louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05463692: CAMELLIA Cohort: A Longitudinal Study to Understand Sexual Health and Prevention Among Women in Alabama
Official title: CAMELLIA Cohort: A Longitudinal Study to Understand Sexual Health and Prevention Among Women in Alabama
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hiv
Sexually Transmitted Diseases
Keywords: HIV prevention education
STI prevention education
Pre-exposure prophylaxis (PrEP)
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-07-19
Enrollment: 830
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Pre-exposure prophylaxis (PrEP) is an important biomedical human immunodeficiency virus (HIV) prevention tool and may particularly benefit black, cis and trans-gender women, who are at an increased risk for HIV and Sexually Transmitted Infections (STIs). The purpose of this study is to use a population-based approach to create a cohort of cis and trans-gender women at risk for future HIV acquisition to better understand the factors associated with the risk of STIs and HIV diagnosis and predictors of PrEP use.

Detailed description: To better understand contextual factors among people who identify as women in Alabama that predict STI/HIV infection and PrEP use, we will refine an existing evidence-based mobile health app (HealthMpowerment or HMP) to optimally engage and retain a digital cohort of women at-risk for HIV infection (i.e. prior infection in the past 3 months with gonorrhea or syphilis). Using a sampling strategy based on geospatial analysis of HIV-risk, we will enroll and follow our cohort longitudinally to assess factors associated with incident STI/HIV infection as well as utilization of PrEP through iterative self-collected STI/HIV testing and survey assessments.

Eligibility criteria: Inclusion Criteria:

* Self identify as a Cis-gender or Trans-gender woman
* Age 18 - 89
* Reported STI in past 3 months by the Alabama Department of Public Health (ADPH)
* Gonorrhea and Syphilis negative
* HIV negative at screening encounter
* Live in Alabama
* Have access to a private smart phone

Exclusion Criteria:

* Live outside of Alabama
* Positive diagnosis for HIV, Gonorrhea, or Syphilis

Primary outcomes:
measure: Annualized Sexually Transmitted Infections (STIs)
timeFrame: From time of enrollment through study completion at 24 months
Secondary outcomes:
measure: Pre-Exposure Prophylaxis (PrEP) uptake
timeFrame: From time of enrollment through study completion at 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Latesha Elopre, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05401292: Skin Preparation for Elective Foot and Ankle Surgery
Official title: Skin Preparation for Elective Foot and Ankle Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Microbial Colonization
Foot and Ankle Disorders
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Surgical site infections (SSIs) make about 31% of all nosocomial infections and they are the most common hospital-acquired infection. For foot and ankle elective interventions, SSI rate is reported between 0.4% and 3.6%. This study will investigate the effectiveness of skin cleaning with isopropyl alcohol and scrubbing with chlorhexidine soap before standard skin preparation in reducing microbial load and surgical site infections for elective foot and ankle surgeries. Current standard of care includes skin preparation with iodine or chlorhexidine solution prior to sterile draping and the start of surgery. Standard of care will be applied to all patients. The use of an additional "pre-scrub" with isopropyl alcohol and scrubbing with chlorhexidine soap will be applied to the experimental group. The control group will receive only the standard of care skin preparation with iodine or chlorhexidine solution prior to draping.


Eligibility criteria: Inclusion Criteria:

* patients undergoing elective foot and ankle surgeries
* age over 18

Exclusion Criteria:

* trauma as the indication for surgery
* open injuries
* non-elective procedures
* amputations
* prior surgical site infection through the planned incision
* pregnancy. All potential participants of child-bearing potential follow the standard pre-operative protocol to ensure they are not in pregnant status prior to SOC surgical procedure.

Primary outcomes:
measure: Surgical Site Infection
timeFrame: 90 days
Secondary outcomes:
measure: Microbial Load
timeFrame: 90 days
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
References:
Clinical trial NCT04699292: International Prospective Registry on Local Treatment Approaches in MLS
Official title: International Prospective Registry on Local Treatment Approaches in Myxoid Liposarcomas
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myxoid Liposarcoma
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
name: Maastro Clinic, The Netherlands
name: University Medical Center Groningen
name: Leiden University Medical Center
name: Vienna General Hospital
name: M.D. Anderson Cancer Center
name: University Hospital, Antwerp
name: Universitetssykehus
name: Haukeland University Hospital
name: Universitäts-Frauenklinik Graz
name: University Hospital Heidelberg
name: Mayo Clinic
name: Aarhus University Hospital
name: National Cancer Center, Japan
name: Princess Margaret Hospital, Canada
name: MOUNT SINAI HOSPITAL
name: University of Sydney
name: Institute for Cancer Research and treatment
name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Institut Curie
name: ANZSA (Australia and New Zealand Sarcoma Association)
First posted: 2021-01-07
Enrollment: 300
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: Patients diagnosed with Myxoid Liposarcoma (MLS) that will be treated in one of the participating Sarcoma Reference Centers according to one of the treatment approaches defined in the 5 cohorts.

Brief summary: To prospectively study commonly used local treatment approaches in Myxoid Liposarcoma (MLS)

Detailed description: In order to confirm the promising results of the 36 Gy dose level in the DOREMY trial (NCT02106312) and to compare outcome with other local treatment approaches.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Biopsy proven MLS, including the reciprocal chromosomal translocation t(12;16)(q13;p11)
* ECOG PS 0-2
* Written informed consent to share coded information in this international Registry

Exclusion Criteria:

* Prior radiotherapy to the target area
* Pregnancy

Primary outcomes:
measure: Local recurrence free survival
timeFrame: From surgery to the end of at least 5 years of follow-up
Secondary outcomes:
measure: Wound complications
timeFrame: From surgery to 6 months of follow-up
measure: Late toxicity
timeFrame: From 3 months after surgery to the end of at least 5 years of follow-up
Other outcomes:
measure: Patient-Reported Outcome Measures (PROMs)
timeFrame: From baseline visit to the end of 5 years of follow-up
measure: Health-Related Quality of Life (HRQoL)
timeFrame: From baseline visit to the end of 5 years of follow-up
Locations:
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute
Study officials:
affiliation: The Netherlands Cancer Institute
name: Rick Haas, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01150292: Effects of Docosahexaenoic Acid (DHA) on Cardiovascular Disease on Diabetic Patients
Official title: Intake of Low Dose of Docosahexaenoic Acid: Effects on Platelet Functions and Redox Status in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: DHA supplementation
Type 2 diabetic patient
Platelet function
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2010-06-24
Enrollment: 16
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Aim: to determine the effects of DHA supplementation:

* on the platelet function through their aggregation and the pathway of arachidonic acid metabolism
* on redox status on cells and plasma
* on inflammation in 16 type 2 diabetic patients in a cross-over study comparing DHA (400 mg/day for 2 weeks) vs Sunflower oil (placebo). Each period is separated by a wash-out period of 6 to 9 weeks.


Eligibility criteria: Inclusion Criteria:

* woman
* Type 2 diabetes
* Menopausal or aged between 55 and 75 years old
* Recent HbA1c between 6.5-10%
* Oral anti-diabetic drugs or insulin therapy
* Hypertension or antihypertensive drug

Exclusion Criteria:

* Tobacco
* Excessive drinking
* Post-menopausal hormonal treatment
* Treatment by acetylsalicylic acid, clopidogrel, gliclazide, ticlopidine, NSAID
* Secondary cardiovascular prevention
* antioxidant using
* Fish intake \>2 times a week
* Anemia \<10g/L
* Thrombopenia \<110g/L
* Creatinine clearance \<30 ml/min and/or proteinuria \>1g/L

Primary outcomes:
measure: Platelet function induced by collagen
timeFrame: 4 blood sampling in 10 to 13 weeks
Secondary outcomes:
measure: Evaluation of cellular and plasmatic redox status
timeFrame: 4 blood sampling in 10 to 13 weeks
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
city: Pierre-benite
country: France
facility: Centre de Recherche en Nutrition Humaine (CRNH) Rhône-Alpes
Study officials:
affiliation: Hospices Civils de Lyon
name: Martine LAVILLE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vericel E, Colas R, Calzada C, Le QH, Feugier N, Cugnet C, Vidal H, Laville M, Moulin P, Lagarde M. Moderate oral supplementation with docosahexaenoic acid improves platelet function and oxidative stress in type 2 diabetic patients. Thromb Haemost. 2015 Aug;114(2):289-96. doi: 10.1160/TH14-12-1003. Epub 2015 Apr 2.
Clinical trial NCT00654992: Effect of Erythropoietin (EPO) in Kidney After Cardiac Surgery
Official title: Prevention of Acute Kidney Injury (AKI) by Erythropoietin (EPO) in Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery - A Prospective Placebo-Controlled Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Kidney Failure, Acute
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2008-04-09
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether erythropoietin is effective in preventing acute kidney dysfunction after coronary artery bypass grafting surgery.

Detailed description: Acute kidney injury (AKI) occurs in 7% to 40% of patients undergoing cardiac surgery, depending on the definition of AKI used. Even small increments in serum creatinine have been shown to be associated with increased mortality after cardiac surgery. However, there are no proven interventions to prevent AKI after cardiac surgery. Erythropoietin (EPO) has been shown to have tissue-protective effects in various experimental models. In this prospective placebo-controlled randomized trial, we evaluated the effectiveness of EPO in the prevention of AKI after coronary artery bypass grafting (CABG).

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective CABG over age 18

Exclusion Criteria:

* Under age 18
* Emergent CABG
* Prior exposure to nephrotoxic drug
* Dialysis patients
* Uncontrolled hypertension

Primary outcomes:
measure: Number of Participants Who Had AKI (Acute Kidney Injury)
timeFrame: at any time within the first 5 days after surgery
Secondary outcomes:
measure: Change in Estimated Glomerular Filtration Rate (eGFR)
timeFrame: during the first 5 days after surgery
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Department of Internal Medicine
name: Ki Young, Na, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03006692: Diagnostic Value of Arterial Blood Gas Analysis in Prehospital Patients
Official title: Diagnostic Value of Arterial Blood Gas Analysis in Prehospital Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unconscious (Psychology)
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 220 patients seen prehospital by the mobile emergency care unit in Odense, Denmark. Patients have to have impaired consciousness (Glasgow Coma Scale \< 13).

Brief summary: In the anesthesiologist-manned mobile emergency car unit an analyzing device for blood gas testing is present since 2014. This study will determine if a prehospital arterial blood gas helps the doctor to make more precise diagnosis prehospitally. Furthermore it will be determined if the doctors find this device helpful in assessing and treating patients with affected consciousness.


Eligibility criteria: Inclusion Criteria:

* GCS \< 13

Exclusion Criteria:

* Pregnant or breastfeeding
* detained or imprisoned patient

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 220 patients in 1.5 year
Secondary outcomes:
measure: Doctor satisfaction
timeFrame: 220 patients in 1.5 year
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Odense University Hospital
state: Odense
Study officials:
References:
citation: Zwisler ST, Zincuk Y, Bering CB, Zincuk A, Nybo M, Mikkelsen S. Diagnostic value of prehospital arterial blood gas measurements - a randomised controlled trial. Scand J Trauma Resusc Emerg Med. 2019 Mar 18;27(1):32. doi: 10.1186/s13049-019-0612-8.
Clinical trial NCT06345092: Comparison Between IPRF With Vit. C and IPRF Alone in Management of ID'Pain
Official title: Comparison Between Injectable Platelet Rich Fibrin With Vitamin C and Injectable Platelet Rich Fibrin Alone in Management of ID'Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TMJ Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial between 2groups,the study group to be injected in the TMJ with injectable platelet rich fibrin with vitamin C and the control group to be injected in the TMJ with injectable platelet rich fibrin alone in management of internal Temporomandibular joint derangement

Detailed description: Randomized clinical trial between 2groups,the study group to be injected in the TMJ with injectable platelet rich fibrin with vitamin C and the control group to be injected in the TMJ with injectable platelet rich fibrin alone in management of internal Temporomandibular joint derangement

Eligibility criteria: Inclusion Criteria:

Patients with internal TMJ derangement (anterior disc displacement with reduction)

Exclusion Criteria:

Pathological conditions ; trauma TMJ cases or any blood diseases

Primary outcomes:
measure: Pain management
timeFrame: at 4;8;12;16 weeks
Secondary outcomes:
measure: disc position using MRI
timeFrame: at 4;8;12;16 weeks
Other outcomes:
measure: maximum mouth opening
timeFrame: at 4;8;12;16 weeks
measure: lateral excursion
timeFrame: at 4;8;12;16 weeks
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry cairo university
Study officials:
References:
Clinical trial NCT06196892: Probiotics Improve Health Young Volunteers' Gut Microbiota
Official title: A Randomized, Double-blind Controlled Trial to Assess the Impact of Probiotic on the Intestinal Health of Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Diseases
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-09
Enrollment: 109
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate whether daily supplementation with the probiotic Bifidobacterium breve BBr60 can improve metabolic, gastrointestinal, and emotional health in healthy adult volunteers aged 19 to 45 years.

The main questions it aims to answer are: Can B. breve BBr60 improve lipid metabolism (e.g., increase HDL and reduce total cholesterol) in healthy adults? Can B. breve BBr60 alleviate gastrointestinal symptoms and improve emotional well-being in a non-clinical population? Researchers will compare a BBr60 supplementation group to a placebo group to see if the probiotic group experiences greater improvements in metabolic, gastrointestinal, and psychological indicators.

Participants will: Take one sachet daily of either B. breve BBr60 (10 billion CFU) or placebo for 8 weeks. Provide blood and stool samples at baseline and week 8. Complete validated questionnaires assessing alcohol dependence, gastrointestinal symptoms, and emotional status.


Eligibility criteria: Inclusion Criteria:

1. Aged 19-45 years;
2. Willing to voluntarily agree to and comply with the trial protocol, and capable of timely participation in screening and follow-up;
3. Have not suffered from gastrointestinal diseases in the past month;
4. Have not taken antibiotics in the past month.

Exclusion Criteria:

1. Individuals under 19 or over 45 years of age, with an allergic constitution or allergy to any component of the test substance, symptoms of alcohol allergy, and pregnant or breastfeeding women;
2. Those who experience discomfort such as diarrhea or bloating after taking the test substance;
3. Patients with serious diseases of the cardiovascular, liver, kidney, hematopoietic systems, autoimmune diseases, endocrine disorders, mental illnesses, existing high blood sugar, or unhealthy gastrointestinal conditions;
4. Those who discontinue the test sample or take other medications midway, making it difficult to judge efficacy or with incomplete data;
5. Recently taken probiotics, prebiotics, or antibiotics related to the function of the test substance, affecting the judgment of results;
6. Individuals with a daily diet that is either too light or too greasy; those with special dietary structures due to weight loss or other reasons (such as a ketogenic diet);
7. Individuals with low body fat, BMI \< 23.

Primary outcomes:
measure: Changes in intestinal flora
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Kang Zou
state: None Selected
Study officials:
References:
Clinical trial NCT03864692: Prediction of Hypotension Using Perfusion Index and Pleth Variability Index After Spinal Anesthesia for C/S
Official title: Prediction of Hypotension Using Perfusion Index and Pleth Variability Index After Spinal Anesthesia for Caesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section Complications
Hypotension
Spinal Anesthesia
Perfusion Index
Pleth Variability Index
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Parturients scheduled for elective low segment caesarean section under spinal anesthesia

Brief summary: Spinal anesthesia for caesarean section is associated with a decrease in systemic vascular resistance and cardiac output and may cause hypotension in a significant portion of the parturients. Hypotension during delivery may cause maternal and fetal complications. If parturients who are likely to develop hypotension after spinal anesthesia can be identified before surgery, anesthesiologists would have opportunity to take measures such as prophylactic vasopressor administration.

Perfusion index (PI) measured by pulse oximetry reflects vasomotor tone which affects the degree of hypotension after spinal anesthesia. This is a non-invasive method of assessing the relative vascular tone with the use of pulse oximeter which calculates the ratio of pulsatile versus the non-pulsatile component of the blood flow. A lower PI indicates greater peripheral vasomotor tone.

Pleth variability index (PVI) is calculated using maximum and minimum values of perfusion index during respiratory cycles. PVI is one of the dynamic indices that can predict fluid responsiveness.

The aim of this study is to investigate whether the PI and PVI values at different patient positions can predict hypotension during caesarean section.


Eligibility criteria: Inclusion Criteria:

* singleton parturient
* planned for elective LSCS under spinal anesthesia

Exclusion Criteria:

* gestational age \< 36 weeks
* emergency cases
* placenta previa, pre-eclampsia
* BMI\>40
* Reynauld disease
* patient refusal
* cardiovascular disease

Primary outcomes:
measure: pleth variability index (PVI)
timeFrame: perioperative
measure: Perfusion index (PI)
timeFrame: perioperative
Secondary outcomes:
measure: heart rate
timeFrame: perioperative
Other outcomes:
measure: Blood pressure
timeFrame: perioperative
Locations:
city: Kahramanmaras
country: Turkey
facility: Kahramanmaras Sutcu Imam University
state: In The USA Or Canada, Please Select...
Study officials:
References: