cyrilzakka/clinical-trials huggingface dataset:
Effects of Furosemide Plus Small HSS in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)

The investigators sought to evaluate the effectiveness of treatment with furosemide + HSS in terms of reduction of serum levels of some chosen markers of heart failure and the response in terms of these markers at a compensated state after an acute saline load.

All consecutive patients aged \>18 years with a diagnosis of acute heart failure or exacerbation in chronic heart failure due to heart failure with reduced ejection fraction ( HFrEF) admitted to the ward of Internal Medicine were enrolled from March 2017 to June 2019. Enrolled subjects were treated with treatment with hypertonic saline solutions + furosemide e.v and control subjects with congestive heart failure randomized to treatment with intravenous furosemide only. Chronic kidney disease patients undergoing dialysis replacement, acute coronary syndrome, myocarditis, pneumonia, myopathies, neoplasms have been excluded.

Patients underwent at T0 (at 24 hours from admission), T1 (after 6-8 days after treatment with high dose furosemide+ HSS ), T2 (after a saline load) venepuncture to obtain venous blood samples for the determination of serum concentrations of N terminal pro B-type natriuretic peptide, High-sensitive cardiac troponin T, Galectin 3, IL-6.

Eligibility Criteria:
Inclusion Criteria:

* Congestive Heart Failure

Exclusion Criteria:

* Acute myocarditis
* active pulmonary or liver diseases
* autoimmune disorders
* infections
* malignant diseases
* muscle disorders
* renal insufficiency
* chronic inflammatory diseases
* rheumatological diseases
* haematological diseases
* chronic treatment with anti-inflammatory drugs
Association Between Handgrip Strength, Skinfold Thickness and Trunk Strength

The main objective was to explore relationship between skinfold measurement at multiple sites, hand grip strength, and trunk muscle strength (flexors and extensors) in healthy participants. Conclusion: There is a moderate association between hand grip strength, T score and trunk muscle strength, evident from the present research. Though no such association was seen for skinfold measurement.

Objectives: The main objective was to explore relationship between skinfold measurement at multiple sites, hand grip strength, and trunk muscle strength (flexors and extensors) in healthy participants. Methods: Cross-sectional design, randomly recruited 40 participants. Finally only 39 participants were included. Measurements for demographic variable and anthropometric variables were done. Then the evaluation for hand grip strength and skin fold was done. Data Analysis: Quantitative variables were designated using means and standard deviations, and qualitative variables described by frequencies. The Repeated measure for Analysis of Variance (RANOVA) was used to analyse whether there was statistically significant interaction between the two groups (smoking vs non-smokers). The Pearson correlation coefficient was used to measure associations of anthropometric traits with grip strength. Multiple linear regression model was also carried to explore the linear relationship between dependent and independent variables.

Eligibility Criteria:
Inclusion Criteria:

* This cross-sectional study Only healthy participants with no known history of previous diseases were included (n=39).

Exclusion Criteria:

* Students who found it difficult to follow the instructions for the tests after one familiarity sessions were excluded (n=0). Students reporting any kind of acute infections, previous history of chronic respiratory diseases were also excluded (n=1).
The Feasibility of a Physical Activity Intervention for Advanced Multiple Myeloma Patients

Although physical activity (PA) is commonly used to manage symptoms and enhance quality of life (QOL) in cancer survivors, relatively little is known regarding the benefits in advanced multiple myeloma (MM). The primary aims of the Physical Activity in Advanced Cancer Treatment (PAACT) intervention were to examine (1) program feasibility and (2) potential impact on patient outcomes. It is hypothesized that an exercise intervention will be feasible and potentially impactful.

While the introduction of novel and more effective treatments has seen improved survival in multiple myeloma (MM), the aggressive nature of the disease and these corresponding agents can have a debilitating impact on quality of life (QOL). Exercise can help manage symptoms and enhance QOL in cancer survivors, however relatively little is known regarding the feasibility or benefits of exercise in MM. The purpose of this study was to examine the feasibility of a group- and home-based exercise intervention for individuals with advanced MM. In this single arm study, advanced MM patients (DS stage II-III) participated in a 12-week aerobic and resistance training intervention, with the option of palliative care consultation. Participants attended once weekly supervised group exercise classes and received individually tailored home exercise booklets. Validated measures of physical functioning and patient-reported outcomes, including QOL, fatigue, anxiety, depression, and self-compassion were obtained at baseline and 12-weeks (post-intervention). Optional semi-structured interviews were conducted halfway (week 6) and at the end of the intervention (week 12)

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with advanced (Durie-Salmon stage II-III) multiple myeloma
* 18 years of age or older and given a survival prognosis greater than 6 months
* stable hemoglobin level of ≥80g/L as measured within 2 weeks of enrollment
* no active infections at the time of enrollment.

Exclusion Criteria:

* refusal of informed consent
* geographically inaccessible
* non-English speaking
* co-morbidities that interfere with participation (i.e., severe mobility issues or cognitive impairments)
* known or active history of substance abuse
Additional Measles Vaccine at 4 Months of Age

Overall objective: To conduct a randomised controlled trial (RCT) to examine whether an early two-dose measles vaccination (MV) strategy at 4 and 9 months will reduce child mortality compared with the WHO strategy of one dose of MV at 9 months.

Specific hypotheses Hypothesis I) Two doses of MV at 4 and 9 months compared with the standard dose of MV at 9 months will reduce mortality by 30% between 4 months and 5 years of age1. As in a previous trial it is expected that the beneficial effect is strongest for girls.

Hypothesis II) Children receiving MV at 4 months in the presence of maternal measles antibodies (MatAb) will have 35% lower mortality between 4 months and 5 years of age than children receiving MV at 4 months with no detectable MatAb.

Implications: These hypotheses are based on a previous RCT showing strong beneficial effects of providing an early measles vaccine, in particular among children with MatAb.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 4 to 7 months who received the third dose of pentavalent vaccine at least 4 weeks earlier

Exclusion Criteria:

* Malformations
* Severely ill
* Severely malnourished
Optical Coherence Tomography Measurements in Eyes With Band Atrophy

The study is designed to evaluate the ability of optical coherence tomography and VCC scanning laser polarimetry to measure and identify the pattern of band atrophy of the optic nerve in patients with long standing chiasmal lesions. The hypothesis is that these new technologies are able to identify such pattern. The idea is that by using eyes with band atrophy one is able to investigate the ability of the new technologies in measuring the retinal nerve fiber layer particularly in the nasal and temporal portions of the optic nerve.


Eligibility Criteria:
Inclusion Criteria:Patients with long standing chiasmal lesions and temporal visual field defect with the following criteria:

1. Visual acuity better than 20/30
2. Refractive error less 5 spherical diopter and 3 cylinder diopter
3. Temporal field defect

Exclusion Criteria:

1. Presence of glaucoma and optic nerve anomalies
2. Anormal nasal field
Edwards Lifesciences Self-Expanding Stent Peripheral Vascular Disease Study

The main objective of this study is to assess the safety and effectiveness of the Edwards Lifesciences LifeStent nitinol self expandable stent device and its delivery system in the treatment of occlusive superficial femoral artery (SFA) disease by reducing the re-intervention rate as compared to percutaneous transluminal angioplasty (PTA) alone

The RESILIENT Trial is a dual stage clinical investigation designed to evaluate the safety and effectiveness of the Edwards Lifesciences self-expanding stent system.

Phase 1 consists of a prospective, multi-center, non-randomized study with a peri-procedure endpoint. Phase 2 consists of a prospective, multi-center, randomized study with a 30-day primary safety endpoint and a 6-month primary effectiveness endpoint.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent approved by the IRB.
* ≥ 18 years old.
* Lifestyle-limiting claudication defined as: Rutherford Cat. 1-3.
* Target lesion(s) is de-novo or restenotic and located within the native SFA and/or proximal popliteal artery
* Angiographic evidence of ≥ 50% stenosis or occlusion
* Target RVD is ≥ 4.0 mm and ≤ 7.0 mm
* Target total length of the lesion or series of lesions is ≤ 150 mm.
* Angiographic evidence of at least one vessel runoff to the foot.

Exclusion Criteria:

* Unable to conform to the study protocol procedures and visits.
* Lifestyle-limiting claudication/CLI (Rutherford Cat. 4-6)
* Patients who are pregnant or planning to become pregnant during the clinical investigation
* Contraindication to study related medications, Ni, Ti, Ta, or other media that is not amenable to pretreatment.
* History of bleeding diatheses or coagulopathy.
* Concomitant renal failure with a creatinine of \> 2.0 mg/dL.
* Concomitant hepatic insufficiency, thrombophlebitis, uremia, SLE, or DVT at the time of the study procedure.
* Receiving dialysis or immunosuppressive therapy.
* Suffered a hemorrhagic stroke ≤ 6 mo prior to the study procedure.
* Prior peripheral vascular bypass surgery involving the target limb.
* Target vessel has been previously stented.
* Target lesion(s) received angioplasty intervention ≤ 6 mo. prior
* Any non-iliac percutaneous intervention(s) \< 7 days prior.
* Currently participating in an investigational drug/device study.
* Limited life expectancy of less than two years.
* Extensive PVD that precludes safe insertion of an sheath.
* Target lesion(s) is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s).
* Unresolved thrombus within the target vessel.
* Poor inflow which would not support a vascular bypass graft.
* Diagnosed with septicemia at the time of the study procedure.
* Additional percutaneous interventional procedures (cardiac/peripheral) planned ≤ 30 days following procedure.
Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment

The purpose of this study is to test if denufosol will remove the fluid build-up in the eye so that the retina can be re-attached without invasive surgery.

The purpose of this trial is to determine if administration of denufosol is well-tolerated and more efficacious than placebo in stimulating subretinal fluid reabsorption and retinal reattachment without surgical intervention in subjects presenting with rhegmatogenous retinal detachment.

Eligibility Criteria:
Inclusion Criteria:

* have rhegmatogenous retinal detachment in only one eye
* be able to receive intravitreal injection of study drug and be able to wait 24(+/- 6) hours to have detachment surgically treated or retinal breaks repaired per judgement of investigator
* no more than 3 separate identifiable retinal breaks that are clustered together and confined within an area no more than 2 clock hours in extent
* retinal detachment must be large enough such that it cannot be immediately repaired with laser photocoagulation or cryotherapy
* have pinhole acuity (using ETDRS) of macula-on, 20/50 or better in both eyes OR macula-off, 20/50 or better in non-study eye and have history, prior to detachment, of reading capability in study eye

Exclusion Criteria:

* have a non-rhegmatogenous retinal detachment
* have large retinal break(s) whose total break area is greater than 1 clock hour in extent
* have evidence of atrophic retinal pigment epithelium, choroid, choroidal detachment or intraocular inflammation
* be monocular
* have a prior retinal detachment repair or a congenital condition that places a greater risk for rhegmatogenous retinal detachment
* have proliferative vitreoretinopathy greater than grade B
* have pre-existing subretinal or vitreous hemorrhage, corneal opacity, or other conditions which limit the view of peripheral retina
* have any co-existing macular pathology or other retinal conditions that can limit visual acuity
* currently have uncontrollable elevated intraocular pressure, advanced glaucoma, or any history or current evidence of endophthalmitis in the affected eye
* have symptoms consistent with a rhegmatogenous retinal detachment such as visual disturbance greater than 14 days prior to screening if macula-on OR history of loss of reading vision in affected eye for greater than 6 days prior to screening if macula-off
* have a retinal detachment with evidence of demarcation lines or evidence of subretinal fibrosis visible upon fundus examination
* be currently taking medications that could obscure or confound study results including acetazolamide (Diamox) and dorzolamide
* have had a periocular, retrobulbar or intravitreal injection in the affected eye, including corticosteroids in the 3 months prior to screening or require one
Books, Videos And Mobile Games İn Pediatric Dentistry

The objective of this study was to examine the impact of educational video viewing, reading educational books, and playing educational mobile games on children's dental anxiety prior to dental examinations. The main questions it aims to answer are:

1. Does reading educational books before dental examinations reduce dental anxiety in children?
2. Does watching educational videos before dental examinations reduce children's dental anxiety?
3. Does playing educational mobile games before dental check-ups reduce dental anxiety in children?

ackground: Behaviour management techniques have an important place in paediatric dentistry. However, alternative methods may be needed if they are found to be ineffective in reducing children's dental anxiety.Aim: This study aimed to evaluate the impact of reading educational books, watching videos and playing mobile games from the child's, dentist's and parent's perspective on children's dental anxiety before treatment.

Methods: A total of 160 patients were randomly assigned to four groups. Anxiety levels of patients in each group were assessed using the Facial Image Scale, the Frankl Behaviour Scale and pulse oximetry. The Corah Dental Anxiety Scale was administered to parents to assess their child's anxiety level. The first group was exposed to the tell-show-do technique, the second group read a book, the third group watched a video and the fourth group played a mobile phone game. The children in each group were then assessed. Anxiety levels were then reassessed using the same scales.

Eligibility Criteria:
Inclusion Criteria:

1. The child must be between 3-6 years old
2. No previous dentist experience
3. No systemic disease or syndrome

Exclusion Criteria:

1. The child is under 3 years old and over 6 years old
2. Having been to the dentist before for an examination or dental treatment.
3. Having any systemic disease or syndrome
Rotational Stability After Nanoflex Collamer Toric Intraocular Lens Implantation in Astigmatic Patients

This study aims to assess the rotational stability of the new collameric Nanoflex toric intraocular lens (T-IOL) by STAAR inserted in astigmatic patients after cataract surgery.

The purpose of this study is also to determine whether the use of a toric intraocular lens (T-IOL) improves visual acuity.

A good rotational stability of toric intraocular lenses (T-IOL) allows an accurate refractive correction. However, many aspects -both pre-operative and post-operative- can interfere causing T-IOL rotation and misalignment.

Complete preoperative ocular evaluation is performed including slit-lamp examination, uncorrected distance visual acuity (UDVA), best-corrected visual acuity (BCVA), Javal keratometry, corneal Scheimplug tomography (Pentacam), optical biometry (IOL Master), Goldman applanation tonometry and fundus evaluation through dilated pupils. The spherical IOL power is calculated considering the axial length obtained with optical biometry, the magnitude of astigmatism derived from Javal keratometry and the steepest axis obtained with corneal tomography. The power of the toric IOL is determined with the online Staar Toric IOL calculator. The reference landmarks are also marked preoperatively with a sterile methylene blue fine point pen. The marking is rechecked in the operating theatre with the electronic toric marker ASICO.

Postoperative evaluation for IOL alignment and rotational stability is performed with slit-lamp photography on dilated pupils. Images are captured with Haag Streit slit lamp BQ 900 and are evaluated with the image-analysis software Protractor (Staar).

Eligibility Criteria:
Inclusion Criteria:

* Patients of 60 years of age ore more
* Cataract
* Corneal astigmatism of 1 diopter (D) or more

Exclusion Criteria:

* Primary or secondary pathological conditions of the cornea
* Zonular fibres pathologies (phacodonesis, pseudoexfoliation syndrome)
* Irregular astigmatism (corneal scar, keratoconus, pterygium)
* Traumatic cataract
* Previous ocular surgery
* Complications during cataract surgery
An Assessment of Dual Site Left Ventricular Endocardial Pacing

We are investigating ways to help patients with heart failure, which is caused by damaged hearts which function less well, and cause symptoms of breathlessness, fatigue, lack of energy and swelling.

Cardiac Resynchronisation Therapy (CRT) pacemakers are used to improve the pumping function of the main heart chamber in certain suitable people with heart failure. CRT requires a pacemaker with 2 wires, one placed inside the right heart chamber and one normally placed on the outside of the left heart chamber. These two wires act together to re-time the coordination of the heartbeat, which is known to improve heart function.

The investigators are assessing whether they might be able to improve heart function even more by placing two wires on the inside of the left heart chamber, rather than one around the outside.

The investigators wish to assess whether:

1. Using two wires within the left side of the heart gives a greater increase in heart function than one.
2. It is possible to choose the best spot inside of the heart by measuring the pattern of the heart beat.
3. Is it possible to use a different type of heart monitor placed outside the body instead of a monitor wire inside the heart to assess improvement in heart function? They are investigating this in people with hearts that beat less effectively than normal.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 60 years or above.
* Having a suitable Atrial Fibrillation/flutter or Ventricular Tachycardia ablation procedure
* Evidence of abnormal Left Ventricular structure and function, as shown by Left Ventricular ejection fraction of less than 40%

Exclusion Criteria:

* Severe peripheral vascular disease (that would make arterial access more risky)
* Haemodynamic instability (such that a longer procedure is inadvisable)
School Based Prevention for Childhood Anxiety

This study was designed to conceptualize a school-based prevention program or childhood anxiety.

This is a project corresponding to a career development grant. The main goal of the proposed research was to identify potential barriers to implementing a school-based anxiety preventive intervention, identify strategies to overcome these barriers, and use this information to test a school-based indicated intervention for child anxiety.

Eligibility Criteria:
Inclusion:

Borderline child anxiety levels based on the Spence Child Anxiety Scale

Exclusion:

Externalizing problems (based on teacher nominations) more severe than Spence Child Anxiety Scale borderline levels
Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease

The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.

The study is multi-center, prospective, double-blind, randomized (3:1) controlled trial.

GUIDE XT may be used for planning of programming as needed.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of bilateral idiopathic PD (H\&Y ≥ 2) with a duration of PD ≥ 5 years.
* Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy.
* Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.

Key Exclusion Criteria:

* Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
* Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol
* Any other active implanted devices including neurostimulators and /or drug delivery pumps
* Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure.
* Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
* A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.