cyrilzakka/clinical-trials huggingface dataset:
MAP-Calcification: MicroRNAs as Potential Biomarkers for Coronary Artery Calcification

Coronary artery disease (CAD) remains the leading cause of mortality in the UK with an estimated 80,000 fatalities in 2010. Coronary artery calcification (CAC) is associated with atherosclerotic plaque burden and cardiovascular mortality. Mechanisms underlying isolated CAC have not been as yet been fully explained. MicroRNAs (miRNAs), known to act as regulators of gene expression, have also emerged as powerful biomarkers in the diagnosis and prognosis of cardiovascular disorders and may be used in the detection of CAC. We aim to investigate the potential for a "microRNA-signature" in patients with CAC by performing a prospective, case-controlled study to identify pathways associated with CAC in humans. Previous research has demonstrated an inverse relationship between CAC and bone mineral density (BMD), suggesting that these processes may be linked. In a further substudy we plan to define the relationship between CAC and BMD as well as a number of markers of bone metabolism.

Patients will be prospectively enrolled whilst attending for elective coronary CT (computed tomography) angiography including a coronary calcium score, at the Royal Surrey County Hospital. Data regarding demographic and clinical characteristics of patients will be collected. Peripheral venous blood sampling will take place on this occasion. Coronary artery calcification scores will be estimated by a Radiologist using default software. Patients eligible for the bone metabolism substudy will be required to attend the University of Surrey for peripheral Quantitative Computed Tomography (pQCT) of bone mineral composition of the radius. In the intervening period we will ask them to complete a 4-day food diary and wear a UV dosimeter, the latter to assess typical UV exposure, for one week.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient is able to provide written, informed consent

Exclusion Criteria:

* Age \> 65 years
* Diabetes mellitus
* Glomerular filtration rate ≤ 60 ml/min
* Abnormal serum calcium
* History or clinical features of cardiac failure
* Systemic inflammatory disease
* Peripheral vascular disease
* Previous history of percutaneous coronary intervention (PCI)
* Previous history of coronary artery bypass grafting (CABG)
* Previous history of reno-vascular disease
* Active infection
* Active malignancy

Additional clinical exclusion criteria for our sub-study are:

* Regular use of sunbeds
* A sun holiday one month prior to or plans for sun holiday within the study
* Use of vitamin D supplements
* Consumption of alcohol above recommended levels
* Pregnancy or planned pregnancy
* Use of a veil
The Effect of Surgical Interventions to Assist Orthodontic Movement of Impacted Maxillary Canines

Impacted canine causes many problems for patients, such as absorption and damages to the adjacent teeth roots, as well as aesthetic problems. Correction of this problem requires a lengthy time. Therefore, many methods have been suggested to accelerate the movement of impacted canines with the help of surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Palatal or Mid-alveolar impacted canine.
2. There is no previous orthodontic treatment.
3. Healthy periodontal tissues and good oral health (i.e., Plaque Index is less or equal to 1 according to Loe and Silness(1963)).
4. No consumption of any drug that may interfere with the tooth movement (Cortisone, NSAIDs, ...).
5. Mild or no crowding in the upper jaw.
6. No history of previous trauma to the maxillofacial region or surgical interventions.

Exclusion Criteria:

1. Any systemic diseases that would affect tooth movement
2. Antidepressant prevents oral surgery
3. Any congenital syndromes or cleft lip and palate cases
4. Bad oral health
5. Previous orthodontic treatment
ENHANCED Device Programming to Reduce Therapies and Improve Quality of Life in Implantable Cardioverter Defibrillator (ICD) Patients

The purpose of this study is to determine whether Enhanced device programming to reduce therapies (i.e. anti tachycardia pacing (ATP) episodes and shocks (both appropriate and inappropriate)) is safe for patients implanted with an Implantable Cardioverter-Defibrillator (ICD). The secondary objective is to examine the impact of Enhanced programming on (i) ATPs and shocks (both appropriate and inappropriate) and (ii) quality of life and distress.

ICD therapy has become the first-line treatment for the prevention of sudden cardiac death both as primary and secondary prevention due to its proven survival benefits as compared to anti-arrhythmic drugs. However, ICD therapy is associated with a number of complications and shocks that may impair patient quality of life and well being but also influence mortality. Hence, reduction of ICD shocks by means of alternative programming of the device is paramount for improving patient-centered outcomes and mortality.

The ENHANCED-ICD study will be a prospective, single-arm safety monitoring study. All patients will receive Enhanced programming. Furthermore, patients will be asked to complete a set of standardized and validated self-report questionnaires prior to ICD implantation, at 3-, 6-, and 12 months post implantation.

Eligibility Criteria:
Inclusion Criteria:

* a primary or secondary prophylactic indication for ICD therapy according to the current European guidelines
* implanted with a Medtronic ProtectaTM ICD/CRT-D device or any future CE-approved and market-released Medtronic ICD/CRT-D devices with SmartShock technology
* between 18-80 years of age
* speaking and understanding Dutch
* providing written informed consent

Exclusion Criteria:

* a life expectancy less than 1 year
* a history of psychiatric illness other than affective/anxiety disorders
* on the waiting list for heart transplantation
* insufficient knowledge of the Dutch language
Metformin and Esomeprazole in Treatment of Early Onset Preeclampsia

Preeclampsia is globally responsible for tens of thousands of maternal and neonatal deaths each year. Currently, there are no medical therapies to halt disease progression and expectant management and delivery remain the mainstay of treatment. An important step in the pathogenesis of preeclampsia is a poor placental invasion and the subsequent release of the anti-angiogenic factors soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin (sEng)into the maternal circulation. Given metformin and esomeprazole successfully mitigate key pathogenic features of preeclampsia, the investigator will study whether combining low-doses of metformin and esomeprazole may be additive or synergistic (or neither) in reducing sFlt-1 and sEng secretion, and mitigating endothelial dysfunction, compared to placebo.

This is a randomized double-blinded placebo-controlled intervention trial investigating preeclampsia, defined according to the International Society for the Study of Hypertension in Pregnancy (ISSHP). The population of interest involves pregnant women diagnosed with pre-eclampsia at a gestational age between 28 and 32 weeks at Aswan university hospital will be invited to participate. To be enrolled, the treating team needs to have determined after their initial assessment that delivery is unlikely to be required within 48 h. A starting point of 28 weeks has been chosen as this would be the earliest gestation that Aswan university hospital to be viable and are suitable to be offered expectant management The intervention involves randomization to oral esomeprazole tablets40 mg plus metformin tablets 1000 mg or identical placebo tablets from recruitment until delivery. Randomization is achieved using computational random allocation, and both participants and researchers will be blinded to the intervention given.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women presenting at a Gestational age between 28 + 0 weeks and 32 + 0 weeks presented with preterm preeclampsia
* The patient will be managed with an expectant management
* Give written informed consent

Exclusion Criteria:

* Multiple pregnancies.
* Previous hypersensitivity reaction esomeprazole or metformin
* Contraindications to the use of esomeprazole or metformin
* The patient is unable or unwilling to give consent
* An established fetal compromise that necessitates delivery
* The presence of any of the following at presentation:

  * Eclampsia.
  * Severe hypertension.
  * A cerebrovascular event as an ischemic or hemorrhagic stroke.
  * Renal impairment.
  * Signs of left ventricular failure which include pulmonary edema.
  * Disseminated intravascular coagulation (DIC)
  * Haemolysis, elevated liver enzymes and low platelets (HELLP syndrome)
Effect of Fermented Soybean (FSB) Supplementation on Gas-troesophageal Reflux Disease (GERD)

Gastroesophageal reflux disease (GERD) is a prevalent chronic condition affecting the well-being of both adults and children in general medical practice. Research on the effects of fermented soy-bean (FSB) supplementation in managing GERD is relatively new, with limited studies available. Existing research often lacks sufficient dosing regimens and study durations to differentiate be-tween transient placebo effects and sustained benefits. In this study, the beneficial effects of FSB supplementation were investigated in 50 voluntary participants. Participants were required to take 1g of FSB supplement once daily for twelve weeks. GERD symptoms were evaluated using the Reflux Disease Questionnaire (RDQ), while inflammatory markers, including interleukin-4 (IL-4), interleukin-6 (IL-6), and interleukin-8 (IL-8), were measured to assess inflammation. The Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire was used to evaluate partici-pants' quality of life. Results indicated that FSB supplementation significantly (P\<0.05) alleviated heartburn and regurgitation symptoms and reduced levels of IL-4, IL-6, and IL-8, indicating a notable anti-inflammatory effect. Additionally, significant (P\<0.05) improvements were observed in QOLRAD scores, particularly in vitality, emotional distress, and physical/social functioning. Collectively, our findings support the use of FSB as an adjuvant approach in managing GERD, with notable improvements in patients' quality of life.


Eligibility Criteria:
Inclusion Criteria:

(1) experienced heartburn, acid reflux, regurgitation, or non-cardiac chest pain within the past three months; (2) aged 18 years or older; (3) demonstrated the ability to comprehend the study protocol and information provided by the investigators; and (4) provided in-formed consent.

Exclusion Criteria:

1) use of medications related to GERD, such as acid inhibitors, antacids, prokinetics, gastric mucosal protectors, herbs, probiotics, or related preparations within the past two weeks; (2) a history of gastro-esophageal or duodenal surgery; (3) diagnosis of peptic ulcer, gastrointestinal bleeding, esophageal or gastric varices, or upper GI malignancies confirmed by endoscopy at tertiary hospitals; and (4) pregnancy or lactation
Evaluation of Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise Alone

This study intends to compare the efficacy and safety of dapagliflozin versus placebo in treatment-naïve subjects with type 2 diabetes who have inadequate glycaemic control with diet and exercise alone.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent before participating in the study
* Diagnosed with type 2 diabetes (high blood sugar); HbA1c ≥ 7.2% and ≤10.0%
* Subjects should be drug naïve
* Women of childbearing potential who comply to use an adequate method of contraception to avoid pregnancy throughout the study \& who have a negative serum or urine pregnancy test

Exclusion Criteria:

* Subjects received Insulin therapy within one year of enrollment
* Subjects who have severe uncontrolled hypertension
* Subjects who have history of unstable or rapidly progressing renal disease
* Subjects who have severe liver disease
* Subjects who receiving treatment for Human immunodeficiency virus (HIV)
Pancreatic Cancer and Carbon Ion Radiotherapy

Irradiation of non-operable pancreatic cancer with carbon ions (C12). This therapy is expected to be more effective than the current Gold Standard of photon irradiation applied in the case of non-operable pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, inoperable primary or local recurrent pancreatic cancer
* Written informed consent (must be available before enrollment in the trial)
* Karnofsky performance score \> 60 or ECOG-status 0/1 (at least: patient should be able to take care of himself, although daily-life activity or work is not possible)
* Age ≥ 18 years

Exclusion Criteria:

* No clear difference between tumor edge and upper gastrointestinal tract in baseline imaging
* Extensive lymphatic metastases
* Disability of subject to understand character and individual consequences of the clinical trial
* Distant metastases
* Previous radiotherapy of the upper abdomen
* Active medical implants (e.g. pacemaker, defibrillator), contradicting radiotherapy at HIT
* Participation in another clinical study or observation period of competing trials, respectively
Night Pain in Patients With Rotator Cuff Syndrome

The aim of this study is to determine the factors that may be associated with night pain in patients diagnosed with rotator cuff syndrome by clinical and magnetic resonance imaging.

Patients who were diagnosed as rotator cuff syndrome by clinical examination and magnetic resonance imaging will be included in this prospective study.

Demographic data (gender, age, education level, occupation), shoulder pain duration, history of trauma to the shoulder, smoking, dominant arm and diabetes will be questioned and body mass indexes will be calculated. Active shoulder range of motion of the patients will be measured by goniometer and recorded .

Specific tests, which are important for rotator cuff lesion, will be performed to determine whether they are positive or not.

Magnetic resonance imaging of the patients with shoulder pathology will be recorded.

A visual analog scale will be used to determine the intensity of day and night pain. Shoulder Shoulder Pain and Disability Index to assess shoulder disability of patients, SF-36 form will be filled by patient to evaluate the effect of shoulder pathology and Kinesiophobia Score to assess the avoidance of pain induced movement.

Eligibility Criteria:
Inclusion Criteria:

* To be diagnosed with rototor cuff pathology by magnetic resonance imaging
* Age range between 18-65 years old
* To be literate and cooperative

Exclusion Criteria:

* Having shoulder pathology other than rototor cuff pathology (Glenohumeral instability, Bisipital tendon lesions, Glenohumeral joint osteoarthritis, Acromioclavicular joint osteoarthritis, Milwaukee shoulder)
* Having complete rotator cuff tear
* Patients with a history of shoulder or cervical surgery
* The presence of cervical pathology
* Patients with a history of fracture in the shoulder with pain
* Local corticosteroid injection history for the shoulder (over the last 6 months) and using painkiller regularly
* Physical therapy history for the shoulder (in the last 3 months)
* The presence of systemic inflammatory disease
* Malignancy
* Pregnancy
* A history of any psychiatric disorders
Microtransplantation for Ovarian Cancer

In this study, we will apply micro transplantation to the field of recurrent and advanced ovarian cancer to study the efficacy and safety.

The eligible patients are assigned to the experimental group (microtransplantation group, MST group) or the control group (CT) according to the availability of suitable donors. In MST group, peripheral blood hematopoietic stem cells from HLA mismatched donors mobilized with granulocyte colony stimulating factor are infused after conventional chemotherapy and/or radiotherapy ; The CT group only received conventional chemotherapy and/or radiotherapy. According to the patient's past medical history, current tumor assessment results, and the latest cancer treatment guidelines, the individualized chemotherapy and / or radiotherapy plan for the patient is formulated after discussion by more than 3 oncologists. After each course of treatment, the efficacy and safety are evaluated. For the patients who are evaluated to be effective or stable (SD) after the first treatment, the second treatment of the same scheme will be given. Those who reach the disease control level will continue to be treated for 4 courses, with an interval of 28 days. The patients who failed to achieve the improvement of SD after two cycles of chemotherapy will be withdrawn from the study. Patients are allowed to receive any treatment, including symptomatic support treatment, after the end of treatment or withdrawal from the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients are 18-80 years old, female，regardless of race;
* Advanced / relapsed ovarian cancer confirmed by clinical or histopathological diagnosis;
* More than two kinds of tumors are allowed;
* Karnofsky score ≥ 60, ECoG physical status ≤ 2;
* Sensitive to chemotherapy or radiotherapy;
* There are measurable lesions;
* There are suitable hematopoietic stem cell donors

Exclusion Criteria:

* have no suitable donor or donor refused
* patient refused to accept donor cells
Validation of Belun Ring Gen3 Deep Learning Algorithms With Subxiphoid Body Sensor

Hypothesis: BR's Gen3 DL algorithms, combined with its subxiphoid body sensor, can accurately diagnose OSA, categorize its severity, identify REM OSA and supine OSA, and detect central sleep apnea (CSA).

Primary Objective:

To rigorously evaluate the overall performance of the BR with Gen3 DL Algorithms and Subxiphoid Body Sensor in assessing SDB in individuals referred to the sleep labs with clinical suspicion of sleep apnea and a STOP-Bang score \> 3, by comparing to the attended in-lab PSG, the gold standard.

Secondary Objectives:

To determine the accuracy of BR sleep stage parameters using the Gen3 DL algorithms by comparing to the in-lab PSG;

To assess the accuracy of the BR arrhythmia detection algorithm;

To assess the impact of CPAP on HRV (both time- and frequency-domain), delta HR, hypoxic burden, and PWADI during split night studies;

To assess if any of the baseline HRV parameters (both time- and frequency-domain), delta heart rate (referred to as Delta HR), hypoxic burden, and pulse wave amplitude drop index (PWADI) or the change of these parameters may predict CPAP compliance;

To evaluate the minimum duration of quality data necessary for BR to achieve OSA diagnosis;

To examine the performance of OSA screening tools using OSA predictive AI models formulated by National Taiwan University Hospital (NTUH) and Northeast Ohio Medical University (NEOMED).


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed informed consent form.
* Clinically assessed and suspicious for OSA with a STOP-Bang score ≥ 3.

Exclusion Criteria:

* Full night PAP titration study.
* On home O2, noninvasive ventilator, diaphragmatic pacing, or any form of a nerve stimulator.
* Having atrial fibrillation-flutter, pacemaker/defibrillator, left ventricular assist device (LVAD), or status post cardiac transplantation.
* Recent hospitalization or recent surgery in the past 30 days.
* Unstable cardiopulmonary status on the night of the study judged to be unsafe for sleep study by the sleep tech and/or the on-call sleep physician.

If a participant did not sleep for at least 4 hours of technically valid sleep based on the Belun Ring method for diagnostic assessments, or a minimum of 3 hours of technically valid sleep during the diagnostic phase of a split-night study, the patient will be excluded from statistical analysis.
Post-operative Analgesic Effect of Oral Nefopam

Primary knee arthroplasty by total prosthesis is a painful surgery, performed on patients with advanced gonarthrosis (stage III), thus already presenting hyperalgesia and hyperalgesia and allodynia. This terrain makes the risk of postoperative hyperalgesia but also of persistent postoperative risk of persistent post-surgical pain.

Nefopam is a non-opioid centrally acting analgesic drug used as a part of multimodal analgesia. The opioid-sparing effect of nefopam is still controversial across various surgical procedures. In France nefopam is only available as a parenteral formulation; however it is often administered orally. There is currently no study addressing the efficacy of oral nefopam for the postoperative pain management including pain prevention.

The investigators conduct a prospective, double-blinded randomized controlled study with the main objective to examine the effect of perioperative orally administered nefopam on postoperative pain after a total knee arthroplasty. Secondary objectives include the quantification of wound allodynia, analysis of adverse events, clinical outcomes, and a pharmacokinetic study of orally given nefopam (plasma and cerebrospinal fluid dosage).


Eligibility Criteria:
Inclusion Criteria:

* adult patients scheduled for a total knee arthroplasty under spinal anesthesia at the Hopital de la Croix Rousse, Hospice Civils de Lyon, France.
* ASA (American Society of Anesthesiology) class between 1 et 3.
* written informed consent

Exclusion Criteria:

* any contraindication for nefopam (known hypersensitivity, past medical history of seizures, urinary retention, benign prostate hyperplasia, angle glaucoma, ischemic cardiomyopathy waiting for revascularization, atrial fibrillation)
* medical conditions known to influence the pharmacokinetics of nefopam (chronic kidney failure with Glomerular Filtration Rate (GFR) \<30mL/min/1,73m2, liver failure, current treatment with rifampicin, carbamazepine, azoles fungicides, macrolides)
* current treatment with benzodiazepines, anxiolytics, antidepressants, histamine H1 antagonists, neuroleptics, baclofen, thalidomide, barbiturates
* medical history of gastric or esophageal surgery.
* phenylketonuria
* pregnancy or breastfeeding
* past use of oral nefopam