cyrilzakka/clinical-trials huggingface dataset:
Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)

Avastin is a novel antiangiogenic agent that has recently been shown to improve response rates and survival of patients with advanced nonsquamous non-small cell lung cancer when added to front-line carboplatin/paclitaxel chemotherapy, and is now being routinely incorporated into the treatment of these patients. Alimta is a recently approved chemotherapeutic that has shown activity against non-small cell lung cancer when given alone and in combination with carboplatin, has a favorable toxicity profile andrequires only a brief (10 minute) infusion time. Therefore we propose to study the combination of Avasin, Alimta, and Carboplatin administered as front-line therapy to patients with advanced nonsquamous non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

I am 18 years of age or older. I have advanced non-small lung cancer. I have not had any major surgical procedures within 28 days prior to my starting treatment.

I have high blood pressure that is controlled. I am not on heparin, coumadin or lovonox for treatment of medical conditions. I do not have serious wound healing problems. I have not received any previous treatment, except radiation therapy for my disease.

Exclusion Criteria:

-
Study and Follow-up of the Clinical Effectiveness and Comparative Safety of Biosimilar Teriparatide in the Management of Postmenopausal or Senile.

Non-interventional observational prospective follow-up study of cohorts of patients with Previous diagnosis of Osteoporosis with high risk of fractures, with/without previous fractures and treatment with bone formers (biosimilar or original Teriparatide), who meet all the inclusion criteria and exclusion, with prior information and signing of prior informed consent documents.

Non-interventional observational prospective follow-up study of cohorts of patients with Previous diagnosis of Osteoporosis with high risk of fractures, with/without previous fractures and treatment with bone formers (biosimilar or original Teriparatide), who meet all the inclusion criteria and exclusion, with prior information and signing of prior informed consent documents.

Primary objective:

Verify the clinical effectiveness of Teriparatide Biosimilar under clinical practice conditions real. Compare this clinical effectiveness with original Teriparatide administered under similar conditions of actual clinical practice. Design: Observational cohort study, prospective, multicenter, nationwide. Study population: Patients with a previous diagnosis of Osteoporosis with a high risk of fractures,with/without previous fractures and in treatment with bone formers since before the start of the study. The patients will be distributed into 2 cohorts based on whether they are receiving similar Teriparatide (cohort A) or original Teriparatide (Cohort B).

Eligibility Criteria:
Inclusion Criteria:

* Signing the Informed Consent Men or women of legal age who have completed somatic growth.
* Previous diagnosis of densitometric osteoporosis in any location (densitometry with DEXA diagnosis within 6 months prior to start of treatment) or previous diagnosis of established osteoporosis (due to previous low-impact fracture, central or peripheral)
* Being in previous treatment with similar Teriparatide (cohort A) or with original Teriparatide (Cohort B).
* Be in possession of mental faculties to understand the therapeutic proposal, understand and follow the follow-up protocol and be able to sign the consent document informed.

Exclusion Criteria:

* The informed consent signature was not obtained.
* Patients who meet any of the contraindications for the use of teriparatide.
Mindfulness for Lung Cancer Patients and Partners

The aim of the current study is to examine the (cost)effectiveness of mindfulness based stress reduction (MBSR) in comparison with treatment as usual for patients with lung cancer and their partners.

Receiving a diagnosis of cancer is a major cause of distress and is usually characterized by anxiety and depression. Compared to patients with other cancer diagnoses, patients with lung cancer report higher levels of distress, which probably can be explained by the poor prognosis. At the time of diagnosis, lung cancer is often locally or systematically advanced and 5-year survival is only 15 percent.

Mindfulness based stress reduction (MBSR) is a recently developed psychological intervention that appears to be promising in terms of reducing psychological distress in cancer patients. It consists of 8 weekly group sessions in which formal and informal mindfulness practices are practiced. As most of the earlier studies have been conducted in patients with breast cancer, it is important to examine the effectiveness of this approach in patients with other types of cancer, such as lung cancer. Furthermore, a diagnosis of cancer is not only highly distressing for the patient but also for the partner and family.

In this study, the (cost)effectiveness of MBSR compared with treatment as usual will be investigated in 110 patients with lung cancer and 110 partners.

Eligibility Criteria:
Inclusion Criteria:

* Cytologically or histologically proven non-small cell lung cancer and small cell lung cancer.
* Patients can participate after lung cancer diagnosis, from start of treatment or after treatment.
* Sufficient understanding of Dutch language.

Exclusion Criteria:

* Former participation in MBSR or MBCT course.
* Current psychological treatment by psychologist or psychiatrist.
* Cognitive impairments hampering participation in MBSR and completion of questionnaires.
* Physical impairments prohibiting participation in MBSR training.
Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 Years

The purpose of this study is to determine the dosing strategy for adolescents aged 2 to 5 years.

This is an open-label, multi-center, cross-over study in male and female pediatric cancer patients, aged 2 to 5 years who are receiving at least 2 cycles of emetogenic chemotherapy requiring 5-HT3 antagonist treatment of up to 5 days duration. The study is designed to evaluate the safety and PK of transdermal granisteron (Sancuso(R) patch) in a pediatric population (aged 2 to 5 years) using a population PK approach.

Eligibility Criteria:
Inclusion Criteria:

1. 2 to 5 years of age inclusive at screening.
2. Written parental (or appropriate legal representative) IRB approved informed consent as appropriate.
3. Confirmed malignancy.
4. Scheduled to receive 2 or more cycles\* of emetogenic chemotherapy requiring 5-HT3 antagonist treatment.
5. Scheduled to receive one or more consecutive days of 5-HT3 antagonist treatment, per cycle, as CINV prophylaxis.

   * The cycles of chemotherapy must be consecutive (i.e. one followed by the other) but do not have to be the first and second cycle of a line of treatment.

Exclusion Criteria:

1. Hypersensitivities, allergies or contraindications to study medications; intolerance of medical tape or sticking plaster.
2. Clinical or laboratory signs and symptoms of significant cerebral, cardiovascular, respiratory, renal, hepatobiliary, pancreatic or infectious disease, which in the Investigator's judgment may interfere with the study assessment or completion of the study.
3. Patients with a known history or predisposition to cardiac conduction interval abnormalities, including QT Syndrome, or known family history of long QT Syndrome or taking medications that are known to prolong the QT interval.
4. Patients scheduled to have routine surgery during the study duration.
5. Patients with a life expectancy of \<6 months.
6. Scarring or significant skin disease on both upper arms.
7. Administration of other investigational drugs within 30 days preceding the screening visit, except for anticancer treatments.
8. Any conditions associated with non-compliance.
Paroxysmal Positional Vertigo & Repositioning Maneuvers

: Benign Paroxysmal Positional Vertigo is a condition related to vestibular system accompanied by dizziness, tinnitus and balance problems leading to increased fall risk and potential disability. Various treatment options are available including pharmacotherapy and vestibular rehabilitation with varied results

Objective: The objective of this study was to compare the efficacy of Modified Epley \& Semont's maneuver with and without Betahistine for BPPV Material \& Methods: The study was a single blind randomized control trail. Total number of patients were 97 as calculated by Epitool calculator. Duration of the study was of one year from 2 January 2021 to 1st January 2022. Out of a total 97 patients, 90 met the inclusion criteria. These participants were randomized by lottery method into two equal groups. Group A (control group) was receiving both maneuvers only while group B (experimental group) included participants receiving betahistine along with both maneuvers. The impact of dizziness and quality of life was measured through EQ-5D-5L questionnaire and dizziness handicap inventory (DHI) in order to analyze the effectiveness of treatments. Pre and Post treatment results were compared within group by Wilcoxon rank test and for between groups, Mann Whitney U test was performed

Eligibility Criteria:
Inclusion Criteria:

* age between 18-60
* positive modified Dix Hil pike test
* repetitive vertigo spells affecting activities of daily livings (ADLs)

Exclusion Criteria:

* any cervical spine problem
* vertigo due to central disease
* tumors
* systemic disease
* cardiac disease
* Parkinson disease
* bed bound patients
Real-time Monitoring of Concentration and Size Variations of Circulating Plasma Free DNA to Predict Early Response to Immunotherapies in Patients With Different Types of Cancer.

Immunotherapy, which can be represented by the immune checkpoint blockade, is a milestone in the progress of the ongoing struggle against cancer. However, the emergence of unexpected tumor response patterns, such as pseudo-progression or hyper-progression, might complicate the management of patients receiving these immune checkpoint inhibitors. A reliable standardized biomarker that can be used in clinical practice for predicting response to treatment, monitoring tumor evolution and evaluating treatment efficacy has not yet been established.

The general aim of this study is to assess the interest of the plasmatic free circulating DNA (cfDNA) on the clinical response for patients with different types of cancer treated with immunotherapies. The primary objective is to assess the performance of the plasmatic free circulating DNA using the estimation of the receiver operating characteristic (ROC) curve and calculation of the area under the curve (AUC) on the response rate.


Eligibility Criteria:
Inclusion Criteria:

* Patients starting anti-PD1 immunotherapy as part of marketing authorization alone or in combination (melanoma, clear cell renal cancer, urothelial carcinomas of the bladder, squamous cell carcinomas of the head and neck and non-small cell lung cancer).
* No contraindications to immunotherapy
* Non-pregnant patient
* Patient not opposed to participation in this study

Exclusion Criteria:

* HIV seropositivity
* Patient with psychiatric or other conditions that may compromise his or her ability to give non opposition or to follow study procedures
Ultrasonography Guided Pleural Biopsy Versus Computed Tomography Guided Pleural Biopsy

This study aims to compare the diagnostic efficiency and reliability of Abrams' needle pleural biopsy under computerized tomography guidance with that of cutting-needle pleural biopsy under ultrasonography guidance in patients with pleural effusion.

Background. In cases with pleural effusion, tissue samples can be obtained through Abrams' needle pleural biopsy, thoracoscopy, or cutting-needle pleural biopsy under the guidance of computerized tomography or ultrasonography for histopathological analysis. This study aims to compare the diagnostic efficiency and reliability of Abrams' needle pleural biopsy under computerized tomography guidance with that of cutting-needle pleural biopsy under ultrasonography guidance in patients with pleural effusion.

Methods. Patients with exudative pleural effusion, who could not be diagnosed by cytological analysis, will be included in the study. All patients were randomized following the thoracic computerized tomography with contrast enhancement. Patients either underwent Abrams' needle pleural biopsy under computerized tomography guidance or the cutting-needle pleural biopsy under ultrasonography. The two groups will be compared in terms of diagnostic efficiency and in terms of complications associated with the methods used.

Eligibility Criteria:
Inclusion Criteria:

* Patients with exudative pleural effusion who require invasive procedure for diagnosis

Exclusion Criteria:

* Patients without pleural effusion
Effect of Different Ventilatory Strategies on Cardiac Function in Patients With Acute Respiratory Failure

Mechanical ventilation with low tidal volume (about 6 ml.kg-1) reduces mortality in ALI/ARDS patients respect to high tidal volume ventilation (about 12 ml.kg-1).

This finding is usually explained by alveolar tidal overdistension associated to high tidal volume. Stretch-induced lung injury may trigger a cytokine-mediated inflammatory response. This may contribute to the development of systemic inflammatory response and multiple system organ failure and death.

High tidal volume strategies might affect organ function by pathways not mediated by inflammatory response.

It is well recognized the inverse relationship between tidal volume and cardiac output during mechanical ventilation. Nevertheless there are no clinical studies about cardiac output changes induced by low (6 ml.kg-1) and high tidal volume (12 ml.kg-1) in ALI/ARDS patients.

The study hypothesis is that high tidal volume ventilation reduces cardiac output in ALI/ARDS patients respect to low tidal volume strategy. Thereafter reduced hemodynamic impact could explain beneficial effect of low respect to high tidal volume ventilation.

If study hypothesis is confirmed, other studies should define the main cause of mortality reduction related to low tidal volume strategies and if appropriate hemodynamic monitoring and support should be required when low tidal volume strategies are harmful (i.e. traumatic brain injury).


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of ARDS/ALI

Exclusion Criteria:

* mean arterial pressure lower than 65 mmHg
* beginning or change of vasoactive agents infusion rate in the last 2 hours
Association of Genetic Polymorphisms With Lipid Lowering Effects of Statin Therapy

The 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors, also known as statins, played an important role in lipid-lowering therapy and reduction of cardiovascular risks. However, it has been observed that the response to statin therapy varies from patient to patient, and gene polymorphism could have contributed to the variation.

Hyperlipidemic patients are retrospectively screened from 2006/1/1 to 2006/12/31. The patient is included if he or she had been receiving atorvastatin or rosuvastatin for at least 3 months and did not receive other lipid-lowering medications 4 weeks before starting atorvastatin or rosuvastatin. Genomic DNA was collected from the blood sample of each patient using genomic DNA purification kit. The single nucleotide polymorphisms (SNPs) were determined afterward.

The correlation between response of statin therapy, defined as changes in lipid profiles including triglyceride, total cholesterol, high density lipoprotein cholesterol and low density lipoprotein cholesterol, and SNPs examined.

Eligibility Criteria:
Inclusion Criteria:

* aged 21-80.
* conforms with the criteria of National Cholesterol Education Program Adult Treatment Panel III for medication therapy.
* have received atorvastatin or rosuvastatin regularly for 12 weeks or longer.
* available lipid profiles such triglyceride, total cholesterol, high density lipoprotein cholesterol and low density lipoprotein cholesterol 12-24 weeks after staring statin therapy.

Exclusion Criteria:

* had been using lipid-lowering medications including statins 4 weeks before starting atorvastatin or rosuvastatin.
* received other lipid-lowering medications, erythromycin, immunosuppressant or azole antifungals concomitantly.
* pregnant, breast-feeding, or able to become pregnant.
* have a history of alcohol or substance abuse.
* liver cirrhosis or ALT exceeds the upper limit of normal range.
* untreated hypothyroidism.
* patients with malignant tumor who have received chemotherapy or radiotherapy.
* known allergy to atorvastatin, rosuvastatin or other statins.
* unwilling to provide written informed consent.
Safety and Efficacy of Plant-based Diets in Hemodialysis Patients

The purpose of this proof-of-concept controlled-feeding study is to evaluate the impact of plant-rich diets, with and without high-potassium fruits and vegetables, on phosphorus and potassium homeostasis in hemodialysis (HD) patients.


Eligibility Criteria:
Inclusion Criteria:

* Receiving thrice-weekly outpatient HD treatments for end-stage renal disease
* 3-month mean serum potassium and phosphorus concentrations of \>4.5 mEq/L and \>4.0 mg/dL, respectively
* No prior episodes of moderate-severe hyperkalemia (potassium ≥6.5 mEq/L) in the past 6 months
* Deemed appropriate for the intervention by the patient's nephrologist, considering the patient's prognosis, cognition and pending treatments (e.g., kidney transplant)

Exclusion Criteria:

* Change in medications that alter potassium homeostasis (e.g., RAAS inhibitors, diuretics, beta-blockers) in the last month
* Diagnosed with bowel diseases or syndromes (e.g., bowel obstruction, major GI surgery, short-bowel syndrome, irritable bowel syndrome, inflammatory bowel disease, chronic diarrhea)
* Anemic, defined as a serum hemoglobin concentration \<9.0 g/dL
* Inadequate dialysis efficacy, defined as a Kt/V of \<1.2
* Dietary restrictions (e.g., allergies) or otherwise unable/unwilling to adhere to study diets (excludes dietary restrictions on high-potassium foods)
* Pregnant or planning to become pregnant during the study
A Feasibility Study of a Fecal Incontinence Management System for Medical Use

The purpose of this feasibility study is to evaluate the performance and skin-friendliness of the barrier of the Fecal Incontinence Management System. The investigator will complete a questionnaire for each of the tested products and the products will be evaluated as regards leakage, wear time, and skin-friendliness.

The purpose of this feasibility study is to evaluate the performance and skin-friendliness of the barrier of the Fecal Incontinence Management System. The investigator will complete a questionnaire for each of the tested products and the products will be evaluated as regards leakage, wear time, and skin-friendliness

Eligibility Criteria:
Inclusion Criteria:

* The subject is at least 18 years of age
* The subject has fecal incontinence

Exclusion Criteria:

* The subject is pregnant and/or breastfeeding
* The subject has perianal fistulas and/or hemorrhoids
* It's estimated that the subject's perianal skin makes it inappropriate for subject to participate in the study (i.e. in case of damaged skin, very sweaty skin or very sinuous and folded skin)
Evaluate 4 Different Formulations of Meningococcal Serogroups A, C, W-135, Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 15-19 Yrs

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy subjects aged 15-19 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose.

3 formulations of GSK's MenACWY conjugate vaccine will be administered in a double-blind manner, while the 4th one will be single-blinded. Administration of the candidate vaccine or of the active control (Mencevax™ ACWY) will be done in an open manner. Subjects will receive one vaccine dose (GSK's MenACWY conjugate vaccine or Mencevax™ ACWY vaccine), and will have 2 blood samples taken, before and one month after vaccination.

Eligibility Criteria:
Inclusion criteria:

* Healthy male or female between, and including, 15 and 19 years of age at the time of vaccination.
* Written informed consent obtained. Subject with previously completed routine childhood vaccinations to the best of his/her knowledge or his/her parents'/guardians' knowledge.
* Female subjects should be of non-childbearing potential, or abstinent, or using an adequate contraception.

Exclusion criteria:

* Previous vaccination against OR history of OR exposure within previous 12 months to meningococcal serogroup A, C, W-135 or Y disease.
* Administration of a tetanus vaccine within 6 months before study vaccination.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of any neurologic disorders or seizures.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.