cyrilzakka/clinical-trials huggingface dataset:
Antimicrobial Susceptibility for Helicobacter Pylori Eradication

Due to the high rate of resistance to clarithromycin in our area the investigators proposed an study to assess the need of antibiogram previous to the empirical OCA 10 treatment, in order to improve the rate of eradication.

Usefulness of antimicrobial susceptibility in the eradication of Helicobacter pylori

PURPOSE

Background:

* The rate of eradication of Helicobacter pylori with standard triple therapy (OCA: omeprazole + clarithromycin + amoxicillin) in our area is less than the expected according to the III Maastricht III consensus. However, the current guidelines recommend the use of this therapy.
* According to the Maastricht III consensus, in populations with high rates of clarithromycin resistance (15-20%) another therapy should be considered, or alternatively, testing antimicrobial susceptibility of the H. pylori prior to treatment.

Objectives:

* To clarify the real rate of eradication with OCA therapy with and without antimicrobial susceptibility in our area (with high rate of resistance to clarythromycin).
* To study which is the diagnostic-therapeutic strategy more cost-effective for the treatment of H. pylori.

Design:

* Participants will be screened with a full medical history.
* Participants will aleatory receive OCA therapy empirically, or after antimicrobial susceptibility test if there is no resistance to clarythromycin, for ten days.
* In all cases the eradication of H. pylori will be checked by 13C urea breath test (UBT) in 8 weeks after the therapy have been finished.
* All the adverse event of the therapy will be reported.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of H. pylori infection provided by culture, histology or UBT.
* Patients need and indication to treat (peptic ulcer disease, firs-degree family history of gastric cancer, MALT lymphoma or dyspeptic symptoms)
* Patients must be 18 years or older.

Exclusion criteria:

* Previous treatment for H. pylori eradication.
* Patients who have severe concomitant disease.
* Patients who have previous gastric surgery.
* Patients who have intolerance to any antimicrobial drugs.
Efficacy and Safety of Oxaliplatin Combined With Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Colon Cancer Patients

The study aims to identify the efficacy and safety of capecitabine plus oxaliplatin (XELOX) in patients with local advanced colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Performance status (ECOG) 0\~2
2. Histologically confirmed colon cancer.
3. No prior treatment
4. CT-defined T4 or lymph node-positive colon cancer
5. Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 8 g/dL Bilirubin level ≤ 1.0 x ULN
6. AST and ALT \< 1.5 x ULN
7. Serum creatinine ≤ 1.0 x ULN
8. Life expectancy of ≥ 3 months
9. Signed written informed consent

Exclusion Criteria:

1. Final stage with cancer cachexia
2. Allergy for capecitabine or oxaliplatin
3. Any evidence of extrahepatic metastases and/or primary tumor recurrence
4. Severe organ failures or diseases, including: clinically relevant coronary disease, cardiovascular disorder or myocardial infarction within 12 months before study entry, severe psychiatric illness, severe infection and DIC
A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection in Argentina

The main aim of this study is to learn about the safety of Maribavir in adults with post-transplant cytomegalovirus (CMV) infection in routine clinical practice in Argentina.

The other aim is to study the effectiveness of the treatment with Maribavir in routine clinical practice in Argentina.

Participants will be treated by their doctors according to normal medical practice. Study data will be collected either from information already available in the medical records or during study conduct.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants (18 years or older) with post-transplant CMV infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet in the real-world setting of common clinical practice in Argentina.
* Have received at least one dose of maribavir according to approved indications.
* Have signed the mandatory informed consent that has been agreed with national regulatory authorities (ANMAT) as applicable.

Exclusion Criteria

- There are no specific exclusion criteria.
Effects of Non-invasive Brain Stimulation in Tobacco Use Disorder

The objective of the study is to determine the effect of non-invasive brain stimulation on craving for tobacco and brain metabolites.


Eligibility Criteria:
Inclusion Criteria:

* Tobacco use disorder (DSM-V)

Exclusion Criteria:

* Other psychiatric disorders
* Contraindication to non-invasive brain stimulation and MRI
Analysis of Cell Count, Viability, and Immunogenicity of Discarded Newly Diagnosed Glioblastoma Tissue or Solid Tumor Tissues

This study examines tumor tissues and blood samples to aid in the development of therapies for brain cancer and other solid tumors. Studying samples of blood and tissue from patients with glioblastoma or other solid tumor in the laboratory may help doctors understand brain tumors and better inform future treatments.

PRIMARY OBJECTIVES:

I. Assessment of cell yield and percentage of viable cells upon tissue receipt at the cell processing facility.

II. Obtain discarded tumor tissue from surgical resections for further studies to aid in development of future therapies for glioblastoma (GBM) and other solid tumors.

SECONDARY OBJECTIVE:

I. Assessment of cell yield and percentage of viable cells from other solid tumor cells shipped to the cell processing facility.

EXPLORATORY OBJECTIVE:

I. An additional line of inquiry will be devoted to scientific exploration of the product's immunogenicity looking at important variables in the course of manufacture.

OUTLINE:

Patients undergo collection of tissue sample during surgery. Patients also undergo collection of blood sample.

Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated informed consent form
* Any individual \>= 18 years old
* Patients must have GBM or other solid tumor and undergoing surgery for diagnostic and therapeutic purposes

Exclusion Criteria:

* Individuals less than 18 years old
* Unable to understand and give consent
* Patients who are not surgical candidates
China Senile Valvular Heart Disease Cohort Study

Valvular heart diseases (VHD) are the most common causes of mortality and morbidity after coronary artery disease, hypertension, and heart failure, especially in senile patients who have more comorbidities and often require intervention. The prevalence of senile VHD is increased gradually as the growth of the age. In addition important changes have occurred as regards the presentation and treatment of the disease over recent years. However, there is little information about senile VHD in China. The purposes of this study are to evaluate the clinical characteristics, reasons for hospitalization, risk stratification, treatment modalities, quality of life and outcomes of senile hospitalized patients with VHD, to determine the risk factors affecting the prognosis, further to lay the foundation for establishing a prognosis model suitable for Chinese senile VHD.


Eligibility Criteria:
Inclusion Criteria:

Hospitalized patients over 60 years old meet one of the following conditions.

* moderate or above valvular heart disease as defined by echocardiography:

  * aortic stenosis, moderate or above, or valve area ≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient ≥20mmHg,
  * aortic regurgitation, moderate or above, or jet width ≥25% of left ventricular outflow tract, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%,
  * mitral stenosis, moderate or above, or valve area ≤2.0cm2,
  * mitral regurgitation, moderate or above, or effective regurgitant orifice ≥0.2cm2, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%,
  * tricuspid stenosis, moderate or above, or valve area ≤1.0cm2,
  * tricuspid regurgitation, moderate or above, or central jet area ≥5.0cm2,
  * pulmonic stenosis, moderate or above, or maximal jet velocity \>4m/sec,
  * pulmonic regurgitation, moderate or above,
* or patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation),
* or diagnosis of endocarditis as assessed by Duke criteria.

Exclusion Criteria:

* Patients cannot be followed up for any reasons.
* Patients in critical condition may be die in the near future.
* Patients have been enrolled in this study.
In Hospital 24 Hour Observation of Syncope Patients

Syncope is very common and has a broad differential diagnosis. Guidelines on syncope recommend to apply guideline based syncope algorithm (SA) to identify low- / intermediate risk syncope patients and recommend to discharge these patients. The time window when to discharge these patients is not defined in the guidelines. In current medical practice low- / intermediate risk syncope patients are either immediately discharged or discharged after 24-hour observation with telemetry (TM). There seems to be an equipoise for both treatment strategies in current medical practice for these low risk syncope patients. A randomized controlled trial to compare discharge after 24 hour observation including TM with immediate discharge has never been done on the Cardiac Emergency Room (CER).

The diagnosis of syncope is a worldwide clinical dilemma. Appropriate identification of low risk vs high risk will reduce inappropriate admission for 24-hour observation with TM. The Dutch Geriatrics Society prioritized syncope management on its research agenda. This project is endorsed by the Dutch Societies of Neurology, Cardiology, Geriatrics, and Internal Medicine and results in freely accessible tutorials on an educational website: www.syncopedia.org.

A randomized clinical trial that includes guideline based SA as routine medical care in the setting of a cardiac emergency room, that compares discharge after 24-hour observation with TM (reference treatment strategy) and immediate discharge (investigational treatment strategy) for low- and intermediate syncope patients will provide new insights and improve syncope health care for these patients.

Eligibility Criteria:
Inclusion Criteria:

All patients that are assessed as low- and intermediate risk syncope, are eligible for inclusion in this trial.

The initial syncope evaluation includes:

1. Complete and thorough history taking of the syncope event and past medical history
2. Physical examination including supine and standing BP measurement and
3. 12 lead ECG.

Exclusion Criteria:

A potential patient who meets any of the following criteria will be excluded from participation in this study:

1. Those aged \<18 years
2. Those in whom syncope / transient loss of consciousness co-exist with trauma or other serious condition identified in the CER (massive bleeding, pulmonary embolus) or any high-risk features upon assessment with guideline based SA
3. Those with any other conditions then syncope / transient loss of consciousness for which admission is required (including social indication for admission, etc.)
4. Contraindication for early discharge as the discretion of the responsible physician
5. Those with a learning disability
6. Those presenting with pre-syncope
7. Those who are unwilling to provide informed consent (those will be asked to be enrolled for the SYNCOPE R.I.S.C-registry)
Radiation Therapy During Surgery in Treating Older Women With Stage I Breast Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving intraoperative radiation therapy may reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving radiation therapy during surgery works in treating older women with stage I breast cancer.

OBJECTIVES:

Primary

* Study the feasibility and reproducibility of intraoperative radiotherapy as the only treatment after lumpectomy in older women with stage I breast cancer.

Secondary

* Study the impact of this regimen on maintaining self-care.
* Study the quality of life (QLQ-C30) and satisfaction with care.
* Study regimen tolerance and cosmetic results.
* Evaluate the economic impact of this treatment.
* Study relapse-free and disease-specific survival.

OUTLINE: Patients undergo conservative breast surgery and axillary node dissection (sentinel node or classic resection). At this point, patients must have either negative axillary lymph nodes after removal of ≥ 6 lymph nodes, negative sentinel nodes, or have had a limited lumpectomy with negative margins ≥ 2 mm. Patients undergo intraoperative radiotherapy during surgery, before closing and reconstruction of the breast.

Patients may begin hormonal therapy after completing study therapy.

After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Inclusion criteria:

* Histologically confirmed stage I breast cancer

  * Size ≤ 20 mm (by ultrasound), N0, any quadrant
* Hormone receptor status not specified

Exclusion criteria:

* Distant metastases
* Inflammatory breast cancer
* Lobular in situ disease
* Invasive cancer or ductal carcinoma in situ
* Nonepithelial disease or sarcoma
* Multicentric disease
* Lymphatic embolism
* Margins of safety unknown or positive (in situ or invasive)
* Preoperative mammography showing diffuse microcalcification

PATIENT CHARACTERISTICS:

* Female
* Menopausal
* Karnofsky 70-100%
* No other prior cancer except basal cell skin cancer, uterine epithelioma in situ, or other cancer in complete remission for the past 5 years
* No geographic, social, or psychiatric reasons that would impede participation in study treatment

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior neoadjuvant therapy
* No concurrent participation in another study
OSI-774 (Tarceva) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer.

The purpose of this study is to determine if OSI-774 will improve overall survival when combined with a standard dose of the chemotherapy drug gemcitabine, to individuals with pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas;cancer which is unresectable, locally advanced or metastatic.

Must have evidence of disease (clinical or radiological). Male or female, 18 years or older. Patients may have received prior radiation treatment for management of local disease providing that disease progression has been documented.

All toxicities have resolved, and the last fraction of radiation treatment was completed at least 4 weeks prior to randomization.

Patients may not have received prior chemotherapy, other then 5FU (+/- folic acid) or gemcitabine given concurrently with radiation treatment as a 'radiosensitiser.'
Sintilimab Combined With Anlotinib for Perioperative Non-small Cell Lung Cancer Based on MRD Evaluation

To study the efficacy of sintilimab combined with anlotinib for perioperative non-small cell lung cancer. To explore the clearance effect of sintilimab combined with anlotinib for postoperative adjuvant therapy based on evaluating minimal residual disease.

Patients with resectable non-small cell lung cancer (NSCLC) have a high postoperative recurrence rate. Perioperative treatment, which can improve the resection rate and clear the minimal residual disease, is the main mean of preventing recurrence, including preoperative neoadjuvant and postoperative adjuvant therapies. In recent years, immunotherapy can significantly improve the pathological remission rate and prolong the survival as a perioperative treatment. In addition to single-agent or combined chemotherapy, the exploration of immunotherapy with other therapeutic strategies is still lacking.

In 2018, we originally designed sintilimab combined with anlotinib in the first-line treatment of advanced NSCLC.

This clinical study plans to: ① apply the "de-chemotherapy" model to the perioperative phase of early NSCLC, ② explore sintilimab combined with anlotinib in preoperative neoadjuvant and postoperative adjuvant therapies, ③ explore clearance effect of sintilimab combined with anlotinib for postoperative adjuvant therapy based on evaluating minimal residual disease (MRD), in order to improve the efficacy of perioperative NSCLC and prolong survival.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cyologically confirmed stage II-IIIa NSCLC patients;
* NSCLC patients with negative driver gene: EGFR wild-type, no ALK fusion mutation, no ROS1 fusion mutation;
* ECOG PS: 0\~1;
* Pulmonary function index meets the surgical criteria;
* No previous systemic anti-tumor treatment.

Exclusion Criteria:

* Patients with central cavitary squamous cell carcinoma or investigator-assessed bleeding symptoms or bleeding tendency were excluded.
Biomarker Guided Treatment in DLBCL

This study is to investigate the strategy of biomarker guided treatment in diffuse large B cell lymphoma


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diffuse large B-cell lymphoma, CD20 positive
* ECOG 0,1,2
* Life expectancy\>6 months
* Informed consented
* IPI\>1

Exclusion Criteria:

* Chemotherapy before
* Stem cell transplantation before
* History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
* Primary CNS lymphoma
* LVEF≤50%
* Lab at enrollment (Unless caused by lymphoma) Neutrophile\<1.5\*10\^9/L Platelet\<75\*10\^9/L ALT or AST \>2\*ULN,AKP or bilirubin \>1.5\*ULN Creatinine\>1.5\*ULN Other uncontrollable medical condition that may that may interfere the participation of the study Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation HIV infection If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
Study of Electroconvulsive Therapy (ECT) Treatment for Agitation and Aggression in Dementia

Agitation/aggression is one of the most common and serious behavioral complications of dementia. If the behavior is refractory to standard care (behavior approaches and off label use of psychotropic medications), other evidence based treatment options are not currently available. Retrospective reviews and preliminary studies have indicated Electroconvulsive Therapy (ECT) may be a safe, effective intervention in this patient population. This study will measure the impact of open-label ECT on symptoms of agitation, aggression, cognition, mood and psychosis for patients referred for ECT who accept this intervention vs. those patients referred for ECT but decline this intervention (i.e. standard care controls). It will also assess adverse events, activities of daily living and caregiver burden during study participation. The hypothesis is that subjects with dementia related aggression/agitation who receive ECT will show significantly greater reductions in these behaviors than subjects who do not consent for ECT and continue with standard care. Pine Rest is partnering with McLean Hospital (Massachusetts) to answer this question. To our knowledge, this is the first prospective study to examine whether patients receiving ECT or standard care differ in reduction of aggression and agitation symptom severity and changes in cognition pre- and post- treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients age 50 years or older from the Older Adult Unit of Pine Rest Christian Mental Health Services or Geriatric Unit at McLean Hospital
* Diagnosis of Dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Criteria
* Mini Mental Status Examination (MMSE) score of 16 or greater
* Fluent in English
* Presence of agitation/aggression symptoms as defined by a minimum aggression score on the Cohen-Mansfield Agitation Inventory Short Version (CMAI): a score of 4 or greater on at least one aggressive item, or a score of 3 on at least 2 aggressive items, or a score of 2 on at least 3 aggressive items, or 2 aggressive items occuring in frequency of 2 and 1 at frequency of 3.
* A therapeutic decision will have already been made by the treating psychiatrist in consultation with the ECT team to use ECT treatment for agitation and aggression associated with dementia, with or without depression/mania. Patients will be included in the ECT treatment group if their legal representative consents to ECT treatment. Patients whose legal representative does not consent to ECT treatment will be included in the Standard Care (Non-ECT) treatment group.
* Informed Consent signed by authorized legal guardian and assent given by the participant
* Signed Authorization for Release of Healthcare Information by authorized legal guardian

Exclusion Criteria:

* Current diagnosis of co-morbid delirium according to DSM-IV upon study entry
* ECT treatment within 90 days prior to study enrollment