louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01132092: The Normal Standard of Brainstem Auditory Evoked Potential in Adults Using a New Device
Official title: The Normal Standard of Brainstem Auditory Evoked Potential in Adults Using a New Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Hearing (76 Subjects)
Subjects With Hearing Loss (15 Subjects)
Keywords: Evoked Potentials, Adult, Hearing Loss
Lead sponsor: Universidade Estadual de Ciências da Saúde de Alagoas
Sponsor class: OTHER
First posted: 2010-05-27
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults Normal hearing subjects and hearing loss Subjects

Brief summary: There are no differences between the exams made with the new device,that evaluates the hearing, and the device gold standard, that is widely used in clinics and hospitals.


Eligibility criteria: Inclusion Criteria:

* hearing thresholds less than 25 dB at all frequencies of pure tone audiometry, with differences between the ears, by frequency, or less than 10 dB.
* The group with bilateral sensorineural hearing loss was made up of adults with hearing thresholds changed from 25 to 60 dB HL for the frequencies 2000-8000 Hz for pure tone audiometry.

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Maceió
country: Brazil
facility: Universidade Estadual de Ciências da Saúde de Alagoas
state: Alagoas
Study officials:
References:
Clinical trial NCT01679392: A Study Investigating Properties of the Transversus Abdominis Plane Block
Official title: Transversus Abdominis Plane Block: A Placebo-controlled Study in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Keywords: Transversus abdominis plane block
Ultrasound guided nerve block
Lead sponsor: Hillerod Hospital, Denmark
Sponsor class: OTHER
First posted: 2012-09-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In this study we investigate the following properties of the transversus abdominis plane block in healthy volunteers:

1. Cutaneous analgesic distribution
2. Muscular affection
3. Reproducibility


Eligibility criteria: Inclusion Criteria:

* Capable
* American society of anesthesiologists classification 1 or 2
* Written informed consent

Exclusion Criteria:

* Age below 18 years
* American society of anesthesiologists classification above 2
* Body weight below 50 kg
* Body mass index \> 35 kg/m2
* Previous abdominal surgery
* Acute or chronic pain
* Use of pain medication less than 24 h prior to study start
* Allergy to local anesthetics
* Pregnancy
* Breastfeeding

Primary outcomes:
measure: Cutaneous analgesic distribution
timeFrame: 90 min
Secondary outcomes:
measure: Muscular affection of the transversus abdominis plane block
timeFrame: 90 min
measure: Reproducibility of the transversus abdominis plane block
timeFrame: At least 2 days
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Hillerød Hospital
Study officials:
affiliation: Hillerod Hospital, Denmark
name: Kion Bo Støving, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hillerod Hospital, Denmark
name: Charlotte Rosenstock, MD
role: STUDY_DIRECTOR
affiliation: Hillerod Hospital, Denmark
name: Kai Lange, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05904392: Effect of Music Therapy on the Anxiety Level of Patients During the Administration of Ocular Intravitreal Injections
Official title: Effect of Music Therapy on the Anxiety Level of Patients During the Administration of Ocular Intravitreal Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety and Fear
Keywords: Music therapy
anxiety
intravitreal injection
pain
quality of life
Lead sponsor: Althaia Xarxa Assistencial Universitària de Manresa
Sponsor class: OTHER
Collaborators: name: University of Vic - Central University of Catalonia
First posted: 2023-06-15
Enrollment: 50
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: Introduction Ocular intravitreal injection is a widely used ophthalmic invasive technique to administer medication directly inside the patient's eye. Despite being usually a quick and painless intervention, some patients report nervousness and anxiety before and during the procedure. Music therapy could help in assessing this discomfort, as previous studies have shown it can beneficial, specially helping to reduce anxiety levels.

Objective This study aims to assess the effect of music therapy on patients undergoing intravitreal injections and how it affects their anxiety.

Methods This is a randomized, prospective, single blind, clinical trial. Patients will be divided into two groups. Group A patients will listen to classical music during the procedure (intervention). Group B patients (control), will not listen to music during the procedure. All other aspects of the procedure will be the same for both groups. To analyze the impact music therapy, patients will fill in the STAI anxiety questionnaire and will be evaluated with the pain visual analogue scale (VAS) before and after the injection procedure.

Expected results Subjects that undergo the procedure with music therapy are expected to experience less anxiety that the ones that do not. Less pain perception is also expected.


Eligibility criteria: Inclusion Criteria:

* Patients must be at least 18 years old.
* Patients must have been prescribed an intravitreal injections of an anti-VEGF drug.
* Subjects must have undergone at least one previous intravitreal injection.
* Patients must fully understand the procedure and the project they will be participating in and agree on signing the informed consent.

Exclusion Criteria:

* Patients with a psychiatric diagnosis with the need to take anxiety medication.
* Patients that before the intervention took medication to relax, such as benzodiazepines or anxiolytics.
* Subjects with hearing difficulty.

Primary outcomes:
measure: STAI
timeFrame: Just before and immediately after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Eduard Pedemonte Sarrias
state: Barcelona
Study officials:
References:
Clinical trial NCT03819192: Predicting EONS in PPROM Patients
Official title: Prediction of Early-Onset Neonatal Sepsis (EONS) in Pregnant Women With Preterm Premature Rupture of Membranes (PPROM) by Vaginal Microbiome Analysis - a Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PPROM
Early-Onset Neonatal Sepsis
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
Collaborators: name: Center of Fetal Surgery, University Hospital Halle Saale
name: Section for Neonatology and Pediatric Intensive Care, University Hospital Halle Saale
First posted: 2019-01-28
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: PPROM cohort = PPROM patients (hospitalization between 22+0 - 34+0 weeks of gestation) and their born preterm neonates, n = 65

* Subgroup 1: with EONS, n = 15
* Subgroup 2: without EONS, n = 50

Brief summary: An EONS occurred in nearly 14-22 % of the preterm infant of pregnant women with PPROM. To this day no risk prediction is established. The main aim of this pilot study is generating primary data with a focus on the vaginal microbiome to set-up a prospective, multi-centre trial investigating the role of the vaginal microbiome for future EONS risk prediction.

The planned PEONS pilot trial is subdivided in three Work packages:

1. Recruitment, sample collection and routine clinical diagnostics
2. Microbiome analysis by 16S rRNA
3. Microbiome/ Metagenome analysis by "Nanopore" (proof-of-principle) and will enroll women with a PPROM event hospitalized between 22+0 and 34+0 weeks of gestation and neonates with signs of EONS (Subgroup 1) and without signs of EONS (Subgroup 2).


Eligibility criteria: Inclusion Criteria:

* full age pregnant woman with PPROM and their born preterm infants
* hospitalization between 22+0 and 34+0 weeks of gestation
* multipara possible

Exclusion Criteria:

* hospitalization with PPROM before limit of viability are reached
* intrauterine fetal death
* no study agreement
* not able to consent

Primary outcomes:
measure: Development of EONS
timeFrame: 3 days after delivery
Secondary outcomes:
measure: vaginal CST in PPROM
timeFrame: until delivery
measure: neonatal microbial colonisation
timeFrame: up to 2 days after delivery
Other outcomes:
Locations:
city: Halle (Saale)
country: Germany
facility: University Hospital Halle/s.
state: Saxony-Anhalt
city: Jena
country: Germany
facility: Jena University Hospital
state: Thuringe
Study officials:
References:
Clinical trial NCT00688792: Maternal Variables Associated With Adherence in Children With Asthma
Official title: Reasons for Poor Adherence for Long-Term Preventing Therapy in Children With Asthma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Keywords: Asthma
Children
Adherence
Maternal factors
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-06-03
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Parents to children aged 2 - 12 years with moderate to severe asthma.

Brief summary: A questionnaire will be used in order to find out the reasons for poor adherence for long-term treatment in children with asthma. The hypotheses is maternal factors including the knowledge that asthma is a chronic disease and fear to administer inhaled steroids are major obstacles for appropriate adherence.

Detailed description: Parents to children aged 2 - 12 years with moderate to severe asthma who need long-term treatment with inhaled steroids will be included in the study. Three weeks after their visit in the clinic, they will be requested to answer a questionnaire by telephone.

Eligibility criteria: Inclusion Criteria:

* Parents to children aged 2 - 12 years with moderate to severe asthma to whom inhaled steroids was described for a period of at least 4 weeks.

Exclusion Criteria:

* Parents who will not agree to sign the consent form and parents who do not speak and understand the Hebrew language.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Dan Engelhard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00051792: Yoga for Treating Shortness of Breath in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Efficacy of Yoga for Self-Management of Dyspnea in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Pulmonary Emphysema
Chronic Bronchitis
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-01-17
Enrollment: 36
Sex: ALL
Minimum age (years): 40
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 evaluate the safety and effectiveness of yoga in reducing shortness of breath in people with chronic obstructive pulmonary disease (COPD). Patients in this study must have moderate to severe COPD and be primarily limited by shortness of breath.

Detailed description: Management of dyspnea (shortness of breath) is a major concern for patients with COPD. The efficacy of complementary exercises to manage dyspnea is unknown. Complementary exercises may be more congruent with patients' lifestyles and values than traditional exercise programs and can be adapted to changes in illness severity and disability. Yoga practice is a complementary therapy that people use to manage their dyspnea. The aims of this study are to: 1) develop a safe and feasible yoga program for patients with COPD; 2) test the efficacy of this program; and 3) determine whether physical performance, psychological well being, and health-related quality of life are positively affected by yoga practice.

Patients in this study will be randomized to receive yoga training or usual care for 12 weeks. Patients will be evaluated at study entry, after each session, and immediately after the training program.

Eligibility criteria: Inclusion criteria:

* Able to commit to a 12-week yoga class in San Francisco, California
* Moderate to severe COPD, clinically stable for at least 1 month prior to study entry
* Forced Expiratory Volume at one minute (FEV1) \< 49% predicted after inhaled bronchodilator
* Activities of daily living limited by shortness of breath
* Ability to speak English and sign consent
* Patients receiving supplemental oxygen will be acceptable if their O2 saturation can be maintained at \> 85% on \< 6 L/min of nasal oxygen

Exclusion criteria:

* Symptomatic illness (e.g., cancer, left heart failure, ischemic heart disease, neuromuscular disease, psychiatric illness)
* Formal pulmonary rehabilitation training within 1 year prior to study entry

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, San Francisco
name: Virginia Carrieri-Kohlman, RN, DNSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01176292: Comparison of High Flex and Standard Rotating Platform Total Knee Arthroplasty (TKA)
Official title: A Prospective Comparison of Rotating Platform Cruciate Substituting Total Knee Arthroplasty With Rotating Platform High-Flex Cruciate Substituting Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: total knee replacement
high flexion
range of motion
rotating platform
TKA
Lead sponsor: Anderson Orthopaedic Research Institute
Sponsor class: OTHER
Collaborators: name: DePuy Orthopaedics
First posted: 2010-08-06
Enrollment: 142
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to determine if the rotating platform high flex design provides improved flexion compared to the standard rotating platform TKA.


Eligibility criteria: Inclusion Criteria:

* Age 40 to 75 years old
* Primary diagnosis of osteoarthritis of the knee
* Patients who, in the investigator's opinion, are appropriate candidates for a cemented, rotating platform TKA.
* Patients who, in the investigator's opinion, are capable of participation in a clinical trial and reliable enough to return for follow-up appointments.

Exclusion Criteria:

* Pregnant or lactating female subjects
* Patients with post-traumatic or inflammatory arthritis
* Patients with a fixed flexion contracture of greater than 20 degrees
* Patients with advanced hip, spine, or ankle disease
* Patients with a BMI greater than 40, where knee flexion may be limited by soft tissues

Primary outcomes:
measure: Clinical Flexion
timeFrame: Preoperative, 4-6 weeks
measure: Clinical Flexion
timeFrame: 4-6 months
measure: Clinical Flexion
timeFrame: 1 year
Secondary outcomes:
measure: Radiographic Flexion
timeFrame: preoperative, 4-6 weeks
measure: Radiographic Flexion
timeFrame: 1 year
measure: Knee Society Score (KSS)
timeFrame: 1 year
measure: Oxford Knee Score
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Anderson Orthopaedic Research Institute
name: William G Hamilton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01993992: Parental Anxiety and Its Relationship With Pediatric Patients' Post-operative Responses
Official title: Parental Anxiety and Its Relationship With Pediatric Patients' Post-operative Responses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post-operative Delirium
Children
Anxiety
Keywords: Anesthesia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 100
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age younger than 16-year-old who required surgery

Brief summary: Post-operative delirium had multiple risk factors, such as pre-operative anxiety status, post-operative pain, and anesthetic method. We currently decrease pre-operative anxiety by parental accompanying until the children put to sleep. However, references indicate that parental anxiety can increase the post-operative delirium. Heart rate variability was used to measure the anxiety status of parents. We think sympathetic tone elevation measured by heart rate variability may not induce by anxiety alone, thus we want to explore this question by using Stat-Trait Anxiety Inventory questionnaire.

Detailed description: Outcome measures

1. Post-operative emergence delirium, observed with an average duration up to 24 hours
2. Sedatives used in recovery unit

Eligibility criteria: Inclusion criteria:

* American Society Anesthesia (ASA) risks classification I or II

Exclusion criteria:

* Parents who have cognitive problems
* Parents who have difficulty finishing questionnaire

Primary outcomes:
measure: degree of emergence delirium
timeFrame: after operation, with an average duration up to 24 hours
Secondary outcomes:
measure: recovery room stay time
timeFrame: after operation, with an average duration up to 24 hours
measure: Sedatives used in recovery room
timeFrame: after operation, with an average duration up to 24 hours
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: YI-CHIA WANG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06127992: Non-invasive Diagnosis of Cold Urticaria
Official title: Photoplethysmography for Non-invasive Diagnosis of Cold Urticaria
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urticaria Cold
Lead sponsor: City Clinical Hospital No.52 of Moscow Healthcare Department
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators subjected 63 patients (39 with typical Cold urticaria and 24 with atypical Cold urticaria ) and 15 healthy controls to TempTest® cold stimulation tests and critical temperature threshold assessments. Blood microcirculation photoplethysmography measurements were performed 5 min before and 10 min after the ice cube on the volar forearm.


Eligibility criteria: Inclusion Criteria:

* Cold urticaria

Exclusion Criteria:

-

Primary outcomes:
measure: Photoplethysmography amplitude
timeFrame: 10 min after the end of cold exposure
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow City Clinical Hospital 52
Study officials:
References:
Clinical trial NCT02027792: Cabbage Leaf Wraps in Osteoarthritis of the Knee
Official title: Randomised Controlled Trial on the Efficacy of Cabbage Leaf Wraps in Symptomatic Primary Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Knee
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 81
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 randomised controlled trial aims to investigate the efficacy of cabbage leaf cataplasms in the treatment of primary symptomatic osteoarthritis of the knee. 81 patients will be randomised into one of 3 groups and apply either cabbage leaf cataplasm or diclofenac gel daily for 4 weeks or receive only usual care. Efficacy will be measured using questionnaire on pain, disability, quality of life and pressure pain sensitivity.


Eligibility criteria: Inclusion Criteria:

* osteoarthritis of the knee, Kellgren Lawrence stadium 2-3
* at least 50% of days with complaints
* initial pain intensity 45mm on a 100mm visual analoge scale

Exclusion Criteria:

* medication with corticoids or immunsupressing drugs
* secondary arthritis/arthrosis
* operation to the knee within 12 months prior
* injection within 4 weeks (cortison) or 6 months prior (hyaluronic acid)
* severe comorbidities (liver, kidney, asthma, psychiatric disorders etc.)
* participation in other studies
* pregnancy, breastfeeding

Primary outcomes:
measure: Pain intensity
timeFrame: 4 weeks
Secondary outcomes:
measure: knee function (WOMAC)
timeFrame: 4 weeks
measure: Quality of Life (SF-36)
timeFrame: 4 weeks
measure: self-efficacy (ASES-D)
timeFrame: 4 weeks
measure: physical function (30second chair test)
timeFrame: 4 weeks
measure: Pressure pain sensitivity
timeFrame: 4 weeks
measure: Adverse events
timeFrame: 4 weeks
measure: knee function (WOMAC)
timeFrame: 12 weeks
measure: Quality of Life (SF-36)
timeFrame: 12 weeks
measure: self-efficacy (ASES-D)
timeFrame: 12 weeks
measure: physical function (30second chair test)
timeFrame: 12 weeks
measure: Pressure pain sensitivity
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 12 weeks
measure: Pain intensity
timeFrame: 12 weeks
Other outcomes:
measure: Course of Pain
timeFrame: 12 weeks
measure: Satisfaction
timeFrame: 20 weeks
Locations:
city: Essen
country: Germany
facility: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Study officials:
References:
citation: Lauche R, Graf N, Cramer H, Al-Abtah J, Dobos G, Saha FJ. Efficacy of Cabbage Leaf Wraps in the Treatment of Symptomatic Osteoarthritis of the Knee: A Randomized Controlled Trial. Clin J Pain. 2016 Nov;32(11):961-971. doi: 10.1097/AJP.0000000000000352.