louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05816902: AI Prediction Model and Risk Stratification for Lung Metastasis in Colorectal Cancer
Official title: Development and Validation of an Artificial Intelligence Prediction Model and a Survival Risk Stratification for Lung Metastasis in Colorectal Cancer From Highly Imbalanced Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lung Metastases
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Harbin Medical University
First posted: 2023-04-18
Enrollment: 2779
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with pathologic confirmation of a primary CRC diagnosis

Brief summary: Background:

To assist clinicians with diagnosis and optimal treatment decision-making, we attempted to develop and validate an artificial intelligence prediction model for lung metastasis (LM) in colorectal cancer (CRC) patients.

Method:

The clinicopathological characteristics of 46037 CRC patients from the Surveillance, Epidemiology, and End Results (SEER) database and 2779 CRC patients from a multi-center external validation set were collected retrospectively. After feature selection by univariate and multivariate analyses, six machine learning (ML) models, including logistic regression, K-nearest neighbor, support vector machine, decision tree, random forest, and balanced random forest (BRF), were developed and validated for the LM prediction. The optimization model with best performance was compared to the clinical predictor. In addition, stratified LM patients by risk score were utilized for survival analysis.


Eligibility criteria: Inclusion Criteria:

* patients with pathologic confirmation of a primary CRC diagnosis

Exclusion Criteria:

* (1) patients with multiple primary cancers or other malignancies; (2) patients identified via autopsy or death certificate; and (3) patients with uncertain clinical data values

Primary outcomes:
measure: lung metastasis
timeFrame: through study completion, an average of 3 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00459602: Incisional Hernia Outcomes Study Using Parietex Composite Mesh
Official title: A Multi-Center, Laparoscopic Abdominal-Wall Hernia Repair Outcomes Study Using Parietex Composite Mesh
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Incisional Hernia
Keywords: laparoscopic surgery
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2007-04-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical clinic

Brief summary: The purpose of this study is to describe the outcomes of laparoscopic incisional hernia repair surgery and to record the outcomes of patients after surgery.

Detailed description: For subjects who agree to participate in this study, participation will last for 1 year. Subjects will undergo all the routine preoperative testing, the same as would be required if they were not participating in this study. This testing includes a blood sample and an electrocardiogram (ECG). Follow up visits will be done at 2 weeks after surgery, 6 weeks after surgery, and 1 year after surgery. Except for the 1 year visit, these office visits are routine and would be requested even if you were not participating in this study. At each of these visits, subjects will be asked about their level of pain and the amount and type of pain medication their are taking. Data gathered for this study will be on outcomes only.

Eligibility criteria: Inclusion Criteria:

* incisional hernia suitable for repair by laparoscopic techniques

Exclusion Criteria:

* not a candidate for laparoscopic surgery
* hernia not suitable for laparoscopic repair techniques

Primary outcomes:
measure: Visual analog (VAS) scale
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University College of Physicians and Surgeons
state: New York
Study officials:
affiliation: Columbia University
name: Dennis L Fowler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02506621: ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation
Official title: Randomised ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Eastbourne General Hospital
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Randomised crossover study comparing the sensitivity and specificity of 5 External loop recorders in detecting pacemaker detected Atrial fibrillation burden.

Detailed description: The purpose of the study is to compare the diagnostic accuracy of the ZIO xt , MoMe, TECHNOMED pocket ECG and Nuubo to the R-test, our current standard clinical practice, in detection of AF burden, in patients with history of Paroxysmal Atrial Fibrillation and have a dual chamber pacemaker or ICD in situ, with sensitivity and specificity of AF detection calculated from the implanted pacemaker monitored beat to beat holters.

Eligibility criteria: Inclusion Criteria:

* History of Atrial Fibrillation
* Dual chamber pacemaker with advanced holter arrhythmia diagnostics

Exclusion Criteria:

* Previous AV node ablation

Primary outcomes:
measure: Sensitivity and specificity in detection of pacemaker detected AF burden in comparison to R-test
timeFrame: 14 weeks
Secondary outcomes:
measure: proportion of pacemaker detected tachyarrhythmias detected in comparison to R-test
timeFrame: 14 weeks
measure: Total wear time in comparison to R-test
timeFrame: 14 weeks
measure: Proportion of symptomatic arrhythmias detected in comparison to R-test
timeFrame: 14 weeks
measure: Cost effectiveness in detection of arrhythmias in comparison to R-test
timeFrame: 14 weeks
Other outcomes:
measure: User satisfaction in interpretation of reports compare
timeFrame: 14 weeks
measure: Participant feedback on device tolerability assessed by Visual Analogue Score (VAS) questionnaire
timeFrame: 14 weeks
Locations:
Study officials:
affiliation: Eastbourne General Hospital
name: Neil Sulke, DM, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00001621: Evaluation and Treatment of Patients With Lung Disease Not Participating in Research
Official title: Evaluation and Treatment of Pulmonary Patients Not Participating in Research (Training Protocol)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease
Keywords: Teaching
Pulmonary Disease
Routine Testing
Medically Indicated
Pulmonary Function Test
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 280
Sex: ALL
Minimum age (years): 8
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pulmonary disease who do not meet the criteria for existing research protocols.

Brief summary: This study was developed in order for the professional-staff at the Pulmonary-Critical Care Medical Branch (PCCMB) of the National Heart, Lung, and Blood Institute to maintain their skills and increase their understanding of lung diseases.

The study will permit PCCMB staff members to evaluate and treat patients with lung disease who do not meet the criteria for other research studies.

Detailed description: The professional staff in the Cardiovascular and Pulmonary Branch (CPB) needs to maintain their clinical skills and to enhance their clinical knowledge. The purpose of this protocol is to permit CPB staff to evaluate and treat patients with pulmonary disease who do not meet the criteria for existing research protocols.

Eligibility criteria: * INCLUSION CRITERIA:

Patients 8 years old and older with signs or symptoms of pulmonary disease of medical interest to the professional staff of CPB will be eligible for participation in this protocol. Only standard diagnostic procedures and conventional therapy will be performed. Patients will not be subjected to any research procedures. This protocol does not commit the NIH to medical or surgical treatment of protocol participants after discharge. Patients will be discharged to the referring physician.

Consenting to pregnancy testing in minors of childbearing age:

We will inform the minor during the assent process that for safety, we need to do a pregnancy test. She will also be told that if it is positive, we will counsel her and help her tell her parents. If the minor does not want to proceed she will be advised not to sign assent and her enrollment on this training protocol will end.

EXCLUSION CRITERIA:

Patients without symptoms of pulmonary disease will be excluded from this protocol.

Primary outcomes:
measure: to permit PB staff to evaluate and treat patients with pulmonary disease who do not meet the criteria for existing research protocols.
timeFrame: 1 visit
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Joel Moss, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06041321: Novel Bioactive Sleeve on Pain and PROMs
Official title: The Effect of a Novel Bioactive Sleeve on Postoperative Pain and Patient Reported Outcome Scores After Arthroscopic Meniscectomy and Meniscus Repairs: A Randomized Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meniscus Tear
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Reparel
First posted: 2023-09-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a phase IV, parallel designed, placebo controlled, randomized clinical trial
Primary purpose: BASIC_SCIENCE

Brief summary: A novel bioactive sleeve will be compared to a placebo sleeve with a similar look and feel to assess pain outcomes, patient reported outcome measures, and effectiveness of healing based on range of motion.

Detailed description: This is a blinded randomized prospective study comparing two postoperative leg sleeves. The novel bioactive sleeve (Reparel Leg Sleeve) will be compared to a regular black sleeve with a similar feel/compression. The main hypothesis for this study is that postoperative use of a novel bioactive sleeve after partial arthroscopic meniscectomy/meniscus repair will decrease pain and improve patient reported outcome scores faster and more reliably than the control non-bioactive sleeve. In order to test this hypothesis, approximately 100 patients scheduled for meniscectomy/meniscus repair will be randomized to one of the two arms in order to minimize bias. The following variables will be assessed: patient reported outcomes (VAS, KOOS JR, VR12, and KSS Satisfaction), physical therapy time, motor testing. Each patient will fill out a series of PROMs preoperatively, and post operatively at the 1-week, 2-week, 6-week, 3-month, 6-month, 1 year, and 2-year mark.

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, over the age of 18, undergoing a meniscectomy or meniscus repair
* In good general health as evidenced by medical history
* Under 45th percentile BMI
* Willing to adhere to the study intervention regimenregimen.
* Kellgren-Lawrence grade 2 or less

Exclusion Criteria:

* Febrile illness within 3 months
* BMI over 40
* Treatment with another investigational drug or other intervention within 6 months
* Kellgren-Lawrence grade 3 or more or 4
* History of autoimmune disease, circulatory disease, or vascular disorder

Primary outcomes:
measure: Visual Analogue Scale (VAS) pain score
timeFrame: 2 years
Secondary outcomes:
measure: Range of Motion
timeFrame: 2 years
Other outcomes:
Locations:
city: Woodbury
country: United States
facility: Orlin and Cohen Orthopedics
state: New York
Study officials:
References:
Clinical trial NCT03293121: Effect of Strength and Coordination Training on Biomechanics and Injury in New Runners
Official title: Effect of Strength and Coordination Training on Biomechanics and Injury in New Runners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injuries
Patellofemoral Pain Syndrome
Iliotibial Band Syndrome
Keywords: running related injuries
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize that new runners participating in an 8 week strength and coordination training program prior to beginning to run will 1) display different coordination patterns , and 2) experience fewer injuries, compared to new runners who do not perform strength or coordination training prior to running.

Detailed description: The study will investigate the effect of a sequenced training program - beginning with strength training, followed by running-specific coordination exercises, and finally a gradual introduction to running - on strength, coordination and injury incidence in a group of novice runners. he investigators hypothesize that runners who perform strength and coordination training prior to beginning to run will 1) demonstrate greater lower extremity strength, 2) demonstrate alters coordination patterns and 3) experience fewer injuries, when compared to a control group of novice runners who perform no physical preparation prior to a gradual introduction to running. The possible long-term benefits of this study include reduced burden of running-related injuries, increased participation in the sport of running, improved cardiovascular and metabolic health characteristics, and reduced incidence of disease such as cardiovascular events and cancer.

Eligibility criteria: Inclusion Criteria:

* No previous participation in running races
* Run less than 10km total in past year
* Able to run continuously (ie at least 5mph) for 5 min (so that biomechanical analysis of running form can be conducted)
* Female participants may not be pregnant
* Participants will be screened using the PARQ+ form, and Parmed-X form completed by a physician if necessary
* Cleared for physical activity through screening
* English-speaking

Exclusion Criteria:

* Previous (at any time of life) training of 3 or months of consistently running 3 or more days per week

Primary outcomes:
measure: Running biomechanics
timeFrame: Change from week 0 to week 16
Secondary outcomes:
measure: Running injury.
timeFrame: Measured in days over the 16 week training period.
Other outcomes:
measure: Running performance
timeFrame: 16 weeks
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Sheryl Finucane, PT, PhD, CEEAA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06229821: Safety and Efficacy of Intrapulmonary Percussive Ventilation in Preterm Infants
Official title: Safety and Efficacy of Intrapulmonary Percussive Ventilation in Preterm Infants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiratory Distress Syndrome in Premature Infant
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 10
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Application of Intrapulmonary Percussive Ventilation (IPV) in preterm neonates, older than 14 days, who require mechanical ventilation. IPV will be administered in increasing intervals, for 15 minutes, starting every 6 hours, and ending every 24 hours; for a total of 7 days.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the benefits and safety of Intrapulmonary Percussive Ventilation in preterm infants. IPV has been demonstrated to be safe, and improve airway secretions clearance and decreased atelectasis in pediatric patients. We aim to evaluate the effects of IPV in preterm infants.


Eligibility criteria: INCLUSION CRITERIA

* Premature infants born before 32 weeks of gestation with birth weight less than 1500 grams.
* Infants requiring positive pressure ventilation by 14 days of life. EXCLUSION CRITERIA
* Infants with known or suspected chromosomal anomalies (Trisomy 13, 18, 21)
* Infants with Congenital Diaphragmatic Hernia
* Presence of air leak syndrome (pneumothorax, pneumomediastinum)
* Previous diagnosis of air leak syndrome.

Primary outcomes:
measure: Mechanical ventilation and supplemental oxygen
timeFrame: From the date of starting treatment protocol to 2 weeks after.
Secondary outcomes:
measure: Diagnosis of Bronchopulmonary Dysplasia
timeFrame: At 36 weeks gestational age
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04541121: 3D Maternal Fetal Attachment and Smoking
Official title: Effects of 3D Ultrasonography and 3D Printed Images on Maternal-fetal Attachment and Its Correlation With Overall Smoking Within Pregnancy and Smoking Cessation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maternal-Fetal Relations
Maternal Behavior
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 96
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3D ultrasound and picture of ultrasound or 3D ultrasound and printed model of fetal face
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determine whether 3D models of fetus' face created from 3D ultrasound will increase maternal attachment and aid in smoking cessation. Half of participants will receive 3D model and half will receive a picture of 3D ultrasound of their baby


Eligibility criteria: Inclusion Criteria:

* Age - Female 19-45 years of age
* Fluent in English
* Currently smoking cigarettes
* Currently pregnant (between 21- and 36-weeks' gestation)
* Have normal 20-week ultrasound

Exclusion Criteria:

* Having received more than 3 ultrasounds prior to study
* Medical need for additional ultrasounds
* Multiple fetuses
* \> 31 weeks gestation
* Does not smoke cigarettes
* Is not fluent in English

Primary outcomes:
measure: Maternal Antenatal Attachment Scale (MAAS)
timeFrame: 5 minutes
measure: The Timeline Follow Back (TLFB):
timeFrame: 10 minutes
measure: Salivary cotinine
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: John Cote, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06240221: A Clinical Registry to Track the Real World Use of the Saber-C® Cervical Fusion Device
Official title: A Clinical Registry to Track the Real World Use of the Saber-C® Cervical Fusion Device When Used for the Treatment of
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cervical Disc Disease
Lead sponsor: Research Source
Sponsor class: NETWORK
First posted: 2024-02-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A patient who meets all inclusion criteria and none exclusion criteria will be enrolled in the study. A patient is considered enrolled upon placement of the Elevation Spine Saber-C System during the surgical procedure. If the surgeon decides intra-operatively not to utilize Saber-C, the patient will be considered a screen failure.

Brief summary: The objective of this registry study is to collect radiographic and clinical outcome measures to determine the effectiveness of the Saber-C device.

Detailed description: The purpose of this Clinical Registry is to track the real world use the Saber-C cervical fusion device when used for the treatment of Cervical Degenerative Disc Disease from C-2 to T1 for Anterior Cervical Discectomy and Fusion (ACDF). The registry is intended to profile the use of the Saber-C cervical fusion device when used according to surgeon standard of care at clinical practices throughout the United States. The focus of the registry will be to track and better understand the safety, effectiveness and market value of the Saber-C cervical fusion device.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Planned treatment with the Saber-C implant
* Subject is willing and able to sign informed consent

Exclusion Criteria:

* Subject is pregnant
* Subject is a prisoner

Primary outcomes:
measure: Cervical spinal fusion status assessed via X-rays and CT scans
timeFrame: 1 year
measure: Clinical outcome via neck visual analog scale (VAS)
timeFrame: 1 year
measure: Clinical outcome via neck disability index (NDI)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Paducah
country: United States
facility: Strenge Spine
state: Kentucky
Study officials:
References: