louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06299384: The Use of Voice-Based AI in 988 Crisis Counseling
Official title: Voice-Based AI to Scale Evaluation of Crisis Counseling in 988 Rollout
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide
Suicide and Self-harm
Keywords: Crisis Counseling
988
Artificial Intelligence
AI
Lead sponsor: Lyssn.io, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ProtoCall Services, Inc.
First posted: 2024-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Effective training requires repeated opportunities for skills practice with performance-based feedback, which is challenging to provide at scale. This research study focuses on developing an AI-based, coding and feedback tool ("LyssnCrisis") for implementation in a nationally utilized crisis call center, training counselors (call-takers) in suicide risk assessment skills, and evaluating LyssnCrisis to improve services and client outcomes. This research study's goal is to maximize the human capacity of call-takers to help assess their callers for risk of suicidality, and thus, a core aspect of the current research is developing a novel training process that supports human call-taker capacities.


Eligibility criteria: Inclusion Criteria:

Must be employed at Protocall Services, Inc.

Exclusion Criteria:

Call-takers who participated in Stage 2 research will not be able to participate in Stage 3 research.

Primary outcomes:
measure: Post-Call Survey
timeFrame: Through study completion, an average of 22 weeks.
measure: Call-taker crisis counseling fidelity
timeFrame: Through study completion, an average of 22 weeks.
measure: System Usability Scale (SUS)
timeFrame: Through study completion, an average of 22 weeks.
measure: Acceptability of Intervention Measure; AIM
timeFrame: For Pilot: at end of 2 week LyssnCrisis period; for RCT, at end of 12-week LyssnCrisis period.
measure: Intervention Appropriateness Measure; IAM
timeFrame: Through study completion, an average of 22 weeks.For Pilot: at end of 2 week LyssnCrisis period; for RCT, at end of 12-week LyssnCrisis period.
measure: Feasibility of Intervention Measure; FIM
timeFrame: For Pilot: at end of 2 week LyssnCrisis period; for RCT, at end of 12-week LyssnCrisis period.
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: ProtoCall Services, Inc.
state: Oregon
Study officials:
affiliation: Lyssn.io, Inc.
name: David C Atkins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05625984: Study With Fascigel
Official title: Multi-centre, Open-label, First-in-man Study With Fascigel Used in Adult Patients Suffered From Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Lead sponsor: Contipro Pharma a.s.
Sponsor class: OTHER
First posted: 2022-11-23
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The product is a Class III Medical Device. Structure is made by 1% sodium hyaluronate polysaccharide in normal saline solution. The device intended use is to help treat back pain by lubricating fascia.


Eligibility criteria: Inclusion Criteria:

* Back pain (VAS above 4 cm)
* Limited range of motion
* Duration of pain for over 3 months
* Patient willing and able to provide the written consent
* Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study

Exclusion Criteria:

* State after back surgery
* BMI \> 35
* Age \< 18 years
* Pregnant or lactating woman
* Patient in terminal stage of living
* Patient with known hypersensitivity or allergy to any of substances contained in Medical Device
* Patient participating in the intervention clinical study
* Alcohol or drug abuse
* Patient undergoing chronic coagulation therapy

Primary outcomes:
measure: - Pain management
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Medicinecare s.r.o.
city: Praha
country: Czechia
facility: FN Královské Vinohrady
city: Praha
country: Czechia
facility: FN Motol
Study officials:
References:
Clinical trial NCT01161784: The Effects of a Probiotic Fermented Milk on Functional Constipation in Adults
Official title: The Effects of a Probiotic Fermented Milk on Functional Constipation in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Constipation
Keywords: Functional constipation
Probiotic
Probiotic microorganism
Lactobacillus casei Shirota (LcS)
Lead sponsor: International Medical University
Sponsor class: OTHER
Collaborators: name: University of Malaya
name: National University of Malaysia
First posted: 2010-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of daily consumption for 4 weeks of a fermented milk drink containing a live probiotic microorganism, Lactobacillus casei strain Shirota (LcS) compared to a placebo without LcS, among adults with functional constipation.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with functional constipation based on ROME II criteria
* Has a constipation severity score (Chinese Constipation Questionnaire or CCQ score) of at least 5, which is the cut-off point for constipated subjects (Chan et al, 2005)
* Free of any cardiovascular related diseases, diabetes, cancer, neurological diseases or any other serious illness, not physically or mentally handicapped
* Living in Klang Valley, with no pre-determined plans to be out of town for one week or longer during scheduled intervention period

Exclusion Criteria:

* Body Mass Index of less than 16, or 30 and above
* Pregnant
* Regular ingestion of probiotic products within the preceding four weeks
* Regular use of laxatives (average once a week or more)
* Intake of anticholinergics medications or medications against diarrhea or antibiotics in the preceding 1 month
* Persons with milk protein allergy
* Persons with constipation of organic or neurological origin based on health screening
* Persons with alarm features as assessed by physician during health screening

Primary outcomes:
measure: Constipation severity score which measures overall signs and symptoms of constipation using the 'Chinese Constipation Questionnaire' or CCQ (Chan et al, 2005)
timeFrame: 4 weeks
measure: Frequency of bowel movement
timeFrame: 4 weeks
Secondary outcomes:
measure: Stool consistency based on modified Bristol Stool scale
timeFrame: 4 weeks
measure: Stool output quantity estimations
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: International Medical University
state: Wilayah Persekutuan
Study officials:
References:
Clinical trial NCT05861284: Developing and Optimizing Transcranial Magnetic Stimulation for Motor Rehabilitation
Official title: Developing and Optimizing Transcranial Magnetic Stimulation for Motor Rehabilitation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Motor Cortex
Motor Skills
Keywords: TMS
Motor system
Healthy
Lead sponsor: New Jersey Institute of Technology
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to evaluate three different transcranial magnetic stimulation protocols and their impact on motor system neurophysiology and skill learning.

Detailed description: Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation method that induces long-term changes in connections between neuronal networks. This and the ability to activate the whole motor system allows the use of TMS to facilitate motor recovery. The motor system has different excitatory states associated with ongoing mu oscillation. Here, the investigators will monitor brain mu oscillations in real-time non-invasively using electroencephalography and modulate the function of the motor system. The investigators will test the impact of three different TMS protocols on motor system neurophysiology and skill learning. These data will provide novel understanding needed to improve TMS approaches for individuals requiring motor rehabilitation.

Eligibility criteria: Inclusion Criteria:

* 18-40 years old
* Able to read, understand, and sign the informed consent in English
* Right-handed

Exclusion Criteria:

* A sensory or physical impairment
* History of epilepsy or seizures in the family
* Non-removable metal or electronics (e.g., a cochlear implant, cardiac pacemaker, or implanted electronic devices) in your head or body
* A head injury with loss of consciousness
* Diagnosis of psychiatric or neurological disorder
* Skin defects or active infections on the scalp or hands
* Pregnancy or breastfeeding

Primary outcomes:
measure: Effect of TMS on motor evoked potentials
timeFrame: Up to 1 second after TMS
measure: Skill learning accuracy
timeFrame: Up to 12 minutes
measure: Skill learning speed
timeFrame: Up to 12 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: New Jersey Institute of Technology
name: Elisa Kallioniemi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05284084: Prevention of Broncho-aspiration (BA) in Adult Subjects During Their ICU Stay
Official title: Prevention of Broncho-aspiration (BA) in Adult Subjects During Their ICU Stay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchial Aspiration
Keywords: Bronchial
Aspiration
Bronchoaspiration
Broncho-aspiration
ICU
Intensive Care Unit
Surgical patients
Surgery
Lead sponsor: Marshall University
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 159
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: Patients of age \>18 yo, admitted to the ICU through the surgery department from 2AUG2021 to 1AUG2022 will be divided into three groups:

1. Patients admitted to the ICU in the first 3-4 months will have their bed head elevated to 15 degrees + H2 blockers administration + mouth wash BID
2. Patients admitted to the ICU in the following 3-4 months will have their bed head elevated to 30 degrees + H2 blockers administration + mouth wash BID
3. Patients admitted in the last 3-4 months will have their bed head elevated to 45 degrees + H2 blockers administration + mouth wash BID.

All patients will have their vital signs, BMI, and fluids ins and outs measured every 24 hours until the discharge from the ICU or death. All patients will be evaluated for GI functions (no vomiting, flatus+, bowel movement +, bowel sounds+, and KUB with normal gas distribution pattern) prior to oral intake.

Patients in the three groups will be matched by age, sex, and BMI with historical controls with broncho- aspiration (BA) (positive controls) and without BA events (negative controls) from a pool of 20,032 ICU admissions (01JAN2010 to 31DEC2019).


Eligibility criteria: Inclusion Criteria:

* Age\>18
* All the patients admitted to ICU by surgery department.
* Development of aspiration pneumonia in patients admitted to ICU department of VA hospital.
* Aspiration Pneumonia development during hospital stay and treating physician indicated the diagnosis of aspiration pneumonia in history and physical exam notes.

Exclusion Criteria:

* Age \<18
* Patient transferred or admitted to the hospital as a primary diagnosis of aspiration pneumonia (development of aspiration pneumonia prior to admission).
* Treating physician not documented aspiration pneumonia in history or physical exam notes.
* Drug overdose, seizure or cardiopulmonary arrest prior to hospital admission.

Primary outcomes:
measure: Rate of Bronchospiration pneumonia among study participants during their ICU admission
timeFrame: 12 Months
Secondary outcomes:
measure: Determine if there is an association between BA events and death rate in the ICU for the specified time period
timeFrame: 12 Months
Other outcomes:
Locations:
city: Huntington
country: United States
facility: Marshall University School of Medicine
state: West Virginia
Study officials:
affiliation: Marshall University School of Medicine
name: Juan Sanabria, MD MSc FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06171984: Thrombophilia Assessment Under DOAC: Effectiveness of Activated Charcoal
Official title: Thrombophilia Assessment Under Direct Oral Anticoagulants (DOAC): Efficacy of Activated Charcoal
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thrombophilia
Keywords: Thrombophilia
direct oral anticoagulants
DOAC
Apixaban
Rivaroxaban
Dabigatran
Hemostasis tests
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subject (≥ 18 years of age) with blood sample already analyzed in a usual way in the laboratory of HUS as part of the care

Brief summary: Direct oral anticoagulants (DOAC) are anticoagulant molecules that act either directly on factor Xa (Apixaban, Rivaroxaban) or on factor IIa (Dabigatran).

AODs interfere with most coagulation tests, especially those performed by chronometric technique.

For this reason, part of the thrombophilia workup (protein S, search for lupus anticoagulants, antithrombin for patients on dabigatran) cannot be performed on DOACs at the HUS.

Recent studies have highlighted the effectiveness of activated charcoal to adsorb DOACs in order to perform certain hemostasis tests.


Eligibility criteria: Inclusion criteria:

* Adult subject (≥ 18 years of age)
* Blood sample already analyzed in a usual way in the laboratory as part of the care
* Subject not objecting to the reuse of his or her medical data for scientific research purposes.

Exclusion criteria:

- Insufficient sample

Primary outcomes:
measure: Interference or not of activated charcoal in the measurement of protein S, antithrombin, and in the search for lupus anticoagulants.
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Laboratoire d'Hématologie - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT02027584: Observational Study of Choline, Its Metabolites, and Phospholipids in Preterm Infants
Official title: Supply of Term and Preterm Neonates With Choline, Lipids and Vitamines
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prematurity
Keywords: infant, premature
infant, newborn
choline
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Universität Tübingen
First posted: 2014-01-06
Enrollment: 414
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: term and preterm neonates, parturients, non-pregnant females

Brief summary: To study concentrations of choline, its metabolites, and phospholipids in cord blood and remnants of clinically indicated blood samples

Detailed description: To collect cord plasma in preterm and term infants. To collect remnants of clinically indicated blood samples in parturients and hospitalized preterm infants during neonatal intensive care.

To determine concentrations of choline, its metabolites, and phospholipids by mass spectrometry.

To compare cord plasma concentrations with postnatal plasma concentrations.

Eligibility criteria: Inclusion Criteria:

* meeting criteria of the 4 cohorts

Exclusion Criteria:

* none pre-defined

Primary outcomes:
measure: Concentration of choline in plasma
timeFrame: at times when a clinically indicated blood sample is taken before discharge home from the initial neonatal hospitalization (at a postnatal age of up to 4-5 months at the most in very preterm infants)
Secondary outcomes:
measure: concentrations of choline metabolites
timeFrame: at times when a clinically indicated blood sample is taken before discharge home from the initial neonatal hospitalization (at a postnatal age of up to 4-5 months at the most in very preterm infants)
measure: Concentrations of molecular species of phosphatidylcholine and phosphatidylethanolamine
timeFrame: at times when a clinically indicated blood sample is taken before discharge home from the initial neonatal hospitalization (at a postnatal age of up to 4-5 months at the most in very preterm infants)
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
Study officials:
affiliation: University Hospital Tuebingen
name: Wolfgang Bernhard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernhard W, Full A, Arand J, Maas C, Poets CF, Franz AR. Choline supply of preterm infants: assessment of dietary intake and pathophysiological considerations. Eur J Nutr. 2013 Apr;52(3):1269-78. doi: 10.1007/s00394-012-0438-x. Epub 2012 Sep 9.
citation: Bernhard W, Raith M, Kunze R, Koch V, Heni M, Maas C, Abele H, Poets CF, Franz AR. Choline concentrations are lower in postnatal plasma of preterm infants than in cord plasma. Eur J Nutr. 2015 Aug;54(5):733-41. doi: 10.1007/s00394-014-0751-7. Epub 2014 Aug 23.
Clinical trial NCT05666284: Radiographic Changes and Clinical Implications of Implantation of Shortened Uncemented Femoral Stems in THA
Official title: Study of Radiographic Changes and Their Clinical Implications at 2 Years of Implantation of Shortened Uncemented Femoral Stems in Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aseptic; Osteonecrosis
Hip Osteoarthritis
Keywords: Hip Osteoarthritis
Aseptic; Osteonecrosis
Coxarthrosis
Avascular Necrosis of the Femoral Head
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient operated for first-line THA for an indication of centric hip osteoarthritis (including minor dysplasia and coxa profunda) and aseptic osteonecrosis of the femoral head

Brief summary: The hip prosthesis market is constantly growing with the number of prostheses reaching 949,000 in 2019. Along with this, there is also an increase in interest in short stems also called shortened stems. Thus on Pubmed, in 5 years, 171 publications have been listed.

Thus, it seems interesting to study and analyze the performance of the shortened stem used in the Department of Orthopedic Surgery and Traumatology of the University Hospitals of Strasbourg and to compare them with the results of the literature.

Detailed description: The objective of this study is to observe the appearance of shortened stem radiological abnormalities at least 2 years postoperatively.

Eligibility criteria: Inclusion criteria:

* Male or female (age ≥18 years old)
* Subject operated for first-line THA for an indication of centric hip osteoarthritis (including minor dysplasia and coxa profunda) and aseptic osteonecrosis of the femoral head
* Subject who received a THA between January 2015 and December 2019
* Subject who received an uncemented shortened SCC or SCLA femoral stem
* Radiological data available: pre-operative, immediate post-operative and post-operative at a minimum of 2 years (≥24 months)
* Subject not objecting to the reuse of their data for scientific research purposes.

Exclusion criteria:

* Subject having expressed its opposition to the reuse of its data for scientific research purposes.
* Patient operated for inflammatory pathology or major dysplasia, recovery
* Associated fractures or sequelae of fractures
* Patient having presented intraoperative or early complications such as infections, intraoperative fracture, dislocation of the hip following the installation of the THA
* Revision of hip arthroplasty during the study follow-up period for a cause not studied in the study.

Primary outcomes:
measure: Bone changes around the femoral implant at 2 years on hip radiographs.
timeFrame: 2 years postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Orthopédique et de Traumatologie du Membre Inférieur - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT00925184: Students' View: Survey of Medical Education in Taiwan
Official title: Students' View: Survey of Medical Education in Taiwan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Understand Students' View Toward Current Medical Education.
Keywords: questionnaire, medical education, medical students.
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2009-06-22
Enrollment: 370
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: medical students at their graduate year will be invited to participated in this study. students who are willing to participate need to help us to fill out a questionnaire about their educational experience in medical school.

Brief summary: The aim of this research project is to establish a students' perspective to most medical schools in Taiwan. We expect that these surveys will provide helpful information to candidates for selection of medical school before admission, and will also be a useful reference guide to improve quality of medical education to our governmental policy makers.

Detailed description: The aim of this research project is to establish a students' perspective to most medical schools in Taiwan. We will select Medical School Graduation Questionnaires, obtained from Association of American Medical Colleges, AAMC, which has been performed in US for more than 30 years. These questionnaires will modify with edition with expert opinions of our country. We will invite students' representative of each school for survey visit and deliver questionnaires to students after complete communication and permission of their schools. These surveys include learning resources, student support services, student daily life, medical education...etc. We expect that these surveys will provide helpful information to candidates for selection of medical school before admission, and will also be a useful reference guide to improve quality of medical education to our governmental policy makers.

Eligibility criteria: Inclusion Criteria:

* medical students at their graduate year and are willing to fill out the questionnaire.

Exclusion Criteria:

* medical students who do not want to fill out the questionnaire.

Primary outcomes:
measure: Filled out the assigned questionnaire.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University-Wanfang Hospital
Study officials:
affiliation: Wan Fang Hospital
name: Wing Pong Chan, MD
role: PRINCIPAL_INVESTIGATOR
References: