cyrilzakka/clinical-trials huggingface dataset:
Research on the Clinical Effect of Effective Prescription in Treating Unstable Angina.

This study evaluates the clinical efficacy of the famous prescription in the treatment of unstable angina pectoris. All of the patients will be divided into 4 arms according to their syndrome type. One of the arms will be treated by conventional western medicine, the other three will be treated by different Chinese herbal medicine prescription at the base of conventional western medicine.

Xuefu Zhuyu Decoction has the function of activating qi and promoting blood circulation, which will be used to treat patients with qi stagnation and blood stasis syndrome.

GualouXiebaiBanxia Decoction compounded with Danshen Decoction has the effect of promoting blood circulation and resolving phlegm, so it will be used for patients taht belong to phlegm and blood stasis type.

Shuanghe Decoction has the function of supplementing Qi and activating blood circulation, which will be used to treat patients with Qi deficiency and blood stasis syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with coronary heart disease through coronary angiography or coronary CTA;

Patients have at least one of these symptoms:

1. The stability of the nature of angina pectoris changes, that is, frequent attacks of angina pectoris, serious degree and prolonged duration;
2. Angina pectoris during rest;
3. The recent occurrence of angina pectoris caused by mild physical activity in the last month.

Exclusion Criteria:

* Patients dignosed with stable angina; Patients with acute myocardial infarction; Chest pain caused by congenital heart disease, valvular heart disease, severe neurosis or arrhythmia; The heart function grade is III or IV; Patients with acute cerebral infarction; Patients complicated with other serious primary diseases; Patients with acute infection in recent 2 weeks; Uncontrolled hypertension (the resting blood pressure \>160/95mmHg within one week); Diabetics emerged with serious diabetic complications; Patients can't finish the questionnaire due to abnormal mental and nervous or mental disorders; Pregnant or lactating women.
Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation

This clinical trial is designed to compare two management strategies for the treatment of asymptomatic/subclinical atrial fibrillation after ablation based on data from the Biotronik ICM (BioMonitor3® or future generation of Biotronik ICM).

In this study, subjects will be randomized (1:1) to conventional AF management vs. Biotronik ICM-guided AF management following ablation for persistent AF. Subjects will be followed for 15 months including a 3 month blanking period following AF ablation. The study subject population will include subjects with persistent atrial fibrillation (sustained AF episode lasting more than 7 days, but less than 1 year), according to current guideline indications for persistent AF ablation and ICM (Biotronik ICM) implantation.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* History of persistent atrial fibrillation (sustained AF episode lasting more than 7 days, but less than a year)
* Planned to undergo first AF ablation with successful Biotronik ICM implant before or at time of ablation

Exclusion Criteria:

* Paroxysmal atrial fibrillation
* Long persistent atrial fibrillation (continuous atrial fibrillation that lasts more than 1 year)
* Permanent atrial fibrillation
* Left atrial diameter of 60 mm or greater
* Patients with CHF status prohibiting EP study and ablation, but may be re-considered for enrollment later after effective treatment
* Patients with metabolic derangements (e.g. renal/hepatic failure, electrolyte disturbance, etc.), prohibiting EP study and ablation or antiarrhythmic medical therapy (e.g. dofetilide, sotalol or amiodarone, etc.)
* Patients with an intra-cardiac thrombus, but may be re-considered for enrollment later after effective treatment
* Serious known concomitant disease with a life expectancy of \< 1 year
* Pregnancy or nursing
* Unwilling or unable to give informed consent
* Existing CIED such as pacemaker or ICD
Hemodynamic Monitoring With Mixed Venous Saturation

In this study the investigators aim to evaluate the utility of a continuous mixed venous saturation monitoring compared to a clinical examination in a group of critically ill patients.

We will compare possible difference in terms of sensibility and specificity regarding the continuous mixed venous saturation monitoring compared to clinical examination in a group of critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients with a central venous catheter

Exclusion criteria:

* Patients with pulmonary catheter
Assessing AThrough Radiofrequency Transseptal Puncture System for Left Atrial Access

This study is a prospective, multicenter, randomized controlled trial with a non-inferiority design. Participants are patients scheduled for atrial septal puncture. After signing informed consent, subjects will be randomly assigned to either the radiofrequency transseptal puncture system group (referred to as the trial group) or the traditional mechanical transseptal puncture system group (referred to as the control group). All participants will undergo immediate postoperative and discharge clinical follow-ups.


Eligibility Criteria:
Inclusion Criteria:

1. Patient age ≥ 18 years;
2. Subjects scheduled to undergo cardiology interventional treatment via the transseptal puncture route;
3. Subjects have been informed about the nature of the study, understand the purpose of the clinical trial, and voluntarily participate and sign the informed consent form.

Exclusion Criteria:

1. Echocardiogram indicates the presence of intracardiac masses, thrombi, or vegetations; left atrial myxoma;
2. Subjects with an atrial septal defect occluder or atrial septal patch implant;
3. Hemorrhagic disease or coagulopathy; or contraindications to antithrombotic medication treatment;
4. Acute myocardial infarction occurred within the last 4 weeks;
5. End-stage heart failure (ACC/AHA stage D); post-heart transplant; or awaiting heart transplant;
6. Pregnant or breastfeeding women;
7. Acute systemic infection or sepsis;
8. Participation in any drug and/or medical device clinical trial within the last month;
9. Researchers judge the patient's compliance to be poor, unable to complete the study as required; or other situations deemed by the researchers as making the subject unsuitable for participation in the study.
Effect of Inhaled Aromatherapy on Chemo-Induced Nausea Vomiting (NCVI): CINVAROM (Chemotherapy Induced Nausea Vomiting and AROMatherapy)

The investigator wish to provide a blend of two essential oils with comparable antiemetic properties; Peppermint essential oil (Mentha x Piperita) and lemon tree essential oil (Citrus Limon). Dry inhalation of these essential oils is safe, but effectiveness has not been determined. Studies on the subject present a questionable methodology. This is why we are proposing this study to measure the effectiveness of this mixture of essential oils on chemo-induced nausea and vomiting.

This study is a first step before a possible study to compare the effects of essential oils with those of a placebo.


Eligibility Criteria:
Inclusion Criteria:

Patients will be eligible if:

* Aged over 18,
* Presenting a solid tumor in the 1st line of chemotherapy administered by intravenous route;
* Treated with adjuvant or neoadjuvant chemotherapy;
* Affiliated with a social security scheme;
* Able to understand the meaning of the questions asked;
* Having given their written consent to participate in the study;
* Whether or not treated with surgery and radiotherapy before entering the study

Exclusion Criteria:

Patients who:

* Do not give their consent to participate;
* Do not master the French language;
* Are deprived of their liberty, under guardianship or curatorship;
* Suffer from cognitive deficits or associated psychiatric disorders that could compromise their ability to participate in the study (eg: schizophrenia);
* Are undergoing radiotherapy;
* Must receive a combination of radio-chemotherapy;
* Whose chemotherapy protocol is composed of several chemotherapy administrations per week during a course of treatment;
* have been previously treated with chemotherapy;
* Have an occlusive syndrome;
* Have primary cancer of the central nervous system or brain metastases;
* Have cancer of the Upper Aero Digestive Tract;
* Simultaneously participate in a therapeutic clinical trial;
* Have an intolerance to a component of essential oils;
* Pregnant or breastfeeding.
Genetic, Neurophysiological and Psychological Predictive Factors of Chronic Neuropathic Pain After Surgery for Breast Cancer

The aim of the study is to establish the genetic, neurophysiological and psychological phenotype of the patients presenting a persistent neuropathic pain after surgery of the breast cancer, by comparing the neuropathic painful patients with the not painful and with the not neuropathic painful . This will be realized on a transverse cohort ("Seintinelle"cohort) and confirmed on a forward-looking longitudinal cohort.


Eligibility Criteria:
For both arms:

Inclusion Criteria:

* Women over 18 years
* Having given a written consent form
* Affiliated to the social security scheme
* French language (read, written and spoken)
* Accepting the principle of the study and able to respect the conditions of the study.

Exclusion Criteria:

* Other cancer or AIDS in evolution
* Bilateral Mastectomy
* Presence of chronic pain before the intervention for breast cancer,
* occupational accident, dispute or search for compensation
* Previous surgery on the same territory
* Peripheral neurological pathology or central (brain damage, multiple sclerosis) susceptible to interfere with the evaluation of the post-operative pain
* Heavy psychiatric histories: psychosis, severe depression having motivated a hospitalization, a suicide attempt
* Current major depressive episode at the time of the evaluation (cf. criterion diagnosis of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5))
* Abuse of drug or psychoactive substance (cf. definition of the DSM-5) during the last six months; cognitive disorders (MMSE 24/30) or psychological incompatible with the respect and/or the understanding of the protocol
* Patients participating in another protocol of biomedical research.

For longitudinal study:

Inclusion Criteria:

* Patients who can be followed during the total duration of the study ( 12 months) for the longitudinal arm of the forward-looking study
* Patients that must be operated for one of the two types of surgery: preservative surgery or mastectomy for breast cancer with ganglionic cleaning out
* Chemotherapy or radiotherapy before the surgery

Exclusion Criteria:

* Previous surgery for a breast cancer
* Patients that must be operated for a surgery of the breast without ganglionic cleaning out

For transversal study:

Inclusion criteria:

- patients operated for a conservative surgery or a mastectomy for breast cancer with ganglionic cleaning out during 2 years before the inclusion

Exclusion criteria

* patients operated for a surgery of the breast without ganglionic cleaning out
* Patients operated for more than 2 years
Opioid Free Anaesthesia in Oncologic Gynaecological Surgery: Is There Any Benefit?

Opioid Free Anesthesia (OFA) is a multimodal anesthesia and emerging technique that spares the use of opioids and involve other adjuvant anesthetics, which have demonstrated in vitro influence on immunologic and inflammatory response, as well as in metastatic progression. For these reasons we believe that OFA may positively influence in oncologic patients postoperative recovery and in its disease progression.

After Local Ethics Committee approval, consecutive consenting patients scheduled for major gynecologic oncologic surgery were included between February 2019 and January 2020 in this observational retrospective study. We Compared OFA to standard technique used in our institution and assessed its effect on Postoperative Systemic Inflammatory Response (SIRS), hospital stay, postoperative complications in the following 2 months, cancer progression and mortality 6 months and 12 months after surgery. OFA protocol consisted of a Total IntraVenous Anaesthesia of Propofol, a Dexmedetomidine infusion of 0,8-1,0 mcg/kg/h, together with 0,2-0,3 mg/kg ketamine and lidocaine 1,5 mg/kg in the first hour of surgery. The standard anaesthetic protocol included opioids (Fentanyl 2mcg/kg at induction, and remifentanyl infusion 0,1-0,2 mcg/kg/min) and volatile agents (sevoflurane or desflurane). Patients in both groups received a regional block when possible, dexamethasone 8 mg at induction and paracetamol 1g plus dexketoprofen 50mg at the end of surgery. Continuous variables were compared using unpaired t-test (or Mann-Whitney U test) and categorical variables by Chi-square test. Statistical significance was set at p \< 0.05

Eligibility Criteria:
Inclusion Criteria:

* Patients who had Major Surgery for gynecologic cancers (cervix, endometrial, ovarian, vaginal, vulvar and breast cancer) under OFA and balanced anesthesia with opioids, both combined with regional anesthesia.

Exclusion Criteria:

* Patients who had Major Surgery for gynecologic cancers (cervix, endometrial, ovarian, vaginal, vulvar and breast cancer) under OFA and balanced anesthesia with opioids, but had later surgery with a different to previous anesthesia technique.
* Patients who had no later follow up during 12 months in the same Hospital, so we cannot register recurrence.
Effect of NLR and MPV on Early Postoperative Outcome in Lower Extremity Arthroplasty Operations

In the planned study the investigators want to evaluate the relation between postoperative complications and minor/ major morbidities, mortality and Mean Platelet Volume (MPV) and Neutrophil/ lymphocyte (N/L) ratio.

* In this study the investigators aim to determine the relation between the MPV and N/L ratio and the incidence of postoperative adverse events and complications in patients undergoing knee arthroplasty.
* In this study only the laboratory tests that are routinely used for the operative patients are going to be used and no extra tests will be performed. The study will begin after the postoperative blood samples are collected for routine laboratory measurements. The patients will be allocated to 4 groups according to the type of anesthesia and VAS scores. Preoperative and postoperative peripheral blood total whole blood MPV and N/L ratio and 1st 6th 12th ve 24th hours VAS scores and complications, morbidities and mortality will be recorded. The patients will receive analgesics according to the routine practice in the ward and the doses of analgesics given will be recorded at 1st 6th 12th ve 24the hours wil be recorded.
* Statistical analysis: the numerical variables will be analyzed tested with Kolmogorov-Smirnov test for normality. For the parametric variables that are normally distributed t-test will be used for the comparison between groups. For the parametric variables that are not normally distributed Mann Whitney-U test will be used. All the categorical variables will be evaluated with q- square tests. A p value \< 0.05 will be determined as statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* knee arthroplasty patients with general or spinal anesthesia.

Exclusion Criteria:

* patients not giving consent
* reoperations
* patients having inflammatory disease
* infection in the knee
* sepsis
* bleeding disorders
* hematologic diseases,
* using steroids.
* trauma
* fracture patients,
* bilateral knee prothesis
* combined surgery procedures
* patients needing perioperative transfusions
* uncooperative patients.
A Study of HS-20094 in Patients With T2DM

This is a 32-week, phase 2, randomized study, HS-20094 and placebo were double-blind, dulaglutide was open-label. Adults with T2D inadequately controlled with diet and exercise alone or with stable metformin, an HbA1c (glycated hemoglobin) ≥53 to ≤91 mmol/mol (≥7.0 % to≤10.5 %) were randomly assigned to receive 5 mg HS-20094, 10 mg HS-20094, 15 mg HS-20094, placebo, or 1.5 mg dulaglutide subcutaneously for 32 weeks. The primary endpoint was change in HbA1C from baseline to 32 weeks, and secondary endpoints included change in fasting glucose, body weight and several additional measures relevant for cardiovascular risks.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients 18 to 75 years of age, inclusive
2. Patients were diagnosed with T2DM for at least 3 months before screening.
3. Have an HbA1c value at screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or a stable dose of metformin (either immediate release or extended release, ≥1000mg/day and not more than the locally approved dose) for at least 2 months prior to screening
4. Body mass index (BMI）≥ 22 kg/m2.

Exclusion Criteria:

1. Type 1 diabetes, gestational diabetes, monogenic diabetes, secondary diabetes, or undetermined diabetes as assessed by the investigator
2. Acute or chronic pancreatitis at any time before screening, or serum lipase/amylase above the upper limit of normal at screening
3. A history of grade 3 hypoglycemia (hypoglycemia with a serious event of consciousness and/or physical alteration requiring assistance from another person for recovery) within 6 months before screening
4. Occurrence of diabetic ketoacidosis, hyperosmolar coma, or lactic acidosis two or more times within 6 months prior to screening
5. Occurrence of any of the following events within 6 months prior to screening: acute myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention (excluding diagnostic angiography), transient ischemic attack, cerebrovascular accident, decompensated congestive heart failure, or Class III or IV heart failure (NYHA classification)
6. Significant weight change (weight gain or loss ≥5%) within 3 months prior to screening (as reported by the participant)
A Retrospective Real-world Study of Abemaciclib in HR+ Breast Cancer

The present study will assess real-world clinical outcomes, adverse events and economics from treatment with endocrine therapy(ET) combined with abemaciclib in patients with hormone receptor-positive(HR+) breast cancer.

Based on clinical trials data, Abemaciclib has been approved for early and advanced breast cancer with HR+ and human epidermal growth factor 2 receptor-negative(HER2-), but clinical trials require real-world research data as supplementary validation supporting evidence. This study will assess real-world clinical outcomes, adverse events and economics from treatment with endocrine therapy(ET) combined with abemaciclib in patients with HR+ breast cancer. In addition, this trial will explore the efficacy of Abemaciclib in patients with HR+ and human epidermal growth factor 2 receptor-positive(Her2+) breast cancer.

This study will now include real-world data on efficacy, toxicity and economics of abemaciclib in the adjuvant setting in HR+ breast cancer. Participants to be enrolled will come from an online platform for researches which all the privacy information has been controlled. The investigators are going to gather 2 groups of breast-cancer-one-other-study(BCOOS) including BCOOS-A and BCOOS-B. Group BCOOS-A includes the patients treated with Abemaciclib and Letrozole/Anastrozole compared with treated with Letrozole/Anastrozole only. Group BCOOS-B includes the patients treated with Abemaciclib and Fulvestrant compared with treated with Fulvestrant only.

Investigators will measure clinical outcomes, adverse events and economics in each group above.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Histologically confirmed HR-positive breast cancer and Imaging/pathological evidence of metastasis is available
* Treatment with abemaciclib in combination with endocrine therapy
* Any endocrine therapy
* Having solid tumor efficacy evaluation criteria RECIST 1.1 measurable lesions

Exclusion Criteria:

* Combined with other primary malignancies
* Associated with serious non-tumor related diseases, such as cardiovascular system, respiratory system, nervous system, blood system, digestive system
* Pregnant or lactating women
* male breast cancer
Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7)

This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in persons living with human immunodeficiency virus (HIV), for the prevention of pneumococcal disease caused by the serotypes in the vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Is infected with HIV
* Is receiving combination anti-retroviral therapy (ART) for ≥6 weeks before study entry with no intended changes to combination ART therapy for 3 months after randomization.
* Is vaccine-naïve

Exclusion Criteria:

* Has a history of opportunistic infections ≤12 months before the first vaccination
* Has a history of noninfectious acquired immune deficiency syndrome-related illness
* Has a history of active hepatitis
* Has a history of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease ≤3 years before Visit 2 (Day 1)
* Has a known hypersensitivity to any component of V116, PCV15, or PPSV23, including diphtheria toxoid
* Has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease
* Has a coagulation disorder contraindicating intramuscular vaccinations.
* Has a recent illness with fever
* Has a known cancer malignancy that is progressing or has required active treatment \<3 years before enrollment
* Had prior administration of PCV15 or PCV20.
* Is expected to receive any pneumococcal vaccine during the study outside of the protocol
* Has received systemic corticosteroids for ≥14 consecutive days and has not completed treatment ≥14 days before receipt of study vaccine
* Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
* Has received any non-live vaccine ≤14 days before receipt of any study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of any study vaccine
* Has received any live virus vaccine ≤30 days before receipt of any study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of any study vaccine
* Has received a blood transfusion or blood products, including immunoglobulins ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of study vaccine
* Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study.