louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02721446: MINDSPACE Strategy for Risk Optimization
Official title: MINDSPACE Strategy for Risk Optimization, Knowledge, and Empowerment (MINDSPACE Stroke)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Indiana Institute for Medical Research
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: Regenstrief Institute, Inc.
name: Richard L. Roudebush VA Medical Center
First posted: 2016-03-29
Enrollment: 641
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to find out which types of written stroke messages may help high risk stroke patients take action to improve their health.

Detailed description: In this project, the investigators will draw on the science that has provided a foundation for behavioral economics as a guide to activation interventions. Specifically, the investigators will use the MINDSPACE framework that was created by some of the founders of behavioral economics. That framework details nine approaches to behavioral activation that have particularly solid evidence bases. Two of these, salience and incentives, the investigative team identified as most promising and practical for stroke activation.

Aims:

1. Use electronic health record data to construct Framingham stroke risk scores in both Richard L. Roudebush Veterans Affairs Medical Center and Eskenazi Health System.
2. Conduct iterative testing with high risk stroke patients from both health systems to refine two different stroke risk messages based on the behavioral strategies of salience and incentives.
3. Conduct a randomized trial of four mailed stroke risk messages, comparing the impact on patient activation of: 1) a standard stroke risk message, 2) a salience-focused stroke risk message, 3) an incentive-focused stroke risk message, and 4) a salience plus incentive message.
4. Compare the proportion in each messaging group that completes a stroke risk factor relevant healthcare system visit within two months of receiving the stroke risk message.

Eligibility criteria: Inclusion Criteria:

* • High risk stroke patients 18 years of age or older, as determined by calculation of a Framingham Stroke Risk Score

  * At least one primary care visit 12 months prior to study initiation with the Richard L. Roudebush VA Medical Center (VHA) or Sidney \& Lois Eskenazi (EHS) Health System primary care clinics

Exclusion Criteria:

* • Patients with at least one primary care provider visit in the prior 12 months in both the VA and EHS systems

Primary outcomes:
measure: Proportion of patients responding to mailings in each of four intervention groups
timeFrame: Eight months with 132 mailings per intervention group per month
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center
state: Indiana
Study officials:
affiliation: Richard L. Roudebush VA Medical Center
name: Linda S Williams, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03487146: HP Improves Sleep and Overall Survival Rate in Maintenance Hemodialysis Patients
Official title: Hemoperfusion in Combination With Hemodialysis for Improvement of Self-reported Sleep Disturbance and Overall Survival Rate in Maintenance Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemoperfusion
Lead sponsor: Shanghai Pudong Hospital
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sleep disturbance has been long-standing torments in most of patients with maintenance hemodialysis (HD). In this study, we attempted to explore whether long-term hemoperfusion (HP) could improve sleep disorder and increase overall survival rate in HD patients.


Eligibility criteria: Inclusion Criteria:

1. duration of maintenance HD should be equal or more than 3 months,
2. patient's age should be equal or more than 18 years

   Exclusion Criteria:

   - i) he/she diagnosed with malignant tumors, an active rheumatism, infectious diseases, or a severe heart failure ii) he/she would disagree with the study
3. he/she has received a short-term poor prognosis
4. he/she would be more than 80 years old

Primary outcomes:
measure: improvement of self-reported sleep disturbance
timeFrame: 2 years
Secondary outcomes:
measure: survival
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02998346: Systemic Metabolic Contribution From Continuous Renal Replacement Therapy (CRRT)
Official title: Quantification of Systemic Metabolic Contribution From Continuous Renal Replacement Therapy (CRRT) Utilizing Regional Citrate Anticoagulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: Nutrition
CRRT
CVVH
citrate
anticoagulation
caloric uptake
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 10
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: Critically ill patients initiated on continuous venovenous hemofiltration receiving regional citrate anticoagulation with ACD-A solution.

Brief summary: The purpose of this observational study is to measure the number of calories delivered from fluids used in continuous renal replacement therapy (CRRT). We are doing this research study because the fluids used in this treatment may deliver an important number of calories. In the future this could help better estimate how much nutrition patients in the Critical Care Unit should get every day from other sources like tube feeding or nutrition through a person's veins.

Detailed description: The goal of this study is to quantify the specific metabolic contribution of standard continuous renal replacement protocols (including citrate anticoagulation) in the intensive care unit patient population at Mayo Clinic in Rochester, Minnesota utilizing a prospective, observational study. This data will allow practitioners to better tailor caloric provision with nutrition support programs, minimizing the risk of overfeeding in this complex critical care patient population.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Patients in an intensive care unit anticipated to receive greater than or equal to 24 hours of continuous venovenous hemofiltration.
* Receiving regional citrate anticoagulation with ACD-A solution.

Exclusion Criteria:

* Vulnerable adults
* Pregnant
* BMI \> 40
* Patient on extracorporeal membrane oxygenation therapy
* Reversal of port connections on the dialysis catheter and dialysis circuit lines

Primary outcomes:
measure: Quantify net glucose uptake from citrate and dextrose-containing fluids from continuous venovenous hemofiltration
timeFrame: Two days
measure: Quantify net citrate uptake from citrate and dextrose-containing fluids from continuous venovenous hemofiltration
timeFrame: Two days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01733446: A Study of the Effect of Arterial Carbon Dioxide Tension on the Recovery of Spontaneous Respiration
Official title: A Study of the Effect of Arterial Carbon Dioxide Tension on the Recovery of Spontaneous Respiration With Respiratory Inductance Plethysmography (RIP) During High Frequency Jet Ventilation (HFJV) Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Anesthesia
Keywords: High frequency jet ventilation
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators data reveal an important new observation regarding the recovery of breathing during emergence from general anesthesia: respiration resumes as a prolonged abdominal expiration event.

The present study aims to further clarify the physiology of recovery of breathing with the addition of a cutaneous monitor for arterial carbon dioxide measurement and a comparison of two different recovery paradigms.

Detailed description: The present study will use non-invasive respiratory inductance plethysmography(RIP) and transcutaneous carbon dioxide measurement to compare recovery of respiration under constant Transcutaneous carbon dioxide measurement( ptcCO2) with continuous high frequency jet ventilation HFJV (study method) with recovery of respiration during rising and apnea (current standard).

The investigators hypothesize that the prolonged abdominal expiration that we observed during recovery of breathing in prior studies will be unaffected by arterial carbon dioxide (CO2) levels.

Eligibility criteria: Inclusion Criteria:

1. Male or Female patients ages \> 18 to \< 80
2. Scheduled for procedures under general anesthesia with jet ventilation
3. Sign informed consent
4. Candidate for total intravenous anesthesia with propofol and remifentanil (which is standard protocol in this type of population)

Exclusion Criteria:

1. Absence of informed consent
2. No planned use intra-operative use of jet ventilation
3. Known difficulties with jet ventilation during prior surgical procedures
4. Emergency surgery
5. Baseline (oxygen saturation)SpO2 \<92% on room air
6. BMI \> 50
7. Pregnant or lactating females
8. Skin damage, rash or significant lesions in the areas covered by the RIP bands or transcutaneous CO2 sensor.

Primary outcomes:
measure: spontaneous breathing
timeFrame: Day 0 in the operating room occurring in the specific time frame of the end of anesthesia to patient 's first breath
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Joshua H Atkins, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03628846: Opioid Use After Traumatic Injury in Adolescents
Official title: A Prospective Survey of Opioid Use After Traumatic Injury in Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Use
Traumatic Injury
Adolescent Behavior
Substance Abuse Disorder
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 123
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Traumatically injured patients admitted to either Eskenazi Hospital or Riley Hospital, between the ages of 12 and 20.

Brief summary: Currently, 1 in 8 adolescents continue to receive prescription opioids a year or more after injury. By longitudinally surveying patients, we can identify risk factors and pathways to nonmedical opioid use. Furthermore, by assessing whether pain management and mental health treatment after injury moderates sustained opioid use and prescription opioid misuse, we can create targeted interventions to reduce future nonmedical opioid use in adolescents.

Detailed description: This is a prospective cohort study that will follow participants for 2 years and administer surveys to adolescents both traumatically injured and uninjured on prescription opioid usage, substance use, utilization of pain management and mental health services, and mental and physical health condition conditions.

Eligibility criteria: Inclusion Criteria:

* Patient is 12-20 years of age
* Adolescent admitted for trauma OR adolescent with no recent trauma
* English speaking
* Consent can be obtained from a parent or guardian

Exclusion Criteria:

- Patients with severe brain injuries or other injuries that prevent survey participation

Primary outcomes:
measure: Prospectively determine drivers of sustained opioid use and prescription opioid misuse.
timeFrame: 2 years
Secondary outcomes:
measure: Identify patient-reported factors for sustained prescription opioid use, including chronic pain and mental health conditions such as PTSD, depression, anxiety, and sleep disorders.
timeFrame: 2 years
measure: Assess behavioral, social, and clinical predictors of prescription opioid misuse and nonmedical opioid use by longitudinally surveying injured adolescents.
timeFrame: 2 years
measure: Qualitatively determine patients' motives for continued opioid therapy, prescription opioid misuse, and nonmedical opioid use by interviewing injured adolescents.
timeFrame: 2 years
measure: Analyze genetic information, obtained via saliva sample and the company 23andMe, from each participant to determine if some people are more likely to use more pain medication than others or respond better to certain pain medications.
timeFrame: 2 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
References:
Clinical trial NCT02492646: Effect of Saline Lubrication on Post-intubation Complications
Official title: Effect of Normal Saline Lubrication of Endotracheal Tube on Post-intubation Complications: A Prospective Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Sore Throat
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-07-09
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the influence of none-lubricated dry tube on the incidence of Postoperative Sore Throat (POST) after general anesthesia with endotracheal intubation.


Eligibility criteria: Inclusion Criteria:

* patients aged between 20-80 years who were scheduled for surgery under general anesthesia requiring orotracheal intubation

Exclusion Criteria:

* history of gastroesophageal reflux disease (GERD)
* congenital or acquired abnormalities of the upper airway such as tumor, polyp, trauma, abscess, inflammation, infection, or foreign bodies
* previous airway surgery; increased risk of aspiration
* coagulation disorders
* previous history of difficult intubation or conditions with expected difficult airway including Mallampati classification ≥ 3 or thyromental distance \< 6.5 cm
* Using the other intubation devices beyond the direct laryngoscopy such as lighted stylet or fiberoptic bronchoscopy
* symptoms of sore throat or upper respiratory tract infection
* expected to place nasogastric tube during perioperative period
* requiring nasotracheal intubation

Primary outcomes:
measure: incidence of postoperative sore throat (POST)
timeFrame: until one day after surgery
Secondary outcomes:
measure: Oropharyngeal injury
timeFrame: 2 hours and 24 hours after surgery
measure: respiratory symptoms
timeFrame: 1 week after the surgery
measure: severity of postoperative sore throat (POST)
timeFrame: When arriving at postanesthesia care unit (PACU) and thereafter 2, 4, and 24 hours after the surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong-Hwa Seo, Associate professor
role: STUDY_CHAIR
References:
citation: Kim E, Yang SM, Yoon SJ, Bahk JH, Seo JH. The effects of water lubrication of tracheal tubes on post-intubation airway complications: study protocol for a randomized controlled trial. Trials. 2016 Nov 25;17(1):562. doi: 10.1186/s13063-016-1699-0.
Clinical trial NCT02067546: Innovative Toilet Seat Test for Patients With Symptoms of Constipation and/or Emptying Disorders
Official title: Innovative Toilet Seat Test for Patients With Symptoms of Constipation and/or Emptying Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Constipation
Keywords: constipation
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-02-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Emptying disorders are of the most common causes of constipation. An adjustable toilet seat was designed by " Shva-Nach" Ltd company, and is designed to facilitate the angle sitting position.

Its efficacy will be evaluated in the current study, on 50 volunteers who suffer from constipation and meet the Rome 3 criteria for constipation.

Detailed description: Emptying disorders are of the most common causes of constipation. Laxatives are usually unsuccessful. Behavioral therapy such as anorectal biofeedback , have a limited success in most hospitals in this country. Toilet seat that lifts the legs and brings us into a sitting position closer to squatting (which is the desired physiological position) can relieve these patients in the emptying process.

The Company " Shva-Nach" Ltd. and its design team designed a seat at an angle slightly elevated and a toilet stool customized to the personal anatomy of each subject.

The purpose of the study: evaluating efficacy elevated toilet seat with a support of a brackets stool making emptying easier in patients with constipation and difficulty in emptying.

Methods: An open, randomized, crossover study in use of a toilet seat and comparing it to a standard seat.

Eligibility criteria: Inclusion criteria:

1. Patients suffering from constipation and meet the criteria of Rome 3. No sub - distribution by emptying disorders or decreased stool frequency
2. Age group 18-80 years
3. Study population may include patients suffering from metabolic diseases such as diabetes mellitus, hypothyroidism and hypercalcemia.
4. Patients who understand the goals of the research and collaborate

Exclusion Criteria:

1. Patients who do not understand the goals of the research and / or unable to cooperate.
2. women with known pregnancy - second trimester and up
3. Patients with obesity - BMI\> 35 and / or weight over 120 kg
4. Neurological diseases - dementia, Parkinson's disease, CVA, multiple sclerosis, muscular dystrophy, spinal cord injury
5. Disabled patients on wheelchairs.
6. Patients with active anal fissure / fistula, active inflammation of the colon, patients after resection of the colon.
7. Minors and no judgment

Primary outcomes:
measure: Improvement in bowel movement frequency
timeFrame: 2 months
Secondary outcomes:
measure: Improvement in quality of life
timeFrame: 2 months
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
References:
Clinical trial NCT02558946: Physical Therapy for Men Undergoing Prostatectomy
Official title: Perioperative Pelvic Floor Muscle Training May Improve Recovery of Continence in Men with Localized Prostate Cancer Undergoing Robot-Assisted Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Urinary Incontinence
Pelvic Floor Physical Therapy
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Indiana University Health
First posted: 2015-09-24
Enrollment: 113
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if pelvic floor muscle training with a physical therapist before and after surgery will improve health-related quality of life following robot-assisted radical prostatectomy.

Detailed description: Goals of the present study will be to determine whether initiating pelvic floor muscle training preoperatively improves quality of life symptoms related specifically to urinary health following robot-assisted radical prostatectomy. Drawing definitive conclusions from past studies is challenging secondary to various inconsistencies including: variability of physical therapy intervention, poorly defined definitions of continence, as well as poorly defined quality of life measurements. Additionally, the vast majority of studies combined open and robotic prostatectomy increasing cohort heterogeneity and further blurring interpretation of results. The investigators' study will focus exclusively on patients undergoing robot-assisted radical prostatectomy. Standardized pelvic floor muscle therapy as well as clearly defined patient outcomes (ie: validated questionnaires) will be utilized to determine whether preoperative initiation of formal pelvic floor physical therapy can improve health-related quality of life following surgery.

In the era of robot-assisted radical prostatectomy does physical therapist initiated preoperative pelvic floor muscle training lessen the expected postoperative drop off in urinary related quality of life and/or improve patient's recovery of continence following surgery?

Eligibility criteria: Inclusion Criteria:

* Patients scheduling to undergo robot-assisted radical prostatectomy
* Patients willing and able to complete the EPIC questionnaire in its entirety
* Ability to provide informed consent

Exclusion Criteria:

* Previous prostate surgery
* Radiation treatment
* History of incontinence defined as any pad use for urinary leakage in the past 6 months

Primary outcomes:
measure: • Comparison of post-op EPIC scores in the two study groups
timeFrame: 4 to 8 weeks post-op
Secondary outcomes:
measure: Return to continence following surgery
timeFrame: Up to 12 months post-op
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health Methodist Hospital and IU Health University Hospital
state: Indiana
Study officials:
References: