cyrilzakka/clinical-trials huggingface dataset:
Comparison Between Base and Cover Slide From Endoscopic Ultrasound Guided Fine Needle Aspiration for Pancreatic Cancer

The purpose of this study is to determine whether there is a difference of diagnostic accuracy between cover slides and base slides from EUS-FNA cytopathologic sample in patients who were previously suspected of pancreatic cancer in radiologic test.

1. background

   1. Pancreatic cancer is the challenging malignancy in diagnosis and treatment.
   2. Recently, EUS-FNA has played a important role in diagnosing pancreatic cancer.
   3. Samples from EUS-FNA are sent to following three types of preparations.

      * cytologic smear (by pull apart method)
      * cell block
      * histologic biopsy
   4. In cytologic smear method, endoscopists tend to send as many as slides, while pathologists want minimal slides if they warrant diagnostic accuracy.
   5. Therefore we are going to find a point of contact between high diagnostic yield and minimal overloading of pathologist.
2. Method

   1. We are going to enrolled the patients who were suspected of pancreatic cancer in previous radiologic test.
   2. One identical and skilled endoscopist performs EUS-FNA with multiple punctures.
   3. We get total 8 pairs of slides (= 8 covers + 8 bases).
   4. All the cover slides are collected to the bottle-A, all the base slide to the bottle-B.
   5. One identical and skilled pathologist inspects these slide in blind method. (She cannot show the label of bottle so that she does not know what bottle is A or B.)
   6. She record the positive or negative in each bottle. (If there is only one slide is positive in malignant cell, the bottle is positive.)
   7. In these manner, we collect the all subjects' cytopathologic results as a pair of outcome. All the possible combinations are following four examples:

      * (cover/base) = (positive/positive) = (+/+)
      * (cover/base) = (positive/negative) = (+/-)
      * (cover/base) = (negative/positive) = (-/+)
      * (cover/base) = (negative/negative) = (-/-)
   8. Then we are going to take a two-sided non-inferiority test of proportion using McNemar's test.

Eligibility Criteria:
Inclusion Criteria:

* patients who were suspected of pancreatic cancer in previous radiologic test such as computed tomography, magnetic resonance imaging or Positron Emission Tomography.

Exclusion Criteria:

* failed smear due to inexperienced assistant
* loss of slide
* patients who were diagnosed with other lesion far from pancreatic cancer in prospective confirmative tests.
* patients who refuse to participate in this study
* report of other pathologist who are not a previously-assigned pathologist
The Impact of a Pharmacist Intervention on Post-discharge Hypnotic Drug Discontinuation in Geriatric Inpatients

This study investigated whether a multifaceted approach was associated with hypnotic drug discontinuation at one month after discharge

Chronic use of hypnotic agents is prevalent in older adults, who as a result are at increased risk for certain adverse events, such as day-time drowsiness and falls. Multiple strategies to discontinue hypnotics have been tested in geriatric patients, but evidence remains scarce. Hence, we aimed to investigate a multicomponent intervention to reduce hypnotic drug use in geriatric inpatients.

A before-after study was performed on the acute geriatric wards of a teaching hospital. The before cohort received usual care while intervention patients were exposed to a pharmacist-led deprescribing intervention, comprising education of health care personnel, access to standardized discontinuation regimens, active patient involvement and support of transitional care. The primary outcome was hypnotic drug discontinuation at one month after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 75 years
* Admitted to an acute geriatric ward of UZ Leuven
* Documented chronic use of a hypnotic drug (hypnotics were defined as benzodiazepines and Z-drugs and chronic hypnotic drug use was defined as hypnotic use for at least five days a week during a minimum of four consecutive weeks.
* Indication: insomnia, anxiety or an undefined reason

Exclusion Criteria:

* Concomitant use of multiple benzodiazepines and/or Z-drugs
* Discontinuation of the hypnotic drug prior to enrollment
* Estimated discharge from the hospital within 72 hours of admission
* No command of the Dutch language
* Severe psychiatric or neurological disease (e.g. bipolar disorder, epilepsy or dystonia) or a severe acute medication condition in the opinion of the treating physician
* End-of-life care.

Study participants who died during their hospital stay were excluded from the analysis as their medication at discharge could not be evaluated. In case of any readmission, only the first admission was included in the analysis.
AGN 201904 Versus Esomeprazole in the Prevention of Aspirin-induced Stomach or Upper Intestinal Damage in Healthy Volunteers

AGN 201904, a proton pump inhibitor, versus esomeprazole in the prevention of stomach or upper intestinal damage following administration of high-dose aspirin in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy Adult Volunteers who have provided written informed consent

Exclusion Criteria:

* Volunteers with a history of upper gastrointestinal disease or who have a current diagnosis of upper gastrointestinal disease.
* Female volunteers who pregnant, nursing, or planning a pregnancy
* Volunteers with a history of drug or alcohol abuse
Psychotherapeutic Text Messaging for Depression Pilot Study

Major depression is the leading cause of disability in the United States and is a major contributor to suicide, a leading cause of premature death. The majority of individuals with depression do not receive adequate pharmacologic or psychotherapeutic treatment due to difficulty accessing services or stopping treatment due to side effects, non-response, or the stigma associated with attending mental health clinic visits. Mobile health information technology services, such as text messaging, have the potential to provide effective self-management support for depression to nearly every adult in the US with depression. Guided self-help via text messaging has been shown to be effective for improving a range of health behaviors as well as symptoms of depression. However, previously studied depression text messaging services have not utilized the breadth of psychotherapeutic techniques shown to be effective for depression nor have they attempted to tailor the psychotherapeutic content to the individual in order to improve acceptability and outcomes. Advanced artificial intelligence methods (e.g., reinforcement learning) offers the capability to weed out ineffective messages and to target messages to individuals in order to substantially improve program effectiveness. This pilot study is the first step in towards developing an artificially intelligent text message service for depression.

The specific aims of the study are to: 1) demonstrate the feasibility of recruiting and enrolling participants from the general population of US adults and delivering a text-messaging intervention for depression, 2) determine whether there are differences in the perceived helpfulness of messages derived from different psychotherapeutic treatment modalities, and whether these differences are moderated by participant characteristics (e.g., age, gender, depression symptom severity), 3) determine whether messages derived from different psychotherapeutic treatment modalities or their perceived helpfulness are associated with changes in depression symptoms, and whether these relationships are moderated by participant characteristics.


Eligibility Criteria:
Inclusion Criteria:

* US resident
* Age 18 or older
* PHQ-9 screening score of 10 or more
* Has a personal cellular phone with a text messaging plan that would allow for as many as 200 additional text messages per month, and agreement that the participant would be responsible for any related charges
* Has a valid e-mail address
* Fluent in English

Exclusion Criteria:

* Unable to provide voluntary informed consent for any reason
Project PAIR: Parent-implemented Articulation Intervention With Recast

Using a single-case multiple baseline across participants design, this study aims to explore the effectiveness of parent-implemented Broad Treatment Speech Recast supplemented with traditional clinician-led articulation therapy on speech production in elementary-aged deaf and hard of hearing children.

To address these objectives, the following research questions will be investigated:

1. Does drill-based articulation therapy, administered by a speech-language pathologist, improve speech sound production in DHH children when parent-implemented BTSR is concurrently utilized at home?
2. Does the combination of parent-implemented BTSR and clinician-led traditional articulation therapy result in generalization of speech sound accuracy at the conversation level?


Eligibility Criteria:
Inclusion Criteria:

* Age 4;0-9;11
* Permanent, prelingual sensorineural hearing loss
* Uses spoken English as their primary home language (≥ 51% of the time)
* Standard score ≥70 on the Leiter
* Standard score ≥70 on the OWLS-II Listening Comprehension
* At least two speech sound errors appropriate to target based on speech norms and general stimulability

Exclusion Criteria:

* Motor speech disorder (e.g., childhood apraxia of speech)
* Oral structural functional disorder (e.g., cleft palate)
* Diagnosis of autism spectrum disorder
* Diagnosis of ADHD
* Uncorrected vision impairment (i.e., identified vision loss without the use of corrective lenses)
Evaluation of Heart Function in Breast Cancer Patients Using Trastuzumab

By dynamically observing the changes of echocardiogram and biomarkers in breast cancer patients using trastuzumab, evaluate the effect of trastuzumab on cardiac function; determine the sensitivity of echocardiography and biomarker indicators And specificity, explore effective and specific early warning indicators, and provide technical support for the evaluation of the cardiac safety of anti-tumor drugs.

Thirty female breast cancer patients using trastuzumab, collected demographic and clinical information of all patients before chemotherapy, performed echocardiography (conventional echocardiography, three-dimensional spot tracking technology), and collected blood samples to detect plasma biology Markers (TnT, BNP, GDF-15, topoisomerase), follow-up echocardiography and biomarkers at 1 month, 3 months and 6 months after chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with breast cancer (18-70 years old)
* Patients who are planning to undergo trastuzumab for the first time

Exclusion Criteria:

* Organic heart disease such as coronary heart disease, heart valve disease, cardiomyopathy
* liver and kidney failure
* severe cerebrovascular disease
* chronic obstructive pulmonary disease
* rheumatic immune system disease
* other tumors
Coverage and Validity of the Swedish Registry of Cardiopulmonary Resuscitation Regarding In-hospital Cardiac Arrest

The study will have an observational retrospective cross-sectional design. Patient records and hospital administrative systems at 10 hospitals in Sweden will be searched using ICD-codes to find all patients treated for an in-hospital cardiac arrest (IHCA) during the time period of 20180101 to 20191231. All found patients will be cross-checked against reported patients in the Swedish Registry of Cardiopulmonary Resuscitation (SRCR). Any differences in patient characteristics or regarding situation factors between reported and non-reported patients will be evaluated. Non-reported patients will be retrospectively reported to the registry. An incidence of IHCA will be calculated using the number of patients treated for IHCA divided by number of hospital admissions during the specific time period. Selected variables will be evaluated regarding compliance to report and regarding concordance with patient records. All missing data will be described and evaluated. Local reporting procedures at each hospital will be described and evaluated regarding compliance to report and regarding missing data.


Eligibility Criteria:
Inclusion Criteria:

* All patients after the neonatal period that have been treated for an in-hospital cardiac arrest.

Exclusion Criteria:

* Patients with an in-hospital cardiac arrest that is not treated (do not attempt resuscitation) or patients in the neonatal period.
Prospective Cohort Study of Robotic Assisted Laparoscopic Sacrocolpopexy Using MPATHY Restorelle Mesh

Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce in regard to long term outcome. This advanced procedure is offered at Morristown Memorial. This protocol will review the one year outcome of patients who underwent this procedure using a polypropylene mesh. These outcomes will include anatomical and quality of life measures.


Eligibility Criteria:
Inclusion Criteria:

* Any patient receiving Robotic assisted laparoscopic sacral colpopexy with polypropylene mesh

Exclusion Criteria:

* Other graft material than polypropylene mesh
* Enrollment in another study
Menevit Study: Menevit Anti-Oxidant Therapy for the Treatment of Male Infertility

Oxidative stress related damage to sperm is believed to be a major cause of male infertility. The object of the Menevit study is to investigate the role of a novel anti-oxidant preparation (Menevit) on sperm function, embryo quality and pregnancy rates in an in vitro fertilization (IVF) setting.

Men will be screened for oxidative stress (free radical) related damage to their sperm. This will include screening for lipid peroxidation of sperm using the LPO-586 assay, HOST test and for sperm DNA fragmentation using the Tunel technique. Those men found to have free radical related damage will be enrolled in a randomized control trial in which they will receive either the Menevit anti-oxidant or placebo (in a 2:1 randomization ratio respectively). The Menevit anti-oxidant is a capsule containing several different anti-oxidants, taken orally once per day. The placebo is identical in appearance and taste. After 3 months of Menevit/placebo the female partners of these men will undergo an IVF oocyte retrieval operation and embryo transfer. Pregnancy rates and embryo quality will be compared between groups. Changes in semen characteristics (count, motility, morphology, membrane integrity) and lipid peroxidation (LPO-586) plus sperm DNA fragmentation (Tunel assay) will be assessed at trial entry, 6 weeks and 3 months. Comparisons between the patients embryo quality in the IVF cycle immediately before and during the Menevit trial will also be compared when possible

Eligibility Criteria:
Inclusion Criteria:

* Evidence of oxidative stress to sperm on LPO-586 assay or poor HOST result or clinical evidence for oxidative stress (heavy smoker, varicocele, poor motility in the abscence of anti-sperm antibodies etc)
* Evidence of significant sperm DNA damage (25% or more DNA fragmentation as assessed by Tunel assay).
* Female partner willing to undergo IVF treatment within 3 months of starting Menevit trial

Exclusion Criteria:

* Female partner 40 years of age or older at trial entry.
* Significantly reduced ovarian reserve in female partner (day 3-5 FSH \> 10 iu/L if no prior IVF cycle or less than 5 oocytes on a prior IVF cycle.
* Sperm count below 0.5 million per ml (impossible to conduct all sperm function assays
Serotoninergic Pathways in Sudden and Unexpted Death in Epilepsy (SUDEP)

The mortality rate is increased in patients with epilepsy, and especially among patients with drug-resistant epilepsy. This increased mortality is mainly related to the risk of SUDEP whose incidence is between 3.5 and 9 per 1,000 for patients with drug-resistant epilepsy. The term SUDEP refers to a sudden death occurring in a patient with epilepsy in whom anamnestic and post-mortem evidence does not identify a particular cause. Experimental and clinical data strongly suggest that most of SUDEP result from a postictal respiratory dysfunction progressing to terminal apnea. Due to the major role of serotonin in regulating breathing rhythms and data in animal models of epilepsy, it is envisaged that an alteration of serotonergic systems of the brainstem and limbic regions may play a central role in the occurrence of SUDEP. The objective of this work is to look for abnormalities of the serotonergic transmission within regulatory regions of respiratory and autonomic functions in brain samples prospectively collected in patients died from SUDEP.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Postmortem time before autopsy \<30 hours

Exclusion Criteria:

* Age \<18 years
* postmortem time before autopsy \> 30 hours
* Any subject whose brain would be of forensic interest
* Any patient who expressed an opposition to organ donation.
Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting

The study is to verify atorvastatin effectiveness and safety in Chinese population, and explore the optimal atorvastatin regimens in high-to-moderate risk for ASCVD。


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged ≥18 years;
* Cardiology patients who has been prescribed atorvastatin by physician's clinical judgment under normal clinical care. These patients will include those with established coronary heart disease, or having multiple risk factors and at risk for cardiovascular disease, or primary hypercholesterolemia.
* Baseline laboratory reports prior to starting atorvastatin therapy can be tracked , including lipid measurement, liver function, and Creatine Kinase (CK) value. The date of baseline reports should be within 1 month before taking atorvastatin or within 24h after starting atorvastatin therapy.
* Evidence of a personally or his/her legally acceptable representative signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study and accept follow-up visit.

Exclusion Criteria:

* Patients who have regularly taken atorvastatin therapy more than 4 weeks before enrollment
* Concomitant any other lipid-lower medication at baseline, or during the study conduction on physician clinical judgement
Iron Status and Human Metabolism

Iron deficiency is common in cardiorespiratory diseases and appears to contribute to a worse outcome. This human physiology study will examine the extent to which human skeletal muscle metabolism and exercise physiology are impaired by iron deficiency.

This is a prospective double-blind randomised controlled study of the effect of endogenous iron status on skeletal muscle metabolism and exercise physiology. 32 healthy volunteers will take part, half of whom will be iron-deficient. The study involves a screening visit and two half-day visits during which assessments are performed. 50% of each group will be randomised to receive iron-repletion with ferric carboxymaltose at the end of the first experimental visit before returning to repeat identical assessments around one week later. This approach will make it possible to explore whether baseline differences in skeletal muscle metabolism are explained by differences in iron status per se, whilst controlling for any learning effect during participation in the study.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent for participation in the study
* Men and women aged 18 years or older and generally in good health
* For iron-deficient volunteers: ferritin ≤ 15 microg/L and transferrin saturation \< 16%
* For iron-replete volunteers: ferritin ≥ 20 microg/L and transferrin saturation ≥ 20%

Exclusion Criteria:

* Haemoglobin \< 8.0 g/dL
* Haemoglobinopathy
* Iron overload, defined as ferritin \> 300 microg/L
* Hypoxaemia (SpO2 \< 94%) or significant co-morbidity that may affect haematinics, metabolic or ventilatory responses
* Iron supplementation or blood transfusion within the previous 6 weeks
* Pregnancy or breast feeding
* Inability to exercise isolated calf muscle using a pedal or on a bicycle ergometer
* Contraindication to magnetic resonance spectroscopy exposure such as metallic implant
* Contraindication to receiving intravenous ferric carboxymaltose
A Phase II Study of Total Neoadjuvant Therapy for Locally Advanced Gastric Cancer

This prospective, single arm phase II study is designed to evaluate the rate of pathologic complete response of neoadjuvant chemoradiotherapy and neoadjuvant chemotherapy followed by surgery for locally advanced gastric adenocarcinoma


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven locally advanced gastric adenocarcinoma in patients staged as cT3-4N+M0
* No distant metastasis in liver,lung,bone,central nervous system(CNS),no peritoneal transplantation
* No prior abdominal or pelvic radiotherapy
* Karnofsky performance status(KPS)≥ 70, predictive life span no less than 6 months
* Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,000 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
* Informed consent

Exclusion Criteria:

* Any prior chemotherapy or other cancer treatment prior to this protocol
* Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
* With any distant metastasis in liver,lung,bone,CNS,or peritoneal transplantation
* History of allergic reactions attributed to similar chemical or biologic complex to S-1 or Xeloda or Oxaliplatin
* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
* History of prior radiation to the abdomen
* Pregnant or lactating females
Evaluation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ELA026 in Single and Multiple Doses in Healthy Volunteers

ELA026 is a fully human IgG1 SIRP-directed monoclonal antibody designed to reduce the myeloid and T cells driving the inflammation. The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ELA026 in Single and Multiple Doses in Healthy Adults.

This is a multi-center, Phase 1, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, PK, and PD of ELA026 following single and multiple IV and/or SC dose administration in healthy adult volunteers, including a subgroup of Japanese volunteers.

The study will consist of 2 parts:

* Part 1: single ascending doses (SAD) in up to 11 SAD cohorts plus a Japanese cohort
* Part 2: multiple doses (MD) up to 6 MD cohorts

Eligibility Criteria:
Inclusion Criteria:

1. Non-Japanese subjects 19 to 60 years of age. Japanese subjects 20 to 60 years of age.
2. Must be in good general health.
3. No clinically significant abnormal laboratory values during screening.
4. Body mass index of 18 - 32 kg/m2.

Exclusion Criteria:

1. Clinical diagnosis or laboratory evidence of renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic disease at Screening.
2. Diagnosed with any form of malignancy (except basal cell carcinoma, fully removed).
3. Clinically significant immunodeficiency or autoimmunity assessed by medical history and/or laboratory test results.
4. Active or latent tuberculosis (TB), regardless of treatment history,
5. Positive drug abuse test.
6. Positive HIV, HBV, HCV test results.
7. Clinically significant ECG test results.
8. Clinically significant vital sign results.