louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03329157: Rebuilding Bridges for Homeless Veterans
Official title: Rebuilding Bridges for Homeless Veterans
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Housing Problems
Lead sponsor: VA Connecticut Healthcare System
Sponsor class: FED
First posted: 2017-11-01
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group design.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pilot study on an intervention called Rebuilding Bridges to help veterans re-engaged with loved ones.

Detailed description: The objective of the proposed project is to examine the feasibility and acceptability of the Rebuilding Bridges intervention, which was designed to help homeless Veterans plan and implement steps to engage friends, family and other loved ones in their lives. The PI and his team will enroll approximately 25-30 Veterans. Veterans will be recruited via provider referral and via advertisements that will be placed in general clinical areas and desks at the Errera Center. The PI will work with the Veterans to create a detailed genogram of family, friends and other supporters in the Veteran's life. This will be followed by a meeting with each Veteran over the course of three 30-minute weekly sessions to help the Veteran identify and engage people listed in their genogram which the Veteran might want to form stronger relationships with. Veterans will also be asked to complete several measures and questionnaires such as housing information, employment, mental health and quality of life.

Eligibility criteria: Inclusion Criteria

1. Over 18 years old
2. Currently in a VA homeless program
3. Able to provide valid consent

Exclusion Criteria

1. Acute psychiatric decompensation requiring inpatient admission or emergency department services within the last month (suicidality, homicidally, mania, psychotic decompensation)
2. Has a conservator

Primary outcomes:
measure: Social Support
timeFrame: 2 years
Secondary outcomes:
measure: Housing status
timeFrame: 2 years
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut
name: Jack Tsai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03544957: Evaluation of the Triage Risk Screening Tool
Official title: Evaluation of the Triage Risk Screening Tool (TRST) as Screening Instrument Elderly Subject Fragility at the Accident and Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elderly Subject Fragility
Keywords: Screening instrument
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 199
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly subject admitted to the emergency department

Brief summary: This study tried to describe diagnostic properties of TRST completed by an emergency doctor, for screening process for fragility of elderly subjects admitted at the accident and emergency department.

Detailed description: A constant increase of emergencies admission of elderly subjects is registered. The current problem is the identification and early screening of these patients upon admission at the accident and emergency department for early tracking in geriatric network. This early assessment could allow a shorter waiting time, a better orientation of patients and a decrease in the number of re-hospitalization.

There are many screening process for fragility tests but there seem to be nonspecifically. The advantage of TRST is its simplicity and speed of filling.

In 2015, Duc et al. have found that TRST may be a screening instrument for elderly subject and is going to require geriatric mobile team (GMT) for evaluation. Unfortunately, the threshold may be too sensitive and GMT solicitation is too high.

Eligibility criteria: Inclusion Criteria:

* Patients who are more than 75 years old
* Admitted to the emergency department for medical or surgical reason
* Admitted from Monday to Friday (8h30 AM- 6h PM)

Exclusion Criteria:

* Patient with specific care (vital emergency, urgent surgery)
* Patient or his support person opposing the use of data

Primary outcomes:
measure: TRST-U
timeFrame: Day 1
Secondary outcomes:
measure: TRST-G
timeFrame: Day 1
measure: SEGA instrument
timeFrame: Day 1
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz Thionville
state: Moselle
Study officials:
References:
Clinical trial NCT02763657: Neural Development of Deductive Reasoning
Official title: Neural Development of Deductive Reasoning: an fMRI Study of Relational and Categorical Reasoning in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Keywords: fMRI
reasoning
development
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Children's understanding of linear-order (e.g., Dan is taller than Lisa, Lisa is taller than Jess) and set-inclusion (i.e., All tulips are flowers, All flowers are plants) relationships is critical for the acquisition of deductive reasoning, that is, the ability to reach logically valid conclusions from given premises. Behavioral and neuroimaging studies in adults suggest processing differences between these relations: While arguments that involve linear-orders may be preferentially associated with spatial processing, arguments that involve set-inclusions may be preferentially associated with verbal processing. In this study, we use functional magnetic resonance imaging to investigate how and when these processing differences appear in children from 8 to 14.


Eligibility criteria: Inclusion Criteria:

* Right-handed
* Affiliated to the French social security
* Whose parents gave informed consent

Exclusion Criteria:

* Neurological disorders
* Psychiatric disorders
* Birth complications requiring admission into neonatal intensive care unit
* Medication affecting central nervous system processing
* Significant hearing impairment
* Uncorrected visual impairment
* Non-native English speaker
* Contraindications for MRI

Primary outcomes:
measure: Identification of brain regions engaged in linear-order and set-inclusion reasoning
timeFrame: 30 days
Secondary outcomes:
measure: Degree of overlap between brain regions involved in linear-order and set-inclusion reasoning
timeFrame: 30 days
Other outcomes:
Locations:
city: Lyon/bron
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT05175157: Assessment of "Gut Feelings" Accuracy Regarding the Effect of Professional Experience in General Practitioners in Clinical Decision Making
Official title: Assessment of "Gut Feelings" Accuracy Regarding the Effect of Professional Experience in General Practitioners in Clinical Decision Making
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gut Feelings
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2022-01-03
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * General practitioners established for more than 3 years
* Interns in the first year of the third cycle of the diploma of specialized studies in general medicine of the Universities of Brest and Rouen

Brief summary: Knowledge, experience and professional development limit the risk of diagnostic error for the clinician in daily practice. However, research has shown that other non-analytical factors are involved in clinical decision making. Intuition (or "gut feelings") is a subjective element involved in medical decision-making, and its place and relevance are being explored. The concept of "gut feelings" comes from General Practitioners (GPs) themselves and their description of their own practice. Several studies have shown its place in medical decision-making models, particularly in the face of diagnostic uncertainty.

A questionnaire used as a standardized measurement tool for gut feelings was created to address this issue. The Gut Feelings Questionnaire (GFQ) has been translated into French, German and Polish during a standardized linguistic validation procedure. It is currently validated and available in five languages. The QGF has been tested and validated in clinical practice by Belgian, French and Dutch physicians. Its feasibility has been evaluated in these three health systems.

The Gut Feelings Questionnaire was used in a prospective study to determine the accuracy of the sense of alarm in patients consulting their GP for chest pain and/or dyspnea. But the role of the practitioner's experience has not been studied: is the gut feeling more accurate in experienced GPs than in first semester interns in general practice?


Eligibility criteria: Inclusion Criteria:

- GP population: General practitioners established for more than 3 years

- Intern population: Interns in general medicine in the first year of the third cycle of the diploma of specialized studies in general medicine

Exclusion Criteria:

- For the 2 populations: Refusal to participate

- Intern population: Interns in the second and third year of the diploma of specialized studies in general medicine

Primary outcomes:
measure: Error assessment
timeFrame: Day 1
Secondary outcomes:
measure: Types of professional activity of installed GPs
timeFrame: Day 1
measure: Type of care
timeFrame: Day 1
measure: Practitioner's orientation
timeFrame: Day 1
Other outcomes:
Locations:
city: Brest
country: France
facility: Dr Marie BARAIS
Study officials:
References:
Clinical trial NCT01497457: Interest of Saline MR Peritoneography for Pre-operative Assessment of Rectal Cancer
Official title: Interest of Saline MR Peritoneography for Pre-operative Assessment of Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Adenocarcinoma
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2011-12-22
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: MR saline peritoneography could be useful to demonstrate the peritoneal outline of the pouch of Douglas. The investigators think that the localization of the rectal tumor in function of this anatomic mark could be decisive for pre-operative assessment.


Eligibility criteria: Inclusion Criteria:

* Rectal adenocarcinoma

Exclusion Criteria:

* Metastatic disease
* under 18y patient
* woman of childbearing age

Primary outcomes:
measure: Determination of the distance between a rectal tumor and the pouch of Douglas
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St Luc - Université Catholique de Louvain
Study officials:
affiliation: Cliniques Universitaires St Luc - Université Catholique de Louvain
name: Cristina A Dragean, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02420457: Tracking Outcomes in Pain Patients Using Fitness Devices
Official title: Tracking Outcomes in Pain Patients Using Fitness Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Back Pain
Keywords: Fitness devices
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2015-04-17
Enrollment: 36
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: Adult patients with chronic back pain

Brief summary: The investigators are assessing the validity of fitness devices as surrogate measures of chronic pain survey outcomes.

Detailed description: The investigators are attempting to validate the usage of personal fitness trackers against the classical survey tools used. These devices are known to be of use in measuring activity and sleep in healthy patients but their use in chronic pain patients has not been assessed. This study will follow participants with chronic back pain undergoing treatment to see if changes in clinical course can be captured with these fitness devices.

Eligibility criteria: Inclusion Criteria:

* Back pain which may benefit from epidural injection
* Assenting to epidural injection for back pain

Exclusion Criteria:

* Inability to wear fitness tracking device

Primary outcomes:
measure: Association of percent improvement in pain and number of steps.
timeFrame: Follow-up assessment approximately 2-4 weeks following epidural procedure.
Secondary outcomes:
measure: Change in pain severity following procedure
timeFrame: Follow-up timepoint approximately 2-4 weeks following procedure
measure: Association in minutes slept as measured by fitness device and percent improvement in pain
timeFrame: Follow-up assessment approximately 2-4 week following procedure
measure: Change in survey measures of pain
timeFrame: Follow-up assessment approximately 2-4 weeks following the procedure.
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
Study officials:
affiliation: Assistant Professor
name: Matthew C Mauck, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00917657: Photorefractive Keratectomy (PRK) for Hyperopia After Radial Keratotomy
Official title: Corneal Wavefront-Guided PRK With Adjunctive Mitomycin-C for the Treatment of Hyperopia After Radial Keratotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperopia
Keywords: photorefractive keratectomy
hyperopia
radial keratotomy
refractive surgery
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-06-10
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the efficacy, predictability, stability and safety of corneal wavefront-guided photorefractive keratectomy (PRK) for correcting hyperopia and astigmatism after radial keratotomy (RK).


Eligibility criteria: Inclusion Criteria:

* Hyperopia or hyperopic astigmatism with spherical equivalent of up to + 9,25 D and astigmatism of up to - 4,5 D;
* Uncorrected Visual Acuity of 20/40 or worse;
* Best-Corrected Visual Acuity of 20/60 or better.

Exclusion Criteria:

* Systemic or ocular conditions that could bias results
* Previous photorefractive surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ghanem RC, Ghanem EA, Kara-Jose N. [Safety of photorefractive keratectomy with mitomycin-C for the treatment of hyperopia after radial keratotomy]. Arq Bras Oftalmol. 2010 Mar-Apr;73(2):165-70. doi: 10.1590/s0004-27492010000200013. Portuguese.
citation: Ghanem RC, Ghanem EA, Kara-Jose N. [Corneal wavefront-guided photorefractive keratectomy with mitomycin-C for consecutive hyperopia after radial keratotomy]. Arq Bras Oftalmol. 2010 Jan-Feb;73(1):70-6. doi: 10.1590/s0004-27492010000100013. Portuguese.
Clinical trial NCT00824057: Effect of Multiple Doses of AZD6280 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)
Official title: A Phase I Open-labeled, Fixed Sequence Study to Determine the Effect of Multiple Doses of AZD6280 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase I
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-01-16
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate the effects of taking repeated doses of AZD6280 on the blood levels of midazolam and caffeine in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects aged 18 to 45 years (inclusive) on Day 1.

Exclusion Criteria:

* Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor.
* Enrollment in another concurrent investigational study or intake of an investigational drug within 3 months or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit

Primary outcomes:
measure: To determine the effects of repeated doses of AZD6280 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine [3-desmethyl] metabolite).
timeFrame: Blood samples will be taken throughout the 19-day inpatient period of the study.
Secondary outcomes:
measure: To evaluate the safety and tolerability of repeated doses of AZD6280 in combination with midazolam and caffeine.
timeFrame: Observations taken post dosing.
measure: Evaluation of the pharmacodynamic effects of AZD6280
timeFrame: Test batteries will be performed before and following study drug administration.
measure: To evaluate the pharmacokinetics of AZD6280
timeFrame: Blood samples will be taken throughout the 19-day inpatient period of the study.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Guy's Drug Research Unit Quintiles Ltd
name: Darren Wilbraham, MBBS, DCPSA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03395457: Tertiary Care With or Without Manual Therapy for Chronic Migraine
Official title: A Pragmatic Randomised Controlled Trial on the Effectiveness of Manual Therapy as an Adjunct to Tertiary Management in Chronic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Migraine
Lead sponsor: Bournemouth University
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pragmatic randomised control trial
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine if adding manual therapy to care as usual reduces the discomfort from chronic migraine compared to care as usual alone


Eligibility criteria: Inclusion Criteria:

Female adults 18 years of age or older with a good command of English (to enable informed consent) Existing patients with chronic migraine as diagnosed by a clinical interview with a neurologist in line with the International Classification of Headache Diagnosis criteria (ICHD) Undergoing care as usual from the neurologist

Exclusion Criteria:

Currently having or had manual therapy for neck, shoulder in the last six weeks.

Having a condition contraindicated for manual therapy including but not limited to inflammatory disorders, severe osteoporosis and tumours.

Identification of any medical 'red flags' by the neurologist including

* Evidence of any central nervous system involvement for example:
* Facial palsy (presence of ptosis/Horner's syndrome)
* Visual disturbance (presence of blurred vision, diplopia, hemianopia)
* Speech disturbance (presence of dysarthria, dysphonia, dysphasia such as expressive or receptive)
* Balance disturbance (presence of dizziness, imbalance, unsteadiness, falls)
* Paraesthesia (presence, location such as upper limb/lower limb, face)
* Weakness (presence, location such as upper limb/lower limb)
* Known major psychiatric or psychological conditions not under control

Primary outcomes:
measure: Change in migraine-related disability
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Migraine Specific Quality of Life Questionnaire Score (MSQoL 2.1)
timeFrame: 12 weeks
measure: Headache Frequency
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
Study officials:
affiliation: University Bournemouth
name: Carol Clark, Dr
role: STUDY_CHAIR
References:
citation: Odell J, Clark C, Hunnisett A, Ahmed OH, Branney J. Manual therapy for chronic migraine: a pragmatic randomised controlled trial study protocol. Chiropr Man Therap. 2019 Mar 27;27:11. doi: 10.1186/s12998-019-0232-4. eCollection 2019.
Clinical trial NCT03477357: Accuracy of Non-contact Thermometry
Official title: A Study to Determine the Accuracy of a Non-contact Thermometer in the Perioperative Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothermia
Lead sponsor: Brighton and Sussex University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be patients undergoing elective gynaecological, vascular or urological surgery at the Royal Sussex County Hospital, and as such will be seen at a pre-operative assesment clinic as part of their normal work up for theatre

Brief summary: Subjects will be admitted to hospital the evening prior, or the morning of surgery, whereupon they will undergo standard admission processes, including pre-operative assessment by the anaesthetist assigned to that list (One of the two study authors). The anaesthetist will then explain the study again, reiterating the potential risks and benefits of the study to the patient themselves, and to the population as a whole. Consent will be sought at this point.

Patients will be transferred to theatre, anaesthetised and operated on as per normal practice. Inclusive of this, in accordance with NICE guidelines, patients will have a nasal or oesophageal Doppler probe inserted to accurately measure core temperature. At this point, patients enrolled in the study will have temperature measurements taken every minute from the oesophageal probe and non-contact thermometers.

If the patients requested it previously, they will be informed of the results of the study at a later date.

Statistics will then be carried out on the data to compare accuracy of the two novel methods to the oesophageal probe.


Eligibility criteria: Inclusion Criteria:

* Participants will be patients undergoing elective gynaecological, vascular or urological surgery at the Royal Sussex County Hospital, and as such will be seen at a pre-operative assessment clinic as part of their normal work up for theatre.

Exclusion Criteria:

- Lacking mental capacity Not speaking English Malignancy in medical history Undergoing open abdominal surgery

Primary outcomes:
measure: Core body temperature measurement will be taken from 30 patients to compare non-contact infra-red thermometer to oesophageal temperature probes
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospitals NHS Trust
state: East Sussex
Study officials:
affiliation: BSUH
name: Jack Reid, MBBS
role: PRINCIPAL_INVESTIGATOR
References: