louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06285669: Effects of Kinesiotaping on Respiratory Muscles in Very Preterm Infants
Official title: Effects of Kinesio Taping Applications on Diaphragm, Respiratory Muscles and Chest Wall In Very Preterm Infants On Non-invasive Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm
Premature
Infant, Newborn, Diseases
Respiratory Distress Syndrome
Neonatal Respiratory Distress
Keywords: respiratory distress syndrome
preterm infant
kinesiotaping
pulmonary function
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 26
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Kinesio-Taping Application
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the effects of kinesio taping on blood gas parameters, respiratory rate, heart rate, oxygen saturation, and pressure limits in preterm infants with RDS who are on NIV. It is hypothesized that the application of kinesio taping to the chest area of preterm infants may improve respiratory functions and oxygenation at the alveolar level, leading to decreased work of breathing, reduced respiratory rate, and improved neonatal stability by promoting respiratory mechanics and enhancing chest expansion.

Detailed description: Very preterm infants are at high risk of respiratory distress syndrome (RDS), due to surfactant deficiency and weak respiratory muscles. This condition can contribute to respiratory workload and irregular breathing. This study aimed to investigate the effects of Kinesio kinesio-taping technique on the respiratory muscles and diaphragm in very preterm infants undergoing non-invasive.

Twenty-six preterm infants born before the 32nd gestational week and requiring non-invasive ventilation (NIV) support due to RDS, were randomly divided into 2 groups as Kinesio taping group and control group. Kinesio taping was applied by a single physiotherapist to support the intercostal muscles,and, the diaphragm and facilitatory method was used on the respiratory muscles. Kinesio taping was removed just after preterm infants were weaned from noninvasive ventilation. Blood gas parameters, respiratory rate, heart rate, FiO2, FiO2/pO2 ratio, PIP, PEEP values, and length of stay in NIV were recorded before and after 3 days of KT application.

Eligibility criteria: Inclusion Criteria:

* Preterm infants diagnosed with RDS
* Preterm Infants born under 32 weeks of gestation

Exclusion Criteria:

* Sepsis,
* necrotizing enterocolitis,
* metabolic disease,
* severe congenital malformations of the chest and abdominal walls,
* congenital heart disease,
* major congenital anomalies

Primary outcomes:
measure: Level of pH
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Nilay Çömük Balci
state: Atakum
Study officials:
affiliation: Ondokuz Mayıs University
name: Nilay Comuk Balci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00414869: Preliminary Efficacy and Tolerability of NCX-1000 After Repeated Oral Doses in Patients With Elevated Portal Pressure
Official title: Preliminary Efficacy And Tolerability Of Oral NCX-1000 After Repeated Administrations In Patients With Portal Hypertension: A Double-Blind Dose Escalating Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Portal Hypertension
Keywords: Liver
Portal pressure
Fibrosis
Nitric oxide
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2006-12-22
Enrollment: 11
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: Chronic liver diseases are often characterized by portal hypertension, a major complication involving haemodynamic changes due to increased intrahepatic vascular resistance. It has become well established that nitric oxide (NO) plays a crucial role in the haemodynamic abnormalities that develop in chronic portal hypertension.

NCX-1000 is a NO-releasing derivative of ursodeoxycholic acid that would compensate for the defective liver NO production in cirrhosis.

This study intends to demonstrate the desired therapeutic activity (reduction in portal pressure) in a small number of target patients, to assess the safety and tolerability after repeated oral administrations of NCX-1000, and to get preliminary pharmacokinetic data in this population.

Detailed description: Brief summary is complete. Study is closed.

Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant female patients of at least 18 years old
* HVPG \> 12 mm Hg in fasting state on Day 1
* Free of any other condition (except liver failure) that may alter absorption, distribution, or elimination of drugs

Exclusion Criteria:

* Oesophageal bleeding in the previous 30 days
* Known intolerance to ursodeoxycholic acid or nitrates
* Liver cancer or liver metastasis from another cancer
* Portal hypertension secondary to venous thrombosis
* Presence of Transjugular Intrahepatic Portosystemic Shunt (TIPS)
* Severe liver failure (Child-Pugh C)

Primary outcomes:
measure: The Hepatic Venous Pressure Gradient (HVPG) will be evaluated at entry (Day 1) and after the Maximal Tolerated Dose (MTD) on Day 16, in fasting and post-prandial (after a standardized liquid breakfast) states.
timeFrame: Day1 and Day 16
Secondary outcomes:
measure: Safety parameters: systolic and diastolic blood pressures, heart rate, physical examination, laboratory tests and Adverse Events (AEs)
timeFrame: At various times
measure: Plasma levels of NCX-1000 and its main metabolites will be evaluated to get preliminary pharmacokinetic data.
timeFrame: 0, 1, 2, 3, and 4 hours after the first 3 doses anf after the last dose
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
Study officials:
affiliation: Clinic Barcelona Hospital Universatiri
name: Jaime Bosch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03579069: Ductus Venosus Doppler at 16 Weeks in Monochorial Pregnancy
Official title: Does the Performance of the Ductus Venosus Doppler at 16 Weeks Allow to Increase the Screening of the Twin-twin Transfusion Syndrome and to Reduce the Neonatal Mortality?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Twin Pregnancy, Monochorionic
Pregnancy Followed
Keywords: Ductus venosus Doppler
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Monochorial pregnancy followed in the hospital of Montpellier or Bicêtre

Brief summary: Studies shows that the realization of the Ductus venosus Doppler may improve the screening of the twin-twin transfusion syndrome. In this study, we want to compare the outcome of monochorial pregnancy when this Doppler was performed during the ultrasound at16 weeks, and when it wasn't. In order to do that, we will compile past reports (January 2015/ January 2018) of all monochorial pregnancy handled in the hospital of Montpellier and Kremlin Bicêtre. We will establish if the Doppler was done or not, if the twin-twin transfusion syndrome appears and the neonatal outcome.


Eligibility criteria: Inclusion criteria:

* Monochorionic diamniotic twin pregnancies
* Monochorionicity diagnosed at the first-trimester
* Follow up and ultrasound realized at the hospital of Montpellier or Kremlin Bicêtre
* Screening for twin-twin transfusion syndrome achieved

Exclusion criteria:

* Missing ultrasound
* Unregistered outcome of the pregnancy
* Eclampsia and pre-eclampsia

Primary outcomes:
measure: Occurrence of a twin to twin transfusion syndrome
timeFrame: 1 day
Secondary outcomes:
measure: neonatal mortality rate
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Celine FOREL
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01729169: Cardiac Sarcoidosis: FDG PET vs. Ga-DOTANOC PET
Official title: Diagnosing Cardiac Sarcoidosis Using FDG PET: Optimization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis
Cardiac Sarcoidosis
Keywords: Sarcoidosis
Cardiac sarcoidosis
18-FDG PET
68Ga-DOTANOC PET
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2012-11-20
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with biopsy proven sarcoidosis suspected of having cardiac sarcoidosis

Brief summary: Diagnosing cardiac sarcoidosis has always been challenging: No single imaging modality has proved effective and cardiac biopsies have a very low sensitivity. 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) PET preceded by at least 12 hours of fasting has previously been demonstrated to have reasonable accuracy, however, in some patients physiological FDG uptake in the cardiac region hampers correct identification of sarcoid granulomas. Gallium Ga 68-DOTANOC is a conjugate of the somatostatin analogue Nal3-octreotide (NOC) and gallium Ga 68-labeled 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid (DOTA). We aim to study whether 68Ga-DOTANOC has superior sensitivity and accuracy than 18-FDG PET in diagnosing cardiac sarcoidosis. In addition, we aim to compare 18-FDG PET preceded by 12 hours fasting with 18-FDG PET during somatostatin blockade of insulin mediated cardiac glucose uptake.

Detailed description: Intervention:

* Study A: Subjects with biopsy proven sarcoidosis suspected of cardiac involvement (prone to arrhythmias, cardiac failure, unexplained dyspnea) are studied twice: 1) 18-FDG PET preceded by 12 hours fasting and 2) 18-FDG PET performed during a 2 hour somatostatin blockade (300 microgram/hour)/Heparin infusion.
* Study B: Subjects with biopsy proven sarcoidosis suspected of cardiac involvement are studied twice: 1) 18-FDG PET preceded by 12 hours fasting and 2) 68Ga-DOTANOC PET preceded by at least 6 hours fasting.

Eligibility criteria: Inclusion Criteria:

* Biopsy proven sarcoidosis
* Suspected cardiac sarcoidosis

Exclusion Criteria:

* Ischemic heart disease
* Diabetes
* Cardiomyopathy

Primary outcomes:
measure: Cardiac sarcoidosis - Sensitivity
timeFrame: 01/01/2015
Secondary outcomes:
measure: Myocardial cardiac glucose uptake assessed by Cardiac SUV
timeFrame: 01/01/2015
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
citation: Gormsen LC, Haraldsen A, Kramer S, Dias AH, Kim WY, Borghammer P. A dual tracer (68)Ga-DOTANOC PET/CT and (18)F-FDG PET/CT pilot study for detection of cardiac sarcoidosis. EJNMMI Res. 2016 Dec;6(1):52. doi: 10.1186/s13550-016-0207-6. Epub 2016 Jun 17.
Clinical trial NCT06530069: Exploring the Risk Factors of Otomycosis: A Case-Control Study
Official title: Exploring the Risk Factors of Otomycosis: A Case-Control Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Otomycosis
Keywords: Otomycosis
predisposing factor
Lead sponsor: Zhongshan Hospital Xiamen University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Our institution is a tertiary first-class comprehensive hospital. Both the disease group and the control group are seen and screened at our facility

Brief summary: The goal of this observational study is to explore the risk factors of fungal otitis externa in the fungal otitis externa patients The main question it aims to answer is:

What behaviors lead to the occurrence of fungal otitis externa? Participants will complete a detailed questionnaire survey. If there is a comparison group: Researchers will compare the healthy group and the disease group to see if there are any differences.


Eligibility criteria: Inclusion Criteria:

* Symptoms in the case group include tinnitus, ear fullness or blockage, itching, ear pain, discharge, and hearing loss. Physical examination reveals the presence of hyphae, scabs, secretions, masses, pus, red skin, erosion, swelling, or granulation in the ear canal. Laboratory fungal cultures must be positive. The control group does not have the aforementioned ear symptoms and has not sought medical attention for ear-related symptoms.

Exclusion Criteria:

* Patients with otitis media, tympanic membrane perforation, or post-radiotherapy.

Primary outcomes:
measure: Odds Ratio
timeFrame: 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Zhongshan Hospital of Xiamen university
state: Fujian
Study officials:
affiliation: Zhongshan Hospital Xiamen University
name: Chunsheng Ye, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02017769: MRI in Diagnosing and Monitoring CIDP
Official title: Magnetic Resonance Imaging and Ultrasound Imaging of Peripheral Nerves in Patients Treated With Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Keywords: Subcutaneous immunoglobulin
Magnetic resonance imaging
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with subcutaneous immunoglobulin for CIDP are invited to participate. They will be recruited from the outpatient clinic at Department of Neurology in Aarhus, Odense and at Rigshospitalet (Copenhagen)

Healthy controls will be recruited by public announcement

Brief summary: We want to study whether MRI can be useful in diagnosing and monitoring patients with CIDP in maintenance treatment with immunoglobulin

Detailed description: Chronic inflammatory neuropathies such as chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) can be successfully treated with immunoglobulin either intravenously (IVIG) or subcutaneously (SCIG).

CIDP is diagnosed by electrophysiology which is time-consuming and unpleasant for the patient.

New techniques suggest that Magnetic Resonance Imaging (MRI) and ultrasound imaging can be used to detect injuries in the peripheral nerves

We want to study if MRI and ultrasound is able to detect damages in peripheral nerves, nerve roots and plexus in patients with CIDP.

Moreover, we want to compare these findings to healthy matched controls and to see if treatment with immunoglobulin changes findings in MRI

Eligibility criteria: Inclusion Criteria:

CIDP patients

* Age \> 18 and \< 80 years
* Diagnosed with definite and probable CIDP and fulfilling the European Federation of Neurological Sciences/Peripheral Nerve Society (EFNS/PNS) criteria

Healthy controls

* Age \> 18 and \< 80 years
* No neurological disorders

Exclusion Criteria:

* Age \< 18 or \> 80 years
* Contraindications to MRI
* Pregnancy
* Other cause of neuropathy (incl. pressure neuropathy)
* Diabetes mellitus

Primary outcomes:
measure: DTI changes in nerves and muscles
timeFrame: At enrolment
Secondary outcomes:
measure: Changes in MRI findings between treated and untreated CIDP patients
timeFrame: All patients are examined at enrolment. Untreated patients are re-examined after 4 months of treatment
measure: Comparing clinical findings to MRI
timeFrame: At enrolment
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Neurology, Aarhus University Hospital
Study officials:
name: Henning Andersen, Prof, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03394469: Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Population of Adult Obese Patients
Official title: Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Population of Adult Obese Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Obesity
Sarcopenia
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This project aims first to determine the prevalence of sarcopenia in a population of obese people of extended age group (18-70 years). In a second step, the factors determining and / or predisposing to sarcopenic obesity will be identified as well as plasmatic and urinary biomarkers specific to this phenotype.

Detailed description: Collection of clinical and paraclinical data (biological and anthropometric) for evaluation of sarcopenic obesity in obese patients.

Biological collection to identify plasma, serum, genetic, urinary and faecal biomarkers associated with sarcopenic obesity

Eligibility criteria: Inclusion Criteria:

* Age: 18-70 years
* Sex: men and women
* Patient followed in clinical nutrition benefiting from a metabolic assessment for optimization of clinical and paraclinical management
* Patient meeting the criteria of obesity defined by BMI\> 30 kg / m²
* Major patient with free, informed and signed consent
* Patient covered by the social security scheme

Exclusion Criteria:

* Patient with cancer or severe chronic disease (renal failure, respiratory failure, liver failure)
* Patient with neuromuscular disease
* Patient with a total inability to walk
* Minor patient
* Refusal of the patient to participate in the study
* Pregnant or lactating women
* Patient deprived of liberty or under guardianship.

Primary outcomes:
measure: Sarcopenia
timeFrame: at day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Yves BOIRIE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00183469: Maintenance Treatment of Bipolar Depression
Official title: Eight-Month Maintenance Treatment of Bipolar Depression With Lamotrigine or Lamotrigine Plus Divalproex Combination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Depression
Keywords: Lamotrigine
Divalproex
Antidepressant
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-16
Enrollment: 86
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 study will compare two different antidepressant treatment regimens to determine which is more effective in reducing symptoms of bipolar depression.

Detailed description: Depression is a serious condition that is often difficult to diagnosis and treat. Bipolar disorder-related depression is especially complex because of the presence of mania symptoms. Lamotrigine and divalproex are commonly prescribed medications for depression. However, their effectiveness in treating bipolar depression has not been thoroughly evaluated. Studies have shown that combining lamotrigine with another antidepressant may be more effective in reducing depressive symptoms than lamotrigine alone. This study will provide participants with either lamotrigine alone or in combination with divalproex and will determine which regimen is more effective in reducing symptoms of bipolar depression.

Participants will be randomly assigned to a daily regimen of either lamotrigine and divalproex or lamotrigine and placebo for 8 months. Participants will be assessed at study entry, at two unspecified times during the study, and at the end of the study. During each assessment, participants will undergo a brief interview and complete a questionnaire about their depressive symptoms, any physical manifestations of their depression, and their overall level of functioning in daily activities.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of bipolar disorder I or II
* Experiencing symptoms of depression at study entry OR have experienced symptoms of depression within 6 months prior to study entry
* Willing to use acceptable methods of contraception
* Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

* History of liver disease
* History of substance abuse
* Previous treatment with lamotrigine or divalproex
* Lamotrigine or divalproex intolerance

Primary outcomes:
measure: Mania Rating Scale
timeFrame: up to 8 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: 210-567-5405
name: Charles L. Bowden, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bowden CL, Singh V, Weisler R, Thompson P, Chang X, Quinones M, Mintz J. Lamotrigine vs. lamotrigine plus divalproex in randomized, placebo-controlled maintenance treatment for bipolar depression. Acta Psychiatr Scand. 2012 Nov;126(5):342-50. doi: 10.1111/j.1600-0447.2012.01890.x. Epub 2012 Jun 18.