cyrilzakka/clinical-trials huggingface dataset:
Progression Free Survival (PFS) Using Erlotinib for Non-Small-Cell Lung Cancer (NSCLC) in Chinese Population

This trial is an extension to ENSURE, a study of erlotinib versus gemcitabine/cisplatin combination chemotherapy as the first-line treatment for patients with non-small-cell lung cancer (NSCLC) with mutations in the tyrosine kinase domain of EGFR.

This study is designed to examine the efficacy of erlotinib versus gemcitabine/cisplatin as a second-line treatment in NSCLC patients from the ENSURE trial (NCT01342965). Patients previously treated with gemcitabine/cisplatin will be given erlotinib daily until disease progression or unacceptable toxicity occurs. Patients previously treated with erlotinib will be given cisplatin on Day 1 and gemcitabine on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first).


Eligibility Criteria:
Inclusion Criteria:

* Participant in ENSURE trial
* Disease progression during first-line treatment

Exclusion Criteria:

* N/A
Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris

the goal of this clinical trial is to measure the efficacy of probiotics for treatment of acne vulgaris, to compare it with azithromycin and to measure the synergistic effect of azithromycin and probiotics for treatment of acne vulgaris

this study aims to answer this research question: in patients of acne vulgaris, is use of probiotics as efficacious as azithromycin in treating acne lesions \& improving quality of life? total 75 patients were divided into 3 groups. group A received azithromycin, group B received probiotics and group C received both drugs. a topical cream was also advised to all groups. outcome was measured as reduction in total lesion count and improvement in patients' quality of life via reduction in Dermatology Life Quality Index score.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Patients of Mild and Moderate acne
* Aged between 15 and 35 years

Exclusion Criteria:

* Severe acne or any systemic inflammatory disease
* Other oral treatment for acne
* Allergic to any drug being used in the study
* Pregnancy
* PCOs
* Any drug which can interact with azithromycin
MR-targeted vs. Random TRUS-guided Prostate Biopsy

To compare prostate cancer (PCa) detection rate of magnetic resonance (MR)-targeted biopsy and transrectal ultrasound (TRUS)-guided biopsy in patients with high PSA values and at least one previous negative prostate biopsy. Subjects will be submitted to a multiparametric MR scan of the prostate and subsequently patients with a suspicious MR for PCa presence will be randomized (1:1) into the two study arms.

In men with previously negative prostate biopsy and persistent elevated PSA value, it is unclear which biopsy strategy offers the highest detection rate for significant PCa. The hypothesis of this study is that MR-targeted biopsy improves the detection rates of significant prostate cancers compared with systematic TRUS-guided prostate biopsy.

Men with at least one previously negative TRUS-guided biopsy and persistently elevated PSA values (\> 4 ng/ml) will be submitted to a multiparametric MR imaging examination of the prostate. Subsequently, participants with suspected regions at MR imaging will be randomized (1:1) into the two study arms. In study arm A patients will be submitted to MR-targeted in-bore prostate biopsy based on the multiparametric MR imaging findings. In study arm B patients will be submitted to systematic TRUS-guided prostate biopsy with saturation scheme.

Eligibility Criteria:
Inclusion Criteria:

* men aged 50-80
* at least one negative TRUS-guided prostate biopsy
* PSA \> 4 ng/ml
* at least one suspected region detected at multiparametric MR imaging
* signed informed consent

Exclusion Criteria:

* known prostate cancer diagnosis
* contraindication against MR imaging or uncooperative patients
Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology

The goal of the 3D-CARDIOPATH study is to investigate the potential added value of emerging 3D imaging modalities by imaging ex vivo cardiac specimens (diseased coronary arteries, calcific aortic valves, and thrombotic materials) in 3D. Specifically, 20 cadaveric coronary artery segments with advanced atherosclerosis will be received from 10 patients with SCD. These segments will first be scanned with intravascular imaging modalities, namely optical coherence tomography (OCT) and intravascular ultrasound (IVUS), and then with micro-computed tomography (micro-CT) and light sheet fluorescence microscopy (LSFM). Additionally, 30 thrombotic specimens aspirated from patients with ST-elevated myocardial infarction, will also be scanned using micro-CT. Finally, 30 surgically removed aortic valves will undergo scanning with micro-CT and LSFM. Traditional histopathological assessment will also be performed on the scanned specimens. Patient laboratory profiles, past medical histories, demographic characteristics, and therapeutic management will be recorded, where applicable.

The 3D-CARDIOPATH study aims to provide 3D volumetric insights into well-characterized disease entities such as Coronary artery disease (CAD) and calcific aortic valvular disease (CAVD). Therefore, this study aims to visualize in 3D:

1. cadaveric coronary artery samples collected from adults with sudden cardiac death (SCD);
2. thrombotic specimens aspirated during percutaneous coronary intervention (PCI) procedures in patients with ST-elevated myocardial infarction (STEMI); and
3. calcific aortic valves surgically removed from patients with CAVD undergoing cardiac surgery for valve replacement.

The utilized 3D imaging means will be:

1. optical coherence tomography (OCT), intravascular ultrasound (IVUS), micro-computed tomography (micro-CT) and light sheet fluorescence microscopy (LSFM) for the assessment of the collected cadaveric coronary arteries;
2. micro-CT for the assessment of the aspirated thrombotic material
3. LSFM and micro-CT for the assessment of the resected aortic valves. Finally, the scanned specimens will be histopathologically assessed at the First Department of Pathology in Athens, Greece by experienced pathologist.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years.
* Patients with sudden cardiac death for coronary artery imaging.
* Patients with STEMI undergoing PCI and thrombus aspiration for thrombus imaging.
* Patients with CAVD undergoing cardiac replacement of calcific aortic valve for valve imaging.

Exclusion Criteria:

* Patients dying after the execution of their cardiac surgery.
* Patients with altered mental status; unable or unwilling to provide informed consent for specimen imaging and clinical follow-up.
Fall Risk Reduction in Multiple Sclerosis: Exercise Versus Behavior

Falls are a serious health concern for persons with multiple sclerosis (MS). Over 50% of persons with MS suffer a fall over a 6-month periodwith the majority of falls resulting in medical attention for injuries (i.e., lacerations, bone fractures, \& head injuries). The effects of a fall are often compounded as it can lead to activity curtailment, physiological deconditioning, and institutionalization. Despite the importance of falls in persons with MS, the appropriate prevention strategies (i.e. rehabilitation approaches) are not clear. The purpose of this investigation is to determine whether exercise based or educational based interventions are more suited for fall prevention in older adults with MS.

Falls are a serious health concern for persons with multiple sclerosis (MS). Over 50% of persons with MS suffer a fall over a 6-month periodwith the majority of falls resulting in medical attention for injuries (i.e., lacerations, bone fractures, \& head injuries). The effects of a fall are often compounded as it can lead to activity curtailment, physiological deconditioning, and institutionalization. Despite the importance of falls in persons with MS, the appropriate prevention strategies (i.e. rehabilitation approaches) are not clear.

It is well known that causes of falls are multifactorial with over 400 risk factors identified. However, it is believed that these factors can be divided into two main classes: intrinsic (e.g. physiological factors) and extrinsic factors. For instance balance dysfunction, spasticity and muscle weakness are physiological risk factors for falls in MS . Behavioral fall risk factors in MS include choosing appropriate footwear, lighting and utilizing appropriate assistive device. There is evidence that both types of risk factors can be minimized with appropriately designed interventions in persons with MS and have been shown to reduce fall risk and incidence in other clinical populations. This has led to calls for the combination of exercise training program that targets specific, modifiable physiological risk factors and educational interventions targeting modifiable behavioral risk factors in persons with MS. However, there is minimal evidence that these interventions in isolation or combination actually reduce fall incidence or risk in persons with MS. This proposal seeks to determine the effectiveness of a combined exercise and educational rehabilitation strategy to prevent falls in persons with MS.

Eligibility Criteria:
Inclusion Criteria:

* Definite multiple sclerosis diagnosis
* ambulatory
* aged 50-75 years of age
* fallen within 12 months

Exclusion Criteria:

* non-ambulatory
* outside age range
* no fall history
Biomarkers for Pharmacoresponse in Bipolar Disorder - Coagulation

Previous studies indicate an association between severe psychiatric disorders, such as bipolar disorder, and increased risk of venous thromboembolism. However, to which extent this association is influenced by lithium treatment is currently unknown. In this prospective cohort study, the investigators aim to investigate the effect of bipolar disorder and lithium treatment on coagulation and the counterpart fibrinolysis.

The investigators will analyse differences in coagulation

* using a case-control design where cases are bipolar patients not yet treated with lithium, and controls are healthy volunteers (Swedish ethical review authority Dnr 2023-05799-02, PI Kristoffer Månsson, KI).
* using a prospective cohort design, following the patients over time.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with bipolar disorder but not yet treated with lithium, where there is a decision by the patient and the responsible doctor to start lithium treatment.

Exclusion Criteria:

* Inability to give informed consent
A Phase III Study of PA21 in Peritoneal Dialysis Patients With Hyperphosphatemia

The purpose of this study is to investigate efficacy and safety, when administering PA21, in peritoneal dialysis patients having hyperphosphatemia.


Eligibility Criteria:
Inclusion Criteria:

* Receiving stable maintenance peritoneal dialysis
* Peritoneal dialysis patients with hyperphosphatemia

Exclusion Criteria:

* Patients having history of a pronounced brain / cardiovascular disorder
* Patients having severe gastrointestinal disorders
* Patients having severe hepatic disorders
Fractal-based Gait Training in Older Adults

The purpose of the study is to investigate the influence of walking with external visual cues on brain adaptations.


Eligibility Criteria:
Exclusion Criteria:

* Neurologic conditions;
* Lower limb disabilities or disease;
* Not able to provide informed consent;
* Unable to walk unassisted for 10-minutes continuously;
* Score below 24 in the Mini-Mental State Examination (MMSE);
* Have a history of falls in the prior six months;
* Have an implanted device (e.g., pacemakers);
* Medication advised against the application of Transcranial Magnetic Stimulation.
A Prospective Double-Blind Study of Retrovir in Early HIV Infection

To evaluate the safety and tolerance of chronic administration of Retrovir (AZT) to adult patients with early manifestations of HIV disease. To assess the efficacy of AZT therapy in the treatment of HIV disease in these patients.

(12/01/89) Information supplied by drug company update. Study discontinued due to positive data from ACTG 016.


Eligibility Criteria:
Inclusion Criteria

Concurrent Treatment:

Allowed:

* Electron beam therapy to an area of less than 100 cm2.

Patient must have signs and symptoms of HIV infection confined to those of stages WRII-V or CDC groups III IV-A, IV-C-2 (except recurrent Salmonella bacteremia, nocardiosis, or disseminated/extrapulmonary Mycobacterium tuberculosis), and IV-E (except diffuse interstitial lymphoid pneumonitis).

* Patient must be able to give informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Evidence of nervous system dysfunction caused by factors other than HIV infection, including chronic alcohol or drug abuse.
* Present or prior known AIDS-defining opportunistic infections, lymphomas, or malignancies based on CDC criteria.
* Present or prior known systemic opportunistic diseases most recently included in the expanded CDC definition of AIDS:
* extrapulmonary or disseminated Mycobacterium tuberculosis infections, recurrent nontyphoidal Salmonella septicemia, coccidioidomycosis, diffuse interstitial lymphoid pneumonitis.
* Evidence of compromised bone marrow function defined by specified lab values.
* Evidence of HIV neurologic disease.
* Evidence of HIV-associated "wasting syndrome".
* Hypersensitivity to zidovudine (AZT).

Concurrent Medication:

Excluded:

* Cytotoxic chemotherapeutic agents.
* Steroids.
* Interferon or immunomodulating agents.
* Any antiretroviral drug including, but not limited to zidovudine (AZT), ribavirin, HPA23, AL 721, or phosphonoformate.

Patients with the following are excluded:

* Evidence of nervous system dysfunction caused by factors other than HIV infection, including chronic alcohol or drug abuse. Present or prior known AIDS-defining opportunistic infections, lymphomas, or malignancies based on CDC criteria. Present or prior known systemic opportunistic diseases most recently included in the expanded CDC definition of AIDS:
* extrapulmonary or disseminated Mycobacterium tuberculosis infections, recurrent nontyphoidal Salmonella septicemia, coccidioidomycosis, diffuse interstitial lymphoid pneumonitis.
* Evidence of compromised bone marrow function defined by specified lab values. Evidence of HIV neurologic disease.
* Evidence of HIV-associated wasting syndrome.
* Hypersensitivity to retrovir.

Prior Medication:

Excluded within 4 weeks of study entry:

* Interferon.
* Immunomodulating agents.
* Myelosuppressive drugs.
* Nephrotoxic agents.
* Other experimental chemotherapy.

Prior Treatment:

Excluded:

* Treatment with radiation therapy (with the exception of electron beam therapy to an area of less than 100 cm2).

Chronic alcohol or drug abuse.
Optimizing the Management of Staphylococcus Aureus Bacteremia (OPTIMUS-SAB)

Staphylococcus aureus bacteremia (SAB) is associated with high morbidity and mortality rates with an incidence disproportionately higher in vulnerable populations. Management according to evidence-based care parameters, in particular Infectious Diseases (ID) consultation, is associated with improved mortality. SAB management is suboptimal in Alberta compared to other jurisdictions. An Alberta-based pilot study confirmed that timely recommendations to optimize SAB care, including ID consultation, was associated with improved adherence to all evidence-based quality-of-care indicators.

Leveraging this pilot work, the investigators aim to implement OPTIMUS-SAB, an enhanced model of the pilot, to optimize and standardize SAB management across Alberta. The implementation study will be a zone-based acute care site stepped wedge design. OPTIMUS-SAB will consist of a centralized SAB care team whom will receive automated notification of all blood cultures positive for S. aureus allowing them to review the patient's medical chart and make preliminary management recommendations according to an evidence-based care bundle.

The investigators will evaluate adherence to evidence-based SAB quality-of-care indicators before and after OPTIMUS-SAB implementation and expect this to improve with a resultant reduction in duration of bacteremia, length of stay, readmission rates, and mortality. In turn, this will translate into cost savings for the health care system.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years at the time of hospital admission
* Confirmed S. aureus bacteremia by blood culture performed at a laboratory in Alberta, Canada
* Admitted to a designated acute care site in Alberta, Canada

Exclusion Criteria:

* The treating team believes death is imminent or inevitable .
* GCD are C-level within 48 hours of admission.
* The patient is transferred in from an out-of-province acute care center with a pre-existing SAB diagnosis.
Impact of Functional Status on 30-day Resource Utilization and Organ System Complications Following Bariatric Surgery

The goal of this observational study is to assess the effect of functional status on bariatric surgical thirty-day outcomes. The main questions it aims to answer are:

* Is functional status associated with higher incidence of 30-day unplanned resource utilization?
* Is functional status associated with higher incidences of secondary adverse events?

Participants will be sampled from the 2015-2019 American College of Surgeons National Surgical Quality Improvement Program


Eligibility Criteria:
Inclusion Criteria:

* Current Procedural Terminology (CPT) codes: 43644, 43645, 43770, 43775, 43842, 43843, 43845, 43846, 43847
* Elective, non-emergent cases
* "General surgery" surgical specialty
* "General anesthesia" anesthetic technique

Exclusion Criteria:

* Documented concurrent or other procedures
* Patients admitted to the hospital for greater than one day preceding surgery
* Acute kidney injury (preoperative)
* End-stage renal disease (preoperative)
* Metastatic disease (preoperative)
* Wound infection (preoperative)
* Sepsis (preoperative)
Neoadjuvant Bev Plus DOF vs DOF in LAGC and Its Association With Circulating Tumor Cell

Background Local advanced gastric carcinoma (LAGC) is suggested to be potentially cured by R0 resection, and neoadjuvant chemotherapy can increase the R0 resection rate but not enough. Bevacizumab (Bev), an anti-tumor angiogenesis monoclonal antibody, combined with chemotherapy has been shown effective in advanced GC. In addition, CTC has been suggested as an indicator of the anti-tumor drugs' efficacy. Therefore, in this study, the investigators plan to evaluate the efficacy and safety of neoadjuvant Bev plus docetaxel/oxaliplatin/5-FU/CF (DOF) versus DOF in mainly gastric antrum LAGC, and to investigate whether CTC is an effectiveness indicator.

Methods 86 patients diagnosed as IIIb-IIIc GC have been enrolled and randomly assigned (1:1) to receive neoadjuvant Bev (5 mg/kg, d1) plus DOF (docetaxel, 75 mg/m2, iv, d1; oxaliplatin, 85 mg/m2, iv, d1; 5-FU, iv infusion 600 mg/m2 and iv injection 400mg/m2, d1-2; CF, 200 mg/m2, d1 and d2) or DOF each 3-week, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles. The primary endpoint is R0 resection rate. CTC was detected every 8 weeks. All patients signed the informed consent.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed locally advanced adenocarcinoma of the stomach.
* Age of 18 to 70, Karnofsky score higher than 80.
* T3-4，N1-3，M0 (AJCC 7th), potentially resectable.
* No severe functional damage of major organ, normal blood cell, normal liver and kidney function.

Exclusion Criteria:

* Clinical findings of distant metastasis or Peritoneal carcinomatosis
* Prior systemic (chemo- or targeted) treatment. Prior radiotherapy to the upper abdomen
* Previous malignancy within 5 years, with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
* Upper gastrointestinal bleeding
* Any contraindication to treatment with docetaxel, 5-fu or oxaliplatin
Massage Therapy for HIV-positive People : Effects on Anxiety, Depression, Hyperventilation and Quality of Life

Massage therapy during 1 month and evaluation of depression, hyperventilation, anxiety and quality of life


Eligibility Criteria:
Inclusion Criteria:

* HIV-positive diagnosis

Exclusion Criteria:

* musculoskeletal disorders
Effects of Filter Ventilation on Sensory Response, Smoking Topography, and Inhalation in Current Every Day Cigarette Smokers

This trial examines the effects of filter ventilation on sensory response, smoking topography, and inhalation in current every day cigarette smokers. The physical design features of cigarettes directly impact their appeal by influencing cognitive and sensory perceptions. The introduction of a now common design feature, filter ventilation, has led to greater public harm than benefit because of the potential for greater toxicity while enhancing product appeal among smokers. Ventilated cigarettes dilute smoke, which promotes perceptions of ?smoothness? and therefore lower health risk, contributing to the overall appeal of these products. The purpose of this study is to assess whether removing ventilation from cigarette filters lowers cigarette product appeal among smokers.

PRIMARY OBJECTIVES:

I. To assess the link between marketing proxies for filter ventilation (product descriptors, packaging) and risk beliefs.

OUTLINE:

Patients smoke 5 cigarettes separated by 30 minute washout periods. Between 48 hours and 1 week later, patients smoke another 5 cigarettes separated by 30 minute washout period with CReSSMicro topography measurement device and BioRadio device for recording inhalation patterns.

Eligibility Criteria:
Inclusion Criteria:

* Currently smoking daily at least 5 cigarettes per day for at least one year
* Primarily using factory-made filtered cigarettes with filter ventilation
* Fair and above physical health
* Fair and above mental health
* Not actively trying to quit smoking or planning to quit in the next 30 days
* Able to converse, read, and write in English
* No alcohol or illegal drug use
* Not pregnant or breastfeeding

Exclusion Criteria:

* Currently smoking daily less than 5 cigarettes per day for at least one year
* Using roll-your-own cigarettes or unventilated filter cigarettes
* Currently using any other tobacco product daily
* Actively trying to quit smoking or planning to quit in the next 30 days
* Not able to converse, read, and write in English
* Adults unable to consent
* Prisoners
* Poor physical health by self report
* Poor mental health by self report
* Alcohol and illegal drug use
* Pregnant or breastfeeding by self report