cyrilzakka/clinical-trials huggingface dataset:
Detecting Auricular Points in OFP by a Novel APD ( APD-OFP)

This is a pilot diagnostic accuracy study conducted to assess the diagnostic ability of a novel APD for auricular point detection among patients with orofacial pain, as compared with an already commercialized device.

The present study is a pilot diagnostic accuracy study conducted to assess the diagnostic ability of a novel APD for auricular point detection among patients with orofacial pain (OFP), as compared with an already commercialized device. This study will examine if the novel APD is more reliable than the traditional devices currently available in the market. Moreover, this study will also use the APD device to test the cutaneous electrical impedance of the ear and further assess whether the orofacial auricular points is with the lowest electrical impedance in the OFP population. This pilot study will enroll 12 OFP patients from the Department of Anesthesiology, Queen Mary Hospital, the University of Hong Kong. 12 healthy subjects will be recruited as control from the university community. Auricular acupoint detection will be accomplished with the new device and a control device. The electrical impedance will be detected and recorded. Patient's condition will also be evaluated by the Penn Facial Pain Scale-Revised (2018). The specificity and sensitivity of the auricular point detection by the APD device will be calculated. Cohen's kappa coefficient (κ) will be used to test the inter-methods reliability, test-retest reliability, and inter-tester reliability. Moreover, the Pearson Correlation Coefficient will be used to test the correlation between the electrical impedance of the auricular point of the orofacial area and the Penn Facial Pain Scale score.

Eligibility Criteria:
Inclusion Criteria:

* When pain attacks, the average unilateral orofacial pain severity \>=5 point measured by a 10-point VAS scale;
* Patient with trigeminal neuralgia can be diagnosed according to Trigeminal neuralgia: New classification and diagnostic grading for practice and research (Neurology, 2016);
* Other kinds of orofacial pain can be diagnosed based on the patient's symptoms;
* Provide written inform consent;
* Free of any other diagnosed psychological conditions;

Exclusion Criteria:

* with any other diseases such as cardiovascular, renal, neurological, digestive, hepatic, respiratory disease;
* Pregnancy or lactation;
* Participation in a clinical study that may interfere with participation in this study;
* History of or current tobacco, alcohol use;
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study;
* Unable to provide written informed consent due to any reason;
Celiac Disease Prevention With Probiotics

Background/Aim: Celiac disease is a common immune-mediated disorder, and the only currently available treatment is a gluten-free diet. Recent studies have shown several probiotics to carry properties that might positively influence the immunological activity in celiac patients.

The aim of the present study is to investigate how daily consumption of probiotics would affect levels of tissue transglutaminase autoantibodies (tTGA), markers of celiac disease autoimmunity in the periphery, as compared to placebo in children at genetic risk for celiac disease.

Methods: Between 2012 and 2015, 90 children were recruited from two ongoing prospective celiac disease screening studies at the Skåne University Hospital, Sweden. Participants were randomized to either daily consumption of 2 lactobacilli strains or placebo for the duration of 6 months.

Blood samples were drawn at 0, 3 and 6 months and analyzed for both IgA-tTGA and IgG-tTGA using radioligand binding assays.


Eligibility Criteria:
Inclusion Criteria:

* Carrier of any of the HLA-types DQ2 and/or DQ8 associated with celiac disease.
* Screened positive for tissue transglutaminase autoantibodies (tTGA) in at least 2 consecutive blood draws (\<30U/ml).
* No celiac disease diagnose
* Currently on a normal gluten-containing diet

Exclusion Criteria:

* Screened positive for Type 1 diabetes associated autoantibodies (GADA, IAA, IA-2A, ZnT8A).
Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia

The purpose of this study is to evaluate the impact of sequential overlapping treatment with PD-1 monoclonal antibody (mAb), pembrolizumab/MK-1375, followed by ibrutinib on endogenous immune function in previously untreated, high-risk CLL patients. Immune function will be evaluated through various laboratory correlative tests.


Eligibility Criteria:
Inclusion Criteria:

* Have high risk CLL
* Have documented previously untreated CLL according to IWCLL criteria
* Willing and able to provide written informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Demonstrate adequate organ function
* Able to take oral medication and willing to adhere to the medication regimen

Exclusion Criteria:

* Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment
* Meets IWCLL criteria to start therapy
* Has had any treatment for CLL including any investigational agent, chemotherapy, mAb, anti-PD-1, anti-PDL-1, or anti-CTLA-4
* Transformation of CLL to aggressive NHL (Richter's transformation or pro-lymphocytic leukemia)
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 90 days after the last dose of trial treatment
* Major surgery or a wound that has not fully healed within 4 weeks of first dose
* Additional criteria may apply
Cardiovascular Risk Factors in Rheumatoid Arthritis Patients ( Comparison Between Seronegative and Seropositive Cases )

The goal of this observational study is to learn about the long-term effects rheumatoid arthritis (RA) on cardiovascular system. The main question it aims to answer is:

Does seropositive raise risk of cardiovascular diseases more than seronegative RA ?

We will investigate cardiovascular risk factors in patients with seronegative and seropositive rheumatoid arthritis.

Complete clinical examination including blood pressure (BP; using an automatic BP monitor) and heart rate (in beats per minute (bpm) either from an automatic BP monitor or a 12 lead ECG) will be measured according to the standard hospital procedures.

Routine Laboratory investigations, including complete blood count (CBC), Blood parameters, including autoantibodies and lipid profile will be determined), liver and kidney function tests, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and lipid profile panel will be recorded.

The disease activity score-28 (DAS-28) and health assessment questionnaire (HAQ) will be assessed.

Framingham risk score will be calculated. Carotid doppler will be done . Current medications use including synthetic disease-modifying anti-rheumatic drugs (DMARDs), in addition to steroids, will be recorded.

Rheumatoid Factor and Anticitrullinated proteins antibodies presence will be determined.

Cardiovascular risk factors, including inflammation, hypertension, smoking, obesity, and dyslipidemia will be observed and a higher risk of Cardiovascular Diseases events (including myocardial infarction, stroke, and heart failure).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years.
* Both sexes.
* All patients with RA confirmed using the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology EULAR classification criteria
* RA diagnosed for at least six months to ensure chronicity.

Exclusion Criteria:

* Diagnosis of other significant autoimmune diseases (e.g., lupus, scleroderma).
* Use of medications known to significantly affect cardiovascular outcomes (e.g., certain anticoagulants or anti-inflammatory agents) that are not part of standard RA treatment.
Effects of WB-EMS and Protein Supplementation on LBM Maintenance During Intended Weight Loss

The present study aimed to determine the effect of different interventions on lean body mass maintenance under weight loss conditions in overweight and obese premenopausal women. Three study groups were implemented: (1) Protein supplementation (only) group (2) Protein supplementation and walking intervention (3) Protein supplementation, walking and WB-EMS-application. All protocols were applied for 16 week of intervention.

A energy deficit of 500 kcal/d was intended however while group (1) focus consistently on energy restriction (500 kcal/d), in group (2) and (3) a combined physical activity (i.e. walking with a volume representing 250 kcal/d) and energy restriction (250 kcal/d) protocol was applied. Total protein uptake including protein supplementation was calculated to average around 1.2 g/kg body mass per day in groups (1) and 1.5 g/kg body mass/d in group (2) and (3). WB-EMS was applied 1.5x 20 min/week (i.e. each Tuesday and every second Thursday).

Primary study endpoint was LBM as determined by Dual Energy x-Ray Absorptiometry.


Eligibility Criteria:
Inclusion Criteria:

* premenopausal women 25-50 years old
* overweight/obesity (body fat rate equal or higher 30%)

Exclusion Criteria:

* medication and diseases affecting muscle and fat metabolism
* pregnant or parturition \< 6 months
* any condition or medication that prevent proper physical activity or WB-EMS application
* holidays equal or more than 1 week during the intervention period
* other interventions with impact on the primary and core secondary outcome (i.e. body fat parameters) started during the last year.
Electrical Stimulation to Strengthen Muscles in the Lower Legs in Patients Requiring Prolonged Mechanical Ventilation

The primary aim of this proposal is to test the effectiveness of NMES in improving functional status and muscle function in patients requirng prolonged mechanical ventilation


Eligibility Criteria:
Inclusion Criteria:

* duration of mechanical ventilation for 14 days or more
* sufficiently awake
* able to speak and comprehend English

Exclusion Criteria:

* known primary neuromuscular disease
* lower extremities paresis or amputee
* patients with left-ventricular assist device (LVAD)
* cardiopulmonary instability
Integrating Caregiver Support Into MS Care

With loss of mobility in multiple sclerosis (MS) comes an increase in amount and types of caregiver assistance, with a concomitant increase in burden for the caregiver. In fact, effect on caregiver burden can be seen as a potential indicator of the efficacy of MS management, suggesting that the caregiver is an appropriate and independent target for MS therapeutic strategies.

MS patients report difficulty implementing and continuing with home exercise, mobility, and walking programs. This feasibility study will test integration of a successful behavioral caregiving intervention into clinical practice to improve functioning of Veterans with multiple sclerosis (MS) and their Caregivers. Caregivers of Veterans with MS will receive a behavioral caregiver intervention designed to address caregiver coping and management of patient concerns, with special focus on patient mobility and walking. A pre-post intervention design will compare outcomes for Veterans and Caregivers.

For Veterans, the intervention will target Caregiver participation in home-based Veteran mobility activities. MS Caregivers report high burden, stress, and depression involved in caring for their loved ones, especially as mobility declines and these outcomes are related to physical and emotional health status of the patient. For Caregivers, the intervention will focus on improving Caregiver coping and on managing MS-related problems. Outcomes for both will be measured at baseline, 3 months, and 6 months.

Study Objectives include:

* Test whether a caregiver intervention can be integrated into an MS clinical setting.
* Determine whether Caregiver outcomes are improved (depression, burden, anxiety, and number of Veteran MS problems and safety alerts reported).
* Determine whether Veteran outcomes are improved (Expanded Disability Status Scale, timed up and go test, self-efficacy, and depression).
* Determine which types of Caregivers will benefit most.
* Determine which types of Veterans will benefit most.
* Refine materials for future clinical research, translation and implementation.


Eligibility Criteria:
Inclusion Criteria:

* Veteran being seen in MS clinic at Memphis VA
* Veteran ambulatory
* Caregiver/care partner who agrees to participate

Exclusion Criteria:

* None
Onset of Action of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray Compared With Placebo in Seasonal Allergic Rhinitis (C93-184)

This study investigated the onset of symptom relief following initiation of treatment with mometasone furoate (MK-0887/SCH 032088) 200 mcg administered once daily compared with placebo for 14 days.


Eligibility Criteria:
Inclusion Criteria:

* Has a 2-year history of seasonal allergic rhinitis
* Has a positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)
* Is in good health and free of any unstable, clinically-significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Women of childbearing potential who are not using an acceptable form of birth control
* Has asthma that requires therapy with inhaled or systemic corticosteroids, cromolyn, or nedocromil
* Has significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical illness or disorder which, in the judgment of the investigator, could interfere with the study, or required treatment which might interfere with the study
* Is on immunotherapy with the exception of maintenance therapy
* Has a clinically significant upper respiratory or sinus infection
* Has used an investigational drug within the previous 30 days
* Has nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow
* Has a history of multiple drug allergies or an allergy to antihistamines or corticoids
* Has dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator
* Has rhinitis medicamentosa
* Is using of any chronic medication which could affect the course of seasonal allergic rhinitis
VEGF and PEDF in Patients With Myopic Choroidal Neovascularization

This was a prospective, case-control study investigating aqueous levels of VEGF and PEDF in eyes with mCNV treated with IVB.


Eligibility Criteria:
Inclusion Criteria:

* pathologic myopia, defined as spherical equivalent \>6 diopters and axial length \>26 mm
* posterior pole myopic retinal changes (posterior staphyloma, chorioretinal atrophy, papillary crescent);
* fluorescein angiography, indocyanine green angiography and optical coherence tomography detection of the subfoveal or juxtafoveal choroidal neovascularization
* clear ocular media;

Exclusion Criteria:

* previous treatment for choroidal neovascularization, including the previous intravitreal drug injection or PDT
* presence of other maculopathy as diabetic retinopathy or retinal vascular occlusion
* history of recent myocardial infarction or other thromboembolic events
* ongoing uncontrolled hypertension or glaucoma
* refractive media opacities
* previous eye surgery
Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery

Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established.

Patients undergoing cardiac surgery employing moderate hypothermic CPB (n=40) are randomly allocated into one of two groups: in Group-ANH(n=20), ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C, ANH is not applied.

After weaning from CPB, intergroup differences of INTEM, EXTEM, FIBTEM and APTEM profiles are analyzed.

As a primary outcome, inter-group difference between maxiaml clot firmness of EXTEM will be determined at 10 min after ANH in Group-ANH and that at control.

Background: Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established.

Method: Patients undergoing cardiac surgery employing moderate hypothermic CPB (n=40) are randomly allocated into one of two groups: in Group-ANH(n=20), ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C ANH is not applied.

Intergroup differences of INTEM, EXTEM, FIBTEM and APTEM profiles are analyzed. after anesthesia induction (control) and after weaning form CPB and protamine neutralization (after-CPB) in both groups. In Group-ANH, those are determined after ANH (after-ANH).

As a primary outcome, inter-group difference between maxiaml clot firmness of EXTEM is determined at 10 min after ANH in Group-ANH and that at control.

As secondary outcomes, intergroup differences of Hematocrit (Hct), Na+, K+, HCO3-, Ca2+, osmolarity, s-Cr are determined Intergroup difference of data at T2 are performed.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing cardiac surgery with cardiopulmonary bypass who signed written informed consent

Exclusion Criteria:

* preoperative renal failure requiring reran replacement therapy
* preoperative liver disease
* preoperative low cardiac output (EF \< 50%)
* Preoperative IABP application, Atrial fibrillation, Pacemaker,
* contraindication for applying TEE
* intraoperative withdrawal
Exercise Training to Atrial Fibrillation

To test the impacts of different exercise training programs to the cardiopulmonary function, muscle metabolism, and body mass composition

Atrial fibrillation (AF) has been a global threat due to its increasing incidence and prevalence, and also its potential complications of embolic stroke and heart failure, and therefore has a great impact on life expectancy and quality of life. AF with preserved ventricular function is associated with exercise intolerance, and the effect of physical training had shown to improve life quality and heart function in the population. However, the optimal physical training modalities and intensities are not well studies.

Here we conduct a prospective, randomized, and interventional trial to investigate the effects of different exercise training programs to the burden of AF. We also exploit advanced imaging modalities, including dual x-ray absorptiometry and muscle magnetic resonance, to explore the change of body mass compositions. With this project, we will be able to explore the effects of different physical exercise modalities to the burden of AF and heart function, and also build up a best exercise training program, specific for this population.

Eligibility Criteria:
Inclusion Criteria:

1. Paroxysmal or persistent atrial fibrillation
2. Daily activity below moderate intensity \< 300 minutes or high intensity \< 150 minutes per week.

Exclusion Criteria:

1. Active infection.
2. Implant cardiac pacemaker.
3. Uncontrolled hypertension.
4. Cardiopulmonary contraindication to exercise training, such as decompensated heart failure, acute pulmonary edema, unstable angina, uncontrolled arrhythmia causing hemodynamic compromise, symptomatic severe aortic stenosis, suspected dissecting aortic aneurysm, severe pulmonary hypertension, acute myocarditis, endocarditis or pericarditis, uncontrolled asthma and SpO2 \< 90% at rest on room air.
5. Inability to follow verbal command or to walk on treadmill or use stationary bike.
Outcomes of the Modified-Brostrom Procedure Using Suture Anchor for Chronic Lateral Ankle Instability

This prospective, randomized study was conducted to compare the clinical outcomes of the modified Brostrom procedure using a suture anchor and bone tunnel for chronic lateral ankle instability.

With With the increased number of participants in sports and leisure time activities, the incidence of ankle ligament injuries has been correspondingly increased. Various surgical methods have been reported for chronic ankle instability. Of these methods, the modified Brostrom procedure is currently used most frequently, and its excellent treatment outcomes have been reported. If there are any methods for obtaining a strong ligament fixation force which are both technically simple and safe, such methods would shorten the operative time and be helpful for surgeons with little experience in managing chronic ankle instability to obtain excellent treatment outcomes. In recent years, a procedure using a suture anchor, which is used for various types of ligament or tendon reconstructions, has been frequently performed. To date, however, few studies have reported clinical outcomes of suture anchor techniques and comparisons of clinical results between suture anchor techniques and other procedures. Given the above background, we prospectively compared the clinical outcomes between the bone tunnel and suture anchor techniques in the modified Brostrom procedure for chronic lateral ankle instability.

Eligibility Criteria:
Inclusion Criteria:

* Patients who complained of subjective instability of the ankle joint in whom repeated sprain injuries for \> 6 months and pain were confirmed
* Patients with marked ankle instability confirmed by the anterior drawer test as compared with the contralateral ankle joint and tenderness involving the lateral ligament of the ankle joint was confirmed on physical examination
* Patients with an talar tilt angle exceeding 10o or a discrepancy of \> 5o as compared with the non-affected side on stress radiography
* Patients with an anterior talar translation exceeding 10 mm or a discrepancy \> 3 mm as compared with the non-affected side.

Exclusion Criteria:

* Patients who concurrently had an ankle fracture or marked tendon damage were excluded from the current analysis.
Preparing Caregivers for the Child Sexual Abuse Examination: Are Informational Leaflets Helpful?

Children are typically inadequately prepared for the sexual abuse medical examination. Caregivers report lack of examination knowledge as a barrier to preparing their children. The purpose of this study was to determine if informational leaflets provided prior to the examination are helpful to caregivers in preparing their children.


Eligibility Criteria:
Inclusion Criteria:

* consecutive caregivers accompanying children for scheduled sexual abuse medical examination

Exclusion Criteria:

* Lack of consent
* Failure to complete study