cyrilzakka/clinical-trials huggingface dataset:
A Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes

The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* Have been taking a basal insulin Glargine, at dose of ≥ 20 units/day, for at least 3 months prior to study start.
* Have been taking basal insulin Glargine at dose of ≥ 20 units/day, in combination with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months prior to study start:

  * Metformin or immediate-release metformin or extended-release metformin alone at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start; or
  * Metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to study start.
* Have an HbA1C \> 7.0% and ≤ 10.0%.
* Have a body mass index (BMI) between ≥ 25 and ≤ 45 kg/m2.

Exclusion Criteria:

* Are currently taking OAM that is not described above and not allowed with concurrent use of insulin per local product label.
* Have taken more than 1 week within 1 month prior to the study start any glucose-lowering medications not included above either alone or in combination formulations, or have used a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar over-the-counter medications).
* Have taken any insulin other than Glargine within the 3 months prior to study start for more than 1 week.
* Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start.
* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
* Have previously completed or been withdrawn from this study after enrollment.
Characterizing Adherence to Treatment and Satisfaction With Care in Patients With Cutaneous Lupus

This multicenter study aims to evaluate treatment adherence and satisfaction of patients with cutaneous lupus, influenced by perception of the disease, fear of side effects, cost of medications and the doctor-patient relationship. Adherence will be measured by a VAS of 80% or higher on the Medical Adherence Self-Report Inventory scale.

This multicenter, cross-sectional study aims to characterize adherence to treatment and satisfaction of patients with cutaneous lupus. Non-adherence to treatment is a major problem, influenced by perception of the disease, fear of adverse effects, cost of medications and the doctor-patient relationship. Adherence will be measured by a VAS of 80% or more on the visual analog scale of the Medical Adherence Self-Report Inventory questionnaire.

The study is descriptive, multicenter and cross-sectional. Participants will be adult patients suffering from cutaneous lupus, diagnosed by a dermatologist and under treatment, able to complete questionnaires. Patients with systemic lupus, cognitive or psychiatric disorders will be excluded from the study.

The inclusion period is two years, with 30 minutes of follow-up per participant. The study will provide a better understanding of the feelings of patients with cutaneous lupus and the factors limiting their adherence to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cutaneous lupus (pure cutaneous or subacute) diagnosed by a dermatologist and under local and/or systemic treatment for cutaneous lupus
* No opposition to participation
* Patient able to complete the questionnaires
* Adult patient

Exclusion Criteria:

* Systemic lupus with multiple visceral involvement
* Cognitive or psychiatric disorders preventing the smooth running of the study
* Pregnant woman
* Patient under guardianship/curatorship or safeguard of justice
Carrilizumab Combined With White Purple for Squamous Cell Carcinoma of Skin

This study intends to conduct a single-arm, prospective and open clinical study, using carrellizumab combined with albumin-binding paclitaxel regimen for first-line treatment of squamous cell carcinoma of the skin, including 24 patients with squamous cell carcinoma of the skin, to further confirm the efficacy and safety of Carrellizumab combined with albumin-binding paclitaxel in the treatment of squamous cell carcinoma of the skin.

This study intends to conduct a single-arm, prospective and open clinical study in the Department of Bone and Soft Tissue of Henan Cancer Hospital. The first-line treatment of squamous cell carcinoma of the skin with carrellizumab combined with albumin-binding paclitaxel regimen is adopted. 24 patients with squamous cell carcinoma of the skin are included. It is intended to further confirm the efficacy and safety of carrellizumab combined with albumin-binding paclitaxel in the treatment of cutaneous squamous cell carcinoma.

Eligibility Criteria:
Inclusion Criteria:

Patients ≥18 years old; ECOG score 0\~1, organ function is good; Histologically confirmed first-line treatment for locally advanced or relapsed metastatic squamous cell carcinoma of the skin.

There were measurable tumor lesions evaluated by MRI or CT during the 21 days prior to enrollment;

If you have received antitumor therapy, the following conditions should be met:

1. The interval between systemic radiotherapy and the first dose in this study was ≥3 weeks, and the interval between local radiotherapy was ≥2 weeks;
2. The interval between previous chemotherapy, targeted therapy, biotherapy, endocrine therapy and other antitumor therapies and the first administration in this study was ≥4 weeks; Normal function of major organs (within 14 days prior to treatment); For female patients who are not menopausal or have not been surgically sterilized: consent to abstinence from sex or use of effective contraceptive methods during treatment and for at least 7 months after the last dose in the study treatment; The patients voluntarily participated in this study and signed the informed consent.

Who can be included as judged by the researcher.

Exclusion Criteria:

Previously received anti-PD-1, anti-PD-L1, anti-PD-L2 drug therapy; Also receiving antitumor therapy in other clinical trials; Had major surgical operations within 4 weeks prior to enrollment, or had not fully recovered from such operations; Serious heart disease or discomfort or concomitant disease that, according to the judgment of the investigator, seriously endangers the safety of the patient or affects the completion of the study; Allergic reactions: Patients who are allergic to the investigational drug or to any investigational drug component in the chemotherapy regimen are not recommended for inclusion.

Pregnant and lactating women, fertile women who tested positive for baseline pregnancy tests, or patients of childbearing age who did not want to take effective contraceptive measures during the entire trial period and within 6 months after the last study; Those considered unsuitable for inclusion by researchers.
Registry Study on "Control Nocturnal Hypertension to Reach the Target "

Ambulatory blood pressure monitoring (ABPM) is a major innovation in the history of hypertension diagnosis. In clinical practice, the most well established indication for using ABPM is to identify patients who have high BP readings in the office but normal readings during usual daily activities outside of this setting or vice versa, and to identify varying 24-h BP profiles. However, in recent years, there has been increasing interest in BP values during sleep, and nocturnal BP is now recognized to be superior to daytime BP in predicting fatal and nonfatal cardiovascular events (stroke, myocardial infarction, and cardiovascular death), especially in medicated patients.

The current direction in the management of hypertension is toward earlier and lower BP control for 24 hours, including the nocturnal and morning periods. Therefore, it may be of great significance to pay attention to the management of nocturnal blood pressure so as to reduce the increased cardiovascular risks.

Information of nocturnal hypertensive patients defined by ABPM was prospectively registered nationwide, and then to investigate whether there was difference in cardiovascular prognosis according to the control of ambulatory nocturnal blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Age 50-79 years old
* Clinical diagnosed hypertension with the use of antihypertensive drugs
* Nocturnal hypertension ( nocturnal systolic blood pressure ≥ 130 mmHg and/or nocturnal diastolic blood pressure ≥ 80 mmHg)
* A 24-hour ambulatory blood pressure monitoring was performed with validated equipment.
* Willing to provide information about disease history and blood biochemical test data within 6 months.
* Sign the informed consent

Exclusion Criteria:

* Without antihypertensive drug use
* Hospitalized hypertension patients
* Non-compliant patient
Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.


Eligibility Criteria:
Inclusion Criteria:

* Rutherford Clinical Category 4-5
* Life expectancy \> 1 year
* Significant stenosis ≥70%
* Patent inflow artery
* Target vessel(s) diameter between 2 and 4 mm
* Target vessel(s) reconstitute(s) at the ankle

Exclusion Criteria:

* Pregnant or planning to become pregnant
* History of stroke within 3 months
* Planned major amputation
* eGFR \<30
* Acute limb ischemia
* Prior stent placement in target lesion
Fundus Optical coheRence Tomography Angiography Evaluation for Small-vessel Health in Cerebral Small Vessel Disease

Cerebral small-vessel disease (CSVD) is a significant contributor to stroke and dementia, primarily impacting individuals over the age of 60. Its prevalence exceeds 70% in the elderly population, imposing a substantial burden on brain health and the economy. Optical coherence tomography angiography (OCTA) is a new type of optical diagnostic imaging technology for non-invasive detection, which can perform multi-dimensional quantitative assessment of fundus retinopathy. Current studies have shown that fundus OCTA-derived parameters may have potential in characterizing imaging changes in CSVD. However, the correlation between retinal/choroidal parameters on OCTA and the CSVD imaging markers remains uncertain. FRESH-CSVD is a prospective, observational study that will use fundus OCTA-derived parameters to screen patients with CSVD, explore the relationship between relevant parameters based on OCTA measurements and CSVD, and evaluate the feasibility and clinical value of identification of CSVD through fundus OCTA.


Eligibility Criteria:
Inclusion Criteria:

1. Older than 35 years old;
2. Patients who underwent Multimodal MRI with any CSVD imaging marker;
3. Subjects who have signed informed consent.

Exclusion Criteria:

1. Patient who was unable to cooperate with examinations;
2. There are known diseases that may cause or worsen CSVD (brain injury, Down syndrome, Alzheimer's disease, Parkinson's disease, etc.);
3. There are known eye diseases or severe underlying fundus lesions that may impact fundus assessment;
4. Suffering from serious systemic diseases, such as heart, liver, kidney diseases or major mental illnesses;
5. Contraindications for imaging examinations

Exit Criteria:

1. Not meet the inclusion criteria.
2. For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator.
3. Any adverse or serious adverse events during the study period judged by investigator
Compare the Effects of Preoperative Pulmonary Rehabilitation Exercises on Postoperative Anxiety and Muscle Strength

Lung cancer, tracheal and bronchial cancers have long been the leading cause of cancer mortality in Taiwan. According to statistics, about 40% of newly diagnosed lung cancers are treated with surgery as the primary treatment. Although early surgery improves survival rates, most patients experience significant decreases in lung function, and physical function after surgery, which affects their quality of life.

Recent studies have found that preoperative and postoperative lung rehabilitation exercises play an increasingly important role in lung cancer care. In Taiwan, postoperative interventions for lung cancer have shown significant benefits, but there is a lack of evidence on the effectiveness of preoperative rehabilitation programs. To understand the effectiveness of the preoperative pulmonary rehabilitation program, a preoperative home rehabilitation program was designed to compare the efficacy of preoperative pulmonary rehabilitation in the current lung cancer care of patients undergoing lung neoplasm surgery.

After confirming that the patient is eligible to participate and the patient signs a consent, basic information and The Hospital Anxiety and Depression Scale (HADS) will be completed at the preoperative clinic, and lung function tests, 30-second 30 seconds sit-to-stand test, grip strength test, physical status assessment, and activity level assessment will be performed. A healthcare instruction manual will be given at the preoperative clinic.

The preoperative exercise group (experimental group) and the control group will be assigned randomly. The preoperative exercise experiment group must complete the related exercises and records. The exercises include upper extremity resistance exercise, lower extremity resistance exercise, aerobic exercise, and respiratory muscle training.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing thoracic surgery with pulmonary resection (including wedge resection, segmentectomy, and lobectomy).
2. FEV1≦80%.
3. over 20 years old.
4. Those who can cooperate with pulmonary rehabilitation and sign the consent form.

Exclusion Criteria:

* Suspected metastases to other organs.
* Unsteady gait, limited mobility, unable to cooperate with exercise training
* Those who cannot communicate in Mandarin or Taiwanese.
* Oxygen saturation ≦85% at rest and without oxygen.
* New York Heart Association (NYHA) defines heart failure as grade IV.
* FEV1\<30% and ever diagnosed COPD patients.
* S/P pneumonectomy patient.
EFFECT OF LOW-LEVEL LASER THERAPY ON STABILITY OF DENTAL IMPLANTS PLACED IN A FRESH EXTRACTED SOCKET

Aim of the study was to evaluate the effect of low-level laser therapy (LLLT) (660nm laser diode 0.5W) on implant stability and crestal bone loss in implants inserted in freshly extracted sockets augmented by Collaplug in the jumping gap.


Eligibility Criteria:
Inclusion Criteria:

* 1. Any non-restorable hopeless tooth: badly decayed tooth that cannot be restored. Tooth with failed endodontic treatment and tooth with longitudinal fracture.
* Type I post-extraction sockets with all bony walls intact.
* No signs of active periodontal disease in the selected tooth.

Exclusion Criteria:

* The presence of any systemic disease that could complicate bone or soft tissue healing after immediate implant placement.
* The presence of acute periapical infection.
* The presence of any local factor that may interfere with extraction as tooth ankyloses.
* Subjects who had undergone therapeutical radiation.
* Patients who had been subjected to or who were under bisphosphonate therapy
Adjustment of Mask Pressure, for Bilevel Positive Airways Pressure Therapy, by Automated Algorithm

The aim of the study is to test the hypothesis that an automated algorithm for desired mask pressure improves breathing pattern and sleep quality in patients with hypercapnic ventilatory failure. For this purpose, The investigators will study different groups of patients, including those with obstructive and restrictive ventilatory defect, and obstructive sleep apnoea, non-naive to conventional bi-level positive airways pressure therapy.

Persisting ventilatory failure associated with chronic obstructive pulmonary disease (COPD), obesity-hypoventilation-syndrome, sleep apnoea or neuromuscular disease is increasingly managed with domiciliary non-invasive positive pressure ventilation (NIPPV).

Optimal settings of non-invasive ventilation are usually titrated manually and require time and expertise. The development of systems lead to automated analysis and development of algorithms to adjust ventilators. However, there is a paucity of optimal algorithms, particularly the problem of upper airway obstruction. Therefore, the central aim of this study is to develop the automated setting of an end-expiratory positive airway pressure (EPAP), because upper airway obstruction is relatively common in this group of patients. We hypothesise that an automated end-expiratory airway pressure (AutoEEP) adjusting algorithm could overcome these problems and further optimise and adjust ventilator settings. Using non-invasive ventilation in patients with hypercapnic ventilatory failure, awake and asleep, we will measure physiological outcome parameters and apply an AutoEEP algorithm, comparing it against usual care.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be patients not naive to noninvasive ventilation, and being so treated for any form of hypercapnic ventilatory failure.
* Previously stabilised on bilevel noninvasive pressure support ventilation.
* Both genders, age \<75years.
* Previously shown to have a requirement for an EEP above cm H2O in order to maintain upper airway patency, or those in whom such a raised EEP would be expected, e.g. obese patients.
* Patients also known to have adequate airway patency at an EEP of 4 to 5 cm H2O will be included to ensure specificity of the algorithm.

Exclusion Criteria:

* Acute critical illness (e.g. acute coronary syndrome, stroke)
* Serious anatomical variations of nose, sinuses, pharynx or oesophagus.
* Any condition at risk of oesophageal bleeding (e.g. oesophageal varices, gastric ulcer, etc.)
* Age \>75 years
* Pregnancy
* Epilepsy
* Psychiatric disorders that could possibly influence the study
* Any kind of addiction
* Insufficient knowledge of the language
* Noninvasive ventilation otherwise contraindicated
Shockwave Therapy Versus LIPUS on Mandibular Fracture Bone Healing

compare between the effect of shockwave therapy and low-intensity pulsed ultrasound on healing process of fresh mandibular fractures

The mandible is the commonest facial bone to fracture. Mandibular fractures represent more than 74% of all maxillofacial fractures.

To compare between the effect of shockwave therapy and low-intensity pulsed ultrasound on healing process of fresh mandibular fractures.

A total of 21 patients; aged between 20-40 years, who have mandibular fracture were selected for this study from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University. In this study all patients were subjected to closed reduction and intermaxillary fixation. This will be followed by shockwave therapy in seven patients as a study group and by low-intensity pulsed ultrasound in seven patients as study group. Seven patients will receive neither and will constitute the control group.

Eligibility Criteria:
Inclusion Criteria -Patients selected for this study will have fresh fracture mandible which is indicated for closed reduction.

Exclusion Criteria

-Patients having the following criteria will be excluded scars, burns, infection in the Skin in the relevant working area
Efficacy and Safety of Deep Sea Water on the Blood Glucose Level

This study was conducted to investigate the effects of daily supplementation of deep sea water on improvement of hyperglycemia

This study was a 8 weeks, randomized, double-blind, placebo-controlled, cross-over clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Fasting plasma glucose concentration of 100-140 mg/dL or 2h-postprandial plasma glucose concentration of 140 \~199 mg/dL

Exclusion Criteria:

* Patients with type 1 or type 2 diabetes
* HbA1c ≥9.0%
* Weight decreased by more than 10% within past 3 months
* Have clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatic biliary system, kidney and Urinary system, neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies, gastrointestinal disorders, etc.
* Hypoglycemic agent, obesity medicine, lipid lowering agent within past 6 months or functional food within past 2 month
* Subjects who have taken corticosteroid within past 1 months
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test by show the following results

  * Serum AST (aspartate aminotransferase) or ALT (alanine aminotransferase) \> 2 times the upper limit of normal range
  * Serum Creatinine \> 2.0 mg/dl
* Pregnancy or breast feeding
* If a woman of childbearing doesn't accept the implementation of appropriate contraception
* Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc
Mastery, Social Support and Depression of Patients With Major Depression

The purpose of this study was to discuss the relation of mastery, social support and depression in patients with depressive disorder. Cross-sectional quantitive study and purposive sampling method were designed. Data collection and analysis was conducted through structural questionnaires (including demographics, social support scale, mastery scale, CESD scale) at a medical center in Taipei. Results showed that patients with depression whose degree of depression was negative correlated with mastery and social support, and mastery was positive correlated with social support. Regression statistics results showed that mastery, social support, age, loss of jobs can predict degree of depression up to 60 percent. The mastery was strongest independent predictable factor to degree of depression, and had partial or total mediate effects to age, loss of jobs, financial condition, and social support. The result of this study suggested that clinically the care of patients with depression should focus on their confidence in mastery and provide strategies to promote their confidence in mastery, which can effectively reduce the degree of depression of those patients.


Eligibility Criteria:
Inclusion Criteria:

* patients with depression

Exclusion Criteria:

-