cyrilzakka/clinical-trials huggingface dataset:
Educational Intervention and Social Support in Diabetes Mellitus

The purpose of this study is to evaluate the impact of an educational program for people with diabetes mellitus based on the family social support.

H0: The person with diabetes who participates in the educational group whose family member/caregiver receives educational interventions hasn't greater glycemic control.

HA: The person with diabetes who participates in the educational group whose family member/caregiver receives educational interventions has greater glycemic control.

Eligibility Criteria:
Inclusion Criteria:

* People with DM2
* Both sexes
* Minimum age of 40 years
* Able to dialogue
* Lack of complications in advanced

Exclusion Criteria:

* Hemodialysis treatment
* Amaurosis
* Sequelae of Stroke and/or Heart Failure
* Previous amputations at any level of the lower limb
* Active ulcer in the lower limbs
* People in wheelchairs and/or litter
* People with limited understanding of the instruments due to cultural factors
Early Versus Late Parenteral Nutrition in the Pediatric Intensive Care Unit

In the PEPaNIC trial it is investigated whether withholding parenteral nutrition during the first week in critically ill children is beneficial, compared to the current standard of the early start of parenteral nutrition.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the PICU with a STRONGkids score of 2 points or more upon ICU admission

Exclusion Criteria:

* Age of 17 years or older
* Patients with a DNR code at the time of ICU admission.
* Patients expected to die within 12 hours (=moribund patients).
* Patient readmitted to ICU after randomization to the PEPaNIC trial, more than 48 hours after the initial discharge
* Patients transferred from another paediatric intensive care after a stay of more than 7 days
* Patients suffering from ketoacidotic or hyperosmolar coma on admission.
* Patients suffering from Short Bowel Syndrome on home PN or other conditions that require home PN
* Patients suspicious or established inborn metabolic diseases requiring specific diet
* STRONGkids score lower than 2 on ICU admission.
* Premature Newborns ( 37 weeks gestational age upon admission in the PICU)
* Prior inclusion in another randomized controlled outcome study
A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* patients at least 18 years of age with moderate to severe active RA for at least 6 months;
* inadequate response to current anti-rheumatic therapies, including 1 or more traditional DMARDs;
* stable DMARD therapy for at least 8 weeks before entering study;
* patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria:

* major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study;
* patients who have previously failed treatment with an anti-tumor necrosis factor agent;
* women who are pregnant or breast-feeding.
Effect of Tracheal Tube Fixation Method on Nasal Pressure of Patients With Nasal Tracheal Intubation

Nasotracheal intubation (NTI) is commonly used in operations of the mouth, pharynx, larynx and also the neck .Various complications can occur such as epistaxis, bacteremia,turbinectomy, retropharyngeal dissection, and nasal alar pressure sores or necrosis.In clinical practice, nasal pressure sores caused by NTI are not uncommon, but have failed to attract clinical attention.The investigators have observed that the surgeon fixed the nasal tracheal tube and threaded tube directly to the patient's head. The investigators suspect that this method can reduce the pressure between the nasal tube and the nose.

Nasotracheal intubation (NTI) is commonly used in operations of the mouth, pharynx, larynx and also the neck .Various complications can occur such as epistaxis, bacteremia,turbinectomy, retropharyngeal dissection, and nasal alar pressure sores or necrosis.In clinical practice, nasal pressure sores caused by NTI are not uncommon, but have failed to attract clinical attention.Oral and maxillofacial surgery usually uses nasal endotracheal intubation to manage the airway. The tube fixation directly presses the skin of the patient's nose. Due to the operation, the surgeon must stand on the head of the patient and there is not enough space to place the tracheal tube bracket. Prolonged vascular compression on the nasal region may be caused by excessive tension and angulation of the nasotracheal tube against the nasal tissue.Studies have proposed the use of nasal packing, hydrocolloidal dressing and modified nasal tracheal tube to reduce the direct contact between the nasal tube and the nose, relieve the pressure between the two, so as to prevent the occurrence of alar pressure ulcers, but there is no objective data to show the degree of pressure reduction.In clinical practice, the investigatorshave observed surgeons fixed the nasal endotracheal tube and threaded the tube directly to the patient's head. The investigators suspect that this method can reduce the pressure between the nasal tube and the nose, so the investigators want to use a pressure sensor to monitor the pressure between the two.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-60 years old
* ASA physical status I and II
* Requiring general anesthesia with nasal intubation

Exclusion Criteria:

* Previous history of pressure ulcers
* Nasal trauma or defect
* The need for emergency surgery
* Contraindications to nasal intubation
* Pregnancy
ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial

Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE (up to 60 % without prophylaxis). The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk, but heparins have to be applied below the skin (subcutaneously). Additionally, there is a chance of developing a heparin-induced thrombocytopenia (decrease in platelets). Therefore, there is still a need for new agents which are safer and more efficient and which are easier to apply.The purpose of this study is to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the licensed drug Enoxaparin. Enoxaparin, a so-called low molecular heparin, is approved and widely used in the area of thromboprophylaxis and will be given once daily subcutaneously.Another important purpose of the study is to find the optimal dose of BAY 59-7939 for thromboprophylaxis after hip replacement surgery. Therefore, there are several dose steps planned.


Eligibility Criteria:
Inclusion Criteria:

* Male patients aged 18 years or above and postmenopausal female patients.
* Patients scheduled for elective primary total hip replacement (cemented or non-cemented prosthesis).
* Patients' written informed consent for participation after receiving detailed written and oral previous information to any study specific procedures.

Exclusion Criteria:

* DVT or PE within the previous 6 months prior to study entry.
* Myocardial infarction (MI) or cerebrovascular attack (CVA), TIA or ischaemic stroke within the last 6 months prior to study entry.
* History of heparin-induced thrombocytopenia, allergy to heparins.
* Intracerebral or intraocular bleeding within the last 6 months prior to study entry.
* History of gastrointestinal disease with gastrointestinal bleeding within the last 6 months prior to the study.
* History or presence of gastrointestinal disease which could result in an impaired absorption of the study drug
* Amputation of one leg.Related to current symptoms or findings
* Heart insufficiency NYHA III-IV.
* Congenital or acquired haemorrhagic diathesis (PT INR/aPTT not within normal limits).
* Thrombocytopenia (platelets \< 50.000/µl).
* Macroscopic haematuria.
* Allergy to contrast media.
* Severe hypertension (SBP \> 200mmHg, DBP \> 100 mmHg).
* Impaired liver function (transaminases \> 2 x ULN).
* Impaired renal function (serum creatinine \> 1.5 x ULN).
* Active malignant disease.
* Presence of active peptic ulcer or gastrointestinal disease with increased risk of gastrointestinal bleeding.
* Body weight \< 45 kg.
* Drug- or alcohol abuse.
* Related to current treatment

  * Therapy with oral anticoagulants (e.g. phenprocoumon, warfarin-sodium).
  * Therapy with acetylic salicylic acid or other thrombocyte aggregation inhibitors (e.g. clopidogrel, dipyridamole and ticlopidine) should be stopped one week before enrolment
  * Treatment with heparins or Factor Xa Inhibitors other than study medication.
  * All other drugs influencing coagulation, (exception: NSAIDs with half life \< 17 hrs will be allowed).
Periodontal Disease Treatment of a Physically Challenged Population

Many physically handicapped patients at the dental department, Toronto Rehabilitation Institute(TRI) have considerable gingival inflammation and breath odour because of the inability to effectively handle a toothbrush. These patients have considerable periodontal disease. There is a concern that these pathogens may have a detrimental effect on wound healing in other areas of the body.

Hypothesis: Patients attending the dental department at TRI that are treated with the antibiotic-antifungal rinse containing metronidazole and nystatin will show substantial decrease in periodontal disease as measured by bleeding points and pocket depth when compared to the group that continues to use their regular oral hygiene methods (control group).


Eligibility Criteria:
Inclusion Criteria:

Participants must be between the ages of 18 to 65 years Participants must have at least 6 teeth. Participants must have some indication of gingivitis and periodontal breakdown. -

Exclusion Criteria:

Patients who are taking Warfarin/Coumadin Patients who are allergic to Metronidazole or chlorhexidine. Edentulous patients will be excluded by those who have at least 6 teeth can be a participant

-
Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation

Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteer

Exclusion Criteria:

* Is pregnant/nursing
* Has an active infection, open sores, or wounds in the treatment area
* Has any preexisting extremity circulation condition
Risk Prediction of Bleeding in Liver Cirrhosis by Combi-elastography

Through the parameters of liver stiffness and spleen stiffness obtained by combi-elastography technique, summarize and analyze the warning index of esophagogastric variceal bleeding in patients with cirrhosis, so as to provide a new and valuable technique for clinical diagnosis.

Firstly,the combi-elastography technique developed by HITACHI uses the method of multi-index and multi-parameter to evaluate the liver stiffness and spleen stiffness comprehensively.

And then,this prospective study is designed to follow up patients with cirrhosis for a period of 12 months, summarize and analyze the warning index of bleeding in patients with cirrhosis,so as to provide a new and valuable technique for clinical diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old, no gender limit;
* The clinical diagnosis is in line with patients with liver cirrhosis caused by chronic hepatitis B, and the gastroscopy is in line with the indications of portal hypertension;
* Gastroscopy needs to provide the degree of gastroesophageal varices;
* Sign the informed consent form.

Exclusion Criteria:

* Patients with cirrhosis and portal hypertension because of other causes or combined with other causes(such as viral hepatitis other than hepatitis B,Autoimmune liver disease, alcoholic liver disease, metabolism-related fatty liver disease, etc.)
* Patients with a history of spleen-related operations, such as splenectomy, splenic embolism;
* Patients undergoing portosystemic shunt or TIPS;
* Isolated esophageal venous tumor and its bleeding patients;
* History of upper gastrointestinal tumor or bleeding from gastric ulcer , etc;
* Those with serious diseases of other systems that cannot cooperate with elastography examination, such as heart failure, renal failure, mental illness, etc;
* Ascites before liver and spleen result unable to complete elasticity examination;
* Pregnant patients.
Therapeutic Drug Monitoring in Patients With Difficult-to-Treat Gram-Negative Bacterial Infections

A prospective, open-label, randomized controlled trial will be conducted to evaluate a novel TDM-guided therapy in management of DT-GNB infections. We hypothesize that TDM-guided antibiotic therapy will reduce 14-day all-cause mortality by 6% (absolute risk reduction) in septic patients with DT-GNB infections, when compared to standard therapy. TDM for 11 antibiotics will be performed for all trial patients although test information will be withheld for the standard therapy arm. The primary aim is to compare the 14-day all-cause mortality rates of novel TDM-guided antibiotic dosing versus standard therapy.

Sepsis remains a major cause of morbidity and mortality worldwide in the face of antimicrobial resistance especially in patients with Gram-negative bacteria (GNB) infections. Limited new antibiotics for GNB infections pose a severe threat to clinical management of these patients and thus call for old antibiotics to be repurposed. Dosing regimens of old antibiotics often fail to achieve therapeutic drug concentrations in some septic patients. Septic patients commonly have significant hemodynamic changes and/or undergo extracorporeal interventions that may increase patients' susceptibility to treatment failure and increase the chance of more resistant bacteria emergence, or toxicity from the antibiotic. Hence, the "one size fits all" dosing principle for antimicrobial treatments of suspect sepsis due to infection by antibiotic-resistant- or less susceptible-GNB \[collectively known as "difficult-to-treat" (DT)-GNB infections\] is no longer viable. This will require therapeutic drug monitoring (TDM) to inform if the dosing is adequate to treat such infections.

This study seeks to provide evidence supporting the application of TDM-guided antibiotic therapy on reducing mortality and morbidity among septic patients with DT-GNB infections and significant hemodynamic changes, which can potentially shift current practice paradigms.

Eligibility Criteria:
Inclusion Criteria:

* 16 years or older
* Receive intravenous therapy of the study antibiotics
* Antibiotic treatment should be aimed for at least 3 days at time of inclusion

Exclusion Criteria:

* Pregnancy
* Antibiotics cessation before first blood sample collection
* Receiving antibiotics only as prophylaxis
* On palliative care or with less than 48 hours of life expectancy
Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy

The aim of this study is to analyze the variation of adiponectinemia and its molecular forms in RA patients receiving tocilizumab therapy.

Rheumatoid arthritis (RA) is a chronic inflammatory disease associated with cardiovascular morbidity. Tocilizumab (TCZ), a monoclonal antibody against the interleukin-6 receptor is an effective new biotherapy for the treatment of RA. This treatment is associated with increased LDL and HDL-cholesterol lipid parameters. Adipokines are adipose tissue-specific secreted molecules, which have many functions such as regulation of appetite, blood glucose or immune response. Among the adipokines, adiponectin exerts beneficial effects on the cardiovascular system. Patients with RA also exhibit body composition changes, including an increase in abdominal visceral fat. The impact of tocilizumab therapy in RA patients on adipokines and body composition is not known.

This project aims to explore the evolution of circulating adiponectin and other adipokines during tocilizumab therapy in RA. Body composition and its variations under tocilizumab therapy will also be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of RA and requiring Tocilizumab therapy
* Subject has provided written informed consent

Exclusion Criteria:

* Corticosteroid therapy (10 mg/day of prednisone or equivalent)
* Pregnant or lactating women
* Uncontrolled type 1 or type 2 diabetes
* Uncontrolled dyslipidemia
* Elevated transaminases (\> three times higher than the normal range)
* History of diverticulitis or intestinal perforation
* Tocilizumab contraindications: Severe or active infections, Hypersensitivity to the active substance or to any of the excipients
Postoperative Delirium in the Post-anesthesia Care Unit

This study aims to investigate the incidence of postoperative delirium (POD) in the PACU and analyze its influencing factors, in order to provide theoretical basis for early screening and intervention for high-risk POD population. Blood samples of some study subjects will be collected and analyzed using molecular detection methods to provide a basis and insights into the pathophysiological mechanisms of POD.

Study design type: Multi-center, observational, case-control study based on propensity score matching. The leading unit is Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, and the participating unit is The First Hospital of Harbin Medical University.

Record general clinical information, surgical-anesthesia-related information, recovery indicators, pain status, adverse events in PACU, and occurrences of postoperative delirium of all study subjects meeting the inclusion criteria of this study. Based on the occurrence of postoperative delirium, the subjects will be divided into delirium group and non-delirium group for univariate analysis. Univariate factors with statistical significance will be included in a multiple logistic regression analysis to further identify risk factors for postoperative delirium. Some selected factors can undergo ROC curve analysis to calculate the optimal cutoff value. Due to the limited number of subjects experiencing postoperative delirium, propensity score matching will be used to improve the statistical efficiency for analysis of risk factors for postoperative delirium. Furthermore, for patients with postoperative delirium, a small amount of blood samples will be collected by the researchers for analysis of inflammatory factors and other components.

Eligibility Criteria:
Inclusion Criteria:

1. Patients voluntarily participating in this study
2. Age ≥18 years old
3. ASA classification I-IV
4. Complete clinical data

Exclusion Criteria:

1. ASA classification V and above
2. History of severe central nervous system diseases, psychiatric disorders, cognitive impairment, intellectual disability, or Mini-Mental State Examination (MMSE) score ≤23
3. Patients with communication barriers
4. Patients with missing clinical data
5. Patients with severe complications during PACU observation requiring reintubation, reoperation, or transfer to the intensive care unit for further treatment
Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search Study

The purpose of this study is to determine if patients implanted with a St. Jude Medical (SJM) implantable cardioverter defibrillator (ICD) will benefit by using AutoIntrinsic Conduction Search (AICS) rather than only a programmed AV/PV delay. This study will compare the two methods of programming with respect to intrinsic activity.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been implanted with a dual chamber SJM ICD with AICS for 1 month (± 2 weeks).
* At the time of enrollment, patient is paced in the right ventricle (RV) ≤25% of the time as determined by the device diagnostics.
* Patient is medically stable.

Exclusion Criteria:

* Patient has evidence of atrioventricular (AV) block (first, second or third degree) such that ventricular pacing would be required as part of the patient's routine management
* Patient is unable to comply with the follow-up visits due to geographical, psychological, or any other reasons.
* Patient is younger than 18 years of age.
* Patient is pregnant.
A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis

The purpose of this study is to compare the long term safety and efficacy of TAK-385, once daily (QD) following continued administration in participants who completed a Phase II dose-finding study.

This study is a long-term extension study for evaluation of the safety and efficacy of TAK-385 following administration for 24 weeks (calculated from Visit 3 in the TAK-385/CCT-101 study) in participants from the Phase II dose-finding study (TAK-385/CCT-101 study).

Eligibility Criteria:
Inclusion Criteria:

1. Participants who have completed TAK-385/CCT-101 study

Exclusion Criteria:

1. Participants who had an adverse event in TAK-385/CCT-101 study which makes continued administration of the study drug difficult
2. Participants who became unable to comply with the protocol due to onset of a new disease, symptom, finding, or aggravation of clinical laboratory findings
3. Participants in whom investigator deems that the study drug shows no efficacy based on the level of pain, menstruation status, and the status of analgesic drug intake in TAK-385/CCT-101 study, or that study continuation represents an unacceptable risk
4. Participants in whom investigator deems that study continuation is difficult due to the occurrence of low estrogen symptoms in TAK-385/CCT-101 study which were attributed to the pharmacological effects of the study drug taking into account the level and frequency of the adverse events etc. as well as the risk-benefit of participants.