louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05733091: Assessment of Functional and Symptom Outcomes for Survivors of Paranasal Sinus, Nasopharyngeal and Skull Base Tumors
Official title: Assessment of Functional and Symptom Outcomes for Survivors of Paranasal Sinus, Nasopharyngeal and Skull Base Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tumors
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: M D Anderson Cancer Center

Brief summary: To learn about the symptoms and changes our patients experience while receiving treatment for sinonasal or nasopharyngeal cancer

Detailed description: Objectives:

* To estimate the prevalence and severity of adverse and functional outcomes in survivors of benign and malignant paranasal sinus, nasopharynx and skull base tumors.
* To estimate the prevalence of health promotion behaviors during skull base tumor survivorship
* To identify possible mediators or predictors of survivorship outcomes and health behaviors in survivors of skull base tumors.
* To develop a database of demographic, clinicopathologic, recurrence, survival, functional and patient reported outcomes (PROS) for patients with benign and malignant paranasal sinus, nasopharyngeal and skull base tumors.
* To assess the utility and limitations of PROs in evaluating functional impairments and symptom burden in skull base patients.

Eligibility criteria: Inclusion criteria:

1. Previously untreated patients with or suspected to have sinonasal malignancy or nasopharyngeal malignancy diagnosis based on either outside pathology report or MD Anderson pathology report.
2. Age ≥ 18 years
3. Plan to obtain the majority of treatment at MDACC including surgery and radiotherapy
4. Ability to understand and willingness to sign written informed consent

Exclusion criteria:

1. History of the previous solid or liquid malignancies, apart from skin cancers treated with local therapy.
2. Existing neurocognitive impairment that is not the result of sinonasal and nasopharyngeal cancers or is treatment.
3. Previous treatment for sinonasal or nasopharyngeal carcinomas, apart from biopsy.

Primary outcomes:
measure: MD Anderson Symptom Inventory Head and Neck Module (MDASI-HN)
timeFrame: through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Shirley Su, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01643291: Ultrasound Use for Difficult Lumbar Punctures in Pediatric Oncology Patients
Official title: Ultrasound Imaging Facilitates Lumbar Punctures in Pediatric Oncology Patients With Difficult Surface Landmarks and/or a History of Difficult Lumbar Puncture
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Leukemia
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hematology-oncology patients may require frequent lumbar puncture for diagnosis, assessment and therapy. When LP is difficult, the patient may endure multiple attempts, prolonged anesthesia time, and with failure of LP may require fluoroscopy-guidance with associated radiation exposure. This investigation will evaluate lumbar punctures performed in the intraoperative setting by oncologists with ultrasound guidance performed by the anesthesiologist in the leukemic pediatric population. The investigators hypothesis is that anesthesiologist guided ultrasound assistance will decrease intraoperative time, number of attempts and need to have the procedure done with fluoroscopy minimizing radiation exposure.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing LP as per Heme-Onc clinic who have been deemed to be difficult LP placements.

Exclusion Criteria:

* Patients having concomitant procedures (bone marrow bx, etc.)

Primary outcomes:
measure: Number of punctures
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
citation: Ferre RM, Sweeney TW, Strout TD. Ultrasound identification of landmarks preceding lumbar puncture: a pilot study. Emerg Med J. 2009 Apr;26(4):276-7. doi: 10.1136/emj.2007.057455.
citation: Abo A, Chen L, Johnston P, Santucci K. Positioning for lumbar puncture in children evaluated by bedside ultrasound. Pediatrics. 2010 May;125(5):e1149-53. doi: 10.1542/peds.2009-0646. Epub 2010 Apr 19.
citation: Ayalin T, Lam SH. Ultrasound-assisted lumbar puncture in infants. Acad Emerg Med. 2011 Apr;18(4):e36. doi: 10.1111/j.1553-2712.2011.01044.x. No abstract available.
Clinical trial NCT03541694: Passive Enhanced Safety Surveillance of Stamaril® Vaccine in Korea
Official title: Passive Enhanced Safety Surveillance of the Live Attenuated Yellow Fever Virus Vaccine Stamaril® in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Yellow Fever
Keywords: Yellow fever
Stamaril®
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2018-05-30
Enrollment: 622
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have been vaccinated against yellow fever with Stamaril® vaccine in Korean yellow fever vaccination centers during the enhanced surveillance period.

Brief summary: This is a passive enhance safety surveillance (ESS) of Stamaril® vaccine in Korea. The objective is to collect suspected related adverse events following vaccination with Stamaril® in routine practice.

Detailed description: This ESS replaces the routing post-marketing surveillance required after product approval in Korea.

Eligibility criteria: Vaccination with Stamaril® vaccine in routine practice in Korea

Primary outcomes:
measure: Number of participants reporting suspected related adverse events
timeFrame: Within 30 days after vaccination
Secondary outcomes:
measure: Number of participants reporting suspected serious related adverse events
timeFrame: Within 30 days after vaccination
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sanofi Pasteur Investigational Site 001
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01360294: Development of Small Airway Disease Questionnaire
Official title: The Development of a Questionnaire to Assess Symptoms of Small Airways Disease in Patients With Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
Small airways disease
Questionnaire
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Chiesi Farmaceutici S.p.A.
First posted: 2011-05-25
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will contain a total of 60 adult patients with asthma, 30 patients with small airways disease and 30 patients without small airways disease.

Brief summary: The aim of this study is to develop a patient reported outcome tool specific to small airways disease, which assesses symptoms and signs of small airways disease and may help in addition to FEF50% to discriminate between asthmatic patients with and without small airways disease.

Detailed description: Inflammation of the small airways contributes to the severity of the disease and affects the quality of life of patients with asthma. However, the exact role and relevance of small airways disease in asthma is still unclear. This is partly due to the difficulty of measuring small airways pathology with a sensitive and specific parameter. The most commonly used variable as an indicator of small airway obstruction is the FEF50%. Currently, it is not known which clinical symptoms are associated with small airways disease and how a patient will perceive small airway abnormalities. This knowledge is important to assess small airways disease in patients with asthma and adjust therapy to improve quality of life.The primary purpose of this study is to develop a questionnaire for patients with asthma with and without small airways disease for general and specialist practice.

Eligibility criteria: Inclusion Criteria:

* A doctor diagnosis of asthma
* Age: ≥ 18 and ≤ 75 years
* An FEF50% value that is included in either the lowest or the highest 25th percentile. (Percentiles based on the total asthma patient group present from Asthma/COPD service)

Exclusion Criteria:

* Recent exacerbation of asthma (\<2 months) or upper respiration tract infection (\<2 weeks)
* Severe airway obstruction at baseline, FEV1pred\< 50% or \< 1.2L
* Diagnosis of COPD or another pulmonary disease
* Pregnancy or lactating women. (i.e. women of childbearing potential who do not use adequate anticonception as judged by the investigator).
* Restriction, defined as FVC \< 80%pred with FEV1/FVC \>0.7

Primary outcomes:
measure: Symptoms associated with small airways disease
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
Clinical trial NCT04952194: Clinical Study of Stalevo in the Treatment of Early Parkinson's Disease
Official title: Clinical Study of Stalevo in the Treatment of Early Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Parkinson Disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 180
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 main goal of PD research is to develop disease-modifying drugs to delay or prevent the underlying neurodegenerative process. Levodopa, as the gold standard for PD treatment, is associated with the occurrence of motor complications. Many previous studies have confirmed that Stalevo can reduce the side effects of levodopa alone. Moreover, the effects of Stalevo on the treatment of PD patients have been extensively studied, but the efficacy of Stalevo in early PD patients has been less studied. Therefore, it is necessary to further study the treatment of early PD with Stalevo, and observe whether increasing the number of medication can reduce the occurrence of dyskinesis. The research results will help to deepen the understanding of Stalevo in the treatment of early PD and its clinical efficacy.


Eligibility criteria: Inclusion Criteria:

* Volunteer to participate in the trial and sign the informed consent
* The enrolled patients were 30 to 70 years old, diagnosed as primary Parkinson's disease according to the 2015 MDS Parkinson's disease diagnostic criteria, H-Y grade \<3, and the onset time was less than 5 years
* Patients can take stable dopamine receptor agonists or other anti-Parkinson's disease drugs (drugs have not been adjusted in the past 4 weeks), and have not used amantadine or entacapone within 1 year.

Exclusion Criteria:

* Atypical Parkinsonism and Secondary parkinsonism

Primary outcomes:
measure: The occurrence and frequency of dyskinesia of participants in two groups were assessed by blind method.
timeFrame: 1 year
measure: The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) of participants in two groups were assessed by blind method.
timeFrame: 1 year
measure: The 9-Item Wearing-Off Questionnaire （WOQ-9） score of participants in two groups were assessed by blind method.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affilliated Hospital Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT02872194: Evaluation of the Stinging Potential of Products in Human Eyes
Official title: Evaluation of the Stinging Potential of Products in Human Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreen Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-08-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this study was to compare the human eye stinging potential of experimental formulas and an industry standard shampoo mixture. The study was conducted under the supervision of a Board Certified Ophthalmologist. The study design was a three cell, single blind study. Subjects were given the industry standard shampoo mixture in one eye and an exploratory sunscreen in the other as according to the randomization schedule.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects, aged 18 to 65 years
* No medical conditions of the eyes as determined by the subjects' medical history and confirmed by ophthalmologist
* Subjects do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the day of and day after the study
* Subject is willing to have the test materials instilled into the eyes and follow all protocol requirements
* Subject is willing to refrain from using false eyelashes of any type or any topical prescription, OTC or cosmetic products on their eyes, eyelids, eyelashes or the peri-orbital areas of the face on the day of the study.
* Subjects should refrain from use of make-up on testing day

Primary outcomes:
measure: Subjective discomfort in the eye was assessed based on questions by an Ophthalmologist to the subject using a 5-category intensity scale
timeFrame: up to 24 hours after instillation
measure: Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score
timeFrame: up to 24 hours after instillation
measure: Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score
timeFrame: up to 24 hours after instillation
measure: Post installation eye effects were assessed using a 5-category intensity score
timeFrame: up to 24 hours after instillation
Secondary outcomes:
measure: Number of adverse events as a measure of safety and tolerability
timeFrame: at 24 hours
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
state: Florida
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03870594: IDH in Diabetic Haemodialysis Patients and Association With Dialytic Age
Official title: Intradialytic Hypotension in Diabetic Haemodialysis Patients and Its Association With Dialytic Age
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intra-dialytic Hypotension
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all haemodialysed end stage kidney disease patients of the haemodialysis unit in Assiut health insurance hospital

Brief summary: Intradialytic hypotension (IDH ) is a serious and the most frequent complication of hemodialysis of the hemodialysis .Diabetes is associated with autonomic neuropathy which contribute to intradialytic hypotension

Detailed description: Intradialytic hypotension (IDH ) is a serious and the most frequent complication of hemodialysis of the hemodialysis.Intradialytic hypotension is a decrease in systolic BP by ≥20 mm Hg or a decrease in mean arterial pressure of 10 mm Hg associated with symptoms like cramps, dizziness, headache ,nausea and vomiting according to The National Kidney Foundation.Intradialytic hypotension occurs during 20%-30% of hemodialysis sessions. It is associated with poor long-term outcomes. Patients with Intradialytic hypotension show increased morbidity and mortality.The etiology of Intradialytic hypotension is multifactorial and depends on patient-related factors, as well as on complications related to the dialysis procedure. The main causes Intradialytic hypotension have been reported to be acute hypovolemia during ultrafiltration and inadequate compensatory mechanisms such as left ventricular dysfunction, inappropriate plasma refilling ,Impaired vasoconstriction induced by dysregulation of autonomic nervous system.

Diabetes mellitus is the most common cause of chronic renal failure .Diabetic patients are more prone to cardiovascular diseases than non-diabetics .Although diabetes is in relation with hypertension ,It is associated with autonomic neuropathy which contribute to intradialytic hypotension . Recent researches suggested that older age and long dialytic age may incease risk of intradialytic hypotension.

Eligibility criteria: Inclusion Criteria:

All haemodialysed end stage kidney disease patients of the haemodialysis unit in Assiut health insurance hospital

Exclusion Criteria:

* 1-Advanced heart failure 2-Clinical instability requiring hospital admission. 3-History of alcohol or substance abuse 4-previous history of psychotic disorders

Primary outcomes:
measure: the correlation between diabetes and intradialytic hypotension
timeFrame: 4 weeks
measure: the correlation between dialytic age and intradialytic hypotension
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05157594: hPG80 (Circulating Progastrin) as a Blood Biomarker for High-grade Glial Tumors
Official title: Pilot Study of hPG80 (Circulating Progastrin) as a Blood Biomarker for High-grade Glial Tumors
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Glial Cell Tumors
Keywords: Glial Cell Tumors
Progastrin
hPG80
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
Collaborators: name: ECS Progastrin
First posted: 2021-12-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female or male, 18 years of age or older, with a primary high-grade glial tumor (Astrocytoma Grade 3; Glioblastoma; Anaplastic Oligodendroglioma) who needs to initiate radiation and/or chemotherapy.

Brief summary: PROGLIO is a French mono-centric study with longitudinal follow-up, in which patients with high grade brain tumors will be included. Blood samples will be taken during their therapeutic follow-up to evaluate plasma concentrations of hPG80 (circulating progastrin).


Eligibility criteria: Inclusion Criteria:

* Female or male 18 years of age or older.
* Patients with a high grade primary glial tumor (Astrocytoma grade 3; Glioblastoma; Anaplastic Oligodendroglioma)
* Patients scheduled to begin radiation and/or chemotherapy.
* Able to give informed consent to participate in the research.
* Enrolled in a social security plan or beneficiary of such a plan.

Exclusion Criteria:

* Patient under guardianship or curatorship
* Psychological disorder (cognitive disorders, vigilance disorders, etc.) or social reasons (deprivation of liberty by judicial or administrative decision) or geographical reasons that could compromise the medical follow-up of the trial.
* Refusal to participate.
* Pregnant or breastfeeding woman.

Primary outcomes:
measure: Plasma concentrations of hPG80
timeFrame: From Radiotherapy 1st session to 9 month follow-up
Secondary outcomes:
measure: hPG80 concentration according to tumor progression
timeFrame: Through study completion, an average of 1 year and 6 months
measure: Sensitivity of hPG80 concentration changes to irradiation
timeFrame: Through study completion, an average of 1 year and 6 months
measure: Interindividual variations of hPG80 concentration
timeFrame: Through study completion, an average of 1 year and 6 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean PERRIN
Study officials:
affiliation: Centre Jean Perrin
name: Xavier DURANDO, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01366794: Macronutrients and Gut Hormone Secretion
Official title: Effects of Macronutrients on Gut Hormone and Islet Hormone Secretion in Healthy Volunteers and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Gut hormones
Insulin secretion
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2011-06-06
Enrollment: 36
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL

Brief summary: Study hypothesis is to examine the relative contribution of macronutrients for gut hormone secretion after a mixed meal in healthy volunteers and in subjects with type 2 diabetes. Individual macronutrients or a mixed meal will therefore be served and gut hormones are measured during the following 300 min.

Detailed description: In healthy volunteers and subjects with dietary regulated diabetes mellitus, glucose, protein mixture or fat emulsion will be served individually and on a separate occasions a mixed meal will be served. Samples will be taken during the following 300 min. Concentrations of the gut hormones glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1, insulin and glucagon will be determined.

Eligibility criteria: Inclusion Criteria:

* Healthy status or type 2 diabetes with dietary regulation

Exclusion Criteria:

* Liver disease
* kidney disease
* thyroid disease

Primary outcomes:
measure: Release of gut hormones
timeFrame: 300 min
Secondary outcomes:
measure: Insulin secretion
timeFrame: 300 min
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Clinical Sciences Lund, Lund University
city: Lund
country: Sweden
facility: Lund University
Study officials:
affiliation: Lund University
name: Bo Ahrén, PhD
role: PRINCIPAL_INVESTIGATOR
References: