cyrilzakka/clinical-trials huggingface dataset:
Conditions Associated With Poorly Controlled Diabetes in Patients With Type 2 Diabetes and HbA1c Changes With Therapy

In Turkey, only 55% of patients with type 2 diabetes have been diagnosed, and 91% of these patients have been receiving treatment. The rate of patients reaching the treatment target is 50%. The pandemic has also affected diabetic patients. We aimed to determine the characteristics of patients with type 2 diabetes (HbA1c \>=10) with poor metabolic control and to evaluate the extent to which metabolic control can be achieved in 3 months.

Patients who applied to Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcin City Hospital Diabetes Polyclinics and have an HbA1c levels of \>= 10% in their examinations will be admitted to the study. Detailed history, including medication usage and previous blood tests will be questioned. The patients will be asked to complete questionnaires about their eating patterns (mindful eating questionnaire), their physical activities (General practice physical activity questionnaire), and whether they have depression (Beck depression questionnaire).

Anthropometric measurements will be taken, and biochemical data will be recorded. Patients will be grouped according to their previous HbA1c values as a) newly diagnosed, b) those whose diabetes was previously controlled, c) those whose diabetes was previously not at the target range but now worsened, and d) those whose diabetes was poorly controlled from the beginning.

Diabetes follow-up will be continued by their respective physicians. The patients will be called again three months after their enrollment to record the most recent biochemical data. Patient characteristics (age, gender, educational status, depression status, eating awareness, exercise characteristics) will be evaluated in accordance with the predetermined HbA1c groups. Again, according to the patient groups, the difference in HbA1c after three months, the frequency of reaching the target, and possible factors associated with the findings will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with type 2 diabetes
* give consent to the study
* accessibility to the previous and recent test results

Exclusion Criteria:

* acute infection or inflammation lasting more than a week
* acute metabolic decompensation
* unable to attend to the follow-ups
* having non-thyroid endocrine diseases
* active oncologic treatment
A Trial of Doxorubicin/Cyclophosphamide (AC), Docetaxel (D), and Alternating AC and D for Metastatic Breast Cancer

To investigate the clinical benefits of Docetaxel or alternating AC-Docetaxel in comparison with standard AC for metastatic breast cancer

power to detect a 50% increase in median TTF at 0.025 one-sided alpha in AC vs. D and AC vs. AC-D.

Results: 441pts (146 in AC, 147 in D, 148 in AC-D) were randomized between 01/99 and 05/03. Major grade 3-4 toxicities were neutropenia (26/45/46% for AC/D/AC-D), febrile neutropenia (3/4/6%), nausea/vomiting (3/3/4%). There was no toxic death. One grade 4 diarrhea in AC-D and 1 secondary leukemia (APL) in D were reported. Response (CR/PR) rates were 30, 41, and 35% for AC, D, and AC-D respectively. Median TTF (AC, D, and AC-D) are 6.4, 6.4, and 6.7 months (p =.255 for AC vs. D, p =.275 for AC vs. AC-D), and median overall survival are 22.4, 25.7, and 25.0 months (p=.092 for AC vs. D, p=.076 for AC vs. AC-D). The same difference was shown by the adjusted Cox model.

Conclusions: No benefit was demonstrated in D and AC-D over AC in TTF, however, D and AC-D tended to be superior to AC in response rate and overall survival. Survival benefit of front-line docetaxel should be re-evaluated by further long follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Hormonal therapy-resistant MBC
2. ER (-), failure of hormonal therapy for MBC, or relapse within 6 months after adjuvant hormonal therapy
3. No anthracyclines for MBC and no prior taxanes
4. At least 6 months from the completion of adjuvant chemotherapy
5. Measurable or evaluable lesions
6. Age: 20 to 75 years
7. PS: 0-3
8. WBC \>= 4,000 /mm3 or ANC \>=1,000 /mm3, Platelet \>= 100,000 /mm3, SGOT/SGPT \<= 1.5 x ULN, T-Bil \<= 1.5 mg/dL, Cr \<= 1.5 mg/dL
9. normal ECG
10. Written informed consent

Exclusion Criteria:

1. pregnant
2. malignant pleural effusion, ascites, or pericardial effusion that requires emergent treatment
3. Active infection
4. other cancer present within the last 5 years
5. previous stem cell transplantation
6. brain metastasis that requires emergent treatment
7. relapse within 6 months after completion anthracycline or during anthracycline
8. more than 250mg/m2 of anthracyclines
9. hypersensitivity of drug
10. interstitial pneumonitis or pulmonary fibrosis
11. positive HBs
12. antipsychotic medication
13. doctor's judgement
Nailfold Capillaroscopy Evaluation in Cushing Syndrome Patients

This cross-sectional, single-center study will assess the microvascular function using a nailfold video-capillaroscopy in patients with endogenous Cushing syndrome.

Endogenous Cushing's syndrome (CS) is associated with increased macrovascular diseases and impaired endothelial function. There is no clear data about the effects of hypercortisolism on microcirculation.

The primary aim of this study is to evaluate the peripheric microvascular area in patients with Cushing's syndrome. The association of microvascular changes with present comorbidities (diabetes, hypertension, etc.) and disease activation will be evaluated.

Method:

Cushing syndrome patients admitted to our clinic will be included in this study for the next six months after given informed consent.

The following clinical laboratory parameters will be evaluated as cross-sectionally.

Previous medical history, available laboratory parameters (fasting plasma glucose, HbA1c, total cholesterol, triglyceride, HDL, LDL, creatine, AST, ALT, complete blood count, ACTH, dexamethasone suppression tests (1 mg- 2mg), urine free cortisol, FSH, LH, total testosterone, estradiol, IGF-1, TSH, free T3, free T4, prolactin), radiologic images (Cranial MRI and Adrenal MRI) will be recorded from medical charts.

Nailfold microcirculation will be evaluated with video-capillaroscopy: it is a non-invasive atraumatic assessment of the morphology and some functional aspects of cutaneous capillaries.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients diagnosed as Cushing syndrome (CS) caused by ACTH-producing pituitary adenoma or cortisol producing adrenal adenoma
* Age between 18 and 70 years

Exclusion Criteria:

* Chronic glucocorticoid use
* CS caused by ectopic ACTH producing tumors
* CS caused by adrenocortical carcinoma
* Pseudo CS
* Patients with Raynaud phenomenon
* Patients with collagen tissue disease
* Patients who use drugs that affect the metabolism of fibrinolysis (such as oral contraceptives)
* Employees at work at risk of microtrauma (such as gardeners, farmers)
* Skin diseases with nail fold involvement (such as dermatitis, psoriasis)
Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension

The study examined the efficacy of LCZ696 in comparison to the ARB olmesartan on Central Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened pulse pressure (PP).


Eligibility Criteria:
Key Inclusion Criteria:

1. Male and female patients ≥ 60 years of age.
2. Patients with essential hypertension, untreated or currently taking antihypertensive therapy.
3. Untreated patients must have an office msSBP ≥150 mmHg and \<180 mmHg at Visit 101 and Visit 201 if they are newly diagnosed or have not been treated with antihypertensive drugs for the 4 weeks prior to Visit 1.
4. Treated patients must have an office msSBP ≥140 mmHg and \<180 mmHg at Visit 102 (or Visit 103) and msSBP ≥150 mmHg and \<180 mmHg at Visit 201 if they have been treated with antihypertensive drugs for the 4 weeks prior to Visit 1.
5. All patients must have pulse pressure \>60 mmHg at Visit 201. Pulse pressure is defined as msSBP- msDBP.
6. Patients must have a difference in msSBP within +/-15 mmHg between Visit 201 (randomization) and the visit immediately prior to Visit 201.

Key Exclusion Criteria:

1. Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
2. History of angioedema, drug-related or otherwise.
3. History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.
4. Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke.
5. History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
6. History of atrial fibrillation or atrial flutter during the 3 months prior to Visit 1, or active atrial fibrillation or atrial flutter on the ECG at screening.
Conversion or Neoadjuvant Therapy in Hepatocellular Carcinoma

This multicenter retrospective study which included patients with hepatocellular carcinoma (HCC) who received conversion or neoadjuvant therapy to explore the best treatment options and the best benefit group.

More than 50% patients with initial hepatocellular carcinoma (HCC) are diagnosed as intermediate or advanced stage diease. Transarterial chemoembolization and systemic therapy are main treatments for these patients. With the rise of targeted drugs and immunotherapy, more and more patients with advanced HCC have access to curative treatment, thereby extending their overall survival time. In clinical practice, there are many combinations used to treat these patients. However, the safety and efficacy of conversion or neoadjuvant therapy in HCC patients remains controversial.

The aim of this project is to establish a multicentre database from Guangxi province, China, to include as many HCC patients receiving conversion or neoadjuvant therapy as possible. HCC patients who received conversion or neoadjuvant therapy as initial treatment, including hepatic artery infusion chemotherapy (HAIC), transcatheter arterial chemoembolization (TACE), tyrosine kinase inhibitors (TKIs), immune checkpoint inhibitors (ICIs), or radiotherapy were retrospectively enrolled. The purpose of this project is to explore the best beneficiaries of conversion or neoadjuvant therapy, the best treatment strategy, and the follow-up treatment options after successful conversion therapy. The ultimate objective is to provide evidence for the necessity and feasibility of conversion or neoadjuvant therapy for patients with HCC.

The data for this study were derived from the database of the regional registry platform entitled "Guangxi Liver Cancer Clinical Study Alliance (GUIDANCE)" sponsored by the Guangxi Anticancer Association Liver Cancer Committee. All of the included patients were not previously reported and were not enrolled in those industry-sponsored clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or clinically confirmed diagnosis of HCC.
* Patients who received conversion or neoadjuvant therapy as initial treatment, including hepatic artery infusion chemotherapy (HAIC), transcatheter arterial chemoembolization (TACE), tyrosine kinase inhibitors (TKIs), immune checkpoint inhibitors (ICIs), or radiotherapy.
* Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1.
* With Child-Pugh 5\~7 scores.

Exclusion Criteria:

* Concurrent with other malignancies within 5 years.
* Incomplete medical data.
* Follow-up time less than 3 months.
BRIANSTORM - Early Identification of Patients With Brain Metastases

A single arm observational study investigating the incidence of brain metastasis in patients with cancer recti and lung metastasis

In this study the investigators want to investigate the incidence of brain metastasis in a selected high-risk group of patients with metastatic colorectal cancer. Possible prognostic biological aspects will be investigated by translational analysis of biological samples. The study population consists of patients with metastatic rectal cancer and presence of lung metastasis. The patients will undergo a standard MRI scan of the brain including injection of intravenous contrast. If positive finding, images will be evaluated at the multidisciplinary tumor board for potential treatment options according to clinical practice. Standard follow-up program is followed, as per clinical practice. If the initial MRI scan of cerebrum detects brain metastasis this will be treated and followed as per clinical practice. Translational blood samples will be drawn at inclusion and at every imaging schedule up til 5 times

Eligibility Criteria:
Inclusion Criteria:

* Primary rectal tumor location

  * Diagnosis of lung metastasis made by histo- or cytopathology, or by clinical and imaging criteria.
  * Able to understand written information
  * Consent to samples for translational research

Exclusion Criteria:

* Contraindications for MRI Priorly treated or known brain metastases
MICHI™ Neuroprotection System (NPS+f) Filter Debris Analysis Study (The F-1 Study)

This study will be conducted in up to 10 hospitals in Europe, up to 75 patients will be enrolled. The purpose of the study is to evaluate any debris that may be captured in the inline filter of the MICHI(TM) Neuroprotection System with Filter (NPS+f) during its use in a transcarotid stenting procedure. The MICHI NPS+f is an embolic protection device that uses reverse flow to protect the brain during stenting of the Internal Carotid Artery. It is CE marked and is used in routine practice for the purpose of this study.


Eligibility Criteria:
Inclusion and exclusion criteria per CE marked Instructions For Use

Inclusion Criteria:

1. Adequate central venous access
2. Common carotid artery reference diameter of at least 6 mm
3. Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomography (CT) angiography or magnetic resonance (MR) angiography

Exclusion Criteria:

1. Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated
2. Patients with unresolved bleeding disorders
3. Patients with severe disease of the ipsilateral common carotid artery
Association of Hypertensive Disorder of Pregnancy With Sleep-disordered Breathing.

This study aims to assess the prevalence of sleep disorder breathing in pregnant women with a singleton gestation who develop hypertensive disorder of pregnancy (HDP) compared to women without HDP, when matched for gestational age and body mass index.

Sleeping disorder breathing is not only underdiagnosed in the general population, but more specifically in pregnant women. Some recent research has found an association between sleep disorder breathing and preeclampsia. Both conditions have shown to be associated with worse pregnancy outcomes. Therefore, more research is needed to find the strength of these associations. By gathering more information, this provides investigators with an opportunity to see if there is a way to slow the progression of complications in preeclampsia through the management of sleep-disordered breathing. Preeclampsia continues to be one of the top reasons for maternal mortality in the U.S. and this percentage continues to grow each year. Through the study, investigators hope to bring awareness of the comorbidity and how its similar pathogenesis can potential exacerbate complications in pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* 1. Subject who is capable of consenting in English
* 2.Women with a diagnosis of a hypertensive disorder of pregnancy
* 3.Greater than 20 weeks pregnant
* 4.Singleton fetus
* 5.Inpatient

Exclusion Criteria:

* 1.With acute respiratory distress, including asthma
* 2.With micrognathia and other severe craniofacial abnormalities
* 3.Active heart failure
* 4.Sepsis
* 5.Subjects in labor.
Sculptra Aesthetic Post-Approval Study

Study is designed to assess the long-term safety of Sculptra Aesthetic in immune-competent subjects as a single regimen for correction of nasolabial fold (NLF) contour deficiencies and other facial wrinkles.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects seeking correction of shallow to deep NLF contour deficiencies.

Exclusion Criteria:

1. Subjects seeking, at entry into the study, correction of other facial wrinkles with Sculptra Aesthetic in the following anatomical sites/lines: horizontal forehead lines, glabellar frown lines, periorbital lines, periauricular lines, upper lip lines, lower lip lines, corner of the mouth lines and/or horizontal neck folds.
2. Subjects that are less than 18 or greater than 75 years of age.
Prospective Cohort Study for Lymphoma: Samsung Lymphoma Cohort Study III

This prospective study enrolls patients who are diagnosed with aggressive lymphoma including Hodgkin and non-Hodgkin lymphomas. Enrolled patients will be treated according to our institution' treatment policy in clinical practice. The disease status including response to therapy and survival status will be regularly updated during the study period. Patients' serum and cell-free DNA will be collected and analyzed.

The study population is aggressive lymphomas requiring systemic chemotherapy. Newly diagnosed or relapsed/refractory patients can be enrolled into the study. Patients can be treated according to the principle of routine care of our institute. The study process is as follows.

1. Registration after informed consent.
2. Laboratory and radiological evaluation after registration including collection of serum and cell-free DNA from patients' peripheral blood
3. Interim and final response evaluation including collection of serum and cell-free DNA from patients' peripheral blood
4. Regular monitoring disease status and update of survival status
5. Laboratory and radiological evaluation after relapse or progression including collection of serum and cell-free DNA from patients' peripheral blood

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically diagnosed Hodgkin and non-Hodgkin lymphomas
2. 20 years
3. Patients requiring systemic chemotherapy with curative intent
4. Written informed consent

Exclusion Criteria:

1. Myeloid malignancy
2. Multiple myeloma
3. Patients do not require systemic chemotherapy with curative intent
Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes

This trial is conducted in Africa, Asia, Europe, Oceania and South America.

This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months
* Ongoing stable treatment with metformin for at least 2 months
* Ongoing stable treatment with minimum half maximal dose of any insulin secretagogue for at least 2 months
* Insulin naive
* HbA1c (glycosylated haemoglobin A1c) between 7.0% and 11.0% (inclusive of both values)

Exclusion Criteria:

* Metformin contraindication according to local practice
* TZD (thiazolidinedione) treatment for the last 5 months before trial start
* Systemic treatment with any corticosteroid 3 months before trial start
* Any disease or condition which according to the Investigator would interfere with the trial
The TRICURE First in Human Trial

The objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.

The TRiCares Topaz Prosthesis is intended to replace a diseased tricuspid heart valve via a transcatheter approach without removing the native valve.

Eligibility Criteria:
Inclusion Criteria:

* Subject of age \>18 years.
* Subject with severe symptomatic tricuspid regurgitation presenting following conditions:

  1. TR severity of at least 3 (severe) on a scale of 0 (none) to 5 (torrential), assessed by independent core lab and/or
  2. symptoms requiring use of diuretics.
* Subject presenting with New York Heart Association Class NYHA ≥II.
* Subject is not eligible for open tricuspid valve surgery due to high operative risk, as determined by a Heart Team decision.

Exclusion Criteria:

* Subject in need of emergent or urgent intervention or any planned cardiac intervention within the next 12 months.
* Subject undergoing cardiac interventions within 30 days prior to index procedure.
* Subject with concomitant clinically relevant mitral, aortic, pulmonary regurgitation/stenosis.
* Subject who had previous tricuspid valve replacement or repair and a device is still in situ.
VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS

The efficiency and safety of PD-1 inhibitor in combination with venetoclax and hypomethylation agent in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndrome remain uncertain. In this study, the investigators aimed to assess safety and response to a new PD-1 inhibitor-based triple-drug combination regimen (venetoclax + hypomethylation agent + PD-1 inhibitor) in relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome patients, or who had positive minimal residual disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with relapsed and refractory acute myeloid leukemia (AML) and patients diagnosed with myelodysplastic syndrome (MDS) who require chemotherapy treatment.
* Patients who did not respond or had disease recurrence after 1 course of induction chemotherapy or had positive immune residues after induction chemotherapy or positive molecular residues (if any) after induction chemotherapy.
* Voluntarily participate in clinical research and sign an informed consent form and be willing to follow and be able to complete all experimental procedures.
* The toxic and side effects caused by the last treatment should be recovered.
* Eastern Cooperative Oncology Group score of 0 to 3 points.
* The organ function is intact.

  * Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2×ULN (Upper Limit of Normal).
  * Creatinine≤2×ULN.
  * Bilirubin≤2×ULN.
* Karnofsky≥70.
* The expected survival period is at least 12 weeks.
* Non-pregnant, non-breastfeeding women.

Exclusion Criteria:

* Suffering from other untreated or unrelieved malignant tumors within 2 years.
* Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, and experimental therapy were performed within 2 weeks of the first medication.
* Suffering from any other known serious and/or uncontrolled disease (eg, uncontrolled diabetes; cardiovascular disease, including congestive heart failure New York Heart Association \[NYHA\] Class III or IV, 6 months patients with myocardial infarction and poorly controlled blood pressure); chronic renal failure; or active uncontrolled infection); the investigators considered unsuitable for this clinical trial.
* Patients who are unwilling or unable to comply with the protocol.
* Currently being treated with other systemic anti-tumor or anti-tumor research drugs.
* Women who are pregnant or breastfeeding.