cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Efficacy of AZARGA® Versus COSOPT® in Patients With Open-Angled Glaucoma or Ocular Hypertension

Subjects are dosed twice daily at 9AM and 9PM for 12 weeks. The primary efficacy variable is the mean change in Intraocular Pressure (IOP) from baseline to 12 weeks. Secondary efficacy variable: % IOP ≤ 18 millimeters mercury (mmHg). Exploratory endpoint: Ocular discomfort scale after first dose.


Eligibility Criteria:
Inclusion Criteria:

1. Must be at least 18 years of age.
2. Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in at least one eye (study eye).
3. Must have IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
4. Must be willing to discontinue the use of all other ocular hypotensive agents prior to receiving the assigned study drug at Visit 1, throughout the study period.
5. Must have an IOP of between 19 to 35 mmHg in at least one eye (which would be the study eye).
6. For the eyes not included in the study, the intraocular pressure should be able to be controlled on no pharmacologic therapy or on the study medicine alone.

Exclusion Criteria:

1. Known medical history of allergy, hypersensitivity or poor tolerance to any components of the preparations to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
2. Presence of other primary or secondary glaucoma not listed in inclusion criterion #2.
3. Any abnormality preventing reliable applanation tonometry in study eye(s).
4. Risk of visual field or visual acuity worsening due to participation in the study, in the investigator's best judgment.
5. Progressive retinal or optic nerve disease from any cause.
6. Use of systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Day 1 Visit or an anticipated change in the dosage during the course of the study.
7. A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
8. Participation in any other investigational study within 30 days prior to Visit 1.
THE EFFECT OF WEB-BASED BREASTFEEDING COUNSELING

This randomized controlled study evaluates the effect of Web-Based Breastfeeding Counseling given to mothers on breastfeeding exclusively with breast milk in the first 6 months, breastfeeding motivation and breastfeeding problems.The main hypotheses it aims to answer are:

1. The web-based breastfeeding counseling given to the mothers in the experimental group is effective on the breastfeeding only for the first six months.
2. The web-based breastfeeding counseling given to the mothers in the experimental group is effective on the breastfeeding motivation of the mothers.
3. The web-based breastfeeding counseling given to the mothers in the experimental group is effective on the breastfeeding problems of the mothers.

In the study, 66 mother will randomly assigned to web-based breastfeeding counseling/experimental group and control group. To the web-based breastfeeding counseling/experimental group (n =33), during the first 6 months after birth, they will be directed to the web-based breastfeeding consultancy website. On this page, mothers will receive counseling on breastfeeding (written, visual, audio materials and telephone counseling) from birth. On the other hand, no other intervention will be applied to the control group other than routine treatment and midwifery care. The primary outcome of the research is the effect of web-based breastfeeding counseling on the breastfeeding only for the first six months of mothers. The secondary outcome of the study is to determine the effect of web-based breastfeeding counseling on the breastfeeding motivation of the mothers. The tertiary outcome of the study is to determine the effect of web-based breastfeeding counseling on the breastfeeding problems of the mothers.

Eligibility Criteria:
Inclusion Criteria:

* treated at the relevant hospital
* who volunteered to participate in the research
* in the age range of 18-40
* oriented to place, time and person
* 37-42 weeks of pregnancy. between the weeks
* having first pregnancy
* having a healthy pregnancy
* Those who do not have any health problems that prevent breastfeeding (HIV, drug use, etc.)
* who is literate
* able to use computer or smart phone
* Those who do not have a communication barrier (not knowing Turkish, mental retardation, etc.)
* with internet at home

Exclusion Criteria:

* any health problem that prevents breastfeeding
* having a baby with any health problem that prevents breastfeeding
* who have a baby who was taken to the intensive care unit due to postpartum health problems
* with multiple pregnancy
Interaction Between Antihypertensives and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

NSAIDs may increase blood pressure and blunt the effects of many antihypertensives. Members of these drug classes differ in their propensity to such an interaction.

To compare prospectively the effects of piroxicam, ibuprofen and acetaminophen on blood pressure control in hypertensive patients with osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Treated hypertensives of either gender aged between 55 and 76 years
* About 50% with concomitant osteoarthritis of the hip or knee

Exclusion Criteria:

* Normotensive persons or untreated hypertensives
* Individuals outside the age limits
* General exclusion criteria (e.g. uncooperative persons, advanced malignancies, participants in other studies)
Kinesiophobia in the Parents of Hemophilia Patients

Recurrent joint bleedings lead to the development of a debilitating arthropathy in the patients with hemophilia (PwH). This hemophilic arthropathy (HA) is characterized by chronic pain, periarticular atrophy and a limited range of motion. HA affects the perceived quality of life in the PwH. This painful situation can lead to catastrophizing thoughts that movement and physical activity will result in further pain and injury, when that painful situation is perceived as threatening. One component of this fear-model includes fear of movement, or kinesiophobia (KP). KP is defined as an irrational and disadvantaging fear of physical movement and activity resulting from feeling vulnerable to painful injury or reinjury. Patients with KP develop the belief that movements will lead to re-injury and pain. Over time, this leads to decreased physical activity, avoidance of daily tasks, functional decline, reluctance to use extremities, and in advanced stages, may result in depression and reduced quality of life. Although factors associated with KP have been examined in various diseases groups such as chronic low back pain, fibromyalgia, osteoarthritis, migraine, coronary artery disease and rheumatoid arthritis, there is limited research on KP and its predictors in PwH. To the best of our knowledge there is still no any research about effects of HA to the PwH parents' behavior differences especially regarding to KP. This study aimed to find out whether there is KP or not in the parents of patients with HA.


Eligibility Criteria:
Inclusion Criteria:

Parents of PwH and parents of healthy children were included.

Exclusion Criterias:

* Parents who failed to complete evaluation instruments
* Difficulty in understanding and writing the psychosocial evaluation questionnaires themselves
* Parents whose child has another health problem
* Parents who failed to sign the Informed Consent Document

exluded from the study.
Use of MgSO4 for Pain After Bariatric Surgery

The purpose of this study was to investigate the effect of magnesium sulfate on pain management for pain after sleeve gastrectomy operation

The purpose of this study is to investigate the effect of magnesium sulfate on pain management for pain after sleeve gastrectomy operation.

Design: A prospective, randomized, controlled clinical study.

Setting: University hospital.

Participants: Eighty patients undergoing sleeve gastrectomy.

Measurements and Main Results: Visual analog scale for pain score, sedation score, mean arterial pressure, heart rate, and valid and invalid analgesic demand will record. Serum magnesium levels will determined at preoperative evaluation, postanesthesia care unit admission and at 24 hours. Side effects will also record.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 year old individuals who underwent laparoscopic sleeve gastrectomy.

Exclusion Criteria:

* One or more of the following: cardio - vascular and respiratory diseases, drug and/or alcohol abuse, use of daily an algesia 24 hours before the surgery, renal failure, and liver dysfunction.
Local Ablative Therapy for Patients With Multiple (4-10) Brain Metastases

To observe the quality of life (QOL) and to report on toxicity and outcome parameters after the (repeated) use of local ablative therapy (LAT) i.e. stereotactic radiotherapy (SRT) for patients with multiple (4-10) brain metastases

Phase IV prospective non-randomized observational trial (registry trial) for patients with a DS-GPA \> 1.5 or an estimated life expectancy of \>3 months and an established diagnosis on dedicated brain MRI of 4-10 BM of any solid primary tumor.

We plan to deliver a local ablative therapy (LAT) i.e. SRT in 1 to 5 fractions on visible BM and post-surgical cavities if applicable.

Our primary aim is to provide quality of life (QOL) data and our secondary aim is to report on several toxicity and outcome parameters for this patient cohort.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, ≥ 18 years of age
2. Minimal 4 and up to a maximum of 10 synchronous BM diagnosed on a high resolution contrast-enhanced MRI scan (T1 gadolinium) not dated more than 4 weeks prior to inclusion.
3. Maximal lesion diameter of single gross tumor volume (GTV) of 3 cm
4. Maximal cumulative GTV (+CTV for cavity) of 30cm3
5. Karnofsky performance status ≥ 70
6. DS-GPA or expected overall survival (if no DS-GPA applicable) of ≥ 1.5 or \>3 months respectively.
7. Any solid primary tumour. Lymphoma, germ cell tumor, small cell lung carcinoma and multiple myeloma are excluded.
8. Ability to provide written informed consent and to participate in the procedure of the questionnaires.

Exclusion Criteria:

1. BM not amenable to SRT
2. Previous SRT or surgery on the same lesion
3. Co-morbidities considered clinically precluding the safe use of an MRI examination or SRT
4. Any psychological, sociological or geographical issue potentially hampering compliance with the study
5. Pregnancy
6. Concurrent use of systemic therapy
7. More than 10 BM on planning-MRI
8. Maximum cumulative GTV (+CTV for cavity) of more than 30cm3 on planning-MRI
9. A brainstem metastasis with a PTV of more than 20 cm3
10. Leptomeningeal disease
ARENA - Project Atrial Fibrilation Rhine-Neckar Region

ARENA aims to inform patients about the symptoms and the risks of atrial fibrilation.

The study design includes three study arms:

1. ARENA Intervention: This project will examine the effectiveness of population education.
2. ARENA Medication: The aim is to examine the patient's adherence and to analyze whether there are any complications.
3. ARENA Migration: ARENA migration aims to examine whether a targeted population education can improve the care of people with a Turkish migration background.

ARENA aims to inform patients about the symptoms and the risks of atrial fibrilation.

The study design includes three study arms:

1. ARENA Intervention:

   This project will examine the effectiveness of population education and other measures to provide care for patients with atrial fibrillation.

   In the end of the control phase (1 year recruitment of approximately 10,000 patients), there will be a wide publicity, informing about the disease.
2. ARENA Medication:

   ARENA records the patient's complete medication at all survey times (up to two weeks after recruitment and follow up). This allows an accurate assessment of interactions between individual substances.

   In addition, attempts are being made to determine drug concentrations of anticoagulants directly by the blood of the patient. Therefore, patients are provided with kits, which they can use to apply a drop of blood from your fingertip to a filter paper. The aim is to examine the patient's adherence and to analyze whether there are any complications.
3. ARENA Migration:

The Metropolregion Rhein-Neckar is characterized by a high proportion of people with a Turkish migration background. ARENA migration aims to examine whether a targeted population education can improve the care of this patient group.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate
* Atiral fibrilation
* 18 years or older

Exclusion Criteria:

* Not willing to participate
Cost-Effectiveness Analysis of a Rehabilitation Protocol With FES Cycling in Persons With Complete SCI

20 patients were recruited by two hospitals (AOUP and AOUC) in Italy from January 2015 to January 2018. The participants have been addressed to two different groups: the ones recruited by the AOUP were submitted to an experimental protocol of rehabilitation with FES Cycling, the ones recruited by the AOUC were submitted to a standard protocol of manual mobilization.

The primary outcome was the thigh circumferences measured at 4 different levels (5-10-15-20 cm) from the superior margin of the patella, while the secondary outcomes were the muscle tone evaluated with Modified Ashworth Scale (MAS) and the sensation of pain registered with International Spinal Cord Injury - Pain Basic Data Set (ISCI-P).

From these outcomes the Quality Adjusted Life Years (QALYs) was obtained. The costs of the two treatments were calculated through a consultation process with the Competent Offices of the two hospitals. The QALYs and the costs were used to calculate the Incremental Cost-Effectiveness Ratio (ICER) in order to verify the cost-effectiveness ratio of the two treatments.


Eligibility Criteria:
Inclusion Criteria:

* complete spinal cord injury
* loss of gait function
* any episode of autonomic dysreflexia
* any important range of motion limitation to hips, knees or ankles
* eccitability of the muscles
* FES tollerability

Exclusion Criteria:

* cognitive deficits
* psychiatric diseases
* cancer
* recent fractures
A Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIR Study)

The term of End Stage of Liver Disease (ESLD) was raised in 80's of 20 Century, but without a restrict definition. Infections are the cause and effect in occurrence and development of ESLD, which not only induce or exacerbate ESLD, but also are the most combined complication. Multi-resistant bacteria, multi-organ injury, selection of anti-microbes, supporting treatment, disorder of intestine microbiota, et al are dilemma in clinical practice. Appropriate and formal diagnosis and treatment of ESLD combined infection are imperious nowadays.


Eligibility Criteria:
Inclusion Criteria:

Decompensation of liver cirrhosis:

1. ALB \<35 g / L; A / G \<1.0
2. TBIL\> 35μmol / L;
3. ALT\> 1 × ULN and / or AST\> 1 × ULN
4. PTA \<60%
5. Ascites or hepatic encephalopathy or esophageal variceal bleeding

Acute-on-chronic liver failure:

1. Chronic liver disease based on: chronic hepatitis or decompensated cirrhosis
2. onset time: \<4 weeks
3. Hepatic encephalopathy: with or without
4. Coagulation: PTA ≤ 40% or INR ≥ 1.5
5. Jaundice: TBIL ≥ 171μmol / L or daily increase ≥ 17.1μmol / L

Chronic liver failure:

1. The basis of chronic liver disease: decompensated cirrhosis
2. onset time: -
3. Hepatic encephalopathy: with or without
4. Coagulation: PTA ≤ 40% or INR ≥ 1.5 Jaundice: significantly higher

Exclusion Criteria:

-
Reliability of Echocardiography From Subcostal View

The purpose of this study is to assess reliability of echocardiographic assessment of ventricular dimensions and function from subcostal view.

Assessment of the function and dimensions of the right and left ventricles is a key part of Point-of-Care ultrasound in critically ill patients. According to the recent guidelines, this evaluation is performed from apical and parasternal views. However, these views may not be clearly visible in the clinical setting of critical illness and subcostal view is often preferred for its higher feasibility. Before clinical adoption, it is necessary to assess whether the isolated examination from subcostal view is reliable enough in the detection of the impairment of systolic function and the size of both ventricles and the investigators decided to evaluate this issue.

Transverse and longitudinal dimensions and function of both ventricles will be measured calculated by transthoracic echocardiography in critically ill patients in the intensive care unit from parasternal and apical views following the recent guidelines. Systolic function of the left ventricle will be expressed by the left ventricular ejection fraction (calculated by biplane method of disc summation) and by the fraction shortening. Systolic function of the right ventricle will be assessed by the tricuspid annular plane systolic excursion, fractional area change, tricuspid lateral annular systolic velocity, and right ventricular index of myocardial performance. From subcostal view, transverse dimensions of both ventricles and novel parameters of systolic function (subcostal tricuspid annular plane systolic excursion, right ventricular subcostal fraction shortening, right ventricular modified subcostal fraction shortening, left ventricular subcostal fraction shortening and left ventricular modified fraction shortening) will be measured.

Then, the reliability of parameters measured in subcostal view will be tested by comparison with conventional parameters taken from apical and parasternal view by correlation analysis and diagnostic test evaluation. The most reliable thresholds of parameters from subcostal view will be calculated by receiver operating characteristic analysis.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients
* All patients hospitalised in intensive care unit indicated for transthoracic echocardiography examination

Exclusion Criteria:

* Age \<18 years
* Insufficient imaging quality of transthoracic echocardiography
* Refusal of echocardiographic examination by patient
Nutrition in Disguise: Development and Palatability Testing of Novel Food Products

Nutrition in Disguise is focused on developing and testing the acceptability of nutrient dense food products appropriate for older adults and specifically those living in long term care.

Project Description: The overall goal of this research is to develop food recipes that are rich in vitamins, minerals and other food components known to support the physical and mental health of older adults. A variety of enhanced food recipes will be initially designed for older adults living in residences with applicability to pre-frail and frail older adults living in the community. It is hypothesized that the nutrient (protein and vitamins and minerals) density and anti-oxidant (i.e. phytochemical) potential of menus used in residential environments can be improved in a cost-effective manner with the inclusion of several enhanced food recipes designed for this population. This will be achieved by identifying high nutrient ingredients that can be incorporated into recipes of foods that are highly consumed by this segment. Initial work will summarize what is known from existing literature about micronutrient deficiencies and interventions with vitamins, minerals and antioxidants to improve the health of older adults. Foods commonly consumed that can be enhanced to promote their nutritional density (e.g. more nutrients in less calories) will be identified and recipes developed and tested with older adults living in the community and in residences. Products that pass this testing will then be introduced into a residence menu rotation to determine if they are well accepted by residents. A cost benefit of introducing these new products into a residence menu will be demonstrated by showing the gains in nutritional quality of the menu for the cost of producing these products in the home.

Relevance to the field of food innovation: Currently, older adults, especially those who are frail or live in residences, do not consume adequate nutrition to optimize their health. Micronutrient inadequacies are a potential problem. Research to date suggests that diet can also be supportive for delaying frailty and slowing the progression of dementia. Yet, food choices and offerings can be low in nutrition. Cost effective, innovative recipes that used common ingredients to reach nutrition goals for older adults are needed.

Anticipated outcomes:

Up to 10 enhanced recipes that have been developed for residences will be developed and tested for palatability. Knowledge tools will be created for home chefs on how to incorporate nutrient dense ingredients into recipes and how to use the information gained in this project for menu planning.

Eligibility Criteria:
Inclusion Criteria:

* Older adults living in the community with no food allergies
* older adults living in long term care with and without dementia with no food allergies

Exclusion Criteria:

-
Effect of Cyclosporine and Remote Ischemic Preconditioning in Reperfusion Ischemia Injury on Tetralogy Fallot Patients With Correction Surgery

The study aimed to evaluate the combined effects of cyclosporine and remote ischemic preconditioning on MDA, calcium cytosol concentration, and mitochondrial edema in tetralogy Fallot patients undergoing corrective surgery.

Forty patients undergoing tetralogy Fallot corrective surgery were randomized to RIPC and cyclosporine (n=20) and control (n=20). Cyclosporin was administered 2 hour pre induction of anesthesia with the dose of 3 mg/kg body weight intravenously. RIPC was performed preoperatively after induction of anesthesia by inflating pressure cuff on the extremity 30 mmHg higher than systolic blood pressure of the patient for 5x5 minutes with 5 minutes reperfusion interval. Blood samples from coronary sinus and biopsies from the myocardial infundibulum were obtained three times at the condition of pre ischemic, ischemic, and reperfusion. MDA was measured from the blood samples, meanwhile calcium cytosol concentration and mitochondrial edema was measured from the biopsy samples.

Eligibility Criteria:
Inclusion Criteria:

* Tetralogy Fallot patient that is undergoing correction surgery
* Has an ideal anatomy for corrective surgery, namely: Pulmonary artery size within normal limits (according to the kirklin table), Mc Goon ratio\> 1.5, Nakata index\> 200, normal coronary artery ostium and good biventricular function.

Exclusion Criteria:

* Patient refuses the procedure
* Patient with acute kidney injury
* Patient without lower extremity
* Patient with cyclosporin allergy