cyrilzakka/clinical-trials huggingface dataset:
Rosacea and Ivermectin

The primary hypothesis is that weekly digital interactions and routine measurement of TEWL rates and SC hydration levels will promote patient adherence to maintenance ivermectin therapy and prevent disease relapse. The project will consist of a trial in which thirty subjects with rosacea receive ivermectin therapy and are randomized to receive either no intervention, a weekly digital survey to assess patient's attitudes towards ivermectin therapy, or a portal hydration measurement device that measures TEWL rates and SC hydration levels. The study team will measure adherence objectively in all groups with electronic monitors attached to the containers of the ivermectin, which all subjects will be told to use daily for maintenance therapy. Additionally, the hydration measurement device can transmit data to an Internet server via a smartphone using Bluetooth technology, thereby allowing providers to monitor a patient's TEWL rate and SC levels.

Subjects will be offered an opportunity to participate in the study. Subjects will either have a diagnosis of rosacea. A total of 30 subjects will be enrolled. After consent and basic demographics, a study team member will use the GPSkin Barrier® to measure the baseline moisture level of the face of all subjects. Subjects will also fill out questionnaires pertaining to quality of life, accountability, and severity of rosacea.

Subjects will be randomized into one of three arms: the control group (n= 10), the digital interaction group (n=10), or the GPSkin group (n=10). All subjects will receive ivermectin equipped with an electronic monitor to measure adherence for daily treatment of rosacea. The digital interaction group will receive a survey by email each week asking about their use ivermectin generated by Causa Research. The subjects in the GPSkin group will receive the GPSkin Barrier® to measure their moisture level of their face daily. Subjects will be instructed to use the ivermectin once daily. Subjects will return at 3 Months. At this visit, the data from the electronic adherence monitoring will be downloaded, the ivermectin will be weighed, and the subject will fill out the same questionnaires (quality of life, accountability, and severity of rosacea). The intervention subjects will be evaluated on their use of the GPSkin Barrier® to measure their stratum corneum hydration. Subjects not randomized to the email intervention group will receive an accountability questionnaire at the beginning and end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or older.
* Subject has a working knowledge of English.
* Subject with a diagnosis of Rosacea
* Subjects without a known allergy to ivermectin
* Subjects with access to a smart phone

Exclusion Criteria:

* Subjects under 18 years of age.
* Subject does not have a working knowledge of English.
* Subject with a diagnosed skin condition other than rosacea
* Subjects with a known allergy to ivermectin
* Subjects without access to a smart phone
Vitamin D in Minorities With Prediabetes

Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D levels will delay the development of diabetes.

Low vitamin D levels 1) are associated with abnormalities in insulin secretion and insulin action, 2) predict the development of diabetes in those without diabetes, and 3) are more common in people with diabetes. Minority populations (African-Americans and Latinos) are more likely to have both low levels of vitamin D and diabetes. This study will identify minority individuals who are at increased risk for diabetes (those with central obesity, family history of diabetes in first degree relatives and either with hypertension or being treated for hypertension), and determine if they have both pre-diabetes, ie, impaired fasting glucose and/or impaired glucose tolerance, and low levels of vitamin D. Those that have both will be randomized to either high doses of vitamin D or placebo and insulin secretion and action as well as changes in the oral glucose tolerance test (reversion to normal, maintenance of pre-diabetes or development of diabetes) will be monitored at 3 month intervals for one year. This study will test the hypothesis that the increased amount of diabetes in minority populations may be due in part to low levels of vitamin D and whether supplementing this vitamin may delay the development of diabetes.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 40.
2. Impaired fasting glucose (FPG level greater than 100 and less than 126 mg/dl); and/or
3. Impaired glucose tolerance (2-h plasma glucose concentration after 75 gram glucose load greater than 140 and less than 200 mg/dl)
4. Serum 25-OHD less than 30 ng/ml
5. Able and willing to provide informed consent

Exclusion Criteria:

1. FPG greater than 126 mg/dl or 2-hour-OGTT plasma glucose greater than 200 mg/dl
2. Major psychiatric disorder on medication (excluding successfully treated depression)
3. Diagnosed diabetes mellitus
4. HIV/AIDS
5. Major hematological, hepatic (AST/ALT levels greater than or equal to 2 times normal) or renal eGFR less than 60 ml/min) disorder
6. History of carcinoma, except skin basal cell or squamous cell skin carcinomas
7. Heart failure, unstable angina or history of a myocardial infarction
8. Alcohol or substance abuse
9. Current treatment with glucocorticoids
10. Current treatment with diabetes medications, including metformin
11. Cushing's syndrome
12. Primary hyperparathyroidism
13. Nephrolithiasis
14. Pregnancy or breast-feeding
15. Regular visits to a tanning salon (unlikely in this minority population)
Anxiety-related Fixation Instability During LASIK

Anxiety is common among patients undergoing eye surgery, which is typically performed under topical anesthesia while the patient is awake. This can be an unsettling experience for patients, who may worry about being able to keep their eyes still during surgery, cooperate with the surgical team, and remain immobile in an unfamiliar environment. Patients may also experience anxiety due to concerns about surgical pain, possible complications, and the uncertainty of the outcome of the surgery.

In this study, the investigators aimed to investigate the correlation between the severity of anxiety symptoms during LASIK, and fixation instability during photo-ablation as plotted by the eye tracker.

Patient cooperation during LASIK is essential for the surgeon's comfort and predictable results. Fixation instability, which is the inability of the patient to keep their eye still during surgery, is a common problem during LASIK surgery and may lead to unexpected outcomes.

Eye movements occur continually during the excimer ablation. These eye movements can have a large amplitude, a frequency of over 100 Hz, and a corneal speed of around 150 mm/s. With the advancement of scanning-spot excimer lasers, much work has focused on increasing the efficacy of the photo-ablation and smoothness of the ablated surface, especially with respect to the position of the patient's eye by developing state-of-the-art eye trackers to help maintain alignment during photoablation, which can improve refractive outcome.

Eligibility Criteria:
Inclusion Criteria:

* Candidates undergoing LASIK with

  1. Myopia up to 12 diopters
  2. Hyperopia up to 6 diopters
  3. Astigmatism up to 6 diopters

Exclusion Criteria:

1. Previous corneal surgery,
2. Pregnant or lactating females,
3. Concomitant ocular or systemic disease that contraindicated LASIK,
4. Patients with communication barriers, hypochondria, previous stressful surgical experiences, taking psychotropic drugs, or having a history of any clinically relevant psychiatric or cardiovascular disease.
A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)

This study will determine the appropriate dosing regimen of aprepitant and fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric participants from 0 months to 17 years of age.

Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after intravenous administration; the pharmacological effect of fosaprepitant is attributed to aprepitant. The birth to one year old cohort will be initiated in Parts III and IV upon completion of Part II (Steps A and B) in participants \<6 months of age.

Eligibility Criteria:
Inclusion Criteria:

* Is 0 (at least 37 weeks gestation) to 17 years of age
* Is scheduled to receive moderately to highly nausea-inducing chemotherapy or participant did not tolerate a previous chemotherapy regimen that is planned to be repeated
* Is expected to receive ondansetron
* Female participants who have begun menstruating must have a negative pregnancy test
* Weighs ≥3.0 kg if \<6 months of age, ≥6.0 kg if \>6 months of age, and ≥7.5 kg if \> 2 years of age
* Has a pre-existing venous catheter

Exclusion Criteria:

* Uses any illicit drugs or abuses alcohol
* Is pregnant or breast feeding
* Has a symptomatic central nervous system (CNS) tumor
* Has an infection or other uncontrolled disease other than cancer
* Has known history of heart QT wave prolongation
Prevalence of Sleep-Disordered Breathing in Children

To investigate the prevalence and clinical significance of sleep-disordered breathing (SDB) in children.

BACKGROUND:

SDB in children appears to be a common condition, affecting approximately 1 to 3 percent of children. Many aspects of childhood SDB remain understudied and poorly understood, including its precise prevalence, the optimal means of identifying children who should undergo polysomnography, and the potentially major impact of this condition on health, cognitive development, and behavior.

DESIGN NARRATIVE:

The population-based, cross-sectional study of 6- to 16-year-old schoolchildren in Dauphin County, Pennsylvania is a two-part study. In the first part of the study, parents of every child enrolled in local elementary schools will complete a questionnaire that will assess general sleep, behavior, and learning problems. In the second part of the study, 1,000 children will be randomly selected based on their risk for SDB, as determined by the questionnaire. They will be evaluated in a sleep laboratory to determine the presence of SDB. A thorough pediatric ear, nose, throat, and pulmonary evaluation will be conducted; school records and behavior will also be assessed. The parents of the children will be interviewed, and information will be collected on the family history of risk factors associated with childhood SDB. This strategy will be beneficial in establishing the prevalence and clinical significance of SDB in children.

Eligibility Criteria:
Inclusion Criteria:

* Phase I: Sampled all children by questionnaire completed by parent or guardian in three school districts in Dauphin County, Pennsylvania
* Phase II: Recruited a representative sample of 700 to complete a more detailed analysis in the laboratory
Drug-eluting Stents to Treat Unprotected Coronary Left Main Disease

The purpose of this study is to evaluate the efficacy of two different drug-eluting stents (Everolimus and Zotarolimus-eluting) for treatment of unprotected left main coronary artery disease.

Restenosis in the left main coronary artery may have severe consequences given the large proportion of the myocardium compromised in this condition, and, in several studies, it has been linked to the 6-month mortality after the index procedure. Drug-eluting stents have reduced the restenosis rate and the need for target vessel revascularization not only in simple lesion but also in high risk subsets of patients and lesions such as diabetics, long lesions or bifurcations. There are no data about their efficacy in left main coronary artery disease. Thus, the aim of this study is to investigate the performance of two different drug-eluting stents (Everolimus and Zotarolimus-eluting) in left main coronary lesions.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50 % stenosis located in unprotected LMCA who are unable to undergo CABG because of cardiac surgeons' refusal (poor surgical candidates) or their own unwillingness.
* Pretreatment with a loading dose of 600 mg clopidogrel.
* Informed, written consent by the patients or her/his legally-authorized representative for participation in the study.

Exclusion Criteria:

* Cardiogenic shock.
* ST-segment elevation acute myocardial infarction (ST-segment ≥ 0.1 mV elevation in ≥ 2 contiguous ECG leads persisting for at least 20 minutes) within 48 hours from symptom onset.
* In-stent restenosis.
* Malignancies or other comorbid conditions with life expectancy less than one year or that may result in protocol non-compliance.
* Prior coronary artery bypass surgery with revascularization of LAD and/or LCx.
* Planned staged PCI procedure within 30 days from index procedure or prior PCI within the last 30 days.
* An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first six months post enrollment.
* Known allergy to the study medications: aspirin, clopidogrel, UHF; sirolimus, paclitaxel; true anaphylaxis after prior exposure to contrast media.
* Pregnancy (present, suspected or planned).
* Patient's inability to fully cooperate with the study protocol.
Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME II)

The purpose of this study is to evaluate the safety and effectiveness of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in native superficial femoral artery (SFA) and/ or proximal popliteal arteries (PPA).

A prospective, multicenter, single-arm trial evaluating the safety and efficacy of the Jetstream Atherectomy System in the treatment of symptomatic occlusive atherosclerotic lesions ≤150 mm in length located in the femoropopliteal arteries in subjects with symptoms classified as Rutherford categories 2-4.

Eligibility Criteria:
Inclusion Criteria:

* Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2-4
* Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA of which meet the following criteria:
* Severely calcified lesions with degree of stenosis ≥70%
* Vessel diameter ≥3.0 mm and ≤6.0 mm
* Total lesion length (or series of lesions) ≤150 mm

Exclusion Criteria:

* Target lesion/vessel with in-stent restenosis
* History of major amputation in the target limb
* Subject has a history of coagulopathy or hypercoagulable bleeding disorder
* Subject with untreatable hemorrhagic disease or platelet count \<80,000mm3 or \>600,000mm3 as baseline assessment.
* History of myocardial infarction, or stroke/cerebrovascular accident (CVA) within 6 months prior to study enrollment
* Unstable angina pectoris at the time of the enrollment
* Septicemia at the time of enrollment
* Presence of other hemodynamically significant outflow lesions in the target limb requiring a planned surgical intervention or endovascular procedure within 30 days after the index procedure
* Presence of aneurysm in the target vessel
* Acute ischemia and/or acute thrombosis of the SFA/PPA prior to the index procedure
* Perforated vessel as evidenced by extravasation of contrast media prior to the index procedure
Prevalence of Primary Aldosteronism in Patients With Resistant Hypertension in China

Recent studies indicate that primary aldosteronism (PA) is a much more common cause of hypertension than had been demonstrated historically. In patients with resistant hypertension, the prevalence of PA from different clinics worldwide is about 10-20%. As has been no such data in China, the investigators are conducting a PA study in different province of China to evaluate the prevalence of PA in patients with resistant hypertension.


Eligibility Criteria:
Inclusion Criteria:

* patients with resistant hypertension
* age 18-65 years

Exclusion Criteria:

* known cause of hypertension
* heart failure
* renal dysfunction
* Stroke, transient ischaemic attack or myocardial infarction in the past 6 months
* cirrhosis
* pregnancy
* undertreatment of glucocorticoid
Pilot Study of an Online Therapeutic Education Program for Patients With Inflammatory Bowel Disease

EDUMICILOR is a monocentric prospective pilot study for patients with inflammatory bowel disease (IBD).

During the study, patients will participate in an online therapeutic education program.

They will first have an appointment with a nurse to establish a personalized educational diagnosis. Then they will participate in the online therapeutic education program for about 6 months (depends on the educational needs, expectations and patient's availabilities).

The main objective of this study is to assess the feasibility of an online therapeutic education program for IBD patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (age ≥ 18 years old)
* Patients with established Crohn's disease or ulcerative colitis diagnosis
* Patients who own the equipment to participate in the online therapeutic education program (computer, webcam....)
* French speaking patients
* Patients who cannot attend regular therapeutic education sessions at the hospital
* Patients able to understand the information provided to them and to give written informed consent for the study

Exclusion Criteria:

* Patient who has not given his/her consent to participate
Early Childhood Attention Battery in Preterm Children

The aims of this project are:

1. To explore, using the ECAB, if and in which measure the attentional abilities of young preterm children are different from term peers, whom reference data are already published27.
2. To correlate the ECAB results with the "Conner's Teacher, Rating Scale- Revised e Conner's Parent Rating Scale", one of the available diagnostic interview that helps to identify signs of Attention Deficit Hyperactivity Disorder (ADHD) in young children, at the age of 6 years and over.
3. To study individual trajectories of attention pattern and development during age.


Eligibility Criteria:
Inclusion Criteria:

* gestational age (GA) \<34 weeks, intellectual functioning with Intelligence Quotient (IQ\>70 verified with Wechsler scales performed within 6 months from the ECAB, age at ECAB assessment between 3 years and 5 years 11 months.

Exclusion Criteria:

* presence of major brain lesions, major motor or behavioral disorders, WPPSI-III subtest receptive vocabulary with a scaled score \<8.
New Generation Low Level Laser Effect in Myofacial Pain Syndrome

Low level laser treatments have been used to treat painful trigger points in myofascial pain syndrome (MPS), but the effectiveness of the appropriate laser type and parameters is still uncertain. The aim of this study was to compare the effectiveness of different types of low level laser treatment (LLLT) in reducing pain levels, changing oxygen saturation and bite force in patients with MPS.

A total of 45 patients with MPS were randomly divided into three groups. First group received LLLT with GRR laser over massater muscle region. Patients in the second group were treated with Nd:YAG laser and the same protocol with Nd:YAG laser was performed in the placebo group using sham device. Pain was evaluated by visual analogue scale (VAS), change in oxygen concentration in the massater muscle was measured by functional near-infrared spectroscopy- fNIRS and bite force was measured with Flexiforce sensors before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

-patients with symptoms of temporomandibular disorders and diagnosed with MPS as a result of the clinical examination.

Exclusion Criteria:

* Patients with internal TMJ irregularities or degenerative joint changes,
* patients with restricted mouth opening, deviation or deflection,
* patients with systemic diseases,
* pregnant women,
* patients who had received MPS treatment within the previous year
Visual Outcomes Following Bilateral Implantation of the Vivity Toric Intraocular Lens

The objective of this study was to evaluate the clinical and patient reported outcomes after bilateral implantation of the AcrySof™ IQ Vivity™ Toric intraocular lens.

This is a prospective interventional case series of 30 patients who underwent cataract surgery and bilateral implantation of the AcrySof™ IQ Vivity™ Toric intraocular lens. This study is represented by an Asian cohort of patients and the study evaluations were focused not only on clinical visual outcomes but also on "real-life" patient reported outcomes such as dysphotopsias, spectacle independence and daily visual tasks all of which were measured at 1 month and up to 3 months postoperatively. The objective would be to provide insight into the performance of this intraocular lens in Asian patients.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 years or older
* bilateral significant cataracts
* bilateral significant corneal astigmatism

Exclusion Criteria:

* previous refractive surgery
* amblyopia
* strabismus
* any ocular co-morbidity which could impact on final visual acuity
* pre-existing zonular weakness
* capsular instability or compromise
Effectiveness Comparison of Thoracic Thrust Manipulation in People With Neck or Low Back Pain

Objective:

To compare the effectiveness of thoracic thrust manipulation, together with massages techniques and stretching, between people with neck pain versus people with low back pain.

Methods:

The research will be performed from August 2021 to October 2021 at the University of Alcala de Henares. (Madrid)

A minimum of forty-six (46) volunteers will participate in this research, and they will be divided in two groups of twenty-three (23). One group will be formed by candidates suffering from neck pain (group A) and the other one by candidate with low back pain (group B).

Both groups will receive the same treatment and specific stretching exercises as applicable in accordance to the pain area, e.g.: group A will get the massage and the stretching exercises more suitable for the neck pain and group B the same but for the low back pain. Nevertheless both groups will receive the same technical thrust manipulation in thoracic area.

All these treatments will be applied of the volunteers at the University of Alcalá.

The treatment includes the following activities:

1. Twenty (20) minutes massage in the pain area, as applicable.
2. Technical thrust manipulation in thoracic area.
3. Ten (10) minutes stretching in accordance to the pain area treated. The stretching shall be repeated twice a week by each volunteer.

A total of six (6) sessions will be carried out during six (6) weeks, one session per week.

Pain, disability, kinesiophobia, HRQoL will be assessed as follow:

1. Before first session. (In this evaluation will be also analyzed demographic variables i.e.: height, weight, age, gender, academic level, smoker/no smoker)
2. Between third and fourth session.
3. After sixth session.
4. Four weeks after sixth session.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* Non-specific neck/low back pain for the last three (3) months before the first session.

Exclusion Criteria:

* Previous surgery in the areas covered by this research (neck and/or low back)
* Red flags: Cancer or tumor, fracture...
* Scoliosis or osteoporosis
* Neck or low back pain with radiculopathy symptoms
* Central nervous system involvement
* Fear to manipulation
* Neck pain associated with whiplash injuries on the last six (6) months
* Pregnant women
* Not understand, write and speak Spanish fluently