louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00185510: Efficacy and Safety Study of Advantan for Maintenance Treatment of Atopic Dermatitis
Official title: Double-Blind, Placebo Controlled, Randomized, Multicenter, Parallel-Group Study to Compare the Efficacy and Safety of Advantan Cream Twice Weekly With Advabase Cream During a Maintenance Phase of 16 Weeks After Successful Treatment of Atopic Dermatitis With Advantan Cream
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dermatitis, Atopic
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2005-09-16
Enrollment: 250
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose of the study:

One bothering feature of atopic dermatitis is its relapsing nature. Hence, it is worthwhile to test modes how to efficiently prevent relapses or at least increase the time until the disease recurs. In order to give recommendations to other patients, this study is to scientifically describe efficacy and safety of a given regimen, namely a maintenance therapy with two days a week Advantan.

Detailed description: The study has initially been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Intendis GmbH, a Bayer HealthCare company, is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Acute 'Severe' or 'Very Severe' flare of atopic dermatitis; no minimum affected body surface
* History of moderate to severe form of atopic dermatitis for at least two years

Exclusion Criteria:

* Pregnancy, breast feeding
* Known immune, hepatic, or renal insufficiency
* Acute herpes simplex or mollusca contagiosa infection
* Acute and severe impetigo contagiosa. A slight superinfection of eczema is no exclusion criterion
* Severe other viral, bacterial, or fungal skin infection (chicken pox, prominent tinea corporis)
* Acute infestations (e.g. head lice, scabies)

Primary outcomes:
measure: Time to relapse in the maintenance phase (MP)
timeFrame: Week 16
Secondary outcomes:
measure: Patients' number of relapses in the maintenance phase
timeFrame: Week 16
measure: Treatment success as assessed by Investigator Global Assessment (IGA) score
timeFrame: Week 16
measure: Percentage change during Acute Phase (AP) and MP assessed by Modified Eczema Area and Severity Index (mEASI)
timeFrame: Week 16
measure: Index lesion monitoring
timeFrame: Week 16
measure: Change of disease during AP and MP as assessed by Patient Global Assessment
timeFrame: Week 16
measure: Visual assessment of signs of atrophy
timeFrame: Week 16
measure: Ultrasound for measurement of skin thickness in selected sites
timeFrame: Up to week 16
measure: Dermatology Life Quality Index (CDLQI, DLQI)
timeFrame: Week 16
measure: Adverse Event Collection
timeFrame: Week 16
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04951310: COVID-19 Vaccinations With a Sweepstakes
Official title: COVID-19 Vaccinations With a Sweepstakes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: COVID19 vaccination
Behavioral science interventions
Vaccination promotion
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Philadelphia Department of Public Health
First posted: 2021-07-06
Enrollment: 3827656
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To reach herd immunity for COVID-19, experts estimate that 70% of the population will need to be vaccinated. However, vaccination rates have begun to slow down in the United States. The investigators will partner with Philadelphia to launch a COVID-19 vaccination sweepstakes, in which residents will be eligible to win if they have received at least one dose of the COVID-19 vaccine prior to a given drawing. Drawings will be held every two weeks; multiple prizes of various sizes will be awarded in each drawing. Half of the prizes in each size category in each drawing will be awarded to residents of a zip code that is randomly selected from a pre-defined list of under-vaccinated zip codes (this zip code will be announced at the start of each 2-week drawing period), the other half will be awarded to residents outside of that selected zip code. The investigators will analyze vaccination rates in Philadelphia as compared with neighboring regions before, during, and after the specified time period, as well as analyze vaccination rates in the three selected zip codes compared to the other zip codes that could have been targeted (the residual set of under-vaccinated zip codes) to determine the effectiveness of the sweepstakes at encouraging vaccinations.


Eligibility criteria: Inclusion Criteria:

* All 18+ residents of the City of Philadelphia will be eligible. Residents will be able to win the sweepstakes prizes if they can verify they received at least one dose of the COVID-19 vaccine before the date of the sweepstakes drawing in question.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Weekly Vaccinations Per 100k Residents
timeFrame: 15 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01428310: Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke
Official title: A Single Center, Single-Blind, Randomized, Crossover Pilot Study to Evaluate the Safety and Effects of Anatabloc™, a Dietary Supplement, in Reducing the Urge to Smoke in Daily Smokers Followed by an Open-Label Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tobacco Use Disorder
Tobacco Dependence
Smoking
Keywords: dietary supplement
nutraceutical
Lead sponsor: Rock Creek Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-02
Enrollment: 109
Sex: ALL
Minimum age (years): 23
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study will consist of 2 phases. Phase 1 will be a one day crossover study to see the effects of study product on a smoker's desire to smoke, measured by changes in scores on questionnaires given over time. Phase 2 will be a two-week extension, in which subjects will self-administer the study product and visit the study site for assessment of desire to smoke and collection of samples for the evaluation of smoking-related biomarkers.


Eligibility criteria: Inclusion Criteria:

* healthy adult smokers
* using at least 1 pack of cigarettes per day, for at least 5 years

Exclusion Criteria:

* allergy to study product components

Primary outcomes:
measure: effect on subject's craving to smoke
timeFrame: 5 hours
Secondary outcomes:
measure: adverse events related to study product
timeFrame: 5 hours
Other outcomes:
Locations:
city: Martinsburg
country: United States
facility: Comfort Inn
state: West Virginia
Study officials:
affiliation: Star Scientific, Inc
name: Maria Varga, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01618110: Transcranial Magnetic Stimulation in Treatment of Attention Deficit/Hyperactivity Disorders
Official title: Transcranial Magnetic Stimulation of the Pre-Frontal Cortex in the Treatment of Attention Deficit/Hyperactivity Disorders: A Randomized, Controlled, Double Blind Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit/Hyperactivity Disorder
Keywords: ADHD
Attention Deficit/Hyperactivity Disorder
TMS
Transcranial Magnetic Stimulation
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2012-06-13
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * ADHD is one of the most common psychiatric disorders.
* While most of the attention is directed towards youth, 60% continue to suffer symptoms into adult life.
* Current treatment is effective, but 30% suffer side effects that lowers QOL, and 20% are non-responders.
* Known mechanism of pathophysiology includes hypoactive dopaminergic system, especially at right PFC.
* It is this study hypothesis that by stimulating the right PFC by TMS, it will be possible to alleviate ADHD symptoms.
* A 10 sessions of treatment will by applied on a randomly allocated group of patients, diagnosed with ADHD, in a 2:1 ratio: The first group will receive an actual TMS treatment, and the second group will receive a sham treatment.
* Improvement of objective and subjective ADHD scale will be examined.


Eligibility criteria: Inclusion Criteria:

* Age 18-50
* Established diagnosis of ADHD
* No C/I for TMS
* Has signed an informed consent form

Exclusion Criteria:

* Major Psychiatric disorders (Psychotic or Affective)
* Active use of drugs (4 weeks prior to participation)
* Neurologic disorder such as Epilepsy.
* No use of stimulants during the previous 7 days

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hod Hasharon
country: Israel
facility: Shalvata MHC
Study officials:
affiliation: Shalvata MHC
name: Yuval Bloch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06517810: QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
Official title: Pediatric Selective Cytopheretic Device (SCD-PED, QUELIMMUNE) for Critically Ill Children With Acute Kidney Injury: A Humanitarian Device Exemption (HDE) Surveillance Registry Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Acute Kidney Injury Due to Sepsis
Keywords: continuous kidney replacement therapy
continuous renal replacement therapy
acute kidney injury
organ failure
inflammation
dialysis
Lead sponsor: SeaStar Medical
Sponsor class: INDUSTRY
First posted: 2024-07-24
Enrollment: 300
Sex: ALL
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients (weight ≥10kg and age ≤22 years) with acute kidney injury (AKI) due to sepsis or a septic condition on antibiotic therapy and requiring renal replacement therapy (RRT), per device Instructions For Use. All patients who receive treatment with QUELIMMUNE as part of their therapy are included in this registry.

Brief summary: QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT.

The purpose of this surveillance registry is to prospectively collect safety data among all patients treated with QUELIMMUNE under the HDE. More specifically, we intend on comparing the incidence of new (secondary) blood stream infections in the first 28 days after SCD-PED initiation to a comparator group of matched CKRT patients with sepsis who did not receive treatment with QUELIMMUNE


Eligibility criteria: Inclusion Criteria:

* All patients initiated on QUELIMMUNE therapy under the HDE-approved indication

Exclusion Criteria:

* Weight \<10kg
* Age \>22 years
* Known allergy to any components of QUELIMMUNE

Primary outcomes:
measure: Safety
timeFrame: 28 days or through hospital discharge, whichever is sooner
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's of Alabama
state: Alabama
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
city: San Francisco
country: United States
facility: UCSF Benioff Children's
state: California
city: Chicago
country: United States
facility: Lurie Children's Hospital of Chicago
state: Illinois
city: Ann Arbor
country: United States
facility: CS Mott Children's Hospital
state: Michigan
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT06595810: Exercise Habits and Preferences of Community Dwelling Older Adults with Chronic Pain
Official title: Exercise Habits and Preferences of Community Dwelling Older Adults with Chronic Pain: an Exploratory Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Pain
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age: Participants are aged 60 years or above. Inclusion Criteria: Must score above 6 on the Abbreviated Mental Test, understand Cantonese, and have a history of non-cancer pain in the past 6 months.

Exclusion Criteria: Excludes those with serious organic diseases, malignant tumors, diagnosed mental disorders, or recent drug addiction.

Recruitment: Participants will be recruited from Neighborhood Elderly Centers.

Brief summary: Objective:

* To explore the exercise habits and preferences of community dwelling older adults with chronic pain
* To explore the facilitating factors and barriers in performing regular exercise for community dwelling older adults with chronic pain

Significance of study:

Chronic pain is a significant issue affecting both physical well-being and socioeconomic aspects across different age groups. Among older adults, physical inactivity is common, especially among those experiencing chronic pain. However, regular physical exercise offers numerous health benefits for the musculoskeletal, cardiovascular, and central nervous systems.

This project aims to explore the exercise habits and preferences of community-dwelling older adults with chronic pain. By identifying facilitating factors and barriers related to exercise, we can develop tailored exercise programs. These programs will promote healthier habits, allowing older adults to continue living independently in their communities and potentially delaying the need for long-term care facilities.


Eligibility criteria: Inclusion Criteria:

* Aged 60 or above
* Scored \&gt;6 in the Abbreviated Mental Test
* Can understand Cantonese
* Have a history of non-cancer pain in the past 6 months

Exclusion Criteria:

* Have a serious organic disease or malignant tumour
* Have a mental disorder diagnosed by neurologists or psychiatrists
* Have further medical/surgical treatment in two months or experienced drug addiction

Primary outcomes:
measure: Brief Pain Inventory
timeFrame: 1 year
measure: Exercise habits and preferences
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04440410: Evaluation of Cutaneous and Circulating Inflammatory Biomarkers in Hidradenitis Suppurativa and Atopic Dermatitis
Official title: Non-interventional Study to Evaluate Cutaneous and Circulating Inflammatory Biomarkers for a Novel IRAK4-targeted Therapeutic in Hidradenitis Suppurativa and Atopic Dermatitis Patient Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hidradenitis Suppurativa
Dermatitis, Atopic
Keywords: IRAK4
Lead sponsor: Kymera Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: York Dermatology Clinic and Research Centre
First posted: 2020-06-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with active mild, moderate, or severe HS or active moderate or severe AD disease.

Brief summary: This non-intervention study will identify the biomarker profiles in hidradenitis suppurativa (HS) and atopic dermatitis (AD) (as a comparator) that would have the most utility in interventional studies evaluating efficacy during therapeutic intervention. Study data will also be used to correlate cellular/molecular changes in blood (cells and serum), and tissue, with clinical/histopathological phenotypes.

Detailed description: This study is an exploratory correlative study in subjects with HS or AD. Blood samples and skin biopsies will be collected from all subjects and used to assess the following: cutaneous and circulating inflammatory biomarkers and IRAK4 target levels in primary samples, correlations between cutaneous and circulating inflammatory biomarkers and disease severity, effects of IRAK4 degradation on IRAK4 levels and downstream inflammatory biomarkers in ex vivo-treated whole blood from patients.

De-identified routine clinical data that is collected will be correlated with the research findings.

Eligibility criteria: Inclusion Criteria:

1. Age 18 or older
2. Active HS or AD disease, diagnosed by PI
3. Patients with mild (HS only), moderate, or severe disease using the HS-PGA or PGA assessment.
4. Must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to participate in the study.

Exclusion Criteria:

1. Patient is currently on a biologic or other immunosuppressive treatment for HS or AD.
2. Use of biologic treatment for HS or AD within 3 months or 5 half-lives, whichever is longer
3. Use of non-biologic immunosuppressive treatment (eg. Cyclosporin) in the last 4 weeks.

Primary outcomes:
measure: Biomarker Identification
timeFrame: Day 1
measure: Determination of Biomarker Correlations
timeFrame: Day 1
measure: Examination of IRAK4 Degradation Effects Ex Vivo
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond Hill
country: Canada
facility: York Dermatology Clinic and Research Centre
state: Ontario
Study officials:
affiliation: York Dermatology Clinic and Research Centre
name: Afsaneh Alavi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06374810: Does Conscious Connected Breathwork Reduce Symptoms of Anxiety?
Official title: Does Conscious Connected Breathwork Reduces Symptoms of Anxiety. A Quantitative Study Conducted in an Online Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: anxiety
Lead sponsor: California Institute of Integral Studies
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants were randomly assigned to either the breathwork group or they were told that they had been placed on a waitlist and that they would participate in the 2nd cohort, which would take place after the 1st 6-week program had been completed.

Participants in the breathwork groups were also given a 10 minute guided conscious connected breathwork recording. They were advised to do this daily to support the integration of their process. This was not mandatory. At the end of the study participants were asked how often they used the guided self-practice. The frequency of use of the self-practice was used a covariate.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test whether conscious connected breathwork reduces symptoms of anxiety in people with mild to severe anxiety symptoms, as measured by the Zung Self Rating Anxiety Scale.

The main questions aims to answer:

1. Does conscious connected breathwork reduce symptoms of anxiety?
2. Does an increased frequency of self-practice lead to even greater reductions of anxiety symptoms.

there is a comparison group: Researchers will compare whether people doing the breathwork to see if \[insert effects\].

Participants will participate in 1, 90 minute breath workshop per week for 6 weeks. These sessions will be held on Zoom by 2 facilitators. Participants will also be given a 10 minute recording of a guided conscious connected breathwork session that they will be encouraged to complete daily.


Eligibility criteria: Inclusion Criteria:

- Scores of 35 or higher on the Zung self-rating anxiety scale

Exclusion Criteria:

* anyone having completed more than 4 sessions of Conscious Connected Breathwork
* Anyone who has recently (within 1 year) started anti-depressant medication or psychotherapy
* Anyone with a history of panic disorder, psychosis, angina, pregnant, seizure disorder, glaucoma

Primary outcomes:
measure: Changes in anxiety symptoms
timeFrame: 6 - 8 weeks between taking the anxiety scale either before and after the breathwork program or remaining on the wait list
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: CIIS
state: California
Study officials:
References:
Clinical trial NCT04406610: CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients
Official title: Chimeric Antigen Receptor-Modified T Cells for GD2 Positive Recurrent and Metastatic Glioma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Glioma of Brain
CAR-T Cell Immunotherapy
Keywords: CAR-T cell immunotherapy
GD2
glioma
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
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 safety and effectiveness of CAR-T cell immunotherapy in treating with GD2 positive glioma patients.

Detailed description: Chimeric antigen receptor (CAR) is a recombinant receptor with both antigen-binding and T cell activating functions. Chimeric antigen receptor T cell Immunotherapy has more advantages compared with conventional immunotherapy, especially in dealing with patients of hematologic malignancies and solid malignant tumors.This study design a novel specific Chimeric antigen receptor aiming at GD2 antigen.After CAR-T cell infusion,At periodic intervals, the investigators will evaluate clinical symptoms Improved conditions of this disease.Through this study,the investigators will evaluate the safty and effectiveness of CAR-T cell immunotherapy in treating with GD2 positive glioma patients.

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Classification of adverse reactions
timeFrame: 3 months
Secondary outcomes:
measure: Progression free survival （PFS）of patients
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: