cyrilzakka/clinical-trials huggingface dataset:
Femto-flap Versus SBK Flap,Predictability and Variability

Laser Insitu keratomileusis (LASIK) has become the most popular procedure for refractive error correction. Lasik flap creation is the first and critical step during LASIK surgery because of its consensual effect on a residual stromal bed, corneal biomechanics, and hence the future risk of ectasia⁴.In the current study, we compared the Visumax FSL flap thickness predictability, accuracy, and variability with the flap created by single-use Moria SBK microkeratome.

Flap creation techniques have evolved from the old manual procedure of mechanical microkeratome to the automated one with the use of microkeratome and more recently to Femto-laser procedure using a variety of machines.

Authors have reported that the primary vision nearly the same despite the different methods of flap creation in the first 6 months post LASER vision correction. Others have reported that a thinner flap is associated with better primary vision and refractive outcomes. SBK (Sub Bowman Keratomileusis), is a procedure in which the Lasik flap is thinner, and has the advantage of leaving a sufficient stromal bed for safer excimer Laser ablation.

There are five types of femtosecond Laser that were already approved currently for Lasik flap creation.

The Zeiss (Visumax FSL ) which has been used in the current study uses 1043 nm, a repetition rate of 500 kHz, and 220-580 femtoseconds pulse duration. Each laser pulse produces micro-photo disruption in the tissue, contiguous few microns sized photo disruptions will create a continuous cut in the corneal tissue at precise preset position and depth.

In the current study, the Visumax flap thickness predictability, accuracy, and variability were compared with the flap created by a single-use Moria SBK microkeratome.

Eligibility Criteria:
Inclusion Criteria:

* Having refractive errors range from -2 to- 6 DS and from -1 to -3.00DC.
* They have stable refraction for at least one year prior to surgery.
* Normal topography by Placido-Scheimpflug (Sirius, Costruzione Strumenti Oftalmici, Florence, Italia) and normal corneal epithelial map by Anterior segment-OCT system (Optovue Inc, Fremont, California, USA)

Exclusion Criteria:

1. Patient with suspicious topography and or corneal epithelial map.
2. Patient with corneal pachymetry below 500µm.
3. Patients who have a history of previous ocular surgery or trauma.
4. Patient with a current or previous history of herpes simplex or herpes zoster.
5. Patient with severe dry eye, diabetes, thyrotoxicosis, and connective tissue diseases.
6. Patient with Combined ocular diseases like retinal dystrophy or glaucoma.
7. Patient with a history of contact lenses use was meant to stop the use of soft contact lenses for at least 2 weeks or hard type for at least 4 weeks before topography and other investigations were done.
8. Patient who refrains from the required follow-up visits; have been excluded from the study.

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Variation of Progesterone in IVF Cycles

to examine if a natural daytime variation in progesterone levels may explain parts of the inconsistent findings from studies reporting divergent results concerning this matter and will be carried out by several blood samples from the same patient during the day of ovulation triggering.

The impact of the progesterone level at the end of the follicular phase in stimulated IVF/ICSI cycles and its effect on the pregnancy rate and oocyte quality is controversial, which arises from conflicting results in retrospective studies and meta-analyses. This study is assumed to examine if a natural daytime variation in progesterone levels may explain parts of the inconsistent findings from studies reporting divergent results concerning this matter and will be carried out by several blood samples from the same patient during the day of ovulation triggering. If variation is present, the impact of variation on the developing oocyte and embryo quality will be estimated by embryo quality indicators.

Eligibility Criteria:
Inclusion Criteria:

* patients 18-45 years
* BMI 18-35 kg/m2
* Menstrual cycle length 24-35 days
* Stimulation with rFSH or hMG

Exclusion Criteria:

* None
Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement

The purpose of this feasibility clinical trial is to explore the role of intranasal fentanyl for pain associated with PICC placement in preterm infants. The primary goals are identifying whether enough infants join the study and complete the study procedures.

Infants admitted to the neonatal intensive care unit (NICU) are subjected to multiple painful procedures as part of clinical care. It is established that early and repeated exposure to pain is associated with negative consequences. However, pain management strategies continue to be underutilized in NICUs worldwide.

Placement of a PICC is a clinically essential painful procedure in infants requiring prolonged intravenous access. The procedure can cause moderate to severe pain. To date, the optimal medication for procedural analgesia during PICC placement is not known.

Intranasal fentanyl has emerged as an option for pain management in infants admitted to the NICU. In preparation for a future definitive clinical trial, this is a feasibility clinical trial exploring the role of intranasal fentanyl for procedural analgesia in preterm infants undergoing PICC placement.

Eligibility Criteria:
Inclusion Criteria:

* Infants with a gestational age at birth \< 32 weeks or birth weight \< 1.5 kg
* Infants considered medically appropriate for the study by the most responsible physician

Exclusion Criteria:

* Infants with choanal atresia, nasal mucosal erosion, or epistaxis
* Infants with facial anomalies
* Infants diagnosed with genetic conditions known to affect neurological development or severe (grade ≥ III) intraventricular hemorrhage
* Infants receiving continuous intravenous infusions or scheduled enteral doses of opioids or sedatives within 12 hours of PICC placement
* Infants with cardiopulmonary instability managed with inotropes, vasopressors, phosphodiesterase enzyme inhibitors, or neuromuscular blocking agents at the time of PICC placement
* Infants prescribed strong CYP3A4 inhibitors (clarithromycin, itraconazole, ketoconazole, posaconazole, ritonavir, voriconazole) at the time of PICC placement
* Infants diagnosed with bronchopulmonary dysplasia (need for supplemental oxygen or need for ventilatory support at 36 weeks corrected gestational age)
* Infants with a previous documented adverse reaction to any formulation of fentanyl

Each eligible infant will be enrolled for one PICC placement only during the study period
Smartphone Enabled Hearing Study

Validation of non-inferiority between headphone amplification settings determined by a participant and settings established by audiologist best practices in individuals 18 years or older.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Proficient in written and spoken English, defined by self-report
* Mild- to moderate- hearing loss as measured by pure tone audiometry (PTA) reference test, or self-report of perceived hearing loss and 15-25 dB HL (by 4PTA)
* Participants have access to stable internet connection

Exclusion Criteria:

* Ear anatomy non-conducive to comfortable wear of headphone
* Active ear disease
* Cerumen impaction that cannot be removed
* Sudden loss of hearing (in the preceding 90 days), defined by self-report
* Self Report of loud environmental sound exposure (e.g., concert; construction site; fireworks) without hearing protection within 72 hours of reference PTA assessed at Clinic Visit 1
* Tinnitus that impacts one's daily life, defined by self-report
* Use of cochlear implants
* Self-reported issues with small or confined spaces such as a single-person enclosed booth, and/or claustrophobia
* Health technology, fitness, media outlet employees (or spouse of employees), or employees of CRO/sites contracted to execute this study
* User noted preference to not wear headphone consistently, or charge headphone and smartphone consistently, during field-use
* Hearing loss \>60 dB HL at 0.25-3kHz and \>65 dB HL at 4kHz in either ear; assessed during PTA
* Hearing loss that requires electroacoustic settings which are not acoustically stable in the participant's ear per audiologist judgement
* Current regular use of hearing aids
* Active treatment, or treatment in the past 6 months, with either a chemotherapeutic drug for cancer, or radiation therapy to the head or neck region
* Active treatment, or treatment in the past 6 months, with parenteral aminoglycoside antibiotics
* In the Investigator's opinion, unable to adhere to study procedures
Treatment Protocol for Hemiplegic Shoulder Pain

The purpose of this study is to determine if a specific stretching and strengthening protocol, in addition to current standard treatment, is more effective for treating post-stroke shoulder pain than current standard treatment alone.

Current standard treatment of post-stroke shoulder pain includes joint protection (i.e., slings and protective positioning) and stretching/strengthening exercises through a pain-free range. Although the added movement of the shoulder blade when moving the post-stroke arm has been recommended in the literature, no studies to date have been found which directly looks at the impact of providing synchronized three-dimensional scapular and humeral movement during therapy. Due to the integral relationship between the scapula and the humerus during movement, it is hypothesized that an increase in 3-dimensional shoulder blade mobility in the painful post-stroke shoulder will contribute to increased pain-free 3-dimensional arm movement. This double-blind randomized-controlled study aims to investigate the effectiveness of this 3-D approach at addressing post-stroke shoulder pain.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of shoulder pain secondary to altered alignment and/or neuro-muscular movement patterns post-stroke;
* medically stable and 2-24 months post onset of stroke;
* between stages of 2-5 of the Chedoke-McMaster stages of upper extremity motor recovery;
* not currently receiving any other active neuro-rehabilitation intervention to promote stroke recovery;
* cognitively able to provide informed consent, follow specific testing commands, and communicate their level of pain during assessment and treatment.

Exclusion Criteria:

* a history of shoulder pain prior to the onset of the stroke;
* shoulder pain which is secondary to any history of trauma, fractures, arthritis or joint instability of the neck, spine, ribs, or shoulder girdle before or after the stroke; possible rotator cuff tears;
* shoulder-hand syndrome; thalamic or central pain; spinal cord pathology; osteoporosis;
* any medical condition which may affect the ability to participate in an active rehabilitation exercise program (i.e., uncontrolled hypertension or angina).
Treatment of Xerostomia by Herbal Preparation

The aims of this study are to investigate the effect of famous herbal formula extract on xerostomia, and to determine whether this formula affect various xerostomia-related questionnaires, salivary flow rate, residual saliva and salivary tests.

Xerostomia is a condition related to both decrease in the amount of saliva produced and a change in its composition, therefore causing dry mouth.It can cause severe decline in quality of life and up to date, there have been few effective treatments for xerostomia.

The purpose of the current trial is to investigate the effect of herbal extract granule named Yukmijihwang-tang (YMT) on dry mouth. The trial is a randomized, double-blinded, placebo-controlled, 2-arm, 2-centered study. Ninety-six patients with xerostomia will be randomly assigned to one of the 2 groups consisting of YMT or placebo. The assigned treatments will last for 8 weeks and the follow-up period will be 2 weeks.

The primary outcomes are Visual analogue scale (VAS) for xerostomia.

The present study is designed to examine the safety and efficacy of YMT on xerostomia. Our study provides the clinical evidence of a new therapeutic strategy for xerostomia.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 60 - 80
2. The visual analog scale for xerostomia must represent more than 4 points during 2wks prior to enrollment
3. One who has less than 0.3 ml/min of unstimulated salivary flow rate
4. One who has complained of xerostomia for at least 3months
5. One who is able to read, write, hear, see something
6. One who agree on not taking other therapies during experimental period
7. One who agree on consent form

Exclusion Criteria:

1. One who is taking the treatment for autoimmune disease such as sjogren's disease, rheumatic disease, systemic lupus erythematosus etc
2. One who has the history of taking radiotherapy on head and neck or history of organ transplantation
3. One who has severe mental illness such as depression
4. One who takes oriental medicine or health functional food within 2 wks before enrollment
5. One who takes the remedies on the purpose of relieving xerostomia such as pilocarpine, cevimeline, gargle solution, frequent gum use, intra oral devices and toothpaste etc.
Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura

To investigate the migraine inducing effect of levcromakalim in patients with migraine with aura.


Eligibility Criteria:
Inclusion Criteria:

* Migraine with aura patients of both sexes.
* 18-70 years.
* 50-100 kg.

Exclusion Criteria:

* Headache less than 48 hours before the tests start
* Daily consumption of drugs of any kind that investigator deems might affect study results or safety.
* Pregnant or nursing women.
* Cardiovascular disease of any kind, including cerebrovascular diseases.
* Tension type headache (TTH) according to International Classification of Headache Disorders version 3 more than 5 times a month on average during the past year
* Known cluster headache according to International Classification of Headache Disorders version 3.
* Psychiatric disorder
* Smoking or abuse of drugs or alcohol
* Hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg) on day of inclusion.
* Hypotension (systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<50 mmHg) on day of inclusion.
A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.


Eligibility Criteria:
Key Inclusion Criteria:

* Part A: Completed study drug treatment in a parent study VX20-121-102 (NCT05033080) and VX20-121-103 (NCT05076149); or had study drug interruption(s) in a parent study but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period in the parent study
* Part B: Completed study drug treatment in Part A; or had study drug interruption(s) in Part A, but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period of Part A

Key Exclusion Criteria:

* History of drug intolerance in a parent study
* Pregnant or breast-feeding females at the time of enrollment in Part A

Other protocol defined Inclusion/Exclusion criteria may apply.
What Information is Remembered by Parents Following the Ingestion of Foreign Body by Their Child?

Foreign body (FB) ingestion is a very common domestic accident in children. The prevention of the recurrence by securing child's environment is mandatory. The study will study whether the advices of follow-up at home and recurrence prophylaxis were given to parents after a foreign ingestion by their child.

Foreign body ingestion (FB) is a very common domestic accident in children. When the FB is not dangerous or it is inaccessible after crossing the pylorus, the child should be monitored. In all cases, recurrence should be prevented by securing the environment of the swallowing child. The information on monitoring and securing the environment should be communicated during hospital care. This prospective study will analyze whether advices were correctly given to the families concerning the follow-up at home and the prophylaxis of FB ingestion.

Eligibility Criteria:
Inclusion Criteria:

* Children under 18 years
* Foreign body ingestion

Exclusion Criteria:

* Refusal to participate in the study
* Non-French speaking parents
The Efficacy of Esomeprazole Premedication on Intraoperative Bleeding During Gastric ESD

This will be a single-centre, randomised, endoscopist-blind, parallel-group study in patients who are scheduled endoscopic submucosal dissection (ESD) for gastric mucosal lesion. The primary objective is to observe whether a regimen of 7-day oral esomeprazole premedication can alleviate intraoperative bleeding in patients scheduled for ESD due to gastric mucosal lesions.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document.
* Female or male aged ≥18 years.
* Patients must have gastric mucosal lesion that are eligible for ESD indications (Japanese Gastric Cancer Association 2011), including early gastric cancer, polyps, adenoma, and precancerous/suspected lesions diagnosed by endoscopy.

Exclusion Criteria:

* Malignancy or other advanced disease with a life expectancy of \< 6 months as judged by the investigator.
* The ASA classification of physical status ≥ 4 as judged by the investigator.
* Severe hepatic disease or renal disease
* Ability to understand and the willingness to sign a written informed consent document.
* Major cardiovascular event at enrollment or within 3 months prior to enrollment such as stroke, myocardial infarction, or hospitalization for treatment of unstable angina pectoris as judged by the investigator.
* Haemorrhagic disorder.
* Patients who had a history of gastrectomy or a recurrent lesion.
* Known or suspected hypersensitivity to any component of any PPI .
* Planned treatment with: warfarin (including other vitamin K antagonists), cisapride, phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus, theophylline, lidocaine, nifedipine.
* Pregnancy, planned pregnancy or lactation. Women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator.
* Known or suspected alcohol, drug or medication abuse.
* Any condition associated with poor compliance as judged by the investigator.
* Participation in any study involving administration of an investigational product or device within the preceding 14 days prior to enrollment.
* Involvement in the planning and conduct of the study. Previous enrollment in the present study.
Pharmacokinetics and Safety of Asasantin Extended Release (RAD-SP) Capsules in Japanese Healthy Male Volunteers

Study to investigate pharmacokinetics, pharmacodynamics and safety of RAD-SP capsule in multiple administration to healthy adult male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers judged by the investigator as appropriate subjects on the basis of screening test results
* Age range: ≥ 20 years and ≤ 35 years
* Body weight between 50 and 80 kg
* Obesity is within ± 20% of the standard body weight
* Ability to provide written informed consent to participate in the study

Exclusion Criteria:

* History of drug allergy
* History of bronchial asthma
* History of drug abuse and alcohol abuse
* History of hemorrhagic tendency or hemorrhagic disease
* Volunteers who have experiences in playing sports such as boxing which may damage the brain
* Accidents associated with brain concussion and contusion (traffic accident, etc.)
* Administration of other study drug within 4 months before start of administration of this study drug
* Collection of whole blood (≥ 400 ml) within 3 months before study drug administration
* Collection of component blood (≥ 400 ml) within 1 months before study drug administration
* Intake of some drug or other within 10 days before the study drug administration
* Excessive physical activities within the last 5 days prior to study drug administration
* Intake of alcohol within 3 days before study drug administration
* Volunteers judged by the investigator to be inappropriate as the subjects of study
Brain Indices of Risk for Posttraumatic Stress Disorder (PTSD) After Mild Traumatic Brain Injury (mTBI)

This is a prospective, longitudinal cohort study to evaluate the associations between indices of brain structure and function (measured at baseline, as soon as possible after injury) and course of post-traumatic stress disorder (PTSD) symptoms. Subjects will be service members who have sustained mild traumatic brain injury (classified as either "impact-induced mTBI" or "blast-induced mTBI"; n = 100 completers) or an extracranial injury (ECI) with no evidence of traumatic brain injury (TBI) (n = 100 completers). Subjects will complete an assessment battery at baseline and 6 months later that includes (1) structural magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI) derived from a 3-Tesla magnet; (2) event-related brain potentials (ERPs) derived from brain electrical activity; (3) neurocognitive tests; and (4) neurological soft signs (NSS). Specific indices of brain structure and function derived from these assessments are hypothesized to demonstrate a significant relationship with course of PTSD symptoms, which will be measured at baseline, 3 months, and 6 months.


Eligibility Criteria:
Inclusion Criteria:

1. Injured while deployed or stateside
2. Must be diagnosed TBI positive or certified as TBI negative by a licensed medical practitioner using Department of Defense (DoD) criteria
3. For mTBI subjects, an initial score of 13-15 on the Glasgow Coma Scale
4. Aged 18-50
5. Defense Enrollment Eligibility Reporting System (DEERS) eligible

Exclusion Criteria:

1. Unable or unwilling to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization ("unable" includes cases in which the potential subject cannot read and understand English well enough to provide informed consent)
2. Penetrating head injury
3. Medical chart reveals a history of significant neurological condition(s) (reviewed on a case by case basis)
4. Diagnosis with or undergoing treatment for an illness that could affect brain function (reviewed on a case-by-case basis)
5. History of major psychiatric condition(s) that interfere with daily functioning as revealed in the medical chart or by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID)
6. Record of drug or alcohol abuse or dependence in the past six months as documented in medical history review
7. Medical chart or SCID reveals current or lifetime PTSD diagnosis related to non-combat life events that occurred prior to most recent deployment