louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04033289: The Clinical Efficacy of Hip Protection Orthosis for the Protection of Hip Dislocation
Official title: The Clinical Efficacy of Hip Protection Orthosis for The Protection of Hip Dislocation in Patients With Severe Cerebral Palsy, Single Blinded, Randomized-control Trial, Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
First posted: 2019-07-26
Enrollment: 66
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Single Blinded, Randomized-control tiral, Multicenter clinical trial


Eligibility criteria: Inclusion Criteria:

* GMFCE level IV or V in the Cerebral palsy
* age from 1 to 10

Exclusion Criteria:

* History of hip joint surgery
* Botulinum toxin injection to hip muscle past 3 months or expected in our study duration

Primary outcomes:
measure: Migration index
timeFrame: 6 months
Secondary outcomes:
measure: Cobb's angle (')
timeFrame: 6 months
measure: Range of motion of hip joint (')
timeFrame: 6 months
measure: Visual analog scale
timeFrame: 6 months
measure: Likert scale (score)
timeFrame: immediately after wearing orthosis
measure: Child Health Index of Life with Disabilities (CPCHILD)
timeFrame: 6 months
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: professor
name: Juseok Ryu, Phd
role: STUDY_CHAIR
References:
citation: Kim BR, Yoon JA, Han HJ, Yoon YI, Lim J, Lee S, Cho S, Shin YB, Lee HJ, Suh JH, Jang J, Beom J, Park Y, Choi JH, Ryu JS. Efficacy of a Hip Brace for Hip Displacement in Children With Cerebral Palsy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2240383. doi: 10.1001/jamanetworkopen.2022.40383.
Clinical trial NCT04988789: Evaluation of Paclitaxel Coated Balloon in the Treatment of Dialysis Access Dysfunction
Official title: Evaluation of Paclitaxel Coated Balloon in the Treatment of Dialysis Access Dysfunction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dialysis Access Malfunction
Kidney Failure
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients above 21 that is undergoing AVF/AVG fistuloplasty with paclitaxel DCB at SGH is included

Brief summary: Recent studies of paclitaxel DCB in the treatment of stenosis at dialysis vascular access have shown promising results. Paclitaxel, an anti-proliferation drug, is released during balloon inflation and potentially improve primary patency by slowing down NIH effect. However, meta-analysis have suggested that the use of paclitaxel in lower limbs have increased risk of death in patients. The effect of paclitaxel DCB on dialysis access however remains unknown. Hence, we aim to set up a database to track long-term treatment outcomes of patients treated with Paclitaxel DCB at SGH for their stenosed dialysis access


Eligibility criteria: Inclusion Criteria:

* All patients above 21 that is undergoing AVF/AVG fistuloplasty with paclitaxel DCB at SGH is included

Exclusion Criteria:

* All patients below 21

Primary outcomes:
measure: Circuit Access Patency
timeFrame: 12 Months
measure: Primary Assisted Patency
timeFrame: 12 months
measure: Secondary Patency
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Tang Tjun Yip
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01594489: Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction
Official title: Effect of Aminophylline on Contrast Induced Acute Kidney Injury in Patients With Acute Myocardial Infarction Treated With Primary Angioplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Kidney Injury
Lead sponsor: Ospedale Misericordia e Dolce
Sponsor class: OTHER
First posted: 2012-05-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether additional therapy with Aminophylline to hydration with sodium bicarbonate and administration of N-acetylcysteine is more effective to prevent contrast induced acute kidney injury in patients undergoing primary coronary intervention for acute ST elevation myocardial infarction.

Detailed description: Due to the clinical relevance of contrast acute kidney injury a large number of prophylactic procedures have been investigated. N-acetylcysteine and hydration with sodium bicarbonate are proved to be protective against contrast acute kidney injury. The adenosine-mediated afferent arteriolar vasoconstriction is a possible pathomechanism of renal impairment by contrast agent. It has been observed that aminophylline/theophylline, competitive adenosine antagonists, improves oxygen delivery to ischemic tissue, diminishes oxidative damage to renal tissue and may also scavenge free radicals.

The purpose of this study was to investigated whether the additional therapy with adenosine antagonist aminophylline reduces the incidence of contrast renal damage in high risk patients who have acute myocardial infarction.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients with AMI candidates for primary PCI presenting within 12 h of symptom onset with ST-segment elevation of more than 1 mm in at least two contiguous leads of the electrocardiogram

Exclusion Criteria:

* contrast medium administration within the previous 10 days,
* end-stage renal failure requiring dialysis,
* refusal to give informed consent

Primary outcomes:
measure: Incidence of Contrast-Induced Acute Kidney Injury
timeFrame: 3 days
Secondary outcomes:
measure: Adverse clinical events
timeFrame: 1 month
Other outcomes:
Locations:
city: Prato
country: Italy
facility: Ospedale Misericordia e Dolce
Study officials:
affiliation: Cardiology Unit, Misericordia e Dolce Hospital, Prato, Italy
name: Mauro Maioli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03751189: Role of Overjet and Trauma in Libyan Children
Official title: Trauma to Permanent Incisors and Overjet in Libyan Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Overjet
Keywords: trauma
overjet
libya
schoolchildren
Lead sponsor: Ajman University
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 1900
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: . Total of 2015 Libyan school children aged 7 to 16 years from urban (Tobruk) and rural (Kufra) areas were examined in the main study. The children were of almost equal number of both sexes from each age group

Brief summary: Traumatic dental injuries are one of the commonly encountered dental emergencies. Missing anterior tooth in children due to any injury can be a source of considerable physical and psychological discomfort for the child. These consequences also have significant impact on parents, who are generally concerned with esthetic and economic aspects of this problem. It varies from small crack in the enamel to complete loss of the tooth. Injury to children teeth can be both painful and traumatic to the children

Detailed description: Traumatic injuries to anterior teeth have reported by several investigators. In Asia and Africa, the prevalence of TDI to anterior teeth among adolescents ranges from 4% to 35% and 15% to 21%, respectively and in America and Europe, the prevalence varied from 15% to 23% and 23% to 35%, respectively . 50% of school children have sustained traumatic injuries prior to graduation . A contributing factors make children susceptible to injuries have been widely investigated. These factors included Class-II, div.1 malocclusion, increased overjet . 71% to 92% of all injuries sustained in a lifetime occur before the age of 19 years, which occur at home, followed by school and public places.The aim of this study is to assess the mean overjet value in Libyan children and to examine the relationship between increased overjet and trauma to permanent incisor teeth

Eligibility criteria: Inclusion Criteria:

* Libyan children.
* The permanent incisors are present \& sufficiently erupted.

Exclusion Criteria:

* Non Libyan children.
* The permanent incisors are absent, or un-sufficiently erupted.

Primary outcomes:
measure: Number of school children with overjet
timeFrame: From baseline to 10 months
Secondary outcomes:
measure: Dental trauma among school children
timeFrame: From baseline to 10 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01255189: Measurement of the Effect of Positional Changes on Cerebral Oxygenation in Preterm Infants
Official title: Measurement of the Effect of Positional Changes on Cerebral Oxygenation in Preterm Infants: A Near Infrared Spectroscopy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: pOSitional Changes of Premature Infants
Keywords: NIRS
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral oxygenation in newborn infants. Using this technique we investigated the effect of positional changes on cerebral oxygenation in preterm infants.

Detailed description: The changes in cerebral perfusion have an important role on the development of intraventricular hemorrhage and periventricular leucomalacia. Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral oxygenation in newborn infants. Using this technique we investigated the effect of positional changes on cerebral oxygenation in preterm infants.

Eligibility criteria: Inclusion Criteria:

1. \<32 gestational age and/or \<1500gr.
2. \>30th day preterm infants

Exclusion Criteria:

1. sepsis
2. shock
3. severe intracranial hemorrhage
4. NEC
5. abdominal and cranial surgery

Primary outcomes:
measure: The effect of positional changes on cerebral oxygenation in preterm infants
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gamze Demirel
Study officials:
References:
citation: Demirel G, Oguz SS, Celik IH, Erdeve O, Dilmen U. Cerebral and mesenteric tissue oxygenation by positional changes in very low birth weight premature infants. Early Hum Dev. 2012 Jun;88(6):409-11. doi: 10.1016/j.earlhumdev.2011.10.005. Epub 2011 Nov 15.
Clinical trial NCT06712589: The Image Characteristics of Adult Appendix on Computed Tomography
Official title: The Image Characteristics of Adult Appendix on Computed Tomography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Location of Appendix
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigator analyze the location of the normal appendix.

Brief summary: A retrospective analysis of CT images from adult patients who underwent scans for reasons unrelated to appendicitis. The study period will span from January 2010 to August 2024. Through this research, we hope to gain a comprehensive understanding of appendix positioning and compile definitive data on its most common locations.

Detailed description: The investigators conducted a retrospective analysis of CT images from adult patients who underwent scans for reasons unrelated to appendicitis. The study period will span from January 2010 to August 2024. Through this research, we hope to gain a comprehensive understanding of appendix positioning and compile definitive data on its most common locations.

Eligibility criteria: Inclusion Criteria:

CT of patients without appendicitis

Exclusion Criteria:

CT of patients with appendicitis

Primary outcomes:
measure: Location of appendix
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: NTUH
name: Wan-Ching Lien
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01662089: The Efficacy in Treatment of Female Pattern Hair Loss Using 5% Minoxidil Solution Combinded With Zinc Supplement
Official title: A Pilot Study of the Efficacy in Treatment of Female Pattern Hair Loss Using 5% Minoxidil Solution Combinded With Oral Chelated Zinc Supplement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Female Pattern Alopecia
Keywords: Female pattern hair loss
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2012-08-10
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Zinc supplement is a popular trace element gave to Female pattern hair loss (FPHL) patient. But the type of patient, efficacy, and side effect in detail of zinc supplement are not well characterized. The purpose of this study is to determine efficacy and side effect of chelated zinc in FPHL who using 5%minoxidil solution.

Detailed description: 5%minoxidil solution is standard treatment for Female pattern hair loss (FPHL) patient. We gave 15mg chelate Zinc / Placebo drug to patient as an additional trace element. Then measure growth of hair by Global photograph, Microscope hair count, micrometer and record case and side effect during 10 months of treatment.

Eligibility criteria: Inclusion Criteria:

* Female Pattern Hair Loss ( Ludwig classification grade 1 and 2 )

Exclusion Criteria:

* Underlying disease ; Anemia, Diabetes, chronic alcoholism, previous gastrointestinal surgery, short bowel syndrome, Crohn's disease, digestive disorder, hypo/hyperthyroidism, sickle cell disease, autoimmune disease, iron deficiency
* Psychologic disorder trichotillomania
* Diet control
* Pregnancy or lactation
* On supplement diet within 3 month prior to trial

Primary outcomes:
measure: Compare clinical improvement before and after treatment
timeFrame: 6 month
measure: Compare hair density before and after treatmen
timeFrame: 6 month
measure: Compare average hair shaft diameter before and after treatment
timeFrame: 6 month
Secondary outcomes:
measure: Number of pateint with Side effect
timeFrame: 6 month
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
References:
Clinical trial NCT02878889: A Phase II Trial of S-1 as Maintenance Treatment After Gemcitabine Plus Cisplatin Regimen Chemotherapy in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 53
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: TREATMENT

Brief summary: A Phase II Trial of S-1 as Maintenance Treatment After Gemcitabine Plus Cisplatin Regimen Chemotherapy in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma.


Eligibility criteria: Inclusion Criteria:

* all proven to have locoregional recurrence after curative treatment and unsuitability for further local treatment, distant metastases at presentation or acquired metastases after curative treatment. the presence of at least one measurable disease, which was defined as lesion that could be measured at least 20 mm in one dimension by conventional computed tomography (CT) or at least 10 mm by spiral CT scan; KPS≥70, and a life expectancy of at least 6 months.

Exclusion Criteria:

* other malignancy prior to study entry; bone-only metastasis;previous radiotherapy within 4 weeks; previous exposure to gemcitabine;patients with any active, non-controlled infection or other severe systemic diseases, such as congestive heart failure, angina pectoris, respiratory insufficiency and arrhythmia were all rejected at enrollment. Other exclusion criteria included concurrent treatment with other investigational drugs, hypersensitivity to platinum compounds,and current pregnancy or breastfeeding.

Primary outcomes:
measure: Objective response rate
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Xiaozhong Chen
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT06234189: The Immediate Effect of Defocus Spectacles On the Choroid Thickness Using Optical Coherence Tomography on Children
Official title: The Immediate Effect of Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) on the Choroid Thickness Using Swept Source-Optical Coherence Tomography (SS-OCT) on Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 16
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose is to examine temporary changes in the subfoveal choroid thickness after removal and after resumed use of Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS).


Eligibility criteria: Inclusion Criteria:

* Myopic children using Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) from the ongoing randomized clinical non-inferiority study: "Defocus Spectacle Lenses (DIMS) versus Orthokeratology lenses (OKL) for slowing myopia progression in children" (ClinicalTrials.gov Identifier NCT05134935)
* Myopia at the time of inclusion in the NISDO study: -2.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes)
* Anisometropia \< 1,5 D cycloplegic spherical equivalent refractive error
* Best corrected visual acuity (inclusive): 1.0 Snellen (equivalent to ≥ 3/5 letter on the 1.0 line = 83 ETDRS letters)

Exclusion Criteria:

* Manifest or intermittent squint
* Contraindications to the use of OKL comprising (not exhaustive): keratoconus, chronic allergic conjunctivitis, and keratoconjunctivitis sicca
* Previous eye surgery
* Chronic eye disease demanding daily use of eye drops
* Non-compliance to eye examinations (unstable fixation or anxiety towards contact lenses)

Primary outcomes:
measure: Choroidal thickness
timeFrame: During 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: The Ophthalmic department, Vejle Hospital
state: Southern Denmark
Study officials:
affiliation: Vejle Hospital
name: Lou-Ann Andersen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02356289: Single Ascending Dose Study of MYK-461 in Healthy Volunteers
Official title: Safety, Tolerability, Preliminary Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of MYK-461 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Hypertrophic Cardiomyopathy
Lead sponsor: MyoKardia, Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and pharmacodynamics of MYK-461 in human subjects. This is a randomized, double-blind, placebo-controlled, sequential group, single ascending (oral) dose study in healthy volunteers aged 18-55 years.


Eligibility criteria: Inclusion Criteria:

* Normal body mass index (BMI)
* Normal LVEF
* Normal electrocardiogram (ECG)
* Females must not be breastfeeding and must be permanently sterilized or are postmenopausal.

Exclusion Criteria:

* Any structural abnormalities on echocardiography
* Positive results of HIV test and/or seropositive for HCV or HBV.

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: 28 Days
Secondary outcomes:
measure: Determination of pharmacokinetics parameters
timeFrame: 28 Days
measure: Determination of pharmacokinetics parameters
timeFrame: 28 Days
measure: Determination of pharmacokinetics parameters
timeFrame: 28 Days
measure: Determination of pharmacokinetics parameters
timeFrame: 28 Days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Quintles LTD
Study officials:
affiliation: MyoKardia, Inc.
name: Jonathan C Fox, MD, PhD
role: STUDY_DIRECTOR
References: