cyrilzakka/clinical-trials huggingface dataset:
Prospective Randomized Trial Comparing Endoscopic Submucosal Dissection Against Laparoscopic Assisted Gastrectomy for Treatment of Early Gastric Cancer

The investigators compared the perioperative, oncological, functional and immunological outcomes of endoscopic submucosal dissection against laparoscopic assisted gastrectomy for treatment of early gastric cancer. With virtually no abdominal incisions and minimal pain induced, endoscopic submucosal dissection is expected to be less invasive when compared to laparoscopic assisted gastrectomy for treatment of early gastric cancer. This study will show that endoscopic submucosal dissection is associated with a significantly better perioperative recovery and less immunological disturbance. Moreover, it will also induce a better long term outcomes as the stomach can be preserved, hence the digestive function is maintained to prevent long term functional morbidities of the gastrointestinal tract.

This study will be the unique first study in the literature to show that intramucosal early gastric cancer can be adequately treated by endoscopic submucosal dissection with better perioperative, functional and quality of life outcomes when compared to laparoscopic assisted gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

1. Early gastric cancer with biopsy confirmed high grade dysplasia or adenocarcinoma (intestinal type)
2. Preoperative investigation with magnifying endoscopy and / or EUS predicted to be mucosal lesion
3. Any tumor size if the early gastric cancer has no ulceration
4. Tumor size ≤ 3cm if the early gastric cancer has ulceration

Exclusion Criteria:

1. Gastric cancer with preoperative magnifying endoscopy and / or EUS predicted to beyond submucosal invasion
2. Poorly differentiated or signet ring cell adenocarcinoma
3. Age \> 80 or \< 16
4. Pregnancy
5. ASA \> IV
Genetic- and Biological-Markers of Predisposition to Atherosclerosis: Leipzig-Heart Study

Atherosclerotic cardiovascular disease is the major cause of morbidity and mortality in Western societies. It is a complex genetic disorder with many genes involved and significant gene-environment interactions. The aim of the study is to identify novel genetic- and biological-markers of atherosclerosis. Atherosclerosis is assessed in the coronary arteries using coronary angiography as well as in the carotid artery (intima-media-thickness) and peripheral vessels (ankle brachial index). Association analysis of genetic and metabolic markers with atherosclerotic burden will be performed to identify novel factors of disposition to atherosclerotic vascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients assigned to coronary angiography

Exclusion Criteria:

* Cancer
* Acute myocardial infarction
* Inability to give informed consent
A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)

This study was conducted to assess the safety, immunogenicity, efficacy and long-term effectiveness of a vaccine being evaluated for the prevention of human papillomavirus (HPV) infection and disease in mid-adult women.

The Base study vaccination period (V501-019) encompassed Day 1 through Month 7, during which time participants received randomly assigned, blinded Gardasil™ (V501, qHPV vaccine) or placebo at Day 1, Month 2 and Month 6. The Base study follow-up period continued through approximately Month 48.

The base study was extended in protocol V501-019-10 (EXT1). Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the Base Study were offered a complete, open-label, 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants were followed to EXT1 Month 7.

A Long Term Follow-Up (LTFU) extension study V501-019-21 (EXT2) was added to observe the long term safety, effectiveness, and immunogenicity of qHPV vaccine in approximately 1,600 women who participated in the Base Study at sites in Colombia. Data were collected over a period of 6-10 years following participant's enrollment in the original Base Study.

Eligibility Criteria:
Inclusion Criteria:

* No history of genital warts, vulvar intraepithelial neoplasia (VIN), or vaginal intraepithelial neoplasia (VaIN)
* Not pregnant and agrees to use effective contraception through Month 7 of the study
* Additional criteria applied

Exclusion Criteria:

* Pregnant
* Concurrently enrolled in a clinical study involving collection of cervical specimens
* Previously received any HPV vaccine
* History of severe allergic reaction that required medical intervention
* Received any immune globulin or blood-derived products within 3 months prior to the first study injection
* History of splenectomy, known immune disorders, or receiving immunosuppressives
* Immunocompromised or diagnosed with human immunodeficiency virus (HIV) infection
* Known thrombocytopenia or any coagulation disorders that could contraindicate intramuscular injections
* History of recent or ongoing alcohol or drug abuse
* Prior treatment for genital warts, VIN, or VaIN
* History of cervical disease (ie, surgical treatment for cervical lesions)
* Hysterectomy
Feasibility Study of a Hemodynamic Parameter Algorithm

An algorithm to calculate hemodynamic parameters based on blood pressure waveform was developed by collecting arterial blood pressure of patients during surgery


Eligibility Criteria:
Inclusion Criteria:

* surgery patients

Exclusion Criteria:

* Weight ≤18kg arrhythmology cardiac disfunction
Effects of Omega-3 Fatty Acids on Outcome After Major Liver Resection

To study the efficacy and safety of intravenous Omegaven™ (vs. Placebo) in reducing postoperative morbidity and mortality after major liver resection.

With two single doses of Omegaven (pre- and postoperatively) we aim to reduce postoperative complications measured by the CCI (Comprehensive Complication Index) and the Clavien Dindo classification of surgical complications. The study will include adults (more than 18 years) patients requiring liver resection of at least 1 segment or multiple wedge resections (≥3).

Eligibility Criteria:
Inclusion criteria:

* Requiring liver resection of at least 1 segment or multiple wedge resections (=3)
* \> 18 years of age
* No coagulopathy (INR \< 1.2, platelets \>150'000 x10E3/µl)
* Understands local language

Exclusion criteria:

* Liver resections \<1 segment
* Wedge resections (\<3)
* Liver cirrhosis
* Coagulopathy (INR \> 1.2, platelets \< 150'000 x10E3/µl)
* Hypertriglyceridemia (\> 5.0 mmol/l)
* Hypersensitivity or allergy to Omegaven™ or any fish oil or lipid emulsions
* Known allergy to egg protein
* Pregnancy
* Nursing women
* Renal failure(estimated GFR \< 30 ml/min/1.73m2)
* Medication impairing platelets aggregation
* Cannot understand local language
Insulin Start Therapy Application With Resources and Training

The purpose of the I-START study is to evaluate an educational phone application (app) designed to support patients with type 2 diabetes (T2DM) by reinforcing the necessary skills needed for insulin administration as part of diabetes self-management.

Despite advances in technology and delivery systems, patients with T2DM continue to be reluctant to begin and adhere to insulin therapy for a variety of reasons. Introducing insulin therapy is particularly problematic during a hospitalization or a brief routine outpatient visit given time and resource constraints. Teaching people to administer an insulin injection requires time and ongoing support. Therefore, this study aims to evaluate an educational phone application designed to support patients with T2DM by reinforcing skills and self-management behaviors needed for insulin administration. Patients with T2DM who are starting insulin or need updated instruction on insulin will be invited to participate in this study to examine the effect of the phone app on psychological barriers to insulin as well as patient and provider satisfaction with and usability of the phone app in both outpatient and hospital settings.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Able to read and follow study instructions in English (translations will not be provided)
* T2DM requiring the use of prandial and/or long-acting insulin
* Ability to self-administer insulin therapy
* Willing to download the study app on their smartphone
* Able and willing to provide a signed consent
* Able and willing to follow all study procedures

Exclusion Criteria:

* Pregnant (self-reported)
* Participants from the same household participating concurrently
* Use of a smartphone with iOS version 10.0 or lower
* Use of a smartphone with Android OS 5.0 "Lollipop" or lower
* Currently using a continuous subcutaneous insulin infusion device
* Participants with major depression
* Currently or planning to participate in a similar study that would affect the results of this study
* Currently or planning to participate in a clinical study that involves taking a drug, supplement, or use of an investigational drug
* Continued hospitalization or transfer to an assisted living facility
* Any condition the PI or designee deems to pose a risk to the participant in the study (includes anything that may prevent full participation in the study)
RESTOR-MV: Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve

The purpose of this prospective, randomized, multi-center, pivotal trial is to compare the safety and effectiveness of the off-pump, closed heart Coapsys System (Myocor, Inc.) to open surgical repair of the mitral valve using an annuloplasty ring or band in patients with moderate to severe functional mitral regurgitation.

Patient clinical evaluations will consist of 3-month, 6-month, and 12-month follow up of the primary endpoints. Additional follow up of 18-month, 24-month, and annually thereafter will also be included.

Eligibility Criteria:
Inclusion Criteria:

* Grade 2, 3, or 4 functional mitral valve regurgitation per 2D echocardiography
* Patient undergoing concomitant coronary artery bypass graft surgery, either on-pump or off-pump
* Left ventricular ejection fraction greater than or equal to 25%
* Age between 18 and 80 years, inclusive
* Patient is willing and available to return for study follow up
* Ability of the patient or legal representative to understand and provide signed consent for participating in the study.

Exclusion Criteria:

* Structural abnormality of the mitral valve (e.g. calcification or thickening of the valve leaflets, ruptured papillary muscle, ruptured chordae tendinae, mitral valve prolapse, mitral stenosis, etc.)
* Asymptomatic Grade 2 MR (those with NYHA Class \< II AND LVEF \> 40%)
* Organic valve disease resulting in insufficiency or stenosis of the aortic, pulmonary or tricuspid valve requiring surgical intervention
* Transmural myocardial infarction within 30 day period prior to surgical placement of Coapsys
* NYHA class IV
* Left ventricular end diastolic diameter \> 7.0 cm
* Cardiac surgery on an emergency or salvage basis
* Left atrial or left ventricular thrombus
* Left ventricular aneurysm
* Previous mitral valve surgery or other previous cardiac surgery that would preclude proper placement of the Coapsys
* Chronic renal failure requiring dialysis
* Open chest surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis, pericarditis)
* Active infection
* Life expectancy of less than 24 months due to conditions other than their cardiac status
* Participation in another investigational drug or device protocol
* Abnormal coronary or cardiac anatomy such that the device could not be placed without interfering with those anatomical structures.
Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheters in Healthy Volunteers

The aim of the study is to test the performance and safety of a newly developed intermittent catheter


Eligibility Criteria:
Inclusion Criteria:

* 1. Have given written informed consent and signed letter of authority 2. Be at least 18 years of age and have full legal capacity 3. Be a male 4. Willing to refrain from using analgetics up to 24 hours prior to catheterization visits 5. Have a negative urine multistix - erythrocytes (Microscopic haematuria) 6. Have a negative urine multistix:

  * Leukocytes
  * Nitrite Or if positive, subsequent negative for bacterial growth in urine culture

Exclusion Criteria:

1. Abnormalities, diseases or surgical procedures performed in the lower urinary tract
2. Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
3. Participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or have previously participated in this investigation
4. Known hypersensitivity toward any of the test products -
S9810: Gemcitabine Plus Cisplatin in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot Be Removed by Surgery

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating patients with malignant mesothelioma of the pleura that cannot be removed by surgery.

OBJECTIVES: I. Estimate overall survival and confirmed and unconfirmed complete and partial response in patients with unresectable malignant mesothelioma of the pleura treated with gemcitabine plus cisplatin. II. Evaluate the qualitative and quantitative toxicities of this regimen in this patient population.

OUTLINE: Patients receive gemcitabine IV over 30 minutes, immediately followed by cisplatin IV over 30 minutes on days 1, 8, and 15. Courses are repeated every 28 days. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients with a complete response receive 2 additional courses of therapy. Patients are followed every 6 months until death.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 25 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of unresectable malignant mesothelioma of the pleura Epithelial, fibrosarcomatous, or mixed type Bidimensionally measurable disease No CNS metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least lower limit of normal Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 2 times ULN AND Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy within the past 5 years except adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission Must have chest x-ray within the past 28 days

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Concurrent hormones for non-disease-related conditions allowed Concurrent steroids for antiemesis, adrenal failure, or septic shock allowed Radiotherapy: No prior radiotherapy No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered
Detecting Colorectal Cancer With Liver Metastatic Lesions Using Novel Precise Imaging Tools

This study will demonstrate the diagnostic utility of PSMA PET among patients with CRC with liver metastasis.


Eligibility Criteria:
Main inclusion criteria:

1. The participants can voluntarily sign informed consent forms
2. The participants are male/female over 20 years old.
3. The participant is currently undergoing cancer staging based on the previous pathological diagnosis of colorectal cancer
4. The participants are confirmed liver metastasis by CT, abdominal ultrasound, MRI, and FDG PET/CT within 30 days before receiving PSMA-PET/CT.
5. WHO performance status ≦ 2 points
6. The participants can lie on table for two hours during PSMA-PET/CT scanning.

Main exclusion criteria: To improve the accurate interpretation of PMSA-PET imaging and reduce the occurrence of related-drug adverse events, the participants will be excluded by following below criteria.

1. The colorectal cancer participants was diagnosed other organs metastases with multiple organ metastases not only the liver.
2. The colorectal cancer participants have undergone any treate after diagnosis of liver metastasis.
3. The participants have suffered from liver dysfunction such as AST/ALT ratio \>2、total bilirubin \>1.5 mg/dL within 6 months.
4. The participants suffered stage IV chronic kidney disease (eGFR\<30 mL/min/1.73 m2) within 6 months.
5. The participants suffered acute kidney injury within 6 months.
6. The participants suffered trauma or fracture.
7. The participants are allergic to any radiopharmaceutical or imaging agent.
8. The participants are history of claustrophobia or are inability to remain quiet during the examination.
Possibilities of Interpreting the Night-to-Day Ratio Specified by 24-hour Blood Pressure Monitoring

Specify the risk rate of incorrect patient classification based on night-to-day ratio specification from singular 24-h ABPM in comparison to the results of 7-day ABPM monitoring

The subjects in the study are divided into 4 groups:

group 1 (40 healthy men and women without exercise); group 2 (40 healthy exercise-training men and women); group 3 (40 patients with ischemic coronary artery disease without exercise); and group 4 (51 patients with ischemic coronary artery disease following cardiovascular rehabilitation).

The subject of the evaluation is the percentage rate of incorrect subject classification (dipper, non-dipper, extreme dipper, and risers) based on the mean blood pressure values for 7 days and from seven independent 24-hour cycles (the mean value mode).

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (without any disease, including the cardiovascular ones, and without any kind of treatment)
* Patients with chronic ischemic coronary artery disease
* Patients treated with ACE inhibitors, beta-blockers or statins.
* To visit routinely in the health centres where the study is carried out

Exclusion Criteria:

* Age under 18 years,
* Pregnant, or breast-feeding,
* Patients on dialysis or being followed by nephrology,
* Severe physical or cognitive limitations,
* Intolerance to the method of measurement
Quality Assessment of a Training Period for Physical and Mentally Disabled People

The aim of the study was to evaluate the effect of a 8 week training period compared with control group in physical and mentally disabled adults. The effect was evaluated in relation to their physical status. Furthermore, physical activity was measured using steps and active minutes.

This study aimed at making a quality assessment of a 8 week training period for adults with physical and mental disabilities. A control group was added to compare the effect of the training with no training. Before the training period the participants were tested in relation to their physical status: weight, height, fat%, blood pressure, Aastrand test, chair stand test and waist circumference. In addition to this, the participants were instructed to wear an accelerometer to measure step and active minutes for 2-3 days a work.

The staff at the day center, where the participants works in daytime, were responsible for the physical training 2 times/week for 8 weeks. The training was an hour of combined aerobic, strength, balance and flexibility training.

The participants were tested after the training period using the same test-protocol as before.

Eligibility Criteria:
Inclusion Criteria:

* User of the centers included in the study
* Being able to stand alone
* Being able to use an exercise bike
* Being able to understand danish

Exclusion Criteria:

* Pregnancy
* Pacemaker
* Not being able to stand up by themselves
The Role of Angiotensinogen Gene Polymorphism in the Pathogenesis of Non-familial Sick Sinus Syndrome

Evidence has been documented for the close relationship between the arrhythmia pathogenesis and the gene expression in renin-angiotensin system. However, it remains unclear for involvement of RAS in the pathogenesis of non-familial sick sinus syndrome. The researchers thus investigated the possible relationship between non-familial sick sinus syndrome and the polymorphism and haplotype of the AGT promoter.


Eligibility Criteria:
Inclusion Criteria:

* sick sinus syndrome

Exclusion Criteria:

* 1.Severe systemic disease.
* 2.Acute coronary syndrome.
* 3.bradycardia with reversible cause.
Impact of Anti-cytomegalovirus Treatment in the Management of Relapsing Ulcerative Colitis Requiring Vedolizumab Therapy

Ulcerative Colitis (UC) is an inflammatory bowel disease that can require the use of anti-TNF alpha therapy. When anti-TNF alpha failed to obtain a clinical response, the use of a new anti-integrin therapy, vedolizumab, can be proposed. The efficacy of vedolizumab has been assessed in a phase 3 study (GEMINI I), with response rates of 41.1% with vedolizumab vs 25.5% with placebo.

CytoMegaloVirus (CMV) reactivation has been associated with resistance to steroid and to several lines of immunosuppressive therapy. Antiviral therapy was proven to decrease the tissue viral load and to restore the response to immunosuppressive therapies (up to 80% in small group of patients). A recent meta-analysis supports the use of valganciclovir in case of CytoMegaloVirus (CMV) reactivation in active Ulcerative Colitis (UC).

Moreover, a study showed that the risk of CMV reactivation seems to be more important with vedolizumab than with anti TNF, and the risk of colectomy is higher in case of CytoMegaloVirus (CMV) reactivation (p\<0.05).

The hypothesis of this study is in Ulcerative Colitis (UC) patients with tissue CytoMegaloVirus (CMV) reactivation ; not responding to anti-TNF or without anti-TNF ; a treatment with valganciclovir, added to vedolizumab, could improve the clinical response.

Eligibility Criteria:
Inclusion Criteria:

* Patient with moderate to severe active Ulcerative Colitis (UC) defined by a Mayo score greater than 5
* Patient with an inflammatory outbreak of Ulcerative Colitis (UC) :

  * without anti-TNF
  * under anti-TNF (infliximab, adalimumab, golimumab) after induction (no primary response) or clinical recurrence (secondary failure).
* Having rectosigmoidoscopy with an endoscopic Mayo score≥ 2 with 2 biopsies of the inflammatory tissue
* Presence of a CytoMegaloVirus (CMV) infection in the inflammatory tissue (viral load greater than 5 IU / 100000 cells by qPCR)
* Patient with a negative pre-treatment assessment including HIV, HBV, HCV, HCV serology, a negative quantiferon or a history of tuberculosis preventive treatment adapted by Rifinah or Rimifon
* Signed informed consent

Exclusion Criteria:

* Patient with severe acute colitis
* Patient treated by ciclosporin or Prograf
* Patient with Human Immunodeficiency Virus (HIV)+, hepatitis B, hepatitis C, tuberculosis
* Clostridium difficile infection.
* Patient with intolerance or contraindications to current therapy
* Pregnant or starts breastfeeding
* Patient who received a live vaccine in the month preceding the study
* Patients with severe renal insufficiency defined by creatinine clearance \<30ml/minute, or hemodialysed