louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00924872: Power Mobility Training for Persons With Stroke
Official title: Power Mobility Training for Persons With Stroke: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Mobility
Keywords: stroke
power wheelchair skills
training
safety
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2009-06-19
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To test the hypothesis that persons with stroke can safely and effectively learn to use power mobility devices. The primary objective of this project is to test the hypothesis that, with formal wheelchair skills training, people who have had a stroke and have been prescribed a power wheelchair will have a larger improvement in performance and safety scores on the wheelchair skills test than people who have not received wheelchair skills training.


Eligibility criteria: Inclusion Criteria:

* be an inpatient at the Nova Scotia Rehabilitation Centre with a primary diagnosis of stroke within the previous 6 months;
* be competent to provide informed consent;
* have permission of the attending physician to participate;
* require no more than minimal assistance for verbal/non-verbal communication and auditory comprehension as evaluated by a therapist or by chart review of the baseline CIHI evaluation;27
* be able to attend during a 20-minute therapy session as evaluated by the occupational or physical therapist;
* use a manual wheelchair for at least 1 hour per day;
* be able to be safely seated in the power wheelchair that we will be using for the study;
* have no significant visual impairment (such that a subject would be unable to see barriers) as evaluated by his/her therapist based on his/her performance during functional tasks;
* Not currently be using a power wheelchair
* have no physical or mental health condition (as determined by the health-care team) that would make participation dangerous.

Exclusion Criteria:

* none

Primary outcomes:
measure: Wheelchair skills test - power mobility version
timeFrame: Pre and post intervention, 3 weeks
Secondary outcomes:
measure: questionnaire
timeFrame: post intervention (3 weeks), 3 month follow-up
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Rehabilitation Centre
state: Nova Scotia
Study officials:
affiliation: Capital Distric Health Authority, Dalhousie University
name: Lee Kirby, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01110772: Comparison of Iodine + Isopropyl Alcohol Versus Iodine + Antimicrobial Sealant for Skin Preparation
Official title: Comparative Study of a Iodine + Cyanoacrylate (Integuseal) vs. Iodine and Isopropyl Alcohol in Skin Preparation for Prevention of Surgical Site Infections in Oncologic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Surgical Site Infection
Keywords: Surgical site infection
Skin preparation
Cost analysis
Lead sponsor: National Institute of Cancerología
Sponsor class: OTHER_GOV
Collaborators: name: Kimberly-Clark de México
First posted: 2010-04-27
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose if this study is to determine whether a microbial sealant (iodine + cyanoacrylate) \[InteguSEAL®, Kimberly-Clark\] reduces surgical site infections when compared to iodine and isopropyl alcohol (povacrylex in isopropyl alcohol) \[Duraprep®\] in oncologic surgery.

Detailed description: Patient's skin flora is a major source of pathogens, and microbial contamination of the surgical site is a likely precursor of SSI. A variety of skin products may be used, including iodophors, alcohol-containing products, and clorhexidine gluconate. Despite these perioperative tactics, bacteria continue to survive at the skin level and migrate to contaminate the wound.

A microbial sealant (InteguSEAL®, Kimberly-Clark) that uses cyanoacrylate to seal endogenous skin flora has demonstrated to reduce wound contamination. The efficacy of the microbial sealant in preventing SSI has been tested in cardiovascular surgery and open inguinal hernia repair, with a reduction on SSI rate when compared to standard skin preparations. This cyanoacrylate has not been tested in oncologic surgeries.

Eligibility criteria: Inclusion Criteria:

* Patients \>= 18 years undergoing elective clean or clean-contaminated breast, gynecologic or digestive tract surgery
* Accepts to participate and signs the informed consent form
* Have a telephone number to be contacted after surgery

Exclusion Criteria:

* Previous allergy to one of the study products
* Two or more procedures in different anatomical sites at the same time / surgery (v.g. hysterectomy and mastectomy)
* Pregnancy
* Breast feeding
* Contaminated or infected surgeries

Primary outcomes:
measure: Surgical site infection
timeFrame: 30-45 days
Secondary outcomes:
measure: Cost analysis
timeFrame: 30-45 days
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Institute of Cancerology
state: DF
Study officials:
affiliation: Instituto Nacional de Cancerologia, Columbia
name: Diana Vilar-Compte, MD;MsC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04488172: Exploring the Effects of Genetic Variants and Inflammation on Vitamins Supplementation Treatment Outcomes in Epilepsy
Official title: Exploring the Effects of Genetic Variants and Inflammation on Individualized Treatment Outcomes of Vitamins Supplementation in Patient With Epilepsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Keywords: pharmacogenomics
antiepileptic drugs
multi-vitamins supplementation
epilepsy
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The management of patients with epilepsy is focused on controlling seizures, avoiding treatment side effects, and restoring quality of life. However, about 30% of people are antiepileptic drugs (AEDs) resistance epilepsy after the adequate trials of two AEDs treatment. Genetic factors may contribute to the high interindividual variability in response or adverse effects (such as weight gain and altered lipid profiles) to AEDs. What's more, previous observational studies indicated that vitamin deficiency, such as vitamin B6, is common in patients with epilepsy due to epilepsy itself, AEDs use, or both. Therefore, investigators aim to (1) evaluate the impact of genetic variants on AED and multi-vitamins supplementation in epilepsy, and (2) establish the pharmacogenomics knowledge base of AED and multi-vitamins supplementation on clinical effectiveness in patients with epilepsy.

Detailed description: In the current study, investigators will evaluate the association among the genetic polymorphisms, epilepsy, and multi-vitamins supplementation from Taiwan Biobank and will further investigate potential genes related to vitamins signal pathways (especially vitamin B6, B9, D, E, and Q) involved in epilepsy. These results will not only generate the field of AEDs pharmacogenomics for further study, but also provide new potential treatment targets that may involve in epilepsy therapeutics. The clinical outcomes indicate disease severity, body weight, metabolic indices (i.e., the fasting levels of lipid), HRQoL, anxiety and depression scores. All outcome indicators will be repeated measured at baseline and after 1, 3 and 6 months multi-vitamins supplementation. All of the participants will be assessed the genotypes.

Eligibility criteria: Inclusion Criteria:

* Diagnostic criteria of epilepsy
* Receive anti-epileptic drugs (AEDs)

Exclusion Criteria:

* Have an organic mental disorder, mental retardation, dementia, or other diagnosed neurological illness
* Have a surgical condition or a major physical illness
* Pregnant or breast-feeding

Primary outcomes:
measure: Seizure severity
timeFrame: 6 months
Secondary outcomes:
measure: Medication Compliance
timeFrame: 6 months
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University (NCKU) Hospital
Study officials:
References:
Clinical trial NCT01625572: Ultrasound-assisted Bilateral Transversus Abdominis Plane Block for Open Prostatectomy
Official title: Ultrasound-assisted Bilateral Transversus Abdominis Plane Block for Open Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatectomy
Transversus Abdominis Plane Blockade
Pain
Keywords: general anaesthesia
epidural catheter
intravenous pain therapy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2012-06-21
Enrollment: 66
Sex: MALE
Minimum age (years): 18
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 quality of a transversus abdominis plane blockade with an intravenous pain therapy with opioids. Due to the relatively low side effect profile and comparably few contraindications, this method offers a good option, to be a standard procedure or better alternative in the treatment of pain in surgery of the prostate.


Eligibility criteria: Inclusion Criteria:

* patients at the age of 18 and above, who need an open prostatectomy
* written consent exists

Exclusion Criteria:

* American Society of Anaesthesiologists (ASA) classification \> III
* Allergy to local anaesthesia
* Contraindications to one of the applied methods
* previous surgery on the abdominal wall
* chronic pain patients
* Myasthenia gravis
* alcohol dependence
* increased intraocular pressure
* lacking willingness to save and hand out data within the study
* Participation in another trial according to the German Drug Law
* accommodation in an institute due to an official or judicial order

Primary outcomes:
measure: Pain in rest in the op-area
timeFrame: 3 days
Secondary outcomes:
measure: Opioid consumption
timeFrame: 3 days
measure: Pain in motion in the op-area
timeFrame: 3 days
measure: Pain outside the op-area
timeFrame: 3 days
measure: Contentment with the pain therapy at all
timeFrame: 3 days
measure: Frequency of postoperative vomiting and nausea
timeFrame: 3 days
measure: Incidence of pruritus
timeFrame: 3 days
measure: Tenesmuses of the bladder
timeFrame: 3 days
measure: Contentment of the Patient at all
timeFrame: 3 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anaesthesiology and Intensive Care Medicine Campus Charitè Mitte, Charite Universitätsmedizin Berlin
Study officials:
affiliation: Charite, Department of Anesthesiology and Intensive Care, Campus Mitte, Universitätsmedizin Berlin
name: Jürgen Birnbaum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04189172: MiDura-Study (Neuro-Patch in Duraplasty)
Official title: Multicenter, International, Prospective, Observational, Study Using Neuro-Patch® in Duraplasty in Neurosurgery (MiDura)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Meningioma
Tumor, Brain
Chiari Malformation
Vascular Malformation
Hydrocephalus
Tethered Cord
Dural Fistula
Craniotomy
Spinal Surgery
Duraplasty
Keywords: duraplasty
dural substitute
synthetic graft
Neuro-Patch®
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2019-12-06
Enrollment: 328
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: adult patients

Brief summary: The aim of this study is to collect systematically and proactively data regarding the performance of Neuro-Patch, like complications and handling, under daily clinical practice when used as intended by the manufacturer


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age \> 18 years
* Duraplasty using Neuro-Patch® according to the Instructions for Use

Exclusion Criteria:

* Use in infected regions
* Use in open cerebrocranial traumata
* Use in open spina bifida
* Known hypersensitivity to implant materials
* Pregnancy
* Representation by a legal guardian or under involuntary commitment

Primary outcomes:
measure: Incidence of complications
timeFrame: until follow-up (up to one year after surgery)
Secondary outcomes:
measure: Handling measures
timeFrame: Intraoperative
measure: Incidence of complications not related to Neuro Patch
timeFrame: until follow-up (up to one year after surgery)
Other outcomes:
Locations:
city: Brest
country: France
facility: Service de Neurochirurgie, Hôpital de la Cavale Blanche
city: Bron
country: France
facility: Hopital Pierre Wertheimer - HCL
city: Homburg/Saar
country: Germany
facility: Klinik für Neurochirurgie, Universitätsklinikum des Saarlandes
city: Meppen
country: Germany
facility: Krankenhaus Ludmillenstift
Study officials:
References:
Clinical trial NCT01724372: The Role of Antidepressants or Antipsychotics in Preventing Psychosis
Official title: The Role of Antidepressants or Antipsychotics in Preventing Psychosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Psychotic Disorder
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
Collaborators: name: The Zucker Hillside Hospital
First posted: 2012-11-09
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled pilot study comparing the antidepressant fluoxetine with the second generation antipsychotic aripiprazole in approximately 10 subjects aged 12-25 at risk for developing psychosis.

Our primary hypotheses are that compared to aripiprazole, fluoxetine will be better tolerated and will lead to greater improvement in symptoms at the end of 6 months of treatment.


Eligibility criteria: Inclusion Criteria:

* 12-25 years of age (inclusive)
* Able to understand and speak English
* Have at least one sub-threshold positive psychotic symptom that is moderate, moderately severe, or severe

Exclusion Criteria:

* Lifetime diagnosis of an Axis I psychotic disorder: schizophreniform disorder; schizophrenia; schizoaffective disorder; bipolar disorder; or major depression with psychotic features
* Current psychosis
* Current diagnosis of Major Depressive Disorder, single episode or recurrent, severe without psychotic features
* Lifetime diagnosis of substance abuse or dependence (excluding nicotine)
* Current stimulant treatment
* Any significant medical condition that contra-indicates treatment with either aripiprazole or fluoxetine, including history of neurological, neuroendocrine or other medical condition known to affect the brain
* Estimated intelligence quotient \< 70

Primary outcomes:
measure: Attenuated positive, negative and general psychiatric symptoms
timeFrame: 6 months
Secondary outcomes:
measure: Social and role functioning
timeFrame: 6 months
measure: Time to all-cause discontinuation.
timeFrame: 6 months
measure: Adverse effects
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03745872: SunSmart Intervention in Schools
Official title: SunSmart Intervention in Schools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Keywords: Sunscreen
Sun Exposure
Behaviors
Baseline Assessments
Follow-up Assessments
Knowledge
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 76
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All students who participate in this study will be given a pre test, instruction regarding sun exposure and a post test to determine their sun exposure behaviors and knowledge of sun exposure risks.
Primary purpose: PREVENTION

Brief summary: A prevention study to improve sun exposure behaviors in children after an educational classroom-based intervention.

Detailed description: This study aims to demonstrate that learning about sun exposure using a more classroom-based intervention will motivate classroom students to reduce exposure at a critical life period and will create lifetime learned sun exposure behaviors. Students' sun exposure behaviors will be assessed prior to the educational intervention. The educational intervention consists of three educational sessions and one lab lesson. At the conclusion of the intervention, students' sun exposure behaviors will be assessed again via a post-intervention questionnaire.

Eligibility criteria: Inclusion Criteria:

* Any children between grades 4 and 8 enrolled in one of the participating schools.

Exclusion Criteria:

* No exclusions, but children or their parents may opt out of participating.

Primary outcomes:
measure: Sun Exposure Knowledge
timeFrame: From the administration of the questionnaire to the end of the followup questionnaire, up to 3 years
measure: Sun Exposure Attitudes
timeFrame: From the administration of the questionnaire to the end of the followup questionnaire, up to 3 years
measure: Sun Exposure Behavior
timeFrame: From the administration of the questionnaire to the end of the followup questionnaire, up to 3 years
Secondary outcomes:
measure: Mediators of Program Effects: Attitudes
timeFrame: During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years
measure: Mediators of Program Effects: Norms
timeFrame: During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years
measure: Mediators of Program Effects: Personal Agency
timeFrame: During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Evelinn Borrayo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01304472: Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment
Official title: Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease (CAD)
Keywords: coronary angioplasty
clopidogrel resistance
prasugrel
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Clopidogrel administration is considered standard of care in patients with stable coronary artery disease post PCI. However , a significant proportion of patients is considered clopidogrel resistant and this is shown to be accompanied by future adverse events. The hypothesis of the study is to define among consecutive outpatient clinics individuals with stable coronary artery disease being on chronic clopidogrel treatment, those that are clopidogrel resistant, as assessed with the VerifyNow point of care assay. Clopidogrel resistant patients will be randomized in a 1:1 fashion to either prasugrel 10mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at Day 14, when treatment crossover will be performed without a washout period. At Day 28 platelet reactivity will be assessed as well.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old
* Patients with history of coronary artery disease under chronic (≥ 6 months) clopidogrel treatment
* High on-clopidogrel platelet reactivity (≥235 Platelet Reactivity Units as assessed with the VerifyNow assay)
* Written Informed Consent

Exclusion Criteria:

* History of bleeding diathesis
* History of active bleeding within 6 months before randomization
* Chronic oral anticoagulation treatment
* Contraindications to antiplatelet treatment
* Known platelet function disorders
* Acute coronary syndrome within 30 days before randomization
* Cardiogenic shock
* Planned Percutaneous Coronary Intervention in the next 30 days
* Cancer
* Haemodialysis
* Platelet count \< 100000/μL
* Hematocrit \< 30%
* High likelihood of being unavailable on the Day 28 visit
* History of stroke
* Known allergy to clopidogrel and/or prasugrel

Primary outcomes:
measure: Change in Platelet Reactivity
timeFrame: At 14 and 28 days after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Dimitrios Alexopoulos
city: Patras
country: Greece
facility: Patras University Hospital Cardiology Department
Study officials:
References:
Clinical trial NCT06768372: Temporomandibular Joint Dysfunction Prevalence and Oral Habits, Food Consumption Frequency and Eating Behaviour
Official title: Investigation of the Relationship Between Temporomandibular Joint Dysfunction Prevalence and Oral Habits, Food Consumption Frequency and Eating Behaviour in University Students: a Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Temporomandibular Joint Disorders
Oral Habits
University Students
Keywords: Temporomandibular Joint Dysfunction
Oral Habits
Food Consumption
Eating Behaviour
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University students

Brief summary: This study was planned to investigate the prevalence of TMD in university students and to determine possible predisposition factors by evaluating oral habits, food consumption frequency and eating behaviors thought to be related to TMD.

Detailed description: No study has been found examining the relationship between temporomandibular joint dysfunction (TMD) and oral habits, food consumption frequency and eating behavior. In this context, it is thought that understanding the relationships mentioned may provide different perspectives and help develop an effective treatment program.

Eligibility criteria: Inclusion Criteria:

1. Continuing undergraduate education at faculties/colleges affiliated with Karadeniz Technical University
2. Being able to read and write in Turkish
3. Agreeing to participate in the study

Exclusion Criteria:

1. Having a local or systemic disease that may affect oral and jaw health
2. Having had an operation / trauma to the cervical region or TMJ

Primary outcomes:
measure: Assessment of Presence and Severity of Temporomandibular Dysfunction
timeFrame: an average of 6 months
Secondary outcomes:
measure: Oral Habits
timeFrame: an average of 6 months
measure: Food Consumption Frequency
timeFrame: an average of 6 months
measure: Eating Behavior
timeFrame: an average of 6 months
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical Univerity
Study officials:
References: