louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00744614: Use Of Capnography As Surrogate Measure Of PC02 In Medical Intensive Care Unit (ICU) Patients
Official title: Use Of Capnography As Surrogate Measure Of PC02 In Medical ICU Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Asthma
Chronic Obstructive Pulmonary Disease
Interstitial Lung Disease
Keywords: PC02
Respiratory Rate
Arterial blood gas
Intubation
Capnography
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2008-09-01
Enrollment: 70
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: MICU patients who are at risk of intubation and who have a history of asthma, COPD, ILD or coronary disease.

Brief summary: The purpose of this study is to evaluate the use of Capnography (Continuous recording of the carbon dioxide content of expired air)as an alternative test to measure PC02 levels in patients with asthma, chronic obstructive pulmonary (COPD,interstitial lung disease(ILD)or coronary disease who are at risk of intubation.

Detailed description: This is a prospective study to evaluate the usefulness of capnography as a non-invasive, accurate method of measuring of PC02 levels in medical intensive care unit patients with asthma, COPD, ILD, or coronary disease who are at risk of intubation.

Eligibility criteria: Inclusion Criteria:

* Medical Intensive Care Patients
* Not intubated
* Age 18 or older
* History of any one of the following: asthma, COPD, ILD, or coronary disease

Exclusion Criteria:

* Sepsis
* Life expectancy less than 1 month
* Requiring BIPAP

Primary outcomes:
measure: PCO2 level
timeFrame: 6 months
Secondary outcomes:
measure: Time to intubation
timeFrame: 6 months
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Clinic, Inc.
state: Massachusetts
Study officials:
affiliation: Lahey Clinic, Inc.
name: David R. Riker, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Torok SS, Leuppi JD, Baty F, Tamm M, Chhajed PN. Combined oximetry-cutaneous capnography in patients assessed for long-term oxygen therapy. Chest. 2008 Jun;133(6):1421-1425. doi: 10.1378/chest.07-0960. Epub 2008 Mar 13.
Clinical trial NCT06770114: Clinical Study to Investigate a New Mouthwash in Reducing Plaque and Helping Prevent Gum Problems on Dental Implants Over a 6-month Period of Product Use
Official title: A Clinical Study to Investigate a New Mouthwash Containing 0.075% CPC and 0.28% Zinc Lactate as Compared to a Fluoride Mouthwash Containing 0.044% NaF in Reducing Plaque and Helping Prevent Gum Problems on Dental Implants Over a 6-month Period of Product Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingivitis
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2025-01-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this six-month clinical research study is to evaluate the clinical efficacy of a new mouthwash on helping prevent gum problems (gingival index scores ) in adults as compared to a control mouthwash.


Eligibility criteria: Inclusion Criteria:

* Availability for the six-month duration of the clinical research study.
* Good general health.
* Minimum of two dental implants (2 different quadrants ), each implant must have a restoration.
* Initial mucositis index of at least 1 .0 as determined by the use of the Mombelli Modified Gingival Index.
* Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque Index.
* Signed Informed Consent Form.

Exclusion Criteria:

* Presence of orthodontic bands.
* Tumor (s ) of the soft or hard tissues of the oral cavity.
* Advanced periodontal disease (purulent exudate, tooth mobility, and /or extensive loss of periodontal attachment or alveolar bone ) or peri-implantitis.
* Five or more carious lesions requiring immediate restorative treatment.
* Antibiotic use any time during the one-month period prior to entry into the study.
* Participation in any other clinical study or test panel within the one month prior to entry into the study.
* Dental prophylaxis during the past two weeks prior to baseline examinations.
* History of allergies to oral care /personal care consumer products or their ingredients.
* On any prescription medicines that might interfere with the study outcome.
* An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
* History of alcohol or drug abuse.
* Self-reported pregnant or lactating subjects

Primary outcomes:
measure: Mombelli Modified Gingival Index
timeFrame: baseline
measure: Mombelli Modified Gingival Index
timeFrame: three month
measure: Mombelli Modified Gingival Index
timeFrame: six month
measure: Mombelli Modified Plaque Index
timeFrame: baseline
measure: Mombelli Modified Plaque Index
timeFrame: three month
measure: Mombelli Modified Plaque Index
timeFrame: six month
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Clinica Odontoiatrica Montesani
state: Rome
Study officials:
affiliation: University of Rome
name: Luigi Montesani, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04991714: Effect of Sweetness Intensity of a Sucrose Solution on Blood Glucose Regulation and Energy Intake
Official title: Einfluss Der Süßintensität Einer Saccharose-Lösung Auf Die Blutglukoseregulation Und Energieaufnahme in Gesunden Männern
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Blood Glucose, Low
Hunger
Lead sponsor: University of Vienna
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the present study is to investigate the influence of the modulation of the sweetness intensity of a carbohydrate (sucrose)-containing solution on metabolic effects, in particular the regulation of blood glucose concentration and regulation of hunger \& satiety.

Detailed description: The study is designed as a randomised cross-over intervention study with four interventions. The study investigates the influence of sweetness modulation by Rebaudioside M (sweetness enhancement) and Lactisol (sweetness inhibition) of a 10% sucrose solution, corresponding to the concentration of a regular soft drink, on blood glucose regulation (blood glucose concentration and regulating hormones) in healthy male volunteers. Furthermore, the study assesses ad libitum energy intake, individual feelings of hunger and satiety, metabolic responses to the interventions, and preference for sweet-tasting foods such as sugar and sweeteners. In addition, the participants' individual thresholds for sweet taste, as well as morphological markers for taste sensitivity and body composition will be recorded as potential influencing factors.

Eligibility criteria: Inclusion Criteria:

* male
* healthy
* non-smoking
* normal taste responses towards sweet taste

Exclusion Criteria:

* female
* regular smokers
* disturbed glucose and/or lipid metabolism
* regular intake of medication
* known allergies against one of the test compounds
* ageusia
* alcohol or drug addiction
* intake of antibiotics within the past 2 months

Primary outcomes:
measure: Blood glucose concentration
timeFrame: over a time span of 120 minutes after drinking the test solution
measure: Insulin concentration
timeFrame: over a time span of 120 minutes after drinking the test solution
measure: GLP-1 concentration
timeFrame: over a time span of 120 minutes after drinking the test solution
measure: GIP-concentration
timeFrame: over a time span of 120 minutes after drinking the test solution
Secondary outcomes:
measure: Food intake
timeFrame: 120 minutes after drinking of the test solution
measure: Metabolic changes
timeFrame: over a time span of 120 minutes after drinking the test solution
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Christian Doppler Laboratory for Taste Research
Study officials:
affiliation: University of Vienna
name: Barbara Lieder, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02746614: Psychomotor Therapy Effects in Adaptive Behavior and Motor Proficiency in Intellectual Disability
Official title: Psychomotor Therapy Effects Adaptive Behavior and Motor Proficiency of Adults With Intellectual Disability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intellectual Disability
Keywords: adaptive behavior
motor proficiency
psychomotor therapy
intellectual disability
Lead sponsor: Faculdade de Motricidade Humana
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: People with intellectual and developmental disabilities (IDD) usually present limitations at adaptive behavior and motor skills, which lead to limitations/barriers in the daily independent functioning of this population. The main goal of this research is to analyze the efficacy of a Psychomotor Intervention Program on adults with and without IDD, through an assessment of their progress both in adaptive behavior competences and motor proficiency skills.

Detailed description: This study sample comprised 15 participants divided by three groups of 5 individuals each: one group with IDD (with different ethiology), another one with Down Syndrome and the third with typical development. Ages range from 22 to 31 years-old (Average=26,5; St. Deviation=3,76), 6 were females and 9 males. All adults with IDD were all institutionalized at an Occupation Activities Centre of an institution and adults without ID were selected by convenience, with ages comprised within the selected range. All groups were compared through both evaluation instruments: the Portuguese version of Adaptive Behavior Scale (PABS) and Bruininks-Oseretsky Motor Proficiency Test (BOT-2). Both tests were applied according to original protocols. Ethics requisites were fulfilled. After the initial assessment, a Psychomotor Intervention Program was designed specifically for participants with IDD. This program integrated individual and group sessions during 3 months, and the main goals of the program were related to motor coordination (balance, manual dexterity and coordination, global and fine praxis), economic and professional activities, academic and verbal skills.

Eligibility criteria: Inclusion Criteria:

* ages above 18 years
* diagnosis of intellectual disability
* institution in Castelo Branco

Exclusion Criteria:

* other co-morbilities associated
* not institutionalised

Primary outcomes:
measure: Test of Motor Proficiency of Bruininski-Oseretsky 2
timeFrame: one year
measure: Portuguese Adaptive Behavior Scale
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00873314: Bed Rest for Threatened Preterm Labor. Pilot Study
Official title: Bed Rest for Arrested Threatened Preterm Labor. Pilot Study for the Design of a Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bedrest
Premature Labor
Lead sponsor: Institute for Clinical Effectiveness and Health Policy
Sponsor class: OTHER
Collaborators: name: Unidad de Investigación Clínica y Epidemiológica Montevideo
First posted: 2009-04-01
Enrollment: 46
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the pilot trial is to assess at what extend women with arrested threatened preterm labor change their activity patterns at home in response to bed rest prescription.

An area of concern for the design of a trial is the strength of health provider's recommendation to change women's behaviors, and their compliance with bed rest recommendations. The study was a randomized parallel design. The intervention group consisted of total bed rest for four days (with allowance to go to the toilet). The control group consisted in the restriction of activities during four days.


Eligibility criteria: Inclusion Criteria:

* Every woman admitted to hospital during the antenatal period because of an episode of TPL. If the attending physician decides that the woman is ready for hospital discharge the woman will be eligible for the study.

Exclusion criteria:

* Multiple pregnancy
* Premature rupture of membranes
* Cervical cerclage and whenever the attendant physician considers that the woman is not eligible to be randomized to bed rest or activity restriction.

Primary outcomes:
measure: The outcome was the amount of activity. In order to measure the outcome, we used: a) an accelerometer which was delivered to the woman at home and b) a diary record that the woman fulfilled during the study.
timeFrame: Four days
Secondary outcomes:
Other outcomes:
Locations:
city: Montevideo
country: Uruguay
facility: Pereira Rossell Hospital
Study officials:
References:
Clinical trial NCT04193514: ACT for High-risk Pregnancy
Official title: Brief Acceptance-based Therapy for Pregnant Women With High-risk Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acceptance and Commitment Therapy
Lead sponsor: Southern Methodist University
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to reduce the psychological distress of women with high-risk pregnancy. Women who express interest and are eligible will have the opportunity to participate in a 7-day acceptance therapy. This therapy is based on the theory that attempts to control internal states, thoughts and feelings can contribute to symptoms of depression, anxiety and/or stress. This study aims to educate women about how the willingness to experience uncomfortable pregnancy-related sensations and thoughts, rather than fighting them, can provide relief. The therapy is completed virtually, with the first therapy session done over video call with the therapist. Following, participants complete the remaining six days of therapy on their own using a work book. All women participating in the study will be asked to complete a series of self-report questionnaires before, during, and immediately following treatment, as well as twice postpartum. Participants will receive up to $60 and a work book for participation.


Eligibility criteria: Inclusion Criteria:

1. Pregnant women with a current high-risk pregnancy.
2. Patients must be willing to engage in brief Acceptance-Commitment Therapy
3. Patients must be English-speaking.
4. Ages 18 years or older.

Exclusion Criteria:

1. Active suicidal ideation or self-harm in the past year; any previous history of suicide attempts.
2. History of bipolar disorder, psychosis, mental retardation or organic brain damage.
3. Currently using substances (alcohol, nicotine, marijuana, etc.)
4. Actively participating in psychotherapy for emotional or psychological problems from another provider

Primary outcomes:
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: 1 week
Secondary outcomes:
measure: Depression Anxiety Stress Scale (DASS-21)
timeFrame: 1 week
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 1 week
Other outcomes:
measure: Acceptance and Action Questionnaire (AAQ-II)
timeFrame: 1 week
Locations:
city: Dallas
country: United States
facility: Southern Methodist University
state: Texas
Study officials:
References:
Clinical trial NCT01069614: A Skin Stretching Wound Closure System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Wounds
Injuries
Keywords: Equipment and supplies
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-02-17
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A skin stretching device has been designed to stretch tissue prior to surgery, during surgery and in order to secure wounds following surgery. The device may be used in non-invasive and invasive applications.


Eligibility criteria: Inclusion Criteria:

* Hard to close wounds

Exclusion Criteria:

* Non-cooperative patients

Primary outcomes:
measure: Safety and efficacy of wound closure
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT03436914: Treatment Response of Maintenance Dose of Proton Pump Inhibitor in Patients With Nonerosive Gatroesophageal Reflux Disease
Official title: Treatment Response of Maintenance Dose of Proton Pump Inhibitor in Patients With Nonerosive Gatroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-erosive Gatroesophageal Reflux Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 62
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: There is only one arm in this study. Patients diagnosed as NERD will take PPI (Esomezol) for 8 weeks.
Primary purpose: TREATMENT

Brief summary: For ERD(erosive reflux disease), which pathogenesis is mainly the acid reflux mechanism, primary treatment is therefore PPI. However, NERD(non-erosive reflux disease) is much more complex than ERD and there are more factors causing the typical symptoms. As a result, there is no consensus for the treatment of NERD besides using PPI similar to GERD(gastroesophageal reflux diseas). This study intent to evaluate the effect of PPI(Esomezol) on NERD patients and analyze the improvement of symptoms and the factors related to the result.

Detailed description: (1) Among GERD patients, EGD(esophagogastroduodenoscopy) must be done before 6 months and must prove there is no erosive lesion. (2) During EGD, esophagus mucosa histology will be taken for evaluation. (3) For NERD patients, Esomezol is given once a day (before breakfast meal), for whole 8 weeks. (4) PAGI-SYM and HAD-K is evaluated and score just before the administration of PPI, 4weeks after and 8weeks after the study initiation.

Eligibility criteria: Inclusion Criteria:

* Patient over 19 years old
* Patient with typical GERD symptom (heartburn or acid reflux more than once a week)

Exclusion Criteria:

* Patient who received EGD since the past 6 months, and diagnosed as GERD endoscopically
* Patient with active gastric/duodenal ulcer
* Patient who received esophagus, stomach or duodenum surgery
* Patient with hypersensitivity to esomezol®
* Patient with no achieved agreement on the study from the guardian or patient himself.

Primary outcomes:
measure: Proportion of PAGI-SYM score (0-2) patients after 8 weeks of PPI(Esomezol)
timeFrame: 8 weeks
Secondary outcomes:
measure: The analysis of factors affecting the PAGI-SYM inculding immunolgic array and esophagus mucosal microbiota
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei university College of Medicine
Study officials:
References:
Clinical trial NCT01523314: Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema
Official title: Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Diabetic Macular Edema
Keywords: diabetic macular edema
intravitreal injection
dexamethasone
Cyclodextrin
eye drops
bevacizumab
macular laser
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The research group has developed new ocular drug delivery technology based on cyclodextrin nanoparticles (NP). The investigators plan to develop and test this technology to help treat diabetic macular edema (DME).

An important step in research was the invention of cyclodextrin nanoparticles, which has just received a US patent. The investigators pre-clinical and clinical work has demonstrated the investigators eye drop suspension with cyclodextrin nano-particles to be superior to conventional eye drops. They increase drug absorbance into the eye and decrease systematic distribution of the drug, hence reducing side effects. Cyclodextrin nanoparticle eye drops deliver drugs to the posterior part of the eye, thus solving one of the biggest obstacles in ocular pharmacology.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Pseudophakic in study eye, i.e. with IOL (intra ocular lens) after cataract surgery
* Diabetic macular edema with central macular thickness over 300 µm on OCT in study eye. If both eyes have DME, then the treatment will be applied to the eye with thicker central macula on OCT.
* Age 18 years or older

Exclusion Criteria:

* Glaucoma or use of any glaucoma medication
* Known steroid IOP response
* Any infectious eye disease
* Treatment for DME within 6 months, such as laser treatment, intravitreal or subtenon injections of steroids, intravitreal injections of anti vascular endothelelial growth factor medication.
* Any eye surgery within 3 months or other eye conditions e.g. corneal disorders, ocular hypotony and retinal detachments.
* Crystalline lens present in study eye
* Known allergy to cyclodextrins, dexamethasone, ranibizumab or any of the components of the study medications

Primary outcomes:
measure: Best Corrected Visual Acuity on ETDRS chart
timeFrame: 3 months
Secondary outcomes:
measure: Intraocular pressure (IOP)
timeFrame: 3 months
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: College of Medicine, King Saud University
Study officials:
References: