louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05813730: Urinary Creatinine Excretion Time in the Neonatal Period
Official title: Definition of Urinary Creatinine Excretion Time in the Neonatal Period, in Full Term Newborns : a Prospective Monocentric Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Function
Keywords: Newborn
Renal Function
Physiology
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 40
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Newborn's renal function is difficult to assess and its physiology during the first days of life is still incompletely known. Studies suggest that the newborn almost completely reabsorbs creatinine during the first 48 to 72 hours of life, while at the same time it continues to produce its own creatinine. Therefore, the initial stock of creatinine at birth still increases through this production and the non or weak clearance. A better knowledge of renal physiopathology in newborns would allow to improve the therapeutic management of the infants, particularly in case of potential nephrotoxicity. No study has attempted to assess the increase in urinary creatinine excretion in neonates from a given time.

Objectives: To show when urinary creatinine excretion in newborns is efficient. Results: this study mightr show an inflection point in urinary creatinine excretion illustrating the postnatal age when renal function becomes efficient.


Eligibility criteria: Inclusion Criteria:

* All full-term newborns (37WA or more)
* From a physiological and spontaneous pregnancy
* Good neonatal adaptation (Apgar 7 at 5 minutes of life)
* Eutrophic (weight \> 10th percentile and \< 90th percentile)

Exclusion Criteria:

* Newborns for whom no urine sample is interpretable
* Those with a significant clinical-biological anomaly
* Neonates with hemodynamic disorders such as low blood pressure (median \< gestational age) or hypovolemia (shock, signs of dehydration, need for volume expansion) during the first 3 days of life

Primary outcomes:
measure: Longitudinal changes in urinary creatinine excretion in newborns
timeFrame: Longitudinal changes of collected samples from birth until discharge from the maternity hospital (i.e. from birth up to 72 hours postnatal age)
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Maternite Regionale Universitaire CHRU NANCY
state: Lorraine
Study officials:
affiliation: CHRU Nancy
name: Nathalie LAMIREAU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06190730: REmote Symptom COllection to improVE postopeRative Care
Official title: REmote Symptom COllection to improVE postopeRative Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Cancer
Gastrointestinal Tumor
Gastrointestinal Tumor Surgery
Gastrointestinal Surgery
Keywords: speech system
large language model
ai
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Voice-Assisted Remote Symptom Monitoring System (VARSMS) will be installed on Amazon Echo Dot
Primary purpose: SUPPORTIVE_CARE

Brief summary: There are vulnerabilities in post-discharge care transition for patients after undergoing resection of malignant gastrointestinal tumors. This study aims to investigate the possibility of utilizing Voice-Assisted Remote Symptom Monitoring System (VARSMS) to alleviate some of these challenges.

Detailed description: Randomized controlled trial comparing post-op patients randomized to using the VARSMS vs control.

Eligibility criteria: Inclusion criteria

1. At least 18 years old. Ages of subjects \>89 will simply be reported as \>90.
2. Scheduled for a GI surgery for management of a tumor in a participating hospital.
3. Fluent in oral and written English.
4. Has consistent and continued full access to an operational Wi-Fi for the duration of the study.

Exclusion criteria

1. Unable to provide informed consent.
2. Not willing to commit to regular participation in the study to include daily use (40 days) of the study application.
3. Life expectancy of less than 60 days.
4. In the opinion of the investigator, participation in this study is contraindicated.

Primary outcomes:
measure: Custom questionnaire based on NCI PRO CTCAE (National Cancer Institute- Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events)
timeFrame: 40 days
Secondary outcomes:
measure: SASSI (Subjective Assessment of Speech System Interfaces)
timeFrame: 40 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: MedStar Health
state: Maryland
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
References:
Clinical trial NCT01209130: A Study of the Safety and Pharmacokinetics of Escalating Doses of DCDT2980S in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia And DCDT2980S in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non Hodgkin's Lymphoma
Official title: An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of DCDT2980S in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia And DCDT2980S in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-27
Enrollment: 91
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: This is a Phase I, multicenter, open-label, dose-escalation study of DCDT2980S administered by intravenous (IV) infusion to patients with relapsed or refractory hematologic malignancies. In addition, at selected sites, DCDT2980S will be studied in combination with rituximab.


Eligibility criteria: Inclusion Criteria:

* Life expectancy of at least 12 weeks
* History of histologically-documented hematologic malignancy for which no effective standard therapy exists: indolent NHL (including Grades 1-3a FL; MZL \[including splenic, nodal, and extra-nodal\]; and SLL), Grade 3b FL, DLBCL, MCL, or CLL
* Must have at least one bi-dimensionally measurable lesion

Exclusion Criteria:

* Prior use of any monoclonal antibody or antibody-drug conjugate within 4 weeks prior to study treatment
* Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent within 2 weeks prior to of study treatment
* Completion of autologous stem cell transplant within 100 days prior to study treatment
* Prior allogeneic stem cell transplant

Primary outcomes:
measure: Incidence and nature of dose-limiting toxicities (DLTs)
timeFrame: Throughout study or until early discontinuation
Secondary outcomes:
measure: Objective response, defined as a partial response (PR) or complete response (CR)
timeFrame: Throughout study or until early discontinuation
Other outcomes:
Locations:
city: Stanford
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Hackensack
country: United States
state: New Jersey
city: Portland
country: United States
state: Oregon
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01681030: The Fibrin Pad Cardiovascular Study
Official title: A Randomized, Controlled, Comparative Phase II Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiovascular Disease
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2012-09-07
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in cardiovascular surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass;
* Subjects must be willing to participate in the study and provide written informed consent.

Exclusion Criteria:

* Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
* Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 30 day follow up period after surgery.
* Female subjects who are pregnant or nursing.

Primary outcomes:
measure: Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.
timeFrame: Intraoperative, 3 minutes following treatment application
Secondary outcomes:
measure: Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application
timeFrame: Intraoperative, 6 minutes following treatment application
measure: Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application
timeFrame: Intraoperative, 10 minutes following treatment application
measure: Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment
timeFrame: Intra-operative, prior initiation of final chest wall closure. Safety Issue:
measure: Number of Participants With Adverse Events Potentially Related to Thrombotic Events
timeFrame: 30 days (+ 14 days) following surgery
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Clinical Investigation Site #5
state: Indiana
city: Kansas City
country: United States
facility: Clinical Investigation Site #6
state: Missouri
city: Camden
country: United States
facility: Clinical Investigation Site #4
state: New Jersey
city: Paterson
country: United States
facility: Clinical Investigation Site #1
state: New Jersey
city: New York
country: United States
facility: Clinical Investigation Site #3
state: New York
city: New York
country: United States
facility: Clinical Investigation Site #2
state: New York
Study officials:
affiliation: Ethicon, Inc.
name: Jerome Riebman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03888430: Transcutaneous PCO2 Assessment During Intubation in ICU
Official title: Transcutaneous PCO2 Assessment During Intubation in ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation in ICU
Keywords: Transcutaneous PCO2
Preoxygenation
Post-intubation hypotension
ICU
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU patients requiring intubation

Brief summary: PtcCO2 assessement during intubation in ICU. Comparison of three different preoxygenation methods.

Detailed description: Transcutaneous PCO2 assessement during intubation in ICU. Comparison of three different preoxygenation methods and hemodynamic changes during this period.

Eligibility criteria: Inclusion Criteria:

* Adult patient 18 years of age or older
* Requiring intubation in Resuscitation

Exclusion Criteria:

* Contraindication to orotracheal intubation
* Intubation in a respiratory or cardiocirculatory arrest situation
* Need for intubation in great urgency preventing the installation of the transcutaneous capnia sensor and its calibration
* Major Incapable
* Opposition of the patient or his relatives to the research

Primary outcomes:
measure: Transcutaneous carbon dioxide partial pressure variation during intubation
timeFrame: 4 hours after intubation (the day of inclusion)
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Aurélien FREROU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03541330: Information and Accompaniment of Siblings Following the Announcement of a Cancer in Pediatric Hematology.
Official title: Information and Accompaniment of Siblings Following the Announcement of a Cancer in Pediatric Hematology.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malignant Haemopathy
Keywords: Siblings
information
malignant haemopathy
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 23
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary objective is to evaluate the experience with the information received on the disease by the healthy brothers and sisters of childrens with malignant haemopathy at the Centre Hospitalier Régional et Universitaire of Lille


Eligibility criteria: Inclusion Criteria:

* Children from 6 to 12 years old
* Brother or sister of a child:

O has malignant haemopathy O follow-up in the pediatric hematology department in Lille, O diagnosed from 6 weeks to 1 year before maintenance of the healthy subject included

* whose parents are able to understand and sign voluntarily informed consent
* Affiliated to a social security scheme
* Ability to understand and answer questions alone during the semi-structured interview

Exclusion Criteria:

* Child under 6 years or over 12 years
* Subject with a pathology that may interfere with the course of the study, according to the investigator's assessment
* Absence of the informed consent of one of the parents and / or the legal representative
* Refusal of participation of the subject

