louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02661607: Point of Care Echocardiography Versus Chest Radiography for the Assessment of Central Venous Catheter Placement
Official title: A Prospective Study to Compare Point of Care Echocardiography Versus Chest Radiography for the Assessment of Central Venous Catheter Placement in Critical Care Environments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Venous Catheterization
Ultrasound
Emergency Medicine
Critical Care
Lead sponsor: University of Göttingen
Sponsor class: OTHER
First posted: 2016-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A prospective study to compare the use of point of care echocardiography versus routine chest radiography for the assessment of central venous catheter placement.


Eligibility criteria: Inclusion Criteria:

* patients who require central venous catheterization in critical care environments (ICU, IMC)
* patients (or legal guardian) who provide written informed consents
* patients aged 18 years or older

Exclusion Criteria:

* patients who are unable/unwilling to give informed consent

Primary outcomes:
measure: Adequate placement of the central venous catheter
timeFrame: 2 hours
Secondary outcomes:
measure: Time needed for the intervention (bedside echocardiography)
timeFrame: 5 Minutes
measure: Performance of residents as assessed by the time needed to perform the echocardiography
timeFrame: 5 Minutes
measure: Time needed for chest radiography to be performed
timeFrame: 2 hours
measure: Adverse Events
timeFrame: 24 hours
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University of Göttingen
Study officials:
affiliation: University Medical Center Göttingen, Department of Nephrology and Rheumatology
name: Peter Korsten, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Korsten P, Mavropoulou E, Wienbeck S, Ellenberger D, Patschan D, Zeisberg M, Vasko R, Tampe B, Muller GA. The "rapid atrial swirl sign" for assessing central venous catheters: Performance by medical residents after limited training. PLoS One. 2018 Jul 16;13(7):e0199345. doi: 10.1371/journal.pone.0199345. eCollection 2018.
Clinical trial NCT02184507: Effect of Insulin Resistance Reducing Agents Pre and Post CABG on Post-operative Metabolic Status and Oxidative Stress
Official title: Effect of Insulin Resistance Reducing Agents Pre and Post CABG on Post-operative Metabolic Status and Oxidative Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: insulin resistance
blood glucose
CABG
oxidative stress
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shiraz University of Medical Sciences
First posted: 2014-07-09
Enrollment: 92
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aimed to evaluate the effect of a combination of insulin resistance reducing agents pre and post coronary artery bypass grafting surgery on post-operative blood glucose and oxidative stress regulation.

Detailed description: The present study aimed to evaluate the effect of a combination of insulin resistance reducing agents pre and post coronary artery bypass grafting surgery on post-operative blood glucose and oxidative stress regulation. The sample size was estimated to be 92 (23 in each group). The participants of the study were selected from the non-diabetic patients scheduled for CABG. The patients were allocated to four groups using balanced block randomization method:

1. Consumption of the supplement (a 20 gram pack of the supplement daily) 7 days before surgery and placebo (a pack of starch) 30 days post surgery
2. Consumption of placebo 7 days before surgery and supplement 30 days post surgery
3. Consumption of the supplement 7 days before and 30 days post surgery
4. Consumption of placebo 7 days before and 30 days post surgery One week before, before the onset of the surgery, after the surgery, 1 week after and 4 weeks after the operation, blood samples were taken and the levels of hemoglobin A1C, glucose, insulin and malondialdehyde were measured. Also, body composition indices were assessed in four times: one week before the surgery, before the onset of the surgery, 1 week after and 4 weeks after the surgery.

Eligibility criteria: Inclusion Criteria:

* Mean age of 30-70 years old, Having Coronary Artery Disease
* Undergoing coronary artery bypass grafting surgery

Exclusion Criteria:

* Positive history of diabetes mellitus, metabolic, hematological, and immune disorders, renal problem, and cerebrovascular accident
* Taking antioxidant supplements
* Cases for emergency operations
* Ejection Fraction \< 30%

Primary outcomes:
measure: Serum glucose
timeFrame: 37days
measure: serum insulin
timeFrame: 37 days
measure: Hemoglobin A1C
timeFrame: 37 days
measure: Insulin Resistance
timeFrame: 37 days
Secondary outcomes:
measure: Body Composition changes
timeFrame: 37 days
measure: malondialdehyde
timeFrame: 37 days
Other outcomes:
Locations:
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Mohammad Hassan Eftekhari, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00458107: Study Evaluating the Safety and Tolerability of SCA-136 in Healthy Japanese and Non-Japanese Female Subjects
Official title: An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of SCA-136 Administered Orally to Healthy Japanese and Non-Japanese Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: Pharmacokinetics
Pharmacodynamics
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-04-09
Enrollment: 64
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being conducted to evaluate the safety and tolerability of ascending multiple oral doses of SCA-136 adminstered to healthy Japanese and non-Japanese female subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese women or non-Japanese of child bearing potential using nonhormonal contraceptives.
* Japanese female subjects are defined as being born in Japan but living outside of Japan for less than 5 years.

Exclusion Criteria:

* Any significant disease.
* Positive urine drug screen, increased liver funtion tests, use of prescription drugs.

Primary outcomes:
measure: Adverse events, safety laboratories results, vital signs, and ECGs will be used to monitor subject safety.
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02037607: Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures
Official title: Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Vein Thrombosis
Keywords: Deep vein thrombosis
Children
Pediatric
Anti-coagulant
Neurosurgical procedures
Blood Clot
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 children between the ages of 1 month-12 years having an elective neurosurgical procedure at James Whitcomb Riley Hospital for Children.

Brief summary: The purpose of this study is to determine how frequently children undergoing elective neurosurgical procedures develop blood clots in the deep veins of the legs while hospitalized. The information gained from this study will help us determine when children children need to receive therapy to help prevent this type of blood clot from forming.


Eligibility criteria: Inclusion Criteria:

* Patients age 1 month-12 years undergoing elective neurosurgical procedures.

Exclusion Criteria:

* Patients undergoing outpatient neurosurgical procedures
* Patients with known DVT
* Patients with known hypercoagulable state
* Patients at high risk for DVT (discretion of surgeon in consultation with the hematology service)

Primary outcomes:
measure: Number of Participants With Post-operative Ultrasound Without Evidence of Thromboembolism
timeFrame: within 72 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: James Whitcomb Riley Hospital for Children
state: Indiana
Study officials:
affiliation: Indiana University
name: Daniel H Fulkerson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scherer AG, White IK, Shaikh KA, Smith JL, Ackerman LL, Fulkerson DH. Risk of deep venous thrombosis in elective neurosurgical procedures: a prospective, Doppler ultrasound-based study in children 12 years of age or younger. J Neurosurg Pediatr. 2017 Jul;20(1):71-76. doi: 10.3171/2017.3.PEDS16588. Epub 2017 May 5.
Clinical trial NCT05915507: Effect of Laser Acupuncture Alone or Combined With Pranayama Exercise on Inflammation in Allergic Rhinitis in Geriatrics
Official title: Comparing the Effect of Laser Acupuncture Alone or Combined With Pranayama Exercise on Inflammatory Status/Markers in Geriatrics With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Allergic Rhinitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Allergic rhinitis (AR) represents one of the most common global health problems with seriously increasing incidence over the last decades.The goal of the treatment of rhinitis is to prevent or reduce the symptoms through reduction of the inflammation of affected tissues. Acupuncture and pranayama yoga exercises had reported a significant improvement in daily symptoms and an increase of symptom-free days in many studies enrolling geriatric patients.

Detailed description: Sixty Egyptian geriatrics with allergic rhinitis, after randomization, will be divided to 2 groups; the first 30-geriatric group will receive 3-session per-week laser stimulation for 8 weeks to some selected acupoints and daily pranyama exercises (nearly every session will be one hour, for 8 weeks), the second group will receive 3-session per-week laser stimulation for eight weeks to some bilateral selected acupoints. the stimulated points will be (LI 19, LI 20, ST2, and ST4. ST6, ST7, ST17, ST36, SI18, BL2, GB14, GV24 and EXHN5). Every acupoint will be stimulated with laser power of 100 mw that will be used on a spot area of 1 cm2 for 1 minute.

Eligibility criteria: Inclusion Criteria:

* geriatrics with allergic rhinitis

Exclusion Criteria:

* chest disease or heart disease or local congenital nose deformities participants received within-previous-eight-months self-prescribed or by-therapist prescribed complementary therapies

Primary outcomes:
measure: erothrocyte sidemention rate
timeFrame: It will be measured after 8 weeks
Secondary outcomes:
measure: Immunoglobulin E
timeFrame: It will be measured after 8 weeks
measure: interleukin 1-beta
timeFrame: It will be measured after 8 weeks
measure: C-reactive protein
timeFrame: It will be measured after 8 weeks
measure: total eosinophil count
timeFrame: It will be measured after 8 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy Cairo University
state: Dokki
Study officials:
affiliation: Cairo University
name: Ali MA Ismail
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03163407: Norepinephrine Versus Ephedrine in Treatment of Hypotension During Spinal Anesthesia for Caesarean Section
Official title: Norepinephrine Versus Ephedrine for Treatment of Hypotension During Spinal Anesthesia for Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Vasopressors
Cesarean Section Complications
Anesthesia Complication
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Prospective, randomized study, including full term parturients scheduled for caesarean section under spinal anesthesia. Spinal anesthesia was performed in sitting position with a 25 G spinal needle and all patients received 15 ml/kg of crystalloid intravenously during the spinal block. Baseline hemodynamics: heart rate, systolic and diastolic blood pressure were recorded before spinal anesthesia and intraoperatively. Postspinal hypotension, defined as decrease of Systolic blood pressure\>20% from the baseline value, was managed using Ephedrine increments 6 mg/3min in patients of GE group or by 5 mcg Norepinephrine/3min for the patients of GN group. Intraoperative hemodynamic data of the 2 groups were compared.

Detailed description: Prospective, randomized study including full term parturients scheduled for caesarean section under spinal anesthesia. All patients were ASA status I/II and patients with arrhythmia were excluded. Spinal anesthesia was performed in sitting position at L3-4 or L4-5. A 25 G spinal needle was used for intrathecal injection of 8 mg of hyperbaric bupivacaine, 2.5 mcg sufentanil and 100 mcg morphine. All patients received 15 ml/kg of crystalloids intravenously during the spinal block. Patients were positioned in left lateral tilt position. Baseline hemodynamics; HR, systolic (SBP) and diastolic blood pressure (DPB) were recorded before spinal anesthesia and intraoperatively (every 2 min). Post anesthesia hypotension was defined as decrease of SBP\>20% from the baseline value. If hypotension occurred, patients were randomized into 2 groups:

* GE group in which hypotension were managed using ephedrine increments of 6 mg Ephedrine every 3 min until correction of SBP
* GN group: patients of this group received 5mcg of Norepinephrine/3 min demographic and hemodynamic data of the two groups were compared.

Eligibility criteria: Inclusion Criteria:

* Fully term parturients
* Caesarean section under spinal anesthesia
* ASA status I or II

Exclusion Criteria:

* Severe cardiac disease
* Cardiac arrhythmia

Primary outcomes:
measure: number of injections
timeFrame: number of injections required in the first hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01222507: Processing Speed as an Objective Measure of Tinnitus
Official title: Processing Speed as an Objective Measure of Tinnitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tinnitus
Keywords: tinnitus
cognition
brain processing speed
Brain Fitness Program
Posit Science
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Posit Science Corporation
First posted: 2010-10-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tinnitus subjects recruited from speciality clinic and community at large.

Brief summary: The overall purpose of this research is to assess whether both the "60 second Brain Game" and the "Brain Speed Test" computer-based programs can be used as assessment tools for objectively defining the severity of the functional impact of tinnitus.

Detailed description: This cross-sectional study aims to assess for deficits in brain processing speed and attention (two cognitive domains whose deficits have been implicated in tinnitus) with the use of the "Brain Speed Test".

Eligibility criteria: Inclusion Criteria:

* Participants must be between the ages of 18 and 80.
* Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6-months duration or longer.
* Participants must be able to read, write and speak using the English language.
* Participants must be able to provide informed consent.

Exclusion Criteria:

* Participants with tinnitus related to Workman's Compensation Claim or other litigation-related situations.
* Participants with active diagnoses of any acute or chronic brain-related neurological conditions that alter normal brain anatomy or function including Parkinson's disease, Multiple Sclerosis, Alzheimer's Disease, cerebral infarcts, traumatic brain injury, history of brain tumor(s), epilepsy, or dementia.
* Participants with tinnitus related to retrocochlear lesions, cochlear implants, or other known anatomic/structural lesions of the brain, skull-base, temporal bone or ear.
* Participants unable to hear the highest volume of the computer-based objective assessments.
* Any medications that may affect or alter cognition including but not limited to sedatives, hypnotics, narcotics, or opiates.
* Any medical condition the PI determines would compromise the safety of the participant or complicate the interpretation of the study results.

Primary outcomes:
measure: Brain Speed Test
timeFrame: Initial study visit
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington Unieversity
name: Jay Piccirillo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03138707: Patients Who Die Within Emergency Department
Official title: Demographic Characteristics of Patients Who Die Within Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Death
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 355
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who die within Emergency Department of Adıyaman University Tranining and Research Hospital, between January 01, 2013 and December 31, 2015.

Brief summary: Emergency services are a crowded and chaotic environment.

Detailed description: Emergency services are a crowded and chaotic environment. Aim of this study is to investigate the clinic features of emergency patients who die after brought to emergency service.

This retrospective study will be conducted on patients who die within Emergency Department a tertiary hospital over between 01 January 2013 and 31 December 2015.

Eligibility criteria: Inclusion Criteria:

* patients who die within emergency department

Exclusion Criteria:

* patients who die outside emergency department patients who die before they were admitted to emergency department

Primary outcomes:
measure: patients who die within Emergency department
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: Adiyaman University Research Hospital
state: Central
Study officials:
affiliation: Adiyaman University Medical Faculty
name: Umut Gulacti
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baker M, Clancy M. Can mortality rates for patients who die within the emergency department, within 30 days of discharge from the emergency department, or within 30 days of admission from the emergency department be easily measured? Emerg Med J. 2006 Aug;23(8):601-3. doi: 10.1136/emj.2005.028134.
Clinical trial NCT01141907: Nurse-Led Heart Failure Care Transition Intervention for African Americans: The Navigator Program
Official title: Nurse-Led Heart Failure Care Transition Intervention for African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
self care
decision support
telemonitoring
navigator
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2010-06-11
Enrollment: 11
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Heart failure (HF) affects over 5 million Americans with HF morbidity reaching epidemic proportions. Annual rates of new and recurrent HF events including hospitalization and mortality are higher among African Americans. In this study, the investigators are testing an interdisciplinary model for heart failure care, with focus on enhancing self management and use of telehealth, which has significant potential to improve self management and outcomes.

The main purpose of this study is to learn how to help African Americans with heart failure care for themselves at home. We hope to find out if a team including a nurse and community health navigator using a computer telehealth device can help people with heart failure stay healthier. The team will help people with heart failure to manage their medication, monitor their symptoms and weigh themselves every day after they leave the hospital. The team will also help people with heart failure learn to solve problems that may keep them from following their treatment plan.


Eligibility criteria: Inclusion Criteria:

* hospitalized with admitting diagnosis of heart failure in prior 8 weeks
* self-identified as African American
* community-dwelling (i.e., not in a long-term care facility)
* residence within a predefined radius in Baltimore City
* working telephone in their home
* provide signed informed consent

Exclusion Criteria:

* cannot speak or understand English
* severe renal insufficiency requiring dialysis
* acute myocardial infarction within preceding 30 days
* receiving home care services for HF post discharge
* legally blind or have major hearing loss
* screen positive for cognitive impairment on the Mini-cog at baseline
* unable to stand independently on a weight scale (limited ability to participate in HAT system)
* weigh more than 325 pounds (exceed scale capacity)
* serious or terminal condition such as psychosis or cancer (actively receiving chemo or radiation)
* pregnant

Primary outcomes:
measure: Rehospitalization
timeFrame: 3 months post enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University School of Nursing
name: Cheryl R Dennison, PhD
role: PRINCIPAL_INVESTIGATOR
References: