louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00004573: Kinetics of Response of Cytomegalovirus With Ganciclovir Treatment Using Quantitative Real-Time PCR
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cytomegalovirus Infections
Keywords: cytomegalovirus viremia
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-02-21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: The overall purpose of this research is to develop and use a blood test to better understand how quickly the viral drug ganciclovir works to clear infection with the CMV virus (Cytomegalovirus) when it occurs. This test will potentially let doctors know early in the course of therapy when a virus is not responding well to the therapy and could therefore be resistant to the drug. The target population of this study will be primarily kidney and lung transplant patients with CMV detected in the blood, although other patients may also be included if they meet criteria. The study will be divided into two phases. Phase I will evaluate a small number of exploratory patients initiating ganciclovir therapy and will require frequent blood sampling to obtain detailed information regarding the kinetic response of the virus to therapy. This information will be analyzed to help guide decisions regarding the number and frequency of blood samples needed in the larger phase II portion of the study. Strains will be characterized using phenotypic and genotypic methods to determine the presence or absence of mutations potentially responsible for the resistance.


Eligibility criteria: Inclusion Criteria:

* Patients affiliated with Barnes-Jewish Hospital with CMV blood infection requiring antiviral therapy
* All patients will have a positive qualitative CMV PCR or viral culture before starting therapy
* Patients will receive treatment with ganciclovir at a dose and duration to be determined by the provider
* It is anticipated that most subjects will be organ transplant recipients but this is not a requirement of the study

Exclusion Criteria:

* Critically ill patients
* Patients with profound leukopenia or abnormal renal function that make a change in the antiviral drug dosage likely during the duration of the study
* Anemia (HGB \< 8 g/dl) that would contraindicate the extra blood draws required by this study
* Problems with vascular access that would interfere with obtaining blood samples required by this study
* Residence outside of the St. Louis metropolitan area during the period of ganciclovir therapy
* Patients who are unable to provide informed consent because of diminished capacity related to illness, dementia, or other reasons

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Infectious Diseases Division
state: Missouri
Study officials:
References:
Clinical trial NCT02584673: Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement
Official title: Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial and Midline Catheterization
Lead sponsor: Clear Guide Medical
Sponsor class: INDUSTRY
Collaborators: name: The Cooper Health System
First posted: 2015-10-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this research is to verify the procedural improvements enabled by use of a CAIG system to supplement existing ultrasound guided, needle-based procedures. The primary focus will be procedures performed by the Anesthesia department.

Detailed description: The study will utilize two groups of patients: control and test. The control group will receive the procedure with traditional methods and equipment currently in use at Cooper University. The test group will receive the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. It is anticipated that 100 patients will be included in the study. After each procedure completion times, number of needle repositions, and punctures will be recorded along with an "ease of procedure" self-reported qualitative metric from the physician performing the procedure.

Eligibility criteria: Inclusion Criteria:

* Undergoing vessel catheterization
* Able to give written informed consent

Exclusion Criteria:

* Unable to give informed consent
* Prisoners, pregnant women, and children

Primary outcomes:
measure: Time Needed to Correctly Insert the Arterial or Midline Catheter.
timeFrame: Immediately following intervention (within 2 hours)
Secondary outcomes:
measure: Clinician Rating of the Device
timeFrame: Immediately following intervention (within 2 hours)
measure: Number of Attempts
timeFrame: Immediately following intervention (within 2 hours)
measure: Number of Times Needle Needs Repositioning
timeFrame: Immediately following intervention (within 2 hours)
Other outcomes:
Locations:
city: Camden
country: United States
facility: The Cooper Health System
state: New Jersey
Study officials:
affiliation: The Cooper Health System
name: Irwin Gratz, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
Clinical trial NCT05755373: A Multinational Survey-based Study to Understand the Real-world Awareness and Perceptions of Systemic inFLAMmation and rolE of hsCRP as a Biomarker in Patients With AtheroSclerotic CardioVascular Disease and Chronic Kidney Disease Among Cardiologists
Official title: A Multinational Survey-based Study to Understand the Real-world Awareness and Perceptions of Systemic inFLAMmation and rolE of hsCRP as a Biomarker in Patients With AtheroSclerotic CardioVascular Disease and Chronic Kidney Disease Among Cardiologists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerotic Cardiovascular Disease (ASCVD)
Chronic Kidney Disease (CKD)
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-03-06
Enrollment: 602
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiologists treating patients with ASCVD and CKD

Brief summary: The purpose of this survey is to collect information for scientific research and to better understand the role of systemic inflammation in identification, treatment and management of patients with ASCVD and CKD.

This study is a cross-sectional design conducted among cardiologists in United Kingdom, Italy, Germany, Brazil, Saudi Arabia, Japan, Australia, China, India and France, treating ASCVD and CKD patients. Study participants will be recruited to complete an approximately 20-minute self-administered online survey. Recruitment will be conducted through email and phone. Data is collected though online data collection using a programmed survey.


Eligibility criteria: Inclusion Criteria:

1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Male or female, age above or equal to 18 years at the time of signing informed consent.
3. Is a Cardiologist.
4. Has been in practice greater than or equal to 3 years.
5. Sees at least 15 ASCVD and CKD patients per month.

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
3. Does not meet inclusion criteria requirements

Primary outcomes:
measure: Cardiologists' perceptions towards the role of systemic inflammation in the identification, treatment and management of patients with ASCVD and CKD. Multi-select from a defined list.
timeFrame: At the time of survey response (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05770973: Effect of Eyelid Patching After Ptosis Surgery
Official title: The Effect of Eyelid Patching After Anterior Lector Reinsertion and Blepharoplasty on Edema, Hematoma, Scar Formation and Ocular Surface Irritation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ptosis, Eyelid
Keywords: Ptosis, Blepharoplasty, Eyelid surgery
Lead sponsor: Augenklinik LMU
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized for compression dressing or none
Primary purpose: TREATMENT

Brief summary: The goal of this randomized, controlled, observer-blinded study is to compare the effect of compression dressing after ptosis surgery.

The main question it aims to answer are:

Effect of dressing on edema, hematoma, scar formation, ocular surface irritation and postoperative pain.

Patients are randomized after surgery for compression dressing or not. Results are scored by a blinded observer.

type of study: clinical trial


Eligibility criteria: Inclusion Criteria:

* Ptosis

Exclusion Criteria:

* kongenital ptosis, pre-surgery, trauma

Primary outcomes:
measure: hematoma
timeFrame: First postoperative day until 8 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: Augenklink LMU
Study officials:
affiliation: Augenklinik LMU
name: Anna Schuh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02020473: Informed Consents for Withholding/Withdrawing Life Support in Intensive Care Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Death Occurring in Intensive Care Units
Keywords: Informed consents
Withholding/withdrawing life support (WLS)
Intensive care unit (ICU)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-12-25
Enrollment: 348
Sex: ALL
Maximum age (years): 92
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who died from January 2012 to December 2012 in the surgical or medical Intensive Care Unit (ICU)

Brief summary: End-of- life care is a major issue in medical ethics with life support technology progress. Intensive care may prolong the dying process in patients who have been unresponsive to the treatment already provided. Withholding or withdrawing of life support (WLS) care was introduced to avoid the suffering of critically ill patients. Decision to WLS is a difficult and affected by several factors including not only disease severity but also ethics, religion, culture, and legal background. In western countries, advance directives had an important role to WLS for dying patients and honor patient autonomy. However, the illegality of advance directives in Korea and Korean culture under Confucianism, requiring children to do the best to treat their parents in the name of filial piety make physicians and family members difficult to WLS in terminally ill patients.

Additionally, WLS in intensive care unit had been usually decided without official documentation before the final legal decision by Supreme Court in Korea. Scanty information exists about end-of-life practices because informed consents of WLS were taken after the legal decision.

Thus, we aimed to investigate the current status of informed consent at the time of decision to WLS and difference between WLS group and non-WLS group in Korea.


Eligibility criteria: Inclusion Criteria:

* patients who died from January 2012 to December 2012 in the surgical or medical Intensive Care Unit (ICU) at Severance Hospital, Yonsei University Health System, in Seoul, Korea.

Exclusion Criteria:

* Patients diagnosed with brain death

Primary outcomes:
measure: Signing of informed consents for withholding/withdrawing life support
timeFrame: 1 year after ICU admission
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Chief of ICUs, Severance Hospital, Yonsei University Health System
Study officials:
References:
Clinical trial NCT01062373: Effect of Docosahexaenoic Acid (DHA)-Enriched Human Milk in Premature Newborns
Official title: Improvement of Polyunsaturated Fatty Acids Status in Premature Newborns Following Docosahexaenoic Acid Enrichment of Human Milk
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Premature
Keywords: Premature Newborns
Human Milk
DHA
Mother-child
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2010-02-04
Enrollment: 2
Sex: ALL
Minimum age (years): 1
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several recent publications showed a reduction in the level of DHA and/or an increase in the arachidonic acid (AA)/DHA ratio in the milk of mother. We hypothesized that the polyunsaturated fatty acid (PUFA) status of the premature newborn fed mother's milk is unbalanced because the content of DHA of the milk of mother nowadays is insufficient, whereas scientific arguments point-out the essential role of DHA and balanced AA/DHA ratio of human milk to explain the beneficial role of the breast-feeding at short, medium and long term. We will study the benefits of DHA supplements (TG-DHA versus GPL-DHA) of mothers in PUGA status improvement in their premature newborn consecutive to DHA enrichment and balanced AA/DHA ratio of human milk. GPL-DHA should be more effective than TG-DHA by protecting both n-3 and n-6 fatty acids pathways.


Eligibility criteria: Inclusion Criteria:

* Childbirth between 34 and 35 GA
* Breast-feeding
* Caucasian
* Affiliation to social security
* Obtained consent from mother, and parents for the child
* Mother with balanced diet
* No allergy to eggs
* Single pregnancy

Exclusion Criteria:

* Allergy to egg
* Unbalanced diet
* Diabetes
* Known digestive disease
* Counter-indication with breast-feeding
* Cigarettes (more than 5 per day)
* Alcoholism (daily consumption of alcohol)
* Multiple pregnancy

Primary outcomes:
measure: To improve PUFA status in premature newborns
timeFrame: 30 days
Secondary outcomes:
measure: PUFA in human milk (HM) and mothers
timeFrame: 6 months
measure: Impact on HM bioactives
timeFrame: 6 months
measure: Change in inflammation and oxydative stress
timeFrame: 6 months
measure: Genes expression in newborns
timeFrame: 6 months
measure: Link between mothers genetics and HM DHA level
timeFrame: 6 months
measure: Newborn survey at 6 month-old
timeFrame: 6 months
Other outcomes:
Locations:
city: Marseille Cedex 05
country: France
facility: Service de Médecine néonatale, Hôpital de la Conception
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Véronique Millet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01861873: Functional Treatment Planning Utilizing 18-FDGal PET/CT in SBRT for Liver Metastases
Official title: Phase 2 Study: Functional Treatment Planning Utilizing 18-FDGal PET/CT in SBRT for Liver Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Metastases
Keywords: liver function
galactose
18-F-deoxy-galactose
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2013-05-24
Enrollment: 28
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: Background: Anatomical (traditional) stereotactic body radio therapy(SBRT) treatment planning assumes homogenous distribution of function in the normal liver tissue. In functional treatment planning, additional information on distribution of the function derived from functional imaging of normal tissue is taken into account. by functional treatment planning it becomes possible to prioritize and spare the best functioning part of an organ.

Aim: To test whether functional treatment planning based on 18-FDGal PET/CT may spare the best functioning liver tissue.

Endpoints: Reduction in hepatic systemic clearance (K) in the dynamic 18-FDGal PET/CT scan one month after SBRT compared to the baseline status in sub-volumes recieving 15 Gy or higher. Secondly, the investigators will evaluate the toxicity to SBRT by a toxicity scoring system that includes biochemical measures as well as symptomatic scores.


Eligibility criteria: Inclusion Criteria:

* Performance status \>2
* liver metastases refereed for SBRT

Exclusion Criteria:

* pregnancy
* claustrophobia

Primary outcomes:
measure: volumetric uptake values of 18-FDGal will be measured and the 18-FDGal PET/CT one month after stereotactic body radioation therapy will be compared to the baseline status in sub-volumes receiving more than 15 Gy
timeFrame: up to 2 years
Secondary outcomes:
measure: evaluate toxicity to SBRT by toxicity scoring system that includes biochemical measures as well as symptomatic scores.
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT01880073: FemVue and Tubal Patency
Official title: Use of FemVue for Assessment of Tubal Patency as Compared to Laparoscopic Chromopertubation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tubal Patency
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2013-06-18
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A thorough infertility evaluation commonly involves determining whether a woman's fallopian tubes are patent. The two most often utilized methods of evaluating the fallopian tubes are hysterosalpingogram (taking an X-ray of the pelvis after injecting dye through the uterus and fallopian tubes) and laparoscopic chromopertubation (a surgical procedure in which dye is visualized passing through the fallopian tubes).

The FemVue Saline-Air device is a new method of assessing tubal patency. The device utilizes a mixture of saline and air bubbles that can be seen passing through the fallopian tubes by ultrasound. FemVue can be efficiently performed in a physician's office and is minimally invasive. Unlike hysterosalpingogram and laparoscopic chromopertubation, it does not carry the risks of anesthesia or surgery, and doesn't expose the patient to radiation or contrast. It does, like the other two methods, carry a small risk of infection.

This study will involve using the FemVue device on patients under anesthesia in the operating room before they undergo scheduled laparoscopic chromopertubation, the gold standard for evaluating tubal patency. The two methods will be compared to determine the accuracy of the FemVue device.

Detailed description: Subjects who agree to participate will have their tubes evaluated by using the FemVue Saline-Air device and laparoscopic chromopertubation.

Eligibility criteria: Inclusion Criteria:

* Pts ages 18-45 undergoing planned diagnostic laparoscopy with chromopertubation.

Exclusion Criteria:

* Adnexal mass \> 3.5cm or uterine size greater than 10 wks

Primary outcomes:
measure: Number of Subjects Who Had Concordant Findings
timeFrame: End of procedure, day 1.
measure: Number of Subjects With Discordant Findings
timeFrame: End of procedure, day 1.
Secondary outcomes:
measure: The Time Frame in Which Patency of the Tubes Was Determined With the FemVue Device.
timeFrame: 10 mins after start of procedure
measure: Time Frame in Which Patency of the Tubes Was Determined by Laparoscopic Chrompertubation.
timeFrame: End of procedure, Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Steven Spandorfer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00646373: Effect of Decreased Pump Prime Volume on Blood Transfusions and Postoperative Complications of Patients Undergoing High Risk Cardiac Surgical Procedures
Official title: Effect of Decreased Pump Prime Volume on Blood Transfusions and Postoperative Complications of Patients Undergoing High Risk Cardiac Surgical Procedures: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Surgery
Keywords: Cardiac surgery
Pump prime
Blood transfusions
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2008-03-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the impact of reduced pump prime on blood transfusions and postoperative complications in patients at high risk of severe hemodilution during CPB.

HYPOTHESIS The use of a new CPB circuit with a smaller internal volume, together with retrograde autologous priming of the lines (RAP) will allow a smaller prime volume and therefore less significant hemodilution on pump.

EXPERIMENTAL DESIGN Overview

Patients will be randomized on the morning of surgery to one of the two study groups in a 1:1 allocation scheme:

1. Low pump prime
2. Standard pump prime Outcomes The primary outcome is the number of units of blood products transfused within the first 24 hours post CPB.


Eligibility criteria: Inclusion Criteria:

* \>18 y of age
* Non-emergent complex cardiac surgery (any procedure other than primary isolated CABG)
* Any of the following: Hb \< 120 g/L (Females) or \< 130 g/L (Males)BSA \< 1.6 m2Creatinine Clearance \< 60 mL/min (Cockcroft Gault Equation)

Exclusion Criteria:

* aPTT \>50 s, INR\>1.5
* Plt \< 100,000 x 106
* Preoperative Hemodialysis
* Tight aortic stenosis (Aortic Valve Area \< 1 cm2)
* Tight lesion of the left main coronary artery (\> 60%)
* Use of Aprotinin requested by the Surgical Team

Primary outcomes:
measure: The number of units of blood products transfused within the first 24 hours post CPB.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: