cyrilzakka/clinical-trials huggingface dataset:
An Open-label Extension Study of an Investigational Drug, Fitusiran, in Patients With Moderate or Severe Hemophilia A or B

Primary Objective:

To evaluate the long-term safety and tolerability of fitusiran in male patients with moderate or severe hemophilia A or B

Secondary Objectives:

* To investigate the long-term efficacy of fitusiran
* To characterize the safety and efficacy of concomitantly administered Factor VIII (FVIII), Factor IX (FIX) or bypassing agents (BPA) and fitusiran for treatment of bleeding episodes
* To assess changes in health-related quality of life (QOL) over time
* To characterize antithrombin (AT) reduction and thrombin generation (TG) increase
* To characterize the pharmacokinetics (PK) of fitusiran

It is anticipated that patients in this study will receive treatment with open label fitusiran for approximately 7 years or until fitusiran becomes commercially available, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

* Completed and tolerated study drug dosing in study TDR14767 (ALN-AT3SC-001)
* Male aged ≥18 years
* Moderate or severe, clinically stable hemophilia A or B as evidenced by a laboratory FVIII or FIX level ≤5% at screening. Patients with a FVIII or FIX level \>5% at screening will be eligible on provision of a historic laboratory report indicating a trough level ≤5%
* Willing and able to comply with the study requirements and provide written informed consent

Exclusion Criteria:

* Clinically significant liver disease
* Patients known to be human immunodeficiency virus seropositive and have a CD4 count \<200 cells/μL
* History of venous thromboembolism
* Current serious mental illness that, in the judgment of the Investigator, may compromise patient safety, ability to participate in all study assessments, or study integrity
* Clinically relevant history or presence of cardiovascular, respiratory, gastrointestinal, renal, neurological, inflammatory, or other diseases that, in the judgment of the Investigator, precludes study participation
The Effect of Remote SMBG Combined With the Application of APP on the Improvement of T2DM Management in the Community

To investigate whether strengthen community diabetes patients self-monitoring of blood glucose can improve the patient's blood glucose control under Chinese guidelines for the prevention and treatment of diabetes (CDS 2017) and whether this intervention produces health and economic benefits.

This project is a cohort intervention study for randomized controlled trials. Community health service centers are the main body of implementing treatment and community diabetes patients are the objects of intervention. 498 T2DM patients with poor blood glucose control (7%\<HbA1c≤9.5%) from 4 different community health service centers will be randomized into two groups (strengthen group and control group). Strengthen self-monitoring of blood glucose by APP is the intervention and its duration is 12 months. Follow-up time of this study is 24 months (12 months after the intervention stopped). The diabetes treatment of patients from both groups follows Chinese guidelines (CDS 2017).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 Diabetes
* Between 18 and 79 years old
* 7.0%\<HbA1c ≤ 9.5%
* Routinely uses a smart phone
* Capability of operating the designated APP
* Long-time residents in Jiading District, Shanghai, China
* Subordinated to Shanghai medical insurance
* Contracted residents of community in Jiading District, Shanghai, China
* Being cognitively able to participate
* Provision of written informed consent

Exclusion Criteria:

* Type 1 diabetes, gestational diabetes mellitus or other types of diabetes mellitus
* Currently pregnant or contemplating pregnancy within the next 24 months
* Lactating women
* Was not able to insist until the end (24 months)
* Cognitive impairment
* Migrant population
Semi-elemental Versus Polymeric EEN in the Preoperative Optimization for Patients with CD

Growing evidence has shown that exclusive enteral nutrition (EEN) plays an important role in the preoperative optimization for patients with Crohn's disease (CD). However, the efficacy and safety of different types of enteral feeds including semi-elemental and polymeric enteral nutrition on CD have not been investigated. The aim of this study was to compare the role of semi-elemental and polymeric enteral nutrition on CD.

Growing evidence has shown that exclusive enteral nutrition (EEN) plays an important role in the preoperative optimization for patients with Crohn's disease (CD). However, the efficacy and safety of different types of enteral feeds including semi-elemental and polymeric enteral nutrition on CD have not been investigated. The aim of this study was to compare the role of semi-elemental and polymeric enteral nutrition on CD. The primary outcome: the reduction rate of CRP/ALB after exclusive enteral nutrition in Crohn's disease. The other outcomes: (1) the changes in Crohn's disease activity index; (2) the tolerance of enteral nutrition; (3) the changes in body mass index; (4) postoperative complications and the incidence of stoma; (5) the rate of surgery; (6) other adverse reactions.

Eligibility Criteria:
Inclusion Criteria:

1. elective bowel resection for Crohn's disease;
2. preoperative diagnosis of Crohn's disease;
3. age between 18 to 65 years old;
4. malnutrition;
5. the Crohn's disease activity index over 150;
6. nasal feeding.

Exclusion Criteria:

1. emergency surgery;
2. preoperative exclusive enteral nutrition before three months;
3. can not tolerate enteral nutrition;
4. less than 6 weeks of exclusive enteral nutrition;
5. preoperative corticosteroids within 3 months;
6. history of gastrointestinal surgery;
7. isolated colon disease;
8. metabolic disease (diabetes, hyperthyroidism).
Elimination of Incretin Hormones in Patients With Severe Kidney Failure

The prevalence of type 2 diabetes (T2D) is increasing rapidly worldwide. T2D is characterized by a severely impaired incretin effect. The incretin effect refers to the insulinotropic action of the nutrient-released incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). The incretin effect is defined as the difference in insulin secretory responses between oral and isoglycaemic intravenous glucose challenges (OGTT and IIGI, respectively) and in healthy individuals it accounts for as much as 70% of the insulin response following oral glucose, whereas patients with T2D exhibit an incretin effect in the range of 0 to 30%. Patients with T2D and non-diabetic patients with severe kidney failure share several pathophysiological characteristics, including decreased insulin sensitivity, fasting hyperinsulinaemia and impaired beta-cell function. The reason for these findings remains to be fully elucidated. An ongoing study in our research group is investigating the incretin effect and the incretin hormone secretory responses following OGTT, IIGI and meal ingestion, respectively. In continuation of this study, essential knowledge of metabolism of incretin hormones in an uremic milieu will be obtained in the present study prior to evaluation of the use of incretin-based agents in patients with impaired kidney function. In this second study we evaluate the elimination and biodegradation of GLP-1 and GIP. The biological active incretin hormones are rapidly degraded by the ubiquitous enzyme dipeptidyl peptidase-4 (DPP-4), generating inactive metabolites. The active hormones are however also eliminated by renal clearance, although the importance of this remains questionable. It is likely that the degradation and elimination of the active hormones will be significantly affected in patients with severe kidney impairment.

We hypothesize that elimination and biodegradation of the two incretin hormones, both in it´s active and inactive forms, will be affected in non-diabetic patients with severe kidney failure.


Eligibility Criteria:
1)

Inclusion Criteria:

* Male or female; aged 18-90 years
* CKD stage 5 in chronic maintenance dialysis treatment
* BMI: 18,5-28 kg/m2
* Normal fasting plasma glucose (\<6,1 mM)
* Normal or impaired glucose tolerance (PG120 min \<11,1 mM following OGTT)

Inclusion Criteria:

* Male or female; aged 18-90 years
* Healthy including normal kidney function
* BMI: 18,5-28 kg/m2
* Normal fasting plasma glucose (\<6,1 mM)
* Normal or impaired glucose tolerance (PG120 min \<11,1 mM following OGTT)

1+2)

Exclusion Criteria:

* Diabetes mellitus
* Chronic pancreatitis / previous acute pancreatitis
* Treatment with oral glucocorticoids, calcineurin inhibitors, thiazides, dipeptidyl peptidase 4 (DPP4) inhibitors or other drugs, which could interfere with glucose or lipid metabolism
* Inflammatory bowel disease
* Malignant disease
* Bowel resection
* Severe anemia (hemoglobin \<6.5 mmol/L)
Reducing Intraoperative ESKAPE Transmission Through Use of a Personal Hand Hygiene System

The investigators hypothesize that the use of a personal hand hygiene system (SafeHavenTM) by anesthesia providers in the adult operating room, combined with a novel infectious pathogen tracking system (OR PathTrac) will decrease participant exposure to pathologic bacteria in the adult operating room.

This will be a prospective, single center, unmasked, controlled before and after study.

Intervention Arm: Use of SafeHaven hand hygiene system in the operating room

Control Arm: Standard of care hand hygiene

Operating Room Selection: Two patients (case-pair) having surgery in a serial manner in a randomly selected operating room will be evaluated for detection of pathogenic bacteria. The operating room for investigation will be randomly selected through the following process:

1. All the operating rooms with scheduled surgeries in the South Operating Rooms on a particular day will be entered into a random number generator (example: operating rooms 2, 3, 5, 7).
2. The random generator will sort these operating rooms into a rank list (example: operating rooms 5, 3, 2, 7).
3. The investigators will start at the top of this list and work down until the first operating room meeting all inclusion criteria is found (example: operating room 5 only has one surgery, operating room 3 has pediatric surgery, operating room 2 meets inclusion criteria)
4. This process will be duplicated for each case-pair

The goal of the study is to map transmission of bacteria through the operating room and compare mapping with the SafeHaven Hand Hygiene system to mapping without the SafeHaven Hand Hygiene system. Thus, case-pairs will be randomized to the same assignment. For example, subject 1 and 2 will have surgery in South Operating Room 8 and both will be randomized to the control group. The first 10 case-pairs will be assigned to the control arm and the second 10 case-pairs will be assigned to the intervention arm.

Eligibility Criteria:
Patient Inclusion Criteria:

Patients ≥ 18 years of age having surgery in an adult operating suite at the research center involving the following specialties: orthopedics/spine, orthopedics/total joint, gynecology/oncology, colorectal, open vascular, and open urological, general abdominal, acute care, cardiothoracic, and plastic/breast.

Patient Exclusion Criteria:

* Patients with a known infection at the time of surgery.
* Prisoners
* Pregnant Women
* Patients lacking capacity to consent
* Patients with an allergy to a component of hand hygiene solution, such as ethyl alcohol
* Refusal of consent

Anesthesia Provider Inclusion Criteria:

• Faculty physicians, resident physicians, or certified registered nurse anesthetists that provide care for adults having surgery at the research center.

Anesthesia Provider Exclusion Criteria:

* Refusal of consent
* Open sores of the hands
* Known skin infection
Ventilatory and Perfusion Abnormalities in Individuals with Post-Acute Sequelae of SARS-CoV-2 Infection

Prospective cohort study to evaluate the utility of quantitative CT analysis to assess ventilation and perfusion defects in patients with Post-acute Sequelae of SARS-CoV-2 (PASC) and functional limitations

This is a study to describe the overall pattern of lung ventilation and perfusion defects in individuals with PASC. Subjects with PASC with a documented history of COVID-19 and persistent symptoms of fatigue, dyspnea, and/or exercise intolerance will complete questionnaires, and undergo pulmonary function tests, 6-minute walk tests, and a low dose CT chest to describe the overall pattern of lung regional ventilation and blood distribution and to compare this pattern to asymptomatic controls with and without prior COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Self-reported or documented SARS-CoV-2 infection by RT-PCR or Antigen testing \> 3 months ago or no previous history of SARS-CoV-2 infection (control group only)
* Normal or mild abnormalities on baseline Pulmonary Function Tests (PFTs)
* New or worsening symptoms of chronic fatigue, dyspnea or exercise intolerance after COVID-19 with otherwise unclear etiology (PASC group only)

Exclusion Criteria:

* SARS-CoV-2 infection by RT-PCR or Antigen testing within the last 3 months
* Inability to provide consent or non-English speaking
* Pregnancy
* Any respiratory infection in last 4 weeks
* PFT relative contraindications
* History of major cardiovascular, pulmonary, renal, hepatic, autoimmune or neuromuscular disease including asthma, COPD, interstitial lung disease, heart failure, pulmonary arterial hypertension, or prior pulmonary embolism
* Active malignancy undergoing treatment or history of malignancy involving the lung
Sleep Apnea and Cognitive Function in Subjects With Subjective or Mild Cognitive Impairment

Obstructive sleep apnea (OSA) is recurrent episodes of partial or complete obstruction of the upper airway during sleep that causes intermittent hypoxia and sleep fragmentation and leads to cardiometabolic and neurocognitive sequelae. Chronic intermittent hypoxia, sleep fragmentation of OSA, and insufficient sleep have been significantly associated with higher risks of neurocognitive impairment, including mild cognitive impairment (MCI) and Alzheimer's disease. Thus, sleep and circadian function might be modifiable neurocognitive impairment factors.

The significance of the study is to understand the relationships of MCI with sleep apnea and sleep-related symptoms, which helps pave the groundwork for further research.

Obstructive sleep apnea (OSA) is recurrent episodes of partial or complete obstruction of the upper airway during sleep that causes intermittent hypoxia and sleep fragmentation. Chronic intermittent hypoxia, sleep fragmentation of OSA, and insufficient sleep have been significantly associated with higher risks of neurocognitive impairment, including mild cognitive impairment (MCI) and Alzheimer's disease. Thus, sleep and circadian function might be modifiable neurocognitive impairment factors.

A recent review of 11 studies involving 5826 subjects \[96% with OSA and 9% with MCI or Alzheimer's disease\] suggests OSA is a modifiable risk factor for cognitive decline. Thus, improving sleep, sleep apnea and circadian function could be a high-value intervention target to alleviate cognitive impairment and decline in subjects with MCI.

The study aims to understand the relationships of prevalent sleep apnea and sleep-related symptoms with neurocognitive status in patients who presented with the main complaint of neurocognitive impairment ( to the Memory clinic). The information would help pave the groundwork for further research.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and above
* Clinical diagnosis of mild cognitive impairment (MCI) based on Petersen's criteria. The criteria include the following: (1) memory problems, (2) objective memory disorder, (3) absence of other cognitive disorders or repercussions on daily life, (4) normal general cognitive function and (5) absence of dementia OR,
* Diagnosis of subjective cognitive impairment, based on the subject's own complaint of cognitive impairment but with an unremarkable assessment of the Hong Kong version of Montreal Cognitive Assessment scores
* Able to speak and read Chinese
* Adequate visual and auditory to perform a cognitive test

Exclusion Criteria:

* Diagnosed psychiatric illness with or without medication, e.g. major depressive disorder.
* Other clear organic causes of cognitive impairment, e.g. old stroke, brain tumour, dementia with Lewy body, Parkinson's disease, normal pressure hydrocephalus, neurosyphilis, autoimmune encephalitis, substance abuse, history of alcohol abuse.
* Diagnosis of major unstable illness or cancer on active treatment
* Unable to perform Home Sleep Apnea Test
* Those patients who require legal guardians
Lung Ultrasound in the Early Detection of Postoperative Pulmonary Complications After Esophagectomy

The perioperative management of esophageal cancer has evolved considerably in recent years.

Over the last 30 years, postoperative mortality has been steadily decreasing. However, respiratory morbidity remains high (30-40%). This is due to the procedure itself requiring a thoracic approach and intraoperative unipulmonary ventilation. The postoperative pulmonary complications (PPCs) are multiple: bronchial congestion, atelectasis, pneumopathy, acute respiratory distress syndrome (ARDS), liquid pleural effusion, pneumothorax.

In general, prevention and early treatment are aimed at limiting the evolution towards acute respiratory failure requiring ventilatory assistance.

Chest radiography is essential for the presumptive diagnosis of pneumopathy in particular, but the interpretation of the images may be difficult.

Thoracic computed tomography (CT) is the gold standard because it is sensitive and can discriminate among differential diagnoses. This is difficult to perform: it requires intra-hospital transport of patient, who is often in acute respiratory failure, and the availability of an examination area.

Lung ultrasound is used at the bedside for diagnosis of lung infection in intensive care unit. This has a sensitivity close to thoracic CT and has the advantage of being feasible at any time, does not require transport of the patient and is not irradiating.

Lung ultrasound allows early detection of the need for ventilatory support in postoperative major abdominal surgery . In addition, the sensitivity of lung ultrasound is close to that of CT, allowing this examination to be relied upon.

The main objective of the study is to determine the role of lung ultrasound in the prediction of postoperative pulmonary complications within one hour after extubation.


Eligibility Criteria:
Inclusion Criteria:

* Thoracic Esophagectomy

Exclusion Criteria:

* Emphysema Death during surgery Refusal
Aromatherapy Massage Applied on Constipation

Aim: This study was conducted as a randomized controlled experimental study to examine the effect of abdominal massage with ginger and lavender oil on constipation in elderly individuals.

Design: The study was completed with 40 elderly individuals in Kayseri nursing home, including 20 in intervention and 20 in control group who met the criteria for inclusion in the study. In the study, written informed volunteer consent was obtained from the individuals with the approval of the ethics committee and the permission of the institution.

The elderly individuals in the intervention group underwent aromatherapy massage with ginger and lavender oils for a period of five days and 15 minutes on weekdays for four weeks according to the abdominal massage application protocol. No application was made to individuals in the control group.

Aim: This study was conducted as a randomized controlled experimental study to examine the effect of abdominal massage with ginger and lavender oil on constipation in elderly individuals.

Design: The study was completed with 40 elderly individuals in Kayseri nursing home, including 20 in intervention and 20 in control group who met the criteria for inclusion in the study. In the study, written informed volunteer consent was obtained from the individuals with the approval of the ethics committee and the permission of the institution. The data were collected by the researcher using the Questionnaire Form, Bristol Stool Scale, Rome IV Criteria, Constipation Severity Scale and Mini Mental Test.

The elderly individuals in the intervention group underwent aromatherapy massage with ginger and lavender oils for a period of five days and 15 minutes on weekdays for four weeks according to the abdominal massage application protocol. No application was made to individuals in the control group. The "Bristol Stool Scale" and "Constipation Severity Scale" were re-applied to the individuals in the intervention and control group before, during the second week of practice and at the end of practice (fourth week).

Eligibility Criteria:
Inclusion Criteria:

* Elderly individuals with constipation determined by the institution doctor,
* Individuals diagnosed with constipation according to the Roma-criteria,
* Individuals, who achieved a score of 24 and higher on the standardized mini mental test (SMMT),
* Individuals, who do not have lesions disrupting skin integrity in the abdominal region,
* And elderly individuals, who agreed to participate in the study were included.

Exclusion Criteria:

* Individuals diagnosed with irritable bowel syndrome (IBS),
* Individuals who have undergone bowel surgery before,
* Individuals diagnosed with colon cancer,
* Individuals with percutaneous endoscopic gastrostomy,
* Individuals with umbilical hernia
* And individuals allergic to lavender and ginger oil.
Stress-Delta Biomarkers for Acute Coronary Syndrome Risk Stratification

Acute Coronary Syndrome (ACS) is a serious heart condition that is a leading cause of death in America. Cardiac stress testing is currently the best test to non-invasively identify which patients might be having ACS and may need more invasive testing such as a cardiac catheterization (placing a tube in the heart) for coronary angiogram (invasive mapping of the blood vessels of the heart). However, stress tests require imaging by highly trained specialists and even then may not correctly categorize a small minority of patients being evaluated for ACS.

Advances in blood tests may now allow detection of the very early stages of heart blood vessel blockage via a simple blood test. The investigators seek to determine whether these blood tests can help to better identify patients with ACS. The study will also store any extra blood sample that may be left over for future use.


Eligibility Criteria:
Inclusion Criteria:

* Any patient presenting to the ED with clinical suspicion of ACS as determined by the treating emergency physician. These include symptoms including but not limited to chest pain, pressure, or burning sensation across the precordium.
* Age 40 years or older.
* As part of their usual clinical care, the subject is scheduled to have a cardiac stress test. This includes nuclear (adenosine, regadenosine, or other adjunct with SPECT), either pharmacologic (dobutamine) or exercise (treadmill) echocardiography, or cardiac magnetic resonance imaging. Prior cardiac testing or observation unit evaluation is not an exclusion criterion.

Exclusion Criteria:

* Patient with cardiac marker diagnosis of acute myocardial infarction or who otherwise is not a candidate for a cardiac stress test.
* Evidence of serious arrhythmias or acute MI or ischemia on ECG
* Unstable vital signs: persistent (\> 2 readings or over 2 hours) hypotension (systolic blood pressure \< 80 mm Hg), pulse \> 110 beats per minute.
* Any medical condition that would be worsened by cardiac stress
* Aortic aneurysm or dissection
* Active myocarditis or pericarditis
* Ventricular dysrhythmia or significant atrial dysrhythmia
* Severe or greater degree of aortic stenosis
* Acute or decompensated heart failure or pulmonary edema
* Pulmonary embolism
* Aortic aneurysm
* Patient is non-English speaking.
* Patient is incarcerated or a prisoner.
* Patient does not have capacity to consent.