louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06465680: Intern Health Study 2024
Official title: Intern Health Study: 2024 Cohort Micro-Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Mood
Sleep
Physical Activity
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to evaluate the efficacy of an intervention (delivered through a smartphone) for improving the mood, physical activity, and sleep of medical interns.

Detailed description: Due to their high stress workloads, medical interns suffer from depression at higher rates than the general population. Interns also tend to have lower sleep and decreased physical activity. The goal of this trial is to evaluate the efficacy of a mobile health intervention intending to help improve the mental health of medical interns. The intervention sends mobile phone notifications which aim to help interns improve their mood, maintain physical activity, and obtain adequate sleep during their internship year.

The primary aim of the study is to evaluate how notifications affect participants' weekly mood, as measured through a daily one question mood survey. The second primary aim of the study is to evaluate how notifications affect participants' long-term mental health, as measured by the Patient Health Questionnaire. The first secondary aim is to evaluate how mood notifications affect participants' weekly mood. The second secondary aim is to evaluate how activity notifications affect participants' weekly step count. The third secondary aim is to evaluate how sleep notifications affect participants' weekly sleep duration. In order to better optimize notification delivery, the final aim (exploratory) is to understand moderators of these effects. Moderators of interest are previous week's mood, previous week's step count, previous week's sleep duration, study week, sex, previous history of depression, and baseline neuroticism.

Eligibility criteria: Inclusion Criteria:

* Medical intern during the 2024-2025 internship year
* iPhone or Android phone user
* Logged into the Intern Health Study mobile app, completed consent, and filled out baseline survey by June 30 prior to the start of intern year

Exclusion Criteria:

* None

Primary outcomes:
measure: Average daily mood
timeFrame: Daily, through study completion at the end of intern year (1 year)
measure: Average daily step count
timeFrame: Daily, through study completion at the end of intern year (1 year)
measure: Average nightly sleep duration
timeFrame: Daily, through study completion at the end of intern year (1 year)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Quarterly (every 3 months for 1 year)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT01710280: Palmitic Acid in the Sn-2 Position of Triacylglycerols and Postprandial Lipemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Men
Raised Fasting Plasma Triacylglycerol Concentrations
Keywords: Lipemia
Vascular function
Blood pressure
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2012-10-19
Enrollment: 11
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether high-fat meals rich in palmitic acid in the sn-2 position decrease lipaemia in men aged 40-70 y with higher than optimal fasting triacylglycerol concentrations.


Eligibility criteria: Inclusion Criteria:

* Healthy males
* Non-smokers
* Aged 40-70 years
* Fasting TAG concentrations ≥1.5 mmol/L.

Exclusion Criteria:

* Reported history of CVD (myocardial infarction, angina, venous thrombosis, stroke), impaired fasting glucose/uncontrolled type 2 diabetes (or fasting glucose ≥ 6.1 mmol/L), cancer, kidney, liver or bowel disease.
* Presence of gastrointestinal disorder or use of drug, which is likely to alter gastrointestinal motility or nutrient absorption.
* History of substance abuse or alcoholism (previous weekly alcohol intake \>60 units/men)
* Current self-reported weekly alcohol intake exceeding 28 units
* Allergy or intolerance to any component of test meals
* Unwilling to restrict consumption of any source of fish oil for the length of the study
* Weight change of \>3kg in preceding 2 months
* Body Mass Index \<20 and \>35 kg/m2
* Fasting blood cholesterol \> 7.8 mmol/L
* Current cigarette smoker.
* Current use of lipid lowering medication

Primary outcomes:
measure: Incremental AUC (change from baseline in overall response) for plasma triacylglycerol concentrations
timeFrame: 1-6 h post-meal
Secondary outcomes:
measure: Incremental AUC for plasma non-esterified fatty acid concentrations
timeFrame: 1-6 h post-meal
measure: Changes from baseline in digital volume pulse
timeFrame: 2,4,5,6 h post-meal
measure: Changes from baseline in blood pressure
timeFrame: 2,4,5,6 h post-meal
Other outcomes:
measure: Incremental AUC for plasma total cholesterol concentrations
timeFrame: 1-6 h post-meal
Locations:
city: London
country: United Kingdom
facility: Diabetes & Nutritional Sciences Division, King's College London.
Study officials:
References:
citation: Sanders TA, Filippou A, Berry SE, Baumgartner S, Mensink RP. Palmitic acid in the sn-2 position of triacylglycerols acutely influences postprandial lipid metabolism. Am J Clin Nutr. 2011 Dec;94(6):1433-41. doi: 10.3945/ajcn.111.017459. Epub 2011 Oct 26.
Clinical trial NCT03752580: An Investigation to Test a Prototype Nasal Mask in the Home Setting
Official title: An Investigation to Test a Prototype Nasal Mask in the Home Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disordered Breathing
Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2018-11-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is to test the interpretation of user instructions of a prototype nasal mask on participants. The clinical investigation will be conducted in New Zealand and participants will interact with the user instructions in a one hour daytime visit. A minimum of 15 participants will participate in this trial.

Detailed description: This investigation is to test the interpretation of user instructions of a prototype nasal mask on participants. The clinical investigation will be conducted in New Zealand and participants will interact with the user instructions in a one hour daytime visit. This investigation is designed to evaluate the interpretation by participants of the user instructions. A total number of 20 participants, diagnosed with OSA will be recruited for the trial. The participants will be recruited from the Fisher and Paykel Healthcare Database of subjects (Ethics reference 18/NTA/62).

Fisher and Paykel Healthcare will act as the investigator and sponsor for this investigation. This study will be conducted in accordance with ICH/GCP Guidelines. No deviation from protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. In such case, the deviation will be reported to the sponsor (Bhavi Ogra) as soon as possible.

Eligibility criteria: Inclusion Criteria:

* OSA Mask Users
* 18+ years of age
* Ability to give informed consent

Exclusion Criteria:

* Inability to give informed consent

Primary outcomes:
measure: Mask User Instructions Interpretation
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Fisher & Paykel Healthcare
Study officials:
References:
Clinical trial NCT06221280: Effects of Nerve Blocks on Pain After Caesarean Section and Postpartum Depression
Official title: Effects of Transversus Abdominis and Erector Spina Plane Blocks on Post-Cesarean Pain Control and Postpartum Depression
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Postoperative Pain
Cesarean Section
Postpartum Depression
Keywords: Nerve block, cesarean, postpartum depression
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: At the end of your cesarean section surgery, which is started by applying medication to the spinal cavity from your waist, pain medication will be applied between the relevant muscle and its covering from your lower abdomen or back with the help of ultrasonography and a special block needle. Then, a patient-controlled pain device with a serum containing painkillers will be connected to your vascular access, and its use and purpose will be explained to you. You will be asked about your pain condition and the severity score of your pain, if any, at certain hourly intervals. At the end of 24 hours, a pain device will be removed, your satisfaction will be questioned and your complaints, if any, will be recorded. Immediately before surgery and 4-6 days after your surgery. An evaluation survey consisting of 10 questions will be asked to you within a 5-minute period during the weeks, at a time when you are free, and your answers will be recorded.


Eligibility criteria: Inclusion Criteria:

1. Having a good mental status,
2. Those aged ≥18 years,
3. Term pregnant (gestational age ≥ 36 weeks),
4. American Society of Anesthesiologists class II-III,
5. Patients who underwent cesarean section with spinal anesthesia will be included.

Exclusion Criteria:

1. Having labor at term or obstetric emergency,
2. Having a twin pregnancy,
3. Having a diagnosed psychiatric disorder/using psychiatric medication,
4. Those who are allergic to local anesthetics and/or drugs used in the study,
5. The patient-controlled anesthesia device is out of use for any reason within the first 24 hours postoperatively,
6. Having peripheral neuropathy or neuromuscular disease,
7. Patients using anticoagulant drugs that will prevent regional anesthesia will be excluded from the study.

Primary outcomes:
measure: Pain (VAS score)
timeFrame: 12 months
Secondary outcomes:
measure: Postpartum depression (Edinnburg Depression Scale)
timeFrame: 12 months
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: KahramanmarasSIU
Study officials:
References:
Clinical trial NCT00874380: Fiber Intake in an End Stage Renal Disease (ESRD) Population Followed Over 2 Years
Official title: Fiber Content of Hemodialysis Patients' Diet and it's Cardiovascular Implications.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Outcome
Kalemia Control
Lipid Profile
Keywords: Fiber
Dialysis
Renal Replacement Therapy
Food Frequency Questionnaire
FFQ
Dietary counseling
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Staten Island University Hospital
First posted: 2009-04-02
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ESRD

Brief summary: Our research involves the detailed description of the content of the diet of x dialysis patients.

For our purpose we used a newly developed "food frequency questionnaire". This is the first validated questionnaire specific for dialysis patients and we were the first to use it.

Our special focus was the fiber content in the diet of our patient. Our thesis that they are way below the recommended guidelines for fiber intake was verified. Our follow will evaluate the effect of such at diet, mosTLy cardiovascular.


Eligibility criteria: Inclusion Criteria:

* Patients with end stage renal disease on hemodialysis
* Patients who are able to give informed consent

Exclusion Criteria:

* Pregnant women.
* Cognitively impaired patients
* PEG feeding

Primary outcomes:
measure: cardiovascular event
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
References:
Clinical trial NCT06243380: B-lactam Databank Algorithm
Official title: Computational Decision Support For Penicillin Allergy Risk Stratification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Beta Lactam Adverse Reaction
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2024-02-06
Enrollment: 921
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and minors with a suspected allergy to beta-lactam antibiotics.

Brief summary: Background:

Antibiotic allergy constitutes a major health problem with serious medical and financial consequences when under- but also overdiagnosed.

About one and a half million Belgians report having an allergy to penicillin. However, in 1.35 million (90%) of these "penicillin allergies", the suspicion is wrong. The issue of false penicillin allergy is therefore seen as an important medical problem with significant implications for the individual patient but also for society.

Today, therefore, there is a global consensus to contain the pandemic of false penicillin allergy as much as possible. This should ultimately lead to correct antibiotic policies for the patient and reduce antibiotic resistance and the cost to society.

The problem with this is that there is no diagnostic test that one can perform on a population of one and a half million people. This is practically and financially unfeasible. So there is a need for proper risk stratification based on anamnestic data to better guide our diagnostics.

Specific question:

The investigators currently have a database of about 1000 patients with a possible hypersensitivity to antibiotics who have been fully diagnosed according to current guidelines. The aim of the study is to use this database to see whether a tool can be developed to reliably perform an initial "screening" to determine in whom further testing is necessary and in whom, based purely on the story, it can be decided that the likelihood of penicillin allergy is extremely low and additional diagnostics are unnecessary.


Eligibility criteria: Inclusion Criteria:

* Adults and minors with a suspected allergy to beta-lactam antibiotics

Exclusion Criteria:

-

Primary outcomes:
measure: A screening tool for the likelihood of penicillin allergy in patients with a selfreported penicillin allergy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
References:
Clinical trial NCT06827080: Study on the Safety, Tolerability, and Preliminary Efficacy of 161Tb-NYM032 in Patients with Metastatic Castration-Resistant Prostate Cancer
Official title: Study on the Safety, Tolerability, and Preliminary Efficacy of 161Tb-NYM032 in Patients with Metastatic Castration-Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Metastatic Castration-resistant Prostate Cancer, MCRPC
Cancer
Lead sponsor: Mianyang Central Hospital
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 161Tb-NYM032 is a radiopharmaceutical labeled with a PSMA ligand, used for the treatment of metastatic castration-resistant prostate cancer, which is needed for clinical trial to be conducted.


Eligibility criteria: \*\*1. Inclusion Criteria\*\*

1. The participant voluntarily signs the informed consent form and is able to complete the trial according to the protocol requirements.
2. Male, aged 18 years or older.
3. Diagnosed with metastatic castration-resistant prostate cancer (mCRPC) as per PCWG3 criteria.
4. Positive results on 68Ga-NYM032 positron emission tomography (PET)/computed tomography (CT) scan.
5. Must have received at least one NAAD treatment (e.g., enzalutamide and/or abiraterone) or at least one taxane-based treatment regimen, or be intolerant to or refuse taxane therapy for metastatic castration-resistant prostate cancer.
6. ECOG performance status of 0-2.
7. Expected survival of ≥6 months.
8. Laboratory parameters must meet the following:

   1. ALT and AST must not exceed 3 times the upper limit of normal (ULN); BUN and Cr must not exceed 1.5 times the ULN.
   2. Blood counts: WBC ≥3.5×10\^9/L, PLT ≥100×10\^9/L, Hb ≥90 g/L.

Primary outcomes:
measure: PSA
timeFrame: 5-6 weeks after each administration.
measure: 68Ga-NYM032 PET/CT
timeFrame: **5-6 weeks after the second and fourth administrations in the same dose-escalation cohort.**
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00437580: Impact of Probiotic Regimen on Vancomycin Resistant Enterococcus Intestinal Carriage
Official title: Impact of Probiotic Regimen on Vancomycin Resistant Enterococcus (VRE) Intestinal Carriage : a Double Blind Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vancomycin Resistant Enterococcus Intestinal Carriage
Keywords: Vancomycin Resistant Enterococcus, probiotic
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2007-02-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study aims to reduce the duration of VRE intestinal carriage by the administration of Lactobacillus casei rhamnosus (strain Lcr 35 LC). Patients will be blindly randomized to be assigned to a 5 weeks regimen with the probiotic (10 9 lactobacillus bid) or to a 5 weeks regimen with placebo.A stool culture will be performed every week for 5 weeks (during the administration of treatment) then every two weeks until 3 consecutive negative stool culture for VRE.

Detailed description: This study aims to reduce the duration of VRE intestinal carriage by the administration of Lactobacillus casei rhamnosus (strain Lcr 35 LC). Patients will be blindly randomized to be assigned to a 5 weeks regimen with the probiotic (10 9 lactobacillus bid) or to a 5 weeks regimen with placebo.A stool culture will be performed every week for 5 weeks (during the administration of treatment) then every two weeks until 3 consecutive negative stool culture for VRE.

Eligibility criteria: Inclusion Criteria:

* Age \>18;
* Vancomycin Resistant Enterococcus intestinal carriage

Exclusion Criteria:

* Neutropenia \<1000 /mm3,
* Immunosuppressive drugs,
* Inhalation

Primary outcomes:
measure: Reduction of the duration of Vancomycin Resistant Enterococcus intestinal carriage.
Secondary outcomes:
Other outcomes:
Locations:
city: Hôpital Gabriel Montpied
country: France
facility: Service des Maladies infectieuses et tropicales
state: Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Olivier LESENS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vidal M, Forestier C, Charbonnel N, Henard S, Rabaud C, Lesens O. Probiotics and intestinal colonization by vancomycin-resistant enterococci in mice and humans. J Clin Microbiol. 2010 Jul;48(7):2595-8. doi: 10.1128/JCM.00473-10. Epub 2010 Apr 26.
Clinical trial NCT05087680: An Acceptance Based PrEP Intervention to Engage Young Black MSM in the South
Official title: An Acceptance Based PrEP Intervention to Engage Young Black MSM in the South
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Prevention
Keywords: ACT
PrEP
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: University of Mississippi Medical Center
First posted: 2021-10-21
Enrollment: 66
Sex: MALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigators will use a generalized framework for the adaptation of EBIs to inform the development of a brief Acceptance and Commitment Therapy (ACT)-based culturally appropriate pre-exposure prophylaxis (PrEP) intervention tailored to young Black men who have sex with men (YBMSM), named ACTPrEP.

Detailed description: Investigators will use a generalized framework for the adaptation of EBIs to inform the development of a brief Acceptance and Commitment Therapy (ACT)-based culturally appropriate pre-exposure prophylaxis (PrEP) intervention tailored to young Black men who have sex with men (YBMSM), named ACTPrEP.

Specific Aim 1) Gather data from YBMSM (n = 20) and clinic staff (n = 10) through in-depth interviews to assess quantitative measures, intervention design, and experiences most relevant to PrEP engagement.

Specific Aim 2) Develop ACTPrEP utilizing Aim 1 data, working iteratively with experts, and an intervention "run through" with a sample of participants.

CLINICAL TRIAL IS AIM 3 ONLY

Specific Aim 3) Evaluate ACTPrEP. Enroll 66 participants. Primary outcomes will be feasibility (measured by percentage eligible, consented, randomized, and retained) and acceptability (measured by the Client Satisfaction Questionnaire). Secondary outcomes will compare ACTPrEP vs. enhanced standard of care condition (ESOC) on behavior outcomes (uptake, adherence, and PrEP persistence) and possible mediators over the course of 24 weeks. Barriers and facilitators to implementing ACTPrEP will be assessed with post-RCT qualitative interviews using the i-PARIHS framework.

Eligibility criteria: Inclusion Criteria:

* English speaking
* Between 18-34 years old
* Male sex assigned at birth
* Identify as African American/Black
* Not enrolled in another PrEP related study
* Able to give consent
* Not taken PrEP in past 3 months
* Report having sex with a man in the past 3 months
* PrEP-eligible according to CDC guidelines

Exclusion Criteria:

* Participating in another PrEP study
* Unable to provide consent

Primary outcomes:
measure: ACTPrEP Feasibility
timeFrame: 12 week visit
measure: ACTPrEP Acceptability
timeFrame: 12 week visit
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: Univeristy of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: Rhode Island Hospital
name: Trisha Arnold, PhD
role: PRINCIPAL_INVESTIGATOR
References: