cyrilzakka/clinical-trials huggingface dataset:
RNA as Prognostic Biomarkers in Patients With Acute Coronary Syndrome

Identify circulating protein-coding (mRNAs) or non-coding (ncRNAs) transcripts (ACS_signature) predictive of ventricular dysfunction in ACS patients undergoing PCI.

Perform an observational, prospective study involving the evaluation of circulating biomarkers predictive of ventricular dysfunction (FE \<45%) in patients with ACS.

In particular, will be to verify whether there are circulating transcripts in peripheral blood, coding or not for proteins (mRNAs or ncRNAs), modulated differently in patients with ACS (ACS_signature) undergoing PCI, distinguished on the basis of evolution towards ventricular dysfunction. The study will be based on whole genome transcriptomic analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years
2. Patients with ACS (first episode), defined according to the guidelines of the European Society of Cardiology (ESC) 2017
3. Indication for percutaneous revascularization treatment
4. Informed consent to study enrollment

Exclusion Criteria:

1. Severe valve disease or other conditions requiring cardiac surgery
2. Previous cardiac surgery including coronary artery bypass grafts
3. Total chronic occlusions
4. Patients with known hypersensitivity or contraindication to any of the following drugs:

   * heparin
   * aspirin,
   * clopidogrel,
   * ticlopidine,
   * sirolimus,
   * everolimus.
5. Any contraindication to drug-eluting stent implantation (DES)
6. Patients with a documented history of myocardial infarction;
7. Left ventricular ejection fraction (LVEF) \<30% before PCI
8. Patients in cardiogenic shock
9. Patients with advanced ST-segment elevation myocardial infarction (\> 48 h from onset of symptoms/Q waves on electrocardiogram) or undergoing fibrinolysis;
10. Patients with prior known cardiomyopathy with LVEF \< 40%
11. Patients with malignant neoplasm or systemic disease with quoad vitam prognosis less than 1 year;
12. Patients with known active infectious diseases;
13. Patients who are unable to express valid informed consent to the act of enlistment
14. Pregnant women
Levetiracetam XR in Very Heavy Drinkers

The primary objectives of this study are to assess the efficacy of levetiracetam XR in increasing the percentage of subjects with no heavy drinking days and in reducing the weekly percentage of heavy drinking days in subjects with alcohol dependence confirmed by DSM-IV criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks per drinking day for women (designated as "very heavy" drinkers).


Eligibility Criteria:
Inclusion Criteria:

1. The subject must be at least 18 years of age.
2. The subject must have a DSM-IV diagnosis of current alcohol dependence.
3. The subject must be seeking treatment for alcohol dependence and desires a reduction or cessation of drinking.
4. The subject must be able to verbalize understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
5. If the subject is female and of child bearing potential, she must agree to use at least one of the following methods of birth control, or she must be surgically sterile or postmenopausal:

   * oral contraceptives
   * contraceptive sponge
   * patch
   * barrier (diaphragm or condom)
   * intrauterine contraceptive system
   * levonorgestrel implant
   * medroxyprogesterone acetate contraceptive injection
   * complete abstinence from sexual intercourse, and/or
   * hormonal vaginal contraceptive ring.
6. The subject must be able to take oral medication, willing to adhere to the medication regimen, and willing to return for regular visits.
7. The subject must complete all psychological assessments required at screening and baseline.
8. The subject must provide evidence of stable residence in the last 2 months prior to randomization, have reasonable transportation arrangements to the study site, and have no plans to move within the next 3 months or unresolved legal problems. Subjects must provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment.
9. The subject must have a breath alcohol concentration (BAC) equal to 0.000 when s/he signed the informed consent document.
Physiologically Guided VT Ablation

The purpose of this study is to determine the efficacy of VT ablation guided by functional evaluation of the substrate to specifically target the reentry-vulnerable zones in patients with infarct-related VT.

Activation mapping of VT is the gold-standard method for description of the reentrant circuit and identification of its isthmus, however this is uncommonly accomplished due to hemodynamic non-tolerance and limited temporal and spatial resolution. Substrate mapping has been developed as an alternative method to identify the isthmus of post-infarction VT during sinus rhythm (SR). However, it has limited specificity to critical VT sites.

Fundamental work in animal models of healed infarction and humans has shown that the VT isthmus corresponds to locations characterized by marked activation slowing during SR. Furthermore, these locations serve as "anchors" for multiple VT morphologies and cycle lengths.

The hypothesis of this study is that activation mapping during SR or pacing can improve the specifically for identifying the critical VT sites.

The aim of this prospective, multi-center controlled study is to evaluate the utility and limitations of functional mapping for guiding ablation of reentry vulnerably zones for long-term control of VT

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. History of myocardial infarction ≥1month before enrolment documented by ECG or cardiac imaging (TTE, SPECT, CMR).
3. Planned for first VT ablation procedure.
4. Patients must have an ICD or a plan for ICD implantation after the ablation.
5. Ability to understand the requirement of the study and to sign an informed consent.

Exclusion Criteria:

1. Patients requiring long-term treatment with class I or class III antiarrhythmic drugs after ablation (for AF).
2. The VT substrate is thought not to be related to coronary disease.
3. Presence of ongoing ischemia that is thought to be the cause of the VT.
4. Contraindication to anticoagulation therapy
5. Stroke within 30 days before enrollment.
6. Life expectancy \<1 year for any medical condition.
Vaccine Therapy in Treating Patients With Melanoma

Phase I trial to study the effectiveness of vaccine therapy in treating patients with melanoma that cannot be treated with surgery. Vaccines may make the body build an immune response that may kill tumor cells. Combining more than one vaccine may kill more tumor cells.

OBJECTIVES:

I. Determine the toxic effects associated with ALVAC-hB7.1 alone or combined with ALVAC-hIL-12 in patients with surgically incurable melanoma.

II. Characterize the inflammatory and lymphokine response to this regimen in these patients.

III. Examine the extent of nodule regression, humoral immune response, and cytolytic T cell activity with this regimen in these patients.

OUTLINE: This is a dose escalation study of ALVAC-hB7.1

Patients receive ALVAC-hB7.1 alone or combined with ALVAC-hIL-12 intratumorally on days 1, 4, 8, and 11. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at each dose level of ALVAC-hB7.1. The maximum tolerated dose is defined as the dose of ALVAC-hB7.1 at which no more than 1 of 5 patients experiences dose limiting toxicity.

Patients are followed at 1, 2, 4, 8, 11, 15, 22, and 43 days after the first vaccination.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed melanoma that is surgically incurable
* At least one dermal, subcutaneous or lymph node metastasis that is evaluable for local response and accessible for injection
* If only one accessible lesion is available, it must be at least 2 cm
* If two or more accessible lesions exist, then none of them are required to be at least 2 cm

PATIENT CHARACTERISTICS:

* Age: Over 18
* Performance status: ECOG 0-2
* Life expectancy: Greater than 3 months
* Leukocyte count at least 3,000/mm3
* Platelet count at least 120,000/mm3
* SGOT and alkaline phosphatase less than 5 times normal
* Bilirubin less than 1.5 mg/dL (unless secondary to hepatic metastasis)
* BUN less than 40 mg/dL
* Creatinine less than 2.5 mg/dL
* No evidence of congestive heart failure, unstable angina, or serious cardiac arrhythmias
* Not positive for hepatitis B virus
* Not positive for HIV
* No history of allergy to vaccinia virus
* No evidence of other primary tumors except for basal cell carcinoma, squamous cell skin carcinoma, or carcinoma in situ of the cervix
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No underlying immunodeficiency disorder

PRIOR CONCURRENT THERAPY:

* At least 30 days since prior biologic therapy (e.g., interferon or IL-2)
* At least 30 days since prior chemotherapy
* No concurrent steroids
* At least 30 days since prior radiotherapy
* Prior radiotherapy to no greater than 50% of nodal groups
* No prior splenectomy
* No concurrent drugs which affect immune function (e.g., glucocorticoids or cimetidine)
Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal

A randomized, double-blind controlled trial comparing treatment outcomes between chlordiazepoxide, or gabapentin to treat alcohol withdrawal syndrome in alcohol dependent veteran subjects. The objective of this trial is to compare the safety and effectiveness of these two medications. Intervention is a fixed dose taper of chlordiazepoxide, or gabapentin over 6 days. Subjects will be evaluated for 7-10 days to monitor alcohol abstinence, withdrawal severity scores, adverse events including ataxia, sedation, cognitive function and alcohol craving.

Chlordiazepoxide 25 mg and matching placebo capsules or gabapentin 300 mg and matching placebo capsules were were used. The chlordiazepoxide/placebo and gabapentin/placebo capsules were not identical in appearance. Study medications were packaged into a 7-day medication organizer. The dosing for each subject was either gabapentin 1200mg or chlordiazepoxide 100 mg orally days 1-3, gabapentin 900 mg or chlordiazepoxide 75 mg day 4, gabapentin 600 mg or chlordiazepoxide 50 mg day 5, and gabapentin 300 mg or chlordiazepoxide 25 mg day 6.

Adherence was assessed by pill counts and serum samples were obtained for study drug analysis. Serum samples were batched and sent to a contract laboratory so that study clinicians were blinded to the results until after the trial was completed. Presence of the assigned study medication in the blood served as a surrogate adherence marker.

Subjects also received prescriptions for daily oral therapeutic multiple vitamin tablets, folic acid 1 mg, and thiamine 100 mg.

A psychiatric history and physical examination, breath alcohol concentration, vital signs, CIWA-Ar (alcohol withdrawal scale), and blood chemistry including transaminases and complete blood cell count were obtained for baseline for all participants. Subjects were seen on weekdays for clinic follow-up appointments. Assessments performed at each study visit included CIWA-Ar, ESS (Epworth Sleepiness Scale), PACS (Penn Alcohol Craving Scale), and a brief examination to document mental status and assess coordination, which included assessment of stance, tandem gait, Romberg test, pronator drift, toe and heel walk, rapid-alternating-movements, and point-to-point movements. Breath alcohol concentration (BAC) was also measured (AlcoSensor, Intoximeters, Inc.) at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Alcohol dependent at risk for withdrawal symptoms

Exclusion Criteria:

* Benzodiazepine dependent
Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

In this pilot study 12 adult outpatients with body dysmorphic disorder that has not responded to at least one adequate trial of a serotonin reuptake inhibitor will be treated openly with a single oral dose of psilocybin. Followup visits to monitor safety and clinical outcome will be conducted over a 3 month period.

In this pilot study, up to 12 adult outpatients with body dysmorphic disorder that has not responded to at least one adequate trial of a serotonin reuptake inhibitor will be treated openly with a single oral dose of psilocybin. Procedures will follow those previously established in depression studies of psilocybin. Patients will receive intensive preparation and support from two therapists, including 8-9 hours accompanying the patient on the day of medication administration in the Biological Studies Unit of New York State Psychiatric Institute. Followup visits to monitor safety and clinical outcome will be conducted at day 1, week1, and months 1,2, and 3 post-administration. Resting state function magnetic resonance imaging will be conducted prior to and one day after psilocybin administration to assess the effect of medication on brain circuits.

Eligibility Criteria:
Inclusion Criteria:

* Body dysmorphic disorder of at least moderate severity, non-delusional subtype, for \>6 months
* History of intolerance of, or nonresponse to, a prior adequate trial of a serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
* Currently in psychotherapy (other than cognitive behavioral therapy (CBT) for body dysmorphic disorder

Exclusion Criteria:

* Current major depressive disorder of greater than moderate severity
* Other significant psychiatric or medical comorbidity or conditions that could interfere with safety of participation or interpretation of outcomes
* Use of: investigational medication within 3 months of baseline; depot antipsychotic within 6 months of baseline; serotonergic medication within 2 weeks of baseline (6 weeks for fluoxetine).
* Females who are pregnant, breastfeeding, or sexually active and not willing to use adequate contraception
* Enrollment in any investigational drug or device study in past 30 days
* Prior adverse effects from psilocybin
The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy

The purpose of this study is to explore the safety, feasibility, long-term and oncologicaloutcomes of laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy.

A prospective single-arm study designed to further evaluate laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy will be performed, to evaluate the safety, feasibility, long-term and oncological outcomes. The evaluation parameters are perioperative mobility and mortality, perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 75 years
* Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
* cT2-4aN+M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
* No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
* Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
* American Society of Anesthesiology score (ASA) class I, II, or III
* Written informed consent

Exclusion Criteria:

* Women during pregnancy or breast-feeding
* Severe mental disorder
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy, previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection)
* History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
* History of other malignant disease within past five years
* History of unstable angina or myocardial infarction within past six months
* History of cerebrovascular accident within past six months
* History of continuous systematic administration of corticosteroids within one month
* Requirement of simultaneous surgery for other disease
* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
* FEV1\<50% of predicted values
High Yield Intraoperative, Autologous Platelet Apheresis

The overall aim is to reduce overall allogeneic transfusion requirements during cardiac surgery when compared to standard management.

To evaluate this the investigators will test the hypothesis that intraoperative, autologous platelet apheresis will primarily avoid allogeneic platelet transfusion. Following induction of anesthesia and intravascular line insertion, the patient will be randomized to control or treatment arms by sealed envelope technique where computer generated, randomization numbers are assigned prior to enrollment based on study patient number which is never reused.

The control arm will have central venous access "sham" connected to the apheresis machine Trima® (Terumo BCT, Denver CO); the treatment arm will be connected and undergo pheresis. The clinical team will be blinded by a sterile sheet acting as a curtain and a recorded playback of the typical sounds of the operation of the apheresis machine. At the end of the pheresis, the platelet units will be disguised with opaque coverings and agitated at room temperature in compliance with the American Association of Blood Banks (AABB) recommendations for platelet storage. On separation from CPB, the blinded administration of autologous platelets or allogeneic (blood bank) platelets will occur after protamine administration, if the surgeon requests platelet transfusion (this is typically the case for these operations). The surgeon will be blinded and he will order subsequent transfusions based on clinical evidence of microvascular bleeding in accordance with standard guidelines, as is the investigators practice for these operations.


Eligibility Criteria:
Inclusion Criteria:

* All elective, aortic reconstruction surgery and other patients at high risk of receiving platelet transfusions such as: combined CABG/valve, more than one valve surgery via median sternotomy, left ventricular assist devise, and pulmonary thromboarterectomy with deep hypothermic circulatory arrest cases.
* Over 18 years of age

Exclusion Criteria:

* renal disease (dialysis dependent, end-stage renal disease or a baseline Cr \>3mg/dl)
* known coagulopathy/bleeding tendency (such as von Willebrand disease)
* platelet count of \<150x109 /liter at baseline
* Hct \< 30%
* platelet inhibitory drugs within 5 days prior to surgery or Aspirin 325 mg within 48 hrs of surgery
* inability to provide written, informed consent
* patients receiving pre-operative parenteral, non-heparin anticoagulants will be excluded
* pregnancy is not an exclusion criterion for the study but, typically, pregnancy is a contraindication to elective cardiac surgery hence pregnant patients are unlikely to be encountered.
Alcohol and Sex Risk mHealth-Enhanced Brief Intervention for BLMSM

Randomized controlled pilot trial to test the feasibility and efficacy of a brief intervention with app-based messaging to reduce sexual risk behavior and heavy drinking among Black/African American and Hispanic/Latino MSM.

This study seeks to develop and provide an initial test of a brief intervention to reduce alcohol use and sex risk behavior among Black and Latino men who have sex with men \[BLMSM\]. The study seeks to recruit BLMSM who are non-monogamous, not currently on pre-exposure prophylaxis \[PrEP\], have engaged in condomless anal intercourse over the past 6 months, who have engaged in heavy drinking defined as \>14 drinks per week or at least 1 heavy drinking episode (5+ drinks on a single occasion) in the past month. All participants will complete baseline measures about past month behavior and if eligible will be assigned to the intervention condition or an assessment only condition. The intervention consists of a single brief video-conferencing intervention coupled with 4 weeks of mobile-messaging related to individualized goals about alcohol use and sexual behavior. Follow-up assessments are scheduled for 4 weeks after baseline (upon completion of the mobile-messaging component of the intervention) and 2 months after baseline. Primary outcomes are feasibility and acceptability of the intervention and mobile-messaging components. Secondary outcomes are changes in frequency of condomless anal intercourse and heavy drinking episodes.

Eligibility Criteria:
Inclusion Criteria:

* Black/African American or Latino/Hispanic
* At least one heavy drinking episode in past month
* At least one episode of condomless anal intercourse with another man in the past 6 months
* Own a smartphone
* English speaking

Exclusion Criteria:

* HIV+
* Currently on PrEP
* Monogamous/exclusive relationship
* Past or current treatment for alcohol (past 3 years)
* Current or past psychiatric treatment (past 3 months)
* Diagnosis of Bipolar Disorder or Schizophrenia
* Brief Michigan Alcoholism Screening Test score \>5
* Lifetime diagnosis of substance use disorder
* ASSIST score of \>/=27 for any individual substance
Correction of Anisometropic Amblyopia in Children.

Anisometropic amblyopia among children in school age may affects quality of life and educational progress of children.

Correction of anisometropic amblyopia depends on type of refractive error and axial length of the eye.

In this study, we will asses the types of anisometropia found in children at school age and investigate possible ways for correction of this type of amblyopia.

Eligibility Criteria:
Inclusion Criteria:

* Anisometropic amblyopia.
* Children at school age ranged from 4 to 12 years old.

Exclusion Criteria:

* Emmetropia children.
* Children had undergone any intraocular surgeries.
* Other types of amblyopia.