louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01142440: Dental Caries Management by Risk Assessment: Identification and Treatment of Risk Factors Among (IDF) Personnel
Official title: Dental Caries Management by Risk Assessment: Identification and Treatment of Risk Factors Among Israeli Defence Force (IDF) Personnel
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dental Caries
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2010-06-11
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our study is designed as an interventional prospective longitudinal study which examines the Israeli defense force personnel. The population of our study is composed out of the IDF personnel which will be randomly be subdivided into 2 different groups - one will be noted as the intervention group and the other will function as a control group. Each participant will be monitored for a period of 18 months.

Detailed description: On the intervention group, which includes a couple of hundreds participants, a thorough caries management by risk assessment plan will be conducted. The risk assessment will include the following criteria:

* Saliva check
* Plaque control
* Plaque acidity
* Diet - Frequency of carbohydrate intake
* Previous caries experience and present carious activity
* Others (prosthetic/orthodontic appliances, systemic diseases etc.)

After obtaining the data the patients will be categorized into 1 of 3 distinct risk level - low, medium, high. Each category will be treated according to a tailored treatment protocol:

* Dietary instructions
* Oral hygiene instructions
* Antibacterial therapy
* Fluorides
* Restoration
* Follow ups The control group will be treated according to standard protocol of treatment in the IDF dental clinics, which is based on removal the cavitated lesions, and lacks any reference to caries as a multifactorial infectious disease.

We assume that personalized treatment of the disease, based on identifying risk factors will lower the number of patients with active disease.

Eligibility criteria: Inclusion Criteria:

* Informed consent

Exclusion Criteria:

* Pregnancy
* Available for 18 month follow-up

Primary outcomes:
measure: Improvement in one of the risk factors (such as eating habits, saliva, plaque control, fluorides).
timeFrame: 6 months
Secondary outcomes:
measure: Progression of the disease in 30% of patients in the control group in comparison to only 15% in the intervention group.
timeFrame: 18 months
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Israeli Defence Force
Study officials:
affiliation: Head, Department of Prosthodontics Hebrew University - Hadassah, Jerusalem
name: erwin weiss, professor
role: STUDY_CHAIR
References:
Clinical trial NCT04179240: Using a Cartoon Questionnaire to Improve Consent of Children
Official title: Using a Cartoon Questionnaire to Improve Consent of Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Development
Ethics, Narrative
Keywords: biospecific nonspecimen specimen
child and adolescent
cartoon
questionnaire
concent
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 300
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In this study, a prospective, multicenter, randomized, and controlled trial will be performed to evaluate the effectiveness of an audio and animated cartoon questionnaire (AACQ) at improving child understanding and enhancing a positive attitude to participate in biospecific nonspecimen specimen donation.

Detailed description: In this study, we will evaluate the effectiveness of an audio and animated cartoon questionnaire (AACQ) at improving child understanding and enhancing a positive attitude to participate in biospecific nonspecimen specimen donation. A prospective, multicenter, randomized, and controlled trial will be performed at some hospitals in China. Three hundred children will be randomly asked to participate in our survey to investigate the participants' willingness and attitudes for donating biospecific nonspecimen specimen.The participants will be randomly allocated to the AACQ group and the text questionnaire (TQ) group. A separate knowledge test to assess the amount of knowledge acquired is included in the questionnaires. Additionally, participants' demographic data and basic information will be also collected. In our present study, we aim to test whether an audio and animated cartoon could help the child to understand the information about our research of biospecific nonspecimen specimen donation, reduce differences in their understanding, and use that information to make an appropriate decision for themselves. Meanwhile, we will exam factors that may influence a Chinese child's willingness to donate biospecific nonspecimen specimen before pediatric surgery.

Eligibility criteria: Inclusion Criteria:

* Patients without obvious communication difficulties in the pediatric surgery wards were invited to participate in this survey.

Exclusion Criteria:

* Patients with obvious communication difficulties

Primary outcomes:
measure: correction rates
timeFrame: 1 hour after completing the questionnaire
measure: attitudes toward biospecific nonspecimen specimens
timeFrame: 1 hour after completing the questionnaire
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Children's Medical Center
name: Shijian Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00606840: Weight Gain Prevention
Official title: Study to Prevent Weight Gain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Gain
Keywords: overweight
prevention of weight gain
young adults
self-regulation
daily weighing
weight gain prevention
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2008-02-05
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The specific aim of the proposed project is to test two separate self-regulation interventions to prevent weight gain in young adults, one based on making sustained small changes in behavior to prevent weight gain and the other on making periodic larger behavior changes resulting in weight loss.


Eligibility criteria: Inclusion Criteria:

* Age 18-35
* Body mass index between 23 and 30
* Interested in preventing weight gain

Exclusion Criteria:

* BMI outside of range specified
* Age outside of range specified
* History of or current eating disorder or substance abuse
* Recent weight loss greater than 5% of weight
* Currently in another research study that would interfere

Primary outcomes:
measure: weight change
timeFrame: 8 weeks and 16 weeks
Secondary outcomes:
measure: frequency of weighing, adherence to intervention, diet, activity
timeFrame: 8 weeks and 16 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Rena R Wing, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00015340: Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14
Official title: Buprenorphine/Nx Treatment of Heroin Dependence-A Compassionate Use Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid Dependence
Substance-Related Disorders
Keywords: Opioid Dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: New York MDRU
First posted: 2001-04-18
Enrollment: 582
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is the safety and efficacy of Buprenorphine/Naloxone in the treatment of opioid dependence. A compassionate use study.

Detailed description: The objective of this study is to provide follow-up compassionate use treatment and evaluate long term safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment for subjects who have completed Cooperative Study 1008 A and B.

Eligibility criteria: Inclusion Criteria:

- Completion of Cooperative Study 1008 A/B

Exclusion Criteria:

- Significant medical or psychiatric illness. Non-compliance with study procedures in the Cooperative Study 1008 A/B

Primary outcomes:
measure: Craving
measure: Retention
measure: Opioid withdrawal
measure: Subjective rating
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California
state: California
city: Tampa
country: United States
facility: VA Medical Center
state: Florida
city: Hines
country: United States
facility: VA Medical Center
state: Illinois
city: New York
country: United States
facility: New York VAMC
state: New York
city: Seattle
country: United States
facility: VA PUget Sound Helath Care System
state: Washington
Study officials:
affiliation: New York VAMC
name: Paul Casadonte, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03624140: A Comparison of Three Methods of Hemoglobin Monitoring in Pediatric Patients
Official title: Hemoglobin Monitoring During High Bleeding Risk Surgery in Pediatric Patients: Equivalence Study of Hemoglobin Transcutaneous Saturation and Hemocue With Total Serum Hemoglobin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child
Keywords: major pediatric surgery
hemoglobin measurement
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 195
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Blood measurement
Primary purpose: DIAGNOSTIC

Brief summary: Investigators compare the accuracy of the SpHb and hemocue with blood Hb levels

Detailed description: The goal of the study is to compare 3 methods of hemoglobin measurement in pediatric patients undergoing major surgery. During general anesthesia investigators will measure and compare at different periods of time blood hemoglobin levels obtained from a radial artery catheter with 2 non invasive methods of measurement using hemocue and SpHb

Eligibility criteria: Inclusion Criteria:

* Paediatric patients scheduled for surgery under general anesthesia
* Arterial catheter necessary in the anesthetic protocol
* BMI\<30
* Written consent of holders of parental authority
* No opposition of children

Exclusion Criteria:

- Hemoglobine disease

Primary outcomes:
measure: level of hemoglobin using 3 different techniques at the time of transfusion decision
timeFrame: within the day of surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00005540: Physical Fitness and Cardiovascular Mortality in Firefighters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Coronary Disease
Hypertension
Obesity
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Enrollment: 3403
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE

Brief summary: To study prospectively the interrelationships among physical fitness, activity, other measured risk factors, coronary heart disease (CHD) and all-cause mortality in a cohort of 3,403 firefighters.

Detailed description: BACKGROUND:

From 1971-1991 the Occupational Health Service of Los Angeles Country measured physical fitness and other CHD risk factors (including physical activity, anthropometric measures, blood pressure, smoking, family history of CHD, and levels of total cholesterol, uric acid, and glucose) in Los Angeles County firefighters at application and routine intervals (approximately every three years). The entire cohort of 3403 firefighters is now followed for mortality up to 1996.

DESIGN NARRATIVE:

The entire cohort of 3,403 firefighers is followed up to 1996 in this longitudinal study. The investigators are using a variety of tracing sources, including the National Death Index, and obtaining death certificates to determine date and cause of death. Cohort data will be analyzed to address the following aims: (1) To provide a longitudinal description of and determine the interrelationships among physical fitness, physical activity, and other measured risk factors; (2) to determine whether levels of physical fitness are related, independently of other known and measured risk factors, CHD and all-cause mortality; (3) To determine whether there is a gradient of decreasing CHD risk with increasing levels of physical fitness, or whether there appears to be some threshold of physical fitness, above which CHD risk stabilizes; (4) To determine whether the relationship between physical fitness and CHD and all-cause mortality varies by such cardiovascular risk factors as age, cholesterol levels, blood pressure, smoking, and obesity.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Southern California
name: Wendy Mack
References:
Clinical trial NCT05602740: Detection of hEad Pulse for Ischemic StrOke Verification Study
Official title: EPISODE-VS: hEad Pulse for Ischemic StrOke Verification Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke, Acute
Lead sponsor: MindRhythm, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Wayne State University
First posted: 2022-11-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are being evaluated in the prehospital environment by Paramedics/EMTs in whom stroke is suspected.

Brief summary: Prehospital providers encounter patients with suspected stroke frequently. Prehospital providers need tools to help triage large vessel stroke patients to comprehensive stroke centers. This device will identify large vessel stroke to ultimately improve triage decisions and optimize outcomes.

Detailed description: Patients suspected of stroke by a prehospital provider will have a headset placed to record their headpulse during the encounter. These measurements will be used to assess the accuracy of the device at predicting the presence of large vessel occlusion (LVO) stroke. The MindRhythm, Inc., Harmony® 5000 device is intended to be used in the pre-hospital setting by medical professionals to diagnose large vessel occlusion stroke in adults suspected of having a stroke.

Eligibility criteria: Inclusion Criteria:

• suspected stroke in the prehospital setting

Exclusion Criteria:

* scalp laceration
* Patient refusal
* Prisoner, other vulnerable population
* Prehospital provider feels that the recording may interfere with care

Primary outcomes:
measure: The primary effectiveness objective is to estimate the sensitivity and specificity of LVO diagnosis with Harmony®.
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne Health
state: Michigan
Study officials:
affiliation: Wayne State University
name: James Paxton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith WS, Keenan KJ, Lovoi PA. A Unique Signature of Cardiac-Induced Cranial Forces During Acute Large Vessel Stroke and Development of a Predictive Model. Neurocrit Care. 2020 Aug;33(1):58-63. doi: 10.1007/s12028-019-00845-x.
Clinical trial NCT02686840: Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage
Official title: Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Missed Abortion
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this work is to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.

Detailed description: In women with first trimetric-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.

Eligibility criteria: Inclusion Criteria:

* All women above 18 years of age
* Less than 12 weeks of gestation.
* Pregnancy is confirmed by pregnancy test or ultrasound scan.
* missed abortion
* Normal general and gynecological examination.
* The size of the uterus on pelvic examination was compatible with the estimated duration of pregnancy

Exclusion Criteria:

* Hemodynamically unstable.
* Suspected sepsis with temperature 38 °C.
* Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism, respiratory illnesses, recent liver disease or pruritus of pregnancy.
* Presence of intrauterine contraceptive device (IUCD).
* Suspect or proven ectopic pregnancy.
* Failed medical or surgical evacuation before presentation.
* Known allergy to misoprostol.

Primary outcomes:
measure: Completeness of abortion: expulsion of Products of conception (POC)x by visual inspection
timeFrame: 7 days
Secondary outcomes:
measure: Successful medical abortion: cervical os is closed with endometrial thickness of less than 15 mm
timeFrame: 7 days
measure: Failure: endometrial thickness of more than 15 mm on day seven (from third dose of misoprostol) or developing of complications before day seven needing early surgical evacuation.
timeFrame: 7 days
measure: Bleeding pattern following treatment
timeFrame: 7 days
measure: Pain resulting from the procedure
timeFrame: 7 days
measure: Additional uterotonic used
timeFrame: 7 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university maternity hospital
Study officials:
affiliation: Ain Shams University
name: Hassan A Bayoumy, MD
role: STUDY_CHAIR
References:
citation: Abdelshafy A, Awwad H, Abo-Gamra A, Alanwar A, Elkotb AM, Shahin M, Abd El-Razek M, Abbas AM. Sublingual vs vaginal misoprostol for completion of first trimester missed abortion: a randomised controlled trial. Eur J Contracept Reprod Health Care. 2019 Apr;24(2):134-139. doi: 10.1080/13625187.2019.1569224. Epub 2019 Feb 12.
Clinical trial NCT06962540: Understanding Individual Listening Strategies
Official title: Understanding Individual Listening Strategies
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hearing Loss, Sensorineural
Keywords: Speech Recognition
Hearing Aids
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will listen to hearing aids programmed specifically for their listening strategies or to ones programmed with typical clinical settings first, then switch strategies.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if hearing aid settings that are customized to individual listening strategies result in better speech understanding than non-customized hearing aid settings. The main question it aims to answer is:

Do customized hearing aid settings result in better speech understanding?

Researchers will compare hearing aid settings that match individual listening strategy to a general setting.

Participants will:

Wear hearing aids for a 2-hour visit to our laboratory. Listen to some sentences in noise and repeat the sentences they hear, with two different hearing aid settings Listen to some sentences in noise and rate how understandable they think those sentences are, with two different hearing aid settings

Detailed description: Participants will complete standard clinical hearing evaluations and a listening profile test to evaluate their individual listening strategy. Hearing aids will then be programmed either based on their clinical hearing evaluations alone using typical hearing aid settings or based on their hearing test with settings further adjusted to account for their individual listening strategies.

Eligibility criteria: Inclusion Criteria:

* Sensorineural hearing loss

Exclusion Criteria:

* Montreal Cognitive Assessment \< 23 points

Primary outcomes:
measure: Speech recognition
timeFrame: Outcome measure is collected during the intervention, a two hour visit to the lab where they are wearing the hearing aids
Secondary outcomes:
measure: Speech Spatial Quality
timeFrame: Outcome measure is collected during the intervention, a two hour visit to the lab where they are wearing the hearing aids
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Pamela Souza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03305640: Identification of an Atypical acetabuLar frActure With an Independent Roof Component: Incidence and Description
Official title: Identification of an Atypical acetabuLar frActure With an Independent Roof Component: Incidence and Description
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acetabular Fracture
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-10-10
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: every patient with acute acetabular fractures managed in a single institution between 2007 and 2013

Brief summary: Treatment of acetabular fractures needs a perfect diagnosis to anticipate surgical difficulties. E. Letournel described a rare atypical both-column fracture which " introduces enormous surgical difficulties ". Its particularity is a sagittal comminution interesting the acetabular roof.

In this experience the particular fracture is probably under-diagnosed. The purpose of this study is to give the exact incidence and a precise description of these fractures to improve their surgical management.


Eligibility criteria: Inclusion Criteria:

* patient with acetabular fracture

Exclusion Criteria:

* other type of fracture

Primary outcomes:
measure: measurement of volume-rendered 3D-CT images on preoperative CT-scans
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: GHPSJ
name: Pomme JOUFFROY, MD
role: PRINCIPAL_INVESTIGATOR
References: