cyrilzakka/clinical-trials huggingface dataset:
Micro-Tech FNB Needle to Obtain Tissue Specimens of Pancreas Malignancy for Personalized Based Chemotherapy

Systemic chemotherapy can improve disease-related symptoms and/or prolong survival in patients with pancreatic cancer. Before the start of chemotherapy, the diagnosis pancreatic carcinoma must be confirmed by tumor tissue samples, which are often obtained during endoscopic ultrasound (EUS) by fine needle aspiration (FNA) or fine needle biopsy (FNB). Obtaining core biopsies by FNB has several potential benefits, such as making a more reliable diagnosis, performing immunohistochemistry for diagnostic reasons and in the future obtaining enough malignant cells to deliver personalized based chemotherapy regimen based on mutations detected by next generation sequencing. Obtaining high quality and sufficient tumor material is essential for genomic profiling with a preference of FNB over FNA. Up to now, no specific FNB needle has been found to be superior in diagnostic accuracy and in obtaining tissue for genomic profiling. In this study, we aim to evaluate the diagnostic accuracy of a new FNB needle (Micro-Tech Europe GmbH, Düsseldorf, Germany) and we study the adequacy of the obtained tissue samples for performing genetic sequencing.

This study is an international multicenter prospective cohort study. The study will be performed in collaboration with the disciplines of Gastroenterology and Pathology of the participating hospitals.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Clinical suspicion of pancreatic adenocarcinoma
* Indication for obtaining EUS-guided histology of a suspected pancreatic lesion
* Written informed consent

Exclusion Criteria:

* Contra-indications to undergoing an EUS (e.g., oropharyngeal abnormalities)
* Altered anatomy (e.g., after previous Whipple-operation, Roux-and-Y gastrojejunostomy)
* Contra-indications to the administration of benzodiazepines, propophol or opioids
* Pregnancy
* Insufficient knowledge of the Dutch language to be able to understand the patient information
Biomarkers in Urine Samples From Patients With Wilms Tumor

RATIONALE: Studying samples of urine from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.

PURPOSE: This clinical trial studies biomarkers in urine from patients with Wilms tumor.

OBJECTIVES:

* To validate the prognostic performance of specific-candidate Wilms tumor markers by measuring their urinary concentration using enzyme-linked immunosorbent assays (ELISAs) in urine specimens collected at diagnosis from 50 patients with favorable histology Wilms tumor who relapsed and 50 patients who did not relapse.

OUTLINE: Urine specimens are analyzed using enzyme-linked immunosorbent assays (ELISAs) for biomarkers.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Urine specimens collected at diagnosis will be selected from patients with stage II-III Wilms tumors, with both local and non-local sites of disease relapse
* Clinical patient information (urinalysis/macro, age, gender, congenital defects/syndromes, comorbidities, tumor stage, size, pathology, therapy, outcome) available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Linking National Guard Veterans With Need to Mental Health Care

This project added an evaluation/research component to an existing peer outreach program, implemented for over 1100 soldiers in the Michigan Army National Guard. The study aims were to: 1) evaluate the implementation of the B2B program to inform ongoing program modifications and facilitate future dissemination efforts, 2) assess whether the B2B program increases mental health and substance use treatment initiation and treatment retention among returning National Guard soldiers, and 3) explore whether the B2B program improves mental health symptoms, deceases hazardous alcohol use, and improves soldier well-being.

The study aims were to: 1) evaluate the implementation of the B2B program to inform ongoing program modifications and facilitate future dissemination efforts, 2) assess whether the B2B program increases mental health and substance use treatment initiation and treatment retention among returning National Guard soldiers, and 3) explore whether the B2B program improves mental health symptoms, deceases hazardous alcohol use, and improves soldier well-being.

The study had three components which addressed each of the three specific aims. The first component assessed B2B implementation using an embedded mixed methods design. This evaluation included real-time assessment and adaptation of the program, as well as retrospective evaluation of implementation process, sustainability, and potential for spread. The second component addressed the impact of B2B on treatment initiation and retention. Preliminary analyses were completed using regression analyses. Pending additional data from the DoD, an interrupted time series design to assess Michigan National Guard soldiers' VA and non-VA services use in multiple time periods before and after the date of B2B implementation will be conducted.. The third study component assessed the impact of B2B on MI ARNG soldiers' outcomes using longitudinal survey data and adjusting for baseline mental health status using data from the Post Deployment Health Assessment (PDHA).

Eligibility Criteria:
Inclusion Criteria:

Michigan Army National Guard soldiers who have returned from OEF/OIF deployments between August 2010 and December 2012.

Exclusion Criteria:

Soldiers who did not return from deployment during the study time period.
Clinical Performance Evaluation of the NeuMoDx™ FluA/FluB/RSV/Severe Acute Respiratory Syndrome-CoV-2 Assay

To demonstrate the clinical performance of the NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 Assay on the NeuMoDx Systems by determining clinical sensitivity and specificity of the Assay.

To evaluate the clinical performance of the NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 Assay on the on the NeuMoDx™ 288 and 96 Molecular Systems, collectively referred to as NeuMoDx Systems. The results of this study will be used to support regulatory registration and product release in the US, Europe and other markets.

Eligibility Criteria:
Inclusion Criteria:

* Fresh specimens shall be collected from all comers across the study duration
* Collected from individuals of any age presenting with influenza-like illness (ILI)
* Nasopharyngeal (NP) swab specimen obtained using a flexible mini-tip flocked swab and collected into 3 mL Copan® Universal Transport Media (UTM) \[Cat. No.305c\] or Beckton Dickinson (BD™) Universal Viral Transport (UVT) \[Cat. No. 220531\]
* Minimum volume for residual specimen approximately 2 mL
* Fresh specimens to be tested within 3 days of collection.
* Fresh specimens to be stored under the recommended stability conditions (2-8°C).

Exclusion Criteria:

* Required information unable to be obtained from associated medical chart.
* Specimens not fitting criteria outlined above.
Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 Therapy

This study will assess the efficacy, safety and tolerability of omalizumab, compared to placebo in 18 to 75 year old Chinese patients with moderate to severe persistent allergic asthma who have inadequate asthma control despite treatment according to GINA (2009) Step 4 therapy.


Eligibility Criteria:
Inclusion Criteria:

* Met study drug-dosing table eligibility criteria (serum baseline total IgE level ≥ 30 to ≤ 700 IU/mL and body weight \> 20 kg and ≤ 150 kg)
* Diagnosed with asthma ≥ 1 year duration at Screening, and a history of asthma that is not adequately controlled with GINA (2009) Step 4 therapy
* Received medium-to-high dose inhaled corticosteroid \> 500 µg Beclomethasone Diproprionate (BDP), or equivalent plus regularly inhaled LABA, either separately or in combination, for at least 8 weeks prior to screening
* Met specific asthma exacerbations eligibility criteria prior to the screening period
* Exhibited inadequate symptom control as demonstrated by specific criteria (in keeping with GINA 2009 guidelines)
* Positive skin prick test to at least one perennial aeroallergen documented by a historical test within 12 months prior to screening, or at Visit 1
* FEV1 ≥ 40% and \< 80% of the predicted normal value for the patient (using local standards), after withholding bronchodilators at Visit 2

Exclusion Criteria:

* Used other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. For biological agent-based investigational drugs, such as monoclonal antibodies, at least six months will need to have passed between the last administration of the drug and the patient's Screening Visit.
* History of malignancy
* History of allergies and diseases that could interfere with the analyses
* Clinically significant abnormality on a 12-lead ECG recorded at Visit 1
* Elevated IgE levels for reasons other than allergy
* Current smokers, or a former smoker with a smoking history of \> 10 pack-years. A former smoker must have abstained for a minimum of 12 months before randomization
* Receiving specific medications
* Clinically significant laboratory abnormalities (not associated with the study indication) at Visit 1

Other protocol-defined inclusion/exclusion criteria may apply
A Clinical Trial of Bio-Germanium for the Evaluation of Efficacy on Immune Function

This study is a 8-week, randomized, double-blind, placebo-controlled clinical trial of Bio-Germanium for the evaluation of efficacy on immune function and immune cell activation.

This study will evaluate Bio-Germanium's efficacy on immune function and immune cell activation in healthy volunteers by assessing improvements in certain immune indices (i.e. NK cell activity, WBC, IFN-γ, TNF-α, IgG1, IgG2, IgM, IL-2, 6, 12).

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female volunteers between the ages of 25 to 75 years
2. Screening result for WBC counts in between 4,000 cells/ul and 8,000 cells/ul
3. Volunteers who have agreed to participate in the study and provided a written content by him/herself or through its legal representative

Exclusion Criteria:

1. Those under the treatment for clinically significant acute or chronic diseases in cardiovascular, immune, respiratory, liver, biliary, renal, urinary, nervous, musculoskeletal system as well as psychiatric, infectious, hematologic and neoplastic diseases (exceptions can be made under the discretion of the researcher)
2. Those with uncontrolled hypertension (140/90mmHg or higher, measured after 10 minutes of resting)
3. Those with uncontrolled diabetes (fasting blood glucose levels greater than 126mg/dl or those starting diabetes medication within 3 months)
4. Those received vaccination within 3 months before screening
5. Those with blood AST(GOT) or ALT(GPT) levels greater than 120IU/L
6. Those with blood creatinine level greater than 2.4mg/dL for male and 1.8mg/dL for female
7. Those who have consumed within 2 weeks before screening or are currently consuming health supplements that can affect immune function
8. Those under the severe gastrointestinal symptoms such as heartburn, indigestion, and such
9. Those who are pregnant, breastfeeding or planning to become pregnant during this study
10. Those who are oversensitive or allergic to the investigational product
11. Those who plan to participate in other researches during this study
12. Those who participated in other researches within 4 weeks of the start of this study
13. Those who are deemed inappropriate by the researcher
Clinical Outcome and Toxicity Data in Patients With Advanced Breast Cancer Treated With CDK Inhibitors Combined With Endocrine Therapy

The present study will assess real-world clinical outcomes and adverse events from treatment with endocrine therapy combined with CDKi in patients with HR-positive, HER2-negative advanced breast cancer.

Patients This will be a retrospective analysis of patients with histologically confirmed HR-positive, HER2-negative advanced (recurrent or metastatic) breast cancer. The investigators will use data from patients treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology. Eligible patients will be of 18 years or older, women of any menopausal status with HR-positive/HER2-negative advanced breast cancer who have received treatment with CDKi in combination with endocrine therapy for their advanced breast cancer. Treatment combinations of CDKi with any endocrine therapy will be accepted. Patients will be included in the analysis if they heve received at least two months of treatment with a CDKi. Patient clinical data will be obtained from their medical records. Toxicity data will be recorded from the clinicians' documentations during scheduled patient clinical visits.

Statistical analysis The primary endpoint of the study will be progression-free survival (PFS), defined as the time from treatment initiation to either the first documented disease progression or death from any cause. Secondary endpoint will be overall survival (OS), defined as the time from treatment initiation to patient death or last contact. Patients alive will be censored at the date of last contact. Adverse events will be graded based on Common Terminology Criteria for Adverse Events (CTCAE, version 4.0). Survival curves will be estimated using the Kaplan-Meier method and compared across groups with the log-rank test. The associations between the clinicopathological factors to be examined and the mortality rate will be evaluated with hazard ratios estimated with Cox proportional hazards model. The statistical analyses will be completed using the SAS software (SAS for Windows, version 9.3, SAS Institute Inc., Cary, NC).

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Αny menopausal status is allowed
* HR-positive/HER2-negative advanced breast cancer
* Patients treated with CDKi in combination with endocrine therapy for their advanced breast cancer
* Combinations of CDKi with any endocrine therapy are allowed
* More than two months of treatment with a CDKi is mandatory

Exclusion criteria:

• Treatment with CDKi as (neo)adjuvant treatment
Endoscopic Variceal Ligation in Children

This is an ambispective single-center cohort study of pediatric patients with portal hypertension and esophageal varices. The study was designed to evaluate the efficacy and safety of primary prophylaxis with endoscopic variceal ligation to prevent upper gastrointestinal bleeding compared to non-selected beta-blockers prophylaxis.

Endoscopic Variceal Ligation group; Inclusion criteria From January 2014 to April 2017, a study group was created, including all paediatric patients with a known chronic liver disease with suspicion of portal hypertension and grade 2 or 3 OV or red spots, regardless of the grade of the OV diagnosed by endoscopy.

Propanolol group Patients in the Endoscopic Variceal Ligation study group were compared with an historical cohort of 30 consecutive patients with portal hypertension and grade 2 or 3 esophageal varices or red spots, regardless of the grade of the esophageal varices in the upper endoscopy, who received propranolol as primary prophylaxis from January 2009 to December 2013.

Ligation sessions were performed every 6 weeks until varices eradication. When eradication was achieved, upper endoscopy was performed at 2 and 6 months to assess the efficacy of the treatment. If no varices were observed, upper endoscopies were performed once a year thereafter.

Eradication was defined as disappearance of all varices or reduction to grade 1 small varices without reddish spots and no gastric varices.

Eligibility Criteria:
Inclusion Criteria for endoscopic variceal ligation cohort

* All paediatric patients (\< 18 years)
* Known chronic liver disease
* Suspicion of portal hypertension based on splenomegaly in the ultrasound, presence of collaterals in the abdominal wall or low platelet count (\<150.000 platelets/L),
* Grade 2 or 3 esophageal varices or red spots, regardless of the grade of the esophageal varices diagnosed by endoscopy
* From January 2014 to April 2017

Exclusion Criteria for endoscopic variceal ligation cohort:

* Patients initially treated with Non-selective beta blockers and subsequently treated with endoscopic variceal ligation as primary prophylaxis were excluded of the study.
* Patients for whom endoscopic variceal ligation was not feasible because of patients' weight/seize were also excluded of the study.

Inclusion Criteria for propranolol cohort

* All paediatric patients (\< 18 years)
* Known chronic liver disease
* Suspicion of portal hypertension based on splenomegaly in the ultrasound, presence of collaterals in the abdominal wall or low platelet count (\<150.000 platelets/L),
* Grade 2 or 3 esophageal varices or red spots, regardless of the grade of the esophageal varices diagnosed by endoscopy
* That received propranolol as primary prophylaxis
* From January 2009 to December 2013.

Exclusion Criteria propranolol cohort:

* Patients initially treated with non-selective beta blockers and subsequently treated with endoscopic variceal ligation as primary prophylaxis were excluded of the study.
Excitotoxicity Markers and the Clinical-radiological Progression After a Demyelinating Event: a Prospective Pilot Study

Multiple sclerosis (MS) is an inflammatory disease of the central nervous system, beginning most often in subjects aged 20-40 years. In France, thanks to recent studies reported during general states of MS in 2006, the prevalence is estimated at 65.5 / 100,000 population (96.3 / 100,000 women and 41.9 / 100,000 men) and incidence at 7.91 per 100,000. In Lower Normandy, the incidence of MS is estimated to 4.45 / 100,000 inhabitants or 60 new cases per year.

The primary objective of this pilot study is to assess the levels of glutamate and aspartate (excitotoxicity markers) and their repercussions on the clinical and radiological outcome in 40 patients experiencing an event demyelinating central nervous system.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman between 18 and 60 years old.
* Patient with one or more type of inflammatory events of Central system suggestive of demyelinating disease (multiple sclerosis, neuromyelitis optical Devic extensive myelitis)
* No treatment with corticosteroids for less than 1 month
* Need for a lumbar puncture performed in the etiologic
* Need a brain MRI performed within the etiologic
* Patient who signed informed consent

Exclusion Criteria:

* Secondary progressive MS
* Any cons-indication for lumbar puncture
* Any contra-indication to MRI
* Minor patient or patient major under guardianship
Evaluating the Foot Touch Framework Model

A Foot Touch framework model has been developed to express the ground reaction force waveforms observed for walking and running. The purpose of this research is to collect ground reaction force data during walking and running that can be used to evaluate and verify the Foot Touch framework.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult men and women
* Capable of independently walking and running at various speeds for a minimum of 30 minutes
* No history of significant injuries in the past six months
* Ability to walk and run without shoes/footwear
* Ability to perform one- and two-footed hops up and down from 5 cm and 10 cm heights
* Ability to provide informed consent

Exclusion Criteria:

* Confounding chronic injury or musculoskeletal problem
* Pregnancy
* Symptomatic cardiovascular disease or chronic obstructive pulmonary disease
* Not able to read and understand English
Subretinal Lucentis for Hemorrhagic Age-related Macular Degeneration (AMD)

Visual outcomes of the eye with large subretinal hemorrhages (bleeding under the retina) due to Age-Related Macular Degeneration (AMD) are poor. The Submacular Surgery Trial (SST) showed that no statistically significant improvement in vision resulted from surgical removal of the layer of abnormal blood vessels causing the bleeding. However, placement of a gas bubble into the gel of the eye along with removal of the blood has shown some success. However, this does not treat the underlying condition of the AMD.

Intravitreal injections (into the gel of the eye) of a drug called Lucentis has been shown to be highly effective in the treatment of AMD, yet its penetration through areas of thick blood caused by subretinal hemorrhage is not known.

This study is proposing to treat the AMD causing the subretinal hemorrhage with a vitrectomy (surgery involving removing the gel inside the eye, and membrane layers of the eye) followed by Lucentis placed between the layers of the retina and then with or without a gas bubble.

In order to determine if the the subretinal Lucentis alone is beneficial, 5 of the 10 patients enrolled will get a gas bubble and the other 5 will not.

Subjects will be followed for a period of 12 months. Based on photographs and other testing procedures, if it is deemed in the subject's best interest, the subject may receive monthly injections of Lucentis to help treat the AMD.

Eligibility Criteria:
Inclusion Criteria:

* Age over 50 years
* Vision 20/200 or worse
* AMD with submacular hemorrhage
* Hemorrhage more than 25% of the lesion
* Fibrosis or scar not more than 25% of the entire lesion
* Hemorrhage less than 3 months old
* Vision loss occuring within 3 months

Exclusion Criteria:

* Pregnancy
* Participating in any other clinical trial
* Prior treatment for AMD
* Other medical conditions causing compromised vision
* Intraocular eye surgery within the previous 12 months
* Inability to obtain necessary eye photographs
* Systemic use of anti-VEGF agents
* Allergy to fluorescein dye
* Unable to complete all study visits
* Glaucoma filtering surgery
* Use of 2 or more treatments for glaucoma
* Lack of lens in the eye or absence of a posterior capsule
Assessment of the Humanisation of Care in Hospitals in Andalusia-Spain

Observational assessment through patient interviews of relational, structural and organisational aspects related to the humanisation of health care. These data will be related to health outcomes such as pain, sleep quality, anxiety levels, adverse events (pressure injuries, falls, and mortality), satisfaction with the care received, and experience in communication processes with health professionals.

Data will also be collected on work ergonomics variables (stress, burnout, working conditions, ratios) of nurses and health technicians, which will also be related to the health outcomes collected.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the internal medicine and emergency units of the participating hospitals during the sampling time.

Exclusion Criteria:

* Patients presenting with haemodynamic instability or emergencies at the time of sampling
* Patients with cognitive impairment
Ex-vivo Ultrasound Guided Radiofrequency Ablation on Pancreatic Solid Lesions

The study investigates the feasibility and the efficacy to treat pancreatic solid lesions as pancreatic adenocarcinomas (PDAC) and neuroendocrine tumors (NET) with ex-vivo radiofrequency ablation (RFA) under ultrasound (US) control.

The study intent is to define the optimal radiofrequency ablation POWER of the system in terms of maximum sizes (diameters) of histological coagulative necrosis obtained at pathological samples. Results will be useful to define the optimal settings to ablate pancreatic solid lesions (PDAC and neuroendocrine tumours).

A probe specifically designed for Endoscopic Ultrasound (EUS) in vivo treatment of human pancreatic solid masses will be used. The probe is connected to a radiofrequency generator on which the power can be set and the tip of the probe (on the tip is present the radiofrequency electrode) is continuously perfused by chilled solution. The generator can stop the power supply when the tissue impedance goes beyond the threshold value to prevent tissue carbonization

Eligibility Criteria:
Inclusion Criteria: pancreatic solid lesion presence (pancreatic adenocarcinoma and neuroendocrine tumors) resected during pancreatic surgery -

Exclusion Criteria: no signature on informed consent

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