cyrilzakka/clinical-trials huggingface dataset:
Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures

The objective of this study is to determine if tAN therapy can reduce the volume of blood lost during dialysis AV graft placement procedures.

This study is designed as a randomized, double-blind, sham-controlled, single-center, pilot clinical trial in which adults undergoing dialysis port placement procedures will be randomized 1:1 into one of two treatment groups:

Group 1: Active tAN + standard of care Group 2: Sham tAN + standard of care

Participants will receive 30 minutes of active or sham tAN immediately prior to the dialysis port placement procedure. Blood loss and blood markers will be measured before and during the procedure to measure the effect of the therapy.

Eligibility Criteria:
Inclusion Criteria:

* Participant is undergoing a dialysis port placement procedure using synthetic graft
* Participant is between 18 and 75 years of age
* Participant is English proficient
* Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements

Exclusion Criteria:

* Participant has a BMI ≥ 40
* Participant is currently taking a platelet inhibitor medication
* Participant has a history of epileptic seizures
* Participant has a history of neurological diseases or traumatic brain injury
* Participant has presence of devices, e.g., pacemakers, cochlear prosthesis, neurostimulators
* Participant has abnormal ear anatomy or ear infection present
* Person of childbearing age, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study
* Person who is pregnant or lactating
* Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
CTCs in Cervix Cancer

This study is a validation study to confirm the ability of Telomescan OBP-401 to identify CTCs in patients with HPV 16 / 18 associated cervical cancer. CTCs identified will be tested for the presence of the HPV 16 / 18 E6 protein, confirming a cervical cancer origin.


Eligibility Criteria:
Inclusion Criteria:

* Able to safely provide 15 ml of blood
* Able to provide informed consent
* Pathologically confirmed invasive cervical cancer
* Proof of serotype HPV 16 or HPV 18 positive within 3 years of the study
* Patients with stages IIA2 to IVB OR recurrent cervical cancer
* For patients with newly diagnosed cervical cancer, they must be enrolled (blood drawn) prior to initiating anti-cancer therapy
* For patients with recurrent cervical cancer, they must be enrolled (blood drawn) prior to initiating a new anti-cancer therapy for progression of disease (based on RECIST 1.1 criteria). Patients who have progressed and are moving to best supportive care are eligible.
* If patients meet criteria 5.1A 5 above, the following criteria must be met:
* At least 21 days have elapsed following treatment with cytotoxic chemotherapy
* At least 14 days have elapsed following treatment with biologic therapy
* At least 14 days have elapsed following radiation therapy

Exclusion Criteria:

* History of any cancer other than cervix cancer within the past five years.
* History of any known germ-line pathogenic mutation (ie BRCA 1 / 2 or Lynch syndrome, but genetic testing is not required)
* Current use of systemic corticosteroids at doses exceeding 10 mg per day of prednisone or its equivalent.
* Active infection including hepatitis B, hepatitis C, HIV.
* Any patient unable to comply with the study criteria.
* Patients taking any anti-inflammatory agents (aspirin, NSAIDs, steroids), within 24 hrs prior to blood draw.
Evaluation of Sleep Quality in Patients With Chronic Neck Pain

This study aimed to investigate the effect of chronic neck pain on sleep quality and to determine the factors that may be related to sleep disturbance.

It is thought that chronic neck pain affects sleepiness negatively. However, there are no studies on chronic neck pain and sleep quality. In this study, we would like to determine whether there is a link between chronic neck pain and sleep quality and the factors that may be related.

Eligibility Criteria:
Inclusion Criteria:

* Patient has chronic mechanical neck pain for at least 3 months and without radicular pain
* Patient's visual analogue scale score is 3 and over

Exclusion Criteria:

* History of neurological deficit
* History of cervical stenosis, cervical surgery, spondylolisthesis, scoliosis
* History of central or peripheral nervous system disorders
* History of inflammatory neck pain
* Pregnant or breast feeding
* History of fibromyalgia disease
* History of severe osteoporosis or osteomalacia
* History of infectious, malignancy, and active psychiatric disease
* Noncooperative
* Patient has chronic pain in a region other than the neck region
Comparative Pharmacokinetic Trial of RGB-03 and MabThera

Pharmacokinetic properties, efficacy, safety and tolerability of RGB-03 and MabThera will be compared in patients suffering from Rheumatoid Arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Active Rheumatoid Arthritis
* Inadequate response or intolerance to other DMARDs and anti-TNFs
* Treatment with Methotrexate

Exclusion Criteria:

* Previous treatment with rituximab
* Patients with systemic manifestations of rheumatoid arthritis
* Patients seropositive for HIV, HCV, HBV
* Female patients nursing

Other protocol-defined inclusion/exclusion criteria may apply.
Edge-To-Edge Technique Used as a Bailout in Case of Sub-Optimal Mitral Repair: Very Long-Term Results

The absence of residual mitral regurgitation (MR) after mitral valve repair is of paramount importance for the long term durability of the valve repair. Thus, ideally, after weaning from cardio-pulmonary by-pass (CPB) the trans-esophageal echocardiogram (TEE) should show no (or only trivial) residual MR, good coaptation length and no iatrogenic mitral valve stenosis. However, mild or more residual MR can be present in up to 4% of the patients after the initial mitral valve repair and a second CPB run may be necessary to improve the repair results. Mechanism of residual MR can be dynamic, related to systolic anterior motion (SAM) or to severe left ventricular dysfunction, and anatomical, related to residual prolapse, cleft, and suture or ring dehiscence. In several cases medical therapy can be effective in the management of the intra-operatively detected SAM, and residual cleft or suture dehiscence can be easily corrected during a second CPB run. However, in other cases SAM is not responsive to medical therapy or the residual MR jet would require complex and time-consuming techniques to be addressed, or even worse scenario, a mitral valve replacement could be necessary. In such cases the edge-to-edge (EE) technique can be used as a bail-out procedure. The anatomical characteristics of the mitral valve after an initial sub-optimal repair are certainly not ideal for the edge-to-edge technique, due to a possible significant reduction in the valve area, especially in case of posterior leaflet resection or small ring implanted. Nevertheless, in the short term the edge-to-edge technique used to rescue patients with sub-optimal initial repair resulted effective. However, the very long-term results of the edge-to-edge technique used as bail-out are not known. Thus, the aim of this study is to evaluate the clinical and echocardiographic results of the edge-to-edge technique used to rescue patients with initial sub-optimal mitral repair.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients;
* Patients underwent mitral valve repair, with more than mild residual MR at the intraoperative TEE after leaving the CPB;
* Patients in whom EtE alone has been added to the repair already performed, as a technique to reduce residual MR after first attempt of mitral valve repair;
* Patients operated both in median sternotomy or in minithoracotomy;
* Patients operated on at the Cardiac Surgery departmet of San Raffaele Hospital since January 1999 to December 2015.

Exclusion Criteria:

* Patients in whom other techniques have been used as a bailout procedure, concurrently or instead of EtE;
* Patients where the initial repair has been modified or undone;
* Patients whose mitral valve has been replaced.
The Transcriptomic Study of Thai Patients With Atopic Dermatitis by Tape Strips

This study will be use the tape strip technique to evaluate the skin biomarkers of atopic dermatitis among Thai patients to differentiate clinical phenotype.

The patients will be enrolled in this study if they have been diagnosed with atopic dermatitis. All participants (AD patients and controls) will be evaluated their skin biomarkers by using tape stripping. The tape strips will be applied to the antecubital fossa to collect the epithelial samples. Then RNA was extracted from the tape strips for mRNA profiling to identify the immune and epidermal barrier genes.

Eligibility Criteria:
Inclusion Criteria:

* Children (age 1-18 years old) with mild atopic dermatitis
* Children (age 1-18 years old) with moderate to severe atopic dermatitis
* Children (age 1-18 years old) with moderate to severe atopic dermatitis and food allergy
* Adult (age 18-60 years old) with atopic dermatitis
* Healthy individuals (1-60 years old)
* Patients with asthma (1-60 years old)

Exclusion Criteria:

* Active skin infections
* Used systemic immunosuppressants within 4 weeks
* Used topical steroids or immunomodulators within 1 week
* Used moisturizers within 12 hours before evaluation
Continuous Glucose Monitoring: A Pilot Study

The purpose of this study is to evaluate connectivity of the FDA approved DexCom G7® continuous glucose monitor in the operating room. Continuous glucose monitors are applied to the skin and a thin sampling filament is inserted into the skin and measures blood sugar in the interstitial fluid. The DexCom G7® is used regularly outside of the operating room to monitor blood sugar, however the use of the device in the operating room environment has been limited by connectivity issues. This study will assess device connectivity at different monitoring sites.

This feasibility pilot study will assess connectivity of the DexCom G7® continuous glucose monitoring device (CGM) in the operating room environment at different locations on the body. The investigators believe device connectivity is affected by use of electrocautery. The monitoring sites were selected to limit electromagnetic interference from electrocautery.

One cohort will have the CGM device placed on the deltoid and the electrodispersive pad placed on the thigh and the other cohort will have the CGM device placed on the thigh with the electrodispersive pad on the opposite thigh.

Study personnel will note when electrocautery is used throughout the surgery and observe if the DexCom G7® continues to maintain connectivity with the receiver and provides a glucose reading. Comparing the timing of electrocautery use with connectivity to the DexCom G7® receiver provides important insight to the relationship between electrocautery and device connectivity.

The CGM readings will solely be used for feasibility purposes for this study and not for determining interventions for the subjects.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 and above able to consent for themselves
* Willingness and ability to participate in study procedures
* Surgery length estimated 3 hours or longer

Exclusion Criteria:

* Cardiothoracic surgical patients
* Plan for intraoperative radiologic imaging
* Patients on IV infusion of insulin prior to surgery
* Anemia with hemoglobin less than 7
* Patients on hydroxyurea
* Patients with known adhesive allergies
* Pregnant women
The Vanderbilt Atrial Fibrillation Ablation Registry

The Vanderbilt Atrial Fibrillation Ablation registry (VAFAR) is a prospective clinical and genetic biorepository that systematically enrolls patients undergoing atrial fibrillation (AF) ablation. The registry was started in 2011 and has greater than 1000 AF ablation records with stored blood and DNA samples. The goals of VAFAR are to: 1) identify clinical, genetic, and serological predictors of response to AF ablation in order to improve patient selection, and 2) to provide a resource for translational research investigating the electrophysiologic mechanisms of AF pathogenesis.

The study population consists of patients at least 18 years of age who are scheduled for AF ablation at Vanderbilt University. Data recorded at enrollment includes a detailed past medical history and measurements from pre-ablation imaging (cardiac MRI or CT). At the time of ablation, a blood sample is collected for storage of plasma/serum and extraction of DNA, and details of the ablation procedure are recorded. Post-ablation monitoring for arrhythmia recurrence is performed according to a standard clinical follow-up schedule at 3, 6, and 12-months. ECG's are performed at each follow-up visit along with placement of an ambulatory ECG-monitor. At 6-months post-ablation, cardiac imaging with a repeat cardiac MRI or CT is performed.

Eligibility Criteria:
Inclusion criteria:

1. Age \>18 years
2. Able to give written, informed consent
3. Scheduled for an ablation procedure to treat atrial fibrillation

Exclusion criteria:

1. None
Cryoneurolysis Outcome on Pain Experience (COPE) in Patients With Low-back Pain

This study will provide information on the effectiveness of cryoneurolysis for patients with facet joint pain syndrome, and help to establish whether cryoneurolysis should be implemented in clinical practice for this patient population.

Background: Low-back pain, including facet joint pain, accounts for up to 20 percent of all sick leaves in Denmark; among these are patients with facet joint pain syndrome. A proposed treatment option is cryoneurolysis. This study aims to investigate the effect of cryoneurolysis in lumbar facet joint pain syndrome

Methods: A single-center randomized controlled trial (RCT) is performed including 120 participants with chronic facet joint pain syndrome, referred to the Department of Neurosurgery, Aarhus University Hospital. Eligible patients receive a diagnostic anesthetic block, where a reduction of pain intensity \>50 % on a numerical rating scale (NRS) is required to be enrolled. Participants are randomized into three groups to undergo either one treatment of cryoneurolysis, radiofrequency ablation or placebo. Fluoroscopy and sensory stimulation is used to identify the intended target nerve prior to administrating the above-mentioned treatments. All groups receive physiotherapy for 6 weeks, starting 4 weeks after treatment. The primary outcome is a reduction in low-back pain intensity and an impression of change in pain after intervention (Patient Global Impression of Change (PGIC)) at 4 weeks follow-up, prior to physiotherapy. Secondary outcomes are quality of life (EQ-5D, SF-36) and level of function (Oswestry Disability Index), psychological perception of pain (Pain Catastrophizing Scale) and depression status (Major Depression Inventory). Data will be assessed at baseline (T0), randomization (T1), day one (T2), 4 weeks (T3), 3 (T4), 6 (T5) and 12 months

Eligibility Criteria:
Inclusion Criteria:

* Low-back pain from facet joint syndrom (facet joint pain) \> 3 months' duration with or without neuropathic pain component.
* Low-back pain on Numeric Rating Scale ≥ 4

Exclusion Criteria:

* Presence of nerve root or spinal canal compression; signs of inflammatory or erosive processes in the spine verified on magnetic resonance imaging (MRI).
* Neurological deficits i.e. symptoms of nerve root compression; tingling, numbness, weakness/ paresis, and reflex loss in the lower extremities.
* Major co-morbidity.
* Anti-thrombotic or anti-platelet treatment which cannot be paused for a week.
* Active malignancies.
* Chronic inflammatory disease.
* Known severe psychiatric disease. Patients with mild and well-treated depression and anxiety are not excluded.
Function and Quality of Life After Emergency vs Planned Creation of a Stoma

The aim is to compare functional outcome and or quality of life in patients with a stoma that was constructed as an emergency procedure with patients where a stoma was created as a planned procedure. To do this data will be retrieved from the Swedish Patient Register to identify all patients with a diagnosis of colorectal cancer and a stoma construction procedure during two previous calender years. To collect data on stoma function and quality of life a specific questionnaire will be sent to the cohort approximately within 2 years of the procedure.

The cohort will be identified through the National in-Patient Register, held by the Swedish Board of Health and Welfare, by using a combination of ICD10 and NOMESCO codes. Two calender years will be the collecytion period to reach group size allowing for statistical analysis. Data from the register will be used to describe the groups (demography) and data from the prescribed drug register to calculate costs for stoma appliances after discharge.

Using the patient ID, all patients still alive at the time, will be contacted first by a letter followed within 2-4 days by a phomecall from the study secretariate, to ask for consent and thereafter to send out the questionnaire.

The questionnaire includes validated questions used before as well as validated instruments, to analyze stoma function in detail as well as quality fo life, as well as questions where answers will be used for adjustment in analyses.

Eligibility Criteria:
Inclusion Criteria:

* stoma permanently or for shorter period

Exclusion Criteria:

* not understanding Swedish
Effect of Bifidobacterium Breve B-3 on Body Fat in Obese Adults

Comparison of a randomized, double-blind, and control-group study for the effect of oral ingestion of Bifidobacterium breve B-3 on body fat reduction in obese adults

Our aim is to investigate the effect of oral ingestion of Bifidobacterium breve B-3 on body fat reduction in adults by a randomized, double-blind, and control-group study.

Eligibility Criteria:
Inclusion Criteria:

* BMI 27\~30 kg/m2

Exclusion Criteria:

* Within the last 6 months, severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease(Angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant diseases (however, although subjects have a history of cerebrovascular disease and heart disease, they can be included if their status are clinically stable)
* Patients with uncontrolled hypertension (blood pressure greater than 160/100 mmHg)
* Diabetic patients with poor glycemic control with a fasting blood glucose of 160 mg/dl or more
* Those who are treated with hypothyroidism or hyperthyroidism
* Creatinine levels: more than twice the normal upper limit
* Aspartate transaminase (AST), Alanine transaminase (ALT) levels: more than twice the normal upper limit
* Those complaining of severe gastrointestinal symptoms such as heartburn and indigestion
* Drugs that affect weight within the last month (absorption inhibitors and Appetite suppressant, health food / supplements related to obesity improvement, psychiatric Drugs, beta blockers, diuretics, birth control pills, steroids, female hormones) If you are taking
* Participated in the commercial obesity program within the last 3 months.
* If you have participated or are planning to participate in another clinical trial within the past month If yes
* Alcohol abuser
* Smoking abstinence within 3 months
* If they are pregnant or lactating or have a pregnancy plan during the clinical trial
* Those with allergic reactions to the constituent food
* Any person deemed inappropriate by the researcher for other reasons
Stool Sampling in the Acute Isolated Patient , Efficient Acquiring With a Novel Device

stool sample device tested on patients admitted to oncological dept. with diarrhea, in order to shorten time in isolation and time to relevant treatment.

the stool sample device will be tested on all patients admitted to an oncological dept. on Zealand University Hospital, with diarrhea, in order to examine if the the device is able to shorten time in isolation and time to relevant treatment.

Eligibility Criteria:
Inclusion Criteria:

* Understanding Danish
* admitted to dept og oncology with diarrhea
* cognitive intact
* Co operable to fecal sampling

Exclusion Criteria:

* expected survival less than 2 weeks
Psychiatric Problems in Chronic Skin Diseases

The purpose of this study is to investigate the prevalence of depression, anxiety, and sleep problems in patients with chronic skin diseases in dermatology clinics at the University of Wisconsin Hospital and Clinics.


Eligibility Criteria:
Inclusion Criteria:

* Subjects suffering from a chronic skin condition that has lasted over six months

Exclusion Criteria:

-
Virtual Group Motivation in Exercise Treadmill Testing

Exercise stress testing is the most frequently used clinical tool for assessment of coronary artery disease. To ensure a high validity of the results, a good Patient compliance is crucial. The aim of this study is to examine the effects of a virtually presented exercise group on the perceived comfort and the exercise capacity of patients during classical treadmill exercise testing. The investigators hypothesis is, that a virtually presented running group will increase the comfort of patients and their exercise capacity.

108 Patients were randomized in an open label trial 1:1 to either exercise treadmill testing while watching a static image of a flower (image group) or to exercise treadmill testing while watching a video of 5 amateur runners, running across and fields, giving the patient the impression of running within the group (video group). After the exercise test patients were asked to score their perceived comfort level and achieved level of their subjective physical limit on a 10 point scale.

Standard exercise treadmill parameters, as well as baseline demographic data were recorded of each patient. Patients with missing data was excluded of the analysis.

Statistic analysis was performed with t-test for normally distributed data and Wilcoxon-Mann-Whitney-Test for non-normal data.

Eligibility Criteria:
Inclusion Criteria:

* indication for exercise stress testing

Exclusion Criteria:

* any contraindication for exercise stress testing
* unability of performing an exercise treadmill test
* recent surgery
A Clinical Trial to Evaluate the Safety and Efficacy of "AG1904" in Acute Bronchitis

A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AGS Compared to AGU for Acute Bronchitis


Eligibility Criteria:
Inclusion Criteria:

* Both gender, 19 years ≤ age ≤ 75 years
* BSS(Bronchitis Severity Score) ≥ 5point at Visit 2 (Randomized Visit)
* Patients without fever based on Visit 2(Randomized Visit)
* Those who can comply with the requirements of clinical trials
* Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

* Patients with respiratory and systemic infections requiring systemic antibiotic therapy
* Patients with bleeding tendency or coagulation disorder
* Patients who investigators determines to severe respiratory disease that would interfere with study assessment
* Those who have participated in other clinical trials within 4 weeks before participating in clinical trials
* In case the investigator judges that it is not suitable for the subject of this clinical trial for other reasons