louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02546271: A Small-group Intervention to Reduce HIV Sexual Transmission Risk Behavior Among HIV-positive Men Who Have Sex With Men
Official title: A Small-group Intervention to Reduce HIV Sexual Transmission Risk Behavior Among HIV-positive Men Who Have Sex With Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Behavior
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
First posted: 2015-09-10
Enrollment: 82
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Gay Poz Sex (GPS) is an HIV prevention and sexual health promotion program for HIV-positive gay and bisexual men, which takes place in a group counselling format. All participants provided written informed consent at the outset of the study. Eligible participants filled out a 1-hour computer-assisted self-interview questionnaire. Subsequently, participants attended seven 2-hour group sessions, led by 2 peer facilitators, who were HIV-positive gay men, in groups of 5-8 men. Immediately and 3 months following the completion of the GPS program, participants were scheduled to attend a 1-hour session to complete the same questionnaire package. Participants received an honorarium and a list of community resources, including mental health or substance use counseling services, at the end of each assessment. Participants also participated in a program evaluation interview at the 3-month follow-up assessment.


Eligibility criteria: Inclusion Criteria:

In order to be eligible to participate in the study, participants had to:

1. identify as male,
2. report engaging in condomless anal sex with another male during the past 3 months,
3. self-report an HIV-positive status,
4. be over the age of 18 years old, and
5. be able to speak and read in English.

Exclusion Criteria:

* Self-reported female gender,
* no condomless anal sex with another male during past 3 months,
* HIV-negative

Primary outcomes:
measure: Serodiscordant condomless anal sex with a casual partner
timeFrame: Past 3 months
Secondary outcomes:
measure: Seroconcordant condonmless anal sex with a casual partner
timeFrame: Past 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Toronto Metropolitan University
name: Trevor A Hart, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hart TA, Stratton N, Coleman TA, Wilson HA, Simpson SH, Julien RE, Hoe D, Leahy B, Maxwell J, Adam BD. A Pilot Trial of a Sexual Health Counseling Intervention for HIV-Positive Gay and Bisexual Men Who Report Anal Sex without Condoms. PLoS One. 2016 Apr 7;11(4):e0152762. doi: 10.1371/journal.pone.0152762. eCollection 2016.
Clinical trial NCT04036097: Prospective Stratification of Infectious Risks in Multiple Sclerosis
Official title: Prospective Stratification of Infectious Risks in Multiple Sclerosis (InRIMS-Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: secondary immunodeficiencies
disease-modifying treatments (DMT)
immunosuppressive therapy
serious infection
respiratory tract infections (RTI)
urinary tract infections
infection diary
Swiss MS Cohort (SMSC)
SUMMIT (Serially Unified Multicenter Multiple Sclerosis Investigation) studies
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss Multiple Sclerosis Society
name: Bangerter-Rhyner Stiftung
name: Center for Chronic Immunodeficiency (CCI) in Freiburg, Germany
First posted: 2019-07-29
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: MS patients participating in the SMSC or SUMMIT study with or without DMT

Brief summary: This monocentric study is to identify factors that increase the susceptibility for infections and establish a questionnaire-based infection score that allows a prospective stratification for infectious risks in patients with multiple sclerosis (MS) (InRIMS-Study). The study will utilize a validated, MS-adapted questionnaire and infection diary from the Airway Infection Susceptibility (AWIS) study in a regularly followed, prospective cohort of MS patients. It is a nested project of the prospective observational Swiss MS Cohort (SMSC) and SUMMIT (Serially Unified Multicenter Multiple Sclerosis Investigation) studies.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent form (ICF) for the InRIMS-study and Swiss MS Cohort (SMSC) and/or Serially Unified Multicenter Multiple Sclerosis Investigation (SUMMIT) study

Exclusion Criteria:

* Not able to sufficiently understand the patient information and questionnaire (German language)
* MS Patients with long-term antibiotic prophylaxis
* MS Patients with known primary immunodeficiency, under chemotherapy due to any malignancy or HIV infection.

Primary outcomes:
measure: AWIS RTI score
timeFrame: Baseline
measure: infection diary score
timeFrame: 24 months
Secondary outcomes:
measure: Comparison of infection scores between patients receiving Disease Modifying Therapies (DMTs) and those who do not receive DMTs
timeFrame: 24 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Department of Neurology
Study officials:
affiliation: University Hospital Basel, Department of Neurology
name: Bernhard Décard, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06784297: INTERMEDIATE-SIZE PATIENT POPULATIONS EXPANDED ACCESS to TREATMENT for SARCOPENIC OBESITY
Official title: INTERMEDIATE-SIZE PATIENT POPULATIONS EXPANDED ACCESS to TREATMENT for SARCOPENIC OBESITY
Study type: EXPANDED_ACCESS
Overall status: TEMPORARILY_NOT_AVAILABLE
Conditions: Sarcopenia
Obesity and Obesity-related Medical Conditions
Lead sponsor: Immunis, Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The expanded access is designed for patients requesting the treatment, and whose medical condition may benefit from treatment, but are unable to participate in any other IMM01-STEM clinical trial in their physician's opinion for reasons that include: (1) They do not meet enrollment criteria, or (2) They cannot perform the assessment of outcomes, or (3) The trial site is not geographically accessible.


Eligibility criteria: Inclusion Criteria:

1. Sex: male or post-menopausal female (as defined by the absence of a period for at least 12 consecutive months)
2. Race/nationality: all races and ethnicities accepted for which there are validated reference values for obesity and sarcopenia diagnostic criteria
3. Disease characteristics: to be eligible, the participant must meet one criterion for obesity and at least one criterion for sarcopenia, as defined below:

Obesity:

1. Abdominal obesity defined by a waist circumference ≥ 40 inches (102 cm) for men, ≥ 35 inches (88 cm) for women (American Heart Association)
2. Abdominal obesity as a waist-to-hip ratio of at least 0.90 in men and 0.85 or more for
3. No obesity, normal BMI women (World Health Organization)

Sarcopenia:

i) Grip strength: \< 16 kg (women), \< 27 kg (men) in the dominant hand, or, ii) Gait speed \< 0.8 m/s (men and women) iii) Clinical evidence of sarcopenia alternative to grips strength and gait speed measurements, as judged by the physician

Exclusion Criteria:

1. Qualifying individuals by the current enrollment criteria that are in a 50-mile geographical radius of any IMM01-STEM clinical trial site or a potential clinical site.
2. Inability to sign an informed consent
3. Concomitant investigational drugs and treatments
4. Concomitant medication included in the table 1.
5. Current malignancy or recent malignancy in complete remission less than 3 years
6. BMI \< 20
7. Major surgical procedures in the past 30 days.
8. Cognitive impairment, Alzheimer disease,
9. Progressive autoimmune disorders including rheumatoid arthritis, muscular dystrophy, multiple sclerosis, systemic sclerosis, inclusion body myositis, idiopathic inflammatory myopathy, and similar conditions.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01823497: Parent/Nurse Controlled Analgesia in the Neonatal Intensive Care Unit
Official title: Parent/Nurse Controlled Analgesia for Post-Operative Pain Management in Neonates: A Preliminary Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Surgery
Thoracic Surgery
Keywords: Neonatal Intensive Care Unit
neonate
pain
morphine
Parent/Nurse Controlled Analgesia
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Children's Hospital and Health System Foundation, Wisconsin
First posted: 2013-04-04
Enrollment: 36
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the safety and effectiveness of 2 morphine delivery systems for post-surgical neonates. The investigators hypothesize that this study will be feasible to conduct, and that neonates receiving morphine via a Parent/Nurse Controlled Analgesia pump will receive less morphine and experience fewer side effects than neonates receiving morphine via continuous opioid infusion.


Eligibility criteria: Inclusion Criteria:

* Surgery Location:

  * Abdominal or Thoracic
  * First surgery only

Age:

* Born ≥ 34-44 weeks post-menstrual age
* Weight: Weight at birth or current weight ≥2 kg Intubated or extubated

Prior opioid exposure:

* \< 2 days of continuous exposure
* if history of \> 2 day continuous exposure, must be off continuous drip for a week
* Intermittent exposure ≤ 2 days prior to surgery Neonates exposed to chronic opioids in utero \*In utero exposure to Selective Seretonin Reuptake Inhibitors and illicit drugs will be screened for and annotated.

At least 1 parent is English-speaking

Exclusion Criteria:

* Surgery Type:

  * Cardiac, Patent Ductus Arteriosus Ligation; Omphalocele (if intubated pre-operatively)

Diagnoses:

• Necrotizing Enterocolitis; Diaphragmatic hernia (unless thoracoscopically repaired); Chemically or physiologically paralyzed Receiving vasopressors Receiving acetaminophen or a benzodiazepine (lorazepam or midazolam) ≤ 24 h before surgery Patients with any of the following: Epidural; Oscillating ventilator

Primary outcomes:
measure: Morphine Consumption
timeFrame: 5 days post surgery
Secondary outcomes:
measure: Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale
timeFrame: 4 days post surgery
Other outcomes:
measure: Methadone Use
timeFrame: up to 3 days after morphine is discontinued
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Keri R Hainsworth, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital and Health System Foundation, Wisconsin
name: Michelle L Czarnecki, MSN RN-BC CPNP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04388397: Immediate-access Arteriovenous Versus Standard Arteriovenous Grafts in Hemodialysis Patients
Official title: Immediate-access Arteriovenous Versus Standard Arteriovenous Grafts in Hemodialysis Patients: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Access Failure
Lead sponsor: Egyptian Biomedical Research Network
Sponsor class: NETWORK
First posted: 2020-05-14
Enrollment: 477
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Arteriovenous fistulae (AVF) are considered the main access for hemodialysis (HD). Arteriovenous grafts (AVGs) are an alternative access modality in patients with exhausted native venous access. Immediate-access arteriovenous grafts (IAAVGs) is a new modality in which dialysis can be started immediately to avoid complications of central venous catheters.

Detailed description: The study aimed to evaluate and compare patency rate and complications of standard arteriovenous grafts (SAVGs) and immediate-access arteriovenous grafts (IAAVGs) in end stage renal disease (ESRD) patients for one year after the intervention. Patients were randomly divided into two groups: SAVGs group and IAAVGs group. Patients with ESRD with no chance for native AVF were examined clinically and by duplex ultrasonography preoperatively. Follow up was for one year. Primary end points were the success rate, complications rate (hematoma, pseudo-aneurysm, graft site infection, systemic bacteremia), time of first cannulation. Secondary end points were primary and secondary patency within one year.

Eligibility criteria: Inclusion Criteria:

* Adult hemodialysis patients

Exclusion Criteria:

* Significant cardiorespiratory comorbidities.
* Peripheral vascular disease.
* Pregnancy or lactation.
* Severe bleeding disorders.

Primary outcomes:
measure: Primary Patency
timeFrame: 1 year
measure: Success rate
timeFrame: 24 hours
Secondary outcomes:
measure: Complications rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine, Zagazig University
city: Zagazig
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Faculty of Medicine, Zagazig University
name: Ahmed Tawfik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tawfik AM, Zidan MH, Salem A, Salem A. A randomized controlled study of early versus standard cannulation of arteriovenous grafts in hemodialysis patients. J Vasc Surg. 2022 Mar;75(3):1047-1053. doi: 10.1016/j.jvs.2021.08.106. Epub 2021 Sep 30.
Clinical trial NCT03941197: A Family Literacy Program for Latino Families
Official title: Ready and Healthy for Kindergarten- A Family Literacy Program for Latino Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Literacy
Keywords: child development
family literacy program
primary care
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A pilot study of a health-focused family literacy program. The program will consist of a series of 8 weekly workshops centered around different health topics (e.g. physical activity) that introduce basic literacy skills. The workshops are designed for children entering kindergarten and their parents

Detailed description: This is a pilot study of a health-focused family literacy program. The program consists of 8 weekly health-themed workshops designed to introduce basic literacy skills to children entering Kindergarten and their parents. There will be a pre and post test assessment for participating parents and children. During the 8 weeks, parents will receive 2-3 weekly text messages to reinforce material presented at the weekly workshop.

Eligibility criteria: Inclusion Criteria:

* Preferred language is either Spanish or English.
* Parent or legal guardian of child
* Parent age 18 or older
* Willing to accept text messages

Exclusion Criteria:

* Children not entering Kindergarten in Fall 2019 and their parents will be excluded

Primary outcomes:
measure: Acceptability of Intervention Measure (AIM) Questionnaire
timeFrame: After 8 week period.
Secondary outcomes:
measure: StimQ-Preschool survey
timeFrame: At enrollment and after 8 week period.
measure: Alphabet knowledge assessment survey
timeFrame: At enrollment and after 8 week period.
measure: Sight word knowledge assessment survey
timeFrame: At enrollment and after 8 week period.
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Manuel E Jimenez
state: New Jersey
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School
name: Manuel E Jimenez, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02270697: Evaluation of an Oligonucleotide Array for Rapid Identification of Dermatophytes in Clinical Specimens
Official title: Evaluation of an Oligonucleotide Array for Rapid Identification of Dermatophytes in Clinical Specimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tinea Unguium
Onychomycosis
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subject were suspect onychomycosis and treatment at National Cheng Kung University Hospital.

Brief summary: The nail specimens from patients with suspect onychomycosis were analyzed. Samples were collected as part of standard patient care from the Department of Dermatology, National Cheng Kung University Hospital (NCKUH, a tertiary referral hospital), Tainan, Taiwan. Comparing the array results with the regular methods by sensitivity, specificity, NPV and PPV.

Detailed description: The nail specimens from patients with suspect onychomycosis were analyzed.

Collection:

Samples were collected as part of standard patient care from the Department of Dermatology, National Cheng Kung University Hospital (NCKUH, a tertiary referral hospital), Tainan, Taiwan.

Nail samples were collected as subungual scrapings, clippings, or curettings. Samples were immediately transported in sterile Eppendorf tubes at room temperature to the laboratory of Department of Dermatology, NCKUH, for KOH stain and routine fungal cultures.

Sample Prepare:

Each sample was cut into small pieces with a surgical blade and homogenization by 2-ml glass homogenizer. The suspension treated by lyticase at 37°C for 30 min and extracted DNA with Blood \& Tissue genomic DNA kit.PCR program and array hybirdization same with previous study.

Analysis:

If the results between array and culture method, discrepant analysis with re-sequencing, KOH mount and the patient's outcome of after antifungal treatment. The performance evaluation of the array and culture methods with Sensitivity, specificity, positive (PPV) and negative predictive value (NPV) were calculated after discrepant analysis. Significant difference was estimated by Fisher's exact test.

Eligibility criteria: Inclusion Criteria:

* Atypically results by culture and microscopy
* Suspect tinea infection

Exclusion Criteria:

* Lost follow
* Not tinea unguium

Primary outcomes:
measure: Oligonucleotide Array Detection Resluts
timeFrame: 1 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Cheng Kung University
name: Tsung Chain Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04886297: A Dose-response Study of Dietary Resveratrol on Lipid Metabolism Disorder
Official title: Department of Nutrition and Food Hygiene,School of Public Health, Sun Yat-sen University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemias
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 168
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In order to study the effect of resveratrol on the improvement of lipid and uric acid metabolism, randomized intervention trials were conducted to compare the effects of resveratrol on the improvement of lipid and uric acid metabolism in different dose groups. To explore the best dose of resveratrol for the prevention and treatment of metabolic diseases provide an important scientific basis.

Detailed description: In order to study the effect of resveratrol on the improvement of lipid and uric acid metabolism, randomized controlled trials were conducted to enrolled 160 patients with dyslipidemia. The subjects were divided into 0 mg / d, 100 mg / d, 300 mg / d, 600 mg/ d four dose groups, intervention for 8 weeks, comparing different doses of resveratrol on lipid and uric acid metabolism. To explore the best dose of resveratrol for the prevention and treatment of metabolic diseases provide an important scientific basis.

Eligibility criteria: Inclusion Criteria:

* Dyslipidemia
* The age between 35 and 70 years old

Exclusion Criteria:

* Intake of any medicine that affect lipid metabolism currently or in the preceding 6 months
* Dietary supplementation with phytochemicals including resveratrol in the preceding 3 months
* History of acute or chronic infectious disease, autoimmune disease, cancer, traumatic injury, or surgery in the preceding 1 month
* History of severe chronic disease including AS and CVD, liver or renal dysfunction, and lactation or pregnancy
* Pregnant woman and Breast Feeding Women

Primary outcomes:
measure: Effect of resveratrol on lipid profile in patients with dyslipidemia
timeFrame: Change from Baseline to 4 weeks and 8 weeks
Secondary outcomes:
measure: Effect of resveratrol on uric acid and xanthine oxidase in patients with dyslipidemia
timeFrame: Change from Baseline to 4 weeks and 8 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: North Campus, Guangzhou Campus, No. 74, Zhongshan 2nd Road, Yuexiu District, Guangzhou
name: Ling Wenhua
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05744297: NLRP3 Inflammasome Activation Among Patients During Acute Gout Flares
Official title: NLRP3 Inflammasome Activation Among Patients During Acute Gout Flares
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gout Arthritis
Lead sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 10
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: Study will be proposed to patients meeting study's criteria

Brief summary: Gout is a chronic joint disease associated with deposition of monosodium urate crystals, as a consequence of hyperuricemia. Gout is an intermittent flaring condition and acute gout flares are driven by NLRP3 inflammasome and IL1-beta production.

However pathogenesis of acute gout flares remains poorly known in vivo in human.

The aim of this study is to evaluate NLRP3 inflammasome activation in vivo in patients cells during acute gout flares.

Detailed description: Blood and synovial fluid will be obtained from remainder of patients' samples during an acute gout flares. White blood cells will be isolated and NLRP3 inflammasome activation will be assessed. Then, NLRP3 inflammasome inhibitors will be tested on cells with NLRP3 inflammasome activity.

Eligibility criteria: Inclusion Criteria:

* Hospitalization for acute gout flare confirmed by joint fluid analysis or Nijmegen score \> 8
* Aged \> 18

Exclusion Criteria:

* Gout treatment already started
* Inflammatory Arthritis other than Gout Arthritis
* Pregnant or breast feeding women
* Patient protected by law

Primary outcomes:
measure: NLRP3 inflammasome activation in white blood cells.
timeFrame: Patient admission at hospital
Secondary outcomes:
measure: NLRP3 inflammasome activation in synovial cells.
timeFrame: Patient admission at hospital
measure: Effects of NLRP3 inflammasome inhibitors on proportion of NLRP3 inflammasome activation in white blood cells/synovial cells
timeFrame: up to 7 days after analysis of NLRP3 activity
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Hospitalier Saint Joseph Saint Luc
Study officials:
References: