louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03044340: Vascular and Neurologic Exploration of Small Nervous Fiber by Sudoscanner and QST
Official title: Vascular and Neurologic Exploration of Small Nervous Fiber by Sudoscanner
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erythermalgia
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Erythromelalgy (EM) is a vascular syndrome very rare affecting the feet. This disease evolve by crisis when the feet extremities become red hot and painful. There are several types of EM but this study concern the adult primitive form. For a long time, the physiopathology was not described but now we know that there is a vascular form, with microcirculatory dysfunction and a neurologic form with small fibers neuropathy. The diagnostic of neurologic form is based on clinical evaluation (DN4 questionnaire, UENS scale...) and an electromyography. Thermotest, a medical device which measure the thermic sensitivity is used to quantify neuropathy. More recently Sudoscan, a device measuring cutaneous impedance to chloride ions detect small nervous fiber in diabetic patients with good correlation with Thermotest.

The purpose of this study is to analyze the vascular side and the neurologic side on patients consulting for Erythromelalgy.


Eligibility criteria: Inclusion Criteria:

* Pain with burn feeling at hands and feet extremities
* Crisis activated by the heat
* Age \> 18 years old

Exclusion Criteria:

* Patients who had burn in extremities

Primary outcomes:
measure: Assessment of Chlorine ion production change
timeFrame: Day1
measure: Assessment of Temperature changing sensitivity
timeFrame: Day1
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
References:
Clinical trial NCT03885440: Age and Sleep Apnea Syndrome
Official title: Age and Sleep Apnea Syndrome: Clinical Features and Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: OSA
Age Problem
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2019-03-21
Enrollment: 3000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with sleep complaints

Brief summary: By clinical record review, this retrospective study aims to compare the different age groups of patients with obstructive sleep apnea, who were diagnosed and treated in Taipei Veterans General Hospital, Taiwan.

Detailed description: This retrospective study aims to compare the characteristics of patients with obstructive sleep apnea (OSA). Patients with sleep problem and received a prior polysomnography at Taipei Veterans General Hospital during Jan. 1, 2016 to Dec. 31, 2017 will be enrolled. Obstructive sleep apnea (OSA) is defined by an apnea-hypopnea index(AHI) at least 5/hr with compatible symptoms. Their clinical record will be reviewed and data including demography, polysomnography, comorbidities and details related to upper airway structure will be collected. The charactereistics would be compared with Student's t tests, Mann-Whitney U tests, or Chi square tests if appropriated.

Eligibility criteria: Inclusion Criteria:

* Patients with sleep complaints and received PSG in sleep center in Taipei Veterans General Hospital

Exclusion Criteria:

* Patients who ever received treatment for OSA
* Patients cannot tolerate PSG examination
* Patients cannot complete the questionnaires before and after PSG examination

Primary outcomes:
measure: Apnea-hypopnea index(AHI)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Body mass index(BMI)
timeFrame: through study completion, an average of 1 year
measure: Posterior airway space (PAS)
timeFrame: through study completion, an average of 1 year
measure: Number of participants with comorbidities
timeFrame: through study completion, an average of 1 year
measure: Sleep efficiency
timeFrame: through study completion, an average of 1 year
measure: arousal index
timeFrame: through study completion, an average of 1 year
measure: oxygen desaturation index
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Chest department, Taipei Veteran General Hospital
Study officials:
References:
Clinical trial NCT05325840: Non Stress Test and Music Performance
Official title: Evaluation of the Effect of Music Played During the Non-Stress Test on Fetal Health, Anxiety Level of the Pregnant and Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Health
Pregnancy Related
Keywords: music
pregnancy
nonstrest test
fetal
health
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 140
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Today, many methods are used in the evaluation of intrauterine fetal well-being. Non-stress test (NST) method is mostly used in the non-invasive evaluation of fetal well-being during pregnancy and labor. NST is a procedure in which fetal heart sounds are recorded and the relationship between fetal movements and fetal heart beat is monitored.3 Various methods are used to minimize the psychological effects that occur during pregnancy. Among these methods, it has been seen in the studies in the literature that music, which is a non-pharmacological method, has a positive effect on the pregnant woman and the fetus. It is easy and enjoyable to listen to music during the routine non-stress test process. However, there are not enough studies to prove the effect of music.

The aim of this study was to examine the effects of the music concert applied during the nonstress test procedure on the health of the fetus, the anxiety level of the pregnant woman and blood pressure.

Detailed description: expected

Eligibility criteria: Inclusion Criteria:

* Become literate
* Be in the 18-45 age range.
* Being at the 32nd and above gestational week
* Not carrying any risk factors during pregnancy (preeclampsia, IUGR, gestational diabetes, etc.)
* Have eaten at least two hours before the NST procedure
* No fetal defined cardiovascular disease
* The pregnant woman is open to communication and does not have mental or mental problems.
* Absence of auditory problems

Exclusion Criteria:

* Absence of illiteracy of the pregnant woman
* Uterine contraction in NST
* Pregnant women who need fetal distress and urgent intervention by the physician

Primary outcomes:
measure: Evaluation of the Effect of Music Played During the Non-Stress Test on Fetal Health, Anxiety Level of the Pregnant and Blood Pressure
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bingöl
country: Turkey
facility: Bingöl Solhan Devlet Hastanesi
state: Solhan Bingöl
Study officials:
References:
Clinical trial NCT03078140: Iodine Supplement Strategies Between Routine Iodine Supplementation and Selective Iodine Supplementation
Official title: The Study to Compare Iodine Supplement Strategies Between Routine Iodine Supplementation and Selective Iodine Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Iodine Deficiency
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 208
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pregnant women who attend at our antenatal clinic will random to 2 groups. First will receive routine iodine supplementation. The other will receive iodinated pill or only iron supplementation base on their urine iodine status.


Eligibility criteria: Inclusion Criteria:

* first visit for antenatal care in the first trimester
* singleton pregnancy
* delivered at Maharaj Nakorn Chiangmai Hospital

Exclusion Criteria:

* thyroid disease which diagnosed before pregnancy or currently
* history of thyroid gland surgery or iodine ablation therapy
* received iodine supplement before pregnancy
* received any medication for thyroid disease treatment, within 6 weeks postpartum women or breast feeding period
* family history of thyroid disease
* having underlying disease or contraindication which cannot received iodine supplement
* loss follow-up or incomplete data.

Primary outcomes:
measure: iodine status
timeFrame: at delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Kuntharee Traisrisilp
Study officials:
References:
Clinical trial NCT04848740: Human Fresh Corneal Lenticule Implantation Criteria in Progressive Corneal Disease Using Relex-Smile
Official title: Human Fresh Corneal Lenticule Implantation Criteria in Progressive Corneal Disease Using Relex-Smile
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Progressive Disease of Corneae
Lead sponsor: Eye Hospital Pristina Kosovo
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Stroma is a fibrous, tough, transparent and the thickest layer of the corneae. The stroma is composed of organised collagen, which maintains transparency. Keratocytes are located between the lamella collagen fibers and secrete an extracellular matrix, which includes collagen, proteoglycan, crystalline proteins to maintain corneal transparency.

Detailed description: Knowing the importance of stroma(90%) in function and anatomy of corneae (transparence, curvature, strength, protection) the inner eye structures from external environment, we have examined the role and function of stroma as a main factor of corneal thickness in implanting fresh corneal lenticule in progressive corneal disease.

We have studied that in many clinical cases where the corneal epithelium and endothelium are healthy and functioning, the cornea can still lose it's transparency by different corneal stromal pathologies (infection ,keratoconus, inflammation ,neurodegeneration and corneal dystrophies).

Eligibility criteria: Inclusion Criteria:

* progressive corneal disease with thin corneal thickness
* corneal low transparenc
* low visual acuity

Exclusion Criteria:

* active anterior segment pathology
* previous corneal or anterior segment surgery
* other infection etc.

Primary outcomes:
measure: Increase of corneal thickness
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pristina
country: Kosovo
facility: Eye Hospital Pristina
Study officials:
References:
Clinical trial NCT02913040: High Flow in Infants With Bronchiolitis
Official title: High Flow Nasal Cannula Therapy for Infants With Bronchiolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Lead sponsor: Princess Amalia Children's Clinic
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 111
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this multi-centre randomized controlled trial the investigators compare the effect on dyspnoea severity of oxgen delivery through High Flow Nasal cannula with Low Flow Nasal Prongs in children \< 2 years of age hospitalised for bronchiolitis with moderate-severe dyspnoea.

Detailed description: In this multi-centre randomized controlled trial the investigators compare the effect on dyspnoea severity of oxgen delivery through High Flow Nasal Cannula with Low Flow Nasal Prongs in children \< 2 years of age hospitalised for bronchiolitis with moderate-severe dyspnoea. The study will take place on the pediatric (Non intensive care) units of 5 different hospitals in the Netherlands.

Eligibility criteria: Inclusion Criteria:

* bronchiolitis PEWS (Pediatric Early Warning Score 0-28) \>= 6 oxygen saturation \< 92%

Exclusion Criteria:

* chronic lung disease hemodynamic significant heart disease syndromal disease facial abnormalities

Primary outcomes:
measure: PEWS (Pediatric Early Warning Score) (in points 0-28)
timeFrame: 24 hours
Secondary outcomes:
measure: Comfort (in points 0-10)
timeFrame: 24 hours
measure: ability to feed (yes or no)
timeFrame: 5 days
measure: duration of hospitalisation in days
timeFrame: 15 days
measure: admission to PICU (Pediatric Intensive Care Unit) (yes or no)
timeFrame: 5 days
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala Klinieken
state: Overijssel
city: Breda
country: Netherlands
facility: Amphia
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Ikazia Hospital
Study officials:
affiliation: Isala
name: Jolita Bekhof, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01329640: Feasibility Study of Metronomic Chemotherapy for Locally Advanced Her2- Positive Breast Cancer (TraQ-Me 01)
Official title: Phase II Feasibility Study of Weekly Paclitaxel Plus Weekly Trastuzumab Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide Plus Weekly Trastuzumab for Locally Advanced HER2-Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Locally Advanced HER2-positive Breast Cancer
Keywords: Metronimic chemotherapy
Locally Advanced HER2-positive Breast Cancer
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação Faculdade de Medicina
First posted: 2011-04-06
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, effectiveness and cost-effectiveness of metronomic chemotherapy combined with trastuzumab as neoadjuvant therapy for locally advanced HER2-positive breast cancer.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of locally advanced breast cancer
* T \> 2 cm (any N), or any T and positive node(needle biopsy is required if tumor size is less than 2cm)
* Non-metastatic disease confirmed by computerized tomography and bone scan
* HER2 positive by IHC (+++) and/or Fish (+) according to international definitions (ASCO 2007)
* Normal left ventricular ejection fraction (LVEF)
* Indication of preoperative chemotherapy
* multifocal tumors acceptable provided that the largest tumor is Her2-positive
* ECOG 0-1

Exclusion Criteria:

* Another malignancy within the last 5 years (except curatively treated skin carcinoma, in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular carcinoma of the breast)
* Clinically significant comorbidities such as cardiovascular diseases, COPD, renal or liver impairment, psychiatric disorders
* LVEF value below institutional limits of normal range
* Detected or suspected distant metastasis
* Neutrophils lower than 1,500/µL, platelets lower than 100,000/µL, hemoglobin lower than 10 g/dL, AST higher than 2.5x upper limit of normal (ULN), total bilirubin higher than ULN, alkaline phosphatase more than 1.5x ULN

Primary outcomes:
measure: INCIDENCE OF FEBRILE NEUTROPENIA
timeFrame: 18 weeks
Secondary outcomes:
measure: TUMOR SIZE
timeFrame: From the beginning of treatment until surgery, disease progression or death
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo
Study officials:
References:
Clinical trial NCT01094340: Thalidomide for Patients With Mild to Moderate Alzheimer's Disease
Official title: "Twenty-Four-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fixed Dose Regimens of Thalidomide and Placebo on CSF and Plasma Biomarkers in Patients With Mild to Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Alzheimer's Disease
Lead sponsor: Banner Health
Sponsor class: OTHER
First posted: 2010-03-26
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 24-week, randomized, double-blind, placebo-controlled study of the effect of thalidomide and placebo on CSF (cerebral spinal fluid) and plasma biomarkers in patients with mild to moderate Alzheimer's disease. This study will evaluate the effects of 24 weeks of treatment with Thalidomide on plasma biomarkers.

Detailed description: A lumbar puncture will be done before treatment (baseline), and at 24 weeks to collect CSF for the quantification of biomarkers. As an exploratory effort, we will test the effects of thalidomide on the same biomarkers in the plasma and will determine if detectable changes mirror changes observed in the CSF.

Eligibility criteria: Inclusion Criteria:

* Subjects must have a screening diagnosis of Probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
* Subjects must have a Mini-Mental State Examination (MMSE) score of 12-26
* Subject must live at home.
* Must have a caregiver to participate in this study

Primary outcomes:
measure: Improve cognition
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
Study officials:
affiliation: Banner Health
name: Carolyn Liebsack, BSN
role: STUDY_DIRECTOR
References:
Clinical trial NCT04887740: Osteoarticular Infections on Material in Children
Official title: Osteoarticular Infections on Material in Children Under 16 Years Old at the CHU of Montpellier From 2014 to 2021
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarticular Tuberculoses
Keywords: Children
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 200
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under 16 years old hospitalized at the CHU of Montpellier

Brief summary: The management of osteoarticular infections on equipment is complex. In order to optimize the management of these infections, the French National Authority for Health (HAS) has published good practice recommendations for prosthesis infections in adults. However, in the pediatric population, this type of infection is rarer and their management less well codified.

The aim of this retrospective and descriptive monocentric study is to identify all osteoarticular infections in children under 16 years of age managed at the Montpellier University Hospital from 2014 to 2021, to study the epidemiology and bacterial ecology of these infections and to evaluate the effectiveness of the therapeutic strategy and side effects, long-term sequels


Eligibility criteria: Inclusion criteria:

* osteoarticular infections on material in children under 16 years old
* hospitalized at the CHU of Montpellier

Exclusion criteria:

* over 16 years of age
* other types of osteoarticular infections

Primary outcomes:
measure: Number of Participants with incidence of osteoarticular infections
timeFrame: day 1
Secondary outcomes:
measure: Number of Participants with Epidemiology of osteoarticular infections
timeFrame: day 1
measure: Number of Participants with bacterial ecology of osteoarticular infections
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Léa DOMITIEN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05285540: Study to Evaluate DT-216 in Adult Patients With Friedreich Ataxia
Official title: A Phase 1a, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of DT-216 in Adult Patients With Friedreich Ataxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Friedreich Ataxia
Lead sponsor: Design Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-17
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of intravenous DT-216 in adult patients with Friedreich Ataxia. This single ascending dose study is randomized, double-blind, placebo-controlled.


Eligibility criteria: Inclusion Criteria:

* Genetically confirmed diagnosis of Friedreich Ataxia with homozygous GAA repeat expansions
* Body mass index (BMI) between 17 and 32 kg/m2
* Stage 5.5 or less on the Functional Staging for Ataxia (FSA)

Exclusion Criteria:

* Has any concomitant medical condition that in the opinion of the investigator, puts the participant at risk or precludes participant from completing the study
* Has clinically significant abnormal laboratory results
* Has significant cardiac disease
* Received an investigational drug within 3 months of screening

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Frequency of treatment adverse events (TEAEs)
timeFrame: Up to approximately 30 days
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax) of DT-216
timeFrame: Up to approximately 30 days
measure: Time to Maximum Plasma Concentration (Tmax) of DT-216
timeFrame: Up to approximately 30 days
measure: Area Under the Concentration-time Curve (AUC) of DT-216
timeFrame: Up to approximately 30 days
Other outcomes:
measure: Frataxin expression
timeFrame: Up to approximately 30 days
Locations:
city: Eatontown
country: United States
facility: Clinilabs
state: New Jersey
Study officials:
References: