louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05825612: EPIRUS FH Reverse Cascade Screening
Official title: Reverse Cascade Screening for Familial Hypercholesterolemia in Children and Adolescents in Northwest Greece
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Familial Hypercholesterolemia
Keywords: children
adolescents
reverse cascade screening
Lead sponsor: Hellenic Atherosclerosis Society
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients genetically diagnosed with familial hypercholesterolemia (FH). Non-affected (non-FH) individuals as healthy controls.

Brief summary: Familial hypercholesterolemia (FH) is the most common inherited metabolic disorder resulting in marked elevations in low-density lipoprotein cholesterol (LDL-C). If left untreated, lifelong exposure to elevated LDL-C leads to a substantially increased risk of premature cardiovascular disease as compared to the general population. Although FH adverse cardiovascular outcomes are potentially preventable through early identification of FH individuals and initiation of effective treatment, available evidence shows that FH is under-diagnosed and under-treated.

Childhood is the optimal period for FH screening, because due to minimal dietary and hormonal influences, LDL-C levels reflect predominantly the genetic component in children and are well suited to discriminate FH from other causes of elevated LDL-C. If FH remains untreated in this latent stage of the disease, individuals show a 10-fold increase of cardiovascular risk during early and middle adulthood. In this context, an effective approach for detecting FH would be a screening during childhood or in young adolescents in combination with reverse cascade screening of first-degree relatives of FH individuals.

EPIRUS-FH registry is a model program of reverse cascade screening for FH in children and adolescents in Northwest Greece that aims to increase public and physician awareness, strengthen the national registry of familial hypercholesterolemia (HELLAS-FH) and constitute the core for a national FH registry in children and adolescents in Greece.


Eligibility criteria: Inclusion Criteria:

* LDL-C \>160 mg/dL on two seperate measurements 3 months apart
* LDL-C \>130 mg/dL + family history of premature coronary artery disease or hypercholesterolemia in one parent
* Children and adolescents on cholesterol-lowering medication

Exclusion Criteria:

* Refusal to sign the consent form and disagreement with the terms of participation.
* Any clinically significant disorder recognized at the time of the preliminary assessment, which in the judgment of the investigator would disqualify patient's participation in the study.

Primary outcomes:
measure: Diagnosis of Familial Hypercholesterolemia
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04302012: Assessment of EyeArt Performance With Retinal Imaging Devices
Official title: Assessment of EyeArt Performance With Retinal Imaging Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Lead sponsor: Eyenuk, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-10
Enrollment: 62
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study subjects will be enrolled at primary care and/or eye care centers

Brief summary: The study evaluates the performance of the EyeArt system for detecting diabetic retinopathy from images captured using multiple retinal imaging devices and operators.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of diabetes mellitus;
* Understanding of study and provision of written informed consent; and
* 22 years of age or older.

Exclusion Criteria:

* Persistent visual impairment in one or both eyes;
* History of macular edema, severe non-proliferative retinopathy, proliferative retinopathy, or retinal vascular (vein or artery) occlusion;
* History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications;
* Subject is contraindicated for fundus photography (for example, has light sensitivity);
* Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;
* Subject is currently enrolled in an interventional study of an investigational device or drug; or
* Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable dilated fundus photographs.

Primary outcomes:
measure: Agreement between multiple EyeArt operations
timeFrame: 1 visit (1 day)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Lundquist Institute
state: California
Study officials:
References:
Clinical trial NCT02098512: Immunotherapy Following Reduced Intensity Conditioning and Allogeneic Stem Cell Transplant for Poor Risk CD30+ Hodgkin Lymphoma Patients
Official title: A Multicenter Pilot Study of Reduced Intensity Conditioning and Allogeneic Stem Cell Transplantation Followed by Targeted Immunotherapy in Children, Adolescents and Young Adults With Poor Risk CD30+ Hodgkin Lymphoma (HL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hodgkin Lymphoma
Keywords: Brentuximab Vedotin
Immunotherapy
Relapsed Hodgkin Lymphoma
Refractory Hodgkin Lymphoma
Reduced Intensity Conditioning
Allogeneic Stem Cell Transplantation
Lead sponsor: New York Medical College
Sponsor class: OTHER
Collaborators: name: St. Baldrick's Foundation
First posted: 2014-03-28
Enrollment: 20
Sex: ALL
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with relapsed or refractory Hodgkin Lymphoma who are CD30+ will receive a standard of care reduced intensity regimen and an allogeneic stem cell transplant (from another person, related or unrelated). Following recovery, patients will receive a medication called Brentuximab Vendotin which is targeted against CD30+ cells. The study hypothesis is that this treatment will be safe and well tolerated in children and young adults.


Eligibility criteria: Inclusion Criteria:

* 45 years of age or less.
* Patients with Hodgkin Lymphoma with either of the following:

  • Primary induction failure (failure to achieve initial CR) and/or primary refractory disease OR First, Second or Third relapse AND History of prior ablative auto HSCT or ineligible for an ablative auto HSCT or ≥25% residual disease after at least two reinduction chemotherapy cycles AND HLA matched family donor (6/6 or 5/6) or matched unrelated adult donor (MUD) (8/8) or matched umbilical cord blood unit (≥5/6) with prethaw cell dose of at least 3 x 107/kg TNC.
* off other investigational therapy for one month prior to entry in this study.
* adequate organ function

Exclusion Criteria:

* Patients with HD with 4th or greater CR, PR, and/or SD are ineligible.
* Patients with rapidly progressive disease (PD) unresponsive to reinduction chemo, radio, or immunotherapy are ineligible.
* Patients who don't have an eligible donor are ineligible.
* Women who are pregnant are ineligible.

Primary outcomes:
measure: Safety
timeFrame: 1 year
measure: Overall Survival
timeFrame: 1 year
Secondary outcomes:
measure: To assess feasibility of developing a bank of LMP-specific CTLs from healthy donors
timeFrame: 3 years
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: New York Medical College
state: New York
Study officials:
affiliation: New York Medical College
name: Mitchell Cairo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06535412: A Study of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
Official title: A Multi-center, Randomized, Double-blind, Placebo Control Phase 1b/II Study to Evaluate the Safety and Efficacy of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Systemic Lupus Erythematosus
Lead sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 218
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 purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of active SLE.

Detailed description: This is a phase Ib/II study, including 2 stage, phase Ib study to find the dose for phase II study between 0.8mg/kg、1.2mg/kg and 1.6mg/kg dose level, Phase II study is a multi-center, randomized, double-blind, placebo control study to evaluate the safety and efficacy of IMC-002 in active Systemic Lupus Erythematosus patients.

Eligibility criteria: Inclusion Criteria:

* Has had a diagnosis of SLE for at least 12 weeks prior to the screening Visit.
* SLEDAI total score ≥ 6 at screening
* BILAG-2004 organ system scores of at least 1 A or 2 B at screening.
* Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.
* Other protocol defined inclusion criteria may apply.

Exclusion Criteria:

* Active or unstable neuropsychiatric SLE or lupus nephritis
* Autoimmune or rheumatic disease other than SLE
* Significant, uncontrolled medical conditions not related to SLE
* Active and/or severe viral, bacterial or fungal infection
* History of malignancy within 5 years
* Other protocol defined exclusion criteria may apply.

Primary outcomes:
measure: SLE Responder Index (SRI-4)
timeFrame: week 52
Secondary outcomes:
measure: SLE Responder Index (SRI-4)
timeFrame: week 24
measure: achieve and sustain a low dose of corticosteroid
timeFrame: week 52
measure: achieve low level of urine protein
timeFrame: week 52
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01162512: Telephone Physical Activity Intervention in Obese Youth
Official title: Telephone-Based Physical Activity Intervention in Obese Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: physical activity
obesity
adolescents
telephone
BMI
body mass index
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2010-07-14
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effectiveness of a telephone-based physical activity (PA) intervention in obese adolescents attending a Health Weight Comprehensive Clinic. Secondary aims focus on increasing the amount of change in obesity markers, namely waist circumference and BMI z-scores. The investigators hypothesize the following: 1.The telephone-based PA intervention will increase PA levels above the mail group; and 2. The telephone-based PA intervention will provide changes in waist circumference and BMI z-scores above the mail group.

Detailed description: Obesity rates in youth have tripled over the past 20 years. Physical activity aids in weight loss and is critical for weight maintenance. Further, physical activity has other physiological and psychological benefits. Obese youth often see specialists for weight loss treatment. Treatment in a pediatric population uses a multi-component approach, but physical activity if often overlooked. Combining physical activity information with physician care and nutritional information could improve weight loss and the overall health of these obese children.

Eligibility criteria: Inclusion Criteria:

* 12 to 18 years old
* attending the ECU Pediatric Comprehensive Healthy Weight Clinic

Exclusion Criteria:

* must be able to read and write in English
* must be able to participate in physical activity

Primary outcomes:
measure: physical activity
timeFrame: 4 months
Secondary outcomes:
measure: BMI
timeFrame: 4 months
Other outcomes:
Locations:
city: Greenville
country: United States
facility: ECU Pediatric Comprehensive Healthy Weight Clinic
state: North Carolina
Study officials:
affiliation: East Carolina University
name: Katrina D DuBose, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: East Carolina University
name: David Collier, MD, PhD
role: STUDY_CHAIR
affiliation: East Carolina University
name: Lesley Lutes, PhD
role: STUDY_CHAIR
affiliation: East Carolina University
name: Amy Gross-McMillan, PT, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01928212: Retinal Nerve Fiber Layer Thickness Changes in Parkinson Disease: A Meta-analysis
Official title: Retinal Nerve Fiber Layer Thickness Changes in Parkinson Disease: A Meta-analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: retinal nerve fiber layer thickness
optical coherence tomography
Parkinson disease
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: Wenzhou Medical University
First posted: 2013-08-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: PD patients and healthy subjects were included and underwent OCT examinations

Brief summary: Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber layer (RNFL) and measure its thickness. A reduction of the RNFL thickness has been detected in several neurodegenerative diseases, such as multiple sclerosis, CADASIL and Alzheimer's disease. Different studies have reported RNFL changes also in Parkinson's disease (PD),a common neurodegenerative disease characterized by motor dysfunctions, originally described by James Parkinson in 1817. PD is characterized by selective dopaminergic neuronal cells loss, which may correlate with RNFL thinning. Previous studies on this subject, however, reported contradicting results. Some investigations reported reductions of the RNFL thickness while others did not. In the present study, in order to determine whether RNFL thickness is reduced in PD patients, we performed a meta-analysis and systematically evaluated RNFL thickness measurements with OCT in a series of PD patients and in the healthy control groups.


Eligibility criteria: Inclusion Criteria:

1. case-control studies;
2. patients with PD were compared with healthy controls;
3. all subjects underwent RNFL thickness measurement by OCT;
4. studies should provide the data of peripapillary RNFL thickness;
5. sample size ≥10 in each group.

Exclusion Criteria:

1. authors did not make RNFL measurements;
2. study without healthy control group;
3. the outcome values can not be used for meta-analysis;
4. duplicated articles.

Primary outcomes:
measure: Retinal Nerve Fiber Layer Thickness
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Wenzhou Medical University
name: Yifan Feng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu JG, Feng YF, Xiang Y, Huang JH, Savini G, Parisi V, Yang WJ, Fu XA. Retinal nerve fiber layer thickness changes in Parkinson disease: a meta-analysis. PLoS One. 2014 Jan 21;9(1):e85718. doi: 10.1371/journal.pone.0085718. eCollection 2014.
Clinical trial NCT00906412: Ventrointermediate Nucleus (VIM DBS) and Working Memory
Official title: VIM DBS and Working Memory
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Tremor
Keywords: Essential Tremor
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Washington University School of Medicine Movement Disorder Clinic

Brief summary: This is part of a larger study for which participants have already completed memory and thinking tests. In this study, investigators are trying to learn how deep-brain stimulation affects memory skills in essential tremor (ET) patients. We are especially trying to figure out how stimulation on each side of the brain may affect working memory.


Eligibility criteria: Inclusion Criteria:

ET PATIENTS:

* Clinical diagnosis of essential tremor affecting the upper extremities.
* Previous unilateral or bilateral DBS of the VIM
* Ages 40 -70
* A useable pre-surgical MR scan

CONTROLS:

* Spouse or acquaintance of enrolled patient participant
* Ages 40 - 70

Exclusion Criteria:

ET PATIENTS:

* Clinical evidence of other neurological conditions
* Significant psychiatric condition

CONTROLS:

* Clinical evidence of other neurological conditions
* Significant psychiatric condition

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Hershey Tamara, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00998712: Gestational Diabetes Mellitus and Cardiovascular Disease: The Role of Vascular Dysfunction
Official title: Gestational Diabetes Mellitus and Cardiovascular Disease: The Role of Vascular Dysfunction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Diabetes Mellitus
Pregnancy
Keywords: gestational diabetes mellitus
pregnancy
cardiovascular disease risk
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2009-10-20
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Black and white women currently in the thrid trimester of a pregnancy complicated or uncomplicated by gestational diabetes.

Brief summary: The purpose of this research study is to look at whether there are differences in blood vessel function, risk for developing diabetes (high blood sugar), lipid (blood fat) levels, and levels of other blood markers between black women and white women who have or do not have gestational diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Healthy women of self-identified African descent (black) and European (white) ancestry,
* 18-40 years of age,
* Body mass index \< 35 kg/m2
* History of regular menstrual cycles,
* Are currently pregnant and in third trimester of pregnancy (after 24 weeks gestational age)
* Have no pregnancy-associated complications to-date
* Are in good health free of hypertension, as well as thyroid, cardiac, or renal disease.

Exclusion Criteria:

* History of smoking
* Are taking potentially vasoactive medications

Primary outcomes:
measure: endothelial function
timeFrame: same day
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital, Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT04153812: Clinical Study on the Safety and Effectiveness of Vagus Nerve Stimulation in the Treatment of Refractory Depression
Official title: Clinical Study on the Safety and Effectiveness of Vagus Nerve Stimulation in the Treatment of Refractory Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Refractory Depression
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Based on the mechanism hypothesis and clinical efficacy of VNS in treating refractory depression, this study will evaluate the safety and efficacy of VNS in treating refractory depression through a small sample of clinical trials

Detailed description: This clinical trial is a prospective, self - controlled clinical validation study. Subjects who met the inclusion criteria and did not meet the exclusion criteria were screened to enter the test. After admission, subjects received vagus nerve stimulation and conventional treatment. Enrolled 10 subjects. Parameter setting and observation were performed 2 weeks after implantation of the vagus nerve stimulation lead and pulse generator, and follow-up evaluation was performed at 3, 6 and 12 months.

Eligibility criteria: Inclusion Criteria:

1. patients with treatment-resistant depression (patients with Hamilton depression scale (HAMD) score reduction rate still less than 50% after adequate treatment with two or more antidepressants)
2. age 18-65; Male or female
3. the patient has a depressive course of 2 years or more or has 2 or more major depressive episodes
4. HAMD-17 score\> 17 was at baseline

Exclusion Criteria:

1. pregnant or lactating women, women of childbearing age who plan or have no safe contraceptive measures
2. a patient who is or has been diagnosed with a mental disorder other than depression; Depressive episode with psychotic symptoms
3. patients currently at serious risk of suicide
4. prior 12 months of alcohol or substance dependence, or prior 6 months of substance abuse other than nicotine
5. patients with cardiovascular diseases (myocardial infarction or cardiac arrest) and organic brain diseases (such as cerebral hemorrhage, massive cerebral infarction, encephalitis and epilepsy)
6. accept other clinical trials
7. patients requiring systemic mri after implantation

Primary outcomes:
measure: HAMD-17
timeFrame: 6 months
Secondary outcomes:
measure: HAMD-17
timeFrame: 12months
measure: MADRS
timeFrame: 12months
measure: IDS-SR
timeFrame: 12months
measure: CGI
timeFrame: 12months
measure: PSQI
timeFrame: 12months
Other outcomes:
measure: safety
timeFrame: 12months
Locations:
city: Xian
country: China
facility: Xijing Hospital
state: Shanxi
Study officials:
References: