cyrilzakka/clinical-trials huggingface dataset:
Effect of Low-dose Esketamine on Postoperative Depression in Patients With Breast Cancer

esketamine is an optical isomer of ketamine. Compared with ketamine, esketamine has the characteristics of higher effective value, stronger receptor affinity, less adverse reactions of nervous system, and pharmacokinetics is controllable.

Domestic and foreign studies have focused on the therapeutic effect of esketamine on major depression, but less attention has been paid to perioperative depression.This study intends to explore the effect of small doses of esketamine on patients with breast cancer.Postoperative depression and pain are observed.

This study intends to explore the effect of small doses of esketamine on patients with breast cancer.WE pay attention to :

1. Safety of low-dose single intravenous injection of esketamine (1)The influence of intraoperative vital signs of patients after medication, such as blood pressure and heart rate fluctuation; (2)the duration of recovery after anesthesia; (3)postoperative adverse reactions, such as nausea and vomiting, dizziness and diplopia, respiratory depression, laryngeal spasm, delirium agitation, etc
2. Effect of single intravenous injection of low-dose ketamine on postoperative depression in patients undergoing radical mastectomy (1) 1 day before surgery, 2 days, 5 days, 30 days, 90 days after surgery Hamilton Depression Scale scores; (2) The serum leptin level 1 day before surgery, 2 days after surgery and 5 days after surgery; (3) Correlation between depression scale score and leptin level
3. Effects of low dose esketamine on acute and chronic pain in patients undergoing radical mastectomy

   * visual analogue scale scores at 6, 12 and 24 hours after surgery;

     * visual analogue scale scores at 3, 5, 30 and 90 days after surgery;

       * the number of analgesic remedies

Eligibility Criteria:
Inclusion Criteria:

* (1) Female patients who planned to undergo unilateral modified radical mastectomy in breast surgery; (2)Years of education ≥5 years,American Society of Anesthesiologists Ⅰ-II grade; (3) All patients undergoing surgery within 1 week after diagnosis of breast cancer, and do not receive preoperative radiotherapy or chemotherapy; (4) All the patients were married and had children, and were mainly cared for by their immediate family members after surgery.

Exclusion Criteria:

* (1) Antidepressant treatment was received within the last 2 months; (2) previous personality disorder, intellectual retardation, brain injury or brain disease, combined with schizophrenia, mania and other mental diseases; (3) Preoperative patients with hyperthyroidism or hypothyroidism, severe cardiovascular disease, diabetes, severe blood deficiency, and abnormal heart, lung, liver, and kidney functions; (4) with diseases of the immune system, or use drugs that have obvious effects on the immune system; (5) Pregnancy or lactation;
Characteristics of Cardiac Tumor and the Risk Stratification of Subsequent Adverse Events (UNIQUE)

This study aims to retrospectively and prospectively collect clinical and biological specimen data from patients with cardiac tumors who meet the inclusion and exclusion criteria. Various techniques, including general molecular biology analysis and multi-omics analysis, will be used to construct a prognostic model for cardiac tumors.

This study aims to construct a retrospective-prospective long-term follow-up cohort and management system for cardiac tumors through a multi-centre collaborative network. The duration of the study will be divided into retrospective and prospective components. The retrospective study will collect cases of cardiac tumors from 2003-2022; the prospective study is expected to collect cases of cardiac tumors from 2022-2030. The study is expected to assess the disease characteristics, progression patterns, clinical features, natural course and long-term prognosis of cardiac tumors.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are regularly visited and followed up in the corresponding cardiovascular center.
* All patients must meet at least one of the following diagnostic criteria for cardiac neoplasms: 1. Cardiac myxoma group; 2. Cardiac fibroma group; 3. Cardiac lipoma group; 4. Cardiac hemangioma group; 5. Cardiac undifferentiated sarcoma; 6. Cardiac angiosarcoma group; 7. Cardiac rhabdomyosarcoma group; 8. Cardiac lymphoma group; 9. Cardiac metastasis group; 10. Other cardiac tumors group.

Exclusion Criteria:

* Age \<3 years or \>80 years old.
* Pregnant and lactating women.
* The patient declined to provide informed consent to participate in the study.
* None of the above was met, but the patient was temporarily unable to sign the informed consent form due to coma and other reasons, and no legal representative signed it instead. Depending on the patient's condition, the patient may not be able to regain consciousness and sign the informed consent form.
Clinical Performance of GYNECARE PROSIMA* Pelvic Floor Repair System for Symptomatic Pelvic Organ Prolapse

The purpose of this study is to evaluate the safety and effectiveness of the GYNECARE PROSIMA\* Pelvic Floor Repair System as a Device in Women with Symptomatic Pelvic Organ Prolapse.

The GYNECARE PROSIMA\* system is a new technique and now available in China. It provides a simplified unanchored mesh repair, making surgery much simpler to perform and reduces the risk of the specific complications that may occur when tunneling devices beyond the pelvic cavity.

In clinical practice, many women have symptomatic prolapse, which requires surgical correction. They are relatively young, and therefore care more about the long-term outcomes and quality of life after procedure. The purpose of this multicenter and prospective study is to evaluate the effectiveness and safety of the GYNECARE PROSIMA\* system in the treatment of symptomatic POP-Q Stage II-III pelvic organ prolapse.

Eligibility Criteria:
Inclusion Criteria:

* Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair. Vaginal hysterectomy and mid-urethral sling procedures for incontinence may be performed concurrently.
* Age ≥ 18 years.
* Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee approved informed consent.

Exclusion Criteria:

* Additional surgical intervention concurrent to the procedure (e.g. sacrocolpopexy, paravaginal repair, tubal sterilisation).
* Previous repair of pelvic organ prolapse involving insertion of mesh.
* Previous hysterectomy within 6 months of scheduled surgery.
* Experimental drug or experimental medical device within 3 months prior to the planned procedure.
* Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
* Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
* History of chemotherapy or pelvic radiation therapy.
* Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spinal cord injury or trauma).
* Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).
* Nursing or pregnant or intends future pregnancy.
* Chronic cough not well-controlled.
* BMI≥30.
* In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.
Parent Intervention to Reduce Binge Drinking

Parent and peer interventions to reduce student drinking

Parent and peer interventions to reduce student drinking:

Efficacy;

Mediation:

Moderation

Eligibility Criteria:
Inclusion Criteria:

* varsity athlete in high school

Exclusion Criteria:

* not a varsity athlete in high school
Characteristics of Post-Traumatic Stress Disorder (PTSD) and Non-PTSD Subjects

Compare PTSD and non-PTSD subjects on several demographic, cognitive and military variables


Eligibility Criteria:
Inclusion Criteria:

* Subjects applied for treatment in the MOH rehabilitation centers or the IDF unit for combat reactions and were diagnosed with PTSD

Exclusion Criteria:

-
Relation Between PRST Score, Skin Conductance and BIS

Determine the relation between PRST (pressure, rate, sweating, tears) score, skin conductance (SC) and Bispectral index (BIS) values during anesthesia

Probability of \>0 points in the PRST as a function of BIS and number of fluctuations in mean skin conductance (NFSC) will be recorded during the anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Minor elective surgery
* General anaesthesia

Exclusion Criteria:

* autonomic neuropathy
* presence of a pacemaker
* medication with anticholinergic drugs
* use of ketamine, clonidine
Circulating Tumor Cells in Lung Cancer

TITLE : Circulating tumor cells identification in advanced stage non-small cell lung cancer (CIRCUBRONCH)

BACKGROUND : Circulating tumor cells identification is a new field of research in oncology, and some studies have been conducted with success on breast and prostate cancer. Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV). Circulating tumor cells identification and monitoring these cells after treatment could help the clinicians to detect relapse or be a prognostic factor.

PRIMARY OBJECTIVE : Circulating tumor cells identification, and monitoring in advanced stage lung cancers (IIIB and IV).

SECONDARY OBJECTIVES : Predictive value of the monitoring of circulating tumor cells on the therapeutic response. Prognostic value of identification of circulating tumor cells at the time of diagnosis.

STUDY DESIGN : This study is a prospective, monocentrique trial analyzing the identification of circulating tumor cells in stage IIIB, and IV non-small cell lung cancers.

Duration of the inclusions: 54 months.

Duration of the study: 66 months.

PROCEDURES : Detection of circulating tumor cells with CellSearch system (Veridex), and a cut-off of 5 cells/7,5 ml of blood.

SAMPLE SIZE : 200 patients

STATISTICAL ANALYSIS : Detection of circulating tumor cells is predicted in 20% of stage IIIB, and IV non-small cell lung cancers included in this study. The cut-off is 5 circulating tumor cells per 7,5 ml of blood.


Eligibility Criteria:
Inclusion Criteria:

* Advanced stage NSCLC (stages IIIB, and IV) with measurable or evaluable disease at diagnosis.
* Age ≥ 18 years.
* Measurable or evaluable disease according to RECIST criteria.
* Ability to sign informed consent.

Exclusion Criteria:

* Prior cancers within 5 years, except for non-melanoma skin cancers, and in situ cervical cancers.
* Prior chemotherapy, radiation or surgery for lung cancer.
* Inability to comply with study and/or follow-up procedures.
A Clinical Study to Evaluate the Safety and Efficacy of Aliskiren Alone and in Combination With Ramipril in Hypertensive, Diabetic Patients.

To demonstrate the efficacy and safety of aliskiren given to patients with both hypertension and diabetes mellitus


Eligibility Criteria:
Inclusion Criteria

* Patients with essential hypertension
* Patients with a documented diagnosis of Type 1 or Type 2 diabetes mellitus.
* Patients who are eligible and able to participate in the study

Exclusion Criteria

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined exclusion criteria may apply
Effect of Exercise on Genes That Control Muscle Function

The proposed project will examine how exercise counteracts metabolic disorders and type 2 diabetes through regulating gene expression. The project is highly relevant to public health because of the global pandemic of diabetes, obesity, and associated metabolic syndromes as well as the well-known metabolic benefit of physical exercise in correcting these disorders.

Exercise is a first-line treatment for type 2 diabetes, and exerts its beneficial effects not only by burning off energy but also by causing prolonged metabolic changes through changing gene expression. Genes are our genetic materials and the expression of genes determines our biology. In our previous study in animals, we identified some factors that drive exercise-induced gene expression changes. Here we would like to address whether the result is also true in human. This work will provide molecular insights into how exercise remodels our metabolism and will potentially find a way to maximize the benefit we get from physical exercise.

The purpose of this study is to determine whether acute exercise activate certain molecular factors in human skeletal muscle. Participants will be asked to undergo an acute bout of aerobic exercise at \~ moderate intensity for about 2 hours. Before and after the exercise, the participants will undergo a muscle biopsy. The muscle tissues will be used for total RNA extraction and RT-qPCR analysis of genes that include but are not limited to de facto JunD/AP-1 target genes and will also be analyzed by Jun D Chip-qPCT to assess binding of Jun D on its de facto target genes.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 - 40 years
* BMI 18.5 - 29.9
* Stable body weight (not more than 2 kg change) during the past 6 months
* Moderate sedentary (regular exercise less than 1 hour per week for the last 6 months)
* Willing to provide informed consent

Exclusion Criteria:

* Failure to provide informed consent
* Any major chronic disease or any condition that would interfere with exercise, in which exercise is contraindicated, or that would interfere with interpretation of results
* Severe orthopedic and or neuromuscular disease that would contraindicate participation in exercise
* Other significant co-morbid disease that would impair ability to exercise
* Uncontrolled hypertension (BP greater than 160/90)
* History of malignancy during the past 5 years
* Diabetes mellitus as determined by self-report with verification (medical records, current treatment, confirmation from health care provider), or HbA1c of exceeding 6.5%
Pre-Operative Immuno-Modulatory SBRT (POIMS Trial): A Pilot Trial in Early Stage NSCLC

The current proposal is structured as a pilot trial to evaluate the impact of non-ablative SBRT (800 cGy X 3 fractions) as an immunomodulatory mechanism in patients with early stage NSCLC who are surgical candidates. Tumor, normal tissue and blood specimens will be analyzed for immunomodulatory changes including phenotypic changes in tumor cell surface marker expression, tumor and normal tissue microenvironment and gene expression profiles, serum/blood immune profile changes, and circulating tumor cell immunophenotypic and gene expression alterations.

Published literature showed that cytotoxic doses of XRT may not elicit a clinically meaningful alteration in the immune profile. Further, studies using an animal model have concluded a fractionated regimen induces a greater abscopal effect than single dose radiation. Furthermore, research has shown a regimen of 800 cGy X 3 fractions yielded the most significant changes in the immune profile compared to 2000 cGy X 1 or 600 cGy X 5.

The immune response within the tumor milieu is a complex dynamic process with an interplay among lymphocyte subsets, antigen presenting cells/dendritic cells, macrophages, and tumor cells. The interactions between the various components is orchestrated by a variety of extracellular and intracellular signaling pathways involving ligand and cell surface expression, cytokine release, and activation or inhibition of a variety of T cell subsets. In order to comprehensively define the immunomodulatory effect of three fractions of 800 cGy on the primary tumor, the investigators will analyze the following: tumor cell surface phenotype, tumor microenvironment immune profile and gene expression profile, T cell repertoire changes in tumor tissue and peripheral blood, and circulating tumor cell phenotype and gene expression profiles. Each of these components has been shown to be impacted by radiation in either a cell culture or animal model systems. By characterizing, quantitating and defining these changes related to three fractions of 800 cGy, it will directly provide important insights to inform rational uses of XRT and immunotherapy in the future.


Eligibility Criteria:
Inclusion Criteria:

* Stage I-II NSCLC
* Adequate diagnostic biopsy tissue to allow pre-SBRT tumor analysis
* Candidate for oncologic surgery (lobectomy or sub lobar resection) for the lung cancer
* Lesion located peripherally, ≥ 2 cm from bronchial margin, and 1 cm from visceral pleura, with location deemed acceptable by cardio-thoracic surgeon for resection.
* Adequate pulmonary function test results

Exclusion Criteria:

* Prior history of lung/chest wall surgery
* Prior chest radiation
* Prior immunotherapy
* History of autoimmune disease
* Currently using immunosuppressive drugs
Safety Study of TXA127 to Elevate CD4+ T-Lymphocyte Counts in HIV-Infected Patients on Stable HAART Therapy

The purpose of this study is to test the safety of an investigational medication, TXA127, and its ability to increase T-lymphocyte counts, specifically CD4+ T-lymphocytes, in persons infected with human immunodeficiency virus who are taking highly active anti-retroviral therapy.

This is a Phase I, single institution, open-label, within-dosing-cohort-schedule randomized, dose escalation study of TXA127 in HIV-infected subjects with CD4+ T-lymphocyte counts less than 250 per mm3 who have responded to highly active retroviral therapy (HAART). The study has been designed to determine the maximum tolerated dose (MTD) of TXA127 in this subject population. This study will also obtain safety and biologic activity information about the subcutaneous injection of TXA127.

Five escalating dosing cohorts will be examined to determine the MTD. The first four dosing cohorts will receive 50, 100, 200 and 300 mcg/kg of TXA127 by subcutaneous injection daily for 14 days, followed by 14 days without treatment. These 28 days will be defined as one cycle. The cycle of therapy will be repeated once, for a total of two courses of treatment. The 5th dosing cohort will receive 300 mcg/kg of TXA127 by subcutaneous injection daily for 28 days, then 14 days without treatment followed by an additional 28 days of TXA127 administration. Dose escalation to the next cohort of subjects will be permitted to the next higher dosing level provided the following criteria have been met.

A standard Simon Phase I dose escalation trial has been proposed. The MTD will have been exceeded if the proportion of subjects that develops the same or similar study-drug-related, DLT in an assigned dosing schedule equals 2/2, 2/3, 2/4, 2/5, and 2/6 subjects. The MTD is defined as the largest dose that \<2 of 6 subjects experiences a DLT. Dose-limiting toxicity is defined as a study-drug-related grade 3 or 4 adverse event (AE).

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected males or non-pregnant, non-breast-feeding females who are \>= 18 years of age;
* CD4+ T-lymphocyte count less than 250 per mm3;
* Successful response to HAART (defined as an HIV RNA viral load of \<50 copies per mL) for a minimum of one year preceding study enrollment.

Exclusion Criteria:

* Opportunistic infection within the 6 months prior to study enrollment
* Active tuberculosis or other mycobacterial infection
* Uncontrolled high blood pressure or congestive heart failure class III or IV
* Systemic glucocorticoid or immunomodulator therapy within 30 days of study entry
* Prior history of Kaposi's sarcoma
* Prior history of lymphoma
* Active substance abuse within the last 30 days
* Uncontrolled psychiatric disorders, including depression
* Abnormal or inadequate liver or renal function
* Inadequate bone marrow function
Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)

The objectives of this study are to develop research methods and corresponding materials for a study of the effectiveness of sitaxentan sodium (Thelin) in "real-world" settings; to pilot test these methods at three study centers in Europe; and to refine and finalize research methods and corresponding materials for possible use in a follow-on, full-scale examination of the effectiveness of sitaxentan sodium (Thelin) in "real-world" settings.

At each centre, approximately 12-15 Pulmonary Arterial Hypertension (PAH) consecutive patients who have received Thelin and who meet all other study entry criteria.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic PAH, or PAH secondary to connective tissue disease
* Receipt of Thelin for treatment of PAH
* 6 months of follow-up (except in the event of death) subsequent to initial receipt of Thelin
* Minimum of one clinic visit documented in the medical record during the 6-month period subsequent to initial receipt of Thelin

Exclusion Criteria:

* Participation in any investigational study of Thelin or any other medication for the treatment of PAH during the period beginning 6 months prior to initial receipt of Thelin and ending 6 months subsequent to such receipt
* Receipt of Thelin prior to January 11, 2005 (i.e., the date following the last day on which patients could be enrolled in double-blind treatment in STRIDE-1, STRIDE-2, and/or STRIDE-6); or
* Known contraindications to Thelin therapy (i.e., known hypersensitivity to sitaxsentan or any of its excipients; mild-to-severe hepatic impairment \[Child-Pugh Class A-C\]; elevated aminotransferases prior to initiation of treatment, defined as aspartate aminotransferase \[AST\] and/or alanine aminotransferase \[ALT\] \>3 times upper limit of normal \[ULN\]; concomitant use of cyclosporin A; lactation)