cyrilzakka/clinical-trials huggingface dataset:
A Non-interventional Study to Investigate the Current Situation of Asthma-COPD Overlap Syndrome in Patients Over Age 40 With Persistent Airflow Limitation in China

To investigate the distributions of the patients with ACOS, asthma and COPD over age 40 with chronic airflow limitation in China.

Sites must be tier 3 hospitals in China. Investigators will mainly be determined according to the following criteria:

* Respiratory physicians working in the respiratory department of tier 3 hospitals
* To include the expected number of patients in a maximum of 12 months, physicians should manage a reasonable number of asthma, COPD or ACOS over age 40 with persistent airflow limitation (post-BD FEV1/FVC\<0.7).
* Physicians should have patients' spirometric data available in the patient's medical files (post-BD FEV1%pred and post-BD FEV1/FVC).

This NIS will collect the data (e.g. medical record, patient or physician-reported data) from about 2000 consecutive outpatients with persistent airflow limitation(post-BD FEV1/FVC\<0.7) in about 20 sites in China for one year. Each site will recruit about 50-150 patients successively.

The data will be collected under routine clinical practice. The treatments or examinations will be determined by their treating physicians. The data are expected to reflect the actual situation about ACOS.

The study population will be about 2000 outpatients, men or women, over age 40, with a clinical diagnosis of asthma, COPD or ACOS with persistent airflow limitation（post-BD FEV1/FVC\<0.7）in China from Q4,2015 to Q3,2016.

Eligibility Criteria:
Inclusion Criteria:

Outpatients, age ≥ 40 years Clinically diagnosed as asthma, COPD/chronic bronchitis/emphysema or ACOS at least 12 months With persistent airflow limitation (post-BD FEV1/FVC\<0.7) Signed informed consent forms

Exclusion Criteria:

Have been involved in other clinical trial within 3 months Having other respiratory diseases which can influence airflow, such as lung cancer, tuberculosis, pneumonia, bronchiectasis, etc With acute exacerbation Inability to understand the study procedures or inability/reluctance to answer questionnaire judged by the investigator
Mindfulness-Based Stress Reduction in Helping Participants With Metastatic Breast Cancer

This randomized trial studies how well a mindfulness-based stress reduction program helps participants with breast cancer that has spread to other places in the body. A cancer diagnosis is a life-changing and highly stressful event for most people, often resulting in marked declines in quality of life both during and after treatment. There are approximately 3 million women living with a history of invasive breast cancer in the U.S., with at least 150,000 living with metastatic disease. Patient preferences suggest a high need for complementary and alternative medicine interventions to address these chronic symptoms. Mindfulness-based stress reduction programs may help women living with metastatic breast cancer manage symptoms related to cancer treatment and improve quality of life.

PRIMARY OBJECTIVES:

I. To develop a novel online mindfulness-based stress reduction (MBSR) treatment for distressed metastatic breast cancer patients in the hope of reaching patients otherwise unable to participate in traditional interventions due to high symptom burden.

II. Determine the impact of the intervention on both patient self-report and biological symptom measures.

OUTLINE: Participants are randomized to 1 of 2 arms.

INTERVENTION ARM: Participants receive online group sessions over 60 minutes for 6 weeks, including 15 minutes of practice on that session's topic and daily meditation or yoga for 45 minutes. At the conclusion of the study period participants participate in mindfulness meditation over 3 hours. Participants also receive a content manual and relaxation compact disc (CD).

CONTROL ARM: Participants randomized to the wait-list control condition complete the online intervention as in the intervention arm after the initial 6-week period has ended.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of metastatic breast cancer within the past 5 years and treated at Roswell Park Cancer Institute (RPCI)
* Ability to read and understand English
* Current distress score of 4+ on the National Comprehensive Cancer Network (NCCN) distress thermometer
* Access to an Internet connection with own device (computer, tablet, smartphone, etc.)
* Patient not currently involved in an ongoing psychological intervention
* If taking prescribed medication for mood or anxiety disorder, dosage has been consistent for prior 3 months

Exclusion Criteria:

* Unable to speak and understand English
* Prior or current experience with mindfulness-based practice
* Diagnosis of a psychotic disorder, bipolar disorder, substance abuse disorder, or reported suicidality
* Current involvement in any other psychological treatment (excluding medication) during study duration
* Currently being treated for another cancer diagnosis other than metastatic breast cancer
Evaluation of Heparin Bonded Vascular Graft Versus Standard Graft in Prosthetic Arteriovenous Access for Hemodialysis

The majority of bridge graft fistula with polytetrafluoroethylene (PTFE) for hemodialysis access will develop stenosis at the venous anastomosis and eventually will fail. Aspirin have been used for many years as a prophylactic drug therapy to prevent thrombosis but good clinical evidence for its benefit is lacking. Many drugs have been used to reduce intimal hyperplasia in animal models. Until recently there has been little success in clinical trials of anti-inflammatory, antiproliferative, antiplatelet, antithrombotic or calcium channel blocking drugs. Recently a major breakthrough was done by GORE when introducing the new heparin bonded PTFE graft by covalent attachment. This trial is planed to assess and compare between the GORE-TEX® PROPATEN vascular graft versus unmodified ePTFE grafts the patency and complication.


Eligibility Criteria:
Inclusion Criteria:

* All the patients who are scheduled for the creation of a new prosthetic access with informed consent will be enrolled in the trial
* Investigators will attempt to enroll a male:female ratio of patients representative of their current patient population

Exclusion Criteria:

* Anticoagulation therapy
Study Evaluating Tigecycline Versus Ceftriaxone In Complicated Intra-Abdominal Infections & Community Acquired Pneumonia

The main purpose of this study is to compare the safety of tigecycline versus a ceftriaxone regimen in pediatric subjects (aged 8 to 17 years) with complicated intra-abdominal infections (cIAI) and community acquired pneumonia (CAP).


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 8 to 17 years old. Children with bone maturation less than 8 years old should be enrolled with caution due to potential risk of tooth discoloration.
* Have a diagnosis of a serious infection (complicated intra-abdominal infections \[cIAI\] or community acquired pneumonia \[CAP\] as applicable) requiring hospitalization and administration of IV antibiotic therapy.
* Criteria related indication (cIAI or CAP - as applicable), e.g., sign of systemic infection, signs and symptom.

Exclusion Criteria:

* Subject with any concomitant illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and/or completion of the study, or could preclude the evaluation of the subject's response (e.g., life expectancy \<30 days).
External Oblique Intercostal Plane Block vs. Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy

The laparoscopic approach has become the gold standard for many abdominal surgical procedures, including cholecystectomy. Compared to laparotomy, laparoscopy allows smaller incisions, reduces perioperative stress response, reduces postoperative pain, and results in shorter recovery time.

However, anaesthesia concerns in patients undergoing laparoscopic surgery are different from patients undergoing open abdominal surgery.

The aim of this study is to investigate the effect of the external oblique intercostal block, which is a new block, on postoperative pain score and opioid consumption.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients
* Laparoscopic cholecystectomy

Exclusion Criteria:

* Chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases
Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge

To determine the effect of a policy of early maternal-newborn infant discharge (12-24 hours) with a home visit on admission to the Level II/III nursery and hospital admissions and readmissions.

This is a randomized controlled trial designed to assess the safety of a policy of early maternal newborn infant discharge compared to a policy of routine discharge 2 to 3 days after delivery. The primary outcome is newborn admissions to the Level II or Level III neonatal care unit or hospital within three days of delivery. Secondary outcomes included admissions and readmissions at 2 weeks, 6 weeks and 6 months following delivery, maternal satisfaction with length of stay and overall birthing experience, lactation continuation rates, maternal anxiety, depression, confidence and family functioning. We applied the American Academy of Pediatrics criteria for early newborn discharge, but planned the analysis by intention to treat.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women enrolling for obstetric care at a large military academic health center

Exclusion Criteria:

* Planning a move from the area before delivery
* Multiple gestations
* Pre-existing maternal diabetes
* Maternal chronic hypertension
* Maternal age \< 18
Testing Hypersensitivity to Metals in Sarcoidosis Patients by Applying the MELISA Test.

The purpose of this study is to apply the MELISA test, that diagnose hypersensitivity to metals, in Sarcoidosis patients with occupational exposure.

Peripheral blood from sarcoidosis patients with occupational anamnesis that involves exposure to metals will be sent to MELISA Medica in Stockholm Sweden. The MELISA test will examine hypersensitivity to metals that can be related to the granulomatous response of sarcoidosis.

Eligibility Criteria:
Inclusion Criteria:

Biopsy confirmed sarcoidosis Granulomatous disease Occupational anamnesis with exposure to metals

Exclusion Criteria:

Patients with interstitial disease No occupational anamnesis
Examining the Immunological Process of Autoimmune Patients

Sjögren's syndrome (SjS) is an autoimmune disease characterized primarily by exocrine gland dysfunction, specifically of the salivary and lacrimal glands, resulting in dry mouth and dry eyes symptoms. It can be systemic by affecting other organs including the gastrointestinal tract, skin, lungs, vasculature, kidneys, bladder and vagina. Involvement of the musculature can lead to fibromyalgia-like symptoms and chronic fatigue, while approximately 20% of patients develop various neuropathies, including sensory, peripheral, cranial and myelopathic neuropathies exhibited by cognitive impairments such as dementia, lack of concentration, memory loss and various psychiatric disorders. Like most autoimmune connective tissue diseases, SjS shows a sexual dimorphism with women affected 10-times more frequently than men, suggesting a role for sex hormones in disease susceptibility or progression. One common feature of SjS is it infiltration of mononuclear cells into the salivary and lacrimal glands, aggregating into clusters referred to as lymphocytic foci (LF). Critical to the studies proposed is the fact that a predominant cell population of LF is the pathogenic TH17 cell that produces IL-17 cytokine and autoreactive B cells reactive to M3R, Ro, and La autoantigens. The goal of this study is characterize the change in receptor gene repertoires of autoreactive B and T cells at different time points during the disease process and examine the correlation with various disease parameters.

Blood from patient and healthy controls will be collected once every 3-6 months. White blood cells from blood samples will be separated. Tests will be done to see which substances these cells make. Using sequencing techniques, the investigators will determine the genetic code of the receptors expressed on these cells. The investigators plan to test how these cells change over the period of at least 3 years at different visits. In addition, the investigators will check how these changes relate to patients' general medical history relevant to autoimmune disease, lab results and physical examinations and exams pertinent to the diagnosis of autoimmune disease, and psychosocial data.

Eligibility Criteria:
Inclusion Criteria for Sjogren's syndrome patients:

* Primary Sjogren's syndrome patients: primary Sjogren's syndrome patients who meet the revised criteria for SjS diagnosis by the American-European Consensus Group.
* Secondary Sjogren's syndrome patients: secondary Sjogren's syndrome patients who meet the criteria for primary Sjogren's syndrome in association with other autoimmune diseases such as systemic lupus erythematosus , dermatomyositis, scleroderma, idiopathic arthritis, mixed connective tissue disease, etc.

Inclusion Criteria for healthy controls:

-Subjects who does not have history of autoimmune diseases.

Exclusion Criteria:

* Pregnant women.
* Patients with history of lymphoma or malignancy.
Patient Convenience Study- NIS RELATE

The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa® to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its approved indication in the approved dosages of 110 mg or 150 mg twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).


Eligibility Criteria:
Inclusion criteria:

Cohort A:

1. A. Written informed consent prior to participation
2. A. Female and male patients \>= 18 years of age with a diagnosis of non-valvular atrial fibrillation.
3. A. At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
4. A. Patients switched to Pradaxa® according Summary of Product Characteristics and physician's discretion.

OR

Cohort B:

1. B. Written informed consent prior to participation.
2. B. Female and male patients \>= 18 years of age newly diagnosed with non-valvular atrial fibrillation and no previous treatment for stroke prevention (no use of any oral anticoagulant (OAC) within one year prior to enrolment).
3. B. Stroke prevention treatment initiated with Pradaxa® or VKA according to Summary of Product Characteristics and physician's discretion.

Exclusion criteria:

1. Contraindication to the use of Pradaxa® or VKA as described in the Summary of Product Characteristics (SmPC).
2. Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in atrial fibrillation.
3. Current participation in any clinical trial of a drug or device.
4. Current participation in an European registry on the use of oral anticoagulation in AF.
Cost-effectiveness Evaluation of the Use of a Patient Specific Instrument for Surgical Resection of Malignant Bone Tumor Within the Pelvis Versus the Conventional Surgical Treatment

Primitive malignant bone tumor or mixt tumor (compounded of soft tissues and bone) is a rare pathology particularly within the pelvis, the sacrum or the hip (between 25 and 80 new cases in France per year).

The reference treatment is a surgical "en bloc" resection associated or not to a medical treatment. This surgery remains highly challenging because of the complex three-dimensional geometry of the pelvic bone and the proximity of important organs and neurovascular structures. The local recurrence rate is significantly increased when the resection does not respect a safe tissues margin (R0 margin).

A new technology has been developed and used in different reference sites the Patient Specific Instrument (PSI), manufactured by 3D-Side. The PSI allows for a more secure and reliable surgical gesture, leading to more frequent R0 margins.

The main objective of this study is to compare the efficiency of the PSI for bone tumor resections within the pelvis with respect to the reference method.


Eligibility Criteria:
Screening Critieria:

Retrospective group (reference)

* Patient already operated for the same indication as detailed in the prospective group inclusion criteria
* Surgery date within the 6 years before the study activation in the participating center
* Adult (18 years old or more) at the time of surgery

Inclusion Criteria:

Prospective group (innovation)

* Primitive malignant pelvic bone tumor or mixt tumor (primary bone sarcoma, soft tissue sarcoma with bone extension, giant cells tumor of bone and any tumor requiring such a resection)
* Indication for a wide monobloc resection according to clinical guidelines of the pathology ("en bloc" resection of iliac bone including a bone section from periacetabular Enneking zone 2 to the sacrum zone 4, hip extra-articular resection for proximal femur tumors and sacral tumor or ilio-sacral tumors that need a vertical osteotomy or horizontal osteotomy above S2)
* Ability to fill in Euroqol and TESS questionnaires
* Adult (18 years old or more)
* Health insurance holder

Retrospective group (reference)

Patient fulfilling the matching criteria with one patient of the prospective group, according to the following matching criteria (in order of importance):

1. Tumor location (Enneking zones 1, 2, 1-2, 2-3, 1-2-3, 1-2-4, 1-2-3-4, 1-4, sacrum)
2. Tumor type (chondrosarcoma, osteosarcoma, Ewing, chordoma, other tumor type)
3. Surgery center
4. Tumor size (as close as possible between both patients)
5. Response to chemotherapy (good, bad, not applicable).

Exclusion Criteria:

Prospective group (innovation)

* Patient suffering from a local recurrence or a metastasis at recruitment time
* Absence of informed consent
* Pregnancy or breastfeeding
* Minors
* Adults under guardianship or trusteeship

Retrospective group (reference)

* Patient not fulfilling the protocol matching criteria
* Refusal to participate
Cirrhosis Readmission Telehealth Project

This is a 2 year research study to study if post discharge phone calls can help lengthen time to hospital readmissions for patients with encephalopathy.

The purpose of this randomized prospective pilot study is to decrease hospital readmissions for patients with hepatic encephalopathy. Patients who were admitted at YNHH with hepatic encephalopathy will be enrolled. Patients will then be randomized to one of two groups upon discharge. The control group will receive usual standard of care for hepatic encephalopathy (encephalopathy education, cirrhosis brochure, stool chart, and routine follow up with their primary care provider and hepatologist). The intervention group will receive usual standard of care as discussed above and phone calls for a 3-month period after their hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Age of at least 18
* Patients with known cirrhosis
* Current hospitalization for overt hepatic encephalopathy as categorized by West Haven encephalopathy score of 2 or more
* Current hospitalization found no precipitants triggering encephalopathy as determined by the primary team
* Encephalopathy resolved at time of enrollment
* Has a telephone
* Able to obtain medications

Exclusion Criteria:

* Altered mental status unrelated to cirrhosis
* Acute liver failure
* Expectation of liver transplant within 1 month after enrollment
* Chronic kidney disease with Cr \> 2 mg/dL
* Respiratory insufficiency:moderate to sever COPD on pulmonary function test
* Electrolyte imbalances not corrected at enrollment
* Sodium less than 125 mmol/L
* Calcium greater than 10mg/dL
* Potassium \< 2.5mmol/L
* Unable to give legal consent
* Deafness
* Infection, spontaneous bacterial peritonitis, gastrointestinal bleeding
Pre-treatment Exercises Versus Post-treatment Exercises for Dysphagia

The purpose of this project is to determine if pre-treatment swallowing exercises can improve post-treatment swallowing function in patients undergoing radiation with or without chemotherapy for advanced squamous cell carcinoma of the head and neck.


Eligibility Criteria:
Inclusion Criteria:

* Stage III or IV squamous cell cancer of teh pharynx and larynx
* Patients who will be receiving chemoradiation
* Age 19 years of age or older
* Must sign informed consent.

Exclusion Criteria:

* Prior cancer diagnosis
* Metastatic disease
* Cognitive Impairment
The Application of Traditional Chinese Medicine Functional Reduction in Muscle Fatigue

In this study, 45 healthy participants between 20 and 40 of age will be included. After obtaining the consent, the participants will be categorized into two(A\&B) groups randomly for cross-over study. Each of group will accept either conventional taping or Chinese medicine technique taping before muscle fatigue exercise. To compare the preventive effect, Myoton PRO, pulse analysis equipment, etc will be applied for evaluation. The application of Chinese medicine technique (ie. Chinese medicine functional reduction) taking the kinetic chain into consideration may improve body's functional movement.

Nowadays, the importance of exercise is highly valued. The prevalence of sports injury is also increasing and may be associated with muscle fatigue. Therefore, the study focused on the prevention of common muscle fatigue in legs during exercise. With the modern sport medicine knowledge and kinesio taping, the investigators tried to figure out whether muscle fatigue can be diminished through the concept of Chinese medicine channel sinews techniques in advance. In this study, 45 healthy participants between 20 and 40 of age will be included. The exclusion criteria are as follows: i.pregnancy ii.current health problem iii.injuries of legs within a month. After obtaining the consent, the participants will be categorized into two(A\&B) groups randomly for cross-over study. Each of group will accept either conventional taping or Chinese medicine technique taping before muscle fatigue exercise. To compare the preventive effect, Myoton PRO, pulse analysis equipment, etc will be applied for evaluation. The application of Chinese medicine technique (ie. Chinese medicine functional reduction) taking the kinetic chain into consideration may improve body's functional movement. Our goal is to enhance the coordination of the entire body structure, not merely the partial body structure improvement. In this way, it will benefit the prevention of exercise injuries and therapeutic effect.

Eligibility Criteria:
Inclusion Criteria:

* participants between 20 and 40 of age

Exclusion Criteria:

* i.pregnancy ii.current health problem iii.injuries of legs within a month