louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01773096: Methylnaltrexone Use for Opioid-induced Postoperative Constipation
Official title: The Use of Methylnaltrexone to Reduce Post-operative Opioid-induced Constipation in the Pediatric Spinal Fusion Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Keywords: opioid-induced
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the routine use of methylnaltrexone in the post-operative pediatric spinal fusion patient will decrease the incidence of constipation.

Detailed description: Methylnaltrexone will be given to pediatric patients post-operative from spinal fusion surgery on post-operative day number 3 and then again on postoperative day number 4, if no laxation achieved. Various outcome measures, safety and efficacy of the drug will be observed and recorded.

Eligibility criteria: Inclusion Criteria:

* spinal fusion surgery
* current opioid use
* 12 years of age and older
* no or inadequate bowel movement by post-operative day 3

Exclusion Criteria:

* known or expected mechanical bowel obstruction
* known or suspected lesions of the GI tract
* unexpected transfer to ICU
* unexpected return to the operating room
* patient or parent refusal of methylnaltrexone
* incomplete data concerning time to laxation

Primary outcomes:
measure: reduction of post-operative opioid induced constipation
timeFrame: first post-operative week
Secondary outcomes:
measure: time to ambulation in post-operative pediatric spinal fusion patients
timeFrame: first post-operative week
Other outcomes:
measure: time to oral intake of pediatric post-operative spinal fusion patient
timeFrame: first post-operative week
Locations:
city: Spokane
country: United States
facility: Shriners Hospitals for Children- Spokane
state: Washington
Study officials:
affiliation: Shriners Hospitals for Children
name: Deborah J. Vermaire, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anissian L, Schwartz HW, Vincent K, Vincent HK, Carpenito J, Stambler N, Ramakrishna T. Subcutaneous methylnaltrexone for treatment of acute opioid-induced constipation: phase 2 study in rehabilitation after orthopedic surgery. J Hosp Med. 2012 Feb;7(2):67-72. doi: 10.1002/jhm.943. Epub 2011 Oct 13.
Clinical trial NCT01256996: Therapy of Peri-implantitis: Scaling Versus Low Abrasive Powder
Official title: A Randomized Multicenter Study in the Therapy of Periimplantitis: Scaling Versus Low Abrasive Powder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Peri-implantitis
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2010-12-09
Enrollment: 40
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: TREATMENT

Brief summary: In the last decade, the number of dental implantations continuously increases. However, at the same time, the prevalence of peri-implantitis increases, too. Although both surgical and non-surgical interventions are available for the therapy, there is no efficient and satisfying therapy option resulting in an adequate improvement of this disease.

An innovative, low abrasive powder has been introduced for the therapy of periodontitis. However, the powder might be suitable for the peri-implantitis therapy, also, and could improve the effectiveness of the therapy. The usage of this powder in peri-implantitis patients has not been assessed in a clinical trial although the effectiveness in natural teeth has been demonstrated.

The aim of this prospective, randomised, multi-centre trial is to assess the effectiveness of the aforementioned powder in peri-implantitis patients.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate peri-implantitis
* age ≥18 years
* capacity to contract
* no subgingival debridement within the last six months
* informed consent

Exclusion Criteria:

* pregnancy
* subgingival debridement within the last six months
* bleeding tendency
* usage of antibiotics within the last three months
* insufficient restorations (including caries etc.)
* Diabetes mellitus
* smoker
* implantats with platform switch

Primary outcomes:
measure: Pocket probing depth
timeFrame: Twelve months
Secondary outcomes:
measure: Assessment of pain levels
timeFrame: One week and six months
measure: Assessment of the oral health related quality of life using the OHIP (14)
timeFrame: One , three, six and twelve months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06584396: Evaluating Mechanical Properties of Post-Mastectomy Skin Flaps to Estimate Reconstruction Risks, the EMPOWER Study
Official title: EMPOwER: Evaluating Mechanical Properties of Post-Mastectomy Skin Flaps to Estimate Reconstruction Risks
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Artidis
First posted: 2024-09-04
Enrollment: 110
Sex: FEMALE
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: Women with history of mastectomy with tissue expander placement recruited from MD Anderson.

Brief summary: This study evaluates the skin and surrounding soft tissue that is removed during an implant reconstruction after a mastectomy.

Detailed description: PRIMARY OBJECTIVE:

I. Characterize the nanomechanical properties of the skin and adjacent soft tissue removed at the time of postmastectomy implant reconstruction.

OUTLINE: This is an observational study.

Patients undergo tissue collection during standard of care surgery, have their medical records reviewed, and complete questionnaires throughout the study.

Eligibility criteria: Inclusion Criteria:

* \* Age 18 and older

  * Female sex
  * Patient with history of mastectomy with tissue expander placement
  * Tissue expander in place at time of study enrollment
  * Patient plans to undergo surgery to exchange tissue expander for permanent breast implant within the next 3 months of signing the informed consent
  * Ability to understand and provide written informed consent in accordance with institutional policies

Primary outcomes:
measure: Nanomechanical properties of the skin and adjacent soft tissue
timeFrame: At time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Benjamin D Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02313896: Cirrhosis Readmission Telehealth Project
Official title: Cirrhosis Readmission Telehealth Project
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cirrhosis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-12-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a 2 year research study to study if post discharge phone calls can help lengthen time to hospital readmissions for patients with encephalopathy.

Detailed description: The purpose of this randomized prospective pilot study is to decrease hospital readmissions for patients with hepatic encephalopathy. Patients who were admitted at YNHH with hepatic encephalopathy will be enrolled. Patients will then be randomized to one of two groups upon discharge. The control group will receive usual standard of care for hepatic encephalopathy (encephalopathy education, cirrhosis brochure, stool chart, and routine follow up with their primary care provider and hepatologist). The intervention group will receive usual standard of care as discussed above and phone calls for a 3-month period after their hospitalization.

Eligibility criteria: Inclusion Criteria:

* Age of at least 18
* Patients with known cirrhosis
* Current hospitalization for overt hepatic encephalopathy as categorized by West Haven encephalopathy score of 2 or more
* Current hospitalization found no precipitants triggering encephalopathy as determined by the primary team
* Encephalopathy resolved at time of enrollment
* Has a telephone
* Able to obtain medications

Exclusion Criteria:

* Altered mental status unrelated to cirrhosis
* Acute liver failure
* Expectation of liver transplant within 1 month after enrollment
* Chronic kidney disease with Cr \> 2 mg/dL
* Respiratory insufficiency:moderate to sever COPD on pulmonary function test
* Electrolyte imbalances not corrected at enrollment
* Sodium less than 125 mmol/L
* Calcium greater than 10mg/dL
* Potassium \< 2.5mmol/L
* Unable to give legal consent
* Deafness
* Infection, spontaneous bacterial peritonitis, gastrointestinal bleeding

Primary outcomes:
measure: Hospital Readmission
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Guadalupe Garcia-Tsao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01373996: Clinical Investigation of Wireless Transmission of Invasive Blood Pressure Signal
Official title: Feasibility and Accuracy of Wireless Transmission of Invasive Blood Pressure Signal From Patient to Patient's Bedside Monitor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Trauma
Shock
Atrial Fibrillation
Perioperative/Postoperative Complications
Keywords: Invasive blood pressure monitoring
Intensive care unit
Wireless Technology
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: Hyb, d.o.o., Slovenia
First posted: 2011-06-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients

Brief summary: The purpose of this study is to determine whether wireless transmission of invasive arterial blood pressure signal (by HMW 10 Wireless System) from patient to patient's bedside monitor is feasible, safe and as accurate as conventional cable connection.

Detailed description: The technology for invasive arterial blood pressure measurement in emergency room, operating theater, recovery room and intensive care unit is well established and uses pressure sensor connected via cable to patient's bedside monitor. The wireless sensors result in reduction of wires attached to the patient and may enhance nursing, treatment and transportation of patients in aforementioned setting.

The HMW 10 Wireless System was developed and incorporates wireless transmission of patient's signal. The purpose of the study was to measure the quality of data transmitted through the HMW 10 Wireless System, and to demonstrate that the quality of the data meets the requirements of European Directive 93/42/EEC (Medical Device Directive - MDD) and EN/IEC 60601-1 and EN/IEC 60601-2-34.

Eligibility criteria: Inclusion Criteria:

* ICU patients requiring invasive blood pressure monitoring

Exclusion Criteria:

* frequent blood sampling through arterial cannula (more than 3 times a day)

Primary outcomes:
measure: Difference between wired and wireless invasive arterial blood pressure
timeFrame: 24 hours of monitoring
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UMC Ljubljana
name: Primoz Gradisek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Ljubljana
name: Neva Pozar-Lukanovic, MD, MMsc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00573196: Far Infrared Radiation Treatment for Bipolar Condition
Official title: Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Bipolar Condition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Bipolar Disorder
Keywords: Affective Psychosis, Bipolar
Depression, Bipolar
Mania
Manic Disorder
Manic State
Manic-Depressive Psychosis
Psychoses, Manic-Depressive
Psychosis, Manic-Depressive
Lead sponsor: GAAD Medical Research Institute Inc.
Sponsor class: OTHER
First posted: 2007-12-14
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A preliminary study to determine the possibility of using far infrared radiation for the treatment of the Bipolar Condition

Detailed description: A 2000 study in the American Journal of Psychiatry reported that, "in those with bipolar, two major areas of the brain contain 30 percent more cells that send signals to other brain cells". This fact explains why famous people with the Bipolar condition like astronaut Buzz Aldrin, financier Robert Campeau, British Prime Minister Winston Churchill, composer Mozart, scientist Isaac Newton, physician Sigmund Freud and media giant \& entrepreneur Ted Turner, excelled in life due to the additional brain power!

The excessive brain power, however, had to be controlled occasionally with mood stabilizers. Mood stabilizers include a number of anticonvulsants and Lithium. These medications, however, have adverse side effects on the kidneys. The proposed evaluation does not have any adverse health effects.

Eligibility criteria: Inclusion Criteria:

* Persons with Bipolar Condition, Depression, Anxiety, Stress and Insomnia

Exclusion Criteria:

* Persons with severe mental illness that are confined to mental hospitals etc. as defined by the USA Diagnostic and Statistical Manual of Mental Disorders (DSM) are excluded from this clinical trial.

Primary outcomes:
measure: The primary end point is to determine the therapeutic effects of far infrared radiation on bipolar condition.
timeFrame: 2 years
Secondary outcomes:
measure: The secondary end point of the study is to evaluate the therapeutic effects of far infrared radiation on other related mental illness including Depression, Anxiety, Stress and Insomnia.
timeFrame: 2 years
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: The Centre for Incurable Diseases
state: Ontario
Study officials:
affiliation: GAAD Medical Research Institute Inc.
name: Kwasi Donyina, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: GAAD Medical Research Institute Inc.
name: Ken Nedd, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03248596: Interest in Evaluating Primary Hemostasis in Patients With Veno-venous Extracorporeal Membrane Oxygenation (ECMO)
Official title: Interest in Evaluating Primary Hemostasis in Patients With Veno-venous Extracorporeal Membrane Oxygenation (ECMO)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Patients With ECMO
Keywords: Extracorporeal Membrane Oxygenation (ECMO)
Primary hemostasis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with ECMO

Brief summary: The aim of the study is a better understanding of hemorrhagic events causes in patients with ECMO, prevent them and decrease the number of transfusion.

Detailed description: The most frequent complication during ECMO is hemorrhage especially as a curative anticoagulant treatment is necessary. The primary hemostasis is also affected with a von Willebrand disease and thrombopathy, well known but not studied by recent tests.The identification of primary haemostasis deficits with these tools would allow to supply them and decrease the morbi-mortality related to the transfusion.

Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years old
* Patient with ECMO
* Patient hospitalized in an intensive care unit at the University Hospital of Rennes

Exclusion Criteria:

* Known history for constitutional pathology of the primary haemostasis
* Platelets \< 100000 / mm3 or hematocrit \< 28 % between H+12 and H+24

Primary outcomes:
measure: Evaluate primary hemostasis in patient with ECMO at University Hospital of Rennes
timeFrame: Day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References:
Clinical trial NCT00660296: Randomized Controlled Trial Comparing Co2 vs. Air in Colonoscopy in Sedated Patients
Official title: Randomized Controlled Trial Comparing Co2 vs. Air in Colonoscopy in Sedated Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Satisfaction
Keywords: CO2
pain
colonoscopy
cancer
screening
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-04-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: CO2 insufflation instead of air for colonic distension in colonoscopy is considered to reduce pain after and during colonoscopy. There is limited data, that Co2 is similar effective in sedated patients. Furthermore it had not been investigated if patient's compliance for participating in cancer screening could be improved by using Co2.

The aim of the study is to assess postoperative pain and satisfaction after colonoscopy by comparing C02 with air.


Eligibility criteria: Inclusion Criteria:

* All patients, who are assigned to an outdoor ambulance for elective colonoscopy in sedation
* Between 18 and 90 years

Exclusion Criteria:

* COPD
* Dementia

Primary outcomes:
measure: Pain after Colonoscopy measured by 100mm visual analogue scale.
timeFrame: 15 and 30 minutes and 6 h and 12 h after colonoscopy
Secondary outcomes:
measure: patients satisfaction (VAS) and its benefit in regard to cancer screening (2 questions)
timeFrame: 30 minutes and 6 hours after colonoscopy
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Dr. Anton Friedrich Weiser
Study officials:
affiliation: Medical University of Vienna
name: Stefan Riss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ärztezentrum Ost, Anton Baumgartnerstrasse 44, 1230 Vienna
name: Anton Weiser, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bretthauer M, Lynge AB, Thiis-Evensen E, Hoff G, Fausa O, Aabakken L. Carbon dioxide insufflation in colonoscopy: safe and effective in sedated patients. Endoscopy. 2005 Aug;37(8):706-9. doi: 10.1055/s-2005-870154.
Clinical trial NCT03663296: Assessing Usefulness of Virtual Reality Mobile Application in Flexible Videoscope Airway Training
Official title: Assessing Usefulness of Virtual Reality Mobile Application in Flexible Videoscope Airway Training - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Education, Medical
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Flexible videoscope orotracheal intubation (FOI) technique is considered an important option in the management of predicted difficult airways. However, it is rarely performed in daily practice. Yet emergency physicians are expected to be able to perform this skill expertly during a crisis scenario. If it is not completed in a timely and proper fashion, the patient will deteriorate rapidly, resulting in morbidity or fatality.

There is a significant learning curve to master this complex psychomotor skill. Providing sufficient training in FOI, particularly hands-on experience in real patients is difficult. Patients with known difficult airway requiring FOI present infrequently to the emergency room. Using patients with normal airway purely for teaching of FOI is ethically controversial. To avoid technical and ethical concerns of training involving real patients, conventional teaching methods incorporate the use of a low-fidelity manikin in replacement. However, the manikin anatomy often lacks the realism of a live human.

The addition of virtual reality technology, in the form of a low-cost mobile application (Airway Ex) into the conventional simulation, may optimize learning by providing an ethical, cost-effective and more realistic modality to acquire the basic skills of FOI. If it is proven to be effective, efforts to integrate virtual reality technology into routine training of such procedures in the ED should be promoted.

We hypothesize that the addition of virtual reality mobile application to conventional training will improve procedural skill dexterity and proficiency and hence, improve learner's satisfaction and confidence in performing FOI.


Eligibility criteria: Inclusion Criteria:

* All doctors from Accidental \& Emergency Department of National University Hospital, Singapore

Exclusion Criteria:

* Refusal for consent

Primary outcomes:
measure: Time taken for successful intubation
timeFrame: 5 minutes
Secondary outcomes:
measure: Time taken for visualisation of vocal cords
timeFrame: 1 minute
Other outcomes:
measure: Quality of flexible videoscope manipulation ability
timeFrame: 5 minutes
Locations:
city: Singapore
country: Singapore
facility: National University Hospital, Singapore
Study officials:
affiliation: National University Hospital, Singapore
name: Ying Wei Yau
role: PRINCIPAL_INVESTIGATOR
References: