louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00541541: Acoustic Cardiographic Assessment of Heart Function and the Role of Phrenic Nerve Stimulation
Official title: Acoustic Cardiographic Assessment of Heart Function and the Role of Phrenic Nerve Stimulation Following Open Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Congestive
Cardiac Pacing, Artificial
Transcutaneous Electric Nerve Stimulation
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
Collaborators: name: Inovise Medical
First posted: 2007-10-10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study, the investigators sought to determine whether a stimulation of the phrenic nerve affects heart function. Heart function is assessed by acoustic cardiography.

Detailed description: Patients who need temporary pacing following open heart surgery and who are willing to participate receive a phrenic nerve electrode during the operation. Heart function is postoperatively assessed by acoustic cardiography (Audicor, Inovise Medical Inc., Portland, USA) during different forms of pacing (right ventricle, left ventricle, biventricular; AAI, DDD) and with or without phrenic nerve stimulation. Acoustic cardiography simultaneously integrates heart sounds and single-channel electrocardiography input to generate multiple parameters that correlate to established hemodynamic measures. Effects of phrenic nerve stimulation on heart function will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Patients following open heart surgery who need temporary pacing

Exclusion Criteria:

* Patients with permanent pacemakers
* Patients with fast changing need of vasopressor therapy

Primary outcomes:
measure: Change of electrical mechanical activation time (EMAT) as measure of heart function on different settings of pacing
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern, Department of Cardiology
Study officials:
affiliation: Luzerner Kantonsspital
name: Paul Erne, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06824441: Feasibility Usability & Acceptability Study: Symptom Reporting by Children Adolescents & Young Adults w/Cancer
Official title: Symptom Reporting by Children, Adolescents and Young Adults With Cancer and Their Caregivers During a Clinic Visit: A Feasibility, Usability and Acceptability Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adolescent Behavior
Pediatric Cancer
Oncology
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 70
Sex: ALL
Minimum age (years): 7
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this project is to pilot test an electronically delivered symptom assessment tool Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE), completed by children/adolescents and young adults (AYAs) and caregivers and shared with their clinicians during an outpatient clinic visit, in preparation for a future test of intervention efficacy.


Eligibility criteria: Inclusion Criteria:

1. First diagnosis of cancer
2. Receiving cancer therapy: surgery, myelosuppressive chemotherapy and/or radiation
3. 7-21 years of age
4. Completed at least 1 month of cancer chemotherapy treatment and are within 7-28 days of starting a treatment cycle or during ongoing therapy, followed at least every month in clinic
5. If surgery was part of treatment, the patient must be 3-6 weeks post surgery before participating in study
6. Caregiver must be present and 18 years and older.
7. Ability to understand and the willingness to personally sign the written IRB approved informed consent or assent document as appropriate.

Exclusion Criteria:

1. Child must be able to read or listen to and understand English and not have cognitive/memory impairments determined by the child's clinician
2. Caregiver must be able to read and understand English.

Primary outcomes:
measure: Feasibility of Utilizing Ped-PRO-CTCAE for Clinician Access to Child/AYA and Caregiver Proxy Symptom Reports During Clinic Visits
timeFrame: 1 year
measure: Evaluation of Usability and Acceptability of Child/Adolescent and Caregiver Symptom Reports (Ped-PRO-CTCAE) for Clinicians in an Outpatient Oncology Clinic Setting
timeFrame: 1 year
measure: Analysis of Symptom-Related Outcome Variables to Inform Sample Size Calculations for a Future Randomized Clinical Trial of the Ped-PRO-CTCAE Intervention
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Kimberly Pyke-Grimm
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05355441: Pain Multidisciplinar Intervention in Major Trauma Patients
Official title: Pain Multidisciplinar Intervention Effect in Major Trauma Patients. Does it Improve the Quality of Life?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Chronic Pain
Psychological Trauma
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Corporacion Parc Tauli
First posted: 2022-05-02
Enrollment: 38
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: Major trauma patients with moderate, severe or incapacitating pain after hospital discharge.

Major trauma patients are defined as trauma patients that require an admission on the ICU.

Brief summary: In Spain, major trauma continues to be the leading cause of death among young people. However, mortality rates represent only a relatively small part of the impact of trauma injuries on the health of the population. Pain and anxiety are two of the most poorly controlled factors that have a huge impact on a patient's quality of life.The type of therapy that has been shown to be most effective in treating post-traumatic pain is one that involves different specialists, given its multicausality, care should be multidisciplinary.

This investigation project consists in an observational study performed by a multidisciplinary team in our center. Major trauma patients with moderate, severe or incapacitating pain will be referred to consultations specialized in chronic pain and psychology. One year after the trauma, patients will be evaluated in terms of quality of life.

The aim of this study is to determinate the impact that multidisciplinary treatment of post-traumatic pain has on the perception of quality of life in severely injured patients.


Eligibility criteria: Inclusion Criteria:

* Major trauma patients with moderate, severe or incapacitating pain (according to EQ-5D-5L scale).

Exclusion Criteria:

* Death in the first 30 days after the trauma.
* Transferred to another center.

Primary outcomes:
measure: Perception of quality of life according to EQ-5D-5L questionnaire
timeFrame: 1 year
Secondary outcomes:
measure: Type of pain according to EVA scale
timeFrame: 1 year
measure: Type of treatments requiered
timeFrame: 1 year
measure: Number of visits requiered in chronic pain and psychologic specialists
timeFrame: 1 year
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
state: Barcelona
Study officials:
affiliation: Corporacion Parc Tauli
name: Nuria Llorach-Perucho, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Corporacion Parc Tauli
name: Salvador Navarro-Soto, MD, PhD
role: STUDY_DIRECTOR
affiliation: Corporacion Parc Tauli
name: Heura Llaquet-Bayo, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01495741: Post-Authorization Safety Surveillance Study of Asenapine in Participants With Bipolar Disorder (P08307)
Official title: An Observational Post-Authorization Safety Surveillance (PASS) Study of Sycrest® (Asenapine) Among Patients Aged 18 and Older Diagnosed With Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Schizophrenia
Keywords: Mania
Manic
Depressive
Manic Depressive
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2011-12-20
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with Bipolar Disorder codes who are included in the United Kingdom Clinical Practice Research Datalink (CPRD) and, if required, The Health Improvement Network (THIN) database.

If pre-specified sample size and exposure criteria are met, secondary objectives will be conducted in 2 separate study populations: 1. Participants treated with asenapine and diagnosed with schizophrenia and no prior and/or concomitant diagnosis of bipolar disorder; 2. Participants treated with asenapine with no prior and/or concomitant diagnoses of bipolar disorder or schizophrenia, but diagnosed with i) Alzheimer's disease, ii) other diagnoses - mental disorders or iii) no diagnosis.

Brief summary: This study will assess asenapine (Sycrest®) use in participants with bipolar disorder; comparison will be made to the use of risperidone (RISPERDAL®CONSTA®) and olanzapine (Zyprexa®). The occurrence of identified and potential clinically important risks will also be assessed.


Eligibility criteria: Inclusion Criteria for the Bipolar Disease Cohort:

* A diagnosis of Bipolar Disorder

Exclusion Criteria for the Bipolar Disease Cohort:

* None

Inclusion Criteria for the potential Schizophrenia Cohort:

* A diagnosis of schizophrenia

Exclusion Criteria for the potential Schizophrenia Cohort:

* A prior and/or concomitant diagnosis of bipolar disease

Primary outcomes:
measure: Number of Participants with Bipolar Disorder with Identified and Potential Clinically Important Risks
timeFrame: Approximately 1 year
Secondary outcomes:
measure: Number of Participants with Schizophrenia with Identified and Potential Clinically Important Risks
timeFrame: Approximately 1 year
measure: Number of Participants without Diagnoses of Schizophrenia or Bipolar Disorder with Identified and Potential Clinically Important Risks
timeFrame: Approximately 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04474041: Study to Evaluate Visual Acuity Measured With the EyeQue Insight Versus a Standard Eyechart.
Official title: A Clinical Study to Evaluate Visual Acuity Measured With the EyeQue Insight Versus an Eyechart in a Healthcare Office Environment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Keywords: visual acuity
screening
vision
eye care
Lead sponsor: EyeQue Corp.
Sponsor class: INDUSTRY
Collaborators: name: Eye Boutique Optometry
First posted: 2020-07-16
Enrollment: 89
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: Open label exploratory study of the EyeQue Insight in healthy volunteers \>=7 years of age.

Detailed description: The primary objective of this study is to determine whether the EyeQue Insight (ETDRS visual acuity test) yields results similar to the standard ETDRS eyechart in the office.

Eligibility criteria: Inclusion Criteria:

1. Male or Female
2. Ages =\>7 y.o.
3. Subjects that are minors (\<18 years old) must have a parent or legal guardian.
4. Binocular vision
5. Willing and able to give informed consent and follow all study procedures and requirements
6. Fluent in English

Exclusion Criteria:

1. Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-19.
2. Has traveled outside the country within the last 4 weeks
3. Medications:

   a. Taking medications that may affect ability to follow instructions.
4. Eye Disease:

   a. Subjects with eye disease deemed by the Investigator to be inappropriate for the study such as an active eye infection.
5. Subjects that:

   1. Lack physical dexterity to properly operate the EyeQue App on the smartphone
   2. Lack the ability to follow instruction
   3. Lack binocular vision
   4. Lack the ability to maintain both eyes open

Primary outcomes:
measure: Acuity Visit 1
timeFrame: Visit 1: Day 0
Secondary outcomes:
measure: Acuity Visit 1 and 2
timeFrame: Visit 1 (Day 0) and Visit 2 (Day 7)
Other outcomes:
Locations:
city: Newark
country: United States
facility: EyeQue
state: California
Study officials:
References:
Clinical trial NCT01790841: DF4 Master Study (Safety and Efficacy Study)
Official title: Master Study of the BIOTRONIK DF4 System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Tachycardia
Ventricular Fibrillation
Sudden Cardiac Death
Heart Failure
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2013-02-13
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with standard ICD/CRT-D indication who are referred to the hospital.

Brief summary: The purpose of the study is to proof the safety and efficacy of the new ICD sytem (Iforia/Ilesto). The devices are available with DF-1 and DF4 connection. A special focus is set on the ICD system with DF4 connection.


Eligibility criteria: Inclusion Criteria:

* Patient has provided written informed consent.
* Patient has standard ICD/CRT-D indication.
* Patient accepts Home Monitoring concept.
* Patient is able to attend the planned hospital follow-up visits.
* Patient has legal capacity and ability to consent.

Exclusion Criteria:

* Patient has a standard contra-indication for ICD/CRT-D therapy.
* Age \< 18 years
* Patient is pregnant or breastfeeding.
* Patient is expected to receive ventricular assist device or heart transplantation within the next 12 months.
* Life expectancy of less than 12 months.
* Participating in any other clinical study of an investigational cardiac drug or device.

Primary outcomes:
measure: Serious adverse device effect (SADE) rate related to the ICD with DF4 connection
timeFrame: until 3 month follow-up
measure: SADE rate related to the Linox smart DF4 lead (ICD shock lead)
timeFrame: until 3 month follow-up
measure: Shift rate of the painless shock impedance measurement
timeFrame: between 3 and 6 month follow-up
measure: Pacing threshold comparison between Linox smart DF-1 and Linox smart DF4 lead
timeFrame: 3 month follow-up
Secondary outcomes:
measure: Comparison of automatic atrial pacing threshold test vs. manual measurement
timeFrame: 3 month follow-up
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Universitaetsmedizin Greifswald
Study officials:
References:
Clinical trial NCT05231941: Comparison of Intraoperative Intravenous Lidocaine Infusion and Transversus Abdominis Plane (TAP) Block for Post-operative Analgesia Following Laproscopic Cholecystectomy
Official title: Comparison of Intraoperative Intravenous Lidocaine Infusion and Transversus Abdominis Plane (TAP) Block for Post-operative Analgesia Following Laproscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Aga Khan University Hospital, Pakistan
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 90
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: TREATMENT

Brief summary: This study is aimed to determine the post operative pain after laparoscopic cholecystectomy by dividing patients into three different group. Group A will receive lidocaine 2mg/kg bolus at induction followed by 1.5mg/kg/hr infusion. Group B will receive bilateral subcostal TAP block with 0.375% 20ml Ropivicaine on each side. Group C will not receive any additional pain regime apart from the routine intraoperative analgesics. Pain score will be assessed post operatively for 24 hours at regular intervals using visual analog score.


Eligibility criteria: Inclusion Criteria:

* Age group (18-65)
* Undergoing elective Laproscopic Cholecystectomy
* ASA status I or II

Exclusion Criteria:

* Participation in any other trial
* Known hypersensitivity to study medications
* Chronic Opioid used
* Seizure disorder

Primary outcomes:
measure: Pain score
timeFrame: On arrival in PACU (0 hours)
measure: Pain score
timeFrame: At 2 hours
measure: Pain score
timeFrame: At 4 hours
measure: Pain score
timeFrame: At 6 hours
measure: Pain score
timeFrame: At 12 hours
measure: Pain Score
timeFrame: At 24 hours
Secondary outcomes:
measure: Post operative nausea and vomiting
timeFrame: On arrival, At 2 hours, 4 hours, 6 hours, 12 hours and 24 hours
measure: Patient Satisfaction
timeFrame: At 24 hours or discharge
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sind
Study officials:
affiliation: Aga Khan University
name: Haris Sheikh, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00013741: The MI-HEART Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Coronary Disease
Keywords: Acute Myocardial Infarction
Diabetes Mellitus
Renal Dialysis
Heart Attack
Coronary Heart Disease
Lead sponsor: National Library of Medicine (NLM)
Sponsor class: NIH
First posted: 2001-03-30
Enrollment: 55
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED

Brief summary: The purpose of the study is to examine ways in which a clinical information system can help patients better recognize the signs and symptoms of an acute myocardial infarction (heart attack) and to take actions to decrease morbidity and mortality that may be related to delay in seeking treatment. The software-based intervention will use the best scientific evidence to create tailored strategies using a patient's specific health data. This approach is based on well-established cognitive and behavioral educational models.


Eligibility criteria: Inclusion Criteria

* Patients at high-risk for an acute myocardial infarction, including any 2 of these risk factors: males age \> 45; females age \>55; family history of premature coronary heart disease (CHD); current cigarette smoker; hypertension; or elevated total cholesterol with low HDL and/or high LDL.

OR have:

* Active angina (chest pain due to coronary heart disease)
* History of coronary heart disease according to the treating physician
* Past history of myocardial infarction documented by electrocardiogram or arteriography
* Diabetes Mellitus
* Renal dialysis

Exclusion Criteria

* Hospitalization within previous 4 weeks
* Persons living in a home with previously enrolled patients
* Patients disoriented to person, place, or time at onset of study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University, Department of Medical Informatics
state: New York
Study officials:
affiliation: Columbia University
name: James J. Cimino, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05229341: Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
Official title: Evaluation of DNA Methylation Signatures in Diagnosis and Management of Thyroid Nodules
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thyroid Gland Carcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-02-08
Enrollment: 1450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial evaluates deoxyribonucleic acid (DNA) methylation signatures in diagnosing and managing thyroid nodules. The purpose of this research is to develop a new test for thyroid cancer. This test will use needle biopsies (small collections of tissue with a needle) from the thyroid to determine whether the participant has a malignant (cancer) or benign (not showing cancer) thyroid tumor. The information learned from this trial may help develop a more accurate test so that patients do not have unnecessary surgeries for nodules that are thought to be suspicious but are actually benign.

Detailed description: PRIMARY OBJECTIVE:

I. To evaluate the effect of Diagnostic DNA Methylation Signatures (DDMS-2) results (positive predictive value \[PPV\], negative predictive value \[NPV\], sensitivity and specificity) on physician decision-making for clinical management of 800 indeterminate thyroid nodules.

SECONDARY OBJECTIVES:

I. To determine sensitivity and specificity, PPV, NPV of DDMS-2 with 1450 needle biopsies including 800 needle biopsies with indeterminate cytopathology.

II. Compare the diagnostic accuracy between DDMS-2 and two currently used diagnostic approaches based on genetic alterations and gene expression within the same prospective cohort of 800 indeterminate needle biopsies.

OUTLINE:

Patients undergo needle biopsy for collection of tissue samples. Tissue samples are analyzed using DDMS-2. Patients' medical records are also reviewed.

Eligibility criteria: Inclusion Criteria:

* Patients without impaired decision-making capacity and who are undergoing needle biopsies for thyroid nodule diagnosis
* Over the age of 18
* Any gender, race and ethnicity
* Patients must provide informed consent prior to use of their tissues and clinical data

Exclusion Criteria:

* Children are excluded from the study, since the biology of children thyroid nodules is different from adults

Primary outcomes:
measure: Sensitivity of Diagnostic Deoxyribonucleic Acid (DNA) Methylation Signatures (DDMS-2)
timeFrame: Up to 5 years
measure: Specificity of DDMS-2
timeFrame: Up to 5 years
measure: Positive predictive value (PPV) of DDMS-2
timeFrame: Up to 5 years
measure: Negative predictive value (NPV) of DDMS-2
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: John H Yim
role: PRINCIPAL_INVESTIGATOR
References: