louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03233867: A Non-interventional Study to Identify Children and Adolescents With ADHD and With or Without mGLuR Mutations
Official title: A Non-interventional Study to Identify Children and Adolescents (Ages 6-17 Years) With Attention Deficit Hyperactivity Disorder and With or Without Copy Number Variants in Specific Genes Involved in Glutamatergic Signaling and Neuronal Connectivity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Avalo Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-31
Enrollment: 2503
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects between the ages of 6 and 17 years, who have been told that they have ADHD, will be eligible for screening.

Brief summary: This is a non-interventional study in children and adolescents (ages 6-17 years) with attention deficit hyperactivity disorder (ADHD) to assess CNVs in specific genes involved in glutamatergic signaling and neuronal connectivity. The screening in this study will be conducted through a combination of online and site performed activities.


Eligibility criteria: Inclusion Criteria:

1. Parent/legally authorized representative (LAR) can speak and read English fluently, have provided informed consent and agree to be contacted for an interventional study prior to being genotyped.
2. Subject is 6 to 17 years of age (inclusive) at the time of informed consent.
3. Parent/LAR confirms that the subject has been diagnosed with or been told by a doctor that their child has ADHD.
4. Parent/LAR confirms that the subject is not pregnant and/or breastfeeding.

Exclusion Criteria:

1. Parent/LAR confirms that the subject has been diagnosed with any of the following conditions (aside from ADHD): conduct disorder, anxiety disorder, major depression, autism spectrum disorder (ASD), bipolar disease, psychosis, hypertension, seizure disorder, syncope, or other serious cardiac problems.
2. Aside from your child's current ADHD medication (if applicable), parent/LAR confirms that the subject is currently taking any of the following medications: antidepressants, anti-anxiety medications, anti-psychotics, and/or mood stabilizers.
3. Parent/LAR confirms that the subject has been genotyped previously in the MDGN-NFC1-ADHD-001, MDGN-NFC1-ADHD-101 clinical study.

Primary outcomes:
measure: Presence of specific copy number variants (CNVs) involved in glutamatergic signaling and neuronal connectivity
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Wayne
country: United States
facility: Aevi Genomic Medicine
state: Pennsylvania
Study officials:
affiliation: Meridien Research
name: Andrew Cutler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01928667: Case-Control Study to Identify Risk Factors for Microscopic Colitis
Official title: Risk Factors for Microscopic Colitis: A Dutch Case-Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microscopic Colitis
Collagenous Colitis
Lymphocytic Colitis
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2013-08-27
Enrollment: 487
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The case group will be selected by a retropective search in the pathology registry. Subjects have to be diagnosed between January 1, 2000 and December 31, 2012; have to be older than 18 years of age and have to be living in the province of Limburg, the Netherlands.

Healthy controls are selected via the municipal personal records databases in the same region.

Brief summary: The purpose of the study is to assess among others environmental and hygiene-related risk factors for microscopic colitis (MC), a common diarrheal disease.


Eligibility criteria: Inclusion Criteria:

* Confirmed Diagnosis of MC (CC or LC) between January 1, 2000 and December 31, 2012.
* Inhabitant of the province of Limburg or the Eindhoven region at the moment of diagnosis

Exclusion Criteria:

* Below 18 years of age at the time of diagnosis
* Not capable of signing an informed consent
* Deceased at moment of approximation

Primary outcomes:
measure: Assessment of environmental and hygiene-related risk factors for microscopic colitis
timeFrame: Retrospective, between 2000 and 2012
Secondary outcomes:
measure: The difference between the CC and LC subpopulation regarding environmental, hygiene-related, and generally known risk factors
timeFrame: Retrospective between 2000 and 2012
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht UMC
state: Limburg
Study officials:
affiliation: Maastricht UMC
name: Marieke J Pierik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University
name: Daisy MAE Jonkers, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht UMC
name: Ad AM Masclee, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04277767: The Role of Ophthalmologic Tests and EEG Imaging in Alzheimer's Disease
Official title: The Combination of Ophthalmologic Tests and EEG Imaging as a New Biomarker for Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Cognitive Impairment
Keywords: AD EEG OCT biomarker
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We would recruit three groups of elders. One is the control group without cognitive impairment, one is the aMCI group which is deemed as the pre-stage of AD, and also the AD group.

Brief summary: Alzheimer's disease (AD) is a prevalent, long-term progressive degenerative disorder with great social impact. It is currently thought that, in addition to neurodegeneration, vascular changes also play a role in the pathophysiology of the disease. Meantime, EEG resting state has also demonstrated significant change in patients with AD in neuroscience research area. Thus, the combination of these sensitive biomarkers would lead to a potential new biomarker for detection of AD, which has higher specificity and sensitivity.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Alzheimer's Disease

Exclusion Criteria:

* neurologic disorders
* psychiatric disorders

Primary outcomes:
measure: OCT retinal and choroidal thickness
timeFrame: 2 days
measure: Retinal Photography vascular caliber
timeFrame: 2 days
measure: functional connection strength in the brain network
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmological Center, Sun Yat-sen University
name: Jin Yuan, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05586867: Study of Markers of Iron Metabolism and Their Relationship With Phosphocalcic and Hepatic Metabolism and Inflammation in Hemodialysis Patients
Official title: Study of Markers of Iron Metabolism and Their Relationship With Phosphocalcic and Hepatic Metabolism and Inflammation in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Iron Metabolism Disorders
Calcium Phosphate Metabolism
Hepatic Metabolic Disorders
Hemodialysis Complication
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2022-10-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemodialysis adult patient

Brief summary: From a scientific point of view and for publication purposes, it therefore seems important to study the metabolism of iron and in particular to define its conditions of absorption, metabolism, elimination and storage in the body at course of advanced renal failure.

The study will follow the evolution of hormones regulating iron metabolism and put into perspective their links with phosphocalcic and hepatic metabolisms as well as inflammation in hemodialysis patients.

The main objective of this program is to study the evolution of hepcidin and erythroferrone levels in hemodialysis patients. These two biomarkers regulating iron metabolism are not performed routinely in dialysis centers and are not listed in the nomenclature.


Eligibility criteria: Inclusion Criteria:

* Adult dialysis patient
* Patient able to understand the information necessary for the study and having signed his written consent to participate
* Affiliated patient or beneficiary of a social security scheme.

Exclusion Criteria:

* Medically unstable or frail patient
* Patient with hemoglobin less than 7g/dl
* Patient with HIV+ or AIDS, patient with replicating hepatitis B or C
* Patient participating in another clinical study requiring an additional blood sample
* Patient benefiting from legal protection measures (guardianship, guardianship, etc.) adult under guardianship, guardianship or other legal protection, deprived of freedom by judicial or administrative decision
* Pregnant, breastfeeding or parturient woman

Primary outcomes:
measure: concentration of the two main markers concerning iron metabolism: hepcidin (ng/ml) and erythroferone (ng/ml).
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Quincy-sous-Sénart
country: France
facility: Hôpital Privé Claude Galien
Study officials:
References:
Clinical trial NCT01497067: Long Term Safety Protocol for the AcrySof CACHET Phakic Lens
Official title: Long Term Safety Follow-up for Subjects Previously Implanted With the ACRYSOF® CACHET® Phakic Lens in Clinical Studies C-02-23, C-02-40, C-03-21 and C-05-57
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Phakic Lens
Intraocular Lens (IOL)
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-12-22
Enrollment: 657
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this long term safety study is to estimate the annualized endothelial cell loss (ECL) rate (for up to 10 years following date of implantation) of subjects previously implanted with the ACRYSOF CACHET Phakic Intraocular Lens (L-series) from precursor clinical studies C-02-23, C-02-40, C-03-21 and C-05-57.

Detailed description: Subjects previously enrolled in protocols C-02-23 (NCT00726024), C-02-40 (NCT00727805), C-03-21 (NCT00726297), and C-05-57 (NCT00727688) who received an L-series lens either in the first eye or second eye (including those who were explanted) were enrolled in this open-label, non-randomized, non-controlled, extension study in which they attended postoperative visits for up to 10 years following the date of implantation. Subjects could enroll in the study at any time, thus the Entrance Visit may have coincided with any visit (Year 4 to Year 10).

Eligibility criteria: Inclusion Criteria:

* Previously implanted with an ACRYSOF CACHET Phakic Lens (L-Series) from clinical studies C-02-23, C-02-40, C-03-21 and C-05-57 and eligible for continued follow-up (i.e., exited from the previous study).
* Able to understand and sign a statement of informed consent.
* Willing and able to complete the yearly postoperative study visits.

Exclusion Criteria:

* None

Primary outcomes:
measure: Central Endothelial Cell Density (All Eyes)
timeFrame: Year 4 to Year 10 postoperative from previous study (C-02-23, C-02-40, C-03-21, and C-05-57)
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon Research
name: Sr. Project Lead, Surgical
role: STUDY_DIRECTOR
References:
Clinical trial NCT06288867: A 12 Months Prospective Study Comparing Functional Outcome Scores in Hip Arthroscopic Labral Repair Versus Debridement
Official title: Arthroscopic Labral Repair Versus Debridement In Hip Labral Tears: A Prospective Comparative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Injuries
Acetabular Labral Tear
Femoro Acetabular Impingement
Keywords: Hip Arthroscopy
Labral Repair
Labral Debridement
Acetabular Labral Tear
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to address hip labral tears and compare between arthroscopic labral repair versus debridement.

Detailed description: Hip arthroscopy will be performed with the patient under general anesthesia. The patient will be placed in supine position, and traction and joint access will be controlled by fluoroscopy. An anterolateral portal and an inferior mid-anterior portal will be used. Any labral, chondral, and/or bony pathology (cam or pincer) will be treated. Labral tears may be debrided or repaired. Labral repairs will be secured with suture anchors.

Patient's functions will be evaluated preoperatively and postoperatively at 1, 3 and 6 months and 1 year and at the last follow-up using the Harris Hip Score (HHS), visual analog score (VAS), Hip Outcome Score Activities-Daily Living Subscale (HOS-ADL), and Sport-Specific Subscale (HOS-SSS).

Eligibility criteria: Inclusion Criteria:

* Sex: both sexes.
* Age: 18 years - 60 years.
* Femoroacetabular impingement (FAI) including all types (cam, pincer, and combined).
* Traumatic Labral tears

Exclusion Criteria:

* Previous hip surgery.
* Hip joint dysplasia, defined by both center edge (CE) angles \<25 degrees and Acetabular Index angle \>10 degrees.
* Osteoarthritis grade \>2 according to Tönnis classification.

Primary outcomes:
measure: Change from baseline in Hip Function, as measured by Hip Outcome Score (HOS)
timeFrame: Baseline, 1 year
measure: Change from baseline in Hip Function, as measured by Harris Hip Score (HHS)
timeFrame: Baseline, 1 year
measure: Change from baseline in Pain, as measured by the Visual Analogue Scale (VAS)
timeFrame: Baseline, 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Karim A Salem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02122367: Study of Stroke Volume Variation and Pleth Variability Index as Predictors of Fluid Responsiveness
Official title: Validation of Stroke Volume Variation and Pleth Variability Index as Predictors of Fluid Responsiveness in Patients Undergoing Robot Assisted Thyroidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Thyroidectomy
Fluid Responsiveness
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
First posted: 2014-04-24
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Appropriate indices to guide fluid therapy are essential for effective hemodynamic management during the perioperative period. Values derived from respiratory changes in arterial pressure waveform or plethysmographic waveform such as stroke volume variation and pleth variability index have been demonstrated to be able to predict fluid responsiveness in surgical or critically ill patients. Their ability to predict fluid responsiveness can be affected by factors that influence the arterial tone or the compliance of the respiratory system by position change. The aim of this prospective trial is to investigate the ability of stroke volume variation and pleth variability index to predict fluid responsiveness in the reverse trendelenberg position.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 20
2. elective robot assisted thyroidectomy

Exclusion Criteria:

1. arrhythmia
2. BMI\>30
3. valvular heart disease
4. pul hypertension
5. peripheral artery occlusive disease
6. lung disease
7. right heart failure

Primary outcomes:
measure: stroke volume variation
timeFrame: 5 minutes after volume replacement
measure: pleth variability index
timeFrame: 5 minutes after volume replacement
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
References:
Clinical trial NCT04171167: The Causal Relation of Nasal Nitric Oxide Levels to the Severity of Chronic Rhinosinusitis and Its Inflammatory Phenotype
Official title: The Causal Relation of Nasal Nitric Oxide Levels to the Severity of Chronic Rhinosinusitis and Its Inflammatory Phenotype
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Rhinosinusitis (Diagnosis)
Keywords: Nasal nitric oxide
Nitric oxide metabolites
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Nitric oxide (NO) reflects changes in inflammatory state of the airways. In pulmonology fractional exhaled nitric oxide concentration (FeNO) has been linked to eosinophilic asthma and is used to guide overall disease control. The measurement of nasal nitric oxide (nNO) may reflect the disease burden and inflammatory phenotype of the paranasal sinuses.

The aim of our study is to evaluate the relation of chronic rhino sinusitis (CRS) severity and inflammatory status to nNO, maxillary sinus NO, nitrite, nitrate and cone beam computed tomography (CBCT).

Three groups (22 patients in each) of referred patients and and 22 healthy volunteers are recruited. Patients are grouped according to the CBCT score and viewed three times in 4-6 weeks intervals.


Eligibility criteria: Inclusion Criteria:

* Patients willing to participate in the study
* Patients who are referred to ENT clinic due to chronic rhinosinusitis (EPOS criteria) or repeatedly diagnosed and treated acute rhinosinusitis

Exclusion Criteria:

* Endoscopic sinus surgery operation previously
* Septal deviation that would need an operation to correct the air flow
* Other severe disease that could pose a risk for the patient during the measurements based on the judgement of the treating physician
* Pregnancy or breastfeeding
* Allergy to used medications
* Inability to co-operate or to tolerate manipulation of the nose

Primary outcomes:
measure: Nasal nitric oxide levels
timeFrame: Change between visit: 0, +5 weeks, +10weeks
measure: Nitric oxide metabolite (nitrate, nitrite) levels
timeFrame: Change between visit: 0, +5 weeks, +10weeks
Secondary outcomes:
measure: CBCT (Zinreich modified Lund-Mackay) scoring
timeFrame: Change between visit: 0, +5 weeks, +10weeks
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
References:
Clinical trial NCT05767567: Evaluating the Efficacy of a Brief Online Intervention Among Current Heavy Drinkers
Official title: Evaluating the Efficacy of a Brief Online Intervention Among Current Heavy Drinkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 867
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Unhealthy alcohol consumption is common in the UK and causes tremendous harm to the individual, as well as harm to others. A significant gap in providing alcohol support is that most people with unhealthy alcohol consumption will never receive advice to cut down on their drinking. However, many are interested in self-directed interventions to help them evaluate their drinking and to motivate reductions in alcohol use. One such promising intervention uses online personalised normative feedback (PNF) which compares a person's drinking with others in the general population of the same age and sex. PNF interventions are thought to work because many people with unhealthy alcohol consumption overestimate how much others drink. Multiple trials have demonstrated that providing PNF to people with unhealthy consumption reduces their alcohol use . While several UK websites do provide feedback on assessment of risk (e.g., Down Your Drink introductory section, Alcohol Change UK), there appears to be no online intervention that provides PNF for unhealthy alcohol consumption.

The major objective of this pilot project is to conduct a two-arm, parallel group randomised controlled trial (RCT) in which 1,318 participants recruited from the Prolific website who have identified themselves as drinking 14 or more units per week are randomly assigned to one of two groups - a) those who are offered a PNF report, and b) those in a no intervention comparator group. Participants in the comparator group will not be provided any intervention materials but will instead be given a list of the different components of the PNF feedback and will be asked to think about how useful they would find each of them. Follow-up assessment will occur at 1 and 6 months post-randomisation. The project is described as a pilot because it is a preliminary evaluation of the PNF intervention in a UK context.


Eligibility criteria: Inclusion Criteria:

1) score 8 or more on the AUDIT (indicating current unhealthy alcohol use); and 2) endorsed the attention check questions correctly.

Exclusion Criteria:

Not meeting these inclusion criteria forms the exclusion criteria

Primary outcomes:
measure: Number of drinks consumed during a typical week
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
References: