louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03091569: Effects of Vitamin K on Redness Associated With Injection Site Reactions in Participants Treated With Plegridy
Official title: Effects of VITAmin K in Lessening Erythema Grade Associated to Injection Site Reactions in Patients Treated With PlegridY (VITALITY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsing-Remitting Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2017-03-27
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective of the study is to investigate whether topical Vitamin K application reduces the grade of erythema in comparison with a vehicle cream (placebo) through physicians' assessment and participant self-assessment.

The secondary objectives of this study are to evaluate in this study population: effects of Vitamin K in reducing the burning sensation and local pain; effects of Vitamin K in reducing the erythema diameter; and the evaluation of participants' satisfaction related to the injection treatment.


Eligibility criteria: Key Inclusion Criteria:

* Relapsing-Remitting Multiple Sclerosis (RRMS) participants for which Plegridy is deemed necessary by the neurologist. Participants switching from other Disease Modifying Treatments (DMTs) will be eligible provided that Plegridy is administered at an injection site different from the previous one.

Key Exclusion Criteria:

* Participants with other skin disorders
* Pregnancy or current breast-feeding
* Depression and other psychiatric disorders
* Unwillingness or inability to comply with the requirements of the protocol.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Change in Clinician's Erythema Assessment (CEA) scale from pre-application of topical cream to 24 hours post-application
timeFrame: Week 4, week 6, and week 8
measure: Change in Participants Erythema Self-Assessment (PSA) scale from pre-application of topical cream to 24 hours post-application
timeFrame: Week 4, week 6, and week 8
Secondary outcomes:
measure: Change in Visual Analogue Scale (VAS) score from pre-application of topical cream to 24 hours post-application
timeFrame: Week 4, week 6, and week 8
measure: Change in Adapted Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) from pre-application of topical cream to 24 hours post-application
timeFrame: Week 4, week 6, and week 8
measure: Change in the longest diameter of erythema from pre-application of topical cream to 24 hours post-application
timeFrame: Week 4, week 6, and week 8
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04366869: Which is More Effective in Management of Bruxism: Botox or Occlusal Splints
Official title: Which is More Effective in Management of Bruxism for Implant Overdenture Patients: Botox or Occlusal Splints - A One Year Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bruxism
Lead sponsor: October University for Modern Sciences and Arts
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the efficacy of Botulinum toxin (Botox) and traditional occlusal splints for the management of bruxism in edentulous patients rehabilitated with MIOD

Detailed description: 42 edentulous patients having implant retained mandibular overdenture suffering from bruxism with clinical manifestation, will be randomly divided into three groups, group 1 control group (traditional approach of removing denture at night) ,group 2 will be managed by occlusal splints whereas group 3 will be managed with botulinum toxin injection (Botox). New maxillary dentures and mandibular over dentures will be constructed for both groups. Muscle activity will be measured at time of denture insertion (T0), 3(T3) 6(T6), 9(T9) and 12(T12) month of treatment. Patients satisfaction will be evaluated at the time of denture insertion (T0), 6(T6), and 12(T12) month of treatment using TMD/ NS numeric scales 10 cm questionnaire which include: headache, face pain, face tension, limitation of mouth opening and complaints during mastication.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with bruxism
* patients had mandibular implant retained overdentures within the previous 3 years
* cooperative patients
* physically and psychologically able patients to tolerate the procedure

Exclusion Criteria:

* patients taking muscle relaxants
* patients without neuromuscular control
* poor oral hygiene

Primary outcomes:
measure: Patient satisfaction: questionnaire
timeFrame: 12months
Secondary outcomes:
measure: Electromyography
timeFrame: 12 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: MSA
Study officials:
affiliation: Lecturer
name: Dina Elawady, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01934569: Drug-Drug Interaction Study With PF-05089771
Official title: Evaluation Of The Effect Of PF-05089771 On The Metabolism Of Multiple Cytochrome P450 And OATP1B1 Transporter Substrates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-09-04
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will test the potential for PF-05089771 to interact with a cocktail of drugs


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years;
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs);

Exclusion Criteria:

* Any condition possibly affecting drug absorption
* History of regular alcohol consumption
* Screening supine blood pressure \>140 mm Hg (systolic) or \>90 mm Hg (diastolic),
* Consumption of coffee, cola or other caffeine containing drinks

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 24h
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 24h
measure: Minimum Observed Plasma Trough Concentration (Cmin)
timeFrame: 24h
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 24h
Secondary outcomes:
measure: Change from Baseline in Lipid Parameters
timeFrame: 14 days
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02165969: Olfactory Function Following Endoscopic Endonasal Skull Base Surgery
Official title: Olfactory Function Following Endoscopic Endonasal Skull Base Surgery: Clinical and Histological Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skull Base Pathology
Keywords: tumor
inflammatory process
fracture
defect
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare a subject's sense of smell before and after endoscopic endonasal surgery to remove a skull base abnormality (i.e. tumor, inflammatory process, fracture, defect, etc.) and use the information collected to validate approaches to surgery that will minimize side effects to the sense of smell function. Data will be collected using a smell identification test along with two questionnaires. In addition, demographic, medical history, treatment, outcome, and follow-up information will be collected.


Eligibility criteria: Inclusion Criteria:

* Patients presenting with skull base pathologies requiring endonasal surgery at The Ohio State University Wexner Medical Center
* 18 years or older
* Able to consent for self
* Negative serum pregnancy test for women of childbearing potential

Exclusion Criteria:

* Patient unable to return to clinic at specific follow-up times
* Pregnant or nursing
* Prisoners

Primary outcomes:
measure: Number of patients with decreased olfactory function after endoscopic endonasal surgery
timeFrame: up to 12 months post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Ricardo Carrau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00599469: Far Infrared Treatment for Alzheimer's Disease
Official title: Phase 1 Study to Determine the Efficacy of Using Far Infrared Radiation for the Treatment of Alzheimer's Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Alzheimer Disease
Keywords: Acute Confusional Senile Dementia
Alzheimer Type Senile Dementia
SENILE PLAQUES
NEUROFIBRILLARY TANGLES
NEUROPIL THREADS
Lead sponsor: GAAD Medical Research Institute Inc.
Sponsor class: OTHER
First posted: 2008-01-23
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Alzheimer's disease is a progressive and fatal brain disease. This study will investigate the use of far infrared radiation treatment for the disease.

Detailed description: Alzheimer's destroys brain cells, causing problems with memory, thinking and behaviour severe enough to affect work, lifelong hobbies or social life. Alzheimer's gets worse over time and it is fatal.

Alzheimer's, which has no current cure, is the most common form of dementia. It is hereby postulated that far infrared radiation of the central nervous and endocrine systems will help with the management of the disease and possibly cure the disease.

Eligibility criteria: Inclusion Criteria:

* People with Alzheimer's disease

Exclusion Criteria:

* None

Primary outcomes:
measure: Management and Cure of Alzheimer's Disease
timeFrame: 1 year
Secondary outcomes:
measure: Management and Cure of Dementia
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Centre for Incurable Diseases
state: Ontario
Study officials:
affiliation: GAAD Medical Research Institute Inc.
name: Ken Nedd, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: GAAD Medical Research Institute Inc.
name: Kwasi Donyina, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04027569: PROMs To Improve Care- Standardized vs Patient Specific
Official title: PROMs To Improve Care: A Pragmatic RCT on Standardized and Patient Specific PROMs on Outcomes After Hand Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hand Injuries
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To examine the impact of using 2 validated PROMs during the care of an orthopaedic condition on shared decision making, patient centered care, and patient outcomes.


Eligibility criteria: Inclusion Criteria:

* hand surgery patients over age 18, english fluency and literacy, able to take informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: Decisional Conflict Scale (DCS)
timeFrame: Immediately after the clinical encounter, same day as clinical encounter
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Robin N Kamal, MD MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00993369: Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies
Official title: Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuro Developmental Delay
Keywords: Prediction of neuro developmental delay
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2009-10-12
Enrollment: 60
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fetus and newborns.

Brief summary: This is a proof of principle study that investigates heart rate variability differences in fetal and neonatal life in a longitudinal study design and compares two subject groups, offspring conceived using in-vitro fertilization and conceived naturally.

Detailed description: This is a proof of principle study that investigates heart rate variability differences in fetal and neonatal life in a longitudinal study design and compares two subject groups, offspring conceived using in-vitro fertilization and conceived naturally.

Eligibility criteria: Inclusion Criteria:

* Fetus or newborn
* Delivery at University of Utah Medical Center, Latter Day Saints Hospital or Intermountain Medical Center

Exclusion Criteria:

* Twins
* Genetic anomaly
* Congenital malformation
* Need for special care

Primary outcomes:
measure: Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies
timeFrame: 2 to 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Salt LakeCity
country: United States
facility: University of Utah Medical Center
state: Utah
Study officials:
References:
Clinical trial NCT06784869: The Efficacy of Scaling and Root Planing on Endothelin-1 Level
Official title: The Efficacy of Scaling and Root Planing on Endothelin-1 Gingival Crevicular Fluid Levels Among Periodontitis Patients: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Periodontitis
Keywords: periodontitis
endotheiln-1
scaling and root surface debritment
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Periodontitis is a chronic inflammatory disease resulting from bacterial invasion. Endothelin (ET-1) is a potent vasoconstrictor critical in the pathophysiology of periodontal diseases.

Aim The present study aimed to measure the ET-1 concentrations in gingival crevicular fluid (GCF) at baseline, one and three months subsequently to non-surgical periodontal therapy.

Material and methods Designed as a clinical trial, 24 periodontitis individuals will be voluntarily consented to participate. Following non-surgical periodontal treatment, GCF samples will be collected to determine the amount of endothelin-1 at baseline, one, and three months. Clinical periodontal parameters will be recorded.

Detailed description: Periodontitis is a chronic inflammatory disease resulting from bacterial invasion. Endothelin (ET-1) is a potent vasoconstrictor critical in the pathophysiology of periodontal diseases.

Aim The present study aimed to measure the ET-1 concentrations in gingival crevicular fluid (GCF) at baseline, one and three months subsequently to non-surgical periodontal therapy.

Material and methods Designed as a clinical trial, 24 periodontitis individuals will be voluntarily consented to participate. Following non-surgical periodontal treatment, GCF samples will be collected to determine the amount of endothelin-1 at baseline, one, and three months. Clinical periodontal parameters will be recorded.

Eligibility criteria: Inclusion Criteria:

* systemically healthy
* Generalized unstable periodontitis with a moderately deep pocket (4,5 or 6 mm)

Exclusion Criteria:

* subjects who wore dental prosthesis
* teeth with grade II mobility,
* alcoholic and smoker, had treated caries
* underwent periodontal therapy within the last four months

Primary outcomes:
measure: PPD
timeFrame: 3 months recall visits
measure: CAL
timeFrame: 3 months recall visits
Secondary outcomes:
measure: ET-1
timeFrame: 3 months recall visits
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01415869: Occult Gastrointestinal Bleeding in Non-pulsatile Left Ventricular Assist Device(VAD)Patients
Official title: Occult Gastrointestinal Bleeding in Non-pulsatile Left Ventricular Assist Device(VAD)Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Bleeding
Complication of Internal Device
Keywords: Ventricular Assist Device
Gastrointestinal Bleeding
VAD
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-08-12
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Group 1 Patients with implanted non-pulsatile ventricular assist devices of any type and at any time after implantation
* Group 2 Patients with usual VAD indications will be invited to participate, when, in the opinion of their treating physician a VAD will be highly likely within one month.

Brief summary: The purpose of this study is to estimate the proportion of Ventricular Assist Device (VAD) patients with abnormal gastrointestinal bleeding as assessed by HemoQuant fecal occult blood test. Also, in patients with gastrointestinal bleeding present, to summarize the extent of gastrointestinal bleeding; to examine the behavior of HemoQuant fecal occult blood test over time by estimating the proportion of VAD patients with a positive test prior to implantation; at one week, one month, three months, six months and one year post implantation, and after explantation of the VAD and to evaluate whether presence of any abnormal fecal HemoQuant test is predictive of a future major bleeding event.


Eligibility criteria: Inclusion Criteria:

* Group 1 - cross sectional study. Patients with implanted non-pulsatile ventricular assist devices of any type and at any time after implantation
* Group 2 - prospective study. Patients with usual VAD indications will be invited to participate, when, in the opinion of their treating physician a VAD will be highly likely within one month.

Exclusion Criteria:

* Unwillingness to provide stool samples for study
* Unwillingness to be followed for study endpoints.
* Unwillingness to follow dietary restrictions necessary for accurate HemaQuant measurement

Primary outcomes:
measure: Proportion of VAD Patients with Gastrointestinal Bleeding as Assessed by HemoQuant Fecal Occult Blood Testing
timeFrame: 1 year
Secondary outcomes:
measure: Examine Behavior of Gastrointestinal Bleeding in VAD Patients By Estimating the Proportion of VAD Patients with an Abnormal HemoQuant Test Prior to Implantation
timeFrame: 1 year
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Joseph L Blackshear, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03173469: Preoperative Breast Magnetic Resonance Imaging for Patients Undergoing Mammoplasty
Official title: The Role of Preoperative Breast Magnetic Resonance Imaging for Surgical Decision in Patients Undergoing Therapeutic Mammoplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All female with operable breast cancer who candidate fot therapeutic mammoplasty,Sample size was calculated using G power, it is 40 patients.

Brief summary: all female with operable breast cancer seeking health care at general surgery department Assiut university hospitals,and decision of therapeutic mammoplasty was taken depending on clinical examination, findings on mammography and sonography, will undergo MRI breast, and see if MRI finding will change decision of the surgery.

Detailed description: * Study Setting: Assiut university hospital, general surgery department (C unit )
* Study subjects: all female with operable breast cancer seeking health care at general surgery department and decision of therapeutic mammoplasty was taken depending on clinical examination, findings on mammography and sonography.

The size, number, and location of breast cancer lesions were identified on US and mammography.

Also size, number, location, pattern of enhancement and presence or absence of intraductal component will be evaluated by preoperative MRI.

The surgical plane will be decided based on US and mammography findings. The final decision will be based on MRI findings. When the initial surgical decision was the same as final decision the patient will be assigned to the unchanged group.

However, if the final decision differed from the initial surgical decision the patient will be assigned to the changed group.

Eligibility criteria: Inclusion Criteria:

* Female patient with operable breast cancer (stage 1 and 2 ) Patient meet the criteria of therapeutic mammoplasty

Exclusion Criteria:

* Inoperable breast cancer (stage 3 and 4) Breast cancer size \> 4 cm in diameter Previous radiotherapy Local recurrence after previous breast conservation surgery Male breast cancer

Primary outcomes:
measure: percentage of patients whom MRI finding that will change the decision of surgery
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospitals
Study officials:
References: