cyrilzakka/clinical-trials huggingface dataset:
EUS-FNA of Solid Pancreatic Mass: Comparison Between Negative Pressure and Slow-pull Technique

50 patients with pancreatic mass will undergo endoscopic ultrasound-guided fine needle aspiration using two techniques: negative pressure and slow-pull. Cytological results will be compared.

The study will analyze the cytological results of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of pancreatic mass using two different techniques of needle suction. Negative pressure and slow-pull. 50 patients with pancreatic mass will be submitted to four passes with both techniques. Each patient will be randomized to decide which technique will be first and subsequently on a alternated fashion until four passes are completed. Smear cytology and cell block preparations for each technique were obtained. The pathologist was blinded for the EUS-FNA technique.

Eligibility Criteria:
Inclusion Criteria:

* pancreatic solid mass

Exclusion Criteria:

* endoscopic ultrasound non accessible lesions
Clinical Evaluation of the iMOST-X1 Hematology Analyzer - Matrix Study

This is a method comparison study for an in vitro diagnostic device. The device is a point of care automated hematology analyzer which measures CBC parameters with a small drop of venous or capillary, e.g., fingerstick blood. The study compared the CBC results from the test device, the Essenlix iMOST X-1 to the predicate laboratory based Horiba Pentra 60C+ analyzer. The CBC parameters were hemoglobin, White Blood Cells (WBC) and the WBC Differential for Granulocytes, Neutrophils, Lymphocytes and Monocytes. The study subjects were patient donors (age 18 and older) attending the hospital clinic from whom Informed Consent had been received.

These studies demonstrate that the iMOST X-1 system yields equivalent results to the Horiba predicate system when using either capillary and venous blood specimens. Furthermore, there are three alternative methods of capillary blood sampling for the iMOST and all have direct applicability to the iMOST system. As has been published in the peer reviewed literature, different fingerstick sample collection methods yield slightly different CBC results, specifically the WBC and the WBC Differential. The iMOST employs an integrated software algorithm with which the use can employ site specific calibration constants to correctly match the selected capillary blood specimen to the venous specimen for the WBC test results. All three methods of blood collection are thus described in the "Instructions for Use".

Eligibility Criteria:
Inclusion Criteria:

* all clinic attendees

Exclusion Criteria:

* unable to provide a venous and fingerstick blood specimen
Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without Pictilisib in Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer

This multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of carboplatin/paclitaxel and carboplatin/paclitaxel/bevacizumab with and without pictilisib in particpants with previously untreated advanced or recurrent non-small cell lung cancer (NSCLC). Particpants will be randomized to receive 4 cycles of carboplatin (C)/paclitaxel (P) and either pictilisib or placebo, with (participants with non-squamous NSCLC) or without (participants with squamous NSCLC) bevacizumab (B). Anticipated time on study treatment is until disease progression or intolerable toxicity occurs. Participants in placebo arms with disease progression may cross over to open-label active pictilisib.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented advanced (Stage IV) or recurrent squamous (Arms A and B) or non-squamous (Arms C, D, E, and F) non-small cell lung cancer (NSCLC)
* Consent to the collection of an archival formalin-fixed paraffin-embedded (FFPE) block or freshly cut unstained tumor slides from archival tumor tissue or a newly collected tumor sample
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Disease that is measurable per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
* Adequate hematologic and end organ function
* Use of two effective forms of contraception

Exclusion Criteria:

* NSCLC with documented epidermal growth factor receptor (EGFR) mutation associated with response to EGFR inhibitors or documented fusion gene involving anaplastic lymphoma kinase (ALK) gene
* Prior therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, radiotherapy, immunotherapy, hormonal therapy, or investigational therapy) before Day 1 of Cycle 1 for the treatment of advanced (Stage IV) or recurrent NSCLC
* Known central nervous system (CNS) disease except for treated brain metastases
* Type I diabetes
* Type II diabetes requiring chronic therapy with insulin
* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk for treatment complications
* Medical conditions that would contraindicate bevacizumab therapy in non-squamous NSCLC (Arms C, D, E, and F)
Study of XB010 in Subjects With Solid Tumors

This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.

This study consists of Dose-Escalation and Cohort-Expansion Stages. The Dose-Escalation Stage is designed to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE\[s\]) of XB010 as a single agent, and to evaluate XB010 monotherapy RDE(s) in combination with pembrolizumab. The Cohort-Expansion Stage is designed to explore the clinical activity and further characterize the safety and tolerability of XB010 as monotherapy in multiple tumor-specific cohorts.

Eligibility Criteria:
* Age 18 years or older on the day of consent.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
* Adequate organ and marrow function.
* Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent.

  * The Cohort Expansion stage will enroll subjects with multiple tumor types (non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell, triple-negative breast cancer).
* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.
Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects

The purpose of this study is to evaluate the safety and tolerability of long-term administration of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. This study will also evaluate the maintenance of the efficacy of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. All subjects enrolled in this study will receive 50 mg once weekly or twice weekly (if qualified after week 12) by subcutaneous injections for at least 48 weeks and up to 72 weeks.


Eligibility Criteria:
Inclusion Criteria:

- Subjects who were randomized and received at least one dose of investigational product in Study 20021639 or 20021642 (provided that they meet all inclusion/exclusion criteria of this protocol)

Exclusion Criteria:

* Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
* Pregnant or breast-feeding females
* Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis
Impact of the Epidemic of COVID-19 Infection Among People Living With HIV (SARS-CoV-2)

The non-essential and non-urgent follow-up consultations of patients living with HIV were postponed or transformed into "teleconsultation" or exchanges of e-mails between practitioners and patients during COVID-19 epidemic. This change in care can have an impact on follow-up and access to treatment for PVVIH.

On 16 March 2020, an instruction to postpone "non-urgent" consultations was given to doctors. Thus, the non-essential and non-urgent follow-up consultations of patients living with HIV were postponed or transformed into "teleconsultation" or exchanges of e-mails between practitioners and patients. This change in care can have an impact on follow-up and access to treatment for PVVIH. In addition, the epidemic itself may have consequences: PVVIH may be at greater risk because of their immunosuppression and associated co-morbidities.

Eligibility Criteria:
Inclusion Criteria:

* Patient followed up for HIV infection in one of the COREVIH Hauts de France centres participating in the study
* Having communicated an email address
* Having given their consent to participate in this study
* Beneficiary subject affiliated or entitled to a social security scheme

Exclusion Criteria:

* Minor patient
* Refusal to participate
* Patient under guardianship
A Retrospective Study in Patients With Mild to Moderate COVID-19

The purpose of this retrospective study is to analyze real-world disease progression in mild-moderate COVID-19 patients with at least one risk factor for serve COVID-19 illness or death.

This study is a retrospective, real world study, without any intervention in clinical diagnosis and treatment, and only real world data are collected for analysis.

The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.

The study will collect and analyze available symptoms, risk factors and SARS-COV-2 Ct value up to 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Participants who have a positive SARS-CoV-2 test result.
* Participants who have one or more mild or moderate COVID-19 symptoms.
* Participants who have one or more of the following requirements: ≤7 days from the first positive test for SARS-COV-2 virus infection to Day 1; ≤5 days from the first onset of COVID-19 symptoms to Day 1.
* Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death.

Exclusion Criteria:

* Participants who are diagnosed with severe/critical COVID-19 before Day 1.
* Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300, or respiratory rate ≥30 per minute before Day 1.
* Participants who have received mechanical ventilation before Day 1.
* Participants who have received or plan to receive a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment) before and during hospitalization.
* Participants who have received convalescent COVID-19 plasma treatment before and during hospitalization.
Study of Various Treatments in Non-alcoholic Fatty Liver Disease (NAFLD) Patients Who Have Aspects of Non-alcoholic Steatohepatitis (NASH)

This clinical study was designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of various single and combination treatments in adult patients with non-alcoholic fatty liver disease (NAFLD) who manifest a non-alcoholic steatohepatitis (NASH)-like biomarker phenotype.

This was a Phase II, non-confirmatory, multicenter, open label, platform study in NAFLD participants with a NASH-like biomarker phenotype to examine the effects of single and combination therapies over 12 weeks of treatment. The study consisted of four distinct study periods:

* Screening Period (Day -60 to -28): Lasted up to a maximum of 33 days where participants were assessed for inclusion and exclusion criteria prior the baseline assessments.
* Baseline Period (Day -27 to -1): Lasted up to a maximum of 27 days and comprised baseline assessments and randomization.
* Treatment Period (Day 1 to 85): Participants were randomized in a 1:1 ratio to LYS006 20 mg (twice a day) arm or to LYS006 20 mg (twice a day) and tropifexor 200ug (once a day). Participants were treated daily during 12 weeks.
* Follow-up Period (Day 85 to 113): After completion of the treatment period, participants were observed until the End Of Study (EOS) visit at Day 113.

Eligibility Criteria:
Inclusion Criteria:

Phenotypic diagnosis of NASH based on the presence of all of the following:

* ALT ≥ 43 IU/L (males) or ≥ 28 IU/L (females)
* BMI ≥ 27 kg/m2 (race other than Asian) or ≥ 23 kg/m2 (Asian race)
* History of type 2 diabetes mellitus with HbA1c ≤ 9%
* ELF test score ≥ 8.5 and ≤ 10.5
* Liver fat ≥ 8%
* Patients must weigh between 40 kg (88 lbs.) and 150 kg (330 lbs.)

Exclusion Criteria:

* Use of other investigational drugs within 5 half-lives of randomization or within 3 months, whichever is longer
* Use of obeticholic acid (OCA) or pharmacologically-active weight loss drugs within 1 month of randomization
* Use of strong CYP3A4/5 inhibitors or strong CYP3A4 inducers within 5 half-lives or 7 days of randomization, whichever is longer
* History or presence of other concomitant liver diseases
* History or current diagnosis of ECG abnormalities
* Patients with contraindications to MRI imaging
* Current or history of significant alcohol consumption
* Clinical evidence of hepatic decompensation or severe liver impairment
* Women of child bearing potential (unless on highly effective methods of contraception)
* Presence of liver cirrhosis
* Use of OAT3 inhibitors within 5 half-lives or 7 days of randomization, whichever is longer
Effects of COP Exercise and HIIT on Vascular Health in Young Overweight Females

The goal of this study is to determine the effects of high-intensity interval training and crossover point exercise training on vascular health in young overweight women.

In recent years, improving cardiovascular health through exercise has become a popular research question, however, it is not clear which intensity and modes of exercise bring more benefits. Crossover point(COP) intensity has great medical potential as a personalized exercise intensity that is based on substrate utilization mode, especially in overweight and obese people.On the other hand, several studies have demonstrated that HIIT is an effective method in improving vascular endothelial dysfunction. During our study, we evaluated the vascular health changes in young overweight women who received either COP exercise or HIIT exercise for 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Female, 18-30 years old
2. Body mass index (BMI) \< 28 kg/m2 and ≥ 24 kg/m2
3. No exercise habit, and no recent new exercise plan
4. No contraindications to exercise

Exclusion Criteria:

1. Participates had an orthopedic or other condition that limited participation in daily exercise
2. Participates had a history of myocardial infarction, stroke, diabetes mellitus, chronic respiratory disease or cancer
3. Participates had smoking or alcohol behavior
Unplanned-extubation in the ICU; Incidence, Characteristics and Prognosis. Success And Failure of Self-Extubation in the ICU

Our study consists of a national observational study assessing quantitatively (incidence) and qualitatively unscheduled extubation in intensive care unit. In addition, we will compare the outcome of patients with "success" or "failure" in the self-extubation subgroup.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Mechanically ventilated with oral or nasotracheal intubation
* Occurrence of an unscheduled extubation (auto-extubation or accidental extubation)
* Extubation is defined as the removal of the orotracheal or nasotracheal tube with the impossibility of reinsertion of the same device.

Exclusion Criteria:

* Opposition to the use of personal data
* Pregnant women
* Person under protective custody or guardianship
Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia

The benefit of the research is to provide information regarding the efficacy and safety of Favipiravir plus the Standard of Care (SoC) for mild-moderate COVID-19 patients to be a reference for policy recommendations regarding the use of Favipiravir as an antiviral drug for the treatment of Covid-19.

Pre-screening is assessing patients who meet the inclusion and exclusion criteria. Screening was carried out to assess whether the subjects met the inclusion and exclusion criteria. Randomization was performed to determine the study drug allocation. The research subjects were inpatients at selected hospitals and at the time of recruitment, the time was called D1. The next day is called D2 and so on Follow-up will be carried out from the first day of recruitment, taking medication up to a maximum of 19 days for test drugs and 11 days for SoC drugs. Recording of clinical and laboratory manifestations will be carried out from recruitment until the patient returns from the hospital.

All results will be recorded in a case report form, and if a case of clinical and laboratory manifestations is found to be severe, it will be written on the adverse case report form and reported immediately according to standard GCP procedures. Subjects may also drop out of the study due to discontinuation of follow-up or a protocol violation

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients 18 years - 59 years
2. Confirmation of Covid-19 based on the results of the Real Time PCR (RTPCR) examination for SARS-COV-2 less than 7 days before the first day of taking the drug
3. Patients with mild-moderate clinical manifestations were admitted to the hospital designated by the physician according to the operational definition of the study protocol
4. Have not received COVID-19 antiviral therapy
5. Consciously and voluntarily participate in research

Exclusion Criteria:

1. Pregnant and lactating women
2. Allergy history to Favipiravir and standard hospital drugs
3. Patients with uric acid examination values above normal male\> 7 mg / dL; women\> 5.7 mg / dL
4. Patients with a history of prolonged ECG / Arrhythmia / QT disorders
5. Cannot swallow drug
Absorption and Excretion Kinetics of the Bioactive Ingredients of Rice Bran Extract

The oral absorption and urinary excretion kinetics of the bioactive ingredients from rice bran (gamma-oryzanol, tocotrienols, tocopherols and ferulic acid esters) after incorporation into an oat porridge (oat porridge) compared to unprocessed rice bran extract oil were investigated. The influence of the type of preparation (with water vs. milk) of porridge on the bioavailability of the bioactive compounds was compared. The study followed a single dose (2 g rice bran extract), randomized, three armed crossover study design with ≥1-week washout periods. Plasma and urine samples were collected at intervals up to 24 h after intake.


Eligibility Criteria:
Inclusion Criteria:

Healthy Volunteers with blood chemistry values within normal ranges

Age 18 to 35 years

BMI 19 to 25 kg per m2

Exclusion Criteria:

Pregnancy or lactation

Alcohol and or drug abuse

Use of dietary supplements or any medications except contraceptives

Any known malignant, metabolic and endocrine diseases

Previous cardiac infarction

Dementia

Participation in a clinical trial within the past 1 week prior to recruitment

Smoking

Physical activity of more than 5 h per wk

Lactose intolerance

Milk intolerance
Can tDCS Enhance Efficacy of Rehabilitative Intervention for Freezing of Gait in Parkinson's Disease?

Freezing of gait in Parkinson's disease (PD) is a major cause of disability and falls and responds often incompletely to conventional therapy. The pathogenesis remains largely unknown and therapeutic alternatives are needed. Rehabilitative interventions that consist of learning cognitive strategies with sensory cueing to prevent and to overcome FOG represent the most efficacious intervention, but difficulties in learning and execution of these cognitive strategies are the main cause of failure. Transcranial direct current stimulation (tDCS) enhances motor task learning and execution in patients with PD and might enhance the efficacy of rehabilitative interventions.

This study intends to address the following question whether tDCS can enhance the efficacy of rehabilitative interventions in the treatment of freezing of gait in Parkinson's disease?


Eligibility Criteria:
Inclusion Criteria:

* men and women aged 30 to 80 years with DOPA-responsive PD Hoehn and Yahr (HY) grade of 2 to 4 while "off"
* must be on a regimen including levodopa
* total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be equal to or more than 300 milligrams per day
* Gait difficulties with Freezing of Gait as defined by MDS-UPDRS I score ≥ 2 in FOG
* Optimal conventional PD medication for \> 1 month prior to screening
* scheduled for rehabilitative intervention for the treatment of freezing of gait

Exclusion Criteria:

* significant concurrent medical or psychiatric disease
* history of seizures and epilepsy
* Dementia or other neurodegenerative disease (besides PD)
* pallidotomy, implanted electrodes and generator for deep brain stimulation
* pregnancy
* surgically or traumatically implanted foreign bodies such as an implanted medical pump, implanted hearing aids, metal plate in the skull, or metal implant in the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during tDCS.
* Study would cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general frailty, or excessive apprehensiveness.
* significant postural instability with daily falls, inability to walk the parcours or inability to walk 10 meters.
* presence of significant cognitive dysfunction as determined by Montreal Cognitive Assessment (MOCA) \<20 or mentally impaired patients having no capacity to provide their own consent (the physician establishing the diagnosis and applying UPDRS will evaluate patient's mental capacity using conventional clinical interview).
* presence of other co-morbid conditions that can contribute to gait dysfunction (orthopedic, rheumatologic, cardiac, other)
* presence of clinically significant hallucinations
* participation in any rehabilitation therapy for FOG within the last six months prior to screening