cyrilzakka/clinical-trials huggingface dataset:
Combined Endoscopic-laparoscopic Sentinel Lymph Node Navigation Surgery in Early Gastric Cancer

The main treatment for early gastric cancer (EGC) include endoscopic submucosal dissection (ESD) and radical gastrectomy. However, appropriate treatment for patients who exceed the absolute indications and noncurative resection of ESD remains unestablished. Combined endoscopic-laparoscopic sentinel node navigation surgery seems to be the promising solution according to previous study, however evidence-based medicine in China was lacking. It is imperative to establish its safety and efficacy in Chinese patients with EGC.


Eligibility Criteria:
Inclusion Criteria:

* 1) Patients aged 18-80 years, regardless of gender. 2) Patients with Eastern Cooperative Oncology Group (ECOG) score ≤ 2 and American Society of Anesthesiologists (ASA) score ≤ 2 who are candidates for a curative D2 gastrectomy.

  3) Patients without prior gastrointestinal surgery, chemotherapy, or radiotherapy.

  4) Patients with normal liver, kidney, heart, lung, and bone marrow function (GPT × 109 /L, PLT\>109 /L).

  5) Patients capable of understanding and adhering to the research protocol. 6) Patients who can provide written informed consent, either personally or through legal representative.

  7) Patients with cT1NxM0 gastric cancer or after non-curative ESD resection, according to the UICC TNM staging system, 8th edition.

Exclusion Criteria:

* 1) Patients with a contraindication for gastroscopy. 2) Patients with uncontrollable diseases, such as coagulation disorders, epilepsy, central nervous system diseases or mental disorders, cardiopulmonary insufficiency, unstable angina, myocardial infarction, a cerebrovascular accident that occurred within 6 months, and other surgical contraindications.

  3) Patients unable to undergo general anesthesia or surgical treatment due to conditions related to other organs, or unwilling to undergo surgery.

  4) Patients with gastric stump cancer, recurrent gastric cancer, multiple primary malignant tumors in the abdominopelvic cavity, or a history of other malignant tumors within the previous 5 years.

  5) Pregnant or lactating women. 6) Participants enrolled in other clinical trials. 7) Patients with undeterminable tracer staining range or contraindications to tracer use.

  8) Patients who fail to receive or fail ESD therapy. 9) Patients who meet the absolute indication of ESD.
The Efficacy and Safety of Aracmyn in Patients With Systemic Latrodectism

The purpose of this study is to compare the safety and effectiveness of an investigational antivenom and the current standard of care (pain management with opioid analgesics) for treating patients with a widow spider bite. The working hypotheses are as follows:

1. the investigational antivenom is more promptly effective at alleviating the pain associated with a widow spider bite than routine management with opioid pain medication
2. the investigational antivenom is as safe a treatment as opioid pain medication in treating patients with a widow spider bite.

The purpose of this randomized, double-blind, multi-center phase II trial is to examine the safety and efficacy of Aracmyn® \[Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2\], a new antivenom, for treatment of patients envenomed by the widow spider. Twenty-four subjects will be randomized to receive either the study drug or control (normal saline) through intravenous (IV) infusion. Following infusion, subjects will be monitored for changes in pain and clinical signs during a two-hour observation period. A standard dose of IV fentanyl will be offered to all subjects as pain medication at specific intervals following treatment. Vital signs, blood samples, and pain intensity scores (using a visual analog scale, VAS) will be collected before and after the infusion, as well as during the observation period. This study uses a treatment failure protocol, which involves administration of Merck Antivenin to subjects who do not obtain adequate pain relief from the study drug or control. Primary efficacy and safety endpoints for this 12-month trial will be improvement in pain intensity and clinical signs and incidence of adverse events, respectively.

Eligibility Criteria:
Inclusion Criteria:

* patient presents for treatment within 72 hours from time of symptoms onset
* clinical diagnosis of widow spider envenomation
* patient has moderate to severe pain intensity

Exclusion Criteria:

* history of significant cardiac, respiratory, hepatic, or renal disease
* distracting injury or chronic pain syndrome that would obscure pain intensity assessment
* history of asthma or known sensitivity to fentanyl, morphine, diazepam, or equine serum
* pregnant or lactating
Drug Interaction and Safety Between Pitavastatin and Valsartan (CWP-PTV-101)

This study is designed to evaluate a pharmacokinetic drug interaction and safety between Pitavastatin and Valsartan in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* Adult males aged 20 to 50 years at screening.
* No significant congenital/chronic disease. No symptoms in physical examination.
* Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
* Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria:

* History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
* History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
* History of known hypersensitivity to drugs including valsartan and pitavastatin.
Clinical Course and Treatment of COVID-19 Inpatients in Hospital

The study is an epidemiological observational study. It serves to collect data from patients with positive COVID-19 test results who are hospitalized. All data describing the course of the inpatient stay are recorded (Length of stay, course of therapy, medication, X-ray and CT results,ventilation mode and duration, laboratory). Furthermore, anthropometric data and information on COVID-19 symptoms is recorded.

The aim of this study is to describe the course of disease and the treatment of patients suffering from COVID-19 who are hospitalized and treated as inpatients:

1. Are there common features (previous illnesses, medication, age, BMI, etc.), which may influence the course of disease?
2. Are there therapeutic procedures that have a positive or negative impact on the course of the disease or the length of stay in the intensive care unit/ the duration of ventilation (early/late intubation, CPAP, NIV, ECMO)?

Eligibility Criteria:
Inclusion Criteria:

* positive COVID-19 test result
* Age \> 18 years

Exclusion Criteria:

* Age \< 18 years
* negative COVID-19 test result
* lack of agreement
* Any medical, psychological or other condition, that restricts the ability of the person to be informed and to give the consent for voluntary participation in this trial
Mindfulness Training for Smoking Cessation

The purpose of this study is to assess the effects of mindfulness training (MT) compared to standard Smoking Cessation Therapy (SCT) on smoking cessation and stress provocation in individuals trying to quit smoking.


Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 18 and 60
2. Smoking 10 or more cigarettes per day
3. Fewer than 3 months of smoking abstinence in the past year
4. Motivated to stop smoking

Exclusion Criteria:

1. Current use of psychoactive medications that have not been at a stable dose for the past six months, are used as mood stabilizers, or are used as smoking cessation treatments. Individuals who are on psychoactive medications that are stable, not mood stabilizers, and not used for smoking cessations are excluded from fMRI sessions but not smoking cessation treatment.
2. Use of another investigational drug within 30 days
3. Any serious or unstable disease within 6 months
4. Meets criteria for substance dependence within the past year
5. Left handed (will be excluded from fMRI only)
The Off Label Use of Glycopyrrolate in the Adults Intensive Care Unit.

Tracheostomized patients in the ICU can have excessive tracheal secretions due to various causes as hyperactive airway, irritation of the mucus producing cells and inhibition of the ciliary functions. Excessive secretions will necessitate frequent suctions which carries the risk of tracheostomy tube obstruction if not managed properly. Excessive tracheal secretions may prolong the ICU stay, increase the nurses workload and increase patients morbidity and mortality.

This clinical trial hypothesizes that the use of glycopyrrolate may decrease the tracheal secretions and hence avoid such complications.

Patients fulfilling the inclusion criteria will be randomly assigned into one of 2 groups:

Group G (Intervention group): Patients will receive Glycopyrrolate 0.2 mg IV every 8 hours.

Group C (Control group): Patients will receive 2 mL Normal saline every 8 hours.

Both injections will be labelled as drug A and drug B in the satellite pharmacy .

Both the attending physician, nurse and data collector will be blinded to the injection given.

Measurements data will be collected and recorded daily in the pre-prepared CRF during the study period.

Eligibility Criteria:
Inclusion Criteria:

1. Patients above 18 years old.
2. Patients who are admitted to ICU for more than 72 hours.
3. Patients who have tracheostomy tubes with reported frequent need for suction of the tracheostomy tube secretions more than once every 4 hours.

Exclusion Criteria:

1. Patients who have evidence of lower respiratory tract infections and have positive cultures from the tracheal aspirate.
2. Patients who have known sensitivity to Glycopyrrolate.
3. Patients who have tachycardia (heart rate above 120 Beats/minute) or known to have tachyarrhythmiase.g atrial fibrillation.
4. Patients with mitral stenosis
Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects

The study objective was to describe the pharmacokinetics (PK) of one or two doses of C1 esterase inhibitor (C1INH-nf) in hereditary angioedema (HAE) subjects who were not experiencing an HAE attack.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in LEVP2005-1 (current or in the past)

Exclusion Criteria:

* C1 inhibitor infusion within the last 7 days
* Signs of any HAE attack
* HAE attack within 7 days before actual infusion of C1INH-nf
* Change in the dosage of androgens in the last 14 days before the study
* Use of antifibrinolytics in the last 7 days before the study
* Change in oral conceptive medication in the last two months before the study
* History of clinically relevant antibody development to C1 inhibitor
* Use of oral anticoagulant medication in the last 14 days
* Use of heparin within the last two days prior to the study
* History of allergic reaction to C1 inhibitor or other blood products
* Current participation (or within the past 90 days) in any investigational drug study other than those sponsored by Lev Pharmaceuticals
* Pregnancy or lactation
* B-cell malignancy
* Any clinically significant medical condition, such as renal failure, that in the opinion of the investigator would interfere with the subject's ability to participate in the study
Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects

Epidemiological studies suggest that certain foods rich in flavanols, including cocoa products, red wine, and tea, are associated with decreased cardiovascular mortality and morbidity. Dietary interventional studies have corroborated this finding and showed that flavanols can acutely and after sustained ingestion improve surrogate markers of cardiovascular risk including endothelial function. Endothelial dysfunction is the key event in the development and progression of cardiovascular disease. Aging is the major non-modifiable cardiovascular risk factor associated with progressive decline in endothelial function, vascular stiffening and increase in blood pressure.

However, in addition to flavanols, other potentially bioactive compounds are present in cocoa, in particular methylxanthines. Little is known about the vascular effects of cocoa methylxanthines, i.e. mainly theobromine, in particular when consumed together with flavanols in cocoa products. The aim of the study is to characterize the nutrient-nutrient interaction between cocoa flavanols and cocoa methylxanthines.


Eligibility Criteria:
Inclusion Criteria:

* healthy male subjects
* \>18 years

Exclusion Criteria:

* acute inflammation
* cardiac arrhythmia
* renal failure
* heart failure (NYHA II-IV)
* diabetes mellitus
* CRP \> 1 mg/dl
* malignant disease
Traumatic Brain Injury Biological Diagnosis Via High Definition Tractography Asymmetry Screening

The primary purpose of this study is to validate the High Definition Fiber Tracking (HDFT/HDFTAS) technology, so that faster, more reliable diagnosis can be implemented in Traumatic Brain Injury (TBI). This study will involve Traumatic Brain Injury Patients and normal controls, in addition to 30 pilot participants who will be undergoing MRI in order to develop a statistically sound range for the metrics derived from HDFT.

This descriptive study sponsored by the United States Department of Defense involves the examination of TBI participants and normal control participants through MRI (Without Contrast) scanning. Normal controls are essential to develop a statistically sound range for the metrics derived from High Definition Fiber Tracking (HDFT). TBI subjects will undergo 1 MRI scan and normal controls will be asked to undergo 1 MRI scan. The study will involve blinded evaluations of results to determine the ability of HDFT imaging methods to evaluate TBI.

In addition to the TBI and normal controls evaluated in this research study, investigators will be running 30 pilot participants. These participants will be undergoing MRI in order to streamline our pulse sequence and calibrate the MRIs. This is part of the technical development for the project and will occur before the recruitment of TBI subjects and normal controls for comparison. Data from the pilot subjects will not serve as control data for the TBI subjects.

Eligibility Criteria:
Inclusion Criteria TBI subjects:

* Documented history of TBI (for Chronic).
* No MRI contraindications such as implanted ferrous metal, pacemakers, body weight above 125 Kg, (might not fit in the scanner), or concerns about claustrophobia.

Exclusion Criteria TBI subjects:

* Inability or unwillingness of subject to provide written informed consent.
* History of penetrating gunshot wound.

Inclusion Criteria Control subjects:

* No prior history of concussion, TBI, blast exposure, stroke, or other major neurological disorder.
* No MRI contraindications such as implanted ferrous metal, pacemakers, body weight above 125 Kg, (might not fit in the scanner), or concerns about claustrophobia.

Exclusion Criteria TBI subjects:

* Inability or unwillingness of subject to provide written informed consent.
* History of concussions, stroke, or penetrating gunshot wound.

Inclusion Criteria Sequence Development Subjects:

* No MRI contraindications such as implanted ferrous metal, pacemakers, body weight above 125 Kg, (might not fit in the scanner), or concerns about claustrophobia.

Exclusion Criteria Sequence Development Subjects:

* Inability or unwillingness of subject to provide written informed consent
* Contra-indication to MR imaging, such as ferrous metal, pacemakers, body weight above 125 Kg or concerns
Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification

This study is evaluating the efficacy of Treatment A for short-term smoking cessation through a blinded randomized controlled trial (RCT) vs.Treatment B.

The overarching study aim is to recruit a population of current smokers who are motivated to quit with the assistance of a mobile solution, enroll them into a study testing apps to help them quit, and randomize them into one of two arms. The core study period will consist of 8 weeks of usage of Treatment A or Treatment B. At the end of this period, users will receive notifications to link them to an online survey, which will record their responses in a secure database.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 65
2. Smokes at least 5 cigarettes daily
3. Is interested in quitting in the next 30 days
4. Owns an iPhone with iOS 9 or higher or Android with OS 4.1 or higher
5. Willing and able to receive SMS text messages
6. Able to comprehend the English-language and the informed consent form
7. Lives in the United States
8. One half of the study sample will be recruited from the general population of smokers via social media advertisements
9. One half of the study sample will be recruited via mail from a Magellan Behavioral Health value-based care network

Exclusion Criteria:

1. Prior use of Clickotine or QuitGuide
2. Current use of pharmacotherapy for smoking cessation or nicotine replacement therapy (NRT)
Developmental Phenomenology of Obsessive Compulsive Disorder and Tourette Syndrome in Children and Adolescents

OBJECTIVES: I. Characterize the natural history, associated features, and severity of symptoms of obsessive compulsive disorder and Tourette syndrome in children and adolescents.

II. Identify factors that influence the clinical course and prognosis of these patients.

PROTOCOL OUTLINE: All patients and their families participate in 6 parts of the study: current severity of symptoms, coincident disease diagnoses, natural history, neuropsychologic assessment, physical and neurologic assessment, and family history and function. The evaluations include the following: Current Severity of Symptoms Assessment, Children's Yale Brown Obsessive Compulsive Scale (CY-BOCS), Clinician's Global Impression-Obsessive Compulsive Disorder (CGI-OC), Leyton Obsessional Inventory-Child Version (LOI-CV), Obsessive Compulsive Personality Rating Scale, Yale Global Tic Severity Scale(YGTSS), Clinician's Global Impression-Tourette Syndrome (CGI-TS), Tourette Syndrome Symptom List (TSSL), Clinician's Global Impression-Anxiety (CGI-A), Covi Anxiety Scale (CAS), Children's Manifest Anxiety Scale-Revised (CMAS-R), Social Anxiety Scale for Children-Revised, Fear Survey Schedule for Children-Revised, Louisville Fear Survey, Children's Depression Rating Scale-Revised (CDRS-R), Clinician's Global Impression-Depression (CGI-D), Children's Depression Inventory (CDI), The Dimensions of Temperament Survey (DOTS), Mosher Guilt Scale-Revised, Real vs. Ideal Self Questionnaire, Harter Self-Perception Profile For Children, The Children's Global Assessment Scale (CGAS), The Child Behavior Checklist (CBCL), Coincident Disease Diagnoses Assessment, Diagnostic Interview Schedule for Children-II (DISC-II), Yale Best Estimate of Diagnoses Schedule (Y-BEDS), Natural History Evaluation, Yale Natural History Questionnaire (YHNQ), Social Readjustment Scale for Children, Neuropsychologic Assessment, Delayed Response Tasks, Continuous Performance Task, Continuous Recognition Memory, Selective Reminding Procedures, Card Sorting Tasks, Wechsler Intelligence Scale for Children-Revised, Digit Span, Digit Symbol and Mazes Paced Auditory, Serial Addition Task, Purdue Pegboard Trail Making Tasks, Fluency Tasks, Rey-Osterreith Complex Figure Stanford-Binet Intelligence Scale-Fourth Edition, Physical, Neurologic, and Neurochemical Assessment Physical exam (abbreviated), Physical and Neurological Examination for Soft Signs (PANESS), 24-hour urinary cortisol and catecholamines, Family History and Family Function Assessment of family history, Assessment of Family Functioning.

The estimated duration of study is 10 years.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Obsessive compulsive disorder or Tourette syndrome meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria
The Association of Pelvic Organ Prolapse Severity and Urinary Symptoms/Sexual Function

Women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction, and analyzing the association will be helpful to identify the indication of proper management. Therefore, the aim of this study is to identify the above associations.


Eligibility Criteria:
Inclusion Criteria:

* all cases with with pelvic organ prolapse

Exclusion Criteria:

* nil
Neurogenic Inflammation in Peri-implant and Periodontal Diseases

Regulatory effects of some neuropeptides substance-P (SP), neurokinin-A (NKA), calcitonin gene-linked peptide (CGRP) and neuropeptide-Y (NPY) )on inflammatory responses in periodontal disease has been described; however, the impact of neuropeptide levels are not clearly defined in healthy and diseased peri-implant tissues.ın order to evaluate the situation, thirty-nine implants that have been loaded over the past 12 months and their symmetrically matching teeth were evaluated using a split-mouth study design. Clinical periodontal examinations included the Silness-Löe plaque index, Löe-Silness gingival index, bleeding on probing, probing pocket depth and clinical attachment level parameters were determined. Gingival crevicular fluid (GCF)/Periimplant sulcular fluid (PISF) samples were collected, and the levels of the neuropeptides were determined by enzyme-linked immunosorbent assay. Correlations between GCF/PISF neuropeptide levels and the clinical examination parameters were evaluated in the peri-implant/periodontal soft tissues.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria for patient selection were as follows:

* Compliance with systematic maintenance care;
* Adult, non-smoker, systemically healthy
* Not using any medicament for the last 6 months ;
* Partially dentated patient treated with implant-supported metal ceramic full crowns and/or fixed partial dentures
* As the study was split-mouth designed, in each individual at least one implant and one matching tooth in the same mouth symmetrically representing the same tooth group (premolars/molars);
* A single type of metal ceramic implant restoration that is functional for at least 1 year; and a matching tooth with no dental or endodontic restorations.

Exclusion Criteria:

* Medical history of cancer, rheumatoid arthritis, diabetes mellitus, or cardiovascular disease and any other systemic disease affecting lipid metabolism (i.e. impaired glucose tolerance, metabolic syndrome);
* Compromised immune system;
* Pregnancy, menopause, or lactation;
* Ongoing drug therapy that might affect the clinical characteristics of periodontitis and lipid metabolism;
* Dental treatment during the 6 months prior to data collection.