louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05769478: Effect of Amifampridine on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA
Official title: A Proof of Concept Study of the Effect of Amifampridine (Firdapse®) on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA (Botox®, BTX-A)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Botulism
Iatrogenic Botulism
Keywords: botulinum toxin injections
Systemic botulism
neuromuscular transmission
single fiber electromyography
amifampridine
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: before-after study that will measure neuromuscular jitter before and after administration of amifampridine
Primary purpose: TREATMENT

Brief summary: if amifampridine can improve neuromuscular transmission in muscles previously injected with OnabotulinumtoxinA (BTX-A)

Detailed description: Amifampridine may also be effective in treating the sequelae of botulinum toxin injections and this study will determine if neuromuscular transmission as measured by single fiber electromyography is improved in patients treated with BTX-A following administration of amifampridine

Eligibility criteria: Inclusion Criteria:

* Age: 18-80 years of either gender and of any racial background
* Underwent BTX-A injection of facial muscles including frontalis with a total dose between 100-200 units between 80 and 150 days prior to study
* Have decision-making capacity to provide informed consent to study drug dosing and Single Fiber Electromyography (SFEMG)

Exclusion Criteria:

* History of cardiac arrhythmia
* History of seizures or uncontrolled asthma
* History of renal or hepatic disease
* History of any generalized neuromuscular disease
* History of Bell's Palsy or facial nerve trauma
* History of treatment with or sensitivity to amifampridine, 3,4 diaminopyridine (DAP) or 4-aminopyridine (Ampyra®)
* Currently experiencing sequelae of previous BTX-A treatment
* Current use of pyridostigmine (known to alter neuromuscular transmission)
* Use of any investigational drug or device within 30 days of enrollment

Primary outcomes:
measure: Percentage of abnormal pairs
timeFrame: Hour 3
measure: Percentage of Jitter
timeFrame: Hour 3
measure: Percentage of pairs that show blocking
timeFrame: Hour 3
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: James B Caress, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04285788: Incidence and Outcomes Associated With the Management of Adenovirus Infections in Allogenic Hematopoietic Cell Transplant Recipients
Official title: Incidence and Outcomes Associated With the Management of Adenovirus Infections in Allogeneic Hematopoietic Cell Transplant Recipients: AdVance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenovirus Infections, Human
Lead sponsor: Chimerix
Sponsor class: INDUSTRY
First posted: 2020-02-26
Enrollment: 216
Sex: ALL
Minimum age (years): 0
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: compromised of all allo-HCT recipients at participating centers during the pre-specified study period

Brief summary: To depict the incidence, outcomes and standards of care (SoC) of adenovirus (AdV) infections and associated practice patterns in allogeneic hematopoietic cell transplant recipients. It is expected that participating centers will be in the United Kingdom, France, Spain, Germany, and Italy.


Eligibility criteria: Inclusion Criteria:

* At least one AdV positive test, regardless of specimen within 6 months following the first allo-HCT
* Subjects first allo-HCT must have been performed between 1 January 2013 and 30 September 2015

Exclusion Criteria:

* AdV negative

Primary outcomes:
measure: Number of participants with non-relapse related mortality 3 and 6 months after first AdV Virema in paediatric allo-HCT recipients
timeFrame: 3 and 6 months after first adenovirus viremia
Secondary outcomes:
measure: Number of participants who were hospitalized To assess the number of hospitalizations
timeFrame: 3 to 6 months
measure: The rate of adenovirus infection progression
timeFrame: 3 to 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04245488: Sour Taste Intensity Matching With Fatty Acids Taste
Official title: Sour Taste Intensity Matching With Fatty Acids Taste
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fat Taste
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: sensory
Primary purpose: BASIC_SCIENCE

Brief summary: Investigators are trying to find the concentrations of fatty acids ( a part of the fat and flavor typically found in normal foods) that have a taste intensity similar to that to the sourness of vinegar solutions.

Detailed description: Participants will first taste 5 sour solution containing acetic acid for sour compounds, sucrose esters, and xanthan gum to help them stay dissolved). Then rate them for their taste intensities. Next, participants will taste 5 butyric acid solutions, 5 hexenoic acid solutions, 5 caprylic acid solutions, 5 lauric acid solutions, 5 palmitic acid solutions, 5 oleic acid solutions, and 5 linoleic acid solutions (all will also contain the sucrose esters and xanthan gums.) and rate them for their taste intensities. This should take no longer than 1 hour. Participants will spit all samples into a cup after tasting them. They will not swallow any samples.

Eligibility criteria: Inclusion Criteria:

* male and female age 18 to 65

Exclusion Criteria:

* taste abnormalities

Primary outcomes:
measure: Intensity
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Richard D Mattes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02369588: Effects of Portion Size of Multiple Items at a Meal on Food Intake of Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Behaviors
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-02-24
Enrollment: 51
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study tests the effect of serving larger portions of all foods in a meal on the outcome of food and energy intake. Using a crossover design, participants are served the meal once a week for four weeks and the portion sizes are varied at each meal. Some of the foods served at the meal are low in calorie density (calories per gram) and some are higher in calorie density. The aim is to determine whether intake in response to larger portions differs depending on characteristics of the subjects or of the foods.


Eligibility criteria: Inclusion Criteria:

* Body mass index of 18 to 40 kg/square meter
* Regularly eat three meals per day
* Willing to eat foods served at test meals

Exclusion Criteria:

* Food allergies or restrictions
* Dieting to gain or lose weight
* Taking medications known to affect appetite
* Smoker
* Athlete in training
* Currently pregnant or breast-feeding
* Questionnaire score indicative of depression
* Questionnaire score indicative of disordered eating attitudes

Primary outcomes:
measure: Differences in meal food intake
timeFrame: Weeks 1, 2, 3, and 4
measure: Differences in meal energy intake
timeFrame: Weeks 1, 2, 3, and 4
measure: Differences in meal energy density
timeFrame: Weeks 1, 2, 3, and 4
Secondary outcomes:
measure: Differences in hunger and satiety
timeFrame: Weeks 1, 2, 3, and 4
measure: Differences in ratings of food properties
timeFrame: Weeks 1, 2, 3, and 4
Other outcomes:
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior
state: Pennsylvania
Study officials:
affiliation: The Pennsylvania State University
name: Barbara J. Rolls
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roe LS, Kling SMR, Rolls BJ. What is eaten when all of the foods at a meal are served in large portions? Appetite. 2016 Apr 1;99:1-9. doi: 10.1016/j.appet.2016.01.001. Epub 2016 Jan 5.
Clinical trial NCT05471388: Assessment of Serum Asprosin Level in Male Patients With Acne Vulgaris
Official title: Assessment of Serum Asprosin Level in Male Patients With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acne Vulgaris
Keywords: Asprosin
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Subject of interest is to evaluate serum level of asprosin in male patients with acne vulgaris, demonstrate the relation between acne vulgaris severity and level of asprosin in these patients \& the relation between metabolic syndrome in acne vulgaris and level of asprosin.


Eligibility criteria: Inclusion Criteria:

* Acne vulgaris male patients (\>18 years) will be included.

Exclusion Criteria:

* Age \<18 years.
* Females.
* Patients with other inflammatory skin disorders.
* Patients with associated systemic diseases.
* Current or previous treatment with isotretinoin in the last 3 month ,anti-inflammatory drugs, systemic antibiotics, androgen or anti androgen therapy, and steroid therapy).
* Patients known on treatment of diabetes, hypertension and dyslipidemia.
* Athletes.
* Patient refusal.

Primary outcomes:
measure: Assess serum asprosin level in male patients with acne vulgaris.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Rocha MA, Bagatin E. Adult-onset acne: prevalence, impact, and management challenges. Clin Cosmet Investig Dermatol. 2018 Feb 1;11:59-69. doi: 10.2147/CCID.S137794. eCollection 2018.
citation: Kovacs D, Fazekas F, Olah A, Torocsik D. Adipokines in the Skin and in Dermatological Diseases. Int J Mol Sci. 2020 Nov 28;21(23):9048. doi: 10.3390/ijms21239048.
citation: Nagpal M, De D, Handa S, Pal A, Sachdeva N. Insulin Resistance and Metabolic Syndrome in Young Men With Acne. JAMA Dermatol. 2016 Apr;152(4):399-404. doi: 10.1001/jamadermatol.2015.4499.
citation: Hong T, Li JY, Wang YD, Qi XY, Liao ZZ, Bhadel P, Ran L, Yang J, Yan B, Liu JH, Xiao XH. High Serum Asprosin Levels Are Associated with Presence of Metabolic Syndrome. Int J Endocrinol. 2021 Mar 2;2021:6622129. doi: 10.1155/2021/6622129. eCollection 2021.
Clinical trial NCT05158088: Video Laryngoscope Versus USB Borescope in Difficult Intubation
Official title: Video Laryngoscope Versus a USB Borescope Aided Endotracheal Intubation in Adults With Anticipated Difficult Airway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult or Failed
Keywords: Airway
Intubation
Videolaryngoscope
Borescope
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Video Laryngoscope Versus a USB Borescope Aided Endotracheal Intubation in Adults With Anticipated Difficult Airway

Detailed description: For patients allocated to the USB-borescope technique, a proper size endotracheal tube will be placed over the USB-borescope (with an external diameter of 5.5 mm) which will be coated externally with water-soluble lubricant. The proper size laryngoscope blade will be inserted. The USB-borescope will be placed through the oral cavity and will be advanced while tracking it on a mobile phone, it will be advanced to the glottic opening. If needed, rotation of USB-borescope and/or external laryngeal manipulation will be used to align it with the vocal cord.

For patients allocated to the intubation over Video Laryngoscope technique, video laryngoscope (Insighters insight is3) proper size blade will be placed and introduction of the Video Laryngoscope till viewing the glottis opening then insertion of a proper sized endotracheal tube

Eligibility criteria: Inclusion Criteria:

* 1.American Society of Anesthesiologist ASA physical status I-II patients. 2.Both genders. 3.Age18-60 years old 4.BMI \<35 5.patients with El-Ganzouri score more than or equal to 4

Exclusion Criteria:

* Presence of pulmonary diseases
* Uncontrolled hypertension
* Ischemic heart disease
* Cervical spine fracture
* Limited mouth opening
* known to have tumors or polyps in the upper airway
* History of difficult intubation or difficult bag-mask ventilation
* Patients with difficult bag-mask ventilation after induction of anesthesia

Primary outcomes:
measure: Time of intubation
timeFrame: 5 minutes
Secondary outcomes:
measure: Blood pressure before intubation, every 5 minutes after intubation till 15 minutes after intubation
timeFrame: 15 minutes
measure: Heart rate Heart rate
timeFrame: 15 minutes
measure: The degree of view clarity
timeFrame: 1 minute
measure: Incidence of complications
timeFrame: 48 hours
measure: Number of trials for correct endotracheal intubation
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT02230488: Intensive Case Diabetes Management (ICDM) to Prevent Readmission
Official title: Intensive Case Diabetes Management to Prevent Readmission of Previously Identified High Risk Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Keywords: Inpatient Diabetes Management
Prevent <31 day readmission in patients with Diabetes
CDEs role in transition of care of inpatients with diabetes
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Barnes-Jewish Hospital
First posted: 2014-09-03
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether intensive case management interventions by a diabetes team, led by an endocrinologist and certified diabetes educator, can prevent \<31 day readmission in previously identified high risk patients with diabetes.The procedures of the study will focus on managing the patient's diabetes and diabetes education while in the hospital, decreasing the patient's risk for hypoglycemia and hyperglycemia in the hospital, and assist in the patient's diabetes management plan for a safe discharge.


Eligibility criteria: Inclusion Criteria:

* Patients admitted with a diagnosis of diabetes, Patients with a previous history of Pharmacy Expert System (PES) alert, Enrollment in research must be within 24 hours of admission

Exclusion Criteria:

* Patients transferred from institutionalized care, Patients who already plan to move to institutionalized care, Patients with severe co-morbidities (e.g. terminal cancer), Patients admitted for surgery within 24 hours, Patients who are unwilling or unable to give written consent (e.g. dementia), Patients who are homeless, Patients previously admitted to the diabetes endocrine service

Primary outcomes:
measure: Prevent <31 day readmission
timeFrame: The length of time between hospital discharge and readmission 31 days
Secondary outcomes:
measure: improve overall glycemic management
timeFrame: Upon the participant's consent (within 24 hours of hospital admission) to hospital discharge- the average length of stay is five days
Other outcomes:
measure: Patient satisfaction
timeFrame: From the time of consent (within 24 hours of admission) to the time of discharge- the average length of stay is 5 days.
Locations:
city: St. Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Garry Tobin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04609488: Surfactant Levels in the Lungs of COVID-19 Patients
Official title: An Exploratory Study to Assess Surfactant Levels in COVID-19 Patients Who Will be on Ventilatory Support Due to Severe Respiratory Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: To Assess Surfactant Levels in Lung Fluid
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients are COVID-19 patients requiring ventilatory support by mechanical ventilation as well as Non-COVID-19 patients requiring ventilatory support by mechanical ventilation.

Brief summary: NAME of STUDY: Surfactant levels in the lungs of COVID-19 patients BACKGROUND

* Infection with SARS-CoV-2 may induce respiratory failure.
* COVID-19 associated respiratory failure may require ventilatory support.
* SARS-CoV-2 uses alveolar type II cells for virus replication.
* Alveolar type II cells are responsible for surfactant production and lack of surfactant causes respiratory failure in preterm neonates.
* Lack of surfactant may play role for respiratory failure in COVID-19 patients DESIGN Exploratory prospective study design without therapeutic intervention of any kind. Lung fluid will be donated as part of standard care procedures.

HYPOTHESIS Surfactant is measurable in tracheal secretions by mid-infrared FTIR spectroscopy determined surfactant spectra. Surfactant is reduced in COVID-19 patients requiring ventilator support as compared to non- COVID-19 patients. Dysfunctional surfactant in COVID-19 patients regain its function when respiratory function improves.

POPULATION Main population is patients with COVID-19 pneumonia that requires ventilatory support.

OUTCOME MEASURES Primary outcome is the level of surfactant in lung fluid as obtained by tracheal suction.

SAMPLE SIZE In total 30 patients will be included: twenty COVID-19 patients and 10 non-COVID-19 patients.


Eligibility criteria: Inclusion Criteria:

1. Patients positive for coronavirus 2 (SARS-CoV-2) AND
2. Respiratory failure requiring mechanical ventilation support OR respiratory failure requiring oxygen supplementation AND
3. Age \> 18 years AND
4. Permission from next of kin

Exclusion Criteria:

Inability to obtain TS or BL as determined by clinical judgement by responsible clinician. Patients with known surfactant dysfunction (such as mutations in the SFTPB or ABCA3 gene). Imminent expected death within 24 hours. Stage 4 severe chronic kidney disease or requiring dialysis. Liver failure. Anticipated transfer to another hospital within 72 hours. Participation in another study which in the opinion of the investigator would prevent enrollment for safety purposes.

Primary outcomes:
measure: Surfactant
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03453788: Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology
Official title: Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Keywords: follow up
side effects
smartphone app
physical activity
empowerment
patient reported outcomes
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: University of Agder
name: Uppsala University
First posted: 2018-03-05
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective cohort study with reference group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot study is evaluating a new smartphone application named the LETSGO app. The LETSGO app is designed to promote empowerment in patients after treatment for gynecological cancer.

Detailed description: Gynecological cancer treatment is increasingly successful, resulting in a rising number of cancer survivors. Many gynecological cancer survivors may experience late side effects from their cancer treatment. In addition, evidence is accumulating that an active lifestyle may increase empowerment and may positively influence well-being after cancer treatment. Through the LETSGO smartphone app, women treated for gynecological cancer will get access to individualized posttreatment information on side effects as well as tailored physical activity advices in order to assume more responsibility for achieving the best outcomes from her care. The participants will also regularly answer patient reported outcomes regarding possible recurrence though the app. As a first step the smart-phone application will be pilot-tested.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed and treated for gynecological cancer who will be followed up at the gynecological outpatient clinic in Kristiansand or Arendal
* No cognitive barriers.

Exclusion Criteria:

* \< 18 years
* Not able to read Norwegian

Primary outcomes:
measure: Satisfaction with LETSGOapp
timeFrame: 8 months
Secondary outcomes:
measure: Recruitment rate
timeFrame: 6 months
measure: Acceptability of goal setting
timeFrame: 8 months
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sorlandet Hospital
state: Vest Agder
Study officials:
affiliation: Chief of Research Department, Sørlandet Hospital
name: Frode Gallefoss
role: STUDY_CHAIR
References: