cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Integrated Nano-technology in Revascularization of Immature Necrotic Teeth

This trial aims to study the effect of photoactivated disinfection using Diod laser (810 nm) to activate photosensitive nanoparticle chitosan as an endodontic irrigant versus sodium hypochlorite followed by saline and then EDTA 17% on 1) postoperative pain and 2) the success of revascularization in patients with necrotic immature maxillary anterior teeth using a randomized clinical trial design.

randomized clinical trial will be conducted to investigate and compare the efficacy of photosensitized nano-chitosan 2% as an endodontic disinfectant during revascularization versus sodium hypochlorite, followed by EDTA 17% according to the standardized protocol of the American Association of endodontics.

Twenty individuals with necrotic, immature permanent anterior teeth will be recruited. They will be randomly assigned into two groups according to the received intervention: control group and test group.

pain will be evaluated as a primary outcome at 24 hours and one week post-intervention using numerical rating scale (NRS). In addition, the root development in terms of change in root length and apical foramen diameter and periapical bone healing will be evaluated as secondary outcomes using cone beam tomography.

Eligibility Criteria:
Inclusion Criteria:

* o Immature necrotic maxillary incisor with open apex greater than 1 mm.

  * Teeth where pulp space are not needed for post and core.
  * A restorable tooth.
  * Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
  * Patients who will agree to the consent and will commit to follow-up period.

Exclusion Criteria:

* o Non-restorable teeth.

  * Teeth with root fractures, internal or external root resorption.
  * Teeth with mature fully developed root with closed apex
  * Patients with any systemic disease that may affect predictable outcome
Alcohol Consumption Relation With Nutritional Knowledge and Body Weight

The increase of overweight and obesity in young Italian people, nowadays showed by several epidemiological data, has been related to the misuse of alcohol and to a lack in nutritional knowledge.

Thus the aim of our study was to investigate if different nutritional knowledge from could affect body composition and drinking habits of a cohort of local young people.

104 healthy subjects (56 males and 54 females) were recruited using oral advertisements among the students of 18-19 years-old belonging to the Istituto Agrario and the Istituto alberghiero Raineri-Marcora of Piacenza. The subjects were asked to complete a questionnaire on alcohol consumption and another one related to nutritional knowledge. Then anthropometric data were measured: height, weight, waist and hips circumferences, waist-hips ratio and skinfolds were evaluated for each subject and body fat mass was calculated.


Eligibility Criteria:
Inclusion Criteria:

* students

Exclusion Criteria:

* pregnant or breast feeding
* vegan or vegetarian
Intermittent Pneumatic Compression in Surgical Patients at Extremely-high Risk for Venous Thromboembolism

The aim of the study is to evaluate efficacy and safety of venous thromboembolism prophylaxis by the combination of graduated compression stockings (GCS), standard doses of low-molecular-weight heparins (LMWH) and sequential compression device (SCD) in the mixed group of surgical patients at high and extremely high risk for venous thromboembolism.

Venous thromboembolism (VTE) is the most common complication after major surgery, especially in high-risk patients. But the high-risk group is inhomogeneous. Some patients included in this group have an extremely high prevalence of postoperative venous thrombosis and pulmonary embolism, in whom the standard complex prophylaxis with elastic compression and standard anticoagulation is less effective. This is particularly so, in patients having a Caprini score of 11 and more, so that at the background of standard prophylaxis postoperative DVT is 10 times higher. This group of patients needs a more effective protocol for VTE prevention.

Sequential compression devices (SCD) combined with graduated elastic compression stockings (GCS) or without them were found to be effective in the prevention of VTE in high-risk patients, especially after neurosurgical interventions, even without the administration of anticoagulants. However, their efficacy in patients at "extremely high risk", having 11+ Caprini scores has not been assessed yet. The aim of the current study is to evaluate efficacy and safety of VTE prophylaxis by the combination of graduated compression stockings (GCS), standard doses of low-molecular-weight heparins (LMWH) and sequential compression device (SCD) in the mixed group of surgical patients at high and extremely high risk for venous thromboembolism

The expected outcome of the study is a reduction of asymptomatic postoperative venous thrombosis rate in the hospital and reduction in all VTE during 6 months after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Age over 40
* Major surgery undergone\*
* High risk of postoperative VTE according to a National guideline\*\*
* 11+ Caprini scores
* Informed consent is given

Exclusion Criteria:

* Acute deep vein thrombosis (DVT) at baseline
* Performed inferior vena cava (IVC) plication or implanted IVC filter
* Regular preoperative anticoagulation
* Postoperative anticoagulation needed at therapeutic doses
* Absence of anticoagulation for more than 5 days after surgery
* Coagulopathy (not related to Disseminated intravascular coagulation syndrome)
* Thrombocytopenia
* Hemorrhagic diathesis
* Lower limb soft tissue infection
* Ankle-brachial index \< 0.6

  * Major surgery - intervention under endotracheal anesthesia with duration of more than 60 min.

    * In accordance with a standard stratification system, high risk of VTE group includes patients over 60 years old after major surgery and patients 40-60 years old with additional risk factors after major surgery.
Evaluation of the Water Drinking Test Response in Supine and Sitting Position Using the Continuous Measurement Device Sensimed Triggerfish Intraocular Pressure in Healthy Subjects

Monocentric, prospective study, comparison of the water drinking test response in the supine and in the sitting position using the intraocular pressure monitoring device Sensimed Triggerfish in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Aged over 18 years
* No previous ophthalmic conditions
* Spherical equivalent from - 6 to +3 diopters

Exclusion Criteria:

* Contact lens use
Extending Omalizumab Treatment Intervals in Patients with Chronic Spontaneous Urticaria

This study is a multicentre, randomized, open-label, non-inferiority clinical trial.

The purpose and aim of this study is to investigate if patients with well controlled (UCT score score ≥ 12) chronic spontaneous urticaria (CSU) on omalizumab 300 mg every four weeks can extend treatment intervals and maintain disease control.

Newly referred patients with CSU who are well-treated (UCT score ≥ 12) 12 weeks after initiating standard treatment with omalizumab 300 mg every four weeks, are randomized into two treatment arms.The first arm will continue standard treatment with omalizumab 300 mg every four weeks for 24 weeks. The second arm will receive treatment in an extended interval of omalizumab 300 mg every six weeks for 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of CSU according to the EAACI/GA2LEN/EDF/WAO guidelines.
* Age ≥ 18 years.
* Omalizumab-naïve prior to initiating treatment with omalizumab.
* Background treatment with four antihistamines daily.
* Candidate for omalizumab treatment according to Danish guidelines.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Planned pregnancy within the next 6 months.
* Weight ≥ 100 kilograms.
* Presence of any other active skin disease or condition that may interfere with the assessment of CSU, such as atopic dermatitis, bullous pemphigoid, senile pruritus, or psoriasis.
* Use of immunosuppressive drugs, such as prednisolone, azathioprine, methotrexate, or cyclosporine.
* Predominantly experience symptoms from chronic inducible urticaria (CIndU).
* Inability to complete study or comply with study procedures.

Patients with a positive basophil histamine release assay (BHRA) are not eligible for the study. Patients may therefore be withdrawn from the trial after enrolment, if they are found to have a positive BHRA test in the initial blood work.
Efficacy of Ultrasound Guided Rectus Sheath Block on Post Operative Quality of Recovery

Effective Postoperative pain management following laparotomy represents a cornerstone in the care of surgical patients. With the growing utilization of Enhanced recovery after surgery protocols (ERAS), a paradigm shift in perioperative care has resulted in reduction of both hospital stay and clinical complications faced by patients.

One important component of successful implementation of ERAS protocol is optimized pain control. It has been shown that opioids have a considerable role in reducing bowel motility in addition; it hinders early mobilization and enteral feeding besides their commonly faced side effects such as nausea and vomiting.

Consequently, ERAS programs encourage the usage of multimodal opioid sparing analgesia which includes neuraxial or regional anesthesia techniques to provide effective pain relief while reducing the opioid related side effects. \[1\]

Regional blocks have remained popular with evidence of superior postoperative pain control when compared with systemic analgesics. Regional anaesthesia techniques have undergone considerable refinement with the advent of ultrasound guidance. Ultrasound visualization of anatomical structures increases both the safety and quality of regional blocks through optimal needle placement. Ultrasound-guided rectus sheath (RS) blocks are an emerging anaesthetic technique providing excellent analgesia after laparotomy. The anatomic characteristics of this block suggest minimal serious complications are likely, and this regional block is particularly useful where epidural is contraindicated


Eligibility Criteria:
Inclusion Criteria:

1. 18-60 years old patients
2. ASA 1-2 patients
3. Patients undergoing elective midline laparotomy.

Exclusion Criteria:

* 1. refusal to consent, 2. previous laparotomy (subsequently amended to exclude only a laparotomy with a paramedian scar), 3. significant hepatic or renal disease, 4. any condition limiting the use of co-analgesics (diclofenac and acetaminophen), 5. coagulopathy (international normalized ratio: 1.5 ) 6. Patients with body weight \\ 50 kg.
Staccato Granisetron® (AZ 010) for the Treatment of Cyclic Vomiting Syndrome

This is a multicenter, randomized, double-blind, parallel group, placebo-controlled, efficacy and safety study of adult outpatients diagnosed with CVS and experiencing recurring episodes of stereotypical vomiting.

A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of Staccato Granisetron (AZ-010) for the Acute Treatment of Moderate to Severe Cyclic Vomiting Syndrome

Eligibility Criteria:
Inclusion Criteria:

* Adult males and females between 18 and 60 years of age, inclusive at the time of signing the informed consent document.
* Diagnosis of cyclic vomiting syndrome (CVS) using the Rome IV diagnostic criteria.
* Otherwise healthy, as determined by the responsible physician, based on a medical evaluation including history, physical examination, vital signs, electrocardiograms (ECGs) and laboratory tests assessed at the screening visit
* Negative urine tests for selected drugs of abuse and alcohol breath test at Screening.

Exclusion Criteria:

* Any significant medical or psychiatric condition that could, in the Investigator's opinion, compromise the subject's safety or interfere with the completion of this protocol.
* Any condition, including the presence of laboratory abnormalities or pulmonary condition, which according to the Investigator places the subject at unacceptable risk if he/she were to participate in the study.
* A diagnosis of any gastrointestinal disorder other than CVS that in the judgement of the Investigator could compromise the subject's safety or interfere with the interpretation of safety or efficacy data.
A Retrospective Observational Study on the Use of Biologics in Monotherapy in Patients With Rheumatoid Arthritis

This retrospective, observational, multi-center study will evaluate the use of biological agents (e.g. RoActemra/Actemra \[tocilizumab\]) in monotherapy in patients with rheumatoid arthritis. Data from medical record files will be collected of patients currently treated with a biologic in monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Diagnosis of rheumatoid arthritis
* Currently receiving a biologic agent in monotherapy (corticosteroids and/or non-steroidal anti-inflammatory drugs are permitted)

Exclusion Criteria:

* Concomitant treatment with disease-modifying anti-rheumatic drugs (DMARDs) for the treatment of rheumatoid arthritis
* Patients that have started their current monotherapy before 01/01/2009
Mobile After-Care Intervention to Support Post-Hospital Transition (MACS)

This study examines the feasibility and acceptability of a mobile device-delivered app, called Mobile After-Care Support (MACS), to improve patients' coping and treatment adherence following a hospitalization related to their psychotic-spectrum disorder.

In the open trial, all participants will receive a study-developed app to be used on a mobile phone. This app will support the use of healthy coping skills post-hospitalization, as well as help participants adhere to their discharge treatment plan. This phase is intended to inform the feasibility and acceptability of the app in preparation for a future randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

1. Currently hospitalized
2. DSM-5 criteria for psychotic disorder (schizophrenia or schizoaffective disorder)
3. 18 years or older
4. Prescribed oral antipsychotic medication upon discharge
5. Ability to speak and read English

Exclusion Criteria:

1. Alcohol/drug use disorders at moderate or severe level
2. Planned discharge to supervised living setting or participation in formal outpatient adherence programs (e.g., medication packaging)
3. Pregnancy or other medical condition (e.g., dementia) contraindicating use of antipsychotic medications.
Postoperative Pain After Vitreoretinal Surgery

Postoperative pain (POP) is frequently underestimated in general and little data are available particularly for POP after vitreoretinal surgery (VRS). The investigators will conduct a 1-year retrospective study on patients undergoing VRS at "Careggi Hospital" . The aim of the study will be to observe the amount of POP, its time course, factors associated with its appearance and finally the efficacy of the pain protocol that is in use.

Post-operative pain (POP) is frequently underestimated, mostly after eye surgery, a type of surgery in which trauma is limited and pain is not investigated as patients are often discharged from the hospital within a few hours. Good POP management can improve clinical outcome and patients' satisfaction and constitutes essential criteria for hospital discharge after day-case or ambulatory surgery. Little data are available particularly for POP after vitreoretinal surgery (VRS).

The investigators will conduct a 1-year retrospective study on patients undergoing VRS at "Careggi Hospital" , a teaching University Hospital in Italy. The aim of the study will be to observe the amount of POP after VRS, its time course, factors associated with its appearance and finally the efficacy of the pain protocol that is in use.

Pain will be evaluated according to the "Numerical Rating Scale" (NRS), a 11-point numeric scale ranging from '0' which represents "no pain" and '10' which represents extreme pain at several intervals after surgery. Analgesic consumption (in terms of type and amount of analgesics) and the efficacy of the analgesic protocol in use will also be recorded.

Factors possibly associated with POP (such as duration of surgery, presence of comorbidities, ASA physical status, age, type of anesthesia (locoregional or general anesthesia)) will be analyzed.

The associations between the principal outcome (amount of POP) and risk factors will be evaluated using a simple and multiple logistic regression model.

Eligibility Criteria:
Inclusion Criteria:

* Vitreoretinal surgery

Exclusion Criteria:

* ASA IV
Induction of Pluripotent Stem Cells From Human Fibroblasts of DM1 Patients

The objective of the study is the modelisation of human cardiomyocyts from pluripotent stem cells in order to study the cardiac alterations induced by CTG expansions.


Eligibility Criteria:
Inclusion Criteria for DM1 patient with cardiomyopathy:

* aged 20-50
* DM1 confirmed by molecular analysis
* Confirmed cardiomyopathy (infrahissiens conduction disorders)
* able to sign the consent form
* affiliated to european social security.

Inclusion Criteria for DM1 patient without cardiomyopathy

* aged 20-50
* DM1 confirmed by molecular analysis
* No cardiomyopathy (no infrahissiens conduction disorders or other trouble linked to DM1)
* able to sign the consent form
* affiliated to european social security.

Inclusion Criteria for controls

* aged over 18
* brother, sister, father or mother of the DM1 patient
* No DM1 confirmed by molecular analysis (CTG repetition under 38)
* No cardiac disorders.
* able to sign the consent form
* affiliated to european social security.

Exclusion Criteria:

* no pragnant or nursing women
* patient unable to understand informed consent
* patient under juridic protection
Association Between Systemic Exposure of Atorvastatin and Metabolites and Atorvastatin-induced Myotoxicity

The aim of this study is to investigate whether the pharmacokinetics of atorvastatin and/or its metabolites is altered in patients with confirmed atorvastatin-induced myopathy compared to healthy controls.

A 24 hour pharmacokinetic investigation of atorvastatin and metabolites will be performed in 15 patients with a history of atorvastatin -induced myotoxicity. The possible link to relevant mutations in SLCO1B1, CYP3A5 and MDR1 will be also be investigated

Eligibility Criteria:
Inclusion Criteria:

* above 18 years
* previous history of atorvastatin-associated myotoxicity

Exclusion Criteria:

* current treatment with drugs or herbal remedies with known pharmacokinetic interaction potential with atorvastatin
* previous CK levels above ten times the upper limit of normal range
* pregnancy and persistent muscular complaints after a four week wash-out period of statin treatment
Comparison of Liraglutide Inhaled Into the Lungs Compared to Liraglutide Injected Under the Skin in Healthy Male Volunteers

This trial is conducted in Europe. The aim of this trial is to determine the relative bioavailability of NNC 90-1170 (liraglutide) when inhaled compared to NNC 90-1170 when injected under the skin.


Eligibility Criteria:
Inclusion Criteria:

* No clinically important abnormal physical findings
* No clinically relevant abnormalities in the results of laboratory screening evaluation
* Normal (or abnormal but not clinically significant) ECG (electrocardiogram)
* Normal (or abnormal but not clinically significant) blood pressure and heart rate
* Body Mass Index (BMI) between 20-30 kg/m\^2 or outwith range but not clinically significant
* Non-smoker
* Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) at least 85% of predicted normal for age, gender and height
* FVC ratio at least 75% of predicted normal for age, gender and height

Exclusion Criteria:

* A clinically significant illness or infection requiring treatment within the last two months
* Any infection involving the respiratory system or adverse event that may, in the opinion of the principal investigator, interfere with blood glucose homeostasis
* Subjects with first and/or second degree relative(s) with diabetes mellitus
* Donation or loss of greater than 500 ml of blood in the period 0-12 weeks before trial entry
* Alcohol use in excess of 28 units of alcohol per week. A unit of alcohol is equivalent to half a pint of average strength beer, a glass (125 ml) of wine or a pub measure (25 ml) of spirits, sherry or port
* Current addiction to alcohol or substances of abuse
* Females
* Presence of hepatitis B surface antigen, hepatitis C antibody or HIV (human immunodeficiency virus) 1 or 2 antibodies
Prospective Registery of Smell/Taste Clinic Ear/Nose/Throat

Smell/taste disorders are common conditions with a significant impact on quality of life. In September 2021, a specific consultation for patients with smell and taste disorders was initiated at the ENT-HNS (ear, nose, and throat, head and neck surgery) department of UZ Leuven, partly in light of post-COVID-19 related smell disorders.

With this observational ambidirectional study, we aim to better map smell/taste disorders in the Belgian/Flemish population. Using standard-of-care diagnostic tests and structured questionnaires, we strive to gain more insight into the severity, impact, and progression/prognosis of smell/taste disorders.


Eligibility Criteria:
The psychophysical testing as well as the questionnaires require a cooperative participant who can understand and follow instructions and communicate their choices. Informed consent is necessary upon participation for prospective registry. There are no exclusion criteria related to sex, gender, or ethnicity. There are no exclusion criteria related to medical history or prior treatments. This study conveys no additional risks for care groups such as pregnant women, or elderly
A FINEH Protein Trial - Part 1

The objectives of this trial are to assess the health benefits of acute hemp protein consumption compared to soybean protein and a non-protein control on: 1) blood glucose, appetite and blood pressure for one hour following consumption, 2) food intake at an ad libitum meal one hour following consumption and 3) blood glucose, appetite and blood pressure following the ad libitum meal to determine the "second meal effect" of hemp protein.


Eligibility Criteria:
Inclusion Criteria:

* Normoglycemic (\<5.6 mmol/L)
* Body mass index (BMI) of 18.5-29.9 kg/m2 Participants will be excluded if they regularly skip breakfast, smoke, or consuming medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year.

Exclusion Criteria:

* Restrained eaters
* Regularly skip breakfast
* Smokers
* Those who are active (organized activities or athletic training at a high intensity; ≥ 150 min per week of moderate to vigorous physical activity)
* Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year.
One-lung Ventilation: Expression of Pulmonary Inflammatory Mediators

One-lung ventilation; organ protection; volatile anesthetics

One-lung ventilation has become a common procedure for thoracoscopic surgery. Two hypothesis will be tested in this study:

1. Are inflammatory mediators increased in the re-ventilated lung after short-period pulmonary collapse?
2. Does Sevoflurane influence the production of inflammatory mediators in the re-inflated lung? Therefore, this study will elucidate the potential protective effect of a volatile anaesthetic (sevoflurane) on the production of inflammatory mediators by the respiratory compartment of the lung, i.e. the alveolar epithelium.

   * Trial with immunomodulatory product / biological


Eligibility Criteria:
Inclusion criteria:

* Thoracic surgery (thoracotomy, thoracoscopy) with one-lung ventilation

Exclusion criteria:

* Immunosuppressive therapy
* Ongoing inflammatory processes