louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01413672: Preliminary Evaluation of CASTLE Barrier North American Prototype
Official title: Peristomal Skin Irritation: A Preliminary Evaluation of CASTLE Barrier North American Prototype
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peristomal Skin Complication
Keywords: ostomy
colostomy
ileostomy
barrier
irritation
Lead sponsor: Hollister Incorporated
Sponsor class: INDUSTRY
First posted: 2011-08-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects currently known to investigators

Brief summary: The purpose of this study is to determine if an ostomy barrier that promotes a healthy skin environment will result in reduced peristomal skin irritation.


Eligibility criteria: Inclusion Criteria:

at least 18 years of age has colostomy or ileostomy current user of two-piece, flat, tape bordered barrier mild to moderate skin peristomal skin irritation community dwelling and cares for stoma independently at least 3 months post-operative provides informed consent

Exclusion Criteria:

presence of fistula on or near stoma prior participation in stoma care study within past 30 days pregnant or lactating (interview only) uses convex product, paste and/or rings known allergy to test barrier composition existing medical condition or therapy that might affect ability to participate or interpretation of study results

Primary outcomes:
measure: Peristomal skin irritation
timeFrame: 30 days
Secondary outcomes:
measure: Security
timeFrame: 30 days
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Jacksonville
country: United States
facility: ET Nursing Services
state: Florida
city: Fenton
country: United States
facility: St. Louis Medical
state: Missouri
city: Kansas City
country: United States
facility: Restored Images
state: Missouri
city: New Westminster
country: Canada
facility: Ostomy Care & Supply Centre
state: British Columbia
Study officials:
affiliation: Hollister Incorporated
name: Richard Murahata, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02690272: "Lived Experience, Representations and Psychic Processes in Patients Awaiting Kidney Transplantation"
Official title: " Expérience Vécue, Représentations et Processus Psychiques Chez Les Sujets en Attente de Transplantation Rénale "
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Tranplant
Keywords: kidney transplant
psychic process
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-02-24
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The kidney transplant remains the privileged treatment of the terminal renal insufficiency. This care is complex for the patient both on a medical surgical plan and by the psychic reorganizations. Among the temporary contraindications of transplantation, us retrouvonsdes psychological reasons. The research work consists in highlighting the psychic mechanisms of the subjects awaiting kidney transplant.


Eligibility criteria: Inclusion Criteria:

* 18 years old
* stade 4 or 5 renal insufficiency
* Registered on waiting list for a first kidney transplant

Exclusion Criteria:

* in ward
* Unsigned consent
* Already transplanted

Primary outcomes:
measure: Measure of anxiety
timeFrame: 6 months
measure: Measure of psychic representations around transplant
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Angers
name: Emmanuelle COURTILLIE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06083272: VitalThings Guardian Contactless Monitoring
Official title: VitalThings Guardian Contactless Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Depression
Respiratory Failure
Deterioration, Clinical
Keywords: respiratory rate
patient monitoring
ultra wideband radar
contactless monitoring
medical device regulation
Lead sponsor: VitalThings
Sponsor class: INDUSTRY
Collaborators: name: St. Olavs Hospital
First posted: 2023-10-13
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The EW study population is beneficial to the study as it offers an unfiltered study population with a broad cross-section of potential admission reasons and diagnoses in a short period of time. Any patient that needs acute treatment/examination (typically triaged as "red") will per standard of care go into dedicated EW rooms and not be part of this study. The safe participation of each patient will be evaluated by a specialist in emergency medicine (PI) before invitation to participate.

Brief summary: This is a confirmatory study without any intervention. It is an uncontrolled, non-randomized and open-label study with measurements made with comparators, and it has a preset hypothesis for the primary endpoint. There are no similar devices to VitalThings Guardian M10 / M10 mobile on the market, consequently one or more different types of devices must be used as comparators.

Detailed description: The purpose of the clinician investigation is to validate a claim made for the investigational device performance. The objective is to confirm that the device performs at +/- 1.2 respirations per minute (RPM) accuracy against the identified comparator device, and compare performance to the standard of care as documented in the literature. The study will be conducted with patients admitted to the emergency ward after the initial treatment and examination.

Eligibility criteria: Inclusion Criteria:

* Adult patients admitted to the Emergency Ward (EW)

Exclusion Criteria:

* Under age (below 18 years) and subjects not able to provide informed consent themselves. Subjects dismissed from the EW rooms within 30 minutes from first registration are removed from the study.

Primary outcomes:
measure: Accuracy
timeFrame: Will be assessed after last participant has finished the investigation. One interim analysis in first week is planned.
Secondary outcomes:
measure: Comparative pulse data
timeFrame: Will be assessed in 2024, furter details not established.
Other outcomes:
measure: Acceptance criteria respiratory rate
timeFrame: Will be assessed after last participant has finished the investigation. One interim analysis in first week is planned.
Locations:
city: Trondheim
country: Norway
facility: St Olavs University Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Line Pedersen, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00962572: The Effects of Aggressive Patient Management on Cancer Therapy Management
Official title: The Effects of Aggressive Patient Management on Cancer Therapy Management
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cancer
Keywords: Outcomes
Cancer
Radiotherapy
Socio-economic
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2009-08-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: rural and minority patients who require radiation therapy

Brief summary: A study to see if coordinated aggressive patient management will improve patient treatment outcomes and is cost effective.

Detailed description: This is an observational study of the effects of aggressive patient management. The records of 50 patients treated under the aggressive management plan will be matched with the records of 50 previous patients and attempts made to assess the improvement, if any, found. Statistical analysis will compare the outcomes of the study group and the matched control group for initial completion of planned therapy as per prescription, weight loss during therapy, intercurrent illness, and intercurrent hospitalizations. Long term analysis will compare the study group's outcomes (compared to expected outcomes) compared to the matched control group.

Eligibility criteria: Inclusion Criteria:

* live 45 minutes from treatment facility
* family income less than 200% federal poverty guideline

Exclusion Criteria:

* none

Primary outcomes:
measure: To test effects of intensive patient management on patient's compliance with referral and subsequent treatment protocol.
timeFrame: 1 year
Secondary outcomes:
measure: To test if increased compliance results in better therapy outcomes and fewer complications of the disease process as evidenced by increased survival and fewer intercurrent hospitalizations.
timeFrame: 1 year
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Radiation Oncology
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Michael C Baird, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06993272: Relaxation Music for Chronic Pain
Official title: Relaxation Music for Patients With Chronic Pain From IBS, Crohn's, or Colitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
IBD - Inflammatory Bowel Disease
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic pain is a common complaint in inflammatory bowel disease (IBD). Compounding these concerns, opioid analgesics are frequently used to treat severe acute pain. An estimated 30% of chronic pain patients due to IBD report opioid use. Those who continue to use opioids can develop opioid misuse, and opioid misuse portends addiction and overdose so there is a need for better, non-addictive treatment options.

Music interventions effectively reduce pain and pain-related symptomology. Meta-analytic results indicate listening to music can reduce acute and chronic pain. Music listening also decreases emotional distress from pain as well as the use of pain medication. Music interventions have demonstrated these positive effects on pain across a number of settings, including surgical, in-patient, and community settings. Importantly, due to the ubiquity of music - especially freely available online music - music interventions are easily accessible and highly scalable.


Eligibility criteria: Inclusion Criteria:

* 18 or older
* Living in U.S.
* Have a pain rating related to IBS, Crohn's, or Colitis of five or greater in average pain on a 0-10 numeric rating scale in the preceding week
* Have had pain related to IBS, Crohn's, or Colitis for at least 3 months and for at least 15 days in the preceding 30 days
* GAD Score (Moderate to Severe Anxiety)

Exclusion Criteria:

* Are currently using or have used prescription opioids in the past 3 months
* Have a current cancer diagnosis
* In one of our prior music studies
* Have formal experience with mindfulness

Primary outcomes:
measure: Pain, Enjoyment, General Activity Scale (PEG)
timeFrame: Baseline and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine
state: California
Study officials:
References:
Clinical trial NCT01151072: A Trial Comparing the Effect of NN1250 After Different Routes of Injection in Healthy Subjects
Official title: A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties of NN1250 After Different Routes of Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-06-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial was conducted in Europe. The aim of this clinical trial was to compare the exposure and effect of NN1250 (insulin degludec) after different routes of injection in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Considered generally healthy upon completion of medical history, physical examination, vital signs and ECG (electrocardiogram), as judged by the Investigator
* Body mass index 18.0-27.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Primary outcomes:
measure: Area under the serum Insulin Degludec concentration-time curve (only for subcutaneous administration)
timeFrame: From 0 to 120 hours after single-dose
Secondary outcomes:
measure: Area under the serum Insulin Degludec concentration-time curve (only for intramuscular administration)
timeFrame: From 0 to 120 hours after single-dose
measure: Area under the serum Insulin Degludec concentration-time curve (only for intravenous administration)
timeFrame: From 0 to 30 hours after single-dose
measure: Maximum observed serum Insulin Degludec concentration after single-dose (only for subcutaneous and intramuscular administration)
timeFrame: Within 0 to 120 hours after dosing
measure: Back-extrapolated initial serum Insulin Degludec concentration after single-dose (only for intravenous administration)
timeFrame: At time zero after dosing
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Nosek L, Coester HV, Roepstorff C, Thomsen HF, Kristensen NR, Haahr H, Heise T. Glucose-lowering effect of insulin degludec is independent of subcutaneous injection region. Clin Drug Investig. 2014 Sep;34(9):673-9. doi: 10.1007/s40261-014-0218-x.
Clinical trial NCT00255372: To Determine the Effect of Forlax® Treatment in Children With Chronic Constipation Who May Also Suffer From Soiling/ Faecal Incontinence.
Official title: Polyethylene Glycol Laxative (Macrogol 4000;Forlax®) for Treatment of Chronic Constipation in Children : A Phase III, Bicentric, Randomized, Double-blind, Lactulose Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Constipation
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2005-11-18
Enrollment: 88
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Forlax® is more effective than placebo in relieving chronic constipation in children who may also suffer from soiling or faecal incontinence.


Eligibility criteria: Inclusion Criteria:

* Chronic constipation (defined as at least 3 months of less than 2 bowel movements (BMs) per week and/or one of the following symptoms : hard stool, painful defecation, encopresis)
* Constipation previously treated by dietary advice (high fiber diet) for at least two weeks without efficacy

Exclusion Criteria:

* Organic bowel diseases
* Suspected GI obstruction
* History of GI surgery

Primary outcomes:
measure: Bowel movement frequency
timeFrame: week 4
Secondary outcomes:
measure: Subjective symptoms associated with defecation.
timeFrame: At every visit
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital, Mahidol University,
city: Nakhon Ratchasima
country: Thailand
facility: Maharat Nakhon Ratchasima Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Treepongkaruna S, Simakachorn N, Pienvichit P, Varavithya W, Tongpenyai Y, Garnier P, Mathiex-Fortunet H. A randomised, double-blind study of polyethylene glycol 4000 and lactulose in the treatment of constipation in children. BMC Pediatr. 2014 Jun 19;14:153. doi: 10.1186/1471-2431-14-153.
Clinical trial NCT05777772: Deprescribing to Reduce Injurious Falls Among Older Adults With Dementia
Official title: Deprescribing to Reduce Injurious Falls Among Older Adults With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-03-21
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: STOP-FALLS-D is an educational intervention to inform and activate patients, their care partner(s), and their primary care providers to work together to reduce use of central nervous system (CNS) active medications and prevent adverse outcomes (falls and injuries) associated with their use.

Detailed description: The study design is a pragmatic, one-arm pilot trial to test the feasibility and acceptability of implementing a deprescribing intervention with older people with dementia and their care partners in primary care. The intervention consists of patient-facing educational brochures on CNS-active medications and decision support for the primary care provider. Ethnic/minority groups will be over-sampled to ensure a diverse study sample.

Eligibility criteria: Older Adult Sample

Inclusion Criteria:

* Diagnosed dementia (dementia diagnosis code or prescription for dementia medication)
* Receiving primary care at a Kaiser Permanente Washington integrated group practice outpatient clinic
* Prescribed at least one CNS-active medication on a chronic (3 months or more) basis

Exclusion Criteria:

* Skilled nursing facility resident
* Current cancer diagnosis
* On hospice or palliative care

Care Partner Sample

Inclusion Criteria:

* Aged 18 years or older
* Self-identify as a care partner for the older adult with dementia

Primary outcomes:
measure: Number of Participants With Dementia With Medically Treated Falls
timeFrame: Through study completion, up to 6 months
Secondary outcomes:
measure: Number of Participants With Dementia With All-cause Emergency Department Visits or Hospitalizations
timeFrame: Through study completion, up to 6 months
measure: Number of Participants With Dementia With Skilled Nursing Facility Placement
timeFrame: Through study completion, up to 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Health Research Institute
state: Washington
Study officials:
affiliation: University of Washington
name: Elizabeth Phelan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00655772: A Clinical Trial to Assess the Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor
Official title: A Randomized, Double Blind, Crossover, Placebo-Controlled Clinical Trial to Assess the Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Halitosis
Keywords: chlorine
dioxide
mouthwash
organoleptic
measurements
volatile
sulfur
compounds
Lead sponsor: Tokyo Medical and Dental University
Sponsor class: OTHER
First posted: 2008-04-10
Enrollment: 15
Sex: MALE
Minimum age (years): 19
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: A mouthwash containing chlorine dioxide would be effective to reduce oral malodor.

Detailed description: A randomized, double blind, crossover, placebo-controlled clinical trial was conducted among 15 healthy male volunteers, who were divided into 2 groups: experimental or control group. In the first test phase, the subjects in the experimental group were instructed to rinse with the mouthwash containing ClO2 and those in the control group with the placebo mouthwash without ClO2. In the second test phase after one week washout period, same procedure was conducted with the opposite mouthwashes. Oral malodor was evaluated at before rinsing, right after rinsing and follows up every 30 minutes till 4 hours with OM, and the concentrations of hydrogen sulfide (H2S), methyl mercaptan (CH3SH) and dimethyl sulfide ((CH3)2S) which are the main volatile sulfur compounds (VSCs) of human oral malodor were evaluated with GC.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of oral malodor
* Rinsing the mouthwash

Exclusion Criteria:

* oral malodor caused by foods

Primary outcomes:
measure: Oral malodor was evaluated at before rinsing, right after rinsing and follows up every 30 minutes till 4 hours with organoleptic measurements.
timeFrame: 4 hours
Secondary outcomes:
measure: Oral malodor was evaluated at before rinsing, right after rinsing and follows up every 30 minutes till 4 hours with the concentrations of 3 kinds gases of human oral malodor analyzing with gas chromatography.
timeFrame: 4 hours
Other outcomes:
Locations:
city: Yushima Bunkyo-ku
country: Japan
facility: Dept. Oral health promotion, Tokyo medical and dental university
state: Tokyo
Study officials:
affiliation: Dept. of Oral health promotion, Tokyo medical and dental university
name: Kayoko Shinada, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shinada K, Ueno M, Konishi C, Takehara S, Yokoyama S, Kawaguchi Y. A randomized double blind crossover placebo-controlled clinical trial to assess the effects of a mouthwash containing chlorine dioxide on oral malodor. Trials. 2008 Dec 9;9:71. doi: 10.1186/1745-6215-9-71.