louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02328469: Aseptic Meningoencephalitis in Slovenia
Official title: Prospective Study of the Etiology, Pathogenesis, Clinical Picture and Outcome of Aseptic Meningitis in Slovenia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aseptic Meningitis
Keywords: aseptic meningitis
tick-borne encephalitis
Lyme neuroborreliosis
inflammation
outcome
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: Slovenian Research Agency
name: University of Ljubljana School of Medicine, Slovenia
name: Harvard University
First posted: 2014-12-31
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients with acute aseptic meningitis/meningoencephalitis

Brief summary: The main objective of this study is:

* to establish etiology of acute aseptic meningitis/meningoencephalitis in Slovenia
* to assess the clinical course and outcome of tick-borne encephalitis and Lyme neuroborreliosis
* to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with tick-borne encephalitis and Lyme neuroborreliosis


Eligibility criteria: Inclusion Criteria:

* clinical picture compatible with aseptic meningitis/meningoencephalitis
* age 18 years or older
* clear cerebrospinal fluid on macroscopic examination
* cerebrospinal pleocytosis (\> 5 x 106 white blood cells per liter)

Exclusion Criteria:

* younger than 18 years
* pregnant women

Primary outcomes:
measure: Changes in selected clinical parameters in patients with acute aseptic meningitis/meningoencephalitis
timeFrame: at enrollment and during 12 months follow-up
measure: Changes in selected laboratory parameters in patients with acute aseptic meningitis/meningoencephalitis
timeFrame: at enrollment and during 12 months follow-up
measure: Changes in selected microbiologic parameters in patients with acute aseptic meningitis/meningoencephalitis
timeFrame: at enrollment and during 12 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana, Department of Infectious Diseases
Study officials:
affiliation: UMC Ljubljana
name: Franc Strle, MD, PhD
role: STUDY_CHAIR
affiliation: UMC Ljubljana
name: Daša Stupica, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02457169: Addressing Systemic Health Disparities in Early Identification and Treatment of Autism Spectrum Disorder (ASD): ABCD Project
Official title: Addressing Systemic Health Disparities in Early ASD Identification and Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University of Massachusetts, Boston
Sponsor class: OTHER
Collaborators: name: Tufts Medical Center
name: Northeastern University
name: National Institute of Mental Health (NIMH)
First posted: 2015-05-29
Enrollment: 31
Sex: ALL
Minimum age (years): 14
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The intervention under examination is designed to promote parents' school engagement following the transition from Early Intervention (EI) to preschool for parents of young children who were diagnosed with ASD through our screening and assessment protocol. The brief intervention employs principles of motivational interviewing to address not only the particular child characteristics and needs associated with ASD but also the unique, system-related challenges of navigating the special education system and advocating for appropriate services. Motivational interventions with parents are designed to elicit parents' specific, action-oriented goals for themselves and their children, enhancing motivation to pursue change, and addressing and resolving obstacles or sources of ambivalence.

By identifying and capitalizing on parents' strengths, empowering parents to develop specific goals, and improving parents' readiness to engage actively with their children's school, teacher, and educational team, we expect that this brief intervention will lead to higher levels of parental school involvement, higher special education engagement, and closer and more productive parent teacher relationships.


Eligibility criteria: Inclusion Criteria: Parents of children who participated in our screening and assessment study, whose children received diagnoses of autism through our assessment, AND

* whose children are turning 3 and transitioning out of Early Intervention services.

Exclusion Criteria: Children who are medically complex OR

* have a previous diagnosis of ASD outside of our study OR
* Don't have a parent/guardian who speak/understand sufficient English or Spanish to complete study materials OR
* Don't qualify for Early Intervention services

Primary outcomes:
measure: parental school involvement
timeFrame: 3 months post-intervention
measure: parent-teacher relationship quality
timeFrame: 3 months post-intervention
measure: parent-special education engagement
timeFrame: 3 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Massachusetts, Boston
name: Alice S Carter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03504969: Perinatal Outcomes in Umbilical Cord Entanglement
Official title: Assiut University,Faculty of Medicine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Umbilical Cord; Complications, Affecting Fetus
Keywords: umbilical cord
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 201
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women in active vaginal delivery

Brief summary: Umbilical Cord Entanglement and Perinatal Outcomes.

Detailed description: Umbilical Cord Entanglement and Perinatal Outcomes neonatal outcomes and the effect on mode of delivery

Eligibility criteria: Inclusion Criteria:

* all vaginal deliveries with or without Umbilical Cord Entanglement

Exclusion Criteria:

* multible pregnancy

Primary outcomes:
measure: perinatal outcomes
timeFrame: one year
Secondary outcomes:
measure: delivery outcome
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01994369: Intraoperative Imagery of Breast Cancer With Folate-FITC (EC17)
Official title: A Pilot & Feasibility Study of the Imaging Potential of EC17 in Subjects Undergoing Surgery Presenting Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Resectable Breast Cancer
Keywords: Breast Cancer
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Breast cancer is the most common cancer and the second cause of cancer mortality in women. There are approximately 200,000 new cases of breast cancer a year. Classically, breast cancers are divided into two groups, invasive and non-invasive. A mainstay of the treatment of both of these types is surgical resection not only for therapeutic purposes but also for diagnostic purposes. Breast conserving therapy includes surgical lumpectomy and post-operative radiation. However, despite best surgical practices, when patients undergo BCT anywhere from 20 - 40% of these patients have margins positive for cancer. This leads to increased rates of reoperation which are quoted to be as high as 30% and increased local recurrences.

There is an over expression of folate receptors located on the surface of many human carcinoma nodules.Specifically for breast cancer up to 33% of all breast cancers over express the folate receptor.

Folate-fluorescein isothiocyanate, or folate-FITC, also identified as EC-17, targets folate receptors over expressed in certain cancers such as breast cancer, and could help in better identifying the margins of the cancer thereby achieving negative margins.


Eligibility criteria: Inclusion Criteria:

1. Adult patients 18 years of age and older
2. Patients presenting with breast cancer presumed to be resectable by lumpectomy and/or mastectomy on pre-operative assessment
3. Good operative candidate
4. Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria:

1. Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
2. Patients with a history of anaphylactic reactions to Folate-FITC or insects
3. At-risk patient populations

   1. "People who would be easily lost to follow up (ex: People who are homeless or alcohol dependent)
   2. Patients unable to participate in the consent process (children and neonates).

Primary outcomes:
measure: The ability of EC17 and the imaging system to detect FRA positive tumors during surgery conducted 2-4 hours post EC-17 administration.
timeFrame: Within two to four hours of injection of EC17
Secondary outcomes:
measure: The number of participants that will have an adverse reaction to the EC17
timeFrame: Day 1- Day 30
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Sunil Singhal, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05487469: Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass
Official title: Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatic Heart Disease
Cardiopulmonary Bypass
Immunotherapy
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Rheumatic heart disease usually accompanied by weakened immune function. And the cardiopulmonary bypass further aggravating the decline of immune function. Therefore, the prevention of Postoperative immune function collapse is of great clinical value, and immunomodulatory therapy with thymosin alpha

1 may be beneficial. This study was designed to test the hypothesis that the administration of thymosin alpha 1 will Improve the immune function and prognosis of patients.


Eligibility criteria: Inclusion Criteria:

* The patients are conformed to 2004 WHO guidelines for Rheumatic fever and rheumatic heart disease;
* Patients planning to undergo cardiac surgery were enrolled.
* The patients' age between 18 \~80 years old.
* Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

* Patients allergic to Thymosin α1;
* Lactating women and pregnant women;
* Patients with mental diseases, drug and alcohol dependence;
* Refuse to participate in this study and refuse to sign the informed consent

Primary outcomes:
measure: The highest Sequential Organ Failure Assessment (SOFA) score of 5 days after surgery
timeFrame: 5 days after surgery
Secondary outcomes:
measure: 30-day mortality
timeFrame: 30 days after randomization
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The first affiliated hospital of nanjing medical university
state: Jiangsu
Study officials:
References:
Clinical trial NCT05627869: Effects of TTPB vs PIFB on Opioid Consumption in Patients After Cardiac Surgery.
Official title: Comparison of Effects of Transversus Thoracic Muscle Plane Block vs Pecto-intercostal Fascial Block on Postoperative Opioid Consumption in Patients Undergoing Open Cardiac Surgery: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Postoperative
Keywords: TTPB
PIFB
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2022-11-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the effects of TTPB vs PIFB on postoperative opioid consumption in patients undergoing open cardiac surgery.

Detailed description: Cardiac surgery performed through median sternotomy is associated with significant postoperative pain.Poststernotomy pain leads to decreased patient satisfaction, delirium, cardiovascular complications (hypertension, tachycardia, arrhythmias), hyperglycemia and respiratory complications (bronchial secretion stasis, atelectasis and pneumonia).High-dose opioids can provide good postoperative analgesia for patients undergoing heart surgery. However, opioids have some side effects.The advent of ultrasound-guided regional anaesthesia led to the development of fascial plane chest wall block as transthoracic plane block and pectointercostal fascial block.

Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 75 years.
2. Patient scheduled to undergo elective on-pump cardiac surgery with sternotomy.
3. American Society of Anesthesiologists classification of physical status \< IV.

Exclusion Criteria:

1. Emergency surgery.
2. Off-pump surgery.
3. Redo surgery.
4. Ejection fraction less than 35%.
5. Refusal of the patient.
6. Known hypersensitivity to LA.
7. Chronic opioid use or chronic pain patient.
8. Psychiatric problems or communication difficulties.
9. Liver insufficiency (defined as a serum bilirubin ≥ 34 μmol/l, albumin ≤ 35 g/dl, INR ≥ 1.7)
10. Renal insufficiency (defined as a glomerular filtration rate \< 44 ml/min).
11. Obstructive sleep apnea syndrome.
12. Coexisting hematologic disorders.
13. Pregnancy or breastfeeding.

Primary outcomes:
measure: The primary outcome will be total morphine consumption
timeFrame: 24 hours
Secondary outcomes:
measure: The secondary outcomes will be the first analgesic request time
timeFrame: 24 hours
Other outcomes:
Locations:
city: Benisuef
country: Egypt
facility: Benisuef University Hospital
Study officials:
affiliation: Benisuef university hospital
name: Mariana A Mansour, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03475069: Which Exercises Should Diabetic Patients do?
Official title: Effects of a Special Exercise Program on Physical Function and Quality of Life Versus Plates and Calisthenics Exercises on Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Physical Activity
Keywords: Type 2 Diabetes Mellitus
Exercise
Physical Performance
Physiological Cost Index
Lead sponsor: Biruni University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2018-03-23
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Type 2 Diabetes Mellitus (DM) is a widespread worldwide disease. Exercise therapy is an effective method but which exercise types are more effective is an important question.

This study was designed to compare the effects of three different exercise programs on physical function and quality of life in Type 2 DM. Forty-two patients with Type 2 DM participated in the study. The patients were randomly assigned to three groups. Client based exercises in accordance with physiotherapy assessment were applied to group 1 (aged 51.42±4.60 years; body mass index 35.28±4.21 kg/m² kg/m²), Clinical Plates exercises were applied to group 2 (aged 53.07 ±5.12 years; body mass index 35.56±4.83 kg/m²) and a standard program including calisthenics exercises were applied to group 3 for 12 weeks, 3 days a week. 6 minutes walk test (6 MWT) and physiological cost index (PCI), timed up and go test (TUG) and SF-36 quality of life questionnaire were performed before and after the 12-week exercise program.


Eligibility criteria: Inclusion Criteria:

* Patients who can walk independently.
* Patients who accept doing exercises for 12 weeks, 3 days a week properly Patients whose cognitive status are enough for understanding and realizing different exercise types.

Exclusion Criteria:

* Patients with orthopaedic or surgical problems that prevent walking.
* Patients with neuropathy that prevent walking.
* Patients who have foot ulcers.
* Patients with neurological problems.
* Patients with cardiac, pulmonary and systematic problems that cause contraindication for exercise.

Primary outcomes:
measure: Energy expenditure after physical performance
timeFrame: 3 months
measure: Quality of life
timeFrame: 3 months
Secondary outcomes:
measure: Timed up and go test
timeFrame: 3 months
measure: Body mass index
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Başar Öztürk
Study officials:
References:
Clinical trial NCT01918969: Reference Values of Circulating Endothelial Progenitor Cells
Official title: Determination of Reference Values of Circulating Endothelial Progenitor Cells CD34+144+CD14- and CD34+VEGF-R2+CD14- in a Blood Donnor Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Aneurysm
Keywords: Endothelial progenitor cells
Healthy blood donors
Lead sponsor: Hopital Jean Minjoz
Sponsor class: OTHER
First posted: 2013-08-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy blood donors

Brief summary: Circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- have been shown to be inversely correlated to aortic aneurysm size. However reference values have not yet been determined. This study is aimed to determine reference values of CD34+144+CD14- et CD34+VEGF-R2+CD14- in healthy men and women blood donors.

Detailed description: At the time of blood donation, 10mL of blood will be used to calculate the concentration of circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- , and the ratio of circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- / all circulating endothelial progenitor cells in order to determine reference values.

Eligibility criteria: Inclusion Criteria:

* Blood donors

Exclusion Criteria:

* age over 65
* Arterial hypertension (treated or not)
* Vascular disease
* smoker or former smoker who stopped smoking for less than a year

Primary outcomes:
measure: Concentration of circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14-
timeFrame: 3 months
Secondary outcomes:
measure: Ratio of circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- / all circulating endothelial progenitor cells
timeFrame: 3 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
Study officials:
affiliation: University of Franche-Comte; France
name: Andrea Perrotti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Etablissement Français du Sang
name: Pascal Morel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Franche-Comte. france
name: Siamak Davani, MD, PhD
role: STUDY_CHAIR
References:
citation: Parietti E, Pallandre JR, Deschaseaux F, Aupecle B, Durst C, Kantelip JP, Chocron S, Davani S. Presence of circulating endothelial progenitor cells and levels of stromal-derived factor-1alpha are associated with ascending aorta aneurysm size. Eur J Cardiothorac Surg. 2011 Jul;40(1):e6-12. doi: 10.1016/j.ejcts.2011.02.065. Epub 2011 Apr 9.
Clinical trial NCT01094769: Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease
Official title: Sympathetic Nervous System Inhibition for the Treatment of Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Nephropathies
Lead sponsor: Baker Heart and Diabetes Institute
Sponsor class: OTHER
First posted: 2010-03-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether moxonidine is effective in reducing urine albumin levels in patients with diabetic kidney disease.

Detailed description: This study will investigate the effect of moxonidine in lowering urine albumin excretion and limiting further damage to the kidneys in patients with diabetic nephropathy. Reducing urine albumin excretion in type 2 diabetic patients is an indicator of successful treatment. Previous studies have shown that drugs that work in a similar fashion to moxonidine (intervene with the sympathetic nervous system)have been very effective in reducing the amount of albumin in the urine and are associated with long term renal and cardiovascular protection.

Eligibility criteria: Inclusion Criteria:

* age: 18-75 years
* diabetic nephropathy as defined by the mean of three consecutive early morning urinary albumin-creatinine ratios (UACR) of \>300mg per gram, or \> 200mg per gram in patients receiving therapy targeted at blockade of the RAS

Exclusion Criteria:

* non-diabetic kidney disease
* UACR of more than 3500mg per gram, an estimated glomerular filtration rate of less than 30ml/min/1.73m2.
* chronic urinary tract infection.
* severe hypertension
* heart failure New York Heart Association (NYHA) class II-IV
* major cardiovascular disease within the previous 6 months
* left ventricular ejection fraction \<55%

Primary outcomes:
measure: Urine albumin/creatinine ratio (UACR)
timeFrame: 12 weeks
Secondary outcomes:
measure: muscle sympathetic nerve activity (MSNA)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred & Baker Medical Unit
state: Victoria
Study officials:
affiliation: Baker Heart and Diabetes Institute
name: Markus P Schlaich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baker Heart and Diabetes Institute
name: Gavin W Lambert, BSc PhD
role: PRINCIPAL_INVESTIGATOR
References: