louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03044678: School Based Prevention for Childhood Anxiety
Official title: School Based Prevention for Childhood Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 109
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was designed to conceptualize a school-based prevention program or childhood anxiety.

Detailed description: This is a project corresponding to a career development grant. The main goal of the proposed research was to identify potential barriers to implementing a school-based anxiety preventive intervention, identify strategies to overcome these barriers, and use this information to test a school-based indicated intervention for child anxiety.

Eligibility criteria: Inclusion:

Borderline child anxiety levels based on the Spence Child Anxiety Scale

Exclusion:

Externalizing problems (based on teacher nominations) more severe than Spence Child Anxiety Scale borderline levels

Primary outcomes:
measure: Change in child anxiety symptoms (clinical)
timeFrame: Change from baseline to 12-month follow-up
measure: Change in child anxiety levels (typical)
timeFrame: Change from baseline to 12-month follow-up
Secondary outcomes:
measure: Changes in child negative cognition
timeFrame: Change from baseline to immediate posttest (at 6-weeks)
measure: Changes in child negative cognition
timeFrame: Change from baseline to 12-month follow-up
measure: Changes in emotion understanding and expression
timeFrame: Change from baseline to immediate posttest (at 6-weeks)
measure: Changes in emotion understanding and expression
timeFrame: Change from baseline to 12-month follow-up)
measure: Changes in self efficacy
timeFrame: Change from baseline to immediate posttest (at 6-weeks)
measure: Changes in self efficacy
timeFrame: Change from baseline to 12-month follow-up)
measure: Changes in child social skills
timeFrame: Change from baseline to immediate posttest (at 6-weeks)
measure: Changes in child social skills
timeFrame: Change from baseline to 12-month follow-up)
measure: Changes in somatic arousal
timeFrame: Change from baseline to immediate posttest (at 6-weeks)
measure: Changes in somatic arousal
timeFrame: Change from baseline to 12-month follow-up)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00371878: Immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine in Lung Fluid of Adults With and Without HIV Infection
Official title: Open Label Study of Lung and Serum Immunoglobulin Responses to 7-Valent Pneumococcal Conjugate Vaccine in HIV Infected and Non-HIV Infected Malawian Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumonia
Meningitis
Invasive Pneumococcal Disease
HIV
Keywords: Vaccine
Lung
Bronchoalveolar lavage
Lymphocyte
Immunoglobulin
HIV
Streptococcus pneumoniae
Conjugate vaccine
Lead sponsor: Royal Liverpool University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Kamuzu University of Health Sciences
name: Liverpool School of Tropical Medicine
name: Wellcome Trust
First posted: 2006-09-04
Enrollment: 40
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Lung immune responses are regulated independently of systemic responses. Injected vaccines may induce optimal responses in blood but not at mucosal surfaces. We compared the responses in serum and lung fluid to injected pneumococcal conjugate vaccine.

Detailed description: We tested the hypothesis that conjugate vaccine offered less protection against pneumonia due to a reduced mucosal response compared to serum. We further hypothesized that this response would be further compromised with HIV co-infection\[32\] due to lack of local CD4 lymphocyte support and an altered alveolar milieu. We measured pneumococcal capsular specific immunoglobulin responses to 7-valent conjugate vaccine in both lung fluid and serum from healthy HIV infected and uninfected volunteers, together with flow cytometric assessment of the relative numbers and phenotypes of BAL T lymphocyte, B lymphocyte and macrophages.

Eligibility criteria: Inclusion Criteria:

* healthy volunteer adults

Exclusion Criteria:

* pregnant, recent illness, previous vaccination, asthma

Primary outcomes:
measure: Immunoglobulin titres in bronchoalveolar fluid
Secondary outcomes:
measure: Immunoglobulin titres in serum
measure: Lung lymphocyte phenotype
measure: HIV viral load
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Wellcome Trust Laboratories and Dept of Medicine, Queen Elizabeth Central Hospital
Study officials:
affiliation: Karonga Prevention Study, London School of Tropical Medicine and Hygience
name: Neil French, PhD FRCP
role: STUDY_DIRECTOR
affiliation: Liverpool School of Tropical Medicine, Liverpool, UK
name: Stephen B Gordon, MA MD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02000271: Does Vaginal Packing Influence Patient Outcomes Following Vaginal Reconstructive Surgery?
Official title: Does Vaginal Packing Influence Patient Outcomes Following Vaginal Reconstructive Surgery? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Packing Following Pelvic Reconstructive Surgery
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vaginal packing is used routinely following vaginal reconstructive surgery. Despite little data to support the practice, purported benefits include reduced pelvic fluid accumulation or blood loss. Patients often complain of discomfort associated with the packing or its removal.

This randomized controlled trial seeks to document differences in subjective impressions of pain in women undergoing vaginal repairs treated with and without packing. The investigators also aim to assess differences in postoperative fluid collection in those with and without packing.


Eligibility criteria: Inclusion Criteria:

* Any female aged 18-85 planning to undergo a vaginal hysterectomy with vaginal reconstructive surgery for pelvic organ prolapse, with or without a suburethral sling. Must be able to speak and read English and be able to understand the informed consent.

Exclusion Criteria:

* Undergoing abdominal prolapse repair or repairs not involving hysterectomy, use of mesh, obliterative procedures, concurrent removal of mesh kit, performance of vaginal relaxing incisions, presence of vaginal, uterine, cervical or ovarian malignancy, having a clotting disorder, taking anticoagulation, needing heparin prior to surgery, having intraoperative blood loss greater than 500 cc, or use of regional anesthesia for surgery.

Primary outcomes:
measure: Pain and satisfaction
timeFrame: From the first post-operative day up to 6 weeks post-operatively
Secondary outcomes:
measure: Pelvic fluid collection measurement
timeFrame: In the morning of the first post-operative day.
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: TriHealth Good Samaritan Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT06569771: Evolution of the Patient's Perception of the Use of the Upper Limb After a Stroke During Intensive Rehabilitation
Official title: Evolution of the Patient's Perception of the Use of the Upper Limb After a Stroke During Intensive Rehabilitation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Upper Limb Ischemia
Lead sponsor: Grand Hôpital de Charleroi
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 100
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 who have suffered a first stroke will be selected on transfer to a neurological rehabilitation service. They will be recruited on admission, provided they meet the inclusion and exclusion criteria.

A combination of self-administered questionnaires and functional assessments will be carried out on the first day of multidisciplinary management in the neurological rehabilitation department and after two months in hospital.

Brief summary: This study is being carried out in the context of rehabilitation after stroke, where persistent upper limb weakness is a major challenge. It aims to explore the relationship between observed function and patients' perceived participation in use.


Eligibility criteria: Inclusion Criteria:

* First stroke as defined by the World Health Organization.
* Upper limb paresis with a NIHSS National Institutes of Health Stroke Scale score \> or = 1/4 for upper limb motor function

Exclusion Criteria:

* Life expectancy \<12 months
* Inability to understand French.
* Pre-existing severe multiple disability affecting arm function.
* Presence of pre-existing central neurological pathologies.
* Mini-Mental State Examination \< 21

Primary outcomes:
measure: To assess whether the perception of use of the impaired upper limb improves during intensive rehabilitation after a stroke.
timeFrame: Up to 2 months
measure: To compare the difference between perception and observed function of the upper limb during intensive multidisciplinary rehabilitation treatment.
timeFrame: Up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
state: Hainaut
Study officials:
affiliation: Grand Hôpital de Charleroi
name: Maxime Valet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00892671: Airway Management and Vascular Access Simulation
Official title: Airway Management and Vascular Access Simulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Management
Vascular Access
Keywords: Perceived effectiveness
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2009-05-04
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: third and fourth year medical studens enrolling in the UAB Department of Anesthesiology rotation

Brief summary: This project involves a pre- and post- airway management and vascular access simulation survey. The purpose of the study is to assess the perceived effectiveness of the simulation course on the performance of medical students enrolling in the Anesthesiology rotation during their third and fourth year of medical education.


Eligibility criteria: Inclusion Criteria:

* medical student enrolled in the Department of Anesthesiology rotation

Exclusion Criteria:

* anyone not enrolled in the rotation

Primary outcomes:
measure: perceived effectiveness
timeFrame: pre- and post- simulation
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham Department of Anesthesiology
name: Thomas R. Vetter, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05286671: Evaluation of Perioperative Management of Curative Anticoagulants in the Geriatric Perioperative Unit in Patient Hospitalized for Femoral Neck Fracture.
Official title: Evaluation of Perioperative Management of Curative Anticoagulants in the Geriatric Perioperative Unit in Patient Hospitalized for Femoral Neck Fracture.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulants; Circulating, Hemorrhagic Disorder
Femoral Neck Fractures
Keywords: older patients
anticoagulant
femoral neck fractures
clinical pharmacy service
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients aged 75 years and older, hospitalized in the geriatric perioperative unit from November 18, 2019 to June 30, 2021, for a hip fracture and with curative anticoagulant therapy prescription at entry.

Brief summary: Pilot study to evaluate the management of curative anticoagulant prescriptions pre- and postoperatively in elderly patients hospitalized for femoral neck fracture.


Eligibility criteria: Inclusion Criteria:

* Patient 75 years or older
* Hospitalized in the geriatric perioperative unit for a femoral neck fracture between 18/11/2019 and 30/06/2021
* Treated with a curative anticoagulant at entry
* Patient enrolled in or receiving a social security plan

Exclusion Criteria:

* Orthopedic patient housed in the geriatric perioperative unit
* Patient who objected to the use of their data

Primary outcomes:
measure: Rate of compliance with the recommendations for direct oral anticoagulants (DOAC)..
timeFrame: Day 0
measure: Rate of compliance with the recommendations for vitamin K antagonists (VKA).
timeFrame: Day 0
Secondary outcomes:
measure: Number of pharmaceutical interventions
timeFrame: Day 0
measure: description of pharmaceutical interventions
timeFrame: Day 0
measure: Evaluation of the morbi-mortality
timeFrame: Day 0
measure: Description of the evolution of the plasma dosage of DOAC and the international normalized ratio (INR) and analysis of the operative delay
timeFrame: Day 0
measure: description of the population
timeFrame: Day 0
Other outcomes:
Locations:
city: Nimes
country: France
facility: Chu Nimes
Study officials:
References:
Clinical trial NCT03142971: Shock Wave Therapy for Lateral Hip Pain, Caused by Tendon Pathology
Official title: Focused Extracorporeal Shock Wave Therapy for Greater Trochanteric Pain Syndrome With Gluteal Tendinopathy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tendinopathy
Keywords: Shock waves
Greater trochanteric pain syndrome
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 50
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: The aim of this randomized controlled study is to investigate if focal shock wave is an effective treatment, with respect to hip pain and lower limb function, in a population affected by greater trochanteric pain syndrome with gluteal tendinopathy.


Eligibility criteria: Inclusion Criteria:

* duration of lateral hip pain of six weeks or longer,
* normal passive hip range of movement (ROM),
* sonographic evidence of gluteal tendinopathy at their insertional site at the greater trochanter

Exclusion Criteria:

* general contraindication to extracorporeal shock wave therapy (pacemaker, pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area),
* history of rheumatologic disease,
* previous fractures or surgery in the affected limb,
* full thickness tear of the gluteal tendons,
* osteoarthritis of the hip (with ROM limitation),
* clinical signs of lumbar radiculopathy,
* corticosteroid injections or other conservative therapies (except pharmacological pain treatments) since the onset of the current pain episode.

Primary outcomes:
measure: p-NRS
timeFrame: Baseline, at two months, at six months
measure: LEFS score
timeFrame: Baseline, at two months, at six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06833671: Preoperative Two Hours Carbohydrate Load On Pediatric Patient Undergoing Elective Surgery
Official title: Effect of Preoperative Two Hours Carbohydrate Load On Pediatric Patient Undergoing Elective Surgery: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoperative
Carbohydrate
Pediatric
Elective Surgery
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 90
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This work evaluated the systemic effect of different preoperative carbohydrate (CHO) loads in pediatrics undergoing elective surgery.

Detailed description: Children undergoing surgery experience stress due to disruptions in their daily routine and exposure to various perioperative circumstances that induce anxiety and pain.

The management of perioperative nutrition in pediatric patients is a crucial aspect of patient care.

The concept of preoperative carbohydrate (CHO) loading has gained attention as a potential strategy to mitigate these drawbacks. The administration of a CHO-rich drink two hours preoperative has been proposed to maintain euglycemia, decline IR, and enhance postoperative recovery

Eligibility criteria: Inclusion Criteria:

* Age from 5 to 10 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I and II.
* Scheduled for elective surgery.

Exclusion Criteria:

* Diabetes mellitus.
* Insulin resistance (IR).
* Renal or hepatic insufficiency.
* Esophageal or gastric surgery or gastrointestinal disorders history (including gastroesophageal reflux, hiatal hernia, or gastritis).

Primary outcomes:
measure: C-reactive protein (CRP) level
timeFrame: 4 hours postoperatively
Secondary outcomes:
measure: Neutrophil/ lymphocyte ratio
timeFrame: 4 hours postoperatively
measure: Level of procalcitonin
timeFrame: 4 hours postoperatively
measure: Homeostatic model assessment for insulin resistance
timeFrame: 4 hours postoperatively
measure: Level of C-peptide
timeFrame: 4 hours postoperatively
measure: Level of random blood glucose
timeFrame: Two hours before the surgery
measure: Patient's parent's satisfaction
timeFrame: 4 hours postoperatively
measure: Incidence of complications
timeFrame: 4 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT00630071: Diagnostic Value of Procalcitonin in Patients With Acute Appendicitis
Official title: A Prospective Study Investigating the Diagnostic Value of Procalcitonin in Patients With Acute Appendicitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appendicitis
Keywords: Diagnostic Appendicitis
Procalcitonin
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2008-03-06
Enrollment: 103
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical Emergency Room

Brief summary: The values of laboratory examinations which are useful for the diagnoses of acute appendicitis are white blood cell count (WBC), C-reactive protein (CRP) and erythrocyte blood sedimentation rate (ESR). Another laboratory value which has recently received considerable attention for the early diagnosis of bacterial infection and sepsis is pro-calcitonin (PCT). In recent studies it has been clearly shown that PCT is one of the most important biochemical indicators which closely correlates with the severity of inflammatory host response to microbial infections. Aim of this open, prospective study is therefore to investigate if PCT has an accurate diagnostic value for the diagnosis of acute appendicitis.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of appendicitis

Exclusion Criteria:

* Antibiotic therapy
* Infection at other body sites
* Age \< 14 years
* Appendectomy in the medical history

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum, Germany
Study officials:
affiliation: Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum
name: Benno Mann, PD Dr. med.
role: STUDY_CHAIR
affiliation: Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum
name: Michael Sand, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sand M, Trullen XV, Bechara FG, Pala XF, Sand D, Landgrafe G, Mann B. A prospective bicenter study investigating the diagnostic value of procalcitonin in patients with acute appendicitis. Eur Surg Res. 2009;43(3):291-7. doi: 10.1159/000232939. Epub 2009 Aug 7.
Clinical trial NCT05728671: Bioavailability Study to Compare Liquid vs Two Solid Formulations of IP2015
Official title: An Open-Label, Bioavailability Study to Compare Liquid vs Two Solid Formulations of IP2015 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Bioavailability
Lead sponsor: Initiator Pharma
Sponsor class: INDUSTRY
First posted: 2023-02-15
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study's primary objective is to determine the bioavailability of two solid formulations of IP2015 compared to a liquid formulation of IP2015 in healthy male subjects

Detailed description: It is planned to include 12 subjects. Each subject will take part in three treatment periods, in which they will receive a single dose of IP2015 liquid and then to different IP2015 solid formulations, respectively, in each treatment period. Overall, each subject will receive each treatment once only.

Eligibility criteria: Inclusion Criteria:

* Subject has a body mass index (BMI) of 18 to 30 kg/m2, inclusive.
* Subject is ≥50 kg.
* Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, clinical laboratory evaluations.

Exclusion Criteria:

* Any significant CNS, cardiac, pulmonary, metabolic, renal, hepatic (including Gilbert's syndrome), gastrointestinal (GI) or psychiatric conditions, or history of fainting or syncope or such condition that, in the opinion of the Investigator, may place the subject at an unacceptable risk as a participant in the study, may interfere with the interpretation of safety or tolerability data obtained in this study, or may interfere with the absorption, distribution, metabolism or excretion (ADME) of drugs, or with the completion of treatment according to this Protocol.
* Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including \[but not limited to\], neurological, psychiatric, endocrine, cardiovascular, respiratory, GI, hepatic or renal disorder).
* Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs or physical findings at Screening. In case of uncertain or questionable results, tests performed during Screening may be repeated to confirm eligibility or judged to be clinically irrelevant for healthy subjects.

Primary outcomes:
measure: AUC
timeFrame: 72 hours
measure: Tmax
timeFrame: 72 hours
measure: Cmax
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MAC UK
name: Sandy Connell, MD
role: PRINCIPAL_INVESTIGATOR
References: