louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03791177: Urodynamics and Music
Official title: The Effects of Listening to Music on Anxiety, Pain and Satisfaction During Urodynamic Study : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incontinence, Urinary
Keywords: Music
Lead sponsor: Aksaray University Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-01-02
Enrollment: 70
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: Today music acts as an analgesic and anxiolytic in a safe, cheap and simple way. Several trials have confirmed its potential administration and benefits in urology practice. We aimed to assess the influence of music therapy on perceived anxiety and pain during outpatient urodynamic study (UDS) using the Visual Analog Scale (VAS) and the State-Trait Anxiety Inventory (STAI) in a prospective, randomized fashion

Detailed description: Urodynamic study (UDS) is often used to help urologists to evaluate the functions of bladder and urethra in outpatient clinic.1 Although a UDS is a reliable tool for accurate diagnosis, the process itself can be accompanied by discomfort and pain as it includes the positioning the catheters urethral and rectally, and the bladder filling. Reports of having such invasive outpatient process whilst awake may demonstrate pain and disquiet that result in incomplete examinations and patient noncompliance2,3.

Various pharmacologic options including lidocaine gel and catheter tip lubrication for urethral catheterization were used to relieve pain and anxiety during UDS. Besides, there are some non-pharmalogical methods such as patient education, heating pad, music, distraction and relaxation4-6.

Music has been considered complementary treatment modality as cheap, safe and effective. In various urological procedures including cystoscopy, transrectal prostate biopsy and extracorporeal shock wave lithotripsy (ESWL) music has been proven helpful on pain and anxiety levels 7-10. However, current literature presents limited and controversial data evaluating the influence of music on pain and anxiety perspective of the patient during UDS. We, therefore, aimed to assess the effect of music on patient satisfaction in a analgesic and anxiolytic way during UDS.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

Exclusion criteria included paraplegia, hearing impairment, taking any analgesic or anxiolytic drug to suppress the symptoms of anxiety until 24 hours prior to UDS, inability to understand or fulfill commands during UDS.

Primary outcomes:
measure: Pain Scale: VAS
timeFrame: 10 minutes after UDS
measure: Anxiety Scale: STAI
timeFrame: 10 minutes after UDS
Secondary outcomes:
Other outcomes:
Locations:
city: Aksaray
country: Turkey
facility: Aksaray University Training and Research Hospital
Study officials:
References:
Clinical trial NCT04766177: Role of Bumetanide in Treatment of Autism
Official title: Role of Bumetanide in Treatment of Autism Spectrum Disorder in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Autism
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Role of bumetanide in Autism

Detailed description: Role of Bumetanide in Treatment of Autism spectrum disorder in children

Eligibility criteria: Inclusion Criteria:

1. All patients with ASD diagnosed by CARS rating Scale⩾30.
2. Age of patients range between (3-12) years.

Exclusion Criteria:

* Patients with ASD associated with neurological antecedents (including epilepsies and febrile seizures), hepatic, renal dysfunction or electrocardiogram abnormalities and syndromatic children(Rett).

Primary outcomes:
measure: Number of patients with improved CARS score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Pediatrics Department- Kafr-Elsheikh University
name: Osama Elagamy, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatrics Department- Kafr-Elsheikh University
name: Abeer Salamah, Dr
role: STUDY_DIRECTOR
affiliation: Pediatrics Department- Kafr-Elsheikh University
name: Esraa Shaker, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03462277: DNA Methylation and Hydroxymethylation Levels in Patients With Coronary Heart Disease
Official title: DNA Methylation and Hydroxymethylation Levels in Patients With Coronary Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Keywords: methylation
hydroxymethylation
atherosclerosis
coronary heart disease
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Coronary Heart Disease and Patients without Coronary Heart Disease.

All patients underwent carotid ultrasound and coronary angiograms.

Brief summary: The purpose of this trial is to investigate the relationship between DNA methylation and hydroxymethylation and the expression of DNMTs, TET family gene and the degree of coronary heart disease.

Detailed description: 1. To determine the levels of DNA methylation and hydroxymethylation with coronary heart disease.
2. To investigate the relationship between DNA methylation and hydroxymethylation and the degree of coronary atherosclerosis.

