cyrilzakka/clinical-trials huggingface dataset:
QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes

QR-Bromocriptine as an add-on treatment to insulin and metformin in the management of type 2 diabetes will result in improved glycemic control, reduced exogenous insulin requirement, increased lean fat mass and improved pancreatic beta-cell function.

To assess improvement in glycemic control, reliance on exogenous insulin, improvements in lean body mass composition, and improvements in pancreatic beta-cell function.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients, age 30 to 65 years of age,
2. Clinical diagnosis of type 2 diabetes at least 6 months prior to enrollment,
3. Stable on current treatment consisting of either human or recombinant multi-dose insulin therapy (MDI) with metformin,
4. HbA1c of 7.5-12%, inclusive,
5. Demonstrated willingness to check and record blood glucose readings at seven time points as instructed in the study protocol.
6. Medically controlled hypertension, at least on one anti-hypertensive
7. Medically controlled hyperlipidemia, on or off cholesterol-lowering therapy
8. BMI \>30

Exclusion Criteria:

1. Pregnancy or Lactating,
2. Type 1 Diabetes,
3. Concomitant use of forbidden medications: prescription sympathomimetics (within seven days of screening), ergot alkaloid derivatives, and anti-migraine medications,
4. Patients with history of drug or alcohol abuse within 3 years of enrollment,
5. Patients at risk for hypotension, including those who have:

   * Recent blood donation within 30 days of enrollment,
   * A history of syncopal migraines, or
   * Significant gastroparesis or orthostatic hypotension which could signify advanced autonomic neuropathy.
6. Uncontrolled mental illness especially with history of psychosis,
7. Any severe, uncontrolled or terminal medical condition which the investigator feels would interfere with the patient's ability to participate and comply with the study protocol,
8. Serum creatinine \>1.4mg/dL in females or \>1.5mg/dL in males that would preclude the patient from taking metformin,
9. LFTs elevated \>3x upper limit of normal,
10. Patients working rotating, varying or night shifts, or
11. Patient with circumstances or abnormalities (e.g. blindness or history of non-compliance) that would interfere with the interpretation of safety or efficacy data or completion of the study.
Effects of the Cognitive Enhancing ICT Contents in Patients With Mild Cognitive Impairment

The purpose of this study is to investigate the effect of cognitive rehabilitation program on the improvement of cognitive functions in patients with mild cognitive impairment(MCI).

The cognitive rehabilitation program was developed to improve cognitive functions of the elderly or patients with cognitive impairments. The study will enroll 40 patients with mild cognitive impairment(MCI) between 55 and 75 years of age. Forty subjects will be randomly assigned into two groups. Subjects in the intervention group will receive four weeks of cognitive rehabilitation training, three times per week and 30 minutes per day. The control group will not receive any intervention. The investigator will measure their cognitive and brain functions three times at pre-intervention, post-intervention and four weeks after intervention to assess the effectiveness of the cognitive training program.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed with mild cognitive impairment through clinical interview, neuropsychological tests and brain imaging
* No history of neurologic diseases

Exclusion Criteria:

* Severe cognitive problems(MMSE\<10)
* Other psychiatric disorder including bipolar or schizophrenic disorder
* Other problems disturbing cognitive tests
Use Of The ABSS In Infants With ARIS Treated With Outpatient Respiratory Physiotherapy

Background. Acute respiratory infections in childhood have high incidence and morbimortality rates, generating significant sanitary and social costs. Due to its diversity of manifestations and clinical forms, the degree of severity varies widely.

Published acute respiratory infections assessment severity scales are mainly focused on acute bronchiolitis, but there is no validated scale to evaluate the effects of respiratory physiotherapy in acute respiratory infections in children.

Objective. To study the usefulness of the Acute Bronchiolitis Severity Scale to assess children under 24 months suffering from acute respiratory infections susceptible to receive outpatient respiratory physiotherapy treatment.

Methods. Pre-post assessment descriptive study using the Acute Bronchiolitis Severity Scale. Children under 24 months suffering from acute respiratory infection will be evaluated during the first outpatient respiratory physiotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* Under 24 months
* ARIS diagnosed
* Medical indication of respiratory physiotherapy
* Evaluated during the first outpatient respiratory physiotherapy treatment

Exclusion Criteria:

* Chronic desease
* ABSS ≥ 7
* Temperature≥ 38ºC
* Stridor
* Expiratory groan
* Sternal sinking
* Any sign or symptom indicative of need for urgent medical evaluation
A Single-center, Open Trials to Evaluate the Safety of Freeze-dried Group ACYW135 Meningococcal Conjugate Vaccine

Safety Evaluation of freeze-dried Group ACYW135 Meningococcal conjugate vaccine in healthy people above 2-months-old

There are five different age groups(18\~55 years/7\~17 years/1\~6 years/7\~10 months/2 months),each group has 40 people and divided into two subgroups. Each subgroup will inject different vaccine(MCV4 4μg,MCV4 8μg).For 7\~10 months\&2 months age groups,there are 2\&3 injection seperately. Each injection interval is 1 months.

After 7 days observation of 1 dose immunization in Group 18-55 years old adults, if there are no serious adverse events associated with vaccines, or severe adverse reactions rate is less than 10%, 7 to 17 years old and 1 to 6 years old age groups will continue to inoculate in order. After the first dose of 7\~10 months group and evaluating safety, 2 months group immunized the first dose. All participants completed the immune procedure, then observed the safety to 30 days after whole immunization.

Data collection: Subjects completed diary card, the researchers collected original data and fill out the case report form for data entry and statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants unimmunized Group A\&C meningococcal conjugate vaccine or Group A meningococcal polysaccharide vaccine which is above 2\~11 months-old, and healthy toddler more than 1-year-old without booster immunization.
* The guardian or himself informed consent, and signed the informed consent form;
* The guardian and family agreed to abide by the requirements of clinical trial scheme;
* Participants has no history of immunoglobulin vaccination in the last 2 months / 2 months-old infants has no history of immunoglobulin vaccination after born, there is no history of other live vaccine inoculation before vaccination in 14 days, within 7 days without other inactivated vaccine immunization history;
* the axillary temperature \< 37.1 ℃;
* 2-months-old group in the age of 61-90 days;
* 7-months-old group in the age of 211-300 days;
* 1-year-old group in age of one full year of life.

Exclusion Criteria:

* Have allergies, convulsions, seizures, encephalopathy and psychiatric history or family history;
* Neomycin, streptomycin and polymyxin B allergies;
* With immunodeficiency, immunosuppressant therapy;
* History of meningitis;
* Women in lactation or pregnant;
* Acute febrile diseases and infectious diseases;
* History of labor abnormalities, choking rescue, congenital malformations, developmental disorders or serious chronic disease patients;
* Had a severe allergic reaction of vaccination in the past;
* Took oral steroids more than 14 days in last month;
* Had high fever (axillary temperature≥38.0℃ or higher)in the past three days;
* Prepare to attend or is in any other drug clinical study;
* Meningococcal vaccine contraindications and any situation which researchers think that may affect test evaluation.
Efficacy and Safety Assessment of IRE of Localized Prostate Cancer

The purpose of this study is to evaluate safety and short-term oncological efficacy of the NanoKnife Irreversible Electroporation System for localised prostate cancer.

Irreversible electroporation (IRE) is the method of focal treatment for prostate cancer, which is already proven by FDA as method of the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.

Detailed Description:

Irreversible electroporation is a newly developed non-thermal tissue ablation technique in which short duration electrical fields are used to form permanent nanoscale defects in the cell membrane which leads to cell apoptosis. Thus, IRE is a non-thermal technique, which means that changes associated with tissue freezing or heating are not relevant.

Moreover, animal studies of IRE in the canine prostate have demonstrated that structures such as ejaculatory ducts, neurovascular bundles, blood vessels, and the urethra heal normally after ablation. The reason is that collagen matrix during treatment with IRE is not destroyed thus allowing for a large structures (blood vessels, nerves, etc.) to heal normally.

This study is a prospective and non-randomized with one group of 12 patients eligible for focal therapy of prostate cancer with IRE (eligibility defined by this protocol).

Before the surgery all patients will underwent transperineal MRI-fusion biopsy to localize the prostate cancer foci.

Objectives of the study: to asses safety of IRE in patients with localized PCa, to asses short-term oncologic efficacy of IRE in patients with localized PCa, to asses functional outcomes after IRE.

All patients will be followed up for 1 year (each 3 months).

Eligibility Criteria:
Inclusion Criteria:

* Verified with MR-fusion biopsy localized Pca
* PSA \< 20 ng/ml
* Gleason score 3+3=6; 3+4=7 OR Grade Group 1 and 2
* Life expectancy \> 10 years
* No post-void residual urine or infravesical obstruction

Exclusion Criteria:

* patients with artificial cardiac pacemaker
* patients not eligible for general anesthesia
* patients after primary Pca treatment
* hormonal therapy six months before the study
* radiotherapy of pelvic organs
* urinary infection
* extracapsular Pca
* patients with metastatic lesions
Contribution Of Nuclear Magnetic Resonance Imaging In The Study Of Diabetic Cardiomyopathy

Diagnosis of diabetic cardiomyopathy is then retained, supposing a change in the coronary microcirculation linked to an endothelial dysfunction. Abnormalities of the myocardial metabolism is frequently associated. It is regrettably about a hypothesis difficult to verify with current medical techniques.This deficiency being not only harmful to the diagnosis, but also to the assessment of the efficiency of the medical treatment on the myocardial metabolism and the endothelial function. Techniques of nuclear magnetic resonance offer interesting perspectives.

These techniques allow in this context:

1. to quantify the myocardial blood flow at rest and after "cold pressor test" in a population of healthy volunteers. The myocardial blood flow will be obtained by estimating myocardial blood flow at the venous coronary sinus site. This allows us to quantify a possible endothelial dysfunction in a reproducible way. No MRI study in diabetic patients has ever been led until now with this technique.
2. to estimate the metabolic and structural abnormalities in this population, with particularly:

   * Quantification of the myocardial metabolism in vivo by spectrometry of phosphorus 31.
   * Structural abnormalities: become integrated into the description of diabetic cardiomyopathy.

Eligibility Criteria:
Inclusion Criteria:

* more than 18 years old
* patient type 2 diabetes affects taken care more than 5 years to Timone Hospital
* patient with a diabetic cardiomyopathy
* informed and consented

Exclusion Criteria:

* less than 18 years
* Pregnant woman
* patient type 1 diabetes affects
* patient presents a cardiomyopathy mixed (no diabetic)
* patients presents an arrhythmia ventriculaire or above - ventriculaire
* Unstable hémodynamique patients
Role of Cross Sectional Imaging Modalities in the Diagnosis and Characterization of Colonic Masses

Colonic masses are frequently encountered in clinical practice and can be benign or malignant. Accurate characterization is crucial for optimal management. Traditional imaging techniques such as colonoscopy remain the gold standard; however, multi-modality imaging-including computed tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography (PET)-has gained importance.

Colorectal cancer (CRC) is one of the most commonly diagnosed malignancies worldwide, ranking as the third most common cancer and the second leading cause of cancer-related mortality. According to the Global Cancer Observatory (GLOBOCAN), in 2020, there were approximately 1.9 million new cases of CRC and over 930,000 deaths. The incidence varies geographically, with higher rates in developed countries due to lifestyle factors, dietary habits, and genetic predispositions. Early detection through screening and imaging plays a pivotal role in reducing morbidity and mortality. (Sung et al., 2021).

Recent studies have demonstrated that multi-modality imaging improves diagnostic confidence in colonic lesions. CT colonography has been shown to have a sensitivity of approximately 96% for detecting polyps ≥10mm (Pickhardt et al., 2019). MRI provides superior soft tissue contrast, aiding in local tumor staging (Beets-Tan et al., 2020). These advancements underline the importance of integrating multiple imaging techniques for comprehensive colonic mass evaluation.

Staging of colorectal cancer is crucial for treatment planning and prognosis assessment. The TNM (Tumor, Node, Metastasis) staging system is widely used:

* T (Tumor size and invasion): Ranges from T1 (tumor confined to the mucosa) to T4 (tumor invading adjacent structures).
* N (Lymph node involvement): N0 (no nodal involvement) to N2 (extensive nodal spread).
* M (Distant metastases): M0 (no metastases) to M1 (presence of metastases). Imaging plays a fundamental role in staging. CT is the primary modality for detecting lymph node involvement and distant metastases (Liu et al., 2020). MRI, particularly with diffusion-weighted imaging, provides superior soft-tissue contrast for local staging, especially in rectal cancer (Maas et al., 2019).

Colonoscopy with histopathological biopsy remains the gold standard for diagnosing colonic masses. It allows direct visualization, biopsy sampling, and polyp removal if necessary.

This study aims to evaluate the diagnostic accuracy and clinical utility of these imaging modalities in detecting and differentiating colonic masses.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years) referred for imaging due to suspected colonic mass. Histopathological confirmation is available.

Exclusion Criteria:

* • Patients with contraindications to contrast imaging as sensitivity to contrast media or renal impairment

  * Patient with contraindication for MRI e.g patients having a devices with Para magnetic effect e.g pacemakers and claustrophobia
  * Patients with prior colorectal cancer diagnosis or surgical intervention
Trial of Different Dietary Fat Sources on Blood Lipids and Other CVD Risk Factors

This is a randomised trial in which healthy volunteers, men and women aged 50-75 years from the general community are randomized into one of three arms: participants will be provided with 50 gm extra virgin coconut oil, or 50 grams butter or 50 extra virgin olive oil to be eaten daily for a month. The food will be provided in the form of processed cheese to mask participants. The key outcome is blood low density lipoprotein cholesterol concentrations and secondary outcomes blood lipid profile (total cholesterol, high density lipoprotein cholesterol, triglycerides) and anthropometric measures: weight and waist circumference. This trial is powered to detect a difference of 0.5 mmol/L LDL-cholesterol difference between the trial arms.

This is a randomized trial in which healthy volunteers from the general community are randomized into one of three arms: consumption of 50 gm of extra virgin coconut oil daily OR 50gm of butter daily OR 50gm of extra virgin olive oil daily (50gm is about 2 ounces, or 2 table spoons), to be consumed over a one month period. The food will be provided in the form of processed cheese to mask participants.

After full informed consent, participants will attend an assessment visit and have a baseline measures of weight, height, waist circumference, blood pressure, a blood sample for assessment of blood lipids and other metabolic markers, and fill in a health questionnaire and dietary questionnaire. Participants will be randomly allocated to one of three arms: coconut oil, butter or olive oil and will be given supplies of these

After one month, participants will return for follow up assessment which will include a repeat blood sample, anthropometric measures and blood pressure, and questionnaire.

Blood samples collected by venipuncture will be stored at the University of Reading.

At the end of the study, all participants will be given the individual participant results of the anthropometric measures and lipid profiles at baseline and follow up as well as the overall findings of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Willing to participate in the trial of dietary interventions for one month within the age range

Exclusion Criteria:

* No known cardiovascular disease: heart disease or stroke; no known cancer; no known diabetes; no use of lipid lowering medication eg. statins; no contraindications to high fat diet e.g. gall bladder or other gastrointestinal condition
Lung Aeration During WEANing From Mechanical Ventilation Determined by Electrical Impedance Tomography and Lung Ultrasound

Evaluation of lung aeration during weaning from mechanical ventilation determined by electrical impedance tomography and lung ultrasound

Prospective clinical study in ICU with patients during weaning from mechanical ventilation comparing lung aeration determined by electrical impedance tomography and lung ultrasound.

Duration of weaning test is 60 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Adult ICU patients during weaning test from mechanical ventilation
* Consent of patients or family
* Arterial line

Exclusion Criteria:

* Tracheotomized patients
* Dressings in the thoracic area
Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer

For extensive-stage small cell lung cancer (SCLC), platinum-chemotherapy (cisplatin or carboplatin) combined with etoposide as the first-line treatment is recommended. However, the recurrence rate is extremely high after the initial first-line treatment. For those who relapse or progress within more than six minths after the end of the-first-line treatment, chose the current guideline recommendation trearment plan has the poor prognosis. A new immunotherapeutic strategy is needed to achieve better anti-tumor effects. JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA), which restrains immune cells; function and leads to immune escape of tumor cells. The combination of PD-1 and BTLA antibodies has shown a good therapeutic effect in solid tumors. This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 combined with platinum-based doublet chemotherapy in extensive-stage SCLC or relapsed within more than six months after radical treatment SCLC.


Eligibility Criteria:
Inclusion Criteria:

1. The patient shall sign the Informed Consent Form;
2. Aged 18 ≥ years;
3. Histological or cytological diagnosis of SCLC by needle biopsy or EBUS, and extensive stage or recurrent confirmed by imageological examinations or relapsed within more than six months after radical treatment SCLC;
4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1;
5. Life expectancy is at least 12 weeks;
6. At least 1 measurable lesion according to RECIST 1.1;
7. Patients with good function of other main organs (liver, kidney, blood system, etc.);
8. Fertile female patients must voluntarily use effective contraceptives from the start of the trial to within 30 days after its completion, and urine or serum pregnancy test results within 7 days prior to enrollment are negative;
9. Unsterilized male patients must voluntarily use effective contraception during the trial period and for 30 days after its conclusion.

Exclusion Criteria:

1. Patients with a malignancy other than SCLC within five years prior to the start of this trial;
2. Participants with any unstable systemic disease (including uncontrolled hypertension, severe arrhythmia, etc.);
3. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
4. Participants who are allergic to the test drug or any auxiliary materials;
5. Participants with active hepatitis B, hepatitis C or HIV;
6. Participants with Interstitial lung disease currently;
7. Pregnant or lactating women;
8. Any malabsorption;
9. Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
10. Other factors that researchers think it is not suitable for enrollment.