louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01080287: The Identification and Characterization of Autonomic Dysfunction in Migraineurs With and Without Auras
Official title: The Identification and Characterization of Autonomic Dysfunction in Migraineurs With and Without Auras
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: autonomic
orthostatic
syncope
biopsy
prevalence of autonomic dysfunction in migraineurs with orthostatic intolerance
characterize autonomic findings utilizing neurocardiac testing, neurophysiological testing and skin biopsies to analyze autonomic fibers in the dermis
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2010-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Migraineurs with and without auras, half having orthostatic intolerance.

Brief summary: This is a study to compare subject response and symptoms resulting from administration of three clinical assessments.

\* The 3 assessments are

1. passive upright tilt table testing,
2. quantitative sudomotor axon reflex testing (QSART)and
3. punch biopsy.

The comparison of results will be from two subject groups:

* Group A, the migraine suffering patient with or without aura
* Group B, the migraine suffering patient with or without aura who has diagnosed orthostatic intolerance (i.e.,feeling dizzy or faint when making a body position change).


Eligibility criteria: Inclusion Criteria:

* age 18 to 65
* male or female
* migraine diagnosis
* may or may not have orthostatic intolerance
* able to demonstrate study understanding and complete informed consent process

Exclusion Criteria:

* subjects who do not meet inclusion criteria
* subjects unable to complete informed consent process

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic NI, Center for Headache and Pain, Desk T-33, 9500 Euclid Avenue
state: Ohio
Study officials:
References:
citation: Low PA, Opfer-Gehrking TL, Textor SC, Benarroch EE, Shen WK, Schondorf R, Suarez GA, Rummans TA. Postural tachycardia syndrome (POTS). Neurology. 1995 Apr;45(4 Suppl 5):S19-25.
citation: Fouad FM, Tadena-Thome L, Bravo EL, Tarazi RC. Idiopathic hypovolemia. Ann Intern Med. 1986 Mar;104(3):298-303. doi: 10.7326/0003-4819-104-3-298.
citation: McCarthy BG, Hsieh ST, Stocks A, Hauer P, Macko C, Cornblath DR, Griffin JW, McArthur JC. Cutaneous innervation in sensory neuropathies: evaluation by skin biopsy. Neurology. 1995 Oct;45(10):1848-55. doi: 10.1212/wnl.45.10.1848.
citation: Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. doi: 10.1111/j.1468-2982.2003.00824.x. No abstract available.
Clinical trial NCT06650787: Application of Ultrasound Technique in Locating the End of the Gastric Tube in Children Aged 0-6 Years
Official title: To Study the Application of Bedside Ultrasound in Gastric Tube Placement and Determination of the Position of the End of the Gastric Tube in Children Aged 0 to 6 Years With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 144
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Application of ultrasound technique to locate the end of the gastric tube in children aged 0-6 years

Detailed description: Bedside blind insertion is the most common method for gastric tube indwelling in clinical practice. The key problem is that the position of the tube cannot be accurately determined in real time.Bedside ultrasound has become a common medical technology, and resources are easy to obtain. Therefore, bedside ultrasound has the advantages of fast, accurate, real-time repeatable, and non-invasive in determining the position of the end of the indwelling gastric tube.The purpose of this study is to investigate the accuracy of bedside ultrasound in guiding gastric tube placement and judging the position of the end of the tube in children with CHD aged 0-6 years. To explore the feasibility and effectiveness of bedside ultrasound guided gastric tube placement during perioperative period in children with congenital heart disease (CHD), this study plans to procedure the prospective randomized controlled study.

Eligibility criteria: Inclusion Criteria:

* Children with CHD who needed gastric tube in CCU were admitted
* children aged 0-6 years
* Informed consent of parents

Exclusion Criteria:

* Children with delayed sternal closure
* The parents had cognitive impairment and mental disorders

Primary outcomes:
measure: Proportion of accurate gastric tube placement
timeFrame: The gastric tube is placed within ten minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: CICU,Cardiovascular Center,Children Hospital of Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT00725387: Combined F-18 NaF and F-18 FDG PET/CT for Evaluation of Malignancy
Official title: Combined F-18 NaF and F-18 FDG PET/CT for Evaluation of Malignancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-07-30
Enrollment: 214
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: Patients must be referred for evaluation of bone metastases.

Brief summary: Fluorine-18 Fluorodeoxyglucose (F-18 FDG) PET/CT is established as a powerful imaging tool for cancer detection and monitoring response to therapy. Sodium Fluorine-18 (F-18) was used in the 1970s for bone scanning and can be used as a skeletal tracer in current PET/CT scanners. The combined administration of F-18 and F-18 FDG in a single PET/CT scan for cancer detection was not attempted to date. We hope to learn what is the best approach for detection of cancer and thus to improve cancer treatment.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18-year-old, diagnosed with cancer
* Patients must understand and voluntarily sign an Informed Consent form after the contents have been fully explained to them

Exclusion Criteria:

* Patients who cannot complete a PET/CT scan
* Pregnant women
* Healthy volunteers
* Patients participating in other research studies

The subjects will not be paid to participate in this protocol. No costs will be charged to the subjects.

Primary outcomes:
measure: Percent of patients with evidence of new lesions on combined F-18/F-18 FDG PET/CT.
timeFrame: not defined
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Aalborg
country: Denmark
facility: Aalborg Hospital
city: Chennai
country: India
facility: Apollo Hospital
city: Coimbra
country: Portugal
facility: Coimbra University Hospital
city: Pretoria
country: South Africa
facility: Pretoria Academic Hospital
Study officials:
affiliation: Stanford University
name: Andrei Iagaru M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iagaru A, Mittra E, Mosci C, Dick DW, Sathekge M, Prakash V, Iyer V, Lapa P, Isidoro J, de Lima JM, Gambhir SS. Combined 18F-fluoride and 18F-FDG PET/CT scanning for evaluation of malignancy: results of an international multicenter trial. J Nucl Med. 2013 Feb;54(2):176-83. doi: 10.2967/jnumed.112.108803. Epub 2012 Dec 14.
Clinical trial NCT00759187: Evaluate Clinical Research From Commerical Oral Care Products
Official title: Evaluate Clinical Research From Commerical Oral Care Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingival Diseases
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 25
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: TREATMENT

Brief summary: The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of commercial oral care products.

Detailed description: The purpose of this study is to compare efficacy of two commercially available toothpastes and one oral rinse on dental plaque control.

Eligibility criteria: Inclusion Criteria:

* Male or female volunteers 18-65 years of age
* Good general health
* Must sign informed consent form
* Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
* No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria:

* Subjects unable or unwilling to sign the informed consent form.
* Medical condition which requires pre-medication prior to dental visits/procedures
* Moderate or advanced periodontal disease or heavy dental tartar (calculus) requiring more than one visit of cleaning sessions
* 2 or more decayed untreated dental sites at screening.
* Other disease of the hard or soft oral tissues.
* Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
* Use of medications that can currently affect salivary flow.
* Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
* Pregnant or nursing women.
* Participation in any other clinical study within 1 week prior to enrollment into this study.
* Allergy to chlorhexidine
* Use of tobacco products
* Subjects who must receive dental treatment during the study dates.
* Current use of Antibiotics for any purpose.
* Presence of an orthodontic appliance.
* History of allergy to common dentifrice ingredients.
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Primary outcomes:
measure: Dental Plaque Index
timeFrame: 4-Day
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University School of Dental Medicine
state: Massachusetts
Study officials:
name: Thomas Van Dyke, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05519787: A Retrospective, Observational, Monocenter, Study to Describe the Utilization and Overall Safety and Performance of POLYSITE®/SEESITE® Implantable Ports
Official title: A Retrospective, Observational, Monocenter, Study to Describe the Utilization and Overall Safety and Performance of POLYSITE®/SEESITE® Implantable Ports
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous System
Venous Access
Chemotherapy
Antibiotics
Antiviral
Parenteral Nutrition
Transfusion Blood
Lead sponsor: Perouse Medical
Sponsor class: INDUSTRY
Collaborators: name: Eclevar Medtech
First posted: 2022-08-29
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population was defined in the protocol as all patients who did receive POLYSITE® or SEESITE® device between 1st October 2016 and 31 December 2017.

Any patient who has disagreed with the collection of their personal data would be excluded from this study.

Brief summary: This study is a retrospective, observational, monocenter case series. The purpose of this study is to collect clinical data to describe the use of POLYSITE® and SEESITE® devices and verify overall safety and performance. This study is part of the Post-Market Clinical Follow-up (PMCF) activities of the PEROUSE MEDICAL manufacturer.

The primary data source for this study was patient's medical records from a French Hospital. The study population was defined as all patients who did receive POLYSITE® and SEESITE®. Data from a minimum of 50 patients were planned for the statistical review.


Eligibility criteria: Inclusion Criteria:

* Adult and pediatric population
* Patient who received the implantation of any POLYSITE® or SEESITE® implantable port referenced in the Annex 1 of the current protocol between 1st October 2016 and 31st December 2017

Exclusion Criteria:

* Patient who refused the data collection according to RGPD regulation applicable in France
* Patient who received the implantation of another device than those presented in Annex 1 of the current protocol.
* Patient who received the implantation of a POLYSITE® or SEESITE® implantable port after 31st December 2017

Primary outcomes:
measure: Identification of veins selected
timeFrame: 30 days
measure: rate of peri-operative complication
timeFrame: Peri-operative procedure
Secondary outcomes:
measure: type of treatments administered
timeFrame: 5 years
measure: Rate of procedural success
timeFrame: Peri-operative procedure
measure: short-term complication
timeFrame: 30 Days
measure: rate of long-term complications
timeFrame: 5 years
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR d'Orléans
Study officials:
References:
Clinical trial NCT00491387: Sympathetic Nervous System Modulation in Hypertension
Official title: Sympathetic Nervous System Modulation in Hypertension by Beta-adrenergic Blockade
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypertension
Keywords: hypertension
sympathetic nervous system
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2007-06-26
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study of patients with high blood pressure who are already treated with an angiotensin converting enzyme inhibitor or receptor blocker and have achieved good or fair blood pressure control. The hypothesis is that addition of the beta-adrenergic receptor blocker, sustained-release metoprolol, will provide additional blockade of the sympathetic nervous system, thereby further improving left ventricular filling and blood pressure control.

Detailed description: Patients were to receive sympathetic cardiac innervation testing with I-123 MIBG at baseline and again after receiving a titrate dose of beta-blocker. Data were to be assesses by repeated measures testing.

Eligibility criteria: Inclusion Criteria:

* Essential hypertension with blood pressure less than 140/90 on either an ACE inhibitor or angiotensin receptor blocker

Exclusion Criteria:

* Known valvular heart disease of more than mild severity
* Known coronary artery disease defined by an angiographic coronary artery stenosis greater than or equal to 50% luminal diameter narrowing, acute or previous myocardial infarction, or previous coronary revascularization
* Known non-ischemic cardiomyopathy with left ventricular ejection fraction less than 50%
* Atrial fibrillation
* Current treatment with a β-adrenergic blocking drug or a calcium channel blocker
* Current treatment with a psychoactive or other drug known to alter 123I-MIBG uptake
* Participation in another research study within the prior 30 days
* A life-limiting disease process that is likely to preclude completion of study participation
* Pregnancy or breast feeding
* Inability or unwillingness to provide informed consent
* Baseline resting heart rate less than 65 beats per minute
* Diabetes
* Iodine allergy
* Unwilling to sign informed consent.

Primary outcomes:
measure: Improvement in Sympathetic Cardiac Innervation as Measured by I-123 MIBG Heart - Mediastinum Ratio
timeFrame: january 2018
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Cincinnati
name: Myron C Gerson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02941887: Global Behavior and Periodontal Disease in Down's Syndrome Patients
Official title: Down's Syndrome Patients Behavior Correlations to Periodontal Disease Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Behavior
Periodontal Diseases
Keywords: Social behavior
Gingivitis
Periodontitis
Down's Syndrome
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2016-10-21
Enrollment: 33
Sex: ALL
Minimum age (years): 15
Maximum age (years): 52
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a medical diagnose of Down's Syndrome

Brief summary: This study aimed at correlating global behavior of Down's Syndrome patients to periodontal disease status.

Detailed description: There is a higher prevalence and severity of periodontal disease in Down's Syndrome patients. Plaque levels in these patients are high due to poor hygiene habits. Behavior also may contribute to the overall periodontal condition.

Eligibility criteria: Inclusion Criteria:

* Down's Syndrome Diagnose characterized by the whole chromosomal aneuploidy 15 to 52 years
* Absence of severe hearing loss could impair the comprehension about the dental treatment
* Absence of severe visual loss that could impair the comprehension about the dental treatment
* Presence of at least four teeth being one for hemiarch.
* Diagnose of gingivitis and periodontitis
* Absence of acute periodontal disease and necrotizing periodontal disease.

Exclusion Criteria:

* Smokers
* Use of alcohol
* Menopause
* Pregnancy
* Absence of all teeth
* Uncontrolled diabetes mellitus
* Uncontrolled hyperthyroidism
* Angina
* Uncontrolled hypertension
* Coagulopathy
* Use of illicit drugs
* Head and neck radiotherapy
* Chemotherapy
* Non-cooperative patients or patients with other diseases as autism.

Primary outcomes:
measure: Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity
timeFrame: One day
measure: Global behavior - observation and scoring based on a behavior scale
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: Bauru School of Dentistry
state: Sao Paulo
Study officials:
References:
citation: Startin CM, Rodger E, Fodor-Wynne L, Hamburg S, Strydom A. Developing an Informant Questionnaire for Cognitive Abilities in Down Syndrome: The Cognitive Scale for Down Syndrome (CS-DS). PLoS One. 2016 May 6;11(5):e0154596. doi: 10.1371/journal.pone.0154596. eCollection 2016.
Clinical trial NCT05777187: Mitigation of Postoperative Delirium in High-Risk Patients
Official title: Integration of Machine Learning and Clinical Decision Support to Prevent Postoperative Delirium in Patients with Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-operative Delirium
Decision Support Systems, Clinical
Cognitive Impairment
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: National Institute on Aging (NIA)
First posted: 2023-03-21
Enrollment: 24426
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Among patients with cognitive impairment (CI) that undergo surgery, the risk for developing postoperative delirium (POD) is high (50%) and associated with further morbidity and mortality. Yet, 30-40% of POD cases are preventable with perioperative management. This randomized pragmatic clinical trial aims to assess incidence of POD in adult surgical patients with CI, as well as provider adherence to a set of 12 perioperative best practice recommendations for perioperative management. Electronic health record (EHR) data will be used to identify patients as high risk for developing POD and clinical decision support (CDS) prompts within the EHR will display best practices. Cases will be randomized to either the control group, usual care or the intervention which includes the high-risk alert and best practice prompts.


Eligibility criteria: Inclusion Criteria:

* Adult patients with a history of cognitive impairment (CI) undergoing surgery at the Mount Sinai Health System.
* Attending physicians, resident physicians, and nurse anesthetists at the Mount Sinai Health System receiving CDS alerts during EHR system implementation.

Exclusion Criteria:

* Patients will be excluded if this not their first surgery since study start, if they do not have cognitive impairment based on EHR data, or if the surgery is for organ donation.
* There will be no exclusion criteria for providers or historical controls.

Primary outcomes:
measure: 4AT Delirium Score
timeFrame: Postoperative days 0-7
Secondary outcomes:
measure: Perioperative Best Practices proportion
timeFrame: Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Health System
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Ira Hofer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06637787: Prospective, Explorative, Research Study with Women to Investigate Menstruation Leakage At Night
Official title: Prospective, Explorative, Research Study with Women to Investigate Menstruation Leakage At Night
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Menstruation
Lead sponsor: Essity Hygiene and Health AB
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with heavy menstruation

Brief summary: The aim of this study is to investigate why and when menstruation leakages occur during sleep while using protective pads at night. Participants will be asked to use a specially designed pad during menstruation and to answer questions.


Eligibility criteria: Inclusion Criteria:

1. Women ≥ 18 years
2. Participant is mentally and physically able to participate in this study
3. Written informed consent to participate in this study
4. Participant with currently heavy menstruations regularly experiencing nocturnal leakages
5. Participant is a regular user of nocturnal menstruation pads
6. Participant is willing to use the prototype pad according to the protocol
7. Willingness to take picture of used pads and transfer to study sponsor anonymously during study duration
8. Available internet connection and device for taking pictures and data transfer (photo upload)
9. Underwear size M or L

Exclusion Criteria:

1. Known allergies or intolerances to one or several components of the study prototype
2. Participants without regular menstruation, pregnant or perimenopausal subjects
3. Participants not experiencing nocturnal leakages
4. Participants with pacemakers and/or implant defibrillator or having persons in the household that have a pacemaker and/or implant defibrillator

Primary outcomes:
measure: Summary of leakage data of the menstruation pad in correlation with participats movements and position at leakage occasion.
timeFrame: 2025
Secondary outcomes:
measure: Evaluation of questionnaire to understand the sleeping pattern during period
timeFrame: 2025
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Essity Study site
Study officials:
References: