louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06616038: Heart Failure Biomarkers
Official title: Biomarker Assessment in Heart Failure with Reduced Systolic Function (HFrEF) and Preserved Systolic Function (HFpEF)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atrial Fibrillation (AF)
Hart Failure
Keywords: Hart failure
Ejection fraction
atrial fibrillation
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 114
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: Will be enrolled 114 patients admitted to the Hospital for heart failure of first diagnosis or already undergoing therapy. In particular, 57 patients with heart failure and 57 patients with heart failure and fibrillation will be included.

Brief summary: Systemic inflammation is closely associated with the development and progression of heart failure (HF). The study assessed the fibrin/albumin (FAR) ratio, a very important biomarker, as a prognostic indicator of HE. Study population is composed by patients who were addicted with heart failure diagnosed for the first time or already under treatment (NYHA class II-IV) and reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF).

Detailed description: Prospective, observational, single-center study, which involves the enrollment of patients affected by heart failure of first diagnosis or already in therapy, who will be subjected to an analysis of the Albumin/fibrinogen ratio. Subjects will not be subjected to specific visits or services for the study: clinical and anamnestic data will be collected during routine visits.

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years
* Patients with newly diagnosed or already treated heart failure (NYHA class II-IV) with HFrEF and HFpEF with and without atrial fibrillation.
* Patients who sign the consent to participate in the study

Exclusion Criteria:

* Patients with infectious/autoimmune diseases, neoplasms, liver failure, renal failure (Cl creatinine \&lt; 30 mL/L), structural cardiomyopathies and pericarditis.
* Pregnant/breastfeeding women (verified by self-declaration)

Primary outcomes:
measure: Evaluation of FAR
timeFrame: At Hospital admission
Secondary outcomes:
measure: FAR (=Fibrinogen/Albumin) and functional ultrasound
timeFrame: At Hospital admission and at hospital discharge (assessed up to 1 months)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Galeazzi-Sant&amp;#39;Ambrogio
city: Milan
country: Italy
facility: IRCCS Ospedale Galeazzi-Sant'Ambrogio
Study officials:
References:
Clinical trial NCT06969638: Influence of "Likes" in Social Media Food Ads on Black and White Adolescents' Food Purchases - Study 2
Official title: A Randomized Trial to Examine the Influence of "Likes" in Social Media Food Ads on Black and White Adolescents' Food Purchases - Study 2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Food Selection
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2025-05-14
Enrollment: 1300
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The intervention is exposure to social media food ads that are either race congruent or race incongruent, and that have varying numbers of likes.
Primary purpose: PREVENTION

Brief summary: This is a randomized trial to examine the influence of number of "likes"on social media food ads on Black and White adolescents' food purchases

Detailed description: The aim of this randomized trial is to test the degree to which visual attention to racially congruent vs incongruent people, and/or number of "likes" in social media ads influence Black and White adolescents' food purchases.

Eligibility criteria: Inclusion Criteria:

* adolescent (13-17 years of age) who identifies as only non-Latino White or only Black/African American; who logs into Instagram once daily; who can read and speak English

Exclusion Criteria:

- participants who do not meet all criteria described above.

Primary outcomes:
measure: Number of Calories Purchased
timeFrame: Day 0 (approximately 5 minutes)
Secondary outcomes:
measure: Attitudes towards Ads
timeFrame: Day 0 (approximately 5 minutes)
measure: Engagement with Ads
timeFrame: Day 0 (approximately 5 minutes)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Marie A. Bragg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05828238: Positron Emission Tomograph(PET) Imaging Explores the Role of SF-DEVD-2 in Monitoring Tumor Efficacy
Official title: PET Imaging Explores the Role of SF-DEVD-2 in Monitoring Tumor Efficacy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Breast Cancer Stage II
Breast Cancer Stage III
Solid Tumor
Lead sponsor: Affiliated Hospital of Jiangnan University
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a single arm study to determining the value of apoptotic molecular probe SF-DEVD-2 in the early evaluation of tumor efficacy and comparing it head-to-head wihe 18F-FDG(18F-2-fluoro-2-deoxy-D-glucose)


Eligibility criteria: Inclusion Criteria:

1. Patients voluntarily signed informed consent;
2. Age18-70, male or female;
3. Diagnosed with stage 2 or 3 breast cancer
4. Solid tumors、masses larger than 2cm with lymph node metastasis
5. Pathology is HER3+、triple negative patients
6. Patients to be treated with neoadjuvant chemotherapy

Exclusion Criteria:

1. Age greater than or equal to 70 years old
2. Abnormal liver and kidney function (more than five times the normal value)
3. Diagnosis level of breast cancer stage 4 or second time tumor patients

Primary outcomes:
measure: Evaluation of tissue distribution of [18F]-DEVD-2
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Jiangnan University
name: Chunjing Yu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00117338: A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma (0476-301)
Official title: A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Pediatric Patients (Ages 6 to 14 Years) With Acute Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-07-06
Enrollment: 276
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will attempt to find out if the addition of an intravenous form of a drug that is already used for treating asthma in children will help resolve asthma attacks faster than using the current standard care alone.

Detailed description: The duration of treatment is a one time dose.

Eligibility criteria: Inclusion Criteria:

* Children 6-14 years of age seeking treatment in emergency departments with acute asthma attacks

Exclusion Criteria:

* Other respiratory conditions (including congenital lung abnormalities) or other acute illnesses that would complicate current treatment and response for asthma

Primary outcomes:
measure: Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration
timeFrame: Baseline and (time weighted average over) 60 Minutes
Secondary outcomes:
measure: Change From Baseline in Modified Pulmonary Index [mPI] Score
timeFrame: Baseline and 60 minutes
measure: Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours)
timeFrame: 120 minutes
measure: Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration
timeFrame: Baseline and (time-weighed average over) 45 Minutes
measure: Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration
timeFrame: Baseline and (time-weighted average over) 30 Minutes
measure: Change in FEV1 After 15 Minutes Following the End of Study Drug Administration
timeFrame: Baseline and 15 Minutes
measure: Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration
timeFrame: 120 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Morris CR, Becker AB, Pinieiro A, Massaad R, Green SA, Smugar SS, Gurner DM. A randomized, placebo-controlled study of intravenous montelukast in children with acute asthma. Ann Allergy Asthma Immunol. 2010 Feb;104(2):161-71. doi: 10.1016/j.anai.2009.11.065.
Clinical trial NCT03373838: Opposition to Diagnostic or Therapeutic Procedures by Aged Hospitalized Patient
Official title: Opposition to Diagnostic or Therapeutic Procedures by Aged Hospitalized Patient on Geriatrics Department.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Refusal, Treatment
Qualitative Research
Epidemiology
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 35
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patient presenting opposition to medical or diagnosis procedure define as :

* Repeated expression (at least 2 times to 2 differents professionnals) without agreed between these 2 oppositions.
* Concerning : medication, invasive diagnosis procedure or withdrawal of catheter.

Brief summary: The main object is to identify and understand why some hospitalized aged patients oppose himself to treatment or diagnosis procedure. This mixed study will used a census in a geriatrics department and a qualitative research.

Detailed description: To complete qualitative study, interview will also be conducted with : patients, general practitioner, relative and home carers. An observation of geriatric multidisciplinary staff will be done for better understanding of complexity.

Eligibility criteria: Inclusion Criteria:

* geriatric department inpatient.
* presenting opposition to medical or diagnosis procedure
* covered by French Social Security System
* agreed to participate to the study

Exclusion Criteria:

* They did not express himself an opposition
* They disagree to participated
* For qualitative research only : major neurocognitive disorder (MMSE \<10).

Primary outcomes:
measure: 30 individual semi-structured interviews
timeFrame: 1 year
Secondary outcomes:
measure: 100 demographic survey
timeFrame: 1 year
measure: 100 medical survey
timeFrame: 1 year
Other outcomes:
Locations:
city: Besancon
country: France
facility: Centre Hospitalier Universitaire
Study officials:
affiliation: CHU DE BESANCON
name: Regis AUBRY, MD/PhD
role: STUDY_CHAIR
affiliation: CHU DE BESANCON
name: Thomas TANNOU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tannou T, Trimaille H, Mathieu-Nicot F, Koeberle S, Aubry R, Godard-Marceau A. Investigation of opposition to diagnostic or therapeutic procedures in older people hospitalized in acute geriatric services: the OPTAH pilot study protocol. Pilot Feasibility Stud. 2020 Dec 14;6(1):194. doi: 10.1186/s40814-020-00742-7.
Clinical trial NCT06640738: Investigating the Optimal Remifentanil and Dexmedetomidine Concentration for Uterine Fibroid Ablation
Official title: Remifentanil and Dexmedetomidine in Uterine Fibroid Ablation: a Comparative Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Uterine Fibroids (UF)
Keywords: Uterine Fibroids (UF)
Remifentanil
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to find a better drug concentration of Remifentanil in Uterine Fibroid Ablation. The main question it seeks to answer is:

\[primary hypothesis 1\] Remifentanil concentration of 2.0 ng/mL provides better pain control in Uterine Fibroid Ablation.

There is a comparison group in this study: Researchers will compare Remifentanil concentration of 1.0 ng/mL to see if provides similar pain control with fewer side effects.

Participants will be separated into two groups, one group with a Remifentanil concentration of 2.0 ng/mL and the other 1.0 ng/mL. During uterine fibroid ablation, the patient\&#39;s pain index will be recorded (using a Visual Analogue Scale (VAS) of 0\~10 points). We will also record vital signs during the procedure.


Eligibility criteria: Inclusion Criteria:

* Aged between 20 and 65 years old
* American Society of Anesthesiology classification I\~III
* Female patients diagnosed with uterine fibroids by obstetricians and gynecologists

Exclusion Criteria:

1. Patients with heart disease (such as arrhythmia or severe ventricular dysfunction)
2. Patients with chronic kidney disease in stage III or above or dialysis patients
3. Long-term alcohol addiction or drug abuse
4. Patients with abnormal liver index or chronic hepatitis
5. Those who are allergic Remifentanil
6. Those who refuse to participate in the experiment

Primary outcomes:
measure: Pain scores during uterine fibroid ablation
timeFrame: From the start of uterine fibroid ablation till 30 minutes after the ablation.
Secondary outcomes:
measure: Vital signs during uterine fibroid ablation
timeFrame: From the start of uterine fibroid ablation till 30 minutes after the ablation.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05555238: An Observational Study to Evaluate the Treatment of Newvast® Tab(Atorvastatin) in Korean Patients With Dyslipidemia
Official title: An Observational Study to Evaluate the Safety and Effectiveness of Newvast Tab(Atorvastatin) in Korean Dyslipidemia Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemia
Keywords: Dyslipidemia
Atorvastatin
Statin
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2022-09-26
Enrollment: 1716
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dyslipidemia

Brief summary: In this study, dyslipidemia patients visited the institutions during the study period and the effectiveness and safety of the treatment of Newvast® Tab(Atorvastatin) in real-practice.

During the routine medical visit, according to the investigator's judgment, with diagnosis that the Newvast® Tab(Atorvastatin) prescription is appropriate, regardless of medical history and concomitant-medication, and after deciding to start treatment, patients with Dyslipidemia who agreed to participate in the study were administered Newvast® Tab(Atorvastatin).

As this study is a non-interventional observational study, all subjects received prescriptions according to the routine treatment procedure, and there were no visits or procedures required according to the observational study protocol.

Detailed description: This study is a multicenter, prospective, non-interventional, observational study of patients administering Atorvastatin(Newvast® Tab) to treat Dyslipidemia.

Data will be collected from patients receiving routine treatment at hospitals in South Korea. Each subject visits the institution according to the protocol that designed the follow-up visits for six months to examine the effectiveness and safety of Atorvastatin(Newvast® Tab).

This study will approved by the institutions' IRBs and is in compliance with clinical research ethics regulations.

Eligibility criteria: Inclusion Criteria:

1. Patient was diagnosed with Dyslipidemia
2. Those who voluntarily consented in writing to this study

Exclusion Criteria:

(1) Patients for whom use of Newvast® Tab is prohibited

Primary outcomes:
measure: The incidence of myalgia
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanmi Pharmaceutical Company Limited
Study officials:
affiliation: Hanmi Pharmaceutical Company Limited
name: Ji-yeon Hong, PM
role: STUDY_DIRECTOR
References:
Clinical trial NCT00611338: Efficacy of Group Intervention to Reduce Stress Symptoms
Official title: Efficacy of Group Intervention to Reduce Stress Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
HIV Infections
Keywords: Complementary Therapies
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research study will examine the usefulness of groups in reducing stress and helping individuals with HIV to stay healthy and avoid problems associated with sexually transmitted diseases. We hope to discover whether being in a group is effective in reducing stress-related symptoms and promoting healthy behaviors.

Detailed description: This is a risk reduction intervention for adults who are living with HIV, are experiencing trauma-related stress symptoms, and are at risk for HIV transmission. By first treating trauma symptoms, the effects of a skills-building HIV risk reduction intervention for adults experiencing trauma-related symptoms such as hyperarousal, dissociation, and avoidance will be enhanced. This is based on a model the proposes trauma-related symptoms have direct effects on HIV risk behavior. Therefore, the successful treatment of trauma-related symptoms will facilitate HIV risk behavior change.

Eligibility criteria: Inclusion Criteria:Must be 18 years or older, must be HIV-positive, report engaging in behavior that could put them at risk for HIV transmission in the past three months, report experiencing one or more trauma-related symptoms within the past three months.

Exclusion Criteria:Exclusion criteria include the presence of gross cognitive impairment, dementia, acute psychosis, or severe physical impairment that would preclude adequate comprehension of assessment material and participation in small group intervention.

Primary outcomes:
measure: To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone post -intervention 3, 6, and 12 months after the group intervention sessions.
timeFrame: immediate post intervention, 3 months, 6 months, and 12 months
measure: To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone
timeFrame: immediate post intervention, 3 months, 6 months, and 12 months
Secondary outcomes:
measure: To determine whether key variables moderate the intervention's effects.
timeFrame: immediate post intervention, 3 months, 6 months and 12 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Cheryl Gore-Felton Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04750538: A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 2)
Official title: A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Keywords: Phantom Limb Pain
BreEStim
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2021-02-11
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and conventional electrical stimulation (EStim) in management of neuropathic phantom limb pain in patients after limb amputation.


Eligibility criteria: Inclusion Criteria:

* has phantom limb pain (PLP) after amputation of one limb, upper or lower limb;
* has chronic pain, \>3 months;
* is stable on oral pain medications at least two weeks. (patients are allowed to continue their pain medications, i.e., no change in pain medications.)

Exclusion Criteria:

* currently adjusting oral pain medications for their PLP;
* has pain, but not PLP (e.g., from inflammation at the incision wound of the residual limb);
* has a pacemaker, or other metal and/or implanted devices;
* has cognitive impairment from brain injury or are not able to follow commands, or to give consent;
* has amputation in multiple limbs;
* have asthma or other pulmonary diseases;
* are not medically stable;
* have preexisting psychiatric disorders;
* alcohol or drug abuse;
* have a history of seizures/Epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants.

Primary outcomes:
measure: Change in Pain Level as Measured by the Visual Analog Scale (VAS).
timeFrame: Baseline, 10 minutes after intervention
Secondary outcomes:
measure: Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Threshold (EST)
timeFrame: Baseline, 5 minutes after intervention
measure: Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Detection Threshold (EPT)
timeFrame: Baseline, 5 minutes after intervention
Other outcomes:
measure: Change in Heart Rate Variability (HRV) Measured by Electrocardiogram (ECG)
timeFrame: Baseline, 10 minutes after intervention
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sheng Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: