cyrilzakka/clinical-trials huggingface dataset:
Comparision of FIBTEM and Blood-loss

Correlation between FIBTEM and intraoperative blood loss


Eligibility Criteria:
Inclusion Criteria:

full sternotomy age \>18 Inform consent signed

Exclusion Criteria:

Hypofibrinogen
Study of the Success and Survival of Dental Composite Restorations Being Repaired Instead of Being Replaced

The objective of this trial is to compare the success (as assessed by a pre-defined set of outcome) of failing composite resin restorations that are repaired using diamond bur induced surface abrasion, to those that are completely replaced.

It is hypothesized that both treatment will have comparable success rate.

This study is a single-blind randomized non-inferiority trial using parallel groups.

Patients recruited into the study will be randomly assigned to one of two treatment groups. Subjects allocated to Group 1 will have their defective restoration completely replaced while subjects allocated to Group 2 will have their defective restoration repaired.

The success of the treatments will be assessed immediately following the intervention (baseline) and 12 months later.

Eligibility Criteria:
Inclusion Criteria:

* Patients of the Dalhousie University Dental Clinic who are:
* Age 18 and over
* Capable of providing informed consent
* Asymptomatic permanent teeth with class III, IV, V or veneer composite restorations on the facial/buccal surface, requiring treatment (e.g. stain, chipping or color discrepancy).
* Restoration must present with a portion (mesial, distal, gingival or occlusal) that can be completely retained to allow repair.

Exclusion Criteria:

* Patients with contra-indications for regular dental treatment based on their medical history
* Teeth with active caries
* Teeth with multiple overlapping composite restorations
* Patients with uncontrolled periodontal disease
* Restorations smaller than 3mm diameter
Evaluation of Balance and Trunk Muscle Endurance in Dancers

This study evaluates endurance of trunk muscles, balance and pulmonary functions in dancers. The participants will be evaluated trunk muscles endurance, pulmonary functions and balance which evaluated by computerized force plate system.

Dance is a form of exercise associated with movements that require balance, flexibility, endurance and skill. In addition to maintaining balance, the endurance of the trunk stabilizer muscles has an important role in sport-specific activities, coordination and athletic performance. Studies which conducted on dancers are mainly focused on abdominal muscle strength / endurance, lower extremity strength and physical performance. In the literature, it was reported that 40-84% of professional dancers and 26-51% of professional dancers had musculoskeletal injuries, particularly lower extremity problems. It is very important to regain balance after returning to the dance after foot and ankle injuries. Considering the function of the trunk as a bridge between the lower and upper extremities, it is known that trunk muscles play a fundamental role in regaining balance. However, in the literature, there is no study showing the effects of trunk stabilizer muscles (abdominal, dorsal extensor, lateral flexor and diaphragm), trunk flexibility and dance-specific properties on balance in dancers. As a result of this study, it is aimed to show the effect of dance on balance and related parameters and to reveal the factors affecting the balance.

Eligibility Criteria:
Inclusion Criteria:

* able and willing to complete the informed consent process.
* performing a sportive latin dancers as a competitive

Exclusion Criteria:

* having a pulmonary system disease
* having a cardiac system disease
* to do regular sports in addition to danc for the last three months
Effectiveness of a Multifactorial Intervention on Frailty

Objective: To evaluate the effectiveness of a multifactorial intervention program based on physical activity and diet, memory workshops and review of medication, to modify frailty parameters, muscle strength and physical and cognitive performance in people 65 years or older with a positive screening for frailty. Secondly, to assess changes in falls, hospitalizations, nutritional risk, disability and institutionalization or home-care.

Methods: randomized clinical trial with a control group, of one year and a half of follow-up, conducted in eight primary care teams in Barcelona. Individuals to be included are 65 years or older with positive frailty screening, timed get-up-and-go between 10 to 30 seconds, and cognitive Lobo test greater than or equal to 18. 165 patients will be selected in each group (difference to be detected on physical performance (Short physical performance battery (SPPB)): 0.5 units; common Standard Deviation : 1.42, 20% lost to follow-up).

Intervention: consists in three different actions on frailty dimensions, applied to each subject in the intervention group, in groups of 15 participants: rehabilitative therapy plus intake of hyperproteic shakes, memory workshop and review of the medication.

Evaluations will be blinded and conducted at 0, 3 and 18 months. Analysis of variance for repeated measures to adjust for differences attributable to intervention effect and for potential confounders such as comorbidity, sensory limitations, social risk, other medical or social interventions, among others.


Eligibility Criteria:
Inclusion Criteria:

* Positive Barber screen
* Timed get-up-and-go 10 to 20 seconds
* cognitive Lobo test greater than or equal to 18

Exclusion Criteria:

* Home Care
* Institutionalization
* Conditions not allowing physical exercise
User Performance Evaluation for DARIO™ BGMS

The study aims to evaluate the accuracy of the blood glucose level results obtained from fingertip using the Dario Blood Glucose Monitoring System (BGMS) compared to Yellow Springs Instrument (YSI) as well as to evaluate the usability of the Dario Blood Glucose Monitoring System (BGMS) by laypersons using only device labeling.

Each subject enrolled in the study will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Blood Glucose Monitoring System (BGMS). Immediately after the subject tested him/herself a trained nurse/technician will collect another blood sample from the subject for testing by the Yellow Springs Instrument (YSI). The subject will complete a usability questionnaire on his/her experience using the Dario Blood Glucose Monitoring System (BGMS) and the nurse/technician will complete a questionnaire assessing the subject's performance. A venous blood sample for Complete Blood Count (CBC) will be taken by the nurse/technician and sent for analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has Type I or Type II diabetes
2. Subject speaks and reads English proficiently
3. Subjects owns and uses Android and iOS based smart mobile device for at least 1 year
4. Subject is able and agrees to sign the informed consent form (minor subjects must be accompanied by a parent or legal guardian to provide consent for their participation in the study).

Exclusion Criteria:

1. Subject has medical training or works in the field of Blood Glucose Monitoring System (BGMS)
2. Subject is critically ill
3. Subject has an impairment that prevents him/her to follow the study procedures
4. Subject has any condition that the Principal Investigator believes may interfere in the subject's participation in the study
Effects of Ivabradine on Residual Myocardial Ischemia After PCI

This is a randomized pharmacological study evaluating the effects of ivabradine in patients with residual angina after PCI. The role of ivabradine in patients with angina, without systolic dysfunction, is not yet clear. The investigators performed in all patients an echostress to evaluate the effects of therapy with ivabradine after 30 days in terms of exercise tolerance and diastolic function.

BACKGROUND. Residual angina after PCI is a frequently-occurring disease. Ivabradine improves symptoms but its role in patients without left-ventricular systolic dysfunction is still unclear. The aim was to quantify the effects of ivabradine in terms of MVO2 indicators and diastolic function.

METHODS. 28 consecutive patients with residual angina after PCI were randomized to ivabradine 5 mg twice/day(IG) or standard therapy(CG). All patients performed a stress echocardiography at the enrollment and after 30 days. Myocardial oxygen consumption was estimated from: double product(DP); triple product(TP) integrating DP with ejection-time(ET). Diastolic function was evaluated determining E and A waves, E' measurements and E/E' ratio both at rest and at the peak of exercise.

Eligibility Criteria:
Inclusion Criteria:

* coronary artery disease with chronic stable angina for more than three months (Canadian Cardiovascular Society-CCS-class I-III);
* percutaneous revascularization with stent implantation at least one;
* signs/symptoms of residual ischemia; sinus rhythm; HR ≥ 70 bpm at rest;
* ability to perform an echocardiogram stress test with the tilting bicycle stress test (BST);
* good acoustic window;
* age ≥ 18 years.

Exclusion Criteria:

* drugs intolerance or hypersensitivity
* EF ≤ 40 %
* NYHA class III to IV;
* CCS IV
* atrial fibrillation or flutter
* presence of a pacemaker or implantable defibrillator
* II or III degree AV block
* HR ≤ 70 bpm at rest or sick sinus syndrome
* any condition that could interfere with the ability to exercise stress test like Wolff- Parkinson-White syndrome, left bundle branch block, left ventricular hypertrophy;
* rate-corrected QT interval (QTc) greater than 500 ms or the use of drugs that prolong the QTc interval
* symptomatic hypotension or uncontrolled hypertension (systolic blood pressure at rest ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg)
* severe liver disease and severe renal impairment (creatinine clearance ≤ 30 ml/min)
* electrolyte disorders
* uncontrolled thyroid disease
* pregnancy.
Safety and Efficacy of Oncoxin Plus Surafineb in Hepatocellular Carcinoma

Oncoxin in combination with Surafenib is safe and results in improved survival in patients with hepatocellular carcinoma (HCC)

To assess therapeutic efficacy and safety of Oncoxin plus Surafenib in hepatocellular carcinoma

To see if there is reduction in serum alpha fetoprotein level in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib

To see if there is reduction tumor size and or number in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib

To see if there is improvement of quality of life in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib

To see if there is improved survival in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib

Eligibility Criteria:
Inclusion Criteria:

* Patients with HCC irrespective of etiology, age, gender and status of underlying liver disease.
* Patients with HCC who are not suitable candidates for established modalities of treatment i.e. surgery and/or chemotherapy.
* Patients with HCC who have evidence of tumor metastasis
* Patients with HCC who are voluntarily unwilling to take established modalities of treatment i.e. surgery and/or chemotherapy.
* Patients with HCC in whom all possible treatment options have been exhausted.

Exclusion Criteria:

* Patients with HCC who are suitable candidates for established modalities of treatment i.e. surgery and/or chemotherapy.
* Patients with HCC who have no evidence of tumor metastasis
* Patients with HCC who are willing to take established modalities of treatment i.e. surgery and/or chemotherapy.
* Patients with HCC who are voluntarily unwilling to be included in the trial
Efficacy of Autologous Adipose Derived Stromal Vascular Fraction for Musculoskeletal Conditions

clinical efficacy of autologous stromal vascular fraction SVF,for inflammatory and degenerative conditions of the knees

to evaluate the clinical effectiveness of point of care autologous adipose derived stromal vascular fraction (SVF) alone or in combination with exosomes,for inflammatory and degenerative conditions of the knees.

Eligibility Criteria:
Inclusion Criteria:

* knee osteoarthritis any grade

  * knee chondromalacia grade 2 and above

Exclusion Criteria:

* active HIV
* pregnant women
* Mental disease
* severe cardio vascular disease
* severe coagulation disorders
* infected tissues
* patients on other experimental studies within 3 months
Changes in Pulse-Oximetry Perfusion Index Induced by Tidal Volume Challenge Versus Fluid Volume Challenge to Detect Preload Responsiveness in Mechanically Ventilated Patients With Low Tidal Volume

The primary goal of this study was to assess the ability of PI changes induced by a Vt challenge or fluid challenge test to detect preload responsiveness in critically ill adult patients on mechanical ventilation with low-tidal volume.

The secondary aims were (i) to compare the changes in PI with VTI during a Vt challenge test (ii) to compare the changes in VTI and PI during a volume expansion challenge test, (iii) to compare the Vt-induced changes in PI to changes induced by fluid challenge test, (iv) to compare the Vt-induced changes in VTI to changes induced by fluid challenge test.


Eligibility Criteria:
Inclusion Criteria:

Patients of both genders aged 18 years or older Invasive mechanical ventilation in assist controlled mode with a Vt of 6 mL/kg PBW, Patients with circulatory failure Decision by the clinicians in charge to assess preload responsiveness through a Vt Challenge and a Fluid Challenge test.

Patients in sinus rhythm

Exclusion Criteria:

Open chest Pulmonary hypertension Poor lung compliance (Crs \<30 ml/cmH2O) Obesity (BMI≥35) Pregnancy Intraabdominal hypertension Prone position Atrial fibrillation
A Phase IV Study, of the Efficacy, Safety, and Acceptability of Moviprep® Versus Colopeg® in Colonoscopy Preparation

Primary:

- To demonstrate the superiority of Moviprep® versus Colopeg® in gut cleansing prior to colonoscopy.

Secondary:

* To assess the safety of Moviprep® versus Colopeg®.
* To assess acceptability of Moviprep® versus Colopeg®.

Primary efficacy analysis will be performed on the ITT population. Secondary efficacy analysis will be performed on both ITT and PP sets. Results will be summarised by treatment and age (overall, 18-35, 36-49, 50-74 and 75-85 years old) and provided in individual data listings.

Safety analysis will be performed on the safety set (ITT population). Safety data of all patients exposed will be summarised by treatment and age (overall, 18-35, 36-49, 50-74 and 75-85 years old).

Acceptability analysis will be performed on the ITT population. Acceptability data of all patients will be summarised by treatment and age (overall, 18-35, 36-49, 50-74 and 75-85 years old).

Eligibility Criteria:
Inclusion Criteria:

1. The patient's written informed consent must be obtained prior to inclusion.
2. Male or female, outpatients between 18 and 85 years old with an indication to colonoscopy.
3. Willing and able to complete the entire procedure and to comply with study instructions.
4. Females of childbearing potential must employ an adequate method of birth control.

Exclusion Criteria:

1. Age \< 18 or \> 85 years old,
2. Ileus,
3. Suspected intestinal occlusion or perforation,
4. Toxic megacolon with severe inflammation conditions of intestinal tract (patients with Crohn's Disease or Ulcerative Colitis included),
5. Gastroparesis,
6. Congestive heart failure NYHA III or IV,
7. Documented Carcinoma or any other colic disease leading to a fragile mucosa,
8. Documented severe renal insufficiency history
9. Known hypersensitivity to MoviPrep®, Colopeg® or to any of their components (PEG, ascorbic acid etc.),
10. Known deficiency in G6PD and/or phenylketonuria,
11. Concurrent participation in an investigational drug/device study or participation within 30 days of study entry,
12. Females who are pregnant, or planning a pregnancy. Females of child bearing potential not using reliable methods of birth control,
13. Clinically significant laboratory abnormality or disease which, in the opinion of the investigator, will create a risk for the patient, obscure the effects of study treatment or interfere with study results.
14. Vulnerable patients (protected by the law) and those admitted to a sanitary/social institution according to Art.L-1121-6 of the French Public Health Code.

    -
Pharmacokinetic Properties of Lu AA21004 (Vortioxetine) in Healthy Young Chinese Men and Women

The rationale for this pharmacokinetic (PK) study is to determine the PK parameters for Lu AA21004 (Vortioxetine) in the Chinese population.


Eligibility Criteria:
Inclusion Criteria:

* The subject is a Chinese man or woman
* The subject is, in the opinion of the investigator, generally healthy
* If female, the subject must have a negative pregnancy test at screening and baseline, and agree not to try to become pregnant from Screening until after the Follow-up Visit

Exclusion Criteria:

* The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.

Other inclusion and exclusion criteria may apply.
Prevention of Severe Acute Graft-versus-host Disease in Pediatric Patients Using a daGOAT Model

To evaluate the efficacy and safety of ruxolitinib for prophylactic therapy of child patients who are predicted to have a high risk for developing severe acute graftversus-host disease (aGVHD) by the dynamic aGVHD Onset Anticipation Tianjin (daGOAT) model.

This study aims to prospectively evaluate the use of the daGOAT model in real-world clinical settings at the Institute of Hematology, Chinese Academy of Medical Sciences (IHCAMS).

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be ≤ 16 years of age;
2. Patients receiving human leukocyte antigen mismatched and non-cord blood allogeneic hematopoietic stem cell transplantation;
3. Patients who can take oral medication;
4. Patients or their guardians have to sign an informed consent form before the start of the research procedure.

Exclusion Criteria:

1. Tandem transplantation or multiple transplantations;
2. Patients who are allergic to or cannot tolerate ruxolitinib;
3. Mental or other medical conditions that make the patients unable to comply with the research treatment and monitoring requirements;
4. Patients who are pregnant or cannot take appropriate contraceptive measures during treatment;
5. Patients who are ineligible for the study due to other factors, or will bear great risk if participating in the study.
Effectiveness of Non-surgical Periodontal Treatment on HbA1c Levels in a Patient With Type 2 Diabetes Mellitus

This study evaluates the effectiveness of an intervention, non-surgical periodontal treatment (SPR), in patients with poorly controlled type 2 diabetes mellitus and moderate-severe periodontal disease aimed at reducing HbA1c levels at 12 months compared with the usual practice in Primary Health Care.

Design: Pragmatic cluster randomized clinical trial with 12 months follow-up. Unit of randomization: dentist. Setting: Primary Health Care Centers in one Spanish region (Madrid) Population: Patients ≥ 35 years of age with moderate-severe periodontal disease and diagnosed with type 2 diabetes with por control (HbA1c \> 7,5). N=288 patients (144 in each arm) will be recruited by dentist before randomization.

Intervention: Both groups will receive education on oral hygiene measures. The experimental group will receive the non-surgical periodontal treatment at the beginning of the study and the control group at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes (code CIAP-2 T90)
* With at least one determination of HbA1c in the last 3 months HbA1c\> 7.5%
* No changes in hypoglycemic or insulin treatment in the last 3 months.
* With generalized moderate-severe chronic periodontal disease.
* Presence of at least 16 natural teeth.
* Informed consent.

Exclusion Criteria:

* Patients with basic systemic diseases with oral involvement (autoimmune diseases of oral involvement: oral lichen planus, lupus, pemphigus, pemphigoid)
* Limited life expectancy.
* Urgent diabetic complications in the 30 days prior to the study.
* They need extensive oral treatment: fistulous trajectories, cellulitis, pulpitis or other oral infections.
* Pregnant, with desire for pregnancy in the 12 months of study or breastfeeding.
* That they have received periodontal treatment in the last 6 months.
* That they have received antibiotic and / or anti-inflammatory regimen continued at least in the last 4 weeks prior to the study (except low doses of acetylsalicylic acid).
* In treatment with corticosteroids or immunosuppressive drugs.
* On dialysis or risk of bleeding (anticoagulant treatment).
* Dependent on alcohol.
* Patients who require antibiotic prophylaxis for the realization of SPR.
* Patients with uncontrolled systemic diseases (with the exception of diabetes): cardiovascular, lung, liver, kidney disease in advanced stages or neoplasms.
Erector Spinae Plane Block Improves Organ Dysfunction in Septic Patients With Acute Gastrointestinal Injury

This study is a prospective, multicenter, parallel-group, open-label, randomized controlled clinical trial. Sepsis is defined as organ dysfunction induced by infections. And sepsis and gastrointestinal injury can be the leading cause for each other. Our previous study showed erector spinae plane block improved the organ dysfunctions in patients with AGI. The aim of the clinical trial is to investigate erector pinae plane block improves the organ dysfunction in septic patients with acute gastrointestinal injury.


Eligibility Criteria:
Inclusion Criteria:

* Septic patients with acute gastrointestinal injury grade II or III;
* Age over 18 years;
* Expected to stay in the ICU for at least 3 days or longer;

Exclusion Criteria:

* Mean arterial pressure less than 65 mmHg after fluid resuscitation, or requirement for an intravenous norepinephrine dose of greater than 0.5 µg/kg/min to maintain a normal mean arterial pressure;
* Heart rates less than 50 beats/min, or concomitant with moderate-to-severe atrioventricular block without a pacemaker;
* Contraindications for erector spinae plane blocks, including infection of the puncture site, spinal diseases or immobilization;
* Primary gastrointestinal disorders requiring a surgical procedure, such as mechanical intestinal obstruction, massive gastrointestinal hemorrhage, and gastrointestinal perforation;
* Gastrointestinal operation within one week before enrollment;
* Neuromuscular disorders;
* Coagulation abnormalities：activated prothrombin time or prothrombin time is prolonged with 2 folds, or platelet count less than 50×109/L;
* End-stage malignant tumor or cachexia;
* History of allergy to amide anesthetics;
* Known pregnancy;
Ozone Therapy for Masticatory Muscle Pain (OTMMP)

This study investigates the efficacy of bio-oxidative ozone application in the treatment of TMD of muscular origin.

Ozone is a natural pale blue gas that can be found in the atmosphere. Medical grade ozone is a powerful oxidizing agent which can be produced commercially in ozone generators. Ozone can have effects on blood components and positively affect oxygen metabolism, cell energy, immunomodulation and microcirculation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of myofascial pain according to the Research Diagnostic Criteria for Temporomandibular Disorder (RDC/TMD)
* Natural posterior occlusion.

Exclusion Criteria:

* Any TMJ internal derangement
* Inflammatory connective tissue disease
* Psychiatric problem
* Tumour
* Hearth disease or pacemaker
* Pregnancy
* Other orofacial region disease symptoms (e.g. toothache, neuralgia, migraine)
* Treatment or medication use for headache or bruxism in the last 2 years
* Local skin infection over the masseter or temporal muscle