louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06217380: Feasibility and Acceptability of Oxygen Saturation Monitoring Using Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program
Official title: Feasibility and Acceptability of Oxygen Saturation Monitoring Using Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Opioid Use
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2024-01-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This Clinical Trial will evaluate the Feasibility and Acceptability of Oxygen Saturation Monitoring using Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program


Eligibility criteria: Inclusion Criteria for Client Participants:

* Participants who are18 years of age or greater
* Participants housed within a supportive housing program who intend to inject opioids
* Participants who have given verbal informed consent to participate in the study

Inclusion Criteria for Staff Participants:

* Participant is research staff and/or Rita Thompson Residence staff
* Participant is willing to give implied consent by reading and completing the staff survey

Exclusion Criteria for Client Participants:

* Participants deemed not suitable for the study at the discretion of the principal investigator, research staff or housing program nurses/staff
* Participants with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as psoriasis, eczema, angioma, burns, scar tissue, substantial skin breakdown, nail polish, acrylic nails, infections, or other abnormalities that may interfere with MSNA functioning
* Participants with known allergic reactions to foam/rubber products and/or adhesive tape

Exclusion Criteria for Staff Participants:

-None

Primary outcomes:
measure: Evaluation of feasibility of Masimo SafetyNet Alert (MSNA) in a supportive housing program
timeFrame: 2-4 weeks
measure: Evaluation of feasibility of Masimo SafetyNet Alert (MSNA) in a supportive housing program
timeFrame: 2-4 weeks
measure: Evaluation of feasibility of Masimo SafetyNet Alert (MSNA) in a supportive housing program
timeFrame: 2-4 weeks
measure: Evaluation of acceptability of Masimo SafetyNet Alert (MSNA) in a supportive housing program
timeFrame: 2-4 weeks
measure: Evaluation of acceptability of Masimo SafetyNet Alert (MSNA) in a supportive housing program
timeFrame: 2-4 weeks
measure: Evaluation of acceptability of Masimo SafetyNet Alert (MSNA) in a supportive housing program
timeFrame: 2-4 weeks
measure: Evaluation of integration and expansion of Masimo SafetyNet Alert (MSNA) to similar housing environments
timeFrame: 2-4 weeks
measure: Evaluation of integration and expansion of Masimo SafetyNet Alert (MSNA) to similar housing environments
timeFrame: 2-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vanier
country: Canada
facility: Research Site
Study officials:
References:
Clinical trial NCT03540680: p16Ink4a in Bronchopulmonary Dysplasia in Children
Official title: Case-control Study Evaluating the Impact of p16Ink4a in Bronchopulmonary Dysplasia in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchopulmonary Dysplasia
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 80
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The bronchopulmonary dysplasia (BPD) is a respiratory disease of the premature child which lead to a reduction of gas exchange surface and to a prolonged respiratory failure. This disease has morphologic and functional consequences at adulthood and is today considered to be an early determinant of respiratory diseases at adulthood.

The physiopathology of BPD is not well known. Several mechanisms could be involved especially a reparation failure favored by an increase of cellular senescence which is a permanent stop of cellular proliferation. The transcription factor 16 Ink4a, considered as a marker of aging, is one of the essential markers of senescence. Its increase during prematurity was shown at the blood cells of the cordon, but its involvement in BPD and its evolution in child are not yet studied.


Eligibility criteria: Inclusion Criteria:

Premature(\< 28 GA) neonates

* Alive neonate born at less than 28 gestational age
* Signed inform consent

Term neonates:

* Alive neonate born at least at 37 GA or more
* Signed inform consent

Child from 7 to 15 years old with BPD:

* Child from 7 to 15 years old
* Child with a BPD diagnosed
* Signed inform consent

Child from 7 to 15 years old without BPD:

* Child from 7 to 15 years old
* Child receiving a blood test
* Signed inform consent

Exclusion Criteria:

Premature (\< 28 GA) and term neonates:

-Congenital malformation

Child from 7 to 15 years old with BPD:

* Cystic fibrosis
* Evolutive cancer
* Chronic inflammatory disease
* Known anemia
* Refusal of participation of child or parental authority

Child from 7 to 15 years old without BPD:

* Other respiratory disease: severe asthma, cystic fibrosis, deficit AAT, bronchial dilatation
* Evolutive cancer
* Chronic inflammatory disease
* Known anemia
* Refusal of participation of child or parental authority

Primary outcomes:
measure: p16 expression
timeFrame: Day 1
Secondary outcomes:
measure: Telomeres length
timeFrame: Day 1
measure: Genetic expression of p21, p53, H2Ax
timeFrame: Day 1
Other outcomes:
Locations:
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
Study officials:
affiliation: CHI Créteil
name: Ralph EPAUD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06932952: A Dose Escalation and Expansion Trial With BYON4228 Alone and in Combination in Patients With Advanced or Metastatic Solid Tumors
Official title: A Dose Escalation and Expansion Trial With the SIRPα-directed Monoclonal Antibody BYON4228 Alone and in Combination to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy in Patients With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Keywords: mAB
Monoclonal antibody
SIRPα
CD47
SIRP
Lead sponsor: Byondis B.V.
Sponsor class: INDUSTRY
First posted: 2025-04-17
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a phase I trial with BYON4228, a humanized monoclonal antibody (mAb) directed against signal regulatory protein (SIRP)α in solid tumors, alone and in combination with pembrolizumab.

Detailed description: This study includes a dose escalation part (Part 1) in which the MTD or OBD and RDE(s) will be determined. This trial includes an expansion part (Part 2) to evaluate efficacy and safety of BYON4228 in combination with pembrolizumab in specific patient cohorts.

BYON4228 is a humanized IgG1 mAb directed against SIRPα. BYON4228 binds SIRPα expressed on innate immune cells, especially monocytes, macrophages and neutrophils. BYON4228 blocks binding of SIRPα to CD47 and inhibits signaling through the CD47-SIRPα axis.

Eligibility criteria: Inclusion Criteria:

* Patient with histologically confirmed, locally advanced or metastatic cancer who has progressed on standard therapy or for whom no standard therapy exists:

  * Part 1 (dose escalation): Solid tumors of any origin;
  * Part 2 (expansion): Patients with other solid tumor types indicated for pembrolizumab monotherapy;
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
* For Part 2 only: at least one measurable cancer lesion as defined by the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1);
* Adequate baseline organ function.

Exclusion Criteria:

* Having been treated with CD47 or SIRPα targeting agents or other anticancer therapy within 4 weeks prior to the start of IMP treatment;
* History of hypersensitivity or allergic reaction to any of the excipients of BYON4228;
* Any contraindication to pembrolizumab treatment;
* For Part 2: Patients previously given a PD-1 or PD-L1 inhibitor who had subsequent disease progression within 8 weeks of initiation;
* Symptomatic brain metastases;
* History of autoimmune disorders;
* Severe active infection or other severe uncontrolled systemic disease;
* Having clinically significant cardiovascular disease;
* Known infection of Hepatitis B, C or E.

Key inclusion and exclusion criteria details are listed here, additional requirements may apply.

Primary outcomes:
measure: Incidence of Dose-Limiting Toxicities
timeFrame: 21 days
measure: Objective Response Rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04927832: Detection of Small Fiber Neuropathies by the Non-invasive SUDOSCAN Method During Chronic Autoimmune Pathologies and / or Unexplained Pain Syndromes
Official title: Detection of Small Fiber Neuropathies by the Non-invasive SUDOSCAN Method During Chronic Autoimmune Pathologies and / or Unexplained Pain Syndromes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Autoimmune Pathologies
Unexplained Pain Syndrome
Lead sponsor: Hôpital Européen Marseille
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Very few studies have evaluated the prevalence of small fiber neuropathy (SFN) during pathologies that may be responsible for small fibers damage.

SUDOSCAN is a new rapid (2 minutes), automated, reproducible and non-invasive technology to assess small fiber neuropathy by sweat function.

With quantitative and reproducible results, SUDOSCAN allows physicians to early detect and follow-up peripheral neuropathy to monitor disease progression and assess treatment efficacy for a better patient management.

SUDOSCAN® could allow the identification of SFN in painful patients apart from another pathology already diagnosed responsible for SFN.

The purpose of the study SUDOCU is to assess the prevalence of small fiber neuropathies (SFN) in patients with systemic autoimmune pathologies or unexplained pain syndrome.


Eligibility criteria: Inclusion Criteria:

* Patient corresponding to one of the two following groups:

  1. Systemic autoimmune pathology known to be complicated by small fiber neuropathies.

     The following autoimmune pathologies will be included: Lupus, Sjogren, Scleroderma, Myositis, rheumatoid arthritis, Sarcoidosis, Vasculitis of small or medium vessels
  2. No conditions known to be responsible at SFN, unexplained pain symptoms
* Aged ≥ 18 years
* Having given free and informed written consent

Exclusion Criteria:

* Chronic alcoholism
* Unbalanced diabetes
* Chemotherapies
* HIV
* Vitamins B12, B1, B6 deficiencies

Primary outcomes:
measure: Percentage of patients presenting diagnosis of small fiber neuropathy in chronic pathologies and / or unexplained pain syndrome
timeFrame: 53 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: BENNANI
Study officials:
References:
Clinical trial NCT01540032: Low Salicylate Diet in Aspirin Exacerbated Respiratory Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aspirin Exacerbated Respiratory Disease
Samter's Triad
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2012-02-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a low salicylate diet will improve the quality of life of patients with Aspirin Exacerbated Respiratory Disease (AERD).

Detailed description: Aspirin-exacerbated respiratory disease (AERD) is clinically diagnosed in patients who suffer from allergy to aspirin, asthma, nasal polyps, and chronic sinusitis. Patients with AERD are often resistant to medical management of nasal polyps, and require multiple endoscopic sinus surgeries to manage recurrences of nasal polyps. Control of AERD can be obtained through aspirin desensitization, which consists of taking aspirin every day. However, there are substantial risks and adverse side effects to taking moderate amounts of aspirin daily. Furthermore, patients experience progressively worsening nasal and respiratory disease even with complete avoidance of aspirin and other NSAIDs.

The active and major component in aspirin/NSAIDs is salicylate, which is also found naturally in some foods. Diet modification is a cost-effective intervention that has the potential to provide long-term remission of AERD. Our study will evaluate whether a low salicylate diet, which is a more cost effective and benign intervention with minimal risks, will improve nasal, sinus or respiratory symptoms, such as congestion, sinusitis, smell, or asthma.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of AERD

Exclusion Criteria:

* Recent use of Prednisone or other systemic steroid (greater than three (3) doses in past three (3) months). This does not include the use of nasal steroids.
* Endoscopic sinus surgery / polypectomy within the past six (6) months
* Other significant systemic disease or immunocompromised state

Primary outcomes:
measure: Change in SNOT-22 scores from Baseline
timeFrame: 6 weeks and 12 weeks
Secondary outcomes:
measure: Change in Lund-Kennedy Endoscopic Score from Baseline
timeFrame: 6 weeks and 12 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT02138032: Effects of Message Content on Intention to Quit Smoking
Official title: Effects of Message Content on Intention to Quit Smoking in Smokers With Peripheral Artery Disease - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: message framing
smoking cessation
peripheral artery disease
Lead sponsor: University of Stirling
Sponsor class: OTHER
Collaborators: name: NHS Forth Valley
First posted: 2014-05-14
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Message framing involves "the presentation of choice alternatives, either in a positive or negative manner" (Huber, Neale, \& Northcraft, 1987; p.137). Positively framed health messages contain potential gains of participating/refraining in specific health behaviour. Alternatively, negatively framed health messages contain potential losses of participating/refraining in specific health behaviour (Verlhiac, Chappe, \& Meyer, 2011). The primary aim and rationale of this study will be to investigate which type of framing has the greatest effect on intentions to quit smoking in patients with vascular arterial disease. The secondary aim is to investigate what other factors may have an effect on intention to quit and also what factors play a part in a patient's intention to quit smoking.


Eligibility criteria: Inclusion Criteria:

* Peripheral Artery Disease
* daily smoker

Exclusion Criteria:

* psychiatric illness or those who are not literate in English will be excluded from the study as informed consent cannot be obtained. Also, patients who are already participating in any other research involving smoking cessation will be excluded

Primary outcomes:
measure: Intention to quit smoking
timeFrame: up to 3 weeks
Secondary outcomes:
measure: Stage of Change - smoking cessation
timeFrame: baseline and 3 weeks
measure: Nicotine Dependence
timeFrame: Baseline and 3 weeks
measure: Outcome expectancy beliefs
timeFrame: Baseline and 3 weeks
measure: Self efficacy
timeFrame: Baseline and 3 weeks
measure: Risk Perception
timeFrame: baseline and 3 weeks
measure: Health locus of control
timeFrame: baseline and 3 weeks
Other outcomes:
Locations:
city: Larbert
country: United Kingdom
facility: Forth Valley Royal Hospital
state: Falkirk
Study officials:
References:
Clinical trial NCT00002332: A Study of Timunox (Thymopentin) in HIV-Infected Patients Receiving Other Anti-HIV Drugs
Official title: Double-Blind Study of the Effect of Timunox (Thymopentin) on Lymphoproliferative Responses and Virus Load in HIV-Infected Subjects Receiving Nucleoside Analog Antiretroviral Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Thymopentin
AIDS-Related Complex
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the mechanism whereby thymopentin appears to retard the progressive immune suppression attributable to HIV infection.

Detailed description: Patients are randomized to receive subcutaneous thymopentin or placebo thrice weekly for 4 weeks.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Asymptomatic or minimally symptomatic HIV infection (no evidence of AIDS).
* CD4 count \<= 400 cells/mm3 within 6 weeks prior to study entry (CD4 count changed to 100 - 400 cells/mm3 per amendment).
* Tolerated the current nucleoside analog antiretroviral treatment for at least 4 weeks prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Known hypersensitivity to thymopentin or any component of the formulation.
* Significant chronic underlying medical illness that would impede study participation.
* Grade 2 or higher peripheral neuropathy related to nucleoside analog antiretroviral treatment.

Concurrent Medication:

Excluded:

* Any antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine.
* HIV vaccines or any investigational or non-FDA approved medication or immunomodulatory or experimental therapy within 30 days prior to study entry.

Patients with the following prior condition are excluded:

Abnormal chest x-ray consistent with active opportunistic infection within 6 weeks prior to study entry.

Prior Medication:

Excluded:

* Any prior antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine within 30 days prior to study entry.

Required:

* Current nucleoside analog antiretroviral treatment.

Required:

* Nucleoside analog antiretroviral treatment for at least 4 weeks prior to study entry.

Significant active alcohol or drug abuse sufficient to prevent study compliance.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Dr Marcus Conant
state: California
city: Tarzana
country: United States
facility: Dr Jeffrey Galpin
state: California
city: Pittsburgh
country: United States
facility: Novum Inc
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04138732: Health Behaviors of Medical Personnel in Hospital Maternity Ward
Official title: Health Behaviors of Medical Personnel in Hospital Maternity Ward- Community Based Participatory Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Behavior
Keywords: Community
Health
Hospital
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to characterize the existing health behaviors and obstacles to healthy lifestyle among the medical staff in a maternity ward in order to develop a specifically-tailored intervention to help improve the health behaviors of hospital shift workers.The findings will be used to establish a community-based participatory health-promoting program in the ward, engaging the staff in its development and implementation.

Detailed description: The purpose of this study is to characterize the existing health behaviors and obstacles to healthy lifestyle among the medical staff in a maternity ward in order to develop a specifically-tailored intervention to help improve the health behaviors of hospital shift workers. Shift-work has been associated with unhealthy lifestyles and increased risk of digestive disorders, heart conditions, various kinds of cancer, reproductive dysfunction, and mental conditions. Thus, the findings will be used to establish a community-based participatory health-promoting program in the ward, engaging the staff in its development and implementation. Community Based Participatory (CBP) approach will be used to build an evaluation and intervention. Baseline/needs assessment will be performed by mixed methods approach, combining in depth interviews with key personnel, focus groups and questionnaires that ask about demographics, physical activity and nutrition behaviors, stress, burnout, BMI, and cardiac risk factors.

Eligibility criteria: Inclusion Criteria:

* Doctors, nurses, secretaries, and assistants

Exclusion Criteria:

* None

Primary outcomes:
measure: Cardiac risk factors
timeFrame: at the end of the 1 year treatment
Secondary outcomes:
measure: BMI
timeFrame: at the end of 1 year of treatment
measure: Burnout
timeFrame: at the end of the 1 year treatment,
measure: Nutrition behaviors
timeFrame: at the end of the 1 year treatment
measure: Physical activity minutes per week
timeFrame: at the end of the 1 year treatment
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Donna Zwas, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: