cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Hyaluronic Acid Injections on Functional Recovery After Surgery for Prostate Adenoma

The purpose of this study is to evaluate the score on urinary function (International Prostate Score Symptom) at 28 days.

The main objective is to assess the efficacy of treatment with Ialuril® Prefill on functional recovery at 4 weeks, based on the International Prostate Score Symptom.

A paired test will be performed to compare the International Prostate Score Symptom score between 0 and 28 days.

This is an interventional, non-comparative, open-label, monocentric study aimed at evaluating treatment with hyaluronic acid in patients who have undergone surgery (HOLEP procedure) for prostatic adenoma.

Eligibility Criteria:
Inclusion Criteria:

* Patient eligible for a HOLEP procedure, according to the investigator ;
* Patient able to understand the information related to the clinical investigation, to read the information leaflet and agrees to sign the consent form.

Exclusion Criteria:

* Known intolerance to one of the treatment components: hyaluronic acid, chondroitin sulphate, calcium chloride;
* Prostatic volume greater than 140 cm3;
* Patient under anticoagulant treatment for secondary prevention;
* Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
* Participating patient, or in a period of exclusion from another clinical trial;
* Patient not benefiting from a social security scheme.
Nasopharyngeal Carcinoma Treated With Reduced Volume Intensity Modulated Radiation Therapy:10-Year Outcome and Late Toxicity, Quality of Life

Nasopharyngeal carcinoma (NPC) is a type of head and neck cancer. The last three decades of research in head and neck radiation oncology have largely focused on improvements in survival, which have mostly come at the cost of long term toxicity for surviving patients.This is an observational study that is being done to evaluate the long-term efficacy, learn about the toxicity and quality of life that survivors of nasopharyngeal carcinoma may have following treated with reduced volume intensity modulated radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Received treatment with Reduced Volume Intensity Modulated Radiation Therapy
* Age 18 or above, upper limit 65
* Ability to comply with the protocol

Exclusion Criteria:

* History of recurrent nasopharyngeal disease
* A history of any physical, psychological or social condition which would impair with the ability of the patient to cooperate in this study
* Unable to provide consent
The Causal Relation of Nasal Nitric Oxide Levels to the Severity of Chronic Rhinosinusitis and Its Inflammatory Phenotype

Nitric oxide (NO) reflects changes in inflammatory state of the airways. In pulmonology fractional exhaled nitric oxide concentration (FeNO) has been linked to eosinophilic asthma and is used to guide overall disease control. The measurement of nasal nitric oxide (nNO) may reflect the disease burden and inflammatory phenotype of the paranasal sinuses.

The aim of our study is to evaluate the relation of chronic rhino sinusitis (CRS) severity and inflammatory status to nNO, maxillary sinus NO, nitrite, nitrate and cone beam computed tomography (CBCT).

Three groups (22 patients in each) of referred patients and and 22 healthy volunteers are recruited. Patients are grouped according to the CBCT score and viewed three times in 4-6 weeks intervals.


Eligibility Criteria:
Inclusion Criteria:

* Patients willing to participate in the study
* Patients who are referred to ENT clinic due to chronic rhinosinusitis (EPOS criteria) or repeatedly diagnosed and treated acute rhinosinusitis

Exclusion Criteria:

* Endoscopic sinus surgery operation previously
* Septal deviation that would need an operation to correct the air flow
* Other severe disease that could pose a risk for the patient during the measurements based on the judgement of the treating physician
* Pregnancy or breastfeeding
* Allergy to used medications
* Inability to co-operate or to tolerate manipulation of the nose
Immunonutrition in Ulcerative Colitis

This study tests the hypothesis that a supplement that combines a functional fiber, long chain omega-3 polyunsaturated fatty acids (PUFAs), vitamin D3, vitamin E, and zinc will reduce clinical symptoms, decrease pro-inflammatory cytokines in the blood and ergo decrease inflammation, promote beneficial microbial activity in the colon, and help recovery of the intestinal mucosa of ulcerative colitis (UC) patients compared with a placebo.

An anticipated 30 participants with newly diagnosed active ulcerative colitis will be recruited to participate in a randomized control trial, with 50% of the subjects distributed to the supplement (n=15) and the other 50% provided a placebo control (n=15). This is considered as a "proof of concept" study to determine if there is evidence that a multi-ingredient supplement (immunonutrition) will reduce UC disease severity.

Eligibility Criteria:
Inclusion Criteria:

* patients with active ulcerative colitis (proof of diagnosis from gastroenterologist), over 18 years old, has over 50% gut remaining, fully connected bowels (no colostomy), currently on 5-aminosalicylates (ASA) drugs, not pregnant or lactating

Exclusion Criteria:

-
An Eight-week Study to Evaluate the Efficacy and Safety of 2 Doses of Saredutant in Patients With Generalized Anxiety Disorder

The primary objective is to evaluate the efficacy of two fixed doses (100 mg and 30 mg once daily) of saredutant compared to placebo in patients with generalized anxiety disorder. The secondary objectives are to evaluate the efficacy of saredutant on disability and quality of life in patients with generalized anxiety disorder, and to evaluate blood levels of saredutant.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of generalized anxiety disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) Plus Generalized Anxiety Disorder module.

Exclusion Criteria:

* Total score of less than 22 on the HAM-A.
* Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than 18.
* Patients with a current history (within 6 months) of major depressive disorder or history or presence of bipolar disorders or psychotic disorders.
* Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
* Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, antidepressants including Monoamine Oxidase Inhibitors (MAOIs) within 1 month, anxiolytics within 2 weeks, mood-stabilizer (lithium, anticonvulsants) within 1 month, and/or high dose or prolonged benzodiazepine (continuous use for 3 months prior to admission) use.

The investigator will evaluate whether there are other reasons why a patient may not participate.
Virtual Reality in MVA for Miscarriage

We are investigating the use of a virtual reality programme to reduce pain and anxiety experienced during manual vacuum aspiration.

Virtual reality (VR) is the computer-generated simulation of a three-dimensional environment that can be interacted with in a seemingly real way by a person using special electronic equipment. In this study a VR headset is worn by the patient allowing them to experience a relaxing environment whilst the procedure manual vacuum aspiration (MVA) is performed.

VR is mostly used in computer gaming but has uses in medical field and has been used in the treatment of long standing pain, treatment of burns, dentistry and treatment of cancer pain. However, its role in the management of pain and anxiety during gynaecological procedures like manual vacuum aspiration has not been researched. This study explores whether it has a place in the treatment of gynaecological pain and reduction of anxiety.

Many simple gynaecological procedures can be performed in an outpatient setting without the need for general anaesthesia. Such office-based procedures include outpatient hysteroscopy, endometrial biopsy, large-loop-excision of the transformation zone and manual vacuum aspiration for the management of miscarriage. Advantages experienced by patients include reduced anaesthetic risk, enhanced recovery time and flexibility of timings. For the healthcare provider there are significant cost benefits on the basis of reduced theatre time, staff and equipment. Patient satisfaction is generally high but influenced by their experience of pain and feelings of anxiety before, during and after the procedure.

The rationale for this study is to invetsigate the role of distraction techniques and the feasibility of using virtual reality for the management of acute pain and anxiety experienced by patients undergoing manual vacuum aspiration

Primary objective

• Feasibility of using virtual reality as a distraction technique in management of acute pain and anxiety in patients undergoing manual vacuum aspiration for miscarriage.

Secondary objectives

* Understanding the acceptability and effectiveness of VR interventions in office gynaecology procedures
* Understanding the factors that might influence the willingness of patients to participate in a future formal trial of the technology.
* Understanding how best to implement the technology and designing of the contents of the VR intervention.

Eligibility Criteria:
Inclusion Criteria:

Patients: Clinical indications for undergoing an MVA will be confirmed. Inclusion criteria will include all women of 18 - 50 years of age, planned for a MVA who are able and willing to give informed consent.

Exclusion Criteria:

* Hearing impairments and blindness
* History of epilepsy or any previous seizures
* Any known anatomical characteristics that may make performing the office procedure more difficult (e.g., cervical conisation)
* Any known characteristics that make the patient unsuitable for undergoing MVA (e.g. known bleeding disorder, gestation \>12 weeks)
* The denial or withdrawal of informed consent
The Diagnostic Value of PET/MRI in Head and Neck Cancer

This study investigates the diagnostic value of PET/MRI for cervical lymph node metastases from head and neck squamous cell carcinomas.

The Danish fast-track cancer program standardizes the work-up of patients suspected of head and neck cancer. Currently, the guidelines recommend head and neck magnetic resonance imaging (MRI) as the standard imaging modality for assessment of the primary tumor site and potential nodal metastases. However, recent studies have shown advantages in the use of 18F-FDG-PET (PET) combined with computed tomography (CT) due to its superiority in detecting metastases and synchronous cancers.

During the last couple of years PET/MRI has been introduced. MRI is known to provide the highest anatomic detail in the head and neck region, and preliminary studies show promising results. However, the evidence is still very sparse.

The purpose of the project is to investigate the diagnostic value of PET/MRI in patients with head and neck squamous cell carcinoma. The hypothesis is that PET/MRI provides a more precise diagnosis of regional lymph node metastases, and thus, make the surgical treatment of the neck more accurate and less invasive resulting in reduced morbidity.

The project is designed as a prospective cohort study based on paired data with head-to-head comparison of CT, MRI, PET/CT and PET/MRI. Patients will be included from the head and neck cancer fast-track program at the Center of Head and Neck Cancer, Odense University Hospital (OUH).

Included patients will be offered PET/MRI in addition to the conventional fast-track imaging. The description of the images will be made blinded. When a neck dissection of the lymph nodes is made, the lymph nodes will be separated in defined regions. The diagnostic accuracy of the individual imaging modalities is assessed for each neck level with histology as standard reference.

Eligibility Criteria:
Inclusion Criteria:

Patients either suspected of or with histologically verified:

* Relapse of head and neck squamous cell cancer with involvement of regional lymph node(s)
* Cervical lymph node metastasis with unknown primary tumor site
* Oral cavity squamous cell carcinoma
* Oropharyngeal squamous cell cancer planned for trans oral robotic surgery

Exclusion Criteria:

* Patients who cannot have a PET/MRI performed for different reasons (allergy, claustrophobia, medical implants)
* Patients who had surgery, infection or other inflammatory inducing conditions on the neck within the last 8 weeks
Safety, Tolerability, Pharmacokinetics And Measurement Of Whole Blood Activity (WBA) Of PNU-100480 After Multiple Oral Doses In Healthy Adult Volunteers

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of multiple doses of PNU-100480 given for 14 or 28 days. Killing activity against the bacterium that causes tuberculosis (TB) will also be measured. The effect of adding an additional tuberculosis (TB) agent (given for 2 days) in addition to PNU-100480 will be evaluated. Linezolid open label to determine activity in whole blood assay (WBA).

Evaluate safety, tolerability, pharmacokinetics and whole blood activity (WBA) of PNU-100480 given for 14 or 28 days; evaluate WBA of PNU with pyrazinamide; evaluate WBA of linezolid

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers willing and able to be confined to the Clinical Research Unit and comply with study schedule.
* Women of non-childbearing potential only.

Exclusion Criteria:

* History of hypersensitivity to, or intolerance of, linezolid.
* Antibiotic treatment within 14 days prior to dosing, or any previous antibiotic use at the discretion of the investigator.
* Previous history of irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD).
Hema Free Versus Hema Containing Adhesives in Posterior Restorations

The aim of study is to evaluate the clinical performance of posterior restorations using HEMA free universal adhesive versus HEMA containing universal adhesive over one year using USPHS criteria.

The study is intended to evaluate the HEMA free universal adhesive versus HEMA containing universal adhesive when both used in conjunction with giomer aesthetic restorations in occlusal cavities in posterior teeth ICDAS III and IV.

The restorations will be evaluated at baseline, 6 and 12 months according to modified USPHS criteria in terms of marginal staining, marginal adaptation and caries recurrence.

Patients will be recruited from outpatient clinic of conservative dentistry department, cairo university according to inclusion and exclusion criteria. patient will be randomly allocated to intervention or control group.

Eligibility Criteria:
Inclusion Criteria of participants:

* Patients with occlusal caries in molars classified as ICDAS III or IV.
* 19-35 years.
* Males or Females.
* Co-operative patients approving to participate in the trial.

Exclusion criteria of participants:

* Pregnancy.
* Disabilities.
* Systemic disease or severe medical complications.
* Allergic history concerning methacrylate.
* Rampant caries.
* Heavy smoking.
* Xerostomia.
* Lack of compliance.
* Evidence of severe bruxism, clenching, or tempromandibular joint disorders.
#WYMarketsMatter: Testing Two Farmers Market Voucher Strategies to Increase Food Security

University of Wyoming (UW) and Wyoming Food for Thought Project (WFFTP) propose to collaboratively develop, pilot, and evaluate a trial on the impact of market vouchers on food security and fruit and vegetable (F\&V) consumption. We will (a) provide farmers market vouchers to families who are enrolled in WIC, SNAP, or free or reduced lunch and/or have incomes ≤185% of poverty line; (b) assess impacts of these supports on household food security and F\&V consumption; and (c) test feasibility and impacts of vouchers valid only for F\&V vs. for any foods that can be purchased with SNAP.

To test the feasibility and preliminary impacts of this approach, we will enroll 30 individuals/households in this study, randomizing 10 to each of the 2 intervention arms and 10 to waitlist control. Qualifying individuals and families will be able to enroll in the study at the WFFTP Tuesday afternoon/evening market on July 30th, 2019. They will be randomized upon enrollment to one of three conditions: receiving $20 in vouchers at each of up to 4 markets ($80 total) that are good for F\&V only, receiving $20 vouchers at each of up to 4 markets that are good for any foods that SNAP/EBT benefits can be used for; or delayed intervention/waitlist control (who, at the final data gathering, will receive 5 x $20 in vouchers good at the WFFTP 2019 and 2020 markets).


Eligibility Criteria:
Inclusion Criteria:

To be eligible for the intervention, a participant must be an adult aged ≥18 years old whose household is enrolled in or eligible for SNAP, free or reduced school lunch program, and/or WIC (i.e., incomes of ≤185% of poverty for household size). UW staff wills screen for eligibility by verifying a participant has an EBT card. If no card is available, participants will be asked to self-report household income and size and UW staff will use the Federal Poverty Level chart to determine the individual's eligibility. They must also self-identify as living in Casper, Wyoming. They must come in person to the market on July 30th, 2019, to enroll.

Exclusion Criteria:

Not meeting the criteria above.
The Effect of Dairy and Non-Dairy Snacks on Food Intake, Subjective Appetite in Children

Dairy products have the potential to be healthy snack foods for children and are provided in a variety of food matrices. For instance, milk represents a fluid product, yogurt can be classified as a semi-solid food, and finally, cheese is the example of solid food. This experiment is aimed to examine the effect of dairy products with different food matrices on satiety and food intake in children. Dairy products will be compared with other non-dairy snacks popular among children including cookies and potato chips.


Eligibility Criteria:
Inclusion Criteria:

* Born at full-term within the normal weight range
* 9-14 year old

Exclusion Criteria:

* Food sensitivities or allergies,
* Dietary restrictions,
* Health, learning, emotional or behavioural problems
* Receiving medication
Bacteriophage Effects on Pseudomonas Aeruginosa

Pulmonary phage therapy to treat bacterial infections of the respiratory tract have been investigated in animals. The aim of the present study is to evaluate the efficacy of bacteriophages in infecting Pseudomonas aeruginosa (PA) strains present in sputum samples. A cocktail of 10 bacteriophages will be applied on 60 sputum samples obtained from cystic fibrosis (CF) patients during 6 hours.We will determine the bacteria and bacteriophages strains in sputum samples collected. Then the sensitivity of individual colony will be tested.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Affiliated or benefit from a disease insurance regimen
* Men and women
* Aged from at least 6 years old
* Confirmed Diagnosis of cystic fibrosis based on presence of 2 mutations of CFTR gene and/or 2 positive tests of sweat chloride and/or 2 measures of pathologic difference of nasal potential associated to cystic fibrosis clinical signs.
* Patients able to produce sputum
* Pseudomonas aeruginosa Chronic infected patients

Exclusion Criteria:

* Simultaneous participation to another project on anti-infection, anti-inflammatory or modificating agents
* Subjet in exclusion period
* Law protected patient
* Realisation of sputum production is contra-indicated
Preoxygenation Method With a Calibrated Leak

During preoxygenation, imperfect seal between the face mask and patient's face can induce an inward air leak decreasing its effectiveness. We assume that noninvasive ventilation could cancel the effect of the leak.

This is a prospective study. Healthy volunteers are randomised in cross-over between spontaneous breathing or noninvasive ventilation pressure support preoxygenation in the presence or absence of a calibrated leak on the inspiratory circuit.

During preoxygenation, imperfect seal between the face mask and patient's face can induce an inward air leak decreasing its effectiveness. We assume that noninvasive ventilation could cancel the effect of the leak.

We planned an experimental study with healthy volunteers (residents in anesthesiology).

Healthy volunteers are randomised in cross-over between preoxygenation through spontaeous breathing or noninvasive ventilation pressure support preoxygenation in the presence or absence of a calibrated leak on the inspiratory circuit. The inspiratory fraction of oxygen is 100%. The exhaled gas (oxygen and carbon dioxide) are monitored.The subjects breathed through a mouthpiece (with a nose clip) connected to an anesthetic ventilator.

The primary endpoint is the time to achieve end expiratory fraction of oxygene of 90% or more.

The secondary endpoint is the proportion of subject with end expiratory fraction of oxygen of 90% or more after a 3 min period (recommended in clinical guidelines).

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* any pathological condition
* active tobaco
The Effect of Immersive Virtual Reality Treatment With Cognitive Behaviour Therapy for Obsessive-Compulsive Disorder

This study will evaluate the clinical effectiveness ofthe Immersive Virtual Reality alongside exprosure and response Prevention (ERP) Treatment in cognitive-Behavioral Therapy for Obsessive-compulsive Disorder, and the underlying neural mechanism by electroencephalography (EEG) and eye-tracking methodology .

The current study aims to the clinical effectiveness of the Immersive Virtual Reality alongside exprosure and response Prevention (ERP) Treatment in cognitive-Behavioral Therapy for Obsessive-compulsive Disorder. 30 OCD patients whose symptom were mainly associated with "contamination/clean" , "Symmetry/precision", "Examination" and "Sex" will be randomized into two groups (i.e. VR ERP or ERP). The treatment will be performed twice a week for the first two weeks. And for the next 4 week, the treatment for OCD patients will be undertook once a week. There will be 8 times in total. The investigators will assess thhe OCD patients'symptom severity in the baseline, 2 weeks, 4weeks and after 8 weeks of the whole combined treatment. Through the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, the Obsessive Compulsive Inventory-Revised (OCI-R), the Beck Depression Inventory (BDI), the Beck Anxiety Inventory (BAI), Perceived Stress Scale (PSS), Pittsburgh sleep quality index (PSQI) and side-effect questionnaire will be obtained by a trained investigator. The patients will also get individual's data of EEG and eye-movement.

Eligibility Criteria:
Inclusion Criteria:

* age: 18-50 years old;
* Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for OCD;
* Y-BOCS total score \> or = 16, discontinued medication for at least 8 weeks before
* the enrollment or the paitients' clinical medication is stable for at least a month (the dose and the types of drugs) .\>or＝9 years education

Exclusion Criteria:

* Any axis I psychiatric disorder comorbidity
* Participants who have received any forms of psychological therapy in the past.
* Patients cannot tolerate or adapt to the somatic discomfort caused by VR .
* Prior history of neurological disease (e.g., epilepsy) or brain surgery for traumatic brain injury
* Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.
* Any current significant medical condition.
* serious suicide risk