louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02200120: Evaluation of Catheter Placement for Renal Replacement Therapy in Patients With Acute Kidney Injury
Official title: Evaluation of Catheter Placement for Renal Replacement Therapy in Patients With Acute Kidney Injury- Assessment of Dialysis Adequacy and Infection Rates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 150
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 admitted to the hospital with acute kidney injury requiring renal replacement therapy

Brief summary: The purpose of this study is to examine the placement, timing, associated complications, efficacy of temporary and tunneled catheters for renal replacement therapy in patient with acute kidney injury.

Detailed description: The purpose of this study is to examine the placement, timing, associated complications, efficacy of temporary and tunneled catheters for renal replacement therapy in patient with acute kidney injury. In particular, we will be assessing renal replacement adequacy for patients on dialysis and continuous veno-venous hemofiltration by monitoring urea reduction ratios, venous and arterial pressures. We will also be monitoring infection rates. We will compare these outcomes in patients receiving tunneled catheters and patients receiving temporary catheters.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to the hospital with acute kidney injury requiring renal replacement therapy

Exclusion Criteria:

* End stage renal disease
* Chronic kidney disease 5 progression to end stage renal disease
* Outside hospital catheter placement

Primary outcomes:
measure: Dialysis adequacy
timeFrame: up to 7d after starting renal replacement therapy
Secondary outcomes:
measure: blood stream infection rates
timeFrame: within 30d of catheter placement
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Sushrut Waikar, MD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Mallika L Mendu
role: STUDY_DIRECTOR
References:
Clinical trial NCT03593174: Étude de l'efficacité du Pansement Rigide Amovible Sous Vide à Titre de modalité de Pansement Post-amputation Tibiale
Official title: Étude de l'efficacité du Pansement Rigide Amovible Sous Vide à Titre de modalité de Pansement Post-amputation Tibiale
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trans-tibial Amputations
Keywords: Amputation
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study will measure the efficiency of a new modality for trans-tibial amputations in Quebec's health system, to reduce the time before prosthesis fitting, compared to the usual modality. The present study will evaluate the feasability of implantation of this new modality in Quebec and demonstrate its superiority in comparison to the usual modality (shorter time before fitting and reduction of costs).

Detailed description: The main objective of the present study is to obtain an estimation of the efficiency of a Removable Rigid Dressing (RRD) -type compression modality immediately following a tibial amputation as an alternative to the elastic bandage, which is the usually-used modality. This pilot study will verify the feasability of implantation of this type of dressing, and to collect data on the main dependant variables of this research projet in order to eventually estimate the expected effect on a larger population.

The main objectives of this study are:

1. To explore the efficacy of the RRD in comparison to the elastic bandage on the size of the stump, associated complications and necessary time to fitting of the prosthesis.
2. Verify the facilitators and obstacles to implantation of the RRD as a post tibial ambutation dressing modality as an alternative to the elastic bandage.

Eligibility criteria: Inclusion Criteria:

* Need of a trans-tibial amputation of atraumatic cause
* Between 40 and 75 years of age

Exclusion Criteria:

- Having a medical condition that could significantly affect the healing process

Primary outcomes:
measure: Stump size
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Université de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Michel Tousignant, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT02921074: STATE Trial: SusTained Attention Training to Enhance Sleep
Official title: STATE Trial: SusTained Attention Training to Enhance Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2016-09-30
Enrollment: 23
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a validation study to document the acceptability of the Tonic and Phasic Alertness Training (TAPAT) training program in older adults with chronic late-life insomnia. The goal of this study is to employ a computerized attention-training program, TAPAT, designed for chronic late-life insomnia in a randomized, controlled trial to assess feasibility and initial efficacy in this population.


Eligibility criteria: Inclusion Criteria:

* Participant must be between ages 55 and 80.
* Participant must meet current diagnostic criteria for Primary Insomnia Disorder based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
* Participant with hypertension must be undergoing treatment for this condition and on a stable medication regimen for hypertension for ≥ 8 weeks prior to screening.
* Participant must be a fluent English speaker
* Participant must have adequate visual, auditory, and motor capacity to use computerized intervention
* Participant must be willing to wear Microsoft Band 2 watch to track sleep patterns

Exclusion Criteria:

* Participants with cognitive impairment, delirium or dementia, or evidence of cognitive impairment from a pre-existing cause.
* Participants with untreated psychiatric conditions, including substance abuse/dependence disorders, untreated obstructive sleep apnea, diagnosis of other sleep disorders (e.g., restless legs syndrome), recent hospitalization, ongoing chemotherapy or other cancer treatment, and concurrent engagement in another insomnia treatment.
* Participants enrolled in another concurrent research study.
* Participants who have difficulty performing assessments or comprehending or following spoken instructions, in the judgment of the screening clinician.
* Participants using computer-based cognitive training programs or has used them within a month of the consent date.

Primary outcomes:
measure: Sleep efficiency and sleep duration scores on the Pittsburg Sleep Quality Index
timeFrame: 4 months
measure: Sleep duration obtained by actigraphy (Microsoft Band 2 watch)
timeFrame: 4 months
measure: Sleep duration obtained by sleep diary
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Posit Science Corporation
state: California
Study officials:
References:
Clinical trial NCT01211574: Pilot Study Testing Professional, Peer, and Mentor Health Coaches for Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obesity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2010-09-29
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants will be randomly assigned to 1 of 3 types of health coaches, Peers, Mentors, or Professionals. The aim of this study is to examine the feasibility and preliminary efficacy of health coaching for weight loss.


Eligibility criteria: Inclusion Criteria:

* age 40-60

Exclusion Criteria:

* Participants will be excluded if they:

  1. Are unwilling to participate in a weight control program that includes weight coaches.
  2. Report not being able to walk 2 blocks (1/4 mile) without stopping.
  3. Are participating in a weight loss program, taking a weight loss medication, have a history of bariatric surgery, or lost ≥ 5% of body weight during the past 6-months.
  4. Are pregnant, lactating, less than 6 months post-partum or plan to become pregnant during the time of the intervention.
  5. Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Participants reporting joint problems, medication use, or other medical conditions that may limit their ability to exercise will be required to obtain written permission from their physician to participate in the intervention.
  6. Report conditions that, in the judgment of the PI, would render the participant unlikely to follow the study protocol (e.g., terminal illness, relocation, substance abuse, bulimia nervosa, dementia, or severe psychiatric condition).

Primary outcomes:
measure: weight change
timeFrame: 0 to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Miriam Hospital / Warren Alpert Medical School at Brown University
name: Tricia M Leahey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06605274: Effectiveness Web-based Training on Perinatal Loss
Official title: Web-based Training Given to Women Who Have Experienced Perinatal Loss the Effect of Psychosocial Well-being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Loss
Psychological Distress
Depression
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective parallel two group unmasked prevention study
Primary purpose: PREVENTION

Brief summary: The study was conducted in a randomized controlled parallel group experimental design to determine the effect of web-based supportive care provided to women who experienced perinatal loss on perinatal grief, depression, hopelessness and coping with stress.

Detailed description: Loss, which includes many complex emotions, is the loss of a person or object that is valuable to the individual after having it. Perinatal loss is the most painful situation that pregnancy can potentially result in. With perinatal loss, parents may show behavioral (shock, anger and loneliness) and physical (crying, loss of appetite or overeating, insomnia, irritability, inability to concentrate, forgetfulness, pain, etc.) reactions. However, emotional problems such as grief and depression after loss are more common than physical and behavioral problems. While the prevalence of major depression in society is 3-10%, this rate varies between 10-51% in those who experience perinatal loss. Loss can become a life crisis with biopsychosocial and spiritual dimensions for parents and especially for women.

Eligibility criteria: Inclusion Criteria:

* spoke Turkish, had at least primary school level education
* did not have a psychiatric disease diagnosis
* could use and access the internet and information technologies
* did not have vision and hearing problems
* experienced pregnancy loss of 12 weeks or more
* were hospitalized in the perinatology clinic

Exclusion Criteria:

* Women who did not accept to participate in the study
* did not use the internet and information technologies and could not access them
* applied to psychological support units during the training process
* started using psychiatric medication during the training process were not included in the study

Primary outcomes:
measure: Perinatal Grief Scale (PGS)
timeFrame: six weeks
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: six weeks
measure: Beck Hopelessness Scale (BHS)
timeFrame: six weeks
measure: Stress Coping Styles Scale (SCSS)
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant Izzet Baysal University
state: Merkez
Study officials:
affiliation: Abant Izzet Baysal University
name: Nevin Bilgin, PhD
role: STUDY_DIRECTOR
affiliation: Abant Izzet Baysal University
name: Tuba Ünal, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00717574: Addition of Nitrous Oxide and Its Effects on Depth of Anesthesia
Official title: Addition of Nitrous Oxide to a Sevoflurane or Propofol Based Anesthetic and Its Effects on Depth of Anesthesia Indices (N20)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Sedation
Anesthesia, General
Keywords: depth of sedation
nitrous oxide
general anesthesia
anesthesia indices
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2008-07-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study hypothesizes that adding 60% nitrous oxide to a steady state sevoflurance or propofol anesthetic will lead to a decrease in both BIS and Entropy indices during a constant level of surgical stimulus

Detailed description: Nitrous oxide is a widely used general anesthetic pas. It is often used in addition to a second, more potent agent. BIS and Entropy are depth of anesthesia monitors in clinical use. There are conflicting reports about the usefulness of these monitors when nitrous oxide is used as a part of the anesthetic regimen. While some studies demonstrate a decrease in BIS and Entropy, this study aims to investigate the effects of adding nitrous oxide to a sevoflurane or a propofol based anesthetic on BIS and Entropy indices.

Eligibility criteria: Inclusion Criteria:

* Ages 18 to 55yrs
* ASA status less than and equal to 2

Exclusion Criteria:

* Surgery on head and neck
* ASA greater than 3
* Contraindication to nitrous oxide
* Pregnant women
* History of dementia and stroke, or other organic brain disorder
* Prisoner
* Ear surgery

Primary outcomes:
measure: The Effect of Nitrous Oxide on Bispectral Index (BIS) and State Entropy Index (SE)
timeFrame: From baseline to 20 minutes after the addition of 60% nitrous oxide
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: Univeristy of Illinois Chicago
name: Mehmet S Ozcan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson RE, Jakobsson JG. Entropy of EEG during anaesthetic induction: a comparative study with propofol or nitrous oxide as sole agent. Br J Anaesth. 2004 Feb;92(2):167-70. doi: 10.1093/bja/aeh036.
Clinical trial NCT03459274: Feasibility of an Immersive Virtual Reality Based Biofeedback Intervention for Outpatients in Rheumatology
Official title: Feasibility of an Immersive Virtual Reality Based Biofeedback Intervention for Outpatients in Rheumatology: An Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Systemic Lupus Erythematosus
Spondyloarthropathy
Vasculitis
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: AppliedVR Inc.
name: Attune Health Research, Inc.
First posted: 2018-03-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with Rheumatoid arthritis, SLE, Seronegative Spondyloarthropathy, Myositis, Psoriatic Arthritis, vasculitis or other autoimmune conditions. Patients must be on a stable regimen of medications. Patients should have pain, measured at the time of entry using a Visual Analog scale, of \>5/10 at least 4 days in the last 30 days.

Brief summary: The purpose is to study the use of virtual reality (VR) and biofeedback in rheumatology clinics to help manage chronic pain in patients with rheumatologic diseases. The objective is to know the usefulness of VR/biofeedback-based therapy in the clinic.


Eligibility criteria: Inclusion Criteria:

* Adult patients with Rheumatoid arthritis, Systemic Lupus Erythematosus, Seronegative Spondyloarthropathy, Myositis, Psoriatic Arthritis, vasculitis or other autoimmune conditions.
* Patients must be on a stable regimen of medications.
* Patients should have pain, measured at the time of entry using a Visual Analog scale, of \>5/10 at least 4 days in the last 30 days

Exclusion Criteria:

* Patients who are deemed by the study team to be unable to use the VR headset and follow instructions for any reason.
* Patients who have a history of vertigo and/or dizziness
* Patients with a history of seizure disorder

Primary outcomes:
measure: Self-reported benefit of virtual reality-biofeedback experience
timeFrame: Within 10 minutes immediately after virtual reality experience completion
Secondary outcomes:
measure: Self-reported interest to try the virtual reality-biofeedback experience
timeFrame: Within 10 minutes immediately before virtual reality experience start
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Attune Health
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Swamy R Venuturupalli, MD, FACR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04750174: Kinesiotape and Dysphagia
Official title: Effectiveness of Kinesiotape on Children With Cerebral Palsy and Oropharyngeal Dysphagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Cerebral Palsy
Keywords: Kinesiotape
Swallowing
Cerebral Palsy
Dysphagia
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who met the study criteria were assigned to either the intervention group or the sham group after being questioned to provide their caregivers understanding of all study procedures and requirements for participation.
Primary purpose: TREATMENT

Brief summary: Dysphagia is common problem in almost all children with cerebral palsy (CP) and there is no consensus about to dysphagia therapy modalities.We aimed to investigate the short- and long-term effects of kinesio taping (KT) on dysphagia in children with CP.

Detailed description: There is a few studies for the effectiveness of KT application in the treatment of dysphagia and its effectiveness is controversial. These small-scale studies conducted to improve control of drooling in the oral phase of swallowing in CP. However, there are no studies that have evaluated swallowing as a whole. Moreover, there is a need to carry out studies evaluating the efficacy of KT in dysphagia treatment with a high level of evidence and duration of effectivenes for a period longer than 3 months. This study is designed to answer the following research questions: "Is KT application effective in the treatment of dysphagia in CP?" ''If it is effective, whether the effect of KT therapy persists more than 3 months''.

Eligibility criteria: Inclusion Criteria:

* Children between the ages of 2 and 6 years who had oropharyngeal dysphagia (OD) symptom and/or finding and were subsequently hospitalized and rehabilitated were included in this study.

Exclusion Criteria:

* Patients with history of maxillary, head or neck surgery or botulinum toxin injection, structural oropharyngeal abnormality, known esophageal dysphagia and/or gastroesophageal reflux disease, who were received medical and/or physical therapy for dysphagia in the last 6 months, using drugs for seizures or spasticity as well as no oral intake and tube dependent completely for feeding were not included.

Primary outcomes:
measure: Functional oral intake scale
timeFrame: 6th week
Secondary outcomes:
measure: Family satisfaction level
timeFrame: 18th week
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep University
Study officials:
affiliation: University of Gaziantep
name: Mazlum Serdar Akaltun, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01212874: Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass (CPB) in Cardiac Surgery
Official title: Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass(CPB) in Cardiac Surgery: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2010-10-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an investigator initiated, sponsored, open label, prospective randomized controlled trial to be performed in adult patients undergoing scheduled cardiac surgery. Patients will be randomized to esmolol infusion or nitroglycerin infusion for control of hypertension that occurs during cardiac surgery from induction of anesthesia to initiation of cardiopulmonary bypass (CPB).


Eligibility criteria: Inclusion Criteria:

* adult patients scheduled for cardiac surgery at LLUMC University Hospital will be eligible for participation in this study.

Exclusion Criteria:

1. severe LV (left ventricle)dysfunction (EF \< 35%).
2. emergency procedures.
3. procedures with combined carotid artery surgery.
4. patients at high risk for stroke.
5. hemodynamically significant dysrhythmias.
6. pre-existing atrial fibrillation or high degree AV (atrioventricular block).
7. pacemaker dependency.
8. known sensitivity to beta blockers.
9. patient refusal.

Primary outcomes:
measure: Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour
timeFrame: Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours
Secondary outcomes:
measure: Title: Systolic Hypertension
timeFrame: Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Richard L Applegate II, MD
role: PRINCIPAL_INVESTIGATOR
References: