cyrilzakka/clinical-trials huggingface dataset:
Zoledronic Acid as Adjuvant Treatment of Triple-negative Breast Cancer

Triple-negative breast cancer is a special type of breast cancer with poor prgnosis and limited choices. Chemotherapy is the only choice of adjuvant systemic treatment options. Previous study suggested that zoledronic acid might have anti-tumor effect by eliminating the number of DTCs(Disseminated Tumor Cell )and had been proved to be effective as adjvant therapy in postmenopausal women whose breast cancer was Homonal receptor positive and who were receiving aromatase inhibitors. So it might be able to improve the survival of triple negative breast cancer patients.

Triple negative breast cancer patients with high risk factor will be randomized to receive either zoledronic acid or observation after the completion of standard chemotherapy/radiotherapy. Recurrence status will be followed and Disease free survival will be compared. Overall survival is the secondary endpoint.

Eligibility Criteria:
Inclusion Criteria:

* •Adult women (≥ 18 years of age) with early stage breast cancer(stage II-III).

  * Histological confirmation of estrogen and/or progesterone-receptor negative (ER-), human epidermal growth factor receptor 2 negative (HER2 -) breast cancer.

ER/PR negative: nuclear reaction\< 1%, HER2 negative: HER2; IHC 0,1+ or FISH/CISH (-) in case of IHC 2+

* axillary lymph node positive with other high risk factors: LVI, T\>5CM, Grade III
* Patients finish standard chemotherapy and/or radiotherapy
* ECOG performance status of 0,1
* Adequate bone marrow, hepatic, and renal function
* Adequate bone marrow and coagulation function as shown by:
* Absolute neutrophil count (ANC) ≥ 1.5 109/L;Platelets\>100 x109/L;Hemoglobin (Hgb) \> 9.0g/dLINR \< 2
* Adequate liver function as shown by:
* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5x ULN
* Total serum bilirubin \< 1.5 x ULN
* Adequate renal function as shown by:
* Serum creatinine\< 1.5 x ULN
* Fasting serum cholesterol \<300 mg/dL or 7.75 mmol/L and fasting triglycerides \<2.5 x ULN. In case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy and when the above mentioned values have been achieved.
* Written informed consent

Exclusion Criteria:

* •Another malignancy within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer.

  * Any severe and/or uncontrolled medical conditions, eg. currently active infection
  * Pregnant or lactating
  * Patients unwilling to or unable to comply with the protocol
Algorithm Guided Treatment Strategies for Bipolar Depression

The purpose of the AGTs-BD study is to compare the treatment outcome and safety profiles between different mood stabilizers combination treatments in the patients with bipolar disorders, currently suffered from depression episode.

The AGTs-BD study is a randomized, open-label, rater-blind, multicenter study, which including an 8-week acute treatment (Phase I), followed by a 24-week recurrence prevention treatment (Phase II), and a 24-week relapse prevention treatment (Phase III). Patients initially enter an up to 4 weeks screening phase to confirm the randomization to whom met DSM-IV criteria of bipolar I or II disorder, currently depressed with Hamilton Depression Rating Scale-17 items (HAM-D) total score ≥17. The protocol was approved by the each sites' appropriate institutional review boards and ethics committees. After screening, patients were randomly allocated to one of three groups: (1) lithium monotherapy; (2) lithium plus quetiapine; (3) lithium plus a Traditional Chinese Medicine (TCM) named as Shuganjieyu capsule (SGJY, St. John's wort and acanthopanax senticosus combination). After phase I, patients who met stable remission, defined as HAM-D total score ≤7 and Young Mania Rating Scale (YMRS) total score ≤10 in two consecutive visit at least 4 weeks, were qualified into phase II and III. Patients remained on the allocated treatment for up to 48 weeks or until treatment failure. The difference between phase II and phase III was that treatment dose could be decreased (within the study ranges) if side-effects became troublesome in phase III, but not for phase II. All patients will be provided with free care (3 visits) by the investigators, for a period of up to 3 months after the end of the study, in order to help them make the transition into routine clinical care.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years old;
* Han Chinese;
* Outpatient and inpatient patients;
* Patients met DSM-IV criteria of bipolar I or II disorder, currently depressed, ascertained with the Mini International Neuropsychiatric Interview (MINI)
* HAM-D total score≥17, HAM-D item 1 (depressed mood) score≥2, and YMRS total score≤10 at baseline;
* Written informed consent was given;
* Junior high school education and above, with enough audio-visual ability to accomplish the visits;
* Normally resident in one country and had a residential address, able to follow-up.

Exclusion Criteria:

* Bipolar disorder rapid cycling or mixed episode;
* Experienced DSM-IV-TR axis I disorders in the 6 months prior to randomization;
* Severe personality disorder, metal retardation, anorexia/bulimia nervosa;
* Actively suicide ascertained by research psychiatrist or HAM-D item 3 score≥3(suicidality);
* Known history of intolerance or hypersensitivity to any of the medications involved in the study, including lithium, quetiapine and SGJY capsule;
* Female patients who were pregnant, planning to be pregnant or breast feeding;
* Severe medical or neurological problems.
Mandibular Implants in Elderly Patients

The purpose of this study is to investigate denture satisfaction following the conversion of existing mandibular complete dentures to implant-overdentures (IOD) in very old edentulous patients who depend on help for activities of daily living (ADL) and evaluate secondary endpoints such as functional, structural, nutritional, cognitive and patient-centered outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* 75 years or older
* living institutionalized or receiving help for the ADL
* edentulous
* wearing complete dentures
* the lower denture had to cause discomfort to the degree that the patients were seeking treatment

Exclusion Criteria:

* severe clinical depression
* dementia
* poorly controlled diabetes
* immunosuppression
* treatment with bisphosphonates
* condition precluding the surgical intervention for implant placement
Self-Management Interventions After an ICD Shock

This study, "Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock," addresses a critical need in cardiology care by describing the feasibility and acceptability of a timely, highly promising, electronically-delivered intervention for patients who have recently received an ICD delivered shock. The study intervention and outcomes are designed to reduce anxiety, enhance return to activities of daily living (ADLs), and prevent the development of severe distress and post-traumatic stress disorder (PTSD), and ultimately promote quality of life. The study is a two-arm, embedded mixed methods, randomized trial (N=60, 30/group). The purpose is to determine feasibility and potential effects of a self-management intervention (SPSM) plus usual care (UC) compared to UC alone, delivered during the critical 1 month period after an ICD shock when distress is high. The intervention will be delivered over 1 month following an ICD shock; a 6-month follow-up will be used to assess the sustainability of intervention effects and determine if the incidence of PTSD is reduced. SPSM includes: 1) training in heart rate (HR) self-monitoring; and 2) individualized learning through 4 self-paced, web-based modules. The study interventions are delivered at a crucial time, closely after an ICD shock when stress is high, but PTSD has not yet developed. The specific aims are to: 1) examine the effects of the SPSM intervention plus UC vs. UC alone on the primary outcome of ICD shock anxiety at 1 and 6 months post-shock event, 2) describe the impact of SPSM plus UC compared to UC alone on the secondary outcomes of total daily physical activity, depression, PTSD symptoms, QOL, salivary cortisol levels, and self-efficacy and outcome expectations at 1 and 6 months post-shock event, and 3) assess feasibility, acceptability, and safety of the SPSM intervention, SDOH will be used to describe differential responses to the SPSM intervention. This study fills a significant gap in the care of patients with an ICD, through the systematic testing of a brief, novel and cost-effective intervention that provides the knowledge and skills to improve quality of life. Study findings will be used to design future larger RCTs to test intervention effectiveness for more diverse samples and settings.


Eligibility Criteria:
Inclusion Criteria:

1. ICD implant for primary or secondary prevention of sudden cardiac arrest (SCA),
2. receipt of at least 1 ICD shock, appropriate or inappropriate, one week prior to enrollment;
3. able to read, speak and write English;
4. access to online resources and telephone for study duration.

Exclusion Criteria:

1. current diagnosis of PTSD, schizophrenia or bipolar disorder;
2. Short BLESSED score \>6 indicating cognitive dysfunction \[73\];
3. age \<18 years;
4. AUDIT-C score ≥4 for alcohol use;
5. regular non-medical use of illicit drugs
Optical Coherence Tomography (OCT) Evaluation of Re-endothelization: A Comparison of the Intrepide™ Stent Versus Taxus™

Patients presenting with ACS (Acute Coronary Syndrome) in the emergency department will be screened for clinical eligibility and asked to sign informed consent to the study.

A total of 40 patients will be randomized. 20 of them will receive a Trapidil eluting stent (Intrepide™ stent), 20 will receive a Paclitaxel eluting stent (Taxus™ stent). After 90 days the patients who were treated with the INTREPIDE stent in the first lesion will be treated with the Taxus stent in the second lesion. After 90 days the patients who were treated with the Taxus stent in the first lesion will be treated with the INTREPIDE stent in the second lesion.

Coronary angiography will be performed through the femoral (groin) or radial (wrist) artery with the use of standard techniques. The doctor will determine if the patient is qualified for enrolment at the end of the diagnostic coronary angiogram


Eligibility Criteria:
Inclusion Criteria:

Clinical

* \>18 years of age,
* symptoms of non ST-elevation ACS (defined by the ACC/AHA criteria) for 30 min but \<48 h
* Patient must provide written informed consent prior to the procedure using a form that is approved by the local Institutional Review Board

Angiographic

* reference vessel diameter of culprit/target lesion between 2.25 to 3.5 mm (visual estimate)
* discrete target lesion (maximum length of 28 mm by visual estimation)
* target lesion is in a native coronary artery
* presence of another lesion more than 70% in a vessel different from the culprit one amenable of planned percutaneous treatment 90 days thereafter.

Exclusion Criteria:

Clinical

* previously documented left ventricular ejection fraction of less than 30%
* estimated life expectancy of less than 12 months
* a history of bleeding diathesis, leukopenia, thrombocytopenia, or severe hepatic or renal dysfunction
* participation in another study
* inability to give informed consent owing to prolonged cardiopulmonary resuscitation
* and dominant Renal impairment (serum creatinine \> 2.0 mg/dl) Angiographic
* non-culprit lesion located in the proximal LAD or in a proximal and dominant Circumflex artery
* previous PCI of the target vessels restenosis or stent thrombosis as culprit lesion
* unprotected left main coronary artery disease
* non-culprit lesion located in a vein graft
* severe multivessel disease (three major epicardial vessel disease) need of overlapping stenting for one lesion
The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset

The goal of this observational study is to learn if offering a point-of-care screening test for exposure to the Hepatitis C virus, before providing a diagnostic test for Hepatitis C infection can increase testing, diagnosis and treatment in Adults. Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of Hepatitis C viral infection. The main question it aims to answer is:

What proportion of the participants that have been diagnosed with HCV infection have started treatment when their records are reviewed 12 weeks after diagnosis?

Participants will have one in-person visit where they will provide informed consent and receive a finger-prick rapid result test for Hepatitis C infection. Participants with no previous Hepatitis C infection will have a screening test to see if they have an immune reaction to Hepatitis C. Participants who know they have been infected with Hepatitis C in the past, and all participants with a positive screening test result will then be given a Hepatitis C diagnostic test at this visit.

No treatment is provided as a part of this study, participants who are diagnosed with Hepatitis C infection will be referred to testing locations standard of care for any additional clinical assessments and treatment initiation. A review of the participant's records will be made 12 weeks after their Hepatitis C result and their treatment data are gathered.


Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent
* ≥ 18 years of age.

Exclusion Criteria:

* Is unable or unwilling to provide informed consent
Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer

Compare the effect of G17DT with that of placebo on the survival of subjects with advanced pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a histologically or cytologically confirmed diagnosis of pancreatic carcinoma, who were not eligible for tumor resection with curative intent (i.e., Stage II, III, or IV disease)
* Male or female subjects over 18 years of age
* Subjects with a life expectancy of at least 2 months
* KPS score of ≥60%
* Written informed consent

Exclusion Criteria:

* Previous, concomitant, or anticipated use (up to Week 12) of chemotherapy, radiotherapy, immunotherapy, or any other anticancer therapy
* Previous (during the 4 weeks before the study), concomitant, or anticipated use (up to Week 12) of immunosuppressants. However, for systemic \[i.e., oral or injected\] corticosteroids, previous use and concomitant use at study entry were prohibited, while introduction during the course of the study was permitted.)
* History of other malignant tumor within the previous 5 years, except nonmelanomatous skin cancer, and in situ carcinoma of the uterine cervix
* Known immunodeficiency
* Females who were pregnant, planning to become pregnant, or lactating (Women who, in the opinion of the investigator, were of childbearing potential were to have a negative pregnancy test before study drug administration.)
* Subjects taking part in another study involving an investigational or licensed drug or device in the 3 months preceding enrollment or up to Week 12 during this study
* Previous G17DT treatment
* Hematological indicators as follows:

  * Hemoglobin \<9.5 g/dL
  * Neutrophils \<2.0 × 109/L
  * Platelets \<100 × 109/L
* Any other condition or circumstance that might have the following results:

  * Worsen if the subject participated in the study
  * Reduce the subject's ability to comply with the protocol
  * Confound the interpretation of the study results
Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)

This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed dyslipidemia to study the effects of ER niacin/laropiprant on lipids.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 to 80 years of age with Primary hypercholesterolemia or mixed dyslipidemia
* Patients will be eligible for the study if their LDL-C values are within protocol specified range and meet other entry criteria

Exclusion Criteria:

* Patient whose LDL-C values are not within protocol specified range
Proteomic Pattern Associated With the Diagnosis of Chronic Thromboembolic Pulmonary Hypertension

Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH) is a rare but severe complication of pulmonary embolism (PE). CTEPH is evoked in patients with persistent dyspnea. According to international guidelines, symptomatic patients with perfusion defects on lung scan and Pulmonary Hypertension (PH)-likely transthoracic echo (TTE) must be evaluated in Pulmonary Hypertension (PH)-centers with right heart catheterism, to confirm or rule out the presence of precapillary Pulmonary Hypertension (PH), and precise the group of Pulmonary Hypertension (PH).

However, persistent dyspnea and perfusion defects are frequent after pulmonary embolism (PE), and the accuracy of transthoracic echo (TTE) is not great for precapillary Pulmonary Hypertension (PH).

This study proposed to seek for a specific proteomic pattern in patients admitted for a suspicion of Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH).

Eligibility Criteria:
Inclusion Criteria:

* Patient with a suspicion of Chronic thromboembolic pulmonary hypertension (CTEPH) with a combination of a perfusion lung scan and transthoracic perfusion scan and transthoracic echocardiography compatible with the diagnosis (according to French recommendations)
* Patients who require a right heart catheterization.
* Patient affiliated or entitled to a social security plan
* Patient having received informed information about the study informed about the study

Exclusion Criteria:

* Patient with a normal perfusion lung scan
* Person under legal guardianship
An Observational Study of Adherence to Anastrozole in Early Breast Cancer Treatment

The purpose of this study is to describe adherence to anastrozole treatment current practice: cases where anastrozole treatment was halted ( timescale and causes) and estimate the proportion of postmenopausal women with early breast cancer who continue anastrozole therapy after one year follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal woman with early breast cancer who are prescribed with anastrozole as adjuvant endocrine therapy under the routine clinical practice.
* Histologically or cytologically proven to be HR+(ER or PR +)
* No other concomitant endocrine therapy such as estrogen therapy or selective estrogen receptor modulators
* Provision of written informed consent

Exclusion Criteria:

* Recurrence of breast cancer
* Known hypersensitivity to anastrozole or to any of its excipients
* Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize adherence with the trial protocol: Amenorrhea\<12 months and a intact uterus; Previous inclusion in the present study; Participation in a other clinical study during the last 30 days·
* Women who does not agreed to participate the program
The Relationship Between Allergic Rhinitis and Geographic Tongue

Allergic rhinitis is a complex chronic inflammatory disease, it always presents with nasal obstruction, nasal itching, sneezing and runny nose. Whether in adults or children, rhinitis is a complex disease. The prevalence of allergic rhinitis in Taiwan is about 24-29%. Taiwan is a developing country. It is a hot and humid country. In developing countries, industrialization, air pollution makes the constantly increasing number of patients with rhinitis. Penghu in 1994 for children aged 7 to 14 by the study found that among 7599 people, 1766 people have allergic rhinitis, about 23.2%. Allergic rhinitis is a complex chronic disease. So, it become a diagnostic challenge, its prevalence always underestimated. The prevalence of rhinitis has increased in recent years. The phenomenon of underestimate is caused by variety of personal and environmental factors. Allergic rhinitis had increased direct and indirect social and economic burden.

Geographic tongue is a benign tongue performance. Geographic tongue has been reported their relevance to allergy. Geographic tongue is a chronic tongue situation. The causes of geographic tongue still remains unknown. Allergic rhinitis is a diagnostic challenge to clinicians. The investigators hope that geographic tongue could play a role in the diagnostic of allergic rhinitis. The prevalence of geographic tongue in the United States is about 1.8%, white Americans and Mexicans have a higher incidence rate. This study will investigate the relevance between allergic rhinitis and geographic tongue. The investigators will analyze the relevant gender, age, severity of inspection reports. The research results wound provide an important reference to the diagnosis of allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* rhinitis and non-rhinitis patients
* willing to complete the study
* no limitation of tongue movement

Exclusion Criteria:

* more than 90 years old or younger than 20 years old
* unable to complete the study
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Assessment of Ypeginterferon Alfa-2a in Healthy Subjects

This study is aimed to study the pharmacokinetic characteristics(e.g. AUC, Cmax, Tmax) of Ypeginterferon alfa-2a and interferon biomarkers(e.g. 2,5-OAS, neopterin) after single dose at different levels.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Age between 18 and 45, inclusive
* Body mass index(BMI)between 19 and 26, inclusive
* Sign informed consent

Exclusion Criteria:

* Women of pregnant or lactation
* Known hypersensitivity to interferon or any other components of the study drug
* History of mental disease or genetic disease
* History of diabetes mellitus, thyroid disease, cancer, autoimmune disease, organ transplant
* Significant disease in heart, liver, kidney, lung or any other major organs
* Alcoholic, smokers or drug abusers
* Blood donation, or massive blood loss due to injury or surgery within 3 months
* Other conditions which in the opinion of the investigator preclude enrollment into the study
Development and Validation of a New Digital Dermatoscope in the United States

A completely new type of digital dermatoscope has been developed in order to take a significant step forward in technology for skin cancer imaging. By means of this study a better insight can be gained of the current performance and workflow in clinical dermatoscopy. This knowledge will be used to further improve the developed technology.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Male or Female, aged less than 18 years, with informed consent of their legally authorized representative.
* Patient presenting with any visible skin lesion for dermatologist review on a body site amenable to optimal photographic imaging.
* Able and willing to comply with all study requirements.
* Patient with a skin lesion that is clinically diagnosed by a dermatologist as benign, malignant or a suspicious skin lesion requiring excisional biopsy for histological diagnosis.

Exclusion Criteria:

* Patients aged under 18 years old where the legally authorized representative is unable or unwilling to provide their informed consent.
* Patients unable to provide informed consent.
* Skin lesions in an anatomical site which is not suitable for photography including hair-obscured site, subungual lesion or inaccessible mucosal site.
* Lesion is at a site where previous surgery was undertaken.