louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00178347: Radiation Dosimetry in Teeth
Official title: Radiation Dosimetry in Teeth
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Radiation Tolerance
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: discarded pathological specimen(teeth)

Brief summary: Irradiation of any tissue creates changes in that tissue. Ionizing radiation imparts charges to the tissue as it interacts with tissue components, changing the tissue structure. The specific type of modification also depends to some extent upon the type of tissue irradiated. It has been shown that it is possible to read the tooth enamel irradiation record using techniques such as electron paramagnetic resonance (EPR), or electron spin resonance (ESR).

It is proposed to examine radiation responses in approximately one hundred (100) human teeth. This would include teeth free of, as well as those containing, amalgam (silver) restorations. For the first group, teeth that have already been collected (pre-existing pathological specimens) would be used. These teeth were surgical/pathological discards collected without identifiers by the dental providers.


Eligibility criteria: Inclusion Criteria:

* Discarded pathologic specimens (teeth)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester, Dept. Radiation Oncology
state: New York
Study officials:
affiliation: University of Rochester, Dept. of Radiation Oncology
name: Paul Okunieff, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03923647: Laparoscopic Exploration Versus Abdominal CT Scan
Official title: Laparoscopic Exploration Versus Abdominal CT Scanning in Abdominal Trauma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Penetrating Abdominal Trauma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable patients with abdominal trauma with good general conditions

Brief summary: Evaluate the efficacy and safety of laparoscopy and it's role with blunt abdominal trauma

Detailed description: Evaluate the role of laparoscopy and Abdominal Ct scan in diagnosis and treatment of abdominal trauma and which is more effective and safe laparoscopy or CT

Eligibility criteria: Inclusion Criteria:

* stable patients with definite occurrence of intra-abdominal injury
* patients with equivocal result by clinical and radiological evaluation

Exclusion Criteria:

* patients with penetrating abdominal trauma
* stable patients not in need for any intervention for conservative management
* patients with marked haemodynamic instability
* polyt-traumatized Patients

Primary outcomes:
measure: Evaluate the role of laparoscopy in diagnosis and management of abdominal trauma
timeFrame: Baseline
measure: Evaluate the role of Abdominal CT scanning in diagnosis of abdominal trauma
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03035747: Ongoing Registry of Treatment of Chronic Venous Diseases
Official title: Russian Registry of Treatment of Chronic Venous Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Varicose Veins of Lower Limb
Keywords: registry
varicose veins
conventional surgery
thermal ablation
radiofrequency
laser
sclerotherapy
Lead sponsor: Medalp Private Surgery Clinic
Sponsor class: OTHER
Collaborators: name: Pirogov Russian National Research Medical University
First posted: 2017-01-30
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing interventions in cases varicose vein disease

Brief summary: Ongoing registration of patients with varicose veins disease treated by means of conventional surgery, endovenous thermal ablations, sclerotherapy, non-tumescent non-thermal methods

Detailed description: Data of patients treated in different Russian medical centers are entered in a prospective digital database, and continuously updated.

There is planned to conduct prospective randomized, cohort and observational studies on the site of register

Eligibility criteria: Inclusion Criteria:

* Varicose veins with any source of pathological reflux, C2 - C6 according to the CEAP classification

Exclusion Criteria:

* no exclusion criteria

Primary outcomes:
measure: Change in patency target veins assessed by duplex ultrasonography in different follow up periods after conventional surgery, endovenous thermal ablations, sclerotherapy or non-tumescent non-thermal methods
timeFrame: Baseline, 3 - 6, 12 months post-intervention
Secondary outcomes:
measure: Change in Quality of Life (QoL), assessed by Short form (SF)-36 health survey (optional)
timeFrame: Baseline, 3 and 12 months post-intervention
measure: Change in Venous Clinical Severity Score (VCSS) (optional)
timeFrame: Baseline, 3 and 12 months post-intervention
measure: Change in Quality of Life (QoL), assessed by Aberdeen Varicose Vein Questionnaire (AVVQ) (optional)
timeFrame: Baseline, 3 and 12 months post-intervention
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Medalp private surgery clinic
Study officials:
References:
Clinical trial NCT01061047: Comparison of Ertapenem Distribution in the Muscle of Six Healthy Volunteers and Six Critically Ill Patients by Microdialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: patients infected with a bacteria sensible to ertapeneme
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2010-02-02
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: Ertapenem is an antibiotic that is highly bound to plasma protein (\> 95%). The effects of this high protein binding on tissue distribution of antibiotics have been few evaluated yet.

In this study, two groups of subjects will be compared: 6 healthy volunteers and 6 critically ill patients (patients with infection due to an Ertapenem susceptible bacteria). Indeed, these 2 populations show changes in binding capacity of drugs to plasma proteins due to a decrease of protidaemia and of the affinity of drugs to transport proteins.

It seems therefore important to clarify the consequences of a modification in protein binding on distribution of antibiotics. That's why we have decided to characterize tissue distribution of ertapenem in healthy volunteers and critically ill patients by assessing: free and total concentrations in plasma and free concentrations in muscle by microdialysis.


Eligibility criteria: Inclusion Criteria:

* Age: from 18 to 80 years
* Patients with infection due to ertapenem susceptible bacteria.

Exclusion Criteria:

* Patients who received ertapenem within 7 days prior to inclusion
* Known allergy to ertapenem or any excipients
* Neutropenia \< 500/mm3
* Hemoglobin concentration \< 9g/dl
* Renal failure (creatinin clearance \< 30ml/min/1.73m²)
* Decompensated heart failure
* Patients receiving vasopressor (adrenalin, noradrenalin), \> 0.5µg/kg/min
* Known hypersensitivity to Elma®
* Positive pregnancy test or currently lactating

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Poitiers University Hospital - 2 rue de la Milétrie - Réanimation chirugicale
Study officials:
References:
Clinical trial NCT01586247: The Effect of a Prebiotic, Probiotic and Synbiotic on the Gut Microbiota and Immune Response of Older Volunteers (GOS)
Official title: A Double-blind, Placebo-controlled, Randomized Crossover Study of a Prebiotic (Galacto-oligosaccharides, GOS), Probiotic (B.Lactis, BI07) and Synbiotic (GOS + BI07) on the Gut Microbiota and Immune Response of Older Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut Microbiota
Immune Function
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: Danisco
First posted: 2012-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Healthy older volunteers will be recruited to a study where they will be given four different treatments over a 28 week period. These treatments include: a prebiotic, a probiotic, a synbiotic (prebiotic + probiotic) and a placebo. Faecal samples, blood and saliva will be collected and analysed for changes in faecal microbial populations and selected immune responses.

Detailed description: The primary objective of this study is to determine the effect of GOS (administered at 8g/day), B. lactis BI07 (administered at 109 CFU/day) and the synbiotic (8g/day of GOS and 109 CFU/day of B. lactis BI07) on the human gut microbiota.

A double-blind, placebo-controlled, randomized crossover study will be conducted in 40 healthy older (≥60 years of age) volunteers. The placebo will consist of maltodextrin (a food grade ingredient, administered at 8g/day).

Changes in the gut microbiota will be determined by measuring bacterial population levels in human faeces using 16S rRNA targeted oligonucleotide probes and fluorescence in situ hybridisation. Faecal pH will be measured and the production of short chain fatty acids (SCFA) will be analysed and quantified using high performance liquid chromatography (HPLC).

The secondary objective of this study is to examine the effect on cellular immune function. This will be achieved by investigating phagocytosis activity, natural killer cells which are CD4+, CD8+, CD25+ and CD2+ and CD3+ subsets, the marker of T-cell maturation period., salivary IgA levels, inflammatory markers (plasma - tumour necrosis factor (TNF), IL6, IL1, chemokines and soluble adhesion molecules).

Eligibility criteria: Inclusion Criteria:

* a signed consent form,
* age \>60 years
* good general health
* not in the residential care.

Exclusion Criteria:

* evidence of physical or mental disease
* planned major surgery
* use of antibiotics within the previous six months

Primary outcomes:
measure: Changes to the gut microbiota
timeFrame: Baseline and after 21d treatment
Secondary outcomes:
measure: Immune function
timeFrame: Baseline and after 21d treatment
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading
name: Robert A Rastall
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06062147: Impact of Teacher Training and the Introduction of Early Adjustments on the Developmental Trajectory of Children at Risk of SLLD in Pre-school.
Official title: Prevention, Detection and Specialised Intervention in Pre-school : Impact of Teacher Training and the Introduction of Early Adjustments on the Developmental Trajectory of Children at Risk of Specific Language and Learning Disorders (SLLD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Language Disorders in Children
Learning; Developmental Disorder
Keywords: Professional development
Preventive approach
Neurological Development
Preschool education
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 165
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic cluster controlled trial (quasi-experimental design)
Primary purpose: OTHER

Brief summary: The high incidence of neurodevelopmental disorders, including specific language and learning disorders, and their profund impact on the schooling of the children concerned remains a major public health concern. Early identification and intervention are a valuable tool for improving these problems. The developmental trajectory of children could be improved by knowledge enhancement, identification and strategies to support the teachers through the involvement of health professionals in the classroom

Detailed description: PRISME - TSLA is a clinical trial developing experiment project for the intervention arm involving teacher training, the implementation of identification grids, follow-up observations in classroom of identified pupils, and the development of special arrangments. For the control arm, the teachers work with standard procedures of the French national education policy.

Eligibility criteria: Inclusion Criteria:

Pupils :

* In a kindergarten school with at least 3 classes of primary school age children.
* At least 5 years old on 31/12/2023.
* Whose 2 parents have given their consent (the consent of a single parent if no contact is possible with the second parent despite repeated attempts)
* Have received age-appropriate explanations about the study and have not refused to take part.

Exclusion Criteria:

Pupils in :

* In a kindergarten school with fewer than 3 classes, making it impossible to randomise the school
* Under 5 years of age on 31 December of the current school year.
* Under guardianship

Primary outcomes:
measure: Improvement in the developmental trajectory of pre-school children at risk of SLLD in the areas of language, learning and coordination
timeFrame: 8 months after inclusion
Secondary outcomes:
measure: Improvement in teachers' knowledge and sense of competence
timeFrame: 8 months after inclusion
Other outcomes:
Locations:
city: Saint-Denis
country: Réunion
facility: CHU de La Réunion
Study officials:
affiliation: Fondation Père FAVRON
name: Magali CARBONNNIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00621647: Seroquel- Agitation Associated With Dementia
Official title: A Multicenter, Double-Blind, Randomized, Comparison of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) and Placebo in the Treatment of Agitation Associated With Dementia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Vascular Dementia
Keywords: Seroquel
dementia
agitation symptoms
Alzheimer's disease
vascular dementia
quetiapine fumarate
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 333
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how safe and effective Seroquel (quetiapine fumarate) is compared to placebo (a non-drug tablet) for a period of up to 10 weeks in the treatment of agitation symptoms in nursing home or assisted care residents.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility criteria: Inclusion Criteria:

* Subjects must have a diagnosis of dementia compatible with probable or possible Alzheimer's disease (AD)
* Subjects exhibit inappropriate verbal, vocal, or motor activity that requires treatment with an antipsychotic medication in addition to or beyond behavioural modification therapy
* Subject must have a score of at least 14 on the PANSS

Exclusion Criteria:

* Current or past symptoms for schizophrenia, schizoaffective disorder, or bipolar disorder
* Symptoms of agitation that are caused by another general medical condition or direct physiological effects of a substance
* Failure to respond on 2 occasions to an adequate regimen of atypical antipsychotic medications for the treatment of agitation and/or aggression

Primary outcomes:
measure: To assess the efficacy of 2 fixed doses of quetiapine compared with placebo
timeFrame: Twice weekly
Secondary outcomes:
measure: To assess the efficacy of quetiapine compared with placebo
timeFrame: Twice weekly
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06831747: MiniLap Vs Standard Laparoscopy in Prophylactic Bilateral Salpingo-oophorectomy in BRCA-Mutated Patients
Official title: MiniLap Vs Standard Laparoscopy in Prophylactic Bilateral Salpingo-Oophorectomy in BRCA-Mutated Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: BRCA Mutation
Keywords: Laparoscopy
BRCA mutations
Salpingo-Oophorectomy
MiniLap
Lead sponsor: Azienda Sanitaria-Universitaria Integrata di Udine
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study hypothesis is that surgical treatment performed with MiniLap results in reduced postoperative pain in a population of patients undergoing prophylactic laparoscopic adnexal surgery. The primary objectives are to assess differences in operative duration, intraoperative blood loss, and postoperative complications in patients undergoing bilateral laparoscopic adnexectomy performed with standard laparoscopy versus MiniLap. The secondary objectives of this study are to compare postoperative pain and patient satisfaction with aesthetic outcomes.

Patients with BRCA 1/2 mutations undergoing prophylactic surgery will be assigned to either MiniLap or standard laparoscopic treatment based on randomization. Subsequently, the necessary study data will be collected using the hospital's electronic management system and medical records.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing prophylactic bilateral adnexectomy via laparoscopic surgery.
* Patients with a germline mutation in the BRCA1/2 gene.

Exclusion Criteria:

* Patients who underwent additional surgery during the adnexectomy procedure.
* Patients in whom an intraoperative frozen section is required.

Primary outcomes:
measure: Perioperative outcomes: operative time (minutes), intraoperative blood loss (mL), postoperative complications (clavien dindo classification)
timeFrame: From enrollment to 30 days postoperatively
Secondary outcomes:
measure: Pain (Visual Analog Score)
timeFrame: From enrollment to 2 days postoperatively.
measure: Cosmetic results (Visual Analog Score)
timeFrame: From enrollment to 60 days postoperatively.
Other outcomes:
Locations:
city: Udine
country: Italy
facility: Department of Maternal and Child Health, Obstetrics and Gynecology Clinic, University Hospital of Udine
Study officials:
References:
Clinical trial NCT00284947: Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids
Official title: REPLACE: Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Adverse Effects
Keywords: Side effects
calcineurin inhibitors
maintenance
basiliximab
Kidney maintenance transplant
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-02-01
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The long-term use of calcineurin inhibitors (CNI) in patients who have received a kidney transplantation is associated with renal dysfunction and hypertension. The study will evaluate the safety and efficacy of replacing the calcineurin inhibitors by using basiliximab at monthly doses.


Eligibility criteria: Inclusion Criteria:

* Patients with a first kidney transplant from a living or deceased donor at least 12 months after transplantation.
* Patients receiving CNI, mycophenolic acid (MPA) and oral corticosteroids.
* Patients who are able to tolerate full dose MPA.
* Patients with glomerular filtration rate (GFR) \> 30 mL/min.
* Patients without an acute rejection episode during the preceding 6 months.
* Patients with signs or symptoms of CNI intolerance (renal dysfunction, poor blood pressure control, diabetes, poor lipid control, hyperuricemia and gout, significant hypophosphatemia or hypomagnesemia, gingival hyperplasia, hypertrichosis, etc.) in whom CNI interruption is justified.

Exclusion Criteria:

* Patients with preformed positive skin test against basiliximab
* Patients with preformed panel reactive antibody (PRA) \> 10%.
* Signs of active immune process on graft biopsy.
* Patients with multi-organ or second kidney transplant

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: to describe the pharmacokinetics of basiliximab over the 6-month study course and to determine whether serum concentrations remain above CD25 receptor saturation levels
timeFrame: 6 months
Secondary outcomes:
measure: to evaluate the risk of sensitization against the chimeric antibody over 6 months
timeFrame: 6 months
measure: to assess the changes in renal parameters after CNI discontinuation
timeFrame: Month 1-6 post trasnplant
measure: to assess the quantifiable changes in vital signs and lab abnormalities possibly related to CNIs
timeFrame: 6 months
measure: to assess semi-quantitatively changes of clinical symptoms possibly related to CNIs
timeFrame: 6 month
measure: to determine the percentage of CD25 positive T cells (CD3) during therapy with Simulect
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT03112447: Treatment of Medial Humeral Epicondyle Fractures in Children With Absorbable Cartilage Nails
Official title: Treatment of Medial Humeral Epicondyle Fractures in Children With Absorbable Cartilage Nails
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fracture Arm
Keywords: medial epicondyle humerus
absorbable cartilage nail
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 32
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare surgical outcomes from medial epicondyle fracture fixation with absorbable cartilage nails to those from traditional Kirschner wire fixation.

Detailed description: From August 2007 to January 2012, 32 patients undergoing surgery for medial humeral epicondyle fractures in our hospital were randomized into group A (traditional Kirschner wire) or group B (absorbable cartilage nail). The same surgical team performed the operations, and patients were followed for over a year. Group A had open reduction with K-wire fixation, and group B was fixed with absorbable cartilage nails. The Bede scoring system was used to evaluate elbow function at follow-up.

Eligibility criteria: Inclusion Criteria:

* fractures with more than 2 mm of displacement were treated with cast immobilization

Exclusion Criteria:

* fractures with less than 2 mm of displacement were treated with cast immobilization

Primary outcomes:
measure: Pain Intensity
timeFrame: on 12th month
measure: Elbow Motion
timeFrame: on 12th month
measure: Stability
timeFrame: on 12th month
measure: Elbow Function evaluation
timeFrame: on 12th month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: