louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03497741: Predictive Value of Procalcitonin for Bacteremia in the ICU
Official title: Predictive Value of Procalcitonin for Bacteremia in the ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Procalcitonin
Keywords: Intensive Care Unit
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the ICU whom blood cultures are taken for suspected bacterial infection.

Brief summary: Association between plasma procalcitonin levels and positive blood cultures in critical illness patients in the ICU.

Detailed description: Rationale: Association of procalcitonin levels and blood cultures in critical illness patients on the ICU.

Objective: Procalcitonin is an acute phase protein. As part of the acute phase response, procalcitonin is produced during sepsis. Previous research shows that procalcitonin is a biomarker for bloodstream infection. However, there is still little known about the value of procalcitonin in diagnostics for micro-organism underlying a sepsis in ICU patients. In modern practice, blood cultures are taken when a patient is septic to determine the responsible micro-organism. When procalcitonin is a predictive value for bacteremia in the ICU, the number of blood cultures can be reduced.

Study design: An observational cohort study intervention: for each patient in the ICU blood cultures were taken, the procalcitonin level was determined. During 6 months 150 patients will be included.

Main study parameters/endpoints: this study will examine the predictive value of procalcitonin in blood cultures on the ICU.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to the ICU
* Age \> 18 years

Exclusion Criteria:

* Hemodialysis/ Continuous Veno-Venous Hemofiltration

Primary outcomes:
measure: The predictive value of procalcitonin in blood cultures on the ICU
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate hospital
state: Gelderland
Study officials:
affiliation: Rijnstate Hospital
name: H.J. van Leeuwen
role: STUDY_CHAIR
References:
Clinical trial NCT01589341: Studying Chromosomes in Samples From Younger Patients With Neuroblastoma
Official title: Prognostic Impact of Segmental Chromosome Aberrations in Non MYCN Amplified Neuroblastomas in Different Age Groups
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroblastoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-05-01
Enrollment: 300
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neuroblastoma patient samples

Brief summary: This research studies chromosomes in samples from younger patients with neuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

Detailed description: OBJECTIVES:

I. Determine the impact on overall survival of patients with non-MYCN neuroblastoma below 18 months of age as compared to neuroblastoma patients above 18 months of age.

OUTLINE:

Archived DNA samples are analyzed for segmental chromosome aberrations by multiplex ligation-dependent probe amplification (MLPA), a polymerase chain reaction (PCR)-based technique. The following genomic regions are being studied: 1p, 1q, 3p, 4p, 7q, 9p, 11q, and 17q, as are the copy numbers of MYCN, NAG, DDX1, and ALK genes.

Eligibility criteria: Inclusion Criteria:

* Samples from neuroblastoma patients who, according to risk stratification, did not receive cytotoxic treatment and did never receive chemotherapy and are in complete response (CR) OR patients who, according to risk stratification, did not receive cytotoxic treatment initially, but had a localized or a systemic (stage Ms or M) relapse with or without following chemotherapy

  * Low-risk Children Oncology Group (COG) designation: no initial cytotoxic treatment, any stage, any age, any outcome
* DNA from untreated neuroblastoma tumor samples (from patients in the age group below and from patients in the age group above 1.5 years of age) available from the COG, Europe, Israel, and Japan
* No MYCN amplification
* No Schwann cell stroma-rich tumors
* No tumor cell content below 60%
* No DOT
* No patients diagnosed before 1997 and after 2005
* No lack of follow-up data
* See Disease Characteristics
* No initial cytotoxic treatment

Primary outcomes:
measure: Overall survival (OS)
timeFrame: From the date of diagnosis to the date of death from any cause, assessed up to 5 years
Secondary outcomes:
measure: Event-free survival (EFS)
timeFrame: From the date of diagnosis to the date of disease progression, death from any cause, or secondary neoplasm, assessed up to 5 years
measure: Incidence of metastatic relapses using cumulative incidences
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Peter Ambros, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02752841: The Effect of Vitamin D Repletion on Kidney Stone Risk
Official title: The Effect of Vitamin D Repletion on Urinary Calcium Excretion in Kidney Stone Formers With Vitamin D Deficiency and High Urinary Calcium
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Calculi
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 20
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: Examine the effect of nutritional vitamin D repletion on urinary calcium excretion and kidney stone burden in calcium kidney stone formers

Detailed description: The investigators plan to conduct a clinic-based interventional study of 50 patients followed at Miriam Hospital Kidney Stone Clinic with history of nephrolithiasis, urinary calcium excretion between 150 and 400 mg/day, and 25-vitamin D deficiency/insufficiency (defined as serum level ≤ 30ng/ml). The intervention is oral ergocalciferol 50,000 IU per week for 12 weeks (repletion course). After that, the same repletion course will be repeated if serum 25-vitamin D remains ≤ 30ng/ml or drops to ≤ 30ng/ml anytime during the study. Otherwise, a maintenance dose of cholecalciferol 1,000 IU daily or ergocalciferol 50,000 IU monthly will be prescribed for the rest of the study. Each participant will serve as his own control. The outcome is the change in urinary calcium excretion and stone burden assessed by renal ultrasound. The planned study duration is 12 months. The investigators will have greater than 95% power to detect a 10% increase in 24-hour urinary calcium.

Eligibility criteria: Inclusion Criteria:

* History of nephrolithiasis
* 25(OH)D deficiency (defined as serum level ≤ 30ng/ml) within 3 months of enrollment
* 24-hour urinary calcium excretion \> 150 mg/day and \< 400 mg/day (measured less than 2 months prior to study enrollment)

Exclusion Criteria:

* Known uric acid, cystine, or struvite stone disease
* Hypercalcemia (serum calcium \>10.4 mg/dl within the past 12 months)
* Gross hematuria within the past 6 months
* Acute stone event within the past 1 month
* Recent stone intervention within the past 1 month
* Suspected or known secondary causes of hypercalciuria such as primary hyperparathyroidism, sarcoidosis, hyperthyroidism, or malignancy (except non-melanoma skin cancer)
* Addition or dose change of medicines potentially affecting urinary calcium since enrollment 24-hour urine collection (including diuretics, magnesium supplements, potassium supplements, potassium citrate, and vitamin D supplementation)
* Pregnancy

Primary outcomes:
measure: Changes in urinary calcium excretion measured by timed urine collection
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Changes in kidney stone burden measured by ultrasound
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03214341: Assessment of Mediastinal Masses With Diffusion Weighted MR Imaging
Official title: Assessment of Mediastinal Masses With Diffusion Weighted MR Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mediastinal Tumor
Keywords: mediastinal masses
MRI diffusion
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients with mediastinal masses

Brief summary: Differentiation between benign and malignant mediastinal tumors as well as characterization and grading of malignancy which is essential for treatment planning as well as for prognosis

Detailed description: Differentiation between benign and malignant mediastinal tumors as well as characterization and grading of malignancy is essential for treatment planning as well as for prognosis .

MRI presents valuable diagnostic information in assessing the mediastinum. In addition, special applications have been developed over recent years diffusion-weighted magnetic resonance imaging is one such technique The advent of echo-planar imaging technique has rendered diffusion weighted imaging of the abdomen and thoracic cavity possible .

Quantitative assessment of the mediastinal mass is possible by calculation of apparent diffusion co-efficient value ,which is related to the proportion of extracellular and intracellular component.

The apparent diffusion co-efficient is inversely correlated with tissue cellularity. It is lower in viable tumor tissue with densely packed diffusion-hindering obstacles than in tissue with less densely packed obstacles such as tumor necrosis and benign tissue .

Eligibility criteria: Inclusion Criteria:

* Any age groups
* diagnosis of mediastinal mass (by Multislice Computed Tomography).

Exclusion Criteria:

* chemotherapy radiotherapy.
* thoracic surgery.
* cystic mass .
* mass with large amount of necrosis or calcification.
* contraindication of MRI (e.g. pacemakers , claustrophobia).

Primary outcomes:
measure: sensitivity and specificity of magnetic resonance imaging diffusion in mediastinal masses
timeFrame: up to one month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: Assiut University
name: Mostafa Thabet Hussein, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00314041: Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants
Official title: A Randomized, Double-blind, Controlled, Active Comparator, Phase II Study to Assess the Tolerance and Immunogenicity of Conjugate Meningococcal C (MnCC) Vaccine in Infants When Administered in Conjunction With Primary DTP/Hib Vaccination at 2, 3, and 4 Months of Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningitis, Meningococcal
Keywords: Infant
Conjugate vaccine
Meningococcal
Antibody
Immune memory
Health
Meningococcal Vaccines
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-04-12
Enrollment: 240
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Infant phase: To determine the safety of and production of antibodies by a group C meningococcal conjugate vaccine (MnCC), when given at 2, 3, and 4 months of age with routine vaccines.

Booster phase: To compare the safety of and production of antibodies by MnCC with and without MMR and to compare the antibody response to that produced by a low dose of plain polysaccharide vaccine as a way of investigating immune memory


Eligibility criteria: Inclusion Criteria:

* Healthy infants 7-10 weeks of age eligible to receive routine immunization

Primary outcomes:
measure: Antibody responses to MnCC and concomitant vaccines
Secondary outcomes:
measure: Safety and reactogenicity
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For United Kingdom, ukmedinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04927741: Essential Oils Following IUD Insertion
Official title: The Use of Topically Applied Sweet Marjoram Essential Oil for Pain Reduction Following IUD Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Muscle
IUD
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 1:1:1 Randomization
Primary purpose: OTHER

Brief summary: This study will measure the effects of topical application of sweet marjoram essential oil + grapeseed oil with massage on uterine cramping/pain post-IUD insertion/placement.

The intention is to conduct a pilot study that could give a first look at the data to determine whether this line of research is worth pursuing with more time, effort, and resources. The results of this pilot study will provide adequate data (e.g., variance estimates) needed for obtaining reasonably reliable sample size estimates if larger studies are warranted in the future.

Detailed description: Patients will be consented and randomized to one of three methods by a member of the study team on the day of their IUD insertion. Several variables of interest will be collected via the electronic medical record and via questionnaire.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older at time of IUD insertion
* English speaking
* Subject has signed study-specific consent form
* Subject has taken clinic recommended NSAID at least 30 minutes prior to IUD insertion

Exclusion Criteria:

* Subject is in post-partum period
* Known allergies to sweet marjoram essential oil or grapeseed oil
* Broken or irritated skin on lower abdomen
* Diagnosis of IBS/IBD

Primary outcomes:
measure: Change in Pain/Discomfort as Assessed by NRS
timeFrame: 15 minutes post oil application/massage
Secondary outcomes:
measure: NRS Patient Pain Rating
timeFrame: Within the 15 minutes following oil application/massage
Other outcomes:
Locations:
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
Study officials:
affiliation: Aurora BayCare Medical Center
name: Vicki F Fresen, RNC, MSN, APNP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01426841: Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer
Official title: Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Small Cell Lung Cancer
Keywords: Small cell lung cancer
Adaptive radiotherapy
Thoracic radiotherapy
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2011-09-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is intended to assess the feasibility of adjusting a radiation plan during its course to accommodate for a shrinking tumor target. The investigators hypothesize that an adaptive radiotherapy (RT) planning strategy for small cell lung cancer (SCLC) patients with chest-confined disease will allow for safe delivery of higher doses of chest RT than a non-adaptive RT planning approach without subjecting normal critical structures to unacceptable doses of radiotherapy.


Eligibility criteria: Inclusion Criteria:

* patients with histologically or cytologically proven newly diagnosed small cell lung cancer
* chest-confined disease (including bulky intrathoracic disease)
* adequate pulmonary function tests (FEV-1\>1.0 L, DLCO\>50%)
* patients of childbearing potential must practice adequate contraception
* Age \> or = 18 years
* Karnofsky performance status \> or = 70
* eligible for concurrent chemoradiotherapy

Exclusion Criteria:

* patients who have undergone complete or subtotal tumour resection
* evidence of non-small cell histology
* prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
* prior RT to the thorax or neck
* compromised lung function with inadequate pulmonary function tests (FEV-1\<1.0,DLCO\<50%)
* pregnant women

Primary outcomes:
measure: Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach
timeFrame: 12-24 months
Secondary outcomes:
measure: Local control and patterns of failure
timeFrame: 12-24 months
measure: Survival
timeFrame: 12-24 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: Cross Cancer Institute, Alberta Health Services
name: Don Yee, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03023241: Diagnosis of Bladder Pain Syndrome / Interstitial Cystitis
Official title: Diagnosis of Bladder Pain Syndrome / Interstitial Cystitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Pain Syndrome
Interstitial Cystitis
Overactive Bladder
Keywords: BPS/IC
OAB
Lead sponsor: Cantonal Hospital, Frauenfeld
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To identify new, simple and reliable biomarkers for bladder pain syndrome/interstitial cystitis (BPS/IC) for diagnosis of this disease.

Detailed description: Collection and analyses of bladder biopsies, bladder washings, blood and urine samples of patients with bladder pain syndrome/interstitial cystitis (BPS/IC), overactive bladder syndrome (OAB) and bladder-healthy controls. Analyses include ELISA, RT-qPCR, DNA sequencing, and immunohistochemistry techniques. Differences between patient groups are statistically evaluated.

Eligibility criteria: Inclusion Criteria:

* patient with diagnosed BPS/IC, OAB or healthy controls
* included healthy controls must have another pelvic surgery planned (e.g. hysterectomy)
* being able to act and judge

Exclusion Criteria:

* unstable endocrinological situation
* severe illness

Primary outcomes:
measure: Identification of new diagnostic markers for BPS/IC
timeFrame: 2 days
Secondary outcomes:
measure: Identification of molecular details that lead to BPS/IC (pathogenesis).
timeFrame: 2 days
Other outcomes:
Locations:
city: Frauenfeld
country: Switzerland
facility: Cantonal Hospital Frauenfeld
state: Thurgau
Study officials:
affiliation: Cantonal Hospital Frauenfeld, Switzerland
name: Volker Viereck, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gamper M, Viereck V, Geissbuhler V, Eberhard J, Binder J, Moll C, Rehrauer H, Moser R. Gene expression profile of bladder tissue of patients with ulcerative interstitial cystitis. BMC Genomics. 2009 Apr 28;10:199. doi: 10.1186/1471-2164-10-199.
citation: Gamper M, Viereck V, Eberhard J, Binder J, Moll C, Welter J, Moser R. Local immune response in bladder pain syndrome/interstitial cystitis ESSIC type 3C. Int Urogynecol J. 2013 Dec;24(12):2049-57. doi: 10.1007/s00192-013-2112-0. Epub 2013 May 14.
citation: Gamper M, Regauer S, Welter J, Eberhard J, Viereck V. Are mast cells still good biomarkers for bladder pain syndrome/interstitial cystitis? J Urol. 2015 Jun;193(6):1994-2000. doi: 10.1016/j.juro.2015.01.036. Epub 2015 Jan 14.
citation: Gamper M, Moser R, Viereck V. Have we been led astray by the NGF biomarker data? Neurourol Urodyn. 2017 Jan;36(1):203-204. doi: 10.1002/nau.22882. Epub 2015 Sep 18. No abstract available.
citation: Regauer S, Gamper M, Fehr MK, Viereck V. Sensory Hyperinnervation Distinguishes Bladder Pain Syndrome/Interstitial Cystitis from Overactive Bladder Syndrome. J Urol. 2017 Jan;197(1):159-166. doi: 10.1016/j.juro.2016.06.089. Epub 2016 Jul 1.
Clinical trial NCT04489641: Brief Group Psychotherapy for Anxiety and Depression
Official title: Brief Group Psychotherapy for Anxiety and Depression: A Randomized Controlled Trial of Efficacy and Mechanisms of Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Affective Disorder
Lead sponsor: Universidad de Córdoba
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present work aims to develop a randomized clinical trial with a sample of 100 patients diagnosed with anxiety and depression in primary care. All participants are tested by several self-reports related to emotional disorders in a repeated measures design, pre and post treatment. It is our aim this study will demonstrate that brief psychological treatments should be prioritized over pharmacological treatment in Primary Care. In addition, emotional regulation will be assessed and examined as a key factor in the clinical improvement.


Eligibility criteria: Inclusion Criteria:

* Anxiety
* Depression

Exclusion Criteria:

* Severe mental disroders
* Drug abuse
* Suicidal ideation/severe depression

Primary outcomes:
measure: Generalised Anxiety Disorder Assessment (GAD-7)
timeFrame: 12 weeks
measure: The Patient Health Questionnaire (PHQ-9)
timeFrame: 12 weeks
measure: Beck Depression Inventory-Second Edition (BDI-II)
timeFrame: 12 weeks
measure: The Patient Health Questionnaire (PHQ-15)
timeFrame: 12 weeks
measure: Patient Health Questionnaire-Panic Disorder (PHQ-PD)
timeFrame: 12 weeks
Secondary outcomes:
measure: Emotional Regulation Questionnaire (ERQ)
timeFrame: 12 weeks
measure: Penn State Worry Questionnaire-Abbreviated (PSWQ-A)
timeFrame: 12 weeks
measure: Ruminative Response Scale-10 (RRS-10)
timeFrame: 12 weeks
measure: Metacognition Questionnaire-30 (MCQ-30)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Jorge Corpas
state: Andalucía
Study officials:
affiliation: Universidad de Córdoba
name: Juan A. Moriana
role: PRINCIPAL_INVESTIGATOR
References: