louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06267352: Epidemiology and Genomic Surveillance of Staphylococcus Aureus in ICU Neonatology
Official title: Epidemiology and Genomic Surveillance of Methicillin-sensitive Staphylococcus Aureus in ICU Neonatology : Rectal and Nasal Screening, Cross Transmission and Decolonisation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: the Aim of This Study is to Describe Genomic Epidemiology of MSSA in Neonatal ICU
Keywords: cross-transmission
prevention and infection control
bacterial typing
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSSA carrier among newborns hospitalized in neonatal ICU

Brief summary: Newborns hospitalized in Neonatology are particularly vulnerable to infections, in particular healthcare associated infection (HAI). Staphylococcus aureus represents the 2nd microorganism responsible for sepsis, this infection is particularly serious and like any HAI, it increases the length of hospitalization of newborns and neonatal morbidity.

In September 2020, the CDC published recommendations for the prevention and control of Staphylococcus aureus infections in neonatal intensive care unit/ICU. They specify the indications for implementing a MSSA surveillance strategy as well as the screening and management methods.

Despite the absence of a defined strategy at the national level, our establishment chose to initiate management measures several years ago following serious infections and MSSA epidemics in neonatal intensive care unit/ICU.

With the aim of improving the efficiency of care and evaluating the strategy chosen at the establishment, it is necessary to describing

* the epidemiology of MSSA carriage and infections
* cross-transmission of MSSA strains between patients
* the success rate of decolonization
* the sensitivity of detection of digestive carriage by stool swabbing in order to limit the number of samples from newborns.


Eligibility criteria: Inclusion Criteria:

* newborns hospitalized in neonatal ICU
* MSSA carrier

Exclusion Criteria:

* none

Primary outcomes:
measure: frequency of MSSA cross transmission as assessed by WGS
timeFrame: Month 24
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Akinboyo IC, Zangwill KM, Berg WM, Cantey JB, Huizinga B, Milstone AM. SHEA neonatal intensive care unit (NICU) white paper series: Practical approaches to Staphylococcus aureus disease prevention. Infect Control Hosp Epidemiol. 2020 Nov;41(11):1251-1257. doi: 10.1017/ice.2020.51. Epub 2020 Sep 14. No abstract available.
Clinical trial NCT00712452: Evaluation of Chemotherapy Influence on Clinical and Biological Markers of Ovarian Reserve
Official title: Evaluation of Chemotherapy Influence on Clinical and Biological Markers of Ovarian Reserve.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Keywords: fertility
chemotherapy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-07-10
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective is to evaluate the influence of chemotherapy, either for auto-immune disease, either for carcinologic disease, on clinical and biological markers of ovarian reserve, for young patients, with normal reproductive functions.

Detailed description: The study will enrol patients between 18 and 35 years, treated with neoadjuvant or adjuvant chemotherapy for systemic lupus erythematosus (Group 1), breast cancer (Group 2) or Hodgkin disease (Group 3)to evaluate the clinical and biological markers of ovarian reserve. The follow-up will last 24 months for each patients with a visit before treatment, and at 3 months, 6 months, one year and two years after treatment.

During this period, we will collect pre and post treatment clinical data,and biological data and ultrasonographic data such as antral follicle count which is a marker of ovarian follicle reserve.These data were not observed in current practice.

Eligibility criteria: Inclusion Criteria:

* Women volunteers treated by chemotherapy,
* ≥ 18 and ≤ 35 years old
* Regular menstrual cyclicity, between 25 and 35 days
* Social security affiliation
* Signed informed consent

Exclusion Criteria:

* Women \< 18 and \> 35 years old
* Pregnancy
* Emergent treatment necessity
* No social security affiliation
* Virgin patients

Primary outcomes:
measure: AMH level and antral follicle count
timeFrame: one year after the chemotherapy treatment
Secondary outcomes:
measure: AMH level and antral follicle count at each visit
timeFrame: 3 months, 6 months, and two years after the chemotherapy treatment
measure: Hormonal status (Estradiol, LH, FSH and progesterone levels)
timeFrame: 3 months, 6 months, and two years after the chemotherapy treatment
measure: Menstrual cyclicity
timeFrame: 3 months, 6 months, and two years after the chemotherapy treatment
measure: pregnancy
timeFrame: 3 months, 6 months, and two years after the chemotherapy treatment
measure: infertility treatment if required
timeFrame: 3 months, 6 months, and two years after the chemotherapy treatment
Other outcomes:
Locations:
city: Clamart
country: France
facility: AP-HP Hôpital Antoine Béclère
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
name: Renato Fanchin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02588352: Evaluation of Salt Sensitivity in Young Adults
Official title: Evaluation of Salt Sensitivity in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The current prospective cross-sectional pilot study is proposed to determine a set of characteristic factors associated with salt sensitivity in young adults by measuring blood pressure, serum aldosterone levels, urine analysis, arterial pulse wave velocity and central arterial pressure in response to short term increases in salt intake.

Detailed description: Since salt sensitivity at an early age is associated with subsequent hypertension and an increase in mortality, intervention by lifestyle modification including the reduction of sodium intake could prevent subsequent increases in blood pressure and development of hypertension, cardiovascular disease and death. It would therefore be beneficial to have a simple method of identifying salt sensitive young adults so that risk factor modification can be achieved to prevent progression of the effects of hypertension on heart function.

This study is a longitudinal pilot study to identify characteristics of salt sensitive young adults so that this population of people can be identified early on and appropriate lifestyle modifications can be made to prevent the subsequent progression of hypertension and cardiovascular disease.

The study will be conducted at 2 visits separated by one week. At the first visit, eligible subjects will be asked to complete questionnaires regarding childhood and current sodium intake.Subjects will be asked about family history of hypertension and cardiovascular disease. Subjects will also undergo blood pressure measurement in both arm, and will provide a blood sample and spot urine sample. Subjects will then be asked to take salt pills 3 times a day for one week, and then return to the study center for a repeat of the above measurements.

Eligibility criteria: Inclusion Criteria:

* Young adults age 21-30
* Able and willing to provide written informed consent

Exclusion Criteria:

* Any cardiovascular or other chronic health problem
* Chronic medications besides oral contraceptive pills in women
* BMI\>30kg/m2
* Blood pressure \>140/90 mmHg
* Inability or unwillingness to adhere to study procedures

Primary outcomes:
measure: Presence of salt sensitivity
timeFrame: Visit 1 (One Week)
Secondary outcomes:
measure: Change in aldosterone level
timeFrame: Baseline to Visit 2 (One Week)
measure: Change in augmentation index (%)
timeFrame: Baseline to Visit 2 (One Week)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Stuart Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03922152: 2D-radiotherapy in Palliation of Advanced Esophageal Cancer
Official title: Short-course Accelerated 2D-radiotherapy in Palliative Treatment of Advanced Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Keywords: palliative care
radiotherapy
pain
quality of life
esophageal cancer
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study wants to define the efficacy of a short course 2D-radiation therapy in patients with symptomatic advanced esophageal cancer.

Detailed description: The study wants to define the efficacy of a short course accelerated 2D-radiation therapy delivered in twice daily fractions and 2 consecutive days for symptomatic palliation of advanced esophageal cancer.

Eligibility criteria: Inclusion Criteria:

* histologically proven advanced esophageal cancer
* excluded from curative therapy because of disease stage and/or presence of multiple comorbidities and/or poor performance status
* age \> 18 years
* Eastern Cooperative Oncology Group (ECOG) \<3

Exclusion Criteria:

* prior radiotherapy to the same region

Primary outcomes:
measure: Assessment of symptoms [odynophagia, chest-back pain, dysphagia, regurgitation]
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Acute radiation toxicity]
timeFrame: 1 year
measure: Assessment of the Performance Status
timeFrame: 1 year
measure: Assessment of the Overall Survival
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Radiation Oncology Center, DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy
name: Alessio G. Morganti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04213352: A Comparison of Two Different Wrist Immobilization Methods
Official title: Muscle Activation Of The Upper Trapezius During Computer Typing Task: A Comparison of Two Different Wrist Immobilization Methods
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Work-Related Condition
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of this study is to examine the effect of the splint and rigid taping on the muscle activation of the upper trapezius muscle during computer typing tasks in office workers.

The study will be conducted on 10 healthy office workers. The study subjects will be asked to type on a computer for 5 minutes (1) without splint or taping, (2) with a splint and (3) with rigid taping which limits the wrist flexion at the dominant side. The upper trapezius muscle activation will be recorded by surface EMG during the task. The mean values will be normalized according to Maximum Voluntary Isometric Contraction (MVIC) and %MVIC values.


Eligibility criteria: Inclusion Criteria:

* Being an office worker between 20-35 years of age
* Using a computer for at least 4 hours a day
* Working full time for at least 1 year without any upper extremity pathology

Exclusion Criteria:

* Having a body mass index of 30 kg / m2 or more on the day of evaluation
* Using muscle relaxants 72 hours before the evaluation
* Exercising within the last 48 hours

Primary outcomes:
measure: Measurement of Muscle Activation for Control Group
timeFrame: It will be recorded at baseline for MVIC and 1 minute after baseline while performing the 5-minute typing task on computer for %MVIC
measure: Measurement of Muscle Activation for Splint Group
timeFrame: It will be recorded at baseline for MVIC and 1 minute after baseline while performing the 5-minute typing task on computer for %MVIC
measure: Measurement of Muscle Activation for Rigid Taping Group
timeFrame: It will be recorded at baseline for MVIC and 10 minutes after baseline while performing the 5-minute typing task on computer for %MVIC
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.
Clinical trial NCT01492452: The Anxiety of Parents of Children Undergoing Cardiac Surgery
Official title: Standard Guidelines Impact of Nursing Anxiety of Parents of Children Undergoing Cardiac Surgery: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: guidelines for nursing
anxiety
cardiac surgery
pediatrics
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2011-12-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This is a randomized clinical trial. The population consisted of parents of children undergoing cardiac surgery from December 2010 to April 2011. We included parents aged over 18 years, and the following were considered exclusion criteria: inability to understand and/or answer the questions for any reason, parents of children undergoing surgery for insertion of the pacemaker and defibrillator, surgical death and not take up the case. 22 parents in the intervention group were randomized and received standardized guidelines for nursing and 22 parents participated in the control group received the guidelines and routine of the institution. Anxiety was assessed using the STAI State-Trait Inventory in the preoperative period and 48 hours after surgery the child.

Detailed description: anxiety

Eligibility criteria: Inclusion Criteria:

* We included parents aged over 18 years

Exclusion Criteria:

* inability to understand and/or answer the questions for any reason,
* parents of children undergoing surgery for insertion of the pacemaker and defibrillator,
* surgical death and not take up the case

Primary outcomes:
measure: anxiety inventory
timeFrame: five months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Cardiology
name: M A Moraes, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04266652: Using the Roots of a Non Restorable Wisdom Tooth as a Block for Augmentation of Localized Defects
Official title: The Effect of Autogenous Tooth Roots for Lateral Alveolar Ridge Augmentation and Staged Implant Placement (A Controlled Clinical Study With Histological Assessment)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Augmentation
Keywords: tooth block
Dental implants
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: assess and compare the efficacy and safety of autogenous tooth roots for lateral alveolar ridge augmentation with staged implant placement in comparison to autogenous bone block.

Detailed description: A total of 14 patients in need of implant therapy and lateral ridge augmentation were allocated to parallel groups receiving either 1) healthy autogenous tooth roots (e.g. retained wisdom or impacted teeth or 2) cortical autogenous bone blocks harvested from the retromolar area. After 26 weeks of submerged healing the horizontal bone gain were assessed both clinically and radiographically. A core biopsy was taken during the implant placement to assess the histology of the newly formed bone.

Eligibility criteria: Inclusion Criteria:

1. Candidate for lateral ridge augmentation
2. Insufficient bone ridge width at the recipient site for implant placement
3. Sufficient bone height at the recipient site for implant placement
4. Healthy oral mucosa, at least 3 mm keratinized tissue.
5. Presence of wisdom teeth free from periapical infection.
6. Missing maxillary or mandibular tooth with moderate horizontal defect (4-8) according to cologne classification

Exclusion Criteria:

* 1) Patients are systemically free according to Modified Cornell Medical Index 2) smokers patients. 3) Pregnant or lactating women.

Primary outcomes:
measure: Clinical and radiographic assessment of alveolar bone width following autogenous tooth roots augmentation.
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Histological analysis of remodeled autogenous bone roots 4 months following horizontal ridge augmentation. Histological analysis of remodeled autogenous bone roots 4 months following horizontal ridge augmentation.
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abbassia
Study officials:
References:
Clinical trial NCT03100552: Prediction of Dysplasia Within Sessile Serrated Polyps Using Endoscopic Imaging; a Prospective Observational Study
Official title: Prediction of Dysplasia Within Sessile Serrated Polyps Using Endoscopic Imaging; a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sessile Serrated Adenoma
Keywords: Colonoscopy
Endoscopic resection
Sessile serrated adenoma
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to a tertiary endoscopic resection practice with any SSP \>= 8mm

Brief summary: Study of endoscopic imaging in the detection of dysplasia within serrated colonic lesions \>= 8mm in size

Detailed description: Observational study Structured endoscopic imaging protocol devised Applied prospectively to sequential SSP \>= 8mm detected in a tertiary endoscopic resection cohort Review of specimens by blinded specialist pathologists Review of incongruent cases by endoscopists and pathologists

Eligibility criteria: Inclusion Criteria:

* Patients referred to a tertiary endoscopic resection practice with any sessile serrated polyp (SSP) \>= 8mm

Exclusion Criteria:

* Patients referred to a tertiary endoscopic resection practice without sessile serrated polyps (SSP)

Primary outcomes:
measure: Dysplasia
timeFrame: at the initial procedure when the sessile serrated polyp (SSP) is analysed by the endoscopist compared with when the SSP is analysed at histopathology less than one week later. no ongoing determination
Secondary outcomes:
measure: Sessile serrated polyp
timeFrame: at the initial procedure compared with histopathology within 1 week. no ongoing determination
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
Study officials:
affiliation: WSLHD
name: Michael Bourke, MBBS, FRACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tate DJ, Jayanna M, Awadie H, Desomer L, Lee R, Heitman SJ, Sidhu M, Goodrick K, Burgess NG, Mahajan H, McLeod D, Bourke MJ. A standardized imaging protocol for the endoscopic prediction of dysplasia within sessile serrated polyps (with video). Gastrointest Endosc. 2018 Jan;87(1):222-231.e2. doi: 10.1016/j.gie.2017.06.031. Epub 2017 Jul 13.
Clinical trial NCT01561352: Efficacy and Safety of Activated Recombinant Human Factor VII in Refractory Haemorrhagic Cystitis
Official title: An Open Label Pilot Study to Test the Efficacy and Safety of Recombinant Factor VIIa (rFVIIa, NovoSeven®) in the Treatment of Refractory Hemorrhagic Cystitis Following High Dose Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Other Haemostasis Disorder
Haemorrhagic Cystitis
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-23
Enrollment: 7
Sex: ALL
Minimum age (years): 2
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The aim of this trial is to assess the efficacy of activated recombinant human factor VII in the treatment of refractory haemorrhagic cystitis (HC) following chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Severe haemorrhagic cystitis (HC)

Exclusion Criteria:

* Patients with overt DIC (disseminated intravascular coagulation)
* Patients with known active atherosclerotic disease, such as active coronary artery disease or recent stroke in the past 3 months
* Central venous access device related thrombus in the last 3 months
* Patients with allergy to activated recombinant human factor VII or any component of its preparation

Primary outcomes:
measure: Reduction of hematuria that failed 24-hour standard therapy evaluated by change of urine color
measure: Reduction of hematuria that failed 24-hour standard therapy evaluated by urine haemoglobin content
measure: Reduction of hematuria that failed 24-hour standard therapy evaluated by urocrit
Secondary outcomes:
measure: Symptoms of venous or arterial thrombosis
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Chapel Hill
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Ashrani AA, Gabriel DA, Gajewski JL, Jacobs DR Jr, Weisdorf DJ, Key NS. Pilot study to test the efficacy and safety of activated recombinant factor VII (NovoSeven) in the treatment of refractory hemorrhagic cystitis following high-dose chemotherapy. Bone Marrow Transplant. 2006 Dec;38(12):825-8. doi: 10.1038/sj.bmt.1705535. No abstract available.