cyrilzakka/clinical-trials huggingface dataset:
Impact of Bariatric Surgery on the Evolution of Nonalcoholic Fatty Liver Disease: a Comparative Clinical Trial Between Sleeve Gastrectomy and Gastric Bypass

Aim: To compare prospectively two bariatric surgery techniques: sleeve gastrectomy (SG) vs gastric bypass (GB) in the evolution of nonalcoholic fatty liver disease (NAFLD) measured by the transient elastography in the first year. Methods: This is a randomized clinical trial with morbidly obese patients, between 18-60 years old from a Federal Hospital, Ministry of Health, Brazil. Patients were divided into 2 groups: group 1 - SG (n = 30) and group 2 - GB (n = 30). The randomization was made by lots. In the GB the investigators created 30 ml pouch, with a pancreatic and an alimentary limb of 1 meter, and a calibrated gastroenterostomy (1.5 cm diameter). In SG the investigators calibrated the gastric tube with a bougie number 32 (70 ml). The variables were compared one week before surgery and in the postoperative time (1, 3, 6 and 12 months). The variables were: patient anthropometry, laboratory tests and the transient liver elastography.


Eligibility Criteria:
Inclusion Criteria:

The eligibility criteria was:

* morbid obesity patient grade II or grade III (BMI \> 35) in prepare to bariatric surgery.

Exclusion Criteria:

The exclusion criteria were:

* age under 18 years or greater than 65 years old,
* chronic diseases (heart failure, chronic liver disease), and
* alcohol abuse (abuse was considered in those who consume more than 14 drinks per week).
IntraCardiac Echocardiography sysTem

To evaluate the safety and effectiveness of intracardiac ultrasound imaging system in Sonosemi Medical Co., Ltd.

A prospective, multicenter, randomized controlled, non-inferiority clinical trial was designed. In the experimental group, intracardiac and large blood vessel imaging, intracardiac Doppler flow assessment and guidance of intracardiac intervention were performed by intracardiac ultrasound imaging system of Sonosemi Medical Co., Ltd. The control group was treated with SOUNDSTAR 3D Diagnostic Ultrasound catheter (SNDSTR10G) and Vivid IQ, intracardiac and macrovascular imaging of the heart, assessment of intracardiac Doppler flow, and guidance for intracardiac intervention. After meeting the entry criteria, they will be randomized by an electronic randomization system, and the researchers will conduct a clinical trial based on the results of the randomization, intracardiac and large vessel imaging, intracardiac Doppler flow assessment, and guidance of intracardiac intervention were performed in both groups

Eligibility Criteria:
Inclusion Criteria:

1. patients aged ≥18 years and ≤85 years, regardless of gender,
2. patients who planned to undergo intracardiac and macrovascular imaging, intracardiac Doppler flow assessment, and intracardiac intervention,
3. subjects who could understand the purpose of the trial, were willing to cooperate with interventional treatment and follow-up, participated in the trial voluntarily and signed a written informed consent.

Exclusion Criteria:

1. known complication of sepsis, thrombosis or severe peripheral vascular disease;
2. angina class IV CCS or NYHA Class IV cardiac function,
3. severe Coagulopathy unable to perform vascular puncture,
4. known to be severely allergic to the materials used in the study;
5. pregnant or lactating women, or those who had planned to become pregnant during the trial;
6. those who were enrolled in any other drug or medical device clinical trial and had not yet left the group;
7. other conditions that the investigator judged unsuitable for enrollment.
Mechanisms of Insulin Resistance and Exercise in South Asians

This study determines the effect of aerobic and resistance exercise training on whole-body and skeletal muscle insulin sensitivity in south Asians and evaluate the mechanisms which contribute to improvements in insulin sensitivity after exercise training.

South Asians (SA) have 2-4 fold higher risk of type 2 diabetes and develop the disease at lower body weights and younger ages than white Europeans. Lower cardiorespiratory fitness and capacity for muscle fat oxidation contributes substantially to SAs' greater insulin resistance, the extent to which this can be improved by exercise training is unclear. This randomised controlled trial will investigate the effects of a 12-week aerobic or resistance exercise training intervention on insulin sensitivity (hyperinsulinaemic-euglycaemic clamp) in South Asian adults (22 control, 22 aerobic exercise group and 22 resistance exercise group). The study will also explore the mechanisms within skeletal muscle which mediate these changes by evaluating aerobic and resistance exercise-training induced changes: in basal and insulin-stimulated microvascular blood volume (using contrast-enhanced ultrasound); skeletal muscle mitochondrial function; and lipid droplet morphology and spatial interaction with mitochrondria, muscle fibre capillarisation, endothelial content of key enzymes controlling dilation/constriction and GLUT-4 translocation (using confocal immunofluorescence microscopy and transmission electron microscopy methods). Thus, this work will integrate physiological and molecular data to determine the extent to which exercise training can improve insulin sensitivity in SA and the mechanisms underpinning this improvement. This knowledge is important for optimising diabetes prevention interventions in SAs and identification of potential novel therapeutic targets.

Eligibility Criteria:
Inclusion Criteria:

* Male
* South Asian ethnicity (self-report of both parents of Indian, Pakistani, Bangladeshi or Sri Lankan origin)
* Age 30-65 years
* At least 10% 10-year risk of developing type 2 diabetes, determined using the QDiabetes®2018 risk score (http://qdiabetes.org/2018/index.php)

Exclusion Criteria:

* Female
* Diabetes (physician diagnosed or HbA1c ≥48 mmol/mol on screening)
* History of cardiovascular disease
* Hypertension (taking anti-hypertensives or BP consistently ≥ 150/90 mmHg on screening).
* Regular participation in vigorous physical activity
* Regular participation in resistance exercise
* Current smoking
* Taking drugs or supplements thought to affect carbohydrate or lipid metabolism
* Taking drugs affecting blood clotting (e.g. aspirin)
* Current treatment with anti-obesity drugs
* Any other significant illness that would prevent full participation in the study
Tegafur-Uracil or Observation in Treating Patients With Stage II Colorectal Cancer That Has Been Completely Removed By Surgery

RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating colorectal cancer.

PURPOSE: This randomized phase III trial is studying tegafur and uracil to see how well they work compared to observation in treating patients with stage II colorectal cancer that has been completely removed by surgery.

OBJECTIVES:

Primary

* Compare the efficacy of adjuvant tegafur-uracil vs observation only in patients with curatively resected stage II colorectal cancer.

Secondary

* Compare relapse-free and overall survival of patients treated with these regimens.
* Compare the occurrence of adverse events in patients treated with these regimens.

OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo observation.
* Arm II: Patients receive oral tegafur-uracil on days 1-5. Treatment repeats every 7 days for 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the colon or rectosigmoid

  * Stage II disease
* Has undergone curative (R0) resection within the past 8 weeks
* No suspicion of hereditary colorectal cancer
* No severe postoperative complications

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* WBC 3,500-12,000/mm³
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9.0 g/dL
* Bilirubin ≤ 2.0 mg/dL
* AST and ALT ≤ 100 IU/L
* Creatinine ≤ 1.5 mg/dL
* Not pregnant or nursing
* Able to take oral medications
* Major organ functions are preserved
* No other active malignancy
* None of the following conditions:

  * Uncontrolled diabetes mellitus
  * Uncontrolled hypertension
  * Myocardial infarction or unstable angina pectoris within the past 6 months
  * Liver cirrhosis
  * Interstitial pneumonia
  * Pulmonary fibrosis
  * Severe emphysema
* No psychiatric disease or other condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior chemotherapy
* No prior or concurrent radiotherapy
* No concurrent prophylactic growth factors
* No concurrent biologic response modifiers
Korean Registry of Target Organ Damages in Hypertension

The objective of this study is to know prevalence of clinical or subclinical target organ damages in Korea hypertensives by constructing nationwide hypertension registry. We will register 5000 consecutive patients with incident hypertension at 20 major university hospitals in South Korea. We will investigate clinical/subclinical target organ damages, renin/aldosterone level and cardiovascular events in each patient.

Background: the exact prevalence of target organ damages in Korean hypertensives are unknown.

Study Objective: to investigate the prevalence of target organ damages in Korean patients with incident hypertension.

Study Design: prospective, multi-center and observational study

Study Populaton: approximately 5000 consecutive patients with incident hypertension, who visited outpatients clinics and agreed to participate in the registry

Primary outcome

* Subclinical organ damages

  1. left ventricular hypertrophy on electrocardiogram or echocardiography
  2. increased intima media thickness of carotid artery (\> 0.9 mm) or plaque
  3. increased pulse wave velocity (\> 12 m/s)
  4. low estimated glomerular filtration rate (\< 60 ml/min/1.73 m2) or creatinine clearance (\<60 ml/min)
* Established CV or renal disease

  1. cerebrovascular disease: ischemic stroke; cerebral stroke; transient ischemic attack
  2. Heart disease: myocardial infarction; angina; coronary revascularization; heart failure
  3. Renal disease: diabetic retinopathy; serum creatinine M \> 133, W \> 124 mmol/L; proteinuria \> 300 mg/24 hr
  4. Peripheral artery disease
  5. Advanced retinopathy: hemorrhage or exudates, papilledema

Eligibility Criteria:
Inclusion Criteria:

* age≧30years
* primary incident hypertension
* singed informed consent

Exclusion Criteria:

* participated in other clinical trials
Impact of Prophylactic Antibiotics on Bloodstream Infections After Liberation From Extracorporeal Membrane Oxygenation

The goal of this prospective interventional study is to evaluate the impact of antibiotic prophylaxis on bloodstream infections after liberation of extracorporeal membrane oxygenation therapy. The main questions aims to answer are:

• does application of vancomycine prior to ECMO liberation have an impact of bloodstream infections?

Participants will get 1 dose of vancomycine I.V. (15-20 mg per kgKG) prior to liberation of ECMO.

Researchers will compare this interventional group to a group without antibiotic prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* adult patients older than 18 years
* ECMO-Therapy

Exclusion Criteria:

* patients younger than 18 years
* fever \>38,5°C
* pregnancy
* antibiotic treatment with Vancomycine, Linezolid, Daptomycin or Tygacil on the day of liberation
* prior adverse events after application of Vancomycine
Clinical Stabilization of Hypercapnia: NIPPV v HVNI

This study will evaluate the ability of High Velocity Nasal Insufflation \[HVNI\] to effect ventilation and related physiologic responses in hypercapnic patients when compared to noninvasive positive pressure ventilation \[NIPPV\].

The overall objective of this randomized study is to evaluate the efficacy of HVNI, in comparison to NIPPV, to clinically stabilize and provide respiratory therapy to patients who have COPD with moderate-to-severe hypercapnic respiratory distress upon presentation. It is hypothesized that HVNI is comparable to NIPPV in the stabilization and relief of moderate-to-severe hypercapnic respiratory distress upon presentation, by relieving the patient's dyspnea (breathlessness) within 4 hours to a comparable degree to NIPPV.

Eligibility Criteria:
Inclusion Criteria:

* Adults, 18 years or older with a known or suspected diagnosis of COPD
* Presentation with acute hypercapnic respiratory failure
* Moderate to Severe patient baseline hypercarbia/hypercapnia, defined as a baseline PCO2 of 60 mmHg or higher
* Venous pH of 7.0 - 7.35

Exclusion Criteria:

* Severe metabolic derangements (e.g. suspected drug overdose, mixed acid/base disorder)
* Need for airway protection
* Primary condition of Congestive Heart Failure
* Need for emergent intubation
* Pneumonia diagnosis with significant infiltrate on chest x-ray that is clinically correlated with pneumonia
* Inability to provide informed consent
* Pregnancy
* Known contraindication to perform procedures listed, or therapies described in the protocol
* Respiratory arrest or significant respiratory depression on presentation
* Significant nasal occlusion either unilateral or bilateral
* Absence of spontaneous respiration or known contraindication to HVNI
* Extreme agitation or uncooperativeness that would hinder either arm of randomized therapy
* Determined by the clinician to be sufficiently unstable or unsuitable for this study
Epidural vs. Systemic Analgesia in the Intensive Care Unit

Many patients admitted to the general intensive care unit suffer from pain, whether acute or chronic. Those patients include post-operative patients, multi trauma, acute pancreatitis and patients with multiple rib fractures. Most patients in the intensive care unit, whether intubated and ventilated or not, are treated with systemic analgesic drugs, usually given intravenously, enterally, or trans dermally (fentanyl patches).

Continuous epidural anesthesia has been shown in several studies to have an advantage over systemic analgesia in specific conditions, such as pancreatitis, multiple rib fractures and upper abdominal surgeries. Some of its benefits include improved gastrointestinal motility (reduction of ileus rates), decreased thromboembolic events (DVT) and better quality of pain control. In intubated and ventilated patients, continuous epidural anesthesia may reduce the amount of required systemic sedation. Reducing the amount of sedation may contribute to a decrease in delirium rates, shortening the time to extubation and reducing other adverse effects associated with high requirements of sedation drugs (such as a decrease in blood pressure).

Most of the studies comparing systemic analgesia to epidural analgesia examined a population of patients hospitalized in the surgical ward, post breast, abdominal or orthopedic surgeries of the pelvis and lower extremities, or due to other conditions such as pancreatitis or multiple rib fractures. There are almost no studies that have examined the effectiveness of epidural analgesia in patients admitted to the intensive care unit, including sedated and ventilated patients, compared with systemic analgesia.

From 2011 until today, our intensive care unit has admitted about 300 patients who were treated with continuous epidural analgesia. In this study we would like to compare them to another group of patients (about 300 patients as well), who were admitted to the unit for similar etiologies (post-operative, multi- trauma, pancreatitis, etc.), and to observe differences between the groups. We would like to examine differences in mortality within 28 days, as well as differences in morbidity, such as the level of analgesia and delirium rates between groups.


Eligibility Criteria:
Inclusion Criteria:Patients aged 18-99, admitted to the General Intensive Care Unit from January 2011 to June 2021 (inclusive), due to a medical condition that may expose them to significant pain during hospitalization: chest, abdominal, pelvic or lower extremity surgery, pancreatitis, multiple rib fractures, trauma including chest, abdominal, pelvic, or lower limb trauma, and treated with epidural or systemic anesthesia during their stay in the unit.

-

Exclusion Criteria:Patients not admitted for the above reasons. -
Enhancing Survivorship Care Planning for Patients With Localized Prostate Cancer Using A Couple-focused Web-based Tailored Symptom Self-management Program

The purpose of this research study is to examine the feasibility of the enhanced survivorship care plans (ESCPs, regular SCPs with the a web-based couple-focused symptom self-management project (PERC) or National Cancer Institute prostate cancer web links) and to conduct an initial benefit assessment of enhanced survivorship care plans among prostate cancer patients transitioning from active treatment to post-treatment self-management, and their partners.

Participation of this study lasts for about for 16 weeks. Depending on participants' need for information, it takes 10-30 minutes of their time each week to review the information about prostate cancer.

Eligible and consented patients with newly treated localized prostate cancer and your partner (couples) are randomly assigned to the regular survivorship care plan (SCPs) with the NCI website or the enhanced survivorship care plans (SCP plus the web-based prostate cancer education program, PERC) groups. They complete baseline (T1, prior to randomization) and 4-month post-T1 follow-up measures (T2).

Methods: A two-group randomized controlled pretest-posttest design will be used and collect data at baseline (T1) and 4 months later (T2) among 50 patients completing initial treatment for localized prostate cancer and their partners. First, the investigators will assess the feasibility of ESCP by recruitment, enrollment, and retention rates, program satisfaction with the ESCP, and perceived ease of use of the ESCP. To achieve the secondary aim, the ESCP users will be compared with the standardized SCP users and assess their primary outcomes of QOL (overall, physical, emotional, and social QOL), secondary outcomes (reduction in negative appraisals and improvement in self-efficacy, social support, and health behaviors to manage symptoms), and number of visits to post-treatment care services at T1 and T2. The primary and secondary outcomes are assessed using measurements with sound psychometrical properties. The investigators will use a qualitative and quantitative mixed methods approach to achieve the research aims.

Conclusions: The results from this study will help design a definitive randomized trial to test the efficacy of the ESCPs, a potentially scalable program, to enhance supportive care for prostate cancer patients and their families.

Eligibility Criteria:
Inclusion Criteria:

Eligibility included men who:

* were diagnosed with localized PC;
* were within 16 weeks of completing their initial curative intent treatment \[26\] at genitourinary and radiation oncology clinics at two comprehensive cancer centers in the U.S southeast;
* were not treated for another cancer in last year; and
* had a partner \> 18 years of age not receiving cancer treatment.

Exclusion Criteria:

* Either member of couple unable to speak English
* Unwilling/unable to provide Informed Consent
A Study of the Effect of FTY720 on Pulmonary Function in Patients With Moderate Asthma

This study will evaluate the effect of FTY720 on the lung function of patients with moderate asthma


Eligibility Criteria:
Inclusion Criteria:

* Forced Expiratory Volume in 1 second of at least 60%
* History of asthma for at least 6 months
* Current use of short-acting beta agonists, inhaled long-acting beta agonists and inhaled corticosteroids (up to a specified dose)

Exclusion Criteria:

* History of lung disease other than asthma
* Smokers
* Use of inhaled corticosteroid above specified dose
* Use of oral beta agonists or corticosteroids or other asthma medications
* Hypersensitivity to the drug
* Respiratory tract infections within 1 month of the study

Other protocol-defined inclusion/exclusion criteria may apply
Improving Quality of Care for Patients With Recurrent Ovarian Cancer

Ovarian cancer is a major cause of cancer related death among women. The disease is usually advanced at diagnosis, because specialist referral is delayed due to vague nature of presenting symptoms. Primary treatment is successful, but most patients experience recurrence. Complaints due to disease and therapy overlap. Furthermore treatment schedules are similar in response rate and survival rates. Toxicity of therapy as scored by the physician is best documented, but varies depending on type of chemotherapy. Moreover most knowledge is acquired in clinical trials and not in daily practice. Patient reported outcome (PROs) concerning effects on symptoms, velocity of relief and quality of life (QoL) by the different regimens is sparce. Also it is unknown which symptoms are best relieved. Most trials take into account progression or survival as primary endpoint but not often symptom relief, which is especially important for patients with recurrent disease, without no chance of cure anymore. Knowledge on rating of problems and needs of patients with recurrent ovarian cancer (ROC) to support them in the course of their disease is needed to come to an evidence based and patient centered treatment of choice together with the patient. Physicians most frequently use the Common Toxicity Criteria (CTC) scale for grading of side effects of treatment, but discrepancies with patient experiences is high. Routine collection of PROs may therefore improve patient expectations and management. In this project the investigators intend to augment knowledge by PROs of different chemotherapy schedules for recurrent ovarian cancer in order to improve shared decision making with the physician.

Objective: primary objective of this project is to explore the relief of symptoms due to ROC, the speed with which this occurs by different chemotherapy schedules and development of complaints due to the regimen of chemotherapy. Secondary the investigators intend (1) to assess preferential symptom relief by patients, (2) to correlate toxicity and symptoms of disease to tumor assessed response to chemotherapy and (3) to correlate symptom relief by psychosocial context.


Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrent EOC or tubal carcinoma or peritoneal carcinoma;
* Histologically and/or cytologically proven epithelial ovarian cancer (including carcinosarcoma of the ovaries)
* Measurable or evaluable disease confirmed by radiological imaging OR ca 125
* ECOG ≤2
* Estimated life expectancy ≥12 weeks
* Patients must be accessible for treatment and follow-up
* Fit to receive chemotherapy

Exclusion Criteria:

* Patients with benign ovarian cancer;
* Patients with non-epithelial cancer;
* Bowel obstruction, sub-occlusive disease or presence of symptomatic brain metastases;
* Patients with other malignancy occurring within 5 years before enrollment
* Patients with impaired cognitive functioning or analphabetic patients
* Patients with an inability to fill in surveys digitally