Primary outcomes:
measure: Level of satisfaction and characteristics of information received about the disease by healthy siblings of children with hematological malignancies
timeFrame: 1 year
Secondary outcomes:
measure: Explore the representations of the disease in healthy siblings
timeFrame: 1 year
measure: Evaluate their information and support needs following the announcement of the disease
timeFrame: 1 year
measure: Identify the possible psychic and social consequences of the disease in these healthy subjects
timeFrame: 1 year
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Jeanne de Flandres, CHU
Study officials:
affiliation: University Hospital, Lille
name: Eva De Berranger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06208930: The Safety and Efficacy of Fecal Microbiota Transplantation in the Treatment of Digestive Diseases and Non-digestive System Diseases Associated With Gastrointestinal Symptoms in the Gastrointestinal Tract.
Official title: The Safety and Efficacy of Fecal Microbiota Transplantation in the Treatment of Digestive Diseases and Non-digestive System Diseases Associated With Gastrointestinal Symptoms in the Gastrointestinal Tract.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fecal Microbiota Transplantation
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The exploration of the safety and efficacy of fecal microbiota transplantation in the treatment of non-digestive system diseases associated with gastrointestinal symptoms in the gastrointestinal tract, while also investigating the impact of fecal microbiota transplantation on the intestinal system, and assessing the improvement of symptoms in other systems.Simultaneously optimizing the conditions during the FMT process, identifying the most effective treatment methods to enhance the therapeutic outcomes of FMT.


Eligibility criteria: Inclusion Criteria:

* Being able to tolerate a nasoenteric tube or swallow a capsule.

Exclusion Criteria:

* Intestinal barrier dysfunction. Inability to tolerate enteral nutrition.

Primary outcomes:
measure: Comparing the therapeutic efficacy of patients after FMT.
timeFrame: 0day, 7days, 30days, 3 months, 6months,12 months
measure: Comparing the differences in microbiota composition in samples such as feces and small intestinal fluid from patients.
timeFrame: 0day, 7days, 30days, 3 months, 6months,12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Le Wang
state: Shanghai
Study officials:
References:
Clinical trial NCT00657930: Observational Study in Type 2 Diabetes Treated by an Intensive Insulin Treatment (ICT) Containing Once Daily Levemir® (Insulin Detemir)
Official title: Evaluation on Glycaemic Control and Weight Change of Once Daily Levemir® (Insulin Detemir) in Type 2 Diabetes Mellitus Treated by an Intensive Insulin Treatment (ICT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-04-14
Enrollment: 2289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult Type 2 Diabetes Mellitus patients on intensive insulin treatment

Brief summary: This study is conducted in Europe. The aim of this observational study is to gain practical experience with once-daily Levemir administration in type 2 diabetes patients who were previously treated with Insulatard®, Humulin® N (NPH insulins) as basal insulin as part of their ICT under normal clinical practice conditions in Hungary.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic subjects on intensive insulin treatment (ICT)
* Eligibility for once daily insulin detemir administration
* Informed consent obtained before any observation-related activities

Exclusion Criteria:

* Known or suspected allergy to insulin detemir
* Subjects previously enrolled in the observation
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within 6 months.

Primary outcomes:
measure: Efficacy (HbA1c)
timeFrame: 24 weeks
Secondary outcomes:
measure: Body weight
timeFrame: 24 weeks
measure: Hypoglycaemia frequency
timeFrame: 24 weeks
measure: FBG variability
timeFrame: 24 weeks
measure: Insulin dose change
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Budapest
country: Hungary
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03853330: Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Patients With Multiple Fracture Ribs
Official title: Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Patients With Multiple Fracture Ribs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fracture; Rib, Multiple
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess the analgesic and respiratory effect of continuous Erector Spinae Plane block versus Thoracic Epidural in patients with multiple fracture ribs.

Detailed description: Erector spinae plane (ESP) block is a recently described technique which may be an alternative to Paravertebral block (PVB) for providing thoracic analgesia. It involves injection of local anesthetic into the fascial plane deep to erector spinae muscle. ESP is a more superficial block with a better defined end-point injection between the bony transverse process and erector spinae muscle. A more superficial ultrasound-guided block will be faster to perform and less painful for the patient. ESP does not have the same risk of pneumothorax as PVB.

Epidural analgesia has become the standard of care. Although thoracic epidurals provide excellent analgesia for the management of rib fractures, they are limited to a certain population due to patient factors and side-effects. Many trauma patients have other injuries which contraindicate the use of epidurals, or which prevent positioning for insertion. There are disadvantages to thoracic epidural analgesia. They are technically challenging to insert, with a risk of dural puncture or spinal cord injury. Adverse effects include hypotension, and if opioids used, urinary retention and pruritus. Patients can develop a motor block and are unable to mobilize with an epidural in situ.

Eligibility criteria: Inclusion Criteria:

* Patients with multiple fracture ribs.

Exclusion Criteria:

* Patient refusal.
* Patients with pre-existing infection at the block site.
* Coagulopathy.
* Allergy to local anesthetics.
* Pre-existing neurological deficits.
* Psychiatric illness.

Primary outcomes:
measure: Pain score (verbal numeric rating scale) as the median VNRS at rest and cough
timeFrame: up to 24 hours
Secondary outcomes:
measure: Pulmonary function test
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
References: