louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03014921: Impact of Iron Injection on Blood Donation
Official title: Effet de l'Injection de Fer Sur la Donation Sanguine, étude randomisée et contrôlée
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Iron Deficiency
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Vaudois
First posted: 2017-01-09
Enrollment: 19
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This trial study and compare in blood and urinary matrices the impact of an iron injection on proteins involved in iron metabolism during a blood donation. The goal is to study the impact of an iron injection on detection markers of a blood donation in the anti-doping field

Detailed description: This study aim to investigate the impact of an iron injection on the proteins involved in iron metabolism during blood donation and to compare the blood and urinary matrix. A messenger RNA profiling will be performed as well. The goal is to investigate the impact of iron injection on the markers of blood donation detection in the anti-doping field.

The study will take place over a period of 8 weeks.

Volunteers will be randomly assigned to two groups. Randomization will be provided by a software made for this purpose. An injection of 500 mg of iron in 250mL of saline solution or a placebo injection containing only the saline solution will be performed. Standard blood sampling (in the arm) and finger prick blood sampling will be carried out. After that, 500 mL blood donation will be done. Standard blood sampling and finger prick blood sampling will be performed before and after the donation.

The study will be done in "simple blind", meaning that volunteers will not know if they get iron or saline solution.

On the days of iron or saline solution injection and blood donation, blood sampling will be done up to 12 hours after the injection. After that, blood sampling will be scheduled up to 30 days after blood donation at a rate of once a day (except for the weekends).

Eligibility criteria: Inclusion Criteria:

* Male between 20 and 35 yo
* BMI between 18 and 30
* Ferritin \< 50ug/l
* Transferrin saturation \< 20 if ferritin between 20 and 50ug/l

Exclusion Criteria:

* high level athlete
* blood donation within 6 months before the study
* liver disorder

Primary outcomes:
measure: Serum ferritin level variations due to iron injection or blood donation
timeFrame: 8 weeks
Secondary outcomes:
measure: Hemoglobin level variations due to iron injection or blood donation
timeFrame: 8 weeks
measure: Reticulocyte% variations due to iron injection or blood donation
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05269121: Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections
Official title: An Open-Label Multicenter Study to Evaluate the Safety and Efficacy of PhageBank™ Phage Therapy in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) for Patients With First Time Culture Proven Chronic Prosthetic Joint Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Prosthetic Joint Infection
Bacterial Infections
Keywords: Prosthetic
Joint
Knee
Hip
Phage
Bacteriophage
Prosthetic Joint
DAIR
Lead sponsor: Adaptive Phage Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will test the feasibility of a regimen of intraoperative (IO) and intravenous (IV) PhageBank™ bacteriophage therapy in conjunction with a DAIR procedure to cure chronic prosthetic joint infection (PJI) without replacement of the prosthesis.

Detailed description: This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections of the hip or knee caused by 1 or 2 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae.

This study will compare the safety and efficacy of phage therapy in conjunction with standard of care antibiotics and a DAIR procedure.

Eligibility criteria: Inclusion Criteria:

* Males or females ≥18 years of age.
* Stopped or not received SAT for 2 weeks
* Female patients of childbearing potential who agree to use contraception.
* First time chronic prosthetic joint infection
* Confirmed phage match
* No anticipated need for long-term antibiotics

Exclusion Criteria:

* Soft tissue defect requiring reconstruction.
* Hardware misalignment
* Additional orthopedic hardware in connection with the infected prosthesis.
* Active infection
* Unable to tolerate SAT
* Septic shock or hemodynamic instability.
* Chronic kidney disease
* Liver disease
* Decompensated heart failure.
* Positive drug screen
* Receiving chemotherapy
* Immunocompromised
* Antiviral treatment within 2 weeks prior to DAIR
* Currently participating in another clinical trial
* Known phage allergy
* Pregnant/ breastfeeding
* Lack of capacity to consent

Primary outcomes:
measure: To evaluate safety and tolerability of phage therapy in adult patients undergoing DAIR for first time chronic prosthetic knee or hip infection
timeFrame: Day 1 through Week 24
measure: Treatment success
timeFrame: 13 months after DAIR
Secondary outcomes:
measure: No recurrence or evidence of infection for any reason
timeFrame: 3, 6, 13, or 24 months after DAIR
Other outcomes:
Locations:
Study officials:
affiliation: Adaptive Phage Therapeutics, Chief Medical Officer
name: Robert Hopkins, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04272021: Multi Neuro-functional Biomarkers for Monitoring the Effects of Treatments in ADHD Children
Official title: Multi Neuro-functional Biomarkers for Monitoring the Effects of Treatments in ADHD Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: MIMOSA study aims to characterize from behavioral, neurophysiological and neurocognitive perspectives children and adolescents with attention deficit hyperactivity disorder (ADHD), in order to identify a possible biomarker of response to medication treatments. To achieve this aim, in the study children with ADHD (drug naive) are recruited and undergo behavioral and clinical screenings, neurocognitive profile, and neurophysiological evaluation with functional near infrared spectroscopy (fNIRS). ADHD group is evaluated before the beginning of medications, at first dose of medication (only imaging evaluation fNIRS), and after a period of two/three months of continuous treatment with medication.


Eligibility criteria: Inclusion Criteria:

* diagnosis of ADHD according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) criteria;
* drug naive

Exclusion Criteria:

* presence of intellectual disability, neurological diseases, epilepsy, genetic syndromes
* and previous treatment with psychoactive drugs

Primary outcomes:
measure: ADHD rating scale
timeFrame: 2-3 months
Secondary outcomes:
measure: CGI-S
timeFrame: 2-3 months
Other outcomes:
measure: Change in functional neuroimaging
timeFrame: 2-3 months
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS Eugenio Medea
Study officials:
References:
Clinical trial NCT00472121: The Precision and Arm-to-Arm Variation of Mechanomyography and Acceleromyography for Monitoring of Neuromuscular Block
Official title: The Precision and Arm-to-Arm Variation og Mechanomyography and Acceleromyography for Monitoring the Neuromuscular Block During Anesthesia, A Randomized Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Blockade
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2007-05-11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of the study is the examine the precision of acceleromyography and mechanomyography during recovery from a neuromuscular blocking agent and to examine whether there is any difference in monitoring block at the dominant or non-dominant arm. Our hypothesis is that there is no significant difference in neither the precision nor the level of block in the contralateral arms.


Eligibility criteria: Inclusion Criteria:

* ASA I-III
* General anesthesia \>1 hour
* Surgery in supine position w. possibility of monitoring the neuromuscular block at both arms (n. ulnaris stimulation/thumb response)
* Written informed content

Exclusion Criteria:

* Neuromuscular disorders, hepatic and renal dysfunction
* Medication expected to interfere with the neuromuscular blocking agent
* Allergy to any medication used during anaesthesia
* Body weight less or exceeding 20% of ideal body weight
* Pregnancy or breastfeeding

Primary outcomes:
measure: Precision at the contralateral arms using the average residual coefficient of variation over subsequent linear regressions (detrending) over time
Secondary outcomes:
measure: Bias and limits of agreement between control TOF, reappearance of T1, T2, T3, T4
measure: T1 height at reappearance of T1-T4
measure: Time to T1=25%
measure: Interval 25-75%
measure: Time to TOF 0.9 and 1.0 with and without normalization
measure: Time to stable T1 and stable TOF
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dep. of Anaesthesia
Study officials:
affiliation: Dep. of anaesthesia 4231, Rigshospitalet
name: Casper C Kjær, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Claudius C, Skovgaard LT, Viby-Mogensen J. Arm-to-arm variation when evaluating neuromuscular block: an analysis of the precision and the bias and agreement between arms when using mechanomyography or acceleromyography. Br J Anaesth. 2010 Sep;105(3):310-7. doi: 10.1093/bja/aeq162. Epub 2010 Jun 30.
Clinical trial NCT06040021: Distinct Metastatic Phenotypes Between Early-onset and Late-onset Colorectal Cancer
Official title: Integrated Analysis of Multi-center Cohorts and Bulk RNA-sequencing Data Reveal Distinct Metastatic Phenotypes Between Early-onset and Late-onset Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early-onset Colorectal Cancer
Late-onset Colorectal Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 15244
Sex: ALL
Minimum age (years): 16
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with colorectal cancer hospitalized in Fudan university Shanghai cancer center.

Brief summary: The clinical and pathological features of early-onset colorectal cancer (EOCRC) differ from those of late-onset colorectal cancer (LOCRC). Our research aims to thoroughly elucidate the distinctions between them by analyzing clinical prognosis, metastatic patterns, gene expression, and genomic mutation profiles. Our deliberation will uncover latent strategies for personalized therapeutic of both EOCRC and LOCRC.


Eligibility criteria: Inclusion Criteria:

* The initial diagnosis of colonoscopy and pathology belongs to colorectal cancer;
* Patients should sign an informed consent form after fully understanding the purpose, procedures and potential risks of the study, indicating their voluntary participation in the research.

Exclusion Criteria:

* Patients with obvious local or systemic severe infection;
* Acute abdomen: intestinal obstruction, peritonitis, intestinal perforation;
* Have a systemic underlying disease that has not been controlled, or is unstable;
* Patients with poor physical fitness or serious other organic diseases who cannot tolerate anesthesia and surgery;
* Women during pregnancy, perinatal and lactation;
* Patients with severe mental disorders (such as schizophrenia, bipolar disorder, etc.) or patients who are mentally incapable or unable to understand the requirements for participation in the study.

Primary outcomes:
measure: OS
timeFrame: 5 years after intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00005921: A Study of the Side Effects of L-743,872 in Men With Candidal Esophagitis
Official title: An Open, Serial-Panel, Multiple-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of L-743,872 in Patients With Candida Esophagitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Candidiasis, Esophageal
HIV Infections
Keywords: Dose-Response Relationship, Drug
Antifungal Agents
Candidiasis
Esophageal Diseases
MK 0991
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe to give L-743,872 to men with candidal esophagitis, an AIDS-related yeast infection in the esophagus.

Detailed description: In this open-label study, patients receive intravenous L-743,872 every 24 hours at one of three dose levels for 14 days. Post-study safety evaluations continue for 4 weeks after the final dose. Pharmacokinetics and safety measurements are taken throughout the 6-week study.

Eligibility criteria: Inclusion Criteria

You may be eligible for this study if you:

* Are an 18- to 65-year-old man with candidal esophagitis.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rahway
country: United States
facility: Gary Calandra
state: New Jersey
Study officials:
References:
Clinical trial NCT03373721: Gut Microbiota of Preterm Infants and Full-term Infants at Early Life
Official title: Gut Microbial Succession of Preterm Infants and Full-term Infants at Early Life
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preterm Infant
Gut Microbiome
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 102
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: About 50 preterm infants and 50 full-term healthy infants

Brief summary: The aim of this study is to obtain a longitudinal view of the gut microbial establishment of a cohort of 51 preterm (PT) infants compared to 50 full-term (FT) infants from birth to 90 days of age, and to identify key clinical factors that affect the establishment of neonatal microbiome.

The hypothesis of the investigators is that the gut microbiota progression of PT group and FT group is different in diversity and composition. Antibiotics and its usage duration is likely the main factor disturbing the colonization and development of the gut microbiome of PT infants.

Detailed description: Premature birth is a global clinical problem. Early colonization and development of the neonatal gut microbiome is critically important with a profound impact on the host lifelong health. V3-V4 region of 16S rRNA amplicons of 581 stool DNA will be sequenced from a cohort of 51 PT infants and 50 FT infants to examine the microbial profiles. A random-effects generalized least square regression model is used to compare the difference in the main bacterial groups over time with the adjustment for multiple variables including gestational age and use of antibiotics .

Eligibility criteria: Inclusion Criteria:

Preterm infants

1. gestational age \<37 weeks;
2. no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis;
3. hospital stay \> 7 days;

Exclusion criteria:

1. NICU stay less than 7 days
2. Necrotizing enterocolitis infant

Control group:

1. Full-term healthy infants;
2. gestational age \>37 weeks;
3. vaginally born;
4. no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis.

Primary outcomes:
measure: changes in gut microbiota over time and in relation to antibiotic treatment
timeFrame: 0-7 years after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of NICU, XinHua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Jie Jia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05187221: Prevalence and Sequelae of Computer Vision Syndrome in Egyptian Universities
Official title: Visual, Ocular Surface and Extraocular Diagnostic Criteria for Prevalence of Computer Vision Syndrome: A Cross-sectional Smart-survey Based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Computer Vision Syndrome
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 8085
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: medical students or staff who are using screens in their medical studies or personal lives and how these screens affect their medical studies and the effect of mandated medical computer use if present on their screen-behaviour and associated risk factor

Brief summary: CVS-F4 questionnaire will be used as an instrument to survey CVS prevalence and severity among medical students

Detailed description: CVS-F4 (30 questions) will be an online survey via the SurveyMonkey Company. We will collect the responses and analyze the results. Informed consent will be obtained from the participants as an item within the survey itself that he/she agrees to use his/her data in this research work. The questionnaire includes questions regarding potential ocular, extra-ocular, musclo-skeletal and neuro-psychatric complains caused by CVS. Complete statistical analysis of the survey data will be done using univariate and multivariate logistic and linear regression analysis. The CVS diagnosis will be based on the 5 diagnostic criteria (5DC) to create a new short self-assessment questionnaire for accurate prevalence of CVS.

Eligibility criteria: Inclusion Criteria:

* university students
* university staff members

Exclusion Criteria:

* ocular surgery
* amblyopia
* anisometropia
* strabismus
* systemic disease

Primary outcomes:
measure: Number of participants suffering from CVS
timeFrame: 3 months
measure: Rate of CVS symptoms-attacks
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag,
country: Egypt
facility: Faculty of medicine
state: Sohag
city: Sohag
country: Egypt
facility: Faculty of medicine
Study officials:
affiliation: Professor of Ophthalmology
name: Mohammed Iqbal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01683721: Post-Market Observational Study of the WINX Sleep Therapy for the Treatment of Obstructive Sleep Apnea (OSA)
Official title: The UNMASK Study: A Post-Market Longitudinal Observational Study of the WinxTM Sleep Therapy System for the Treatment of Obstructive Sleep Apnea (OSA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Lead sponsor: ApniCure, Inc.
Sponsor class: INDUSTRY
First posted: 2012-09-12
Enrollment: 1000
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: Subjects with obstructive sleep apnea (OSA)

Brief summary: The objective of the Study is to observe the use and utility of the Winx Sleep Therapy System in a clinical practice, for the treatment of patients with obstructive sleep apnea (OSA).


Eligibility criteria: Exclusion Criteria

* Has a severe respiratory disorder, such as severe lung disease, pneumothorax, etc.
* Has loose teeth or advanced periodontal disease.
* Is under the age of 18.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Petersburg
country: United States
facility: St. Petersburg Sleep Disorders Center
state: Florida
city: Dallas
country: United States
facility: Sleep Medicine Associates of Texas (SMAT)
state: Texas
Study officials:
References:
Clinical trial NCT05162521: The Impact of Lower Limb Fractures on Body Mass Index (BMI)
Official title: The Impact of Lower Limb Fractures on Body Mass Index (BMI)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fracture
Lead sponsor: Kuwait Institute for Medical Specialization
Sponsor class: OTHER_GOV
First posted: 2021-12-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with lower limb fractures

Brief summary: The study will prospectively follow patients with lower limb fractures to assess changes in weight after injury


Eligibility criteria: Inclusion Criteria:

* Adults with lower limb fractures

Exclusion Criteria:

* Polytrauma
* Upper limb fractures
* No consent
* Lack of follow up
* Patients opting for weight management treatments
* Patients with pre-existing mobility status impairment

Primary outcomes:
measure: The impact of lower limb fractures on body mass index (BMI)
timeFrame: Change in weight over one year at different time intervals
Secondary outcomes:
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: AlRazi Orthopedic Hospital
Study officials:
References:
Clinical trial NCT01401621: The Effect of a Scratch Off Prompt on Health Engagement
Official title: The Effect of a Scratch Off Prompt on Health Engagement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure Check (Hypertension Screening)
Cholesterol Test (Lipid Disorder Screening)
Keywords: behavioral economics
nudge
scratch off
blood pressure check
cholesterol test
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2011-07-25
Enrollment: 84953
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: The goal of this project is to determine whether prompting the recipient of a health reminder mailing to scratch off targeted area.

Detailed description: The investigators will randomly assign individuals with different scratch off messages to 3 groups. The investigators are interested in whether the scratch off message will result in an increase in compliance with the recommended health behavior.

Eligibility criteria: Inclusion Criteria:

* Indications according to Spring 2011 CDC criteria for a blood pressure check
* Indications according to Spring 2011 CDC criteria for a cholesterol test
* Employee at partner corporation that implemented the study

Primary outcomes:
measure: Number of Participants that schedule an appointment for receipt of the relevant test
timeFrame: up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Katherine L Milkman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: