cyrilzakka/clinical-trials huggingface dataset:
Liver Cancer Disparities in American Indian and Alaska Native Persons

We are performing a pilot and feasibility randomized controlled trial (RCT) of HCC screening by US + AFP every 6 months (n=100), the current standard-of-care, versus aMRI + AFP every 6 months (n=100) for 12 months (i.e. at time 0, 6 and 12 months) among AI/AN patients with cirrhosis or HBV.

We are performing a pilot and feasibility randomized controlled trial (RCT) of HCC screening by US + AFP every 6 months (n=100), the current standard-of-care, versus aMRI + AFP every 6 months (n=100) for 12 months (i.e. at time 0, 6 and 12 months) among AI/AN patients with cirrhosis or HBV.

We will compare the aMRI vs. the US arm with respect to the following outcomes:

1. Compliance/feasibility of conducting all three screening tests (0, 6 and 12 months) - Primary Outcome
2. Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system - Primary Outcome
3. Proportion diagnosed with HCC and stage at diagnosis - Secondary Outcome

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis, any etiology, or chronic HBV infection
* High risk of HCC
* Age 18-75
* Competent to provide informed consent

Exclusion Criteria:

* Prior diagnosis of HCC
* Current suspicion of HCC
* Prior receipt of any organ transplantation
* Participation in another HCC screening trial
* CTP score \>=10
* MELD-Na score \>20
* GFR\<30
* Poor life expectancy (\<5 years)
* Contraindication to MRI
* Inability to complete study visits
* Currently pregnant
Rotational Thromboelastometry Activated Transfusion In Trauma Trial

This is a randomized controlled trial to compare viscoelastic (VE) guided resuscitation to fixed-ratio resuscitation in trauma patients with hemorrhagic shock on the utilization of blood products, effects on coagulation and inflammatory mediators, and how these strategies affect post resuscitation adverse events.

This is an open labeled study as the VE guided resuscitation will be based on the visible VE results. Aim 1 will compare the number of blood products utilized in each resuscitation strategy. Aim 2 will analyze the coagulation and inflammatory mediators in each resuscitation strategy to determine if there is a difference in the mechanism of coagulopathy. Aim 3 will determine if the different resuscitation strategies have an effect on post resuscitation adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Trauma patient
2. MTP Activation
3. Only patients ≥ 14 years old
4. Alive at 31 mins after arrival in ED

Exclusion Criteria:

1. Transfer from OSH
2. Received CPR for more than 5 mins
3. Burned
4. Pregnant or Prisoner
5. Known DNR
6. Jehovah's witness
The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial

MICS CABG (Minimally invasive coronary surgery), where coronary artery bypass grafting (CABG) is completed through a small incision over the left chest, has evolved to become a safe and less invasive alternative to conventional sternotomy CABG. Several observational studies have suggested significantly shorter time to return to physical activity for MICS CABG patients compared to sternotomy CABG patients. A randomized study is warranted to validate these findings, provide higher level of evidence, and potentially lead to changes in practice. The MIST Trial is a multi-centre, prospective, open label, randomized control trial comparing quality of life and recovery in the early post-operative period, between patients undergoing MICS CABG versus patients undergoing sternotomy CABG. Patients referred for isolated CABG for multi-vessel coronary artery disease and deemed technically suitable for sternotomy CABG as well as for MICS CABG are considered for enrollment into the trial. Quality of life questionnaires (The SF-36, Seattle Angina Questionnaire and EQ-5D-5L) will be used to assess the quality of life and recovery in patients undergoing sternotomy CABG or MICS CABG at 1 month, 3 months, 6 months and 12 months follow up.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Angiographically-confirmed multi-vessel coronary artery disease lesions with \>=70% in at least 2 major epicardial vessels in 2 or more coronary artery territories (left anterior descending (LAD), circumflex (CX) and right coronary artery (RCA)) OR lesions \>=50% in the left main (LM)
* Patients who, in the opinion of the investigator, are amenable for coronary surgery through either median sternotomy or minimally-invasive approach.
* Patients who are willing and able to comply with all follow-up study visits.

Exclusion Criteria:

* \<18 years of age
* concomitant cardiac procedure with CABG (e.g. valve repair or replacement)
* Previous cardiac surgery, mediastinal irradiation, or significant trauma to the chest
* Contra-indications for MICS CABG, including: severe pectus excavatum; severe pulmonary disease; hemodynamically significant left subclavian stenosis; morbid obesity; severe left ventricular (LV) dysfunction; no adequate PDA or marginal branch target; absence of femoral pulse bilaterally.
* Contraindications for conventional CABG via sternotomy
* Concomitant life-threatening disease likely to limit life expectancy to \<2 years
* Emergency CABG with hemodynamic compromise
* Inability to provide informed consent.
Epidemiology of Treatment Resistant Depression in Taiwan

The purpose of this study is to assess the epidemiology of Treatment Resistant Depression (TRD) in the nationally insured population in Taiwan including incidence, duration of clinical episodes, and prevalence by age and sex.

This is a retrospective study of approximately one million subjects randomly selected from an anonymized database National Health Insurance Research Database (NHIRD). Participants aged 18 years or older who have had neither a depression diagnosis nor a dispensing of an antidepressant medication in the last four months of 2004 will enter the study when they receive in 2005 a depression diagnosis and a dispensing of an antidepressant medication within 30 days of each other and will be followed up to 8 years or until they have 4 months with neither a depression diagnosis nor a dispensing of an antidepressant medication. Treatment Resistant Depression (TRD) Incidence, TRD prevalence by age and sex and duration of clinical episodes will be estimated.

Eligibility Criteria:
Inclusion Criteria:

* Participants who have been continuously enrolled in the insurance plan since January 1, 2004 (ignoring breaks of less than 30 days) and have not received an exclusion diagnosis and during the last 4 months of 2004, a) Have not received a diagnosis of depression and b) Have not received a dispensing of an AD medication
* Participants with a diagnosis of a depressive disorder including dysthymic disorder (International Classification of Diseases \[ICD\]-9 codes 296 depression-related, 300.4, 311) and Major Depressive Disorder (ICD-9 296.2, 296.3) will be followed through December 31, 2013

Exclusion Criteria:

- Participants who receive following diagnosis will be excluded, a) Mania, b) Schizophrenia (ICD-9 codes 295), c) Bipolar disorder (ICD-9 codes 296 bipolar-related), D) Dementia (ICD-9 codes 290 or 294); Note: Major depressive disorder (MDD) with psychotic behavior (ICD 296.24 for single episode, ICD 296.34 for recurrent episode) is not an exclusion
Tocilizumab for Acute Chest Syndrome

The investigators are evaluating the role of a low dose of tocilizumab in treating acute chest syndrome in patients with sickle cell disease. Tocilizumab inhibits interleukin-6 (IL-6) receptors and is used to treat rheumatoid arthritis and severe cytokine release syndrome, which can be seen with chimeric antigen receptor T-cell (CAR-T) therapy, and it is also authorized for treatment of COVID-19. Since IL-6 levels are elevated in the sputum of patients with acute chest syndrome, the investigators are hopeful that this will be an effective strategy. The investigators will be looking at how a low dose of tocilizumab affects oxygen status, clinical outcomes, and laboratory markers in patients admitted to the hospital with acute chest syndrome.

In this randomized, placebo-controlled, double-blinded phase II study, enrolled patients admitted to the University of Chicago who are diagnosed with acute chest syndrome will receive one dose of tocilizumab 80 mg IV and one normal saline placebo dose. The order of these doses will be randomized at a 1:1 ratio. After collecting oxygenation data as a baseline for 8 hours, patients will then receive tocilizumab versus placebo as their early dose and then the opposite (placebo versus tocilizumab) 48 hours later. Clinical, laboratory, and patient-reported outcome data will be collected during their admission and compared between arms.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 12 years of age
* Prior diagnosis of sickle cell disease (Hb SS, Hb SC, Hb Sb+, and Hb Sb0)

Exclusion Criteria:

* Pregnant patients or breastfeeding mothers.
* Prior treatment with gene therapy or a stem cell transplant.
* Current enrollment in a clinical trial involving an FDA-regulated drug or biologic.
* Current neutropenia (absolute neutrophil count \&amp;lt; 1000/mm\^3)
* Current thrombocytopenia (platelet count \&amp;lt; 50,000 mm\^3)
* Aspartate aminotransferase (AST) or alanine transaminase (ALT) \&amp;gt; 10 times the upper limit of normal (ULN)
* History of tuberculosis (TB).
* Positive purified protein derivative (PPD) TB screening test.
* On active therapy with a Bruton's tyrosine kinase-targeted agent, which include the following: Acalabrutinib, Ibrutinib, Zanubrutinib
* On active therapy with a JAK2-targeted agent, which include the following: Baricitinib, Ruxolitinib, Tofacitinib, Upadacitinib
* Any of the following biologic immunosuppressive agent (and any biosimilar versions thereof) administered in the past 6 months:

Abatacept, Adalimumab, Alemtuzumab, Atezolizumab, Belimumab, Blinatumomab, Brentuximab, Certolizumab, Daratumumab, Durvalumab, Eculizumab, Elotuzumab, Etanercept, Gemtuzumab, Golimumab, Ibritumomab, Infliximab, Inotuzumab, Ipilimumab, Ixekizumab, Moxetumomab, Nivolumab, Obinutuzumab, Ocrelizumab, Ofatumumab, Pembrolizumab, Polatuzumab, Rituximab, Sarilumab, Secukinumab, Tocilizumab, Tositumumab, Tremelimumab, Urelumab, Ustekinumab
Quality of Life (QOL) Following Parathyroid Surgery

The only established treatment for the complete resolution of hyperparathyroidism is the surgical removal of the affected glands. While proven as a means of resolving hyperparathyroidism, there have been no comprehensive preoperative and postoperative assessments to determine quality of life for patients undergoing minimally invasive vs. traditional parathyroid surgery. Quality of life will be assessed in subjects undergoing minimally invasive procedures and traditional procedures using a clinically validated survey. We will gather data one week preoperatively as well as one week and one year postoperatively then compare the survey results from the two study groups to each other. We will also compare the study groups to a control group consisting of patients undergoing thyroid surgery. Our ultimate goal is to clarify if minimally invasive parathyroid surgery techniques contribute to a higher patient quality of life as compared to traditional techniques.


Eligibility Criteria:
Inclusion Criteria:

* parathyroidectomy

Exclusion Criteria:

* subjects under the age of 18
The Effect of SOD Enzyme on Frailty and HRQOL Among Indonesian Pre-frail Elderly: A Double Blind Randomized Controlled Trial

The primary objective is to determine the effect of SOD enzyme on frailty and health related quality of life among Indonesian pre-frail elderly.

The secondary objective is to determine the effect of SOD enzyme on anti-oxidant status, morbidity, and hospitalization among Indonesian pre-frail elderly.

The study hypothesis:

1. SOD enzyme can improve frailty status and health related quality of life among Indonesian pre-frail elderly.
2. SOD enzyme can increase anti-oxidant serum status among Indonesian pre-frail elderly.
3. SOD enzyme can decrease morbidity among Indonesian pre-frail elderly.
4. SOD enzyme can decrease hospitalization events among Indonesian pre-frail elderly.

1. Study design: randomized double blind placebo controlled trial.
2. Location and time of study: Geriatric Outpatient Clinic and Internal Medicine Outpatient Clinic in Cipto Mangunkusumo National Hospital Jakarta. Study will be conducted on April 2016 to April 2017.
3. Study subject: elderly outpatient (aged 60 years old or more) with pre-frail status, who visit the clinic for medical consultation.
4. Data sampling: consecutive method.
5. Sample size: 150 subjects (75 control group, 75 intervention group).
6. Data collection: demographic data, frailty status, health related quality of life, anthropometric data, anti-oxidant serum status, hospitalization during intervention, morbidity, nutritional status, food intake, hand grip strength.
7. Intervention: SOD+Gliadin in capsule with a dose of 250 mg twice a day for 24 weeks will be given to intervention group, while placebo group will be given placebo capsule (amylum).

Eligibility Criteria:
Inclusion Criteria:

* Elderly aged 60 years or more with pre-frail condition
* Patients with SOD enzyme deficiency
* Willing to participate

Exclusion Criteria:

* Patients with cognitive function impairment (AMT score \< 8)
* Patients with depression (Geriatric depression scale score \>= 10)
* Patients with history of cirrhotic hepatic disease or severe hepatic disease
* Patients with kidney function impairment
* Patients with gluten allergy and derivative products
* Patients consume other antioxidant and omega-3 supplement
Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Large Non Pedunculated Colonic Adenomas: a Randomized Comparative Trial

Initially developed in Japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (ESD) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. It allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2% However, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for WF-EMR) and longer. Submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by WF-EMR.

Scientific debate is agitating the Western world1,2 and Japanese experts do not perform WF-EMR anymore, whereas no comparative prospective study has compared these two procedures.

We therefore propose to compare these two endoscopic resection strategies in terms of recurrence rate at 6 months and to estimate the differential cost-effectiveness and cost-utility ratios over a 36-month time horizon.


Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from non-pedunculated polyp suspected larger than 25 mm in the colon
* Colon localization beyond 15 cm of the anal margin.
* Indication for endoscopic treatment
* Patients aged ≥ 18 years old
* Patients able to fill in questionnaires written in French

Exclusion Criteria:

* Prior endoscopic resection attempt
* Contra-indication to colonoscopy
* Contra-indication to general anesthesia
* Inability to stop antiplatelet agents and anti-coagulant according to the European Society of Gastro-Intestinal Endoscopy guidelines.
* Recurrent adenoma: post-endoscopic or surgical resection
* Pregnant or lactating women
* Genetic polyposis (Familial Adenomatous Polyposis, Lynch Syndrome, Peutz-Jeghers Syndrome)
* Inability to provide informed consent
* Patient under legal protection and or deprived of liberty by judicial or administrative decision
* Patient already participating in an interventional clinical research protocol
* Patient who cannot be followed for the duration of the study
* Non-pedunculated polyp ≤ 25 mm
* More than one lesion \> 25 mm that fulfilled the inclusion criteria
* Suspicion of deep submucosal cancer by analysis of macroscopic appearance (Paris 0-III), vascular pattern and pit pattern (SANO IIIB, KUDO Vn)
* Non granular pseudodepressed Laterally spreading tumors due to the high risk of nonvisible submucosal cancer
* Polyp involving the appendice deeply (type 2 or 3 of classification of Toyonaga)
* Polyp inside the ileo-caecal valvula
* Tattoing under the lesionInflammatory Bowel Disease with expected fibrosis (Crohn disease or ulcerative colitis)
* Colon localization \< 15 cm of the anal margin.
* Polyp invading a diverticulum
* Pedunculated polyp
* Absence of lesion
Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and 50 in Subjects With Type 2 Diabetes

This trial is conducted in Japan. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of biphasic insulin aspart 30 (NN-X14Mix30) and biphasic insulin aspart 50 (NN-X14Mix5050) in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Duration of diabetes for at least 1 year
* Body Mass Index (BMI) maximum 30.0 kg/m\^2
* HbA1c maximum 10.0%

Exclusion Criteria:

* Recurrent severe hypoglycaemia
* Proliferative or preproliferative retinopathy diagnosed within the last 12 weeks or laser therapy for retinopathy within the last 12 weeks
* Impaired hepatic function
* Impaired renal function
* Cardiac problems
* Uncontrolled treated / untreated hypertension
* Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
* Total daily insulin dose exceeding 40 IU
* Treatment with OHAs (oral hypoglycaemic agents) or insulin preparations twice or more frequently a day
* Treatment with OHAs or insulin preparations once a day later than noon
* Subjects who smoke more than 15 cigarettes per day
Self-administered Hyperinsufflation Chest on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit

In patients with neuromuscular disease, chest mobilization by hyperinsufflation slows respiratory decline by almost 80% compared to controls, and prevents complications like pneumonia, atelectasis and respiratory distress.

This insufflation technique improves the airway clearance and reduces the need for invasive ventilation. It also improves CV and DEPtoux in patients with neuromuscular pathology

During multiple sclerosis (MS), although expiratory involvement and reduced sputum capacity are predominant, automated techniques of hyperinsufflation and in-exsufflation remain underused and undervalued. A single retrospective study suggests a decrease in the decline in respiratory function with regular manual hyperinsufflation.

Evidence of a benefit of chest mobilization by hyperinsufflation by a controlled trial is therefore necessary before recommending its use in MS.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed MS diagnosis (McDonald criteria)
* EDSS ≥ 7
* Age greater than or equal to 18 years.
* Expiratory flow during a coughing effort (DEPtoux) ˂4.5L / s.

Exclusion Criteria:

* ENT and / or thoracic surgery less than 6 months old
* Progressive or past pneumothorax / pneumomediastinum
* Severe swallowing disorders.
* Inability to use the device under study
Graft Patency After FFR-guided Versus Angio-guided CABG (GRAFFITI) Trial

This is prospective, randomized, multicenter, multinational, randomized (1:1) study. The aim of this study is to assess the importance of functional assessment of coronary artery disease prior to bypass surgery. In particular, an FFR-guided strategy will be compared to the traditional Angio-guided strategy in the guidance of surgical revascularization by aorto-coronary bypass grafting.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stable angina, unstable angina or NSTEMI candidate to CABG
* Significant LAD and/or LM lesion - proved by FFR or Angiography AND
* At least one more, angiographycally intermediate lesion

Exclusion Criteria:

* Significant valvular disease with indication to surgical replacement
* Severe left ventricular dysfunction (EF\<35%)
* Acute STEMI
* Atrial fibrillation, if Maze procedure is planned
Development and Effects of a Structural Education Program in Adult Kidney Transplant Recipients

Kidney transplantation is the treatment of choice for patients with end-stage renal disease. The purpose of this randomized and controlled study is to evaluate the efficacy of a structured education program for adult kidney transplant recipients. Patients are randomly assigned to an educational program or to a standard care control group. The education group receives 8 lessons (each 90 minutes, 1 lesson per day), starting 4 days after kidney transplantation. Kidney transplant survival, number of rejections, infectious complications, length of hospital stay, blood pressure, HbA1c, glomerular filtration rate, quality of life (QoL) and knowledge are measured in both groups after 6, 12 and 24 months. The investigators postulate that the education group will have superior outcomes compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* being over 18 years recently had a kidney transplantation able to speak, write and understand german willing to participate regular visits after kidney transplantation

Exclusion Criteria:

* severe complications after recent kidney transplantation early loss of the kidney allograft severe allograft dysfunction