louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05143645: A New Protocol for Continuous Vancomycin Infusion Dosing.
Official title: Evaluation of a New Clinical Protocol for Dose Selection of Vancomycin for Continuous Infusion in ICU Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Vancomycin Treatment
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients.

Brief summary: This observational study prospectively collect data on chosen dosing, renal function, measured plasma concentrations and adherence to the recommended clinical protocl for ICU patients treated with continuous vancomycin infusion.


Eligibility criteria: Inclusion Criteria:

- Start of continuous vancomycin infusion during the course of intensive care and at least one measurement of plasma concentration.

Exclusion Criteria:

* Vancomycin treatment within 96 h before admission to the unit.
* Vancomycin treatment started with intermittent bolus infusions.

Primary outcomes:
measure: Time (days) from start of treatment to first measurement of a plasma vancomycin concentration between 20 and 25 mg/mL
timeFrame: Until the end of treatment or discharge from unit
measure: Relationship between time to intended concentration (15-20 mg/L) and adherence to the dosing protocol (% complete adherence).
timeFrame: Until the end of treatment or discharge from unit
Secondary outcomes:
measure: Percentage of the total treatment duration with the intended plasma concentration 15-20 mg/L.
timeFrame: Until the end of treatment or discharge from unit
measure: Relationship between Percentage of the total treatment duration with the intended plasma concentration (15-20 mg/L) and adherence to the dosing protocol.
timeFrame: Until the end of treatment or discharge from unit
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
Study officials:
References:
Clinical trial NCT04692545: Preoperative Immunonutrition in Normonourished Patients Undergoing Fast-track Laparoscopic Colorectal Surgery
Official title: Preoperative Immunonutrition Versus Standard Dietary Advice in Normo-nourished Patients Undergoing Fast-track Laparoscopic Colorectal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All normonourished patients undergoing elective ERAS laparoscopic colorectal resections for cancer at Minimally Invasive Surgery Unit of Tor Vergata University Hospital

Brief summary: Immunonutrition (IN) appears to reduce infective complications and in-hospital length of stay (LOS) after gastrointestinal surgery. More specifically, it seems to be beneficial also in colorectal cancer surgery. Potential benefits of combining preoperative IN (PIN) with protocols of enhanced recovery after surgery (ERAS) in reducing LOS in laparoscopic surgery are yet to be determined.


Eligibility criteria: Inclusion Criteria:

* laparoscopic colorectal resection for cancer following ERAS protocol
* \>18 years old
* elective setting

Exclusion Criteria:

* age below 18
* malnutrition
* inflammatory bowel disease
* acquired or congenital immunodeficiency
* preoperative infection
* ASA IV
* pregnancy
* emergency setting
* conversion to open surgery
* multivisceral resections

Primary outcomes:
measure: Length of hospital stay
timeFrame: up to 30 days after discharge
Secondary outcomes:
measure: Time to postoperative food intake
timeFrame: up to 30 days after discharge
measure: Time to first defecation
timeFrame: up to 30 days after discharge
measure: 30-days postoperative complications
timeFrame: up to 30 days after discharge
measure: Surgical site infection
timeFrame: up to 30 days after discharge
measure: Anastomotic leak
timeFrame: up to 30 days after discharge
measure: Readmission
timeFrame: up to 90 days after discharge
measure: 30-days Mortality
timeFrame: up to 30 days after discharge
measure: Pneumonia
timeFrame: up to 30 days after discharge
measure: Ileus
timeFrame: up to 30 days after discharge
measure: Prolonged length of stay
timeFrame: up to 30 days after discharge
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02620345: Fibroids in Women of Reproductive Age and Women Pregnancy
Official title: Uterine Fibroids Are a Very Common Finding in Women of Reproductive Age. Ready Safety Study Dydrogesterone + Multivitamin Nature in Women of Reproductive Age and Women Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fibroids
Keywords: Fibroids
Lead sponsor: Trieu, Nguyen Thi, M.D.
Sponsor class: INDIV
First posted: 2015-12-03
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dydrogesterone Multivitamin Nature treatment of fibroids in women of reproductive age and women pregnancy to lost the size fibroids.

Detailed description: Uterine fibroids are a very common finding in women of reproductive age. But may fibroids grow in the first trimester pregnancy.

Clinically has shown that:

Uterine fibroids are associated with an Heavy or prolonged menstrual periods. Abnormal bleeding between menstrual periods.

Uterine fibroids are associated with an increased rate of spontaneous miscarriage, preterm labor, placenta abruption, malpresentation, labor dystocia, cesarean delivery, and postpartum hemorrhage, pain is the most common complication of fibroids during pregnancy. Can usually be controlled by conservative treatment on Dydrogesterone Multivitamin nature.

Eligibility criteria: Inclusion Criteria:

* Procedure to treatment of fibroids in pregnancy and in women desiring future fertility.

Exclusion Criteria:

* Whether or not you are having symptoms from the fibroids
* If you might want to become pregnant in the future
* The size of the fibroids
* The location of the fibroids
* Your age and you might be

Primary outcomes:
measure: Measure of fibroid size in millimeters
timeFrame: from 4 weeks to 20 weeks
Secondary outcomes:
measure: Measure of fibroid size in millimeters
timeFrame: from 20 weeks to 48 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Tran Minh Duc, Dr.
name: Nguyen Thi Trieu, Master
role: STUDY_DIRECTOR
References:
Clinical trial NCT04407845: Atrial Fibrillation in Patients Receiving Ibrutinib
Official title: Etude de l'Incidence et Des Facteurs prédictifs de la Survenue de Fibrillation Atriale Sous Ibrutinib
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leukemia, Chronic Lymphatic
Mantle Cell Lymphoma
Keywords: atrial fibrillation
haematology
systemic hypertension
prognosis
heart
Lead sponsor: European Georges Pompidou Hospital
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 60
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: Prospective consecutive cohort

Brief summary: Ibrutinib (a tyrosine kinase inhibitor targeting Bruton) is a standard of treatment in haematology. According to retrospective data, atrial fibrillation and systemic hypertension are common ibrutinib-related advserse events. The investigators aim at prospectively establishing the incidence of thesedrug related advsere events through clinical monitoring and attempt at identifying populations at risk.


Eligibility criteria: Inclusion Criteria:

* All patients deem to start ibrutinib therapy

Exclusion Criteria:

* Past history of ibrutinib therapy

Primary outcomes:
measure: Incidence of cardiovascular events on ibrutinib
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of supra-ventricular arrythmias
timeFrame: 6 months
measure: Incidence of systemic hypertension
timeFrame: 6 months
measure: Incidence of arterial embolism
timeFrame: 6 months
measure: Incidence of hemorraghe
timeFrame: 6 months
measure: Safety mesures
timeFrame: 1 year
measure: Anticoagulants
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique Hôpitaux de Paris - Centre Université de Paris
Study officials:
References:
Clinical trial NCT04562545: Twin Block Appliance in Incremental Versus Maximum Bite Advancement in Skeletal Class II
Official title: Effect of Incremental Versus Maximum Bite Advancement in Class II Subjects Using Twin Block Appliance : Randomized Clinical Trials
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mandibular Retrognathism
Mandibular Hypoplasia
Keywords: Twin Block
Bite Advancement
Growth Modification
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 24
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Type: Two arm, parallel, randomized clinical trial. allocation ratio 1:1 framework: superiority
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare to different protocols to treat Class II malocclusion in growing subjects using the twin block appliance

Detailed description: * Patients will be clinically and radio-graphically examined for eligibility
* Eligible patients will be randomly assigned to one of two groups:

  * Control Group: Twin Block Appliance fabricated to Maximum Bite Advancement group
  * Intervention Group: Twin Block Appliance fabricated for Incremental Bite Advancement group
* Records will be taken and impressions will be made and poured. In the control group, bite registration will be made with maximum mandibular advancement. In the intervention group, bite registration is made to habitual bite to make a modified twin block.
* Patients will be recalled every 6 weeks for 8 months for monitoring and reactivation of the appliance.

Eligibility criteria: Inclusion Criteria:

* Growing Female Patient
* Skeletal Class II Malocclusion due to deficient mandible
* Overjet of 7 to 10 mm
* Short or normal vertical facial pattern
* No previous orthodontic nor orthopedic treatment

Exclusion Criteria:

* Syndromes or Chronic Illness
* Skeletal Class II Malocclusion due to excessive maxilla
* Vertical skeletal growth pattern
* Habits

Primary outcomes:
measure: To asses Skeletal and dentoalveolar changes in Mandible
timeFrame: 8 Months
measure: To asses patient compliance
timeFrame: 8 months
Secondary outcomes:
measure: To asses Skeletal and dentoalveolar changes in Maxilla
timeFrame: 8 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
References:
citation: DeVincenzo JP, Winn MW. Orthopedic and orthodontic effects resulting from the use of a functional appliance with different amounts of protrusive activation. Am J Orthod Dentofacial Orthop. 1989 Sep;96(3):181-90. doi: 10.1016/0889-5406(89)90454-x.
citation: Banks P, Wright J, O'Brien K. Incremental versus maximum bite advancement during twin-block therapy: a randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2004 Nov;126(5):583-8. doi: 10.1016/j.ajodo.2004.03.024.
Clinical trial NCT03647345: Noninvasive Dual-mode Stimulation Therapy for Neurorehabilitation in Mild Cognitive Impairment
Official title: Investigation for Individualized Noninvasive Neuromodulation in Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Noninvasive brain stimulation
Repetitive Transcranial Magnetic Stimulation
Transcranial Direct Current Stimulation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of mild cognitive impairment (MCI) patients' cognitive function by altering the cortical excitability. Recently, more challenging approaches, such as stimulation of two or more sites or use of dual modality have been studied in MCI patients. In this study, simultaneous stimulation using both facilitatory rTMS (10Hz) and anodal or cathodal tDCS (dual-mode stimulation) over bilateral dorsolateral prefrontal cortices (DLPFCs) was investigated to compare its modulatory effects with single facilitatory rTMS stimulation in mild cognitive impairment patients.


Eligibility criteria: Inclusion Criteria:

* Patients with mild cognitive impairment diagnosed via a history, a neurocognitive test, and brain imaging

Exclusion Criteria:

* K-MMSE score under 9
* Major active neurological disease or psychiatric disease
* A history of seizure
* Metallic implants in their brain

Primary outcomes:
measure: Accuracy of 2-back verbal working memory task
timeFrame: Change from Pre-intervention at 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT02842645: Growth-Health and Development in Children Exposed to Drugs During Pregnancy
Official title: Growth-Health and Development in Children Exposed to Drugs During Pregnancy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Failure
Mental Health Disorder
Foetal Exposure During Pregnancy
Keywords: Foetal Exposure During Pregnancy
Health
Growth
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2016-07-25
Enrollment: 170
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children exposed to drugs during pregnancy are followed up at school age regarding mental disorders and status of their care situation.

Approximately 130 children are invited to the study.

Brief summary: "Children exposed to alcohol or drugs during pregnancy: Growth, health and development" Background Children exposed to drugs during pregnancy are at risk of developmental disorders. The scope and size of this problem is poorly known in Norway.

Alcohol has a known teratogenic effect on the fetus. How other drugs affect the fetus, is associated with more uncertainty. Withdrawal in the neonatal period has been perceived as the main problem. There is less knowledge about long-term outcome of exposure to drugs during pregnancy.

Aim The aim of the study is to investigate the physical and mental health of children exposed to drugs during pregnancy. Identify the children's need for measures in the home and school, and how many of the children who are taken care of in fostercare.

A sample of the children will be offered radiological examination of the brain (f-MRI). The purpose is to study the relationship between exposure to drugs, child development, environment and organic brain dysfunction.

Design The project is a quantitative study. The relationship between exposure to drugs and development will be measured by questionnaires, clinical examination, neuropsychological tests and radiological examination (f-MRI).

Children aged 2-15years who were referred, examined or treated for drug related problems at the Department of Pediatrics, Haukeland University Hospital will be invited to participate in the study.

Information retrieval and examination of the children are expected to be completed during 2011. Data analysis and further processing of data are expected to be completed during 2013.


Eligibility criteria: Inclusion Criteria:

* Foetal exposure of drugs during pregnancy.

Exclusion Criteria:

* Non exposed children

Primary outcomes:
measure: Mental Health Disorder
timeFrame: 2012
Secondary outcomes:
Other outcomes:
measure: Social status
timeFrame: 2012
Locations:
city: Bergen
country: Norway
facility: Haukeland universitet sykehus
city: Bergen
country: Norway
facility: Haukelans universitetssykehus
Study officials:
affiliation: Department of Child and Adolscent Psychiatry, Haukeland University Hospital, N-5018 Bergen
name: Irene B Elgen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04593745: Intraocular Pressure in Children With Acute Lymphoblastic Leukemia (ALL) Treated With High Dose Steroids
Official title: Intraocular Pressure in Children With ALL Treated With High Dose Steroids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ALL, Childhood
Steroid-Induced Glaucoma
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Childhood ALL patients are treated with high dose steroids. The study will follow the intraocular pressure of children treated in according to an AIEOP-BFM protocol, during the induction phase that will be compared to the pressure before treatment. Potential risk factors for developing elevated intraocular pressure will be estimated.

Detailed description: Children with ALL in Israel are treating according to the BFM ALL Protocol which contains high dose steroid therapy. One of the known side effects of high dose steroids is Intraocular hypertension, glaucoma, and even irreversible optic nerve injury. Early diagnosis of elevated intraocular pressure (IOP) and early therapeutic interventions might help to prevent future ocular damage.

The purpose of this study is to determine the risk of developing evaluate Intraocular pressure during high dose steroid therapy. If elevated IOP will be common enough, we will try to corelate the risk of elevated IOP with potential risk factors, such as initial IOP, WBC at diagnosis, etc.

Intraocular pressure will be measured by ophthalmologists using iCare devise: TONOPEN during general anesthesia at the day of diagnosis of ALL before steroid therapy initiation, and then after 15 and 33 days. Children with elevated IOP will continue ophthalmologists' follow up and treatment as necessary.

All parents or patients' guardians will sign informed consent for participating in the study.

The study group contains all newly diagnosed children with ALL in Schneider Children Medical Center.

Eligibility criteria: Inclusion Criteria:

* ALL diagnosis
* treated with an AIEOP-BFM protocol (including steroids)

Exclusion Criteria:

\* Any prior eye condition that can affect intra ocular pressure or its measurement

Primary outcomes:
measure: intra-ocular pressure (IOP)
timeFrame: 15 days of steroid treatment
measure: intra-ocular pressure (IOP)
timeFrame: 1 month of steroid treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
affiliation: Schneider Children's Medical Hospital
name: Shlomi Barzilai Birenboim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02828345: Bio-marker Analysis Using Circulating Tumor Cells in Patients With Melanoma
Official title: Bio-marker Analysis Using Circulating Tumor Cells in Patients With Melanoma
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Melanoma
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Melanoma

Brief summary: This research trial studies the levels of a type of biomarker, circulating tumor cells (CTCs), in the blood of patients with stage I-IV melanoma. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. Studying samples of blood in the laboratory obtained before and after treatment from patients with melanoma may help doctors learn more about changes that occur in CTC levels and whether they may predict how well patients will respond to therapy.


Eligibility criteria: Inclusion Criteria:

* Subjects must have signed tissue collection consent as described in protocol IRB# 703001,UPCC# 08607, PI: Giorgos Karakousis, MD
* Subjects must be competent to consent for themselves.
* Subjectsmust be adult (18 years or older).
* Subjects must be initiating a new therapy for melanoma (so a pretreatment CTC count can be obtained).

Exclusion Criteria:

* Children (less than 18yrs)
* Patients in whom a pre-treatment CTC level cannot be obtained.

Primary outcomes:
measure: Number of changes in CTC level from pre- to post-treatment
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Giorgos Karakousis, MD
role: PRINCIPAL_INVESTIGATOR
References: