louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01388998: Fluid Management Study to Evaluate Changes in Intravascular Volume After Applying Various Pressure Levels on the Caval Vein
Official title: External Pressure Applied on the Caval Vein and Its Effects on Difference in Pulse Pressure (dPP) and Pleth Variability Index (PVI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravascular Volume
Respiratory Changes
Keywords: fluid management
fluid therapy
dPP
difference in pulse pressure
PVI
pleth variability index
external pressure applied on the caval vein
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2011-07-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Fluid therapy optimization in the perioperative period has been considered as major contributor to improve oxygen delivery. A recent, noninvasive approach to estimate fluid requirements in the anesthetized patient with arterial line is the assessment of difference in pulse pressure (dPP). Intraoperative fluid management by dPP is a goal-directed fluid management approach to avoid both hypervolemia and hypovolemia. However, several clinical factors may impede dPP measurements. Surgical manipulations in abdominal procedures may interfere with hemodynamic stability due to obstruction of the caval vein. Physiological considerations make us hypothesize that only intense pressure impedes caval blood flow and thus hemodynamics and dPP. Therefore, the investigators want to assess those changes after standardized application of three different pressure levels (2 N, 5 N, 10 N) on the caval vein.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective hepatic surgery procedures (hemihepatectomy) qualifying for arterial line

Exclusion Criteria:

* pregnancy
* cardiac insufficiency (NYHA 4, EF \< 25 %)
* coronary (CCS 4)
* coagulopathy
* symptoms of infection or sepsis
* malignant hyperthermia
* porphyria
* oesophageal varicose veins
* absence of sinus rhythm

Primary outcomes:
measure: Change of dPP from start of intervention to 2 minutes after start of the intervention
timeFrame: Application of pressure for 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)
Study officials:
affiliation: Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)
name: Lydia T. Strys, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)
name: Dorothea Closhen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)
name: Gunther Pestel, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05503498: Pharmacokinetic Model of Fibrinogen Plasma Levels After Fibrinogen Administration
Official title: Population Pharmacokinetic Modeling of Fibrinogen in Patients With Congenital or Acquired -Chronic or Acute- Hypofibrinogenemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibrinogen; Deficiency, Acquired
PHARMACOKINETICS
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: University of Barcelona
First posted: 2022-08-16
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AFIBRINOGENEMIC, TRAUMATIC AND CIRRHOTIC AFTER FIBRINOGEN ADMINISTRATION

Brief summary: characterize the fibrinogen PK in patients with acquired -chronic (cirrhotic patients) or acute- hypofibrinogenemia (severe trauma or critical haermorrhage), showing endogenous production.

Detailed description: Fibrinogen, a plasma-soluble protein synthesized by the liver, is the key substrate for the plasmatic blood coagulation, reaching a critically low plasma concentration earlier than other coagulation factors in case of bleeding. Fibrinogen Pharmacokinetics (PK) after single doses of fibrinogen concentrate (FC), using modeling approaches, has only been evaluated in congenital afibrinogenaemic patients. The aims of this study are to extend the modeling process to characterize the fibrinogen PK in patients with acquired -chronic (cirrhotic patients) or acute- hypofibrinogenemia (severe trauma or critical haermorrhage), showing endogenous production. Influencing factors of differences on the fibrinogen PK between sub-populations will be identified.

Eligibility criteria: Inclusion Criteria: AFIBRINOGENEMIC, TRAUMATIC AND CIRRHOTIC AFTER FIBRINOGEN ADMINISTRATION -

Exclusion Criteria: NA

-

Primary outcomes:
measure: plasma fibrinogen level
timeFrame: JUNE 2021- AUGUST 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Barcelona
country: Spain
facility: Hospitla Clinic
Study officials:
affiliation: Hospital Clinic of Barcelona
name: ANNABEL NA BLASI, PMPHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00456898: Study Evaluating the Potential of DVS SR to Inhibit the CYP2D6 Pathway
Official title: A Randomized, Open-Label, 3-Period Crossover Study to Evaluate the Effect of Multiple Doses of DVS SR and Paroxetine on the CYP2D6 Biotransformation of Codeine to Morphine in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depressive Disorder, Major
Diabetic Neuropathies
Fibromyalgia
Vasomotor Symptoms
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-04-05
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the effects of multiple oral doses of desvenlafaxine sustained release (DVS SR) and paroxetine on the biotransformation of codeine to morphine in healthy subjects. To assess the safety and tolerability of DVS SR and paroxetine when coadministered with codeine to healthy subjects.

Detailed description: This is a randomized, open-label, inpatient/outpatient, 3-period crossover study in healthy subjects.The study will consist of 3 treatment periods. In treatment period 1, subjects will be randomly assigned on study day 1. A single 60-mg dose of codeine will be administered to all subjects. In periods 2 and 3, subjects will receive either DVS SR 100 mg/day or paroxetine 20 mg/day until the steady state is reached. At steady state, subjects will receive codeine 60 mg concomitantly with either DVS SR 100 mg or paroxetine 20 mg, depending on the treatment sequence to which they are assigned. DVS SR 100 mg or paroxetine 20 mg administration will continue for an additional 2 days. In treatment period 3, subjects will receive the alternative treatment sequence.

Eligibility criteria: Inclusion criteria:

* Healthy men and nonlactating and nonpregnant women of nonchildbearing potential aged from 18 to 45 years.
* Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.
* Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion criteria:

* History of bronchial asthma, of seizure disorder (other than a single childhood febrile seizure)and of any clinically important drug allergy and any known allergy to desvenlafaxine, venlafaxine, paroxetine, codeine, or any of the non-active excipients in the dosage forms.
* Use of any CYP2D6 inhibitors or inducers within 30 days before test article administration.
* Demonstration of a positive orthostatic test at screening.

Primary outcomes:
measure: the biotransformation of codeine to morphine and the safety and tolerability of DVS SR
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05091398: Erector Spinae Plane, Paravertebral Versus Intercostal Nerve Block for VATS Surgery
Official title: Erector Spinae Plane, Paravertebral Versus Intercostal Nerve Block for VATS Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic
Keywords: Erector spinae plane
paravertebral
intercostal nerve block
VATS
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 105
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: OTHER

Brief summary: The optimal analgesia method in video-assisted thoracoscopic surgery (VATS) remains controversial. 105 patients scheduled to undergo video-assisted thoracic surgery under general anesthesia will be included. Patients will be randomly allocated to receive ultrasound-guided ESP blocks on T4 and T6 levels (Group ESPB, n = 35),PVB (Group PVB, n = 35) after the anesthesia induction and turning the patient in the lateral position or (Group ICNB, n=35) with 30 mL 0.5% bupivacaine +50 µ adrenaline will be injected by the surgeon through the thoracoscope .

Detailed description: Standard general anesthesia was applied Patients will be randomly allocated to receive single shot of ESP blocks (Group ESPB), Paravertebral blocks (Group PVB) or (Group ICNB )at T4 and T6 levels according to a random number list that will be generated by a computer and will be stored in sealed envelopes. An independent experienced anesthesiologist will perform the first two blocks or surgeon will perform the third one through the thoracoscope according to the random number. The study coordinator, attending anesthesiologist, data collection resident and the patients will be all blinded to the treatment group assignment. All blocks will be applied on patient's back in a lateral position. Postoperative analgesia regimen consisted of a continuous infusion of iv iboprofen and morphine as a second rescue drug. Demographic data, past medical history, surgical and anesthetic data will be documented. Postoperative pain scores, consumption of analgesia and quality of recovery will be recorded to evaluate the analgesic effect.

Eligibility criteria: Inclusion Criteria:

* ASA I and II patients
* Thoracic surgery

Exclusion Criteria:

* Coagulation defect

Primary outcomes:
measure: end tidal sevoflurane
timeFrame: 150 minutes
Secondary outcomes:
measure: Blood pressure
timeFrame: 150 minutes
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Mona Mohamed Mogahed
state: Elgharbia
Study officials:
References:
Clinical trial NCT01249898: The Treatment and Intra-operative Imaging of Scaphoid Fracture Reduction and Fixation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Scaphoid Fractures
Keywords: Fracture in the Scaphoid fractures
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-11-30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that suffer fron Scaphoid fractures(nonunion included).

Brief summary: Scaphoid fractures are the most common carpal bone fractures, and second most common wrist fractures (second to distal radius fractures). Lack of proper immobilization or displacement of these fractures commonly results in fracture nonunion or malunion followed by the development of wrist post-traumatic osteoarthritis. In addition, proper reduction and fixation of these fractures are challenging to the most experienced hand surgeons.

The investigators are going to follow-up the patients population suffering from Scaphoid fractures(nonunion included) for one year. The investigators will evaluate this follow up results in two ways:

1. Intra-operative imaging of scaphoid fracture fixation - feasibility evaluation.
2. Treatment of scaphoid fracture non-union.


Eligibility criteria: Inclusion Criteria:

1. Ages of 18 and 60 during the study period;
2. Scaphoid fractures to be operatively reduced and fixated, including fracture non-unions;
3. Signed informed consent.

Exclusion Criteria:

1. Non-displaced fractures of the scaphoid.
2. Soldiers in active military service.
3. pregnant women

Primary outcomes:
measure: Intra-operative imaging of scaphoid fracture fixation - feasibility evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organizaton
Study officials:
References:
Clinical trial NCT05974098: Quality of Life Influencing Factors
Official title: Exploring the Impact of Illness Perceptions, Coping Strategies on Quality of Life in Paroxysmal Atrial Fibrillation Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are from the Department of Cardiology and Department of Psychiatry, a comprehensive tertiary hospital in China. All patients who are interviewed provided written informed consents.

Brief summary: Background: quality of life is impaired in patients with paroxysmal atrial fibrillation. The purpose of this study is to explore the mediating effects of self-efficacy, coping, depression, and anxiety on the quality of life of patients with paroxysmal atrial fibrillation. Methods: It is a cross-sectional study trial. This study aims to enroll 100 patients with paroxysmal atrial fibrillation. Illness perceptions (Brief Illness Perceptions Questionnaire; BIPQ), coping styles (Carver Brief-COPE scale; B-COPE), depression Patient Health Questionnaire-9 ,PHQ-9),anxiety (The Generalized Anxiety Disorder Questionnaire, GAD 7) and quality of life (12-item Short Form Health Survey,SF12) will be analysed. This study intends to use correlation analysis and mediation analyses to assess the mediating effects of self-efficacy, coping, depression and anxiety on the quality of life of patients with paroxysmal atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

1. age 18-75 years;
2. AF diagnosis, based on a 12-lead ECG and cardiologist-led examination following the 2016 ESC Guidelines for the Management of Atrial Fibrillation
3. paroxysmal AF diagnosis given by a cardiologist according to the conversion back to the normal sinus rhythm occurs spontaneously within a week
4. ability to read and write in Chinese.

Exclusion Criteria:

1. severe complications such as unstable coronary artery disease, heart failure with severe systolic dysfunction(ejection fraction≤35%)
2. AF soon after thoracic surgery;
3. malignant disease with a 1-year survival rate or a terminal illness diagnosis;
4. a diagnosed psychiatric condition that interfered with participation (including severe depression, bipolar disorder, psychotic illness of any type, dementia, acute suicidality, severe personality disorder)
5. participation in another study
6. cognitive impairment interfering with their ability to participate in the study

Primary outcomes:
measure: The 12-item Short Form Health Survey (SF-12)
timeFrame: Quality of life was measured at the start of the study，Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Shan Qu
state: Beijing
Study officials:
References:
Clinical trial NCT05873998: Detecting Lung's Closing Pressure by Capnography
Official title: Analysis of CO2/Volume and CO2-pressure Curves to Detect the Lung's Closing Pressure in Ventilated Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atelectasis
Keywords: carbon dioxide
mechanical ventilation
Lead sponsor: Hospital Privado de Comunidad de Mar del Plata
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing general anesthesia for mediastinoscopy.

Brief summary: General anesthesia is associated with loss of pulmonary functional residual capacity and the consequent development of atelectasis and closure of the small airway.

Mechanical ventilation in a lung with reduced functional residual capacity and atelectasis increased the dynamic alveolar stress-strain, inducing a local inflammatory response in atelectatic lung areas known as ventilatory-induced lung injury. This phenomenon may appear even in healthy patients undergoing general anesthesia and predisposes them to hypoxemic episodes that can persist in the early postoperative period.

Lung recruitment maneuvers restore the functional residual capacity and, therefore, protect the lungs from lung injury. A key issue in this kind of treatment is detecting the lung's closing pressure in order to maintain the end-expiratory pressure above such a limit.

Detailed description: This is a prospective and observational study designed to measure the lung's closing pressure. The investigators will study 20 mechanically ventilated patients scheduled for mediastinoscopy surgery under general anesthesia.

Lung mechanics and capnography will be assessed during surgery. A slow pressure-volume curve will be automatically performed by the ventilator, and the small airway closing pressure will be determined as the inflection point in the alveolar slope of the pressure-CO2 and volume-CO2 curves. Then, a lung recruitment maneuver will be applied following a descending positive end-expiratory pressure trial to determine the lung's closing pressure. The investigator will see if the lung's closing pressure found with these two techniques is similar.

Eligibility criteria: Inclusion Criteria:

* Age \> 17 years ole
* Programmed surgery

Exclusion Criteria:

* Pregnancy
* No programmed surgery
* Hemodynamic instability
* Severe COPD
* Acute respiratory infection

Primary outcomes:
measure: Airway pressure
timeFrame: 30 minutes
measure: Carbon dioxide
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mar del Plata
country: Argentina
facility: Hospital Privado de Comunidad
state: Buenos Aires
Study officials:
affiliation: Hospital Privado de Comunidad
name: Nora Fuentes, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03865498: Twitter Based Social Support for Hispanic and Black Dementia Caregivers
Official title: Using Twitter to Enhance the Social Support of Hispanic and Black Dementia Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Emotional Stress
Keywords: Family Caregivers
Dementia
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
name: National Institute on Aging (NIA)
First posted: 2019-03-07
Enrollment: 966
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The prevalence of dementia is higher in Hispanics and African Americans than non-Hispanic Whites. Moreover, dementia caregivers often experience loneliness as well decreased health status. The expansion of social media use among Hispanics and African Americans, particularly Twitter - a short message service - offers great promise for improving social support. This study aims to evaluate changes of discussion topics, sentiment and networking styles (i.e., number of followers) among anonymous followers of our two Twitter networks; the African American/Black dementia caregiver group and the Hispanic dementia caregiver group.

Detailed description: The study will utilize Twitter networks to post a daily message for dementia caregivers for a year, and set up a monthly group chat.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Black or Hispanic, living in the U.S. including the U.S. territories
* a dementia caregiver with any duration, able to speak English or Spanish/bilingual
* must agree to terms of conditions of use and privacy policy and rules of one of the two dementia caregiver network (Hispanic @dcnh, Black @dcnaab), the Twitter user agreement of the terms of service, Twitter privacy policy and Twitter rules including intellectual property, violence, misconduct, abuse behavior, private information and spam and security
* use a smartphone or a feature phone (i.e., a cell phone with text messaging)

Exclusion Criteria:

* do not have de-identified Twitter account, children, not a dementia family caregiver

Primary outcomes:
measure: Number of Participants Who do Not Engage in Twitter Activities
timeFrame: 12 months
measure: Emotional Valence Score
timeFrame: 12 months
Secondary outcomes:
measure: Number of Auto-detected Small Groups
timeFrame: 12 months
measure: Percentage of Balanced Triads
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Associate Research Scientist in the Department of Medicine
name: Sunmoo Yoon, PhD
role: PRINCIPAL_INVESTIGATOR
References: