cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia

The purpose of this study is to determine whether treatment with candesartan cilexetil for at least 6 months in patients with chronic heart failure improves clinical signs and symptoms of chronic heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosed chronic heart failure
* Patients treated for at least 6 months with candesartan cilexetil
* Signed Informed consent

Exclusion Criteria:

* Hypersensitivity to candesartan cilexetil
* Pregnancy / lactation
* Severe hepatic impairment
Remote Ischemic Conditioning on Cerebral Small Vessel Disease

This trial is a randomized, controlled, single-center, double-blind trial. Cerebral small vessel disease (CSVD) patients will be recruited and randomized into RIC or control group.The protective effect of remote ischemic conditioning (RIC) on CSVD will be investigated.


Eligibility Criteria:
Inclusion Criteria:

1. 45-80 years old, and gender not limited;
2. patient and/or caregiver report of cognitive declines with regard to memory and/or other cognitive domains lasting for at least 3 months;
3. neither normal nor demented on the basis of the criteria of the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) with normal or slightly impaired activities of daily living9, with Mini-mental State Examination (MMSE) score ≥ 20 (primary school) or ≥ 24 (junior school or above)10 and Montreal Cognitive Assessment (MoCA) score ≤ 26;
4. the presence of lacunes and/or WMHs and/or CMBs on MRI
5. absence of vascular narrowing \>50% luminal diameter that could cause hemodynamic changes (MFV\>90 cm/s for the intracranial internal carotid artery, 100 cm/s for MCA, \>80 cm/s for basilar artery \[BA\] or vertebral artery) measured by TCD

Exclusion Criteria:

1. clinical manifestations indicating that the patient was at the end-stage of cSVD;
2. hereditary or inflammatory small vessel disorders
3. cerebral venous injury or changes;
4. diagnosis of nervous system degenerative diseases Alzheimer's disease, DLB, frontotemporal dementia (FTD), and so on;
5. history of intracranial hemorrhage or significant bleeding in other parts of the body
6. brain tumor, psychoses, or acute stroke within 6 months;
7. cardiogenic embolism;
8. significant bleeding coagulation dysfunction;
9. serious liver and kidney function is not complete, malignant tumor, or serious diseases need to medical intervention or surgery;
10. any soft tissue or vascular injury, and any disease of the extremities that may contraindicate RIC;
11. pregnant women;
12. life expectancy\<6 months;
13. refused to sign a consent form, poor compliance, or not to cooperate to complete whole treatment, and so on.
Benefits of Standard ONS in Indian Adults

This is a prospective, single arm, baseline-controlled multicenter study to observe benefits on Oral Nutritional Supplement (ONS) intake in adults with medical conditions associated with poor nutritional status.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory adult patients \>or equal to 45 years of age
* Patients at the risk of malnutrition (MST \> or equal to 2)
* Patients who understand nature of the study, willing to participate in all scheduled visits and trial procedures \& provide a written informed consent.

Exclusion Criteria:

* Subject using commercially available macronutrient food supplements or another ONS
* History or evidence of hypersensitivity to any component of study product
* History of any Gastrointestinal disorder/surgery that affects digestion and/or absorption of food
* Evidence of active TB, Hepatitis B, Hepatitis C or HIV infection, type 1 or type 2 diabetes mellitus, malignancy and any other disease affecting appetite and weight loss
* History or evidence of any medical condition that in the opinion of Investigator can interfere with the study assessment of outcome or Patients with scheduled surgery during the duration of the study
* Subjects who are unlikely to comply with the study protocol or follow up regularly for study assessments
* Pregnant or lactating women
DOAC in Unusual Site Venous Thrombosis

Unusual site venous thromboembolism (VTE) refers to thrombosis occurring in venous districts outside the veins of the lower extremities and the pulmonary arteries, and includes splanchnic vein thrombosis (SVT), cerebral vein thrombosis (CVT), retinal vein thrombosis, ovarian vein thrombosis, and renal vein thrombosis. The use of the novel direct oral anticoagulants (DOAC), thrombin or factor Xa-inhibitors (such as dabigatran, apixaban, edoxaban, rivaroxaban), in patients with unusual VTE in clinical practice is increasing. Through an international multicentre prospective registry, the investigators aim to evaluate the rationale for the use of the DOAC for the treatment of unusual site VTE and to assess the safety and effectiveness of this approach in real life clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Objective diagnosis of venous thrombosis not involving the upper limbs, lower limbs and pulmonary arteries
* Treatment with one of the DOAC (e.g. apixaban, dabigatran, edoxaban, rivaroxaban)

Exclusion Criteria:

• Enrolment in interventional studies evaluating the DOAC for the treatment of unusual site VTE
Efficacy of a Nurse Telephone Follow-up on Pain Intensity After Removal of Tonsils in Children

The purpose of this study is to determine if a nurse telephone follow-up to parents of children who underwent a removal of their tonsils would be effective in reducing pain intensity, complications and resort to other healthcare services

Tonsillectomy in children is a common elective day surgery. In the United States, 530 000 children under 15 years of age underwent a tonsillectomy in 2006. This minor surgery generates moderate to severe pain and many postoperative complications, both in the early postoperative phase and for at least 7 days. Patients are discharged home a few hours after tonsillectomy, and parents take over their child's care. But not all parents have the ability and knowledge required to adequately manage the pain and complications. This sub-optimal care situation has a significant impact on the child's convalescence and can lead to poor pain management, dehydration, poor rest and sleep quality, nausea, vomiting as well as an increase in the risk of secondary haemorrhage. Many interventions have been evaluated to improve pain management, such as education strategies for parents or children and tools to guide parents. However, none of these strategies have obtained significant results on children's pain intensity post-tonsillectomy.

A nurse telephone follow-up can significantly reduce pain intensity of adults who undergo ambulatory surgery. This intervention is defined as multiple telephone calls made to the patient by a nurse, after discharge, to provide information, and review discharge prescriptions and management of care by the patient himself or by a care-giver. Only a few studies have explored nurse telephone follow-up for children who underwent tonsillectomy. The design of these studies, including the time-periods chosen for data collection, were not properly determined to adequately evaluate the impact of the intervention on management of pain and prevention of postoperative complications. Thus, we planned to determine if a nurse telephone follow-up, made to parents following their child's tonsillectomy, would contribute to decrease pain intensity, incidence of postoperative complications and resort to other healthcare services.

Eligibility Criteria:
Inclusion Criteria:

* ASA I or II
* Elective surgery for tonsillectomy
* Parents or children able to read, and understand French or English
* Family equipped with a phone at home
* Child discharged home after the surgery

Exclusion Criteria:

* Abused cases
* Children with a cognitive deficit
* Children suffering from chronic pain
* Child who had another surgical procedure within a month
Clinical Biocompatibility Evaluation of Contact Lens Coatings

The primary objective is to evaluate corneal staining observed after 2 hours of wear with contact lenses with investigational coating against PureVision™ lenses, all pre-cycled with OPTI-FREE® RepleniSH® multi-purpose disinfection solution.

In this contralateral crossover study, qualifying subjects will wear a total of 2 pairs of study contact lenses. Lenses will be worn according to a randomized lens sequence assignment. Each pair will consist of a test lens (Test 1 or Test 2) and a control lens.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and must sign an Informed Consent;
* Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
* Manifest cylinder less than or equal to 1.50 diopter (D) in each eye;
* Best Corrected Visual Acuity (BCVA) 20/25 or better in each eye;
* VA with habitual spectacles 20/40 in both eyes (OU) or better and willing to wear spectacles as needed during the washout period and during study lens exposure;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
* History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye;
* Ocular or intra-ocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
* Current or history of pathologically dry eye in either eye that would preclude contact lens wear;
* Current or history of herpetic keratitis in either eye;
* Eye injury in either eye within 12 weeks immediately prior to enrollment;
* History of intolerance or hypersensitivity to any component of the study lenses or solutions;
* Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
* Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
* Other protocol-specified exclusion criteria may apply.
Effect of Kinesio Taping on Muscle Strength in Lower Trapezius

The purpose of this project is to investigate the effect of Kinesio tape on muscle strength of the lower trapezius in people with shoulder symptoms and decreased muscle strength in the lower trapezius - a randomized controlled trial.

The aim of the study is to investigate the effect of recoil tape with 0-30% tension, by using one application of Kinesio tape over the muscle fibers of the lower trapezius from its origin to its insertion. The participants will be divided into intervention group (taping) and control group (no intervention). Muscle strength test will be performed before and immediately after taping (20-30 minutes) for both groups using hand-held dynamometer measurements (MicroFET 3).

Work is based on the following hypothesis: "Kinesio taping using recoil taping provides increased isometric muscle strength in lower trapezius immediately after application".

Eligibility Criteria:
Inclusion Criteria:

* Shoulder problems
* Low muscle strength in lower trapezius
* Positive manual recoil-test for the lower trapezius

Exclusion Criteria:

* Shoulder surgery \<3 month
* Pathology in the shoulder related to tumors, fractures, neurology, rupture of tendons
Procalcitonin Level as a Surrogate for Catheter-related Blood Stream Bacteremia Among Hemodialysis Patients

Hemodialysis patients frequently develop catheter-related blood stream bacteremia (CRBSI). Procalcitonin is a marker of sepsis in bacterial infection. this study for detection of its role as a surrogacy marker in CRBSI.

Catheter-related blood stream bacteremia is common among hemodialysis patients. Clinically, fever and/or rigors with laboratory indicator of inflammation as leucocytosis and elevated c-reactive protein level are considered as markers for CRBSI before blood culture results became available.

Procalcitonin is a valid indicator of sepsis. In this study, Procalcitonin level will be measured in any patient with suspected CRBSI and correlation will be tested for proved CRBSI by blood cultures.

Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis patients with a dialysis catheter
* signs suggestive of CRBSI: fever/chills or leucocytosis with no other site of infection.
* Informed consent signed to be enrolled in the study

Exclusion Criteria:

* Patient with identified cause of fever other than CRBSI
Body Schema Alterations in Musculoskeletal Disorders : Effect of Laterality

This study assess ocular movements in a hand laterality judgment task in a population of musculoskeletal disorders. Reaction time, error rate and visual strategy are compared between musculoskeletal disorders and healthy patients, and between the different locations of the disorder.

Musculoskeletal disorders are a major public health issue. Recent studies showed that body schema alterations are involved in the chronification of those disorders. Those alterations bring the opportunity for new exploration or therapeutic solutions. Our hypothesis is that musculoskeletal disorders lead to motor imagery alterations relative to body schema disorders. Reaction time extension et error rate increase in a hand laterality judgment task would confirm that hypothesis. It is assumed that body schema alterations of patients suffering from musculoskeletal disorders could change with localisation, dependant on disorder's laterality and distality.

It is a monocentric, prospective, case-control trial, with 4 subgroups of 30 patients : shoulder rotator cuff tendinopathy, carpal tunnel syndrome, chronic low back pain, healthy subjects. We compare reaction time and error rate on a hand laterality judgement task. In that task, participants are asked to identify hand right or left laterality, when those hand is presented on a computer screen, by answering with the keyboard. Hands are shown on palmar or dorsal view and with 12 different angles of rotation. An eye-tracking device register participant eye movements during the task.

Eligibility Criteria:
Inclusion Criteria:

* normal visual acuity
* social security affiliation
* signing consent
* rotator cuff tendinopathy, chronic low back pain, carpal tunnel syndrome or healthy subject

Exclusion Criteria:

* recent trauma or surgery
* psychiatric or neurological disorder
* psychotropic consumption
* previous experience with motor imagery
* bad french comprehension
* protected persons
* other painful affection than the inclusion criteria
Corneal Epithelial Autograft With Middle Lamellar Keratoplasty for Severe Ocular Burns

The purpose of this pilot study is to explore whether corneal epithelial autograft (EA) combined with allogeneic middle lamellar keratoplasty (AMLK) is more effective than limbal autograft (LA) with AMLK for ocular surface reconstruction in patients with severe ocular burns.


Eligibility Criteria:
Inclusion Criteria:

1. Unilateral severe ocular burns with more than half limbal stem cells deficiency (LSCD). The history of the disease is at least 12 months at the time of screening visit.
2. Presence of superficial neo-vascularization affecting at least 2 cornea quadrants and involving central cornea.
3. Informed consent signed by a patient or legal guardian, or having the ability to comply with study assessments for the full duration of the study.

Exclusion Criteria:

1. LSCD of mild degree, with less than 2 quadrants of neo-vessel invasion and without central cornea involvement.
2. LSCD by ocular surface disorders other than ocular burns.
3. Eyelids malposition.
4. The center corneal thickness\<450µm, the depth of corneal opacity\<150µm or the full corneal lamellar opacity.
5. High myopia with a spherical equivalent of -15.0 D or less.
6. Corneal or ocular surface infection within 30 days prior to study entry.
7. Ocular surface malignancy.
8. Uncontrolled diabetes with most recent HgA1c greater than 8.5%.
9. Renal failure with creatinine clearance ≤ 25mL/min per 1.73 m2.
10. Alanine aminotransferase \> 40IU/L, or aspartate aminotransferase \> 40IU/L.
11. Platelet levels \< 150,000 or \> 450,000 per microliter.
12. Hemoglobin \< 12.0 g/dL (male) or \< 11.0 g/dL (female);
13. Prothrombin time \> 16s and activated partial thrombin time \> 35s in patients not accepting anticoagulant therapy; An international normalized ratio greater than 3 in patients accepting anticoagulant therapy.
14. Pregnancy (positive test) or lactation.
15. Participation in another simultaneous medical investigation or clinical trial.
16. Severe cicatricial eye disease; Conjunctival scarring with fornix shortening.
17. Ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases.
18. Severe dry eye disease as determined by Schirmer's test \< 2mm at least in one eye.
19. Any medical or social condition that in the judgment of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.
20. Signs of current infection, including fever and treatment with antibiotics.
21. Active immunological diseases.
22. History of anti-glaucoma surgeries.
Contributions of a Paramedical Approach in the Prevention and Treatment of Side Effects Associated With Radical Prostatectomy

The paramedic urology team at Martinique University Hospital has developed a "personalized rehabilitation oncosexology program for patients undergoing radical prostatectomy (RP) for localized prostate cancer". The aim of this project is to assess the effectiveness of this program by comparing the sexual quality of life 1 year after surgery between patients participating and those who do not.

80% of patients undergoing radical prostatectomy report urinary incontinence and erectile dysfunction \[Johanssen et al. 2011. Scandinavian Prostate Cancer Group Study\]. In the West Indies, the incidence of prostate cancer is one of the highest in the world (World-standardized incidence in Martinique is 164.5 versus 88.8 per 100,000 person-years in Metropolitan France). Over 2007-2014 an average 530 new cases of prostate cancer were diagnosed each year in Martinique, representing 55% of all male cancers \[Regional estimates report Public Health France, January 2018\]. The prostate is a symbol of male vulnerability \[French Association of Urology-Global Market Research and Public Opinion Specialist, 2006\]. For other authors, virility is above all a cultural representation, and the "crisis of virility", a recomposition of male identity. Surgery on a sexual organ can alter body image and masculinity. According to Colson et al., patients treated for prostate cancer and their partners clearly place sex in first place in the importance of quality of life domains.

Eligibility Criteria:
Inclusion Criteria:

* Men diagnosed with localized prostate cancer and consulting in the urology department of Mangot Vulcin site of the Martinique University Hospital
* Patients newly diagnosed for prostate cancer and who will benefit from radical prostatectomy (regardless the technique : laparotomy, laparoscopy or robot-assisted micro-invasive surgery)
* Fluent in French or Creole
* Patients who give consent
* Patients affiliated to social security

Exclusion Criteria:

* Patients diagnosed with another tumor
* Person under legal protection
Telemedicine for Patients Suffering From COPD (Danish Telecare North Trial)

There are two main aims in this study. The first objective is to evaluate whether a particular telehealth solution, in addition to standard treatment and care, lead to a significant decrease in the mortality and an increase in health related quality of life for patients suffering from COPD that may benefit from telehealth compared with only standard treatment and care. The second objective is to examine the additional costs of the telehealth solution and assess whether this solution is a cost-effective way to care for patients with COPD across patients and municipality districts.

It is hypothesized that telehealth care will increase patients quality adjusted life years at both the cluster and individual level compared to usual practice, since no difference in mortality and a higher health related quality of life is expected. Furthermore, it is hoped that there will be a 30% reduction in the number of admissions and readmissions to hospitals and a 30% reduction in the number of outpatient visits resulting in fewer costs for hospitals. However, it is uncertain as to whether these savings are offset by other costs such as more visits to general practitioners, community care or the implementation costs.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed COPD by spirometry
* in treatment corresponding to GOLD-guidelines
* motivated for treatment of COPD
* COPD is the primary disease
* fixed residence and be affiliated to a general practitioner in North Denmark Region
* At least one of the following criteria should also be met: MRCm (modified) ≥ 2 or MRC ≥3, CAT ≥ 10, have had at least 2 exacerbations within the last 12 months

Exclusion Criteria:

* no phone line or GSM coverage
* unable to understand Danish sufficiently to complete study questionnaires
* have a cognitive impairment
Enhancing Motivation to Quit Smoking Via Self-Help Intervention Targeted to Cancer Type

The purpose of this research study is assess feasibility and acceptability of a recently developed brief self-help intervention targeted by cancer type to increase motivation to quit smoking.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who smoke and recently (i.e., within 6 months) received a diagnosis of breast, colorectal, gynecological, skin melanoma, or bladder cancer (n = 20 per cancer type). (Investigators will consider smokers individuals who report having smoked ≥1 cigarette in the past 30 days.)
* Able to read/write English;
* Able to give informed consent;
* Not currently enrolled in a smoking cessation program;
* Age ≥18 years old.

Exclusion Criteria:

* Male patients diagnosed with breast cancer will be excluded as lifetime risk for breast cancer in men is far below 1%