cyrilzakka/clinical-trials huggingface dataset:
Study Comparing Foster Efficacy Maintenance and Reliever Versus Foster Maintenance + Salbutamol Reliever in Asthmatics

Double-blind, multinational, multicentre, randomized, 2-arm parallel-group study

To compare efficacy of Foster as maintenance therapy plus additional inhalations as reliever with Foster as maintenance plus salbutamol as reliever in asthmatics

Eligibility Criteria:
Inclusion Criteria:

* Written signed and dated informed consent obtained.
* Male or female patients aged ≥ 18 years.
* A positive reversibility test
* Patients who experienced at least one severe exacerbation in the 12 months before entry (but not in the last month)
* Using inhaled corticosteroids (ICS) in monotherapy or using ICS in a fixed or free combination with long acting beta2 agonists (LABA) at a constant dose for two months before screening visit
* Not fully controlled asthmatics (which means partly controlled or/and uncontrolled patients according to GINA guidelines 2007) in the last month before screening visit
* Forced expiratory volume in the first second (FEV1) ≥ 60% of predicted for the patient normal value.
* Non smokers or ex-smokers

Exclusion Criteria:

* Pregnant or nursing (lactating) women. Women of child-bearing potential UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \>40 mIU/mL or are using one or more of acceptable methods of contraception
* Body Mass Index (BMI) \> 34 kg/m2.
* Patient with lower respiratory tract infections affecting the patient's asthma within 30 days of the screening visit.
* Use of systemic steroids in the last month.
* Patients with other lung diseases such as COPD, cystic fibrosis, interstitial lung diseases or any other clinically or functionally significant lung disorder.
* Patients who have an uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease.
* Clinically relevant laboratory abnormalities
* Patients who have an abnormal QTcF interval value
* Intolerance or contra-indication to treatment with beta2-agonists and/or ICS or allergy to any component of the study treatments.
* Patients treated with slow-release corticosteroids in the 3 months prior to screening visit.
* Patients being treated with anti-IgE antibodies.
* Patients treated with LABA or ICS/LABA fixed combination in the 24h before screening visit
* Severe asthma exacerbation in the last month before screening visit
Evaluation of Use of Clinical Decision Support System in HIV Care in Resource Constrained Settings

The purpose of this study is to determine whether the use of a Computerized Decision Support System (CDSS) in form of alerts to clinicians enhances early detection of immunological treatment failure in HIV patients.

We hypothesize that there is no difference in the time to detecting immunological treatment failure among HIV patients in resource poor settings whether the clinicians use an Electronic Medical Record (EMR) system with a Computerized Decision Support (CDSS) or an EMR without a CDSS. In this study, 20 clinics were assigned to the intervention (EMR+CDSS) arm and non-intervention arm (EMR only) and will be followed up for 12 months to assess whether there are any differences in time taken to detect immunological treatment failure based on CD4 cell count.

Eligibility Criteria:
Inclusion Criteria:

* All HIV patients enrolled in participating clinics
Detecting Dementia in the Retina Using Optical Coherence Tomography

This retrospective case control explores the retinal features of dementia associated with neurodegenerative diseases, particularly Alzheimer's disease. By linking a pseudonymised dataset of three-dimensional retinal scans, called optical coherence tomography, with nationally held data on dementia, corresponding characteristics will be evaluated through descriptive statistics and machine learning techniques.

By 2025, it is estimated that approximately 1 million people in the United Kingdom (UK) will suffer from dementia, a syndrome associated with progressive decline in brain function. While there is currently no cure for most types of dementia, early diagnosis can help patients receive the appropriate treatment and support to help maintain mental function.

The focus of this project is to identify changes in retinal structure associated with dementia. In collaboration with bioinformatics experts at University College London (UCL), the investigators propose to analyse our repository of \>1 million retinal scans, termed optical coherence tomography (OCT), performed regularly on patients since 2008. OCT scans will be linked at a patient level to data from the Hospital Episode Statistics (HES) database to identify those who have been diagnosed with dementia or went on the develop dementia. Thus, a pseudonymised classified dataset of retinal scans will be generated for qualitative and quantitative analysis. The primary objective is to characterise changes in the layers of the retina associated with dementia. Machine learning techniques may also be employed to identify novel patterns of retinal change associated with dementia.

Eligibility Criteria:
Inclusion Criteria:

All patients over the age of 40 who have undergone an optical coherence tomography scan at Moorfields Eye Hospital NHS Foundation Trust

Exclusion Criteria:

Poor quality image
Optical System to Continuously Measure Arterial Blood Pressure

Comparison of an optical method to continuously measure blood pressure against an invasive arterial catheter.

The measurement of blood pressure during anesthesia is commonly performed by the inflation of a brachial cuff providing only intermittent blood pressure measurements. In some case, it is required to add a continuous invasive monitoring of blood pressure, via the insertion of an arterial catheter. Unfortunately, the related morbidity is not negligible. To limit the consequences of such a gesture, some developments have been done in the past to allow for continuous non-invasive measurements of blood pressure during anesthesia. Unfortunately, most of these devices are subject to important limitations and constraints of use.

A new system has been designed by CSEM consisting of an optical system fixed on patient's skin, absolutely non-invasive and easy to use. In order to study the reliability of this device, the investigators plan to compare its blood pressure estimates against gold-standard arterial catheter measurements during induction of general anesthesia on:

* 40 patients wearing the optical system at the chest.
* and 40 patients wearing the optical system at the fingertip

Eligibility Criteria:
Inclusion Criteria:

* patient requiring the placement of an arterial catheter for general anesthesia
* minimum of 18 years
* written consent

Exclusion Criteria:

* minor patient or incapable of discernment
* patient with AIMD
* thoracic surgery
The Influence of Leg Length Discrepancy After Total Hip Arthroplasty on Function and Quality of Life

Leg length discrepancy (LLD) is a complication of THA and may result in patient dissatisfaction, gait disorder, greater trochanter pain, low back pain. In the literature, LLD is reported to vary widely among studies e.g. 6 to 35 mm. However, the threshold at which a LLD is clinically important is still a matter of debate. The aim of this study was to determine the influence of non-corrected LLD after THA on patients' reported hip function and quality of life. This prospective cohort study was conducted at Sundsvall Teaching Hospital in Sweden after it was approved by the regional ethics committee at Umeå University (No. 07-052M and No. 12-287-32M). Between September 2010 and April 2013, all patients with unilateral primary osteoarthritis (OA) treated with THA were considered for inclusion. Informed consent was obtained from all patients. Patients with secondary OA, previous spinal, pelvic, or lower limb injuries or fractures were excluded.

The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index that measures functional outcome (ref). The secondary outcome measure was the EQ-5D and visual analogue scale (VAS) scale. Patients were assessed preoperatively and at follow-up at 1 year postoperatively. The posterolateral approach was used in all operations. LLD was measured on the postoperative x-rays. patients were divided into three groups: shortening group where the operated leg was more than 5mm shorter compared with the contralateral side, the restoration control group where the operated leg was within 5mm shortening and 9mm lengthening compared with the contralateral side, and the lengthening group where the operated leg became more than 9mm longer compared with the contralateral side.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral primary osteoarthritis (OA) treated with THA were considered for inclusion.

Exclusion Criteria:

* Secondary OA.
* Previous spinal, pelvic, or lower limb injuries or fractures.
* Bilateral coxarthrosis.
Study of Muscle Effects of BYM338 in Mechanically Ventilated Patients

The purpose of this study is to evaluate the effect of BYM338 on muscle mass and function in Group III failure to wean patients, as compared to placebo controls.


Eligibility Criteria:
Inclusion Criteria:

* Adults on mechanical ventilation for at least 7 days with a tracheostomy in place for \>24 hours.
* Expected to survive at least 14 days.
* Receiving adequate nutritional support, defined as at least 20 kcal/kg and 0.6 g/kg protein per day (unless lower protein intake required by clinical status).

Exclusion Criteria:

* Patients deemed to be terminal wean patients.
* Patients who have progressive neuromuscular degenerative disorders.
* Patients who are comatose.
* Evidence of unstable medical status.
Pharmacokinetic Study of Daptomycin in Healthy Chinese Subjects Living in China

The primary objective of this study is to characterise the pharmacokinetics and dose proportionality of daptomycin after single and multiple (once daily) 4mg/kg and 6 mg/kg doses of daptomycin in healthy Chinese volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Men or women (not of childbearing potential) of Chinese ethnicity
* Weight between 55Kg to 90Kg and have a Body Mass Index (BMI) between 18 and 25 kg/m2
* Have a calculated creatinine clearance within range from 80 to 120 ml/min inclusive

Exclusion Criteria:

* Unable to discontinue use of HMG-CoA reductase inhibitor therapy within 7 days prior to first dose of study drug through discharge from unit
* CPK \> 2X ULN (upper limit of normal)
Effect of Prednisone onTregs and TH17

The primary objective of this study is to see whether systemic corticosteroids (such as Prednisone) have an effect on the peripheral blood Treg and Th17 function in patients with CRS. Patients are taking prednisone as part of their routine medical care.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CRS.
* A CT scan performed in the last year depicting the severity of the disease or nasal polyps on endoscopy.
* Symptomatic at the time of entry into the study as determined by scores ≥ 1.4 on the Rhinosinusitis disability index

Exclusion Criteria:

* Women who are pregnant or breastfeeding.
* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, diabetes, osteoporosis, cataracts, glaucoma, neurological, oncologic, liver disease or a contraindication to taking prednisone).
* Use of any other investigational agent in the last 30 days.
* Use of clinical drugs like antihistamines, leukotriene modifiers, intranasal steroids, systemic corticosteroids in the last 15 days or immunotherapy in the last year.
* Upper respiratory infection within 14 days of study start
* Smoking within the last 2 months.
Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

The aim of this study is to investigate the potential benefits of the correction of growth hormone (GH) deficiency with GH replacement therapy in patients with chronic heart failure due to left ventricular systolic dysfunction.

To date, a wide range of alterations in the GH/IGF-1 axis have been described in patients with chronic heart failure (CHF): reductions in GH levels, reductions in IGF-1 and a pattern of peripheral resistance to GH, in particular in patients with severe heart failure and cardiac cachexia. Unpublished experience of our group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current guidelines(GH stimulation test).

Our study hypothesis is that correction of GH deficiency in patients with chronic heart failure may exert a beneficial effect on their cardiac function and remodeling, performance status and quality-of-life.

Since this was a preliminary study, no sample size calculation was performed; treatment effects from were sought in left ventricular function (as assessed by cardiac MRI), cardiopulmonary exercise performance, clinical status, vascular reactivity, biochemistry and neurohumoral markers of disease (NT-proBNP).

Eligibility Criteria:
Inclusion Criteria:

* Heart Failure in ew York Heart Association functional class II to IV
* Left ventricular end diastolic diameter \> 60 mm
* Left ventricular ejection fraction \< 40%
* Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation with GHRH + Arginine \< 9 ng/dl)
* Age 18-80 years
* Clinical stability, guideline-oriented maximal pharmacological therapy
* Informed consent

Exclusion Criteria:

* Active Myocarditis
* Hypertrophic Cardiomyopathy
* Active endocarditis
* Active malignancy
* End stage renal disease
* Severe liver disease (Child B-C)
The Effect of Combination of Vitamin A, Vitamin E, Sodium Hyaluronate 0.15% Eye Drop Compared With Sodium Hyaluronate 0.1% Eye Drop to Tear Film Stability and Conjunctival Goblet Cells Density in Patient With Non-Proliferative Diabetic Retinopathy (NPDR), and Proliferative Diabetic Retinopathy (PDR)

Commonly know that one of the complications caused by Diabetes Mellitus (DM) is microangiopathy. Microangiopathy in the long term may lead to neuropathy of the corneal nerves. Neuropathy of the cornea will lead to dry eyes in DM patient. One of the artificial tears used in treating dry eyes is sodium hyaluronate. But until recently no research had been done in examining the effect of giving combination of sodium hyaluronate, vitamin A and vitamin E in dry eyes. The antioxidant, and capability of vitamin A and E in promoting cell proliferation may alleviate the symptoms of dry eyes. In this paper we used Ocular Surface Disease Index (OSDI), Tear Break Up time, Schirmer I test and impression cytology to assess baseline and 28 days post therapy in patient with Non-Proliferative Diabetic Retinopathy (NPDR), and Proliferative Diabetic Retinopathy (PDR)

The study is double blind randomized clinical trial, comparing the usage of combination of sodium hyaluronate 0.15%, vitamin A and vitamin E eye drops compared to sodium hyaluronate 0.1% eye drop only in patient with NPDR or PDR with decreased corneal sensitivity. The examination consisted of OSDI questionnaire, tear film break up time, Schirmer I, and goblet cell density, examined at baseline and 4 weeks (day 28) after the initial eye drops is given. For sample size calculation, estimated 96 patients are required to give statistical effect, this number already calculating the possibility of 20% drop out rate. Every eligible patient is then randomized with block randomization into each allocated arm. Statistical analysis used for this study is unpaired T test if the data distribution is normal, if not Mann-Whitney test will be used.

Eligibility Criteria:
Inclusion Criteria:

* DM patients with NPDR or PDR
* Corneal sensitivity less than 45 mm with Cochet Bonnet esthesiometer

Exclusion Criteria:

* Patient with anterior chamber inflammation
* Patient with history of ocular surgery (ex. Repair of corneal rupture, cataract surgery, Lasik)
* Patient with history of cerebrovascular event that may affect cognitive function
* Patient had event of disease which may impact corneal sensitivity (ex. Viral keratitis, ophthalmic Herpes Zoster)
* Patient with corneal cicatrix
* Patient on anti-allergic medication
* Pregnant or lactating woman
The Effect of Watching Mukbang on the Desire to Eat

The current study is designed to find the effect of mukbang on dieters. Mukbang is an online eating broadcast where a host (Asian mukbangs generally feature a young and slim female host) consumes a large amount of food while chatting with audiences. Since some dieters watch mukbang to get satiation and control their appetites, the investigators proposed the hypothesis that mukbang could increase people's satiation level and decrease their desire to eat. To test this hypothesis, one randomized controlled study was conducted and female participants were randomly selected to watch either a mukbang or a non-food related video. Their desire to eat were reported and measured after the video.


Eligibility Criteria:
Inclusion Criteria:

* Female, English native speakers

Exclusion Criteria:

* Male, English is not mother language
Study Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor Occupancy

The study will include a preliminary pharmacokinetics (PK) / safety / tolerability evaluation in healthy elderly subjects followed by the Receptor Occupancy (RO) evaluations in healthy elderly subjects and in Alzheimer's Disease (AD) subjects.


Eligibility Criteria:
Inclusion criteria:

* Men or women from 60 years of age at screening.
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Exclusion criteria:

* History of drug abuse within 1 year before study day 1.
Efficiency And Safety Of Association Arbutin, Triamcinolone And Tretinoin In Treatment Of Melasma

The objective of this study is evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone) in the treatment of epidermal melasma.

The melasma is a common hipermelanosis, acquired, symmetrical, with irregular occurring in areas such as photo-exposed face, forehead and temples, can affect the eyelids and tion. The facial regions most affected are: zigomatic (82.4%), parotid (64.7%), front (64.7%), mandible (35.3%) and nasal (35.3%). The injuries of melasma is variable increase of epidermal melanin and inflammatory infiltrate of mild to moderate intensity. Treatment with compounds such as hydroquinone and derivatives, tretinoin, corticosteroids moderate or combination of them all have shown good results, diminishing the training, reducing the stability and promoting the destruction of melanocytes. The primary objective of this study is evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone) manufactured by Glenmark Laboratory, and as the comparator drug product Triluma ® (hydroquinone + fluocinolone + tretinoin), in the treatment of epidermal melasma through parameters of clinical course of the disease (improves) and its security.

Patients who are included in the study will be randomly and automatically receive one of the treatments (New association or Triluma ®), which should use for 12 weeks. The products should be applied in the regions affected once a day, during night.

The evaluation of clinical improvement, as well as security, will be held on periodic visits, as described below, which will be held the record and supply of medicines to patients.

In each visit, beyond the clinical examination of photographs and large, it filled the Area and Severity Scale (Melasma Area and Severity Index - MASI), which quantifies the melasma and will be the main tool of control of clinical improvement.

At the end of the study, data will be compared, showing no inferiority or inferiority of clinical drug testing in relation to the comparator.

Eligibility Criteria:
Inclusion Criteria:

* Women adults aged more than 18 years;
* Patients suffering from melasma Epidermal the face of mild and moderate;
* Patients who have not done any treatment for melasma in the 3 months preceding the study;
* Patients with good mental and physical health;
* Patients who agree with the purposes of the study and sign the TCLE.

Exclusion Criteria:

* Patients with skin diseases other than melasma, which interfere in clinical evaluation as hemangiomas and queloides;
* Patients with melasma skin or mixed;
* Patients with sensitivity to agents hipopigmentantes;
* Patients with sensitivity to fotoprotetores;
* Patients who are pregnant or breastfeeding;
* Patients who, at the discretion doctor, are not able to participate in the study;
* Patients who have carried out any treatment for melasma in the 3 months preceding the study
* Patients who do not agree with the terms described in the Statement of Informed Consent
COVID-19 in Nursing Homes 2020 and 2021

To describe the effect on mortality in nursing home facilities during three separate equally long periods during the pandemic and more specifically to analyse the effect on mortality of improved preventive routines and vaccination.

Retrospective descriptive cohort study in Östergötland County Council, Sweden comprising 136 nursing home facilities with a possibility to host 4500 residents. All residents in any of these NHs who had a laboratory confirmed COVID-19 diagnosis between March 2020 to April 2021 and who died within 30 days after the verified diagnosis are included. The study is undertaken as a retrospective record review. From the records patient-level data on demographic variables, clinical signs, comorbidity, performance status, and cause of death are collected.

Eligibility Criteria:
Inclusion Criteria:

* All residents in any of 136 nursing homes in Östergötland County Council, Sweden who had a laboratory confirmed COVID-19 diagnosis and who died within 30 days after the verified COVID-19 were included in three separate periods: First period from March 31 to June 30 2020; second period from October 15 2020 to January 15 2021; third period from January 16 to April 18 2021.

Exclusion Criteria:

-
A Novel Echocardiography Modality to Assess Left Ventricular Dyssynchrony

The investigators hypothesize that the relation between mechanical and hemodynamic left ventricular dyssynchrony might better predict response to Cardiac Resynchronization Device(CRT) than currently existing echo indices.

Cardiac resynchronization therapy is emerging to be a highly effective treatment option for selected patients with symptomatic congestive heart failure on optimal medical therapy and evidence of left ventricular (LV) conduction delay and contraction dyssynchrony. It can improve quality of life and results in better survival in this selected group of patients. However, patients have different responses to CRT, and up to 30% of those implanted show no response at all. Ongoing trials, whether prospective or retrospective, have been trying to define best predictors of response to CRT and to measure ventricular dyssynchrony. Despite this, no single echo criterion to date can predict successful CRT over current guidelines.

In this study, we propose to compare LV muscle mechanical dyssynchrony assessment by speckle tracking to hemodynamic dyssynchrony assessment by 4D segmental ejection fraction (EF), a novel modality brought recently by University of Missouri Echocardiography laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac Resynchronization Therapy(CRT) device implanted in the last 5 years.

Exclusion Criteria:

* Acute decompensated congestive heart failure.
* chronic permanent atrial fibrillation