louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01397526: Colloid Osmotic Pressure During Heart Surgery in Children
Official title: Colloid Osmotic Pressure During Heart Surgery in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Defects, Congenital
Keywords: Congenital heart disease
Cardiopulmonary bypass
Capillary leak
Colloid osmotic pressure
Children
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
First posted: 2011-07-19
Enrollment: 9
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children scheduled for open heart surgery with the use of Cardiopulmonary Bypass at Oslo University Hospital

Brief summary: Clinical oedema is seen after open heart surgery with the use of cardiopulmonary bypass and hypothermia in children. The oedema formation is due to increased fluid transport from blood to tissue. This transcapillary fluid transport is dependent on differences in interstitial and plasma colloid osmotic pressure. The purpose of this investigation is to evaluate changes in interstitial colloid osmotic pressure before, under and after the use of cardiopulmonary bypass in children. The study hypothesis is that oedema developed during cardiopulmonary bypass and hypothermia is caused by increased micro vascular protein leakage and reduced colloid osmotic pressure gradient through the capillary membrane.


Eligibility criteria: Inclusion Criteria:

* The diagnosis of a congenital heart defect
* scheduled for open heart surgery with the use of cardiopulmonary bypass
* under 13 year of age
* informed consent obtained from the parents

Exclusion Criteria:

* renal failure
* liver failure

Primary outcomes:
measure: Interstitial colloid osmotic pressure
timeFrame: Before, during and after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Gunnar Norgard, Prof. PhD
role: STUDY_CHAIR
affiliation: Haukeland University Hospital
name: Ansgar Berg, Prof. PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03077126: Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer
Official title: Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: elastography
ultrasound
prostate
cancer screening
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 10
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: The main purpose of this study is to determine the accuracy and feasibility (possibility) of Aixplorer® ShearWave Elastography (SWE™) Ultrasound System (made by SuperSonic Imagine, Inc.) for detecting prostate cancer in men undergoing radical prostatectomy.

Detailed description: The point estimate and its 95% confidence interval will be calculated using the exact binominal method. Identification of suspicious cancer tissue in a 12 prostate zone schema: Participants will undergo USE: Aixplorer® ShearWave Elastography (SWE™), (SuperSonic Imagine). Areas of the prostate with high suspicion for harboring cancer will be recorded in a 12 zone prostate schema. For study purposes the prostate will be divided into Zone 1(Left Lateral Base), Zone 2 (Left Base), Zone 3 (Right Base), Zone 4 (Right Lateral Base), Zone 5 (Left Lateral Mid), Zone 6 (Left Mid), Zone 7 (Right Mide), Zone 8 (Right Lateral Mid), Zone 9 (Left Lateral Apex), Zone 10 (Left Apex), Zone 11 (Right Apex), Zone 12 (Right Lateral Apex).

Eligibility criteria: Inclusion Criteria:

* Men with prostate cancer who elect surgery as the primary treatment of their cancer and to be performed at the Moffitt Cancer Center.
* Biopsy confirmed prostate cancer with at least ten biopsies performed for diagnosis.
* Location of cancer specified in the pathology report.
* Pathology reviewed by Moffitt pathologist

Exclusion Criteria:

* Less than ten biopsies obtained at time of diagnosis.
* Location of cancer not specified.
* Pathology not reviewed by Moffitt pathologist.

Primary outcomes:
measure: Rate of Correlation Between Ultrasound Results and Pathology Results
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Julio Pow-Sang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06792526: Prospective Study on Monitoring Parotid Gland Injury After Radiotherapy for Head and Neck Tumors Using Multimodal Radiomics
Official title: Monitoring Salivary Gland Damage After Radiotherapy in Patients with Head and Neck Cancer Using Multimodal Radiomics
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Xerostomia, Radiation-induced Parotid Damage,Predictivevalue,Head and Neck Cancer
Lead sponsor: Hainan People's Hospital
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 20
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: The study population consists of adult patients (18 years of age or older) who have been diagnosed with a head and neck tumour and are planning to receive radiotherapy as part of their standard treatment. Recruitment will take place at the Department of Radiotherapy, Hainan Provincial People's Hospital. Applicants must be able to undergo an MRI scan and provide informed consent.

Brief summary: Exploring a non-invasive and objective method for ultra early quantitative assessment of radiation-induced parotid gland injury. To provide a new and early method for evaluating changes in parotid gland function in clinical practice, and to guide the timing of interventions to protect the parotid gland.

Detailed description: Exploring the application value of magnetic resonance fingerprinting (MRF) and intravoxel incoherent motion (IVIM) techniques in dynamically monitoring parotid gland injury and predicting the risk of dry mouth after radiotherapy for head and neck tumors. The study evaluated the changes in parotid gland cell density and microcirculation function by quantifying MRF (T1/T2 relaxation time, proton density) and IVIM parameters (D value, D \* value, f value), combined with parotid gland volume reduction rate, to establish an early risk model for predicting dry mouth syndrome and optimize parotid gland protection strategies.

Eligibility criteria: Exclusion Criteria:

1. Contraindications to MRI, such as metallic implants or claustrophobia.
2. Severe comorbid conditions, including significant renal or hepatic dysfunction.
3. Concurrent participation in another interventional clinical trial.
4. Pregnant or breastfeeding.
5. Any condition that may impair compliance with study procedures.

Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of nasopharyngeal carcinoma.
2. Scheduled to undergo radiotherapy as part of standard treatment.
3. Aged 18 years or older.
4. No contraindications to MRI scans (e.g., no implanted metallic devices).
5. Written informed consent has been provided.

Primary outcomes:
measure: Quantitative assessment of salivary gland changes using IVIM and MRF imaging
timeFrame: From baseline to 3 months post-radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02169726: A Pilot Study Non-Invasive Guidance for Therapeutic Ultrasound Treatment of Lower Back Muscle Injuries
Official title: A Pilot Study to Investigate Non-Invasive Metabolic Guidance for Improving Therapeutic Ultrasound Treatment of Lower Back Muscle Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Injury; Muscle, Back, Lower
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2014-06-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will be selected from Univesity of California Irvine Medical Center

Brief summary: Back injuries are the most common reason people seeking for effective treatment. One of the most common treatments in sports medicine for muscular injuries is therapeutic ultrasound, which is designed to heat the injured tissue and increase the flow of blood to promote healing.

Detailed description: Researchers at Beckman Laser institute, using a technology developed at University of California, Irvine. The device call Diffuse Optical Spectroscopy, this device developed with harmless light that can measures and detect the change of blood flow, oxygen level, temperature and muscle tissue in lower back during therapeutic ultrasound therapy treatment.

The researchers can provide information in real-time tissue change before, during, and after treatments that can determine the effectiveness of the treatment and speed up recovery time.

Eligibility criteria: Inclusion Criteria:

* Male or Female over 18 years of age,
* No back injuries, No plan treatment
* Currently diagnose with back injuries, with plan treatment of therapeutic ultrasound

Exclusion Criteria:

* Minors
* Obese
* Pregnant

Primary outcomes:
measure: Normal lower back muscle
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute
state: California
Study officials:
affiliation: Beckman Laser Institute, UCI
name: Bruce Tromberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02767726: A Non-Invasive Cervical Cancer Screening Modality: A Pilot Study
Official title: A Non-Invasive Cervical Cancer Screening Modality: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Women With Abnormal Pap Smears
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Cervix cancer is a major global health concern. A way to screen and immediately treat precancerous lesions (Screen-and-Treat) is greatly needed. Developed by MobileOCT, polarized difference imaging and conventional imaging are used to identify suspicious lesions. We aim to compare this non-invasive method with colposcopy. Patients at the Dickens Clinic will have 3-5 minutes of non-invasive imaging before colposcopy. Pathology will be compared both to colposcopy impression versus MobileOCT.


Eligibility criteria: Inclusion Criteria:

* Subjects capable of giving informed consent or have an acceptable surrogate capable of giving consent on subjects behalf.
* Subjects are 18 years of age or older
* Subjects are scheduled for colposcopy clinic based on screening with abnormal pap smear or have repeat colposcopy indicated for specific clinical indications, based off of American Society of Cosposcopy and Cytology.
* Subjects are women.

Exclusion Criteria:

* Pregnancy.
* Males (males do not have a cervix and thus cannot undergo colposcopy).

Primary outcomes:
measure: Number of suspicious lesions identified
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Danielle Burkland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05092126: Development & Validation of Preoperative Objective Physiological Evaluation
Official title: Development & Validation of Preoperative Objective Physiological Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiorespiratory Fitness
Keywords: areobic power
cardiopulmonary exercise testing
exercise capacity
functional capacity
physical activity
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All subjects will be asked to complete the exercise test and the fitness questionnaire
Primary purpose: DIAGNOSTIC

Brief summary: This study will compare the measured oxygen consumption (VO2) obtained during sub-maximal exercise testing with the estimated VO2 derived from a non-exercise questionnaire.

Detailed description: All surgical patients presenting at the Preoperative Anesthesia \& Surgical Screening (PASS Clinic) will complete the Duke Activity Status Index (DASI) self-reported questionnaire as standard of care. If the DASI score is 34 or greater, the patients will not be considered for the study. If the DASI score is 33 or lower, the patient will be considered as a potential study participant. Eligible study participants will then complete a sub-maximal exercise test (Six Minute Step Test, 6MST) with measured VO2.

The VO2 is an integral part of preoperative assessment of cardiorespiratory fitness (CRF). A low CRF is associated with a higher incidence of post-operative complications and mortality. The study will evaluate the ability to estimate VO2 from exercise-derived measurement with questionnaire-derived estimation.

Eligibility criteria: Inclusion Criteria:

* Age 18 and older
* Able to speak English
* Ambulatory \[assistive devices ok\]
* Preoperative Anesthesia and Surgical Screening (PASS) clinic patient with DASI score \<34
* Able to provide informed consent

Exclusion Criteria:

* Acute myocardial infarction (3-5 days)
* Unstable angina
* Severe untreated arterial hypertension at rest (\>200 mm Hg systolic, \>120 mm Hg diastolic)
* Resting heart rate \> 120 bpm
* Room air desaturation at rest on room air \<85%
* Inmate of correctional facility (i.e. prisoner)
* Diagnosed history of dementia
* Inability to ambulate independently
* Considered inappropriate to participate by Principal Investigator

Primary outcomes:
measure: Total amount of oxygen consumed per minute
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: David MacLeod, FRCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01894126: Mobile Phone Messaging to Improve Women's and Children's Health (Mobile WACh) in Kenya
Official title: Mobile Phone One Way Short Message Service (SMS) Versus SMS Dialogue for Women's and Child Health (Mobile WACh) in Kenya: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Health
Neonatal Health
Family Planning
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Nairobi
name: Kenyatta National Hospital
First posted: 2013-07-09
Enrollment: 300
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: With the increased prevalence of cellular phones, mobile technology provides an important tool to reach underserved populations in low to middle income countries. mHealth interventions offer promise to improve maternal child health throughout the reproductive health continuum if they contribute to increasing skilled birth attendance, family planning and exclusive breastfeeding. We propose a randomized clinical trial to determine effect of using mobile phones to deliver SMS (one-way) versus an interactive SMS dialogue (two-way) on uptake of reproductive and neonatal health services and maternal and infant outcomes


Eligibility criteria: Inclusion Criteria:

* Pregnant
* Access to a mobile phone
* Able to read SMS messages
* Willing to receive SMS messages

Exclusion Criteria:

* Unwilling or unable to meet inclusion criteria

Primary outcomes:
measure: Contraceptive uptake
timeFrame: 10 weeks postpartum; 24 weeks postpartum
measure: Facility Delivery
timeFrame: Postpartum
measure: Exclusive Breastfeeding
timeFrame: 24 weeks postpartum
Secondary outcomes:
measure: ANC attendance
timeFrame: Postpartum
measure: Infant Immunizations
timeFrame: Six months postpartum
measure: Maternal mortality
timeFrame: 6 months postpartum
measure: Infant mortality
timeFrame: Six months postpartum
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Mathare North Health Centre
Study officials:
References:
citation: Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
Clinical trial NCT00000326: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1
Official title: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1(1)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Heroin Dependence
Opioid-Related Disorders
Keywords: Heroin Dependence
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.

