cyrilzakka/clinical-trials huggingface dataset:
Improving Mental and Physical Health and Decreasing Hospital Readmission After Pancreatectomy Through Enhanced Patient and Caregiver Education and Engagement

The study of readmission is in its infancy in the surgical world, and there are no prospective studies, to the investigators' knowledge, evaluating the efficacy of interventions on preventing readmission following pancreatectomy. Undoubtedly, patients and their caregivers will play a key role in any useful intervention to reduce readmission. Therefore, the investigators' approach is to target perioperative education and engagement of patients and their caregivers in the postoperative recovery of pancreatectomy patients.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for major pancreatectomy (i.e., pancreaticoduodenectomy, total pancreatectomy, or a distal pancreatectomy).
* At least 18 years of age.
* Able to read and understand English (the SAFECARE at Home program is only implemented in English)
* Has internet access.
* Knowledge of the internet and how to use web-based programs.
* Not pregnant or breastfeeding.
* Able to understand and willing to sign an IRB-approved written informed consent document.
Effect of Konjac-mannan in Individuals With Insulin-Resistance Syndrome

To study whether a diet high in fiber from Konjac-mannan (KJM) has an effect on metabolic control in individuals with insulin resistance syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Impaired glucose tolerant
* Clinical absent of CHD
* BMI less than 30 kg/m2
* Presence of full insulin resistance syndrome
* Reduced HDL cholesterol
* Elevated serum triglycerides
* Moderate hypertension

Exclusion Criteria:

* Regular smoking
* Regular alcohol consumption
* Family history of premature coronary heart disease
* Hypothyroidism
* Renal, hepatic or gastrointestinal disease
* Taking medications for hyperglycemia
* Taking medications for hyperlipidemia
* Taking medications for hypertension
Comparing the Ketogenic Effect of Coconut Oil and Different MCTs

The aim of this study is to compare the ketogenic effect of coconut oil and three MCT oils (60-40 , tricaprylin and triheptanoate) on the production of ketones in healthy adults. Each oil are evaluated individually or in combination over a 8h-period during which repeated blood sampling is performed.

The study is composed of eight successive visits. Each visit consists of the consumption of one individual oil or a mixture of oils (20 g of coconut oil or 10 g of coconut oil + 10 g of MCT 60-40 or 20 g MCT 60-40 or 10 g coconut oil + 10 g tricaprylin or 20 g tricaprylin or 10 g coconut oil + 10 g triheptanoate or 20 g triheptanoate) and a 8h follow-up during which repeated blood samples are taken for laboratory analysis (plasma beta-hydroxybutyrate, acetoacetate, glucose, free fatty acids, triglycerides, total cholesterol, lactate and insulin).

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult over 18 y old.

Exclusion Criteria:

* Fasting plasma glucose ≥7.0 mM (diabetics or pre-diabetics);
* Smoking
* Clinically-significant gastro-intestinal disease/conditions.
* Clinically-significant liver disease/dysfunction.
* Clinically-significant cardiac disease/conditions.
* Clinically-significant abnormal coagulation.
* Taking a medication that could affect lipid and glucose metabolism
* Hypertension
* Pregnancy or breastfeeding
* Exercising more than 3 times a week
Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair

X-ray computed tomography imaging (CT) is routinely used in follow-up after endovascular aneurysm repair (EVAR). Contrast-enhanced ultrasound (CEUS) has been shown to give accurate information about endoleak after EVAR. Benefits of CEUS over CT include less radiation exposure, avoidance of renal function deterioration due to repeated X-ray contrast agent application and decrease in the cost of EVAR follow-up. This study is designed to investigate if results from literature are reproducible in St Olavs Hospital in Trondheim (Norway), to gain experience with the technique and to introduce CEUS as an alternative for detection of endoleak in this hospital.


Eligibility Criteria:
Inclusion Criteria:

* in follow-up after endovascular implantation of abdominal aortic prothesis

Exclusion Criteria:

* None
Assessing the Clinical Effectiveness of Serum Biomarkers in the Diagnosis of Metastatic Uveal Melanoma

Uveal melanoma is the most common primary intraocular tumor in adults. The local treatment is effective, but patients still die of metastatic disease. It has been shown that early diagnosis of a few isolated metastases can result in a clean surgical excision of the metastases and an extension of the expected survival from 7-12 months to over 10 years on some patients.

Many serum biomarkers are employed in Oncology. It makes sense to try the relevant ones in the diagnosis of metastatic uveal melanoma.

The investigators hypothesis is that a soluble serum biomarker level changes upon development of metastatic disease either by secretion by the tumor cells themselves or by their environment. Detection of changes in biomarker level may lead to the diagnosis of metastases before they can be detected by imaging modalities, thus allowing for early treatment of the metastases and a better chance of success.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of uveal melanoma

Exclusion Criteria:

* refusal to participate in the study
A Extension Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance ( EMPIRE-02 )

A multicenter, open-label, single-arm, extension study with regard to the safety and efficacy of empagliflozin in patients with refractory diabetes mellitus with insulin resistance.

To determine the safety and efficacy of oral administration of empagliflozin 10 mg or 25 mg once daily for 28 weeks (52 weeks of the EMPIRE-01 study) in subjects who participated in the EMPIRE-01 study, which was conducted on refractory diabetes mellitus patients with insulin resistance (insulin resistance syndrome, lipoatrophic diabetes mellitus) in a multicenter, open-label, single-arm, extension study.

Eligibility Criteria:
Inclusion Criteria:

1. A patient who completed the preceding EMPIRE-01 study and does not meet any discontinuation criteria
2. A patient who has received sufficient explanation with regard to information such as the objectives and details of this study, expected drug efficacy/pharmacological action and risks, and has given written consent by her/himself

Exclusion Criteria:

1. A patient with a medical history of acute coronary syndrome (including non-ST-elevation myocardial infarction, ST-elevation myocardial infarction and unstable angina pectoris), stroke or transient ischemic attack (TIA) within 3 months before obtaining consent
2. A patient with suspected hepatic dysfunction that either of serum ALT, AST or alkaline phosphatase is exceeding 3-fold of upper limit of normal range prior to starting extension study treatment (Day 0)
3. A patient who is receiving a systemic steroid at the time of consent (except for type B)
4. A patient whose thyroid hormone product dose has been changed within 6 weeks before obtaining consent
5. A patient with unstable endocrine diseases other than diabetes mellitus
6. A patient with hemolysis or blood diseases that destabilize erythrocytic cells and other various disorders (e.g., malaria, babesiosis, hemolytic anemia)
7. A premenopausal female patient (the latest menstruation was within 1 year before obtaining consent), a lactating or pregnant patient, or a patient who may be pregnant (without hysterectomy or ovariectomy) who has no intention to use efficacious contraception defined in this study during the study period and would not agree to receive regular pregnancy tests during the study period
8. A patient who has experienced alcohol abuse or drug abuse within 3 months before obtaining consent, which may disturb the study participation
9. A patient who is in the condition that makes it difficult to administer the study drug
10. A patient with renal dysfunction of eGFR (MDRD calculating formula) \<45 mL/min/1.73 m2 prior to starting extension study treatment (Day 0)
11. A patient who indicates a hypersensitivity response to empagliflozin or its excipients, or a patient with lactose-intolerance
12. A patient with severe ketosis, diabetic coma or precoma, severe infection, perioperative status, or serious trauma
13. A patient that the investigator and/or coinvestigator, etc., has judged to be ineligible to this study for other reasons
Lumbar Proprioception in Patients With Lumbar Spinal Stenosis

The primary aim of this study was to compare spinal proprioception in patients with Lumbal Spinal Stenosis (LSS) (with or without surgery) and healthy controls. A secondary aim was to investigate the effect of pain at target positions where repositioning error (RE) was assessed and TLF flexibility on spinal proprioception deficiency.This cross-sectional and healthy controlled study was conducted in patients with LSS. Participants will be grouped as: Healthy control (Group I), chronic low back pain due to LSS (Group II) and undergoing surgery due to LSS (Group III). Reposition error (RE), pain at target positions of RE and flexibility of the TLF were assesed with iphone tiltmeter app, VAS and goniometric platform, respectively. Target positions of reposition error were: 30º forward bending and 15º backward bending in sitting and standing.

This cross-sectional and healthy controlled study was conducted in patients with LSS. Participants will be grouped as: Healthy control (Group I), chronic low back pain due to LSS (Group II) and undergoing surgery due to LSS (Group III). Reposition error (RE), pain at target positions of RE and flexibility of the TLF were assesed with iphone tiltmeter app, VAS and goniometric platform, respectively. Target positions of reposition error were: 30º forward bending and 15º backward bending in sitting and standing.

The general study inclusion criteria were as follows: age between 20 and 50 years and not having had lower extremity surgery.

In addition to the general inclusion criteria, the inclusion criteria for the control group were as follows: not having a chronic spinal disorders and not having low back pain in the last week. Group II consisted of patients diagnosed with LSS and confirmed by MRI findings.

In addition to the general inclusion criteria, the inclusion criteria for the LSS group were as follows: having low back pain for more than 3 months and having low back pain intensity of 4 or more assessed with VAS.

There was not any additional inclussion criteria for Group III. The exclusion criteria of current study are; having any previous inner ear inflammation or vestibular disorders, having diabetes and being pregnant.

Eligibility Criteria:
Inclusion Criteria:

* age between 20 and 50 years
* not having had lower extremity surgery
* not having a chronic spinal disorders
* not having low back pain in the last week
* having low back pain for more than 3 months
* having low back pain intensity of 4 or more assessed with VAS

Exclusion Criteria:

.having any previous inner ear inflammation or vestibular disorders .having diabetes and being pregnant.
Tau Positron Emission Tomography (PET) Longitudinal Substudy Associated With: Study of Crenezumab Versus Placebo in Preclinical Presenilin1 (PSEN1) E280A Mutation Carriers in the Treatment of Autosomal-Dominant Alzheimer's Disease

This substudy will evaluate the effect of crenezumab on the longitudinal tau burden in a subgroup of preclinical Presenilin1 (PSEN1) E280A mutation carriers and non-carriers, who were enrolled in study NCT01998841 (GN28352). Participants will receive up to three intravenous (IV) injections of \[\^18F\] Genentech Tau Probe 1 (GTP1) and will undergo a tau positron emission tomography (PET) scan after each IV injection of \[18\^F\]GTP1. The purpose of this substudy is to increase the understanding of disease progression in the preclinical stage of familial Alzheimer's Disease (AD).


Eligibility Criteria:
Inclusion Criteria:

- Enrolled in main Study NCT01998841 (GN28352).

Exclusion Criteria:

- Contraindication to PET scan procedures, possibly including, but not limited to current, past, or planned participation in studies involving radioactive agents, including the main Study NCT01998841 (GN28352) and this Tau PET substudy, such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.
Malignant Pleural Effusion: Pleur-X vs. Chemical Pleurodesis in VATS

This is a prospective randomized study whose aim is to compare the efficacy of the permanent thoracic catheter (Pleur-X) versus chemical pleurodesis in videothoracoscopy (VATS) in the treatment of malignant pleural effusion at the first diagnosis.Patients with malignant pleural effusion for whom there is indication of surgery and who agree to participate in the study will be randomized 1: 1 in the Pleur-X arm (arm 1) or in the chemical pleurodesis arm (arm 2).

The arm 1 provides for the installation of a permanent drainage under local anesthesia while the arm 2 provides a pleurodesis with talc in VATS under general anesthesia.

Both procedures are standard of care.

Before the study procedure the patients will be requested to perform some examination as physical and radiological examination. Patients will also complete questionnaires for quality of life assessment (EORTC QLQ 30) and symptoms (VAS for pain). Patients will then be randomized into one of the two arms.

For patients included in arm 1, a permanent drainage (Pleur-X) is provided under local anesthesia performed on an outpatient basis while for patients included in arm 2 a pleurodesis with talc in VATS is planned under general anesthesia. Arm 2 patients will be hospitalized for 5 days.

Patients will then be followed up to 3 months after surgery. During this period a medical examination will be required at 1 week, 4 weeks and 3 months after the intervention during which the patient will be asked to complete questionnaires for the evaluation of quality of life (EORTC QLQ 30) and symptoms (VAS for pain ). A chest radiograph will be performed after four weeks to evaluate the primary parameter. Adverse events will be collected throughout the study period.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years, \<80 years
* First diagnosis of malignant pleural effusion
* Indication to treat the malignant pleural effusion with surgery
* Informed informed consent

Exclusion Criteria:

* Previous surgeries on the same hemitorace
* Pregnant women
* Trapped lung syndrome
* Patients with estimated life expectancy \< 4-8 weeks
Prospective Köln Bonn Registry for the Extraction of Pacmaker and ICD Leads

The KOBES registry is an all-comers prospective clinical registry of the cooperative Köln Bonn lead extraction center. All patients undergoing complex lead extraction procedures (i.e. indwelling leads \> 6months) in the hybrid operating room with cardiothoracic standby will be included in the registry. Preoperative, intraoperative/procedural and postoperative parameters will be recorded. All patients will be asked to provide written informed consent. Data will be pseudonomyzed and entered into a data sheet. Data will be monitored by a board and evaluated independently.

The following parameters will be included in the registry Preoperative

General:

* pacemaker / ICD indication
* Ejektionsfraktion
* previous cardiac surgery / TAVR
* specific cardiac disease: IHD, CMP (DCM, HCM, andere), Primary electrical disease if ICD:
* primary / secondary prevention concomitant disease:HTN, DM
* CRF; GFR (ml/min)
* if yes: dialysis ?
* anticoagulation / antithrombotic therapy: Ja/Nein

Indication:

* infection (local/systemic), classification
* blood culture positive/negative
* swab positive
* classification
* TEE: pos/neg
* Device malfunction
* Phlebography y/n
* Vascular access y/n
* Number of Leads and Type
* uni/bipolar / age / abandoned leads
* ICD-leads: single-/dual-coil, age / abandoned leads

Intraoperative:

General:

* type of anaethesia
* TEE y/n
* Safety wire y/n
* temporary pacing wire y/n

Access:

* Subclavia r/l/bil
* Femoral: y/n; if yes: planned / Bailout: geplant Tools
* LLD: y/n; Number
* Mechanical sheath and type
* Laser sheath
* Additional tools: Loop-Snare / Needle-Eye Snare / Rat-Tooth Result : extraction: complete / partial / failed
* procedural success: y/n
* infection: procedural / clinial success
* Safety lead y/n
* temporary pacing wire in situ Intraoperative complications
* vascular injury
* pericardial effusion / tamponade
* pericardiocentesis
* occlusion ballon
* thoracotomy
* Intraoperative catecholamines
* death

Postoperative:

* duration
* hospital stay
* postoperative active system
* transvenous / epicardial / capsule/ subcutaneous / extravascular
* type of pacemaker
* type of ICD
* Wenn ja: transvenös / subkutan

Postoperative complications:

* hematoma / seroma / fistula
* further interventions: Revision / hematoma/ reinfection

Eligibility Criteria:
Inclusion Criteria:

* All patients with a standard indication for lead extraction according to the HRS / EHRA guidelines

Exclusion Criteria:

* None
Urinary Proteomics Analysis for Sepsis and Prognosis

As a noninvasive examination, urinary proteomics is a very useful tool to identify renal disease. The purpose of the present study was to find differential proteins among patient with SIRS and sepsis(included survivors and non-survivors), and to screen potential biomarkers for the early diagnosis of sepsis and its prognosis. Urinary proteins were identified by iTRAQ labeling and LC-MS/MS. The bioinformatics analysis was performed with the Mascot software and the International Protein Index (IPI) and the Gene Ontology (GO) Database and KEGG pathway Database. The differentially expressed proteins were verified by Western blot by another sample collected from clinical.


Eligibility Criteria:
Inclusion Criteria:

* Male and female aged 18 years old and over;
* clinically confirmed infection;
* fulfilled at least two criteria of systemic inflammatory response syndrome
* (a) core temperature higher than 38 °C or lower than 36 °C
* (b)respiratory rate above 20/min, or PCO2 below 32 mmHg
* (c) pulse rate above 90/min, and
* (d) white blood cell count greater than 12,000/μl or lower than \< 4,000/μl or less than 10% of bands.

Exclusion Criteria:

* younger than 18 years of age;
* acquired immunodeficiency syndrome;
* reduced polymorphonuclear granulocyte counts (\< 500 μL-1);
* died within 24h after admission into the ICU, or refused to participate in the study, or declined treatment during the period of observation.
Effects of Exercise Intervention on Muscle Strength in Severely Ill Patients

In recent years, due to the improvement in the survival rate of the intensive care unit, the problem of severe systemic fatigue (Intensive care unit acquired weakness; ICUAW) has continued to receive attention. Muscle mass decreases by 3-11% within a week, resulting in decreased muscle strength and muscle atrophy. Current studies suggest that ICUAW can lead to poorer function, prolonged ICU stay, and decreased quality of life.

This study aimed to understand the muscle strength of critically ill patients and to explore the effect of exercise intervention on improving muscle strength. The experimental group received a four-week exercise bike intervention plus conventional rehabilitation exercises, while the control group received conventional rehabilitation exercises.

The content of the exercise is to use an exercise bike, start pedaling on the first day, time setting: 20 minutes, speed: 2, and adopt passive mode. If you can complete the exercise on the first day, the time will be adjusted to 30 minutes on the second day. If you cannot complete the exercise on the first day, the time will still start from 20 minutes on the second day. The maximum time is 30 minutes. If you can complete 30 minutes of passive exercise for 3 consecutive days, the fourth day will be adjusted to active exercise. The entire exercise training is seven days a week, once a day, once a 30-minute, at least 5 days. Those who were discharged to the general ward continued to complete this exercise training for up to 28 days. Stop exercising if heartbeat \> 140, mean arterial pressure \< 65, blood oxygen \< 90%, respiration \> 35 beats/min, or the patient requests to stop during exercise.

Eligibility Criteria:
Inclusion Criteria:

1. Aged over 20 years old
2. Conscious
3. willing to participate in this study, and signed the consent form
4. no lower extremity activity taboo, and can walk independently before admission

Exclusion Criteria:

1. Have neuromuscular disease.
2. Unable to step on a bed bike.
Acute Effects of Incremental Inspiratory Loads on Respiratory Mechanics and NRD in Patient With Stable COPD.

Inspiratory muscle training has been an important part of pulmonary rehabilitation program directed at patients with COPD. It can increase respiratory muscle strength, relieve dyspnea ,improve the quality of life in COPD patients. However, there is no uniform standard for the intensity of inspiratory muscle training. By comparing a series of indexes, such as maximal inspiratory pressure, maximal expiratory pressure, degree of dyspnea and exercise capacity before and after the training under different intensity, a large number of literatures have explored the appropriate intensity of inspiratory muscle training. But to date, there are few studies about the effects of different intensity of inspiratory muscle training on respiratory physiological mechanism. It has been shown that inspiratory muscle training may be more beneficial to improve the pulmonary rehabilitation effect of COPD patients with inspiratory muscle weakness. So it is not clear whether there is a difference in respiratory physiology between patients with normal inspiratory muscle strength and those with lower inspiratory muscle strength. Respiratory central drive, as an important physiological index, which can be reflected by minute ventilation volume, mouth pressure, mean inspiratory flow and diaphragm electromyography,is closely related to the symptoms and the severity of the disease.Therefore,the purpose of this study was to investigate the changes of respiratory mechanics and central drive in COPD patients at different inspiratory loads, and at the same loads between patients with and without respiratory muscle weakness.That can provide more evidential evidence for setting up the intensity of inspiratory muscle training.

The patients with COPD will be admitted in one intervention groups(performing on threshold loading device).Before using threshold loading device, we will measure the relevant parameters of lung volume, respiratory flow,diaphragm electromyogram, central drive mechanical and other baseline index.Then incremental inspiratory load will be applied to investigate the effects of inspiratory load on the above mentioned respiratory mechanics parameters.

Eligibility Criteria:
Inclusion Criteria:

- Patients with pulmonary function test of forced expiratory volume at one second (FEV1)/forced vital capacity(FVC) \< 70% after inhalation of bronchial dilation agent. Patients in a clinically stable state.

Exclusion Criteria:

- Patients were excluded if they had other respiratory diseases ,or evidence of pneumothorax or mediastinal emphysema and pacemaker installed.

Patients with acute cardiovascular event and severe cor pulmonale. Patients with poor compliance. An Other causes of diaphragmatic dysfunction