cyrilzakka/clinical-trials huggingface dataset:
Electroacupuncture as a Complement to Usual Care for Patients With Non-acute Pain After Back Surgery

The purpose of this study is to find out the effectiveness of integrative medicine model for pain relief and improvement of function and quality of life on the patients with pain after back surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients whose low back pain persisted or recurred after back surgery with or without leg pain.
* Patients whose pain has been persisted at least 3 weeks recently and who are necessary to care intermittent medical treatments (eg. medication, injection, physio therapy).
* Patients with pain, defined as an Visual Analogue Scale (VAS) value ≥ 50mm.
* Patients who are 19 - 70 years of age.
* Patients who agreed to voluntarily participate in this study and signed informed consent.

Exclusion Criteria:

* Patients who have been diagnosed with a serious disease that can cause low back pain (e.g., cancer, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equine compression, or other disqualifying conditions).
* Patients with progressive neurological deficit or severe neurological symptoms.
* Patients whose pain causes are not resulted from spine or resulted from soft tissue diseases(e.g., cancer, fibromyalgia, rheumatoid arthritis, gout).
* Patients with a chronic disease that could influences the effects of the treatment or the analysis of treatment results (e.g., cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, dementia, epilepsy, or other disqualifying conditions).
* Patients for whom acupuncture would be inappropriate or unsafe (e.g., hemorrhagic disease, clotting disorders, a history of receiving anticoagulant therapy, severe diabetes with a risk of infection, severe cardiovascular disease, or other disqualifying conditions)
* Patients who are currently pregnant or planning the pregnancy.
* Patients with psychiatric diseases.
* Patients who are participating in other clinical trial.
* Patients who are unable to sign informed consent.
* Patients who are judged to be inappropriate for the clinical study by the researchers, such as inability to read and write Korean.
Imaging Activated Macrophages in the Lungs

To test whether folate-based positron emission tomography (PET) imaging using 68Ga-EC2115 can differentiate chronic obstructive pulmonary disease (COPD) patients from control subjects and determine whether the PET signal correlates with measurements of inflammation and disease severity.

Investigators intend to enroll patients who are undergoing bronchoscopy for diagnosis of solitary pulmonary nodules from the Vanderbilt lung nodule evaluation clinic, including 30 patients with COPD and 15 patients without COPD. Folate imaging will be performed with 68Ga-EC2115 within one week prior to scheduled bronchoscopy or from 1 week to 6 months after scheduled bronchoscopy, which will be performed for clinical purposes. The unused portion of the bronchoalveolar lavage (not necessary for clinical purposes), will be interrogated to compare PET imaging with parameters of inflammation in bronchoalveolar lavage (BAL). In addition, PET imaging data will be compared with disease severity based on pulmonary function testing.

Eligibility Criteria:
Inclusion Criteria:

* ≥45 years of age
* Pulmonary function testing done within last 2 years

  * For COPD group, forced expiratory volume at one second/forced vital capacity (FEV1/FVC) ratio \< 0.7 and FEV1 \< 80% predicted.
  * For control group, FEV1/FVC ratio \> 0.7 and FEV1 \> 80% predicted.
* Scheduled to undergo bronchoscopy for diagnostic evaluation of solitary pulmonary nodule (\< 3 cm in diameter)

Exclusion Criteria:

* Inability to provide informed consent
* Pregnant or lactating women. (Serum pregnancy testing will be required for pre-menopausal women within 24 hours of PET scanning)
* Diagnosis of chronic lung disease other than COPD, i.e. - asthma, idiopathic pulmonary fibrosis
* History of diagnosis or treatment of lung cancer
Visual Perception Difficulties After Stroke

The goal of this observational study is to learn how well the Oxford Visual Perception Screening (OxVPS) tool can identify stroke survivors with visual perception difficulties.

The main aim is to determine the accuracy and utility of the OxVPS compared to the current gold standard assessment in stroke survivors. In other words, how well can the Oxford Visual Perception Screening tool (OxVPS) identify stroke patients with visual perception problems?

Participants will completed the OxVPS and the current gold standards visual perception screening tool.

This is a non-experimental cross-sectional study. It aims to compare the new screening test OxVPS to the gold standard tests for visual perception difficulties.

Patients will be recruited at stroke rehabilitation units at hospitals in the North East of England and in Oxfordshire.

Following consent:

* Participants will complete the paper version of the Oxford Visual Perception Screen OxVPS (\~15 min).
* Participants will complete screening for visual perception problems with a validated screening tool (\~30-120 min).
* Participants will complete screening for cognition alterations and sensory vision with validated screening tools. (\~30 min)
* Stroke details (time since stroke, severity) and demographic data (age, socio-economic status) will be collected to evaluated representativeness of the sample.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of stroke (ischemic stroke and/or intracerebral haemorrhage).
* Within 6 weeks of confirmed stroke.

Exclusion Criteria:

* Insufficient understanding of English
* Clinical concerns that patient is unable follow simple instructions.
* Clinical concerns that patient is unable to concentrate for 15 minutes.
* No capacity to provide informed consent.
A Long-Term Safety Extension Study of WA19926 in Participants With Rheumatoid Arthritis

This extension study of WA19926 will assess the long-term safety and the efficacy of RoActemra/Actemra (tocilizumab) treatment in participants with rheumatoid arthritis. Participants who have completed the core study WA19926 are eligible to participate. Participants will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. The anticipated time on study drug is 104 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>/=18 years of age who have completed the core study WA19926 and according to the investigator may benefit from RoActemra/Actemra treatment
* No current or recent adverse event or laboratory finding preventing the use of the study drug dose at baseline
* Receiving treatment on an outpatient basis

Exclusion Criteria:

* Females who are pregnant
* Participants who have prematurely withdrawn from the core study WA19926 for any reason
* Treatment with any investigational drug since the last administration of the study drug in the core study WA19926
* Treatment with an anti-tumor necrosis (TNF), anti-interleukin 1 agent or T-cell costimulation modulator since the last administration of the study drug in the core study WA19926
* Immunization with live/attenuated vaccine since the last administration of the study drug in the core study WA19926
* Diagnosis since the last WA19926 visit of rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
* Abnormal laboratory values
Evaluating the Efficacy of Current Treatments for Reducing Postoperative Ileus

Aim was to investigate efficacy of current treatments - water, chewing gum, and olive oil, in resolving postoperative ileus.


Eligibility Criteria:
Inclusion Criteria:

* Patients underwent abdominal surgery for non neoplastic diseases

Exclusion Criteria:

* Metastatic disease
* History of inflammatory bowel disease
* Postoperative fever
* Gastrointestinal fistula
* Mint or olive allergy; and/or
* Earlier abdominal radiation
Guaranteeing the Continuity of the Care Pathway for the Elderly Patient: Evaluation of a Territorial Approach of Clinical Pharmacy

In the context of the ageing of the French population, drug iatrogeny in the elderly is a major public health issue, responsible for approximately 7,500 deaths per year and 3.4% of hospitalizations among patients aged 65 and over.

The interest of the Medication Reconciliation (MR) in reducing medication errors and unintentional discrepancies in prescriptions at transition points in patients' medication care pathways no longer seems to be in doubt both in France and abroad.

On the other hand, the literature on the clinical impact of these drug errors (i. e. occurrence of an adverse drug event (ADE) or readmission rates) is currently limited in France and presents variable results abroad.

The medication reconciliation implementation mobilizes human resources (pharmacists, pharmacy technician, nurses...) and constitutes an investment for healthcare institutions. However, the resulting improvement in patients' health status (and the potential reduction in ADEs) could reduce their care consumption and thus reduce costs from a healthcare system perspective. We therefore propose to assess the cost-effectiveness of this care strategy.

Finally, we will study the impact of the MR deployment on existing professional organizations, both in hospital and between community healthcare professionals and hospital as well as its conditions of implementation.

Eligibility Criteria:
Inclusion criteria :

* Patient \> 65 years old
* Patient hospitalized inside one of the thirteen wards in the 6 hospitals participating in the study
* Informed consent given

Non inclusion and Exclusion Criteria :

* Patients in palliative care
* Persons deprived of their liberty
Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)

This trial will evaluate the efficacy, safety, and tolerability of NOV03 ophthalmic solution in comparison to a saline control for the treatment of the signs and symptoms of Dry Eye Disease (DED) associated with Meibomian Gland Dysfunction (MGD).


Eligibility Criteria:
Inclusion Criteria:

* Signed ICF (Informed Consent Form)
* Subject-reported history of Drye Eye Disease (DED) in both eyes
* Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

* Women who are pregnant, nursing or planning pregnancy
* Unwillingness to submit a blood pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
* Clinically significant slit-lamp findings or abnormal lid anatomy at screening and Visit 1
* Ocular/peri-ocular malignancy
* History of herpetic keratitis
* Active ocular allergies or ocular allergies that are expected to be active during the study
* Ongoing ocular or systemic infection
* Wear contact lenses within 1 month prior to screening or anticipated use of contact lenses during the study
* Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have planned ocular and/or lid surgeries over the study period
* Presence of uncontrolled systemic diseases
* Presence of known allergy and/or sensitivity to the study drug or saline components
* Use of any topical steroids treatments, topical cyclosporine, lifitegrast, serum tears or topical anti-glaucoma medication within 2 months prior to screening
AnticoaguLation ONE Year After Ablation of Atrial Fibrillation in Patients With Atrial Fibrillation (ALONE AF Study)

There has no evidence for the anticoagulation in patients who had undergone catheter ablation of atrial fibrillation, and has maintained sinus rhythm for more than 1 year. However, anticoagulation can increase the risk of bleeding, the study evaluating the role of oral anticoagulation is needed in this patients. This study will compare the efficacy and safety of non-vitamin K anticoagulants (apixaban) and no oral anticoagulation in patient with sinus rhythm one year after catheter ablation of AF.

This study is a prospective randomized study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is atrial fibrillation patients with moderate or high stroke risk (CHA2DS2-VASc\>=1 male, and \>=2 female) who had undergone catheter ablation of atrial fibrillation, and has maintained sinus rhythm for more than 1 year. Anticoagulation (Apixaban group) will take apixaban (5 mg bid or 2.5 mg bid according to dose guideline) for 2 years, and nonanticoagulation group will not take any oral anticoagulants for the same period. If the patients have the recurrence of AF, they will take anticoagulation according to standard treatment, and will be censored. We will analyze and compare the efficacy and safety of non-vitamin K anticoagulants (apixaban) and no oral anticoagulation in these patients.

Eligibility Criteria:
Inclusion Criteria:

1. no recurrence of atrial fibrillation one year after catheter ablation of atrial fibrillation
2. CHA2DS2-VASc score \>=1 (male) or \>=2 (female)
3. age: 19 to 80 years
4. non-valvular atrial fibrillation
5. those who consent the study.
6. those who can be followed after enrollment

Exclusion Criteria:

1. Severe liver or kidney dysfunction
2. Thyroid dysfunction
3. Pregnant or breastfeeding women
4. Malignant tumors that have not been completely cured
5. Severe structural heart disease
6. Predicted survival is less than 12 months
7. Patients who do not understand the content of the study or disagree with it
Detection of Propofol in Exhaled Breath

This study involves the use of an experimental device which will measure how much propofol is present in your exhaled breath during surgery compared to how much is in your blood. The study results will look at whether the device is as accurate as conventional methods for measuring propofol levels during surgery.


Eligibility Criteria:
Inclusion Criteria:

* Be between 18 and 65 years old
* Healthy Male or Female
* BMI between 18.5 and 30.0
* Have a planned surgery or other medical procedure requiring anesthesia
* Physical status ASA I, II, or III

Exclusion Criteria:

* Known allergy to any component of propofol formulation components
* History of lung disease or tobacco use in the past 5 years
* Any finding not detailed above encountered on medical history or during screening physical and clinical laboratory examinations that, in the investigators judgment, might place the subject at unacceptable risk for injury during study participation
Assessment of Left-sided Cardiac Sparing Through the Use of 3-dimensional Surface Matching-based Deep Inspiration Breath Hold and Active Breathing Control

The standard treatment for breast cancer is surgery followed by adjuvant breast radiation therapy in most cases. For left sided breast cancers, the heart dose delivered by the radiation treatment is often of particular concern. In order to spare the heart, different strategies are currently available, including active breathing control (ABC) and voluntary deep in inspiration breath hold (DIBH) (both strategies are currently being used at our centre). To perform accurate heart-sparing treatments, it is important to ensure that patients are positioned consistently. One available approach is through surface imaging which tracks the position of a portion of the skin surface, known as the AlignRT system (VisionRT Ltd, London, UK).


Eligibility Criteria:
Inclusion Criteria:

* Women with diagnosis of left-sided breast malignancy
* Women who require left chest wall or breast irradiation status post mastectomy or lumpectomy
* Treatment with modified wide tangents to include IMCs
* Treatment with four-field technique
* Age \>18 years
* Performance status ECOG \<3
* Patient must be able to maintain a 30 second breath hold
* Conventional chest wall or breast radiation delivery dose of 50Gy/25 or hypofractionated chest wall/breast radiation delivery dose of 42.56Gy/16 with or without a boost

Exclusion Criteria:

* Right sided breast cancer patients
* Treatment with partial breast irradiation
* Previous left breast/chest wall irradiation
* Locally advanced breast cancer
* Pregnant patients
* Unable to follow commands
Effects of Change in Blood Pressure on Retinal Capillary Rarefaction in Patients With Arterial Hypertension

To evaluate whether in patients with initially poorly-controlled arterial hypertension, structural and functional differences in the retina and choroid remain after achieving a well-controlled blood pressure.

Optical Coherence Tomography Angiography (OCT-A) is an ocular imaging technique which allows fast and non-invasive assessment of the retinal microvasculature. With the OCT-A, a reduction in capillary density in patients with arterial hypertension has been found. In animal experiments, this so called retinal capillary rarefaction could be reversed after administration of antihypertensive medication.

The main aim of the present study is to evaluate whether in patients with initially poorly-controlled hypertension, an increase in capillary density can be demonstrated, if patients achieve well-controlled blood pressure with antihypertensive medication. In addition changes in retinal oxygen metabolism and choroidal blood flow will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women aged ≥ 18 years
* Signed informed consent
* Apart from hypertensive retinopathy, normal ophthalmic findings
* Non-Smokers
* Patients with initially diagnosed or pre-existing mild to moderate primary arterial hypertension (systolic office blood pressure ≥ 140 mmHg and/or diastolic office blood pressure ≥ 90 mmHg)
* Planned initiation of antihypertensive medication or planned adaption of antihypertensive medication by the Department of Cardiology
* Subject agrees to perform regular blood pressure self-measurements and to document blood pressure values in a diary

Exclusion Criteria:

* Participation in a clinical trial in the three weeks preceding the study
* Blood donation in the three weeks preceding the study
* Symptoms of a clinically relevant illness in the three weeks preceding the study
* History of family history of epilepsy
* Secondary hypertension (e.g.: hyperaldosteronism, pheochromocytoma, renal artery stenosis, renal parenchymal diseases, Cushing-syndrome, Coarctatio aortae)
* History of hypertensive encephalopathy or intracerebral bleeding
* Diabetes mellitus Type 1 or Type 2
* Pregnant or breast-feeding women
* Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception
THE EFFECT OF HAND AND FOOT MASSAGE ON FATIGUE IN HEMODIALYSIS PATIENTS

Hemodialysis patients face many problems related to disease and treatment, fatigue is stated as the most common of these problems. Therefore, The aim of this study is to examine the effect of hand massage and foot massage on fatigue in hemodialysis patients.

In parallel with the recent technological advances in medicine, increasing the possibilities of diagnosis and treatment of diseases has increased the average life expectancy and the incidence of chronic diseases. Chronic renal failure (CRF), which is one of the increasing chronic diseases, has become an important public health problem due to its negative impact on quality of life both in the world and in our country, high morbidity, mortality and treatment costs. According to the Joint Report of the Turkish Ministry of Health and Turkish Nephrology Association; by the end of 2016, Renal Replacement Therapy (RRT) applied total 74,475 patients (including pediatric patients), RRT is applied and while the most common form of treatment has been found to be hemodialysis treatment with 76.12%. Unless a successful renal transplantation is performed, hemodialysis treatment required to be performed until the end of life and provides a longer life, but it also causes biological, psychological, social and economical problems arising from treatment. Fatigue, which often related to problems with its biological dimension, reduces the quality of life by adversely negatively affecting individual's daily life activities.

Eligibility Criteria:
Inclusion Criteria:

* - Taking HD therapy, in the dialysis unit of a public hospital in Turkey, between October 19, 2018 - February 11, 2019,
* Agree to participate in the study with a written permission,
* Over the age of 18,
* Open to communication with complete orientation,
* Speaks and understands Turkish
* Receiving HD treatment 3 times a week for 6 months and longer,
* No loss of sensation, mass, fracture or ingrown toenail (onyxis),
* In the lower extremities; without pathological and tumoral disease, phlesis, embolism and no bleeding disorder related to amputation, fracture, infection, wound, skin disease, muscle and bones,
* Patients with a Standardized Mini Mental Test (SMMT) score of 24 or more, in patients older than 65 years,

Exclusion Criteria:

-
Long-term Outcome After Edoxaban Versus Vitamin K Antagonists for Acute VTE

The HOKUSAI post VTE study contains of two different research questions; one on the long term outcomes of deep vein thrombosis and one on the long term effects of pulmonary embolism, post thrombotic syndrome (PTS) and chronic thromboembolic pulmonary hypertension (CTEPH) respectively. Our aim of the study is to compare the long term outcomes along with the quality of life assessment of VTE in a group treated with heparin+VKA versus a group treated with heparin+edoxaban in the acute setting.


Eligibility Criteria:
Inclusion Criteria:

* Participant in the HOKUSAI VTE trial

Exclusion Criteria:

* None
BIP CVC Clinical Safety and Performance Study

The primary objective of this trial was to determine Bactiguard coated BIP CVC's safety and performance and compare it to corresponding standard uncoated CVC.

The primary objective of this study is to determine the safety for the medical device of 'BIP central venous catheter". Safety is assessed by evaluation of adverse events (according to ISO 14155:2011). Examples of CVC related common events are phlebitis, infection at the infection site, catheter related bacteremia/fungemia, septicemia, sepsis, thrombosis, lung emboli and pneumothorax.

The secondary objective is to assess the overall performance by evaluating if there were any CVC handling problems experienced by the physician/health care personnel.

Furthermore, an exploratory objective of this study is to assess coating and microbial colonization.

Included in the study were men and women aged 18 years or older undergoing elective standardized large surgery with a planned CVC catheterization in right or left jugular vein or subclavian vein planned for at least 3 days.

This study is a single-centre, randomized, single-blind, controlled study of tolerability and safety of BIP CVC with noble metal alloy coating.

All statistical analyses is performed using the SAS® System, version 9.3 or higher (SAS Institute Inc., Cary, NC, USA). Data is to be summarized using descriptive statistics.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women ≥ 18 years of age
* Were, in the opinion of the investigator, able to communicate with and understand the trial personnel and comply with the requirements of the trial
* Requiring CVC catheterization for venous access, via right (most often) or left jugular vein or subclavian vein, during and after elective large surgery (liver or pancreas resection or intestinal/bowel surgery) planned for at least 3 days
* Had signed the informed consent

Exclusion Criteria:

* Known transmissive blood disease
* Known multiresistant bacterial colonization
* Ongoing infection
* Thromboembolism
* Anti-coagulation treatment excluding prophylaxis
* CVC during last 2 months
* History of problems with CVC
* Pregnancy