louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02001246: Two Anger Management Programs for Teens.
Official title: An Exploratory Study of Two Intervention Programs for Anger Management for Teens.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anger
Hostility
Aggression
Keywords: mindfulness
cognitive behavior therapy
awareness
anger
aggression
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 35
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The general aim of the proposed pilot study is to evaluate the the efficacy of mind-body bridging (MBB) for anger management compared with the Real Deal anger management program, in helping adolescents control or reduce their anger.

Detailed description: In this pilot randomized-controlled study, we evaluate the effects of MBB as compared with an established anger management program (Real Deal), in helping youth prone to anger develop tools to effectively reduce and control their anger, and potentially reduce other negative emotions and feelings that might be associated with their anger.

Eligibility criteria: Inclusion Criteria:

* English-speaking
* self-, or allo-referred (parents, peers, court-ordered, school, etc.), based on their propensity for displaying various disruptive, externalizing behaviors, including, anger, hostility, oppositional behavior, and temper outbursts, and as such identified by Youth Services (YS) as a suitable candidate to attend a YS anger management program.

Exclusion Criteria:

* none

Primary outcomes:
measure: Change from baseline at Post-assessment in the measure of the Youth Outcomes Questionnaire 30-item (YOQ30)
timeFrame: Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
measure: Change from baseline at Post-assessment in the measure of the Brief Aggression Questionnaire (BAQ)
timeFrame: Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
Secondary outcomes:
measure: Change from baseline at Post-assessment in the measure of Mindfulness
timeFrame: Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
measure: Change from baseline at Post-assessment in the measure of Self-compassion
timeFrame: Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Pain Research Center, Anesthesiology, University of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Salt Lake County Youth Services
state: Utah
Study officials:
affiliation: University of Utah
name: Yoshio Nakamura, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05668546: Is Isokinetic Testing an Indicator of Total Knee Arthroplasty
Official title: Is Isokinetic Knee Muscle Strength an Indicator of Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: arthroplasty
diagnostic x-ray
knee
muscle strength dynamometer
visual analog scale
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2022-12-30
Enrollment: 29
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: In this study, investigators analyzed whether the isokinetic knee muscle strength of patients undergoing unilateral total knee arthroplasty (TKA) is a predictor for surgery.

Patients and Methods: In total, 29 unilateral TKA candidates (58 knees; mean age = 66.69 ± 7.42 years; mean symptom duration = 10 ± 5.40 years) were enrolled. The knees of patients with bilateral advanced knee osteoarthritis (stage 3 or 4), according to the Kellgren-Lawrence (K-L scale), that were scheduled for unilateral TKA were divided into surgical and non-surgical groups. An isokinetic testing system was used to assess knee flexor and extensor muscle strength (peak torque) at angular velocities of 60°/s and 180°/s (five cycles per velocity). The radiological (X-ray-based K-L scale and magnetic resonance imaging (MRI)-based quadriceps angle) and clinical findings (isokinetic test and visual analog scale pain scores) in both groups were compared. The isokinetic test results correlated with the radiological findings of the surgery group.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of advanced (Kellgren-Lawrence stage 3 or 4) bilateral knee osteoarthritis (OA).
* Unilateral total knee replacement surgery recommended by orthopedics according to pain status

Exclusion Criteria:

* Neurological diseases that could affect knee muscle strength
* Rheumatological diseases
* Diagnosis of osteoarthritis below 3 according to Kellgren-Lawrence classification

Primary outcomes:
measure: Knee flexion and extension muscle strengths assessed by isokinetic dynamometer
timeFrame: cross-sectional study, baseline
measure: Osteoartritis gradings assessed by Kellgren-Lawrence grading system
timeFrame: cross sectional study, baseline
measure: Pain assessed by Visual analog scale
timeFrame: cross sectional study, baseline
measure: Quadriceps angle
timeFrame: cross sectional study, baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Memorial Sisli Hospital
Study officials:
affiliation: Bahcesehir University, Department of Health Sciences
name: ilknur saral, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00099346: MK0457 (an Aurora Kinase Inhibitor) Study in Patients With Advanced Colorectal Cancer and Other Advanced Solid Tumors (0457-001)
Official title: A Phase I/IIa Study Evaluating the Safety/Tolerability, Pharmacokinetics, and Efficacy of MK0457 Administered as a 5-Day Continuous Infusion in Patients With Advanced Colorectal Cancer and Other Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Colorectal Cancer
Advanced Solid Tumors
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-12-13
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: Study with an investigational drug in patients with recurrent or non-responsive colorectal cancer or other advanced solid tumors.

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).


Eligibility criteria: Inclusion Criteria:

* In Part I, patients who are at least 18 years of age with advanced solid tumors and colorectal cancer will be eligible for the first part of this study. Patient must have recovered from and be at least 3 weeks from previous cancer treatment.
* In Part II, only patients with colorectal cancer will be eligible to participate. The patients may have received up to 3 prior treatments for their colorectal cancer. Patients must have recovered from and be at least 3 weeks from previous therapy.

Exclusion Criteria:

* Patients who have had treatment with any investigational drug within the past 30 days.
* Patients who have certain types of blood cancers such as leukemia or lymphoma.
* Patients who have uncontrolled congestive heart failure (CHF), chest pain, or heart attack within the past 3 months.
* Patient is pregnant or nursing.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04524546: Sternomental Displacement Test for Predicting Difficult Airway in Obese Patients
Official title: Sternomental Displacement and Neck Circumference as Predictors of Difficult Airway in Obese Patients During General Anesthesia: a Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Difficult Airway Intubation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of either sex, aged between 18-60 years old, ASA physical status II \& III with BMI \> 30 Kg/m2

Brief summary: Difficulties airway significantly contribute to the morbidity and mortality associated with anesthesia. Identifying situations and patients at risk for airway management problems is the key to optimal care and has been the focus of numerous publications. Although controversial, Body Mass Index (BMI) is considered as associated with difficult intubation in both and operating theaters. A modified measurement of SMD is obtained with the head in neutral position (SMD neutral), then the difference between SMD extension and SMD neutral was calculated and it was referred to as sternomental displacement (SMDD). SMDD was proved to be a good objective predictor for difficult laryngoscopy in adult patients, and its predictive ability was increased when combined with other tests as neck circumference (NC). To the best of our knowledge, the validity of the SMDD test was not previously assessed in obese patients.


Eligibility criteria: Inclusion Criteria:

* Patients of either sex, aged between 18-60 years old, ASA physical status II \& III with BMI \> 30 Kg/m2 undergoing elective surgical procedures under general anesthesia using endotracheal intubation by conventional laryngoscopy.

Exclusion Criteria:

* neuromuscular disorders, craniofacial abnormalities, abnormal dentition, lesions or scares in head and neck limiting the neck mobility, uncooperative, who needed awake intubation and patients who underwent emergency operations

Primary outcomes:
measure: A a cut-off value, sensitivity (Sn), specificity (Sp), positive predictive values (PPV), negative predictive values (NPV) of sternomental displacement in predicting difficult laryngoscopy in obese patient undergoing GA.
timeFrame: before induction of general anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Anesthesia department - Faculty of medicine- Cairo University
Study officials:
References:
Clinical trial NCT02347046: Clinical Pharmacology of FYU-981 (Subjects With Renal Insufficiency)
Official title: Clinical Pharmacology Study of FYU-981 for Subjects With Renal Insufficiency.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Insufficiency
Healthy
Lead sponsor: Fuji Yakuhin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-01-27
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with renal insufficiency and with normal renal function.


Eligibility criteria: Inclusion Criteria:

* Japanese adult subjects
* Body mass index: \>=18.5 and \<30.0

Exclusion Criteria:

* Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study

Primary outcomes:
measure: Pharmacokinetics (Cmax: Maximum plasma concentration)
timeFrame: 48 hours
measure: Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
timeFrame: 48 hours
measure: Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
timeFrame: 48 hours
measure: Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
timeFrame: 48 hours
measure: Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
timeFrame: 48 hours
measure: Pharmacokinetics (kel: Elimination rate constant)
timeFrame: 48 hours
measure: Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
timeFrame: 48 hours
measure: Pharmacokinetics (MRT: Mean residence time)
timeFrame: 48 hours
measure: Pharmacokinetics (Ae: Amount of drug excreted in urine)
timeFrame: 48 hours
measure: Pharmacokinetics (fe: Fraction of dose excreted in urine)
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kagoshima
country: Japan
facility: Japan
Study officials:
References:
citation: Fukase H, Okui D, Sasaki T, Fushimi M, Ohashi T, Hosoya T. Effects of mild and moderate renal dysfunction on pharmacokinetics, pharmacodynamics, and safety of dotinurad: a novel selective urate reabsorption inhibitor. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):17-24. doi: 10.1007/s10157-019-01825-3. Epub 2019 Dec 10.
Clinical trial NCT00377546: Comparison of Vitreous Levels of Acular LS 0.04%, Xibrom 0.09%, and Nevanac 0.1%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitrectomy
Keywords: Retinal Surgery
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2006-09-18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To compare the penetration of three different NSAIDs.


Eligibility criteria: Inclusion Criteria:

* Males or females scheduled to undergo Vitrectomy surgery
* Likely to complete all study visits and able to provide informed consent
* Visual potential of 20/25 or better

Exclusion Criteria:

* Known contraindications to any study medication or ingredients
* Active ocular diseases or uncontrolled systemic disease
* Active ocular allergies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
Study officials:
affiliation: Ophthalmic Consultants of Boston
name: Jeffrey Heier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02274246: Validation of the Efficacy of the Tool GIMIAS® for the Assessment of Left Atrial Fibrosis in a Group of Healthy Volunteers (RESTORE-HV)
Official title: GIMIAS® Tool Validation for the Detection of Left Atrium Fibrosis Through Late Enhancement Magnetic Resonance Image Processing. Pattern Determination in a Cohort of Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Left Atrial Fibrosis
Keywords: Segmentation
GIMIAS® program
Atrial fibrillation
Left atrial fibrosis
Healthy volunteers
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2014-10-24
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to validate the technique for the detection of left atrial fibrosis through segmentation of endocardial and epicardium landmarks of the images obtained with 3 Tgadobutrol-enhanced magnetic resonance with the software GIMIAS® in a cohort of healthy volunteers, without atrial fibrillation or known cardiovascular risk factors.

Detailed description: 3D reconstructions obtained by GIMIAS® will be evaluated. Processing images will be carried out by two independent operators, and will calculate the kappa interobserver agreement .

Subsequently, the processed images are compared with images previously obtained in 10 patients with persistent atrial fibrillation adjusted for sex and age. A qualitative visual comparison will be made.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers capable of being subjected to the prespecified tests of the study.
* Healthy volunteers that sign the informed consent after being informed.

Exclusion Criteria:

* Healthy volunteers with:
* A medical history of atrial fibrillation, hypertension or diabetes mellitus.
* A medical history of heart disease, structural, ischemic or arrhythmic.
* A medical history of chronic obstructive pulmonary disease/obstructive sleep apnoea/hypopnoea syndrome
* Sport habits: intense sport activities during three or more hours in a week
* Any assumption that contraindicates the magnetic resonance and/or the use of gadolinium or other contrast mediums, including a medical history of previous allergic or not allergic reactions with the use of gadolinium or other contrast mediums, bronchial asthma or allergic diseases.
* Pregnancy or breast feeding.

Primary outcomes:
measure: Proportion of subjects with contrast enhancement in left atrium, measured through the reconstruction and processing of late enhancement magnetic resonance images with GIMIAS.
timeFrame: Baseline
Secondary outcomes:
measure: Adverse events
timeFrame: 1 week after intervention
measure: Interobserver variability in the generation of segmented images of left atrium, measured through the kappa index.
timeFrame: 1 week after intervention
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
Study officials:
References:
Clinical trial NCT00553046: Last 3 Months of Life in Home Ventilated Patients
Official title: Italian Multicenter Survey on the Last 3 Months of Life in Patients Ventilated at Home
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Keywords: ethics
COPD
end of life
mechanical ventilation
CRF home ventilated patients
Lead sponsor: Fondazione Salvatore Maugeri
Sponsor class: OTHER
First posted: 2007-11-02
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Home MV patients in the last 3 months of life

Brief summary: To verify with a specific questionnaire, the families' perceived quality of end-of-life care and of dying in the last 3 months of life of 168 patients (Chronic Obstructive Pulmonary Disease-Amyotrophic Lateral Sclerosis (ALS)-Restrictive disorders-Neuromuscular disease- others) with chronic respiratory failure needing domiciliary mechanical ventilation (MV).

Detailed description: Participants: 168 patients' relatives presenting five categories of diseases (Chronic Obstructive Pulmonary Disease-Amyothrophic Lateral Sclerosis (ALS)-Restrictive disorders-Neuromuscular disease- others) answered to questionnaire.

Interventions: none Measurements and Main Results: 35 questions grouped in 6 specific domains (Control of pain and symptoms (domain 1-D1), awareness of disease (D2), family burden (D3), the process of dying (D4), medical troubles including hospitalizations (D5) and technical problems linked to MV(D6) were asked after the patient's death to a family member by means of a face to face interview. Answers to the binary 35-item questionnaire were distributed into just two clusters per each domain.

Eligibility criteria: Inclusion criteria:

All patients mechanically ventilated at home who died

Exclusion criteria:

patients with cancer

Primary outcomes:
measure: level of family burden
timeFrame: 3 months after patient's death
Secondary outcomes:
measure: influence of diagnosis and modality of ventilation
timeFrame: 3 months after patient's death
Other outcomes:
Locations:
city: Lumezzane
country: Italy
facility: FSM Respiratory Unit
state: BS
Study officials:
affiliation: Fondazione S. Maugeri IRCCS
name: michele vitacca, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singer PA, Martin DK, Kelner M. Quality end-of-life care: patients' perspectives. JAMA. 1999 Jan 13;281(2):163-8. doi: 10.1001/jama.281.2.163.
citation: Vitacca M, Comini L & Barbano L. Home mechanical ventilation difficulties in the last 3 months of life as reported by caregivers. J Med Pers 11:30-36, 2013. DOI 10.1007/s12682-012-0128-8
Clinical trial NCT04683146: Pre-surgical Antisepsis Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate ( Sorbectol )
Official title: Effectiveness of Pre-surgical Hand Washing in Reducing Bacterial Load, Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Antisepsis
Lead sponsor: Centro Ortopedico y Quirurgico del Pie
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment Crossover design is used
Primary purpose: TREATMENT

Brief summary: The present study evaluates the effects of bactericidal load reduction after surgical hand antisepsis using the reference antiseptic product propanol- 1 60% as control versus a surgical hand antisepsis with addition of a solution of alcohol, chlorhexidine digluconate and potassium sorbate in order to test if pass the standard european norm 12791.

Detailed description: The investigators conducted a crossover clinical trial to evaluate the antiseptic effectiveness of surgical hand antisepsis using propan-ol-1 60% by using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand antisepsis with addition of a solution of alcohol, chlorhexidine digluconate and potassium sorbate in order to test if pass the standard european norm 12791. Samples will be taken from the hands of each volunteer after a surgical hands antiseptic.

Eligibility criteria: Inclusion Criteria:

* Participants with healthy skin in both hands and short fingernails.
* No use of antibacterial agents for at least three days before the intervention.
* Not received antibiotic treatment for at least ten days before the intervention.

Exclusion Criteria:

* Known systemic pathologies
* Wearing hand jewelry on the hands
* Allergy to any ingredient of which the solutions used in the clinical trial are composed
* Cognitive and / or motor limitation that makes it impossible to carry out instructions for hand washing

Primary outcomes:
measure: Reduction of bacterial load immediately after hand scrub
timeFrame: Change from bacterial load at 5 minutes]
Secondary outcomes:
measure: Reduction of bacterial load after 3 hours of hand scrub
timeFrame: Change from bacterial load at 3 hours
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Complutense de Madrid
name: Ricardo Becerro de Bengoa Vallejo
role: PRINCIPAL_INVESTIGATOR
References: