louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00281281: Pharmacokinetics of Vancomycin in Adults Receiving ECMO
Official title: Pharmacokinetics and Posology of Vancomycin in Adults Receiving ECMO
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Extracorporeal Membrane Oxygenation
Keywords: Extracorporeal Membrane Oxygenation
vancomycin
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2006-01-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Vancomycin is a drug that requires precise dosing and close monitoring to avoid drug toxicity.
2. There is limited data on the change of vancomycin pharmacokinetics in patients who need extracorporeal membrane oxygenation (ECMO).
3. This control trial is to understand:

   1. whether the pharmacokinetics of vancomycin is influenced by the use ECMO
   2. design the most appropriate dose of vancomycin in adult patients using ECMO.

Detailed description: 1. Vancomycin is a drug that requires precise dosing and close monitoring to avoid drug toxicity.
2. Oftentimes it is used in intensive care units (ICU) for patients who need a life-saving machine for heart and lung failure called extracorporeal membrane oxygenation (ECMO).
3. There is limited data on the change of vancomycin pharmacokinetics in these patients.
4. This is a control trial using ICU patients who need vancomycin but not ECMO as a control to understand:

   1. whether the pharmacokinetics of vancomycin is influenced by the use ECMO
   2. design the most appropriate dose of vancomycin in adult patients using ECMO.
5. After the 4th dose of vancomycin, blood was drawn at appropriate time spots (1 mL each) to determine the time concentration curve and to calculate the pharmacokinetic parameters for 2 groups of patients to determine if there is any difference.

Eligibility criteria: Inclusion Criteria:

* \>18 y/o
* receiving ECMO for study group
* without ECMO for control group (sex, age, creatinine clearance match with study group)

Exclusion Criteria:

* severe burn (\>30-40% BSA)
* receiving continuous renal replacement therapy or hemodialysis concurrently

Primary outcomes:
measure: pharmacokinetic parameters
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Fe-Lin L Wu, MSCP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02835781: Acellular Dermal Matrix in Breast Reconstruction
Official title: Allogenic Acellular Dermal Matrix Use in Patients With Breast Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Implants
Acellular Dermal Matrix
Lead sponsor: University Hospital Bratislava
Sponsor class: OTHER
Collaborators: name: Comenius University
First posted: 2016-07-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohort will be selected from patients with breast cancer and in remission, sent to plastic and reconstruction surgery clinics for breast reconstruction after therapeutical mastectomy.

Brief summary: Allogenic acellular dermal matrix has been used in burn injuries or abdominal walls reconstructions. However, it is solely used in breast reconstructions after breast carcinoma amputation. The efficacy of such allogenic dermal matrix can be advantageous when compared to current treatment options, however, this has to be proved.

Detailed description: This is a prospective study, where patients undergoing breast reconstruction surgery using acellular dermal matrix (ADM) with expander use in first phase of reconstruction will be included. The permanent breast implants will be implanted approximately half year during second surgery. Acellular dermal matrix is a soft tissue graft that is formed by decellularization, however with intact extracellular dermal matrix. Such structure is able to re-create adequate skeleton for host cells with subsequent incorporation and revascularization. The safety and appropriateness of such ADM in breast reconstruction surgery will be analyzed.

Eligibility criteria: Inclusion Criteria:

* signed informed consent
* total one-side mastectomy due to breast cancer
* age between 18-60 years

Exclusion Criteria:

* failure to obtain signed informed consent

Primary outcomes:
measure: Number of complications in patients receiving acellular dermal matrix evaluated at 6 months after primary implantation
timeFrame: 6 months
Secondary outcomes:
measure: Histologic evaluation of ADM implants upon planned explantations
timeFrame: 6 months
measure: Satisfaction with breast reconstruction outcome evaluated by Breast-Q questionnaire
timeFrame: 2 years
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: University Hospital Bratislava
Study officials:
affiliation: University Hospital Bratislava, Pazitkova 4, Bratislava, Slovakia
name: Miroslav Bdzoch, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Bohac M, Varga I, Polak S, Dragunova J, Fedeles J Sr, Koller J. Delayed post mastectomy breast reconstructions with allogeneic acellular dermal matrix prepared by a new decellularizationmethod. Cell Tissue Bank. 2018 Mar;19(1):61-68. doi: 10.1007/s10561-017-9655-0. Epub 2017 Aug 16.
Clinical trial NCT05837481: Guided Meditation to Decrease Perioperative Anxiety and Increase Patient Intraoperative Compliance in Vascular Surgery
Official title: Decreasing Sedative Requirements for Peripheral Vascular Interventions Using Preoperative Guided Meditation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2023-05-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this clinical trial is to test the feasibility of implementing a perioperative guided meditation program for patients undergoing peripheral vascular interventions that are performed under procedural sedation and analgesia.

Detailed description: This is a prospective, randomized, controlled study involving 30 adult patients undergoing peripheral vascular interventions. Patients will be randomized to two arms: an intervention arm where patients will participate in perioperative guided meditation, and a control arm where patients will receive standard of care without any meditation intervention.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Undergoing an endovascular procedure for peripheral vascular disease
* Anesthesia plan for procedural sedation and analgesia

Exclusion Criteria:

* Pre-existing psychiatric disorder such as anxiety, panic disorder, depression, psychosis, or bipolar disorder
* Non-English speaking
* Prior history of ipsilateral lower extremity amputation
* Urgent or Emergent Surgery
* Anesthesia plan for general anesthesia
* Undergoing a hybrid procedure (simultaneous endovascular and open surgery)

Primary outcomes:
measure: Feasibility of Implementing Preoperative Guided Meditation
timeFrame: Immediately before surgery
Secondary outcomes:
measure: Anxiety - STAI-6
timeFrame: Preoperative (prior to meditation)
measure: Interoceptive Attention - MAIA (Noticing Sub Scale)
timeFrame: Preoperative (prior to meditation)
measure: Anxiety - STAI-6
timeFrame: Postoperative (within 6 hours after surgery)
measure: Interoceptive Attention - MAIA (Noticing Sub Scale)
timeFrame: Postoperative (within 6 hours after surgery)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Newton
country: United States
facility: Newton Wellesley Hospital
state: Massachusetts
city: Salem
country: United States
facility: Salem Hospital
state: Massachusetts
city: Nashua
country: United States
facility: Southern New Hampshire Hospital
state: New Hampshire
Study officials:
affiliation: Massachusetts General Hospital
name: Chien Yi M Png, MD
role: STUDY_CHAIR
affiliation: Massachusetts General Hospital
name: Chien Yi M Png, MD
role: STUDY_DIRECTOR
affiliation: Massachusetts General Hospital
name: Anahita Dua, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00175981: Interaction Between Fluvoxamine and Sildenafil
Official title: Pharmacokinetic and Pharmacodynamic Evaluation of the Interaction Between Fluvoxamine and Sildenafil in Healthy Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Aim of the study is to assess the interaction between sildenafil and fluvoxamine and its effect on the venous response to sodium nitroprusside.

Detailed description: In a randomised, double-blind, placebo-controlled, cross-over study in healthy men we will assess the effect of oral fluvoxamine (50mg qd on day 1-3; 100mg qd on day 4-10) on sildenafil kinetics (single oral 50mg dose on day 11). Sildenafil plasma concentrations will be determined by LC/MS. We will also assess the effect of sildenafil on venodilation induced by a constant dose-rate of the NO-donor sodium nitroprusside (SNP) during preconstriction with phenylephrine (dorsal hand vein compliance technique).

Eligibility criteria: Inclusion Criteria:

* Healthy, male individuals, age: 18-45.
* Able and willing to give written informed consent

Exclusion Criteria:

* Hypotension ( 65 mmHg diastolic and  100 mmHg systolic blood pressure)
* Bleeding disorders in medical history
* Intake of medication impairing platelet function or influencing coagulation (for example aspirin, NSAID and others) during the preceding 4 weeks
* Known condition causing endothelial dysfunction (e.g. diabetes, hyperlipidaemia, arterial hypertension, hyperhomocysteinaemia, smoking)
* Anatomic deformity of the penis like angulation, penile fibromatosis (peyronie's disease) or diseases favouring priapism (e.g. leukaemia, plasmocytoma, sickle-cell anaemia)
* Regular medication and/or treatment with drugs within the preceding 4-6 weeks (exclusion has to be decided in each case)
* alcohol (\>30 g/d) or drug abuse
* Acute or chronic illness
* Blood donation within the preceding 2 months
* Participation in clinical trial within 2 month before the study
* Drug and/or alcohol abuse.

Primary outcomes:
measure: Drug-induced changes of hand vein compliance
measure: Drug-induced changes of pharmacokinetic parameters
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Dept. of Internal Medicine VI, University of Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: Heidelberg University
name: Walter E Haefeli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03038581: Comparison of Self-inflicted Deep Wrist Injuries to Traumatic Deep Wrist Injuries
Official title: Comparison of Self-inflicted Deep Wrist Injuries to Traumatic Deep Wrist Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Wound
Wrist Injuries
Keywords: Deep wrist injury
Self inflicted
Traumatic wrist injury
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: Psychiatry, University of Schleswig-Holstein
First posted: 2017-01-31
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with deep wrist injuries that were treated 2008-2018 in University Hospital Schleswig-Holstein

Brief summary: Self-inflicted wrist injuries require special psychiatric knowledge and tactical skills. There is no protocol for treating such injuries. We analyze self-inflicted wrist injuries and compare them to traumatic wrist injuries.

Detailed description: Self-inflicted wrist injuries are regularly treated in hand surgery centers. These injuries involve risks that require special psychiatric knowledge and tactical skills. There is no protocol for treating such injuries. Therefore, the investigators analyze self-inflicted wrist injuries and compare them to traumatic wrist injuries.

Eligibility criteria: Inclusion Criteria:

* Deep wrist injury from 2008-2018
* Treated in University Hospital Schleswig-Holstein
* Agreed to retrospective analysis, questionnaires and hand function assessment

Exclusion Criteria:

* Non-compliance

Primary outcomes:
measure: Hand function
timeFrame: Up to 10 years
Secondary outcomes:
measure: Psychiatric history
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: University of Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
affiliation: University of Schleswig-Holstein, Campus Lübeck, Germany
name: Tobias Kisch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05905081: Acute Effects of Moderate Intensity Aerobic Exercise on Cognitive Functions in Young Adult Males
Official title: Acute Effects of Physical Fitness and Aerobic Exercise on Cognitive Functions in Young Adult Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Keywords: acute aerobic exercise
cognition
university students
physical fitness
Lead sponsor: Izmir University of Economics
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 61
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group comparison, before and after intervention
Primary purpose: BASIC_SCIENCE

Brief summary: 60 healthy male university students will be included in this study. Physical fitness parameters, fluid intelligence, and physical activity level will be measured at baseline. Participants will be randomised to one of two testing schedules, groups will complete either a 30-minutes aerobic exercise session or a resting control condition. Cognitive measures (simple reaction time task, go/nogo task, spatial cueing, n-back task) will be tested before and after the intervention.


Eligibility criteria: Inclusion Criteria:

* No known psychiatric, cognitive or physical health problems
* No limiting issue for performing exercise according to Physical Activity Readiness Questionnaire (PAR-Q+)
* Physical activity level according to International Physical Activity Questionnaire (IPAQ) \< 3000 MET

Exclusion Criteria:

* Discomfort/illness that will interfere with physical activity
* Using any medication or stimulants
* Having limitations for performing exercise according to Physical Activity Readiness Questionnaire (PAR-Q+)

Primary outcomes:
measure: Change in motor inhibition
timeFrame: Baseline and 30 mins after baseline
measure: Change in working memory capacity
timeFrame: Baseline and 30 mins after baseline
Secondary outcomes:
measure: Change in psychomotor rate
timeFrame: Baseline and 30 mins after baseline
measure: Change in visual inspection and attention
timeFrame: Baseline and 30 mins after baseline
Other outcomes:
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: At baseline
measure: VO2max
timeFrame: At baseline
measure: Raven's Progressive Matrices
timeFrame: At baseline
measure: Muscle strength
timeFrame: At baseline
measure: Plank test
timeFrame: At baseline
measure: T-test
timeFrame: At baseline
measure: Body composition
timeFrame: At baseline
Locations:
city: İzmir
country: Turkey
facility: Izmir University of Economics
Study officials:
affiliation: Izmir University of Economics
name: Şermin Tükel Akay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00179595: Does the Relaxation Response Inhibit Acute Stress?
Official title: Does the Relaxation Response Inhibit Acute Stress?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: nitric oxide, volumetric oxygen consumption
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2005-09-16
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purposes of this study are:

1. To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.
2. To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.

Since stress is a factor in the development of many health conditions, a further understanding of the mechanisms of the RR should be developed. The project is designed to determine how the RR can improve the quality of life that has been adversely affected by stress.

Detailed description: The purposes of this study are:

1. To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.
2. To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.

Since stress is a factor in the development of many health conditions, a further understanding of the mechanisms of the RR should be developed. The project is designed to determine how the RR can improve the quality of life that has been adversely affected by stress.

Eligibility criteria: Inclusion Criteria:

* healthy individual
* age:18-49 years
* able to read and understand English
* able to attend al study visits
* access to a telephone (to schedule visits)

Exclusion Criteria:

* current smoking
* asthma
* current use of any prescription or psychoactive medications or supplements
* either:

  1. no prior experience with RR eliciting techniques
  2. at least 3 years of regular RR elicitation (at least 20 min/day)
* BMI \>30
* exhaled nitric oxide levels \>60 ppb
* abnormal lab values (Hct \<32,creatinine \>1.3, glucose \>200
* pregnancy

Primary outcomes:
measure: To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.
Secondary outcomes:
measure: To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth-Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Herbert Benson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01599195: Use of Amplified Sound Signal to Identify Presence of Carotid and Femoral Stenosis
Official title: Use of Amplified Sound Signal to Identify Presence of Carotid and Femoral Stenosis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Carotid Stenosis
Femoral Arterial Stenosis
Carotid Bruit Asymptomatic
Carotid Murmur
Keywords: carotid stenosis
femoral artery ischemia
carotid bruit asymptomatic
carotid murmur
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: any person age 19 through 90 years who have been clinically determined to require evaluation of carotid or femoral arteries for suspected stenosis

Brief summary: The purpose of the study is to test a new amplified stethoscope(AudioDoc) that can detect the presence of bruit by using an acoustic signal to represent the bruit. This pilot study will address two questions: is there a detectable difference in recorded sound signal of carotid and femoral bruit when compared to sound signals captured when there is no bruit present; is the use of a visual recorded signal more accurate in identifying carotid and femoral bruit when compared to traditional auscultation with a regular stethoscope and ultrasound.

Detailed description: Recorded signals are stored on a laptop computer. The signals later undergo Fourier analysis are then compared to the findings on carotid ultrasoud as to degree of stenosis. Subjects with high grade stenosis in which no bruit was ascultated but in which carotid ultrasound data suggests a bruit may be present are studied for soft /inaudible bruits. When available, data will be correlated to CT/conventional angiographic studies.

Eligibility criteria: Inclusion Criteria:

* age 19-90 years
* having clinical ultrasound evaluation of carotid or femoral artery

Exclusion Criteria:

* under age 19; over age 90 years

Primary outcomes:
measure: Comparison of bruit signal obtained from the amplified stethoscope(AudioDoc) to that found by conventional ultrasonography.
timeFrame: subjects will be followed for duration of hospital stay, typically four days.
Secondary outcomes:
measure: To assess the frequency spectral differences obtained from the different recording modalities
timeFrame: duration of hospital stay, typically four days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Albert Einstein Healthcare Network
state: Pennsylvania
Study officials:
affiliation: Albert Einstein Healthcare Network
name: Jonathan Dissin, MD
role: PRINCIPAL_INVESTIGATOR
References: