louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04172662: Music Therapy as an Adjunct in CIED Lead Extraction Procedures
Official title: Music Therapy as an Adjunct in Cardiac Implantable Electronic Device (CIED) Lead Extraction Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: C.Surgical Procedure
Stress
Pain, Procedural
Anxiety
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Academy of Music
First posted: 2019-11-21
Enrollment: 68
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study will investigate possible effects of music therapy as an adjunct in an invasive cardiac procedure where infected or broken pacemaker leads, or leads from implantable cardioverter-defibrillators are removed from inside the heart through the vein. The procedure is performed in local anaesthesia with the patient awake. Analgesic and anxiolytic drugs are given at the start of the procedure, and repeated if needed. In spite of the drugs, most patients will experience som degree of pain and/or anxiety and increased stress during the procedure. The music therapy intervention contains individually facilitated music listening and coping techniques, aiming to regulate stress responses. The music listening and guidance is provided by a certified music therapist before, during and after the invasive procedure.

Detailed description: See study protocol

Eligibility criteria: Inclusion Criteria:

1. Planned pacemaker or intracardiac defibrillator (ICD) lead extraction performed in local anaesthesia.
2. Lead implanted \> 12 months ago
3. Able to speak and read Norwegian
4. Willing to participate All inclusion criteria must be fulfilled.

Exclusion Criteria:

1. Significant hearing impairment
2. Previous and/or acute psychiatric diagnosis
3. Cognitive and mental deficits or impaired functioning

Primary outcomes:
measure: Patient satisfaction with pain management during the procedure
timeFrame: 1 hour after completion of the procedure
measure: Patient experience of pain intensity during the procedure
timeFrame: Mean pain intensity during the procedure
Secondary outcomes:
measure: Patient experience of anxiety level during the procedure
timeFrame: Mean anxiety level during the procedure
measure: Effect on vital sign
timeFrame: Mean arterial blood pressure during the procedure
measure: Consumption of analgetic drugs during the procedure
timeFrame: Total amount of analgesic drug (fentanyl) given throughout the procedure
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Ullevål, Hjertemedisinsk avdeling
Study officials:
affiliation: Ullevaal University Hospital
name: Sigrun Halvorsen, Prof. MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00518362: To Compare the Efficacy and Safety of Tripterygium (TW) Versus Valsartan in the Diabetic Nephropathy (DN)
Official title: To Compare the Efficacy and Safety of TW vs Valsartan in the DN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Nephropathy
Keywords: TW
Valsartan
treatment
diabetic nephropathy
Proteinuria
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2007-08-20
Enrollment: 67
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
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 compare the efficacy and safety of Tripterygium (TW) versus Valsartan (ARB) in the Diabetic Nephropathy (DN).

Detailed description: Diabetic nephropathy with heavy proteinuria have high risks of progressing to end stage renal disease. Though recent studies have shown that ACEI or ARB could reduce proteinuria of DN and slowed the progression to ESRD. But ARBs can only reduce proteinuria about 30%, so some patients still have heavy proteinuria,and then loss their renal function rapidly. So, to reduce the proteinuria of DN is a very important therapy target.

Tripterygium (TW) is a Chinese traditional patent drug, it can reduce proteinuria of chronic glomerular nephritis. So, we designed this randomized, prospective clinical trial to assess the efficacy and safety of TW versus ARB in the treatment of heavy proteinuria of DN.

Eligibility criteria: Inclusion Criteria:

1. A new diagnosis of diabetic nephropathy proved by histology and(or) serology.
2. Proteinuria \> 2.5 g/24 h
3. serum creatinine \< 3 mg/dl
4. age 35-65 years

Exclusion Criteria:

1. Co-existence of anther chronic glomerular nephritis.
2. Severe disfunction of the liver
3. White blood cell \< 3000/ul
4. Severe infection in the past 1 month
5. Malignant hypertension which in hard to control
6. Myocardial infarct or heart failure or sever cerebral vessels complication in the past 6 month

Primary outcomes:
measure: To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of diabetic nephropathy
timeFrame: 6 months
Secondary outcomes:
measure: To investigate the safety and tolerability of TW vs ARB. To access whether TW can delay the progression to ESRD or creatinine-doubling in diabetic nephropathy with heavy proteinuria.
timeFrame: 6 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Research Institute of Nephrology
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, China
name: Zhihong Liu, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ge Y, Xie H, Li S, Jin B, Hou J, Zhang H, Shi M, Liu Z. Treatment of diabetic nephropathy with Tripterygium wilfordii Hook F extract: a prospective, randomized, controlled clinical trial. J Transl Med. 2013 May 31;11:134. doi: 10.1186/1479-5876-11-134.
Clinical trial NCT03845062: Contribution of Drug Induced Sleep Endoscopy of Pediatric Obstructive Sleep Apnea Hypopnea Syndrome
Official title: Contribution of Drug Induced Sleep Endoscopy in the Management of Pediatric Obstructive Sleep Apnea Hypopnea Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea Hypopnea Syndrome
Keywords: drug-induced sleep endoscopy
pediatric obstructive sleep apnea hypopnea syndrome
tongue base
epiglottis
occult laryngomalacia
lingual tonsillectomy
epiglottopexy
aryepiglottic folds division
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 31
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with clinical obstructive sleep apnea hypopnea syndrome in University Health Center

Brief summary: The role of drug-induced sleep endoscopy (DISE) in the management of obstructive sleep apnea hypopnea syndrome (OSAHS) is not precisely defined for children. The primary objective of this study was to describe the consequences of DISE in the therapeutic management for children with OSAHS. The secondary objectives were to analyze the correlation between the number of obstructive sites found during DISE, the value of apnea-hypopnea index (AHI), and the type of OSAHS.

Detailed description: Retrospective single center study of 31 children (mean age: 5.5 ± 2.6 years) who benefited from DISE between 2015 and 2018 in the management of OSAHS. Modification of therapeutic management was noted. A correlation between the number of obstructive sites and the IAH on the one hand, and between the number of obstructive sites and the type of SAHOS on the other hand, was sought.

Eligibility criteria: Inclusion criteria:

- OSAHS confirmed by overnight sleep monitoring (respiratory polygraphy or overnight polysomnography)

Exclusion criteria:

- Lack of data

Primary outcomes:
measure: sleep endoscopy
timeFrame: 1 day
Secondary outcomes:
measure: Number of obstructive site during
timeFrame: 1 day
measure: value of apnea-hypopnea index
timeFrame: 1 day
measure: type obstructive hypopnoea apnea syndrome of sleep
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Mohamed Akkari, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06459362: Serum Cystatin C for Early Detection of Acute Kidney Injury After Primary Percutaneous Coronary Intervention
Official title: Serum Cystatin C for Early Detection of Acute Kidney Injury After Primary Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Kidney Injury
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with typical chest pain and treated by primary percutaneous intervention

Brief summary: This study aims to evaluate whether the serum levels of Cystatin C (CysC) can be used as early biomarkers for the identification of patients who are prone to AKI after cardiac interventional surgeries as primary percutaneous coronary intervention (PCI)

Detailed description: Acute Kidney Injury (AKI) is defined as an absolute increase in serum creatinine ≥0.3 mg/dl (≥26.4 μmol/l), a percentage increase in serum creatinine ≥50% (1.5-fold from baseline), or a reduction in urine output (documented oliguria \< 0.5 ml/kg/hour for \> 6 hours) Serum creatinine which is considered the gold standard currently for diagnosis of AKI remains unchanged until 50% of kidney function falls down. It is affected by non-specific factors like diet, age, dehydration, muscle mass, gender, and drugs There were evidences of the association between AKI and acute coronary syndrome (ACS); First, AKI detection may be missed by cardiologists. Physicians tend to disregard mild or transient serum creatinine elevation during hospital stay for ACS, and they often attribute small serum creatinine increases to laboratory variations.

Cystatin C (CysC), a cystatin protease inhibitor, is less affected by non-specific factors. When GFR decreases, CysC begins to increase. CysC was recommended to be measured in addition to creatinine in GFR estimation.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years.
2. Patient with absolute increase in serum creatinine ≥0.3 mg/dl (≥26.4 μmol/l) or with percentage increase in serum creatinine ≥50% (1.5-fold from baseline)
3. Patient with reduction in urine output (documented oliguria \< 0.5 ml/kg/hour for \> 6 hours)
4. Patient with typical chest pain, ECG changes, Echocardiogram positive finding

Exclusion Criteria:

1. History of nephrectomy
2. patient with renal transplantation
3. patient with renal replacement therapy initiated before admission
4. patient with chronic kidney disease
5. patient on regular haemodialysis
6. patient known to be diabetic

Primary outcomes:
measure: prevention and screening for early detection of acute kidney injury
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05976191: Comparison of Fasting Blood Glucose Measurements From Fingertip and Intravenous on Patient Satisfaction in Patients With Diabetes Mellitus
Official title: Istanbul University Cerrahpaşa-IUC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes mellitus
Fear of finger piercing
patient satisfaction
blood glucose measurement
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment This research was designed in a pretest posttest randomized controlled experimental type
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study was designed as a randomized controlled experimental study in order to compare the fasting blood glucose values measured by puncturing the fingertips and using the intravenous route of patients diagnosed with diabetes mellitus, and to determine the effect on patient satisfaction. The blood glucose measurement via the intravenous catheter has an effect on increasing the comfort of the patient compared to the fingertip measurement. It is thought that information can be provided to increase patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* No advanced hearing and vision problems
* Able to speak and understand Turkish
* Easy to communicate
* literate
* Agreeing to participate in the research voluntarily
* Patients who are hospitalized
* Regular finger blood sugar monitoring,
* Patients with an intravenous vascular access date within the first 24 hours
* Patients who had been diagnosed with Type 2 Diabetes Mellitus for at least one year were.

Exclusion Criteria:

* Those who are treated with sedative drugs
* Patients using antipsychotic medication
* Patients with continuous drug infusion through the intravenous line
* Patients whose intravenous vascular access date has passed 24 hours
* Patients in unconscious, confused, apathetic state

Primary outcomes:
measure: Blood Glucose Measurement Patient Satisfaction Form
timeFrame: four months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpaşa (IUC)
state: Şişli
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpaşa (IUC)
state: Şişli
Study officials:
References:
Clinical trial NCT02845362: Validation of the French Version of the Sydney Swallow Questionnaire in Patients With Neuromuscular Diseases
Official title: Validation of the French Version of the Sydney Swallow Questionnaire in Patients With Neuromuscular Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Neuromuscular Diseases
Keywords: Neuromuscular
dysphagia
Swallowing disorders
Questionnaire
Assessment
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 250
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Measurements of dysphagia severity are important when making management decisions and in the objective evaluation of swallowing impairments. The Sydney Swallow Questionnaire (SSQ) is a validated self-report inventory using a visual analogue scale. This questionnaire permits a quantitative, sensitive, specific, repeatable and easily responsive evaluation of dysphagia in different pathology. Opposed to largely used videofluoroscopy swallowing study and endoscopy examinations, the SSQ is noninvasive, less expensive, avoids radiation exposure and enables a readily available assessment. Validated French version is not yet available. In the first phase of the study the investigators will validated this translation in dysphagic patients and control. Secondly, the investigators will validate the SSQ in Neuromuscular patients.


Eligibility criteria: Inclusion Criteria:

Phase 1:

Group 1:

* Healthy participants
* Able to speak, read and write in French
* Aged at least 18 years old

Group 2:

* Patients, with symptoms indicative of a deglutition disorder, referred for a videofluoroscopic study to the Otolaryngology, Head and Neck Surgery Department, Voice and Swallowing Clinic
* Able to speak, read and write in French
* Aged at least 18 years old

Phase 2:

* Clinical diagnosis of neuromuscular diseases
* Able to understand French

Exclusion Criteria:

Phase 1:

Group 1:

* History of neurological or neuromuscular disease
* History of any diagnosticated swallowing disorder

Group 2:

* Patients who could not be cataloged as dysphagic or non-dysphagic after the videofluoroscopic study evaluation
* Patients unable to answer the questionnaire

Phase 2:

* Patients who could not be cataloged as dysphagic or non-dysphagic
* Patients unable to answer the questionnaire

Primary outcomes:
measure: Sydney Swallow Questionnaire
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint Luc
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc, Brussels, Belgium
name: Nicolas Audag, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03054662: Non Substitutive Strategies to Improve Haemophilia Care in Developing Countries. Experience in Ivory Coast.
Official title: Non Substitutive Strategies to Improve Haemophilia Care in Developing Countries. Experience in Ivory Coast.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Haemophilia
Developing Countries
Keywords: Haemophilia
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: World Federation of Hemophilia
First posted: 2017-02-15
Enrollment: 142
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: monocentric prospective study with longitudinal data collection of a single group
Primary purpose: OTHER

Brief summary: This study aims to make an inventory of the condition and care of patients with haemophilia and carriers for haemophilia in Ivory Coast and to promote the use non substitutive strategies that are not costly and available in Ivory Coast, to improve the management of haemophilia in this country. The purpose of this project is to evaluate the extent to which the active promotion of these various measures will improve the care of patients with haemophilia and carriers in Ivory Coast.

Detailed description: 1. Establish a baseline of the condition of haemophilia in Ivory Coast (number of patients, demographics, reassessment of diagnosis, joint status...).(year 1)
2. Develop tools to assess the intervention (eg transcultural validation of QoL questionnaires, develop booklets to record bleedings...). (year 1)
3. Intervention phase that will focus on education of patients and their family, education of caregivers, training of the laboratory to the diagnosis of haemophilia and promotion of non substitutive strategies to improve haemophilia care in Ivory Coast (DDAVP, antifibrinolytics, physiotherapy, dental care,...).
4. Follow-up phase during 2 years.
5. Outcome analysis

Eligibility criteria: Inclusion Criteria:

* Males with severe and moderate haemophilia A and B in Ivory Coast (any age).
* Females over 12 years who are carriers for severe and moderate haemophilia A and B in Ivory Coast.
* Exclusion Criteria: subjects not willing to participate.

Primary outcomes:
measure: Improve haemophilia care in Ivory Coast
timeFrame: 2 years after intervention
measure: Improve haemophilia diagnosis of haemophilia in Ivory Coast
timeFrame: 3 years
measure: Improve haemophilia care in Ivory Coast
timeFrame: 2 years after intervention
measure: Improve knowledge about haemophilia in Ivory Coast
timeFrame: 2 years after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Abidjan
country: Côte D'Ivoire
facility: CHU de Yopougon
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Catherine M Lambert, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01330862: Epidemiological Study to Describe Non-small-cell Lung Carcinoma (NSCLC) Clinical Management Patterns in MENA. Lung-EPICLIN/ KSA
Official title: Epidemiological Study to Describe NSCLC Clinical Management Patterns in MENA. Lung-EPICLIN/ KSA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NSCLC Patient Characteristics
Keywords: patient outcomes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-04-07
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All NSCLC patients attending the responsible department of treating this type of patients (e.g. Oncology Department) for the first time (regardless of whether the patient is diagnosed with locally, advanced or metastatic disease) at the participating sites from the first of April 2011 to the end of September 2011

Brief summary: The study is to provide accurate, reliable information on NSCLC clinical management across MENA (Middle East North Africa) countries in order to detect unmet medical needs of this disease, it is a purely observational study; therefore patients are not assigned to a particular therapeutic strategy beforehand by a protocol. Treatment will be according to current clinical practice.


Eligibility criteria: Inclusion Criteria:

* Confirmed NSCLC diagnosis (e.g. bronchoscope or FNAB), all stages, men and women, attending the responsible department of treating this type of patients for the first time between April 1st 2011 and March 31 2012, for PRO sub-sample: ability to read and write since they will be asked to participate in the PRO part of the study. Selection will not be based on the disease stage of each patient, in order to avoid a selection bias

Exclusion Criteria:

* According to the study design there will not be any exclusion criteria in order to provide a high validity and to obtain the most accurate real daily practice information.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Qassim
country: Saudi Arabia
facility: Research Site
state: Central
city: Riyadh
country: Saudi Arabia
facility: Research Site
state: Central
city: Dammam
country: Saudi Arabia
facility: Research Site
state: Eastern
city: Jeddah
country: Saudi Arabia
facility: Research Site
state: Western
Study officials:
affiliation: King Fahad National Guard Hospital
name: Dr. Abdul Rahman Jazieh
role: STUDY_CHAIR
affiliation: King Fahad Specialist Hospital
name: Dr. Ahmed Abdulwarith
role: PRINCIPAL_INVESTIGATOR
affiliation: King Fahad Medical City
name: Dr. Rasha Moastafa
role: PRINCIPAL_INVESTIGATOR
affiliation: Prince Faisal Bin Bander oncology centre
name: Dr. Sherif Wafa
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Erfan & Bagedo Hospital
name: Dr. Maged Mansour
role: PRINCIPAL_INVESTIGATOR
affiliation: King Fahad Specialist Hospital
name: Dr. Mohamed Rahhal
role: PRINCIPAL_INVESTIGATOR
References: