cyrilzakka/clinical-trials huggingface dataset:
Intraoperative Dexmedetomidine and Long-term Outcomes in Elderly After Major Surgery

This is a 3-year follow-up of patients enrolled in a previous randomized controlled trial which showed that intraoperative dexmedetomidine reduced delirium in elderly patients after major non-cardiac surgery. The purpose of this study is to clarify the effects of intraoperative dexmedetomidine on long-term outcomes of these patients.

Dexmedetomidine is a highly selective α-2-receptor agonist with sedative, analgesic and anxiolytic effects. When used as an supplement during general anaesthesia, it reduces the consumption of the anaesthetics and relieves surgery-related stress response and inflammation. In a recent randomized ontrolled trial of the applicants, 620 elderly patients who underwent major non-cardiac surgery were randomized to receive dexmedetomidine or normal saline during general anesthesia. The results showed that use of dexmedetomidine reduced delirium (5.5% \[17/309\] with dexmedetomidine vs. 10.2% \[32/310\] with placebo, P=0.026) and 30-day non-delirium complications (9.4% \[60/309\] with dexmedetomidine vs. 26.1% \[81/310\] with placebo, P=0.047) after surgery.

The effects of intraoperative dexmedetomidine on long-term outcomes after surgery remains unclear. In another study of the applicants, use of low-dose dexemeditomidine in ICU patients after surgery increased survival up to 2 years and improve quality of life in 3-year survivors. On the contrary, it was reported in a retrospective study that intraoperative use of dexmedetomidine was associated with shortened overall survival in patients after lung cancer surgery. Therefore, it is urgent to clarify the impact of intraoperative dexemeditomidine on long-term outcomes of patients undergoing major surgery, especially those undergoing cancer surgery.

This study is a 3-year follow-up of patients who were enrolled in a randomzied controlled trial of the applicants in order to clarify the effects of intraoperative dexmedetomidine on long-term outcomes after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Elderly patients (age ≥60 years);
* Scheduled to undergo elective major non-cardiac surgery with expected duration ≥2 hours under general anaesthesia.

Exclusion Criteria:

* Do not provide written informed consent;
* Previous history of schizophrenia, epilepsy or Parkinson's disease;
* Visual, hearing, language or other barriers which impede communication and preoperative delirium assessment;
* History of traumatic brain injury;
* Severe bradycardia (heart rate \<40 beats per minutes), sick sinus syndrome, or atrioventricular block of degree 2 or above without pacemaker;
* Severe hepatic dysfunction (Child-Pugh grade C);
* Renal failure (requirement of renal replacement therapy);
* Neurosurgery.
A Study in Healthy People to Test Whether BI 730357 Affects How 4 Other Medicines (Rosuvastatin, Digoxin, Metformin, and Furosemide) Are Taken up in the Body

The main objective of this trial is to investigate the effect of BI 730357 under steady state conditions on the pharmacokinetics of digoxin, furosemide, metformin and rosuvastatin given as a cocktail (Reference, R: cocktail alone; Test T: cocktail given under steady state conditions of BI 730357).


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory Tests
* Age of 18 to 55 years (inclusive)
* BMI of 18.5 to 29.9 kilogram per square meter (kg/m2) (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
* Male subjects, or female subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion: -- Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device

  * Sexually abstinent
  * A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
  * Surgically sterilised (including hysterectomy or bilateral tubal occlusion)
  * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with levels of Follicle-stimulating hormone (FSH) above 40 units per liter (U/L) and estradiol below 30 nanograms per liter (ng/L) is confirmatory)

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetres of Mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* During COVID-19 pandemic: laboratory test indicative of an ongoing SARS-CoV-2 infection
* further exclusion criteria apply
A Feasibility Study on Ultrafiltration and Blood Volume Measurements

The objective of this feasibility study is to characterize the performance of the Aquadex FlexFlow® System with the hematocrit (HCT) feature in conjunction with Daxor's blood volume analyzer (BVA-100). The study will monitor blood volume changes during ultrafiltration (UF) therapy as a potential means to guide the removal of fluid in subjects hospitalized with acute decompensated heart failure (ADHF).

The study will measure blood volumes at various time intervals using the BVA-100 for comparison to corresponding readings of hematocrit (HCT) levels from the Aquadex FlexFlow HCT sensor. Establishing a correlation between BVA measurements (off-line measurements) and HCT sensor measurements (on-line measurements) may enable the use of the BVA-100 to guide ultrafiltration therapy by the Aquadex system for fluid removal.

BVA-100 measurements would be used at baseline to accurately determine patient suitability for fluid removal and while HCT measurements would be used to monitor blood volume changes during ultrafiltration therapy, potentially guiding the removal of fluid in subjects hospitalized with ADHF.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Subject or legally authorized representative is able to provide appropriate consent to participate
3. Hospitalized for ADHF with fluid overload as indicated by at least two of the following:

   1. Pitting edema ≥ 2+ of the lower extremities
   2. Jugular venous distention \> 8 cm
   3. Pulmonary edema/pleural effusion on chest x-ray
   4. Paroxysmal nocturnal dyspnea or ≥ two- pillow orthopnea
   5. Respiration rate ≥ 20 per minute

Exclusion Criteria:

1. Unable or unwillingness to provide informed consent or to comply with study requirements
2. Subject who is pregnant
3. Acute coronary syndrome
4. Known bilateral renal artery stenosis
5. Serum creatinine \> 3.0 mg/dL at the time of presentation
6. Subject receiving ongoing active treatment with diuretics (up to 2 doses of IV diuretics are permitted before initiation of ultrafiltration therapy)
7. Systolic blood pressure ≤ 90 mmHg
8. Poor or unattainable central access
9. Has bleeding disorder
10. Contraindications to systemic anticoagulation
11. Allergic to iodine, albumin, or iodinated I-131 albumin
12. Active myocarditis or hypertrophic obstructive cardiomyopathy
13. Severe uncorrected valvular stenosis
14. Complex congenital heart disease
15. Systemic infection
16. Previous organ transplant
17. Enrollment in other clinical trials
18. Life expectancy ≤ 6 months
Correlation Between the Changes of Retinal Structure and Function and Ischemic Stroke

Ischemic stroke is the most common type of stroke, accounting for 60%-80% of all types of strokes, and is one of the leading global causes of death and severe disability. In the risk factors of stroke, carotid atherosclerosis have higher incidence.As the only visible microvessels in vivo, retinal can provides an accurate window into cerebrovascular and systemic vascular conditions. Optical coherence tomography angiography (OCTA) and electroretinogram (ERG) can be used to quantitatively analyze the retinal structure and function in patients with ischemic stroke, and find out the valuable parameters. Electroencephalogram(EEG) can collect the electrical activity of cerebral cortex in patients with ischemic stroke and find the correlation between EEG and ERG. Finally, it is of great significance to establish a non-invasive, more objective, convenient and safe risk prediction model for stroke in combination with carotid atherosclerosis, retinal structural and functional parameters and EEG.

Firstly, this study will cross sectional analyze the retinal structure and function of patients with ischemic stroke to find the closely related parameters. Secondly, based on the results of cross section analysis, a cohort study will be established to build a risk prediction model for stroke combining carotid atherosclerosis, retinal structure and function parameters and EEG.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ischemic stroke

Exclusion Criteria:

* Refractive interstitial turbidity affect the examination results
* Any retinal diseases
* Other causes of ischemic stroke (cardiogenic embolism, dissection aneurysm, hemagglutination disorder, polycythemia, vasculitis, vascular malformation, etc.)
* Fails to complete an ophthalmic examination or the follow-up
Outcomes of Elderly Patients Admitted to the Intensive Care Unit With Severe Acute Cholangitis

The aging of the population goes along with an increased demand for intensive care among very elderly patients (above 75-80 years old). At the same time, there is a decline in the supply of intensive care units (ICU). The 1-year mortality of patients above 80 years old in ICU ranged from 40 to 70%. Moreover, many survivors suffer from long-term sequelae as poor quality of life, cognitive impairment and functional disability.

It is unclear under what conditions older patients may benefit from ICU admission. Cholangitis frequently occured in older patient. Moreover, severe acute cholangitis is a potentially life threatening disease characterized by a biliary obstruction and an infection of the bile possibly evolving towards systemic infection, shock and death. Because of its potential rapid reversibility of symptom thanks to early intravenous antibiotics and biliary decompression with drainage, old patients suffering from acute cholangitis are easily admitted to intensive care unit.

To date, there is a lack of data about the outcome in this population admitted to the intensive care unit with acute cholangitis.

The aim of the current study is to describe the outcomes in elderly patients (\> 75 years old) admitted to the ICU with acute cholangitis and to identify prognostics factors associated with long term mortality (6 months).


Eligibility Criteria:
Inclusion Criteria:

* \> 65 years old
* ICU admission for acute cholangitis
* follow up in the same center after the ICU stay

Exclusion Criteria:

* none
A Prospective Controlled Study on Treatment of Giant Cavernous Hemangiomas of the Liver

In the past, the investigators often treated giant cavernous hemangiomas of the liver by hepatectomy.Recently RFA and laparoscopic hepatectomy are also available and could be applied to cure this disease.But we can't get a clear answer about their effectiveness and safety. Hence the investigators conduct this study to explore the effectiveness and efficiency of the these two methods and compare their short to mid-term outcomes.


Eligibility Criteria:
Inclusion Criteria:

* giant cavernous hemangiomas with a diameter larger than or equal to 5 cm diagnosed by more than one imaging modalities
* age between 18 years to 65 years
* without gender restriction
* PLT account more than 50 e9
* without abnormal of liver function test
* with substantial evidence of growing size than before
* symptom associated cavernous hemangiomas
* with a strong desire of the patients for the treatment

Exclusion Criteria:

* pregnant women
* abnormal of liver function or coagulation dysfunction and/or concurrent with sever cardiac or pulmonary disorders
* patient with a poor condition that can't bear the approach of either RFA or laparoscopic hepatectomy
* tumor size more than 20cm
Tolerability & Safety of Premarin Vaginal Cream in Indian Postmenopausal Women

This post-marketing study will provide local safety and tolerance data on the use of Premarin® vaginal cream.


Eligibility Criteria:
Inclusion Criteria:

* Patients in whom Premarin vaginal cream is indicated.
* In the opinion of the investigator, sufficient intelligence and motivation for the patient to continue throughout the study.
* Provide signed informed consent.

Exclusion Criteria:

* Patients not willing to give informed consent.
Combining Wearable Technology to Crate Internet+Digital Hospital-remote Home Type 2 Diabetes Follow-up Management Mode

This study intends to combining wearable technology to crate Internet+Digital Hospital-remote Home Type 2 Diabetes follow-up management mode.To preliminarily explore compared with the traditional medical treatment mode, whether the new management mode of DM can improve the management objectives and patient satisfaction of T2DM and reduce medical costs. The study provides a powerful reference for establishing corresponding platforms and promoting such models at the government management level in the future.

Background:The prevalence of T2DM in Chinese adults has exceeded 10%, and the prevalence of abnormal glucose metabolism has exceeded 40% in people older than 18 years. This will lead to a significant increase in the prevalence of DM complications in the next decade, and the disability and death caused by complications will also seriously affect the quality of life of patients and bring a huge social and economic burden.This randomized controlled trial intends to combining wearable technology to crate Internet+Digital Hospital-remote Home T2DM follow-up management mode.To preliminarily explore compared with the traditional medical treatment mode, whether the new management mode of DM can improve the management objectives and patient satisfaction of T2DM and reduce medical costs. The study provides a powerful reference for establishing corresponding platforms and promoting such models at the government management level in the future.

Methods:The study was a parallel-group, randomised, controlled trial. the number of cases planned to be included in 200 cases. Participants were randomly assigned to the intervention or control group.The intervention group receives Internet + Digital Hospital-remote home management mode,including remote monitoring devices+Internet management platform, dietary recommendations, exercise supervision, web education, information pushing, doctor-patient interaction, etc.The control group receives the traditional management mode, including routine dietary and exercise recommendations, education as well as monitor in the clinic.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes according to the World Health Organization criteria;
* Aged between 18 and 70 years;
* Glycosylated haemoglobin (HbA1C%) between 7% and 9%.

Exclusion Criteria:

* Type 1 diabetes;
* Gestational diabetes;
* Other special types of diabetes;
* Moderate-severe insufficiency of heart , liver, kidney and lung;
* Complicated with acute disease or stress status.
Risk Factors for Post-ESWL and Post-ERCP Pancreatitis

The study aimed to identify risk factors for post-ERCP pancreatitis(PEP) after ESWL, and the relationship between the occurrence of post-ESWL pancreatitis and PEP.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with chronic pancreatitis and treated with both ESWL and subsequent ERCP

Exclusion Criteria:

* Patients with isolated pancreatic tail stone
* Patients with suspected or established malignancy
* Patients with pancreatic ascites
* Patients attending other interventional clinical trials
* Patients with non-correctable coagulation disorder
* Patients with pregnancy
Steps Toward Adapting Physical Activity Guidelines for the Lower Mississippi Delta Population

This feasibility study specifically addresses the issue of adapting US dietary guidelines physical activity recommendations to the population of the Lower Mississippi Delta. The hypothesis is that including a pedometer as a self-monitoring tool as part of adapted physical activity guidelines will result in greater immediate increases in physical activity (as monitored by an accelerometer) than an education program alone.

The purpose of this study was to determine if a short-term pedometer-based intervention results in immediate increases in time spent in moderate-to-vigorous physical activity (MVPA) compared to a minimal educational intervention.A sample of 43 overweight adults 35 to 64 years of age participated in a one week pedometer-based feasibility trial monitored by accelerometry. Participants were randomized into a one-week education-only group or a group that also wore a pedometer. Accelerometer-measured MVPA was measured over 7 days at baseline and post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* 35 to 64 years of age
* body mass index (BMI) between 25 and 34.9 kg/m2
* being able to walk without limitation

Exclusion Criteria:

* cardiovascular, respiratory, gastrointestinal, neuromuscular, neurological, or psychiatric problems; musculoskeletal problems interfering with exercise
* immunodeficiency problems
* malignancies in the last 5 years
* any other medical condition or life threatening disease that could be aggravated by exercise
Predictors of Respiratory Failure Following Extubation in the SICU

Respiratory failure following extubation causes significant morbidity and increases mortality in teh surgical intensive care unit (SICU). However the causes of respiratory failure following extubation remain poorly understood. The investigators hypothesize that extubation failure can be predicted based on preoperative risk factors as well as ICU acquired morbidities including muscle weakness and renal failure.

Both extubation delay and extubation failure are related to adverse outcomes. A spontaneous breathing trial is therefore recommended to predict extubation readiness. However, depending on the disease entity and local culture, a range of 10-20 per cent incidence of extubation failure has been described from tertiary care hospitals. The aim of this trial is to identify additional variables in surgical patients that can be used to support a clinician's decision on whether or not to extubate a patient's trachea.

Te investigators have recently developed and validated the SPORC (Brueckmann, 2013), a score that predicts the risk of extubation failure following surgery based on patients comorbidities and the acuity of the disease leading to surgery, and the investigators hypothesize that the SPORC will also predict extubation failure in the surgical ICU.

In addition, it is likely that ICU acquired morbidity also predicts extubation failure. In fact, the investigators have recently shown that muscle weakness is a predictor of aspiration (Mirzakhani, 2013), and the investigators speculated that muscle weakness may also respiratory failure after extubation.

Finally, it has been suggested that the increased mortality seen in patients with acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT) versus end stage renal disease (ESRD) patients requiring CRRT can be attributed to an increased need for mechanical ventilation. (Walcher, 2011). Therefore, the investigators also hypothesize that acute kidney injury increases the vulnerability of patients to postextubation respiratory failure.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years of age or greater)
* Patients who have been extubated following mechanical ventilation in the surgical ICU

Exclusion Criteria:

* Preexisting end-stage renal disease
* Neurological disorder associated with severe muscle weakness
* Goals of care focused on comfort
NK Cells Treatment for COVID-19

Since december 2019, acute respiratory disease due to 2019 novel coronavirus (2019-nCoV) emerged in Wuhan city and rapidly spread throughout China. There is no confirmed antivirus therapy for 2019-nCoV infection. Natural killer (NK) cells are innate lymphocytes that may serve as useful effectors against danger infection. The purpose of this clinical investigation is to evaluate the safety and efficiency of NK Cells in combination with standard therapy for pneumonia patients infected with 2019-nCoV.


Eligibility Criteria:
Inclusion Criteria:

* 1. Male or female, aged at 18 years-65 years old
* 2. Pneumonia that is judged by chest radiograph or computed tomography
* 3. Laboratory confirmation of NCP infection by reverse-transcription polymerase chain reaction(RT-PCR) from any diagnostic sampling source

Exclusion Criteria:

* 1. Pregnancy or breastfeeding
* 2. Known HIV, HBV or HCV infection
* 3. Patients with malignant tumor, other serious systemic diseases and psychosis
* 4. Patients who are participating in other clinical trials
* 5. Inability to provide informed consent or to comply with test requirements
JAK2 Inhibitors RUXOLITINIB in Patients With Myelofibrosis

JAK2 inhibitor RUXOLITINIB before allogeneic hematopoietic stem cell transplantation (HSCT) in patients with primary or secondary myelofibrosis : a prospective phase II

JAK2 inhibitor RUXOLITINIB before allogeneic hematopoietic stem cell transplantation (HSCT) in patients with primary or secondary myelofibrosis

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 69 years
* No comorbidity contraindicating the transplantation :

  * Severe respiratory failure defined as dyspnea grade III or more
  * Severe cardiac failure defined as EF \< or = 30%
  * Severe renal failure defined as creatinine clearance \< 30 ml/min or dialysis
  * Dementia or non-ability to give informed consent for the protocol
  * Major alteration of performance status defined as ECOG \> 2
  * Severe liver disease defined as a cirrhosis or bilirubin \> 2 x ULN, or AST/ALT \> 5 x ULN
* Primary or secondary myelofibrosis diagnosed according to WHO definition (Tefferi, et al 2007)
* Palpable splenomegaly or splenomegaly measured by any imagery (maximum size\> 15 cm by ultrasound scan, Magnetic Resonance Imaging or computer tomography)
* Disease if intermediate or high risk according to published criteria and summarized as follows:

At least one criterion among the following:

* Haemoglobin \< 100 gr/L (unrelated to medication toxicity)
* Leucocytes \< 4 G/L (unrelated to medication toxicity) or \> 25 G/L
* Poor prognosis cytogenetics : complex karyotype, abnormalities of chromosomes 5, 7 or 17 , +8, 12p-, inv(3), 11q23

Two criteria among the following criteria :

* General symptoms (weight lost \> 10% in less than 6 months, night swears, specific fever \> 37.5°C)
* Peripheral blastosis \> 1% observed at least twice
* Thrombocytopenia \< 100 G/L (unrelated to treatment toxicity)

Exclusion Criteria:

* Myelofibrosis transformed into acute leukaemia with 20% blasts of more in blood or bone marrow
* Previous treatment with JAK2 inhibitor
* Thrombopenia \< 50 G/L
* Comorbidities contraindicating the transplantation
* Comorbidity score Sorror \> 3
* Pregnant or lactating women