cyrilzakka/clinical-trials huggingface dataset:
Antidiabetic Potential of Galician High-phenolic Extra Virgin Olive Oils in Patients With Type 2 Diabetes Mellitus.

Since Galician virgin olive oils have a high content of bioactive phenolic compounds and these are attributed to a large part of the healthy properties of the Mediterranean Diet, our starting hypothesis is that these olive oils could attenuate insulin resistance, improving glycemic control in terms of fasting plasma glucose and/or glycated hemoglobin and insulin sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes mellitus for at least 1 year prior to inclusion.
* Older than 18 years old
* Current treatment with diet and/or oral hypoglycemic agents (biguanides, thiazolindiones, α-glucosidase inhibitors, iDPP4, aGLP-1, iSGLT2).
* Body mass index ≥ 25 kg/m2 and \< 40 kg/ m2.

Exclusion Criteria:

* Patients on treatment with insulin, SU or rapid-acting insulin secretagogues.
* History of severe ketosis or hyperglycemic decompensation.
* Pregnancy, pregnancy planning or breastfeeding.
* Body mass index ≥ 25 kg/m2 and \< 40 kg/m2.
* Difficulty or great inconvenience in changing eating habits or a low predicted probability of changing eating habits.
* Serious medical condition that may affect the person's ability to participate in a nutritional intervention study (e.g., digestive disease with fat intolerance, malignant disease, or significant neurological, psychiatric, or endocrine disease).
* Any other medical condition considered to limit survival to less than 1 year.
* Immunodeficiency or HIV positive status.
* Illegal drug use, chronic alcoholism or problematic alcohol use or total daily alcohol intake \> 80 g/d.
* Participation in any clinical trial or use of any investigational drug within the past year.
* Patients institutionalized for chronic care.
Dynamic Infrared Thermography in Breast Cancer Diagnostics

This study evaluate diagnostic accuracy of dynamic infrared thermography compared to mammography (reference test) in breast cancer diagnostics. Women aged 50-70 years, selected for assessment after mammography screening were invited to dynamic infrared thermography before clinical mammography and further examination.

This study evaluate diagnostic accuracy of dynamic infrared thermography compared to mammography (reference test) in breast cancer diagnostics.

Dynamic infrared thermography (DIRT) is an imagine procedure offering a non-invasive, painless examination without risk of radiation. Dynamic infrared thermography does not provide information on the morphological characteristics of the breast, rather it provides functional information on thermal and vascular conditions of the tissue (Fitzgerald, 2012).

During the study period from April 2009 until June 2012, a total of 168 women aged 50-70 years who were recalled for assessment after positive mammography screening were offered dynamic infrared thermography before further tests (clinical mammography, clinical examination and if necessary breast tissue biopsy).

Radiographers at the Breast Diagnostic Center (BDS) at University Hospital North Norway collected information about parity, menopausal status, use of hormone therapy and size of bra.

The same radiographers also carried out all the dynamic infrared thermography examinations. PI Åshild O. Miland and Professor James B. Mercer interpreted the thermograms and entered the data into the thermography database. Both were blinded for further assessments (mammography, clinical examination and biopsy) and non of them talked to any of the participants after the examination.

The health professionals who were responsible for the women during mammography, clinical examination and biopsy were blinded for the results from the infrared digital thermography examination. They were not allowed to ask the women about the infrared digital thermography examination.

The three radiologists at BDS made the interpretation of the mammographies and entered data into the digital patient journal and to the mammography database at The Norwegian Cancer Registry. One of the radiologist took, when necessary, breast biopsies. A breast surgeons were responsible for the clinical breast examination. Pathologists verified the histology.

Breast radiologist Jan Ole Frantzen and researcher Merethe Kumle, MD, PhD collected information about breast cancer results from the digital patient journal and Roentgen information system (RIS) and entered it into a separate mammography database.

The thermography database and the mammography database was still not merged at the time of registration in ClinicalTrials.gov (March 2015).

Eligibility Criteria:
Inclusion Criteria:

* women,
* aged 50-69
* attending the Norwegian Breast Screening Program,
* recalled for assessment after positive mammography screening

Exclusion Criteria:

* not attending the Norwegian Breast Screening Program,
* recalled to mammography for other reason than positive screening mammogram.
Exparel Use in Adductor Canal Block After Total Knee Arthroplasty

Exparel has been shown to have better pain control compared to previously used infiltration agents, including bupivacaine, while having a minor side effect profile. The purpose of this study is to explore the effectiveness of Exparel (liposomal bupivacaine) in Adductor Canal Blocks for peri-operative pain control following a total knee arthroplasty (TKA) procedure.

The effectiveness of an Exparel Block (Bupivacaine Liposomal Injectable Suspension) for post-operative pain control has been well studied with encouraging results. At the investigators' institution, Exparel has been approved as a safe and effective option for use in shoulder surgeries and have had encouraging results in adductor canal use for pain control in patients undergoing TKA. Exparel has been shown to have better pain control compared to previously used infiltration agents, including bupivacaine, while having a minor side effect profile. The purpose of this study is to explore the effectiveness of Exparel (liposomal bupivacaine) in Adductor Canal Blocks (ACB) for peri-operative pain control following a total knee arthroplasty (TKA) procedure. Specifically, the investigators look to see if Exparel ACB reduces opioid requirement use post-operatively, reduces pain scores post-operatively, provides earlier mobilization, and decreases length of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Patients were eligible for inclusion if they were undergoing unilateral primary TKA for a diagnosis of knee osteoarthritis and were not undergoing any additional concomitant procedures were.

Exclusion Criteria:

* Patients were not eligible for our study if they were undergoing revision TKA, if they were undergoing bilateral TKA or concomitant procedures, or if they had an active infection.
Visual Aids for Induction of Labor RCT

This study aims to develop a visual aid tool for induction education informed by the experiences and needs of historically marginalized pregnant women, as well as determine the impact of the patient-informed visual aid on patient knowledge, satisfaction, and trust in physicians regarding induction methods.

This is a multi-phased study of patients undergoing IOL. Only the second phase of the study will be detailed in this protocol, as this will be the RCT portion of the study's design. We will test the efficacy of the visual aid by conducting a randomized trial of routine counseling versus counseling with the use of a visual aid (informed by patient interviews in the first phase) at the time of admission for IOL and studying the effect of the visual aid on patient knowledge, trust in providers, and satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for or admitted for induction of labor and who can speak, read, and write in the English language.

Exclusion Criteria:

* Patients undergoing induction termination or with a history of prior cesarean section, major fetal anomaly, known chromosomal anomaly, or fetal growth restriction with doppler abnormalities. Patients whose induction has already commenced will also be excluded.
Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes

Chicago is an epicenter for asthma health disparities in the U.S., with African-American children 5-11 yrs bearing a disproportionate share of the burden. Among the most visible of these disparities is the high rate of visits to the Emergency Department (ED) for uncontrolled asthma. Clinical uncertainties regarding the real-world effectiveness of guideline recommendations for ED discharge and strategies to reduce environmental triggers at home contribute to practice variation and poor adherence to guidelines. The CHICAGO Plan tests both ED- and home-level interventions to improve clinically meaningful outcomes in a minority pediatric ED population with uncontrolled asthma.


Eligibility Criteria:
Inclusion criteria (all of the following):

1. Child is 5-11 years of age (a population in whom a diagnosis of asthma is generally reliable, and in whom exacerbations are common);
2. Child is presenting to the ED, urgent care center, or observation unit at a participating clinical center (Anne and Robert H. Lurie Children's Hospital of Chicago, Sinai Health System's Mount Sinai Hospital, John H. Stroger Jr. Hospital of Cook County Health \& Hospitals System, Rush University Medical Center, University of Chicago Medicine Comer Children's Hospital, and the University of Illinois Hospital \& Health Sciences System);
3. Child is treated with at least 1 dose of an inhaled or nebulized short-acting bronchodilator (quick-relief medication);
4. Child received systemic corticosteroids in the ED OR the caregiver reported at least 1 additional acute care visit for asthma in the previous 6 months (defined as an asthma-related ED visit or urgent care visit, or course of systemic corticosteroids);
5. Child and caregiver approached at least 1 hour after receipt of the first dose of quick-relief medication or systemic corticosteroids, whichever occurred first;
6. Diagnosis of asthma exacerbation by treating clinician;
7. Treating ED clinician indicates the child is likely to be discharged to home; and
8. Caregiver reports that English or Spanish is the preferred language at home.

Exclusion criteria (none of the following):

1. Caregiver declines to provide informed consent, or the child declines to provide assent;
2. Child is admitted to an intensive care unit or transferred to another healthcare facility;
3. Child or another member of the child's primary household is a current or previous participant in the CHICAGO Plan;
4. Child is enrolled in another study involving a health-related intervention;
5. A CHW is already visiting the home as part of another program;
6. Child does not reside in Chicago.
Bioavailability Study of Ondansetron 16 mg Orally Disintegrating Tablets Under Fasting Conditions

Single-dose cross over comparative bioavailability of Ondansetron 16 mg ODT and Zofran 16 mg ODT

To Compare the single-dose bioavailability of Kali's Ondansetron 16 mg ODT with that of GlaxoSmithKine's Zofran 16 mg ODT under fasting conditions

Eligibility Criteria:
Inclusion Criteria:

* Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form(ICF) duly signed by the volunteer
* Males and females aged between 18 and 55 years with a body mass index (BMI) greater or equal to 19 and below 30 kg/ m2
* Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance(laboratory tests are presented in section 6.1.1.3)
* Healthy according to the laboratory results and physical examination.
* Non- or ex- smokers

Exclusion Criteria:

* Significant history of hypersensitivity to ondansetron or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs.
* Presence or history of significant gastrointestinal, liver or kidney disease, or any conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
* Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
* Females who are pregnant, lactating or are likely to become pregnant during the study phases.
* Females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the body.
* Positive serum pregnancy test before and during the study.
* Maintenance therapy with any drug, or significant history or drug dependancy, alcohol abuse (\>3 units of alcohol per day, intake of excessive alcohol, acute or chronic).
* Any clinically significant illness in the previous 28 days before day 1 of this study.
* Use of enzyme-modifying drugs in the previous 28 days before 1 day of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.).
* Participation in another clinical trial in the previous 28 days before day 1 of this study.
* Donation of 500 mL of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study.
* Positive urine screening of drugs of abuse (drug names are presented in section 6.1.1.4).
* Positive results to HIV, HBsAg or anti-HCV tests.
A Comparison of Protein-bound and Large Molecular Weight Uremic Toxin Removals With Novel Super High-flux Dialyzer Between Hemodialysis and High Volume Online HDF Modalities

The goal of this prospective, randomized, crossover study is to study about using super high-flux dialyzer in the chronic hemodialysis patients.

The main questions aim to answer are the reduction ratio of protein bound uremic toxins

Participants will undergone the pre-dilution online hemodiafiltration and conventional hemodialysis for each 8 weeks followed by washout phase for 4 weeks.

Other secondary outcomes that the researcher wants to study are

1. The reduction ratio of Beta2microglobulin, kappa and lambda free light chain
2. Serum albumin and dialysate albumin loss
3. Quality of life, muscle mass and nutritional status of the patients

Eligibility Criteria:
Inclusion Criteria:

* Chronic hemodialysis patients in King Chulalongkorn Memorial hospital
* Residual renal function less than 100 ml/day

Exclusion Criteria:

* Dialyzer allergy
* Malnutrition requiring intradialytic parenteral nutrition
* Cirrhosis child C or decompensated cirrhosis
* Active uncontrolled infection
* Active cardiovascular disease
* Advanced stage malignancy
* Predicted to be undergone living related kidney transplant within 1 year
Comparison of Physical Activity Level Between Patients With Bronchiectasis and Healthy Subjects

The purpose of this study is to compare physical activity levels between patients with bronchiectasis and healthy subjects.

We hypothesize that patients with bronchiectasis will have lower levels of physical activity, since physical activity levels is affected by reduced exercise tolerance, severity of disease and other disease related symptoms and conditions.

Physical activity limitation in chronic respiratory diseases is caused by many factors including respiratory, hemodynamic, and peripheral muscle weakness. Bronchiectasis is characterized by irreversible widening of the medium-sized airways, with inflammation, chronic bacterial infection and destruction of the bronchial walls. In addition to pulmonary function worsening, extra pulmonary features such as reduced peripheral muscle endurance can be a significant physical problem which causing a decrease in physical activity levels.

Despite physical activity is considered to be essential for the management of chronic respiratory diseases, there is a lack of scientific study, which compares physical activity levels between patients with bronchiectasis and healthy subjects.

This study will assess physical activity level, exercise capacity, quality of life and peripheral muscle strength in patients with bronchiectasis compared to healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria of the Bronchiectasis Group:

1. Diagnosis of bronchiectasis
2. Being 18 years of age or older
3. Able and willing to complete the informed consent process.
4. Able to walk and co-operate

Exclusion Criteria:

Exclusion criteria of Bronchiectasis Group:

1. Unstable medical condition
2. To have severe neurological, orthopedic problems or severe heart failure.

The control group will consist of healthy subjects.
The Efficacy and Cerebral Mechanism of Intradermal Acupuncture for Major Depressive Disorder

Major depressive disorder (MDD) is highly prevalent, affecting nearly 4% of the global population. Pharmacotherapy is the frontline treatment recommended by the guideline, but it also has some limitations such as delayed onset, inadequate response, and drug resistance. Intradermal acupuncture (IA) is a method of using short indwelling needles retained under the skin to produce continuous stimulation for long-term efficacy. It has been reported that IA combination medication appears to be more valuable than medication alone in the treatment of MDD, however, there is a lack of high-quality clinical evidence.While several studies have proposed that manual or electroacupuncture can improve MDD symptoms by modulating brain networks, the cerebral mechanism of IA as superficial acupuncture for MDD has not been reported. Hence, investigators designed a multicentre randomized controlled trial to assess the clinical efficacy and safety of IA for MDD and preliminarily explore the potential therapeutic mechanisms for IA by functional magnetic resonance imaging (fMRI) .

A total of 120 patients with MDD who meet the inclusion criteria will be included in the study. Participants will be randomly assigned 1:1:1 to the waiting list group (patients in this group will be treated with selective 5-hydroxytryptamine reuptake inhibitors (SSRIs) only), sham intradermal acupuncture combined with SSRIs (SIA) group and active intradermal acupuncture combined with SSRIs (AIA) group. The study will assess the efficacy and safety of intradermal acupuncture for MDD. In addition, investigator will explore the possible cerebral mechanisms by which IA exerts its antidepressant effects.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with MDD according to the International Classification of Disease-10 (ICD-10);
2. Aged between 18 and 60 years (no limitation on gender);
3. Administration of SSRIs;
4. Patients undergoing MRI and MRS should be right-handed and free of traumatic brain injury, claustrophobia or metal implants;
5. Written informed consent is obtained by the person or guardian.

Exclusion Criteria:

1. ICD-10 diagnoses: schizophrenia, bipolar disorder, manic episode or other psychotic disorders; alcohol and drug addiction;
2. Significant skin lesions, severe allergic diseases, tumors, and severe or unstable internal diseases involving the cardiovascular, digestive, endocrine, or hematological system;
3. Acute suicidal tendency;
4. Allergy to adhesive tape and fear of intradermal acupuncture;
5. Pregnancy and lactation;
6. Mental retardation and difficulty cooperating with doctors.
7. Participating in other clinical trials.
Clinical and Functional Outcomes at Least 2 Years After Hamstring Muscle Repair

This study is to evaluate functional outcomes of a new, intraoperative lateral positioning of the anchors on the tuber ischiadicum, in comparison to regular anatomical anchoring direct on top of the tuber ischiadicumafter hamstring muscle repair. This study is to quantify at least 2 years postoperative functional, biomechanical and clinical outcomes including side-to-side differences in muscle strength, unipedal balance, gait, jumping and squatting function, muscle activity, in patients treated by hamstring muscle repair.

The design of this pilot study is a descriptive cross-sectional single centre analysis involving all patients previously treated with hamstring repair. All of these patients will be asked to participate in clinical and detailed functional analysis at least 2 years after surgery. Specifically, biomechanical and functional data including isokinetic muscle strength, clinical scores, ROM, joint kinematics and kinetics during walking, running, squatting and single leg jumps, muscle activity and single leg balance ability in the affected and contralateral leg will be collected. These parameters will be compared between legs and correlated with clinical scores.

Eligibility Criteria:
Inclusion Criteria:

* At least 2 years since hamstring muscle repair

Exclusion Criteria:

* Revision surgery within 6 months before testing on the ipsilateral knee and hip
* BMI \> 35 kg/m2
* Previous injury and surgical procedures of the contralateral knee and hip within the last year
* Neuromuscular disorders affecting lower limb movement
* Additional pathologies that influence the mobility of the lower extremity
* Inability to provide informed consent
Drug-coated Balloons in Big de Novo Coronary Disease

A prospective, multicenter, randomized controlled, open-label, non-inferiority trial. Plan to recruit 240 patients whose lesions are de novo coronary artery disease (reference vessel diameter ≥ 3.0 mm), diameter stenosis ≥ 75% with ischemic symptoms or objective evidence of ischemia (ECG, cardionuclide, or FFR), and are suitable for implantation DES or DCB. After successful preconditioning, patients were randomly assigned to two PCI treatment groups(drug-coated balloon or drug-eluted stent) in a 1:1 ratio. The safety and efficacy of drug-coated balloons in PCI treatment of de novo coronary artery lesions (reference diameter 3.0 mm and above) were evaluated by comparing the late lumen loss of two groups of subjects in 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old;
* Asymptomatic myocardial ischemia, stable or unstable angina;
* The subject (or legal guardian) understands the trial requirements and treatment process, and signs a written informed consent before performing any prescribed inspection or operation;
* Willing to undergo all follow-up evaluations requested by the trial, including admission angiographic evaluation at 12 months;
* The target lesion must be the de novo lesion, and the diameter of the reference vessel is ≥3.0mm.

Exclusion Criteria:

* Patients with acute ST-segment elevation myocardial infarction/non-ST-segment elevation myocardial infarction within 3 months;
* Hypersensitivity to the investigational balloon/stent system or concomitant medications required by the protocol;
* Intolerant of dual antiplatelet therapy, or clinical conditions requiring long-term use of oral anticoagulants;
* Life expectancy is less than 12 months;
* eGFR≤30ml/min/1.73m2 or blood purification treatment;
* LVEF≤40% or NYHA cardiac function class≥III;
* Clinical conditions of severe hepatic insufficiency and coagulation disorder
* Pregnant or breastfeeding women;
* Participating in another clinical trial and have not completed the primary endpoint observation of the trial;
* Reference lumen diameter \> 4.0mm;
* Branch vessels ≥ 2.0 mm in diameter that may require intervention in the target lesion;
* The vessel where the target lesion is located has an independent lesion with a diameter stenosis of ≥50% and requires interventional therapy;
* Chronic total occlusive disease;
* Left main stem disease;
* Severe calcification, tortuous blood vessels, existing dissection or severe thrombus burden, the investigator judges that DCB is not suitable for treatment of lesions;
* Lesions with failed preprocessing, or lesions whose length exceeds the length of a single DES/DCB need to be covered after preprocessing