louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06213090: Patterns of Neurodevelopmental Disorders
Official title: Patterns of Disease, Outcomes and Treatment Response in Children With Neurodevelopmental Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurodevelopmental Disorders
Autism Spectrum Disorder
Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcal Infection
Pediatric Acute-Onset Neuropsychiatric Syndrome
Down Syndrome
Epilepsy
Mitochondrial Encephalomyopathies
Cerebral Folate Deficiency
Lead sponsor: Rossignol Medical Center
Sponsor class: OTHER
Collaborators: name: Autism Discovery and Treatment Foundation
First posted: 2024-01-19
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who present to Rossignol Medical Center for standard care related to neurodevelopmental disorders.

Brief summary: The purpose of this study is to systematically evaluate the results of medical investigations to identify symptom and biological patterns and common etiologies of neurodevelopmental disorders.

Detailed description: Although neurodevelopmental disorders are very prevalent (for example Autism affects 1 out of every 36 children and dyslexia affects up to 15% of the population), the etiology of such disorders is not known. The purpose of this investigation is to identify common etiologies of neurodevelopmental disorders (i.e., speech delay, global developmental delay, autism) and determine if it is possible to find early indicators of the diagnosis and foster the potential for a better prognosis of these disorders. At this time the investigators examine patients with neurodevelopment disorders with various medical investigations, but the results of these investigations are not systematically evaluated. One of the goals of this research is to systematically examine this information in order to identify patterns of test abnormalities that have not been previously described. Another goal of this research is to identify the common etiologies typically identified by the medical evaluation, so we can further refine our approach. In addition, the investigators now have the ability to evaluate biological samples for biomarkers that have potential to be diagnostically useful.

Eligibility criteria: Inclusion Criteria:

Neurodevelopmental delays Clinical visit at an Rossignol Medical Center

Exclusion Criteria:

-

Primary outcomes:
measure: Number of Patients with Specific Medical abnormalities
timeFrame: up to 7 years
Secondary outcomes:
measure: The number of children with abnormal clinical lab
timeFrame: up to 7 years
measure: The number of children who respond to specific treatments
timeFrame: up to 7 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Rossignol Medical Center
state: Arizona
Study officials:
References:
Clinical trial NCT00374790: Iron Supplementation of Lead-exposed Infants
Official title: Pilot Study to Determine the Efficacy of Iron Supplementation in Preventing the Elevation of Blood Lead Concentrations in Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lead Toxicity
Keywords: Lead toxicity
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2006-09-11
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the efficacy of iron (12.5 mg as ferrous sulfate) and placebo given for 6 months in preventing the elevation of blood lead concentration in children 6-9 months of age.


Eligibility criteria: Inclusion Criteria:

* Infants included if gestational age \>36 weeks, birth weight \> 2500g, no chronic illness, blood lead concentration \<10 mcg/dL, hemoglobin \>9 g/dL, zinc protoporphyrin \>90 mmol/mol heme
* Mothers included if 18 years or older

Exclusion criteria:

* Hemoglobin \>11.5 g/dL

Primary outcomes:
measure: Incidence of blood lead concentrations > 10 mcg/dL
measure: Mean hemoglobin concentration
measure: Mean zinc protoporphyrin concentration
Secondary outcomes:
measure: Anthropometry
measure: Oxidative stress
Other outcomes:
Locations:
city: Montevideo
country: Uruguay
facility: Clinic for Environmnetal Contaminants
Study officials:
affiliation: Cornell University
name: Katarzyna Kordas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cornell University
name: Rebecca J Stoltzfus, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03874390: Effects of Ozone Therapy on Clinical Parameters and Inflammatory Cytokines in Chronic Periodontitis Patients
Official title: Effects of Ozone Therapy Adjunct to Initial Periodontal Therapy on Clinical Parameters and Inflammatory Cytokines in Chronic Periodontitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate of ozone therapy on both clinical and biochemical effects in periodontally patients.

Detailed description: This study is evaluated clinical and biochemical effect of ozone therapy at 8 weeks in periodontitis patients.

Eligibility criteria: Inclusion Criteria:

* systemically healthy
* non-smokers
* chronic periodontitis participants

Exclusion Criteria:

* smokers
* pregnancy or lactation
* individiuals with any systemic disease

Primary outcomes:
measure: Clinical atachment level baseline
timeFrame: baseline (before treatment)
measure: Plaque index baseline
timeFrame: baseline (before treatment)
measure: Gingival index baseline
timeFrame: baseline (before treatment)
measure: Bleeding on probing baseline
timeFrame: baseline (before treatment)
measure: Probing of depth baseline
timeFrame: baseline (before treatment)
measure: Biochemical outcomes baseline
timeFrame: baseline (before treatment)
Secondary outcomes:
measure: Clinical attachment level after 8 weeks
timeFrame: 8 weeks after treatment
measure: Plaque index after 8 weeks
timeFrame: 8 weeks after treatment
measure: Gingival index after 8 weeks
timeFrame: 8 weeks after tretament
measure: Bleeding on probing after 8 weeks
timeFrame: 8 weeks after treatment
measure: Probing of dept after 8 weeks
timeFrame: 8 weeks after tretament
measure: Biochemical outcomes after 8 weeks
timeFrame: 8 weeks after tretment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00186290: Allo BMT in Advanced Leukemia or High Grade Lymphoma
Official title: Fractionated Total Body Irradiation (FTBI), Etoposide (VP-16) and Cyclophosphamide (CY) Followed by Allogeneic Bone Marrow Transplantation for Patients With Advanced Leukemia or High Grade Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma, Non-Hodgkin
Leukemia
Blood and Marrow Transplant (BMT)
Lymphomas: Non-Hodgkin
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 145
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the role of ablative allogeneic hematopoietic cell transplantation in the treatment of advanced leukemia or lymphoma.

Detailed description: To determine the disease free survival and overall survival of patients with ALL and ANLL after induction failure, in relapse, or subsequent remission from CML in several phases or recurrent lymphoblastic lymphoma who receive fractionated TBI, etoposide and cyclophosphamide followed by allogenic bone marrow grafting from histocompatible sibling donors. Fractionated Total Body Irradiation (FTBI), Etoposide (VP-16) and Cyclophosphamide (CY) Followed by Allogeneic Bone Marrow Transplantation for Patients with Advanced Leukemia or High Grade Lymphoma

Eligibility criteria: Inclusion Criteria:HLA identical donor

* adequate organ function
* other life threatening disease

Primary outcomes:
measure: overall survival
timeFrame: october 2009
measure: disease free survival
timeFrame: October 2009
Secondary outcomes:
measure: early and late toxicities of the treatment regimen
timeFrame: October 2009
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Robert Lowsky
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05750290: CKD-702 Plus Irinotecan in Gastric Cancer
Official title: CKD-702 Plus Irinotecan as a ≥3L Therapy for Gastric and Gastroesophageal Junction Adenocarcinomas Overexpressing EGFR or MET
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2023-03-01
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: CKD-702 is a tetravalent bispecific IgG1 targeting hepatocyte growth factor receptor (MET) and epidermal growth factor receptor (EGFR). The investigators will test a hypothesis that CKD-702 may augment the efficacy of biweekly irinotecan as a 3L or later therapy for gastric cancer overexpressing either MET or EGFR.


Eligibility criteria: Inclusion Criteria:

* Failed 2 or more lines of chemotherapy
* Tumor overexpressing either MET or EGFR
* Measurable lesion

Exclusion Criteria:

* Prior treatment with anti-MET/EGFR bispecific antibody

Primary outcomes:
measure: Best objective response rate
timeFrame: Through study completion, an average of 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi
Study officials:
References:
Clinical trial NCT00556790: Fast Track in Open Colonic Surgery - A Multicentric Randomized Controlled Trial
Official title: Fast Track in Open Colonic Surgery - A Multicentric Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Elective Colectomie
Median Laparotomie
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: University of Zurich
name: Kantonsspital Olten
name: Kantonsspital Winterthur KSW
name: Spital Uster
First posted: 2007-11-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the real value of a fast track protocol compared to a standard care protocol regarding postoperative complications and hospital stay in a multicentric setting in an intention to treat fashion.

Detailed description: Our fast track protocol contains the four major components perioperative fluid restriction, epidural analgesia, early oral feeding and enforced mobilisation

Eligibility criteria: Inclusion Criteria:

* all patients admitted for open colonic surgery

Exclusion Criteria:

* no primary anastomosis and/or stoma rectum resection emergency situation patients not speaking german immobile patients

Primary outcomes:
measure: complications until 30 days after surgery according to the zurich classification
timeFrame: 30 days postoperative
Secondary outcomes:
measure: hospital stay, adherence to Fast track protocol
timeFrame: 30 days
Other outcomes:
Locations:
city: Olten
country: Switzerland
facility: Kantonsspital Olten
city: Uster
country: Switzerland
facility: Spital Uster
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
Study officials:
affiliation: University of Zurich
name: Sven Muller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hubner M, Muller S, Schafer M, Clavien PA, Demartines N. Impact of the nutritional risk score in fast-track colon surgery. Dig Surg. 2010;27(5):436-9. doi: 10.1159/000313692. Epub 2010 Nov 5.
citation: Muller S, Zalunardo MP, Hubner M, Clavien PA, Demartines N; Zurich Fast Track Study Group. A fast-track program reduces complications and length of hospital stay after open colonic surgery. Gastroenterology. 2009 Mar;136(3):842-7. doi: 10.1053/j.gastro.2008.10.030. Epub 2008 Nov 1.
Clinical trial NCT06592690: Effect of Rate-responsive Compared to VDD Pacing in Cardiac Resynchronization Therapy Recipients
Official title: Effect of Rate-responsive Compared to VDD Pacing in Cardiac Resynchronization Therapy Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Wide QRS Complex
Keywords: atrial pacing
cardiac resynchronization therapy
heart failure
implantable cardioverter defibrillator
rate-adaptive pacing
Lead sponsor: Ospedale Centrale Bolzano
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, cross-over, double-blind, multicenter study
Primary purpose: TREATMENT

Brief summary: This study aims to understand the best programming pacing mode for cardiac resynchronization therapy devices used to treat chronic heart failure.

Detailed description: Cardiac resynchronization therapy (CRT) efficacy trials to date used atrial-synchronous biventricular pacing wherein there is no or minimal atrial pacing. However, bradycardia and chronotropic incompetence are common in this patient population.

Despite neutral results on hard clinical outcomes of the atrial support in CRT patients, it is not clear if a rate-responsive pacing may add incremental benefits on exercise capability.

The aim of this study is to assess the impact of RR pacing compare to VVD pacing in patients implanted with CRT devices in term of functional capacity, measured by the six-minute walking test (6MWT). This simple test has shown to be an independent predictors of mortality in this cohort of patients.

Eligibility criteria: Inclusion Criteria:

* Patients willing to participate in the study and signing the approved Patient Informed Consent (PIC) Form;
* Patients with approved indication for CRT by European Society of Cardiology/European Heart Rhythm Association guidelines (ESC/EHRA).
* Sinus rhythm at the time of CRT device implantation with heart rate at rest above 50 bpm.

Exclusion Criteria:

* Permanent Atrial Fibrillation;
* Inability to perform 6MWT;
* Suboptimal HF drug therapy;
* Heart rate at rest above 50 bpm.

Primary outcomes:
measure: distance walked during the 6MWT
timeFrame: A consecutive 6-month treatment period with the same pacing mode.
Secondary outcomes:
Other outcomes:
Locations:
city: Bolzano
country: Italy
facility: Ospedale Centrale di Bolzano
Study officials:
References:
Clinical trial NCT03012490: Efficacy, Safety and Cost of Remote Monitoring of Patients With Cardiac Resynchronization Therapy
Official title: Efficacy, Safety and Cost of Comprehensive Versus Standard Remote Monitoring of Patients With Cardiac Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Cardiac Resynchronization Therapy
Keywords: Remote monitoring
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Biotronik France
First posted: 2017-01-06
Enrollment: 652
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective is to determine whether comprehensive remote follow-up in HF patients with CRT will reduce the combined endpoint of all-cause mortality or worsening heart failure hospitalizations, whichever comes first, when compared to basic remote monitoring, over a 27-month follow-up.


Eligibility criteria: Inclusion Criteria:

* Patient more than 18 years old, newly implanted, in accordance to the latest European guidelines, with a CRT-P or CRT-D device (upgrading is tolerated but no device replacement), with Home-Monitoring® activated
* Patient willing and able to comply with the protocol and who has provided written informed consent

Exclusion Criteria:

* Lead model under advisory
* Non-functional lead except particular case of non-functional or deactivated right atrial lead due to atrial fibrillation
* Known drug or alcohol abuse
* Pregnant woman or woman who plan to become pregnant during the trial (the data will be collected by querying the patient without a pregnancy test is required)
* Participation (ongoing or planned during the trial) in another interventional clinical study, and/or another remote monitoring and/or follow-up concept, unless authorized by the Executive Committee
* Participation (ongoing or planned during the trial) in an investigational HF program (e.g. PRADO, PIMPS, OSICAT, CARDIAUVERGNE)
* Estimated life-expectancy, regardless of the cardiovascular condition, \<1year
* Patient under- or planned for - ventricular assistance
* Patient not living in Metropolitan France and/or not geographically stable

Primary outcomes:
measure: composite criteria including death from any cause and hospitalization for worsening HF
timeFrame: during the 27 months follow-up
Secondary outcomes:
measure: Costs including hospital costs for unplanned cardiovascular hospitalizations, medical charges for ambulatory follow-up of CRT devices and transportation related costs
timeFrame: 27 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Institut coeur poumon, CHRU
Study officials:
affiliation: University Hospital, Lille
name: Laurence Guedon-Moreau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01091090: Cognitive Behavioral Smoking Cessation Intervention for Adults With Chronic Pain
Official title: Cognitive Behavioral Smoking Cessation Intervention for Adults With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking cessation
Nicotine dependence
Chronic pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-03-23
Enrollment: 26
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: TREATMENT

Brief summary: Millions of individuals with chronic pain smoke and our preliminary research suggests that currently available strategies to help people quit smoking may not be effective for individuals with chronic pain. This is important in that smokers with chronic pain have worse pain-related health outcomes compared to nonsmokers with chronic pain. The primary aim of this research project is to develop a smoking cessation intervention for specific use in an outpatient clinical setting for smokers with chronic pain.


Eligibility criteria: Inclusion Criteria:

* Chronic pain
* Age \> 18 years
* Cigarette smoker \> 10 per day

Exclusion Criteria:

* Concurrent substance use disorder other than nicotine dependence
* Concurrent major psychiatric disorder

Primary outcomes:
measure: The key measurement to be used to assess the effect of the experimental intervention will be the status of cigarette smoking at 6-month follow-up.
timeFrame: 6 months
Secondary outcomes:
measure: A key secondary outcome measure will be self-report pain severity at 6-months following completion of the experimental intervention.
timeFrame: 6 month
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Pain Rehabilitation Center
state: Minnesota
Study officials:
References:
citation: Hooten WM, Townsend CO, Bruce BK, Shi Y, Warner DO. Sex differences in characteristics of smokers with chronic pain undergoing multidisciplinary pain rehabilitation. Pain Med. 2009 Nov;10(8):1416-25. doi: 10.1111/j.1526-4637.2009.00702.x. Epub 2009 Sep 1.
citation: Hooten WM, Townsend CO, Bruce BK, Warner DO. The effects of smoking status on opioid tapering among patients with chronic pain. Anesth Analg. 2009 Jan;108(1):308-15. doi: 10.1213/ane.0b013e31818c7b99.
citation: Hooten WM, Townsend CO, Bruce BK, Schmidt JE, Kerkvliet JL, Patten CA, Warner DO. Effects of smoking status on immediate treatment outcomes of multidisciplinary pain rehabilitation. Pain Med. 2009 Mar;10(2):347-55. doi: 10.1111/j.1526-4637.2008.00494.x. Epub 2008 Aug 18.
Clinical trial NCT06296290: Impact of Prolonged Cold-water Swimming on Heart Rate and Cardiac Function
Official title: Impact of Prolonged Cold-water Swimming on Heart Rate and Cardiac Function in Healthy Swimmers.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothermia
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Swimmers participating in the 6-hour cold-water swim, qualifying for the English Channel swim at the Channel Swim Camp (Dinard, France).

Brief summary: A significant medical risk associated with hypothermia during exercise in a cold environment cardiac arrhythmia due to a possible autonomic conflict. However, little is known about the changes in heart rate and cardiac function after prolonged cold water swimming.

The investigators propose to measure the changes in core temperarure during and after a cold water swim at at a water temperature below 15.5°C qualifying for English Channel swim and to test the association with changes in heart rate variability, resting electrocardiogram and left ventricle function.


Eligibility criteria: Inclusion Criteria:

* swimmers taking part in the Channel Swim Camp
* swimmers above 18 years of age
* swimmers willing and able to give informed consent for participation in the study

Exclusion Criteria:

* swallowing disorder
* chronic gastrointestinal disease
* MRI scheduled within 48 hours after the race.
* known cardiac arythmia or cardiovascular disease

Primary outcomes:
measure: Heart rate from a resting ECG recording
timeFrame: Two Time points (1) the day before the race and (2) at 30 min after ending the race
measure: Heart rate from a 5-minute ECG recording
timeFrame: Two Time points (1) the day before the race and (2) at 30 min after ending the race
measure: Transthoracic echocardiography (TTE) analysis
timeFrame: Two Time points (1) the day before the race and (2) at 30 min after ending the race
measure: Change in Body Core Temperature
timeFrame: Time Frame: Continuous measurement was collected from 30 minutes before the race until 2 hours after the end of the race for each swimmer]
Secondary outcomes:
measure: Body composition, body fat mass
timeFrame: One measurement assessed the day before the race
measure: Body composition, fat-free mass
timeFrame: One measurement assessed the day before the race
measure: Duration
timeFrame: The duration of swimming was collected from the organisers immediately after the race
measure: Individual characteristics, gender
timeFrame: One evaluation assessed the day before the race
measure: Individual characteristics, age
timeFrame: One evaluation assessed the day before the race
measure: Individual characteristics, training in cold environment
timeFrame: One evaluation assessed the day before the race
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen Normandie
Study officials:
References: