louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02391428: The Correlation Between Blood omega3 and ADHD
Official title: The Correlation Between Blood omega3 and ADHD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: ADHD
omega3
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2015-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Attention deficit hyperactivity disorder (ADHD) is a major problem in children and adolescents. Clinical and biochemical evidence suggests that deficiencies of polyunsaturated fatty acids (PUFA) could be related to ADHD. PUFAs are the major components of brain with important physiologically active functions.

Aim: Study the relationship between omega3 blood values and ADHD clinical status.

Methods: The investigators will recruit 30 children, who have been diagnosed with ADHD by a child psychiatrist. In addition the investigators will recruit a control group of 30 children without ADHD and related neuropsychiatric syndromes. Blood will be taken from all children.

The ADHD children will be asked to consume omega3 capsules for 6 month. After 3 and 6 months, all children will undergo clinical examination and blood tests will be taken for omega3 index analysis. Blind frozen samples of isolated red blood cell (RBC) will be analyzed according to the omega3 index methodology.

Detailed description: Attention deficit hyperactivity disorder (ADHD) is a major problem in children and adolescents. Clinical and biochemical evidence suggests that deficiencies of polyunsaturated fatty acids (PUFA) could be related to ADHD. PUFAs are the major components of brain with important physiologically active functions.

Aim: To investigate influence effects of omega3 dietary supplementation on ADHD symptoms and the measured blood values.

Methods: The study will be authorized by the Ziv Helsinki Committee and the Ministry of Health. Written Informed consent will obtained from parents. The investigators will recruit 30 children, who have been diagnosed with ADHD by a child psychiatrist. In addition the investigators will recruit a control group of 30 children without ADHD and related neuropsychiatric syndromes. Blood will be taken from all children.

Eligibility criteria: Inclusion Criteria:

- ADHD group: Children diagnosed with ADHD aged 6-14; children who have not received a dietary supplement of omega3 in the last month

Control group inclusion criteria: Children without ADHD and related neuropsychiatric syndromes aged 6-14, Children who have not received a dietary supplement of omega3 in the last month.

Exclusion Criteria:

- Children with severe chronic or autoimmune disorders, children who received a dietary supplement of omega3 in the last month

Primary outcomes:
measure: blood omega3
timeFrame: 6 month
Secondary outcomes:
measure: ADHD Symptoms
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05720728: Research of New Serological Markers for the Diagnosis and Monitoring of Candidaemia in Hospitalized Patients
Official title: Research of New Serological Markers for the Diagnosis and Monitoring of Candidaemia in Hospitalized Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Candida Infection
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients hospitalized one or more positive blood cultures for Candida spp, positive beta-glucanemia and the presence of at least one clinical symptom of infection will be considered cases of candidemia.

Controls will be defined as patients at risk of candidaemia but with negative blood cultures and who have never started antifungal therapy in the 30 days following the date of the 1st blood culture.

Patients at risk are defined as patients with fever who have at least two of the following factors: CVC, parenteral nutrition, antibiotic therapy in the previous 30 days for at least 7 days, abdominal surgery, polytrauma, dialysis, diabetes, at least two sites colonized by Candida.

Brief summary: Bloodstream infections due to Candida spp remain a serious medical challenge because of their high incidence and poor outcome. Diagnosis and monitoring of patients are still problematic, hindering efficient clinical management of the disease. The invastigators propose here to perform a retrospective study in a clinically well-characterized candidemic patient, with the goal of recognizing host immunological factors and virulence-associated fungal molecules relevant in the onset and evolution of infection. The researchers' ultimate goal is to identify new diagnostic and/or prognostic benchmarks useful in clinical settings. By combining serologic and immunologic expertise with clinical expertise, the research team has real potential to generate new markers of host pathogenesis and immune response in candidemia and to inform prospective clinical trials to control this terrible disease


Eligibility criteria: Inclusion Criteria:

* patients hospitalized
* one or more positive blood cultures for Candida spp,
* positive beta-glucanemia
* the presence of at least one clinical symptom of infection will be considered cases of candidemia.

Exclusion Criteria:

* age less than 18 years
* state of immunosuppression
* incompleteness of clinical data
* unavailability of serum samples in sufficient quantities for analysis and in good condition.

Primary outcomes:
measure: levels of antibodies
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione PoliclinicoAgostino Gemelli IRCCS
state: Roma
Study officials:
References:
Clinical trial NCT03779828: Evaluating the Effectiveness of Telemonitoring System in the Management of Patients With CIDP
Official title: A Multicenter Pilot Study to Determine Criteria for Evaluating the Effectiveness of Two Comparative Monitoring Methods in the Management of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Receiving Home-based Treatment With IVIg (Privigen®)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Inflammatory Demyelinating Polyneuropathy
Keywords: CIDP
Telemonitoring
Telemedicine
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2018-12-19
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving home-based IVIg therapy with Privigen

Brief summary: Chronic inflammatory demyelinating polyneuropathy (CIDP) is a chronic demyelinating polyneuropathy of autoimmune origin with a progressive or relapsing course.

Diagnosis is based on clinical presentation and electrophysiological findings in accordance with the EFNS/PNS consensus guidelines. IVIg is the first line treatment witch has been shown to be effective in several placebo-controlled trials.

Once IVIg therapy produces a response and is well tolerated, some patients are able to continue their treatment in the home setting. The HOME LINK system offers an integrated, global solution based on telemonitoring technology providing continuous, remote monitoring of Privigen® infusions administered at home.


Eligibility criteria: Inclusion Criteria:

* Patient with a diagnosis of CIDP as per EFNS/PNS criteria.
* Patient already receiving home-based treatment with Privigen®

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Evaluate HOME LINK telemonitoring system for patients receiving home-based IVIg therapy
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Pellegrin, Bordeaux University Hospital (CHU)
city: Créteil
country: France
facility: Hôpital Henri Mondor - APHP
city: Lille
country: France
facility: Hôpital Roger Salengro - CHRU
city: Lyon
country: France
facility: Hôpital Pierre Wertheimer - HCL
city: Marseille
country: France
facility: Hôpital La Timone - APHM
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac - Montpellier University Hospital (CHU)
city: Nice
country: France
facility: Hôpital Pasteur 2 - Nice University Hospital (CHU)
city: Paris
country: France
facility: Hôpital La Pitié-Salpêtrière - APHP
city: Paris
country: France
facility: Hôpital Lariboisière - APHP
city: Saint Etienne
country: France
facility: Hôpital Nord - Saint Etienne University Hospital (CHU)
Study officials:
References:
Clinical trial NCT01852461: Perfusion Index Variability in Respiratory Distress Syndrome
Official title: Perfusion Index Variability in Preterm Infants Treated With Two Different Natural Surfactants for Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poor Peripheral Perfusion
Keywords: natural surfactants; perfusion index
Lead sponsor: Dr. Sami Ulus Children's Hospital
Sponsor class: OTHER
First posted: 2013-05-13
Enrollment: 92
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Perfusion index may vary according to type of surfactant during the treatment of respiratory distress syndrome.

Detailed description: Peripheral tissues of preterm infants are very sensitive for hypoperfusion, but there are rare data in the literature for peripheral perfusion after surfactant treatment. In this study the investigators aimed to compare the perfusion index (PI) variability in premature infants with respiratory distress (RDS) following instillation of one of two different natural surfactant preparations.

Eligibility criteria: Inclusion Criteria:

* premature infants \< 32 weeks of gestational age

Exclusion Criteria:

* congenital malformation
* Apgar scores \<3 at 5 min

Primary outcomes:
measure: perfusion index
timeFrame: 1 week
Secondary outcomes:
measure: Duration of mechanical ventilation
timeFrame: 4 weeks
Other outcomes:
measure: Mortality
timeFrame: 4 weeks
Locations:
Study officials:
affiliation: Sami Ulus CH
name: Dilek Dilli, Assoc Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT06845761: Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making
Official title: Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use
Suicidal Ideation/Behavior
Keywords: Alcohol
Cognitive Behavioral Therapy
Suicide
Remote
Self-Guided Therapy
CBT4CBT
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2025-02-25
Enrollment: 100
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 purpose of this single groups trial is to (Aim 1) determine relationships between alcohol use, suicidal thoughts and behaviors (STBs), and behavioral economic decision-making in a community sample (N = 100) of alcohol using adults who are 18 years of age or older, (Aim 2) is to determine factors that predict engagement with a remote intervention (computer based training for cognitive behavioral therapy; CBT4CBT) for alcohol and its effects on alcohol use, STBs, and decision-making with those same adults.

Participants will complete a baseline assessment and be given access for remote, self-guided CBT4CBT modules for alcohol use. Following this, participants will remotely complete three follow-up assessments over three months. This will allow for determination of incidence and predictors of alcohol use and STBs and determination of predictors of engagement and efficacy of a remote intervention for alcohol use in both samples.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Consume alcohol at least weekly
* A score of 8 or greater on the Alcohol Use Disorder Identification Test (AUDIT)
* Some interest in cutting back on drinking or quitting
* Read and understand English

Exclusion Criteria:

* A score of 31 or greater on the Alcohol Use Disorder Identification Test (AUDIT) at baseline
* Reporting schizophrenia and/or other psychiatric diagnoses other than depression or anxiety at baseline
* Already being in treatment for alcohol use disorder at baseline
* Past month substance use other than cannabis or tobacco

Primary outcomes:
measure: Change in Alcohol Use
timeFrame: Assessed at study week 0, 4, 8, and 12
measure: Engagement with Self-Guided Cognitive Behavioral Therapy for Alcohol Use
timeFrame: Assessed at study week 12
measure: Change in Suicidal Thoughts and Behaviors
timeFrame: Assessed at study week 0, 4, 8, and 12
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Mark J Rzeszutek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02247661: Hip Abductor Strengths, Limping and Trochanteric Tenderness After Hip Arthroplasty Due to Femoral Neck Fracture
Official title: Hip Abductor Strengths, Limping and Trochanteric Tenderness After Hip Arthroplasty Due to Femoral Neck Fracture: A Comparison Between the Lateral and Posterolateral Approaches
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoral Neck Fracture
Trochanteric Pain
Keywords: Femoral neck fracture,surgical approach, limp, abductor strenght, trochanteric pain
Lead sponsor: Sundsvall Hospital
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 48
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Sundsvall hospital with a displaced femoral neck fracture operated with either a total or hemiarthroplasty.

Brief summary: A prospective cohort study to compare the direct lateral and poster-lateral approach concerning abductor function. Patients admitted with a femoral neck fracture operated with a hemiarthroplasty through a direct lateral or a poster-lateral approach were screened for inclusion. Patients with altered mental status SPMSQ \>7, pathological fractures, non-walkers were excluded.

Those who fulfilled the inclusion criteria and non of the exclusion criteria were followed 1 year postoperatively by clinical examination. Sample size were estimated to 30 patient in each group. Primary outcome variables were trendelenburg test, abductor strength measured with dynamometry, trochanteric tenderness measured with algometry and palptation.


Eligibility criteria: Inclusion Criteria:

* Displaced femoral neck fracture
* Walker
* Hemarthroplasty
* Preiffer test \>7/10

Exclusion Criteria:

* Pathological fracture
* Non-walker
* Pfeiffer test \<7/10 indicating mental alteration.

Primary outcomes:
measure: Trendelenburg Test
timeFrame: 1 year
Secondary outcomes:
measure: Abductor strenght
timeFrame: 1 year
measure: Trochanteric tenderness
timeFrame: 1 year
measure: Trochanteric tenderness
timeFrame: 1 year
Other outcomes:
Locations:
city: Sundsvall
country: Sweden
facility: Orthopaedic department, Sundsvall hospital
state: Västernorrlands län
Study officials:
References:
citation: Skoldenberg O, Ekman A, Salemyr M, Boden H. Reduced dislocation rate after hip arthroplasty for femoral neck fractures when changing from posterolateral to anterolateral approach. Acta Orthop. 2010 Oct;81(5):583-7. doi: 10.3109/17453674.2010.519170.
citation: Pai VS. Significance of the Trendelenburg test in total hip arthroplasty. Influence of lateral approaches. J Arthroplasty. 1996 Feb;11(2):174-9. doi: 10.1016/s0883-5403(05)80013-0.
citation: Kiyama T, Naito M, Shinoda T, Maeyama A. Hip abductor strengths after total hip arthroplasty via the lateral and posterolateral approaches. J Arthroplasty. 2010 Jan;25(1):76-80. doi: 10.1016/j.arth.2008.11.001. Epub 2009 Apr 8.
Clinical trial NCT06433128: Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections
Official title: Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections Who Have no Other Treatment Options
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Invasive Fungal Infections
Keywords: Fungal infection
Candida
Anti-fungal
Yeast
Mold
Rare mold
Lead sponsor: Basilea Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2024-05-29
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The EAP is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the EORTC-MSGERC criteria) who have exhausted their treatment options, primarily due to an infection with a resistant fungal pathogen, and for whom no other treatment options are available through marketed drugs or investigational agents in clinical studies ongoing in the respective indication.


Eligibility criteria: The EAP is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the EORTC-MSGERC criteria) who have exhausted their treatment options, primarily due to an infection with a resistant fungal pathogen, and for whom no other treatment options are available through marketed drugs or investigational agents in clinical studies ongoing in the respective indication.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05992961: The Effects of Troponin I Surveillance Among Patients Undergoing Acute High-risk Abdominal Surgery
Official title: The Effects of Troponin I Surveillance Among Patients Undergoing Acute High-risk Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdomen, Acute
Myocardial Injury After Non-cardiac Surgery
Troponin I
Myocardial Injury
Emergency Surgery
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 558
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing acute high-risk abdominal surgery at Copenhagen University Hospital - North Zealand, Denmark during the period February 1, 2018, to February 28, 2021.

For patients undergoing acute high-risk abdominal surgery on more than occasion during the period of observation, only the first case of surgery was included.

Brief summary: Treatment of disorders such as gastrointestinal tract (GI) perforation, ischemia and obstruction often require acute high-risk abdominal surgery, which is associated with a high risk of complications such as myocardial injury after non-cardiac surgery (MINS) and mortality. The majority of patients with MINS will not experience any symptoms, and thus MINS remains undetected without routine troponin measurements.

The investigators hypothesized that implementing surveillance with troponin I as a standard care might be useful as risk stratification, and that increased surveillance, examinations, and subsequent individually based medical interventions, might improve the outcomes for patients with MINS.


Eligibility criteria: Inclusion Criteria:

* Eligible patients were 18 years or older
* Undergoing surgery for gastrointestinal perforation, obstruction, mesenterial ischemia or necrosis, or anastomotic leakage.

Exclusion Criteria:

* Not undergoing surgery for one of the conditions above

Primary outcomes:
measure: compare the mortality rate before and after implementing troponin I surveillance
timeFrame: 30-, 90-, and 365-day
Secondary outcomes:
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Copenhagen University Hospital - North Zealand
Study officials:
affiliation: Copenhagen University Hospital - North Zealand
name: Claus Anders TB Bertelsen, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01511861: Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device
Official title: Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Lead sponsor: GlucoVista
Sponsor class: INDUSTRY
First posted: 2012-01-19
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients with diabetes mellitus type 1 or type 2.

Brief summary: Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic goal that is difficult to achieve with current blood glucose monitoring technology. Home blood glucose monitoring (HBGM) technology, which requires finger pricking, is a source of severe inconvenience and hence, a lack of compliance.Thus, the need for non-invasive and easy to operate glucose monitoring in DM patients for strict glycemic control cannot be overemphasized.

The Glucometer GM-205 blood glucose readings are accurate and measure blood glucose with an acceptable mean relative error when compared to acceptable invasive blood glucose measurements.

The primary objectives of the trial are to determine:

1. Assessing the reliability of the Glucometer GM-205 in evaluating blood glucose levels compare to the standard glucose blood test
2. Creating database of glucose levels readings utilizing the Glucometer GM-205.


Eligibility criteria: Inclusion Criteria:

1. Diabetes Mellitus type one or type two.
2. Patients that are using Insulin.

Exclusion Criteria:

1. Vascular diseases
2. Pregnant and lactating women.
3. Exclusive use of long term Insulin.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
Study officials:
References: