cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Sinus-Venous Stent for the Treatment of Iliofemoral Venous Occlusive Disease

Post market clinical follow-up study about the Sinus-venous stent. Patients with venous iliofemoral occlusive disease are treated with the Sinus-venous stent. This observational study will provide 1 year data about safety and efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. Age at study entry is at least 18 years.
2. Patient must sign the informed consent form prior to the index-procedure.
3. Patient suffers from acute or chronic venous occlusive disease indicated to be treated with a venous stent.
4. Target lesion is located in the femoral vein, common femoral vein, external iliac vein, or common iliac vein.

Exclusion Criteria:

1. Intolerance to anticoagulant medication.
2. Contra-indication for prolonged anticoagulant treatment.
3. Life expectancy less than 1 year.
4. Target vessel has been stented before.
5. Coagulopathy or known uncorrectable bleeding diathesis.
6. Recent (\<1 year) pulmonary embolism.
7. Pregnancy.
8. Known hypersensitivity to nitinol and/or nickel.
9. Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history).
10. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study.
11. Patients in custody by juridical order.
12. Patients who do not agree to the transmission of their coded data within the liability of documentation and notification.
13. Close affiliation with the investigational site: e.g. a close relative of the investigator or a possibly dependent person (e.g. employee or student of the investigational site).
Patterns of Breast Cancer Management and Prognosis of Breast Cancer in China

This is a multicenter, prospective, e, real-world cohort survey initiated by researchers to focus on the patterns of breast cancer management and prognosis of breast cancer in China, and to establish the multicenter, prospective breast cancer data platform. A total of 18 sites in Guangdong and Henan have cooperated to build a cooperative network unit. The sites will conduct prospective and standardized records concerning the clinical pathological features, treatment and prognosis of the early breast cancer patients who are treated in their own site each year, registering in the REDCap system.This real-world cohort study aims to provide a representative and reliable survey data of epidemiological characteristics, clinical treatment and prognosis of patients with early breast cancer in China and explore the establishment of a national multi-center breast cancer data platform model.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are hospitalized and treated in a collaborative network unit
* Agree to enroll in the study and sign the informed consent form
* Histological diagnosis of ductal carcinoma in situ or invasive breast cancer
* Accept the Surgery-based surgical treatment
* Willing to cooperate with follow-up work

Exclusion Criteria:

* Previously Excisional biopsy (including minimally invasive resection) of the patient's breast
* Previously received neoadjuvant chemotherapy
* Imaging or histological evidence of distant metastasis
Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI) and Fluorothymidine Positron Emission Tomography (FLT PET) in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy

The objective of this pilot study is to determine the effectiveness of Fluorothymidine Positron Emission Tomography (FLT PET) and Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI) in assessing tumour response to neoadjuvant chemotherapy (NA CT) in women with locally advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologic proof of breast cancer (invasive ductal or lobular carcinoma). Breast sarcoma and lymphoma are not eligible.
* Clinical diagnosis of locally advanced breast cancer (Stage IIB (T3,N0,M0), Stage IIIA, IIIB, or IIIC, according to American Joint Committee on Cancer (AJCC) Tumour-Node-Metastasis (TNM) Cancer Staging), including inflammatory breast cancer.
* Ability to undergo neoadjuvant chemotherapy.

Exclusion Criteria:

* Evidence of metastatic disease (identified on chest x-ray, liver ultrasound, bone scan or other imaging tests);
* Previous chemotherapy or hormonal therapy for breast cancer;
* Significant concurrent medical problems that result in the patient being unfit for surgery (e.g. uncontrolled diabetes, active cardiac disease, severe chronic obstructive pulmonary disease);
* Known pregnancy or lactating female (e.g. positive serum beta human chorionic gonadotropin (B-hCG) pregnancy test);
* Inability to lie supine for imaging with Positron Emission Tomography (PET);
* Any contraindication to undergoing Magnetic Resonance Imaging (MRI) or PET;
* Currently receiving Antabuse;
* Inability to provide informed consent (e.g. dementia or severe cognitive impairment).
Tempus Pro Monitor Registry

A multicenter, prospective and retrospective, observational, post market study.

This observational study is to collect real-world data on the safety and performance of the Tempus Pro device, its accessories and the IntelliSpace Corsium telemedicine software device when used according to its intended purpose and the instructions for use, when used for patient monitoring.

Eligibility Criteria:
Inclusion Criteria:

Patients monitored by using Tempus Pro during pre-hospital care (ambulance transportation)

One or more 12-lead ECG recorded

Use of 3 or more of the following sensors to measure vital signs

* NIBP (Non-Invasive Blood Pressure)
* HR (Heart Rate)
* SpO2 (Oxygen Saturation)
* PVI (Pleth Variability Index)
* SpCO (Carboxyhemoglobin)
* SpOC (Oxygen Content)
* SpHb (Total Hemoglobin)
* SpMet (Methemoglobin Saturation)
* EtCO2 (End-tidal Carbon Dioxide)

Exclusion Criteria:

* None defined
Comparison of Multiple Exercise Trainings in Chronic Respiratory Disease

The present study aims to investigate the effect of different exercise training in patients with chronic respiratory disease.

Background： Chronic respiratory and chronic obstructive pulmonary disease is the one of the major causes of global morbidity and mortality. Patients with chronic respiratory disease often experience exercise limitation and physical inactivity due to muscular weakness and severe dyspnea. Symptoms of COPD may contribute to activity restriction, deconditioning, and exercise intolerance. Pulmonary rehabilitation has been demonstrated to improve clinical outcomes and exercise capacity in patients with chronic respiratory disease. However, the optimal exercise training modality is remaining unclear.

Study Design： This is a one-year, single-centre, prospective randomized controlled trial

Methods： The investigators expected a total of 60 participants were be enrolled, then randomly assigned into three groups (control group, experimental-1, and experimental-2). All participants will receive a graded exercise test, then followed a 9-weeks of exercise training. After 9-weeks of exercise training, the maximal oxygen consumption will be analyzed as a primary outcome of this study. Physiological parameters, hemodynamic outcome, respiratory function, and strength of lower limb muscle will be recorded.

Effect： After 9 weeks' exercise training, VO2 will significantly improve in eccentric cycling exercise groups, furthermore, heart rate and perceived exertion will be lower in the eccentric cycling exercise combined with helmet ventilation.

Key words： Pulmonary rehabilitation; eccentric cycling exercise; helmet ventilation; chronic respiratory disease

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 80 years
* Diagnosed with chronic respiratory diseases
* Having undergone pulmonary rehabilitation for more than 3 months

Exclusion Criteria:

* Existing of tracheostomy
* Those who use oxygen therapy or ventilator at home
* Severe left heart failure (NYHA III-IV)
* Neuromuscular disease
* Acute exacerbation within the past three months
* Those who are unable to cooperate with the cardiopulmonary exercise test
A Comparative Study of EMG Biofeedback and Pharmacotherapy for the Treatment of Masticatory Muscle Hyperactivity in Bruxism Patients

This study examines the effect of electromyography biofeedback on masticatory muscles hyperactivity on patients with bruxism.

Bruxism is a movement disorder characterized by excessive activity of the masticatory muscles, resulting in teeth clenching and grinding. It affects 50% to 95% of the adult population. Unlike normal, voluntary chewing movements associated with eating, bruxism involves involuntary jaw muscle contractions that cause tension, leading to muscle soreness and pain. Common symptoms include localized muscle tenderness, orofacial pain, anxiety, stress, fatigue, headaches (especially in the temporal region), restricted mouth opening, and temporomandibular joint stiffness. These symptoms can disrupt sleep, causing transitions from deep to light sleep, increased micro-arousals, and sleep fragmentation, leading to daytime fatigue that impacts social life and work performance.

Bruxism can also lead to masticatory muscle hypertrophy (especially the masseter), tongue burning, linea alba on the cheeks, excessive tooth wear, damage to dental prosthetics, changes in saliva secretion, severe craniofacial pain, and TMJ stiffness. Common treatments for bruxism-related pain often involve medications like Botox, clonazepam, or diazepam, but these are typically temporary and do not address the underlying causes. Moreover, long-term use of these medications may cause complications, and their high cost can limit accessibility.

Non-pharmacological treatments for bruxism include biofeedback, muscle relaxation exercises, occlusal splint therapy, and psychotherapy. Biofeedback, which provides real-time information on bodily functions, helps individuals recognize and modify harmful behaviors. Electromyography (EMG) biofeedback, recognized as effective for temporomandibular disorders (including bruxism), is endorsed by the American Association of Psychophysiology and Biofeedback (AAPB) as an evidence-based intervention.

This study aims to compare the effects of EMG biofeedback training versus oral medications in reducing masticatory muscle hyperactivity in bruxism patients, focusing on addressing the underlying pathophysiology, a topic that, to the authors' knowledge, has not been explored in previous research.

Eligibility Criteria:
Inclusion Criteria:

* Twenty adult subjects with definite mild to moderate bruxism examined by a dentist prior to the study.
* Tenderness of masticatory muscles on palpation grade one and two according to the digital palpating scale
* Mild to moderate myofascial pain around the temporomandibular joint causing discomfort in the morning.

Exclusion Criteria:

* Took any Botox or PRP injection treatment for this condition for the last six months
* Had any advanced periodontal disease.
* Any intraoral fixed splints.
* Pregnancy.
* Under psychiatric care.
* Parkinson
* Have any visual or auditory impairment.
* Any cervical posture abnormalities.
Bioactive Surfaces vs. Conventional Surfaces in Implants Placed in Atrophic Maxilla With Simultaneous Sinus Lift

In this controlled clinical study, a maxillary sinus lift (crestal approach) with OSSIX® Bone will be performed, and then implants MultiNeO CS (control group) and NINA MultiNeO NH (test group) will be inserted in edentulous posterior maxillae of study subjects. .+the clinical and radiographic results of the rehabilitation of posterior edentulous maxillary areas, obtained with traditional surface implants (MultiNeO CS, control group), are compared with those obtained with bioactive surface implants (NINA - MultiNeO NH, test group ).

In this post- market controlled clinical study, the tested CE-marked dental implants are MultiNeO CS 1930 and NINA MultiNeO NH 9330, both manufactured by Alpha-Bio Tec. NeO or MultiNeO is defined as a system since it includes three types of connections: a conical narrow connection (CHC), a conical standard conical connection (CS) and an Internal Hex connection (IH). The fixture has a straight coronal part, a slightly tapered body, and a conical apical part. We will use MultiNeO CS to treat control group. One of the MultiNeO CS biggest clinical advantages since it is as good at bone type 4 as it is at bone type 1, 2 or 3.

MultiNeO CS has an implant surface with a sub-micron scale roughness created by Aluminum oxide blasting and double acid etching.

NINA MultiNeO NH is used for tret group, it has got an innovative bioactive surface.

NINA MultiNeO NH surface is a combination of the abovementioned roughening process and the creation of titanium oxide nano structure. Its hydrophilic part is created by resorbable salt thus maintaining its hydrophilicity Patient requiring sinus floor elevation with native bone crest height \> 4 mm will be enrolled.Although a variety of implant surface are available for implant supported rehabilitation, the first hypothesis is that NINA MultiNeO NH Alpha-Bio Tec will be present faster osteointegration time compared to MultiNeO CS when adopted to rehabilitate of missing teeth in case of critical areas such as in the posterior mandible with critical bone defects. The second hypothesis is that NINA MultiNeO NH will promote a better apical bone regeneration in patients treated with sinus lift compared to MultiNeO CS due to its bioactive surface.

Eligibility Criteria:
Inclusion Criteria:

* edentulous posterior maxillae
* residual bone height \> 4mm
* healthy periodontal conditions

Exclusion Criteria:

* smokers over 5 cigarettes/day
* Pregnancy (confirmed by verbal inquiry)
* Chronic systemic pathologies and neoplastic of the Oro-Facial District
* bisphosphonates intake
* Any sites where an implant already failed sites
* Untreated Periodontitis
* Sites with acute infections
* Chronic inflammatory diseases of the oral cavity
* Autoimmune diseases (cortisone intake)
* Allergy declared to one or more medicaments to be used during treatment
* Alcoholics patients and/or drug addicts
* collagen hypersensitivity.
New MRI Techniques for Diagnosis and Treatment of Patients With Abdominal Aortic Aneurysms

An abdominal aortic aneurysm (AAA) is a pathological dilatation of the aorta in the belly which can rupture leading to bleeding within the belly. To prevent rupture elective surgery can be performed. Endovascular repair (EVAR) is a surgical intervention whereby a stent is inserted into the AAA to prevent it from further growth and rupture.

Standard AAA management has several drawbacks. To start: maximum AAA diameter is used to determine upon timing of elective repair but is imprecise in predicting the risk of rupture resulting in an unmet clinical need. Secondly, EVAR outcome and complication occurrence remain unpredictable due to poor prediction ability of computed tomography (CT) and ultrasound (US) utilised in the follow-up protocol. Lastly, patients and physicians are being repeatedly exposed to cumulative radiation toxicity. All these drawbacks could be solved by trading the standard imaging modalities by magnetic resonance imaging (MRI). Within the MARVY, advanced MRI techniques are used to find out if standard imaging techniques could be replaced by MRI in three phases of the AAA management (surveillance, surgery planning and post-operative follow-up). The two most important MRI techniques that will be used are 4D flow MRI and dynamic contrast enhanced (DCE) MRI which give respectively information about the blood flow within the AAA and perfusion of the aortic wall.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with AAA
* provision of written informed consent

Inclusion Criteria for surveillance part:

* maximum AAA diameter between 3-5 cm
* not scheduled for aneurysm repair at the time of inclusion

Inclusion Criteria for planning part:

* planned for elective EVAR

Inclusion Criteria for follow-up part:

* ten complication free years after EVAR or sac regression after EVAR; or
* type I endoleak after EVAR; or
* type II endoleak after EVAR;

Exclusion Criteria:

* Supra- or pararenal AAA
* Inflammatory, infectious or mycotic AAA
* Vasculitis and connective tissue disease
* Patients that underwent open surgical repair for their AAA
* Patients with ruptured AAAs
* Patients that previously presented with allergic reactions to intravenous contrast agents

Exclusion Criteria for surveillance part:

* previous AAA repair
* severely reduced renal function
* previous allergic reactions to intravenous contrast agents

Exclusion Criteria for planning part:

* previous AAA repair

Exclusion Criteria for follow-up part:

* severely reduced renal function
* previous allergic reactions to intravenous contrast agents
The First ERAS Protocol for Cesarean Delivery in Serbia at the University Hospital

This study is designed to help us with ERAS (Enhanced Recovery After Surgery) Protocol for Cesarean Delivery implementation with goal to improve patient satisfaction and decrease length of stay at hospital. This will improve patient treatment and decrease total hospital costs.

ERAS assumes cooperation between obstetricians, anesthesiologists and parturient. This is the new concept because patient have an active role in the whole process. Pregnant patient receives the first information about ERAS from obstetrician and anesthesiologist before the scheduled cesarean delivery. Patient condition optimization is necessary. Antibiotic prophylaxis, no bowel preparation and arriving to the hospital on the day of surgery are basic principles. All patients are done under spinal anesthesia. DVT (Deep Venous Thrombosis) prophylaxis starts postoperatively. Early mobilization, early oral intake and urinary catheter removal on the day of surgery with multimodal analgesia is mandatory.

Eligibility Criteria:
Inclusion Criteria:

* All healthy patients from 18-45 years for scheduled Cesarean Delivery

Exclusion Criteria:

* Age younger then 18 years old and older then 45 years
* Urgent and emergent Cesarean Delivery
* Preeclampsia
* Contraindications for spinal anesthesia
* Abnormal placentation
Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome

This is a compassionate use study. In addition to providing compassionate use access to mifepristone, objectives of the study will be to evaluate the safety and utility of mifepristone in the treatment of the signs and symptoms of endogenous Cushing's syndrome when given on a compassionate use basis. The study will only enroll subjects whose physicians have determined that medical treatment is needed to control the symptoms or signs of hypercortisolemia.


Eligibility Criteria:
Inclusion Criteria:

1. Have a confirmed diagnosis of endogenous hypercortisolemia caused by ACTH dependent or ACTH independent etiologies including:

   * Cushing's Disease that (more than one may apply)

     * has recurred after primary pituitary surgery
     * has persisted despite pituitary surgery (failed pituitary surgery)
     * has been treated with radiation therapy to the pituitary
     * is not treatable with surgery
     * exists in subjects who are not candidates for or who refuse surgery
   * Ectopic ACTH
   * Ectopic CRF secretion
   * Adrenal adenoma
   * Adrenal carcinoma
   * Adrenal autonomy
2. Have documented biochemical evidence of endogenous hypercortisolemia which includes elevated urinary free cortisol.
3. Require medical treatment of hypercortisolemia.

Exclusion Criteria:

Individuals not eligible to be enrolled into the study are those who:

* Have de novo Cushing's disease and are surgical candidates for pituitary surgery.
* Have an acute or unstable medical problem, which could be aggravated by mifepristone treatment.
* Taking medications within 14 days of the baseline visit (Day 1) that a) have a large first pass metabolism largely mediated by CYP3A4 and a narrow therapeutic margin and/or b) are strong CYP3A4 inhibitors.
* Female patients of reproductive potential, who are pregnant or who are unable or unwilling to use medically acceptable, non-hormonal methods of contraception during the study.
* Have received investigational treatment (drug, biological agent or device) within 30 days of Screening
* Have a history of an allergic reaction or intolerance to CORLUX (mifepristone)
* Have a non-endogenous source of hypercortisolemia such as factious hypercortisolemia (exogenous source of glucocorticoid, iatrogenic Cushing's syndrome), factious or therapeutic use of ACTH
* Have Pseudo-Cushing's syndrome.
* Postmenopausal women with an intact uterus who have experienced unexplained vaginal bleeding within 12 months of Screening are excluded.
The Use of Heliox in Obstructive Sleep Apnea Syndrome

The goals of the project is to evaluate the effects of Heliox therapy on obstructive sleep apnea syndrome (OSAS).

Obstructive sleep apnea syndrome (OSAS) is a common condition affecting up to 2-4 % of the general population. The pathophysiologic consequences of OSA include: excessive daytime sleepiness leading to increased car and work related accidents; and increased incidence of hypertension (HTN), stroke and possibly coronary artery events. In addition, patients with severe and untreated obstructive sleep apnea (OSA) have increased mortality compared to patients with treated severe OSA.The main stay of treatment of OSAS is the application of continuous positive airway pressure (CPAP) during sleep. The main problem with CPAP therapy is compliance. Heliox, a mixture of oxygen and helium has been used for many years in the treatment of upper airway obstruction. In this study, the investigators will evaluate the effectiveness of Heliox in the treatment of OSAS. Adult subjects with the diagnosis of obstructive sleep apnea syndrome who are referred for repeat sleep study for CPAP titration will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 or older with obstructive sleep apnea syndrome (OSAS) presenting for CPAP titration.

Exclusion Criteria:

* Professional singers.
* Television or Radio hosts.
* Disk Jockeys.
* Subjects requiring oxygen therapy.
* Subjects younger than 18 year old.
* Pregnant women.
* Patients with chronic obstructive pulmonary disease (COPD) with forced expiratory volume 1 (FEV1) less than 50%.
* History of anatomic upper airway obstruction.
* Uncontrolled asthma.
Effect of Probiotics in Reducing Infections and Allergies in Young Children Starting Daycare

The aim of the intervention is to examine the effect of a combination of the two bacterial strains BB-12 and LGG, provided for 6 month, on the prevalence of infections and allergic manifestations in small children, and how a combination of BB-12 and LGG affects the immune system, gastrointestinal tract and the microbiota. Children are enrolled during 2 winter seasons.


Eligibility Criteria:
Inclusion Criteria:

* Expected to start daycare between the age of 8-14 month
* Intervention start 0 days to 12 weeks before starting daycare
* Expected to start daycare from september to february (both month included)
* Single born

Exclusion Criteria:

* Exclusion Criteria:
* Children born before 37th gestational week
* Children with a birth weight \< 2500 g
* Children suffering from severe chronic illness
* Children receiving regular medication
* Children who have received antibiotics within a month before intervention start
* Children whose parents do not speak Danish