cyrilzakka/clinical-trials huggingface dataset:
LASIK Flap Thickness and Visual Outcomes Using the WaveLight FS200 Femtosecond Laser

The objective of this study is to evaluate the visual outcome, accuracy, predictability and complications of LASIK flap creation using the Alcon Wavelight FS200 Femtosecond laser and compare these results to those obtained using current IntraLase FS60 Femtosecond laser. The primary outcome to be evaluated is the flap thickness accuracy.

Laser in situ keratomileusis (LASIK) is a method for treating myopia, hyperopia and astigmatism. In LASIK, the cornea is reshaped to focus images more clearly on the retina without the aid of glasses or contact lenses. LASIK involves two steps: creation of a corneal flap, which can be performed by a mechanical microkeratome or a femtosecond laser, and reshaping of the cornea by another laser, an excimer laser.

The accuracy of the LASIK flap thickness is a key safety consideration to reduce the likelihood of complications following LASIK. Femtosecond laser technology has significantly improved the predictability of LASIK flap dimensions while supporting similar visual acuity results.

The Alcon FS200 femtosecond laser is approved for human use by the United States Food and Drug Administration and was recently released in the US market. This study will directly compare outcomes of LASIK performed with this newer laser to those performed with the AMO IntraLase femtosecond laser.

Eligibility Criteria:
Inclusion Criteria:

* All patients with ametropia (Spherical, spherocylindrical, presbyopic) suitable for treatment by LASIK, including different target refractions (Plano or Monovision).

Exclusion Criteria:

* Patients unsuitable for LASIK procedure because of an estimated residual stromal bed \< 300 microns after calculation of the ablation (Corneal thickness - flap thickness - simulated stromal ablation for the desired correction).
* Patients unsuitable for LASIK due suspicious topography for ectasia, form frust keratoconus or unstable ( more than 0.50 diopter change in sphere or cylinder in the last year) refraction.
* Patients with amblyopia or any eye disease that might limit the visual recovery.
* Patients younger than 18 years old.
TelePharmaceutical Care Diabetes Trial

The prevalence of Diabetes Mellitus (DM) in the world is currently around 9.3% of adults aged between 20 and 79 years, which corresponds to 463 million people living with DM, and about 80% of these people are found in developing countries. In Brazil, fourth in the number of patients with Type 2 Diabetes Mellitus (DM2) in the world, the prevalence of DM is around 12%, with a significant increase in the last three decades. Non-adherence to DM treatment is known as a problem in the scenario and internationally, as it impairs the physiological response to the disease, increasing the direct and indirect cost of treatment. Pharmaceutical care is a practice model characterized by the provision of pharmaceutical services that optimize treatment, improve the process of medicines used, and aim at their best use. With the calamity situation arising from the COVID-19 pandemic created in the state of Rio Grande do Sul, the Pharmaceutical Telecare service was implemented. Dapagliflozin was recently incorporated into the Brazilian public system for the treatment of type 2 DM. Considering that there are no studies in Brazil to date on the use, treatment adherence, and problems related to pharmacotherapy (PRM) associated with dapagliflozin, and also considering that the guidance and monitoring of patients remotely have become more frequent and necessary, the purpose of this protocol is to describe a clinical trial that will evaluate the impact of a pharmaceutical telecare service in aspects related to treatment adherence, disease control, and costs, offered to people with DM2 using dapagliflozin. The hypothesis that will be tested is that Pharmaceutical Telecare can be as effective as standard care for type 2 diabetes and assess the associated costs related to teleconsultation in public health settings.


Eligibility Criteria:
Inclusion Criteria:

* People aged 18 years or older, with a previous diagnosis of type 2 diabetes mellitus and who take dapagliflozin at the Special Medicines Pharmacy of the State of Rio Grande do Sul, Brazil, will be selected. In addition, it will be considered an inclusion criterion that the person is available to receive phone calls.

Exclusion Criteria:

* Do not present a telephone record registered in the system;
* Be participating in another diabetes education program;
* Pregnancy;
* Severe cognitive problems;
* Communication difficulties;
* Presence of other injuries;
* Patients who are hospitalized at the time of recruitment will also be excluded from participation in this study.
Trial of the Treatment of Chronic Laryngitis With Amitryptiline

The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.

The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis. At the baseline visit, subjects will be assigned at random to amitriptyline or placebo which they will take for 8 weeks. Subjects will be seen in the clinic at baseline and at 8 weeks. Improvement will be measured using standardized symptom scales, and a self-reported subjective improvement percentage.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older and able to consent for themselves.
* Structural pathology such as tumor previously ruled out using flexible laryngoscopy.
* Able to speak and read the English language.
* Failed a trial of a proton pump inhibitor for the treatment of gastopharyngeal reflux.
* Women under 55 years of age who may become pregnant must have a negative pregnancy test and agree to barrier or hormonal methods of contraception during the study.

Exclusion Criteria:

* Environmental allergies.
* Smoking within past 5 years.
* Using ginko bilboa (or unwilling to cease using it).
* Current upper respiratory infections.
* Use of narcotics (e.g. oxycodone, methadone).
* Any prior history of amitryptiline use.
* Use of monoamine oxidase inhibitors (MAOIs) within the past 4 weeks (selegiline, phenelzine, tranylcypromine, isocarboxazid, rasagiline, phenelzine sulfate, selegiline hydrochloride, rasagiline mesylate, tranylcypromine sulfate).
* History of urinary retention.
* Any history of major depressive disorder.
* Any prior history of allergy to a tricyclic antidepressant.
* Current diagnosis of gastroesophageal reflux (GERD).
* For women 18-55 years of age without history of menopause: currently nursing or pregnant, plans to become pregnant, or unwillingness to utilize contraception (barrier or hormonal methods).
SOVA Ambassadors Community Setting

The purpose of this study is to examine participant adherence to intervention feasibility and acceptability of intervention, attention control, and implementation strategy.

A 1:1 pilot randomized controlled trial of the SOVA Peer Ambassador Program compared to attention control: brief psychoeducational independent assignments (i.e. reading SOVA articles and responding to open-ended questions without content creation and without peer interaction) (N=40) and evaluate feasibility of implementation strategy.

Eligibility Criteria:
Inclusion Criteria:

* Ages 14 to 21

Can read and understand English

Has completed 6th grade

Scores at least 5 or greater on the PHQ-8 (depression) and/or 5 or greater on GAD-7 (anxiety) consistent with at least mild symptoms

Exclusion Criteria:

* no access to internet

Has an intellectual or physical ability which prohibits reading text on the internet (can participate if able to use with assistance, e.g. can use text to speech)

No active email account (can participate if plans to create one)
A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis

This open-label randomized 2arm study will investigate the pharmacokinetics, pharmacodynamics, efficacy and safety of subcutaneously administered tocilizumab in patients with rheumatoid arthritis who have shown an inadequate response to methotrexate. Patients will be randomized to receive tocilizumab 162 mg sc either weekly or every other week, in combination with methotrexate, for 12 weeks. Assessments will be made at regular intervals during treatment and on the 3 weeks of follow-up.Target sample size is \< 50 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adults 18 - 75 years of age
* active rheumatoid arthritis of \>/= 6 months duration
* inadequate response to at least 12 weeks of methotrexate, the last 8 prior to baseline on stable dose
* swollen joint count (SJC)\>/=4, tender joint count (TJC)\>/=6 at screening and baseline
* DMARDs and anti-TNFs, other than methotrexate, withdrawn prior to baseline
* oral corticosteroids (\</= 10mg/day prednisone or equivalent) and NSAIDS on stable dose \</= 4 weeks prior to baseline

Exclusion Criteria:

* rheumatic autoimmune disease other than rheumatoid arthritis
* prior history or current inflammatory joint disease other than rheumatoid arthritis
* major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
* functional class IV by ACR classification
ACCUvein Measure Before ULtrasound as A facilitataTION Tool for Venous Marking

Ultrasound marking of saphenous veins before varicose vein surgery or for saphenectomy for vascular or coronary artery bypass grafting is a long, tedious, low-grading examination, generating overconsumption of many consumables including marking markers that may damage the probes, of the modern and expensive ultrasound doppler. Augmented reality devices can visualize the superficial veins and hope to simplify the investigation, improve the comfort of the patient during the examination by significantly reducing the time of the examination. There is few data in the literature on the value of using augmented reality devices of this type. The AccuVein® system is a patient-friendly, non-contact, non-invasive technique that minimizes discomfort due to standing time and thus improves patient comfort.

At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed. No register of non-included patients will be kept. In included patients, in parallel to the standard ultrasound investigation for marking of saphenous veins for which the patient is referred, AccuVein® system will be performed as explained later in arm description.

Usual ongoing treatments are obtained by history and recorded. The end of the visit is the end of the participation of the subjects.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for venous marking
* Affiliation to the French National healthcare system
* French speaking patients

Exclusion Criteria:

* pregnancy
* inability to understand the study goal
* patients protected by decision of law
Pulmonary Embolism and COVID-19

The charts of patients who developed pulmonary embolism in the course of COVID-19 will be evaluated, retrospectively. Clinical features and laboratory data will be analyzed.

Patients with COVID-19 infection will be evaluated retrospectively. Demographic data, clinical and laboratory findings will be recorded. Findings of patients with pulmonary embolism and withour pulmonary embolism will be compared.

Eligibility Criteria:
Inclusion Criteria:

- All patients with positive RT-PCR for COVID-19

Exclusion Criteria:

- All patients with negative RT-PCR for COVID-19
The Sound Mind Warrior Study

The purpose of this prospective, double-blind, repeated measures study is to assess the efficacy of Binaural Beat Technology (BBT) on anxiety and anxiety related cardiovascular measures as well as to assess the feasibility of implementing a BBT intervention in a military population during the high risk post-deployment window.

The purpose of this prospective, double-blind, repeated measures study is to assess the efficacy of Binaural Beat Technology (BBT- a sound technology that uses special tones \[embedded in music\] through stereo headphones to affect your brainwaves in order to put you in a more relaxed state) on anxiety and anxiety related cardiovascular measures as well as to assess the feasibility of implementing a BBT intervention in a military population during the high risk post-deployment window.

A sample of 74 Warriors who have deployed will be randomly placed into two groups (music with BBT and music without BBT). Each group will be exposed to their respective intervention for 30 minutes at bedtime, 3 times a week, for 4 weeks. Quantitative and qualitative measures will be collected as follows...

1. Cardiovascular reactivity, c-reactive protein, and state anxiety measures will be collected at baseline and after the 4 week intervention.
2. Morning blood pressure (BP) surge and evening BP decline measures will be collected at baseline and weeks 0, 2 and 4.
3. Input from the participants will be collected via daily logs and at the completion of the 4 week intervention.

Aim 1 - To assess the feasibility of implementing a binaural beat technology intervention in a military population during the high risk post deployment window. Feasibility will be measured by assessing:

1. retention
2. number of refusal during recruitment
3. number of drop outs
4. reason for drop outs
5. reason for staying
6. number of days the technology was used
7. selection of music
8. ease of use and comfort of equipment
9. adherence to the protocol
10. evaluation of recruitment strategies

Aim 2 - To assess the impact of binaural beat technology on anxiety and relevant CV health measures. These measures included:

1. Comparison of pre and post intervention state anxiety scores
2. Observing the trend of morning blood pressure surge over time
3. Observing the trend of evening blood pressure decline over time
4. Comparison of pre and post intervention heart rate variability measures
5. Comparison of pre and post intervention c-reactive protein measures

Eligibility Criteria:
Inclusion Criteria:

* Military personnel who

  1. Have deployed
  2. Are eligible to receive healthcare at WRNMMC or FBCH
  3. Are 18 years and older
  4. Are able to commit to a 5-week study

     Exclusion Criteria:
* Military personnel who...

  1. Are taking any medication in the anti-hypertensive category
  2. Are taking any medication in the anti-anxiety category
  3. Have been diagnosed with moderate or severe traumatic brain injury
  4. Have a history of epilepsy
  5. Are taking any medication in the anti-seizure category
  6. Have hearing deficit and/or wear a hearing aide
iCare® Home vs Goldmann Applanation Tonometry

Self-tonometry with iCare Home is regularly performed at Sankt Erik's Eye Hospital since a few years back. The purpose of this study was to show that the eye pressure measurements made with iCare® Home by patients / relatives do not vary more than those made with the standard method, Goldman applanation tonometry (GAT), by different healthcare professionals. This will hopefully confirm the usefulness of self-tonometry.

Since a few years back, self-tonometry with iCare® Home has been available in glaucoma care. Sankt Erik's Eye Hospital was first in Sweden to use the new technology. Several studies have shown good agreement between measurements made by patients or healthcare professionals with iCare® Home and Goldman applanation tonometry (GAT). However, some researchers raise critical voices about the reliability of iCare® Home measurements because they can differ from GAT. GAT is considered the gold standard method of tonometry to which all other instruments are compared. But like all other methods, GAT has some limitations.

At the clinic, the eye pressure is usually measured with GAT by different staff (ophthalmological nurses, opticians or doctors) from visit to visit. This can sometimes lead to pressure variations that may affect the follow-up of glaucoma patients. This raises the question of whether the difference between GAT and iCare® Home is statistically and clinically significant.

The purpose of this study was to show that the eye pressure measurements made with iCare® Home by patients / relatives do not vary more than those made with the standard method GAT by different healthcare professionals. This will hopefully confirm the usefulness of self-tonometry.

Eligibility Criteria:
Inclusion Criteria:

* primary open angle glaucoma (POAG)
* pseudo-exfoliation glaucoma (PEX)
* ocular hypertension (OHT)
* no eye disease,

Exclusion Criteria:

* inability to perform measurements due to limited hand or arm mobility (eg rheumatism, tremor)
* measurements outside the iCare® Home manufacturer's recommendations.
HT-0712 vs. Placebo in Subjects With Age-Associated Memory Impairment (AAMI)

This is a Phase 2 randomized, multicenter, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy of HT-0712 in improving memory and cognitive performance in subjects with Age-Associated Memory Impairment (AAMI)


Eligibility Criteria:
Main Inclusion Criteria:

* Complaints of memory loss in everyday life
* Performance at least one standard deviation below the mean established for young adults on standardized memory tests
* Absence of dementia
* Intact global intellectual function

Main Exclusion Criteria:

* Diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's Disease
* Evidence of dementia
* Evidence of psychiatric or neurological disorder that could influence cognition or contributed to the subject's memory loss
* Use of any drugs that could influence cognition
Oral Gabapentin and Median Nerve Mobilization in the Treatment of Carpal Tunnel Syndrome

The present randomized clinical trial will perform a comparison of the pain reduction effects produced by the application of a non invasive and non pharmacological median nerve neural mobilization (physiotherapy treatment), to those effects produced by Gabapentin and the absence of treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.

The present randomized clinical trial will perform a comparison of the pain reduction effects produced by the application of a non invasive and non pharmacological median nerve neural mobilization (physiotherapy treatment), to those effects produced by Gabapentin and the absence of treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome. Additionally, effects over the functionality of the affected upper limb will be evaluated and compared. Subjects will be invited to participate and randomly allocated to 3 different groups.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be medically diagnosed with unilateral carpal tunnel syndrome (with confirmative electrodiagnostic findings).
* Full understanding of written and spoken Spanish (language).
* Participants must freely consent to participate.
* The presence of positive Phalen an Tinel sings.
* The presence of carpal tunnel syndrome signs and symptoms

Exclusion Criteria:

* The lack to meet inclusion criterions, the presence of cognitive impairment, tumors, cancer, recent (affected) upper limb surgery or trauma, pregnancy, , deformities of the (affected) upper limb, recent skin injuries or infections (in the affected upper limb), autoimmune inflammatory conditions or flu type symptoms, allergy to gabapentin, and also: participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive).
Hypoalgesic Effects of Walking and Running Imagined

The main objective is to identify the hypoalgesic effect of the imagination of actions in sedentary subjects with high levels of physical activity.


Eligibility Criteria:
Inclusion Criteria:

* asymptomatic participants
* men and women aged 18 to 65 years

Exclusion Criteria:

* insomnia
* nausea
* headache
* pregnancy
* use of painkillers in the last 24 hours
* presence of metal inside the head
* pacemaker
* wound on the area of electrodes' application
* drug consumption; (j) recent application of tDCS
* psychiatric disease impeding understanding of the study.
Two Approaches in Enhancing the Efficacy of Inferior Alveolar Nerve Block During Treatment of Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis

The study is designed as a randomized parallel controlled trial with three groups. Participants aged above 18 years with the first permanent molars with symptomatic signs of irreversible pulpitis will be randomly assigned into 3 groups. The first group (experimental group) will be injected with 4% articaine 1:100.000 epinephrine (inferior alveolar nerve block) will be anesthetized using 4% articaine 1:100.000 plus cryotherapy application, and the second group (experimental group) will be anaesthetised with IANB plus buccal infiltration. For the third group (control group), the mandibular molars will be anaesthetized using epinephrine using the inferior alveolar nerve block.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged above 18 years
* Presence of at least one mandibular first permanent molar, with signs and symptoms of irreversible pulpititis

Exclusion Criteria:

* Participants with a history of taking medications that could interfere with the action of the anaesthetic solutions
* Presence of paresthesia
* Presence of psychological problems
* Taking analgesics or other medications that would alter the inflammatory response of the pulp or provide analgesia 12 h pre-operatively
Right Ventricular Function During Liver Transplantation as Assessed by Transesophageal Echocardiography.

Cirrhotic patients undergoing liver transplantation might develop acute transient right ventricular dysfunction, ranging from mild to severe form. More than two decades ago, a number of studies with pulmonary artery catheters looked at this particular issue with controversial results. However, the pulmonary artery catheter as a monitor for right ventricular function (RVF) has several limitations, while the echocardiogram is deemed to be more accurate in this regard. Therefore, we sought to evaluate the RVF with the transesophageal echocardiogram, and particularly whether the RVF significantly varies during this procedure.

Evaluation of right ventricular function (RVF) during orthotopic liver transplantation (OLT) has been extensively reported with modified pulmonary artery catheters that measure the right ventricular ejection fraction. However, quantitative analysis of RVF using transesophageal echocardiography (TEE) are scarce in this setting.

Methods: Nineteen cirrhotic patients who underwent OLT from April-2012 to April-2013 will be studied. Analysis of echocardiogram-derived parameters routinely used to evaluate ventricular function will be done. In particular, the RVF was quantitatively assessed by two parameters derived from TEE: tricuspid annular plane systolic excursion (TAPSE) and right ventricular fractional area change (RVFAC). Exclusion criteria: pulmonary hypertension, fulminant hepatitis, age less than 18 or greater than 65 years old and cardiopulmonary diseases. All echocardiographic and hemodynamic data set have been collected at 5 stages during the procedure, according to Institutional Protocol: baseline, hepatectomy, anhepatic phase, post-reperfusion, and closure.

Statistical Analysis: One-way ANOVA for repeated measurements will be used if the data have normal distribution, otherwise Friedman test will be used. P\<0.05 is to be considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who underwent orthotopic liver transplantation from april 2012 to april 2013.

Exclusion Criteria:

* Pulmonary hypertension (any type)
* Cardiopulmonary disease (eg: chronic obstructive pulmonary disease (COPD), valvular heart disease, ischemic heart disease)
* Fulminant hepatitis.