cyrilzakka/clinical-trials huggingface dataset:
Effect of Virtual Reality Distraction on Anxiety and Pain Reduction in Children Undergoing Dental Treatment

The aim of the study is to evaluate and compare the effect of virtual reality glasses (VR) as an audiovisual distraction method to audio distraction using music on child's dental anxiety during dental treatment.

a randomized clinical trial with parallel-group and allocation ratio (1:1). intervention group: audiovisual distraction using virtual reality glasses control group :audio distraction using music. in children aged 5-8 years who need dental extraction for primary molars.

For both groups:

1. Taking personal data, medical and dental history.
2. Diagnosis and determination of the required treatment.
3. Measuring preoperative anxiety (expressed by heart rate) using a pulse oximeter.
4. Using the behavior guidance technique:

   Intervention group: The Child is introduced to the virtual reality glasses device, and was given instructions on how to use it and was allowed to choose one of previously chosen cartoons to be played during the procedure.

   Control group: The child is introduced to the headphones and was given instructions on how to use it, and a relaxing music is played during the procedure.
5. Administration of topical anesthesia.
6. Administration of local anesthesia.
7. Check the effectiveness of local anesthesia using dental probe.
8. Extraction of the affected tooth.
9. Measuring postoperative anxiety (expressed by heart rate) using the pulse oximeter.
10. Evaluate the objective pain using Face, Legs, Cry, Consolabiliy scale .
11. Self-reporting of subjective pain using Visual analogue scale.
12. Post extraction instructions are given to the patient.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 5-8 years.
* Children without any mental or systemic disorder.
* Children need extraction of primary molars under local anesthesia.

Exclusion Criteria:

* Children with visual impairment.
* Children with hearing disabilities.
* Patients or caregivers who refuse to sign the consent.
Kanagawa Intravenous and Endvascular Treatment Registry

The K-NET registry is a prospective, multicenter, observational registry study for all consecutive patients who received intravenous tPA therapy and/or endovascular treatment for acute ischemic stroke. This study is attended by 40 of the 58 Primary Stroke Centers in Kanagawa Prefecture, which is located in the Tokyo metropolitan area and has a population of 9.24 million. Patient enrollment for this study began in January 2018.

Inclusion criteria for this study are all consecutive patients who meet either or both of the patients who received intravenous tPA therapy for acute ischemic stroke and intention to perform EVT for large vessel occlusion. There were no exclusion criteria. The local neurologists, neurosurgeons, and neurointerventionalists at each institution made the decision to perform EVT and intravenous tPA.

The primary outcome was good as defined by the modified Rankin Scale (mRS) of 0 to 2 at three months. We also determined a favorable outcome: mRS 0-2 or not worsening of the mRS score at three months. Secondary analyses included predicting a favorable outcome using multivariate logistic regression analysis.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for this study are all consecutive patients who meet either or both of the patients who received intravenous tPA therapy for acute ischemic stroke and intention to perform EVT for large vessel occlusion.

Exclusion Criteria:

There were no exclusion criteria. There are no upper or lower age limits for this study.
Xenon Inhalation for Treatment of Posttraumatic Stress Disorder

This study is a double-blind, randomized, placebo-controlled, clinical trial in parallel groups in patients with PTSD.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a current diagnosis of PTSD (documented diagnosis of PTSD based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition \[DSM-5\] criteria and a Clinician Administered PTSD Scale \[CAPS-5\] total severity score of \>30).
* Male and female patients between the ages of 18 and 85 years.

Exclusion Criteria:

* History of schizophrenia, bipolar and other psychotic disorders.
* Patients with underlying pulmonary disease, chronic obstructive pulmonary disease (COPD), asthma or any other respiratory conditions / diseases that may affect the respiratory function.
* Currently undergoing PTSD-targeted psychotherapy.
* Currently undergoing exposure-based psychotherapy for any condition.
Influence of Residual Astigmatism on Visual Acuity in Patients Undergoing Cataract Surgery With Trifocal Intraocular Lens Implantation

MAIN OBJECTIVE: To assess the influence of residual astigmatism on visual acuity in the different lens foci in patients operated on for cataracts with a trifocal intraocular lens implant.

SECONDARY OBJECTIVE: To study the influence of residual astigmatism on the visual quality of the patient in the far focus and to determine if there are differences of affectation in the two study groups.

It will be studied how small residual astigmatisms after cataract surgery degrade the visual acuity of patients in the three focal planes of trifocal IOLs. Not only VA will be studied, but also visual quality through contrast sensitivity curves.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral surgery performed by the same surgeon
* IOLs implanted IOLs FineVision (MicroF) and FineVision Toric (PodFT)
* Patients with pre-surgery corneal astigmatism less than 2.5 D
* Patients whose pupillary diameter in physiological position (conditions of lower photopic pupil) not over 4 mm.

Exclusion Criteria:

* Post-surgical refractive residual astigmatisms ≧ 1.55D
* Previous corneal or intraocular surgeries
* Active diseases
* Eye complications during the 3-month follow-up
Safety and Immunogenicity of Inactivated Influenza Virus Vaccine Among Healthy Children 6-12 Weeks of Age

Study of the safety and immunogenicity (antibody producing capability) comparing inactivated influenza vaccine to placebo given to infants at 2 and 3 months of age. Infants will receive inactivated influenza vaccine at the same time as other vaccines on the routine immunization schedule. Infants will be randomized at enrollment to receive inactivated influenza vaccine or placebo at a 2:1 ratio. This study is double-blind, randomized, and placebo-controlled.

Methods: A double-blind, randomized, placebo-controlled trial was conducted in 1375 healthy US infants 6-12 weeks of age. Subjects received either 2 doses of trivalent inactivated influenza vaccine (TIV, Fluzone®, sanofi pasteur 2005-6 pediatric formulation) (N=915) or placebo (N=460) 1 month apart, along with indicated concomitant vaccines. Solicited adverse events were collected for 7 days following each vaccination, unsolicited adverse events for 28 days, and serious adverse events for 6 months. Hemagglutination inhibition antibodies to all 3 vaccine strains were measured following the second TIV/placebo dose.

Results: No significant differences were seen between TIV and placebo groups for any safety outcomes. Fever ≥38oC rectal within 3 days of vaccination was seen in 11.2% vs 11.7% of TIV vs placebo recipients. Serious adverse events within 28 days of vaccine/placebo were reported in 1.9% of TIV and 1.5% of placebo recipients; only one (hypersensitivity reaction in a TIV recipient) was considered vaccine-related. Significantly increased antibody responses (p\<0.001) were seen against all 3 strains in TIV recipients by titer ≥ 1:40 or geometric mean titer (GMT) (p\<0.001). Altogether, 50% of infants had antibody titers ≥ 1:40 for H1N1, 86% for H3N2, and 11% for B compared with 7%, 10%, and 0.3% in the placebo group. The reciprocal GMT for influenza recipients was 33, 95, and 11 for H1N1, H3N2, and B vs. 7, 9, and 5 for placebo recipients. Over 90% of infants who received TIV had antibody ≥ 1:40 for at least one vaccine strain and 49.6% for 2 strains, vs. 16.4% and 0.9% in the placebo group.

Conclusions: TIV administered to young infants beginning at 6-12 weeks of age is safe and immunogenic.

Eligibility Criteria:
Inclusion Criteria:

* Age 42 to 84 days on the day of inclusion
* Full term (born at \>=36 weeks with birth weight \>=2.5 kg
* Considered to be in good health
* Parental consent obtained and available
* Available for the study duration (6 months)

Exclusion Criteria:

* Reported allergy to egg proteins, chicken proteins
* Previous history of influenza vaccination or disease
* Receipt of any vaccine other than Hepatitis B prior to enrollment
* Acute illness with rectal temperature \>= 38.0 (defer enrollment)
* Known bleeding disorder
* Participation in other interventional clinical trial within 30 days prior to enrollment
Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement

To evaluate influence of therapy on the following efficacy and safety parameters in different TeaRx dose groups and Enoxaparin group:

* Total venous thromboembolic events (VTE), which includes confirmed deep venous thrombosis (DVT), nonfatal pulmonary embolism (PE), and total mortality
* Incidence of DVT (total, proximal, distal)
* Incidence of nonfatal PE
* Incidence of symptomatic VTE (DVT, PE)
* VTE caused mortality
* Non-VTE caused mortality
* Incidence of all hemorrhagic complications
* Incidence of major and clinically relevant non-major bleeding
* Adverse events (AEs) and serious adverse events (SAEs) from subject complaints, physical examination, vital signs, laboratory results


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age ≥ 18 years;
* Planned total knee replacement surgery;
* Signed informed consent form;
* Willing to comply with the protocol;
* Willing to use adequate contraception during the trial.

Exclusion Criteria:

* Surgery for acute fracture 4 weeks before screening; history of septic inflammation in the joint; prosthesis revision or one leg missing
* History of venous thrombosis of any location or PE
* History of heparin induced thrombocytopenia or other thrombocytopathy; hemorrhagic diathesis
* History of evident coagulopathy or in a relative
* Congenital thrombophilia
* Bleeding within 6 months of screening; increased risk of bleeding
* BMI less than 18,5 or more than 40 kg/m2
* Systolic BP \> 180 mmHg and/or diastolic BP \> 110 mmHg registered twice within 15-30 minutes
* Hb ≤ 10.5 g/dL in female or ≤ 11.5 g/dL in male
* Platelets \< 100 000/mm3
* Clinical significant abnormalities of APTT and/or INR
* GFR \< 30 ml/min/1.73 m2
* ALT or AST ≥ 2 x ULN or total bilirubin ≥1,5 x ULN
The Effect of Activity Feedback Enabled by Smart Watches During In-patient Stroke Rehabilitation

The amount of activity completed by individuals within rehabilitation programs, even when units are well staffed, is often far below that required for optimal stroke rehabilitation, and is not individually adapted on a day-to-day basis. Daily feedback on their activity levels may motivate stroke survivors to engage in greater skills practice and thus outcome after stroke. To date only a few trials suggests that augmented feedback may be effective. There is a need for a large pragmatic trial to explore the impact of augmented activity feedback on top of their standard care. The purpose of this study is to determine the effect of augmented activity feedback by smart watches to support in-patient stroke rehabilitation.

This study had a feasibility and pilot development phase from September 2015 to April 2016, and then moved into the main study with some changes in design and execution occurring in the light of experience. Its execution has also been constrained by external factors beyond control.

It is in essence asking whether wearing a Smart Watch which gives feedback on activity every two hours, with a specific target tailored to the patient's performance 24 hours earlier will be associated with a higher rate of physical activity than seen in people wearing the same watch without and feedback been given.

The intervention only lasts unto 21 days, but earlier discharge will terminate that patient's participation sooner. A telephone interview at 12 weeks after entry collect data on mobility.

Outcome measures will assess mobility, activity, and health status.

Eligibility Criteria:
Inclusion Criteria:

* Admission for acute/sub-acute in-patient neurorehabilitation of a first stroke at the 2nd affiliated hospital of Anhui University of Traditional Medicine and Acupuncture, Hefei, China.
* Time from onset of stroke to admission for rehabilitation \<16 weeks.
* Ability to follow a two stage command; pick up an object, put object on table.
* Independent in mobility prior to admission. Subjects can use any type of assistive device and brace needed.
* Able to understand and repeat information related to the Informed Consent.

Exclusion Criteria:

* Admission for second stroke.
* Subjects who are unable to provide consent due to a cognitive impairment.
To Compare Blephapad Combo vs Standard Treatment for Eyelid Cleansing in Bilateral Posterior Blepharitis

The purpose of this study is to evaluate the efficacy of, and patient satisfaction with Blephapad Combo in the treatment of posterior blepharitis.

Blepharitis is the most common condition in patients seeking an eye examination due to discomfort or eye irritation. Treatment of blepharitis is recommended even in mild cases as chronic inflammation may cause permanent damage to the Meibomian glands.

Each eye of each patient represents an experimental unit. Each patient will apply Blephapad Combo to one eye and standard treatment to the other eye in accordance with the randomization procedure.

The aim of this randomized, controlled study with a closed sequential design is to evaluate versus standard treatment the efficacy of, and patient satisfaction with Blephapad Combo in the treatment of posterior blepharitis.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 40 years
* Male or female
* Diagnosis of bilateral posterior blepharitis
* Written informed consent of patient

Exclusion Criteria:

* Treatment with topical ophthalmic drugs (artificial tears allowed)
* Ocular surgery in the previous 6 months
* Pregnant or breastfeeding women
* Alcohol abuse
* Psychiatric disorders
* Cognitive impairment that could affect evaluation of preferences
* Participation in other clinical studies in the last month
* Hypersensitivity to one or more components of the study products
Hookworm Immune Regulation Project

The main objective of this study is to characterize the regulatory immune response induced by hookworm in an infected Vietnamese rural population from the periphery of HCM, evolution after infection treatment and during potential naturally reinfection.

Population: 20 healthy adults (18-65 years) infected and non infected by Hookworm will be recruited and treated according to Good Clinical Practice recommendations.

Allergy will be excluded by skin prick tests. Amount and phenotype of Treg will be explored at several time points. Subsequent culture with environmental antigen will be performed on cryopreserved cells.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old adults in good health status
* To live in rural regions at risk of soil transmitted helminthes
* Hookworm infection (infected group)
* Uninfected by Hookworms (control group)

Exclusion Criteria:

* Pregnant woman
* Positive allergic history
* Auto-immune and/or HIV disease
* Antihelminthics drug in the last 6 months and other current parasitic infection
Hemodynamic Response to Angiotensin-II When Used as the Second Vasopressor Agent for Septic Shock

Norepinephrine is a catecholamine that is the first-line vasopressor for septic shock. The addition of non-catecholamine vasopressors, including vasopressin and angiotensin-II may be used in adults with septic shock that have inadequate mean arterial pressure while on norepinephrine. Uncertainty exists regarding the timing of initiation of these agents and there is a lack of data comparing their safety and efficacy.

The current literature suggests that earlier initiation of angiotensin-II will have a more significant reduction on norepinephrine-equivalent dose compared to later initiation. In addition, approximately half of patients initiated on vasopressin do not have an early hemodynamic response 6 hours after initiation. The purpose of this study is to evaluate the efficacy of angiotensin-II when used as the second vasopressor agent for septic shock.

Objectives:

Primary Objective:

1. To evaluate the efficacy of ang-II when used as the second vasopressor agent for septic shock

Secondary Objectives:

1. To assess the duration of response to ang-II
2. To assess overall survival
3. To assess the amount of time spent in the ICU
4. To assess the need for renal replacement therapy
5. To assess the overall duration of vasoactive medication use
6. To assess toxicity and tolerability

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the ICU within 12 hours of presentation to the emergency department for septic shock requiring 15-25 mcg/min of norepinephrine. Septic shock will be defined as having a known or presumed infection with two or more criteria of systemic inflammatory response syndrome, a mean arterial pressure \<65 mm Hg despite fluid resuscitation requiring vasopressor support, and a serum lactate \>2 mmol/L. Criteria of systemic inflammatory response syndrome include a temperature \>100.4°F or \<96.8°F; heart rate \>90/min; respiratory rate \>20/min and a white blood cell count \>12,000/mm3 or \<4,000/mm3.

Exclusion Criteria:

* Age \<18 years
* Pregnancy or lactation
* Known allergic reactions to angiotensin-II or hydrocortisone sodium succinate
* Requiring \>25 mcg/min of norepinephrine or on any vasopressor other than norepinephrine at study enrollment
* Clinically significant bleeding precluding the use of chemical prophylaxis for venous thromboembolism
* Treatment with another investigational drug or other intervention during study timeframe
Sun Protection Factor Assay (318/2016)

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
A Pilot Study of Dietary Chloride Supplementation on Cardiorenal Function in Heart Failure

The purpose of this study is to determine if administration of supplemental chloride in the form of lysine chloride to patients with congestive heart failure will affect their neurohormonal profile as well as response to diuretics.

This prospective pilot "pre-post" study was designed to determine if supplementation of sodium free chloride ion as a lysine chloride to patients with heart failure could improve parameters of neurohormonal status and diuretic responsiveness. Volunteers will receive Lysine Chloride 7 grams three times daily for three days. At baseline and then again post lysine chloride patients will undergo sampling of venous blood for determination of neurohormonal parameters in addition to formal diuretic responsiveness testing.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Fluency in English
* Heart failure requiring loop diuretic therapy
* Loop diuretic dose ≥ 80mg/day furosemide equivalents
* Stable volume status and diuretic requirement as assessed by treating physician

Exclusion Criteria:

* Unstable heart failure
* renal replacement therapy or an estimated GFR \< 30 ml/min/1.73m2
* Significant bladder dysfunction
* History of hepatic failure
* Pregnancy
* History of hyperinsulinemia/hyperlysinuria
Mechanistic Insights to Weight Loss Maintenance Through SGLT2 Inhibitors

Obesity increases the risk of cardiometabolic diseases such as hypertension and diabetes. Weight loss interventions such as low-calorie diet and physical activity are effective for weight loss in the short term, but weight loss maintenance (WLM) with low-calorie diet and physical activity is challenging. Weight loss is associated with a reduction in the amount of calories needed to maintain the body at rest, called the resting energy expenditure (REE), which may be a probable mechanism for this lack of WLM. Most individuals are unable to adequately change their diet and increase their physical activity levels to overcome this decrease in REE which prevents WLM. Therefore, techniques that increase REE may promote WLM in these individuals. Pre-clinical studies for Empagliflozin - Sodium-glucose Cotransporter-2 (SGLT2) inhibitor have shown an increase in REE. Thus, in addition to reducing the cardiovascular risk, SGLT2 inhibitor may promote WLM by increasing REE. This study aims to promote WLM in obese individuals by increasing the REE using SGLT2 inhibitor therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age more than or equal to 18 years
* Body mass index more than or equal to 30 kg/m2 who have lost ≥5% of body weight within the past 6 months without taking any pharmacotherapy for weight loss

Exclusion Criteria:

* Age less than 18 years at screening.
* Untreated systolic BP \<100 or \>160 mmHg at baseline, or diastolic BP \<80 or \>100 mmHg at baseline
* Women who are pregnant or breastfeeding or who can become pregnant and not practicing an acceptable method of birth control during the study (including abstinence)
* Taking pharmacotherapy indicated for weight loss, such as GLP-1 agonists or with weight loss as an adverse event
* History of Type I Diabetes
* History of lung disease
* Have any past or present illness of cardiovascular disease, including myocardial infarction, angina, cardiac arrhythmia, diabetes, stroke, TIA, or seizure
* Current or past (\<12 months) history of smoking
* Estimated glomerular filtration rate (GFR) \< 60 ml/min/1.73 m2 (CKD-EPI equation) urine albumin creatinine ratio ≥30 mg/g
* Hepatic Transaminase (AST and ALT) levels \>3x the upper limit of normal
* Significant psychiatric illness
* Anemia (men, Hct \< 38%; women, Hct \<36%)
* Inability to exercise on a treadmill
* Consumption of more than 2 alcoholic drinks daily
* Any contraindications to empagliflozin
Evaluation of a Video-ludic Re-education of the Paretic Upper Limb in Chronic Hemipartic Patients Post Cerebral Vascular Accident

The aim of this randomized controlled study with stroke patients is to demonstrate that a re-education with interactive table with instrumented objects delivering sensory feedback and serious game improve certain motor functions of the paretic upper limb than rehabilitation based on a standardized self-rehabilitation program.


Eligibility Criteria:
Inclusion Criteria:

* Stroke patients
* Subject with gripping ability: capable of peeling off the connected object from the table, presented in its grip area.

Exclusion Criteria:

* Severe cognitive disorders preventing the completion of the task
* Bilateral brain lesions