cyrilzakka/clinical-trials huggingface dataset:
mFOLFIRI as the Second Line Chemotherapy for Advanced Esophageal Carcinoma After Failure of 1st Line Treatment of Paclitaxel/DDP : a Phase II Single Center Prospective Clinical Trial

There are few studies about 2nd line treatment in advanced esophageal carcinoma(AEC), some showed that irinotecan may be effective. The investigators previous study has shown the efficacy and safety of paclitaxel/cisplatin as 1st line treatment, so in this phase II study, the investigators would like to observe the efficacy and safety of Irinotecan/5FU/leucovorin as 2nd line treatment if AEC after failure to 1st treatment of PTX/DDP.


Eligibility Criteria:
Inclusion Criteria:

* Having signed informed consent
* Age 18 to 70 years old
* Histologically confirmed esophageal squamous carcinoma,failed to 1st line treatment of paclitaxel/cisplatin
* Unresectable recurrent or metastatic disease
* Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
* Karnofsky performance status ≥70
* Life expectancy of ≥3 month
* No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
* ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
* Serum AKP \< 2.5 times ULN (within 7 days before enrollment)
* Serum creatinine \<1.0 times ULN (within 7 days before enrollment)
* Bilirubin level \< 1.0 times ULN (within 7 days before enrollment)
* WBC\>4,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl(within 7 days before enrollment)
* No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever\>38℃；
* Good compliance

Exclusion Criteria:

* More than 1 Previous systemic therapy for metastatic esophageal squamous carcinoma
* Known hypersensitivity to irinotecan
* Only with Brain or bone metastasis
* Tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung
* No measurable lesions, eg. pleural fluid and ascites
* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
* Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months or
* Pregnancy or lactation period
* Other previous malignancy within 5 year, except non-melanoma skin cancer
* Chronic diarrhea
* Mentally abnormal or disable cognition,including CNS metastasis
Oral Hygiene Self-efficacy in Patients With Grief

to investigate the effect of oral hygiene self-efficacy in patients with grief (G) and complicated grief (CG)

Aim: to investigate the effect of oral hygiene self-efficacy in patients with grief (G) and complicated grief (CG). Study design: randomized controlled trial. Setting: Institute of Psychiatry-FMUSP (Ipq-FMUSP). Subjects: cases: patients seeking for treatment or under treatment for CG (Group 1), and patients with normal grief (Group 2). Controls: Hospital staff at the HC-FMUSP or volunteers from a list of other studies conducted at the Ipq-FMUSP (Group 3). Method. Psychiatric evaluation: Structured Clinical Interview (SCID), Texas Revised Inventory of Grief (TRIG) and clinical interview. Intervention: instruction of oral hygiene. Dental evaluation: probing depth, clinical attachment level, bleeding on probing, and frequency of plaque at six sites per tooth. Procedures: all participants will complete the psychiatry and dental evaluation at baseline. The bleeding on probing and frequency of plaque will be recorded at baseline, once a week (1 month follow-up) and at 3 months. The probing depth and clinical attachment level will be recorded at baseline and at 3 months. After 3 months, the patients will be referred for dental treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of grief or complicated grief
* Informed consent signature

Exclusion Criteria:

* Patients with severe major depressive disorder at risk for suicide;
* Substance abuse or dependence,
* Psychotic disorders
* Systemic alteration that precludes periodontal clinical examination
Left Chamber Function in Mitral Regurgitation and Predicting Outcome After Replacement and Targeting for Early Surgery

The study aims to analyze the role of left ventricular and left atrial functional parameters by speckle tracking echocardiography in predicting outcome after mitral valve replacement and targeting for early intervention compared to guideline parameters.

Without surgical treatment, the 10-year morbidity and mortality for patients with severe mitral regurgitation can be as high as 90%.

In contrast, with successful surgical correction of mitral regurgitation before the appearance of symptoms, patients may have life expectancies similar to that of the general population.

According to European recommendations, mitral valve replacement must be proposed to symptomatic patients and to patients with significant left ventricular remodeling as a consequence of the severity of mitral regurgitation.

A significant decline in left ventricular function is defined, in these recommendations, echocardiographically as an left ventricular ejection fraction \< 60% or an left ventricular end-systolic diameter \> 45 mm.

Preoperative left ventricular systolic function and left ventricular end systolic diameter are important postoperative prognostic factors.

The early detection of left ventricular systolic dysfunction remains a challenge. Mitral regurgitation causes low left ventricular afterload, and the ejection fraction thus remains normal or supernormal until the disease reaches an advanced stage.

Some authors have suggested the additive value of deformation indices as more sensitive than the ejection fraction to detect subclinical left ventricular systolic dysfunction Speckle tracking echocardiography has been well validated as a quantitative assessment tool for left ventricular function, and more recently this technique has been described for assessment of regional and global left atrial function

Eligibility Criteria:
Inclusion Criteria:

* Patients with rheumatic severe mitral regurgitation who will have mitral valve replacement in Assiut University Heart Hospital

Exclusion Criteria:

* Degenerative mitral regurgitation, ischemic mitral regurgitation, severe rheumatic mitral regurgitation with atrial fibrillation or impaired left ventricular ejection fraction, associated mitral stenosis, or significant aortic regurgitation and ischemic heart disease.
Analysis of the Inner Diameter of the Distal Radial Artery and the Influencing Factors in Chinese Patients

Cardiovascular intervention via distal radial artery (DRA) approach has become more and more extensive. However, the DRA is smaller than conventional radial artery (CRA). Assessing the size of the DRA before vascular intervention is extremely important to select suitable patients. There are still few large-sample studies to evaluate the size of DRA and its influencing factors in the Chinese population.

In recent years, the clinical application of distal radial artery (DRA) approach in cardiovascular intervention has become more and more extensive. However, compared with CRA, the DRA is smaller, resulting in an increased proportion of patients requiring multiple punctures and a lower success rate of implantation. It has been found that the mismatch between artery sheath and vessel size is one of the independent risk factors for postoperative vascular approach complications. Therefore, assessing the size of the DRA before vascular intervention is extremely important to select suitable patients, improve the success rate of puncture, and reduce the complications associated with the approach There are still few large-sample studies to evaluate the size of DRA and its influencing factors in the Chinese population.

Eligibility Criteria:
Inclusion Criteria:

* Patients who is prepare for coronary angiography

Exclusion Criteria:

* Lack of upper limbs
Reduce Bolus Injection of Bivalirudin

There are fewer studies on the bleeding risk of the currently administered bivalirudin bolus injection dose and the safety of bivalirudin in patients with CKD. A non-inferiority, randomized, stratified controlled trial study has been conducted to evaluate the non-inferiority and safety of the low dose (80%) bolus injections of bivalirudin in patients with or without CKD.This study will provide a safe, effective and economical anticoagulation strategy.


Eligibility Criteria:
Inclusion Criteria:

* 1 Age 18 to 80 years old; 2 Medically judge to require coronary angiography; 3 Patients agree to use bivalirudin 4 Patients signe informed consent.

Exclusion Criteria:

* 1.Cardiogenic shock; 2.Thrombolytic therapy administered before randomization or any anticoagulant administered within 48 hours of randomization; 3.Active or recent major bleeding or bleeding predisposition; 4.Major surgery within 1 month; 5.Clinical syndrome suspicious for aortic dissection, pericarditis, or endocarditis; blood pressure higher than 180/110 mm Hg; 6.Known hemoglobin less than 10 g/dL,platelet count less than 100 × 109/L, aminotransferase level greater than 3 × the upper limit of normal; 7.History of heparin-induced thrombocytopenia; 8.Ellergy to any of the study drugs or devices; 9.Eregnancy or lactation; 10.Any condition making PCI unsuitable or that might interfere with study adherence; 11.Patient unwilling or unable to provide written informed consent 12. Researchers think it is not suitable to participate in this study.
Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Germany)

This prospective cohort study will provide information about: characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed Phenprocoumon for the first time, the occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.


Eligibility Criteria:
Inclusion Criteria:

* All male and female patients who have been prescribed for the first time either Rivaroxaban or standard of care from the date of market authorization of rivaroxaban to Dec 31, 2017

Exclusion Criteria:

* Patients who have any record of being dispensed their index drug in the year before index date (i.e. cohort entry), or who qualify for both cohorts on the same day
Interpersonal Psychotherapy for Depressed Adolescents and Parents

The purpose of this study is to examine the feasibility and acceptability of an adaptation of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) that includes greater and more structured involvement of the parents in the treatment.

Adolescent depression is a significant public health problem, and it increases the risk of poor psychosocial outcomes in adolescence and adulthood. Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) has been found to be an effective treatment for reducing adolescents' depressive symptoms and improving their global and social functioning. The purpose of the current study is to examine the feasibility and acceptability of IPT-A when it is delivered with greater and more structured involvement of the parents in the treatment.

Participants will receive 15 weeks of Interpersonal Psychotherapy for Depressed Adolescents and Parents (IPT-AP). Eight the therapy sessions are conducted with the adolescent individually, two are with the parent(s) individually, and five are conducted with the adolescent and parent(s) together. At the end of the 15 weeks, participants who have demonstrated at least a 50% reduction in depressive symptoms will participate in three booster sessions delivered on a monthly basis. All participants will be assessed at baseline, week 5, week 10, week 15 (post-treatment), and 3 months post-treatment to measure depressive symptoms, global and social functioning, and attitudes toward treatment.

Eligibility Criteria:
Inclusion Criteria:

* Meets diagnostic criteria for major depression, dysthymic disorder, depressive disorder not otherwise specified, or adjustment disorder with depressed mood
* Score between 10 and 28 on the HRSD
* Score of 65 or less on the C-GAS
* English-speaking adolescent
* Parental or legal guardian consent to participate

Exclusion Criteria:

* Actively suicidal
* Score greater than 28 on the HRSD
* Mentally retarded
* Meets diagnostic criteria for current substance abuse, schizophrenia, bipolar disorder, psychosis, conduct disorder, or eating disorder
* Currently in active treatment for depression
* Taking antidepressant medication at the time of baseline assessment
* Medical illness likely to complicate or interfere with treatment
* Victim of ongoing or previously undisclosed child abuse
* Parent psychiatrically hospitalized within the past 3 months
Trial to Reduce Antimicrobial Use in Nursing Home Residents With Alzheimer's Disease and Other Dementias 2.0

The goal of this pragmatic cluster randomized clinical trial is to compare management of suspected infection in nursing home residents with dementia The main questions it aims to answer whether residents with dementia in nursing homes randomized to use a multicomponent intervention to optimize suspected infection management ( versus usual care) use less antibiotics and fewer burdensome interventions.

This 52-month study (8 months preparation; 34 months trial conduct; 10 months data analyses and manuscript preparation)is a parallel cluster ePCT of an intervention to improve infection management for suspected infections among residents with moderate to advanced dementia (N=600; N=300/arm) living in NHs (N=50; N=25/arm). Facilities are members of a provider managed care network, Iowa Health Care Quality Network ('Network'). The intervention will be similar to the original TRAIN-AD program, but adapted for moderate to advanced dementia and rolled out in the Network. At each intervention NH, the intervention will be implemented for 24-months. Control NHs will employ usual care. In all NHs, there will be a 2-month startup period, 12-month resident enrollment period, and 24-months data collection period (Figure 2). Eligible residents with dementia will be identified using the EHR and Minimum DataSet (MDS) and followed up to 12 months. Outcome data will be ascertained from the EHR. Randomization and program roll out will be at the facility level. Analyses at the resident level. Clinical outcomes compared between arms at 12 months will be: 1. Antimicrobial courses/person-year in residents with moderate to advanced dementia (primary outcome) and all residents with dementia (secondary outcome) (Aim 1); and 2. Number of burdensome procedures/person-year used to manage suspected infections among residents with moderate to advanced dementia and those at all stages of dementia including: hospital transfers, urine specimens, chest x-rays, and blood cultures (secondary outcomes) (Aim 2). A process evaluation of implementation will be conducted in the intervention arm based on the RE-AIM framework1 (Aim 3) using quantitative and qualitative data (stakeholder interviews).

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 60
2. A diagnosis of dementia (any type)
3. Cognitive Functional Scale (CFS) \> 1
4. NH length of stay \>90 days

The CFS score categorizes cognitive impairment status based on data in the electronic health record into: 1. None, 2. Mild, 3. Moderate, and 4. Severe (advanced). For the primary outcome, the analysis will be restricted to residents with a CFS score of 3 or 4.

Exclusion Criteria:

1. Less than 60 years of age
2. Living in nursing home for less than 90 days
3. Does not have diagnosis of dementia
4. Does not meet CFS \>1 score
A Phase II Multi-institutional Study Assessing Simultaneous In-field Boost Helical Tomotherapy for 1-3 Brain Metastases

Helical tomotherapy is a novel radiation treatment machine that combines two existing technologies: spiral radiotherapy treatments combined with simultaneous computed tomotherapy imaging of the body. This new machine can potentially allow radiation treatments to be focused more precisely, and delivered more accurately than with existing radiation machines. In this study, helical tomotherapy will be used to provide radiation treatments (whole brain radiotherapy, daily over 10 treatments) that are commonly used to treat cancer metastatic to the brain. In addition, the individual spots of cancer (metastases) in the brain will be treated to a higher dose (approximately 2 times higher) than the dose to the whole brain. The purpose of this study is to determine the effectiveness of whole brain radiation with lesion boosting with the helical tomotherapy machine.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of primary cancer
* Contrast enhanced MRI demonstrating 1-3 metastases within 6 weeks of enrollment
* Age greater than or equal to 18
* Karnofsky performance status greater than or equal to 70
* Patient available for subsequent follow-up appointments and testing as well as health-related quality of life questionnaires
* Anticipated survival (independent of the brain metastases) greater than 3 months
* Patient informed consent obtained
* Metastatic suitable for synchronous boost
* Extracranial disease controlled or to be treated

Exclusion Criteria:

* Underlying medical condition precluding adequate follow-up
* Prior cranial radiotherapy
* Concurrent cytotoxic chemotherapy
Residential Cleaning of Indoor Air to Protect COPD Patients

This study looks at whether air cleaning devices put in the bedroom and living room of your home could reduce the irritation of your lungs and body that is caused by indoor air pollution. While participating in this study there will be two, 2 month long study segments (Study Period 1 and Study Period 2) where the air filter units, placed in your living room and bedroom windows, will be turned on at your home.


Eligibility Criteria:
Inclusion Criteria:

* severe COPD (FEV1 \< 50%)
* live in Monroe County
* referred for pulmonary rehabilitation
* suffered from an AECOPD in the past year
* have standard sized windows in their bedroom and living room amenable to installation of the HEPAirX® device
* expect to sleep each night of the 4 months (2 months of Period 1, and 2 months of period 2) in either their bedroom or living room for at least 6 hours/night, and not use other air filtering devices during the study

Exclusion Criteria:

* under age 18
* smoking at the time of their prior COPD exacerbation
* current smokers
* those who live with an active smoker
* those with an occupation that has a high pollutant exposure (e.g. professional drivers)
* those who already have a home air filtration device (other than basic furnace filter)
Comparing The Cyberlink Control System to the Manual Letter Board for Communication Purposes in the ALS Patient Population

New technologies are giving people with motor disabilities alternative communication and control channels. The investigators are interested in using the Cyberlink Control System as a hands free means to access a computer for people with Amyotrophic Lateral Sclerosis (ALS). The goal of this project is to determine whether this device is a practical and realistic means for ALS patients to communicate with only the use of facial muscle, brainwave, and eye movements.

The benefit of this study may be of substantial value to many people with severe motor impairment. Additionally, it is hoped that some of the study subjects may benefit by incorporating hands-free computer use into their daily lives.

This study is intended to evaluate the effectiveness of the cyberlink as a tool for daily communication compared to the standard manual letter board.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of definite or possible ALS by the El Escorial Criteria
* Between ages of 18 to 89 years.
* Scored two or less in the ALS FRS category 1 (Speech)
* Scored two or less in the ALS FRS category 4 (Handwriting)
* Cognitively intact with no other neurological diseases
* No unstable medical problems

Exclusion Criteria:

* Any subject not meeting the inclusion criteria
* Patients unable to give informed consent either themselves or via a legally authorized personnel.
* Patients diagnosed with neurological problems other than ALS (upon examination by the principal investigator)
Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia

Fast awakening from anesthesia is one of the major characteristics of remifentanil-associated anesthetic induction and maintenance, whereas corresponding pain during awakening influences patient's rehabilitation strongly. In addition, such early postoperative pain results in significant stress responses, which displays as further release of stress hormones such as cortisol and β-endorphin as well. How to prevent such acute pain resulting from remifentanil's fast metabolism endows clinical significance. This study is designed to compare the analgesic efficacy of fentanyl, sufentanil and butorphanol delivered after gynecological laparoscopic surgeries that underwent remifentanil induction and maintenance, and investigate corresponding influence on the levels of blood cortisol and β-endorphin.


Eligibility Criteria:
Inclusion Criteria:

1. ASA physical status I-II
2. Chinese
3. 19-45yr
4. Selective laparoscopic surgeries

Exclusion Criteria:

1. Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
2. Participants younger than 18 years, older than 45 years or pregnancy was eliminated
3. Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study
4. Those who were not willing to or could not finish the whole study at any time