louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05866939: Development of a Multidisciplinary Network for Clinical and Laboratory Research for SMA
Official title: Development of a Multidisciplinary Network for Clinical and Laboratory Research for Spinal Muscular Atrophy and Other Rare Motoneuron Diseases
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Spinal Muscular Atrophy
Keywords: spinal muscular atrophy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Ospedale Pediatrico Bambin Gesù
name: IRCCS Eugenio Medea
name: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
First posted: 2023-05-19
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with spinal muscular atrophy regardless of age, type of SMA or treatment

Brief summary: The goal of this observational study is to to establish profiles of clinical progression in patients affected by the different types of SMA (type I, II and III) treated with the currently approved drugs using a structured battery of clinical tests.

Another goal of the study is to assess the progression of the disease in patients identified through neonatal screening.

Detailed description: The collection of 2-year longitudinal clinical data will be conducted in newly treated patients at baseline, 6-, 12-, 14- and 22-months post-treatment. Parameters will include motor function, fatigability, respiratory function, event-free survival and death, and swallowing and feeding modalities. It is anticipated that at least 30 new patients will be enrolled in the study.

Importantly, information will also be collected on patients who may decide to switch treatment during the duration of our study, trying to establish if the switch to a new drug (or as an add-on should patients take a new treatment after being treated with gene therapy) may be associated with changes in clinical phenotype.

The aim is to apply a newly established clinical protocol that allows identifying minor signs of disease that are easily missed in the absence of an NBS-detected diagnosis. Indeed, not all infants identified as SMA-positive through the NBS are truly asymptomatic, as a proportion of them may appear paucisymptomatic and their minor signs could be possibly not detected in the absence of a positive screening test.

Eligibility criteria: Inclusion Criteria:

* All SMA patients

Exclusion Criteria:

* Inability to understand or to provide informed consent.

Primary outcomes:
measure: Establish profiles of clinical progression in patients affected by the different types of SMA (type I, II and III) treated with the currently approved drugs using a structured battery of clinical tests.
timeFrame: 2-year
measure: Assess the progression of the disease in patients identified through neonatal screening
timeFrame: 2-year
measure: Identification of molecular biomarkers that associate with disease course and response to therapies
timeFrame: 2-year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01921439: OCAST Cessation Study
Official title: Matching Brief Smoking Interventions to Stage of Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Smoking Behavior
Cigarette Smoking Behavior
Second Hand Tobacco Smoke
Tobacco Use Cessation
Keywords: smoking
quit smoking
smoking cessation
smoking study
secondhand smoke
smokers
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Oklahoma Center for the Advancement of Science and Technology
First posted: 2013-08-13
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The long-term goal is to improve the quality of life of children and their parents who smoke tobacco by facilitating parental smoking cessation in a way that is easy to administer yet effective. We aim to accomplish this goal by administering an interactive computer-based program that will facilitate motivation and readiness to engage in smoking cessation by providing personalized feedback about the financial and health effects of the parent's smoking. We will compare the changes in motivation and readiness to quit smoking after the parent has taken the computer-based program and compare them to the changes in motivation and readiness to quit in parents who receive only information about the Oklahoma Tobacco Helpline. We will also measure salivary cotinine levels in both parents and children, to objectively measure changes in smoking habits and secondhand smoke exposure. Our hypothesis is that our computer-based program will cause a greater increase in motivation and confidence to quit smoking in the group that receives the customized feedback than the group that receives only information about the Tobacco Helpline. We also predict that both parent and child cotinine levels will show a greater decrease in the group randomized to receive personalized feedback.


Eligibility criteria: Inclusion Criteria:

* Parent or primary caregiver of a child patient at the OU Children's Physicians General Pediatrics clinics
* Current cigarette user
* Able to read study forms and verbally communicate with the study staff in English

Exclusion Criteria:

* Nonsmokers
* Unable to read or speak English well enough to complete the survey and study tasks

Primary outcomes:
measure: Self-Reported Readiness and Motivation to Quit Smoking
timeFrame: Baseline, 1-month, 6-months, 12-months
measure: Parent and Child Salivary Cotinine
timeFrame: Baseline, 1-month, 6-months, and 12-months
measure: Change in self-reported cigarette use
timeFrame: baseline, 1-month, 6-months, and 12-months
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma Tobacco Research Center
state: Oklahoma
Study officials:
affiliation: The University of Oklahoma Health Sciences Center
name: Stephen Gillaspy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03874039: Sweat and Gas Sensor for Healthy Skin and Atopic Dermatitis
Official title: Exploratory Study of Sweat Cytokines and Insensible Gas Losses From Skin in Healthy Normal Adults and Patients With Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Adults
Atopic Dermatitis
Wearables
Sweat Sensor
Gas Sensor
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults and adults with prior diagnosis of atopic dermatitis from made by board certified dermatologist

Brief summary: Pilot study of a wearable gas and sweat skin sensor

Detailed description: The objective of this study is exploratory and deploys two wearable sweat and gas sensors which detect the composition of sweat proteins and volatile gases emitted from the skin in healthy subjects and patients with atopic dermatitis.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old
* Subjects willing and able to comply with requirements of the protocol
* Healthy adults or subjects with atopic dermatitis

Exclusion Criteria:

* Age \<18 years old
* Subjects unwilling and able to comply with requirements of the protocol
* History of skin allergy to medical adhesive tape
* History of heat stroke, heat related or exercise related
* Non-English speaking subjects

Primary outcomes:
measure: Evaluation of gas exudates
timeFrame: 20 minutes
measure: Evaluation of sweat proteins
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Shuai Xu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04470739: Is Thymus Size of Infants Who Born to COVID-19 Positive Mothers Associated With Neonatal Morbidities?
Official title: Is Thymus Size of Infants Who Born to COVID-19 Positive Mothers Associated With Neonatal Morbidities?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Thymic Hypoplasia
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 20
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: COVID-19 infected pregnant women is thought to have variable degrees of inflammatory response against the disease. Investigators of present study, suggested that fetuses are affected from the possible fetal inflammatory syndrome in case of maternal COVID-19. Therefore the aim of his study is to evaluate that if the cardiothymic index is affected by the maternal COVID-19 and to demonstrate any possible association of this measurement with neonatal morbidities.

Detailed description: COVID-19 infected pregnant women is thought to have variable degrees of inflammatory response against the disease. Fetus is known to be influenced by maternal systemic infections. Thymus size of fetus and the neonate, is proven to be changed by primarily inflammatory/infectious diseases. Investigators of present study, suggested that fetuses are affected from the possible fetal inflammatory syndrome in case of maternal COVID-19. Therefore the aim of his study is to evaluate that if the cardiothymic index is affected by the maternal COVID-19 and to demonstrate any possible association of this measurement with neonatal morbidities.

Eligibility criteria: Inclusion Criteria:

* Infants born to COVID-19 positive or negative mothers
* Accepted to participate with an informed consent
* Infants who required to get chest X-ray within the first 6 hours

Exclusion Criteria:

* Infants whose mothers' have any kind of acute or chronic systemic disease or inflammation/infection
* Lack of an informed consent
* Infants who did not require to get chest X-ray within the first 6 hours

Primary outcomes:
measure: Cardiothymic index
timeFrame: 4 months
Secondary outcomes:
measure: Immune profile
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT05349539: Instrumental Assessment of Motor Symptoms by Means of Wearable Sensors in Patients With Parkinson's Disease
Official title: Instrumental Assessment of Motor Symptoms by Means of Wearable Sensors in Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Motor Disorders
Keywords: Parkinson's disease
Wearable sensors
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include a heterogeneous cohort of patients with Parkinson's disease, with and without typical motor complications, including fluctuations and the ON-OFF phenomenon, and with and without paroxysmal gait disorders, such as freezing of gait.

Brief summary: The clinical management of Parkinson's disease (PD) is frequently challenged by the occurrence of motor disorders and complications, such as freezing of gait, fluctuations and the ON-OFF phenomenon, primarily manifesting at home. Therapeutic decisions are usually based on periodic neurological examinations and patients' anamnestic experience collected in an outpatient setting, thus limited by several issues, including "recall bias" and subjective, semi-quantitative and operator-dependent evaluations in non-ecological settings. In the last two decades, new wearable technologies, consisting of "wireless" sensors (e.g., inertial, electromyography), have been widely applied to quantitatively assess movements in physiological and pathological conditions, even for prolonged periods in free-living settings (i.e., long-term monitoring). The aim of this study is to evaluate motor symptoms in patients with PD, such as bradykinesia, tremor, gait disturbances and balance disorders, objectively and quantitatively through the application of wearable sensors in intra- and extra hospital settings, also during common activities of daily living, in order to obtain ecological data possibly useful in the therapeutic management of the disease.


Eligibility criteria: Inclusion Criteria:

* diagnosis of idiopathic Parkinson's disease according to current consensus criteria and confirmed by follow-up clinical evaluations;
* ability to walk independently

Exclusion Criteria:

* dementia (MMSE \< 24/30);
* comorbidities affecting gait (e.g., rheumatological or orthopedic issues);
* atypical parkinsonism.

Primary outcomes:
measure: Time of OFF state of therapy during daily activity hours;
timeFrame: 24 hours
measure: Number of "Wearing Off" and "ON-OFF" phenomena
timeFrame: 24 hours
measure: Number of "freezing of gait" episodes
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Pozzilli
country: Italy
facility: IRCSS Neuromed
Study officials:
References:
Clinical trial NCT06597539: The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Hepatobiliary Malignancy
Official title: A Prospective Study on Investigating the Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Hepatobiliary Malignancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatobiliary Malignancy
Keywords: 68Ga-grazytracer PET/CT
Immunotherapy
Advanced hepatobiliary malignancy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients and outpatients at Ruijin Hospital who meet the inclusion criteria.

Brief summary: This study aims to investigate the value of 68Ga-grazytracer in predicting the efficacy of immunotherapy for advanced hepatobiliary malignancies.

Detailed description: The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-grazytracer PET/CT after 3 cycles of immunotherapy to evaluate response. The imaging response measurements will be compared with the histopathological or clinical assessment results as gold standard.

Eligibility criteria: Inclusion Criteria:

1. Pathological and clinical diagnosis of advanced hepatobiliary malignancy requiring immunotherapy or combination immunotherapy after evaluation according to clinical guidelines
2. Signed and dated informed consent form
3. Commitment to comply with research procedures and co-operation in the implementation of the full research process
4. aged 18-75 years old
5. The patient is in good general condition with an expected survival of \&gt; 6 months

Exclusion Criteria:

1. Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
2. Intestinal perforation, complete intestinal obstruction
3. Uncontrolled diabetes patients or fasting blood glucose levels ≥11 mmol/L on the day of the trial
4. Pregnant women and women who may be pregnant, women who are breastfeeding.
5. Non-compliant person

Primary outcomes:
measure: Evaluation the responses to immunotherapy of advanced hepatobiliary malignancy
timeFrame: up to 9 weeks
measure: Standardized uptake value(SUV)
timeFrame: up to 9 weeks
measure: Target-to-background ratio(TBR)
timeFrame: up to 9 weeks
Secondary outcomes:
measure: Progress free survival
timeFrame: 1 years
measure: Overall survival
timeFrame: 1 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT06437639: MEXIDOL® Sequential Therapy of Patients With Primary Open-angle Glaucoma (POAG)
Official title: Prospective, Open, Comparative, Randomized Study of the Efficacy and Safety Evaluation of the Mexidol® Sequential Therapy of Patients With Primary Open-angle Glaucoma (POAG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Open-Angle Glaucoma (POAG)
Keywords: Glaucoma
Primary Open-Angle Glaucoma (POAG)
Glaucomatous Optic Neuropathy (GON)
Mitochondrial Dysfunction
Neuroprotection
Mexidol
Ethylmethylhydroxypyridine Succinate
Lead sponsor: Pharmasoft
Sponsor class: INDUSTRY
First posted: 2024-05-31
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: The use of neurocytoprotectors helps restore the functional activity of mitochondria, improve the nervous activity of the retina and optic nerve, and stabilize the glaucomatous process.

Detailed description: Hypothesis: Mexidol® allows to optimize POAG therapy by reducing mitochondrial dysfunction and stabilizing glaucomatous optic neuropathy by improving the functional activity of mitochondria and its energy-producing function

Eligibility criteria: Inclusion Criteria:

* An advanced stage of POAG in one or two eyes
* Hypotonic-compensated intraocular pressure (IOP)

Exclusion Criteria:

* Degenerative diseases of the central nervous system, diabetes mellitus
* Primary mitochondrial dysfunction
* A history of surgical interventions and damage to the organ of vision
* Acute or chronic inflammatory or hereditary degenerative eye diseases (anterior and posterior sections)
* Decompensation of concomitant somatic diseases
* Taking antioxidants/nootropic drugs 6 months before inclusion in the study
* Hypersensitivity to ethylmethylhydroxypyridine succinate or to any of the excipients

Primary outcomes:
measure: Degree of expression of mitochondrial dysfunction
timeFrame: 90 days
measure: Dynamics of the structural and functional characteristics of mitochondria
timeFrame: 90 days
Secondary outcomes:
measure: Аssessment of differential light sensitivity of the retina
timeFrame: 90 days
measure: Structural and topographic changes in the layer of nerve fibers and the retinal ganglion [Optical Coherence Tomography (OCT) parameters]
timeFrame: 90 days
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 90 days
Other outcomes:
Locations:
city: Tyumen
country: Russian Federation
facility: Tyumen Scientific Center of the Russian Academy of Sciences
Study officials:
References:
Clinical trial NCT00691639: Collection of Blood Specimens From Patients in AL-3789 Studies for Elevated Intraocular Pressure (IOP)
Official title: Collection of Blood Specimens From Patients in AL-3789 Studies for Elevated Intraocular Pressure (IOP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open-Angle Glaucoma
Keywords: Open-angle glaucoma
IOP
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-06-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who received anecortave acetate treatment

Brief summary: The objective of this study is to obtain blood samples from patients who are or were participants in any Alcon AL-3789 clinical trial. Association will be conducted to search for genetic markers in patients with glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Patient must be currently or previously enrolled in Alcon clinical study and received AL-3789

Exclusion Criteria:

* Age related

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center
state: Texas
Study officials:
References:
Clinical trial NCT05505539: Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia
Official title: Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia: a Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Oral Leukoplakia
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2022-08-17
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: TREATMENT

Brief summary: This is a single center, open-label, interventional pilot study to assess the feasibility, safety, and preliminary efficacy of intralesional 5-FU injections for the treatment of oral leukoplakia (OL).

Detailed description: PRIMARY OBJECTIVE:

I. Evaluate the feasibility of intralesional 5-fluorouracil (5-FU) injection for the treatment of oral leukoplakia

SECONDARY OBJECTIVE:

I. Evaluate the safety profile and side effects of the study drug.

OUTLINE:

Participants diagnosed with OL will receive multiple intralesional injections of 5-FU solution over a maximum period of 6 weeks, followed by a follow-up visit after 3 months.

Eligibility criteria: Inclusion Criteria:

* Adults, 18 years of age or older
* Any gender, race, or ethnicity
* Clinical diagnosis of oral leukoplakia and biopsy proven dysplasia (any grade)
* Oral leukoplakia at least 1 cm in largest diameter
* Ability to understand and willingness to sign a written informed consent document
* Willingness to provide blood and tissue from diagnostic biopsies
* Any smoking history is permitted

Exclusion Criteria:

* Pregnant or lactating women
* Men and women unwilling to use contraception while on study
* History of malignancy that required cytotoxic chemotherapy within the previous 3 months
* Use of 5-FU (systemic or topical) within 3 months prior to study enrollment
* History of allergic reaction or severe hypersensitivity to 5-FU and/or lidocaine
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

Primary outcomes:
measure: Proportion of participants s who complete 5-FU injections
timeFrame: Up to 6 weeks
measure: Number of participants with treatment-related adverse events
timeFrame: Up to 3 months
Secondary outcomes:
measure: Change in area of clinically visible oral leukoplakia lesions
timeFrame: Up to 3 months
measure: Proportion of participants with a change in histologic grade
timeFrame: Up to 3 months
measure: Change in scores on the oral mucosal diseases quality of life questionnaire (COMD-QLQ)
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Kyle Jones, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: