louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06737627: Development and Validation of the Observatory Battery of Common Eye Disorders for Adults With Intellectual Disability
Official title: Development and Validation of the Observatory Battery of Common Eye Disorders for Adults With Intellectual Disability
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intellectual Disability
Keywords: Intellectual disability, Adults, Visual Scale, Caregiver
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 740
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intellectual disability

Brief summary: Background:

Around 15% of the global population has some form of disability. Rights to obtain proper health care is an emphasis in the United Nationals Convention on the Right of People with Disability. Due to the importance of improving vision health for people with disabilities, studies on how to identify vision problems becomes extremely important in policy formulation for all countries. Among all types of disabilities, people with intellectual disability (ID) are among the ones where vision problems are the hardest to detect.

Currently, no caregiver assessable scales are available, as a result, adults with ID are at high risk of delayed diagnose for common ocular conditions. Objectives: This is a one-year project.

The objective of this study is two folds:

1. To develop an item bank of ocular conditions of adults with ID;
2. To develop a scale for caregivers to detect ocular conditions for adults with ID, and to validate the reliability, construct validity and responsiveness of the scale.


Eligibility criteria: Inclusion Criteria:

1. Age 20 and above
2. Primary caregivers for at least one adult with ID (have disability identification or (and) certification).

Exclusion Criteria:

1. Unable to communicate in Mandarin or Taiwanese.(Primarycaregivers)
2. Unable to cooperate with eye examination.(ID)

Primary outcomes:
measure: Collection of Socioeconomic Data for Individuals with Disabilities
timeFrame: 1-3 months
measure: Assessment Scales for Individuals with Disabilities
timeFrame: 1-3 months
measure: Ophthalmologic Examination Form
timeFrame: 1-3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Care facility
city: Taipei City
country: Taiwan
facility: Care facility
Study officials:
References:
Clinical trial NCT04944927: HEmiplegia Arrhythmia Retrospective Trial
Official title: Role of Alternating Hemiplegia of Childhood Genotype in Cardiac Repolarization. HEART: HEmiplegia Arrhythmia Retrospective Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alternating Hemiplegia of Childhood
Keywords: QTc
Cardiac repolarization and arrhythmia
ECG
Alternating Hemiplegia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Alternating Hemiplegia of Childhood

Brief summary: Alternating Hemiplegia of Childhood (AHC) is a rare and severe disease that is in need of effective, and hopefully even curative, therapies. Afflicted patients suffer from severe paralyzing crises, often excruciatingly painful muscle spasms, severe often life threatening epileptic seizures, frequently severe developmental and psychiatric/psychological disabilities and other comorbidities, such as cardiac disturbances. Recent data indicate that AHC genotype is in relation to cardiac repolarization troubles and to cardiac arrhythmias. The primary hypothesis to explore is that there is an association between genotype and cardiac phenotype in AHC.


Eligibility criteria: Inclusion Criteria:

* Patients that meet the clinical diagnostic criteria (Aicardi et al, 1995) for typical alternating hemiplegia with or without identified mutations in ATP1A3.
* At least one ECG study is required.
* Patients ages yearand more

Exclusion Criteria:

* Informed consent or assent not obtainable
* ATP1A3 testing not performed
* No ECG studies are available

Primary outcomes:
measure: Measurement of QTc interval and all relevant cardiac repolarization measurements
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Department of Clinical Epileptology, Sleep Disorders and Functional Neurology in Children, Hôpital Femme Mère Enfant, University Hospitals of Lyon (Hospices Civils de Lyon)
Study officials:
References:
Clinical trial NCT01844427: Memantine Monotherapy for Executive Dysfunction and ADHD
Official title: Memantine Monotherapy for Executive Dysfunction and ADHD: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: ADHD
Executive Function Deficits (EFD's)
Keywords: ADHD
Executive function deficits
Psychiatry
Psychopharmacology
Namenda
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-05-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 12-week clinical trial evaluating the efficacy and safety of memantine hydrochloride (Memantine HC1, brand name Namenda) in the treatment of executive function deficits (EFDs) in adults with Attention Deficit Hyperactivity Disorder (ADHD). After screening procedures, memantine is prescribed in randomized, double-blind fashion (equal chance of medication or placebo) for 12 weeks.

The investigators hypothesize that memantine hydrochloride will prove to be an effective, safe, and well-tolerated agent for the treatment of EFDs in individuals with ADHD interested in non-stimulant medications.


Eligibility criteria: Inclusion Criteria:

1. Male and female adults ages 18-45 years;
2. a diagnosis of DSM-IV \[78\] ADHD-combined type
3. a score of at least 20 on the AISRS (a score of 20 in the AISRS identifies subjects with at least moderate severity of symptoms);
4. a BRIEF-A Global Executive Composite T-score of \>6; and
5. proficiency in English. -

Exclusion Criteria:

1) Pregnant or nursing females; 2) investigator and his/her immediate family (spouse, parent, child, grandparent, or grandchild); 3) any serious, unstable medical illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease and hypertension), endocrinologic, neurologic, immunologic, or hematologic disease; 4) hypersensitivity to memantine; 5) multiple adverse drug reactions; 6) current or past history of seizures; 7) any history of a major psychiatric disorder including schizophrenia, psychosis, bipolar disorder (BPD), or autism spectrum disorder (ASD); 8) meets DSM-IV criteria in the last month for major depression or any major anxiety disorder or has a Hamilton Rating Scale for Anxiety (HAM-A) or Hamilton Rating Scale for Depression (HAM-D) score greater than 14; 9) meets DSM-IV criteria for substance abuse or dependence in the last month or has a positive drug urine screen; 10) judged to be at serious suicidal risk; 11) use of any other concomitant medication with primarily central nervous system activity; or 12) IQ \< 80.

-

Primary outcomes:
measure: Brief-A Self-Report
timeFrame: Baseline to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04941027: Evaluating Genetic Modifiers of Cutaneous Neurofibromas in Adults with Neurofibromatosis Type 1
Official title: Evaluating Genetic Modifiers of Cutaneous Neurofibromas in Adults with Neurofibromatosis Type 1
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurofibromatosis 1
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: University of California, San Francisco
First posted: 2021-06-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants aged 40 or older that have been clinically diagnosed with NF1 and currently have neurofibromas present.

Brief summary: The main goal of this protocol is to develop a well-phenotyped genetic biobank to identify genetic variants associated with the heterogeneous clinical presentations of Neurofibromatosis Type 1 (NF1). This will allow for improve understanding of NF1 pathogenesis and more personalized disease management. The investigators will conduct a GWAS analysis to identify common genetic risk variants associated with the development of cutaneous neurofibromas.


Eligibility criteria: Inclusion Criteria:

* Age 40 or older.
* NF type 1 diagnosed using clinical criteria.
* At least one neurofibroma present at time of enrollment.
* Patient able to read and understand consent form (or equivalent translation) and able to give consent.
* Patient able and willing to complete all study procedures.

Primary outcomes:
measure: Determination of genetic variants associated with clinical presentations of NF1.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: California
city: Redwood City
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Kavita Sarin, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Jaishri Blakely, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Carlos Romo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03850327: BIO|CONCEPT.BIOMONITOR III
Official title: BIO|CONCEPT.BIOMONITOR III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Syncope
Tachyarrhythmia
Keywords: Implantable Cardiac Monitor
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2019-02-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to confirm the safety and efficacy of the BIOMONITOR III system. Furthermore, the insertion procedure, the use and handling of the incision and insertion tools and the sensing quality of the BIOMONITOR III will be assessed.


Eligibility criteria: Inclusion Criteria:

* Patient is at high risk of developing a clinically important cardiac arrhythmia; or Patient is undergoing investigation for symptoms such as palpitations, pre-syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or Patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or Patient is planned for AF ablative procedure or has already undergone an AF ablative procedure.
* Patient is able to understand the nature of study and has provided written informed consent.
* Patient is willing and able to perform all follow up visits at the study site.
* Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.

Exclusion Criteria:

* Patients implanted with ICD or pacemaker.
* Patient is pregnant or breast feeding.
* Patient is less than 18 years old.
* Patient is participating in another interventional clinical investigation
* Patient´s life-expectancy is less than 6 months.

Primary outcomes:
measure: Adverse Events
timeFrame: 1 month
measure: R-wave amplitude
timeFrame: 1 month
Secondary outcomes:
measure: Insertion procedure of the BIOMONITOR III by using the incision and insertion tools
timeFrame: At the day of insertion of the BIOMONITOR III
Other outcomes:
Locations:
city: Auchenflower
country: Australia
facility: HeartCare Partners - Wesley Testing
state: Queensland
city: Bundaberg
country: Australia
facility: Bundaberg Cardiology
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Balwyn
country: Australia
facility: HeartCare Victoria - Doncaster
state: Victoria
city: Perth
country: Australia
facility: Mount Hospital
state: Western Australia
city: Canberra
country: Australia
facility: The Canberra Hospital
city: Melbourne
country: Australia
facility: The Alfred Hospital
Study officials:
affiliation: The Alfred Hospital, Melbourne, Australia
name: Olivier van den Brink, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04510727: Optical Coherence Tomography Guided C&D
Official title: Using OCT Imaging to Determine the Presence of Residual Tumor Cells After C&D for Superficial and Nodular BCC: A Prospective Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Basal Cell Carcinoma
Keywords: Superficial basal cell carcinoma
Nodular basal cell carcinoma
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to identify the presence of residual superficial and nodular basal cell carcinoma (BCC) status-post curettage and desiccation (C\&D) by using optical coherence tomography (OCT).


Eligibility criteria: Inclusion Criteria:

* Patients of any: age, gender, Fitzpatrick skin type and ethnicity.
* Primary BCC of any type, except aggressive types that fit the criteria for Mohs surgery
* No prior treatment on the lesion within the last 3 months.
* Lesions anywhere except the head, neck and distal extremities.
* Willing and able to sign informed consent

Exclusion Criteria:

* Aggressive BCC types.
* Recurrent tumors.
* Lesion treated within last 3 months.
* Lesions on head and neck (high risk areas)
* Lesions on distal extremities (thin epidermis not preferred for OCT).
* Pregnant women.
* Patients less than 18 years old.
* Prisoners.
* Any other condition or circumstance that, in the opinion of the Investigator, may compromise the subject's ability to comply with the study protocol

Primary outcomes:
measure: The incidence of residual basal cell carcinoma tumor cells
timeFrame: 2 months (post C&D procedure)
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Maria V Muniz
state: Florida
Study officials:
affiliation: University of Miami
name: Keyvan Nouri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00037427: Airway Responses Following Chlorine Gas Exposure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lung Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2002-05-17
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To determine lung airway responses following chlorine gas exposure.

Detailed description: DESIGN NARRATIVE:

The specific aims of the study are to determine: (1) the effects of asthma with pre-existing airway hyper reactivity on the pulmonary function and airway reactivity and inflammation responses to chlorine; (2) the effects of chlorine concentration on the pulmonary function and airway reactivity and inflammation responses to chlorine; and (3) to assess the time dynamics of the pulmonary function and airway reactivity and inflammation responses to chlorine. It is hypothesized that both airway hyperactivity and higher chlorine concentration will result in larger changes in pulmonary function and airway reactivity and inflammation responses, and that these changes will have differential time courses following chlorine exposure. This study uses two controlled human exposure experiments, utilizing a single-blind, repeated-measures, and counter- balanced design. The two subject groups for both experiments will consist of 21 individuals with no airway hyperactivity, and 21 individuals with both asthma and airway hyperactivity. In Experiment One, subjects are exposed for 15 minutes separately to each of: (1) chlorine at 0.4 ppm; (2) chlorine at 1.0 ppm; and (3) filtered air (Control). Pulmonary function and airway reactivity are measured immediately pre-exposure and 1 and 20 hours post-exposure. Airway inflammation, as determined by cellular and biochemical components from sputum-induction, is measured 65 hours pre-exposure and 20 hours post-exposure. In Experiments Two, subjects are exposed for 15 minutes separately to each of: (1) chlorine (concentration determined from Experiment One); (2) filtered air (Control). Pulmonary function and airway reactivity are measured immediately pre-exposure and at 3 and 72 hours post-exposure. Sputum-induction is performed 65 hours pre-exposure and at 3 and 72 hours post-exposure. The results of this study will provide information on a major irritant chemical relevant to occupational environments. Specially, the susceptibility of a large sub-population at increased risk, the dose-response effects, and the post-exposure time dynamics of the effects of chlorine gas will be determined.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California at San Francisco
name: Colin Solomon
References:
Clinical trial NCT02839473: Hydrosorb® Versus Control in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial
Official title: Hydrosorb® Versus Control (Water Based Spray) in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Radiation Dermatitis
Lead sponsor: Institut Curie
Sponsor class: OTHER
Collaborators: name: Paul Hartmann
First posted: 2016-07-21
Enrollment: 278
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective consisted of avoiding deterioration and/or restoring the integrity of the skin of patients treated by radiotherapy, right from the first signs of grade 1 or 2 radiation dermatitis.


Eligibility criteria: Inclusion Criteria:

* Women treated by normo fractionated radiotherapy for breast cancer
* Presenting grade 1 or 2 radiation dermatitis during the treatment and who provided their written informed consent were included in the study.

Exclusion criteria:

* Were male patients
* Radiation dermatitis already treated or caused by another treatment
* Subjects deprived of their freedom or under guardianship
* Subjects in whom medical follow-up was impossible
* A cancer wound or skin flap on the irradiated zone
* A history of allergic skin reaction
* Concomitant chemotherapy or concomitant bevacizumab therapy and bilateral irradiation.

Primary outcomes:
measure: local treatment failure defined as interruption of radiotherapy because of skin radiotoxicity or change of local care because skin alteration.
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: skin colorimetry measured by a colorimeter
timeFrame: day0, day 7, day 14, day 21, day 28
measure: pain level assessed by the visual analog pain scale
timeFrame: day0, day 7, day 14, day 21, day 28
measure: quality of life assessed with the Dermatology Life Quality Index questionnaire
timeFrame: day0, day 14, day 28
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
city: Saint Cloud
country: France
facility: Centre René Huguenin
Study officials:
affiliation: Institut Curie
name: Youlia Kirova, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06584773: Efficacy of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients
Official title: Efficacy and Impact on CMV Infection of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Disorder Related to Renal Transplantation
Keywords: kidney transplantation, sensitized, immunosuppression
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Carlucci G Ventura
name: Daniel R Salomon
name: Fabiana Agena
name: Flavio J de Paula
name: Francine B Lemos
name: Gislene Bezerra
name: Helcio Rodrigues
name: Maria da Luz Fernandes
name: Nelson Zocoler Galante
name: Noemia B de Lima
name: Paschoalina Romano
name: Patricia S Souza
name: Vivian Onuchic
name: Elias David Neto
First posted: 2024-09-05
Enrollment: 80
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: In this study, sensitized renal transplant recipients, who present an increased risk of acute rejection, will be evaluated for the benefit of quadruple immunosuppression, adding sirolimus to the traditional scheme with tacrolimus, mycophenolate, and prednisone.


Eligibility criteria: Inclusion Criteria:

* Sensitezed renal transplant recipients with reactivity panel of antibodies (PRA) greater than 30% who agree and sign the consent form.

Exclusion Criteria:

* Obese patients (body mass index above 35 m2);
* History of GESF or membranoproliferative glomerulonephritis (MPGN) as primary cause of renal failure;
* Proteinuria (protein/creatinine ratio) greater than 0.5 mg/dL at the time of initiation of Sirolimus;
* Triglyceride levels greater than 300 mg/dl at enrollment;
* Active infection by hepatitis B virus, hepatitis C virus or HIV;
* CMV nonreactive IgG sorology at the time of transplantation.

Primary outcomes:
measure: Occurrence of acute rejection and/or positive viremia for CMV
timeFrame: From enrollment to the end of treatment at 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Renal Transplantation Service
Study officials:
References: