cyrilzakka/clinical-trials huggingface dataset:
Clinical Performance of Existing Wearers of Avaira Sphere Following a Refit With Clariti Elite Sphere

The aim of this dispensing study is to evaluate the clinical performance of existing wearers of Avaira sphere lenses following a refit with Clariti Elite sphere over 4 weeks of daily wear.

This is a 30-subject, prospective dispensing study comparing the clinical performance of the subjects' habitual Avaira sphere lenses following a refit with Clariti Elite sphere lenses. Subject's habitual Avaira sphere lenses will be evaluated at the first visit and then re-fitted with a pair of Clariti Elite sphere lenses for 4 weeks of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks and 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Is between 18 and 40 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted Avaira sphere contact lens (CL) wearer (at least 1 week in Avaira sphere)
* Has a contact lens spherical prescription between -1.00 to - 6.00 (inclusive)
* Has a spectacle cylinder up to 0.75D in each eye.
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter.
* Patient contact lens refraction should fit within the available parameters of the study lenses.
* Is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so).
* Is willing to comply with the visit schedule

Exclusion Criteria:

* Is not a habitual wearer of Avaira sphere lenses
* Has a contact lens prescription outside the range of the available parameters of the study lenses.
* Has a spectacle cylinder ≥1.00D of cylinder in either eye.
* Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
* Presence of clinically significant (grade 2-4) anterior segment abnormalities
* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
* Slit lamp findings that would contraindicate contact lens wear such as:

  * Pathological dry eye or associated findings
  * Pterygium, pinguecula, or corneal scars within the visual axis
  * Neovascularization \> 0.75 mm in from of the limbus
  * Giant papillary conjunctivitis (GCP) worse than grade 1
  * Anterior uveitis or iritis (past or present)
  * Seborrheic eczema, Seborrheic conjunctivitis
  * History of corneal ulcers or fungal infections
  * Poor personal hygiene
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea.
* Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.
Pelvic Varicose Veins Treated With Vascular Plugs Type Amplatzer: REPiVAC

Spanish multicentric record to study the efficacy and safety of the treatment with plugs in Pelvic Congestion Syndrome.

This is an prospective observational study of patients that have been treated with plugs (type Amplazer) at least one of the pelvic varicose veins.

Patients are recruited when the plug is implanted, and the investigators perfom a patients follow-up during 1, 3, 6, 12, 24 months

Eligibility Criteria:
Inclusion Criteria:

* Female \< 18 years
* Present symptomatology
* At least one image diagnosis

Exclusion Criteria:

* Female \> 18
* Non present symptomatology
* Non diagnosis
Efficacy Study of High Dose Symlin to Treat Type 2 Diabetes Mellitus

The hypothesis of the study is that those obese patients with type 2 diabetes mellitus who do not respond to the FDA approved dose of 120 mcg of pramlintide (Symlin®) 3 times daily with expected glucose control require higher than FDA approved dosage.

The primary objective of the study is to determine whether higher doses of pramlintide (Symlin®) in patients with type 2 diabetes mellitus control glucose better than the FDA approved dose of 120 mcg three times daily.

The secondary objectives include proving whether higher dose pramlintide (Symlin®) is more efficacious in causing weight loss and reduction in waist circumference than standard dose pramlintide (Symlin®),to determine whether blood levels of certain hormones correlate with need for higher dose therapy,and to determine whether or not the rate of common adverse effects exceeds the maximum FDA approved pramlintide (Symlin®) dose of 120 mcg three times daily.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years.
2. Type 2 diabetes mellitus.
3. Obese (BMI \> 30 kg/m2), waist circ. \>35" women, \>40" men.
4. Basal insulin plus at least 2 injections of mealtime insulin daily or pre-mixed insulin.
5. On stable insulin dose for at least 3 mos (baseline + 20%, no minimum).
6. If pramlintide treated, on stable full dose for at least 3 months.
7. A1c \> 7.0% and \< 9.0%.
8. Women of childbearing age if using a reliable form of birth control.
9. Women of childbearing age if post tubal ligation or surgical menopause.
10. Able to consent.
11. Willing to perform self-monitoring of glucose.
12. Willing to attend study visits.
13. Written informed consent to participate in the study.
14. Agreement to maintain prior diet and exercise throughout the full course of the study.

Exclusion Criteria:

1. Age \<18 or \>80 years.
2. Confirmed gastroparesis or taking medications affecting gastric motility.
3. A1c \<7.0% or \>9.0%.
4. Recurrent severe hypoglycemia or hypoglycemic unawareness.
5. CHF.
6. Creatinine clearance \<30 ml/min.
7. History of MI \<6 mos prior to enrollment.
8. History of ventricular arrhythmia.
9. History of cancer or chemotherapy \<6 mos prior to enrollment.
10. Laboratory abnormalities as follows:

    1. Liver enzymes \>3X ULN.
    2. Hematocrit less than 30.
    3. Serum creatinine \>2.5 mg/dl.
    4. Fasting triglycerides \>500 mg/dl.
11. Cirrhosis.
12. Pregnancy or nursing.
13. Inability to provide consent.
14. Unwilling to attend study visits.
15. Unwilling to perform self-monitoring of glucose.
16. Chronic oral or parenteral glucocorticoid therapy (over one week of treatment) within 3 months prior to screening.
17. Investigational drug treatment within 3 months prior to screening.
18. Donation of blood, significant blood loss or transfusion within 3 months of screening.
19. History of acromegaly or Cushing's syndrome.
20. Use of prohibited concomitant medications.
21. Type 1 diabetes mellitus.
22. Acute metabolic complication (hyperosmolar state) \<6 months prior to screening.
Efficacy of Breast Milk Expressed and Sucrose in Procedural Pain in Preterm

The aim of this study is to assess the non-inferiority of non- pharmacological breast milk expressed versus oral sucrose in relief procedural pain of venipuncture in preterm neonates.

This is an experimental comparative study of non-inferiority randomized crossover, to be performed in Neonatal units of hospitals in the Community of Madrid.

The 54 pair of preterm that after the selection criteria are included in the study, they performed the randomization of the sequence and breast milk expressed receive oral or 24% sucrose.

The doses administered are: 0.1ml preterm less than 27 weeks corrected gestational age (CGA), 0.25 ml for infants 27 to 31 weeks CGA and 0.5 ml for infants of 32-37 weeks. Both groups will be accompanied by non-nutritive sucking and swaddling and administered two minutes prior to venipuncture.

The outcome variable, pain, will be determined by the scale Premature Infant Pain Profile (PIPP) and by percent of cry.

Data for the primary objective was analysed per intention to treat. This study was approved by local ethical committee.


Eligibility Criteria:
Inclusion Criteria:

* Preterm neonates.
* Weight less than 2500 grams.
* Feed breastfeeding (exclusive or not) or can obtain weight expressed breastmilk .
* Be informed and consent to the parents of those infants previously requested.

Exclusion Criteria:

* Maternal use of opioids or insulin-depent
* infants with invasive artificial respiration
* infants with major congenital anomalies
* infants with grade II or IV intraventricular hemorrhage or strokes
* receiving parental sedatives or vasoactive drugs
* infants with necrotizing enterocolitis
* with surgical interventions
* infants in absolute diet
* infants with abstinence syndrome
18F-FAPI PET Imaging in Pancreatic Adenocarcinoma

To explore the potential efficacy of 18F-FAPI-04 PET/CT for PDAC tumour staging and compare the results with those obtained using 18F-FDG PET/CT.

Accurate diagnosis and staging are crucial for selecting treatment for patients with pancreatic ductal adenocarcinoma (PDAC). The desmoplastic responses associated with PDAC are often characterised by hypometabolism. Here we investigated 18F-fibroblast activation protein inhibitor (18F-FAPI-04) positron emission tomography/computed tomography (PET/CT) in evaluation of PDAC, and compared the findings with those obtained using (18F)-fluorodeoxyglucose (18F-FDG).

Eligibility Criteria:
Inclusion Criteria:

patients who were suspected to have PDAC by radiological imaging patients who underwent paired 18F-FAPI-04 PET/CT and 18F-FDG PET/CT for metastasis screening, recurrence confirmation, or tumour staging patients who were willing to participate in clinical trials and signed an informed consent form.

Exclusion Criteria:

patients with a history of severe contrast allergy pregnant patients patients who were not pathologically diagnosed as showing PDAC.
Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy

The primary objective of this crossover trial is to compare the 3-month, mean 24-hour intraocular pressure (IOP) control and safety obtained with two popular fixed combinations in glaucoma patients insufficiently controlled with latanoprost monotherapy. This study will compare the 24-hour efficacy of travoprost/timolol fixed combination without benzalkonium chloride given once in the evening, versus the latanoprost/timolol fixed combination given in the evening. It is assumed that travoprost/timolol fixed combination will provide better quality of 24-hour pressure control.


Eligibility Criteria:
Inclusion Criteria:

* Primary open-angle glaucoma or exfoliative glaucoma
* Patients who require additional IOP lowering on latanoprost monotherapy
* Morning IOP greater than 20 mm Hg on latanoprost monotherapy
* Untreated morning IOP greater than 26 mm Hg
* Patients older than 29 years
* Patients with early to moderate glaucoma (less than 14 decibel (dB) mean deviation visual field loss attributed to glaucoma and 0.8 or better vertical cup-to-disc ratio)
* On therapy with latanoprost monotherapy for at least 3 months
* Patients with a reliable visual field
* Best corrected distance Snellen visual acuity \>1/10
* Corneal pachymetry within the 550 ± 50 μm range
* Patients should understand the study instructions
* Patients willing to attend all follow-up appointments and willing to comply with study medication usage
* Patients who have open, normal appearing angles

Exclusion Criteria:

* History of combined topical therapy
* Contraindication to prostaglandins or timolol
* History of ocular trauma or inflammation; intraocular surgery; severe dry eyes; use of contact lenses
* Sign of ocular infection except for mild blepharitis
* Any corneal abnormality that could have affected the measurement of IOP
* Chronic use of topical corticosteroids in the last 3 months before entering the study
* Current, or previous use of systemic corticosteroid treatment
* Uncontrolled systemic disease
* Change of a systemic medication during the study period
* Women of childbearing potential or lactating mothers
* Inability to understand the instructions and adhere to medications
A Research Study Looking Into Levels of the Medicine NNC0385-0434 in the Body and How Well it is Tolerated in Participants With Impaired Kidney Function Compared to Participants With Normal Kidney Function

Novo Nordisk is developing a new medicine, NNC0385-0434, to help people lower their cholesterol level.

The aim of this study is to look at how NNC0385-0434 works in the body and how it is removed from the body in people with impaired kidney function.

All participants will receive the same dose (100 mg) of the study medicine NNC0385-0434, which will be given for 10 days in a row. Participants will get the study medicine in a tablet taken orally once-daily. The study medicine needs to be taken in the morning after overnight fasting and 30 minutes before the first meal of the day.

The study will last for about 9-14 weeks.

Participants will have 15 visits to the study centre, including 2 in-house stays of 3 days and 2 nights and 13 ambulatory visits.

Participants' vital signs (heart rate, blood pressure, body temperature) will be measured, participants will have blood draws, urine will be collected and electrocardiograms (ECGs) will be recorded.

Participants cannot take part in the study if they have gastrointestinal disorders or unusual meal habits and special dietary requirements.

Women can only take part in the study if they cannot get pregnant.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 20.0 and 34.9 kg/m\^2 (both inclusive).
* Meeting the pre-defined estimated glomerular filtration rate (eGFR) values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation according to KDIGO 2012:

Group description eGFR (mL/min)

1. Normal renal function more than or equal to 90
2. Mildly decreased renal function 60 - less than 90
3. Moderately decreased renal function 30 - less than 60
4. Severely decreased renal function less than 30 not requiring dialysis

Exclusion Criteria:

* Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the study doctor.
* Unusual meal habits and special dietary requirements or unwillingness to eat the food provided in the study.
Nutrition Education Program in Spinal Cord Injury (SCI)

The purpose of this research is to assess the effectiveness of a nutrition education program in increasing nutrition knowledge and improving health-related biomarkers in individuals with spinal cord injury (SCI).


Eligibility Criteria:
Inclusion Criteria:

- Adults with SCI with complete and incomplete (American Spinal Injury Association Impairment Scale Score A-D) paraplegia or ventilator-independent tetraplegia.

Exclusion Criteria:

* Participants who do not meet inclusion criteria.
* Adults unable to consent.
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women (self-report)
* Prisoners
Effectiveness of Anti-VEGF Treatments in Wet AMD in Active Smokers

" Wet Age-related Macular Degeneration (wet AMD)" is characterized by the appearance of new choroidal vessels. Several clinical studies have shown the effectiveness of intra-vitreous injections of anti-VEGF (bevacizumab, ranibizumab and aflibercept) against these choroidal neovessels. However, some eyes appear to respond less well or be resistant to anti-VEGF injections, which affects visual acuity. To improve the clinical management of patients with wet AMD, it is important to be able to determine which factors determine the response to anti-VEGF treatment.

Non-modifiable factors such as visual acuity or the patient's age at the time of the first injections, the type and size of choroidal neovascularization, as well as certain genetic polymorphisms are known. Two studies, one carried out in Korean patients, the other in different centers in Singapore, New Zealand, Australia and Switzerland showed that active smoking was associated with a poorer response to intra-vitreous injections of ranibizumab, since smoking is also an already well-known modifiable risk factor for the onset of AMD. Another study in the Netherlands shows a poorer visual prognosis after five years of injection treatment in patients who smoke.

This study aims to study the effect of active smoking on the visual prognosis of patients with exudative AMD and treated with anti-VEGF injections in a Belgian cohort.


Eligibility Criteria:
Inclusion Criteria:

* CHU Brugmann Hospital patients
* Patients who received three intra-vitreous injections of ranibizumab, aflibercept or bevacizumab 4 weeks apart as the first intra-vitreous treatment between January 2016 and December 2020.
* Visual acuity measured before the start of the injections (maximum 1 month) and after the series of three injections (4 to 8 weeks after the last injection)
* Patients whose smoking status is known and for whom the following history appears: hypertension, diabetes, taking anti-coagulants or anti-aggregants.

Exclusion Criteria:

* Patients who have already received another intravitreal treatment in the past.
* Patients who have been treated with dynamic phototherapy before or at the same time as the injections.
Resistant Hypertension and Physical Activity Performed in a Heated Pool

patients with resistant hypertension will be submitted to an exercise protocol in a heated pool for three months

pacient´s blood pressure behavior will be compared before and after intervention

Eligibility Criteria:
Inclusion Criteria:

* patients with uncontrolled blood pressure despite concurrent use of 3 antihypertensive agents, including a diuretic, or the need for more than 3 medications to control blood pressure

Exclusion Criteria:

* poor adherence to the treatment
* obesity
* diabetes
* smokers
* secondary causes of hypertension
* motor disabilities to perform the training
Meditative Slow Breathing or Isha Kriya Meditation in Improving Cancer-Related Symptoms in Hospitalized Participants With Cancer

This trial studies how well meditative slow breathing or Isha Kriya meditation works in improving cancer-related symptoms in hospitalized participants with cancer. Meditative slow breathing or Isha Kriya meditation may help to decrease perceived stress and enhance well-being in hospitalized cancer participants.

PRIMARY OBJECTIVES:

I. Test the feasibility of the meditation practice.

SECONDARY OBJECTIVES:

I. Explore the acceptability of meditation in cancer patients through modified Global Symptom Evaluation (GSE) and on day 7 +/- 1 day and day 28 +/- 3 days.

II. Explore the effect of meditative practices in cancer patients through Edmonton Symptom Assessment Scale (ESAS) on the day of enrolment and a weekly basis until the end of study at four weeks.

OUTLINE: Participants are randomized to 1 of 3 groups.

GROUP I (MSB): Participants are instructed on the meditative slow breathing (MSB) technique and then perform MSB over 15 minutes twice daily (BID) for 28 days.

GROUP II (IK MEDITATION): Participants are instructed on the 3 steps of Isha Kriya (IK) meditation and then perform IK meditation over 15 minutes BID for 28 days.

GROUP III (WAITLIST): Participants are placed on a waitlist and receive standard supportive care for 28 days. After 28 days, participants may crossover to Group II.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of malignancy
* Admitted to the hospital
* Able to follow instructions
* Eastern Cooperative Oncology Practice (Eastern Cooperative Oncology Group \[ECOG\]) score of 3 or below
* Fluency in English

Exclusion Criteria:

* Patients with life expectancy less than 2 months per attending physician or advance practice provider's note or assessment of prognosis
* Patients with cognitive dysfunction
* Patients who are admitted for observation for \< 48 hours will be excluded from the study, as one day would be difficult to provide the necessary information
* Patients who are delirious
* Patients who are unable to follow instructions due to their medical condition
* Patients admitted to the intensive care unit
* Patients with ESAS \> 4/10 on dyspnea
* Patients requiring oxygen more than 2 liters
* Patients who are current meditation practitioners
Stellate Ganglion Block to Treat Long COVID 19 Case Series

An assessment of the effectiveness of Stellate Ganglion Block in alleviating symptoms of Long COVID-19.

We evaluated the treatment results of 41 patients (18 male and 23 female) aged between 18 and 89, who received Stellate Ganglion Block (SGB) with Ultrasound guidance for Long COVID-19 Syndrome. The patients were from the United States and received treatment at our Colorado clinics during the period of September to December 2022.Those who responded to our post-procedure follow-up calls were included in the study population.

Eligibility Criteria:
Inclusion Criteria: People who scheduled themselves for a SGB in our clinics in Colorado.

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Exclusion Criteria:

Stellate Ganglion Block Contraindications

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Relationship Between Exposure to Phenols and Pregnancy Outcomes After Embryo Transfer

The goal of this observational study is to explore the association between phenol exposure and pregnancy outcome after embryo transfer. The main question it aims to answer \[is/are\]:

Whether exposure to phenols is associated with adverse pregnancy outcomes in pregnant women undergoing assisted reproductive technology?

First of all, paper questionnaires were used in this study, including general information questionnaire, health effect questionnaire, health survey summary form, and dietary assessment questionnaire. Secondly, obtain the relevant information of the medical record system, including: assisted reproduction protocol, IVF examination results, B-ultrasound examination results, laboratory test indicators, pregnancy outcome information and newborn information. Finally, urine samples were detected using a high performance liquid chromatography mass spectrometer.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese citizens over the age of 20;
2. IVF/ICSI assisted reproductive treatment in our center;
3. Complete clinical data, reproductive outcomes and questionnaire data of both sexes;
4. Knowing about this research and voluntarily accepting this research;

Exclusion Criteria:

1. The patient receives sperm or egg donation treatment;
2. The patient gave up the egg collection operation due to various reasons, and the cycle was canceled;
3. The patient abandons treatment before achieving clinical pregnancy, but the fertile frozen embryo is not transferred;
4. There are contraindications to pregnancy, such as serious liver and kidney diseases, malignant tumors, serious mental diseases, uncorrected coagulation function abnormalities or endocrine indicators abnormalities;
5. Incomplete or missing clinical data or follow-up data;