louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02903043: Expression of miR-204 and Consequences on Capillarization in Limb Muscles of Patients With COPD
Official title: Expression of miR-204 and Consequences on Capillarization in Limb Muscles of Patients With Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: MicroRNAs
Angiogenesis
Skeletal muscle
COPD
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2016-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COPD

Brief summary: Limb muscle dysfunction, characterized by loss of capillaries, is amongst the most troublesome systemic consequences of chronic obstructive pulmonary disease (COPD) leading to poor functional status and premature mortality.

One prevailing hypothesis stipulates that modification in the expression of miR-204 leads to change the regulation of angiogenesis in vastus lateralis of patients with COPD when compared to controls.

Detailed description: The investigators objective is to investigate the impact of COPD on key signaling pathways involved in the muscle angiogenesis. Mild to severe COPD patients and healthy controls will be recruited. All of the investigators patients will undergo a thorough baseline assessment in pulmonary capacity and body composition. Blood sampling and biopsy of the quadriceps will be done. Key proteins and microRNAs of signaling intramuscular pathways involved in angiogenesis will be measured in the quadriceps.

Eligibility criteria: Inclusion Criteria:

* COPD (FEV1/FVC \< 0.70)
* Healthy subjects: no evidence of airways obstruction (FEV1/FVC \> 0.70 and FEV1 \> 0.80 predicted)
* Smoking history \> 10 pack-years
* Ex-smoker \>6 months

Exclusion Criteria:

* Chronic hypoxemia and/or hypercapnia (PaO2 \< 60 mmHg or SpO2 \< 88% at rest and/or PaCO2 \> 45 mmHg)
* Recent exacerbation or oral corticosteroids (\< 2 months)
* Recent cancer (\< 3 years)
* Diabetes
* Myopathy, neuromuscular, neurological or articular diseases
* Kidney disease
* Other respiratory diseases
* Unstable cardiac disease
* Physical activity score \> 9 in the Voorips questionnaire
* BMI \> 30

Primary outcomes:
measure: miR-204 in limb muscles in patients with COPD
timeFrame: At baseline (COPD patients in a stable state of the disease)
Secondary outcomes:
measure: microRNAs in limb muscles of patients with COPD
timeFrame: At baseline (COPD patients in a stable state of the disease)
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec
Study officials:
affiliation: Laval University
name: François Maltais, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05055843: Novel Synthetic T2W MR Imaging and Spin Parameter Mapping Techniques for Screening Prostate Cancer
Official title: Novel Synthetic T2W MR Imaging and Spin Parameter Mapping Techniques for Prostate Cancer Without an Endorectal Coil
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Adenocarcinoma
Prostate Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This clinical trial studies examines a 3D magnetic resonance imaging (MRI) compared to standard MRI imaging techniques in screening patients with prostate cancer. Diagnostic procedures, such as MRI, may help find and diagnose prostate cancer. Computer systems that allow doctors to create a 3-dimensional (3-D) picture of the tumor may help in planning.

Detailed description: PRIMARY OBJECTIVE:

I. To determine whether the image quality of the novel 3-dimensional (3D) T2-weighted imaging (T2W) synthetic imaging technique without endorectal coil is comparable to the 2-dimensional (2D) T2W imaging technique without endorectal coil.

SECONDARY OBJECTIVE:

I. To evaluate the qualitative diagnostic quality of the T2W images provided by the novel 3D technique, as determined by subjective scoring by experienced readers.

EXPLORATORY OBJECTIVE:

I. To investigate the feasibility of novel 3D synthetic imaging and multi-spin parameter mapping technique of prostate for the detection of clinically significant prostate cancer (csPCa).

OUTLINE:

Patients undergo 3D MRI imaging over 15 minutes with standard of care MRI or at a separate time.

Eligibility criteria: Inclusion Criteria:

* Male, age \>= 18
* Untreated, biopsy-proven with intermediate and high-risk adenocarcinoma of the prostate
* Patient is being considered for curative-intent treatment with radical prostatectomy
* Patient has provided written informed consent for participation in this trial
* Patient should be eligible for scanning on a 3T magnet

Exclusion Criteria:

* Low-risk adenocarcinoma of prostate
* Any prior therapy for prostate cancer
* A history of other active malignancy within the last 2 years
* Prostate cancer with significant sarcomatoid, spindle cell, or neuroendocrine small cell components
* Cardiac pacemaker
* Orthopedic hardware in the pelvis and spine
* Claustrophobia

Primary outcomes:
measure: To be assessed with scoring of quantitative image metrics in regions of prostate cancer and benign tissue
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Tharakeswara Bathala
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01111643: Longitudinal Strain in Addition to Visual Assessment of Wall Motion for Ruling in Ischemia in the Emergency Room
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chest Pain
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-04-27
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the ER because of chest pain with no prior history coronary artery disease.

Brief summary: To assess the utility of technician-based analysis of echocardiograms with longitudinal strain for ruling-in ischemic chest pain in the emergency room, compared to emergency room (ER) physician opinion and expert echocardiographer analysis of wall motion, both the latter blinded to any relevant clinical data .


Eligibility criteria: Inclusion Criteria:

* Chest pain
* No indication of acute myocardial infarction

Exclusion Criteria:

* Patients admitted for acute myocardial infarction
* Patients with known coronary artery disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Emergency Department Hille Yaffe Medical Center
Study officials:
References:
Clinical trial NCT02830243: Comparison of Analgesic Effect of Volatile Anesthetics
Official title: The Comparison of Analgesic Effect of Volatile Anesthetics Using Surgical Pleth Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this clinical trial is to compare analgesic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using surgical pleth index.

Detailed description: Volatile anesthetics vary in their relative hypnotic potency. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetic agents may produce different bispectral index values. However, the difference between analgesic effects of volatile anesthetics have not yet been investigated. The purpose of this clinical trial is to compare analgesic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using surgical pleth index-guided remifentanil infusion.

Eligibility criteria: Inclusion Criteria:

* patients undergoing balanced general anesthesia using volatile anesthetics and remifentanil
* patients with american society of anesthesiologist physical status I, II
* patients aged 19-65 years
* patients obtaining written informed consent

Exclusion Criteria:

* patients with a history of any psychiatric or neurological disease
* patients who had received any medication affecting the central nervous system
* patients who had received medication affecting the sympathetic or parasympathetic nervous systems
* patients undergoing tracheal intubation for airway management
* pregnant women

Primary outcomes:
measure: Remifentanil consumption (µg/kg/min)
timeFrame: During the intraoperative period
Secondary outcomes:
measure: Target effective site concentration of remifentanil (ng/ml)
timeFrame: After at least 10 min of stable surgical pleth index values
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Kyoungho Ryu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ryu KH, Kim JA, Ko DC, Lee SH, Choi WJ. Desflurane reduces intraoperative remifentanil requirements more than sevoflurane: comparison using surgical pleth index-guided analgesia. Br J Anaesth. 2018 Nov;121(5):1115-1122. doi: 10.1016/j.bja.2018.05.064. Epub 2018 Jul 4.
Clinical trial NCT04368143: COVID-19 Immune Repertoire Sequencing
Official title: COVID-19 Immune Repertoire Sequencing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
SARS-CoV 2
Corona Virus Infection
RDT
B Cell
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
First posted: 2020-04-29
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted in an in-patient hospital setting. Patients will be recruited at UZA, where SARS-CoV-2 infected individuals might present. Patients with (mild) respiratory complaints and suspected risk of having contracted SARS-CoV-2 (risk contact with confirmed case, travel history to endemic area) will be tested and isolated in awaiting laboratory SARS-CoV-2 test results. In case of mild respiratory complaints, people will be discharged immediately for home isolation; while patients in need for hospital care will be hospital-admitted (in isolation rooms). If SARS-CoV-2 test results return positive, these hospitalized patients will be asked to participate in this study.

Brief summary: This concerns a single-center prospective interventional cohort study. Laboratory-confirmed COVID-19 patients will be asked to donate blood at at least two different timepoints. This will allow us to investigate T and B cell evolutions during the course of infection and recovery. The expected duration of the study is four months or the total duration of the SARS-CoV-2 circulation in Belgium (whichever is shortest).


Eligibility criteria: Inclusion Criteria:

* laboratory confirmed COVID-19 acute infection
* be older than 18 years of age
* be hospitalized at the UZA
* willing and able to provide written informed consent by the participant or its legal representative (for instance in case of medical incapacitation)

Exclusion Criteria:

* younger than 18 years old
* Ambulatory patients

Primary outcomes:
measure: provide proof-of-concept that (longitudinal) B cell repertoire mining allows identification of emerging virus specific B cell receptor variable regions.
timeFrame: 4 months
Secondary outcomes:
measure: study evolutions in B and T cell repertoires to understand COVID-19 specific immune responses fundamentally.
timeFrame: every 7 days during hospitalization a bloodsample is taken
measure: clinical and epidemiological description of UZA hospitalized COVID-19 patients
timeFrame: at hospitalization
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Universitairy hospital of Antwerp
Study officials:
References:
Clinical trial NCT02867943: GapCO2 and Respiratory Rate in Patients Under Volume Mechanical Ventilation
Official title: Effects of Respiratory Rate on Venous-to-arterial CO2 Tension Difference in Septic Shock Patients Under Volume Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shock
Keywords: sepsis, shock,Lactate,volume controlled ventilation
Lead sponsor: 105 Hospital of Chinese People's Liberation Army
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 28
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: The subjects were sequentially admitted to the Department of Critical Care Medicine of 105 Hospital of PLA from March of 2016 till the end of this study.

Brief summary: As an approximate of the difference between venous-to-arterial CO2 tension (∆PCO2), ∆PCO2 is proportional to CO2 production and inversely related to cardiac output (Fick equation). Anaerobic CO2 production is thought to occur when tissue hypoxia is present, mostly because of buffering of bicarbonate ions by the protons produced in excess secondary to the hydrolysis of adenosine triphosphate. Therefore ∆PCO2 has been proposed as a marker of tissue hypoxia.

Detailed description: An increased ∆PCO2 (\> 6 mmHg) could be used to identify patients who still remain inadequately resuscitated, when deciding when to continue resuscitation despite a central venous oxygen saturation (ScvO2) \> 70% associated with elevated blood lactate levels.

Under steady states of both VO2 and VCO2, P (v-a) CO2 was observed to increase in parallel with the reduction in cardiac output. However, spontaneous breathing and hyperventilation may reduce PaCO2 and prevent the CO2 stagnation-induced rise in PvCO2.

To date,these studies of ∆PCO2 and respiratory rate in septic shock patients Under Volume Mechanical Ventilation are rarely.

Eligibility criteria: Inclusion Criteria:

Patients were included in the study, if the attending physician find the persistence of signs of hypoperfusion (oliguria, mottled skin, central venous oxygen saturation (ScvO2) \<70 % despite a hemoglobin \> 8 g/dl),despite achieving adequate intravascular volume and adequate mean arterial pressure (MAP) \> 65 mmHg as recommended by the Surviving Sepsis Campaign.

Exclusion Criteria:

Exclusion criteria were pregnancy, COPD，age less than 18 years old, unstable hemodynamic condition (change of vasoactive drug dosage or fluid administration within 1 h preceding the protocol) and uncontrolled tachyarrhythmias (heart rate\>140 beats/min).

Primary outcomes:
measure: Effects of respiratory rate on venous-to-arterial CO2 tension difference in septic shock patients Under Volume Mechanical Ventilation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05189743: The Dermisgraft Epithelialization and Late Scar Healing
Official title: A Prospective Multi-centre Randomised Study for Treatment of Burns With Dermis Graft or Split-thickness Skin Auto-graft.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 23
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: Study Synopsis

Title; The dermis graft: epithelialization and late scar evaluation A Clinical Prospective multicenter trial

Objectives; The objective of this study is to compare a dermal graft with a conventional split thickness skin graft regarding healing quality and scarring.

Design; the study is a prospective, controlled clinical multicenter trial.

Study population; Atleast 20 burn patients (18-80 years) with a full thickness burn that requires permanent skin cover.

Time plan; Enrollment will continue until atleast 20 patients have been included and completed the study.

Detailed description: Background: Donor site morbidity is a major concern such as wound healing disturbances, hypertrophic scarring and hypo-/hyperpigmentation. The dermal graft technique is an alternative to the standard split-thickness skin graft (STSG) technique to minimize donor site morbidity. Immediate cover of the donor site after harvest leaving a non-exposed wound is a big advantage. The aim of the study was to compare the functional and aesthetic outcome between two treatment methods (dermal graft with STSG).

Methods: From February 2017 to December 2020, 21 patients received a dermis graft and a regular split-thickness skin graft in a prospective randomized study design. The recipient and the donor site were compared separately regarding healing time, scarring and patient subjective satisfaction. All sites (both donor and recipient) were analyzed histologically regarding remodeling and scar formation.

Eligibility criteria: Inclusion Criteria:

* Thermal \& chemical burns \< 30 % TBSA
* Males \& females between 18-80 years old
* At least one coherent full thickness wound measuring 15 x 7.5 cm
* A minimal of 15 x 7.5 cm coherent undamaged skin located at frontal or lateral side of one of the thighs for graft harvest.

Exclusion Criteria:

* Patients with severe cutaneous trauma at the same site as the burn injury
* Previous burns at the treatment site
* Severe cognitive dysfunction or psychiatric disorder
* Chronic skin disorder
* Chronic use of systemic or local corticosteroid
* Chronic use of anticoagulants or platelets
* Autoimmune disease
* Active hepatitis
* Full thickness burns of head, genitalia, axilla or upper third of medial upper arm

Primary outcomes:
measure: Healing time
timeFrame: 4 weeks
measure: Aesthetic outcome
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköpings Unversity Hospital
Study officials:
References:
Clinical trial NCT03589443: Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus
Official title: Phase I In-vivo Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Barrett Esophagus
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The overall aim of this feasibility study is to develop new technologies for improved detection of Barrett's neoplasia using the scanning fiber endoscope(SFE) multiplexed imaging system. This study will combine the use of fluorescent-labeled peptides that bind specifically to pre-cancerous mucosa in the esophagus for use as novel imaging agents to guide endoscopic biopsy or endoscopic mucosal resection (EMR). This Phase 1 study will be used to provide early evidence of efficacy for the topical application of a panel of two peptides that bind to molecular targets that are specific for esophageal dysplasia. A panel is needed because cancer in the esophagus is genetically heterogeneous. The study will look at peptide binding in subjects with known or suspected Barrett's esophagus.


Eligibility criteria: Inclusion Criteria:

* Known or suspected Barrett's esophagus
* Scheduled for a clinically-indicated upper endoscopy
* Medically cleared for the procedure
* Willing and able to sign informed consent

Exclusion Criteria:

* Known allergy or negative reaction to the near infrared fluorophores Cy5, li-cor IRDye800CW, or derivatives
* One active chemotherapy or radiation treatment
* Pregnant or trying to conceive

Primary outcomes:
measure: Validate the binding of the peptides using the SFE
timeFrame: 1 year
Secondary outcomes:
measure: Use of the SFE to detect QRH and KSP via signal to noise ratio (SNR)
timeFrame: 1 year
measure: Use of the SFE to detect QRH and KSP via tumor-to-background ratio
timeFrame: 1 year
measure: Use of the SFE to detect QRH and KSP via contrast
timeFrame: 1 year
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
References:
Clinical trial NCT04734743: Muscle Strength, Functional Capacity, Respiratory Function and Quality Of Life In Cystic Fibrosis Patients
Official title: Upper Extremity Muscle Strength and Endurance, Functional Capacity, Respiratory Function and Quality of Life in Child and Adolescent With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Muscle Strength
Pulmonary Function
Functional Capacity
Exercise Tolerance
Muscular Endurance
Keywords: muscle strength
pulmonary function
Cystic Fibrosis
functional capacity
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 63
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study was designed to investigate the relationship between upper extremity muscle strength and endurance, functional capacity, and quality of life child and adolescent with cystic fibrosis

Detailed description: Child and adolescent with cystic fibrosis patients were assessed for upper extremity muscle strength and (Shoulder abductors muscle strength, Elbow flexion muscle strength, Handgrip strength) muscular endurance(arm pull-up test), lung function test, and functional capacity (six-minute walk test distance), and Quality Of Life (Cystic Fibrosis Questionnaire-Revised)

Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed with CF with clinical findings and gene mutations consistent with CF, having over 60mEq / L in two measurements in sweat chlorine examinations

Exclusion Criteria:

* Patients who did not exacerbate the disease in the last four weeks, who had good cooperation and did not have any orthopedic problems in the hand-shoulder-arm complex were included.

Primary outcomes:
measure: Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: 1 day
measure: Six-minute walk test
timeFrame: 1 day
measure: Forced Vital Capacity (FVC)
timeFrame: 1 day
measure: Peak Expiratory Flow (PEF)
timeFrame: 1 day
measure: Upper Limb Muscle Strength
timeFrame: 1 day
measure: Upper Limb muscular endurance
timeFrame: 1 day
measure: Ouality of Life
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu Universty
state: Şahinbey
Study officials:
affiliation: Hasan Kalyoncu University
name: Çağtay maden, MSc, Pt
role: STUDY_DIRECTOR
References: