louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06086509: Letting Children Listen to Music During Computed Tomography
Official title: Effect of Music on Fear and Anxiety in Children During Tomography: Randomized Controlled Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear
Computed Tomography
Keywords: Child
Music
Anxiety
Fear
Lead sponsor: Gümüşhane Universıty
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: They were divided into two groups: control group and experimental group.
Primary purpose: PREVENTION

Brief summary: This study examines the effect of music during computed tomography in children. This study, conducted on a total of 60 children, was divided into two groups: the music group and the control group. According to the research results; showed that music reduces fear and anxiety levels in children and stabilizes vital signs (pulse and respiratory rate) during a tomography scan.

Detailed description: Aim: This research was conducted to determine the effect of music played during computerized tomography (CT) imaging in children on fear, anxiety and vital signs.

Method: This randomized, double-blind controlled trial was conducted with Consolidated Standards of Reporting Studies (CONSORT) guidelines. The sample includes children aged 5-10 years who had CT scans in the emergency department of a public hospital in eastern Turkey between April 18 and May 20, 2023 and met the inclusion criteria for the study. The research was completed with a total of 60 children, divided evenly into one of two groups. The nursing intervention of the research is to listen to music. Data were collected through face-to-face interviews using the Child and Family Information Form, the Child Fear Scale, the State Anxiety Scale for Children, and the Vital Signs Monitoring Form (pulse, blood pressure, and oxygen saturation). Ethical principles were followed in the research.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 5-10
* Hospitalization is for diagnostic or treatment purposes
* The child and the parent speak and understand Turkish comfortably.

Exclusion Criteria:

* Having previous tomography shooting experience
* Having chronic diseases
* Visual, auditory, speech and mental disorders
* There is a history of sedative, analgesic or narcotic substance use within 24 hours before application.

Primary outcomes:
measure: Children's Fear Scale (CFS)
timeFrame: one month
Secondary outcomes:
measure: Child Anxiety Scale-State (CAS-S)
timeFrame: one month
Other outcomes:
Locations:
city: Gümüşhane
country: Turkey
facility: Gümüşhane University
Study officials:
affiliation: Ataturk University
name: Fatma KURUDİREK
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05320133: Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection
Official title: The Effect and Safety of Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection, a Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
IgA nephropathy
Jinghua Weikang Caplsule
Bismuth-containing quadruple therapy
Eradication
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the efficacy and safety of the Jinghua Weikang Capsule (a Chinese patent medicine for peptic ulcer and gastritis) containing quadruple therapy (Jinghua Weikang Caplsule plus triple therpy) for eradicating Helicobacter pylori in IgA nephropathy.


Eligibility criteria: Inclusion Criteria:

* IgA nephropathy diagnosed by renal biopsy;
* Current Helicobacter pylori infection;
* Age 18-65.

Exclusion Criteria:

* ①eGFR\<90ml/（min·1.73m2）-
* History of Helicobacter pylori treatment
* Present taking hormones or immunosuppressants
* Malignant tumor and high-grade intraepithelial neoplasia and severe dysplasia of gastric mucosa
* Allergy history to medicines used in the study
* History of gastric surgery
* Uncontrolled chronic diseases such as diabetes, cardiovascular and cerebrovascular diseases, respiratory diseases, mental disorders and other researchers are considered to affect treatment and assessment
* Combined with other primary or secondary nephropathy except for IgAN
* Combined with acute renal injury
* Female patients with pregnancy, lactation and planned pregnancy.

Primary outcomes:
measure: Helicobacter pylori eradicaion rate
timeFrame: The forth week after the treatment.
Secondary outcomes:
measure: Blood creatinine level
timeFrame: Baseline, the third and sixth month after the treatment, respectively.
measure: Blood urea nitrogen level
timeFrame: Baseline, the third and sixth month after the treatment, respectively.
measure: eGFR
timeFrame: Baseline, the third and sixth month after the treatment, respectively.
measure: 24hrs urine protein level
timeFrame: Baseline, the third and sixth month after the treatment, respectively.
measure: Blood presure
timeFrame: Baseline, the third and sixth month after the treatment, respectively.
measure: IgA level
timeFrame: Baseline, the third and sixth month after the treatment, respectively.
measure: IgA1 level
timeFrame: Baseline, the third and sixth month after the treatment, respectively.
measure: Gd-IgA1 level
timeFrame: Baseline, the third and sixth month after the treatment, respectively.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: HUI YE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00616733: 12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients
Official title: An Open-label, Escalating-dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral CS-0777, Administered for 12 Weeks, in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis, relapsing, secondary progressive, clinically isolated syndrome, MRI
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 12-week study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of clinically isolated syndrome or a relapsing form(s) of MS, based on Poser or McDonald criteria (may include patients with secondary progressive disease)
* Clinical relapse within the past 3 years or a gadolinium enhancing lesion on a brain MRI scan within the past 12 months
* Baseline EDSS score of 0 - 6.5
* Female subjects who are sexually active, unless sterile or post-menopausal for at least 1 year, must be willing to use double-barrier contraception

Exclusion Criteria:

* Primary progressive MS
* Any medical condition that predisposes to immunocompromise
* History of malignancy, tuberculosis, invasive fungal infections, herpes zoster infection (or shingles), or other opportunistic infection, or any current active infection
* Concurrent diagnosis of any other autoimmune disease (eg, rheumatoid arthritis or lupus)
* Treatment with cyclophosphamide or mitoxantrone within 6 months of study initiation
* Treatment with cyclosporine, azathioprine, methotrexate or other immunosuppressant within 3 months of study initiation
* Treatment with interferon beta or glatiramer acetate within 2 months of study initiation
* Prior treatment with natalizumab or rituximab

Primary outcomes:
measure: Safety and tolerability.
timeFrame: 12 weeks, with 4 weeks to follow-up
Secondary outcomes:
measure: Pharmacodynamic response (lymphocyte counts Pharmacokinetics Exploratory efficacy based on brain MRI lesions)
timeFrame: 12 weeks, with 4 weeks to follow up.
Other outcomes:
Locations:
city: Denver
country: United States
state: Colorado
city: Port Orange
country: United States
state: Florida
city: Lenexa
country: United States
state: Kansas
city: Billings
country: United States
state: Montana
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01156233: Tube Tip Position in Orally Intubated 0-4year Old Children: Assessment of the Precision of Two Clinical Techniques
Official title: Endotracheal Tube Tip Position in Orally Intubated 0-4 Year Old Children: Comparative Assessment of the Precision of Two Clinical Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation, Endotracheal
Keywords: evaluating precision of tube tip position with two methods
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2010-07-02
Enrollment: 69
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In pediatric anesthesia it is very important to place the endotracheal tube into the right position. This study compares two clinical location methods. The hypothesis means that the two techniques have the same precision of the location of the tip position of a cuffed MICROCUFF (Kimberly-Clark)endotracheal tube.

Detailed description: Appropriate location of the tip of an endotracheal tube (TET), in relation to the carina and vocal cords, is of great importance in pediatric anesthesia. A not optimal laying tube causes life threatening consequences. Therefore, it is very essential to have reliable methods how to place the tube tip in regard of the precision of the localisation. There are no standardized methods how to accomplish a precise position. The study compares two most applied techniques. The first one is the cuff palpation technique (CPT), the second one the deliberate right mainstem intubation technique (RMT).

Eligibility criteria: Inclusion Criteria:

* Age 0-4 years
* ASA I-II
* requiring endotracheal tube for surgical/diagnostic procedures

Exclusion Criteria:

* patients with abnormal airway anatomy
* kyphoscoliosis
* syndromes known to affect airway anatomy

Primary outcomes:
measure: Localisation and precision of the tip of the endotracheal tube (TET) in the trachea
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitätskinderspital beider Basel
Study officials:
affiliation: University Childrens Hospital beider Basel Postfach CH 4005 Basel
name: Franz Frei, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03598933: Cricopharyngeal Dysfunction in Adults
Official title: Cricopharyngeal Dysfunction in Adults: Diagnostic and Therapeutic Effects of Cricopharyngeal Botulinum Toxin (Botox) Injection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Upper Esophageal Sphincter
Keywords: Upper Esophageal Sphincter
botulinum toxin
Cricopharyngeal dysfunction
Cricopharyngeal botulinum toxin injection
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Subject having at least one injection of botulinum toxin A in the crico-pharyngeal muscle for Upper Esophageal Sphincter dysfunction in the ENT department and cervico-facial surgery of Hautepierre.

Brief summary: The objective of the study, after reviewing the recent literature, is to corroborate the thesis of the authors considering the injection of botulinum toxin as a gesture that is both diagnostic and therapeutic in the disorders of the Upper Esophageal Sphincter and reinforce the results already published with a larger series of patients.


Eligibility criteria: Inclusion Criteria:

* Man or woman whose age older than 18 years
* Dysphagia with solids and / or liquids
* Dysfunction of primary or secondary Upper Esophageal Sphincter with indirect video-fibroscopy and / or video-fluoroscopy and / or high resolution pharyngo-oesophageal manometry
* Subject having at least one injection of botulinum toxin A in the crico-pharyngeal muscle for Upper Esophageal Sphincter dysfunction in the ENT department and cervico-facial surgery of Hautepierre.
* Subject who has consented to the use of his data from his medical file for the purpose of this research

Exclusion Criteria:

* Myotomy in the first place
* Refusal of the subject to participate in the study
* Subject under the protection of justice
* Subject under guardianship or curatorship

Primary outcomes:
measure: Deglutition Handicap Index
timeFrame: The period from January 1st, 2017 to December 31st, 2017 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service ORL et chirurgie cervico-faciale
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Philippe Schultz, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02727933: Postmarketing Surveillance of the Safety and Effectiveness of Daclatasvir and Asunaprevir for the Treatment of Chronic HCV Genotype 1B Infection in the Routine Clinical Practice in Korea
Official title: Postmarketing Surveillance of the Safety and Effectiveness of Daclatasvir and Asunaprevir for the Treatment of Chronic HCV Genotype 1B Infection in the Routine Clinical Practice in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-04-05
Enrollment: 1941
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: The primary objective of this study is to describe the safety of the combination of Daklinza (daclatasvir) and Sunvepra (asunaprevir) when used for the treatment of chronic hepatitis C (CHC) genotype 1b patients in real-life conditions when used according to its registered indications.


Eligibility criteria: Inclusion Criteria:

* Patients with CHC genotype 1b and compensated liver disease, including cirrhotic patients
* Eligible for treatment with Daklinza and Sunvepra as indicated in the locally approved prescribing information.

Exclusion Criteria:

* Off-label use of Daklinza and Sunvepra
* Patients with a contraindication for the use of Daklinza and Sunvepra as described in the locally approved prescribing information

Primary outcomes:
measure: Frequency of expected and unexpected adverse reactions (AEs) and serious adverse events (SAEs)/reactions. These include laboratory abnormalities
timeFrame: 6 months to 5 years
Secondary outcomes:
measure: Incidence proportion of AEs leading to discontinuation of study therapy
timeFrame: 6 months to 5 years
measure: Incidence rate of AEs leading to discontinuation of study therapy
timeFrame: 6 months to 5 years
measure: Timing of laboratory abnormalities by toxicity grade
timeFrame: 6 months to 5 years
measure: Percentage of patients with HCV (Hepatitis C Virus) RNA (Ribonucleic acid)< lower limit of quantification (LLQ) target not detected and detected
timeFrame: 4 Weeks to 24 Weeks
measure: The sustained virologic response (SVR12) of the combination of Daklinza and Sunvepra (HCV RNA < lower limit of quantification [LLQ] target not detected and detected (HCV RNA < 25 IU/mL)
timeFrame: 24 Weeks to 36 Weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06828133: Egyptian Physical Therapists' Perceptions of Tele- Rehabilitation
Official title: Egyptian Physical Therapists' Perceptions of Tele- Rehabilitation: an Online Open Survey on Acceptability, Preferences, and Needs
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acceptability, Preferences, and Needs
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: both male and female age between equale and more 25

Brief summary: The healthcare industry has undergone a significant transformation with the integration of digital technologies, and one of the notable advancements in this field is tele-rehabilitation. Tele-rehabilitation, a subset of telehealth, involves the use of digital platforms to deliver physical therapy services remotely. This innovative approach allows healthcare providers to extend their reach, offering therapy to patients who might otherwise face barriers to accessing care,tele-rehabilitation has been recognized for its numerous benefits. It enhances access to physical therapy services, particularly for individuals living in remote or underserved areas. By reducing the need for travel, tele-rehabilitation offers significant convenience to patients, enabling them to receive therapy in the comfort of their homes.


Eligibility criteria: * Must be a licensed physical therapist with at least 3 years of experience practicing in Egypt.
* Must be 25 years of age or older.
* Must have access to the internet and be able to complete an online survey.
* Available to complete all survey-related questions.

Exclusion Criteria:

* Not currently practicing as a physical therapist.
* Diagnosed with conditions that impair the ability to complete an online survey.

Primary outcomes:
measure: acceptability
timeFrame: 6 months
Secondary outcomes:
measure: preferences
timeFrame: 6 month
Other outcomes:
measure: needs
timeFrame: 6 mnoth
Locations:
Study officials:
References:
Clinical trial NCT01212133: A Post Marketing Surveillance (PMS) Study of Liraglutide in Subjects With Type 2 Diabetes Mellitus in India
Official title: A Post Marketing Surveillance (PMS) Study of Liraglutide in Subjects With Type 2 Diabetes Mellitus in India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-09-30
Enrollment: 1386
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with type 2 diabetes, including newly-diagnosed subjects, who are considered to need treatment with liraglutide are eligible for the study

Brief summary: This study is conducted in Asia. The aim of this study is to evaluate the safety and effectiveness of liraglutide in subjects with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Subjects with type 2 diabetes, including newly-diagnosed patients / those already receiving other anti-diabetic medications including GLP-1 analogues, who require treatment with liraglutide according to the clinical judgment of their treating physician
* Subjects who are capable of giving study-specific signed informed consent before any collection of information

Exclusion Criteria:

* Subjects with type 1 diabetes
* Subjects who are or have previously been on liraglutide
* Subjects who have previously been enrolled in the study
* Subjects who are participating in another clinical trial
* Subjects with a hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections)
* Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the following 6 months

Primary outcomes:
measure: The number of serious adverse drug reactions (SADRs) during the study period
timeFrame: during 26 weeks of treatment
Secondary outcomes:
measure: The number of adverse drug reactions (ADR) during the study period
timeFrame: during 26 weeks of treatment
measure: The number of serious adverse events (SAE) during the study period
timeFrame: during 26 weeks of treatment
measure: Frequency of hypoglycaemic episodes
timeFrame: during 26 weeks of treatment
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Wangnoo SK, Kumar S, Bhattacharyya A, Tripathi S, Akhtar S, Shetty R, Ghosal S. Liraglutide effect and action in diabetes-In (LEAD-In): A prospective observational study assessing safety and effectiveness of liraglutide in patients with type 2 diabetes mellitus treated under routine clinical practice conditions in India. Indian J Endocrinol Metab. 2016 Nov-Dec;20(6):838-845. doi: 10.4103/2230-8210.189232.
Clinical trial NCT00033033: Reserpine for the Treatment of Cocaine Dependence - 1
Official title: Phase 2, Double-Blind, Placebo-Controlled Trial of Reserpine for the Treatment of Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Substance-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Cincinnati VA Medical Center
First posted: 2002-04-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
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 assess the efficacy and safety of reserpine for the treatment of cocaine dependence.

Detailed description: To assess the efficacy and safety of reserpine in reducing cocaine use in subjects with cocaine dependence. This is a double-blind, placebo-controlled, parallel-group design with a 2 week baseline period.

Eligibility criteria: Inclusion Criteria:

Be at least 18 yrs of age; DSM-4 diagnosis of cocaine dependence; treatment seeking individuals; have the ability to understand and provide written informed consent; females of child bearing potential using appropriate birth control method

Exclusion Criteria:

Additional criteria available during screening at the site.

Primary outcomes:
measure: Cocaine use
measure: Addiction severity
measure: Cocaine withdrawal
measure: Adverse events
measure: Clinical improvement
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center
state: Ohio
city: Dayton
country: United States
facility: Dayton VA Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati VA Medical Center
name: Eugene Somoza, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winhusen TM, Lewis DF, Somoza EC, Horn P. Pharmacodynamics must inform statistics: an example from a cocaine dependence pharmacotherapy trial. ISRN Addict. 2014 Feb 5;2014:927290. doi: 10.1155/2014/927290. eCollection 2014.
citation: Winhusen TM, Somoza EC, Lewis DF, Kropp F, Theobald J, Elkashef A. An Evaluation of Substance Abuse Treatment and HIV Education on Safe Sex Practices in Cocaine Dependent Individuals. ISRN Addict. 2014 Mar 4;2014:912863. doi: 10.1155/2014/912863. eCollection 2014.