Eligibility criteria: Inclusion Criteria:

Male and Female. Patients older than 65 years old who are willing to participate in the study. CHD patients was defined as at least one lesion in a coronary artery or branches in coronary angiograms. Control group was defined as people with negative findings in coronary angiograms.

Exclusion Criteria:

Patients with concurrent infection or any documented inflammatory illness, such as arthritis or connective tissue diseases, or any other malignancy. Patients with a history of cardiomyopathy. Pregnant women. Severe hepatic dysfunction or End-stage renal failure. Uncontrolled hypertension.

Primary outcomes:
measure: DNA Methylation and Hydroxymethylation Levels
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Dongying Zhang, doctor
role: STUDY_DIRECTOR
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Dan Jiang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06778577: The Efficacy of Suprascapular Nerve Radiofrequency and Intra-articular Steroid Injection in Frozen Shoulder Treatment
Official title: Comparison of the Efficacy of Ultrasound-guided Suprascapular Nerve Pulsed Radiofrequency Neuromodulation and Intra-articular Steroid Injection in Frozen Shoulder Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frozen Shoulder
Radiofrequency Ablation Treatment
Intra-articular Injection
Keywords: frozen shoulder
radiofrequency ablation treatment
intra-articular injection
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical study is to compare the effectiveness of suprascapular nerve pulsed radiofrequency and intra-articular steroid injection in patients with frozen shoulder (adhesive capsulitis). The main questions it aims to answer are:

1. What is the effectiveness of intra-articular steroid injection in frozen shoulder?
2. What is the effectiveness of suprascapular nerve radiofrequency in frozen shoulder?
3. Should these two methods be used together in frozen shoulder?


Eligibility criteria: Inclusion Criteria:

* unilateral side involvement.
* ≥50% loss of passive ROM (external rotation or abduction) in the glenohumeral joint comparing to the unaffected side.
* duration of symptoms ≥3 months.
* age≥ 20year old.
* Patients with VAS ≥4 before the procedure

Exclusion Criteria:

* ever received manipulation of the affected shoulder with/without anesthesia. systemic disease, severe degeneration, or trauma involving the shoulder. (ie, rheumatoid arthritis, osteoarthritis, history of injury to the labrum or articular cartilage or malignancies in the shoulder region, etc.)
* neurologic diseases such as stroke or peripheral nerve neuropathy that have already affect the activity of shoulder.
* pain or disorders of the cervical spine, elbow, wrist, or hand.
* a history of drug allergy to local or corticosteroids.
* Pregnancy or lactation.
* Received corticosteroids, or hyaluronic acid intra-articular injection into the affected shoulder during the preceding 4 weeks.
* Patients with VAS \<4 before the procedure

Primary outcomes:
measure: Change of The Visual Analogue Scale (VAS)
timeFrame: baseline and at 4 weeks and 12 weeks after the beginning of the treatment.
Secondary outcomes:
measure: The active ROM
timeFrame: Baseline and at 4 weeks and 12 weeks after the beginning of the treatment.
measure: Change of scores of the Shoulder Pain and Disability Index (SPADI)
timeFrame: Baseline and at 4 weeks and 12 weeks after the beginning of the treatment.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Department of Algology
Study officials:
References:
Clinical trial NCT00383877: Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes
Official title: Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2006-10-04
Enrollment: 263
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: This trial is conducted in China. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of insulin detemir or NPH-insulin given once daily at bedtime as add-on to oral anti-diabetic drug(s).


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* HbA1C greater than 7.5% and less than or equal to 11.0%
* Currently on any oral antidiabetic drug (OAD) more than or equal to 3 months

Exclusion Criteria:

* Previous acute treatment with insulin for more than 7 days.
* Treatment with OAD(s) which does not adhere to the approval labeling.
* Proliferate retinopathy or maculopathy that has required acute treatment within the last year.
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia, that may interfere with study participation as judged by the Investigator.

Primary outcomes:
measure: HbA1c
timeFrame: after 20 weeks of treatment
Secondary outcomes:
measure: FBG
timeFrame: after 20 weeks of treatment
measure: Safety profile
timeFrame: during 20 weeks treatment
measure: Proportion of subjects achieving HbA1c less than or equal to 7.0%
timeFrame: after 20 weeks of treatment
measure: Within-subject variation of self measured blood glucose (SMBG) before breakfast during the trial at the end of the trial
timeFrame: before breakfast during the trial at the end of the trial
Other outcomes:
Locations:
city: Beijing
country: China
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01341977: Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution
Official title: Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution (MPDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Contact Lens Wearers
Keywords: Contact Lenses
Contact Lens Care
Multi-Purpose Solution
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-04-26
Enrollment: 573
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if Alcon MPDS is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.

Detailed description: The purpose of this study is to determine if Alcon Multi-Purpose Disinfecting Solution (MPDS) is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.

Eligibility criteria: Inclusion Criteria:

* Silicone hydrogel or soft contact lens wearers who wear their lenses daily wear (i.e. disinfect lenses every night).
* Patient must be able to read.
* Vision correctable to 20/30 or better with contact lenses.

Exclusion Criteria:

* Sensitivity to multi-purpose solutions.
* Using any topical ocular OTC or prescribed topical ocular medications.
* History or current ocular infections or ocular inflammatory events.
* Ocular surgery within the past year.
* With a medical condition or using medications that cause ocular side effects.
* Participation in any investigational study within the past 30 days.

Primary outcomes:
measure: Subjective Acceptance
timeFrame: Day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon Research
name: Jessie M Lemp, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT02761577: A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia
Official title: A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia With the Use of Standard Laboratory Measures and Novel Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Diseases
Contrast Media Reaction
Keywords: Acetylcysteine
Sodium Bicarbonate
Lipocalins
Creatinine
Blood Urea Nitrogen
Lead sponsor: Clinical Hospital Centre Zagreb
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 90
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 study is analysis of the incidence of contrast-induced nephropathy (CIN) in patients with previously normal renal function undergoing angiography and comparison between the three different treatment protocols on renal function.

Patients are randomly assigned to the three groups: 1) peroral hydration, 2) Na bicarbonate (NaHCO3), and 3) NaHCO3 plus N-acetylcysteine (NAC) infusion.

Serum creatinine (SCr), blood urea nitrogen (BUN), and neutrophil gelatinase-associated lipocalin (NGAL) are measured before and 48 hours after the angiography. CIN was defined as an absolute increase of 0.5 mg/dL or a relative increase of \>25% in creatinine levels 48-72 hours after the procedure

Detailed description: Patients are randomly assigned to the three groups: 1) peroral hydration, 2) Na bicarbonate (NaHCO3), and 3) NaHCO3 plus N-acetylcysteine (NAC) infusion The first group of patients receives standard peroral hydration of 1500 ml water on the day of the procedure.

The second group receives 3 mL/kg/hour of Na bicarbonate, an hour prior to angiography and 1 mL/kg/hour, within six hours after angiography.

The third group receives parenteral NAC (1200 mg twice a day) one day before angiography, on the day of the angiography, and one day after the diagnostic procedure in addition to Na bicarbonate solution on the day of the angiography.

The low-osmolar iodinated contrast agent was used.

Eligibility criteria: Inclusion Criteria:

* angina (stable, unstable)
* coronary artery disease
* cardiomyopathy
* valvular disease
* vasculitis
* peripheral arterial disease

Exclusion Criteria:

* kidney dysfunction
* uncontrolled hypertension (systolic blood pressure \>160 mm Hg and/or diastolic blood pressure \>100 mm Hg)
* pregnancy
* lactation
* history of allergic reaction to contrast agents
* cardiogenic shock
* pulmonary edema
* multiple myeloma
* urgent coronary angiography
* receiving contrast agents two days prior to the study and 48 hours within the study

Primary outcomes:
measure: renal function before and after diagnostic procedure by measuring Serum creatinine in µmol/mL
timeFrame: 48 hours
Secondary outcomes:
measure: blood urea nitrogen in mmol/L
timeFrame: 48 hours
measure: neutrophil gelatinase-associated lipocalin in ng/mL
timeFrame: 48 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03770377: Laryngeal Adaptation for Speech and Swallowing
Official title: Laryngeal Adaptation for Speech and Swallowing
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Spinocerebellar Ataxia
Cerebral Stroke
Dysphagia
Dysarthria
Keywords: speech
swallowing
rehabilitation
stroke
deglutition
dysphagia
dysarthria
laryngeal
ataxia
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: National Institutes of Health (NIH)
First posted: 2018-12-10
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A cross-sectional study design will be used to examine laryngeal adaptation across all study groups.
Primary purpose: TREATMENT

Brief summary: This study will test laryngeal adaptation in speech and swallowing function in healthy adults, in patients with cerebral stroke, and in patients with spinocerebellar ataxia type 6. The findings from this proposal will be the first step toward implementing rehabilitation techniques that help patients to prevent speech and swallowing errors before they occur.


Eligibility criteria: Patient Inclusion Criteria:

All stroke and ataxia

Ataxia

* DNA diagnosis of SCA6 and phenotype consistent with the DNA diagnosis
* No recessive, X-linked or mitochondrial

Stroke

* Bilateral or unilateral middle cerebral artery (MCA) stroke
* No structural abnormalities (i.e. nodules)
* Dysphagia involving laryngeal dysfunction

Stroke and ataxia with speech and swallowing disorders

* no structural abnormalities
* dysphagia involving laryngeal dysfunction

Patient Exclusion Criteria:

* Montreal Cognitive Assess. \<24
* Moderate to severe hearing loss
* Barium allergy
* Other confounding speech disorder (i.e. stuttering)
* Chemo-radiation, surgical head and neck treatment
* Smoking Hx in the past 5 yrs or \>5 years at any one time
* Twenty one years of age or older
* Breathing disorders or diseases

Primary outcomes:
measure: Laryngeal Adaptation in Speech
timeFrame: Day 1
measure: Laryngeal Adaptation in Swallowing
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03210077: Romanian Entropy Clinical Study Network
Official title: Romanian Entropy Clinical Study Network
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: General Anesthetic Drug Adverse Reaction
Keywords: general anesthesia
Entropy
Hypnosis
Lead sponsor: Romanian Society of Anesthesia and Intensive Care
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who needs general anesthesia and meet the inclusion criteria.

Brief summary: The critically ill patient is one of the most complex cases with regard to the optimization of the anesthesia, as well as postoperative management. One of the most important steps in the complex management of such patients is the modulation of anesthesia for every patient needs. We start with the assumptions that the optimization of anesthesia should depend on each patient, being conducted in an individual manner. We also believe that by individualizing the anesthesia by monitoring the entropy it is possible to obtain an appropriate management regarding hemodynamic complications during anesthesia including tachycardia, bradycardia, hypotension and hypertension.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I, II, III;
* written consent accepted to be enrolled in the study; in polytrauma patients in the operation theatre who are brought directly through the emergency department, written consent is obtained from the relatives, in accordance to the national law number 206, of 2004, for a good and correct scientific research, in the situation where the patient is no capable to sign or give the written consent;

Exclusion Criteria:

* cardiac pacemaker;
* atrial fibrillation at the time of presentation in the operation theatre;
* any subject with epidural catheter, placed pre-operatively;
* allergy to Propofol or another anesthetic drugs;
* pregnancy;
* presence of neuromuscular disease;
* presence of neurologic disease;

Primary outcomes:
measure: Change of systolic blood pressure baseline
timeFrame: Change from Baseline Systolic Blood Pressure at 10 minutes
measure: Change of heart beat rate baseline
timeFrame: Change from Baseline heart rate at 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Timisoara
country: Romania
facility: Romanian Society of Anesthesia and Intensive Care
Study officials:
affiliation: Romanian Society of Anesthesia and Intensive Care
name: Alexandru Florin Rogobete, PhDs
role: PRINCIPAL_INVESTIGATOR
affiliation: Romanian Society of Anesthesia and Intensive Care
name: Dorel Sandesc, Prof
role: STUDY_CHAIR
affiliation: Romanian Society of Anesthesia and Intensive Care
name: Ovidiu Bedreag, Assoc Prof
role: STUDY_DIRECTOR
References: