cyrilzakka/clinical-trials huggingface dataset:
Adjuvant Therapy With Thalidomide After Curative Resection of Hepatocellular Carcinoma

Postoperative recurrence of hepatocellular carcinoma (HCC) is a major problem after surgical resection. To date, adjuvant chemotherapy or other adjuvant modalities have not been proven effective in preventing or delaying recurrence. The aim of this prospective randomized study was to evaluate the effectiveness of Thalidomide as a postoperative adjuvant regimen in inhibiting the recurrence of HCC

A number of modalities for preventing HCC recurrence after resection have been proposed and analyzed. Both preoperative and adjuvant transcatheter arterial chemoembolization (TACE) were found to be unable to reduce the risk of postoperative recurrence significantly, or confer a survival advantage. Vitamin K (VK) is a fat-soluble vitamin that regulates clotting factor production by acting as a coenzyme for a VK dependent carboxylase that catalyzes carboxylation of glutamic acid residues into gamma-carboxyglutamic acid. The findings in vitro have indicated that VK2 has an antiproliferative effects against hepatoma cell lines, but its efficacy in suppressing HCC recurrence was not confirmed in human studies. Interferon has a variety of biologic properties, including antiviral, immunomodulatory, antiproliferative, antiangiogenic and tumoricidal effects. It is reported that interferon is effective in preventing the development of HCC recurrence after its curative treatment in HCV-related cirrhosis. However, interferon treatment also has side-effects, including flu-like symptoms, fatigue, neutropenia, thrombocytopenia, depression, bone marrow suppression, and unmasking or exacerbation of autoimmune illnesses, which lead either to treatment disruption or dose modification. Polyprenoic acid, an acyclic retinoid, reportedly is effective in prevention of second primary hepatomas, but long-term safety and efficacy data are lacking.

Thalidomide possesses immunomodulatory,anti-inflammatory, and antiangiogenic properties.It has successfully been applied for the treatment of various malignancies including HCC.To investigated whether postoperative adjuvant therapy with Thalidomide could inhibite the recurrence of HCC after radical resection,we planed to conduct this clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. 18-75 years old,male and female
2. Patients who did not receive any anti-tumor therapies prior to the surgery (including liver transplantation, TACE, local tumor ablation, chemotherapy, radiotherapy, molecular targeted therapy and other anti-tumor therapy) resection of hepatocellular carcinoma
3. Patients who underwent radical resection of HCC, and 1 month after surgery,dynamic computed tomography showed on lesion in the liver and no signs of extrahepatic metastasis
4. Sign the informed consent

Exclusion Criteria:

1. Women who were pregnant or breast-feeding
2. signs showing recurrence or metastasis one month after surgery
3. Recurrent HCC
4. Patients unable to take drug orally
5. Patients inappropriate to participate in the trial upon the investigator's judgment
Ultrasound Parameters to Predict Difficult Videolaryngoscopy

Ultrasound has become an essential tool for the daily work of any doctor, but in certain specialties such as Anaesthesiology, its use has greatly increased the safety offered to patients throughout the perioperative period, either to perform nerve blocks, for vascular access, intraoperative hemodynamic management or any other use that allows increasing quality of care.

The management of the upper airway and the diagnosis of pathological conditions are essential skills for any doctor especially for Anaesthesiologist, ER physician, or Intensive Care physician. Because an inadequate airway management continues to be an important contributor to patient mortality and morbidity, any tool that can improve it should be considered as an addition to conventional clinical evaluation.

Unfortunately, most of the clinical parameters that should allow us to assess a potential difficult airway, do not always lead us to an adequate prediction, that is why US(Ultrasound) is use as an emerging tool in many fields, is also gathering strength in this search for a definitive predictor parameter.

Ultrasound has many obvious advantages (safe,fast, repeatable, portable, widely available and gives dynamic images in real time).

Sonographic studies are operator-dependent and although the identification of basic structures could be acquired with only a few hours of training, but more complex studies require a learning curve of months or even years. The high frequency linear probe (5-14 MHz) is probably the most suitable for the airway because images are of superficial structures (within 0-5 cm below the skin surface).

The growing academic interest in the use of US to look for predictors of difficult airway is centred mainly on measurements at the level of pretracheal tissues. But the greatest limitation of these studies is the disparity of the fat distribution that exists between different ethnic groups and and sexes, and the lack of standardization method in patient´s intubation conditions.

So, this study propose to assess different ultrasound windows at the level of pretracheal tissues such as independent predictors of Difficult Vydeolaryngoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patients (male or female) ASA I-III, aged between 18 and 90 years, undergoing scheduled surgery requiring orotracheal intubation. The signature of the informed consent is required authorizing its inclusion in the study.

Exclusion Criteria:

* Obesity class II defined as a BMI greater than 35.
* Pregnant.
* Cervical tumors, goiter or patients who have required radiotherapy at the cervical level
* Abnormalities that condition anatomy alterations such as facial / cervical fractures.
* Maxillofacial abnormalities
* People who cannot give their consent
Rapid Computerized Visual Acuity Test

A novel computerized visual acuity test was developed and tested on both healthy persons and patients with ocular conditions. Visual acuity outcomes of the computerized test will be compared to the Early Treatment Diabetic Retinopathy Study (ETDRS) in measures of reproducibility, accuracy and numbers of questions.


Eligibility Criteria:
Inclusion Criteria:

- age 18 years old and older

Exclusion Criteria:

* visual acuity \<0.2 decimal for the patient group
* visual acuity \<0.5 decimal for the healthy group
Intrarater and Interrater Reliability Physical Function Measures in HD BCN

The investigators will calculate values of absolute and relative reliability for intrarater reliability when the measures are taken during a hemodialysis treatment day and during a non-dialysis day. Interrater reliability between two different observers will be also calculated

Patients suffering from End Stage Renal Disease are commonly involved in haemodialysis treatment, which is the most common treatment at this stage. Haemodialysis substitutes the renal function but is associated with several alterations that lead to decrease in functional capacity. Many studies show that functional capacity is significantly worse than their healthy sedentary age - matched counterparts. The purpose of the present study is to calculate values of absolute and relative intrarater reliability (dialysis vs non dialysis day) and interrater reliability of different physical function measures (Short Physical Performance Battery, one-leg balance, Timed Up and go, sit to stand to sit tests, triceps and handgrip strength, six-minute walking test).

Eligibility Criteria:
Inclusion Criteria:

* At least 3 months in hemodialysis treatment
* Clinically stable

Exclusion Criteria:

* Recent cardiac events (less than 3 months)
* Unable to exercise
Kinetic Anesthesia Device Study

Patients experience discomfort from lidocaine injections. Vibrating kinetic anesthesia devices (KAD) have been shown to reduce pain of injections in dentistry, pediatrics, and dermatology, though no studies of lidocaine injections in sites common to dermatologic surgery exist. We will conduct a randomized split-body study, in which healthy volunteers will rate the pain of lidocaine injections on a visual analog scale, with and without the vibrating kinetic anesthesia device being used during injection

The study will be an open label split-body crossover trial, using healthy adult volunteers recruited from the faculty, staff and student body of the University of Pennsylvania, and from the University City area of Philadelphia. Participants will be randomized to one of three anatomic sites deemed relevant: the nasofacial sulcus, the lateral forehead, and the upper back. Participants will then be randomized to receive injection with the KAD first or second. The injection will be 0.5 cc of room temperature buffered lidocaine injected at constant slow speed (approximately 5 seconds) through a 30-gage needle held perpendicular to the skin by the same surgeon, with verbal cues standardized. Injections will be given in accordance with the standard of practice. When the KAD is used it will be used as directed: firmly pressed on the skin adjacent to the injection, with the needle aimed into the lighted area. Volunteers will evaluate each injection immediately after it is complete using the visual analog scale. When both injections are completed, participants will indicate their preference of injection, complete qualitative questions, and note necessary demographic information. Injection location and order of intervention (i.e. first or second) will be noted.

Eligibility Criteria:
Inclusion Criteria:

1. Adult volunteers greater than or equal to 18 years of age
2. Able and willing to provide informed consent
3. Able to comprehend and comply with study instructions, and able to complete necessary evaluations.

Exclusion Criteria:

1. Patients unable or unwilling to provide informed consent.
2. Patients with lidocaine allergy
3. Patients with known pain-related or neurological condition.
4. Patients with a known cardiac condition
5. Vulnerable populations
Personalized Feedback Intervention for Alcohol and Opioid Use Among Adults with Chronic Pain

Over one-quarter of American adults engage in hazardous drinking (i.e., a pattern of alcohol consumption that increases risk for harmful consequences), which is the third leading cause of preventable death in the U.S. Rates of hazardous drinking are significantly higher among individuals with (vs. without) chronic pain. Moreover, 20% of individuals prescribed opioids endorse concurrent alcohol and opioid use, which may interfere with chronic pain treatment and lead to dangerous/potentially fatal health effects. No interventions to date have targeted either hazardous drinking or concurrent use of alcohol and opioids in the context of chronic pain. The current four-year R01 builds upon our past work by developing a brief, single-session, computer-based, personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse pain-alcohol-opioid interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding concurrent use of alcohol and prescription opioid medications. Specifically, we will develop an integrated PFI for hazardous drinkers with chronic pain who are prescribed opioids (PA-PFI). Our approach will follow a staged model consistent with NIH guidelines for developing and standardizing behavioral interventions. Phase IA activities will involve collecting qualitative and quantitative feedback from three iterative focus groups (N = 21) to refine intervention content and evaluate treatment acceptability and feasibility. Phase IB activities will include a proof-of-concept and highly rigorous randomized clinical trial designed to compare PA-PFI to control PFI (C-PFI) among a sample of 174 hazardous drinkers with chronic pain who are currently prescribed opioid medications. This study represents an important and pivotal step in the larger landscape of translating basic research to more efficacious strategies for reducing hazardous drinking among underserved populations with medical comorbidities. This intervention would be highly disseminable and relevant to millions of hazardous drinkers with chronic pain. Given the collective public health impact of chronic pain, hazardous drinking, and concurrent alcohol-prescription opioid use, we believe the current study will yield findings that enhance scientific knowledge, enhance our understanding of mechanisms in reciprocal pain-alcohol-opioid relations, and inform the development of novel treatments for hazardous drinkers with chronic pain that are adaptable and easily implemented across a variety of healthcare settings.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 21 years of age
* Current hazardous drinker
* Current chronic pain
* Current use of prescription opioid medications.

Exclusion Criteria:

* Current alcohol or other substance use treatment
* Not being fluent in English
* Current psychiatric distress or thought disorder.
Early Initiation of Low Dose Tirofiban for PPCI in STEMI Patients.

Anti-platelet therapy is a key point of acute myocardial infarction (AMI) treatment. Nowadays, dual anti-platelet therapy based on aspirin and ADP-P2Y12 receptor inhibitor is the preferred treatment before primary percutaneous coronary intervention (PPCI). Restricted by pharmacokinetic and pharmacodynamic characteristics, ADP-P2Y12 receptor inhibitors cannot take effect immediately after oral administration. However, platelet glycoprotein Ⅱb / Ⅲa inhibitors take effect faster. Previous clinical trials indicated that combination of full dose of glycoprotein Ⅱb / Ⅲa inhibitor and dual anti-platelet therapy reduced AMI related ischemia events but increased bleeding events significantly. The high dose of glycoprotein Ⅱb / Ⅲa inhibitor may be the key factor contributing to the increased bleeding events. Therefore, this study aims to evaluate the effectiveness and security of triple anti-platelet therapy based on a small dose of glycoprotein Ⅱb / Ⅲa inhibitor, aspirin and ADP-P2Y12 receptor inhibitor in AMI patients receiving PPCI.


Eligibility Criteria:
Inclusion Criteria:

* Time after onset of chest pain: ≥ 30 minutes and ≤ 24 hours;
* ST segment elevated ≥ 0.1mV in adjacent two or more leads;
* Scheduled for primary percutaneous coronary intervention without contraindications;
* Written informed consent is obtained.

Exclusion Criteria:

* Life expectancy ≤ 1 year;
* History of cerebral hemorrhage;
* History of stroke in 6 months;
* Active hemorrhage;
* Severe hepatic and renal dysfunction(ALT \> 3 folds of upper limit of normal, eGFR \< 30ml/min/1.73mm\^2 or Scr \> 200 mmol/L);
* Known hemorrhagic diseases;
* Known malignant tumour diseases；
* Active peptic ulcer disease;
* Blood platelet counts \< 100×10\^9/L;
* Blood hemoglobin \< 90g/L;
* Pregnancy or lactation period；
* Take part in other intervention clinical trials；
* Investigators think not suitable to participate in this trial.
Nicotine Patch, Blood Flow and Oxidative Stress Study

This study will address the hypothesis that nicotine, like cigarette smoking acting as a pro-oxidant may have adverse effects on arterial function.

Smoking causes \>400,000 deaths from cardiovascular disease (CVD) per year. The molecular basis of smoking induced tissue injury remains unclear but considerable evidence supports a role for oxidant stress (OS).

Arterial function has been shown to be impaired in smokers even before the onset of angiographically demonstrable atherosclerosis. Defects in endothelium dependant flow mediated vasodilatation (FMD) are seen in those at risk of or with overt vascular disease.

Cigarette smoking is highly addictive. Spontaneous quit rates approximate 3%. Even those using nicotine replacement therapy (NRT) have high relapse rates (67-75%) on completion of the 8-12 week course of NRT. Thus there is interest in the use of extended NRT as a "safer" alternative to cigarette smoking. However such assumptions may be premature. Nicotine demonstrates proxidant effects in vitro and in small studies has been associated with endothelial dysfunction. Studies simultaneously assessing the effects of nicotine on oxidative stress and arterial function in humans have not been performed.

The current proposal will address the hypothesis that nicotine, like cigarette smoking acting as a pro-oxidant may have adverse effects on arterial function.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Nonsmokers who have never smoked
* Normal medical history
* Normal physical examination
* Normal laboratory data
* Negative urinary pregnancy test for females

Exclusion Criteria:

* Previous CVD
* Chronic medication use
* History alcoholism
* History of smoking
* Current pregnancy
* Subjects, who have less than or equal to 60% platelet aggregation in response to arachidonic acid will also be excluded.
fMRI and Opioid Abstinence

This project examines functional connectivity patterns associated with subsequent relapse to illicit opioids during treatment for OUD.


Eligibility Criteria:
Inclusion Criteria:

* recent initiation of methadone or buprenorphine at APT Foundation within the last year (i.e., period of time during which treatment drop-out and risk for relapse is highest);
* eligibility for MRI scanning;
* ability to commit to study visits.

Exclusion Criteria:

* current acute psychosis, mania, or suicidal ideation with intent, as assessed during screening with the SCID-5;
* current intoxication or acute withdrawal at time of study visit sufficient to prevent participation based on: behavioral observation, breathalyzer, and SOWS assessment;
* severe cognitive impairment as determined via trained clinical research staff through consent process and during consent quiz or as indicated by a PROMIS Cognitive Function tscore \<30 (i.e., severe impairment)
* past or present history of intellectual disability, developmental disorder, or neurological disease;
* head trauma with loss of consciousness \>30 min;
* organ dysfunction or any unstable or untreated medical conditions that may interfere with study participation.
18F-FDG PET/CT to Evaluate pD-1 Monoclonal Antibody With First-line Chemotherapy in Advanced NSCLC

This study is a diagnostic study. Subjects were enrolled from clinical stage IIIB or IV NSCLC patients who received standard first-line chemotherapy combined with PD-1 monoclonal antibody immunotherapy and received 18F-FDG PET/CT imaging before treatment, after 2 courses of treatment, and at the time of disease progression.At the same time, the blood routine, liver and kidney function, inflammatory indexes and other laboratory data of the subjects participating in the study were collected. Based on 18F-FDG PET Ipercist standard and comprehensive laboratory indicators, the subjects were evaluated for tumor biological characteristics prediction and clinical staging, PD-1 immune efficacy monitoring and evaluation, tumor recurrence monitoring and re-staging. At the same time, the systemic immune response and immune-related adverse events during the treatment process were evaluated in order to establish a better evaluation standard and system for the comprehensive evaluation of PD-1 immunotherapy.This study plans to set the sample size as 50 cases.

This is a diagnostic study. Subjects were enrolled from clinical stage IIIB or IV NSCLC patients who received standard first-line chemotherapy combined with PD-1 monoclonal antibody immunotherapy and underwent 18F-FDG PET/CT imaging before treatment, after two lines of treatment and at the time of disease progression, while routine blood counts, liver and kidney function, inflammatory indices and other laboratory data were collected from subjects enrolled in the study. Based on standard 18F-FDG PET Ipercist and comprehensive laboratory indicators, subjects were evaluated for prediction of tumour biological characteristics and clinical staging, monitoring and evaluation of PD-1 immune efficacy, monitoring of tumour recurrence and restaging. At the same time, the systemic immune response and immune-related adverse events during the treatment process were evaluated to establish a better evaluation standard and system for the comprehensive evaluation of PD-1 immunotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age 18 or above), gender unlimited;
* Pathological diagnosis of non-small cell lung cancer stage IIIB or above;
* Agree to carry out the standard first-line chemotherapy combined with immunosuppression established in this study;
* Consent to 18F-FDG PET/CT imaging and related laboratory examination before and during treatment;
* The patients themselves or their legal representatives are aware of this study and can sign the informed consent.

Exclusion Criteria:

* Acute systemic diseases and electrolyte disturbances;
* Pregnant or lactating women;
* The patient or his legal representative is unable or unwilling to sign the informed consent.
Patients' Attitudes Towards Open-Label Placebo Implementation Into Clinical Practice

The aim of this project is to assess patients' opinions, attitudes, and ideas regarding the administration of OLPs in clinical practice, although they might never have had contact to placebos. A qualitative approach is used and online focus group discussions (FGD) with patients with different clinical conditions, entailing chronic back pain, Parkinson's disease, chronic migraine, chemotherapy induced emesis, and menopausal complaints are conducted.

Substantial placebo effects have been known for several decades for a multitude of physical as well as psychological complaints. It is essential to test the acceptability of Open-label placebos (OLPs) of patients and health professionals. The aim of this project is to assess patients' opinions, attitudes, and ideas regarding the administration of OLPs in clinical practice, although they might never have had contact to placebos. A qualitative approach is used and online focus group discussions (FGD) with patients with different clinical conditions, entailing chronic back pain, Parkinson's disease, chronic migraine, chemotherapy induced emesis, and menopausal complaints are conducted. A semi-structured topic guide with open-ended questions will be used.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed Consent form (see Appendix)
* Capable of consent (language/cognitive)
* At least 18 years of age
* Ability to attend an online conference in regard of physical and psychological condition and technical knowhow and equipment
* In addition, participants have to be affected by one of the following conditions/disorders:

  * Chronic back pain
  * Chemotherapy-induced emesis (last occurrence at least before 14 days and at maximum before one year)
  * Chronic migraine
  * Parkinson's disease
  * Clinically significant menopausal complaints

Exclusion Criteria:

* Severe ailment and medication side-effects which would interfere with study participation (e.g., due to concentration impairment)
* Acute psychological crisis which would affect study participation essentially or suicidality
* Co-morbidity that overlaps in symptoms with the symptoms necessary for inclusion
* Essential psychiatric disorders other than moderate depression