Detailed description: Alternate-day dosing with the 8mg buprenorphine-naloxone tablet is as safe and effective as daily dosing. Outcomes are improved when the total weekly dose provided during alternate-day dosing is equal to that given during daily dosing.

Eligibility criteria: Inclusion Criteria:

Individuals must be currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency.

Exclusion Criteria:

Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

Primary outcomes:
measure: Drug use
measure: Retention
measure: Subjective dose estimate
measure: Observed withdrawal rating
measure: Opioid agonist rating
measure: Opioid antagonist rating
measure: Pupil diameter
measure: Compliance
measure: Analog rating scale for drug effects
measure: Drug effect characteristics
measure: Dose order estimate-nurse
measure: Dose order estimate-client
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Leslie Amass, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: (presented at ACNP 1997. Kamien, J.B., Mikulich, S.K., and Amass, L., Efficacy of the buprenorphine/naloxone tablet for daily vs. alternate-day opioid dependence treatment. Presented to the 1998 Meeting of the College on Problems of Drug Dependence.. Presented at ACNP 1997 and CPDD 1998.
Clinical trial NCT01784926: Late Dislocation of Intraocular Lens (IOL) Following Cataract Surgery: an Evaluation of Two Different Surgical Methods
Official title: Late Dislocation of Intraocular Lens (IOL) Following Cataract Surgery: an Evaluation of Two Different Surgical Methods
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intraocular Lens Dislocation
Keywords: cataract surgery
scleral suturing
Verisyse
Late in-the-bag IOL dislocation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2013-02-06
Enrollment: 104
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective randomized study on patients with late in the bag intraocular lens (IOL) dislocation, after cataract surgery. To obtain normal visual function, these patients needs surgery. In this study the investigators will look for advantages and dis-advantages after two different surgical approaches to late in-the-bag IOL dislocation.

Detailed description: In this prospective, randomized study The investigators will include at least 80 patients with late intraocular lens (IOL) dislocation in the capsular complex, after cataract surgery. To obtain normal visual function, these patients needs surgery. Today, there are two different methods used for this condition; scleral suturing of the capsular complex or exchange of IOL to an iris-fixated IOL (Verisyse). In this study the investigators will look for advantages and dis-advantages for these two methods.

Eligibility criteria: Inclusion Criteria:

* patients with dislocation of IOL in the capsular complex who agree to participate in the study

Exclusion Criteria:

* patients with total dislocation of the capsular complex'
* patients with reduced general health
* patients who can't be randomized

Primary outcomes:
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: 6 months, 1 year and 2 years
measure: Intraocular Pressure (IOP)
timeFrame: 6 months and 2 years
measure: Endothelial Density
timeFrame: 6 months
measure: Postoperative Complications
timeFrame: 6 months and 2 years
Secondary outcomes:
measure: Keratometry
timeFrame: 6 months (only analyzed/reported for this time frame)
measure: Questionnaire Visual Function-14 (VF-14) Score
timeFrame: 6 months (only analyzed/reported for this time frame)
measure: IOL Location
timeFrame: 2 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Liv Drolsum, MD, PhD
role: STUDY_CHAIR
References:
citation: Dalby M, Drolsum L, Kristianslund O. Repositioning surgery of different intraocular lens designs in eyes with late in-the-bag intraocular lens dislocation. J Cataract Refract Surg. 2021 Sep 1;47(9):1147-1152. doi: 10.1097/j.jcrs.0000000000000588.
citation: Kristianslund O, Ostern AE, Drolsum L. Astigmatism and Refractive Outcome After Late In-The-Bag Intraocular Lens Dislocation Surgery: A Randomized Clinical Trial. Invest Ophthalmol Vis Sci. 2017 Sep 1;58(11):4747-4753. doi: 10.1167/iovs.17-22723.