louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02899351: The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants
Official title: The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Complications
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 30
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intubated infants less than 12 months of age who are admitted to an Intensive Care Unit

Brief summary: In this research study, the investigators want to learn more about whether the Respiratory Volume Monitor (ExSpiron) can accurately measure breathing in infants less than 12 months of age. The Respiratory Volume Monitor uses up to 5 stickers that are placed on the chest to measure the amount of air going in and out of the lungs with each breath (Tidal Volume), the number of times per minute a breath is taken (Respiratory Rate), and the amount of air going in and out of the lungs per minute (Minute Ventilation).

It is important for medical staff to be able to collect information about breathing non-invasively because it may help determine if certain children are experiencing breathing problems sooner than the way it is currently detected.

The goal of this study is to determine if the Respiratory Volume Monitor works accurately in infants less than 12 months of age.


Eligibility criteria: Inclusion Criteria:

* less than 12 months of age
* currently intubated in the ICU

Exclusion Criteria:

* ExSpiron monitor will interfere with a healing surgical procedure site or standard of care

Primary outcomes:
measure: Respiratory rate accurately measured by the ExSpiron monitor during controlled ventilation
timeFrame: During 1 hour period in ICU
measure: Tidal Volume accurately measured by the ExSpiron monitor during controlled ventilation
timeFrame: During 1 hour period in ICU
measure: Minute ventilation accurately measured by the ExSpiron monitor during controlled ventilation
timeFrame: During 1 hour period in ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Viviane Nasr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Atkinson DB, Sens BA, Bernier RS, Gomez-Morad AD, Imsirovic J, Nasr VG. The Evaluation of a Noninvasive Respiratory Volume Monitor in Mechanically Ventilated Neonates and Infants. Anesth Analg. 2022 Jan 1;134(1):141-148. doi: 10.1213/ANE.0000000000005562.
Clinical trial NCT05540951: VIC Regimen Versus Bevacizumab Plus Chemotherapy as First-Line Treatment for BRAF V600E-Mutated Advanced Colorectal Cancer
Official title: VIC Regimen (Vemurafenib/Irinotecan/Cetuximab) Versus Bevacizumab Plus Chemotherapy as First-Line Treatment for BRAF V600E-Mutated Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, we compared first-line VIC regimen with chemotherapy plus bevacizumab in Chinese patients with initially unresectable BRAF V600E-mutated mCRC. The principal goal was to evaluate the safety of VIC regimen, and to investigate the tumor response, the radical resectability, and the patient survival.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 and ≤80 years old
* Histologically confirmed colorectal adenocarcinoma
* Histologically confirmed BRAFV600E mutated and RAS wild-type
* Initially unresectable metastatic or local CRC
* ECOG performance status of 0-1 and life expectancy ≥3 months
* adequate hepatic, renal, and hematologic function

Exclusion Criteria:

* Previously taken any targeted therapy, chemotherapy, intervention therapy, or radiotherapy for CRC within 6 months
* Other cancers (with the exception of cervical cancer in situ and squamous cell carcinoma of the skin) within the previous 5 years.

Primary outcomes:
measure: progression-free survival
timeFrame: 3 years
measure: overall survival
timeFrame: 3 years
measure: objective response rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of General Surgery, Zhongshan Hospital, Fudan University
Study officials:
References:
Clinical trial NCT05000151: Lung Volume Perception and Impact of a Cognitive Task on Ventilation in Hypermobile Ehlers-Danlos Syndrome.
Official title: Lung Volume Perception and Impact of a Cognitive Task on Ventilation in Healthy Subjects and Subjects With Hypermobile Ehlers-Danlos Syndrome.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypermobile Ehlers-Danlos Syndrome
Lead sponsor: Clinique de la Mitterie
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited through practitioners working with the clinic, who will propose participation in the study during consultations with patients diagnosed with EDS.

The recruitment of subjects for the control group will be carried out by internal communication within the Clinique de la Mitterie on a voluntary basis.

Brief summary: Patients with hypermobile Ehlers-Danlos syndrome have respiratory and proprioceptive disorders. The aim of this study is to explore whether there is an alteration in lung volume perception in patients with hEDS compared to healthy subjects, and whether a cognitive task can influence ventilation control differently in subjects with hEDS than in healthy subjects.


Eligibility criteria: Inclusion Criteria (common):

* More than 18 years old
* Understanding French

Inclusion Criteria (hEDS Patients):

* hEDS diagnosis

Inclusion Criteria (healthy subjects):

* Age (±5 years), Gender and BMI (±2.5kg/m²) matching

Exclusion Criteria (common):

* Pregnancy

Exclusion Criteria (hEDS Patients):

* Respiratory comorbidity independent of hEDS
* Previous participation in a rehabilitation programme at the clinic

Exclusion Criteria (healthy subjects):

* Known respiratory or proprioceptive pathology
* Hypermobility (evaluated with the Beighton score)

Primary outcomes:
measure: Accuracy of lung volume perception
timeFrame: Baseline
Secondary outcomes:
measure: Minute ventilation with or without cognitive task
timeFrame: Baseline
measure: Respiratory rate variability
timeFrame: Baseline
Other outcomes:
Locations:
city: Lomme
country: France
facility: Clinique de la Mitterie
Study officials:
affiliation: Clinique de la Mitterie
name: Cyrille Bergoin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UREPSSS
name: Patrick Mucci, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05826951: Social Effects of Alcohol
Official title: Social Effects of Alcohol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alcohol Drinking
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2023-04-24
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: In this study the investigator will assess the effect of a moderate dose of alcohol on emotional responses and feelings of connection during a dyadic semi-structured social interaction

Detailed description: The study will use a within-subject crossover design with four sessions, in which participants receive alcohol or placebo across sessions. During the four sessions, the participants will engage in a conversation with a stranger, and emotional responses and feelings of connection will be assessed.

Eligibility criteria: Inclusion Criteria:

* non-problem alcohol consumption of 2-20 drinks per week
* high school diploma or equivalent
* BMI between 19 and 26
* verbal fluency in English

Exclusion Criteria:

* High blood pressure
* Any medical condition requiring regular medication
* Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
* Women who are pregnant or trying to become pregnant.

Primary outcomes:
measure: facial emotional responses
timeFrame: during the length of the conversation (45 min)
measure: self-reported feelings of connection
timeFrame: at the end of each session (3.5 hrs post-drug administration). Changes across sessions will be assessed
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Harriet de Wit
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05269251: Effects of Brachial Plexus Block on Tissue Oxygenation
Official title: Effects of Brachial Plexus Block Applied With Different Approaches on Tissue Oxygenation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tissue Oxygenation
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ASA I-III patients aged 18-65 years, who were decided to apply axillary,infraclavicular and interscalene blocks as the anesthesia method, will be included in the study.

Brief summary: The aim of this study is to measure the effects of sympathetic blockade caused by peripheral nerve blocks performed with the axillary, infraclavicular and interscalene approach on tissue oxygenation with Near Infrared Spectroscopy (NIRS), to evaluate and compare the radial artery flow velocity and diameter in the blocked extremity, and to investigate whether there is a relationship with the quality of the sensory and motor block.

Detailed description: It has been reported that vasodilation after peripheral nerve blocks increases tissue oxygenation and increases arterial circulation on the ipsilateral side . Near Infrared Spectroscopy (NIRS), a noninvasive measurement method of tissue oxygen level, is used to measure regional hemoglobin oxygen saturation of arterial, venous and capillary blood .

Many studies have compared the effects of upper extremity peripheral nerve blocks on the onset, quality, extent, and postoperative pain of sensory and motor block through axillary, infraclavicular, supraclavicular and interscalene approaches.

The aim of this study is to measure the effects of sympathetic blockade caused by peripheral nerve blocks performed with the axillary, infraclavicular and interscalene approach on tissue oxygenation with Near Infrared Spectroscopy (NIRS), to evaluate and compare the radial artery flow velocity and diameter in the blocked extremity, and to investigate whether there is a relationship with the quality of the sensory and motor block.

Eligibility criteria: Inclusion Criteria:

* ASA I-III patients
* Patients between the ages of 18 and 65
* Patients who applied axillary block
* Patients who applied infraclavicular block
* Patients who applied interscalene block

Exclusion Criteria:

* Peripheral nerve disease a history
* History of thrombosis in the extremity to be blocked
* History of embolism in the extremity to be blocked
* Presence of neuropathy

Primary outcomes:
measure: tissue oxygenation
timeFrame: 30 minutes
Secondary outcomes:
measure: Radial artery diameter
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Demet Coskun
Study officials:
References:
Clinical trial NCT06356051: Cardiovascular Disease Risk in Children With Type 1 Diabetes Mellitus
Official title: Evaluation of Cardiovascular Disease Risk in Children With Type 1 Diabetes Mellitus by Oscillometric Method and Echocardiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 202
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: type 1 diabetes mellitus and age and gender mathced healthy children

Brief summary: Epicardial fat thickness, carotid intima-media thickness, and augmentation index from arterial stiffness indicators are increased in children with T1DM compared to the healthy control group. These results support the idea that children with T1DM present significant changes in important subclinical indicators for the development of cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

1. type T1DM patients
2. body mass index (BMI) between the 5th and 85th percentile according to age and gender
3. having T1DM for at least 2 years
4. ages 8-18 years

Exclusion Criteria:

1. having any chronic diseases other than T1DM
2. presence of a congenital and/or acquired heart disease, hypertension etc.

Primary outcomes:
measure: Epicardial fat thickness
timeFrame: january 2023-june 2023
Secondary outcomes:
measure: carotid intima-media thickness
timeFrame: january 2023-june 2023
measure: arterial stiffness parameters such as pulse wave velocity, augmentation index
timeFrame: january 2023-june 2023
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
References:
Clinical trial NCT01096277: Vascular Effects of Sitagliptin in Diabetes Mellitus
Official title: Metabolism-independent Vascular Effects of the Dipetidylpeptidase-4-inhibitor Sitagliptin in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2010-03-31
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Glucagon-like peptide 1 (GLP-1) is a 30-amino acid gut hormone secreted in a nutrient-dependent manner that stimulates insulin secretion and inhibits glucagon secretion and gastric emptying, thereby reducing postprandial glycemia.1,2 GLP-1 is derived from posttranslational proteolysis of preproglucagon, and its peptide sequence is identical in mouse, rat, and human.2,3 After secretion from enteroendocrine L cells, GLP-1(7-36) amide is rapidly degraded by dipeptidyl peptidase-4 (DPP-4) to its N-terminally truncated metabolite GLP-1(9-36), which does not interact with the known GLP-1 receptor.4,5 The diverse actions of GLP-1 include the proliferation, differentiation, and protection from apoptosis of pancreatic β cells and the induction of satiety. GLP-1 also improves memory and learning, stimulates afferent sensory nerves, and has neuroprotective functions.1,6 Furthermore, GLP-1 receptor agonists have been reported to have cardiac and vascular actions in rodents and humans that include effects on contractility, blood pressure, cardiac output,7-10 and cardioprotection.11-14

Detailed description: The aim of this study is to evaluate the effect of a therapy with the DPP-4-inhibitor sitagliptin on the prognostic relevant endothelial function and endothelial progenitor cells in patients with type 2 diabetes mellitus.

Primary endpoint: Endothelium-dependent vasodilation before and after treatment of patients with type 2 diabetes mellitus with the DPP-4-inhibitor Sitagliptin and placebo treatment respectively.

Secondary endpoint: effect of sitagliptin on mobilization, NO-production and in vivo regenerative capacity of human endothelial progenitor cells before and after treatment of patients with type 2 diabetes mellitus with the DPP-4-inhibitor sitagliptin and placebo treatment respectively

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes mellitus

Exclusion Criteria:

* Allergy to sitagliptin
* Treatment with PPAR-gamma agonist

Primary outcomes:
measure: Endothelial function
timeFrame: Before and after two week treatment
Secondary outcomes:
measure: Effect on EPCs
timeFrame: Before and after two week treatment
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: Sajoscha A. Sorrentino, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05273177: Muscle Strength Assessment in Patients With Chronic Ankle Instability
Official title: Valutazione Della Funzione Neuromuscolare Dei Muscoli Flessori ed Estensori Del Ginocchio in Pazienti Con instabilità Cronica di Caviglia (CAI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Ankle Instability
Keywords: ankle instability
muscle strength
quadriceps
hamstrings
maximal voluntary isometric contraction
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Orthopaedic hospital and community individuals

Brief summary: Patients with chronic ankle instability (CAI) show biomechanical and neuromuscular alterations during the performance of functional movements not only at the ankle joint level, but also in more proximal joints and segments. Few studies have been conducted to investigate the effects of chronic ankle instability on neuromuscular control at the knee joint level. The aim of this study is to investigate whenther abnormalities exists in maximal and sub-maximal isometric muscle strength expression in patients with CAI.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 40 years
* chronic ankle instability
* physically active individuals

Exclusion Criteria:

* sedentary behaviour
* previous injuries or surgeries to the lower limbs
* neurological disorders

Primary outcomes:
measure: Forces exerted by knee extensor and flexor muscles
timeFrame: Day 1
Secondary outcomes:
measure: Knee extensor and flexor muscles activations
timeFrame: Day 1
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: IRCCS Istituto Ortopedico Rizzoli
name: Maria Grazia Benedetti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04199377: Retrospective Evaluation of Clinical and Functional Results and Survivorship of Total Knee Replacement and Total Hip Replacement, Both Isolated or Combined.
Official title: Retrospective Evaluation of Clinical and Functional Results and Survivorship of Total Knee Replacement and Total Hip Replacement, Both Isolated or Combined.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIP REPLACEMENT
KNEE REPLACEMENT
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 500
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: Retrospective evaluation of clinical and functional results and survivorship of total knee replacement and total hip replacement, both isolated or combined.

Detailed description: Retrospective evaluation of clinical and functional results and survivorship of total knee replacement and total hip replacement, both isolated or combined.

Evaluation performed 1, 2, 5, 10 and 15 years after surgery

Eligibility criteria: Inclusion criteria:

* Age ≥ 18 years
* Patients underwent total knee or hip replacement, both isolated or combined with other surgical procedures

Exclusion criteria

- Patients underwent other types of knee or hip replacement

Primary outcomes:
measure: HARRIS HIP SCORE
timeFrame: 10 years
measure: KNEE SOCIETY SCORE
timeFrame: 10 years
measure: HARRIS HIP SCORE
timeFrame: 5 years
measure: KNEE SOCIETY SCORE
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Irccs Istituto Ortopedico Galeazzi
Study officials:
References:
Clinical trial NCT00779077: Cystic Fibrosis (CF) Flow Rates Study
Official title: An Open, Observational, Non-Interventional Study of Inspiratory Flow Rates and Volumes in Subjects With Cystic Fibrosis Inhaling Via a Spirometer With the High Resistance RS01 Dry Powder Inhaler Device in Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: device characteristics
Lead sponsor: Syntara
Sponsor class: INDUSTRY
First posted: 2008-10-24
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CF 6yrs and above

Brief summary: We wish to measure the inspiratory flow and volumes generated by the subjects inhaling from a spirometer with a high resistance dry powder inhaler in series in subjects with cystic fibrosis.


Eligibility criteria: Inclusion Criteria:

* CF
* FEV1 ≥ 30% and \< 90% predicted

Exclusion Criteria:

* Be considered "terminally ill" or listed for lung transplantation
* Have had a lung transplant
* Have had a significant episode of haemoptysis (\>60 ml) in the three months prior to enrolment
* Have had a myocardial infarction in the three months prior to enrolment
* Have had a cerebral vascular accident in the three months prior to enrolment
* Have had major ocular surgery in the three months prior to enrolment
* Have had major abdominal, chest or brain surgery in the three months prior to enrolment
* Have a known cerebral, aortic or abdominal aneurysm
* Be breast feeding or pregnant
* Be using beta blockers
* Have unstable asthma

Primary outcomes:
measure: inspiratory flow rates
timeFrame: single visit
Secondary outcomes:
measure: inspiratory volumes
timeFrame: single visit
Other outcomes:
Locations:
Study officials:
References: