louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02173197: Effectiveness of Occupational Therapy Intervention in Complex Patients
Official title: Study on the Effectiveness of Occupational Therapy Intervention in Complex Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complex Patients: Patients With High Level of Complexity Regardless of the Pathology of Origin
Keywords: Occupational Therapy
Complex patients
Occupational performance problem
Rehabilitation Complexity Scale
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
Collaborators: name: Azienda USL Reggio Emilia - IRCCS
First posted: 2014-06-24
Enrollment: 20
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: In-hospital complexes patients as defined by way of the Rehabilitation Complexity Scale, regardless of the diagnosis and in charge of the rehabilitation ward

Brief summary: To date, there are no studies that demonstrate that the intervention of Occupational Therapy (OT) in patients considered to be complex, regardless of diagnosis, could improve clinical and functional outcome for the patient.

For this reason, we intend to undertake a study that will allow us to deepen the knowledge about the impact of the OT on in-hospital patients considered "complex" according to the assessment by the Rehabilitation Complexity Scale (RCS ).

Our hypothesis is that the intervention of OT can improve their care by qualified and focused on the needs of the person interventions.

Detailed description: We will therefore first af all to implement an observational pilot study, aimed at defining the characteristics and needs of the population in question, and the OT intervention "protocol". This information will then be used to implement a subsequent randomized controlled trial designed to demonstrate the effectiveness of the OT intervention on the basis of clinically relevant outcome measures.

Eligibility criteria: Inclusion Criteria:

* 18 years old
* in charge of the rehabilitation ward of the hospital
* defined complexes as assessed by RCS
* consent to the processing of sensitive data for research purposes.

Exclusion Criteria:

* primary psychiatric conditions
* language barrier;
* cognitive impairment
* communicative disability

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Azienda USL Reggio Emilia - IRCCS
name: Stefania Fugazzaro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arcospedale Santa Maria Nuova - IRCCS
name: Claudio Tedeschi, MD
role: STUDY_CHAIR
References:
citation: Schiavi M, Costi S, Pellegrini M, Formisano D, Borghi S, Fugazzaro S. Occupational therapy for complex inpatients with stroke: identification of occupational needs in post-acute rehabilitation setting. Disabil Rehabil. 2018 May;40(9):1026-1032. doi: 10.1080/09638288.2017.1283449. Epub 2017 Feb 7.
Clinical trial NCT06040697: Formative Usability Assessment of Wireless Thermal Anisotropy Devices
Official title: Formative Usability Assessment of Wireless Thermal Anisotropy Devices Measuring Flow in Cerebrospinal Fluid Shunts
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hydrocephalus
Lead sponsor: Rhaeos, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-15
Enrollment: 145
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with an existing Cerebrospinal Fluid (CSF) shunt

Brief summary: Measurements of shunt flow will be performed non-invasively. This study will generate usability data via observed tasks and comprehension questions to enable future device design improvements.


Eligibility criteria: Inclusion Criteria:

1. Existing ventricular CSF shunt with a region of intact skin overlying the shunt catheter appropriate in size for application of the study device
2. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
3. Subject or caregiver can clearly communicate and document information in English
4. Verbal assent by minors 12 years of age and older who can understand the study and communicate their decision
5. Subject is at least 5 years old but not more than 80 years old

Exclusion Criteria:

1. Presence of an interfering open wound in the device application region
2. Subject-reported history of adverse skin reactions to adhesives

Primary outcomes:
measure: Exploratory device usability feedback
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rhaeos, Inc.
state: Illinois
Study officials:
References:
Clinical trial NCT06275997: GAIN Project: Gastric Cancer and Artificial Intelligence
Official title: Gastric Cancer and Artificial Intelligence: a National-level Project
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 6600
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel/Crossover Study Model; Patients will be randomized 1:1:1:1
Primary purpose: PREVENTION

Brief summary: Our GAIN project comprises four core work packages (WPs): WP1. Nation-level randomized controlled trial; WP2. Development of an innovative AI tool; WP3. Novel microsimulation modelling; WP4. Patient inclusion.

The nation-level multi-center tandem randomized controlled trial (WP1) will contribute to a better understanding of how the real-time AI algorithm can reduce miss rate of early gastric cancer and dysplasia during gastroscopy. Moreover, the innovation project will contribute to development of a novel AI tool (WP2) that can stratify the risk of gastric cancer by identifying in vivo precancerous conditions. Furthermore, a microsimulation modelling will allow us to predict how the use of AI can prevent gastric cancer and affect cost and patients' burdens. The assessment of the balance between benefits and harms is quite crucial especially for this type of medical device because the value of innovative tools is sometimes overestimated due to stakeholders' enthusiasm (WP3). Finally, we will take care of patients' perspective throughout the study project by including patient organization in both WP1, 2, and 3 (WP4).


Eligibility criteria: Inclusion Criteria:

* All \>60 years-old patients undergoing upper-gastrointestinal (GI) endoscopy for selected indications in Italian areas at high-risk of gastric cancer (Lombardia, Emilia Romagna, Veneto, Friuli-Venezia Giulia).

Exclusion Criteria:

* contraindications to upper-GI endoscopy.
* contraindications to biopsy.
* active upper-GI bleeding or urgent upper-GI endoscopy.
* patients with previous upper-GI surgery involving the stomach.
* patients who were not able or refused to give informed written consent.

Primary outcomes:
measure: Miss rate reduction
timeFrame: 2025: 12 months enrollment
Secondary outcomes:
measure: Change number of Detections
timeFrame: 1 day procedure and follow up for 2 years
measure: patient satisfaction
timeFrame: 2025: during the 12 months enrollment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05208697: Tele-Harm Reduction
Official title: Tele-Harm Reduction for Rapid Initiation of Antiretrovirals in People Who Inject Drugs: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: IV Drug Usage
HIV Infections
Hepatitis C
Keywords: heroin
needle exchange
syringe services program
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test 2 different methods for offering medications that treat HIV, cure Hepatitis C Virus (HCV) (if applicable) and treat substance use disorder (if desired) to people who inject drugs.


Eligibility criteria: Inclusion Criteria:

* age 18 or older
* able to speak English
* enrolled in IDEA Miami or IDEA Tampa SSPs
* injection drug use in past 12 months by self-report
* willing and able to sign informed consent, provide locator information and medical records release
* testing reactive for HIV by rapid test
* HIV RNA\>200 copies/ml as determined by on-site labs or abstracted medical records (result within 3 months of randomization date)

Exclusion Criteria:

* testing HIV negative via rapid test
* receipt of THR intervention in the past 6 months
* inability to provide informed consent
* planning to leave the area within 12 months
* Principal or site investigator discretion
* currently in prison or jail
* Enrollment in Clinical Trials Network 121

Primary outcomes:
measure: Viral suppression
timeFrame: up to 12 months
Secondary outcomes:
measure: Initiation of medications for opioid use disorder
timeFrame: up to 12 months
measure: HCV cure
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Care Resource The SPOT
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of Miami
name: Hansel Tookes, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00813397: Manageability and Safety Assessment of Sepraspray in Abdominal Surgery.
Official title: Manageability and Safety Assessment of the SepraSpray Anti-adhesion Barrier in Abdominal Coelioscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesion Prevention
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-12-23
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the performance of SeprasSpray in patients undergoing abdominal surgery (laparoscopic).


Eligibility criteria: Inclusion Criteria:

* Patients 18 years old and over that require laparoscopic abdominal surgery

Exclusion Criteria:

* Patients who are pregnant or have an ongoing infectious complications from a previous surgery

Primary outcomes:
measure: Morbidity
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens Cedex 1
country: France
facility: CHU Amiens Nord
city: Bobingy
country: France
facility: Hopital Avicenne
city: Clichy
country: France
facility: Hopital Beaujon
city: Eaubonne Cedex
country: France
facility: Centre Hospitalier Simone Veil
city: Marseille cedex 20
country: France
facility: Hopital Nord
city: Nantes Cedex 1
country: France
facility: CHR Nantes-Hopital Hotel Dieu
city: Nice
country: France
facility: CHU Hopital de le'Archet
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Pessac Cedex
country: France
facility: CHU Bordeaux-Hopital du Haut Leveque
city: Pierre Benite
country: France
facility: CHU Lyon Sud
city: Poissy
country: France
facility: Centre Hospitalier Intercommunal de Poissy Saint-German
city: Rouen Cedex
country: France
facility: CHU Charles Nicolle
city: Talence Cedex 1
country: France
facility: CHU Bordeaux Saint Andre
city: Toulouse Cedex 9
country: France
facility: Hopital Purpan
city: Tours
country: France
facility: CHU Hopital Trousseau
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Berdah SV, Mariette C, Denet C, Panis Y, Laurent C, Cotte E, Huten N, Le Peillet Feuillet E, Duron JJ. A multicentre, randomised, controlled trial to assess the safety, ease of use, and reliability of hyaluronic acid/carboxymethylcellulose powder adhesion barrier versus no barrier in colorectal laparoscopic surgery. Trials. 2014 Oct 27;15:413. doi: 10.1186/1745-6215-15-413.
Clinical trial NCT00917397: The Outcome of Treatment of Traumatised Refugees With Psychotherapy and/or Antidepressants
Official title: The Outcome of Treatment of Traumatised Refugees With Trauma-Focused Cognitive Behavioural Therapy and / or Antidepressants - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-Traumatic Stress Disorder
Keywords: Traumatized refugee
treatment
antidepressants
psychotherapy
PTSD in traumatized refugees
Lead sponsor: Psykiatrisk Center Gentofte
Sponsor class: OTHER
First posted: 2009-06-10
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the effect of treatment of traumatized refugees with a diagnosis of Post-Traumatic Stress Disorder (PTSD). The existing evidence point towards antidepressants of the type SSRI and trauma-focused cognitive Behavioural Therapy being the most effective treatments of PTSD, but very little evidence of treatment effects exist for the group of multitraumatized refugees. This study therefore seeks to investigate the treatment effect of 6 months drug therapy with antidepressants (Sertraline and/ or Mianserine) and/or trauma-focused cognitive behavioral therapy. A total of 200 individual will undergo treatment. They will be randomized to 4 different groups: antidepressants, psychotherapy, a combination og drug and psychotherapy and a waiting list. Outcome measures include symptoms, life quality and function. Patients with a diagnosis of drug abuse or psychosis will not be included. The hypothesis is that a combination of antidepressants and psychotherapy will be more effective than either of the two treatment regimes on their own.


Eligibility criteria: Inclusion Criteria:

* Adult traumatised refugee with PTSD

Exclusion Criteria:

* psychosis and drug abuse

Primary outcomes:
measure: Score on Harvard Traume Questionnaire (PTSD)
timeFrame: before entry, after 6 months treatment and at follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Psykiatrisk Center Gentofte
Study officials:
References:
citation: Buhmann CB, Nordentoft M, Ekstroem M, Carlsson J, Mortensen EL. Long-term treatment effect of trauma-affected refugees with flexible cognitive behavioural therapy and antidepressants. Psychiatry Res. 2018 Jun;264:217-223. doi: 10.1016/j.psychres.2018.03.069. Epub 2018 Apr 4.
citation: Buhmann CB, Nordentoft M, Ekstroem M, Carlsson J, Mortensen EL. The effect of flexible cognitive-behavioural therapy and medical treatment, including antidepressants on post-traumatic stress disorder and depression in traumatised refugees: pragmatic randomised controlled clinical trial. Br J Psychiatry. 2016 Mar;208(3):252-9. doi: 10.1192/bjp.bp.114.150961. Epub 2015 Nov 5.
Clinical trial NCT01958697: Age and Gender Corrected Body Mass Index
Official title: Age and Gender Corrected Body Mass Index: When Preoperative Weight Loss and Underweight Are Becomming Clinically Significant in Esophagectomy for Cancer.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Cancer
Keywords: Nutritional Disorders
Feeding Behavior
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Esophageal cancer patients recieving an esophagectomy

Brief summary: Esophagectomy for cancer is often accompanied with severe preoperative weight loss. Body Mass Index (BMI) values are age-independent and the same for both sexes. From the perspective that these two parameters should actually be taken into account too, we developed a model to calculate "age-gender specific BMI-percentiles" (AG-BMI) and tested this model in relation to survival outcome after esophagectomy for cancer.

Detailed description: Age-Gender specific BMI percentiles are more accurate compared to the current BMI classes in predicting Overall Survival (OS) after esophagectomy for cancer. Furthermore we believe in a more devastating impact on OS from underweight and not from overweight.

By preoperatively identifying risk patients for poorer OS, especially the non-tumoral deaths, this can be a tool to tailor postoperative nutritional strategies to counter further weight loss and bringing postoperative weight to normal ranges.

Eligibility criteria: Inclusion Criteria:

* any type of esophagectomy

Exclusion Criteria:

* Preoperative organ metastasis (cM+ or yM+)
* esophageal bypass surgery

Primary outcomes:
measure: Overall 5 year survival
timeFrame: 5 years after esophagectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Univresity Hospital Leuven - dept. Thoracic Surgery
Study officials:
References:
Clinical trial NCT00459797: Comparison of Conventional GlideScope to Single-Use GlideScope Cobalt for Orotracheal Intubation
Official title: Comparison of Conventional GlideScope to Single-Use GlideScope Cobalt for Orotracheal Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: GlideScope
cobalt
single-use
intubation
airway
Elective surgical patients requiring orotracheal intubation
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2007-04-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients presenting for elective surgery requiring orotracheal intubation will be randomized to being intubated with either the conventional (reusable) GlideScope videolaryngoscope or the single-use GlideScope videolaryngoscope. The primary outcome is time to intubation.


Eligibility criteria: Inclusion Criteria:

* Any patient who is ≥ 18 yrs. coming for elective surgery.
* Endotracheal tube is indicated for the procedure in the opinion of the attending anesthesiologist.
* Any operator who has performed ≥ 10 GlideScope intubations.

Exclusion Criteria:

* Any patient in whom the use of the GlideScope is contraindicated in the opinion of the attending anesthesiologist.
* Any patient with cervical spine abnormalities.
* Any patients with known or probable difficult airways (this rare occurrence is unlikely to be evenly distributed between the groups and could skew the data).
* Any patient requiring rapid sequence induction.

Primary outcomes:
measure: Time to intubation (seconds)
timeFrame: Immediate
Secondary outcomes:
measure: Ease of intubation
timeFrame: after intubation
measure: Number of intubation attempts per group
timeFrame: after intubation
measure: Incidence of trauma in each group
timeFrame: after intubation
measure: Number of failures to intubate per group
timeFrame: after intubation
measure: Use of external laryngeal pressure per group
timeFrame: after intubation
measure: Laryngoscopic grade distribution in each group
timeFrame: after intubation
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Philip M Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones PM, Turkstra TP, Armstrong KP, Armstrong PM, Harle CC. Comparison of a single-use GlideScope Cobalt videolaryngoscope with a conventional GlideScope for orotracheal intubation. Can J Anaesth. 2010 Jan;57(1):18-23. doi: 10.1007/s12630-009-9204-9. Epub 2009 Oct 31.
Clinical trial NCT05447897: Designing an Implementation Strategy for Lung Screening and Smoking Cessation Treatment in Community Health Centers
Official title: A Systematic Approach to Designing an Implementation Strategy to Increase Lung Cancer Screening and Smoking Cessation Treatment Among Federally Qualified Community Health Center Patients Who Smoke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-07-07
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Tobacco use is the leading preventable cause of death in the US and a major driver of health disparities. Among our tools for reducing the harms of tobacco is lung cancer screening (LCS). This study will combine a review of existing qualitative and quantitative data on barriers to lung cancer screening and smoking cessation in underserved populations, a quantitative analysis of predictors of lung cancer screening and smoking cessation treatment use among Massachusetts Federally Qualified Health Centers (FQHC)s, and a stakeholder advisory group to synthesize these data and select implementation strategies that reflects the critical determinants and the strengths and resource constraints of the Federally Qualified Health Centers (FQHC) context.

Detailed description: Aim 1) To design an implementation strategy that targets critical components in the delivery of SCT or LCS services for patients who smoke.

Aim 2) To assess the acceptability, appropriateness and feasibility of the implementation strategy among community health center staff.

Eligibility criteria: Inclusion Criteria:

FQHC implementation team including staff in the intervention FQHCs and their lung screening partners

Exclusion Criteria:

FQHC staff or partners who leave the organization before end of study

Primary outcomes:
measure: Feasibility of Intervention Measure
timeFrame: End of study, up to 16 weeks
Secondary outcomes:
measure: Acceptability of Intervention Measure
timeFrame: End of study, up to 16 weeks
measure: Intervention Appropriateness Measure
timeFrame: End of study, up to 16 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massacusetts General Hospital
state: Massachusetts
Study officials:
affiliation: University of Colorado, Denver
name: Gina Kruse, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: