or spondylolithesis
5. History of lower extremity injury within 6 months prior to the study

Primary outcomes:
measure: Knee extension ROM
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo university
Study officials:
affiliation: Lecturer,Cairo University
name: Nasr A. Abdelkader, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01940913: Efficacy and Safety of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Antibiotic-associated Loose/Watery Stools
Lead sponsor: Probi AB
Sponsor class: INDUSTRY
First posted: 2013-09-12
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess the tolerability and effect of a probiotic product, when co-administered with antibiotics, on the incidence and duration of loose/watery stools following the antibiotic treatment in children.


Eligibility criteria: Inclusion criteria

1. Children at the age of 1-11 years that have been ordinated to start antibiotic treatment except for penicillin.
2. Possibility to initiate the probiotic treatment within 24 hours after the first dose of the antibiotic treatment.
3. Children whose parents or legal caregivers have signed the informed consent to participate in the study.

Exclusion criteria

1. Chronic intestinal disease.
2. Current immunodeficiency or immunosuppressive treatment.
3. Chronic or acute diarrhoeal disease.
4. Use of laxatives the week before inclusion in the study.
5. Antibiotic treatment for the last four weeks before inclusion in the study.
6. Known hypersensitivity to any of the ingredients in the probiotic product or the placebo \[potato starch, silicon dioxide, capsule (hypromellose, water) ± bacterial culture\].
7. Intake of any probiotic products for the last two weeks before inclusion in the study.
8. Patient requiring hospitalisation. Lack of parents´/legal guardians´ informed consent.

Primary outcomes:
measure: Reduction of the incidence of loose/watery stools following antibiotic treatment in children.
timeFrame: 19-24 days
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Multicenter study at 13 health care centers in Warsaw
Study officials:
References:
citation: Olek A, Woynarowski M, Ahren IL, Kierkus J, Socha P, Larsson N, Onning G. Efficacy and Safety of Lactobacillus plantarum DSM 9843 (LP299V) in the Prevention of Antibiotic-Associated Gastrointestinal Symptoms in Children-Randomized, Double-Blind, Placebo-Controlled Study. J Pediatr. 2017 Jul;186:82-86. doi: 10.1016/j.jpeds.2017.03.047. Epub 2017 Apr 21.