louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04976114: Reducing Preoperative Anxiety in Parents of Surgical Patients
Official title: Reducing Preoperative Anxiety in Parents of Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 140
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomised and blind clinical trial. The parents could be randomly assigned to the control group, and received the standard procedure, or to the experimental groups. Three experimental groups were possible regarding the various types of interventions: story book (IG1), video (IG2), or both instruments (IG3)
Primary purpose: TREATMENT

Brief summary: Aims and objectives: To investigate preoperative anxiety in parents of paediatric surgical patients, testing whether the provision of information (using video and story books) regarding the surgical process can impact on reducing anxiety. Analyse if some personal factors influence the reduction of anxiety.

Background: Attending a surgical theatre generates anxiety in all types of patients, especially in the case of children. The effect of different preoperative intervention procedures in children that attempt to reduce their anxiety level have been studied a great deal. However, although their parents also suffer high anxiety levels, potential intervention to reduce their levels have not received the same attention.

Study design: Randomised Clinical trial Methods: One hundred and twenty-five parents of children (8-12 y.o.) undergoing surgery in Hospital Universitario Central de Asturias hospital (Oviedo, Spain) were randomly assigned to the control group (34 individuals) or one of the 3 experimental groups (91). After the pre-anaesthesia consultation, children and parents of the experimental groups were provided with a story book, a video with additional information of nursing, or both. In the antechamber of the operating room and prior to the surgical intervention, the State Anxiety and Trait Anxiety of the parents and children were measured using the STAI and STAIC questionnaires respectively. The data collection, including different demographic variables was carried out for 12 months starting in October 2016


Eligibility criteria: Inclusion Criteria:

* Undergoing surgery at Asturias Central Hospital

Exclusion Criteria:

* Children not in the age range,
* Emergency surgery,
* Children not able to understand or read
* Parents not present or refused to participate.

Primary outcomes:
measure: Anxiety level
timeFrame: Presurgery, just the moment before to surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02146014: Effects of Transcranial Direct Current Stimulation on Cigarette Addiction
Official title: Effects of Transcranial Direct Current Stimulation of the Prefrontal Cortex on Cigarette Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Addiction
Keywords: cigarette smoking, smoking
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2014-05-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tobacco addiction is treatable with behavioral and pharmacological means, but results are often less than optimal. Transcranial direct current stimulation is a new non-invasive technique that applies weak electrical currents through the skull and has been shown to alter the excitability of certain brain areas. It is currently being tried in disorders where there is abnormal brain excitability, such as epilepsy and depression. A few studies have also been able to diminish drug craving, suggesting that brain excitability might also be altered in drug addiction.

This study aims at non-invasively changing the excitability of certain brain areas-a procedure called neuromodulation- in order to help smokers quit smoking more easily.


Eligibility criteria: Inclusion Criteria:

* smokers

Exclusion Criteria:

* use of psychoactive drugs
* age above 70

Primary outcomes:
measure: Change in Visual Analogue Scale of Cigarette Craving
timeFrame: Before and 7 days after treatment
Secondary outcomes:
measure: Change in Visual Analogue Scale of Motivation to Quit Smoking
timeFrame: Before and 7 days after intervention
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Hospital Universitário de Brasília- HUB
state: DF
Study officials:
affiliation: University of Brasilia
name: Raphael Boechat-Barros, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vitor de Souza Brangioni MC, Pereira DA, Thibaut A, Fregni F, Brasil-Neto JP, Boechat-Barros R. Effects of Prefrontal Transcranial Direct Current Stimulation and Motivation to Quit in Tobacco Smokers: A Randomized, Sham Controlled, Double-Blind Trial. Front Pharmacol. 2018 Jan 26;9:14. doi: 10.3389/fphar.2018.00014. eCollection 2018.
Clinical trial NCT06741514: A Study of Precice Intramedullary Limb Lengthening System (IMLL) Limb Lengthening Procedures
Official title: A Clinical Benefits Survey Study of Precice Intramedullary Limb Lengthening System (IMLL) Limb Lengthening Procedures
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Limb Length Discrepancy
Keywords: Precice
limb lengthening
limb lengthening discrepancy
surgery
index bone
femur
tibia
limb length
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2024-12-19
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents or legal guardians of patients who were enrolled in the Precice IMLL arm of the retrospective data collection study (NUVA.IMLL0723).

Brief summary: The Sponsor is conducting a survey to understand how parents or legal guardians feel about the benefits of using the Precice IMLL System to lengthen limbs in children who are 12 years old or younger.

Detailed description: All participants in this survey study will be the parent or legal guardian of a child who previously underwent surgery for limb length discrepancy according to the practitioner's standard of care, was 12 years of age or younger at the time of surgery, and is enrolled in the Precice IMLL arm in protocol NUVA.IMLL0723. The parent or legal guardian will be familiar with the patient's preoperative and postoperative condition, surgical treatment, postoperative care, and clinical outcomes.

Each parent or legal guardian will complete the perceived clinical benefits survey questionnaire once. The survey will be administered as either a paper-based questionnaire via mail or over the phone or an electronic questionnaire completed via a secure online application.

Eligibility criteria: Inclusion Criteria:

* To be eligible for inclusion in this perceived clinical benefit survey study, the following inclusion criteria must be met:

  1. Participants must be a parent or legal guardian of a subject already enrolled in the Precice IMLL arm of the study, "A Retrospective Review of the Clinical and Radiographic Outcomes Following the Use of the Precice Intramedullary Limb Lengthening System (IMLL) in Pediatric Limb Lengthening Procedures" (NUVA.IMLL0723).
  2. The parent or legal guardian must be familiar with the patient's preoperative and postoperative condition, surgical treatment, postoperative care, and clinical outcomes.
  3. Informed consent from the parent or legal guardian of the patient is required for participation.

Exclusion Criteria:

* There are no exclusion criteria.

Primary outcomes:
measure: Perceived clinical benefits of the Precice Intramedullary Limb Lengthening (IMLL) Survey System
timeFrame: 1 year post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Childrens Hospital
state: Ohio
Study officials:
affiliation: Globus Medical Inc
name: Medical Affairs Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04610814: Blood Transfusion by Boston MedFlight Registry
Official title: Blood Transfusion by Boston MedFlight Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemorrhagic Shock
Keywords: Blood transfusion
Pre-hospital care
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Boston MedFlight
name: Boston Medical Center
name: Tufts Medical Center
name: Lahey Clinic
name: Beth Israel Deaconess Medical Center
First posted: 2020-11-02
Enrollment: 500
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: Any patient being transported by Boston MedFlight with hemorrhagic shock

Brief summary: The primary aim of this observational registry is to study the outcomes of patients with hemorrhagic shock transported by Boston MedFlight receiving blood products during transport.

Detailed description: Boston MedFlight, a critical care transport organization, based on a consortium of the academic medical centers in Boston, will begin carrying PRBC in 2019. The program is intended to provide BMF clinicians with 24-hour immediate access to appropriate blood products to be utilized if needed for patients following life-threatening illness or injury. The four fundamental goals of this program are: save lives' ensure transfusion safety; minimize blood product waste; and conduct continuous quality assurance. Our goal is to observationally evaluate this new protocol of administering blood products in the pre-hospital setting. We will collect data on patients with hemorrhagic shock being transported by Boston MedFlight, who receive or would have been eligible to receive pre-hospital blood transfusion by the inclusion criteria.

Eligibility criteria: Inclusion criteria:

* Adult patients who would be eligible to receive blood products;

  * systolic blood pressure \<90 mmHg
  * a shock index of \> 0.9
  * clinical signs of shock as determined by the transport clinicians.

Exclusion Criteria:

* Age \< 18 years old

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital and Boston MedFlight
name: Susan R Wilcox, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04330014: Factor Affecting Childhood Immunization Among Childern.
Official title: Factor Affecting Childhood Immunization Among Childern Below Two Years
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child Immunization
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: childern below two years

Brief summary: The aim of study to evaluate the factor affecting underutalization of childhood vaccination immunization among childern below two years of age.

Detailed description: Childhood vaccination has proven to be one of the most effective public health strategies to control and prevent disease.1-5 In an effort to reduce childhood morbidity and mortality, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) issues annual recommendations and guidelines for childhood and adolescent immunizations.2,6-8 However, some parents decline or delay vaccinating their children or follow alternative immunization schedules because of medical, religious, philosophical, or socioeconomic reasons.2,3,4,5,7,9-12Health care provider-based interventions have been suggested to overcome such vaccine noncompliance, including patient counseling; improving access to vaccinations; maximizing patient office visits; offering combination vaccines; and using electronic medical records (EMRs) and practice alerts.2,3,4,7,10,11 Community- and government-based interventions to improve parent and patient adherence include public education and reminder/recall strategies, financial incentives, and providing alternative venues for vaccination.2,7.

Eligibility criteria: Inclusion Criteria:

* All childern in first two years of life who admmitted in hospital or out patient clinic.

Exclusion Criteria:

* : Immunodeficiency (e.g chemotherapy,long term immuno suppressive therapy, hematologic tumor).

Primary outcomes:
measure: Comparison between childern below two years who took vaccinations and those who didnot.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mohamed Mahmoud, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Ismail Lotfy, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04024514: Renal Protocol Protection in CKD Patients
Official title: Development of Renal Protection Protocol Using Low Dose Contrast Media and Spectral Computed Tomography in Chronic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HCC
CKD
Keywords: CT
Spectral
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to investigate whether acceptable image quality is achievable using low contrast media dose and low keV imaging in chronic kidney disease.


Eligibility criteria: Inclusion Criteria:

* High risk group for developing HCC
* Scheduled contrast-enhanced CT for HCC diagnosis or surveillance
* chronic kidney disease (Estimated GFR \< 60mL/min/1.73m2)

Exclusion Criteria:

* not a high risk group for developing HCC
* congestive hepatopathy
* on dialysis
* no venous access on forearm
* anticipated beam hardening artifact due to prosthesis
* relative/absolute contra-indication of contrast-enhanced CT except CKD (Estimated GFR \< 60mL/min/1.73m2)

Primary outcomes:
measure: Overall image quality
timeFrame: 6 months after complete enrollment
Secondary outcomes:
measure: Contrast media (CM) dose
timeFrame: 3 months after complete enrollment
measure: Incidence of Contrast media-induced nephrotoxicity
timeFrame: 3 days after contrast media administration
measure: Image contrast
timeFrame: 12 months after complete enrollment
measure: Lesion conspicuity
timeFrame: 12 months after complete enrollment
measure: lesion (HCC) detection
timeFrame: 12 months after complete enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04317014: the Association Between Obesity and Early Puberty
Official title: Polymorphisms in Obesity-related Genes Are Associated With Risk of Early Puberty in Han Chinese Girls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Puberty
Lead sponsor: Shenzhen Center for Disease Control and Prevention
Sponsor class: OTHER_GOV
First posted: 2020-03-20
Enrollment: 628
Sex: FEMALE
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese Han girls from Shenzhen Children's Hospital or monitoring schools in Shenzhen

Brief summary: childhood obesity and early puberty are closely related, but existing reports usually focus on their relationship from the perspective of phenotype. This study was designed to investigate the association between obesity-related genic polymorphisms and the risk of early puberty in Chinese Han girls.

Detailed description: the genotypes of obesity-related SNPs were determined and the unstimulated luteinizing hormone, follicle stimulating hormone and estradiol levels were also detected.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of central precocious puberty or early and fast puberty.

Exclusion Criteria:

* The participants who were not the first visit to the hospital and had been treated before.
* The participants who were with endocrine disorders.

Primary outcomes:
measure: genotypes of SNPs in the obesity-related genes
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00492414: Costs of Lost Productive Time Among Korean Workers With Panic Disorder and Effect of Treatment With Paroxetine Controlled Release
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Panic Disorder
Keywords: Panic disorder (PD)
Lead sponsor: Inje University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2007-06-27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Panic disorder(PD)is a disabling psychiatric condition associated with significant impairment in psychosocial, occupational functioning and quality of life, as mentioned by mogotsi et al. So, most patients with panic disorder suffers from the consequences of the impairment in occupational function. This impairment is not only individual problem, but also social one. Since productivity is very important item required to employees, lost productive time among workers with psychiatric illness should be reduced by the proper management. But few data were reported in this field by now.


Eligibility criteria: Inclusion Criteria:

1. Male or female outpatients aged 20-50 years
2. In female, is eligible to enter this study if she is if

   * Non-childbearing potential(note:women who are 6 months post-menopausal are not considered women of child-bearing potential)
   * child-bearing potential, has a negative urine dipstick pregnancy test, and is practicing a clinically acceptable method of contraception such as oral contraception, surgical sterilization, I.U.D.,systemic contraception, or double barrier contraception(any two of diaphragm/spermicidal foar/condom)
3. Subject currently meets the diagnosis for PD according to korean version of Anxiety Disorder Interview Schedule for DSM-IV(ADIS-IV) through a comprehensive psychiatric evaluation and not being treated currently.
4. Subject must have the ability to comprehend the key components of the consent form and provide informed consent.

Exclusion Criteria:

1. Subject who has a history of any other major medical or psychiatric illnesses except PD or PD with major depressive disorder.
2. Subject who retired or left his job or who plan to retire within two years.
3. is a current homicidal or suicidal risk in the investigator's judgement.
4. is currently pregnant, lactating or planning to become pregnant within the next 3 months
5. is currently participating in any other clinical trial or taking any non-approved or experimental medication.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Paik Hospital, Inje University
Study officials:
affiliation: Seoul Paik Hospital, Inje University
name: Jong-Min Woo, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03821714: Effects of Glucocorticoid Combined With Vitamin C and Vitamin B1 on Microcirculation in Severe Septic Shock
Official title: Effects of Glucocorticoid Combined With Vitamin C and Vitamin B1 Versus Hydrocortisone Alone on Microcirculation in Severe Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Keywords: septic shock
glucocorticoid
vitamin C
microcirculation
Vitamin B1
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 22
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: TREATMENT

Brief summary: This study aimed to investigate the effect of Glucocorticoid combined with vitamin C and vitamin B1 versus hydrocortisone alone on microcirculation in septic shock patients.

Detailed description: This prospective, double-blind, randomized, controlled trial enrolled septic shock patients admitted to the intensive care unite of a tertiary teaching hospital. We randomly assigned the enrolled patients to the treatment group (hydrocortisone combined with vitamin C and vitamin B1 added to standard care) and the control group (hydrocortisone alone added to standard care) in a 1:1 ratio. The primary outcome was perfusion vascular density (PVD) at 24 hours after treatment. We used the sublingual microcirculation imaging system to monitor PVD. We further validated the primary outcome by observing differences in renal perfusion monitored by renal contrast-enhanced ultrasound (CEUS) between the treatment group and the control group.

Eligibility criteria: Inclusion Criteria:

1. Septic shock
2. A dose of norepinephrine (\>15ug/min)
3. Age ≥18 and ≤80 years old
4. Signing Informed Consent

Exclusion Criteria:

1. Meet the inclusion criteria for more than 12 hours
2. Clinician judges that corticosteroid therapy should not be used
3. Pregnant
4. Uncontrolled malignancy
5. Glucocorticoid therapy was used within seven days before admission.
6. Expected death within 24 hours
7. The sublingual microcirculation cannot be measured

Primary outcomes:
measure: Perfused vessel density (PVD)
timeFrame: 24 hours after treatment
Secondary outcomes:
measure: proportion of perfusion vessels
timeFrame: 24 hours after treatment
measure: total vascular density
timeFrame: 24 hours after treatment
measure: microvascular flow index
timeFrame: 24 hours after treatment
measure: renal contrast-enhanced ultrasound parameters
timeFrame: 24 hours after treatment
measure: lactate
timeFrame: 24 hours after treatment
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Zhongda Hospital, Southeast University
state: Jiangsu
Study officials:
affiliation: Southeast University
name: Jingyuan Xu, PhD
role: PRINCIPAL_INVESTIGATOR
References: