cyrilzakka/clinical-trials huggingface dataset:
NeuroTrainer Cognitive Training For Academic Focus

This clinical trial aims to evaluate the feasibility and efficacy of NeuroTrainer cognitive training in improving attentional and executive control functions in students with and without attention-related difficulties.

The goal of this clinical trial is to test the feasibility and efficacy of NeuroTrainer cognitive training in improving attentional and executive control function in students with and without attention-related difficulties. The main questions it aims to answer are (1) does NeuroTrainer improve attentional and executive control function, (2) does NeuroTrainer engage the target of ADHD inattention symptoms by identifying the target and demonstrating proximal changes in it, and (3) does NeuroTrainer demonstrate transfer of skill with improvement in academic behaviors. Researchers will compare students who use NeuroTrainer to a control condition to see if the NeuroTrainer intervention produces significant improvements.

Participants in the intervention group will engage in virtual reality (VR) sessions which include physical activity and cognitive training. Cognitive training will maximize time at performance thresholds and optimize for variability in task dynamics and demands.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic criteria met ADHD for any ADHD presentation type, with severity ratings of subthreshold, moderate or severe
* Estimated IQ of 80 or greater
* Between 11-17 years of age

Exclusion Criteria:

* Presence of suicidality
* Presence of psychotic disorders
* Visual or hearing impairment
* Presence of severe depression
Cardiac Manifestation and Inherited Metabolic Diseases

The aim of this study is to report and describe cardiac manifestations associated with IMD in a cohort of patients followed in a reference center for rare diseases (Lausanne University Hospital, CHUV) from 2017-2020.

Inherited metabolic diseases (IMD) are genetic disorders resulting from an enzyme defect and/or transport proteins in metabolic pathways affecting proteins, fat, carbohydrate metabolism or impaired organelle function. As IMDs can affect the primary sources of energy (glycogen, fatty acids), they can lead to cardiac dysfunction. Although most of IMDs are multisystemic diseases, in some cases, the cardiac dysfunction they cause is the main clinical feature and source of major complications which will determine the prognosis, like heart failure, ventricular arrythmias or even sudden death. Information regarding cardiac manifestations in adult IMDs is currently scarce and little is known about their clinical and radiological characteristics.

A database was created in 2017 including all patients with IMD followed at the Adult Metabolic Clinic in the CHUV. This database was part of a protocol submitted and approved by the Ethics committee (# 2017-02328). The results of this first analysis were published in the Journal of Orphan Rare Diseases. Investigators will use this database to identify all the patients who had cardiac examination. Only patients from the Lausanne University Hospital followed jointly with the Division of Cardiology will be included in the analysis. Electronic and paper patient charts from the Division of Genetic Medicine and Division of Cardiology (Lausanne University Hospital) will be reviewed for type of IMD and cardiac investigations (cardiac ultrasound, multiple resonance Imaging, electrocardiogram). All variables will be entered in an excel database.

Eligibility Criteria:
Inclusion Criteria:

* All IMD adult patients followed at the adult metabolic clinic at the Lausanne University Hospital from 2017 to 2020 with cardiac investigations

Exclusion Criteria:

* Age \< 16 years. Any document attesting a refusal to participate will exclude the data entry of the concerned patient
The Effects of Immersion in 42℃ Thermal-mineral Water on Chronic Low-back Pain

In this controlled, follow-up study the effects of immersion in 42℃ radon, natrium, calcium, bicarbonate content thermal-mineral water on clinical parameters and quality of life of patients with chronic low-back pain is evaluated. The participants in the intervention group are treated with balneotherapy plus usual care, while in the control group only with usual care. The planned participants number is 120. Follow up period is 3 months.

In this controlled, follow-up study the effects of immersion in 42℃ radon, natrium, calcium, bicarbonate content thermal-mineral water on clinical parameters and quality of life of patients with chronic low-back pain is evaluated. The participants in the intervention group are treated with balneotherapy plus usual care, while in the control group only with usual care. The balneotherapy takes place in Rudas Spa in Budapest, 15 times in 3 weeks. The intensity of pain in rest and during activity evaluated on Visual Analogue Scale (VAS), the Oswestry Disability Index and the Euroqol-5D is taken at week 0., at week 3. and at week 12. The planned participants number is 120. Follow up period is 3 months.

Eligibility Criteria:
Inclusion Criteria:

* outpatients suffering from non-specific chronic low back pain standing for at least 12 weeks; only slightly reduced mobility (able to admit the treatments or visits on his own or without the help of another person);
* pain intensity of low back pain during activity at least 35 on Visual Analog Scale (0-100 mm VAS); likely degenerative symptoms

Exclusion Criteria:

* severe neurological deficit associated with the lower back;
* suspected vertebral compression of osteoporotic or other aetiology;
* malignancy;
* pain due to inflammatory spinal disease;
* severe spondylolisthesis (grade 2 or above);
* balneotherapy within 3 months prior the enrollement
* steroid therapy within 1 month prior the enrollement
* and general contraindications to balneotherapy: decompensated cardiopulmonary status (unstable hypertension, earlier tromboembolia, serious arteriosclerosis obliterans, serious varicositas, etc), unbalanced endocrinological and metabolic disease, fever condition, infectious disease, extensive inflammation/injury/absence of the skin, other severe interstitial, urogenital, and other diseases, malignancy, urine and stool incontinent, decompensated psychosis and neurosis, unconsciousness, pregnancy, postoperative status, alcoholic influence, and lack of compliance.
Effects of Incretin on the Blood Pressure and Lipid in Patients With Overweight or Obese Diabetes

Obesity is one of the characteristics of type 2 diabetes mellitus. Most of the obese diabetes patients are combined with dyslipidemia or hypertension. The clustering of diabetes, obesity, hypertension and dyslipidemia increases the risk of cardiovascular events for patients. GLP-1 (glucagon like peptide-1) is a kind of incretin discovered in recent years. It was reported that beside its hypoglycemic and losing weight effects, activator of GLP-1 receptor could decrease blood pressure and improve lipid metabolism. Therefore, activation of GLP-1 receptor may become a new comprehensive treatment strategies for improving glucose and lipid metabolism, blood pressure level and cardiovascular complication. But, it is lack of evidence-based medicine proof on the relationship between GLP-1 and blood pressure or serum lipid. So, investigators designed a prospective, randomized, open-label, active control study, and try to evaluate the effects of activator of GLP-1 receptor (liraglutide) on lowering blood pressure, improving vascular function and lipid metabolism in overweight or obese type 2 diabetic patients with masked hypertension.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age between 35-60 years old
2. Type 2 diabetes
3. 24kg/m²≤BMI≤32kg/m², or WC≥90cm for male and WC≥85cm for female
4. Grade 1 hypertension or masked hypertension diagnosed via 24-h ambulatory blood pressure monitoring (daytime blood pressure load 50%≥135/85 mmHg, night time blood pressure load 50%≥125/75 mmHg or 24h blood pressure load 50%≥130/80 mmHg）

Exclusion Criteria:

1. Type 2 diabetes with serious complications, such as diabetic neuropathy, diabetic retinopathy, stage IV diabetic nephropathy, or acute diabetic complications.
2. Type 1 diabetes.
3. Diagnosed moderate to severe sleep apnea syndrome(SAS).
4. Grade 2 or Grade 3 hypertension.
5. Triglyceride≥5.65mmol/L
6. History of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months.
7. Hypohepatia (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
8. Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
9. Chronic obstructive pulmonary disease (COPD), chronic respiratory failure or hyoxemia.
10. Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
11. Fertile woman without contraceptives.
12. Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
13. Allergic to or have contraindication to the intervention drugs.
Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months
* Current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months
* Body mass index (BMI) below or equal to 35.0 kg/m\^2
* HbA1c below or equal to 11.0%

Exclusion Criteria:

* Total daily insulin dose at least 1.4 IU/kg
* Treatment with oral hypoglycaemic agents within the month prior to inclusion
* Recurrent severe hypoglycaemia (as judged by the investigator)
* Active proliferative retinopathy
* Impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl)
* History of pancreatitis
Vibro-tactile Pressure Feedback of the Prosthetic Foot for Trans-tibial Amputees

The aim of the study is to investigate the influence of a vibro-tactile device on trans-tibial amputees in terms of gait, pain and perception of the prosthesis.

The study is divided into three phases. The initial phase lasts 6 to 8 weeks for each subject. For subjects of group 2 the length of the initial phase depends on the progression of the re-innervation. The initial phase ends, when the subject can perceive the tactile stimulate at the re-innervated area of the skin. During the initial phase, all subjects get a new prosthesis. To minimize the adjusting to the new prosthesis only a new socket, which houses the vibro-tactile Feedback system, is fabricated and the old prosthetic food is re-used. After a period of 3 weeks minimum, where the subjects use the new prosthesis, a gait analysis and an assessment of the sensitivity of the skin at the stump are performed.

Subsequently the intervention phase starts and the vibro-tactile feedback system is activated. For a period of 6 months the subjects use the new prostheses with the integrated vibro-tactile feedback system in daily living. After 2 and 4 months, the subjects visit the study site for an assessment of the sensitivity of the skin. After 6 months a second gait analysis and an other assessment of the sensitivity of the skin a the stump are performed. Afterwards the vibro-tactile feedback-system is disabled.

During the observing phase the subjects use the prosthesis with the disabled vibro-tactile feedback system for 4 months.

During all three phases the subjects answer the questionnaires every 2 months.

Eligibility Criteria:
Inclusion Criteria:

* unilateral trans-tibial amputation
* uses a prostheses already for more than 1 year
* sufficient touch sensitivity at the stump
* unimpaired contralateral lower extremity

Exclusion Criteria:

* psychiatric disorder
* cognitive restrictions
* pregnant or breast feeding women
Chlorhexidine Gel and Peribioma Periogel Use in Peri-implant Mucositis Sites: a Split-mouth Randomized Clinical Trial.

The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of peri-implant mucositis.

Patients with bilateral implants with peri-implant mucositis will undergo professional dental hygiene with ultrasonic handpiece and manual scaler, followed by the application of glycine Airflow powders. Then, patients will be randomly divided into two groups: the Trial Group will undergo a split-mouth application of chlorhexidine gel 1% for quadrants 1 and 4 and of Biorepair Periogel 0.12% for quadrants 2 and 3, with one daily home application for the following 15 days after the visits and the use of Biorepair Parodontogel toothpaste; the control Group will not use any gels.

The improvement of peri-implant mucositis will be evaluated between the two groups and differences between the two gels will be assessed, if present.

The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of peri-implant mucositis.

Patients with bilateral implants with peri-implant mucositis will undergo professional dental hygiene with ultrasonic handpiece and manual scaler, followed by the application of glycine Airflow powders. Then, patients will be randomly divided into two groups:

* Trial Group: split-mouth application of chlorhexidine gel 1% for quadrants 1 and 4 and of Biorepair Periogel 0.12% for quadrants 2 and 3. Home oral care will be continued with 1 application per day of the two gels for the following 15 days after the visits for the same quadrants, and the use of Biorepair Parodontogel Toothpaste.
* Control Group: no application neither of chlorhexidine gel nor of Biorepair Periogel.

The improvement of peri-implant mucositis will be evaluated between the two groups and differences between the two gels will be assessed, if present, evaluating periodontal indices at the baseline, after three months and after six months.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18-70 years)
* Bilateral presence of peri-implant mucositis
* Patients with high compliance

Exclusion Criteria:

* Patient with cardiac pacemaker
* Patients suffering from psychological, neurological or psychiatric disorders
* Patients suffering from systemic, metabolic or autoimmune diseases
* Pregnant women
Multidisciplinary Approach to Reduce Cardiovascular Health Disparities

The goal of this observational study is to investigate the potential differences in thrombogenicity between black and white patients admitted with atherothrombotic events including acute coronary syndrome, multi-vessel coronary disease, and ischemic stroke.

Participants will engage in laboratory testing and health outcome assessments.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age admitted with ACS, AIS, or multi-vessel CAD
* Competent mental condition to provide informed consent and able to participate in follow-ups

Exclusion Criteria:

* Pregnant women
* Currently enrolled in an investigational drug or device trial
* Undergoing treatment for neoplastic, autoimmune, or connective tissue disease
* COVID-19 infection within 30 days of enrollment
* Known history of hepatitis or HIV
* Deemed unfit to participate according to the investigator
* Known history of drug abuse
* Known platelet count of \<100,000/mm3
* Hematocrit \< 25%
Docosaexahenoic Acid and Gross Motor Milestones in Infants

To examine whether daily supplement of docosahexaenoic acid throughout the first year of life may speed up the achievement of gross motor development milestones in healthy infants, a total of 1160 healthy infants randomly allocated to receive throughout the first year of life daily oral supplement of vitamin D3 (400 IU) plus docosahexaenoic acid (20 mg) or vitamin D3 (400 IU) alone. Primary outcome measure: time of achieving gross motor development milestones. Secondary outcome measure: time of achieving early fine motor development milestones and language.


Eligibility Criteria:
Inclusion Criteria:

* weight at birth equal or above 2500 g;
* gestational age between 37 and 42 completed weeks;
* single birth;
* absence of neonatal or birth abnormalities;
* Apgar score greater than or equal to 7 at 5 m;
* white parents.

Exclusion Criteria:

* presence of neonatal diseases requiring hospitalisation for longer than 7 days;
* unknown father;
* parents unable to understand the protocol requirements and to fill out the infants diary;
* infant already enrolled or selected for another clinical study.
Effect of Continuous Positive Airway Pressure Delivered by Two Different Modalities on Breathing Pattern in Preterm Infants

In this study, the investigators want to observe how continuous positive airway pressure delivered by two different modalities affects breathing pattern in small preterm infants. Using a specialized feeding tube in the stomach, the investigators can measure and compare how the diaphragm (a large breathing muscle) might be affected by those two modalities.

Many preterm very low birth weight infants require continuous positive airway pressure(CPAP) for breathing support because of lung immaturity. CPAP can be delivered by the infant flow(TM) device which is well studied. Prolonged use of nasal prongs CPAP has been shown to cause discomfort and, rarely, nasal injury leading to long term disfigurement. On the other hand, High flow nasal cannula (HFNC) ,which is another modality of delivering CPAP, creates less pressure on the nose and less disfiguring effect but previous research showed that the use of HFNC may be less effective than IF-CPAP in providing breathing support in these infants.

We plan to study 10 stable preterm infants born less than 32 weeks' gestation and 1.5 kilograms at birth after being stable for at least 48hours on IF-CPAP. babies will be randomized to start on IF-CPAP or HFNC for 30 minutes. After 45 minutes of adaptation, baby will be switched to the other modality for another 30 minutes. By inserting a specialized feeding tube with sensors into the stomach, we can measure the electrical activity of the diaphragm (EAdi). By analysing EAdi with each modality of delivering CPAP, we want to directly assess how HFNC affects breathing compared to IF-CPAP.

Eligibility Criteria:
Inclusion Criteria:

* Birth weights ≤ 1500g
* Gestational age less than 32 week
* Stable on nasal continuous positive airway pressure (CPAP) of 5-6cmH20 support for at least 48 hours
* Treated with methylxanthines for apnea of prematurity
* In less than 35% oxygen

Exclusion Criteria:

* Congenital and acquired problem of the gastrointestinal tract
* Phrenic nerve injury and/or diaphragm paralysis
* Esophageal perforation/tracheoesophageal fistula
* Congenital/acquired neurological deficit and/or seizures
* Hemodynamic instability
* Congenital heart disease (including symptomatic patent ductus arteriosus)
* Undergoing treatment for sepsis or pneumonia
* Use of muscle relaxants, narcotic analgesics, or gastric motility agents
* Congenital anomalies of respiratory tract (e.g. CCAM)
* Infants requiring more than 35% oxygen
* Infants with facial anomalies
* Infants with pneumothorax and/or pneumomediatinum
* Infants in the immediate postoperative period
* Infants with significant gastric residues and vomiting
Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers.

This study aims to explore for the first time how the different ALK TKIs have been sequenced in real-world clinical practice and with which outcomes for Swedish lung cancer patients


Eligibility Criteria:
Inclusion Criteria:

-Inclusion criteria for ALK-positive NSCLC patients will be based on prescription data i.e. defines eligible patients as adult patients with at least one filled prescription of ALK-inhibitors identified by the national prescription register. Only prescriptions filled at pharmacies can be captured in prescription registers, as they do not include data on hospital drugs. ALK-inhibitor treatments for patients with NSCLC are given primarily outside of the hospital setting minimizing the selection bias under the inclusion criteria.

Exclusion Criteria:

-not applicable
Clinical Study to Evaluate Efficacy and Safety of DA-1229 in Patients With CAVD

This study will evaluate the efficacy and safety of DA-1229 in patients with calcific aortic valve disease.


Eligibility Criteria:
Inclusion Criteria:

* Adult male and female subjects of ages in the range over 19
* The subjects whose echocardiography or heart CT result meets the criterion in the screening period or 4 weeks before screening visit

  * Criterion : 2.0m/s ≤ peak aortic-jet velocity \< 4.0m/s or aortic valve calcium score ≥300AU
* The subjects completely understood the clinical trial through detailed explanation presented, determined to participate in the clinical trial spontaneously, and agreed to observe precautions suggested thereby through written consent

Exclusion Criteria:

* The cause of CAVD is niether degenerative nor bicuspid aortic valve
* The subjects who have other aortic valve disease as other clinically significant aortic insufficiency or mitral disease
* The subjects who had an aortic valve operation or are expected to need aortic valve operation
Efficacy of a Combination of Conservative Treatments Compared to Isometric Exercise on Clinical Outcomes in Patients With Cervical Radiculopathy

This intervention study is to evaluate the efficacy of a combination of conservative treatments compared to isometric exercise on clinical outcomes in patients with cervical radiculopathy. It is a randomized, parallel, 2-arm superiority trial study. The study will be conducted at the District General Hospital in Trincomalee, where patients with cervical radiculopathy seek medical care. Patients who refer to the Department of Physical Medicine (DPM) from the Out Patients Department (OPD), orthopedic clinic and surgical clinic with a diagnosis of cervical radiculopathy or neck and arm pain (symptoms extending distal to the shoulder) will be eligible for recruitment. The study details will be explained to the subjects in the language that they best understand. Written informed consent will be obtained from the individuals who express their willingness to participate in the study, and they will sign the informed consent document accordingly.


Eligibility Criteria:
Inclusion Criteria:

* 35-60 years
* Neck pain \> 3 months
* Clinical Prediction Rules - Positive Spurling's test (+) Distraction test (+) Upper limb tension test A (+) Cervical rotation on affected side \< 60

Exclusion Criteria:

Presence of any signs or symptoms of medical red flags

* Less than 3(positive) items for the CPR
* Bilateral arm radiating pain
* Osteoporosis
* Tumor
* Whiplash injury
* Pregnancy woman
* Rheumatoid arthritis
* Post-surgery to cervical/thoracic spine