louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02585752: A Study of Expiratory Pressure Modulation in Moderate to Severe COPD Patients - Phase 1b
Official title: A Study of Expiratory Pressure Modulation in Moderate to Severe COPD Patients - Phase 1b
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2015-10-23
Enrollment: 20
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: OTHER

Brief summary: Dynamic pulmonary hyperinflation (DH) and intrinsic positive end-expiratory pressure (PEEP) are well known problems in COPD patients with acute and chronic respiratory failure. Measurement of intrinsic PEEP level during both, invasive and non-invasive ventilation is of major importance since in some circumstances (e.g. during exercise or during exacerbations) it can significantly increase respiratory workload of COPD patients. Extrinsic PEEP applied during both, invasive and noninvasive ventilation is used to overcome intrinsic PEEP and therefore to avoid or reduce dynamic hyperinflation.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years who are contractually capable and mentally able to understand and follow the instructions of the study personnel
2. Signed informed consent
3. Moderate to severe COPD patients (FEV1/FVC ratio \<70% and FEV1 \< 50% pred) with chronic hypercapnic respiratory failure (PaCO2 \>45 mmHg)
4. Currently using NIV

Exclusion Criteria:

1. Acute exacerbation of COPD, acute respiratory failure (ph \< 7,35 and/or respiratory rate \>30/min)
2. Unstable heart failure
3. Cardiac failure with dehydration
4. Pregnancy/breastfeeding women
5. Pneumothorax/-mediastinum
6. Increased risk of pneumothorax, pneumomediastinum or venous air embolism
7. In the opinion of the investigator, the patient is unsuitable for the study

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 1 day
Secondary outcomes:
measure: Minute ventilation
timeFrame: 1 day
measure: Respiratory rate
timeFrame: 1 day
measure: Tidal volume
timeFrame: 1 day
measure: CO2 transcutaneous (tcCO2)
timeFrame: 1 day
measure: pO2 arterial (paO2)
timeFrame: 1 day
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
state: Nordrhein-Westfalen
Study officials:
affiliation: Universitätsklinikum Aachen
name: Michael Dreher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cornelissen CG, Müller T, Schmitz S, Dreher M. Nichtinvasive Beatmung: Patientenkomfort und Sicherheit einer Modulation des expiratorischen Flusses. Pneumologie 2018; 72(S01), S11
Clinical trial NCT03011359: The Comparison of Postoperative Pain After Colon Resection in Intravenous Patient-controlled Analgesia Between Conventional Mode and Optimizing B.I Mode With 'PAINSTOP' Equipment
Official title: The Comparison of Postoperative Pain After Colon Resection in Intravenous
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Keywords: Colon resection
Patient Controlled Analgesia
Optimizing Basal Infusion Mode
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Colon resection is one of the major surgery, the postoperative pain is so severe that it is necessary to use additional analgesics as well as a patient controlled analgesia (PCA). The most common pain management of this surgery is the intravenous (IV) PCA. If it is relatively insufficient amount of narcotic analgesics ,in the case of IV PCA, may be failed to reduce the pain effectively. Consequently, it may result in the a lot of rescue analgesics use, which leads to the adverse effects in patients who are very sensitive to narcotic analgesics. And the patient's satisfaction to the PCA may be low.

For the recently released PCA instrument 'PAINSTOP', the investigators can specify the mode setting including total volume, flow rate (basal rate) per hour, bolus dose, and lock out time (LOT). Furthermore, this device can be set to optimize basal infusion (B.I), which is a new mode, so that the administered rate and amount of drug can be increased or decreased according to the patient's use of bolus button. Therefore, this PCA device can be implemented to the conventional mode, and added the function of automatically controlling the basal rate and administered amount of drug according to the use demand of the patient. However, since there are few studies related to this new mode of PCA, more research is needed in patients with postoperative pain.


Eligibility criteria: Inclusion Criteria:

1. The subjects who undergoing colon resection due to colon cancer
2. ASA class Ⅰ-Ⅲ
3. Written consents obtained to participate voluntarily in this clinical trial

Exclusion Criteria:

1. Sudden change of surgical plan
2. Patients who have the hypersensitivity to the pain killers including narcotics
3. Patients who are unable to express the degree of pain

Primary outcomes:
measure: pain
timeFrame: At postoperative 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT05881759: Integrating Food Rx With Best Feeding Practices With EFNEP
Official title: Integrating Food Rx With Best Feeding Practices for Chronic Disease Prevention Among EFNEP Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dietary Habits
Childhood Obesity
Food Selection
Feeding Behavior
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Prairie View A&M University
name: University of Houston
First posted: 2023-05-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess feasibility and acceptability of of integrating Food Rx and Best Feeding Practices with EFNEP participants via a pilot study.

Detailed description: The purpose of the pilot study is to test the FFYF feeding curriculum material and procedures for implementation, staff training, recruitment, and data collection.

Eligibility criteria: Inclusion Criteria:

* Living in Harris or Fort Bend counties
* being a parent of a child 4-8 years old
* ability to speak in English or Spanish
* have ready access to a telephone
* have access to the Internet with a smart phone, a tablet, a laptop, or a desktop computer

Exclusion Criteria:

* parents of children with disabilities and/or those on prescription medications that affect weight and/or appetite
* parents who are not able to complete self-report questionnaires

Primary outcomes:
measure: Change in feeding practices at 3-months will be assessed using the Food Parenting Inventory
timeFrame: baseline and post-intervention at 3-months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
Clinical trial NCT05911659: Individualized and Combined Effects of Diabetes and Smoking on the Antiplatelet Activity of Ticagrelor in Acute Myocardial Infarction Patients Undergoing Primary PCI
Official title: Ndividualized and Combined Effects of Diabetes and Smoking on the Antiplatelet Activity of Ticagrelor in Acute Myocardial Infarction Patients Undergoing Primary PCI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Individualized and Combined Effects of Smoking and Diabetes on the Antiplatelet Activity in Patients Undergoing Primary Percutaneous Coronary Intervention
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Al-Azhar University
First posted: 2023-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with ACS undergoing PCI

Brief summary: Background:Diabetes and smoking are common factors found to increase platelet reactivity in patients undergoing primary PCI. Objective: Compare the individualized and combined effects of smoking and diabetes on the antiplatelet activity in patients undergoing primary PCI. Methods: sixty patients were recruited in this study. Patients were allocated to one of four groups according to the diabetes and smoking status. Non smokers- non diabetic patients, smokers non diabetic patients, non smokers diabetic patients, and smokers diabetic patients, 15 patients in each group. All patients received 180 mg ticagrelor before PCI. Platelet reactivity index(PRI) and maximum platelet aggregation were measured 24 hours after ticagrelor loading dose for each patient as indicators for antiplatelet efficacy. PRI and/or MPA values \> 50% were defined as high platelet reactivity.


Eligibility criteria: Inclusion Criteria:

Acute coronary syndrome (ACS) undergoing PCI

Exclusion Criteria:

Patients who had a history of severe bleeding, serious bleeding tendency, history of intracranial hemorrhage, signs of active bleeding, thrombocytopenia, uncontrolled hypertension, hypersensitivity to the used drugs (clopidogrel or ticagrelor), concomitant use of strong CYP inducers or inhibitors, and/or severe liver disorders were excluded from the study.

Patients with previous history of coronary artery disease, previous PCI or patients administering other antiplatelets were excluded from the current study.

Primary outcomes:
measure: Platelet Reactivity Index and maximum platelet aggregation
timeFrame: 24 hours after PCI
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine of girls, Cardiology department, Al-Azhar University in Cairo
Study officials:
References:
Clinical trial NCT02594059: Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis
Official title: Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Fibrosis
Keywords: endothelial function, idiopathic pulmonary fibrosis
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to assess the peripheral endothelial function in adult patients with idiopathic pulmonary fibrosis (IPF) and the relationship between the peripheral endothelial function and the severity of the IPF.

Detailed description: The primary criteria is the peripheral endothelial function that will be assessed by the measure of flow-mediated dilation (reactive hyperemia-peripheral artery tone index). The pulmonary function will be assessed by the measures of the forced expiratory volume at one second (FEV1), the forced vital capacity (FVC) and the total lung capacity (TLC) and the diffusing capacity of the lung for carbon monoxide (DLCO). The dyspnea will be assessed with the New York Heart Association (NYHA) score. The exercise capacity will be assessed by the 6-min walk test. Pulmonary arterial pressure will be recorded through cardiac echography or catheterization.

Eligibility criteria: Inclusion Criteria:

* IPF according to ATS/ERS 2011's criteria
* Stable IPF (no reduction of FVC or DLCO of more than 10% and 15% respectively)

Exclusion Criteria:

* Patients with a significant disease other than IPF. A significant disease is defined as a disease which, in the opinion of the investigator, may influence the results of the trial.
* Pregnant or nursing women.
* Non-pulmonary fibrosis
* treatment by pulmonary vasodilators that cannot be stopped for 24 hours for the assessment of endothelial function

Primary outcomes:
measure: measure of reactive hyperemia-peripheral artery tone index
timeFrame: day 1
Secondary outcomes:
measure: endothelial function
timeFrame: 1, 2 and 3 years
measure: measure of reactive hyperemia-peripheral artery tone index
timeFrame: 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou, dpt of pneumology
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
References:
Clinical trial NCT02231359: Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Airways Disease
Official title: Berodual® Respimat® 20/50µg/Dose Solution for Inhalation in Patients With Chronic Obstructive Airways Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-04
Enrollment: 2006
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis chronic obstructive airways disease recruited at general practitioners, internal specialists and specialists in pneumology in practice

Brief summary: Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease in daily practice


Eligibility criteria: Inclusion Criteria:

* Men and women presenting with the symptoms of chronic obstructive airways disease were given Berodual® Respimat® 20/50µg/dose solution for inhalation only where this was considered necessary in medical terms
* Patients who have not been treated prior to the post-marketing surveillance study as well as patients who have been treated with Berodual® metered dose inhaler (MDI) or other respiratory medications prior to the Post-Marketing Surveillance Study could be included

Exclusion Criteria:

* Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information

Primary outcomes:
measure: Change in overall severity of clinical picture rated on 3-point scale
timeFrame: up to 12 weeks
measure: Change in breathlessness rated on a 4-point scale
timeFrame: up to 12 weeks
measure: Change in restriction of activity due to breathlessness rated on a 4-point scale
timeFrame: up to 12 weeks
measure: Change in number of awakening due to nocturnal breathlessness rated on 4-point scale
timeFrame: up to 12 weeks
measure: Global assessment of efficacy by the patients rated on 5-point scale
timeFrame: after 4, 8 and 12 weeks
measure: Global assessment of efficacy by the investigator rated on 5-point scale
timeFrame: after 4, 8 and 12 weeks
measure: Number of patients with adverse drug reactions
timeFrame: up to 12 weeks
measure: Assessment of tolerability on a 5-point scale
timeFrame: after 4, 8 and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02653859: Evaluate the Auxiliary Diagnostic Value of Circulating Tumor Cells in Benign and Malignant Lung Nodules
Official title: Evaluate the Auxiliary Diagnostic Value of Circulating Tumor Cells(CTC) in Benign and Malignant Lung Nodules
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Solitary Pulmonary Nodule
Keywords: CTC
PCR
Lead sponsor: GenoSaber
Sponsor class: INDUSTRY
Collaborators: name: Second Affiliated Hospital, School of Medicine, Zhejiang University
First posted: 2016-01-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: New Solitary Pulmonary Nodule

Brief summary: By testing the CTC number of new solitary pulmonary nodule patient, evaluating the correlation of CTC number and benign and malignant lung nodules auxiliary diagnosis, the correlation of CTC number and the size of lung nodules of the malignant patients, the correlation between the CTC number and subtypes of malignant lung nodules patients.The CTC and tumor markers will be detected before the patient received treatment. Tumor markers include Pro-GRP, NSE, CEA, CYFRA211, SCC.


Eligibility criteria: Inclusion Criteria:

* New Solitary Pulmonary Nodule patients
* first visit patient
* Heart, liver and kidney function is normal.
* 18-80 years old.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Blood collection time is not in the scheduled time.
* The plasma sample hemolysis or condensation.
* Whole blood samples less than 3 ml.
* poor compliance

Primary outcomes:
measure: The number of circulating tumor cells will be detected in baseline by Immunomagnetic negative screening and targeted polymerase chain reaction(PCR) method.
timeFrame: 1 months
Secondary outcomes:
measure: The concentration of the tumor marker of pro gastrin releasing peptide(Pro-GRP) will be detected in baseline by Electrochemical luminescence.
timeFrame: 1 months
measure: The concentration of the tumor marker of neurone specific enolase(NSE) will be detected in baseline by Electrochemical luminescence.
timeFrame: 1 months
measure: The concentration of the tumor marker of carcinoembryonic antigen(CEA) will be detected in baseline by Electrochemical luminescence.
timeFrame: 1 months
measure: The concentration of the tumor marker of cytokeratin 19 fragments(CYFRA211) will be detected in baseline by Electrochemical luminescence.
timeFrame: 1 months
measure: The concentration of the tumor marker of squamous cell carcinoma antigen(SCC) will be detected in baseline by Electrochemical luminescence.
timeFrame: 1 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03312959: Heavy Bupivacaine in Peribulbar Block
Official title: Heavy Bupivacaine Versus Plain Bupivacaine in Peribulbar Block
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthetics, Local
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Most of the ophthalmic procedures are performed under local anesthesia as the patient is often elderly and with diseases. This may increase the risk of morbidity and mortality under general anesthesia. Different eye blocks have been practiced with great success. Moreover, it is associated with less hemodynamic instability, less respiratory depression, better postoperative pain relief, and less nausea and vomiting than general anesthesia. It is also associated with a reduction in stress response, maintained oxygen saturation and cardiovascular stability, in addition to the production of good akinesia and anesthesia alleviating occulo-medullary reflexes, all make local anesthesia more superior and safe technique.

Detailed description: Peribulbar anesthesia is widely practiced now as a safe local block for cataract eye surgeries. However, the limited duration of these blocks was shown to be the main problem encountered intra-operatively. Therefore, additional top-up doses are usually needed to continue the operation. Many kinds of research tried to introduce solutions in order to prolong the duration of the local anesthetics used. Many researchers tried different volumes, doses and adjuvant to local anesthetics, and studied their effects There are many studies that evaluated the effect of baricity of local anesthetic on the potency of motor block and the duration of motor and sensory blockade.

However, no properly designed randomized, controlled studies have evaluated the feasibility and reliability of baricity local anesthetic agents used for the peribulbar block.

Aim of the work prospective, randomized study was conducted to evaluate the effects of the baricitized bupivacaine used for the peribulbar block in patients undergoing posterior segment surgeries.

Eligibility criteria: Inclusion Criteria:

* Patients with American Society of Anesthesiology (ASA) I or II.
* 30-80 years old
* Patients scheduled for elective unilateral posterior segment surgeries.

Exclusion Criteria:

* Patient's refusal.
* orbital deformity
* axial length( \>28 mm )
* increased intraocular pressure, or if they were blind in the contralateral eye, international normalized ratio (INR) \> 1.5
* allergy to local anesthetics, mentally retarded patients

Primary outcomes:
measure: The onset and duration of lid and globe akinesia
timeFrame: 12 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Giza
Study officials:
References:
Clinical trial NCT06468059: Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot
Official title: Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Lead sponsor: Little Room Innovations, LLC
Sponsor class: INDUSTRY
Collaborators: name: Kennesaw State University
First posted: 2024-06-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators have developed a novel layered low-profile prosthetic foot that is able to provide enhanced compliance without sacrificing strength for individuals with transtibial amputation who have long residual limbs. It is hypothesized that the proposed prosthesis will offer similar benefits to these individuals as comparable higher profile prostheses offer users with shorter residual limbs. The primary goal of this Phase I proposal is to assess the degree to which the proposed prosthesis can provide benefits to prosthesis users in this population, along with characterizing the degree to which the novel prosthesis emulates its taller counterparts.


Eligibility criteria: Inclusion Criteria:

1. 18-89 years old
2. unilateral transtibial amputation
3. daily use of a low profile foot
4. cognitive ability to understand and willingness to provide informed consent and follow the study protocol

Exclusion Criteria:

1. unable to perform walking for 2 minutes without an assistive device
2. other health conditions which may prevent them from participating in the study

Primary outcomes:
measure: Total Energy Stored (TES)
timeFrame: through study completion, an average of 1 day
measure: Ankle Range of Motion (ROM)
timeFrame: through study completion, an average of 1 day
Secondary outcomes:
measure: Ankle Quasi-Stiffness (AQS)
timeFrame: through study completion, an average of 1 day
measure: Walking Speed
timeFrame: through study completion, an average of 1 day
measure: Rollover Shape from Motion Capture
timeFrame: through study completion, an average of 1 day
measure: Device Satisfaction survey of the Orthotics and Prosthetics Users Survey (OPUS)
timeFrame: through study completion, an average of 1 day
Other outcomes:
Locations:
city: Kennesaw
country: United States
facility: Kennesaw State University
state: Georgia
Study officials:
References: