cyrilzakka/clinical-trials huggingface dataset:
Atherosclerosis in Rheumatoid Arthritis

To test the theory that accelerated inflammation-promoted atherosclerosis occurs in patients with rheumatoid arthritis (RA).

BACKGROUND:

Premature cardiovascular disease is a major cause of mortality in rheumatoid arthritis (RA). The mechanisms underlying accelerated atherosclerosis and its relationship to inflammation in RA are poorly understood. Recent studies indicate that inflammation through the effects of inflammatory cytokines, and oxidative stress, through lipid peroxidation, are important in the pathogenesis of atherosclerosis. The study's hypothesis is that accelerated, inflammation-promoted atherosclerosis occurs in RA.

DESIGN NARRATIVE:

The study tests the hypotheses: 1) that structural and functional vascular damage is more frequent and more severe in patients with established RA than matched controls and is related to cumulative disease severity; 2) that this impairment of vascular integrity is associated with clinical and laboratory markers of inflammation, plasma homocysteine concentrations, and oxidative stress. To address these two hypotheses the relationship between longstanding inflammation and vascular integrity will be determined in a cross-sectional study of 75 patients with established RA in whom prospectively obtained clinical data are available for 15 years, and 75 matched non-RA controls. Endothelium-dependent, flow-mediated dilation of the brachial artery measured by ultrasound, and coronary calcium volume measured by electron beam computed tomography (EBCT) will provide functional and structural measures of vascular integrity, respectively. F2-isoprostane excretion, a reliable index of lipid peroxidation in vivo, homocysteine and lipid concentrations will be measured. Vascular integrity, oxidative stress, lipids and homocysteine will be compared in controls and RA patients. In the RA patients the relationship between RA activity and damage indices obtained over 15 years and vascular function and damage measures will be determined. Using the same techniques we will address hypothesis 3) that the rate of progression of vascular disease in patients with early RA can be altered by control of inflammation. In a prospective cohort of 100 patients with early RA receiving usual clinical care and 100 matched non-RA controls followed over 24 months the relationship between clinical and biochemical measures of inflammation and vascular integrity will be determined by comparing "responders" and "non-responders". These studies will provide a basic understanding of the interrelationship between inflammation, lipids, oxidative stress and vascular damage, and will suggest strategies for reversing or preventing such damage in RA and, potentially, other diseases.

Eligibility Criteria:
must meet ACR criteria for RA
Protein Expression as a Potential Diagnostic Biomarker of Cervical Dysplasia and/or Cancer

This diagnostic trial is studying the presence of a specific protein as a potential biomarker of cervical dysplasia and/or cancer. The presence of specific proteins may allow a doctor to determine whether a patient has cervical dysplasia and/or cancer.

OBJECTIVES:

I. Evaluate the utility of MN protein, a novel tumor-associated antigen, as a potential diagnostic biomarker for cervical glandular and/or squamous neoplasia in patients with a cytologic diagnosis of atypical glandular cells of undetermined significance (AGUS).

II. Measure the frequency and type of cervical pathology associated with the diagnosis of AGUS in these patients.

III. Determine whether the presence of a high-risk type of human papilloma virus (HPV) in a ThinPrep cervical cell specimen predicts the presence of cervical glandular and/or squamous cell neoplasia in these patients.

IV. Determine the relationship between MN antigen expression and the presence of high-risk HPV in these patients.

OUTLINE: This is a multicenter study.

Patients undergo a Pap smear followed by a ThinPrep cervical cell specimen collection at the time of direct colposcopic examination. Patients then undergo a cone biopsy of the cervix using loop electrosurgical excision procedure with an endocervical curettage, an excisional cone biopsy of the cervix with or without endocervical curettage, or a hysterectomy. Patients who are perimenopausal or postmenopausal or have a negative cervical cone biopsy also undergo endometrial biopsy or curettage. The Pap smear specimen is analyzed to determine MN antigen expression and the ThinPrep specimen is analyzed for the presence of high-risk human papilloma virus and to determine MN antigen and other marker (e.g., P16) expression.

Patients who do not undergo hysterectomy are followed every 6 months for 2 years. All other patients are followed at 4, 26, and 30 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Cytologically confirmed atypical glandular cells of undetermined significance (AGUS)
* Must be scheduled to undergo complete histologic examination of the cervix by cone biopsy using loop electrosurgical excision procedure with an endocervical curettage, excisional cone biopsy with or without endocervical curettage, or hysterectomy within 6 months of the initial cytologic diagnosis of AGUS
* No history of endometrial hyperplasia
* No history of cancer of the endometrium, vagina, or cervix
* HIV negative
* No pregnant patients who are at high risk for excessive bleeding or preterm labor if a cone biopsy is performed
* No prior cytotoxic chemotherapy for vaginal and/or cervical cancer
* No prior radiotherapy to the vagina or cervix
* No concurrent radiotherapy to the vagina or cervix
* No prior hysterectomy
Effect of Low-level Laser Therapy During Maxillary Molar Distalization Using a Skeletally Anchored Appliance

study will be directed to evaluate the effect of low-level laser therapy during maxillary molar distalization using a skeletally anchored appliance

Effect of low-level laser therapy during maxillary molar distalization using a skeletally anchored appliance

Eligibility Criteria:
Inclusion Criteria:

* 1- An age range from 14-17 years old. 2- All permanent teeth are present (except for third molars). 3- Bilateral dental Class II malocclusion. 4- Skeletal Class I or mild Class II relationship. 5- Normal or reduced vertical face height. 6- No posterior crowding or spaces.

Exclusion Criteria:

1. Patients who required surgery to correct skeletal discrepancies.
2. Patients with congenital dentoskeletal disorders.
3. Missed or mutilated teeth in maxillary arch.
4. Patients with poor oral hygiene and/or periodontally compromised patients.
Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Renal or Hepatic Impairment or Advanced Age"

The purpose of this survey is to evaluate the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in type 2 diabetes mellitus patients with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more) in the routine clinical setting.

The drug being tested in this survey is called alogliptin and metformin hydrochloride combination tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more).

This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in the routine clinical setting. The planned number of observed patients will be approximately 600.

This multi-center observational trial will be conducted in Japan.

Eligibility Criteria:
Inclusion Criteria:

* Participants should meet one or more of the following:

  1. Have renal impairment (mild)
  2. Have hepatic impairment (mild or moderate)
  3. Elderly (aged 65 years or more)

Exclusion Criteria:

* Participants with any contraindication for study drug.
Evaluation of CO2 Rebreathing During Exercise With the Increasing Ventilation Assisted by NIV With a Dual-limb Circuit

Ventilated by a single-limb tubing with PEV caused CO2 rebreathing to COPD patients during exercise with the increasing ventilation. The aim of this study was to evaluate whether CO2 rebreathing could be avoided with the use of the dual-limb circuit, to provide a theoretical basis of more rational clinical application of NIV in the setting of increasing ventilation(eg, after exercise).

Exercise training is a key component of pulmonary rehabilitation. It has shown signifcant improvements in both exercise tolerance and quality of life in patients with COPD. The intensity of exercise training is of great importance to yield a true physiologic effect. However, in patients with severe COPD, exertional dyspnea and leg fatigue make it impossible for the patient to maintain intensity of training for enough time to achieve a physiologic training effect. NIV has been reported to be used as support for exercise to improve exercise tolerance and respiratory performances in patients with mild-to-severe COPD with inconsistent results. Evidence from previous studies have suggested that NIV with a single-limb circuit with Whisper Swivel II expiratory valve or Plateau exhalation valve assisted during exercise in patients with COPD caused CO2 rebreathing. CO2 rebreathing may have a negative impact on efficacy. Previous studies have proved that exercise tolerance was improved ventilated by NIV with a dual-limb circuit. In theory, NIV with a dual-limb circuit consists of one inhalation limb that introduces air into the patient's airways and one exhalation limb that leads exhaled gas outside of the airways, there is no risk of rebreathing. However, there was no report on whether there's no risk of rebreathing in COPD patients ventilated during exercise by a dual-limb circuit. Therefore, the aim of the study was to determine whether there was no CO2 rebreathing occurred assisted with NIV with dual-limb circuit in patients with stable severe COPD after exercise with exertional dyspnea.

Eligibility Criteria:
Inclusion Criteria:

* presented clinically stable (no exacerbation in the 4 weeks prior to study
* participation or with no change in medications);
* physician diagnosed COPD, forced expiratory volume in 1s (FEV1) \< 50% predicted; dyspnea as a main symptom that limited daily activities.

Exclusion Criteria:

* subjects with obvious pulmonary bullae demonstrated by chest CT scan or X-ray; examination or facial trauma/malformation, recent facial, upper airway or upper gastrointestinal tract surgery, that would preclude receiving NIV therapy;
* a history of coronary artery disease or cardiac arrhythmias or potential electrocardiographic alterations;
* a history of uncontrolled hypertension, or other respiratory diseases;
* patients with musculoskeletal or neurological disorders;
* failure to comply with the research protocol.
International T1 Multicenter Outcome Study

Mapping of magnetic relaxation within the myocardial tissue using T1 (and T2) mapping using cardiovascular magnetic resonance (CMR) are novel measures of quantifiable (scalable) myocardial tissue characterisation. Evidence suggests that myocardial mapping could be useful in detection of diffuse myocardial disease, complementing late gadolinium enhancement (LGE) as the tool for regional myocardial disease. A handful of studies, three single centre study of a single T1 index with outcomes and one multicentre study for all indices reported strong associations with all cause mortality and heart failure. These studies were based on a single-vendor platform and were using a single sequence. The main unknowns pertaining the successful translation of this technique and the transferability of the methodology beyond a single centre and lack of outcome evidence from broad and large populations. In this study, we will assess the diagnostic accuracy of T1 (and T2) mapping measurements in health and disease, and the prognostic relevance of T1 mapping measurements by associations with outcome. This study is builds upon/integrates the evidence of the NCT02407197 study, which remains active for follow-up, but is currently no longer recruiting.


Eligibility Criteria:
Inclusion Criteria:

1. Adults (\>18 years of age)
2. Able to provide informed consent
3. Clinically indicated cardiac magnetic resonance imaging study

Exclusion Criteria: contraindications for clinical cardiac magnetic resonance imaging due to MR unsafe devices or objects
SHR-A2102 Combined with Adebrelimab As Neoadjuvant Therapy for Early Triple-Negative Breast Cancer

This is a prospective, open-label, multicenter Phase II study evaluating the efficacy and safety of of SHR-A2102 in combination with Adebrelimab in Early Triple-Negative Breast Cancer(TNBC)

This study plans to enroll patients with early-stage TNBC. The patients will first receive 8 cycles of neoadjuvant therapy, with imaging examinations conducted every 2 cycles to evaluate the treatment response. Subjects who complete the 8 cycles and are suitable for surgery will undergo surgical treatment after the completion of neoadjuvant therapy. The postoperative adjuvant therapy will last for one year. Subjects will continue medication until surgery is completed, or until disease progression, intolerable toxicity, withdrawal of informed consent, or when the investigator determines that medication must be terminated.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients aged ≥ 18 years;
2. Histopathologically confirmed triple-negative invasive breast cancer, with no previous systemic anti-cancer treatment specifically for breast cancer;
3. At least one measurable target lesion according to RECIST V1.1;
4. ECOG performance status score of 0 to 1;
5. Life expectancy ≥12 weeks;
6. Adequate bone marrow reserve and organ system function reserve;
7. Participants should be able and willing to comply with the study protocol requirement;

Exclusion Criteria:

1. Breast cancer not histologically confirmed;
2. Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
3. Previous treatment with anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1), or anti-PD-L2 drugs, or other immunotherapy;
4. Concurrent receipt of any other form of anti-cancer therapy;
5. History of a second primary malignancy, except for adequately treated skin cancer;
6. Participation in other drug clinical trials within 4 weeks before enrollment;
7. Major surgical procedures unrelated to breast cancer within 4 weeks prior to the first drug administration, or not fully recovered from such procedures;
8. Presence of any active autoimmune disease or history of autoimmune disease with potential for recurrence;
9. Uncontrolled or significant cardiovascular and cerebrovascular diseases;
10. Subjects with known or suspected interstitial pneumonia;
11. Presence of active hepatitis B, hepatitis C, liver cirrhosis; or severe infections requiring antibiotic, antiviral, or antifungal drug control;
12. Known inherited or acquired bleeding and thrombotic tendencies;
13. Known allergy or contraindication to the study drug and its excipients;
14. Pregnant or lactating female patients;
15. History of definite neurological or mental disorders, or any other conditions that the investigator believes make the patient unsuitable for participating in this study.
Validity Of Turkish Version Of ABC Scale In Diabetes Mellitus Patients

Activities-specific Balance Confidence (ABC) scale is a well-known tool to evaluate functional balance. Diabetic patients suffer more often from balance disorders than the rest of the population. The aim is to investigate the validity of the Turkish version of ABC short form in patients with diabetes mellitus (DM).

Thirty patients with DM will be included according to the inclusion and exclusion criteria. All the participants will be evaluated by ABC form and Timed Up and Go Test (TUG). The Cumulative Illness Rating Scale (CIRS ) will be used for all the patients.

ABC scale is a self-assessment test with 16 items that helps assess balance impairments and falling risk, and it also investigates how confident people are while they are in some specific activities both indoors, and outdoors. Total score changes between 0-100.

The HbA1c values of all patients will be noted if a blood test will be performed in the last three months.

Eligibility Criteria:
Inclusion Criteria:

* 45-75 years old
* Diabetes mellitus
* The complete existence of the data to be used in the study in the records of our hospital

Exclusion Criteria:

* Not having any other additional disease that will affect balance coordination
* No lower extremity joint replacement or lower extremity amputation at any level
A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).

This study will look at whether our drug (sorafenib) in combination with chemotherapy delivered directly into your tumor using beads (DC Bead) will slow the progression of the disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing the adverse effects that normally occur with chemotherapy.

Safety issues will be reported in Adverse Event section. In addition to the secondary outcome measures, Biomarkers and Patient Report Outcome will also be analyzed as other variables.

Eligibility Criteria:
Inclusion Criteria:

* Unresectable, multinodular asymptomatic tumor without vascular invasion or extrahepatic spread
* Confirmed Diagnosis of HCC:
* Cirrhotic subjects: Clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria
* HCC can be defined in cirrhotic subjects by one imaging technique (Computed tomography \[CT\] scan, Magnetic resonance imaging \[MRI\], or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter.
* Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria.
* Non-cirrhotic subjects:

For subjects without cirrhosis, histological or cytological confirmation is mandatory

* Documentation of original biopsy for diagnosis is acceptable
* Child Pugh class A without ascites
* Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:

Exclusion Criteria:

* Patients on a liver transplantation list or with advanced liver disease as defined below:
* Child Pugh B and C
* Active gastrointestinal bleeding
* Encephalopathy
* Ascites
* Lesions having previously been treated with local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) or cryoablation can not be selected as the target lesions.
Endoscopic Evaluation for Predicting the Complications Related to Gastric Conduit After Esophagectomy

Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and strictures. Thus, the purpose of this study is the safety and efficacy of endoscopic evaluation about reconstructive organs after esophagectomy. The investigators evaluate endoscopic predictions using classifications in acute phase after esophagogastrostomy.

The development and improvement of thoracoscopic esophagectomy (TE) reduced the severe pulmonary complication after esophagectomy. However, the postoperative complications relative to gastric conduit reconstruction are still common issues after esophagectomy. The ischemia of the proximal portion of the graft predisposes these patients to a high incidence of anastomotic complications after esophagectomy. Less commonly, severe graft ischemia can lead to transmural necrosis. Thus, early diagnosis of ischemic reaction may provide the suitable postoperative management and therapeutic intervention to prevent leakage, strictures and necrosis. Thus, the purpose of this study is the safety and efficacy of endoscopic evaluation about reconstructive organs after esophagectomy. The investigators evaluate endoscopic predictions using classifications in acute phase after esophagogastrostomy.

Eligibility Criteria:
Inclusion Criteria:

- Malignant or end-stage benign esophageal disease. Esophagectomy with reconstruction by a gastric pull-up.

Exclusion Criteria:

- Severe heart failure and pulmonary dysfunction Severe renal and liver dysfunction Allergenic history Pregnancy
Role of Simvastatin Microsponges in Treatment of Periodontitis

the aim of our study is to enhance the dissolution and subsequently the local penetration of the drug through the sulcus in addition to controlling the drug release so that, the drug could be potentially absorbed.

Patients will be divided randomly into three groups: Group (I);will be treated with subgingival debridement and subgengival injection of chitosan 2% gel containing a microsponges formulated (SV), Group (II); will be treated with subgingival debridement and subgingival injection of chitosan 2% gel containing free (SV) and Group (III); will be treated by subgingival debridement and placebo gel injected subgingivally. Pocket depth and clinical attachment loss bone gain were recorded preoperative and six months postoperative for all groups.

Eligibility Criteria:
Inclusion Criteria:

* patients with chronic periodontitis with minimum two sites of pocket depth \> 5 mm
* patients with normal lipid profile
* nonsmokers
* patients free from any systemic disorders
* committed patients to complete the treatment with follow-ups.

Exclusion Criteria:

* patients with hyperlipidemia
* patients taking lipid lowering drugs
* smokers
* pregnant
* Lactating women women, patients with mental or psychological illness and medically compromised patients.
Comparison of the Analgesic Efficacy of Serratus Anterior Plane Block and Intercostal Block

More than 50% of patients presenting with chest trauma experience rib fractures and these rib fractures are associated with significant morbidity, mortality, and long-term disability. Many of these adverse outcomes result from poorly controlled pain that interferes with breathing, leading to atelectasis, pneumonia, and respiratory failure. Therefore, early provision of adequate analgesia is crucial in the management of these patients. The basic stones of analgesic therapy are oral and intravenous drugs such as paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids. However, patients with more significant injuries or comorbidities often require interventional procedures to provide adequate analgesia and avoid opioid-related side effects. Thoracic epidural analgesia and thoracic paravertebral blocks have traditionally been used, but these techniques are associated with side effects and may cause hemodynamic instability. Today, the use of ultrasonography (USG) guided block techniques such as erector spinae plane block (ESPB), serratus anterior plane block (SAPB) and intercostal block (ICB) has increased. These techniques are considered to be simpler and theoretically safer. Although ICB is frequently mentioned in the literature, the publications of new plane blocks such as ESPB and SAPB are new and few in number. In this study, SAPB and ICP to be performed with USG will be evaluated in terms of analgesic effect.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* American Society of Anesthesiologists physical status I-II-III
* Body mass index between 18-30 kg/m2
* Patients with 6 or less rib fractures

Exclusion Criteria:

* Patient refusing the procedure
* History of chronic analgesic or opioid therapy
* History of local anesthetic allergy
* Infection in the intervention area