cyrilzakka/clinical-trials huggingface dataset:
Study Comparing Etanercept 50 mg Once Weekly to 25 mg Twice Weekly in Patients With Ankylosing Spondylitis

The purpose of this study is to compare efficacy, pharmacokinetics, and safety of investigational formulations of etanercept administered as 50 mg once weekly with 25 mg twice weekly and placebo in patients with ankylosing spondylitis (AS).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.
* Active AS, defined by average of visual analog scale (VAS) of ≥ 30 for duration and intensity of morning stiffness and at least 2 of the following: VAS for patient global assessment ≥ 30; average of VAS for nocturnal and total pain ≥ 30; BASFI ≥ 30 (all scores on a scale of 0 to 100).

Exclusion Criteria:

* Complete ankylosis (fusion) of spine.
* Previous treatment with etanercept, antibody to Tumor Necrosis Factor α (TNFα), or other TNFα inhibitors or other biologic agents.
* Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Subjects treated with hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.
* Receipt of multiple nonsteroidal anti-inflammatory drugs (NSAIDs) at baseline.
* Dose of NSAID changed within 2 weeks of baseline evaluation.
* Dose of prednisone \>10 mg/day (or equivalent) or changed within 2 weeks of baseline evaluation.
Elucidation of the Effects of Growth Hormone (GH) Deficiency and GH Replacement on Clot and Platelet

Large population studies of hypopituitary adults (patients with pituitary gland failure) on conventional hormone replacement, but not growth hormone, have an approximate two fold increase in death rate (mortality). The vast majority of this excess mortality relates to vascular disease. While it is possible that overreplacement with steroids, underreplacement with thyroid hormones and sex hormone deficiency contribute, there are increasing data to support a role for GH in the cause of the excess vascular risk. Although a number of surrogates of vascular risk are described in patients with GH deficiency (GHD), how these translate mechanistically into atherothrombotic (blockage of the arteries) disease has not been fully elucidated.

This proposed study will analyse both traditional (body composition, serum lipids, handling of sugars)and more complex markers (inflammation, procoagulation, fibrinolysis) of vascular risk/disease. In addition the study will examine 24hr blood pressure, arterial wall thickness, clot structure and function, as well as platelet action. Measurements will be performed at baseline and will be reassessed after patients have been on a stable dose of GH replacement for at least three months.

The results of the study will characterise risk factors for vascular disease, and take this a step further to elucidate how these changes translate mechanistically in to vascular damage.


Eligibility Criteria:
Inclusion Criteria:

* Able to give written consent
* Adults with confirmed GHD (Insulin stimulation test \<3ug/L)
* Other hormone replacement therapy stable for at least three months

Exclusion Criteria:

* active malignancy
* an acute vascular event within three months of the study
* any therapy other than hormone replacement
* serum creatinine \>120 micromol/l
* abnormal LFTs (ALT\>3 fold upper limit of normal)
Mechanisms and Innovations in Cardiac Resynchronisation Therapy

The aim of this study is to compare the effectiveness of multiple modalities of cardiac resynchronisation therapy using high precision acute electrical and haemodynamic measurements.These modalities include biventricular pacing and conduction system pacing utilising His bundle and left bundle pacing. Conduction system pacing is a more physiological form of pacing. The study hypothesises that this will produce more effective cardiac resynchronisation.

This is a single centre acute electrical/haemodynamic and observational study of a subgroup of patients with heart failure. A total of 60 will be recruited. The acute study involves within patient comparison of biventricular and conduction system pacing using detailed electrical mapping and high precision haemodynamic measurement protocol.

Participants will have permanent conduction system pacing if;

* Baseline left bundle branch block and QRS \> 140ms or QRS \>150ms and any QRS morphology AND
* Conduction system pacing is successful at reducing QRS duration by 20ms or more with satisfactory pacing parameters.

Participants who receive permanent conduction system pacing will have follow up at 6 weeks, 3 months, 6 months and 12 months. Non-invasive markers including mechanical activation pattern (echocardiography and cardiac MRI) and electrical activation pattern (ultra-high frequency electrocardiography) will be used to identify the characteristics of patients who benefit from conduction system pacing.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for conventional CRT
* Severe heart failure (LVEF, a measure of heart pumping, \< 35% - severe)
* Prolonged QRS duration (\>120ms)
* Adults willing to take part (age \> 18 years)
* Able to give consent

Exclusion Criteria:

* Unable to give consent
* Children (age \< 18 years)
* Pregnant women
Do müllerian Anomalies Affect Embryo Implantation?

Müllerian anomalies (MA) are associated with infertility and affect approximately 6.3% of the infertile population. The estimation of the frequency of MAs is not without controversy because it depends on the diagnostic method used and sometimes on the established diagnostic criteria. This pathology is associated with abortion during the second trimester in addition to other complications that include preterm labor, fetal malpositions and an increased rate of caesarean section, although some patients may remain asymptomatic. An association between MA and endometriosis has been described and in particular the case of the septum uterus, therefore it is difficult to establish whether the reproductive results of women with MA tdepend only on the uterine factor or also on the quality of the oocytes.

The main reproductive problems associated with these malformations include, abortion , recurrent abortion ectopic pregnancy and preterm delivery . The experience gained from oocyte donation shows that these women are pregnant less, even with the transfer of good quality embryos. The hypothesis of this poor uterine receptivity is in the poor endometrial vascularization that can decrease embryo implantation. The reason for infertility in women with AM includes decreased muscle mass, decreased endometrial vascularization, decreased capacity of the endometrial cavity, less receptive areas (septum). The lower fertility observed in some women with Müllerian malformations has been partially explained by its tubal factor and its association with endometriosis, with a higher prevalence in them, compared to patients without malformations.

Studies have confirmed an irregular differentiation and estrogenic maturation of the endometrium lining the uterine septum or its internal structure, which has less presence of connective tissue and more muscle mass. Given the confusion generated if the unfavorable reproductive result is due to oocyte quality or endometrial receptivity, it is necessary to use a model that guarantees oocyte / embryo quality and this is offered by oocyte donation. The aim is to evaluate the implantation rate in women with MA who receive donated oocytes compared to women without MA.

Eligibility Criteria:
Inclusion Criteria:

* Women included in the oocyte donation program at IVI Vigo and Valencia 2000-2019.
* Sperm count greater than 1,000,000 per ml.
* Transfer on day 5 of embryo development of at least one good quality embryo.

Exclusion Criteria:

* Testicular biopsy.
* Any indication for preimplantation genetic diagnosis or screening.
* Uterine fibroid greater than 4 cm.
* Presence of ultrasound or diagnosis by HSG or laparoscopy of hydrosalpinx uni or bilateral.
* Recurrent abortion.
* Any abnormality of the uterine cavity other than MA: submucosal myoma, endometrial polyp, or uterine synechiae.
Study of Cervix and Inflammation in Preterm Birth Prediction

Preterm birth rate is 7.2% in Quebec, it's risen worldwide in the past decade and it's the leading cause of perinatal mortality and morbidity. Preterm birth is a major public health problem. Preterm labor leading to preterm birth is difficult to diagnose and prediction of preterm birth is a medical challenge. In the past years, research found that transvaginal ultrasound to assess the cervix of the uterus and vaginal detection of inflammatory protein, specific bacteria and fetal fibronectin can help to detect women at increase risk of preterm delivery. The investigators believe that a combination of these tests can lead to a better prediction of preterm delivery. The investigators want to conduct a study among women judged at increase risk of preterm delivery by their physician (having contractions, modified cervix, past-history of preterm delivery or multiple pregnancy) and assess their cervix by ultrasound and sample their vaginal secretion. The investigators want to analyze the vaginal sampling and look for inflammatory proteins. The objective of this study is to prove the feasibility of this assessment method and elaborate a better predictive test that the investigators can easily use in obstetrics clinics and hospitals.

Preterm birth rate in Quebec is 7.2% and, despite extensive research, the rate of preterm birth has risen worldwide over the past decades. Preterm birth is, all over the world, the first cause of perinatal mortality and morbidity. Spontaneous preterm birth (sPTB) groups premature births with intact and ruptured membranes and represents 70% of preterm delivery. The two conditions associated with sPTB share a common physiopathology and a progressive cascade of events. Extensive evidence supports a central role for the production of prostaglandins, inflammatory cytokines and matrix metalloproteinases (MMP) in the cervix and decidua to promote cervical ripening and decidual and fetal membrane activation but, the exact progression of events remains unclear. Several factors were described as risk factor for sPTB like bacterial vaginosis, inflammatory cytokines and fetal fibronectin in vaginal secretions. The transvaginal ultrasound of the cervix (TVUS), which estimates the length and the aspect of the cervix, can be used as predictive factor of preterm birth. To date, no study has addressed the supra-cervical region by transvaginal ultrasound. This region may be an important key of the inflammatory process leading to sPTB. The assessment of this region by ultrasound can be a predictive marker of sPTB. We want to prove the feasibility of this new approach of sPTB prediction : the transvaginal ultrasound assessment of the supracervical and cervical region associated with detection of vaginal inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Live singleton or multiple pregnancy
* Clinical risk of preterm delivery
* Pregnancy between 20 and 34 gestational weeks

Exclusion Criteria:

* Delivery on the day of the ultrasound
* Major fetal anomaly
* Previa placentation
Best Assessment of Sore Throat and Antibiotic Prescribing

This project aims to investigate if an organisational change of patient flow away from medical practitioners can reduce unnecessary antibiotic prescribing in patients attending with a sore throat as the main complaint.

Today patients appear either at a PHC centre or at the Pharmacy. The Pharmacy may provide advice on analgesic or refer the patient to a PHC centre. At the PHC centre, the patient may first appear to the medical practitioner or a nurse pending on local routines. The current Swedish guideline recommends no antibiotics and no testing for patients with 0-2 Centor criteria. For patients with 3-4 Centor criteria the guideline recommends testing and only consider antibiotics if GAS is present.

COVID-19 has gradually transformed from expressing itself as a severe lower respiratory tract infection to be more of an upper respiratory tract infection. Furthermore, COVID-19 is likely to transform from a pandemic to an endemic state with a low continuous incidence. Hence, in response to COVID-19 it seems crucial to identify to what extent the common sore throat is caused by the SARS-CoV-2.

Furthermore, a large controlled clinical trial is required to sort out if patients attending with a sore throat as the main complaint are best managed by medical practitioners, nurses or pharmacists. This study aims to perform such a controlled clinical trial comparing the outcome of sore throat patients management by medical practitioner, nurses and pharmacists. This study also aims to investigate to what extent the SARS-CoV-2 virus is identified in these patients.

Eligibility Criteria:
Inclusion Criteria:

* The patient is contacting/attending PHC centre or Pharmacy presenting with a sore throat as the main complaint.
* Male or female, aged ≥6 years.
* Fluent in Swedish (reading, writing, conversational) (applicable to caregivers/parents/guardians in case of children).
* Mental state such that he or she can understand and give informed consent to participation in the study by signing the Information and Consent Form.
* Provision of signed and dated Informed Consent Form.

Exclusion Criteria:

* The illness episode is classified as potentially complicated or potentially critically ill
* Presence of SARS-CoV-2 virus in a patient first appearing at the PHC in a cluster where the assessment is supposed to be done by the pharmacists. The patient will not be sent to the pharmacist in case of presence of SARS-CoV-2-virus.
* Patient request to be withdrawn from the study.
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2

The main objectives of the study are:

-to unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (inhaled corticosteroids)

The investigators have developed a non-invasive technique based on mRNA analysis of induced sputum that enables us to study airway inflammation in detail. This technique forms the basis for our current project based on the following hypotheses:

1. different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels can be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.
2. Based on our previous research and preliminary data that non-Th2 asthma can be further divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2, Th17 or Th1 characteristics also exist. The investigators hypothesize that the epithelial cell cytokine, TSLP, can be increased as an early marker of airway inflammation in this latter group.
3. these subgroups have different responses to anti-inflammatory treatment.


Eligibility Criteria:
Inclusion Criteria:

* steroid naive asthmatics

Exclusion Criteria:

* viral/bacterial/fungal infection +fever(\<1month)
* asthma exacerbation (\<3months)
* other airway diseases (CF, ciliary dyskinesia, bronchiectasis)
A Randomized Controlled Single-Blind Study of the Effects of Instrument-Applied Spinal Manipulative Therapy on Postural Control

To determine the effects of instrument-applied chiropractic manipulative therapy (CMT) on postural control.


Eligibility Criteria:
Inclusion Criteria:

* Students, staff or faculty

Exclusion Criteria:

* No previous lower extremity injury, surgery, visual or vestibular condition that would affect balance
* Systemic illness that could have an adverse effect on balance
* Local infection, injury or other malignancy affecting the lower extremity
* any unstable joints of the lower extremity
* Any Spinal manipulation within 48 hours
* Prescription or herbal muscle stimulants, relaxants, etc. that could affect balance
* Pregnancy
ERNIE4: Urine and CRP Point-of-care Test in Acutely Ill Children

This study aims to assess the accuracy of a novel urine test for diagnosing urinary tract infections in acutely ill children presenting to ambulatory care. The accuracy of this novel test will be compared to the accuracy of conventional dipstick testing. In addition, the evidence on urine tests will be added to the existing algorithm for diagnosing serious infections in children. Finally, the study aims to describe the relation between the CRP level at study entry and the duration of symptoms and final diagnosis over the following 30 days.

The design is a cross-sectional cohort study with a nested longitudinal follow-up in acutely children presenting to ambulatory care.

The cross-sectional cohort study will compare an innovative urine test with conventional dipstick testing to establish their relative accuracy to diagnose urinary tract infections, and construct an algorithm consisting of clinical features, urine test results and CRP point-of-care testing to identify serious infections. The longitudinal follow-up study will describe illness trajectories of children with an intermediate CRP test result (5-80 mg/L) at first contact.

The study will run in general practices and community paediatrics in Flanders. Recruitment to the study is expected to last 18 months, with each patient entering the study only once. Children and their parents/guardians will be approached for possible participation in the study by practice staff. There is only one study visit.

Those who agree to participation via written informed consent will have demographics and clinical features recorded. All children will be asked to provide a urine sample on study entry. Subsequently, CRP point-of-care testing will be conducted in all children testing positive on a clinical prediction rule, and in a random sample of children testing negative on that rule. Follow-up information for all children will be collected using general practice notes, hospital records and direct patient/parent contact.

Treatment and other management decisions will be left to the treating physicians' discretion.

Eligibility Criteria:
Inclusion Criteria:

* Aged 3 months to 18 years
* Presenting to a general practice or community paediatrics
* Acute illness of a maximum of 10 days
* Parent or guardian is willing and able to give informed consent for participation

Exclusion Criteria:

* Clinically unstable warranting immediate care
* Urinary catheter in situ
* Immunosuppressant medication taken in the previous 30 days
* Trauma is the main presenting problem
* Antibiotics taken in the previous 7 days
* Children who present to community paediatrics as a result of direct GP referral
Enteral Feeding in Infants With Duct Dependant Lesions.

This is a multicenter randomised controlled trial to assess whether standardised enteral feeding in newborns with duct dependenty congenital heart disease decreases the risk of necrotising enterocolitis (NEC). The investigators plan to include a total 384 infants. The study will be carried out in three level III hospitals in Poland. The primary end will be NEC and/or death. Secondary end points include weight gain, hospital length of stay, time required to reach full feeding.


Eligibility Criteria:
Inclusion criteria:

1. Duct dependent congenital heart disease
2. Term infants
3. Parental/legal guardian consent

Exclusion criteria:

1. Potential contradictions to early central feeding
2. Feeding intolerance
3. Hemodynamic instability
4. Death
5. \> 50% formula based enteral feeding
6. Birth weight less than 2500g
Feasbility and Efficacy of S-Press Leg Strengthening Device

The proposed study will examine the use and effectiveness of a novel strength training device - The S-Press within an NHS environment. The S-Press is a portable exercise device that can be used seated or lying down and specifically targets the knee extensors and flexors. The knee extensors are particularly important in the performance of activities of daily living such as rising from a chair, walking up and down stairs and walking.

Resistance training is the most effective strategy to help to reduce muscle wasting in response to ageing or chronic disuse; however as current in-patient settings likely fail to produce an overload stimulus to the muscle for hypertrophy and strength gains, there is a need to develop new interventions and equipment to help deliver this. The S-Press is designed by a Physiotherapist with the goal of increasing muscle strength and improving physical function in patients who may be confined to their bed or chair or unable to join in with standard physiotherapy treatments.

This mixed methods study will examine the efficacy of the S-Press to improve muscle size using B-Mode Ultrasound and physical function, using sit to stand x5 with use over 6 weeks, alongside the qualitative experience of the use of the S-Press through a one to one semi structured interview.


Eligibility Criteria:
Inclusion Criteria:

* Any in-patient admitted onto the ward sites for therapy intervention, assessed as medically stable and physically able to participate by nursing staff and able to provide informed written consent for participation.

Exclusion Criteria:

* Any patient who is unable to give informed consent.

  * Significantly confused patients - may not understand or retain the information to perform the exercises so will be excluded from this study.
  * Patients with unstable or deteriorating medical conditions or are acutely unwell with an infection.
  * Patients unable to do leg press exercise
  * Patients who have had major surgery or myocardial infarction within the past 6 months.
  * Patients who have major surgery scheduled during the intervention period.
  * Patients currently undergoing treatment for cancer
  * Patients who currently have high blood pressure that is uncontrolled (Systolic \>200mmHg or Diastolic \> 110mmHg)
  * Patients with a physical disability that precludes safe and adequate testing.
An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C

This prospective, multicenter, observational cohort study will evaluate the efficacy and safety of pegylated interferon alfa (peginterferon alfa) (e.g. Pegasys) plus ribavirin and treatment regimens containing direct-acting antivirals in participants with chronic hepatitis C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Data will be collected from participants receiving treatment according to current Summary of Product Characteristics (SPC) and local labeling for the duration of their treatment and a 24-week follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Adult (according to local legislation) participants
* Chronic hepatitis C (HCV)
* Naive or treatment experienced, HIV-HCV co-infected or HCV mono-infected
* Receiving treatment for HCV with pegylated interferons plus ribavirin or regimens containing direct-acting antivirals (DAA) according to standard of care and in line with current SPC/local labeling

Exclusion Criteria:

* Contraindications according to SPC/local labeling
* Treatment started \>4 weeks before entering study