cyrilzakka/clinical-trials huggingface dataset:
Surgical Outcome of HCC With Portal Vein Tumor Thrombosis on the Basis of Risk Scoring

The goal of this multicenter retrospective cohort study is to investigate the clinical outcomes and prognostic factors after hepatic resection in patients with HCC exhibiting PVTT, and to develop a prognostic index that can be helpful in determining the treatment strategy.

Hepatocellular carcinoma (HCC) frequently invades the surrounding liver vasculature, with portal vein tumor thrombosis (PVTT) being the most common form of macrovascular invasion. At the time of HCC diagnosis, PVTT is detected in approximately 10%-40% of patients and is associated with an extremely poor prognosis.

In most staging systems and guidelines, HCC with PVTT, regardless of the extent of the tumor, is classified as an advanced stage, and surgical resection is not recommended as the first-line treatment. Instead, consensus guidelines such as those from the American Association of Study of Liver Disease(AASLD), the Asian Pacific Association for the Study of Liver(APASL), and the European Association for the Study of Liver(EASL) recommend systemic and targeted therapy for these patients. Despite these recommendations, experienced liver centers in Asia have been attempting surgical resection for some patients with HCC exhibiting PVTT, and the outcomes are favorable in selected patients. However, most of the studies were conducted in only one center, had a small sample size, and obtained undesirable surgical treatment outcomes in most of the patients. Thus, surgical resection has not yet been widely accepted as an effective treatment for patients with HCC and PVTT. In addition, a prognostic index that can indicate which surgical resection is beneficial in comparison with nonsurgical treatment remains unestablished. A randomized controlled trial could be the best way to compare the outcomes of surgical resection and nonsurgical treatments, but it is difficult to conduct because of difficulties in ethical approval and allocation concealment. Therefore, adequate studies with large sample sizes are needed to clarify the benefits of surgical resection in patients with HCC and PVTT and the prognostic index, which can specify the criteria for surgical resection in these patients.

This study aimed to investigate the clinical outcomes and prognostic factors after hepatic resection in patients with HCC exhibiting PVTT, and to develop a prognostic index that can be helpful in determining the treatment strategy.

Eligibility Criteria:
Inclusion Criteria:

The patients underwent liver resection for HCC with portal vein tumor thrombosis between Jan 2005 and Dec 2019 at 10 university-affiliated hospitals in South Korea.

Exclusion Criteria:

* Metastatic cancer \& extrahepatic metastasis
* Intrahepatic cholangiocarcinoma
* Mixed type hepatocellular-cholangiocarcinoma
* Recurred hepatocellular carcinoma
* not available medical records.
* Child-Pugh classification B or C
Structural Description of Skin Biopsies With Dynamic Full-field Optical Coherence Tomography on Suspected Basal Cell Carcinoma Lesions, a Pilot Study (DOCTOBA)

Basal cell carcinoma (BCC) are the most frequent skin cancers. Their incidence is constantly increasing. BCC diagnosis is first clinically suspected and then confirmed following histological examination of either a skin biopsy or the excisional specimen. Surgery is the first-line treatment and some procedures (notably Mohs surgery) require extemporaneous histological analysis of the edges to ensure a complete excision. Such on-site histopathological examination can be time consuming and associated with decreased sensitivity. Skin imaging techniques have already been tested to overcome these limitations and seem promising. Although some of them - such as confocal microscopy - are already even used in vivo, there is to date no report of the use of full-field optical coherence tomography for the diagnosis of BCC.

The DOCTOBA study intends to describe direct histopathological examination of fresh skin biopsy or excisional specimen with dynamic full-field optical coherence tomography.


Eligibility Criteria:
Inclusion Criteria:

- patient \> 18 years of age who received skin biopsy or excision of basal cell carcinoma suspected lesion between start study date and primary completion date

Exclusion Criteria:

* inability to perform dynamic full-field optical coherence tomography observation at the moment of skin biopsy
* diagnosis of basal cell carcinoma disproved
24-week Open-label Extension Study Evaluating PXT00864 Effect in Mild AD Patients Further to PLEODIAL-I Completion

PLEODIAL-II study is an extension of the previous pilot PLEODIAL-I study (CLN-PXT00864-03 protocol) and is designed for the descriptive analysis of patients with mild AD who are exposed to PXT00864 over an additional 24-week period.

Patients having completed the previous 12-week PLEODIAL-I study were eligible to receive PXT00864 in this 24-week open-label extension PLEODIAL-II study in order to collect some additional long-term data regarding the safety and the potential effect of PXT00864 on cognitive and behavioural impairments.

Eligibility Criteria:
Main Inclusion Criteria:

* Mild Alzheimer's Disease patient who was included in PLEODIAL-I study
* Mini Mental State Examination (MMSE) score greater or equal to 20

Main Exclusion Criteria:

* Patient who was not compliant with the previous PLEODIAL-I study protocol
* Patient who experienced significant adverse events which necessitated treatment discontinuation during the PLEODIAL-I study
Study on Safety and Efficacy of Monopolar Radio Frequency Device for Facial Skin Tightening

Objective:

The goal of this clinical trial is to evaluate the safety and efficacy of the VOLNEWMER monopolar radiofrequency device developed by CLASSYS Inc. This study is a prospective, single-center, single-arm, pilot clinical trial.

Research Questions:

1. Does the VOLNEWMER device improve skin elasticity?
2. Is the safety profile of the VOLNEWMER device acceptable?

Subject Procedures:

Subjects will:

* Receive a single treatment session using the VOLNEWMER device.
* Attend follow-up visits over a 12-week period to assess improvements in elasticity and safety.

The primary outcome is the improvement in skin elasticity of the face and cheeks, measured 12 weeks after treatment using the Cutometer R7. Secondary outcomes include the Global Aesthetic Improvement Scale (GAIS). Safety assessments involve monitoring treatment-emergent adverse events (TEAEs) associated with the application of the investigational medical device.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are aged 19 to under 65 at the time of consent.
* Subjects who seek improvement in facial skin elasticity (both cheeks).
* Subjects who agree not to undergo other procedures affecting skin elasticity during the study.
* Subjects who provide written consent and commit to full trial participation.

Exclusion Criteria:

* Subjects with conditions at the investigational device application site (e.g., scars, open wounds, metal stents, or implants, that could affect the trial)
* Subjects with inappropriate skin conditions or treatment history
* Subjects with allergies or predispositions
* Subjects using inappropriate medications that have the potential to increase the risk of bleeding or delay skin healing.
* Subjects with lifestyle or other unsuitable conditions (Smoking history, participation in another interventional clinical trial prior to screening, not agreeing to use medically acceptable contraception, pregnant or breastfeeding women)
* Subjects deemed inappropriate by the investigator
Use of EL-FIT App to Promote Physical Activity

Transplant-eligible patients with cirrhosis and ESLD, age 40-70, MELD \>/= 10 referred to transplant physical therapy will be invited to participate. The investigators will exclude those who lack a smartphone or the understanding of its functionality, lack home wireless internet, or have recurrent/persistent overt hepatic encephalopathy. Following signing of informed consent, each participant will be given a Fitbit Charge 3 and have EL-FIT and Fitbit apps downloaded to their smartphone. After a brief session with a member of the research team explaining the basic components and functionality of EL-FIT and Fitbit, patients will be provided with general physical activity recommendations (as per our current standard of care) and asked to explore all features of EL-FIT and Fitbit apps, up until their 12-week follow-up visit. Phone calls to incentivize physical activity and exercise will be performed by members of the research team.

The study consists of two visits, baseline and 12-week follow-up, with at least one follow-up phone call on a weekly basis. Visit one is expected to last for 30 minutes and visit 2 for 60 minutes, whereas each phone call should take no more than 15 minutes. Twice during the study period, the investigators will draw serum and plasma samples for future translational research. Daily, the physical trainer will review collected data on EL-FIT research database and Fitabase. Each participant will have an exit interview by the end of week 12 with the trainer and a member of the research team to talk about their impressions of using EL-FIT and Fitbit, through a structured questionnaire assessing about how user friendly it was to use the EL-FIT app. Finally, trainers will be asked to compare the type of prescription that they provided to patients as part of the standard of care (based on liver frailty index or 6-minute walk test), to compare it with the allocation provided by EL-FIT stratification algorithm.

To learn about how to improve EL-FIT the investigators will ask patients and their caregivers open-ended questions as part of their exit interview. This will allow us to identify barriers precluding them from keeping up with physical trainer recommendations, and what would they like to include to enhance motivation as part of a physical activity program. A member of the research team will act as a facilitator during this session.

Eligibility Criteria:
Inclusion Criteria:

* cirrhosis and ESLD
* transplant eligible
* MELD \>/=10
* referred to transplant physical therapist

Exclusion Criteria:

* those who lack a smartphone or the understanding of its functionality
* lack home wireless internet
* have recurrent/persistent overt hepatic encephalopathy
Evaluation of Preventive (Stay Safe) Training Program of Child Abuse for Teachers and Children

The current study aims to elaborate the effectiveness of stay safe programme which is a child abuse prevention programme for children, this study examine the effectiveness of this programme on children and teachers of Multan city schools. Mainly, this study enhance the understanding of teachers and children to provide protection and confidence by following programme.

The study examine the stay safe programme effectiveness among school teachers and children, as Pakistan is today badly indulge in this issue; In this circumstances this type of study provide essential role in society. some schools from Multan city are included, the quasi experimental study is used, where the participants are randomly divided into two groups (control and experimental). school based sampling method is used where different campuses of one school is included, through random number generator, six schools are selected for participation where 3 schools are included in control group and 3 are in experimental group. the participants consist of school teachers and children, where each group (children \& teachers) is further divided into control and experimental group. children and teachers of class 1 and 2 are included. scales used in the study are Battle self-esteem inventory and children knowledge and skills questionnaire for children while teachers knowledge and skills questionnaire for teachers is used in study. 1 week time gap is also considered between pre and post testing for better examination of change. stay safe programme is very powerful tool as it cover different sensitive issues and provide confidence or safety skills to children.it also provide teachers with the strategies that they should use to make classroom environment healthy or encourage children to speak up and also provide guidance to deal with issues safely and listen every child carefully. Different videos, worksheets, basic knowledge that cover 5 major topics like feeling safe and unsafe, wanted and unwanted touch, bullying, tell adults about negative interaction with bullies and victimizers, strangers and dealing with strangers are all include in the stay safe programme. The lessons that include in this programme are so healthy and best for the protection of child, it also boost their self-esteem and make them worthy and active cognitively. informed consent is provided to participants for initiating the study properly, as it is ethical. every participant data would be confidential or the theme of study would be debrief to the control group after study.

Eligibility Criteria:
Inclusion Criteria:

1. students enrolled in class 1-2
2. age range between 5-9
3. students allowed by their parents to participate in the study.

Exclusion Criteria:

1. students not enrolled in class 1 or 2
2. students not within age range.
Sepsis: Prognosis and Evaluation of Early Diagnosis and Intervention (SPEEDI Study)

BACKGROUND: In November 2003 the Medical Director at Copenhagen University Hospital, Hvidovre, gathered a group of doctors involved in the diagnosis and treatment of patients with sepsis.

AMIS: To develop a fast and reliable tool that can guide the physician in the diagnosis and treatment of the septic patient thereby reducing mortality and morbidity. The measurement of markers of inflammation, coagulation, infection and specific bacterial antigens in the same plasma sample will give insight to the pathogenesis of sepsis and SIRS and the bodies responds to the disease.

MATERIAL AND METHODES: Case-Control study nested in cohort. 300 patients admitted to the hospital from 1.01.05 to 01.07.06. Copenhagen University Hospital, Hvidovre, an 800 beds hospital, covers a part of Copenhagen with a wide variety in the population's socioeconomic and cultural background. For the analysis of markers the luminex 100 lab analysis system is used. It utilizes xMAP® technology which enables you to simultaneously assay up to 100 analytes in a single well of a microtiter plate, using very small sample volumes. Assay development of a 15-plex is don In-house.

COWORKERS \& FOUNDING: The following departments at the hospital, are coworkers in the SPEEDI study: Clinical Research Unit, Departments of Infectious Disease, Clinical Microbiology, Clinical Biochemistry, Gastroenterology (incl. surgery), Intensive Care Unit, Emergency Room, and the Hospital Board of Directors. All departments have research experience and a long tradition of publication of scientific works. The study received founding for equipment and salaries during the first phase of the study from the hospitals Board of Directors. Applications to major public foundations in Denmark are awaiting answer. No commercial interest are involved in the study.

FUTURE APPLICATIONS: A second phase of the study including children admitted at the hospital is in preparation. The very small sample volume is a great advantage in diagnosing infection in children. The applications of the study results will hopefully provide the physician with the needed tool for a fast and reliable diagnosis, prognosis and treatment guide for the patients suffering from SIRS and sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted with ≧ 2 of the following 4 symptoms of SIRS:

  * Resp. rate \> 20/min
  * Heart rate \> 90/min
  * Temperature \> 38ºC or \<36ºC
  * Leukocytes \>12.000 or \<4.000

Exclusion Criteria:

* Admitted to a hopital \>24 h prior to inclusion
* Antibiotic therapy initiated at a hospital \>8 h prior to inclusion
Rectus Sheath Block for Analgesia After Gynecological Laparotomy

Thirty subjects undergoing laparotomy for Gynecologic oncology surgery will be prospectively enrolled and will receive a bilateral rectus sheath block (RSB) under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side. Cases will be matched in a 1:2 ratio by age, race, insurance status and duration of surgery with historical controls who received postoperative analgesia using thoracic epidural analgesia.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥18 years presenting for a laparotomy for Gynecologic malignancy with a vertical incision.
2. ASA Classification II or III.
3. English speaking patients

Exclusion Criteria:

1. BMI \>50 kg/m2.
2. Chronic pain or chronic opioid therapy.
3. Allergy or contraindication to local anesthetics or any component of the multimodal analgesic regimen (NSAIDs and acetaminophen)
Does Improving Vagal Tone Increase Mitochondrial Bioenergetics

This study evaluates the effect of auricular neurostimulation on mitochondrial bioenergetics and inflammation through vagal nerve modulation via non-invasive percutaneous electrical nerve field stimulator in children with functional gastrointestinal disorders.

In understanding the pathophysiology of pediatric functional gastrointestinal disorders (FGID), it has been documented that subjects have decreased vagal tone. Vagal tone in turn modulates mitochondrial bioenergetics and plays a role in anti inflammatory effects. Further defining these brain-body connections that underlie FGID's could help guide future treatment.

The investigators postulate that a 4 week neuro-stimulation with an Electro Auricular Device that has already shown to increase vagal tone will produce an increase in mitochondrial bioenergetics and decrease in inflammatory markers in this patient group.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking and able to verbalize their condition and concerns about nausea, pain and other symptoms
* Subjects will meet Rome IV criteria for functional nausea, irritable bowel syndrome, dyspepsia or functional abdominal pain as determined by a pediatric gastroenterologist
* Patients must have an intact external ear that is free of infection or severe dermatological conditions, have stable vital signs for their respective age, no history of seizures and no currently implanted electrical device

Exclusion Criteria:

* Mental retardation or pervasive developmental disorder or epilepsy
* Psychosis
* Genetic or chromosomal disorders
* Pregnancy
* Subjects who admit to substance abuse during screening
* Patients with findings of peptic ulcer disease, H.pylori gastritis, celiac disease, inflammatory bowel disease, allergic disorders, or any chronic condition or medication that may cause nausea or pain
* Patients who are treated with opioids or who had any changes in their medical regimen in the past four weeks prior to study
* Patients with a history of allergy to adhesives
Collateral Ligation in Failing Fistulas

Arteriovenous fistulas (AVFs) for hemodialysis often fail to become usable due to failure to mature (FTM). The most common cause is narrowing of the artery or vein (stenosis). Another potential cause is the presence of collateral or side branch veins that steal blood flow from the main fistula channel. Some believe that occluding these veins might help maturation of those failing AVFs. To evaluate if this actually works, patients with FTM will be randomly assigned to side branch vein ligation (or not), and rates of AVF maturation of the two groups will be compared.

Arteriovenous fistulas (AVFs) for hemodialysis often fail to become usable due to failure to mature (FTM). The most common cause is stenosis of the artery or vein. Another potential cause is the presence of collateral or side branch veins that steal blood flow from the main fistula channel. The utility of ligating these veins to improve maturation of those failing AVFs is controversial. To evaluate this, 35 patients presenting for fistulograms for evaluation of AVFs with FTM, found to have side branch veins will be prospectively enrolled. After management of stenoses (if present), they will be randomly assigned to ligation of the venous side branches or not. Maturation rates for each group will be prospectively assessed. For patients assigned to the control group who have persistent failure to mature, a cross-over intervention will be performed and side branch ligation will be offered.

Eligibility Criteria:
Inclusion criteria:

- Patients with upper extremity autogenous AVF presenting with FTM with evidence of collaterals on ultrasound and/or clinical exam.

Exclusion criteria:

* Age under 18 years
* Pregnant women
* Prior endovascular or surgical procedure in the fistula after its creation (with the exception of surgical superficialization or mobilization)
* Clinical evidence of infection associated with the AVF
* Uncorrectable coagulopathy (International Normalized Radio \>2.5, platelet count \<50.000/μL)
* Absence of significant venous side branches on angiogram (defined as those that arise in the initial 10 cm, including the future cannulation zone, and have maximal diameter greater than or equal to one third of the widest diameter of the fistula's main venous channel in this segment).
Effect of Calcium- D Supplement on Hypertension

Triple-blind randomized clinical trial was done on 98 hypertensive women of postmenopausal ages in 2019. The study was executed for 8 weeks with close follow up and , 24-hour Ambulatory blood pressure monitoring (ABPM) was used to record the initial and final blood pressures of all participants. Patients were randomized to calcium-D supplement and placebo

Triple-blind randomized clinical trial were performed on 98 hypertensive women of postmenopausal ages in 2019. They were randomly divided into a control group of 50 members and a treatment group of 48 members. Randomization was based on block randomization method with block size=2 and ratio 2:2 for drug and placebo. To achieve triple blinding, patients were divided into "A" and "B" groups(by the mentioned randomization method). "A" was assigned to treatment and "B" to placebo but this assignment was not revealed to the patients, trial conductors and result assessors till the end of data analysis.

Oral calcium-D supplements were given to the treatment group in the form of tablets named Vana Flex® from Vana Darou Gostar Co. (VDG Co.). Each tablet contained 500 milligrams of calcium carbonate and 200 international units (IU) of vitamin D3(cholecalciferol). The placebo pills for the control group were chose in a way that looked similar to the calcium-D tablets in shape and color. The placebo tablets we used in this trial were made up of magnesium stearate 0.2 %, starch 10%, avicel 30%, and lactose 60%. The calcium-D and placebo tablets were both packed identically in order to assure blindness and the patients were told to take one tablet per day. The treatment and placebo group started drugs beside their previous hypertension medications.

24-hour Ambulatory blood pressure monitoring (ABPM) was done primarily for all of the participants to record the initial blood pressure of patients and after completion of study period

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal female with hypertension
* receiving antihypertensive drugs

Exclusion Criteria:

* history of coronary artery disease
* congestive heart failure
* chronic renal disease
* hypercalcemia
* nephrolithiasis
* any other contraindications of calcium use