cyrilzakka/clinical-trials huggingface dataset:
Blood-pressure Measuring in Patients Carrying a Left Ventricular Assist Device

To prove the novel device is able to reliably detect pulsatility in patients with CF-VADs and to analyze whether pre-programmed intrinsic pulsatility of the 3rd generation CF-VADs can also be picked up. The study is not designed to measure blood pressure.

Should this pilot study be successful in detecting enough pulsatility a follow-up study would then try to transfer the results into blood-pressure values with the help of comparators in order to identify an easier and more reliable method to measure BP in CF-VAD patients. .

The number of patients supported by left ventricular assist device (LVAD) is increasing as durable mechanical support has become widely available for end stage heart failure as destination therapy and as bridge to transplantation. The accurate measurement of blood pressure (BP) as well as the recognition and management of hypertension in patients with LVADs is an essential component of optimal clinical care. Hypertension is an established long-term risk factor for cardiovascular disease. The measurement of BP and the management of hypertension in patients with CF-VADs can present unique challenges. Patients with LVADs often do not have a palpable pulse, and therefore traditional BP measurement by auscultation or automated cuff is less reliable. Conventional occlusive BP measurement is able to to pick up signals in approximately 50% of cases due to coincidental phases of pulsatility. The arterial line is the gold standard, but is an invasive procedure and not practical for routine outpatient use.

Although efforts are underway to identify an easier and more reliable method to measure ambulatory BP in these patients not one has been able to match the quality of an invasive arterial line.

Eligibility Criteria:
Inclusion Criteria:

* Patients carrying one of the two third generation CF-VADS (Heartware HVAD, Heartmate 3)
* Patients \>18y
* Good understanding of written and oral German
* Signed informed consent
* Scheduled for routine outpatient appointment.

Exclusion Criteria:

* In the population of the outpatient clinic's CV-LVAD patients no known exclusion criteria exists
The Effects of Oral Curcumin on Heme Oxygenase-1 (HO-1) in Healthy Male Subjects

Heme oxygenase 1 (HO-1) serves as a protective gene. Induction of HO-1 has therapeutic potential for several indications. The inducibility of HO-1 by curcumin will be evaluated in this pilot study. Furthermore, the influence of a modulating factor of HO-1 gene activity on the dinucleotide guanosine thymine repeat (GT) length polymorphism in the promotor region will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure.
* Male patient aged between 18 and 45 years (inclusive) at screening.
* No clinically significant findings on the physical examination at screening.
* Body mass index (BMI) between 18 and 28 kg/m2 (inclusive) at screening.
* 12-lead ECG without clinically relevant abnormalities at screening.
* Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.
* Negative results from urine drug screen at screening.
* Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.

Exclusion Criteria:

* Known hypersensitivity to the study drug or any excipients of the drug formulation.
* Treatment with another investigational drug within 3 weeks prior to screening.
* History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs.
* Smoking within the last 3 months prior to screening.
* Previous treatment with any prescribed or OTC medications (including herbal medicines such as St John's Wort) within 2 weeks prior to screening.
* Regularly intake of curcumin rich food
* Loss of 250 ml or more of blood within 3 months prior to screening.
* Positive results from the hepatitis serology, except for vaccinated subjects, at screening.
* Positive results from the HIV serology at screening.
* Presumed non-compliance.
* Legal incapacity or limited legal capacity at screening.
Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD

Objective: A prospective multicenter randomized controlled trial to assess the efficacy and safety of Xuebijing injection for acute exacerbation of chronic obstructive pulmonary disease(AECOPD).

Methods: 254 AECOPD inpatients will be recruited in 6 hospitals in China over 2 years. They will be randomly assigned to Experimental group and Placebo group，Experimental: Xuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days；Placebo Comparator: Normal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days. Compare the following index between the two groups: Invasive mechanical ventilation rate, length of hospital stay, Treg cell,Th1,Th2,HLA-DR,CRP,PCT,IL-4,IL-6,IL-10,TNF-α，IFN-γ, APACHEⅡ, CAPS score.

A prospective multicenter randomized controlled trial to assess the efficacy and safety of Xuebijing injection for acute exacerbation of chronic obstructive pulmonary disease(AECOPD).

Eligibility Criteria:
Inclusion Criteria:

1. Body weight≥40kg and ≤100kg
2. Diagnosis of COPD :(following Global initiative for Chronic Obstructive Lung Disease，GOLD2016)
3. Forced Expiratory Volume in 1 second of less than 70% predicted value after bronchodilator
4. Acute exacerbation of COPD: the clinical presentation of the patient complaining of an acute change of symptoms(baseline dyspnea,cough,and/or sputum production)that is beyond normal day-to-day variation.
5. Assessment of COPD Exacerbations: Medical History:severity of COPD based on degree of airflow limitation;Duration of worsening or new symptoms;Number of previous episodes (total/hospitalizations); Comorbidities; Present treatment regimen;Previous use of mechanical ventilation;
6. sign the informed consent

Exclusion Criteria:

1. Pregnant women, lactating women；
2. Be allergic to Xuebijing；
3. Acute exacerbation of COPD onset of more than 72 hours；
4. AECOPD with severe hypoxemia：oxygenation index \<150 or received Endotracheal intubation invasive mechanical ventilation；
5. Participation in another experimental protocol within 30 days of study entry
6. Primary diseases：Asthma，Cystic fibrosis，Lung cancer，Tuberculosis，Pulmonary sarcoidosis，Pulmonary interstitial fibrosis，Malignant neoplasms，Blood system diseases，HIV；
7. Complications：Pulmonary embolism，shock，DIC，Unstable cardiovascular disease，Upper gastrointestinal bleeding，pneumothorax，Severe liver and kidney dysfunction；
8. Mental incompetence or active psychiatric illness
9. used the following drugs within 72 hours days of study entry：Ulinastatin，Tanreqing， Reduning，Qingkailing；
10. The investigator judged that the subject could not be completed or should not participate in the trial：Hemodialysis more than 1 mouth，Organ transplant patients with potential medical dispute.
Cervical Stabilization Exercises in Patients With Spondyloarthritis

The aim of this study is to investigate the effectiveness of cervical stabilization exercises on cervical positioning error in spondyloarthritis patients.

The position sense and kinesthesia are defined as proprioception. In other words, proprioception allows being aware of positions of the body parts in the space. Muscles, tendons, joint capsules are source of proprioception.

Possible damage to these structures due to inflammation may cause diminished proprioception sense. Decreased proprioception was shown for cervical region in axial spondyloarthritis patients in a recent study.

Different exercise programs may help increasing proprioception. Therefore, the aim of the present study is investigate the effects of cervical stabilization exercises on cervical proprioception accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed as axial spondyloarthritis according to ASAS criteria
* Being able to understand and follow the exercise commands
* Willingness to participate in the study

Exclusion Criteria:

* Trauma history related to cervical region
* A completed ankylosis in cervical region
* Surgery history related to cervical region
* Any vestibular disorders
* Upper extremity involvement other than axial spondyloarthritis
Levonorgestrel Intrauterine System and Adenomyosis

Adenomyosis is defined when the endometrial tissue (gland and stroma) is present within the myometrium . The depth of endometrial penetration which uses in diagnosis of adenomyosis not yet agreed; opinions range from one high power field to 25% of the myometrial thickness. It is a common condition in women aged 40-50 years and is considered an important cause of dysmenorrhea and menorrhagia in around 65 % of cases.

Until past few years; hysterectomy was the suggested definitive treatment, however; this may not be acceptable to women not willing to loss their fertility. Many treatment lines were studied and proved their beneficial effect on adenomyosis such as GnRH agonists, danazol, combined oral contraceptive pills, dienogest and finally endometrial ablation. However, these line of treatment are not commonly used because high incidence of side effects and relatively high cost of some of them.

The levonorgestrel-releasing intrauterine system (LNG-IUS) was emerged as an effective line for treatment of adenomyosis associated pain and bleeding. It can successfully, within 6 to 12 months, down-regulate the estrogen receptors in adenomyotic tissues which lead to decidualization and atrophy of the adenomyosis .

In fact, some adenomyotic women respond well to LNG-IUDs and show high acceptability and satisfaction, on the other hand; a group of women may not respond to LNG-IUDs and opt to remove it and start a new medical or surgical option for treatment.

However, factors related to LNG-IUS effectiveness in patients with adenomyosis were not well available. Only one report states that a large uterine volume could be a factor associated with LNG-IUS treatment discontinuation in adenomyotic patient.

For this reason; the prediction of the responsiveness to LNG-IUS is interesting issue which should be addressed. The present study examines the hypothesis that patient's data reported at baseline visit before using LNG-IUSfor controlling pain/bleeding with adenomyosis can help the prediction of the responsiveness for this important line of treatment at 6 months follow up visit. Up to our knowledge; no clinical trial had been registered or conducted to predict the responsiveness for LNG-IUS in controlling the pain/ bleeding with adenomyosis.


Eligibility Criteria:
Inclusion Criteria:

* adenomyosis
* request for contraception
* resident in the nearby vicinity to make the follow-up easy and feasible

Exclusion Criteria:

* history of ectopic pregnancy
* puerperal sepsis
* pelvic inflammatory disease
* evidence of coagulopathy
* abnormalities of the uterine cavity
Non-exercise Physical Activity Intervention

Physical inactivity is prevalent in older adults and poses a risk factor for the development of type 2 diabetes. The aim of this pilot study was to examine the effect of non-exercise physical activity using a standing desk on clinical variables in older adults with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* older participants (65+ years) with clinically confirmed type 2 diabetes
* Body mass index above 25 and less than 40 kg/m2

Exclusion Criteria:

* participants unable to perform a short clinical and motor function test battery (sABC test, Mini-BEST)
Effect of DHEA on Patients With Poor Ovarian Responds

The purpose of this study is to investigate the effect of DHEA for treatment of subfertile patients with poor ovarian reserve and post-treatment evaluation of IVF outcome.

The aim of this randomized controlled study is to compare the effect of DHEA and placebo on live birth rate in poor ovarian responders. Consecutive infertile women attending the subfertility clinic for IVF treatment will be approached. Those fulfilling the selection criteria would be recruited and a written consent will be obtained after detailed explanation and counseling.

Baseline assessment will be performed at early follicular phase (Day 2 or 3) at recruitment. Patient characteristics including age, body mass index (BMI), and smoking status would be recorded and blood test including follicular stimulating hormone (FSH), estradiol (E2), testosterone and anti-Müllerian hormone (AMH) would be checked. Pelvic scan will be performed to assess the total antral follicle count (AFC) and total ovarian volume.

Subjects will be randomized divided into two groups:

1. DHEA group: Subjects will take DHEA (Vitacost) 25mg three times a day for 12 weeks prior to the start of IVF treatment.
2. Placebo group: Subjects will take placebo three times a day for 12 weeks prior to the start of IVF treatment.

Ultrasound assessment will be repeated in follicular phase (D2 or 3) of every month or cycle followed by a IVF treatment using antagonist protocol based on our standard departmental regimen. Cycle characteristics including the dose of gonadotrophins use, duration of stimulation, number of oocytes obtained, number of fertilized embryos and good quality embryos will be recorded and follicular fluid will be saved for hormonal profiles.

Eligibility Criteria:
Inclusion Criteria:

* Indicated for IVF treatment according to our standard department protocol
* Age \< 42
* Regular menstrual cycles (21-35 days)

Poor ovarian responders are defined according to the Bologna criteria fulfilling 2 out of 3 of the following:

* Advanced maternal age (≥40) or any other genetic or acquired risk factor for POR
* Previous poor ovarian response (POR) (≤3 oocytes with a conventional stimulation protocol using at least 150IU gonadotrophins per day)
* Abnormal ovarian reserve test (i.e. AFC \< 5-7 or AMH \< 0.5-1.1ng/ml). Alternatively, two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ORT.

Exclusion Criteria:

* Previous chemotherapy or pelvic irradiation
* Polycystic ovarian syndrome or polycystic ovaries
* On hormonal supplementation for any indication at the time of recruitment (e.g. estrogen, testosterone or DHEA)
EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA

Since end of December, a new coronavirus, close to the 2002 SARS coronavirus, cause serious pneumonias throughout world. There is currently no strong evidence of an efficient specific treatment. Hydroxychloroquine is an old chloroquine-derived drug, prescribed for auto-immune disorders. It has shown efficacy against Sars-CoV-2 in vitro. Some studies showed that Hydroxychloroquine might improve the clinical status of Sars-CoV-2 infected patients. Azithromycin is a macrolide antibiotic, with immunomodulatory properties. Adding Azithromycin to a hydroxychloroquine-based treatment showed an apparent accelerated viral clearance in infected patients. This study wants to evaluate the clinical impact of adding Azithromycin to Hydroxychloroquine in the treatment of Sars-CoV-2 pneumonia


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Positive Sars-CoV-2 RT-PCR on nasopharyngeal swab
* CT scan suggestive of Sars-CoV-2 pneumonia

Exclusion Criteria:

* Negative Sars-CoV-2 RT-PCR on nasopharyngeal swab
* Known hypersensitivity to Hydroxychloroquine, Azithromycin or a macrolide family member
* Long term prescribed treatment contraindicated with azithromycin (colchicine, ergotamine, dihydroergotamine) and/or hydroxychloroquine (citalopram, escitalopram, hydroxyzine, domperidone, piperaquin)
* Retinopathy or maculopathy
* Porphyria
* Severe renal failure (GFR less than 30 mL/min/m²)
* Dyskaliemia, (ie less than 3,5 mmol/L or more than 5,5 mmol/L)
* Hypomagnesiemia, ie less than 0,7 mmol/L
* Severe cholestasis, cirrhosis or severe hepatic failure
* Known cardiac medical history of congestive heart failure or myocardial infarction
* Bradycardia less than 50 beats per minute
* Prolonged corrected QT interval, (ie cQT more than 440 ms in men and 450 ms in women) or medical history of ventricular cardiac rhythm disorders
* Blood disorders with history of hematopoietic stem cells allograft
* Known history of G6PD deficiency
* Pregnancy
* Breastfeeding
* Subject protected by law under guardianship of curatorship
* Inability to take oral medications
Sarcopaenia is a Useful Risk Stratification Tool for Surgeons to Prognosticate Splenic Abscess Patients

Sarcopaenia is associated with poor prognoses of in-hospital mortality in splenic abscess patients. Investigators recommend its use by surgeons in the ED to rapidly risk stratify and identify patients requiring urgent and aggressive intervention, to maximise patient outcomes and survival chances.

Splenic abscess is a life-threatening surgical emergency which requires early diagnosis and intervention to maximise patient outcomes. This can be achieved through accurate risk stratification in the emergency department (ED). Sarcopaenia refers to an age-related loss of skeletal muscle mass and strength with major physiologic and clinical ramifications. This study evaluates sarcopaenia as a radiological risk stratification tool to predict in-hospital mortality of splenic abscess patients.

99 adult patients at four training and research hospitals who had undergone abdominal contrast CT scans in the ED with the final diagnosis of splenic abscess from January 2005 to December 2015 were recruited. Evaluation for sarcopaenia was performed via calculating psoas cross-sectional area at level of L3 and normalising for height. Univariate analyses were used to evaluate the differences between survivors and non-survivors, with subsequent logistic regression analysis to assess odds ratio of sarcopaenia with respect to in-hospital mortality. A receiver operating characteristic (ROC) curve was plotted to determine predictability of sarcopaenia, with its corresponding sensitivity, specificity, and accuracy rate calculated.

Eligibility Criteria:
Inclusion Criteria:

All adult patients older than 20 years of age admitted to the aforementioned hospitals who had undergone an abdominal contrast CT scan in the ED with the final diagnosis of splenic abscess from January 2005 to December 2015

Exclusion Criteria:

Patients who could not be assessed for sarcopaenia in line with our study methodology and/or had other coexisting infections were excluded. Patients with abscesses involving the psoas muscles were also excluded.
DFDBA and Amniotic Membrane in the Treatment of Periodontal Osseous Defects

Amniotic membrane may be considered as a biologically active scaffold, which in combination with Bone Replacement Grafts (BRG) can be widely used to reconstruct periodontal Intrabony Defects (IBDs), due to the presence of stem cells and growth factors. The goal of the present study was to evaluate if a biologic AM in combination with DFDBA applied in periodontal IBDs would enhance the regeneration of periodontium.

Periodontitis is a bacterially induced inflammatory disease of the supporting tissues of the teeth. It is one of the major dental diseases that affect human populations worldwide and has a huge economic impact on national health care systems.The consequence of periodontitis is commonly the formation of intrabony defects.Intrabony defects are more amenable for regenerative procedures. Periodontal regeneration remains a fundamental therapeutic goal for the preservation of teeth through the restoration of health, function, and esthetics of the periodontium. Several treatment procedures like open flap debridement (OFD), autogenous bone replacement bone grafts (BRG), guided tissue regeneration (GTR), bioactive agents like EMD, rhPDGF-BB, laser assisted regeneration (LAR) have shown histologic proof of principle that the periodontal ligament apparatus can be regenerated in human studies. Intrabony defects with the depth of \>3 mm and radiographic defect angle ≤ 25 are amenable for periodontal regeneration. DFDBA has stood the test of time and has shown consistent good quality patient oriented evidence in achieving periodontal regeneration with long term stability. GTR techniques have shown added advantage of space maintenance, clot stability, guided cell population, epithelial cell occlusion and the combination therapies. Periodontal regeneration with GTR and BRG demonstrates better results as compared with GTR alone. More recently in the realm of reconstructive biology, the concept of Tissue engineering (TE) has been introduced which utilizes mechanical, cellular or biologic mediators to facilitate reconstruction/regeneration of a particular tissue.

The combination of this novel biologic membrane AM and the already established BRG-DFDBA can be an added advantage in treatment of IBDs. To the best of the investigators knowledge only one clinical trial reports this combination therapy in the scientific literature. There is a need for further research in this area.

Eligibility Criteria:
Inclusion criteria:

* Age group of 25-45 years
* Moderate periodontitis with pocket probing depth more than 6mm
* Bilaterally similar intrabony defects
* Systemically healthy patients
* Vital or endodontically treated teeth
* Good compliance

Exclusion criteria:

* Medically compromised
* Pregnant and lactating women
* Smoking
* Teeth with mobility and furcation involvement
Gait Pattern Between a Cemented and Non-cemented Femur Stem

Acute cervical femoral neck fracture patients randomized to either cemented or non-cemented stem. The investigators used gait analysis to evaluate if patients operated with a cemented stem showed more favourable hip kinematics and kinetics when compared with a group of patients operated with a non-cemented stem.

45 patients randomized to receive either a cemented or a non-cemented stem were studied . 2 years after the operation gait analysis was performed with a 16-camera motion capture system together with 2 force-plates. Hip kinematics and kinetics were analysed and 70 subjects served as controls.

Eligibility Criteria:
Inclusion Criteria:

* acute collum femoris fracture

Exclusion Criteria:

-