louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03175822: Effects of Visual Art Training on Dementia
Official title: Effects of Visual Art Training on Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Lead sponsor: York University
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 83
Sex: ALL
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 the proposed study is to better understand what benefits visual art has on reducing problematic symptoms in dementia patients, including those with Alzheimer's disease.

Detailed description: Participants:

Participants will be residents, attendees and/or members of assisted living locations and/or dementia (or related) day programs. There will be two groups: an art training group and a waitlist control group.

Data Analysis:

1. For primary measures, t-tests on pre-post difference scores comparing art training and waitlist groups.
2. For possible confounding effects, tests for confounds related to background factors (socioeconomic status, education level, gender, activity participation).

Procedure:

A randomized controlled trial design will be utilized to assess two groups of dementia patients: an art training experimental group and a structured usual-activity waitlist control group. The experimental group will participate in a visual art training program and the waitlist control group will participate in their usual structured group activities. The waitlist control group will receive the art training program once post-testing is complete. Before, during, and/or after the art programs and/or control activities, participants will be observed and complete assessments.

Eligibility criteria: Inclusion Criteria:

* Dementia

Exclusion Criteria:

* Inability to participate in the art training program due to physical or cognitive limitations

Primary outcomes:
measure: Change in cognition
timeFrame: baseline up to three weeks prior, and final assessment one to two weeks post-intervention
measure: Change in visual working memory
timeFrame: baseline up to three weeks prior, and final assessment one to two weeks post-intervention
measure: Change in auditory working memory
timeFrame: baseline up to three weeks prior, and final assessment one to two weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: Canada
facility: Alzheimer's Society of York Region
state: Ontario
Study officials:
References:
citation: Johnson KG, D'Souza AA, Wiseheart M. Art Training in Dementia: A Randomized Controlled Trial. Front Psychol. 2020 Dec 15;11:585508. doi: 10.3389/fpsyg.2020.585508. eCollection 2020.
Clinical trial NCT00168922: Study to Determine the Efficacy of Bendamustin in Patients With Recurrent Small Cell Lung Cancer (SCLC)
Official title: Phase II Study to Determine the Efficacy of Bendamustin (Ribomustin) in Patients With Recurrent Small Cell Bronchial Carcinoma After Cytostatic Polychemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent Small Cell Lung Cancer
Keywords: recurrent SCLC
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: ribosepharm GmbH
First posted: 2005-09-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Determination of response rate Assessment of toxicity and determination of "time to progression"

Detailed description: Phase II Study to determine the efficacy of Bendamustin(Ribomustin) in patients with recurrent small cell bronchial carcinoma after cytostatic polychemotherapy

Eligibility criteria: Inclusion Criteria:

* Patients with histological proven, curative non treatable small lung cell carcinoma
* Recurrence \>8 weeks, \> 1 year after 1st line treatment with platin- and etoposide polychemotherapy, without brain metastases

Exclusion Criteria:

* Brain metastases
* WHO-PS 3 - 4

Primary outcomes:
measure: Determination of response rate ( CR + PR) after cytostatic therapy with Bendamustin 120mg/m2, day 1+2, repeat d 22
measure: (primary goal)
Secondary outcomes:
measure: Assessment of toxicity, determination of time to progression, for median survival and one-year survival rate,investigation of life quality (secondary goal)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Hematology & Oncology Charité CBF Berlin, Germany
Study officials:
affiliation: Charité Campus Benjamin Franklin University Clinic
name: Ulrich Keilholz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05778422: Bupivacaine or Radiofrequency for Shoulder Pain
Official title: Comparative Study Between Pulsed Radiofrequency in Suprascapular Nerve or Bupivacaine Block for Chronic Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Rotator Cuff Impingement Syndrome
Impingement Syndrome
Adhesive Capsulitis
Rotator Cuff Injuries
Keywords: shoulder pain
Pulsed radiofrequency
Bipuvacaine
Nerve block
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1 - pulsed radiofrequency Group 2 - bupivacaine
Primary purpose: TREATMENT

Brief summary: Comparative study between pulsed radiofrequency in suprascapular nerve or bupivacaine block for chronic shoulder pain

Detailed description: Prospective, randomized, comparative study of 40 participants with chronic shoulder pain allocated into two groups. Patients in group 1 underwent pulsed RF (180sec, with a fixed temperature at 42C, twice) on the suprascapular nerve, and the other group, 2, underwent nerve block with bupivacaine (5ml). After the procedure, patients were evaluated for 3 months regarding pain intensity, shoulder range of motion and dose of rescue opioids.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years old
* Chronic shoulder pain (more than 3 months)
* Clinical and imaging diagnosis: rotator cuff injury, adhesive capsulitis, supraspinatus, tendinopathy, bicipital tendinitis, impingement syndrome, subscapularis tendinopathy, , subacromial and subdeltoid arthrosis, acromioclavicular arthrosis, subdeltoid subacromial bursitis
* Pain intensity ≥4 on movement, on a numerical scale from zero to 10 (where zero means no pain and 10 the most intense pain imaginable).

Exclusion Criteria:

* Arrhythmia
* Cognitive change (inability to answer questions)
* Psychiatric illness
* Infection at the site of the procedure
* Coagulopathy,
* Use of anticoagulants
* Hypersensitivity to medications
* Pregnant
* Use of pacemaker

Primary outcomes:
measure: Comparison of pain intensity after application of pulsed RF in the suprascapular nerve versus injection of a local anesthetic.
timeFrame: 12 months
Secondary outcomes:
measure: To assess the range of motion of the shoulder joint
timeFrame: 12 months
measure: Need for additional analgesic.
timeFrame: 12 months
measure: Duration of the analgesic effect.
timeFrame: 12 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo - Hospital Sao Paulo
Study officials:
References:
Clinical trial NCT06447922: Metal Ion Concentrations After Total Knee Arthroplasty
Official title: Analysis of Metal Ion Concentrations After Robotic-assisted Total Knee Arthroplasty Compared to Conventional Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthroplasty, Replacement, Knee
Total Knee Replacement
Blood Metal Ion Concentration
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients eligible for a primary total knee replacement who have not had a prior joint replacement or surgery where metal implants were placed.

Brief summary: The purpose of this study is to analyze the metal ion concentrations in the patients blood following robotic-assisted total knee arthroplasty (TKA) compared to conventional total knee arthroplasty using cutting guides.

Detailed description: This study focuses on comparing metal ion levels in 50 inpatient participants undergoing primary total knee arthroplasty (TKA) with either conventional cutting guides or robotic assistance. Baseline blood examinations for Cobalt, Chromium, Titanium, and Nickel will be performed before TKA implantation at preoperative visits and on the first day following the procedure. The investigation will encompass patients receiving both conventional and robotic-assisted primary TKA, framed within a prospective cohort study design. Baseline characteristics and additional follow-up information will be gathered.

Eligibility criteria: Inclusion Criteria:

* Adults undergoing conventional or robotic-assisted TKA
* Consent to the study

Exclusion Criteria:

* Patients who have undergone any previous arthroplasty procedures.
* Patients with metal implants, such as plates, nails, and screws, used in the repair of traumatic injuries.
* Patients below 110 pounds.

Primary outcomes:
measure: Overall blood metal ion differences between procedures (Conventional TKA vs Robot-Assisted TKA)
timeFrame: Pre-operatively, first post-operative day.
Secondary outcomes:
measure: Comparison of post-operative blood metal levels between procedures: Cobalt
timeFrame: First post-operative day
measure: Comparison of post-operative blood metal levels between procedures: Chromium
timeFrame: First post-operative day
measure: Comparison of post-operative blood metal levels between procedures: Titanium
timeFrame: First post-operative day
measure: Comparison of post-operative blood metal levels between procedures: Nickel
timeFrame: First post-operative day
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew P Abdel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00974922: Vitamin D Deficiency in Patients With Hypertension
Official title: Vitamin D Deficiency, Renin Inhibitor Response, and Vitamin D Supplementation in Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Vitamin D Deficiency
Hypertension
Keywords: Vitamin D
Hypertension
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2009-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effects of Vitamin D replacement and the effects of an approved medication for hypertension, aliskiren (Tekturna), in patients with high blood pressure who have low levels of vitamin D in their blood. The study will compare the effects of vitamin D or aliskiren alone and in combination on 24-hour blood pressure and biochemical parameters.

Detailed description: This study will assess whether aliskiren will lower clinic blood pressure and 24-hour blood pressure in patients with hypertension and vitamin D deficiency. Additionally, this study will further explore the potential additional effects of adding vitamin D to aliskiren in this patient population.

Eligibility criteria: Inclusion Criteria:

* Men or women over 21 years of age with a history of Stage 1 or 2 hypertension (defined as a seated diastolic BP ≥ 90 mmHg and \< 110 mmHg in the untreated state).
* Patients under treatment for hypertension must be willing and able to discontinue any previous antihypertensive medications for the duration of the study.
* 25-hydroxyvitamin D levels \< 30 ng/ml and \> 12 ng/ml.
* Women of childbearing potential must be using a medically acceptable form of birth control for the duration of the trial, must have a negative serum pregnancy test at screening, and must have a negative urine pregnancy test within 7 days before initiating aliskiren therapy.

Exclusion Criteria:

* Vitamin D levels \< 12 ng/ml
* Known hypersensitivity or allergy to aliskiren
* Clinic blood pressure \> 180/110 mmHg
* Known forms of secondary hypertension
* Chronic atrial fibrillation
* Uncontrolled or unstable cardiovascular diseases
* Shift or night workers
* Mid-arm circumference \> 42 cm in diameter
* Current or recent (\<1 year) alcohol or drug abuse
* Pregnant or lactating women

Primary outcomes:
measure: Change From Baseline in Ambulatory Diastolic Blood Pressure
timeFrame: six weeks
Secondary outcomes:
measure: Change From Baseline Blood Pressure Measurement in 24-hour Systolic BP, Changes in Awake and Sleep Systolic and Diastolic BP, and Changes From Baseline in Clinic Systolic and Diastolic BP.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: Pat and Jim Calhoun Cardiology Center, University of Connecticut Health Center
name: William B White, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04829422: Early Access Program of Lazertinib in Republic of Korea
Official title: Multi-center, Prospective, Early Access Program of Lazertinib in Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Patients With T790M Mutation-positive After 1st/2nd Generation EGFR TKIs Therapy to Assess the Safety and Efficacy of Real World Evidence.
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Lung Cancer
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2021-04-02
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT

Brief summary: This early access program will be conducted to provide access to Lazertinib for adult patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with T790M mutation-positive after 1st/2nd generation EGFR TKIs Therapy.

Detailed description: Lazertinib is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase inhibitors (TKIs) targets both the T790M mutation and activating EGFR mutations while sparing wild type-EGFR.

This is a Multi-center, Prospective, Early Access Program of Lazertinib in locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) patients with T790M mutation-positive after 1st/2nd generation EGFR TKIs therapy to assess the safety and efficacy of real world evidence as second-line treatment.

Eligibility criteria: Inclusion Criteria:

* Patients aged at least 19 years
* Patients who have written consent for use of personal and medical information for the study purpose
* Patients who are prescribed and administered with approved indication for Lazerinib in Korea and not been treated with Lazertinib previously.

Exclusion Criteria:

* Patients with hypersensitivity to Lazertinib or its any ingredients
* Patients who belong to contraindication listed on lazertinib label in Korea
* Patients who are treated for an indication not approved for the use of Lazertinib
* Women who are pregnant or may possibly become pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02206022: Remifentanil And Local Anesthesia Compared With Local Anesthesia For The Insertion Of Central Venous Catheters
Official title: REMIFENTANIL AND LOCAL ANESTHESIA COMPARED WITH LOCAL ANESTHESIA FOR THE INSERTION OF CENTRAL VENOUS CATHETERS IN AWAKE PATIENTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Local Anesthesia
Keywords: Central Venous Catheter
Remifentanil
local anesthesia
pain
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: At present, there is no reference protocol for Central Venous Catheter (CVC) insertion assuring analgesia, anxiolysis and safety. Medical teams use various levels of analgesia and anesthesia to realize this gesture, from single local anesthesia to general anesthesia. Remifentanil has been shown to decrease pain scores for insertion and removal of long-term central venous access. Remifentanil is also often employed for pediatric or labor analgesia for short acts as procedural sedation.


Eligibility criteria: Inclusion Criteria:

* more than 18 years old
* eligible for CVC insertion

Exclusion Criteria:

* pregnancy
* patients who can't give their consent
* contra-indications to remifentanil infusion

Primary outcomes:
measure: Maximal pain score on numeric rating scale (NRS) will be assessed after the insertion
timeFrame: up to 60 minutes
Secondary outcomes:
measure: Evaluation of patient's anxiety by the Face Anxiety Scale
timeFrame: up to 60 minutes
measure: Patient and physician's satisfaction by a 10-points numeric rating scale
timeFrame: up to 60 minutes
measure: Number of adverse events
timeFrame: up to 60 minutes
measure: Number of realized punctions
timeFrame: up to 60 minutes
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: CHU Toulouse
name: Jean RUIZ, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vardon Bounes F, Pichon X, Ducos G, Ruiz J, Samier C, Silva S, Sommet A, Fourcade O, Conil JM, Minville V. Remifentanil for Procedural Sedation and Analgesia in Central Venous Catheter Insertion: A Randomized, Controlled Trial. Clin J Pain. 2019 Aug;35(8):691-695. doi: 10.1097/AJP.0000000000000725.
Clinical trial NCT02199522: Clinical Observation of Titration Induction and Convention Induction of Propofol
Official title: Clinical Observation of Titration Induction and Convention Induction of Propofol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Propofol Overdose of Undetermined Intent
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As we know propofol is popular use in the anesthesia induction with kilogram and it always cause hypotension. So we compare haemodynamic changes and drug consumption between propofol titrated administration and traditional administration for anesthesia induction.

Detailed description: GroupⅠreceived propofol 2 mg/kg intravenously by Fresenius pump at the speed of 250 mg/min, GroupⅡreceived propofol intravenously by Fresenius pump at the speed of 1 mg/kg/min, and observe's assessment of alertness and sedation(OAA/S) scale of the patients was titrated to 1, then changed to a maintenance dose

Eligibility criteria: Inclusion Criteria:

* Patients with American Society of Anesthesiologists(ASA)Ⅰor Ⅱ and aged 18-60 yr, who were scheduled for general anesthesia.

Exclusion Criteria:

* Hypertension, Severe heart,pulmonary,brain，liver and renal dysfunction; excess obesity , predicted difficult intubation,hearing obstacles;. Allergic to propofol or its fat emulsion;addictive to sedative and other drugs.

Primary outcomes:
measure: systolic pressure diastolic pressure mean blood pressure
timeFrame: 15minutes
Secondary outcomes:
measure: total dosage of propofol using
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Anesthesia ,Sixth Affiliated hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Department of Anesthesia ,Sixth Affiliated hospital of Sun Yat-sen University
name: san q Jin, docter
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02830022: Sleep, Autonomic Nervous System and Cardiorespiratory Capacity in Autism Spectrum Disorders Children (APAUTRES)
Official title: Sleep, Autonomic Nervous System and Cardiorespiratory Capacity in Autism Spectrum Disorders Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autonomic Nervous System Diseases
Sleep
Keywords: autism spectrum disorder
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 78
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Autism Spectrum Disorders (ASD) is a neurodevelopmental disorder which involves social and behavioural impairments. Autonomic dysfunctions and disturbed sleep were often associated to ASD. The investigators proposed to explore the impact of physical activity on these disorders. In this context, it is necessary to characterize the cardiorespiratory capacities of ASD children in order to promote physical activity for this population. To examine potential differences between ASD and control children, some explorations were proposed: a maximal treadmill test, motor evaluation, and orthostatic test (for the evaluation of autonomic nervous system).

An actimetry during one week (evaluation of physical activity and sleep) completed this study in order to specify sleep characteristic and established the possible link between physical activity sleep characteristics and physical fitness in ASD children.


Eligibility criteria: Inclusion Criteria:

* children physically active
* children with an intellectual quotient \>70
* for autism children a diagnosis of autism in accordance to DSMV

Exclusion Criteria:

* history of cardio-vascular disease
* history of asthma or respiratory disease
* Behavior disorders.
* medical treatment by neuroleptic or melatonin or antiepileptic

Primary outcomes:
measure: cardiorespiratory evaluation
timeFrame: 1 day
measure: autonomic nervous system evaluation
timeFrame: 1 day and 3 nights
measure: sleep evaluation
timeFrame: 7 nights
Secondary outcomes:
measure: physical activity
timeFrame: 7 days
measure: Motor capacities
timeFrame: 1 day
measure: Behavioural characteristics
timeFrame: 1 hour
measure: biological parameters
timeFrame: 1 day
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble
Study officials:
affiliation: CHU Grenoble France
name: Véronique BRICOUT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Grenoble France
name: Michel GUINOT, Dr
role: PRINCIPAL_INVESTIGATOR
References: