louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04039490: Novel Device for Ultrasound-guided Pediatric Vessel Cannulations
Official title: Novel Device for Ultrasound-guided Pediatric Vessel Cannulations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients
Keywords: pediatrics
vessel cannulations
ultrasound-guided
Lead sponsor: Clear Guide Medical
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: Children's National Research Institute
First posted: 2019-07-31
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two-arm study, comparing ultrasound-only pediatric vessel cannulations versus SCENERGY-guided pediatric vessel cannulations
Primary purpose: OTHER

Brief summary: Clinical Trial to investigate whether the use of a novel device to be used in conjunction with ultrasound in pediatric vessel cannulations is superior to ultrasound-only pediatric vessel cannulations in terms of number of cannulation attempts.

Detailed description: Use of needle guidance plus ultrasound imaging for CVC placement in the pediatric high-risk population may facilitate the procedure with a single needle pass and decrease the incidence of adverse effects by minimizing additional needle passes. This study will compare the use of ultrasound-only guidance with the Clear Guide SCENERGY guidance in terms of successful first-attempt vessel cannulations such as internal jugular and fermoral artery access. The question is whether it is possible to make ultrasound-guided pediatric vascular access less technically challenging in order to improve adoption and utilization leading to decreased iatrogenic complications and improved patient safety.

Eligibility criteria: Inclusion Criteria:

* any pediatric patient scheduled for a vessel cannulation at CNMC

Exclusion Criteria:

* none

Primary outcomes:
measure: Successful first-attempt vessel cannulation
timeFrame: 1 hour
Secondary outcomes:
measure: Non-IR Personnel Successfully Cannulate Pediatric Patients
timeFrame: 1 hour
measure: Point-of-Care Successful Cannulation
timeFrame: 1 hour
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
Study officials:
References:
Clinical trial NCT02249390: Assisted Reproductive Technology Survey (ART Survey)
Official title: ART Survey: Assisted Reproductive Technology Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Reproductive Problem
Male Reproductive Problem
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 336
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the community. Parents of children who have participated in a research study at Pennington Biomedical Research Center or patients from local fertility clinics.

Brief summary: The purpose of the study is to collate local information to better understand the motivations, accessibility and frequency of assisted reproductive technology (ART) use in the community.

Detailed description: The ART survey study recruitment will last about 6 months with the study completed within 1 year. Study participation is an online survey which takes approximately 3 minutes to complete.

The goal is to apply for future funding to study the metabolic consequences of being conceived with ART.

Eligibility criteria: Inclusion Criteria:

* Any individual may complete this survey

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Method of Conception
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Leanne M Redman, MS, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01253590: Cardiac Monitoring of Post-Operative Cancer Patients Experiencing Atrial Fibrillation
Official title: Feasibility of Remote Cardiac Monitoring of Post-Operative Cancer Patients Experiencing Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Post-Operative Cancer Patients Experiencing Atrial
Fibrillation
Keywords: atrial fibrillation
ECG monitor
Blood pressure device
Remote Cardiac Monitoring
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-12-03
Enrollment: 5
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two cardiology attending physicians, Dr. Michelle Johnson and Dr. Carol L. Chen, who are members of this research team, will identify post-operative patients whose primary attending has made a decision to discharge.

Brief summary: The purpose of this study is to assess whether it is possible and acceptable to monitor patients at a distance who experience a condition called atrial fibrillation after their cancer surgery. Some patients have no other clinical reason for staying in the hospital after cancer surgery except in order to control their heart rhythm. Being able to send these patients home earlier and monitor them at a distance from their home can be good for their quick recovery. Studies have shown greater quality of life and patient satisfaction when patients are monitored at a distance for conditions like atrial fibrillation, however cancer patients have not been studied.


Eligibility criteria: Inclusion Criteria:

* Post-Operative cancer patients experiencing atrial fibrillation and otherwise clinically ready to be discharged.
* Must attend two outpatient visits at MSKCC's cardiology practice during the study period, as specified by the participant's Attending.
* Must be older than 21 years of age.

Exclusion Criteria:

* Non-English speaking patients

Primary outcomes:
measure: Assess the feasibility and acceptance of continuous remote cardiac monitoring
timeFrame: 4 to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Michelle Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06419790: Effect of Electrode Belt Used for Lung Monitoring With EIT on Tidal Volume
Official title: Effect of Electrode Belt Used for Lung Monitoring With Electrical Impedance Tomography on Tidal Volume of Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: EIT Electrode Belt Stiffness
Tidal Volume Changes
Keywords: electrode belt
EIT
spirometry
tidal volume
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Tidal volumes of ten spontaneously breathing healthy volunteers were measured using spirometer in two situations: wearing EIT electrode belt and without electrode belt. The changes of the tidal volumes were analysed in order to conclude whether the electrode belt has any impact on the volumes.

Detailed description: Ten healthy, spontaneously breathing volunteers were in supine semi-sitting position and their tidal volume was measured for 15 min using spirometer Ergostick (Geratherm) twice: with electrode belt placed around the subjcest thorax in the level of 4th to 6th intercostal space in the parasternal line, and then without the electrode belt. The subjects were breathing for approx. 15 min sponatenously with deep, forced breathing in the last minute.

The stiff silicone electrode belt used for lung monitoring with electrical impedance tomography system PulmoVista 500 (Dräger Medical) is being placed tightly around the subjects chest in order to monitor distribution of the ventilation. The aim of the study is to analyse the differences in tidal volumes of the spontaneously breathing subject with and without the electrode belt.

Since the electrode belt is relatively stiff and the manufacturer recommends putting the belt on tightly, there is a possibility that it affects the breathing effort of the spontaneously breathing patients, which could possibly lead to lower tidal volumes.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* morbid obesity
* Tiffeneau index lower than 80 %
* wounded skin in the electrode belt location

Primary outcomes:
measure: Changes in tidal volumes
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kladno
country: Czechia
facility: Faculty of Biomedical Engineering, Czech Technical University in Prague
Study officials:
affiliation: Faculty of Biomedical Engineering, Czech Technical University in Prague
name: Kristýna Koldová, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04177290: A PK Similarity Study of Two Sintilimab Products Produced by Different Processes in Advanced or Metastatic NSCLC Patients
Official title: A Phase I PK Similarity Study of Two Sintilimab Products Produced by Different Processes in Advanced or Metastatic NSCLC Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced or Metastatic NSCLC
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2019-11-26
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this is a phase I study comparing PK similarity of sintilimab by different production process (approved versus M1b) in Chinese advanced or metastatic NSCLC patients who have failed or been intolerant to at least one prior line of standard treatment


Eligibility criteria: Inclusion criteria

1. Histologically or cytologically confirmed locally advanced, recurrent or metastatic NSCLC patients who have received or been intolerant to at least one prior line of standard treatment.
2. No EGFR mutation or ALK rearrangement.
3. ECOG PS score 0 or 1.
4. BMI ≥ 21.0kg/m2 and ≤ 26.0kg/m2
5. Body weight ≥ 60.0kg and ≤ 75.0kg.
6. Adequate organ function per protocol-defined criteria.

Exclusion criteria

1. Exposure to any anti-PD-1, PD-L1, PD-L2 antibodies.
2. Allergic to any component of sintilimab.
3. Active autoimmune diseases.
4. Clinically unstable central nervous system metastasis.

Primary outcomes:
measure: PK is defined as AUC0-∞.
timeFrame: 28 days
Secondary outcomes:
measure: PK is defined as Cmax.
timeFrame: 28 days
measure: Safety of sintilimab (approved) versus sintilimab (M1b). AE is defined as treatment-related adverse events assessed by CTCAE v5.0.
timeFrame: from randomization through 90 days after last dosing
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
Study officials:
References:
Clinical trial NCT02990390: The Epidemiology of Recurrent Spontaneous Abortion Associated With Thrombophilla
Official title: Shanghai First Maternity and Infant Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recurrent Pregnancy Loss
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 45000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Woman who had their Second miscarriage before 12(th) week of gestation.

Brief summary: RSA is a multifactorial disorder resulting from genetic factors, anatomic factors, autoimmune disorders, endocrine dysfunction, thrombophilia, life style factors, and maternal infections. However, the underlying causes remain undetermined in up to 50% of cases. In this clinical cohort study, we intended to get an epidemiological evidence for patients with recurrent spontaneous abortion associated with thrombophilla.


Eligibility criteria: Inclusion Criteria:

* Woman who had 2 miscarriages before 12(th) week of gestation.Signed consent form.

Exclusion Criteria:

1. having experienced severe allergies, trauma history and/or operation history within 3 months;
2. with a history of mental illness and/or family history of mental illness
3. limb disabled
4. taking medicine within one month
5. suffering major events or having mood swings
6. with a history of recurrent pregnancy loss
7. having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine)
8. chromosome aberrations in anyone of the couple.

Primary outcomes:
measure: D-Dimer
timeFrame: through study completion, an average of 3 year
Secondary outcomes:
measure: BMI in kg/m^2
timeFrame: through study completion, an average of 3 year
measure: platelet aggregation time
timeFrame: through study completion, an average of 3 year
measure: anticardiolipin antibody
timeFrame: through study completion, an average of 3 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai first Maternity and Infant health hospital, Tong Ji University
Study officials:
References:
Clinical trial NCT05078723: CYP2C19 Variants and Limonene Metabolism
Official title: Functional Consequences of CYP2C19 Variants on Limonene Metabolism in Humans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CYP2C19 Genetic Variants
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Human volunteers participating in this study will be given an over the counter orange peel extract and limonene levels will be measured.
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators will examine whether a non-invasive screening tool for CYP2C19 genetic variants can be developed by measuring limonene metabolism.

Detailed description: Cytochrome P450 2C19 is an important enzyme that metabolizes many drugs. However, individuals with genetic variants of CYP2C19, such as CYP2C19\*2 and CYP2C19\*3, are poor metabolizers of these drugs. Therefore, it is of interest to determine whether the investigators can develop a non-invasive assay to identify genetic variants of CYP2C19 by using a substrate for CYP2C19 found in citrus fruit, limonene. The purpose of the study is to examine changes in limonene levels in human breath after drinking orange peel extract for people with CYP2C19\*2 and CYP2C19\*3 genetic variants versus those that do not.

Eligibility criteria: Inclusion Criteria:

* Age range: Greater than 18 years and less than 45 years.
* Gender: Male or Female
* Ethnicities: East Asian

Exclusion Criteria:

* Pregnant and/or Breastfeeding
* previous allergic reaction to limonene, citrus fruits, bovine gelatin, glycerin
* past medical history of cerebrovascular or cardiovascular disease
* veganism
* history of chest pain or shortness of breath in the past month
* certain medications that are CYP2C19 substrates or CYP2C19 inhibitors
* Non-East Asian descent
* age less than 18 y.o or age greater than 45 y.o

Primary outcomes:
measure: Breath limonene value in parts per billion
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford School of Medicine
state: California
Study officials:
References:
Clinical trial NCT00241423: Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes
Official title: Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes Using Metformin or Metformin Plus a Thiazolidinedione
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: exenatide
diabetes
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2005-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the hypothesis that in patients with type 2 diabetes, the addition of exenatide will result in lower time-averaged serum glucose during a 24-hour period, compared with placebo.


Eligibility criteria: Inclusion Criteria:

* Subject has an HbA1c between 7.0% and 10.0%, inclusive.
* Subject has a body mass index (BMI) \>25 kg/m\^2 and \<50 kg/m\^2.
* Subject is on a stable dose of metformin or metformin plus a thiazolidinedione.

Exclusion Criteria:

* Subject has been treated with any of the following medications: \*exogenous insulin for more than 1 week within 3 months of screening, \*sulfonylureas or meglitinides within 2 months of screening, \*alpha-glucosidase inhibitors within 2 months of screening, \*pramlintide acetate injection within 2 months of screening.
* Subject has received exenatide, GLP-1 analogs, DPP-IV inhibitors, or has participated in this study previously.

Primary outcomes:
measure: Time-averaged serum glucose during a 24-hour period
timeFrame: Every half-hour to hour for 24 hours
Secondary outcomes:
measure: To compare the effects of exenatide and placebo on serum glucose
timeFrame: Each half-hour to 2 hours for 24 hours
Other outcomes:
Locations:
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: San Antonio
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: James Malone, MD
role: STUDY_DIRECTOR
References:
citation: Brodows RG, Qu Y, Johns D, Kim D, Holcombe JH. Quantifying the effect of exenatide and insulin glargine on postprandial glucose excursions in patients with type 2 diabetes. Curr Med Res Opin. 2008 May;24(5):1395-7. doi: 10.1185/030079908x297268. Epub 2008 Apr 3.
Clinical trial NCT05512923: Incidence and Risk Factors of Venous Thrombosis of the Lower Limbs After Hospitalization in Medical Patients at Risk
Official title: Incidence and Risk Factors of Venous Thrombosis of the Lower Limbs After Hospitalization in Medical Patients at Risk
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patients Hospitalized for More Than 48 Hours
Acute Medical Illness
Keywords: MTE
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients included adults aged at least 40 years old, hospitalized for more than 48 hours for an acute medical illness

Brief summary: In Tunisia, the available data are limited regarding the incidence of venous thrombosis of the lower limbs (TVMI) post-hospitalization, whether symptomatic or subclinical. The thromboprophylactic strategy will certainly depend on the incidence of this complication and its severity. In this study, we performed a systematic screening for TVMI in a well-characterized cohort of patients discharged after hospitalization \>48h for an acute medical condition.

Detailed description: This is a prospective follow-up of patients after hospitalization for more than 48 hours 6 weeks after discharge. The study must be approved by the ethics committee and all patients will have given their written informed consent.

Eligibility criteria: Inclusion Criteria:

* patients included adults aged at least 40 years old
* hospitalized for more than 48 hours for an acute medical illness (i.e. heart failure, active cancer, acute ischemic stroke, infectious diseases, inflammatory disease and respiratory failure acute)
* patients at risk of MIVT due to moderate or severe immobility, history of thrombophilia (factor C or S deficiency, etc.), body mass index of 30 kg/m2.

Exclusion Criteria:

* hospitalised for less than 48
* patients who required intensive care, patients with cognitive impairment, patients admitted for SARS-CoV-2 infection or patients with a hospital stay \<2 days, patients with a pre-existing reason for anticoagulation (therapeutic), such as atrial fibrillation or ETD and patients in whom MIVT is discovered on first ultrasound examination upon discharge from hospital.

Primary outcomes:
measure: presence of any symptoms suggestive of venous or arterial thromboembolic disease
timeFrame: Day7
Secondary outcomes:
measure: presence of any symptoms suggestive of venous or arterial thromboembolic disease
timeFrame: day45
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Nouira
Study officials:
affiliation: CHU Fattouma Bourguiba Monastir, service des urgences
name: nouira semir, Pr
role: STUDY_DIRECTOR
References: