cyrilzakka/clinical-trials huggingface dataset:
A Phase II Trial of Adjuvant Chemotherapy With S-1 Plus Oxaliplatin for Locally Advanced Gastric Cancer

Patients with advanced gastric cancer have showed poor prognosis. Only 81% of the patients could underwent curative surgery. In those, about 60% of patients would survive after 5 years from the surgery. As a result, role of chemotherapy has been increased. In ACTS-GC trial, S-1 adjuvant therapy after D2 gastrectomy increased overall survival rate in advanced gastric cancer patients. However, subgroup analysis showed that S-1 adjuvant therapy was insufficient in patients with stage III or IV (according to the AJCC 6th criteria) gastric cancer. In addition, CLASSIC trial demonstrated that oxaliplatin plus capecitabine adjuvant therapy could increase disease-free survival after D2 gastrectomy in advanced gastric cancer patients. Notwithstanding these trial, optimal adjuvant regimen of advanced gastric cancer has not been established. We aimed to evaluate efficacy of S-1 plus oxaliplatin as adjuvant chemotherapy after D2 gastrectomy in stage III (according to the AJCC 7th criteria) gastric cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Age, between 19 and 75
* Histologically proven advanced gastric cancer
* R0 resection after D2 gastrectomy
* Stage III (according to the AJCC 7th criteria)
* ECOG status 0 to 2

Exclusion Criteria:

* Malignancy history other than gastric cancer
* Previous chemotherapy history for gastric cancer
* Previous radiotherapy history for gastric cancer
* Pregnancy or breast milk feeding
* Grade 3 or more of neuropathy
* Active infection
* Severe hepatic dysfunction
* Severe renal dysfunction
* Severe bone marrow dysfunction
* Significant neurologic or psychologic disease
* Inadequate condition for receiving chemotherapy due to significant systemic disease
* Patients who receives drugs which can be interacted with S-1
Exploratory Study on the Role of the Digestive Microbiota in Adults Living With HIV-1

Chronic immune activation present in aviremic people living with HIV under treatment promotes the onset of insulin resistance and metabolic syndrome, paving the way for the comorbidities that are currently the main causes of morbidity. This activation continues despite effective antiretroviral therapy. In the ACTIVIH study (NCT02334943) the analysis of 68 AI markers allowed classification of 120 aviremic PLHIV under treatment for at least 2 years according to 5 different immune activation profiles. Among these 5 profiles, Profile 2 was characterized by high blood pressure figures, high waist sizes, low HDL-cholesterol levels, high triglyceridemia, and especially hyperinsulinemia. Several studies have shown that the digestive microbiota of this population is less rich and less diverse than that of healthy subjects. However, the digestive microbiota and in particular bacterial proteins and metabolites seem to play a key role in immune activation in people living with HIV. Finally, the digestive microbiota has already been shown to have an impact on insulin sensitivity.

The study investigators hypothesize that a particular digestive microbiota could promote the appearance of Profile 2. This microbiota could be the cause of digestive dysbiosis leading to intestinal inflammation, digestive permeability and bacterial translocation.


Eligibility Criteria:
Inclusion Criteria:

* Patient informed of the implementation of the study, its objectives, its constraints and the patient's rights.
* Male and Caucasian patient.
* Patient with HIV-1 infection determined by positive serology or plasma viral load (HIV RNA) measurement.
* Patient on effective triple antiretroviral therapy, stable for more than 6 months, with a plasma viral load \<50 copies / ml for at least 6 months before inclusion (2 measurements).
* Patient whose immune activation profile has been characterized beforehand (profiles 1, 2, 3, 4 and 5).
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

* Vulnerable person according to article L1121-6 of the CSP.
* Adult person protected according to article L1121-8 of the CSP.
* Patient presenting with a non-infectious pathology which may be the cause of an immune abnormality.
* Patient having undergone treatment with an immunomodulator molecule or chemotherapy within 60 days before inclusion in the research or has an indication planned for the duration of the research.
* Patient with a chronic digestive pathology or who had been operated on the previous year
* The subject is participating in a category 1 interventional study, has participated in another interventional study in the last 3 months or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
Safety of Regular Diet as the First Meal in Patients Who Underwent Surgical Treatment for Gynecologic Cancer

The purpose of this study is to determine whether it is safe to give a regular diet as the first postoperative meal in patients who underwent surgical treatment for clinically early-stage gynecologic cancer.

Paralytic ileus, a temporary inhibition of bowel motility, is believed to follow all abdominal surgery. Surgeons have customarily withheld postoperative oral intake until the return of bowel function as evidenced by a presence of bowel sound, a passing of flatus/stool, and a feeling of being hungry. The major concern has been that early oral intake would result in vomiting from severe paralytic ileus with subsequent aspiration pneumonia, wound dehiscence, and anastomotic leakage. Recently, the practice of delayed postoperative oral intake has been challenged by evidence from extensive gastrointestinal physiologic studies that examine contractile activity of the intestine. These data have suggested that the concept of postoperative ileus as paralysis of the entire bowel with complete absence of any functional contractile activity is misleading. If postoperative ileus takes place, it is usually transient and not significant clinically. Several possible clinical benefits of early feeding after surgery exist that include better wound healing, postoperative stress ulcer prevention, reduced sepsis, improved sense of well being, shorter length of hospital stay, and cost saving. Currently, the practice of early administration of liquid diet after surgery has become widely accepted. For early regular diet administration, the proposed additional benefits would be lesser risk of aspiration, faster recovery of intestinal motility, and better nutritional status. Patients who had surgery as a treatment for gynecologic cancer deserve special attention in this regard as they generally have higher risk of developing postoperative ileus due to extensive and/or multiple intraabdominal surgical procedures including radical hysterectomy, pelvic lymph node dissection, and surgical staging procedures. At the same time, this is the group of patients that would benefit most from the aforementioned positive effects of early regular diet feeding.

Comparisons: Regular versus liquid diet as the first postoperative meal on the first day after surgery for clinically early-stage gynecologic cancer.

Eligibility Criteria:
Inclusion Criteria:

* Clinically early-stage gynecologic cancer patients who underwent standard abdominal surgery as a primary treatment of their diseases

Exclusion Criteria:

* Peritonitis
* Perioperative hyperalimentation
* Bowel surgery (except appendectomy)
* Bowel obstruction
* History of bowel surgery or inflammatory bowel syndromes
* History of abdominal/pelvic radiotherapy
* Need for continued postoperative endotracheal tube or naso/orogastric tube placement
* Need for postoperative Intensive Care Unit (ICU) administration
* Pregnancy
Computerized Assessment and Referral System Screener for Mental Health Evaluations in the Emergency Setting

This is a hybrid effectiveness-implementation randomized controlled trial which will be conducted at the emergency department (ED) at the University of Arkansas for Medical Sciences (UAMS) in Little Rock, Arkansas.

The hypothesis of this study is that use of the CARS (a computerized mental health screener) will modify emergency department treatment of patients with previously undiagnosed mental illness.

This pragmatic mixed methods clinical trial will compare the intervention of providing a CARS screener report to emergency providers to not providing the report. It will also collect qualitative data regarding implementation of the CARS screener and report. Consecutive patients presenting when a research associate is available will be approached to participate. Patients will be approached after evaluation by an emergency physician.

The Computerized Assessment and Referral System (CARS) is based on the Composite International Diagnostic Interview (CIDI), a validated instrument for assessing mental health diagnoses.CARS was piloted at 6 different sites in 2016, all in DUI populations. As CARS has not been specifically validated on non-DUI populations, investigators will collect alcohol history (see below). The CARS self-assessment version (CARS-SA) will be utilized in this study.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Not incarcerated
* English-speaking and English-writing (as translators will not be available for this study)

Exclusion Criteria:

* Unable or unwilling to complete CARS screener
* Unable or unwilling to provide any history of alcohol abuse
* Currently presenting with a chief complaint of a psychiatric symptom
* Currently presenting with a substance use complaint
* History of a known psychiatric condition
* Patients taking psychiatric medication
POST-dilatation to Improve Outcomes in Acute STEMI Patients Undergoing Primary With OCT Assessment

To evaluate the effective and safety of post-dilatation in patients with acute ST segment elevated myocardial infarction undergoing primary percutaneous intervention after thrombus aspiration assessed by optical coherence tomography to examine stent Incomplete apposition and strut coverage in patients treated with drug-eluting stents .


Eligibility Criteria:
Clinical Inclusion Criteria:

* Age ≥18 years
* STEMI \>20 mins and \<12 hours in duration
* ST-segment elevation of ≥1 mm in ≥2 contiguous leads; or Presumably new left bundle branch block; or True posterior MI with ST depression of ≥1 mm in ≥2 contiguous anterior leads
* Written, informed consent

Angiographic Inclusion Criteria

* The presence of least 1 acute infarct artery target vessel\* in which:

  1. ALL significant lesions are eligible for stenting with study stents, and
  2. ALL such lesions have a visually estimated reference diameter ≥2.5 mm and ≤4.0 mm
  3. All culprit lesion TIMI Flow ≤ 0 or 1 Grade prior to guide wire crossing
* Expected ability to deliver the stent(s) to all culprit lesions (absence of excessive proximal tortuosity or severe calcification)
* Expected ability to fully expand the stent(s) at all culprit lesions (absence of marked calcification)

Clinical Exclusion Criteria:

* Contraindication to any of the study medications
* Patients with cardiogenic shock
* History of bleeding diathesis or known coagulopathy , or will refuse blood transfusions
* History of intracerebral mass, aneurysm, AVM, or hemorrhagic stroke; stroke or TIA within 6 months or any permanent neurologic deficit; GI or GU bleed within 2 months, or major surgery within 6 weeks; recent or known platelet count \<100,000 cells/mm3 or hgb \<10 g/dL
* Planned elective surgical procedure that would necessitate interruption of thienopyridines during the first 6 months post enrollment

Angiographic Exclusion Criteria

* Bifurcation lesion definitely requiring implantation of stents in both the main vessel + side branch
* Infarct related artery is an unprotected left main
* \>38 mm of study stent length anticipated
* Infarction due to stent thrombosis, or infarct lesion at the site of a previously implanted stent
* High likelihood of CABG within 30 days anticipated
* The culprit lesion will be judged unsuitable for OCT procedure, because of conditions such as left main trunk disease or shock vital
Clinical Evaluation of Two Multifocal Contact Lenses

The aim of this study is to evaluate the patient subjective experiences of the monthly multifocal lens when compared to the daily disposable multifocal lens after 15 minutes of daily wear.

This is a single-blind, interventional, prospective, direct refit, bilateral wear study.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 42 years of age and has full legal capacity to volunteer.
* Has read and signed an information consent letter.
* Self-reports having a full eye examination in the previous two years.
* Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Habitually wears multifocal soft contact lenses, or sphere lenses for monovision, or sphere lenses for monovision, or sphere lenses for distance vision correction and use spectacles for near vision correction, for the past 3 months minimum.
* Has refractive astigmatism no higher than -0.75DC.
* Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D.
* Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS).

Exclusion Criteria:

* Is participating in any concurrent clinical or research study.
* Has any known active ocular disease and/or infection that contraindicates contact lens wear.
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
* Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
* Has known sensitivity to the diagnostic sodium fluorescein used in the study.
* Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
* Has undergone refractive error surgery or intraocular surgery.
A Prospective Case-control Clinical Study of the Ultrasound Imaging Reporting and Data System for Diagnosis of Anterosuperior Acetabular Labral Tears

The goal of this clinical trial is to develop an ultrasonic imaging reporting and data system for diagnosis of anterosuperior acetabular labral tears (ALT). Participants will receive a comprehensive clinical diagnosis or a hip arthroscopy to determine whether there is a torn labrum of the hip. Comparing the ultrasonographic characteristics of hip labrum in tear group and non-tear group, establishing diagnostic model is conducive to early diagnosis and differential diagnosis of this disease.


Eligibility Criteria:
Inclusion criteria: a)18 years of age and above; b) Combined with clinical symptoms, signs, and MRI, a senior orthopaedic surgeon or a final arthroscopy will determine whether the labrum of the hip is torn.

Exclusion criteria: a) other diseases affecting the hip joint (tumors, infections and fractures); b) A history of hip surgery; c)BMI≥30 kg/m²; d) Pregnant patients.
Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination

ISIS- ICD study has been designed to evaluate the impact of PARAD+ algorithm on inappropriate shocks, in a general population implanted for primary or secondary prevention with a dual or tri chamber device at one year follow-up

The primary endpoint is to demonstrate that 95% of patients implanted with PARAD+ algorithm are free from inapproporiate shock compared to 92.5% in general ICD population.

Eligibility Criteria:
Inclusion Criteria:

1. Patient eligible for implantation (according to current accepted guidelines, or scheduled for implant (primo-implant, replacement, upgrade) with a Paradym/Paradym RF (CRT-D or DR-ICD) within the next 30 days, or has already been implanted within the last 30 days
2. Patient in sinus rhythm, or patients with paroxysmal atrial tachyarrhythmia or patients with persistent atrial tachyarrhythmia in whom a cardioversion is planned within three months

Exclusion Criteria:

1. Any contraindication for ICD therapy
2. Atrial lead not implanted
3. Patient with permanent atrial tachyarrhythmia
4. Patients implanted with a ventricular assist device (VAD)
Use of Intra-Operative Shear Wave Ultrasound Vibrometry for Characterization of Esophageal Malignant Tumors

Using the analysis of group velocity for a screening application and then higher order analysis based on the elastic and viscious components of the shear modulus may allow discrimination between extent of tumor invasion through the esophageal wall if appropriately correlated with pathological findings.

Use of ultrasound-based vibrometry in this setting would allow for a relatively simple study and translation of clinical practice, as the same devices are already used in this setting, and operators have familiarity with the equipment. Incorporating another additional method to generate contrast for determining malignant tissue from normal based on biomechanical properties with the same probe would have benefit as an additional diagnostic modality.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Scheduled to undergo esophageal reconstruction for presumed or known esophageal cancer
* Subject is able to understand the study procedures and provide informed consent.

Exclusion Criteria:

* Subject is pregnant or breast feeding.
Clinical Course of Alcohol Use Disorder Recovery

The goal of this single-arm clinical trial is to better understand the ways in which individuals seeking treatment recover from Alcohol Use Disorder (AUD). The main aims are to:

* To establish operational definitions of types of change in relation to National Institute on Alcohol Abuse and Alcoholism's (NIAAA) new definition of recovery, and to distinguish between treatment response, remission versus recovery, and relapse versus recurrence.
* To describe patterns of recovery, including the frequency of within-person transitions between types of change in clinical course to better understand the dynamic nature of recovery.
* To examine the predictive relationships between theoretically important cognitive, behavioral, and affective process variables and changes during recovery, with a focus on how people initiate versus maintain change.

Participants will:

* Receive 12 weeks of psychotherapy for Alcohol Use Disorder
* Complete brief assessments after each treatment session.
* Complete brief assessments bi-weekly via phone for 1-year following treatment.
* Complete in-person interviews at 3 or 6-month intervals post-treatment.

The aim of the current application is to examine the utility and validity of National Institute on Alcohol Abuse and Alcoholism's (NIAAA)new definition of recovery within the context of a novel theoretical model. The proposed study will recruit participants seeking treatment for Alcohol Use Disorder (AUD) from the community. Participants will complete a structured clinical interview and provide information on their current alcohol use and related behaviors. All participants will receive 12 weeks of AUD psychotherapy and complete brief assessments at the end of each treatment session and biweekly during the first 12-months post treatment. In addition, participants will complete in-person interviews at 3-month and 6-month intervals post-treatment for the duration of the study (for up to 24-54 months post treatment depending on time of enrollment). Findings from the proposed research have the potential to increase understanding of the dynamic nature of recovery and thereby improve clinical decision-making and generate future research. Specifically, our goal is to address the question of "Are the constructs of relapse, recurrence remission, or recovery useful heuristics for clinical practice and research, and if so, how?"

Eligibility Criteria:
Inclusion Criteria:

1. current diagnosis of AUD (initial screening AUDIT ≥ 8, confirmed with diagnostic interview),
2. live within commuting distance of the program site,
3. provide informed consent.

Exclusion Criteria:

1. acute psychosis or severe cognitive impairment (assessed via Psychotic Module of the M.I.N.I and Mini-Mental State ≤ 23),
2. current drug use diagnosis other than nicotine or marijuana use disorders,
3. lack of sufficient familiarity with the English language to comprehend the recruitment and consent procedures,
4. legally mandated to attend treatment
Non-expensive and Widely Available Tests as Diagnostic Tools in Dementia and Their Ability to Predict Disease Progression

Alzheimers disease (AD) is the most common course of cognitive decline and thereby the course of more than half of all cases of dementia. A proper AD diagnosis is rested on a number of examinations and tests, which combined can make AD diagnosis likely. But no single test or examination can unambiguous determine whether the patient has AD or not. Comparatively no examination or test can with accuracy predict whether a healthy person or a person with only mild cognitive (MCI)impairment in time will evolve AD.

Quantitative Electroencephalography (qEEG), cerebrospinal fluid (CSF) biomarkers, linear CT analyses and Timed Up and Go - Dual Task (TUG-DT) are relatively inexpensive and and widely available diagnostic methods, which have the potential to diagnose AD at an early stage in a reliable accurate way. But they also have the potential to predict which patients diagnosed with MCI have particular risk of developing dementia.

The purpose of the study is to investigate the relations between qEEG, CSF biomarkers, CT analyses and TUG-DT outcome and clinical features in healthy persons as well as patients with MCI and AD Furthermore to investigate whether qEEG or CSF biomarkers can predict which patients with MCI will in time evolve AD.


Eligibility Criteria:
Inclusion Criteria:

For patients:

* age 50 to 90
* diagnosed with MCI or AD
* cerebrospinal fluid examination and EEG performed at baseline

For control persons:

* age 50 to 90
* MMSE score equal or above 26
* ACE score equal or above 85
* Normal physical examination, including normal blood samples, CT of cerebrum and EEG examination

Exclusion Criteria:

* Pregnant or breastfeeding
* psychiatric disease, former depression is allowed if antidepressive treatment has been initiated of a leat 3 months duration
* Neurologic or somatic disease, including former severe head trauma or neuroinfection
* Antipsychotic treatment
* Former severe abuse of alcohol, medication or drugs
* ECT treatment or anaesthesia within the last 3 months
* no closely related person to assist the patient

Additionally exclusion criteria for healthy control persons:

* meet the diagnostic criteria for MCI or AD