cyrilzakka/clinical-trials huggingface dataset:
18F-FDG Metabolism Imaging Monitoring Non-small Cell Lung Cancer Curative Effect of Chemotherapy Multicenter Clinical Study

The subject is going to use 18F-FDG PET/CT to assess different genetic NSCLC metabolism after cisplatin chemotherapy and targeted therapy, define the assessment criteria for the role of 18F-FDG PET/CT in NSCLC treatment respone and at last build multi-centre clinical trial platform of molecular classification and molecular imaging for cancer chemotherapy assessment.

Non-small-cell lung cancer (NSCLC) is the first leading cause of cancer death in the world. Systemic chemotherapy has contributed to the only choice for more than 50% NSCLC patients. The genetic abnormalities lead to different therapy response to the same chemotherapy scheme in NSCLC patients. At present, early assessment and prediction is the key for optimize NSCLC therapy. 18F-FDG PET/CT is a noninvasive cell metabolism reaction molecular imaging technology which can assess cancer glucose metabolism sensitively and react cancer proliferation to some degree. Hence 18F-FDG PET/CT may be used to assess NSCLC therapy response noninvasively. It is a reliable method to individualize NSCLC treatment clinically by define the appropriate metabolism response cut-off values and assess time points of 18F-FDG PET/CT in predicting different genetic NSCLC patients.The subject is going to use 18F-FDG PET/CT to assess different genetic NSCLC metabolism after cisplatin chemotherapy and targeted therapy, define the assessment criteria for the role of 18F-FDG PET/CT in NSCLC treatment respone and at last build multi-centre clinical trial platform of molecular classification and molecular imaging for cancer chemotherapy assessment.

Eligibility Criteria:
Inclusion Criteria:

* pathological biopsy for NSCLC; stage III-IV; plan to palliative chemotherapy (such as neoadjuvant chemotherapy, convention and targeted therapy) due to unable to surgery; not radiation therapy or chemotherapy for 6 months before enrollment; the predictive survival time more than half year;

Exclusion Criteria:

* with diabetes and chest radiotherapy chronic disease; brain metastases patients; with secondary primary maligmant cancer in 5 years
Screening of Colorectal Cancer in the Public Healthcare Sector in Argentina

Introduction: Early detection of certain types of cancer significantly increases the likelihood of successful treatment and reduces mortality from these causes. However, the use of screening and the early detection of selected tumors such as colorectal cancer (CRC) are lower than those expected in our country. The objective of this project is to evaluate the effectiveness of a multicomponent strategy that improves the screening and early detection of CRC in the population at risk of Primary Health Care Clinics (PCCs) of the public health system.

Population: people leaving in the catchment area of 10 selected primary care clinics from the public health system in the province of Mendoza, Argentina.

Design and methods: a Randomized clinical study by clusters. 10 PCCs will be included: 5 will be randomly assigned to receive an intervention to increase the CRC screening rates (improvement cycles) and 5 to the control arm (usual care). 150 participants will be included in each PCCs, in total, 1500 participants.

Intervention: An innovative vision is proposed, which combines a participatory and dynamic methodology based on improvement cycles. This approach includes the implementation of participatory learning sessions for health providers, involving the effectors of the design of the intervention. In the intervention branch at least 3 workshops (sessions) will be held with the members of the care system, in order to identify opportunities for improvement oriented to the design and application of an innovative intervention based on best practices. Each one of the sessions will constitute an analysis of the improvement cycle, following the following steps: 1) Selection of participants of the initial workshop; 2) Development of work model based on bibliographic review and initial qualitative phase; 3) Initial workshop with effectors for training in continuous improvement, objectives, interventions and data collection; 4) Learning workshops to discuss results, applicability of interventions and modifications to the work plan; 5) Closing session to evaluate preliminary results and discuss continuity of interventions beyond the project.

Outcomes: 1) Percentage of the population at risk that completes the screening; 2) Percentage of the population classified as at habitual risk or increased by risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have public health coverage
* Age between 50 and 75 years old
* Residence in the catchment area of the PCCs
* With an indication to perform screening for CRC with FOBT
* People who consent to participate

Exclusion Criteria:

* People who are bedridden.
* People who plan to move in the next 3 months.
APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis

The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in patients with transthyretin (TTR) mediated amyloidosis. An open-label, single-arm, long-term follow-up extension study NCT02510261 (ALN-TTR02-006) was initiated to provide participants who completed this study with continued patisiran-LNP (lipid nanoparticle) treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of 18 to 85 years of age (inclusive);
* Have a diagnosis of FAP
* Neuropathy Impairment Score requirement of 5-130
* Meet Karnofsky performance status requirements
* Have adequate complete blood counts and liver function tests
* Have adequate cardiac function
* Have negative serology for hepatitis B virus (HBV) and hepatitis C virus (HCV)

Exclusion Criteria:

* Had a prior liver transplant or is planned to undergo liver transplant during the study period;
* Has untreated hypo- or hyperthyroidism;
* Has known human immunodeficiency virus (HIV) infection;
* Had a malignancy within 2 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated;
* Recently received an investigational agent or device
* Is currently taking diflunisal, tafamidis, doxycycline, or tauroursodeoxycholic acid
Effect of Non-surgical Periodontal Treatment and C-reactive Protein Levels in Hemodialysis Patients

The presence of periodontitis has been hypothesized as a risk factor for several systemic outcomes, including chronic kidney disease (CKD). Therefore, the aim of this study is to evaluate the impact of non-surgical periodontal treatment on CRP levels and quality of life of patients with chronic kidney disease undergoing hemodialysis (HD) in Santa Maria-RS.

C-reactive protein (CRP) has been identified as a possible mediator of the association between periodontitis and various systemic diseases. The presence of periodontitis has been hypothesized as a risk factor for several systemic outcomes, including chronic kidney disease (CKD). Therefore, the aim of this study is to evaluate the impact of non-surgical periodontal treatment on CRP levels and quality of life of patients with chronic kidney disease undergoing hemodialysis (HD) in Santa Maria-RS. A total of 88 patients with severe periodontitis who are on HD therapy will be included in this study. At baseline, periodontal, radiographic, blood test, and quality-of-life questionnaire will be assessed for all patients, after which severe periodontitis will be defined according to the American Association of Periodontology and European Federation of Periodontology. The 88 patients with periodontal disease will be randomized and divided into two groups. One group will receive full mouth non-surgical periodontal treatment (TPNC) and a late treatment group that will receive TPNC only at the end of the study. All patients will receive follow-up of periodontal parameters and blood collection for initial CRP assessment at 3 and 6 months after treatment. Outcome evaluators will be blind to the group the patient belongs to. Patients in the immediate treatment group will receive follow-up oral hygiene instructions and use 0.12% chlorhexidine mouthwash during the first week after treatment.

Eligibility Criteria:
Minimum Age: 18 Years Sex: All Accepts Healthy Volunteers: No

Criteria:

Inclusion Criteria:

* Having been diagnosed with chronic kidney disease (CKD) for at least 90 days.
* Have at least 8 teeth in the mouth.
* For the patient to be classified as having periodontal disease, he must have at least two nonadjacent sites with insertion loss of 3mm or more and two nonadjacent sites with probing depth of 4mm or more.

Exclusion Criteria:

Ineligible individuals were characterized by exhibiting one of the following conditions:

* Patients diagnosed with malignant neoplasia;
* Patients diagnosed with carriers of the HIV virus;
* Pregnant or lactating women;
* Patients with absence of all dental elements (total edentulous);
* Patients undergoing orthodontic treatment;
* Patients who have received periodontal treatment in the last 6 months.
* Patients with active infection (other than periodontitis) who require antibiotic prophylaxis;
Effect of AKB-6548 on the Pharmacokinetics of Celecoxib

To assess the single dose pharmacokinetics (PK) of celecoxib in healthy subjects when administered alone and following multiple daily doses of AKB-6548.

To assess the single dose plasma pharmacokinetics (PK), safety, and tolerability of celecoxib in healthy subjects with CYP2C9 extensive metabolizer (EM) genotype when administered alone and following multiple daily doses of AKB-6548.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between 18 and 55 years of age, inclusive, and with a body mass index between 18 and 30 kg/sq.meters, inclusive.
* Subjects with the following genotype based upon pharmacogenetic testing results: CYP2C9 EM: \*1\*1.

Exclusion Criteria:

* Current or past history of cardiovascular, cerebrovascular, pulmonary, renal or liver disease.
* Positive serology results for HBsAg, HCV, and HIV at Screening.
* Significant renal impairment as evidenced by an estimated glomerular filtration rate (eGFR) of \<65 mL/minute/1.73 sq.meters.
* Known hypersensitivity to celecoxib or sulfonamides.
* History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
* Known active cancer or history of chemotherapy use within the previous 24 months.
* Current or past history of gastric or duodenal ulcers or other diseases of the GI tract (including gastric bypass surgeries) that could interfere with absorption of study drug.
* Current or past history of gastrointestinal bleeding.
* Any history of alcohol or drug abuse within the previous year prior to Screening.
* Subjects with a known history of smoking and/or have used nicotine or nicotine containing products within the past 6 months.
Application of Diffusion Tensor Imaging and Tractography in Epilepsy Surgery

Using Synaptive Medical's BrightMatter™ products to better visualize and plan epilepsy surgeries by considering white matter tracts, and considering whether the technology results in improved clinical outcomes.

A common goal of focal brain resection is the removal of a lesion while preserving healthy eloquent tissues of the brain. One such eloquent area that is commonly aimed to be preserved are the white matter nerve fiber tracts which is critical of brain communication and function. This study aims to investigate whether the use of Synaptive Medical's BrightMatterTM technology can help neurosurgeons to better visualize and plan surgeries by considering the white matter tracts, and whether it results in improved clinical outcomes. This study will investigate the preservation of the optic radiations in anterior temporal lobectomy epilepsy surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with temporal lobe epilepsy between 18 and 65 years of age.
* Patients whose seizures are disabling and/or are not controlled by any form of epileptic medication.
* Patients whose clinical pre-surgical investigations indicates the need for anterior temporal lobe resection (ATLR).

Exclusion Criteria:

* Prior resective epilepsy surgery.
* Past or planned non resective epilepsy surgery (such as a corpus callosotomy and vagal nerve stimulator placement).
* Contraindication to MRI, and/or whom are (or suspect to) being pregnant.
* Complicated medical problems such as cancer or heart disease.
Characteristics and Risk Ratios of Late Intraocular Lens (IOL) Complication

Late in-the-bag intraocular lens (IOL) dislocation occurs up to 30 years after cataract surgery and the prevalence ranges from 0.1% to 3.0%. Before the introduction of the continuous curvilinear capsulorhexis, late dislocation was very uncommon but since then several case reports and case series were observed. In-the-bag IOL dislocation is a well-known postoperative complication, especially in eyes with weak zonules as seen in pseudoexfoliation syndrome (PXF), high axial myopia, uveitis and retinitis pigmentosa (RP).

In this retrospective study, medical records of all patients with IOL related problems after implantation of one hydrophilic acrylic single-piece lens at the Department of Ophthalmology Graz, Medical University Graz, Styria, Austria are reviewed. Characteristics and predisposing factors for late in-the-bag, out-of-the-bag IOL dislocations, and haptic complications will be investigated and compared amongst each other or control patients. Incidence rates for each IOL complication will be calculated. For in-the-bag dislocations odds ratios for each predisposing factor will be calculated.

This is a retrospective cohort study. Data of all patients treated at the hospital from June 1997 to October 2015 for a complication after IOL implantation will be obtained from an electronic medical record and database (FileMaker Inc., v3 - 6 and EyMed). Additional data, e.g. axial length (AL) or diopters of the implanted IOL, are taken from the patients' medical files. Collected data are age, sex, laterality of the eye, and predisposing eye conditions (PXF, relevant myopia defined as ≥ 25.5 mm axial length, uveitis, RP and ocular trauma). Other parameters are preoperative surgical interventions, the use of a capsular tension ring (CTR), perioperative complications, diopters of the IOL, pre- and postoperative corrected distance visual acuity (CDVA) in logMAR, and post-operative manifest refraction. Time to dislocation, additional interventions after cataract surgery, and symptoms due to the IOL complication will recorded. Type of dislocation (in-the-bag or out-of-the-bag), location (anterior chamber, pupillary plane or vitreous), pre- and post-operative CDVA, pre- and post-operative manifest refraction, type of secondary intervention, and in case secondary implantation was performed, type of secondary IOL are collected.

Differences regarding prevalence for various predisposing risk factors are investigated by means of logistic regression methods. Odds ratios and 95% confidence intervals are calculated unadjusted as well as adjusted for age, gender, and the four predisposing risk factors: PXF, relevant myopia, uveitis, and RP. Prevalence and incidence of in-the-bag IOL dislocations will be calculated from all patients that had an implantation of the ACR6D SE at the Department of Ophthalmology in Graz.

Eligibility Criteria:
Inclusion Criteria:

* Phacoemulsification or extracapsular cataract extraction with the hydrophilic acrylic IOL ACR6D SE at the Department of Ophthalmology Graz in Styria, Austria.

Exclusion Criteria:

* Intracapsular cataract extraction
Embo Registry; National Registry for Artery Embolization

Embo Registry is a retrospective and prospective observational study to evaluate real world effectiveness and the use of Artery Embolization as a treatment for chronic pain with patients that have osteoarthritis and localized pain to provide symptomatic relief. This study is to determine the efficacy and validity of procedure and that following procedure patients had decreased pain and improved quality of life.

Embolic Solution are intended for use in occluding blood vessels for therapeutic or operative purposes. The embolic solution is used during an outpatient procedure, the physician will insert a small catheter onto the artery supplying the lining of the target joint or target localized pain. Tiny particles are then injected through the catheter into these arteries, reducing blood flow to the target area. This reduces the amount of inflammation associated with osteoarthritis, tendonitis, tenosynovitis or an injury, a process that can help decrease symptoms or eliminate the associated localized pain to this area. With understanding that it does not treat the underlying cartilage destruction or underlying condition causing pain but would like to determine the efficacy and validity of this treatment. For the study to determine efficacy and overall improvement of patients post procedure by comparing patient's pain preoperative and post operatively, if there is a decreased use of medication preoperatively compared to post procedure and increased quality of life preoperative and post procedure. Clinical outcomes of improvement will be determined by improvement of Visual Analog Scale (VAS) scores, Western Ontario and McMaster Universities Index (WOMAC), EQ-5D-5L Quality of Life Questionnaire, and to determine if patients had decrease used of medication prescribed preoperatively.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age undergone artery embolization interventions for the treatment of chronic pain due to osteoarthritis or other diagnoses that cause localized pain.

Exclusion Criteria:

* None
Nexplanon Removal: Subcutaneous vs. Topical Lidocaine

A randomized trial of using EMLA cream for anesthesia to remove Nexplanon versus the standard route of subcutaneous lidocaine for anesthesia. Primary endpoints are pain during procedure and time to removal.


Eligibility Criteria:
Inclusion Criteria:

* Females with Nexplanon implant in place, desiring removal No allergy to lidocaine or any component of EMLA cream Age greater than or equal to 18years English as primary language Not pregnant

Exclusion Criteria:

* pregnant non-emglish speaking age less than 18 yo Allergy to lidocaine or EMLA
This Study Investigates the Impact of Single Nucleotide Polymorphisms in Genes Involved in the Pharmacokinetics and Toxicity of Doxorubicin (DOX) in Egyptian Female Patients with Breast Cancer. It Also Aims to Explore the Association of Pretreatment Neutrophil to Lymphocyte Ratio to PCR

This study aims to investigate the effect of single nucleotide polymorphisms (SNPs) of genes involved in doxorubicin transport and metabolism on its pharmacokinetics and toxicity in Egyptian breast cancer patients.

It also aims to explore the association of pretreatment neutrophil to lymphocyte ratio (NLR) with pathological complete response (pCR).

Plasma concentrations of doxorubicin will be determined and venous blood samples will be obtained from each patient for SNP genotyping of genes involved in doxorubicin transport and metabolism on its pharmacokinetics and toxicity in Egyptian breast cancer patients \[prospective study\].

A complete blood count was carried out at baseline for patients receiving neoadjuvant chemotherapy. The neutrophil to lymphocyte ratio (NLR) was calculated as the ratio between the absolute count of neutrophils and the absolute count of lymphocytes \[ retrospective study\].

Eligibility Criteria:
Inclusion Criteria:

* Females aged ≥ 18 years
* Performance status 0 or 1
* No contraindication to chemotherapy
* Adequate bone marrow
* Adequate hepatic function
* Adequate renal function

Exclusion Criteria:

* Poorly controlled diabetes mellitus
* Ischemic heart disease
* Uncontrolled hypertension
* Active infections
* Baseline ejection fraction \&amp;lt; 50%
* Performance status ≥ 2
* Pregnancy Lactation, bilateral breast cancer, male patients, primary surgery, distant metastases, other malignancies, inflammations, hematological disorders, autoimmune diseases, and patients taking non-steroidal anti-inflammatory drugs (NSAIDs), steroidal and antibiotic therapy.
Physiological Effects Ketone Ester in Heart

The study is aimed to phenotype with cardiac MRI the physiological effects of ketone esters on the heart. Patients with heart failure will be recruited and given ketone esters or placebo in a randomized fashion. Cardiac MRI will be performed at baseline and after 12weeks follow up.


Eligibility Criteria:
Inclusion Criteria:

* heart failure EF \< 40%

Exclusion Criteria:

* Claustrophobia
* Contraindicated implanted device
Validation Study of ClassIntra®

Whereas there are several validated systems for reporting postoperative complications, there are only a few and not prospectively validated systems for reporting intraoperative complications. The investigators developed a definition and CLASSification for Intraoperative Complications CLASSIC within a Delphi study involving international interdisciplinary experts. As both surgery and anaesthesia may be involved in complications in the perioperative period, all patient-related intraoperative complications occurring between skin incision and closure are considered in this reporting system. CLASSIC was updated to ClassIntra® v1·0, by encompassing five severity grades to align with the validated Clavien-Dindo Classification for grading postoperative complications.

The aim of this international multicentre observational cohort study is to assess the validity and practicability of this newly derived and updated classification system ClassIntra® in patient undergoing an in-hospital surgical procedure. Providing an easy applicable and internationally validated classification system is a contribution to improve quality of health care and patient safety.


Eligibility Criteria:
Inclusion Criteria:

* All in-hospital patients (consecutive or random sample) undergoing surgery in the operating room with anaesthesia involvement

Exclusion Criteria:

* Outpatients (patients undergoing one-day-surgery) (with and without anaesthesia-involvement)
* Procedures without anaesthesia-involvement (in- or out-patient)
* ASA risk classification (ASA) VI patients (brain-death organ-donor)