louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01806558: Pilot Study: Combined Molecular Breast Imaging/Ultrasound System for Diagnostic Evaluation of MBI-detected Lesions
Official title: Pilot Study: Combined Molecular Breast Imaging/Ultrasound System for Diagnostic Evaluation of MBI-detected Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
molecular breast imaging
breast
breast lesion
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-03-07
Enrollment: 12
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A combined molecular breast imaging / ultrasound system will enable coregistration of a functional abnormality seen on Molecular Breast Imaging (MBI) with the corresponding anatomical abnormality seen on ultrasound.


Eligibility criteria: Inclusion Criteria:

* The pilot study will comprise 12 women age 40 and older who have at least one of the following inclusion criteria:

  1. Have a finding of a mass lesion on mammography or breast MRI (BIRADS 0, 4 or 5) that is \>0.5 cm and \< 2 cm in size and has had or will have additional workup with focused ultrasound.
  2. Have a finding of a mass lesion on ultrasound (BIRADS 0, 4 or 5) that is \> 0.5 cm and \< 2 cm in size.
  3. Have a positive finding on MBI that is \< 2 cm in size and requires additional diagnostic workup with focused ultrasound.

Exclusion Criteria:

1. Are unable to understand and sign the consent form
2. Are pregnant or lactating
3. Are physically unable to sit upright and still for 40 minutes
4. Have undergone bilateral mastectomy
5. Are not scheduled to undergo conventional ultrasound

Primary outcomes:
measure: To evaluate the potential benefits of co-registered MBI and ultrasonic information relative to independent acquisition of each modality.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael K O'Connor, PhD, R-D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rhodes DJ, Hruska CB, Phillips SW, Whaley DH, O'Connor MK. Dedicated dual-head gamma imaging for breast cancer screening in women with mammographically dense breasts. Radiology. 2011 Jan;258(1):106-18. doi: 10.1148/radiol.10100625. Epub 2010 Nov 2.
Clinical trial NCT05102058: Magnesium and Dexmedetomidine in Pheochromocytoma
Official title: Magnesium and Dexmedetomidine Combination Reduces Sodium Nitroprusside Requirement in Laparoscopic Pheochromocytoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Phaeochromocytoma Crisis
Hemodynamic Instability
Keywords: Magnesium
Dexmedetomidine
Nitroprusside
Pheochromocytoma
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients' data who were aged 18-75, had the American Society of Anesthesiologists classification (ASA) 1-3 and high urinary catecholamine or metabolites. Patients with tumor sizes \< 5 cm and body mass index (BMI) \<35 kg.m-2 were examined, who were evaluated according to Endocrine Society Practice Guideline and provided the Roizen criteria.

Brief summary: Anesthesia management of pheochromocytoma excision surgery is associated with severe hemodynamic fluctuations.The objective of this study was to compare the hypertensive episodes requiring sodium nitroprusside administration between the group treated with magnesium-dexmedetomidine and conventional group in pheochromocytoma.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists classification (ASA) 1-3
* high urinary catecholamine or metabolites
* tumor sizes \< 5 cm
* body mass index (BMI) \<35 kg/m2

Exclusion Criteria:

* open surgery
* bilateral masses
* tumor larger than 5 cm
* incomplete data

Primary outcomes:
measure: Sodium nitroprusside (SNP) requirement
timeFrame: intraoperative period
Secondary outcomes:
measure: vasoactive therapy
timeFrame: intraoperative period
Other outcomes:
Locations:
Study officials:
affiliation: Attending anesthesiologist
name: Nükhet Sivrikoz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03659058: Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After SVR
Official title: Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After Achieving Sustained Virological Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibrosis, Liver
Keywords: fibrosis
HCV
Reversal
sustained virological response
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2018-09-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 200 patients will receive silymarin 420 mg + antioxidants + colchicine
Primary purpose: TREATMENT

Brief summary: with the introduction of Direct-acting antiviral agents in the management of HCV, the scope of inclusion criteria had been widened to include patients with compensated cirrhosis and even in special situations patients with decompensated liver disease; a chance that was not offered by the limited and strict inclusion criteria needed for treatment by pegylated interferon-based regimen. this made the number of patients with progressive liver fibrosis of cirrhosis had been inv=creased even after achieving SVR. the debate about the impact of SVR on halting fibrosis progression had risen; some studies postulated that patients benefit from an SVR through reduction of mortality, morbidity, and improved quality of life ; however, some patients may maintain their level of fibrosis or even progress to cirrhosis despite achieving SVR and the risk for HCC remains even after virologic eradication.


Eligibility criteria: Inclusion Criteria:

* chronic HCV
* compensated liver disease (Child class A-B)
* sustained virological response
* liver stiffness by fibroscan \>12.5 kPa denotes cirrhosis

Exclusion Criteria:

* decompensated liver disease
* chronic active HCV
* hepatocellular carcinoma
* other liver diseases as alcoholic liver disease, autoimmune liver disease, drug-induced liver disease
* pregnancy

Primary outcomes:
measure: Improvement in liver stiffness measurement by Fibroscan
timeFrame: 1 year
measure: Improved portal hypertension parameters
timeFrame: 1 year
measure: Improved splenic stiffness measurement
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06481358: Deep Learning-based Artificial Intelligence for the Diagnosis of Small Bowel Obstruction
Official title: Study Using Deep Learning-based Artificial Intelligence for the Diagnosis of Small Bowel Obstruction
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bowel Obstruction
Artificial Intelligence
Lead sponsor: Nagoya University
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 20 people

Brief summary: The study will compare the diagnostic accuracy and time to diagnosis of computed tomography images of patients with suspected intestinal obstruction seen in the emergency room by residents and surgeons, with and without artificial intelligence.

Detailed description: DESIGN: This is an diagnostic study. SETTING: We developed a deep learning-based AI technology to automatically extract the intestinal tract from CT images using 5 200 CT images of 158 patients. The CT images of patients who visited the emergency department and were suspected of small bowel obstruction between June 6 and July 26, 2018, were obtained from two tertiary referral centers, which were used as the test samples. Data analysis was completed in December 2023.

PARTICIPANTS: Residents and surgeons participated in the study. INTERVENTIONS: Residents and surgeons were divided into two groups: one group read using the AI technology, and the other group read without the AI technology.

MAIN OUTCOMES AND MEASURES: Participants indicated whether or not small bowel obstruction and obstruction location. The time for diagnosis was also collected. We applied a hierarchical Bayesian model.

Eligibility criteria: Inclusion Criteria:

* Persons with documented consent

Exclusion Criteria:

* Persons without documented consent

Primary outcomes:
measure: The diagnosis of the obstruction site
timeFrame: September, 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya University Graduate School of Medicine
state: Aichi
Study officials:
affiliation: Nagoya University Graduate School of Medicine, Pediatric Surgery
name: Hieoo Uchida, PhD.
role: STUDY_CHAIR
References:
Clinical trial NCT05802758: CFT-focused Mental Health Intervention With Exposure Training for Youngsters
Official title: Compassion-focused Mental Health Intervention With Exposure Training in Virtual Reality for Youngsters Living in an Institution
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Conduct Disorder
Psychopathic Personality Trait
Keywords: psychotherapy, virtual reality, boys
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 144
Sex: MALE
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to explore if individual CFT-based intervention with exposure training in virtual reality decreases conduct disorder symptoms and callous-unemoitonal traits , as well as increases subjective emotional welbeing among 15-to-20 year-old male prisoners and boys placed to state's residential schools. We will also study factors that may predict adherence to the intervention. These factors include mental well-being, motivation, and working alliance. In addition, we will evaluate the costs of the program.


Eligibility criteria: Inclusion Criteria:

* Express conduct disorder psychopathology and psychopathic personality traits
* Are placed to a prison or a state residential school for at least 9 months

Exclusion Criteria:

* Females
* Non-Finninsh-speaking
* Remaining in the institution facility less than 9 months
* Intellectual dissability
* Presence of psychotic symptoms
* Autism
* History of epilepsy
* Currently participating another psychotherapeutic intervention

Primary outcomes:
measure: The self-reported change in Youth Pysychopathic traits Inventory- short version (YPI-S) and in the factors of it
timeFrame: 5 months
Secondary outcomes:
measure: Short Warwick-Edinburgh Wellbeing scale (SWEMWBS)
timeFrame: 5months
measure: Difficulties in Emotion Regulating Scale-Short form (DERS-SF)
timeFrame: 5 months
measure: WHO's quality of life questionnaire- Brief version (WHOQOL-BREF)
timeFrame: 5 months
measure: Self-Compassion Scale- Short Form (SCS-SF)
timeFrame: 5 months
measure: Santa Clara Compassion Scale
timeFrame: 5 months
measure: Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE)
timeFrame: 5 months
measure: Situational intrinsic and extrinsic motivation scale (SIMS)
timeFrame: 5 months
measure: Toronto Alexitymia Scale (TAS-20)
timeFrame: 5 months
measure: The Personal Feelings Questionnaire- brief version (PFQ-2 Brief)
timeFrame: 5 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: State Residential Schools
city: Helsinki
country: Finland
facility: Prison and Probation Service of Finland
Study officials:
affiliation: University of Helsinki
name: Nina Lindberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03783858: Image Collection of Normal Eyes for Development of an EU RDB
Official title: Image Collection of Normal Eyes on the Optos P200TE for Development of an EU Reference Database
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Optos, PLC
Sponsor class: INDUSTRY
First posted: 2018-12-21
Enrollment: 356
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is designed to collect in-tissue OCT scans on the Optos P200TE on normal healthy eyes to develop a EU reference database


Eligibility criteria: Inclusion Criteria:

1. Subject 22 years of age or older on the date of informed consent
2. Subject able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subject presenting at the site with normal eyes\* (Cataracts and LASIK and PRK are allowed)
4. BCVA 20/40 or better (each eye)
5. Subject is able to comply with the study procedures in the view of the investigator \*Normal eyes are defined as eyes judged normal for the subjects age as determined by the PI or sub-investigator

Exclusion Criteria:

1.1. Subject unable to tolerate ophthalmic imaging 2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images 3. History of leukemia, dementia or multiple sclerosis

Primary outcomes:
measure: Retinal thickness
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: Simon Browning Optometrist
state: England
city: London
country: United Kingdom
facility: Barnard Levit Optometrists
state: England
city: London
country: United Kingdom
facility: London Vision Clinic
state: England
city: Belfast
country: United Kingdom
facility: Queens University
state: Northern Ireland
city: Edinburgh
country: United Kingdom
facility: Cameron Optometry
state: Scotland
Study officials:
affiliation: Queens University Belfast
name: Tunde Peto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03331458: Physical Activity in Men Newly Diagnosed With Prostate Cancer: A Feasibility Study
Official title: Physical Activity in Men Newly Diagnosed With Prostate Cancer: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: physical activity
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Recent research has indicated that physical activities incorporating moderate-intensity exercise can be safely performed during treatment and substantially reduces treatment-related side effects, such as fatigue, sleep disturbances, cognitive impairment, and nausea. However, little is known about physical activity levels prior to treatment and whether providing an exercise intervention pre-treatment may improve functional capacity during treatment.

The purpose of this study is to

1. Measure physical activity levels and functional capacity in men newly diagnosed with prostate cancer prior to treatment and
2. Explore whether a 2-week physical activity intervention is feasible during the pre-treatment timeframe:

   1. Examine intervention safety and tolerance by self-report
   2. Examine changes in functional capacity by 6-minute walk test
   3. Examine changes in symptom experience by self-report


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed with prostate cancer
* will not start treatment for at least 2 weeks
* able to read and understand English
* capable of giving informed consent
* at least 18 years old

Exclusion Criteria:

* patients who are incompetent for interview (documented diagnosis of active psychosis or dementia)
* unable to provide informed consent as assessed by the interviewer
* too sick to participate, as judged by a member of the research team or the exercise physiologist
* have been treated for another cancer

Primary outcomes:
measure: Change in 6 minute walk test
timeFrame: baseline, 2 weeks post intervention
measure: Change in balance test
timeFrame: baseline, 2 weeks post intervention
measure: Change in time up to go test
timeFrame: baseline, 2 weeks post intervention
measure: Change in Godin Leisure Time Score
timeFrame: baseline, 2 weeks post intervention
measure: Change in rate of perceived exertion
timeFrame: baseline, 2 weeks post intervention
measure: Change in metabolic equivalent
timeFrame: baseline, 2 weeks post intervention
measure: Change in distress score
timeFrame: baseline, 2 weeks post intervention
measure: Change in self-efficacy score
timeFrame: baseline, 2 weeks post intervention
measure: Change in symptom inventory score
timeFrame: baseline, 2 weeks post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Duke Raleigh Cancer Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Deborah Allen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06722196: BiodEgradable Soaked Amiodarone PaTch Use for the Prevention of Atrial Fibrillation After Cardiac Surgery
Official title: BiodEgradable Soaked Amiodarone PaTch Use for the Prevention of Atrial Fibrillation After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Atrial Fibrillation (AF)
Lead sponsor: Jilin Heart Hospital
Sponsor class: OTHER
Collaborators: name: Cornell University
First posted: 2024-12-09
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of the present prospective, randomized, double blind, controlled study is to assess whether the application of 2 oxidized regenerated cellulose (SurgicelTM FibrillarTM) patches soaked with amiodarone hydrochloride over the anterior wall of the left atrium and the lateral wall of the right atrium results in a reduction in the incidence of POAF


Eligibility criteria: Inclusion Criteria:

* All patients who are candidates for elective cardiac surgery trough complete sternotomy with indications of coronary artery disease (both off-pump and on-pump), aortic valve disease, mitral valve disease, tricuspid valve disease, and ascending aorta disease, whether as an isolated pathology or in combination

Exclusion Criteria:

* patients with a clinical history of atrial or ventricular arrhythmia of any nature and duration, patients undergoing reoperation, patients with emergency surgical indications due to acute myocardial infarction or cardiogenic shock, patients with thyroid disfunction, patients with HOCM and those with pacemakers or ICDs

Primary outcomes:
measure: postoperative atrial fibrillation versus control
timeFrame: within 5 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Jilin Heart Hospital
name: Massimo G Lemma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00941096: Intraocular Pressure Reduction With the Bimatoprost/Timolol Fixed Combination
Official title: Efficacy Of The Bimatoprost/Timolol Fixed Combination In Patients Treated With Bimatoprost for Primary Open Angle Glaucoma, Exfoliation Glaucoma or Ocular Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Ocular Hypertension
Lumigan
Ganfort
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
First posted: 2009-07-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the ocular hypotensive effect of Bimatoprost and the potential additional effect of the Bimatoprost/Timolol fixed combination in eyes with ocular hypertension, primary open angle glaucoma or exfoliation glaucoma.


Eligibility criteria: Inclusion Criteria:

* Primary open angle glaucoma
* Exfoliation glaucoma
* Ocular hypertension

Exclusion Criteria:

* Younger than 18 years old
* Inability to understand and/or follow study requirements
* Women of childbearing potential not using reliable birth control, pregnant or lactating women
* History of chronic obstructive pulmonary disease, heart failure, 2nd or 3rd AV block
* Anticipated modification of treatment for systemic hypertension during the study period
* History of ocular herpes, corneal scarring, conventional or laser surgery or macular pathology
* History of allergy, poor tolerability or poor response to study medication
* Best corrected visual acuity less than 0.4
* Significant visual field defect (MD\<15.0 dB)

Primary outcomes:
measure: Mean diurnal intraocular pressure
timeFrame: Five weeks on each medication
Secondary outcomes:
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University Eye Clinic
state: Thessaly
Study officials:
References:
Clinical trial NCT03416296: Role of Ultrasound in Diagnosis of Placenta Previa and MAP
Official title: Evaluation of Role of Ultrasound TA,TV,TP in Diagnosis of Placenta Previa and MAP(Morbidly Adherent Placenta )
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbidly Adherent Placenta
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Cairo University
name: National Research Centre, Egypt
First posted: 2018-01-31
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant females with previous cs will be subjected to US to assess placental location and MAP

Brief summary: Placenta accreta occurs when the placental implantation is abnormal. The marked rise in incidence has been assumed the increasing prevalence of cesarean delivery in recent years.

Detailed description: The most accepted theory is that abnormal placentation . The most important risk factor for placenta accreta is placenta previa after a prior cesarean delivery. The first clinical manifestation of placenta accreta is usually severe , life-threatening hemorrhage. The recommended intervention of suspected placenta accreta is planned preterm cesarean hysterectomy with the placenta left in situ.

Eligibility criteria: Inclusion Criteria:

* pregnant ladies with previous cesarean sections
* GA above 30 weeks

Exclusion Criteria:

* Primigravida patients
* GA below 30 weeks

Primary outcomes:
measure: number of participants who will be diagnosed to have normal placenta or placenta previa or morbidly adherent placenta by US
timeFrame: within 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy
role: PRINCIPAL_INVESTIGATOR
References: