cyrilzakka/clinical-trials huggingface dataset:
Techcyte SureView Cervical Cytology System Clinical Validation Study

The clinical study is a multi-center, retrospective, blinded, matched-pair, two-arm clinical study in which one test assessment and a control assessment of liquid-based cytology (LBC) pap tests are performed and compared to a reference.

The control method is defined as the assessment of LBC pap tests performed by a cytotechnologist (CT) and/or cytopathologist (CP) using standard laboratory cervical cytology practices (i.e. a manual assessment) and following The Bethesda System for Reporting Cervical Cytology (TBS). The control method is referred to as the "standard method".

The test method is referred to as the AI-assisted method. The AI-assisted method is defined as the assessment of the same LBC pap test as in the standard method, but with the Techcyte SureView Cervical Cytology System, which has pap tests being scanned on the Pramana SpectralHT Cubiq whole slide scanner, analyzed with the Techcyte Cervical Cytology Algorithm (TCCA) and presented on the Techcyte Viewer, using the Dell U3223QE Monitor for assessment by a CT/CP following the TBS.

In addition, the time spent reviewing the samples with both methods will be measured such that the CT workload limit for AI-assisted assessment can be established.

The LBC pap tests to be assessed in the clinical study must have been prepared with either ThinPrep® Pap Test (Hologic) or BD SurePath™ (Beckton, Dickinson and Company). The study aims to enroll for each preparation method an equal number of samples.


Eligibility Criteria:
Inclusion Criteria:

* Glass slides with cervical cytology specimens prepared with Hologic ThinPrep according to the pap test manufacturers Instructions for Use (IFU) using any of Hologic's processors (i.e. ThinPrep2000, ThinPrep 3000, ThinPrep 5000, ThinPrep Genesis). OR Glass slides with cervical cytology specimens prepared with BD SurePath according to the pap test manufacturers IFU using any of BD's processors (i.e. BD Totalys MultiProcessor, BD Totalys SlidePrep, BD PrepStain).
* Slide has the original diagnosis available.
* Slides that fit within the required sample size strata using the sample collection procedure.
* Glass slides with QR code, barcodes, or plain text labels.
* Glass slides with coverslips.
* Slides that are 5 years old or less, except where rare specimens require it. Those specimens will have to be reviewed for degradation per the sample collection procedure.
* Only one sample per patient and all are to be collected, processed and scanned.

Exclusion Criteria:

* Broken or cracked slides.
* Slides with air bubbles or scratched, cracked or broken/missing cover slips.
* Slides with markings (e.g., handwritten pen marking) that cannot be removed according to standard laboratory procedures.
* Degraded slides (ex: slides whose stains have lost color or specimens that are not intact).
* Glass slides with cervical cytology specimens prepared with methods other than Hologic ThinPrep or BD SurePath.
* Glass slides with specimens other than cervical cytology specimens.
* Slides from the same patient.
Peripheral IV Dressing and Phlebitis in Patients From Amazon

Pragmatic, randomized, single-blinded, controlled clinical trial of the effect of dressing and stabilization of peripheral intravenous catheters on the occurrence of phlebitis in adult patients attended at a hospital from the Western Brazilian Amazon.

Peripheral venous catheterization is the most commonly performed invasive procedure in healthcare. Care practices and the use of technologies may influence the results of the use peripheral intravenous catheters (PIC), contributing to the reduction of complications and adverse events. Phlebitis is characterized as one of the most serious complication related to the use of PIC and this study has as hypothesis to analyze if the occurrence of phlebitis associated with PIC is influenced by the use of sterile dressing. Objectives: To verify the effect of using sterile dressing and sterile adhesive tape compared to non-sterile adhesive tape in PIC on the occurrence of phlebitis in adult patients attended at a hospital from the Western Brazilian Amazon. Methods: Pragmatic, randomized, controlled and single-blinded clinical study conducted in Rio Branco, Acre. The sample was calculated in 330 patients, aged 18 years or older and who met the inclusion criteria. Data collection took place between June 2018 and September 2019, after approval of ethical merit. To identify the type of sterile transparent dressing to be studied, was carried out an implementation study with a final sample of 71 patients, focusing analysis from the perspective of the patient, professional and clinics. The patients of the clinical study were randomly allocated to one of the study groups: Experimental group (sterile transparent dressing) or Standard Group (non-sterile adhesive tape). Phlebitis was diagnosed by the bedside nurse, according to presence and severity. If present, the nurse removed the CIP and an external evaluator was called to perform a diagnose of phlebitis with blindness regarding the intervention. Variables related to patient characterization, intravenous therapy, peripheral venipuncture, reasons for withdrawal and length of PIC stay, reasons for removal and length of coverage, and associated complications were investigated. For the statistical analysis, Chi-square, Fisher's Exact, student t test, and Mann-Whitney U tests were used. The multiple analysis was performed using the logistic regression model to estimate the Relative Risk (RR) and the Kaplan-Meier model, Cox regression, for survival analysis. RR calculation for 95% Confidence Interval (IC) was applied to estimate the degree of association between variables. In all tests, the significance level of 5% was considered.

Eligibility Criteria:
Inclusion Criteria:

* IV access for more 48 hours obtained in the studied wards.
* IV access 20 and 22 G.
* without confusion or agitation
* Aged more or equal 18 years

Exclusion Criteria:

* Sepsis
* Skin lesions
Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis

Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis.


Eligibility Criteria:
Inclusion criteria

* Active and severe ankylosing spondylitis
* Ankylosing spondylitis refractory to standard anti-rheumatic treatment
* Between 18 and 70 years of age

Exclusion criteria

* Prior exposure to any TNF-inhibitor, including etanercept
* DMARDs (other than hydroxychloroquine, methotrexate and sulphasalazine) within 4 weeks of study drug initiation
* Dose of NSAIDs changed within two weeks of study drug initiation
ToleroMune House Dust Mites (HDM) Exposure Chamber Study

House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDM allergens in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients.

ToleroMune HDM is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of HDM allergy

This study will look at the efficacy, safety and tolerability of three doses of ToleroMune HDM in HDM allergic subjects following challenge with HDM allergen in an Environmental Exposure Chamber (EEC)).

This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of ToleroMune HDM in HDM allergic subjects with allergic rhinoconjunctivitis. The efficacy of ToleroMune Ragweed will be explored in subjects using an EEC.

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 16 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 3 visits to the EEC. Eligible subjects will complete a daily diary card at home for two weeks following the final visit to the EEC.

In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of four groups and will receive treatment over 11 visits in 3 dosing periods for each subject. Within each dosing period visits will take place at intervals of 4 weeks (28±2 days). There will also be two EEC visits during the treatment period and one post treatment EEC visit. Following the final visit to the EEC, subjects will complete a daily diary card at home for two weeks.

In Period 3, Follow-up will be conducted 16-21 days after the final EEC visit.

Eligibility Criteria:
Inclusion criteria

* Male or female, aged 18-65 years.
* Minimum 1-year documented history of rhinoconjunctivitis on exposure to HDM.
* Positive skin prick test to Der p allergen.
* Minimum qualifying rhinoconjunctivitis symptom scores

Exclusion criteria

* History of asthma (asthma in childhood .
* A history of anaphylaxis to HDM allergen.
* Subjects with an FEV1 \<80% of predicted.
* Subjects who cannot tolerate baseline challenge in the EEC.
* Subjects for whom administration of epinephrine is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
* A history of severe drug allergy, severe angioedema or anaphylactic reaction to food.
* A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment).
Efficacy of EMF BCI Based Device on Acute Stroke

The study tests the efficacy of a non-invasive device with low intensity electromagnetic field dedicated treatment to enhance the recovery of stroke patients impaired hand motor function

The study investigates the effect of BCI based stimulation device on upper limb motor function of acute stroke patients.

The BQ device (BrainQ Technologies Ltd., Israel), a Brain Computer Interface based stimulation device, uses machine learning tools to identify high resolution spectral patterns associated with motor functions in EEG measurements of healthy/non healthy subjects. These patterns are then translated into a tailored frequency dependent low intensity, non-invasive electro-magnetic treatment protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of 1st ever ischemic stroke confirmed by imaging or 1st recurrent ischemic stroke with no previous neurological impairment in the same limb before current stroke happened
2. 72h to 15 days from stroke onset or 21 days from stroke onset in case the patient was still unstable at day 15 from stroke onset).
3. Medically stable patients
4. Age: \> 18, \<80 years, and independent in their daily activities before the stroke
5. Right dominant hand
6. FM \>10, \<45 of upper tested limb.
7. Able to sit in a chair for 70 consecutive minutes and follow three verbal instructions:

   * Bring your healthy arm to the level of your shoulder
   * Pick up this pen with your healthy hand.
   * Put your healthy hand on your waist
8. Able to understand the information provided and provide informed consent

Exclusion Criteria

1. Contraindication for performing MRI scanning
2. History of recent epileptic seizures or epilepsy and/or currently taking medication that are known to lower the seizure threshold
3. Patients with an acute problem such as active infection at the time of recruitment for research
4. Previous disease of the central nervous system
5. Damage to the joints, bones and muscles causing restriction of movement of the upper limb being tested
6. Patients known to suffer from some peripheral nerve damage of the upper limb that being tested
7. Pregnant women and women who have the ability to become pregnant unless they are on an acceptable method of contraception during the study.
8. Alcoholism or drug addiction as defined by DSM-IV within last 5 years
Phase 1 Study of DS-8895a in Subjects With Advanced Solid Tumors

This is an open-label, sequential dose escalation and expansion study to evaluate the safety, tolerability, and pharmacokinetics of DS-8895a in Japanese subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available.
* Eastern Cooperative Oncology Group performance status(PS) of 0 or 1

Exclusion Criteria:

* Have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment:

Cardiac failure (NYHA ≥ ClassIII), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, deep-vein thrombosis or clinically severe thromboembolic event, or clinically severe pulmonary disease (eg, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, drug induced pneumonia)

* Severe or uncontrolled concomitant disease.
* Clinically active brain metastases defined as symptomatic or requiring treatment.
Quality of Life in Patients Who Are Receiving Either Vinorelbine, Gemcitabine, and Docetaxel or Paclitaxel and Carboplatin for Advanced Non-Small Cell Lung Cancer

RATIONALE: Studying quality-of-life in patients undergoing cancer treatment may help identify the intermediate and long-term effects of treatment on patients with cancer.

PURPOSE: This clinical trial is studying quality of life in patients who are receiving either vinorelbine, gemcitabine, and docetaxel or paclitaxel and carboplatin for advanced non-small cell lung cancer.

OBJECTIVES:

* Compare the quality of life of patients with advanced non-small cell lung cancer treated with vinorelbine, gemcitabine, and docetaxel vs paclitaxel and carboplatin on protocol JMTO-LC00-03.

OUTLINE: This is a multicenter study. Patients receive treatment on protocol JMTO-LC00-03.

Quality of life is assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L), FACT-Taxane, and Functional Assessment of Chronic Illness Therapy-Spirituality (FACIT-Sp) questionnaires at baseline, weeks 9 and 18, and at the completion of treatment.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed primary non-small cell lung cancer, including any of the following:

  * Newly diagnosed selected stage IIIB (T4 lesion due to malignant pleural effusion) disease
  * Newly diagnosed stage IV disease
  * Recurrent disease after prior surgery and/or radiotherapy
* Any of the following cellular subtypes are allowed:

  * Adenocarcinoma
  * Large cell carcinoma
  * Squamous cell carcinoma
  * Unspecified carcinoma
* Enrolled on protocol JMTO-LC00-03

PATIENT CHARACTERISTICS:

Performance status

* Zubrod 0-1

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

PRIOR CONCURRENT THERAPY:

Radiotherapy

* See Disease Characteristics

Surgery

* See Disease Characteristics
Clinical Evaluation of OSNA Breast Cancer System in Breast Cancer Patients Receiving Neoadjuvant Therapy

The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the OSNA Breast Cancer System for patients receiving Sentinel Lymph Node biopsies after receiving neoadjuvant hormonal/chemotherapy as compared to permanent section Hematoxylin and Eosin (H\&E) and Immuno-histochemistry (IHC) staining.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18 years of age or older
* Diagnosed pre-surgically with T1-T3 or T4 non-inflammatory breast cancer, clinically node positive or node negative upon clinical examination
* Scheduled for SLN biopsy after receiving neoadjuvant hormonal or chemotherapy
* Subjects (or the subjects' legal representatives) who have read, understood (to the best of their ability) and signed the informed consent form.

Exclusion Criteria:

* Pregnant subjects, confirmed by interview with either subject or treating physician
* Subjects previously diagnosed with other invasive cancer. Subjects with skin cancer (basal cell and squamous cell carcinoma) may be included, except for subjects diagnosed with melanoma
* Participation in other neoadjuvant protocols specifically requiring SLN biopsy prior to administration of neoadjuvant chemotherapy or hormonal therapy
* Subjects who have been judged to be an inappropriate candidate by any medical care provider (e.g., surgeon, oncologist or pathologist).
Effects of Inulin on Satiety and Food Intake

To assess the effect of inulin on appetite profile ratings, food intake and satiety hormones.

Based upon a slower digestion and the fermentation in the intestinal tract, food containing soluble dietary fibres, such as inulin, is hypothesized to be more satiating, and to limit energy intake, in humans. Does supplementation of inulin (at 2 dosages) versus placebo over 13 consecutive days in normal to overweight men and women, lead to an increase in satiety, a reduction in food intake and stronger postprandial increases in GLP-1 and PYY?

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 60 years
* BMI between 23 and 28 kg/m2
* dietary unrestraint (TFEQ: F1\<9)

Exclusion Criteria:

* age under 18 and above 60 years
* BMI under 23 and above 28 kg/m2
* dietary restraint (TFEQ: F1\>9)
* use of medication
* pregnant or breastfeeding
Probiotics in Infants With Gastroschisis

Infants born with gastroschisis usually require surgery shortly after birth. After surgery the intestine is often unable to digest human milk or formula for weeks or months. During this time the baby has to remain in the hospital to receive special nutrition through an IV. How bacteria colonize the intestine in these babies is unknown. Probiotics are bacteria that appear to have beneficial effects on digestion. This study will test whether giving probiotic bacteria to babies after surgery for gastroschisis will change the bacteria in the intestine to be more like those of a healthy breast-fed baby.

Infants with gastroschisis have decreased intestinal motility. This decrease in intestinal motility delays the introduction and advancement of feeds which prolongs hospitalization. The use of probiotic bacteria may improve intestinal motility. It is unknown whether the intestinal microbiota of infants with gastroschisis differs from that of healthy infants without gastroschisis and whether probiotics will change the microbiota. The primary outcome in this study is the composition of the fecal microbiota in infants with gastroschisis following surgical correction treated with Bifidobacterium infantis or placebo. We will also look at differences in hospital length of stay.

Eligibility Criteria:
Inclusion Criteria:

* Gastroschisis
* Born at or transferred to UC Davis Children's hospital

Exclusion Criteria:

* None
Comparison of the Effects of Robotic Rehabilitation Versus Traditional Balance Training on Balance and Fear of Falling in Stroke Patients

In the literature, it has been observed that traditional balance training (TBT) and robot-assisted walking training (RAGT) in stroke patients stimulate the balance mechanism by supporting the spinal muscles symmetrically and functionally. However, it is seen that there is no clear protocol for RAGT in the chronic period. Combined RAGT and TBT approaches over ten weeks have been shown to be more effective than TBT alone for the acute and subacute period. However, there is no definite expression for chronic period effects. No study was found in the literature in which an objective measuring device was used for balance assessment of patients receiving TBT and RAGT. If changes are detected between the two treatment groups in balance education in stroke patients as a result of objective evaluation, our study will lead to the necessity of including these changes in the treatment. Considering the effect of balance on activities of daily living, we believe that objective evaluation of the changes in balance after TBT and RAGT in stroke patients and shaping the treatment according to the evaluation results will contribute to the literature.


Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older
* Volunteering to participate in the study
* Having been diagnosed with stroke (at least 3 months)
* Age range 18 ≥ or 75 \<
* Being able to walk independently (Functional Ambulation Scale\> 3)
* Modified Ashworth Scale ≤ 2 spasticity value

Exclusion Criteria:

* Being under the age of 18
* Having severe visual and cognitive impairment
* Having severe cardiovascular disease
* Having experienced musculoskeletal injuries (osteoarthritis, contracture, osteoporosis, etc. in the joints of the lower extremities) or any skin problem (such as pressure sores)
* Being involved in a robotic rehabilitation program before
Peritoneal Dialysis Daily Versus Six Days Per Week

The study will enroll patients receiving daily peritoneal dialysis who have significant residual native kidney function. The investiators will visit the patients at a routinely scheduled clinic visit and again at a non-routine visit after the patients skip a single day of dialysis. Blood samples will be obtained and a quality of life questionnaire will be administered at both visits.

The primary aim will be to determine whether the patients would prefer daily treatment or being allowed to skip one day per week.

Other aims will be to determine the effect of skipping a day on plasma levels of urea nitrogen and creatinine.

The patients' preference will be assessed by asking the simple question would you prefer to perform peritoneal dialysis daily of six days per week.

The quality of life questionnaire to be used will be the Dialysis Symptom Index (DSI) which has a range of 0 to 150 with a high score reflecting worse quality of life.

The chemical to be measured will be the plasma urea nitrogen in mg/dl and the plasma creatinine in mg/dl as measured by the clinical laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Daily treament with peritoneal dialysis and residual native kidney funciton with residual urea clearance greater than 2 ml/min.

Exclusion Criteria:

* less than 3 months on peritoneal dialysis
* recent change in the dialysis prescriptoin
* recent peritonitis