cyrilzakka/clinical-trials huggingface dataset:
Turkish Version of The Pediatric Anesthesia Emergency Delirium

Emergence delirium (ED) is a mental disorder seen in children during recovery from general anesthesia. The Pediatric Anesthesia Emergence Delirium (PAED) scale is the only valid scale to assess ED in pediatric patients undergoing general anesthesia. The aim of this study is to translate and adapt the PAED scale to Turkish.

A five-stage translation and adaptation process will be performed. The reliability of the Turkish version of the PAED scale was independently assessed by a group of two raters (anesthesiologists or postanesthesia care unit nurses) in pediatric patients after general anesthesia. ED was defined by a cut-off point of ≥ 10 points on the PAED scale


Eligibility Criteria:
Inclusion Criteria:

1. Parents consented to the study,
2. Transferred to PACU after general anesthesia,
3. Between 2-16 years of age,
4. ASA physical status class I-II,
5. Cognitively intact children.

Exclusion Criteria:

1. Children without parental consent,
2. Children under 2 years of age and over 16 years of age,
3. Children with ASA physical status class III and above,
4. Children who underwent surgery under general anesthesia under emergency conditions,
5. Children with cognitive and behavioral disorders,
6. Children who developed major complications after the operation,
7. Children who are expected to require postoperative mechanical ventilation.
Modified Ultrafiltration in Cardiac Surgery

The purpose of this study is to find out, whether filtration of the blood in patients undergoing cardiac surgery, beneficially influences the coagulation system.

The impact of modified ultrafiltration following extracorporeal circulation on primary and secondary hemostasis is controversial. In this study we intend to assess both, primary and secondary hemostasis prior to and after the usage of modified ultrafiltration. Primary hemostasis is assessed using Multiple Electrode Aggregometry (Multiplate) and secondary hemostasis is assessed performing thrombelastometry using the ROTEM device. Patients are preoperatively randomized to receive either modified ultrafiltration or no filtration.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing complex cardiac surgery procedures

Exclusion Criteria:

* none
Cognitive-Behavioral Treatment for Mild Alzheimer's Patients and Their Caregivers

The purpose of this study is to determine whether a comprehensive cognitive-behavioral therapy-based, multi-component treatment programme is effective in the treatment of neuropsychiatric symptoms of patients with mild Alzheimer's dementia.

Mild Alzheimer's dementia (AD) cases are with 15 millions worldwide the largest fraction of all AD cases. Most patients are cared for by their family at home. Neuropsychiatric symptoms are very common in AD, even as early as in mild AD: About 90% of all mild AD cases experience neuropsychiatric symptoms, most frequently depression, anxiety, and irritability. These symptoms are associated with greater morbidity, reduced quality of life for the patient, increased burden and depression for the caregiver, higher costs of care, and nursing home placement. Thus, interventions aimed at treating these symptoms could have a tremendous effect on pa-tients, caregivers, and society.

This study is a randomized, controlled trial (RCT) evaluating a comprehensive CBT-based, multi-component treatment programme consisting of eight modules (diagnosis and goal-setting; psycho-education; engagement in pleasant activities; cognitive restructuring; life review; training caregiver in behavior management techniques; interventions for the caregiver; couples counseling) and 20 sessions.

This trial aims at significantly reducing depressive and other neuropsychiatric symptoms in the AD patients, and secondary in reducing burden and depressive symptoms of the caregivers. Patients with AD alone or mixed AD and vascular dementia that are in the mild stage and suffer under any neuropsychiatric symptom will be included. The patients and their caregiver will be randomized to either the CBT-based intervention or to the control condition that receives treatment as usual (TAU).

Eligibility Criteria:
Inclusion Criteria:

* Patients have to meet NINCDS-ADRDA criteria for probable or possible AD (McKhann et al., 1984). Mixed Alzheimer and Vascular dementia cases will also be included.
* Only AD cases with a mild dementia severity will be included, determined by the Clinical Dementia Rating (CDR) scale (i.e. scores of 0.5 or 1, Morris, 1993) and by the Mini Mental State Examination (MMSE) (i.e. scores of 20 or more, Folstein, Folstein, \& McHugh, 1975).
* The patient must suffer under any non-cognitive symptom that motivates him to accept psy-chotherapeutic help.
* A caregiver must be available to take part in most of the therapy sessions.

Exclusion Criteria:

* concomitant alcohol or drug addiction and a history of a malignant disease, severe organ failure, metabolic or hematologic disorders, neurosurgery or neurological condition such as Parkinson's disease, epilepsy, postencephalitic and postconcussional syndrome
HFNO Improves Blood Oxygen Saturation During Asphyxia During Pulmonary Surgery With Double-lumen Endotracheal Intubation

With the continuous strengthening of the concept of rapid rehabilitation, great progress has been made in minimally invasive thoracic surgery, and thoracoscopic surgery has developed rapidly. Double-lumen endotracheal(DLT) intubation is still the most reliable way of intubation in lung surgery. However, hypoxemia faced during double-lumen intubation still threatens the perioperative safety of thoracic surgery patients. In recent years, high-flow nasal oxygenation (HFNO) has great potential in the field of anesthesia, especially playing a new and important role in the prevention and treatment of short-term hypoxia and life-threatening airway emergencies. However, the use of HFNO in pulmonary surgery patients with poor pulmonary function lacks evidence-based basis, and there are few reliable clinical data.

This study adopted a prospective, randomized, controlled, single-blind design. A total of 100 patients aged 18-60 years who underwent elective thoracoscopy-assisted pulmonary surgery were included and randomly divided into the experimental group: HFNO was used in the process of double-lumen intubation asphyxia; the control group: according to the traditional intubation process, No oxygen therapy equipment was used during intubation asphyxiation. The lowest blood oxygen saturation during intubation, the incidence of hypoxemia during intubation, perioperative complications, and postoperative hospital stay were compared between the two groups.

This study explores the advantages of HFNO in complex endotracheal intubation, assuming that HFNO can improve the oxygen saturation of double-lumen intubation; optimize the intubation method of DLT, and tap its new potential to prevent and manage emergency airway crisis.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-60;
* Patients planning to undergo video-assisted thoracoscopic (VATS) lung surgery requiring DLT intubation;
* Patients who agreed to participate in this study.

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) classification \> IV;
* Patients with severe nasal obstruction; expected difficult intubation or difficulty with mask ventilation;
* Morbid obesity \[Body Mass Index (BMI)\>35kg/m2)\];
* Airway anatomical abnormalities;
* Abnormal coagulation function;
* Emergency surgery;
* Patients at high risk of reflux aspiration, including ileus, full stomach, esophageal reflux disease;
* Pregnant or breastfeeding women.
Pentoxiphylline and Vitamin E Versus Vitamin E in Patients With Non- Alcoholic Steatohepatitis

120 patients of biopsy proven NASH will be randomized into two groups. Cases group will receive combination of pentoxiphylline and Vitamin E, and control group will receive only Vitamin E.

The investigators plan to randomise 120 patients of biopsy proven NASH into cases and control groups.

Baseline investigations:

Clinical characteristics

* Age
* Gender
* Anthropometry (BMI, waist circumference, waist- hip ratio, triceps skin fold thickness, mid arm circumference)
* Alcohol intake should be nil

Laboratory characteristics

* Hemogram, INR, KFT
* LFT (especially ALT, GGT) , APRI (AST to platelet ratio)
* Fasting Lipid Profile
* Other possible etiologies of liver disease (viral markers, ferritin, ANA, IgG, ceruloplasmin )
* HOMA-IR (II)
* Serum uric acid levels Liver stiffness
* Fibroscan
* MR elastography Radiological characteristics
* USG abdomen Variceal status by UGI endoscopy Alpha fetoprotein Pro- inflammatory markers
* TNF-alpha, IL-6, adiponectin, leptin and osteopontin Liver biopsy and NAS score

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 70 years
* Persistently abnormal ALT \>1.2 times upper limit of normal
* Histological evidence of NASH/cirrhosis on liver biopsy. ( The minimal criteria for diagnosis of NASH included the presence of lobular inflammation and either ballooning of cells or perisinusoidal or pericellular fibrosis in Zone 3 of the hepatic acinus)

Exclusion Criteria:

* A known case of Type 2 diabetes mellitus on treatment
* Alcohol intake of more than 40gm / week
* If they had evidence of cirrhosis with significant portal hypertension
* Ongoing total parenteral nutrition/ jejunal-ileal bypass
* Other known liver disease (Hepatitis A to E, autoimmune liver disease, Wilson's disease, alpha 1 antitrypsin deficiency and hemochromatosis)
* Medication like estrogens, amiodarone, MTx, tamoxifen, ATT
* Pregnancy or lactation
* Hypersensitivity to methylxanthines (e.g., caffeine, theophylline, theobromine )
* Recent retinal/cerebral hemorrhage
* Acute myocardial infarction or severe cardiac arrhythmias
* Impaired renal function
* Hypothyroidism
Fluency Stent-Graft Versus Luminex Stent for Angioplasty of Recurrent Stenosis of the Cephalic Arch in Autogenous Arteriovenous (AV) Access for Hemodialysis

The type of hemodialysis access and preservation of this access greatly influences the quality of life and survival of patients undergoing hemodialysis. The Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines for vascular access recommend the primary placement of native or autogenous hemodialysis fistulas in preference to polytetrafluoroethylene (PTFE) grafts and central venous catheters because the former form of access has fewer complications and a longer durability. However, autogenous hemodialysis fistulas, like polytetrafluoroethylene grafts, are also subject to dysfunction and eventual failure. Endovascular angioplasty has become an accepted alternative treatment to surgical revision for hemodialysis access-related venous stenoses and occlusions. However, the patency rates in the follow-up period are low because of the high frequency of restenosis due to intimal hyperplasia. Since 1988, noncovered stents have been used to improve fistula patency. In the central veins, bare stents demonstrate better patency rates than percutaneous transluminal angioplasty (PTA) alone. Neointimal hyperplasia is the major reason for restenosis following stent placement. The cephalic vein forms the outflow conduit for radiocephalic and brachiocephalic autogenous fistulas. It has recently been suggested that a focal area of the cephalic vein is prone to developing hemodynamically significant stenosis, in what is now termed the cephalic arch. This is the perpendicular portion of the cephalic vein in the region of the deltopectoral groove before its junction with the axillary vein. To overcome the problem of restenosis due to intimal hyperplasia in the cephalic arch the investigators used the insertion of a stent-graft as an alternative approach. In this study they investigated the use of a PTFE-covered nitinol stent-graft (Fluency, Bard) versus a Luminex (Bard) stent.


Eligibility Criteria:
Inclusion Criteria:

* Patients included in this study would be presented for intervention after observation in the Vascular Access Unit for one of the following:

  * the recurrent cephalic arch stenosis identified on periodic duplex scanning, performed by one of the surgeons from the Vascular Access Unit;
  * reduction of flow rate of more than 20% from baseline access flow rate;
  * dynamic venous pressures exceeded threshold levels three consecutive times; or
  * clinical signs (arm swelling, pulsatile fistula, prolonged bleeding from puncture sites) suggesting fistula dysfunction in a patient with previously treated cephalic arch stenosis.
Synergistic Immunomodulatory Effect of Synbiotics Pre and Postoperative Resection of Pancreatic Ductal Adenocarcinoma

The goal of this interventional study was to evaluate the synergistic effect of symbiotics (a combination of probiotics and prebiotics) compared to probiotics alone in terms of their impact on anti-tumor immunomodulation in patients with pancreatic ductal adenocarcinoma (PDAC). The study also aimed to assess the effects of these interventions on postoperative complications and outcomes. In the study, a probiotic agent (Nowfoods, USA), containing ten strains of bacteria with a total dosage of 25 billion colony-forming units (CFU) was administered. This probiotic regimen involved taking two capsules once daily, starting two weeks before the surgery and continuing for one month after the surgery. For the synbiotic group, in addition to the probiotic agent, two capsules per day of inulin supplement (HERBAMAMA, USA) were also taken.

The study included three groups: the synbiotics group, the probiotics group, and the placebo group. The researchers compared the pathological status of immune cell infiltration (specifically CD8 cells) and interferon-gamma expression, as well as the levels of interleukins 10, 6, and 10 in the participants' serum. Four blood samples were collected from each participant: one taken 14 days before the surgery, one on the surgery date, one two weeks after the surgery, and one 30 days after the surgery.

The main research question addressed by the study was whether there was a significant difference in the immunomodulatory effect and postoperative complications between the synbiotics group and the probiotics group. The placebo group likely served as a control to compare the effects of the interventions against no intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary PDAC with complete pathological and follow-up data
* Patients without long-distance metastasis
* Patients without chronic diseases
* Patients without any treatments before the surgery.

Exclusion Criteria:

* Patients who suffered from other tumors or other chronic diseases or accidentally died
* Lack of pathological and follow-up data.
* Patients with long-distance metastasis before the surgery.
Impact of Computerized Decision Support on Racial/Ethnic Disparities in Hypertension Outcomes

In response to the Finding Answers: Disparities Research for Change call for proposals by the Robert Wood Johnson Foundation, we were funded to evaluate the effectiveness of a planned computerized decision support (CDS) intervention aimed at medical providers to overcome clinical inertia when treating blood pressure for hypertensive patients. Based on prior evaluation of the Brigham and Women's Hospital (BWH) adult primary care clinics, we hypothesize that racial and ethnic differences in blood pressure outcomes are largely attributable in differences in providers' aggressiveness in managing patients with hypertension based on patients' race and ethnicity. Within our network of 14 hospital and community-based Brigham and Women's Hospital adult primary care clinics, we aim to determine if the use of CDS to remind to medical providers of poorly controlled hypertensive patients to intensify their hypertension therapy will improve overall rates of blood pressure control and reduce the previously documented racial and ethnic disparities in blood pressure outcomes among our hypertensive patient population. Clinics will first be stratified by location (hospital-based versus community-based) and within each strata will be randomized to either have their providers receive CDS for hypertensive patients whose most recent blood pressure was uncontrolled or to usual care for hypertensive patients. More specifically, we will evaluate our planned intervention by utilizing an 18 month cluster-randomized controlled trial to examine the effectiveness the CDS for intensification of hypertension therapy in: improving levels of blood pressure control, improving provider adherence with recommended changes in drug therapy, and reducing racial/ethnic disparities in the processes of hypertension care and outcomes among our patients receiving primary care for a diagnosis of hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 20 years) with ICD-9 of hypertension with a minimum of 2 outpatient primary care visits in from 10/2008-10/2009 who receive care for hypertension in the outpatient practices at least once for hypertension from 10/2009-7/2001

Exclusion Criteria:

* Pregnancy, age \< 20 years, fewer than two hypertension-related visits from 10/2008-10/2009
CETIC-I (CEra Traction Improves Cervical Kyphosis -I)

The study is a Prospective, Randomized, Single-blinded, Sham device controlled, Parallel Treatment Grouped, Multi-center, Exploratory Clinical Trial to Evaluate Improvement of Cervical Lordosis and Safety of CGM MB-1701 (Spinal warm massage device, Ceragem Master V6) in Subjects with Cervical Kyphosis and Posterior Neck Pain.

The Cervical Kyphosis are also commonly referred to as "turtle neck syndrome." It refers to the deformation of the neck bone into an inverted C-shape due to abnormalities or degenerative changes, and it is named to mean that the neck is bent like a turtle.

This device, Ceragem Master V6 (CGM MB-1701), has been certified as a combination of a personal warmer that can be used to relieve muscle pain by applying constant heat to the human body and a medical vibrator of a device that applies physical energy (vibration, shock, pressure, etc.). Also, the device got approval for use with intermittent pneumatic compression and electrically-powered orthopedics traction.

The primary purpose of this clinical trial is to confirm the temporary cervical lordosis angle improvement (height) in subjects with cervical kyphosis through the combined function of the test device.

Eligibility Criteria:
Inclusion Criteria:

1. Adult male and female subjects who have voluntarily decided to participate and agreed in writing after being briefed on the characteristics of this clinical trial and medical device
2. Subjects with cervical kyphosis angle between cervical lordosis 20 degrees and cervical kyphosis 5 degrees.
3. BMI betweeen 18.5 and 30
4. Chronic neck pain NRS 4 or higher lasting more than 3 months

Exclusion Criteria:

1. Secondary spondylosis
2. A tumor of the spine
3. Inflammatory spondylitis
4. Myelopathy
5. Multiple adjacent radiculopathies and others
The Intraoperative Physiologic Changes of Patients Under Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cytoreductive Surgery; Prospective Observational Study

The most popular surgical treatment of peritoneal cancer is the type known as hyperthermic intraperitoneal chemoperfusion (HIPEC), a type of cytoreductive surgery for which a significantly high survival rate has been demonstrated by several studies. It is widely known that HIPEC entails severe physiological changes and precautions during anesthesia. However, very few studies have systematically outlined and organized these changes for each system, and most existing studies only report retrospective data or are limited to gynecological surgeries. Therefore, the present researchers planned a prospective observational study to determine the physiological changes that occur in patients during HIPEC cytoreductive surgeries performed in the colon and rectal surgery department of the investigators hospital. The investigators planned to monitor the patients' body temperature, metabolism, cardiovascular and respiratory changes during HIPEC cytoreductive surgery and analyze the anesthetic methods applied to identify the optimal anesthetic management strategy for HIPEC cytoreductive surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 20 years of age or older who will undergo HIPEC cytoreductive surgery at the colon and rectal surgery department of our hospital

Exclusion Criteria:

* Cases in which there is a sudden change of surgery plans, or those in which consent forms are retracted.
Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type II Diabetes

The purpose of the study is to assess if the addition of vildagliptin as add-on therapy improves glucose variability in type 2 diabetes mellitus (T2DM) patients inadequately controlled with insulin, with special emphasis in hypoglycemic episodes measured by continuous glucose monitoring.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent read and signed before any protocol procedure.
2. Free will to sign the informed consent.
3. Male and female between 18 and 80 years. If female, patient must be non-fertile or of childbearing potential using a medically approved birth control method.
4. Type 2 diabetes mellitus
5. Patient under insulin treatment within 3 years with stable insulin NPH (Neutral ProtamineHagedorn) regimen at dose of at least 20 UI/day up to 40 UI/day for a minimum of 4 weeks prior to enrolment, only NPH and glargine insulin are allowed.
6. HbA1c between 7.5 to 9%.
7. Fasting plasma glucose (FPG) less than 270 mg/dL.
8. Body mass index (BMI) between 20 to 35 kg/m2.
9. Free willing to take the vildagliptin tablets during the study.

Exclusion Criteria

1. Pregnant or lactating female or without birth control method if of childbearing potential.
2. Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome.
3. Acute cardiovascular complications or metabolic complications within the past 4 months.
4. History cerebrovascular disease during the last year.
5. History of Torsades de Points, ventricular tachycardia or ventricular fibrillation.
6. Ischemic heart disease (e.g. myocardial infarction, unstable angina, coronary artery bypass surgery).
7. Congestive heart failure requiring pharmacologic treatment.
8. Any known serious heart condition.
9. ALT and/or AST greater than three times the upper limit of the normal range.
10. Serum creatinine levels greater than 1.5 mg/dL
11. Malignancy including leukemia and lymphoma within the last 5 years

Other inlcusion/exclusion criteria may apply