louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04106258: A Pilot Study of Hemoporfin PDT in Children(2-7 Years Old) With Port-wine Stain
Official title: A Pilot Study of Hemoporfin Photodynamic Therapy in Children (2-7 Years Old) With Port-wine Stain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Port-wine Stain
Lead sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-09-27
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This pilot study aims to evaluate the safety and efficacy of hemoporfin photodynamic therapy (PDT) with different light doses for port-wine stain (PWS）in 2-7 years old children. The pharmacokinetic behavior and pharmacokinetic parameters of hemoporfin in children will be investigated as well.


Eligibility criteria: Inclusion Criteria:

* Children with clinical diagnosis of PWS；
* ≥2 years old and \<7 years old；
* The guardians agreed to voluntarily participate in this study and signed the informed consent agreement

Exclusion Criteria:

* Therapy area located outside of head and neck;
* Other skin diseases that might interfere with the efficacy evaluation;
* Patients with respiratory disease, severe pulmonary dysfunction, history of airway hyperresponsiveness, or family history of suspected malignant hyperthermia;
* Preexist scars in the treatment area caused by previous treatment, which might interfere with the efficacy and safety evaluation;
* with allergic diseases; known to be allergic to eggs, milk or soy protein; known to have skin photoallergies, porphyria or known allergic history of experimental drugs (porphyrins) and chemically structure similar drugs; known allergic history of anesthetics; allergic constitution;
* Cicatricial constitution;
* Immunocompromised conditions or need long-term use of glucocorticoids and immunosuppressive agents;
* Electrocardiographic abnormalities or organic heart diseases;
* Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase or total bilirubin \> 1.5 upper limit of normal \[ULN\], or serum creatinine or blood urea nitrogen \> 1.5 ULN);
* Coagulation disorders;
* Patients with severe neurological, psychiatric, endocrine and cardiovascular diseases; with epilepsy history or recent epileptic seizures;
* Be evaluated not suitable for anaesthesia by risk assessment before anaesthesia；
* Previous therapy of PWS within the last 4 weeks;
* Participation in any clinical studies within the last 4 weeks;
* Be judged not suitable to participate the study by the investigators

Primary outcomes:
measure: Response rate
timeFrame: week 8
measure: Incidence of adverse events and adverse reactions
timeFrame: up to 24 weeks after the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT06019858: A Clinical Trial to Assess the Effects of a Vitamin Shot on Energy Levels
Official title: A Clinical Trial to Assess the Effects of a Vitamin Shot on Energy Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy
Fatigue
Mood
Weight Loss
Cognition
Lead sponsor: Vitamin Energy®
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a virtual, single-arm clinical trial that will last 30 days. Participants will drink 1 bottle of the Vitamin Energy® shot daily and complete questionnaires at baseline, Day 7, Day 14, and Day 30.

Participants' energy, mood, and cognitive function will be evaluated at baseline and at each check-in. Bodyweight will also be assessed at baseline and Day 30. Likert scale responses will be examined from baseline to each check-in. Participant responses on product feedback will be presented as % scores.


Eligibility criteria: Inclusion Criteria:

Men and women 18 years and over

Self-reported issues with:

* Energy
* Focus
* Brain fog Participants who often feel fatigued Willing to maintain the same caffeine consumption during the study period Generally healthy - don't live with any uncontrolled chronic disease

Exclusion Criteria:

Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.

Anyone with known severe allergic reactions. Women who are pregnant, breastfeeding, or attempting to become pregnant Unwilling to follow the study protocol.

Primary outcomes:
measure: Change in energy levels. [Baseline to Day 30]
timeFrame: 30 days
Secondary outcomes:
measure: Change in ability to concentration. [Baseline to Day 30]
timeFrame: 30 days
measure: Change in participant-perceived productivity. [Baseline to Day 30]
timeFrame: 30 days
measure: Changes in mood. [Baseline to Day 30]
timeFrame: 30 days
measure: Changes in brain fog. [Baseline to Day 30]
timeFrame: 30 days
measure: Change in body weight. [Baseline to Day 30]
timeFrame: 30 days
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT01276158: Pediatric Radial Arterial Cannulation
Official title: Ultrasound-image Versus Doppler-guided Radial Artery Cannulation in Infants and Small Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2011-01-13
Enrollment: 104
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective randomized study was designed to compare ultrasound guided technique with Doppler assisted technique for radial arterial cannulation in infant and small children.

Detailed description: In infants, percutaneous cannulation of radial artery requires considerable expertise. People have been using Doppler guided radial artery cannulation technique to improve success rate for more than 20 years. Recently, Ultrasound sonography has been utilized for central line placement in pediatrics. The purpose of this study is whether ultrasound guided radial artery cannulation technique improves the success rate compared to traditional doppler guided technique.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria

  1. Pediatric patient undergoing scheduled major surgery which require continuous arterial pressure monitoring
  2. Term neonates and children \< 4 years old weighing \>/= 3 kg and \< 12 kg

Exclusion Criteria:

* Exclusion criteria

  1. Patients with a skin wound or infection around puncture site
  2. Abnormal circulation in the hand (known vascular compromise, mottling, cool skin temp relative to other hand, poor capillary refill)
  3. Recent radial arterial puncture (less than 1 month)
  4. Any emergency surgery or profound hemodynamic instability requiring urgent arterial cannulation.

Primary outcomes:
measure: The primary object is to compare the first attempt success rate between each group.
timeFrame: 10 minutes
Secondary outcomes:
measure: As a secondary object, a comparison will be made between groups for overall Success rate within a 10 minute time period.
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Kenichi Ueda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04250558: ICG Fluorescence Imaging in Lower Extremity Amputation Patients
Official title: Indocyanine Green Fluorescence Guided Imaging in Lower Extremity Amputation Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma Injury
Keywords: Trauma
Amputation
Orthopaedic
Lower Extremity
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Dartmouth College
First posted: 2020-01-31
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients 18 years of age or older who present to DHMC and are scheduled to undergo a lower extremity amputation (either below knee, through knee or above knee) will be considered for study enrollment.

Brief summary: This is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG) fluorescence imaging at several steps during surgical procedure.

Detailed description: This is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG) fluorescence imaging at several steps during surgical procedure. The data collected in this study will inform the development of methodology and thresholds around providing surgeons with objective data regarding critically injured bone in the setting of musculoskeletal trauma and/or bone infection. This will improve our management of and decrease variation associated with management of these disabling conditions.

Eligibility criteria: Inclusion Criteria:

1. Patients 18 years of age or older
2. Scheduled for a lower extremity amputation (either below knee, through knee or above knee)
3. Provision of informed consent

Exclusion Criteria:

1. Iodine allergy
2. Pregnant women

Primary outcomes:
measure: Total Bone Blood Flow (TBBF)-Post Osteotomy
timeFrame: 4 hours
measure: Total Bone Blood Flow (TBBF)-Post Osteotomy+Stripping
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Ida L Gitajn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06747858: Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
Official title: A Phase 2, Open-label, Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability and Efficacy of ARCT-032 in People With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cystic Fibrosis
CFTR Gene Mutation
Keywords: CFTR
mRNA
Lead sponsor: Arcturus Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Multiple ascending dose
Primary purpose: TREATMENT

Brief summary: ARCT-032-02 is a Phase 2, open-label, multicenter, multiple-ascending dose study of ARCT-032 in adults with CF who are not eligible for CFTR modulator therapy or are not taking CFTR modulators due to drug intolerance, poor response, or lack of access to modulators.

Detailed description: This is an open-label, multiple-ascending dose study of ARCT-032 in adults with CF who are not on CFTR modulator therapy. After successful screening, eligible participants will receive nebulized ARCT-032 daily for 4 weeks, and then followed for safety for a total of 12 weeks.

Eligibility criteria: Key Inclusion Criteria:

1. Confirmed diagnosis of Cystic Fibrosis
2. Not eligible for CFTR modulator therapy, or not taking CFTR modulators for at least 60 days prior to dosing (e.g. due to intolerance, poor response, or lack of access to modulators).
3. FEV1 between 40% and 100% of predicted value

Exclusion Criteria:

1. History of illness or medical condition that might pose an additional risk or may confound study results
2. Recent moderate or severe hemoptysis
3. Recent major surgery
4. Solid organ or hematologic transplant
5. Requirement of supplemental oxygen while awake or \> 2L per minute while sleeping.
6. Chronic maintenance systemic corticosteroids exceeding equivalent of daily 15 mg oral prednisone or 30 mg every other day
7. Adequate liver and kidney function as determined by lab tests

Primary outcomes:
measure: Incidence, severity and dose relationship of adverse events
timeFrame: 16 weeks
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: Up to 6 weeks
measure: Pharmacodynamics--Lung Function
timeFrame: 4 weeks
measure: Pharmacodynamics--Cystic Fibrosis Quality of Life Questionnaire-Revised (CFQ-R)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Central Florida Pulmonary Group
state: Florida
city: Northfield
country: United States
facility: The Cystic Fibrosis Institute
state: Illinois
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: San Antonio
country: United States
facility: UT Health
state: Texas
Study officials:
References:
Clinical trial NCT06655558: Validating the Clinical Effect of a Knee Orthosis
Official title: Validating the Clinical Effect of a Knee Orthosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Medial Gonarthrosis
Keywords: knee orthosis
knee brace
validation
WOMAC
knee pain
knee stiffness
daily activities
knee function
Lead sponsor: TOPMED
Sponsor class: OTHER
Collaborators: name: Natural Sciences and Engineering Research Council, Canada
name: O3D inc.
First posted: 2024-10-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudal treatment validation
Primary purpose: TREATMENT

Brief summary: The aging population is steadily increasing, partly due to increasing life expectancy. At the same time, chronic diseases, including those affecting the musculoskeletal system (e.g., osteoarthritis), whose prevalence increases with age, limit the daily activities of those affected and thus affect more and more people. Arthrosis is the most common form of these diseases worldwide. According to the l'Institut de la statistique du Québec, nearly one in two Quebecers aged 15 and over is affected by a chronic health problem.

Knee orthosis is one form of treatment that helps patients suffering from knee gonarthrosis. This treatment aims to compensate for certain biomechanical deficits in patients. A variety of joint configurations exists to target specific biomechanical deficits. A constant challenge for companies manufacturing orthoses is transmitting the orthosis's biomechanical effect to the patient. The desired effect requires a change in the forces applied inside the knee, but the orthosis cannot directly transmit forces to the patient's bones due to its external nature to the body. Customization of orthoses is crucial to improve the transmission of the biomechanical effect as well as tolerance to it. O3D Inc. aims to validate the effectiveness of its new custom orthosis for treating knee gonarthrosis symptoms.


Eligibility criteria: Inclusion Criteria:

* Suffering from medial gonarthrosis
* Receiving a regular model of the O3D orthosis

Exclusion Criteria:

* Suffering from tricompartmental gonarthosis
* Having completed the delivery appointment for a O3D orthosis

Primary outcomes:
measure: WOMAC total score
timeFrame: Before intervention begins and after 8 weeks of intervention
measure: WOMAC pain score
timeFrame: Before intervention begins and after 8 weeks of intervention
measure: WOMAC stiffness score
timeFrame: Before intervention begins and after 8 weeks of intervention
measure: WOMAC functional limitation score
timeFrame: Before intervention begins and after 8 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Topmed
state: Quebec
Study officials:
affiliation: TOPMED
name: Edith Martin, Phd. metallurgical engineering
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00254358: A Brain Imaging Study of Nicotine Release in Cigarette Smokers
Official title: A Brain Imaging Study of Nicotine Release in Cigarette Smokers
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Nicotine Dependence
Keywords: Nicotine
Dopamine
IBZM
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Herzog Hospital
First posted: 2005-11-16
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: smokers in treatment with bupropion

Brief summary: Tobacco Smoking is the most prevalent addiction in society today causing directly major health hazards and sharing morbidity with other psychiatric disorders. Nicotine binds to acetylcholine receptors and thus elevates DA release and inhibits DA transport. There are few studies using advanced brain imaging techniques to investigate how nicotine releases dopamine in humans. These studies utilized dopamine displacement paradigms with \[11C\] Raclopride binding to D2 receptor in Positron Emission Tomography (PET). There is evidence that smokers (particularly those who enjoyed smoking) showed decreased \[11C\] Raclopride binding in the caudate/nucleus accumbens and putamen after smoking cigarettes. These results also indicated that the effects of nicotine on dopaminergic neurotransmission are mediated by pleasure and craving. We propose to investigate the effects of smoking a cigarette ad lib on dopamine release by using dopamine competition paradigm with \[I123\] IBZM in SPECT. Secondly, we will test the hypothesis that dopamine deficiency is a major vulnerability factor for smoking. This may provide further evidence that dopamine deficiency in some smokers pre-disposes them to enjoy and desire smoking cigarettes more than others.


Eligibility criteria: Inclusion Criteria:

* Chronic smokers and healthy non-smokers.

Exclusion Criteria:

* Pregnant and breast feeding women.
* Age below 20.
* Neurological disorders.
* Others drugs.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Yodphat Krausz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01163058: Tyrosine Kinase Inhibitors In Metastatic Non Small Cell Lung Cancer
Official title: Retrospective Analysis Evaluating Molecular Factors of Primary Resistance to Tyrosine Kinase Inhibitors in Metastatic Non Small Cell Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2010-07-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: non small cell lung cancer patients treated with gefitinib or erlotinib

Brief summary: Aim of the present retrospective study is to evaluate molecular factors of primary resistance to tyrosine kinase inhibitors in metastatic non small cell lung cancer (NSCLC) patients. The investigators assess first, the incidence of epidermal growth factor receptor (EGFR) and Kirsten ras sarcoma viral oncogene homolog (KRAS) mutations, SOS and hepatocyte growth factor (HGF) expression, anaplastic lymphoma kinase (ALK) translocation and expression and, secondly, the investigators correlate molecular markers with clinical features and outcome in terms of response rate, progression free survival and overall survival.

Detailed description: Non small cell lung cancer patients.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of NSCLC (non small cell lung cancer) with available tumor tissue for mutational analysis
* Metastatic disease treated with gefitinib or erlotinib
* Presence of at least one measurable lesion according to RECIST criteria

Exclusion Criteria:

* No tumor tissue available
* No clinical data available

Primary outcomes:
measure: Determine the incidence of EGFR (Epidermal growth factor ) and KRAS (Kirsten ras sarcoma viral oncogene homolog ) mutations in 300 NSCLC (non small cell lung cancer) patients treated with gefitinib or erlotinib
timeFrame: 1 year
Secondary outcomes:
measure: Investigate the association of clinical features such as sex, age, smoking history and histology with oncogenic alterations.
timeFrame: 1 year
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
affiliation: Istituto Clinico Humanitas
name: Armando Santoro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00817596: Prometra's Utilization in Mitigating Pain (PUMP)
Official title: Prometra's Utilization in Mitigating Pain (PUMP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intractable Pain
Lead sponsor: Flowonix Medical
Sponsor class: INDUSTRY
First posted: 2009-01-06
Enrollment: 110
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: Clinical evaluation of the safety and efficacy of the Prometra Programmable Infusion Pump to accurately supply drug to the intrathecal space for the treatment of chronic pain.

Detailed description: Chronic conditions of pain and spasticity are and have been major challenges to traditional medical treatment. Chronic pain and spasticity seriously reduce the quality of life and restrict normal daily activities for many people. The first line of defense is normally oral medications. However, a significant number of these patients require additional or alternative therapy due to the side effects of the oral medications or the intractable nature of the condition.

In 1979, Wand et. al. found that small amounts of morphine, when injected into the sub-arachnoid space, had significant affect in reducing pain. Since that time a number of drug products and infusion pumps have been developed to address this condition. The primary drug used for this purpose in preservative-free morphine sulfate solution which is delivered via an implanted intrathecal catheter. The Prometra Intrathecal Pump System is only the second programmable pump to be used in the treatment of chronic pain.

Eligibility criteria: Inclusion Criteria:

* suffering from chronic pain
* 18 years of age or older
* life expectancy \>6 months
* failure to respond to less invasive methods
* patient undergone successful morphine trial
* patient agrees with Protocol requirements
* patient considered good subject per clinician

Exclusion Criteria:

* Existing spinal problems that prevent treatment
* systemic infection
* patient is pregnant or breast feeding
* known allergy or sensitivity to materials
* coexisting medical condition that precludes pump usage
* subject requires MRI post procedure
* subject unwilling/unable to comply

Primary outcomes:
measure: Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed.
timeFrame: 6 months - acute study
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Pain Control Network
state: Kentucky
city: St. Louis,
country: United States
facility: Center for Pain Management
state: Missouri
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
Study officials:
References: