cyrilzakka/clinical-trials huggingface dataset:
Hemodynamic Stability During Induction of Anaesthesia

The study aim is to investigate if preoperative volume bolus based on lean body weight could preserve mean arterial pressure during target controlled infusion of anaesthesia (TCI) or rapid sequence induction of anaesthesia (RSI) in non-cardiac, non-morbidly obese surgery.

40 individuals are enrolled to TCI and RSI groups respectively. The randomization process for preoperative fluid bolus prior to induction of anaesthesia is conducted in respective group at the day of surgery. Preoperative colloid fluid therapy (6 ml/kg LBW, Gelofusine™, Fresenius Kabi Ab, Sweden) is infused rapidly before non-invasive baseline blood pressure (NIBP) measurements in twenty individuals in each group. No other intravenous fluids before induction of anaesthesia.

NIBPs, pulse frequency, peripheral saturation (SpO2) are registered and collected 20 minutes post induction.

Eligibility Criteria:
Inclusion Criteria:

* 80 individuals over 18 years, body mass index ≤ 35 kg/m2, electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.

Exclusion Criteria:

* instable angina pectoris at the day of surgery, severe bronchial asthma or COPD.
A Pilot Trial Examining Digital Parent Training Programs

The purpose of this pilot study is to preliminary examine the impact of a design mechanism aimed at increasing engagement in an unguided digital parent training program for child's behavior problems. Parents will be enrolled into one of two digital parent training intervention arms, dedifferentiated by their level of correspondence with the related deign mechanism.

The purpose of this pilot study is to preliminary examine the impact of a design mechanism aimed at increasing engagement in an unguided digital parent training program for child's behavior problems. The design mechanism manipulated in this pilot relates to the extent to which program design promotes a positive behavior change. To achieve these goal two unguided digital parent training interventions, differentiated by their level of design (DPT-Standard vs. DPT-Enhanced), will be tested. This pilot aims to recruit 40-60 parents who report behavior problems in their children who will randomly receive one of the two interventions for 10 weeks.

The impact of DPT-E on user engagement and reported child behavior problems will be assessed based on comparison with DPT-Standard. Parental behaviors and sense of competence will be collected to assess the impact of intervention design on these mechanisms of change. In addition, the role of parents' motivation, and their ability to invest effort in making changes during the intervention will be assessed, to examine whether these variables moderate the impact of intervention's design on the aforementioned relationships. The investigators also aim to explore whether the relationship between usage and clinical outcomes is stronger in those using DPT-E compared with DPT-Standard.

Eligibility Criteria:
Inclusion Criteria:

1. Parents report they have a child between the ages of 3 and 7, who:
2. Has externalized behavior problems based on A) Parents report at least 1 of the two first criteria of behavior problems to be above 4 (the middle point) \& the average of all items ≥ 4, on a screening scale that consists of 9 items (on a Likert scale between 1 and 7) that is based on DSM-V symptoms for ODD.

   B) Parents report ECBI Problems to be above 14 OR Intensity to be above 130.
3. Parents have access to computer at home with an Internet connection and a smartphone with a mobile data plan.
4. Parents can read and understand Hebrew.

Exclusion Criteria:

1. Parents report that the relevant child has been diagnosed with developmental delay, intellectual disability and/or autism spectrum disorder.
2. Parent and/or child are already receiving therapeutic intervention (for the child) in other setting.
3. The relevant child is treated with psychiatric medication.
Physical Therapy for Diabetes Mellitus

Background: The aim of this study to compare the effect of moderate exercises versus light exercises on patients with type 2 diabetes mellitus.

Methods: This 3-month, 2-arm cluster randomized controlled trial involved 60 patients aged between 35and 60 years divided randomly into two groups. Group 1 received 30 minutes of aerobic exercise at 40-60% of maximum heart rate. Group 2,Treated by walking30 minutes daily divided into 5minutes every 2 hours to break sedentary position for 12 hours daily.

Results: At the base line no significant difference were found in both groups in all parameters. After three months of treatment, there is no significant difference in all parameters BMI, p=0.111, waist to hip ratio, p=0.245, 6 minutes' walk, p=0.614, blood glucose, p=0.105 and sf-36, p=0.106. The study approved by ethical committee of faculty of physical therapy, Cairo University REC/012/002607.

Conclusion: Light exercise has the same effect on blood glucose as moderate exercise, so just walking for 5 minutes every 2 hours can be useful for patients with type 2 diabetes mellitus.

78 patients have been chosen from department of internal medicine, Cairo university hospitals, Egypt. 8 patients were excluded because 3 have chronic renal failure, 3 have cardiopulmonary diseases and 2 have severe osteoarthritis of knees.

They were divided randomly into two groups, group one will be treated by moderate exercises and group and group 2 will be treated by light exercises.

after division all the procedures were explained to patients.5 patients refused to sign informed consent and excluded from the study.33 patients in group1 and 32 patients in group2.3patients dropped in group1 and excluded from the study and two patients didn't continued the programmed treatment in group 2 and their data removed.

Thirty patients in each group signed an informed consent and complete the treatment program.

Eligibility Criteria:
Inclusion Criteria:

* Type2 diabetes mellitus.
* Age between 35 and 60.
* BMI≥30

Exclusion Criteria:

* Renal failure.
* Cardiopulmonary diseases.
* Lower limb diseases or fracture.
ALTERRA Post-Approval Study

This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting

This is a single arm, prospective, multicenter post-approval study.

Eligibility Criteria:
Inclusion Criteria:

1. Native or surgically-repaired RVOT with severe PR
2. Clinically indicated for pulmonary valve replacement
3. Planned for treatment with the Alterra prestent and SAPIEN 3 THV

Exclusion Criteria:

1. Inability to tolerate an anticoagulation/antiplatelet regimen
2. Active bacterial endocarditis or other active infections
Neurofeedback Study ADHD

Neurofeedback has proved to be effective in treating Attention deficit hyperactivity disorder (ADHD) in experimental settings. This study investigates whether neurofeedback can be used as a therapeutic intervention in regular outpatient care. The investigators compare high frequent neurofeedback with high frequent self-management therapy and suppose that both result in comparable effects.


Eligibility Criteria:
Inclusion Criteria:

* children with ADHD aged 7 to 11
* full command of the German language.

Exclusion Criteria:

* IQ below 80

Children with symptoms of:

* inattention,
* hyperactivity or
* impulsivity due to other medical reasons such as:

  * hyperthyreosis,
  * autism,
  * epilepsy,
  * brain disorders and
  * any genetic or medical disorder associated with externalizing behavior that mimics ADHD.
Diagnostic and Prognostic Accuracy of Gold Nanoparticles in Salivary Gland Tumours

Nano-based diagnostic tool can provide promising highly sensitive, specific biomarker for early detection and treatment of salivary gland tumours compared to non-conjugated biomarkers and in turn improves patient prognosis and outcome.

Cancer stem cells form a small subset of highly tumorigenic cells within the bulk of the tumours which mainly responsible for initiation, invasion, rapid growth, metastasis and therapeutic resistance in different types of human cancers. Nowadays, nanotechnology has increasing attention in multi-disciplinary research fields. Conjugated gold nanoparticles are widely used as biomarkers and bio-delivery vehicles in the medicine as well as early and advanced cancer detection and treatment. The current work aimed to introduce a novel diagnostic and prognostic approach in early detection of cancer stem cells in salivary gland tumours using gold nanoparticles conjugated to CD24 (CD24-Gold Nanocomposite).

Eligibility Criteria:
Inclusion Criteria:

* Benign PA of major and minor salivary glands (PA group),
* CXPA of major and minor salivary glands (CXPA group).
* Border of excision biopsy of mucocele in the lip mucosa of healthy individuals used as normal controls (Control group).
* Surgical excision of tumors with no preoperative chemotherapy or radiotherapy. For parotid tumours partial or total parotidectomy, Surgery was performed with or without facial nerve preservation and the later was carried out commonly when the nerve was involved by tumour. For tumours in the other glands, complete surgical excision with the involved gland and the suspicious adjacent structures was performed.

Exclusion Criteria:

* All epithelial origin salivary gland tumours other than PA and CXPA.
* All mesenchymal origin salivary gland tumours.
* All inflammatory and cystic lesions of salivary glands.
* Metastasis in salivary glands.
* Patients received preoperative chemotherapy or radiotherapy.
Efficacy and Safety of Simvastatin in the Treatment of Portal Hypertension

The purpose of this study is to evaluate the effects of continuous simvastatin administration on the hepatic venous pressure gradient (HVPG), as a surrogate marker of prognosis, and its safety in patients with cirrhosis and portal hypertension.

Statins exert beneficial vascular effects independently of cholesterol reduction by improving endothelial dysfunction. In cirrhosis sinusoidal endothelial dysfunction further increases intrahepatic resistance and portal pressure. Previous studies have shown that statins improve hepatic endothelial dysfunction in cirrhosis, suggesting that statins could be an effective therapy for portal hypertension (PHT). This randomized controlled trial evaluated the effects of continuous simvastatin administration on the hepatic venous pressure gradient (HVPG), as a surrogate marker of prognosis, and its safety in patients with cirrhosis and PHT.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 75.
2. Clinical, analytical, ultrasound or pathological criteria of cirrhosis.
3. Severe sinusoidal portal hypertension (HVPG \>12 mmHg)
4. Signed informed consent

Exclusion Criteria:

1. Pregnancy or lactation
2. Advanced liver disease defined as one of the following: Prothrombin rate \<40%, Bilirubin \>5 mg/dl, hepatic encephalopathy \> grade I or Child-Pugh score \>12).
3. Portal vein thrombosis
4. Multinodular hepatocellular carcinoma or single hepatocellular carcinoma \> 5 cm.
5. Heart, renal or respiratory failure
6. Previous portal-systemic shunt
7. Treatment with organic nitrates
8. Hypersensitivity to HMG-CoA reductase inhibitors
9. Previous treatment with HMG-CoA reductase inhibitors
10. Treatment with calcium channel blockers
Predictive Factors for Chronic Rejection in Lung Transplant Recipients: COLT Study

Obliterative Bronchiolitis (OB) is the major cause of long-term lung allograft loss for patients with end stage pulmonary diseases like cystic fibrosis. Numerous cells and proteins are implicated in this process, which have never been studied prospectively in a multicentric longitudinal cohort. The aim of this study is to detect predictive risk factors of OB through a national multicentric cohort of 500 newly transplanted recipients (COLT). COLT will consist in a large database, associated with a recipient bio-collection, and specific projects using these resources. COLT will aggregate all the 11 French centres of pulmonary transplantation. Patient will be followed-up during 5 years. Blood samples will be obtained. Induced sputum, bronchoalveolar lavage fuid, exhaled breath condensate and trans bronchial biopsies will be also taken. T cells, known to be involved in chronic rejection will be studied, and genomic, microarray and proteomic approaches will be used to detect further predictive factors. A study on Circulating Endothelial Cells and Circulating Endothelial Progenitors is also realised from blood samples. COLT will prove molecular markers to be predictive of early OB, before the development of severe airway obstruction and will allow the identification of patients at high risk of OB. COLT will identify potential targets for future treatments of OB. This collaborative project makes research and clinical teams working together, and creates the conditions of a long term network, extendable to other laboratories with new projects and additional European transplant centres.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults aged ≥ 18 years
* who have signed an Inform Consent Form
* double or heart-lung transplant recipients

Exclusion Criteria:

* Pregnant or nursing women
* Patients with concomitant chronic inflammatory disease, independently of acute or chronic rejection or infection
A Single-center Trial of Patients With Aortic Dissection in the Chinese XinJiang Province

To evaluate epidemiological features of risk factors for aortic dissection (AD) in Chinese XinJiang Province patients.

The epidemiological features of risk factors for aortic dissection (AD) in China were obtained from developed population in east of China, however, such information was not available for the remote population. Moreover, people in the western region have significant difference with developed population in lifestyle, diet, ethnic and so on. Therefore, the aim of our study was to evaluate epidemiological features of risk factors for AD in Chinese remote patients. We anticipated that this analysis would provide helpful information preventing and controlling AD in Chinese XinJiang Province.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of aortic dissection
2. ≥18 years old
3. good compliance with the instructions and cooperate with follow-up voluntarily signed the informed consent form

Exclusion Criteria:

1. pregnant or lactating female
2. bad compliance with the instructions and follow-up
3. estimated remaining life is less than 12 months
4. Aortic aneurysm、Acute Myocardial infarction、Acute Cerebral accident
Trial Comparing Different Methods of Support With Stopping Smoking (PORTSSS/Stop Together Trial)

This study shall determine whether or not proactive telephone support for smoking cessation delivered to quitline callers is more effective than standard 'reactive' provision and whether or not the offer of a voucher for a cost free supply of nicotine replacement therapy (NRT) has any additional impact on smoking cessation rates achieved by behavioural interventions.

There is evidence from other studies that telephone helplines are effective in helping individuals to stop smoking. This study will investigate whether or not two interventions that have been proven effective in other contexts are effective when offered via telephone helplines. The two interventions which will be tested are (1) additional proactive counselling via telephone(several calls from a trained smoking cessation advisor over a certain period) and (2) the offer of Nicotine Replacement Therapy.

This trial will determine whether or not: (1)additional (proactive) telephone support for smoking cessation delivered to users of the National Health Service (NHS)Smoking Helpline, is more effective than standard support given by the helpline, and (2) whether the offer of free Nicotine Replacement Therapy influences rates of stopping smoking in individuals receiving either standard (reactive) or proactive telephone support.

Current smokers over 16 years of age will be recruited by helpline staff with the appropriate consent. Participants will then be randomised into one of four groups:

(i) usual care delivered by the helpline (called the Together Programme) (ii) usual care plus a programme of proactive telephone counselling (iii) usual care AND the offer of Nicotine Replacement Therapy (NRT) (iv) usual helpline support, proactive telephone counselling AND the offer of NRT.

The researchers will not be aware of which group participants have been allocated. The results will determine if the use of proactive telephone counselling is effective in helping individuals to stop smoking. It shall also find out if the offer of NRT medication via a telephone helpline assists individuals in their efforts to stop smoking.

Eligibility Criteria:
Inclusion Criteria:

* Participants are over 16 and will need to agree to i) receive counselling ii) to set a quit within two weeks and iii) consent to follow up processes.

Exclusion Criteria:

* Telephonists will not enrol potential participants who are not capable of giving informed consent or who have not got access to a phone contact number to which calls can be made by Essentia staff.
Blood Pressure and Subclinical Organ Damage

Background: The purpose of this study is to analyze the relationship between central and peripheral blood pressure (clinic and ambulatory) with vascular structure and function, assessed by carotid intima-media thickness (IMT), artery venous retinal index, pulse wave velocity (PWV) and ankle-brachial index in patients with diabetes type 2 and without diabetes type 2. Develop and validate a software to measure the retinal vessels and to estimate arterio-venous index automatically.

Methods/design: The investigators will Perform a coss-sectional study with control group, with follow-up of 4 years in primary care. The study population will be diabetic type 2 patients with a control group without diabetes mellitus. The investigators will include by consecutive sampling 300 patients between 34 and 75 and without previous cardiovascular disease, half of each group. Main measurements: age, sex, height, weight and waist circumference. Lipids, creatinine, microalbuminuria, blood glucose, HbA1C, insulin, fibrinogen, hs-CRP and markers of endothelial dysfunction. Clinic and ambulatory blood pressure (MAPA). Ultrasonography to assess carotid IMT, retinography to assess arterio-venous ratio. ECG to evaluate left ventricular hypertrophy, ankle-brachial index and morphology analysis (PWA) and pulse wave velocity (PWV) in Sphigmocor System.

Discussion: The investigators provide information regarding various parameters derived from MAPA and pulse wave analysis of with target organ damage, especially with the vascular structure and function assessed by IMT and PWV and endothelial dysfunction in patients with diabetes type 2 and without this disease. The investigators also hope to demonstrate the usefulness of the tool developed for automatic evaluation of retinal vascularization in the early detection of abnormalities of vascular structure and function and the prognosis of cardiovascular disease in the medium term.


Eligibility Criteria:
Inclusion criteria:

* Patients aged 34 years or more but less than 75 years, with and without type 2 diabetes.

Exclusion criteria:

* Patients who fail to meet the requirements of the protocol (mental disorders and / or cognitive uncooperative, education and understanding limitations),
* Patients with ischemic heart disease, cerebrovascular disease or other atherosclerotic disease
* Patients who are participating or will participate in a clinical trial during the study
* Patients with serious comorbidity that might endanger his life in the next 12 months.
Effect of Exercise on Appetite in Response to Meals

This clinical trial's primary aim is to investigate the acute effect of two exercise bouts (short \[10 minutes\] and long \[30 minutes\]) on appetite and appetite-regulatory hormone responses to a standard meal test. The secondary aim is to investigate when the changes in appetite and appetite-regulatory hormones occur during exercise. As an exploratory aim, the researchers will test if the two exercise bouts influence ad libitum energy intake in the periods after the standard meal test. The researchers will compare three groups (control, short exercise, and prolonged exercise) to see if the exercise bouts affect appetite, appetite-regulatory hormones, and energy intake in healthy men.

Study Design

Screening visit Before conducting the main experiments, the participants will attend a screening visit where consent will be obtained, and they will complete questionnaires to assess health, food preferences, and physical activity. The researchers will then measure the participants' height, weight, waist circumference, and body composition.

After the researchers confirm the eligibility criteria, participants will take part in two treadmill tests to establish maximum oxygen uptake test (V̇O2 max) (Broom et al. 2017).

Experimental design After the screening visit, the participants will complete three main experiments (control, short high-intensity exercise, and prolonged high-intensity exercise) in a counter-balanced design. All experiments began at \~0930, following an overnight fast of at least 10 hours. Participants will consume a prescribed meal in the evening before each main experiment. Following this meal, participants are only allowed to drink water until the start of the main experiments.

At the beginning of the exercise conditions, participants will run on the treadmill for 10 minutes (short) or 30 minutes (prolonged) at a speed estimated to elicit a 75% V̇O2 peak, followed by rest in the laboratory. In the control condition, the researchers will follow the same protocols except that the participants will not perform any exercise. The participants will have a standardized meal after exercise and then an ad libitum buffet meal afterward.

During each experiment, the researchers will assess appetite ratings using 100 mm visual analog scales (Flint et al. 2000). The researchers will also collect blood samples to examine ghrelin, peptide YY, glucagon-like peptide 1, and possibly other blood-borne measures.

Eligibility Criteria:
Inclusion Criteria:

* Males aged 18 years or older.
* Have stable body mass for at least six months (within ±2 kg).

Exclusion Criteria:

* Females
* People who are younger than 18 or older than 65 years old.
* Have food allergies.
* Have significant contraindications to exercise (e.g., an injury that would inhibit running).
* Smoking.
* Suffering from metabolic health issues, e.g., history of diabetes, cardiovascular disease, or eating disorders.
Cerebral Oximetry With Near-infrared Spectroscopy and Negative Postoperative Behavioral Changes in Pediatric Surgery

The main objective of the present study was to evaluate whether cerebral oxygen saturation is associated with an increase of NPOBC in pediatric patients undergoing major surgery.

This prospective and observational study involved consecutive patients aged between 2 and 12 years undergoing a major surgery using general anesthesia. Cerebral oxygen saturation, non-invasive arterial pressure, pulse oximetry, and heart rate were recorded at the following stages of the surgical intervention: baseline, induction, intubation, surgical incision, end of surgery, and extubation. Preoperative anxiety was evaluated by using the modified Yale Preoperative Anxiety Scale, and NPOBC was determined by using the Post-Hospital Behaviour Questionnaire on 7th and 28th postoperative days. A logistic regression was created to identify factors associated with the development of NPOBC

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 2 and 12 years undergoing major surgery using general anesthesia.

Exclusion Criteria:

* Children aged below 2 or over 12.
* Neuropsychiatric disorder, or undergoing an emergency surgery.