cyrilzakka/clinical-trials huggingface dataset:
Transarterial Ethanol Ablation(TEA) for Unresectable Hepatocellular Carcinoma(HCC)

The objective of this trial was to evaluate the clinical outcome, treatment toxicity and tumor response of TEA for unresectable HCC.

Transarterial therapy has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic lesions not eligible for surgical resection, transplantation, or local ablative therapy. Among the various options of transarterial therapy including chemoembolization (TACE), bland embolization, radioembolization, and TEA, chemoembolization is the only one that has been proven to be of survival benefits versus best supportive care in randomized controlled trials. TEA is a hybrid of bland embolization and chemical ablation. Utilizing a liquid agent of Lipiodol-ethanol mixture consisting of 33% ethanol by volume, TEA offers complete and long lasting embolization of both the arterioles and portal venules supplying the tumor and could possibly be more effective than particulate embolic agents in tumor vessel embolization. The component of ethanol very likely offers synergistic effect to embolization and causes tumor ablation.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent by patient
* Age above 18 years
* Child-Pugh A or B cirrhosis
* Eastern Cooperative Oncology Group(ECOG) performance score 2 or below
* No serious concurrent medical illness
* No prior treatment or surgery for HCC
* Histologically or cytologically proven HCC except for lesions of size 1 to 2 cm, with typical features of HCC on two dynamic imaging techniques, or lesions larger than 2cm, with typical features on one dynamic imaging techniques, or lesions larger than 2cm with alpha feto protein(AFP) level \> 200 ng/mL
* Unresectable disease without extra-hepatic involvement on chest X-ray(CXR) and CT
* Massive expansive tumor type with measurable lesion on CT
* Total tumor mass \< 50% liver volume
* Tumor size ≤ 15cm in largest dimension
* Tumor number ≤ 5

Exclusion Criteria:

* History of prior malignancy except on the condition that the patient has been disease free for ≥ 3 years
* Concurrent ischemic heart disease or heart failure
* History of acute tumor rupture presenting with hemo-peritoneum
* Serum creatinine level \> 180 umol/L
* Biliary obstruction not amenable to percutaneous drainage
* Child-Pugh C cirrhosis
* History of hepatic encephalopathy
* Intractable ascites not controllable by medical therapy
* History of variceal bleeding within last 3 months; serum total bilirubin level ≥ 50 umol/L
* Serum albumin level \< 25g/L
* International normalized ratio(INR) \> 1.5
* Extrahepatic metastasis
* Infiltrative or diffuse tumor
* Tumor number \> 5
* Thrombosis of target hepatic artery
* Partial or complete thrombosis of the main portal vein; tumor invasion of portal branch of contralateral lobe
* Hepatic vein tumor thrombus
* Significant arterio-portal venous shunt
* Significant arterial-hepatic venous shunt
An Observational Study for Gastric Cancer in Asymptomatic Carriers of High Risk Helicobacter Pylori

This study is intended to be a prospective observational cohort study. The incidence of gastric cancer and progression of gastric precancerous lesions will be compared between groups through prospective follow-up of a population of asymptomatic carriers harboring high-risk Hp SNP subtypes and non-high-risk subtypes.

Primary study objective: to assess the difference in the incidence of gastric cancer between asymptomatic carriers of high-risk SNP subtypes of H. pylori and the non-high-risk population during the follow-up period.

Secondary research objectives: 1. To observe and compare the cumulative incidence and progression of gastric precancerous lesions (e.g., atrophic gastritis, intestinal metaplasia, etc.) in each population group during the follow-up period.2. To explore the interaction of high-risk SNPs on the risk of gastric cancer in the context of different age, gender or other risk factors (e.g. diet, smoking, alcohol abuse, family history, etc.).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old, gender is not limited;
2. No previous history of gastric cancer (no radical surgery or radiotherapy treatment for gastric cancer);
3. Able and willing to provide informed consent and willing to accept baseline and follow-up examinations;
4. Able to cooperate in completing HP testing (breath test, gastroscopic biopsy or other standard testing methods) and HP SNP typing by stool testing;
5. No obvious gastric symptoms at the time of initial screening, no progressive gastric cancer or serious gastric diseases (e.g., perforated acute ulcers, upper gastrointestinal hemorrhage, etc.) detected, and no need for urgent surgery (not planned within 3 months) or other therapeutic interventions for the time being.

Exclusion Criteria:

1. Diagnosed gastric cancer or other malignant tumors of the digestive tract;
2. Comorbid serious underlying diseases (e.g., severe cardiopulmonary insufficiency, liver and renal failure, etc.) that are expected to have a short survival time or are not suitable for long-term follow-up;
3. Inability to complete or refusal to undergo HP testing, SNP gene testing or follow-up;
4. Presence of severe mental illness or incapacity for civil behavior that prevents completion of the study;
5. Pregnant or breastfeeding women who are temporarily excluded;
6. Other conditions that the investigator considers unsuitable for participation in this study.
A Clinical Study of Laparoscopic Proximal Gastrectomy Based on PTST(Parachute-tunnel- Style Technique) Esophagogastric Anastomose.

1. To evaluate the safety, simplicity and effectiveness of the gastric function (anti-reflux) preservation of the innovative "parachute-tunnel-style technique" (PTST) in laparoscopic proximal gastrectomy.
2. To investigate the correlation between anastomotic stenosis and blood supply of serosa-muscle flap,suture after esophagogastric anastomosis.(obtain objective indexes such as blood supply, healing pattern and length change of serosa-muscle flap through animal experiments)


Eligibility Criteria:
Inclusion Criteria:

* Gastric cancer was confirmed histopathologically;
* Patients who may undergo proximal gastrectomy according to guidelines;
* Early upper gastric cancer, more than 1/2 of the distal gastric remnant remained after resection;
* Esophagogastric junction carcinoma with maximum diameter ≤4 cm;
* Patients with advanced upper gastric cancer (MSI-H) achieved cCR by neoadjuvant immunochemotherapy.

Exclusion Criteria:

* Patients with systemic conditions that cannot tolerate laparoscopic surgery;
* Distal gastric remnant was less than 1/2 after proximal gastrectomy.
Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.

In this pilot study the feasibility continous recording of vital signs in pediatric patients under chemotherapy for cancer, is studied.

Vital signs and are recorded with two different wearable devices (WDs): Everion®, by Biovotion (now Biofourmis), Zurich, Switzerland and CORE® by GreenTEG, Zurich, Switzerland. Patients can choose if they want to wear one or both WDs during this study. Those opting to wear two WDs can choose if they want to wear them in parallel, or sequentially.

Results from the two different WDs will be compared. Study duration for each participant is 14 days per device.

In a previous study (Bern 2019 WD Pilot, NcT04134429) the investigators found that continuous recording of vital signs with the Everion® is feasible in good quality across a wide age range (3 to 16 years) of pediatric patients undergoing chemotherapy for cancer. However, the pre-defined criterion to claim feasibility was not formally reached and low compliance was the main reason identified.

In this study the investigators want to assess the impact of measures aiming to increase compliance on feasibility for the Everion®.

Second, the investigators want to assess the feasibility of a second device, made commercially available only in October 2020, the CORE® WD by GreenTEG. Results from the two different wearable devices will be compared. Study duration for each participant is 14 days per device.

Eligibility Criteria:
Inclusion Criteria:

* Chemotherapy treatment because of any malignancy, expected to last ≥1 month at time of recruitment for myelosuppressive therapy; or at least one cycle of myeloablative therapy requiring autologous (Bern/Basel) or allogeneic (Basel) hematopoietic stem cell transplantation.
* Age from 1 month to 17.99 years at time of recruitment
* Written informed consent from parents and participants, where applicable

Exclusion Criteria:

* Local skin diseases prohibiting wearing of the WD.
* Denied written informed consent from participants
Future Internet Social and Technological Alignment Research

Bipolar disorder patients frequently presents recurring episodes and often experience subsyndromal symptoms, cognitive impairment and difficulties in the functioning with a low quality of life, relapses of disease and recurring hospitalization. Early diagnosis and appropriate intervention may play a role in preventing the neuroprogressive course of bipolar illness. The new technologies represent an opportunity to develop psychological standardized treatments using internet devices that minimizing the limitations of face to face treatments because of its accessibility that allow adjusting to the availability of each user. However, although exist many online psychological programs through web and mobile devices for bipolar disorder, there is not evidence about their efficacy and effectiveness due to the variability in measures and methodology used.

Future Internet Social and Technological Alignment Research (FI-STAR) clinical trial is a randomized simple blind evaluation within an European project. FISTAR is developed to compare this technical solution with treatment as usual. Bipolar disorder patients are to be included and randomly assigned to one of two treatment groups: 1) the experimental group (tele-care support) and the control group. Participants in both groups will be evaluated at baseline (pre-treatment) and at post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of bipolar disorder.
* Being aged between 18-50 years.
* Being in remission (euthymic state).
* Being familiarity with new technologies (computer and /or smartphone).
* Being treatment in the mental health network of the Basque Country (Osakidetza).

Exclusion Criteria:

* Having listening, reading or writing problems.
* Having a diagnosis of mental retardation.
* Unavailability of a smartphone.
* Having manic or depressive symptomatology at the time of inclusion (HAMD\> 16 and YOUNG\> 8).
* Having suicidal ideation.
Dining With Diabetes in Pennsylvania

Penn State Extension's Dining with Diabetes program is an evidence-based community education program for people with or at risk for type 2 diabetes. The program teaches participants how to prevent or manage their disease by providing practical knowledge and strategies to make the necessary lifestyle changes that will lead to healthier living and reduction in the risk of complications. The overall goals and objectives of the program are as follows:

Increasing knowledge of healthy food choices for families with or at risk for diabetes Promoting behavior changes by offering demonstrations and tasting of healthy food.

Increasing knowledge of essential medical tests associated with diabetes management.

Promoting physical activity as a component of diabetes control. Encouraging self-management and self-efficacy skill. Connecting participants to their healthcare providers for long-term follow-up. The program is designed to meet 4 consecutive weeks and then a 3 month follow-up. Participants A1c and blood pressure are taking at the first and follow-up classes. Classes consist of a nutrition lesson, physical activity, cooking demonstration and food tasting.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with type 2 diabetes individuals with pre-diabetes individuals at risk of developing type 2 diabetes healthy family members/caretakers healthy volunteers

Exclusion Criteria:

* under age 18
Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects

The purpose of this study is to determine the impact of an autologous umbilical cord patch for dural closure on the repair of open neural tube defect. The outcomes will evaluate successful defect closure, creation of a more capacious spinal canal, and reduction in inflammatory tissue response versus historical controls.


Eligibility Criteria:
Inclusion Criteria:

* Neonates born with prenatal diagnosis of open neural tube defect (myelomeningocele or myeloschisis)
* Resident of the United States
* Provision of signed and dated informed consent form
* Stated willingness by legally authorized representative (LAR) to comply with all study procedures and availability for the duration of the study
* Maternal age 18 years and older
* Mother is English or Spanish Speaking

Exclusion Criteria:

* Sepsis or signs of infection of the neonate
* Febrile or other acute illness of the neonate at time of delivery
* Major congenital anomaly unrelated to spina bifida that may impact safety of neonate for surgery
* Evidence of intra-amniotic or maternal infection related to pregnancy at time of delivery
* Maternal use of steroid therapy during pregnancy or neonate use of steroid therapy,except for lung maturity indications
* Vaginal delivery
* Patch closure of dura is deemed unnecessary
* Umbilical cord abnormality
* Insufficient autologous cord tissue or patch
* Autologous umbilical cord patch that does not meet laboratory safety standards per standard operating procedure (SOP)
* Treatment with an investigational drug or other intervention that would influence morbidity or mortality
Evaluation of the Superiority of VAsopressin Versus NOradrenaline in the Management of Patients at Risk of Kidney Failure Undergoing Cardiac Surgery With Extracorporeal Circulation

This is a randomized, double blind, multicenter study following surgery with extracorporeal circulation to compare blood pressure optimization with vasopressin versus noradrenaline. It is planned to include 840 patients in order to have 420 patients with vasoplegic syndrome.

The primary objective of this study is to determine whether the use of vasopressin to maintain blood pressure following cardiac surgery decreases the number of patients with acute renal failure and/or death compared with the usual use of norepinephrine.

Participation in the study involves daily follow-up at D1, D2, and D7 of the onset of the syndrome and then follow-up at D30 and D90.


Eligibility Criteria:
Inclusion Criteria:

* Patient who has given free, written and informed consent
* Patient of legal age.
* Negative pregnancy test for women of childbearing age
* Patient requiring cardiac surgery:

  * Scheduled (\> 24h)
  * With extracorporeal circulation (ECC)
  * Myocardial revascularization (coronary bypass), and/or surgical correction of valvulopathy (aortic, mitral, pulmonary, tricupsidian), and/or of the ascending aorta and/or removal of an intracardiac tumor, and/or closure of a PFO/ASD
* Patient with at least 3 risk factors for acute kidney failure including:

  * age \> 70 years, combined surgery (more than two procedures), common trunk lesion, preoperative anemia, chronic respiratory failure, obliterative arterial disease of the lower extremities, diabetes, glomerular filtration \< 60 ml min-1 m², LVEF \<40%, redux, intra-aortic counterpulsation balloon, expected duration of bypass surgery \> 100 min, albuminuria

Exclusion Criteria:

* Patient not affiliated to national health insurance or not beneficiary of a social security system,
* Patient subject to a measure of legal protection (curatorship, guardianship),
* Pregnant, parturient or breastfeeding women,
* Patients of legal age who are incapable or unable to express their consent,
* Patients who have already been included in this study
* Patients requiring emergency surgery (less than 24 hours)
* Patient with chronic kidney failure on dialysis,
* Patient with a cardiac transplant,
* Patient on left-sided monoventricular assistance,
* Patient on ECMO/ECLS,
* Patient with acute circulatory failure in the immediate preoperative period (sepsis, hemorrhage),
* Patients with known hypersensitivity to the active ingredient (argipressin) or to one of the excipients of REVERPLEG®.

Secondary exclusion criteria:

* Patient not developing persistent arterial hypotension (vasoplegic syndrome), within 12 hours after completion of surgery, defined as persistent mean arterial pressure (MAP) \<65 mmHg despite correction of preload and inotropism, with a cardiac index \>2.2 l min-1 m-2, and not responding to 30 mg cumulative of ephedrine in bolus
* Patient with hemorrhagic shock perioperatively before receiving vasopressor therapy (treatment under study)
Probiotics in Hospitalized Patients Study

The purpose of this study is to compare the effect of enhanced probiotic (EP, Live Rx) versus placebo (PL) on the incidence of Clostridium difficile associated diarrhea (CDAD) or antibiotic associated diarrhea (AAD) in hospitalized patients initiated on antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older admitted to SSH and prescribed antibiotics for an expected duration \>3 days (may include patients on antibiotics prior to admission).

Exclusion Criteria:

* 1. History of chronic diarrhea illness (Irritable Bowel Disease (IBD), Irritable Bowel Syndrome (IBS), Celiac Disease, Chronic pancreatitis 2. Diarrhea at screening 3. Active Colitis of any etiology 4. History of colectomy 5. Regular consumption of probiotics within 72 hours 6. Unable to provide written consent 7. History of or active pancreatitis 8. Severe Sepsis or Septic Shock (sepsis with end organ failure e.g. renal failure, ARDS, MS changes and or meets criteria by n ational guideline, and or requiring vasopressors) 9. Hypersensitivity to any ingredient in probiotic product 10. Severe Immunosuppression (ANC \<1000, AIDS/CD4 count \<200 cells, cancer on active chemothereapy, h/o of solid or bone marrow transplant) 12. Acute burn injuries
Smartphone Twelve Lead Electrocardiogram Utility In ST-Elevation Myocardial Infarction

Is the Smartphone ECG (electrocardiogram) an acceptable replacement for a standard ECG in the identification of STEMI (ST Elevation Myocardial Infarction).

The primary objective of this study is to determine if the Smartphone electrocardiogram (ECG) is an acceptable replacement for a standard ECG in the identification of ST Elevation Myocardial Infarction (STEMI).

Toward this objective, this study involves the following:

Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone "12-lead equivalent" ECG on patients presenting with chest pain in which the STEMI protocol was activated.

Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone "12-lead equivalent" ECG on patients presenting to the Emergency Department for evaluation of chest pain, not necessarily presenting with STEMI.

Reading of ECGs (standard 12-lead and iPhone) by three independent cardiologists, who are blinded to the initial clinical ECG readings, the type of ECG equipment used, and the patient's clinical information.

Assess the operational feasibility of using the Smartphone to obtain "12-lead equivalent" ECG recordings in patients suspected to have STEMI, and

Determine the possibility of pooling the data obtained from this study with data from other institutions conducting identical studies, and developing a future and statistical analysis plan to compare the sensitivity, specificity, positive predictive value and the negative predictive power of the iPhone ECG, using a paired standard 12-lead ECG as the gold standard.

There will be no therapeutic interventions. A single research-related procedure will be required, i.e., an iPhone ECG. Effort will be made to ensure that the performance of this procedure will not delay any treatment and/or diagnostic procedures that are part of usual or specialized care that the patient requires.

The individual patient's participation in the study will actually be only one day, i.e., the day the informed consent is obtained and the two comparison ECGs will be done.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures (patient or legally acceptable representative).
* Symptoms of chest pain upon presentation

Exclusion Criteria:

* Inability or refusal of the patient and/or the patient's legally-acceptable representative to provide written informed consent for any reason.
* Other conditions that in the opinion of the Principal Investigator or Co-Investigator(s) may increase risk to the subject and/or compromise the quality of the clinical trial.
Study of Ixekizumab in Healthy Participants

The purpose of this study is to compare the tolerability of injections of each of 3 formulations of ixekizumab using a prefilled syringe. Information about any side effects (including injection site reactions \[ISRs\]) will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male participants or female participants who agree not to get pregnant
* Are male participants or female participants with chronic, stable medical problems that, in the investigator's opinion, will not place the participant at increased risk by participating in the study

Exclusion Criteria:

* Have a significant history of, or current, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of the investigator poses an unacceptable risk to the participant if participating in the study
* Are allergic or hypersensitive to the study medicine
* Have dullness or loss of sensitivity on either side of your abdomen
* Have any condition that could affect pain perception from an injection
* Had a vaccination with a live vaccine within 12 months prior to the first check-in or intend to get a vaccine for tuberculosis within 12 months of completing treatment on this study
* Have any type of hepatitis, human immunodeficiency virus (HIV) infection, or other serious infection
* Show evidence of active or latent tuberculosis (TB)
* Presence of significant neuropsychiatric disorder or a recent history of depression
* Have excessive tattoos or scars over the abdomen or other factors such as rash or excessive folds of skin that would interfere with injection site assessments
* Have had any active or recent infection within 4 weeks of Day 1 that, in the opinion of the investigator would pose an unacceptable risk to the participant if participating in the study