louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02417948: Improving Sun-Protective Behaviors and Skin Self-Examinations Among African Americans
Official title: Improving Sun-Protective Behaviors and Skin Self-Examinations Among African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Carcinoma
Skin Melanoma
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-04-16
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized clinical trial uses an educational brochure and online tutorial program to assess sun-protective behavior and skin self-examination among African Americans. Skin cancer is very common among African Americans, with a disproportionately high mortality rate. Providing a brochure and an online educational program about sun-protective behaviors may encourage African Americans to take preventative measures against skin cancer, help improve early skin cancer detection, determine how far the disease has spread, and plan the best treatment.

Detailed description: PRIMARY OBJECTIVES:

I. To assess whether an educational brochure and online program will increase sun-protective behaviors among African-American patients who present at the general dermatology clinic.

SECONDARY OBJECTIVES:

I. To assess whether the educational brochure and online program will improve skills for skin self-examinations among African-American patients who present at the general dermatology clinic.

OUTLINE: Participants are assigned to 1 of 2 arms.

ARM I: Participants receive a skin cancer educational and preventive brochure distributed by the National Cancer Institute and watch a 30-minute online tutorial video called X-Plain about skin cancer, preventative behaviors, and skin self-examinations.

ARM II: Participants receive an educational brochure as in Arm I.

After completion of study, participants are followed up at 30 days.

Eligibility criteria: Inclusion Criteria:

* Self-identified African-Americans who are literate and fluent in English

Exclusion Criteria:

* Non-African-Americans
* English illiteracy
* non-fluency in English

Primary outcomes:
measure: Change in sunscreen use among African-American patients
timeFrame: Baseline to day 30
measure: Change in apparel use when exposed to sun among African-American patients
timeFrame: Baseline to day 30
measure: Change in frequency of tanning among African-American patients
timeFrame: Baseline to day 30
Secondary outcomes:
measure: Change in skin self-examinations among African-American patients as measured by knowledge, behavior and anxiety
timeFrame: Baseline to day 30
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Jeremy Bordeaux
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01968148: Mechanisms of Ultra-acute Hyperglycemia After Successful Resuscitation From Out-of-hospital Cardiac Arrest
Official title: Mechanisms of Ultra-acute Hyperglycemia After Successful Resuscitation From Out-of-hospital Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Arrest
Cardiac Arrest
Keywords: glucose
cardiac arrest
resuscitation
insulin
GLP-1
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2013-10-23
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: NON_PROBABILITY_SAMPLE
Study population: Successfully resuscitated patients treated by physician staffed mobile intensive care unit in Helsinki area.

Brief summary: The aim of the study is to describe the mechanisms of ultra-acute hyperglycemic response after return of spontaneous circulation (ROSC) in patients suffering out-of-hospital cardiac arrest. The investigators hypothesize that ischemia and reperfusion injury leads decreased secretion of insulin and glucose-like peptide 1 (GLP-1).

Two blood samples will be drawn: (1.) Immediately after ROSC and (2.) 60 minutes after first sample. Concentrations of glucose, insulin, glucagon and GLP-1 will be compared between the samples.

Metabolic profile will be compared between: (1.) diabetic and non-diabetic patients and (2.) survivors and non-survivors.


Eligibility criteria: Inclusion Criteria:

* age ≥18 years
* witnessed cardiac arrest
* interval form emergency call to return of spontaneous circulation 10-45 minutes

Exclusion Criteria:

* severe pre-arrest disability leading to withdrawing treatment in prehospital phase
* no concent from next of kin

Primary outcomes:
measure: Change in level of insulin
timeFrame: 60 minutes
measure: Change in level of glucagon
timeFrame: 60 minutes
Secondary outcomes:
measure: Blood cortisol level
timeFrame: 60 minutes after ROSC
measure: Blood interleukin-6 level
timeFrame: 60 minutes after ROSC
measure: Change in blood glucose level
timeFrame: 60 minutes
measure: Change in level of GLP-1
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki Emergency Medical Services
city: Vantaa
country: Finland
facility: Helsinki Area Helicopter Emergency Medical Services
Study officials:
affiliation: Helsinki University Central Hospital
name: Jouni Nurmi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01996748: Clinical Study to Assess the Efficacy and Safety of DF277 Compared to Placebo in the Treatment of Otic Eczema
Official title: A Multicenter, Randomized, Parallel, Double-blind, Clinical Trial Study to Assess the Efficacy and Safety of DF277 Compared to Placebo in Patients With Otic Eczema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Otic Eczema
Lead sponsor: Salvat
Sponsor class: INDUSTRY
First posted: 2013-11-27
Enrollment: 135
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of DF277 for the treatment of otic eczema.


Eligibility criteria: Inclusion Criteria:

* 12 years or older
* Clinical diagnosis of otic eczema suitable for local treatment

Exclusion Criteria:

* Other diseases.

Primary outcomes:
measure: Analysis of the Itching Change at the End of Treatment.
timeFrame: Baseline and days 4-8
Secondary outcomes:
measure: Change in Signs/ Symptoms
timeFrame: Baseline and days 9-15
measure: Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Treatment (Day 8) Compared to Baseline (Day 1).
timeFrame: Baseline and day 8
measure: Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Follow-up (Day 15) Compared to Baseline (Day 1).
timeFrame: Baseline and day 15
Other outcomes:
Locations:
city: Esplugues de Llobregat
country: Spain
facility: Laboratorios SALVAT, S.A.
state: Barcelone
Study officials:
References:
Clinical trial NCT00467948: Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients
Official title: Double Blind Randomised Study of 2 Days and 5 Days Cefazolin Prophylactic Method in Laryngeal Oncologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Laryngeal Cancer
Keywords: clean contaminated, laryngectomy, wound infection
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-05-01
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients who need major head \& neck surgery are at risk of post operative wound infection. In spite of role of antibiotics in prophylaxis of clean contaminated head and neck surgery has been well documented, controversy exists in the optimal antibiotic regimen

Detailed description: Patients undergoing laryngeal oncologic surgery are at relatively high risk of developing complication.

Efficacy of cefazolin as a prophylactic antibiotic in head and neck surgery was reviewed in many researches \[6\] but considering the costs and morbidities of prolonged antibiotic regimen we have presented a prospective and randomized study in 90 patients comparing the efficacy of 2 day over 5 day protocols.

Eligibility criteria: Inclusion Criteria:e.

* Patients eligible to be included in this trial were those who histologically confirmed squamous cell carcinoma of larynx and hypopharynx and they were candidate of total or partial laryngectomy with or without neck dissection and with negative history of neck or laryngeal radiation were included in this study.

Exclusion Criteria:

* Patients having recurrences or another primary tumor, and those who underwent reconstruction with a flap were excluded from the study, because they had been submitted to prolonged antibiotic administration. Also cases with Diabet mellitus and Immune suppression or tumor types other than squamous cell carcinoma were excluded from the study.
* In addition, the following exclusion criteria were taken into account: pregnancy, hypersensitivity to penicillins or cephalosporins, patients who received a systemic antibiotic drug within one week prior to the planned procedure, those who had clinical or laboratory evidence of a preexisting infection or had serious systemic renal disease.

Primary outcomes:
measure: wound infection
timeFrame: prospective
Secondary outcomes:
measure: drug complication
timeFrame: 3 week after surgery
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Imam khomaini hospital
Study officials:
affiliation: tehran university of medical science
name: taghi khorsandi, professor
role: STUDY_CHAIR
References:
Clinical trial NCT05318248: The Role of Stress Neuromodulators in Decision Making Under Risk (Part II)
Official title: The Role of Stress Neuromodulators in Decision Making Under Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 82
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the proposed project is to combine precise pharmacological manipulation of the noradrenergic system with behavioral modeling of memory processes, and fMRI methods to study the effect of a pharmacologically induced blockade of the noradrenergic system on memory processes. Behaviorally, the investigators will focus on the effect of the noradrenergic blockade on working memory performance, and recognition memory.

Detailed description: Affective states like acute stress can influence cognition, i.e., memory processes. Physiologically, acute stress elicits an array of autonomic and endocrine responses, including a fast release of norepinephrine from the locus coeruleus noradrenergic (LC NA) system. Compelling evidence shows that in healthy humans, stimulation of the noradrenergic system increases memory performance whereas noradrenergic blockade reduces memory performance. Functional magnetic resonance imaging (fMRI) studies have shown that manipulations of the noradrenergic system affects responsiveness and connectivity within networks that are important for autonomic-neuroendocrine control and temporal and spatial attention orientation. So far, no study investigated the neural underpinnings of memory processes after a pharmacologically induced noradrenergic blockade. The aim of the proposed project is to combine precise pharmacological manipulation of the noradrenergic system with behavioral modeling of distinct memory processes, and fMRI methods to study the effect of a pharmacologically induced blockade of the noradrenergic system on two distinct memory processes. Behaviorally, the investigators will focus on the effect of the noradrenergic blockade on working memory performance, and recognition memory. Participants are randomly assigned to one of two groups: (A) clonidine, or (B) placebo.

Eligibility criteria: Inclusion Criteria:

* right handed, high-school diploma

Exclusion Criteria:

* former \& present DSM-5 axis I disorders, medication,

Primary outcomes:
measure: Working Memory (n-back task)
timeFrame: 11 minutes
measure: Recognition Memory (word list learning)
timeFrame: 25 minutes
measure: Blood-oxygen-level-dependent (BOLD) response
timeFrame: 46 minutes
Secondary outcomes:
measure: blood pressure
timeFrame: 2.5 hours
measure: Heart rate
timeFrame: 2.5 hours
measure: salivary cortisol
timeFrame: 2.5 hours
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University
Study officials:
References:
Clinical trial NCT01770548: Neurophysiological Molecular and Developmental Analysis of the Glutamate Synapse in Autism
Official title: Autism and Glutamatergic Synapse : Research of Genetic Mutations and Identification of Clinical and Neurophysiological Markers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 497
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Neurophysiological, Molecular and Developmental Analysis of the glutamate synapse in Autism

Detailed description: Analysis about 50 genes in glutamate synapse

Eligibility criteria: Inclusion Criteria:

* have a Pervasive Developmental Disorder

Exclusion Criteria:

* N/A

Primary outcomes:
measure: screening of about 50 genes encoding proteins of the NMDA receptor complex, chosen according to their chromosomal localisation located in hotspots depicted by genome-wide screens in large population of autistic patients
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU - Centre de Ressources Autisme (CRA)
city: Rouen
country: France
facility: CHS du ROUVRAY
city: Tours
country: France
facility: Chru - Cic
city: Tours
country: France
facility: CHRU - Pédopsychiatrie
Study officials:
affiliation: University François Rabelais of TOURS
name: Frédérique BONNET-BRILHAULT, MD PHD
role: STUDY_DIRECTOR
References:
citation: Bonnet-Brilhault F, Alirol S, Blanc R, Bazaud S, Marouillat S, Thepault RA, Andres CR, Lemonnier E, Barthelemy C, Raynaud M, Toutain A, Gomot M, Laumonnier F. GABA/Glutamate synaptic pathways targeted by integrative genomic and electrophysiological explorations distinguish autism from intellectual disability. Mol Psychiatry. 2016 Mar;21(3):411-8. doi: 10.1038/mp.2015.75. Epub 2015 Jun 9.
Clinical trial NCT03187548: Evaluation of CPP-ACP Prophylactic Effect on Enamel Surface During Orthodontic Treatment
Official title: Evaluation of the Demineralizing Effect on Enamel Surface During Orthodontic Treatment With and Without the Addition of Casein Phosphopeptides-Amorphous Calcium Phosphate (CPP-ACP) on: A Randomized Clinical Trial, Split Mouth Design
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: White Spot Lesion
Enamel Hypomineralization
Keywords: WSL
CPP-ACP
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 45
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is aiming in preventing the formation of WSL associated with orthodontic treatment which occurs to more than 50% of orthodontically treated patients through applying CPP-ACP on the enamel surface once every 2 weeks for 3 months.

Detailed description: CPP-ACP will be applied on premolars to be extracted in orthodontic patients whose treatment plan indicates extraction of at least 2 premolaes of the maxillary arch. Application will continue on one premolar either the right or left one once every 2 weeks for the first 3 months of the treatment.

Eligibility criteria: Inclusion Criteria:

* severe crowding
* Increased overjet
* Protruded maxillary base
* Sound maxillary premolars
* medically free
* molar classification class II
* Canine classification class II

Exclusion Criteria:

* spacing of teeth
* Decreased overjet
* Molar classification III Medically compromised patients
* pregnant females
* carious premolars
* hypoplasia

Primary outcomes:
measure: Effect on enamel surface color
timeFrame: 3 months
measure: Effect on enamel surface
timeFrame: 3 mnths
Secondary outcomes:
measure: Surface texture
timeFrame: 3 months
measure: Microhardnes
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Department of orthodontics
name: Maha Swelam, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01206348: Combination Treatment for Moderate to Severe Acne
Official title: A Phase IV, Open-Label Study Evaluating the Use of Solodyn (Minocycline HCL Extended-Release Tablets), Ziana, and Triaz Foaming Cloths as Combination Acne Therapy Prior to Treatment With Isotretinoin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne
Keywords: Acne
Lead sponsor: Medicis Global Service Corporation
Sponsor class: INDUSTRY
First posted: 2010-09-21
Enrollment: 97
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine if a combination of three currently approved acne products are safe and effective for the treatment of moderate to severe acne

Detailed description: A Phase IV, Open-Label Study Evaluating the treatment for Combination Acne Therapy.

Eligibility criteria: Inclusion Criteria:

* moderate to severe acne, IGA = 3 or 4 (Investigator Global Assessment)

Exclusion Criteria:

* pregnancy and allergies

Primary outcomes:
measure: Proportion of patients showing improvement from Baseline and Week 12
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Santa Monica
country: United States
state: California
city: Hockessin
country: United States
state: Delaware
city: Chestnut Hill
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Henderson
country: United States
state: Nevada
city: High Point
country: United States
state: North Carolina
city: Hershey
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Medicis Global Service Corporation
name: Mary Sanstead, BSN, CCRP
role: STUDY_CHAIR
References:
Clinical trial NCT00735748: Comparison of Tramadol Orally Versus an Optimized Dose of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery
Official title: Comparison of the Therapeutic Efficacy and Side Effects of Tramadol Per os (Tradonal Odis® Orodispersible Tablets) Versus an Optimised Dosis of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Patients who will undergo a general anesthesia for a procedure in short stay
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2008-08-15
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages versus tramadol IV given in 3 unit dosage of 35 mg during the first 6 hours postoperatively and to investigate the time course and accuracy of pain relief versus the onset and duration of side effects. The first unit dose will be administered at arrival at the PACU when a Visual Analogue Pain (VAS) score of more than 3 is reached. The second and third unit dose will be administered after 1 and 2 hours, respectively, when a VAS of more than 3 is observed.


Eligibility criteria: Inclusion Criteria:

* ASA I and II female or male patients undergoing wisdom teeth extraction
* Aged 18-70 years
* Scheduled for ambulatory surgery requiring postoperative pain medication

Exclusion Criteria:

* Weight less than 70% or more than 130% of ideal body weight
* Neurological disorder
* Recent use of psycho-active medication, including alcohol
* Patients suffering from chronic pain receiving pre-operative pain medication including NSAID's
* Use of chronic anti-emetic medication
* Use of chronic corticoid therapy

Primary outcomes:
measure: Difference in pain score between groups
timeFrame: In the first hours after anaesthesia and surgery
Secondary outcomes:
measure: Difference in side-effects between the groups
timeFrame: In the first hours after anaesthesia and surgery
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Michel Struys, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06471348: Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine With Epinephrine
Official title: Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Operative Pain
Spinal Fusion
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 128
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial (RCT) investigating whether the local anesthetic injection of liposomal bupivacaine during posterior spinal fusion (PSF) for AIS is more effective in reducing acute postoperative opioid consumption compared to an equal volume injection of 0.25% bupivacaine with epinephrine for patients aged 10 to 17, with 128 patients randomly assigned to one of two arms: liposomal bupivacaine or 0.25% bupivacaine with epinephrine.


Eligibility criteria: Inclusion Criteria:

* ≥10 years old and ≤17 years old at assessment
* Diagnosis of Adolescent Idiopathic Scoliosis
* Planned surgical treatment of progressive spinal deformity with posterior spinal fusion

Exclusion Criteria:

* Diagnosis of neuromuscular, syndromic, or congenital scoliosis
* History of known allergy to local anesthesia
* Chronic pre-operative opioid consumptions
* Any other analgesic treatment for chronic pain before surgery
* Psychiatric or neurological disorders
* Cannot fluently read or speak English

Primary outcomes:
measure: Total amount of morphine equivalents per kilogram
timeFrame: 72 hours postoperatively
Secondary outcomes:
measure: Numeric Rating Scale (NRS) pain scores
timeFrame: 72 hours postoperatively
measure: Pain, functional ability, and mental health scores
timeFrame: 1-, 6-, 12-, and 24-months postoperatively
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Craig Birch, MD
role: PRINCIPAL_INVESTIGATOR
References: