louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03785314: Optic Nerve Sheath Diameter Difference
Official title: Effect of Different Posture on Optic Nerve Sheath Diameter During Thoracic Epidural Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Optic Neve Sheath Diameter
Keywords: Optic Nerve Sheath Diameter Different Position
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intracranial pressure is measured indirectly using optic nerve sheath diameter with ultrasound. It is reported that epidural pressure varies according to different posture ( lateral decubitus vs. sitting position).

This study is designed to measure the optic nerve sheath diameter in lateral decubitus and sitting position, respectively.

Detailed description: According to previous study, injection of different volume of local anesthetics (1.0 ml/kg vs. 1.5 ml/kg) during caudal anesthesia, high volume of local anesthetics resulted in significant increase of intracranial pressure (ICP). Increase of ICP can reduce regional cerebral flow and oxygen saturation causing the safety of patients. In addition, increase of ICP can result in headache, syncope, and transient loss of visual acuity. Although it is very invasive method, ICP can be measured directly at the brain parenchyme. Among methods to measure the ICP indirectly, measurement of optic nerve sheath diameter using ultrasound is known to reflect the degree of ICP. It is reported that optic nerve sheath diameter increases when higher volume of medication is injected during epidural anesthesia. Previous reports showed that epidural pressure varies according to different posture. When epidural pressure was measured in patients of spinal stenosis, lumbar flexion showed lower epidural pressure than epidural pressure of lumbar extension. In addition, when epidural pressure was measured in the sitting position, it showed lower pressure than pressure of lateral decubitus.

Eligibility criteria: Inclusion Criteria:

* lung cancer
* liver cancer
* stomach cancer
* pancreas cancer

Exclusion Criteria:

* coagulopathy
* infection
* previous spine fusion at thoracic level
* previous brain surgery

Primary outcomes:
measure: optic nerve sheath diameter change among 4 time period
timeFrame: Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Hong ji HEE
Study officials:
affiliation: Keimyung University
name: Ji Hee Hong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03830814: The Effects of Sacubitril/Valsartan on the Heart Functions
Official title: What Are the Effects of Sacubitril/Valsartan on the Heart Functions? Can It Increase the Ejection Fraction?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Effect
Keywords: Sacubitril/Valsartan
Heart Failure
Ejection Fraction
Lead sponsor: The Young Investigator Group of Cardiovascular Research
Sponsor class: NETWORK
First posted: 2019-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred patients with heart failure with reduced ejection fraction (HRrEF) who have indications for the use of sacubitril/valsartan as recommended by recent guidelines were prospectively enrolled.

Brief summary: Background:

Sacubitril/valsartan, has been found to be more beneficial than enalapril for reducing the incidences of sudden cardiac death, death from worsening heart failure (HF), and hospitalization. However, there is no prospective echocardiographic data describing the effects of sacubitril/valsartan on the heart functions and left ventricular (LV) reverse remodeling. Therefore, the aim of our study was to evaluate the effects of sacubitril/valsartan on the LV functions using two dimensional (2D), three dimensional (3D) echocardiography and the 3D strain parameters.

Methods:

In 100 patients with HF with reduced ejection fraction (HRrEF) who have indications for the use of sacubitril/valsartan as recommended by recent guidelines were prospectively enrolled. The basal 2D and 3D echocardiographic parameters were compared to those obtained 3 months after starting the sacubitril/valsartan treatment.


Eligibility criteria: Inclusion Criteria:

* Age is more than or equal 18 years old
* Able to provide written informed consent
* Indicated for the use of sacubitril/valsartan as recommended by the European Society of Cardiology (ESC) heart failure guidelines 2016
* Left ventricular ejection fraction of 40% or less

Exclusion Criteria:

* Cardiac resynchronization therapy (CRT) device implantation less than 3 months prior to the start of this study or CRT implantation intentions
* Atrial fibrillation
* Poor echocardiographic images
* Sacubitril/valsartan treatment intolerance during the follow-up period

Primary outcomes:
measure: Two dimensional left ventricular ejection fraction
timeFrame: 3 months
measure: Three dimensional left ventricular ejection fraction
timeFrame: 3 months
Secondary outcomes:
measure: Two dimensional left ventricular volumes
timeFrame: 3 months
measure: Three dimensional left ventricular volumes
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04036214: Efficacy and Safety Outcomes of Optometrist Performed Selective Laser Trabeculoplasty (SLT)
Official title: Selective Laser Trabeculoplasty (SLT): Efficacy and Safety Outcomes of Optometrist (OD) Performed SLT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Open-Angle Glaucoma, Unspecified Eye
Ocular Hypertension
Lead sponsor: Northeastern State University
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Existing patients at primary eye care optometric facilities.

Brief summary: To measure the efficacy and safety outcomes of SLT performed by optometrists.

Detailed description: Participants will undergo a pre-procedure examination in order to record baseline findings and to determine if they meet the inclusion criteria in order to undergo the procedure. Participants will undergo the SLT procedure and will be examined at 1 hour, 1 week and 6 weeks. Follow up examinations will evaluate eye pressure reduction and post-procedure complications. The rate complication post-procedure are typically low.

Eligibility criteria: Inclusion Criteria:

1. Ability to provide written informed consent;
2. At least 18 years of age, male or female, of Native American or Alaskan Native descent;
3. Diagnosed with primary open angle glaucoma or ocular hypertension;
4. Documented intraocular pressure greater than or equal to 23 mmHg;
5. No prior glaucoma treatment unless treated with one topical drop.

Exclusion Criteria:

1. History of trauma or ocular surgery within the last 6 months;
2. History of corneal dystrophy;
3. Current use of topical or systemic steroids;
4. Advanced or severe glaucomatous findings based on comprehensive examination;
5. Diagnosed with other types of glaucoma such as pseudoexfoliation syndrome, pigmentary glaucoma, normal tension glaucoma, and other additional glaucoma subtypes.

Primary outcomes:
measure: Intraocular Pressure via Goldmann tonometry
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tahlequah
country: United States
facility: Northeastern State University
state: Oklahoma
Study officials:
affiliation: Northeastern State University
name: Nate Lighthizer, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04487314: Registry for Chronic Venous Disease Incidence and Natural Course
Official title: Russian Registry for Chronic Venous Disease Incidence and Natural Course
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Varicose Veins of Lower Limb
Lead sponsor: Russian Phlebological Association
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 10000
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The main cohort is formed from those who do not have CVD, who are affected by different factors that we register (various physical activities, the presence or absence of pregnancy, etc.).

An additional cohort is formed from those who have CVD at the time of inclusion.

The goal is to track the natural evolution (progression) of the disease, to evaluate the incidence and risk factors of complications.

An extremely important criterion for the formation of the study population is the possibility to control the lower legs veins of observed individuals by a qualified vascular specialist. To date, a qualitative assessment of veins according to the CEAP classification is a weak point in longitudinal epidemiological studies.

Brief summary: A prospective cohort study of patients with primary varicose veins to assess the morbidity, risk factors and development of chronic lower limb vein disease.

Detailed description: Multicenter prospective cohort observational study based on a termless epidemiological registry.

Periodic inspection and collection of data from the subjects is carried out annually, in the last quarter of the current year.

Patient data is recorded in a promising digital database and is constantly updated.

Eligibility criteria: Inclusion Criteria:

* A family members of the researcher (spouse, childrens, brothers and sisters, parents) or the researcher himself
* The possibility of annual clinical and ultrasound assessment of the venous system of the observed individuals

Exclusion Criteria:

* Any invasive treatment of the chronic venous disorder in anamnesis
* Venous thrombosis in the anamnesis or at the time of inclusion

Primary outcomes:
measure: Incidence of Chronic Venous Disease
timeFrame: 1 year
measure: Natural Course of Chronic Venous Disease
timeFrame: 1 year
measure: Incidence of chronic venous insufficiency
timeFrame: 1 year
measure: Incidence of superficial vein thrombosis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: "Medalp" private surgery clinic
Study officials:
References:
Clinical trial NCT01675414: Understanding Gastrointestinal Conditions in Children With Autism Spectrum Disorder (ASD)
Official title: Understanding Gastrointestinal Conditions in Children With ASD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Disorders
Autism Spectrum Disorders
Keywords: ASD
autism
gastrointestinal
gastrointestinal conditions in children with ASD
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Autism Speaks
name: Columbia University
First posted: 2012-08-30
Enrollment: 131
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: 131 nonselected subjects with ASD

Brief summary: The purpose of this research study is to help us learn if children with Autism Spectrum Disorder (ASD) have gastrointestinal (stomach and intestine) problems more frequently than children without ASD do. The investigators hope to learn if children with ASD and gastrointestinal (GI) disorders have certain Problem Behaviors (PB), such as self-injury and aggression, more than children with ASD but no GI disorders do. The investigators want to learn if the Gastrointestinal Symptoms Questionnaire (GIQ) can help us tell which children with ASD also have gastrointestinal disorders.

Hypothesis 1: Children with ASD exhibit high rates of symptomatic GI dysfunction that are not identified by current diagnostic evaluation.

Hypothesis 2: Painful or discomfort-causing gastrointestinal dysfunctions contribute to an elevated incidence or severity of PB in an identifiable subpopulation of PB-expressing children. The investigators anticipate that the proposed study will raise the standard of medical care for children with ASD by improving current methods of identifying GI dysfunction and determining whether there is a significant relationship between GI dysfunction and PB in this population.


Eligibility criteria: Inclusion Criteria:

* Children who are ATN Registry subjects between 2 and 17 years old (inclusive)
* Meet criteria for an ASD according to the diagnostic measures Autism Diagnostic Observation Schedule (ADOS) and DSM-IV Symptom Checklist, which were conducted at an established ATN center within the last 18 months

Exclusion Criteria:

* Diagnoses of Rett Syndrome, Childhood Disintegrative Disorder, or other genetic disorders (e.g. Fragile X, Down syndrome, etc.).

Primary outcomes:
measure: diagnosis of active gastrointestinal disorder/dysfunction based on the medical history reviewed by and the physical examination performed by a pediatric gastroenterologist
timeFrame: 6 months after initial evaluation by pediatric gastroenterologist
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: LADDERS, Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Harland S Winter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03681314: Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU)
Official title: Long-term Outcomes of Umbilical Cord Milking in Term and Late Preterm Neonates Who Are Depressed at Birth
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypoxic-Ischemic Encephalopathy
Birth Asphyxia
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: NPKSIMS, Nagpur, India
name: Sharp HealthCare
First posted: 2018-09-24
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 26
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Neurodevelopmental assessments will be done at 2 years of age (22-26 months) for subjects who were randomized to receive either immediate cord clamping or umbilical cord milking as part of the MIDAB trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: An extension of the MIDAB trial, the MIDAB-Follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were depressed at birth and received umbilical cord milking (UCM) or immediate cord clamping (ICC).

Detailed description: The MIDAB-Follow-up trial will examine the difference in survival and neurodevelopmental impairment of infants who were depressed at birth and enrolled in MIDAB trial. The difference in survival and neurodevelopmental impairment in infants who received UCM and ICC will be assessed using standardized neurological and developmental assessment tools at 22-26 months of age.

Eligibility criteria: Inclusion Criteria:

* Enrolled in MIDAB trial

Exclusion Criteria:

* None

Primary outcomes:
measure: Neurodevelopmental Outcome at 2 Years of Age
timeFrame: 22-26 months
Secondary outcomes:
measure: Fidgety Movements at 3 months of age
timeFrame: 3-5 months
measure: Neurodevelopmental Outcome at 1 Year of Age
timeFrame: 10-14 months
measure: Autism Outcome
timeFrame: 22-26 months
Other outcomes:
Locations:
city: Nagpur
country: India
facility: Daga Memorial Woman and Children Hospital
state: MS
city: Nagpur
country: India
facility: Government Medical College and Hospital
state: MS
city: Nagpur
country: India
facility: NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital
state: MS
Study officials:
affiliation: Nemours Children's Clinic
name: Zubair Aghai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04941014: Effects of Physical Activity on Quality of Life Among Female Undergraduate Students
Official title: Effects of Physical Activity on Quality of Life Among Female Undergraduate Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Lead sponsor: Health Education Research Foundation (HERF)
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assignment
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to determine the effects of physical activity on quality of life among female undergraduate students


Eligibility criteria: Inclusion Criteria:

-moderate level of academic stress measured on academic stress scale

Exclusion Criteria:

* students with diagnosed psychological disorders
* systematic diseases

Primary outcomes:
measure: Quality of Life (QOL),
timeFrame: A change from baseline to six weeks of intervention will be observed
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Bilquis Postgraduate College for Women Pakistan Air force (PAF)
Study officials:
References:
Clinical trial NCT03790514: Heat Wrap for Renal Colic
Official title: Alternative Therapy for Pain Management in Patients With Renal Colic: Heat Wrap
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Colic
Keywords: Heat wrap
Lead sponsor: Aksaray University Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-steroidal anti-inflammatory drugs (NSAIDs) (diclofenac, kotorolac, piroxicam) opioids (petidine, tramadol, fentanyl), paracetamol and topical agents (EMLA, diclofenal gel), have been shown to be effective in the treatment of renal colic . NSAIDs are commonly used to treat renal colic, but they can reduce renal blood flow and cause kidney damage. In addition, there are limitations in use in cases such as gastrointerstinal ulcers, hepatic insufficiency and chronic obstructive pulmonary disease. Gastrointestinal complications (ulcers, reflux, etc.) may cause hypersensitivity reactions (allergy) and coagulation disorders. On the other hand, opioids may cause nausea, vomiting, hypotension, sedation, dizziness and even respiratory depression. In addition to these pharmacological agents, stair-stroke, Turkish bath, blanket or hot water bag and local warming are now used in the treatment of renal colic in traditional methods.

Heat Wrap is an effective, natural solution designed to remove muscle pain with the help of heat and used regularly by physical therapists. The heat wrap is activated by air contact within a few minutes after its removal from its sheet and does not contain any drugs. It contains heat from the active iron particles in contact with air. After a few minutes of application, it begins to spread the natural, long-term (8 hours) heat by targeting the source of the pain. The patient satisfaction is high because it is odorless and thin.

In the literature, considering the success of heat therapy in patients with renal colic (bath entrance, electric blanket heating) in this study we have aimed to evaluate the efficacy of alternative treatment with pain-relieving alternative treatments with little potential for side effects and to see its applicability in daily treatment plans.


Eligibility criteria: Inclusion Criteria:

- Patients with renal colic

Exclusion Criteria:

* Pregnants
* Known allergies to heat tapes

Primary outcomes:
measure: Pain Intensity Scale
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Aksaray
country: Turkey
facility: Murat Gül
Study officials:
References:
Clinical trial NCT03184714: Noninvasive Positive Pressure Ventilation in Overlap Syndrome
Official title: The Effectiveness of Noninvasive Positive Pressure Ventilation Treatment in Overlap Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Sleep Apnea Syndromes
Non-invasive Positive Pressure Ventilation
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 292
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: non-invasive positive pressure ventilation
Primary purpose: TREATMENT

Brief summary: Chronic obstructive pulmonary diseases (COPD) coexisting with obstructive sleep apnea is called overlap syndrome (OS). Patients with OS seem to have worse prognosis than patients with only one disorder. Noninvasive positive pressure ventilation is an efficient treatment in obstructive sleep apnea, but the effectiveness in improving outcomes of OS patients is still not fully investigated. The aim of this non-randomized concurrent control trial is to evaluate noninvasive positive pressure ventilation's effectiveness in OS patients.


Eligibility criteria: Inclusion Criteria:

* patients with COPD and sleep apnea dyspnea syndrome

Exclusion Criteria:

* patients with non-stable hemodynamics;
* patients with limited life expectancy;
* patients with other severe respiratory diseases;
* patients with motor neuron diseases;
* patients with contraindications for NIPPV

Primary outcomes:
measure: COPD acute exacerbations
timeFrame: 3 years
Secondary outcomes:
measure: COPD assessment test (CAT) score
timeFrame: 3 years
measure: modified British medical research council (mMRC) score
timeFrame: 3 years
measure: all-cause mortality
timeFrame: 3 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
References: