louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03319290: Increase Surveillance for Breast and Ovarian Cancers, Also to Determine Targeted Risk-reducing and Preventative Strategies
Official title: Medical Provider Experience Assessment Healthcare Decisions Post-Testing, Risk Reducing, and Preventative Strategies Using BRCA2 and BRCA2 Genetic Testing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hereditary Cancer
Lead sponsor: Data Collection Analysis Business Management
Sponsor class: OTHER
Collaborators: name: PAS Research Services
First posted: 2017-10-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current standard operating procedures for providers

Brief summary: Observational study is to increase surveillance for breast and ovarian cancers, also to determine targeted risk-reducing and preventative strategies.

Detailed description: The general design of this study is collecting data and reviewing the Principal Investigators' (P.I.) Standard Operating Procedures (SOP) on BRCA testing and changes made to their specific SOP.

Eligibility criteria: Inclusion Criteria:

* Must be a Medical Practitioner

  * Medical Doctor (MD)
  * Doctor of Osteopathic (DO)
  * Physician Assistant (PA)
  * Advanced Practice Registered Nurse (APRN)
  * Nurse Practitioner (NP)
* Must have a current standard operating procedure that includes obtaining/reviewing medical history and family medical history

Exclusion Criteria:

* Government-funded insurance data cannot be included in the study.

Primary outcomes:
measure: Provider Structures and Processes
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Land O' Lakes
country: United States
facility: DCABM
state: Florida
Study officials:
References:
Clinical trial NCT02770690: the Effect of Spray on Propofol Injection Pain
Official title: the Effect of Ethyl Chloride Spray on Propofol Injection Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: While propofol is widely used an anesthetic induction medication, it causes the mild to moderate pain. Investigators will investigate the effect of ethyl chloride spray on propofol injection pain.


Eligibility criteria: Inclusion Criteria:

* the female patients undergoing hysteroscopy

Exclusion Criteria:

* the patients who are pregnant, have Raynaud's syndrome, or receive the pain killer

Primary outcomes:
measure: propofol injection pain
timeFrame: right after the propofol injection
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Youngeun Moon
state: Seocho-gu
Study officials:
affiliation: Assitant Professor
name: Youngeun Moon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00279890: Topical Agent for Treatment of Red Skin
Official title: Proof of Concept Trial:SR-01 for the Treatment of Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rosacea
Bilaterally Symmetric Red Skin on Cheeks
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2006-01-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: SR-01 may reduce facial redness. it is a topically applied product. The agent will be applied to local skin areas of subjects with red facial skin to assess affect, and then applied to the whole face to assess efficacy and safety


Eligibility criteria: Bilaterally symmetric red skin on cheeks Caucasian Age 18-60 years

Primary outcomes:
measure: Reduction of redness
Secondary outcomes:
measure: Safety and tolerability
measure: Cosmetic acceptability
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Mark V. Dahl, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05371990: Evaluation of Nutritional Habits of University Students
Official title: A Cross-sectional Study on the Evaluation of Nutritional Habits of Students at Istanbul Medeniyet University.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eating Habit
Health Knowledge, Attitudes, Practice
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 912
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: University students studying at Istanbul Medeniyet University and volunteering to participate in the research

Brief summary: This cross- sectional, single-center study was conducted with the participation of 912 students studying at \[removed for blind peer review\] Faculty of Health Sciences, Faculty of Engineering and Natural Sciences, Faculty of Educational Sciences, Faculty of Social Sciences, Faculty of Law and Medicine. The sample size was calculated to be a minimum of 379 with 95% confidence over the total number of students, 5301. The study was carried out between October 2020 and December 2020. The compliance of the study with the ethical rules was evaluated by the Istanbul Medeniyet University Social and Human Sciences Research and Publication Ethics Committee at its meeting dated 27.10.2020 and approved with the decision numbered 2020/39.

At the beginning of the study, verbal and written consent was obtained from the individuals and a questionnaire containing 29 questions was distributed by the researchers. The questionnaire form consists of three parts. The first part includes 10 questions to determine the demographic characteristics of the participants, the second part includes 17 questions to determine their eating habits, and the third part includes 2 questions to evaluate the status of following the news about nutrition and heart health and whether they find the public service ads on this subject sufficient.


Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the research
* Istanbul Medeniyet University students between the ages of 18-25

Exclusion Criteria:

* Individuals who did not volunteer to participate in the study
* Adults over 25
* All university students studying outside of Istanbul Medeniyet University
* Elderly individuals
* Children under 18

Primary outcomes:
measure: Reaching the targeted participant
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul Medeniyet University
Study officials:
References:
Clinical trial NCT04506190: Prospective Robotic-assisted Revisional Bariatric Study
Official title: A Prospective Multicenter Study to Evaluate the Perioperative Outcomes of Robotic-assisted Revisional Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Candidate
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2020-08-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who have had one previous bariatric surgery, are undergoing a revisional bariatric surgery applicable to this study, and who are deemed qualified by study inclusion and exclusion criteria.

Brief summary: Very few studies have compared robotic-assisted (RRBS) versus laparoscopic revisional bariatric surgeries (LRBS). To date, there has not been a prospective study comparing the perioperative outcomes of patients undergoing robotic-assisted and laparoscopic revisional bariatric surgery. This study aims to enroll patients undergoing RRBS and LRBS and evaluate the outcomes through 45 days, including the perioperative period. We hypothesize that RRBS may be associated with lower rates of perioperative outcomes.


Eligibility criteria: Inclusion Criteria:

1. Subject is 18 years or older at the time of consent
2. Subject has a history of prior bariatric surgery
3. Subject's revisional procedure will be either laparoscopic revisional bariatric surgery (LRBS) or robotic-assisted revisional bariatric surgery (RRBS)
4. Subject undergoes revisional bariatric surgery that is applicable to study

Exclusion Criteria:

1. Subject is undergoing a primary bariatric procedure
2. Subject has undergone more than one previous bariatric procedure
3. Subject's revisional bariatric procedure is an emergent procedure
4. Subject is contraindicated for general anesthesia or surgery
5. Subject is unable to comply with the follow-up visit schedule
6. Subject is pregnant or suspects pregnancy
7. Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
8. Subject belonging to other vulnerable population, e.g, prisoner or ward of the state

Primary outcomes:
measure: Rate of conversions
timeFrame: During the surgical procedure
Secondary outcomes:
measure: Postoperative rate of anastomotic leak
timeFrame: 45 days after date of procedure
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health
state: Florida
Study officials:
References:
Clinical trial NCT04959890: Methodology Study of Retroviral Insertion Site Analysis in Strimvelis Gene Therapy
Official title: Methodology Study to Investigate the Utility of Retroviral Insertion Site Analysis in Samples From Subjects Treated With Strimvelis Gene Therapy.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Severe Combined Immunodeficiency Due to ADA Deficiency
Keywords: ada-scid
retroviral vector
gene therapy
Lead sponsor: Fondazione Telethon
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will use biological samples previously taken from subjects treated with Strimvelis gRV-GT.

Brief summary: This study is a post approval commitment to evaluate the accuracy and precision of retroviral insertion site (RIS) analysis and its utility for investigating and predicting the potential for insertional oncogenesis in subjects treated with Strimvelis.

Detailed description: This non-interventional, retrospective, methodology study will use peripheral blood and bone marrow samples previously taken from subjects treated with Strimvelis. The study does not require subjects to undergo any further treatment, intervention or blood withdrawal.

The objective of this methodology study is to evaluate the accuracy and precision of shearing extension primer tag selection ligation-mediated polymerase chain reaction (S-EPTS/LM-PCR) for RIS analysis and its utility for investigating and predicting the potential for insertional oncogenesis in subjects previously treated with Strimvelis for severe combined immunodeficiency (SCID) due to adenosine deaminase (ADA) deficiency.

Eligibility criteria: Inclusion Criteria

Subjects must have previously received treatment with gRV-GT, either during clinical development (clinical trials and early access programs) or in the post-marketing setting as the approved product (Strimvelis) or under hospital exemption, and for whom at least one biological sample is available that meets the following eligibility criteria::

1. Peripheral blood, bone marrow, or DNA extracted from either source.
2. Taken at least 6 months after gRV-GT.
3. Stored at -20oC or below since the time of sampling.
4. Likely to provide at least 1.5 μg of DNA (following extraction by the central laboratory).

Exclusion Criteria N/A

Primary outcomes:
measure: To assess the precision of S-EPTS/LM-PCR methodology for RIS analysis using control insertion site DNA
timeFrame: Retrospective sample analysis.
measure: To assess the accuracy of S-EPTS/LM-PCR methodology for RIS using control insertion site DNA
timeFrame: Retrospective sample analysis.
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale San Raffaele
Study officials:
affiliation: Fondazione Telethon
name: Fondazione Telethon
role: STUDY_DIRECTOR
References:
Clinical trial NCT06720090: Light Therapy for Obsessive-compulsive Disorder (OCD)
Official title: Light Therapy for Obsessive-compulsive Disorder: A Circadian Medicine Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: OCD
Keywords: ocd
sleep
light therapy
circadian
behavioral treatment
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test whether light therapy is effective for reducing symptoms in young adults with OCD and late bedtimes (1am or later). The main question\[s\] it aims to answer are:

Does light therapy reduce OCD symptoms? Does light therapy advance the circadian clock? If there is a comparison group: Researchers will compare a higher dose of light therapy to a lower dose to see if dose amount affects symptom reduction.

Participants will asked to:

1. Wear light therapy glasses for 1 hour each morning and complete a daily light therapy log for 5 weeks
2. Track their sleep every day with a wearable monitor and an electronic sleep diary for 5 weeks
3. Complete a 1-time assessment of sensitivity to light exposure
4. Complete self-report measures of OCD 4 times/day at baseline (2 weeks), mid-treatment (1 week), and end of treatment (1 week)


Eligibility criteria: Inclusion Criteria:

1. Primary DSM-5 OCD diagnosis
2. Bedtime 0100 or later
3. Age 18-35
4. English speaking

Exclusion Criteria:

1. Subjects must not be currently participating in another research study that would influence their participation in our study.
2. Diagnostic status
3. Treatment status
4. Night shift work or travel more than 1 time zone outside of Central Standard Time (CST) in the past month
5. Pregnancy status
6. Medication status
7. Regular nicotine or marijuana use

Primary outcomes:
measure: Yale Brown Obsessive-Compulsive Scale (YBOCS)
timeFrame: Administered at baseline, in treatment week 3, and post-treatment (3 administrations over 7 weeks)
measure: Daily Perseverative Thinking Questionnaire
timeFrame: Administered 4 times/day for 2 weeks at baseline, 4 times/day for 1 week in treatment week 3, and 4 times/day for 1 week in treatment week 5
Secondary outcomes:
measure: Circadian melatonin phase
timeFrame: At baseline and post-treatment (after 5 weeks of treament)
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Rebecca Cox, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01080690: Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)
Official title: Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Pain
Keywords: endosonography, right side abdominal pain
Endosonography (diagnostic value in right side abdominal pain)
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2010-03-04
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Hypothesis: Endosonography (EUS) in a single setting is equivalent to the standard algorithm combining abdominal sonography, gastroscopy, endosonography in patients with acute right side abdominal pain.

Patients with acute right side abdominal pain will be randomized in one of two groups. In each group all examinations (sonography, gastroscopy, endosonography) will be performed. The study group only defines the order of the examinations. Abdominal sonography will always be performed before endoscopic procedures. In group 1, gastroscopy is first followed by endosonography. In group 2 endosonography is first followed by gastroscopy.

Two physicians will review all results of all examinations, patient charts as well as a follow up visit and establish a clinical diagnosis.

Yield of the clinical diagnosis by EUS results alone will be compared to the yield by combined results of sonography, EGD and EUS.


Eligibility criteria: Inclusion Criteria:

* acute right side abdominal pain
* willing participate study

Exclusion Criteria:

* acute disease
* malignancy
* other disease which might cause discomfort

Primary outcomes:
measure: Yield of the clinical diagnosis by EUS results alone will be compared to the yield by combined results of sonography, EGD and EUS.
timeFrame: within the first week of complaints
Secondary outcomes:
measure: Calculate the time and cost savings and number of procedures for endosonography alone versus the combined approach of abd. sonography, gastroscopy and endosonography.
timeFrame: one year
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum r.d. Isar, Technical University Munich
Study officials:
affiliation: II Med Dep, TU Munich
name: Alexander Meining, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04333290: Study Evaluating the Safety of Myeliviz Myelin-Targeting PET Agent
Official title: Phase 1 Study Evaluating the Safety of [11C]MeDAS Myelin-Targeting PET Agent in Humans
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: myelin
PET
central nervous system
brain
spinal cord
demyelination
MRI
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
First posted: 2020-04-03
Enrollment: 0
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: DIAGNOSTIC

Brief summary: This study evaluates the safety of \[11C\]MeDAS, a PET radiotracer.

Detailed description: Myelin PET imaging provides a new type of information regarding the integrity of the central nervous system based on molecular imaging of myelin. Preclinical studies have shown \[11C\] MeDAS uptake in the brain and spinal cord to be an indicator of the microstructural integrity of the tissue.

\[11C\]MeDAS PET (Positron Emission Tomography) scans will be performed on healthy subjects at 2 timepoints to assess for safety of the radiotracer and to assess its performance in humans. Following measurement of \[11C\]MeDAS pharmacokinetics and biodistribution, an optimal protocol for dosing and imaging will be established.

Eligibility criteria: Inclusion Criteria:

* Subject reports no known physical diseases of the central nervous system including no history of mental health disorders.
* Capable of giving informed consent
* Efforts will be made to include approximately equal numbers of women and men. Efforts will be made to include individuals of diverse ethnicities, as reflected in the local clinic population.

Exclusion Criteria:

* Age \<18 or \>65
* History of malignant hypertension or hypertensive crisis
* Known infectious disease requiring treatment during the course of the study
* Subject reported history of substance abuse
* inability to undergo an MRI or PET scan

Primary outcomes:
measure: Radiation dosimetry
timeFrame: Less than or equal to 2 hours
measure: Biodistribution analysis
timeFrame: Less than or equal to 2 hours
measure: Metabolism analysis
timeFrame: Less than or equal to 2 hours
measure: Pharmacokinetic analysis based on PET scan data
timeFrame: Less than or equal to 2 hours
measure: Analysis of time-dependent radiotracer distribution based on arterial blood sampling
timeFrame: Less than or equal to 2 hours
Secondary outcomes:
measure: Brain imaging characterization
timeFrame: Less than or equal to 2 hours
measure: Spinal cord imaging characterization
timeFrame: Less than or equal to 2 hours
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Robert Fox, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02075190: Trial of a Nationwide Cognitive-Affective Remediation Training Intervention in Depression
Official title: Trial of a Nationwide Cognitive-Affective Remediation Training Intervention in Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cognitive-affective Exercises
Engaging Exercises
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective is to examine the efficacy of computerized interventions for increasing well-being and cognitive functioning. The study will seek to validate emerging online delivery methods of psychiatric assessment and treatment. This will allow us to test the efficacy of this intervention in a larger and more geographically broad sample than is possible through traditional recruitment and treatment, and to do so in a highly cost-effective manner.


Eligibility criteria: Inclusion Criteria:

* computer and broadband internet access
* 18 years of age
* Elevated anxiety and depression
* Native English speaker

Exclusion Criteria:

Primary outcomes:
measure: Cognitive function
timeFrame: 1 month
Secondary outcomes:
measure: Self-report mood and anxiety symptoms
timeFrame: 3 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Anett Gyurak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00511290: Measurement of Soluble Factors and Particulate Matter in Induced Sputum and EBC in Inflammatory Diseases of the Lung
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Chronic Obstructive Pulmonary Disease
Interstitial Lung Diseases
Occupational Lung Diseases
Keywords: Primary disease or condition being studied: Asthma -COPD-Interstitial Lung Diseases-Occupational Lung Diseases
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-08-03
Sex: ALL
Minimum age (years): 7
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE

Brief summary: In the present study inflammatory mediators will be isolated in induced sputum and exhaled breath condensate and will be correlated with particulate matter measured in these samples.Particulate matter will be assessed by partcle size distribution method and shape analysis.

The aim of the study is to perform biological monitoring in environmental and occupational diseases in a non invassive fashion.


Eligibility criteria: Inclusion Criteria:

* Ages 7-80

Exclusion Criteria:

* FEV1 \< 75% predicted pO2 \< 75

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: Tel Aviv University
name: Fireman Lizy, PhD
role: PRINCIPAL_INVESTIGATOR
References: