cyrilzakka/clinical-trials huggingface dataset:
Symptomatic Remission and Social Function in Participants Treated With Paliperidone Extended Release (ER)

The purpose of this study is to explore the relationship between achieving symptomatic remission status by means of the 8 items of Positive and Negative Syndrome Scale (PANSS), and personal and social functioning by means of the Personal and Social Performance (PSP) scale in participants treated with flexibly dosed paliperidone ER.

This is an open label (all people know the identity of the intervention), multicenter (when more than one hospital or medical school team work on a medical research study) and prospective (study following participants forward in time) 12-week study. Participants can be either in- or outpatients. The total study duration will be 12 weeks for each participant and will include following visits: Screening, Week 0, 4, 8, and 12 (end of treatment or early withdrawal). Throughout the study, participants will receive paliperidone ER in a flexible dosing range of 3 to 12 milligram per day (mg/day). Efficacy will primarily be evaluated by PANSS and PSP scale. Participants' safety will also be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants who meet the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self)
* Participant is drug naive or participant's previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons
* Participants or their legally acceptable representatives had signed an informed consent document indicating that they understand the purpose of and procedures required for the study and were willing to participate in the study
* Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study and must have a negative urine pregnancy test at screening

Exclusion Criteria:

* Participants with use of clozapine, paliperidone extended release (ER), any conventional depot neuroleptic or Risperdal CONSTA during the last 3 months
* Participants with serious unstable medical condition, including known clinically relevant laboratory abnormalities
* Participants with history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
* Participants with known hypersensitivity to paliperidone ER or risperidone
* Participants with inability to swallow the whole study medication tablet with aid of water
Substudy - Evaluation of Patients With Iliac Vein Thrombosis

Patients with previous diagnosis of iliac vein thrombosis are enrolled in this registry. Using standardized questionnaire, clinical data detailing venous thromboembolism and contributing VTE risk factors are recorded. Results of technical and laboratory investigations including screening of thrombophilic disorders were additionally entered into the database.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* subjects with iliofermoral thrombosis, which has been proven by objective measurements (Duplex sonography, phlebography, CT/MRT) later than 1996

Exclusion Criteria:

* \<18 years
* \> 80 years
* surface or deep vein thrombosis without affection of pelvis
The Order Effect of Acute Concurrent Exercise on Executive Function: An Event-Related Potential Study

Executive function is a high-level cognition which plays an important role in our life. Meta-analysis study has demonstrated that acute exercise could improve executive function. However, it is still unclear whether executive function can be enhanced by the concurrent exercise that combines aerobic and resistance exercise. Moreover, the sequence of concurrent exercise may result in different blood lactate concentration which may affect executive function. Therefore, the purposes of present study are: (1) Measuring the order effect of acute concurrent exercise on executive function. (2) Measuring whether order effect of acute concurrent exercise on executive function is mediated by blood lactate.

Executive function is a high-level cognition which plays an important role in academic performance, career, and interpersonal relationship. Meta-analysis study has demonstrated that acute exercise could improve executive function, and also observed similar positive effect through both aerobic and resistance exercise. However, it is still unclear whether executive function can be enhanced by the concurrent exercise that combines aerobic and resistance exercise. Moreover, the sequence of concurrent exercise may result in different blood lactate concentration which may affect executive function. Therefore, the purposes of present study are: (1) Measuring the order effect of acute concurrent exercise on executive function. (2) Measuring whether order effect of acute concurrent exercise on executive function is mediated by blood lactate.

Eligibility Criteria:
Inclusion Criteria:

1. no history of psychiatric or neurological disorders
2. no history of cardiovascular disease
3. normal or corrected to normal vision and normal color perception
4. right handed
5. 18.5 \< BMI \< 27

Exclusion Criteria:

1. Diagnosed with epilepsy
Comparison of Erector Spinae Plane Block and Intravenous Analgesic in Nefrectomy

The efficacy of erector spinae plane block versus intravenous analgesics compared relate to the morphine consumptions

Patients undergoing elective nefrectomy were enrolled. Patients divided into two groups with a sealed envelope technique to ESP+ pca morphine group or iv analgesic + pca morphine group. All patients will premedicated. then esp will applied to one group before surgery at the preoperative care unit by the same anesthesiologist. The other group will receive intravenous tramadol 1 mg/kg + NSAID 1 ampule + parol 10 mg/ kg + ondansetron 4 mg bolus. İntravenous morphine pca with a concentration of 0.5 mg/cc were applied. And administered 1 mg boluses every 15 minutes lock time and 4 hour limit as 4 mg arranged. An anesthesia nurse who is responsible of all pcas' in the hospital was recorded the variables of these patients in the service

Eligibility Criteria:
Inclusion Criteria:18-65 years age

* ASA I-II
* undergoing elective nephrectomy

Exclusion Criteria:- ASA\>3

* heart disease
* pregnancy
* lung disease
* scoliosis
* bleeding disorder
* infection at the manipulation side
Safety, Tolerability, and Pharmacokinetic Study of ISIS ApoC-III Rx in Hypertriglyceridemia

The purpose of this study is to evaluate the dose/response pharmacodynamic effects of ISIS ApoC-III Rx vs. Placebo on fasting total apoC-III levels.


Eligibility Criteria:
Inclusion Criteria:

* Severe hypertriglyceridemia

Exclusion Criteria:

* HbA1c \>/=9.0%, type 1 diabetes, or history of outpatient insulin use for more than 2 weeks in the last year
* Body mass index (BMI) \>40 kg/m2
* History of bariatric surgery or currently on weight loss drugs
* Use of oral contraceptives or hormone replacement therapy or statins unless stable for 3 months prior to dosing
* Group 1 and 2 patients: Use of systemic corticosteroids, fibrates, niacin, fish oil or other products containing omega-3 fatty acids within 6 weeks of dosing. Group 3 patients: unable to discontinue use of systemic corticosteroids at least 6 weeks prior to dosing ; use of niacin, fish oil, or other products containing omega-3 fatty acids unless on a stable well controlled dose for at least 30 days prior to screening that is not anticipated to change during the study period. Group 4 patients: unable to discontinue use of systemic corticosteroids at least 6 weeks prior to dosing; use of fibrates niacin, fish oil, or other products containing omega-3 fatty acids unless on a stable well controlled dose for at least 30 days prior to screening that is not anticipated to change during the study period.
* Use of topical corticosteroids, anticoagulants, or drugs or dietary supplements with potential lipid-altering effects unless dose is stable and well controlled for 30 days prior to dosing
* Any Screening laboratory values that are out of allowed reference ranges
* Inability to comply with protocol or study procedures
* Any other significant illness or condition that may adversely affect the subjects participation in the study
A Study of LioCyx in Patient With Recurrent HBV-related HCC Post Liver Transplantation

Hepatocellular carcinoma (HCC) represent approximately 70-85% of liver cancer, in which Hepatitis B virus (HBV) is the major etiologic agent accounting for at least 80% of HCC in Asian countries. Overall, transplantation remains the best option however, HCC recurrence rate is high among liver transplant patients.

While there are limited treatment measures for HBV-related HCC recurrences, the study hypothesized that LioCyx is capable of lysing target liver cells expressing the HBV cognate antigens and provide clinical benefit to patients with HBV-related HCC.

The study is a Phase I/II, open label, single-arm, multicenter study of LioCyx. Subjects with recurrent hepatitis B virus-related hepatocellular carcinoma who undergone liver transplantation will be enrolled.

Approximately 6-12 subjects will be enrolled in Phase 1 dose regimen exploration, and approximately 60 subjects will be enrolled to characterize the safety and evaluate the efficacy of LioCyx"

All subjects will be followed up for survival until death.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent locally advanced and/or metastatic hepatocellular carcinoma (HCC) post liver transplantation
* Life expectancy of 3 months or greater
* Have measurable disease by the revised response evaluation criteria in solid tumors (mRECIST)
* History of positive test for hepatitis B virus surface antigen (HBsAg)
* Expression of LioCyxTM target epitopes within specific human leukocyte antigen (HLA) class I profile
* Had received treatment with at least one standard therapy or refused, appropriate approved therapy for their disease
* 21 years of age or older
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* Willing and able to comply with all study procedures

Exclusion Criteria:

* Known, clinically suspected or has history of central nervous system (CNS) and bone metastasis
* Tumor burden in the liver exceeding 70%
* Significant ongoing immunologic rejection based on pathology and clinical diagnosis
* Evidence or history of significant bleeding diathesis or coagulopathy
* Prior exposure to any cell therapy such as, but not limited to NK, CIK, DC, CTL, stem cells therapy
* Known history of testing positive for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
* Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples
* Women who are pregnant or breast-feeding
Intraoperative Body Core Temperature Monitoring: Oesophageal Probe vs Heated Controlled Servo Sensor

Monitoring of intraoperative core temperature is essential for patient safety, reducing the risk of perioperative hypothermia. A recently developed measuring system, SpotOn® (3M, St. Paul, MN), measures the core temperature in a non-invasive manner. Its accuracy in patients undergoing general surgery has not been investigated yet. The study was aimed at comparing the accuracy of the SpotOn® in comparison with the oesophageal probe which is considered the current standard in our care units.

Monitoring of intraoperative core temperature is essential for patient safety, reducing the risk of perioperative hypothermia. A recently developed measuring system, SpotOn® (3M, St. Paul, MN), measures the core temperature in a non-invasive manner. Its accuracy in patients undergoing general surgery has not been investigated yet. The study was aimed at comparing the accuracy of the SpotOn® in comparison with the oesophageal probe which is considered the current standard in our care units. In this study, patients who were candidates for major or urological surgery will be considered eligible for enrollment. The core body temperature will be thus measured with both a single-use oesophageal probe and a SpotOn® heated controlled servo sensor.

Eligibility Criteria:
Inclusion Criteria:

* age\>18 years
* patients scheduled for major abdominal surgery
* patients scheduled for general anesthesia
* expected surgery duration longer than 30 minutes

Exclusion Criteria:

* skin infection in the forehead
* upper airway anatomy alterations
* pre-existing oesophageal disease
(MIGA) Mini Geriatric Assessment To Replace the Comprehensive Geriatric Assessment

This is a comprehensive Geriatric Assessment (CGA) currently used to evaluate elderly people in order to be able to assess their multiple organ pathology, cognitive, functional and social problems. This CGA is a very time consuming tool although a powerful one.

The investigators want to present a new assessment test witch is short and comprehensive tool witch will be checked in ambulatory and in-hospital geriatric patients.

MIGA test (Mini Geriatric Assessment) includes the following parameters Walking outdoors, Transfer, ADL-Dressing, Washing, Continence, Vision, Hearing, Pain, Sleeping, Weight loss, Get-Up-And-Go test, Short term memory, Clock drawing test, Falls, functional reach of hands, Depression, Behavioral problems, social support, Admissions, Polypharmacy,

All patients will be assessed by the traditional CGA and by the new MIGA test. Time consuming of the two tests will be measured and compared.

Eligibility Criteria:
Inclusion Criteria:

* Elderly people age 65 and above,
* In patients hospitalized in the geriatric department
* Out patients -from the geriatric out patient clinic
* Elderly patients visiting in the emergency room

Exclusion criteria:

* People under 65 years old
* Critically ill patients ( acute infection, acute myocardial infarction, hypoxia, hemodynamic instability)
Assessing the Efficacy of a Preoperative Navigation System in Anterior Cruciate Ligament Reconstruction

The ACL surgery robot features a preoperative navigation system that enhances the precision of bone tunnel placement. As the first dual-bundle reconstruction surgical robot developed in China, it integrates advanced technology to ensure accurate anatomical alignment. This multi-center study aims to evaluate the robot's effectiveness in improving surgical outcomes and reducing complications, demonstrating the potential of domestic innovations in orthopedic surgery. With its high accuracy in locating bone tunnel footprints, this robot represents a significant advancement in ACL reconstruction techniques.

The trial is designed as a randomized controlled trial (RCT) led by a prospective randomized cohort. The study is initiated by Tsinghua University's long-term professor, Yu Jiakuo, and the product has received China's Class III clinical registration certificate.


Eligibility Criteria:
Inclusion Criteria:

1. Preoperatively, the participant or guardian is willing and able to sign the informed consent form;
2. Patients aged 18 to 80 years (inclusive of 18 and 80 years), regardless of gender;
3. Patients who meet the diagnostic criteria for anterior cruciate ligament (ACL) tear and have no contraindications for implantation;
4. Patients with mature skeletons;
5. Good compliance and willingness and ability to participate in follow-up observations as required.

Exclusion Criteria:

* (1) Participants who have previously participated in other clinical studies of drugs, biological agents, or medical devices but did not meet the primary study endpoint within the specified timeframe; (2) Patients with a known allergy to one or more implanted materials; (3) Patients who are physically frail or unable to tolerate surgery due to other systemic diseases; (4) Presence of active infectious lesions in the knee joint or other parts of the body; (5) Obesity with a BMI \> 35; (6) Patients with severe diabetes (acute complications of diabetes, preoperative random blood glucose ≥ 16.7 mmol/L with or without altered consciousness, such as diabetic ketoacidosis, suspected diabetic ketoacidosis, hyperglycemic hyperosmolar state, or lactic acidosis; chronic complications of diabetes leading to severe target organ damage requiring urgent treatment, such as acute cardiovascular and cerebrovascular diseases, renal insufficiency, severe vision loss due to retinal disease, intermittent claudication and ischemic symptoms due to peripheral vascular disease, diabetic foot); (7) Women who are pregnant or breastfeeding; (8) Drug users and substance abusers; (9) Patients who are mentally incapacitated or unable to understand the requirements for participating in the study, making cooperation difficult; (10) Those expected to have poor compliance, unwilling or unable to follow postoperative therapy and/or rehabilitation program instructions; (11) Other comorbid conditions that limit participation in the study, hinder compliance with follow-up, or affect the scientific integrity of the study; (12) Other conditions judged by the investigator to be unsuitable for inclusion.
The Impact of Policies Regarding E-cigarette on Adolescents and Young Adults' Cognition and Behavior for E-cigarette

Based on the Knowledge，Attitude，Belief and Practice model(KABP model), this study intends to use a mixed method to explore the influencing mechanism of youth and adolescents' cognition and behavior for e-cigarette before and after the promulgation of the new regulations on e-cigarette . Information from network epidemiology (including network links, text, images, audio, video, etc.) was captured to expand the data abundance, and the retrieval behavior of e-cigarettes and the trajectory changes of e-cigarette-related events were explored. Finally, summarize the data, integrate and explain the influencing mechanism of youth and adolescents' attention and cognition on e-cigarette, and provide ideas for subsequent e-cigarette control, as well as theoretical and practical basis for relevant departments to formulate corresponding policies.

Mixed method will be used: the cross-sectional surveys will be conducted on the demographic characteristics, e-cigarette use intentions, e-cigarette use behaviors, attitudes towards e-cigarette , knowledge of e-cigarette harm, reasons for using e-cigarette and the degree of understanding of the new regulations on e-cigarette control ; semi-structured interviews will be conducted with some young people and adolescents interviewed by using phenomenology and qualitative research methods, and the content of the interview will be summarized and analyzed. The primary and secondary categories and dimensions are coded; the analysis results of quantitative data and qualitative data are combined to explain the influencing mechanism of the trial implementation of e-cigarette regulatory regulations on youth and adolescents' cognition of electronic cigarettes and changes in their use behaviors.

Using the network epidemiological method, use the "drop-down word deep mining function" of the 5188 marketing big data website to obtain the relevant keywords of "electronic cigarette", and use the Baidu index and 360 index tools to explore the retrieval behavior of electronic cigarettes and related electronic cigarettes Event trace changes.

Combined with online epidemiological data and mixed method study results, summarize the changes in youth and adolescents' cognition and use of e-cigarettes before and after the promulgation of the new regulations, and provide a theoretical basis for formulating e-cigarette control policies in the future.

Eligibility Criteria:
Inclusion Criteria:

* 14-35 years old;
* Being able to read and write in Chinese.

Exclusion Criteria:

* Those who are unable to communicate due to serious mental or physical illnesses such as deafness, unclear consciousness due to mental illness, etc.
Effect of Topical Imiquimod on Lentigo Maligna

The purpose of this study is to determine if topical imiquimod is effective in the pathological complete regression of lentigo maligna.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of lentigo maligna (LM) (acquired pigmented macule present for more than 12 months with no change in skin surface texture or contour, no palpability, diameter \>10 mm, sited on the head or neck). The lower anatomical limit is the root of the neck - a line joining the medial end of the clavicles with the medial insertion of trapezius.
* Histological findings consistent with LM (increased numbers of atypical melanocytes confined to the epidermis, sun damaged skin) in one or more 4mm punch biopsies(s) from the darkest area, reported by a pathologist with expertise in the diagnosis of melanocytic lesions, and part of a recognised NHS skin cancer Multi-Disciplinary Team.
* The upper limit of the lesion is not defined by size, but it must be suitable for complete surgical excision using a 5 mm lateral margin.
* The outline of the lesion must be easily defined visually in daylight around its entire circumference.
* Patient fit enough and willing to undergo surgery as required by the protocol.

Exclusion Criteria:

* Clinical or histological evidence of invasive melanoma including any palpability of the lesion, or clinical and/or histological evidence of regression or dermal invasion
* Aged less than 45 years
* Recurrent LM - the index lesion must not have been previously treated
* Life expectancy of less than 12 months
* Other skin lesions which may compromise the ability to complete this study, such as co-existing or adjacent melanoma or non-melanoma skin cancer. Co-existing adjacent actinic keratoses would not exclude the patient from the study
* Women of childbearing potential, who are pregnant, plan to become pregnant during their study participation or breastfeeding.
* Unable to give informed consent.
* Hypersensitivity to imiquimod or to any of the excipients (methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), cetyl alcohol and stearyl alcohol).
* Taking immunosuppressive medication.
* Taking part in any other intervention study.
Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting

The aim of this study is to determine the effect of pregabalin versus dexmedetomidine on the treatment and lasting duration of delirium in fast tracking elderly patients after Coronary Artery Bypass Grafting.

Delirium is an acute brain disorder that involves changes in consciousness, attention, cognition, and perception.The incidence of postoperative delirium (POD) is high among patients undergoing cardiac surgery, ranging from 20 to 50%, and the risk is even higher in the elderly.

Eligibility Criteria:
Inclusion Criteria:

* CABG patients ≥ 65 years of age both genders American Society of Anesthesiologists (ASA) physical status classification II or III planned for fast track developed postoperative delirium (POD).

Exclusion Criteria:

* Patients who had history of psychiatric diseases; inability to communicate;
* previous history of POD; preoperative sick sinus syndrome, allergy/sensitivity to pregabalin or dexmedetomidine, severe bradycardia (heart rate \<50 beat per minute), second-degree or above atrioventricular block without pacemaker; severe hepatic or renal insufficiency.
* Previous cardiac or thoracic surgery, known diagnosis of depression or other major psychiatric diseases, cognitive impairment or inability to cooperate with the study, renal insufficiency, and history of substance abuse.