louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06459089: The Effects of Familiar Toy and Parental Presence Combination on Perioperative Pediatric Anxiety
Official title: The Effects of Familiar Toy and Parental Presence on Perioperative Pediatric Anxiety
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative Anxiety
Emergence Delirium
Keywords: Anxiety State
Familiar Toy
Child Behavior
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 child patients between the ages of 5-12 who will undergo ENT surgery

Brief summary: This study will evaluate the effect of presence of favorite toy and parent during perioperative period on pediatric anxiety and emergence delirium. Half of the patients patients will be accompanied with their ownselected parent and the other half will be accompanied with their favorite toy in addition to their own selected parent.

Detailed description: To reduce the incidence of preoperative anxiety in children, anesthesiologists have used a number of prevention strategies, including sedative premedication, parental presence during anesthetic induction, behavioral preparation programs, music therapy, hypnosis, and acupuncture.One of these distraction tool is familiar toy, children may also be comforted by familiar toys. Therefore, parent presence during perioperative period or playing with a favorite toy seems likely to alleviate preoperative anxiety in children. Until now, combination of these two method to reduce anxiety is not observed in literature. Then, the aim of this observational study is to evaluate the effect of both presence of favorite toy and parental presence compare to only parental presence during perioperative period on anxiety and emergence delirium in patients undergoing ambulatory surgery in our hospital's otorhinolaryngology department.

Eligibility criteria: Inclusion Criteria:

Patients with ASA 1 and 2, Those who have the ability to speak and obey commands will be included.

Exclusion Criteria:

Mentally challenged Deaf Child Cerebral Palsy Premedicated Child Language Problem Unco-operative Previous surgery or anesthesia history

Primary outcomes:
measure: Modified Yale Preoperative Anxiety Scale (mYPAS) of the children undergoing elective surgery under general anesthesia.
timeFrame: Perioperative period
Secondary outcomes:
measure: Evaluation with Pediatric Anesthesia Emergence Delirium Scale (PAED) in the postoperative waiting room
timeFrame: Postoperative 1st day
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Training and Research Hospital
Study officials:
affiliation: Karaman Training and Research Hospital
name: Ayşe Duran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00079989: Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms
Official title: A Phase 3, Open-label, Noncomparative Study of Tigecycline for the Treatment of Subjects With Selected Serious Infections Due to Resistant Gram-negative Organisms Such as Enterobacter Species, Acinetobacter Baumannii, and Klebsiella Pneumoniae
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gram-Negative Bacterial Infections
Keywords: Bacterial Infections
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2004-03-23
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of tigecycline in the treatment of subjects with selected serious infections caused by resistant gram-negative bacteria, eg, Acinetobacter baumannii, Enterobacter species, Klebsiella pneumoniae or other resistant gram-negative pathogens, for whom antibiotics have failed or who cannot tolerate other appropriate antimicrobial therapies. The primary efficacy endpoint will be the clinical response.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 18 years or older
* Isolation of a resistant gram-negative pathogen, eg, Enterobacter species, Acinetobacter baumannii, Klebsiella pneumoniae, or other resistant gram-negative pathogens, alone or as 1 isolate of a polymicrobial infection
* Resistant gram-negative organisms are defined by the likely presence of ESBL or related mechanisms which limit the therapeutic alternatives for the treatment of complicated infections

Exclusion Criteria:

* Subjects with any concomitant condition or taking any concomitant medication that, in the opinion of the investigator, could preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up assessment will be completed or that will substantially increase the risk associated with the subject's participation in this study
* Anticipated length of antibiotic therapy \< 7 days
* Known or suspected hypersensitivity to tigecycline or other compounds related to this class of antibacterial agents (eg, tetracyclines, minocycline, doxycycline)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05916989: Stimulant Use and Methylation in HIV
Official title: Stimulant Use and Methylation in HIV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Methamphetamine-dependence
Methamphetamine Abuse
Keywords: HIV
Methamphetamine
Methylation
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: New York University
name: Northwestern University
name: University of California, San Francisco
name: National Institute on Drug Abuse (NIDA)
First posted: 2023-06-23
Enrollment: 53
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sexual minority men with HIV who use methamphetamine residing in the San Francisco Bay Area.

Brief summary: This study will leverage extracted leukocyte DNA specimens from a completed NIH-funded project to examine the efficacy of a behavioral intervention model that reduced stimulant use on DNA methylation over 6 months.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Documentation of HIV-positive serostatus
* Speak English
* Biological verification of recent methamphetamine use
* Completion of at least three contingency management (CM) visits
* Self reported anal sex with a man in the past 12 months

Exclusion Criteria:

* Inability to provide informed consent, evidenced by cognitive impairment
* HIV negative serostatus

Primary outcomes:
measure: Neuroimmune Signaling
timeFrame: 6 Months
Secondary outcomes:
measure: DNA Methylation Pathways
timeFrame: 6 Months
measure: Immune Dysfunction
timeFrame: 6 Month
measure: Dysregulated Metabolism of Amino Acid Precursors for Neurotransmitters measured via high-performance liquid chromatography (HPLC)
timeFrame: 6 Months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
affiliation: Florida International University
name: Adam W Carrico, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06977789: Comparison of Holter vs S-Patch for Arrhythmia Detection in Older Falls Patient
Official title: Comparison of Holter vs S-Patch for Arrhythmia Detection in Older Falls Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradyarrhythmia
Arrythmia
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
Collaborators: name: Samsung SDS Asia Pacific Pte Ltd
First posted: 2025-05-18
Enrollment: 73
Sex: ALL
Minimum age (years): 60
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to compare Holter versus S patch in a group of elderly patients who are referred to the Geriatrics service in Changi General Hospital for falls from Accident and Emergency department, clinic and wards.

The investigator hope to assess the feasibility, adherence and patient acceptability as an alternative to Holter monitoring. The investigator also hope to learn if S-Patch EX monitoring system can be as effective or equivalent to Holter in the monitoring of arrhythmias and the possibility of deploying it for longer term monitoring of arrhythmias.

Participants who consented to be in this study will be offered S patch and Holter consecutively. Holter will be worn for 24 hours and S patch will be worn for 72 hours. The order which Holter or S patch will be worn first will be determined via randomisation.


Eligibility criteria: Inclusion Criteria:

1. Aged 60 to 120 year old inclusive
2. Refer for Holter testing as part of clinical care
3. Participants with symptoms suspected to be due to bradyarrhythmia. This could include, but not limited to unwitnessed fall, syncope, near syncope.

Exclusion Criteria:

1. Participants who are already known to have significant bradyarrhythmia who would benefit from a permanent pacemaker.
2. Patients unable to tolerate Holter monitoring.

Primary outcomes:
measure: Participant's Compliance
timeFrame: From date of randomization until the day participant completed both device monitoring, assessed up to 4 days.
Secondary outcomes:
measure: Device sensitivity and specificity
timeFrame: 72 hours for S Patch3-Cardio/S-Patch Ex and 24hours for Holter
measure: Durability of the device
timeFrame: 72 hours for S Patch3-Cardio/S-Patch Ex and 24hours for Holter
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Yeo Colin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03885089: Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Psoriasis)
Official title: Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis Vulgaris
Psoriasis Arthropathica
Pustular Psoriasis
Erythrodermic Psoriasis
Keywords: Infliximab
biosimilar
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-03-21
Enrollment: 10
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis treated by Infliximab BS

Brief summary: To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis under actual status of use.

Detailed description: This study will be conducted with all-case investigation system in patients with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis.

This study will be conducted in patients who used this drug after the day of approval of dosage and administration for psoriasis at contracted medical institutions. Patients who used this drug before conclusion of the contract with the medical institution will also be included in this study (retrospective patients will be included).

Therefore, Time Perspective is retrospective and prospective.

Eligibility criteria: Inclusion Criteria:

* Patients with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis who started treatment with this drug
* Patients who received this drug for the first time at the medical institution after the day of launch of this drug.

Primary outcomes:
measure: Incidence of adverse drug reactions
timeFrame: 30 weeks from the day of initial dose
Secondary outcomes:
measure: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response
timeFrame: Week 30
measure: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response
timeFrame: Week 30
measure: Change from Baseline in Body Surface Area (BSA)
timeFrame: Baseline, Week 30
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer Local Country Office
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01238289: Randomized Trial of Peer Led Education-Project Dulce
Official title: Peer-Led Diabetes Education Programs in High Risk Mexican Americans Evaluates Glycemic Control Compared to Standard Approaches: A Project Dulce™ Promotora Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: peer education
diabetes
randomized
trial
Lead sponsor: Scripps Whittier Diabetes Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Center for Research Resources (NCRR)
name: San Diego State University
First posted: 2010-11-10
Enrollment: 207
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the effect of a culturally sensitive diabetes self-management program on glucose control and metabolic parameters in low income Mexican-Americans with type 2 diabetes using the Project Dulce model utilizing a low cost, peer-educator format.

Detailed description: To recruit 207 Mexican-Americans patients from federally-funded community health centers in San Diego County with Hemoglobin A1c (HbA1c) \> 8% and randomize to Project Dulce peer intervention or continuation of standard diabetes care. The primary outcome will be the percent change in HbA1c levels at 10 months following randomization.

Eligibility criteria: Inclusion Criteria:

* Mexican American, men and women, 21-75 years old, who were under-insured patients at federally qualified community health centers in San Diego County with type 2 diabetes and HbA1c \> or = 8%.

Exclusion Criteria:

* Individuals with a physical or mental health condition that would preclude fulfilling the requirements of the study were ineligible to participate, HbA1c \< 8,pregnant with gestational diabetes

Primary outcomes:
measure: mean percent change Hemoglobin A1c (HbA1c)
timeFrame: Baseline, 4 months and 10 months
Secondary outcomes:
measure: Body mass index, blood pressure and lipid changes
timeFrame: Baseline, 4 months and 10 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
Study officials:
affiliation: Scripps Whittier Diabetes Institute
name: Athena Philis-Tsimikas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04990089: VIVO European Observational Registry
Official title: VIVO in a Practical Clinical Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Arrythmia
Ventricular Tachycardia
Premature Ventricular Contraction
Lead sponsor: Catheter Precision. Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-04
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients experiencing ventricular tachycardia (VT) or premature ventricular contractions (PVC) and being considered for or have a scheduled a ventricular ablation procedure.

Brief summary: A multi-center, observational registry conducted in Europe and the UK to prospectively review VIVO in a clinical setting in 125 patients.


Eligibility criteria: Inclusion Criteria:

* Patients must at least 18 years of age Patients who have signed an IRB/EC approved patient informed consent and applicable patient privacy protection authorization per local law
* Patients who have previously had contrast cardiac imaging or will have cardiac imaging ordered per standard of care
* Patients will be selected without regard to gender.

Exclusion Criteria:

• Patients that are unable to receive contrast cardiac imaging (MR or CT)

Primary outcomes:
measure: Measure the effectiveness of VIVO within different types of VA procedures
timeFrame: 1 day
measure: Measure the safety by observing adverse events related to the device and procedure
timeFrame: 1 day
Secondary outcomes:
measure: Effectiveness
timeFrame: 12 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Mater Private Hospital
city: Ascoli Piceno
country: Italy
facility: Mazzoni Hospital
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Lisbon
country: Portugal
facility: La Luz Hospital
city: Leicester
country: United Kingdom
facility: Glenfield University Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe University Hospital
Study officials:
affiliation: Glenfield University Hospital
name: Andre Ng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04142489: In Vivo Damage Induced bu UV in the Epidermis of the Scalp
Official title: Clinical Study of In Vivo Damage Induced bu UV in the Epidermis of the Scalp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Squamous Cell Carcinomas
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 10
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Squamous cell carcinomas (SCC) are the second most common skin cancer in humans. The incidence of SCCs in the USA in 2012 was estimated at 700,000 casesSCCs have a metastatic course in 3% to 5% of cases that is of poor prognosis. In men, the SCCs of the scalp represent the most frequent location of the head and neck, the 3rd location of the whole body. The SCCs of the scalp are more undifferentiated than in other locations. In addition, actinic keratoses of scalp, precursors of SCC, are more resistant to treatment than in other areas. These particularities of the SCCs of the scalp suggest the existence of specific factors at the epidermis level of the scalp.

UV-induced damage to DNA is the defining event in skin photocarcinogenesis. It has already been shown that DNA damage induced by UV and the kinetics of repair of this damage may vary with age or phototype of patients, but the topographic variation of DNA damage has never been studied, although it is known that gene expression in skin cells may differ from one region of the body to another.

the hypothesis is therefore that the particular characteristics of KAs and SCCs at the scal level could be explained by an increased sensitivity to UV-induced damage. It is planned to study UV-induced damage and its repair at the scalp level in humans compared to the forearm.


Eligibility criteria: Inclusion Criteria:

* Male subject
* Subject aged 40 to 60 years
* Subject of phototype III or IV
* Subject with no skin lesions on the scalp and forearms
* Subject who has not been exposed to the sun for at least 1 month
* Subject affiliated to social security
* Subject who signed the informed consent form

Exclusion Criteria:

* Subjects with photosensitivity,
* Subject taking photosensitizing drugs
* Subjects with a history of skin cancer
* Subjects with abnormal healing
* Subjects with immunosuppression

Primary outcomes:
measure: number oh epidermal cells positives
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice Hospital
Study officials:
References:
Clinical trial NCT06973889: Evaluation of IgY Antibody Efficacy in Egg Yolk Against Helicobacter Pylori in Bacterial Elimination and Clinical Symptoms Improvement of Gastrointestinal Patients
Official title: Evaluation of IgY Antibodies Effectiveness in Egg Yolk Against Helicobacter Pylori in Removing Bacteria and Improving Clinical Symptoms in the Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HELICOBACTER PYLORI INFECTIONS
Gastrointestinal Disease
Keywords: IgY
Helicobacter pylori
clinical trial
Antibody
gastrointestinal disease
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Investigating its effectiveness in removing bacteria in invivo conditions
2. Investigating the effectiveness in improving the clinical symptoms of patients


Eligibility criteria: Inclusion Criteria:

* Patients with gastritis or stomach ulcers whose Helicobacter infection has been confirmed by a doctor and age group 18 to 78 years, all genders, if accepted

Exclusion Criteria:

* Acute perforation of esophagus, stomach and duodenum Hyperlipidemic people Those who are allergic to egg proteins Patients with stomach cancer

Primary outcomes:
measure: Respiratory urea level (UBT) higher than cut off 50
timeFrame: Determination of respiratory urea (UBT) at the beginning of the study and 8 weeks after the start of the intervention
Secondary outcomes:
measure: Examining the patient's clinical symptoms including: abdominal pain, nausea, vomiting and bloating.
timeFrame: During the treatment period for 4 weeks from the beginning of the intervention.
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad University of Medical Sciences
state: Khorasan
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad university of medical sciences
state: Khorasan
Study officials:
References:
citation: Suzuki H, Nomura S, Masaoka T, Goshima H, Kamata N, Kodama Y, Ishii H, Kitajima M, Nomoto K, Hibi T. Effect of dietary anti-Helicobacter pylori-urease immunoglobulin Y on Helicobacter pylori infection. Aliment Pharmacol Ther. 2004 Jul;20 Suppl 1:185-92. doi: 10.1111/j.1365-2036.2004.02027.x.