cyrilzakka/clinical-trials huggingface dataset:
Personalized Treatment Planning in Intracranial Aneurysm Surgeries.

Patients who will undergo a intracranial aneurysm (IA) surgery are educated concerning their disease and the surgical procedure.The objective of this study is to explore the advantages of conventional, virtual reality and 3D stereolithographic models for patient and resident education in the treatment of lAs.

Patient understanding of their medical condition and treatment satisfaction has gained increasing attention in medicine. As for neurosurgical conditions however, the treatment plan is often difficult for patients to comprehend, with many of them having an inaccurate understanding of the involved anatomy.

Novel technologies therefore may play a role in facilitating patient education. In particular, conventional 2D images makes it sometimes difficult for surgeons to inform their patients about the planned intervention and potential complications. This is why new modalities have been developed for patient information and may have further an impact on resident education to better estimate the treatment plan and potential complication. For the latter, given that intracranial aneurysms (lAs) are increasingly treated via endovascular methods, training opportunities are reduced and understanding of the vascular anatomy can become difficult.

The objective of this study is to explore the advantages of conventional, virtual reality and 3D stereolithographic models for patient and resident education in the treatment of lAs.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing elective surgery for non-ruptured IA during the study period will be considered for inclusion. Patients are included if they are at least 18 years old and are able to give informed consent and signed the informed consent form.

Exclusion Criteria:

* Patients with ruptured or mycotic IA are not considered. Furthermore, patients elected for IA surgery that are younger than 18 years old, as well as patients who are unable to give informed consent (e.g. neurological impairments) will not be included.
Comtess® Versus Cabaseril® as Add-on to Levodopa in the Treatment of Parkinsonian Patients Suffering From Wearing- Off.

Multi-centre, randomised, parallel-group study, rater-blinded. Total duration of the study per subject is 12 weeks plus a one- to two-week screening period. There are 6 pre-planned visits per subject: screening visit followed by 5 visits. Approximately 300 patients altogether in up to 25 active German study centres and up to 3 active Lithuanian study centres will be randomised.


Eligibility Criteria:
Inclusion Criteria:

* patients suffering from idiopathic Parkinson's Disease (PD) with wearing-off phenomenon
* OFF-time per day \>= 60 min after the first ON-period in the morning
* 3-5 daily dosages of standard levodopa/DDC inhibitor
* stable antiparkinsonian treatment 3 weeks prior to the randomisation

Exclusion Criteria:

* symptomatic parkinsonism
* concomitant treatment with non-selective MAO inhibitors or a selective MAO-A inhibitor while treated with a MAO-B inhibitor already
* concomitant treatment with one of the following catechol-structured drugs: rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine or apomorphine
* concomitant treatment with alpha-methyldopa, reserpine, typical or atypical neuroleptics, neuroleptic antiemetics (such as metoclopramide) or other drugs with antidopaminergic action
* treatment with COMT-inhibitors 4 weeks prior to the randomisation
* treatment with dopamine agonists 4 weeks prior to the randomisation
* known hypersensitivity to ergot derivatives and entacapone
* dementia (MMSE \<= 24)
* depression (Beck Scale \>= 17)
Community Based Strategies to Reduce Maternal Mortality in Northern Nigeria

The objective of this cluster randomized controlled trial is to assess the impact of several community-based interventions that address the key factors underlying the high maternal mortality, as well as neonatal mortality and morbidity in northern Nigeria. The interventions, include:

1. a Voluntary Health Worker Program (VHW)
2. the VHW program with provision of a safe birth kit
3. the VHW program with community folk media activities.


Eligibility Criteria:
Inclusion Criteria:

* Women of reproductive age who live in the study clusters who provide consent.

Exclusion Criteria:

* Eligible women who do not consent.
Evaluation of Biological Biomarkers Diagnostic of Toxoplasmosis Uveitis

Toxoplasmosis affects one to two newborn each 10000 births. Among them, 1 to 2 % develop learning disabilities or die, and 4 to 27 % develop a chorioretinitis sometimes leading to an amblyopia responsible for visual impairment. Toxoplasmosis uveitis affects too adults immunocompetent and immunodepressed who have had an acquired toxoplasmosis. Clinical diagnosis of ocular toxoplasmosis is more complicated in presence of posterior neuro-retinitis, inflammation of the papilla, uveitis without chorioretinitis, fuchs heterochromic iridocyclitis, scleritis, diffuse necrotizing or multifocal retinitis. In this situation biological markers diagnostic and prognostic of toxoplasmosis uveitis are useful.

Highly kept molecules (during evolution) like stress proteins (Hsp) are are found in the host and the pathogen and there can trigger a crossed immune response. Stress proteins haven't been explored yet, in the context of toxoplasmosis uveitis on humans.

The hypothesis is that Hsp70 and antibodies anti-Hsp70 are diagnostic and prognostic markers of ocular toxoplasmosis.

The goal is to evaluate diagnosis value of biological markers (Hsp70 and antibodies IgG anti-Hsp70) in toxoplasmosis uveitis.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Subjects clinically suspected at least of one active source of toxoplasmosis chorioretinitis infection
* Persons affiliated to national social security

Exclusion Criteria:

* Pregnant, parturient or breastfeeding women
* Persons deprived of liberty by judicial or administrative decision, person under legal protection
* Refusal by a patient to do the PCA (anterior chamber puncture)
* Patients whose following will be difficult or nonexistent
Efficacy and Safety of So-Cheong-Ryong-Tang on Perennial Allergic Rhinitis

The aim of this study is to investigate the short and long term efficacy and the safety of SCRT treatment for PAR


Eligibility Criteria:
Inclusion Criteria:

1. age 18-60 years
2. presence of two or more nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) with severity score ≥ 2 (0 = no symptom, 1 = mild symptom, 2 = moderate symptom, and 3=severe symptom)
3. presence of nasal symptoms more than 2 consecutive years; and
4. positive reaction to the one or more perennial allergen in skin prick test.

Exclusion Criteria:

1. treatment with nasal/oral corticosteroids within the past month; nasal cromolyn or tricyclic antidepressants within the past two weeks; or nasal/oral decongestants, nasal/oral antihistamines, or antileukotrienes within the past week
2. presence of rhinosinusitis (paranasal sinus X-ray demonstrating mucosal thickening, or partial or complete opacification of the paranasal sinuses)
3. presence of hypertension (systolic ≥ 180 mmHg or diastolic ≥ 100 mmHg)
4. presence of abnormal liver function (aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 100 IU/L) or abnormal renal function (blood urea nitrogen (BUN) ≥ 30 mg/dL or creatinine ≥ 1.8 mg/dL (male), 1.5 mg/dL (female))
5. presence of neoplasm, severe systemic inflammation, other systemic disease that affects rhinitis
6. history of drug allergy
7. history of anaphylaxis for allergic tests
8. pregnancy or lactation
9. participation of other clinical study within the past 3 months.
Clinical Comparison of LED- and Diode Laser-activated Bleaching

To clinically compare the effects of LED- or Diode laser-activated bleaching on colour change, tooth-sensitivity, gingival-irritation and temperature variation over 9-months.

Thirty-five patients with tooth colour A2 or higher will be included in the study. In a split-mouth design, using a 35% HP bleaching agent (Whiteness HP); one side of each mouth will be randomly activated by a diode laser (Epic X) and the other side by an LED (Radii Plus) light-source. During bleaching, the temperature variations will be recorded using a thermocouple from the buccal surface of canine teeth. Colour change (ΔSGU, ΔE) will be evaluated by subjective (Vita classic/bleached guide) and objective methods (spectrophotometry) before treatment and immediately, 48h, 1 week, 1, 6, 9 months after. Tooth-sensitivity and gingival- irritation will be assessed by visual analogue scale (VAS) and Gingival Index.

Objective: The aim of this split-mouth, randomized clinical study is to evaluate the effect of LED or Diode laser-activated bleaching applications on colour change, tooth sensitivity, gingival irritation and temperature variation with 35% hydrogen peroxide bleaching gel after 9 months. Material and Methods: Thirty-five patients with anterior teeth without caries and no restoration will be included in this study. In a split-mouth design, a bleaching agent containing 35% HP (Whiteness HP, FGM) will be used, one side of each jaw will be activated by a diode laser (Epic X, Biolase) and the other side will be activated by an LED (Radii Plus, SDI) light source. During the bleaching treatments, the temperature variations will be recorded using a thermocouple (DT-3891G K type Thermometer datalogger, CEM Instruments) from the buccal surface of canine teeth. Tooth sensitivity will be assessed by Visual Analogue Scale (VAS) before the treatment and during, immediately, 48 hours, 1 week, 1, 6 and 9 months after. Color change will be evaluated by subjective (Vita Classic and Vita 3D Master Bleachguide) and objective methods (Vita Easy Shade, spectrophotometer) before the treatment and immediately, 48 hours, 1 week, 1, 6 and 9 months after. Color change (ΔE and ΔSGU) will be performed by analysis of variance in repeated measurements. Multiple comparisons will be evaluated by Bonferroni test. Temperature variation will be evaluated by t-test in dependent groups. Tooth sensitivity will be analyzed using Friedman test. Wilcoxon test will be used to compare two light sources (Diode Laser/ LED) in each time period (p\< 0.05).

Eligibility Criteria:
Inclusion Criteria:

* healthy vital anterior teeth without restorations which have A2 or darker tooth shade on Vita Classical Scale (Vita Classical Scale, VITA Zahnfabrik, Bad Säckingen, Germany).

Exclusion Criteria:

* Pregnant or lactating woman smokers Participants with periodontal diseases, tooth sensitivity internal tooth discoloration (tetracycline/ fluorosis stains), exposed engine, peroxides allergy malpositioned teeth
Axis Length and Its Relationship With Refractive Error in Chinese University Students

To investigate the relationship between axis length (AL) and refractive error. eyes of low hyperopia to emmetropia subjects, comprising eyes with moderate to high myopia (-11.00D ≤ SE ≤ -4.00D) were analyzed in this cross-sectional study. Cycloplegic refractive error was measured with the autorefractor, AL was measured with the IOL master. Association between AL and refractive error were evaluated by linear regression analysis. The mean of AL and its correlation with SE, sex, and age were evaluated.

To investigate the relationship between axis length (AL) and refractive error (RE). 894 eyes with low hyperopia to emmetropia (-0.50D ≤ spherical equivalent (SE) ≤ +2.00D), comprising 1007 eyes with moderate to high myopia (-11.00D ≤ SE ≤ -4.00D) were analyzed in this study. Cycloplegic RE was measured with the autorefractor, AL was measured with the IOL master. Association between AL and refractive error were evaluated by linear regression analysis. The mean of AL and its correlation with SE, sex, and age were evaluated.

Eligibility Criteria:
Inclusion Criteria:

with moderate to high myopia (SE ≤ -4.00D) without myopia (-0.50D ≤ spherical power ≤ +2.00D) no concurrent eye disease best corrected visual acuity is 1.0

Exclusion Criteria:

significant systemic illnesses congenital myopia, media opacity uveitis glaucoma intraocular surgery refractive surgery neurologic diseases retinal disease
Diagnosis of Gastric Precancerous Lesions by a Blood Test GastroPanel in Patients With Increased Gastric Cancer Risk

Despite the declining incidence, gastric cancer (GC) remains the second leading cause of cancer death worldwide. In France, it is the second digestive cancer with 7,000 new cases per year. It is now well demonstrated that patients with H. pylori infection, atrophic gastritis and intestinal metaplasia, have a high risk of developing GC. It is therefore important to detect these pre-neoplastic lesions at an early stage to improve patients prognosis.

Thus, the aim of this project is to investigate the possible screening of gastric precancerous lesions by a blood test (GastroPanel®) in France, in patients with oesophagogastroduodenoscopy (EGD) prescription.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing oesophagogastroduodenoscopy (EGD) according to usual care
* Patients with increased risk of gastric cancer (at least one of the following criteria):

  * age \> 50 years,
  * family cases of gastric cancer,
  * known precancerous lesions,
  * Biermer disease,
  * H. Pylori infection,
  * genetic predisposition (ex: Lynch syndrome),
  * MALT lymphoma,
  * dyspepsia.
* Subjects affiliated with an appropriate social security system

Exclusion Criteria:

* Subjects with known active cancer
* Pregnancy
* Patients receiving proton-pump inhibitors
* Conditions that may interfere with the study objectives according to the investigator
Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes

The purpose of this study is to evaluate postmastectomy radiotherapy in breast cancer patients with one to three positive nodes.

Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region,and no radiotherapy.

During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Ipsilateral histologically confirmed invasive breast cancer
* Undergone total mastectomy and axillary dissection
* T1-2 and one to three axillary lymph nodes positive
* A minimum of 10 axillary nodes dissected
* Fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation
* Written,informed consent

Exclusion Criteria:

* Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region
* Previous or concurrent malignant other than non-melanomatous skin cancer
* Unable or unwilling to give informed consent
Study of CM313(SC) Injection in Subjects With Relapsed/Refractory Aplastic Anemia

This is a randomized, open-label, phase IB/II clinical study to evaluate the safety, tolerability and preliminary efficacy of CM313(SC) injection in patients with relapsed/refractory aplastic anemia


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of idiopathic aplastic anemia.
2. Patients must meet the requirements of relapsed/refractory aplastic anemia defined in the protocol.
3. Male or female, age≥18 years.
4. The Eastern Cooperative Oncology Group (ECOG) physical status score ≤2.
5. Willing and able to comply with the requirements for this study and written informed consent.

Exclusion Criteria:

1. The inherited bone marrow failure syndromes.
2. Previously treated with the anti-CD38 monoclonal antibody.
3. Have an allergy to humanized monoclonal antibody or any part of CM313.
4. Pregnant or breastfeeding females, or females planning to become pregnant during the study.
5. Any condition considered to be ineligible for the study by the investigator.
Novel Evaluation of Aspirated Follicular Fluid

A molecular study of follicular fluid aspirated from ovarian follicles during routine in vitro fertilization treatment, after the eggs were identified and separated.

Ovarian stimulation is a routine part of in vitro fertilization treatment: this process involves an inflammatory response in the developing follicles. We still do not completely understand the complex interactions leading to the maturation of the egg and the multiple interactions of the egg with its supporting cells. In this study we will assess follicular fluid, letf over after the eggs were identified and separated, for the presence of inflammatory mediators, dendritic cells , vasorin and soluble Flt1. The presence and quantification of these factors, as well as their correlation with the size of the aspirated follicle is the focus of this study.

Eligibility Criteria:
Inclusion Criteria:

* All women going through a fertility/ fertility preservation indicated egg retrieval in the in vitro fertilization (IVF) unit in 'Meir medical center',
* Patients' informed consent

Exclusion Criteria:

* Patients refusing to take part in the study
Recombinant Human Granulocyte Macrophage Colony Stimulating Factor(rhGM-CSF) Treating Oral Mucositis

This is a open,randomized phase II trial comparing effectiveness and safety of local use of rhGM-CSF and Compound Vitamin B12 to Compound Vitamin B12 solution alone treating oral mucositis in primary nasopharyngeal cancer. The main end point is the incidence of grade II and less oral mucositis at the end of treatment.The hypothesis of the study is that the local use of rhGM-CSF and Compound Vitamin B12 can decrease the incidence of grade III and more oral mucositis at the end of treatment compared to local use of Compound Vitamin B12 alone.

Inclusion Criteria:

1. Grade II oral mucositis induced by chemoradiotherapy in patient with primary nasopharyngeal carcinoma.
2. Receiving 68-72 Gray of radiation dose.
3. Age between 18 and 65 years.
4. KPS≥70.
5. Patient who has given his/her written consent before any specific procedure of the protocol.

Exclusion Criteria:

1. Severe uncontrolled infection.
2. Pregnant or breast-feeding females.
3. Allergy to this medicine.
4. Diarrhea.

Outcome measures:

1. Grade of oral mucositis:NCI Common Terminology Criteria for Adverse Events v3.0, NCI CTCAE v3.0
2. Pain: WHO,Numerical Rating Scale(NRS)
3. Tumor response to chemoradiotherapy:Response Evaluation Criteria in Solid Tumors,RECIST1.1

Eligibility Criteria:
Inclusion Criteria:

1. Grade II oral mucositis induced by chemoradiotherapy in patient with primary nasopharyngeal carcinoma.
2. Receiving 68-72 Gray of radiation dose.
3. Age between 18 and 65 years.
4. KPS≥70.
5. Patient who has given his/her written consent before any specific procedure of the protocol.

Exclusion Criteria:

1. Severe uncontrolled infection.
2. Pregnant or breast-feeding females.
3. Allergy to this medicine.
4. Diarrhea.
Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury

Intracranial pressure (ICP) in patients with traumatic brain injury (TBI) is influenced by several factors of which one is arterial CO2 tension. Patient with TBI are often sedated and mechanically ventilated in order to secure a stable PaCO2. This study compares two ventilation modus; Pressure Controlled Ventilation (PC) and Pressure Regulated Volume Controlled ventilation (PRVC) in order to observe which of the two ventilation strategies results in a more stable ICP and arterial CO2 pressure (PaCO2).


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained from the patients next-of-kin.
* moderate or severe TBI according to Head Injury Severity Scale (Glasgow Coma Scale (GCS) score 3-13).
* treated at the neurosurgical ICU or the main ICU at St Olav University Hospital.
* intubated and receiving controlled mechanical ventilation.
* continuous measurement of ICP with either an intraventricular or an intraparenchymal pressure monitor device.
* sedation to a level of sedation corresponding to MAAS (Motor Activity Assessment Score) 0 or 1 with continuous intravenous infusions of midazolam/propofol and morphine/fentanyl/remifentanil14.

Exclusion Criteria:

* Pregnancy
* ICP above 25 mmHg
* ongoing cerebral anti edema therapy corresponding to Step III at St Olav University Hospital therapy guideline
* continuous external drainage of cerebrospinal fluid (CSF)
* Clinical pulmonary condition prohibiting changes in respiratory therapy
Safety Study of Three Formulations of the Dermal Implant ELAPR

This is a Phase I study to assess the safety of three formulations of the dermal implant ELAPR.

A Phase I study to assess the safety of three formulations of the dermal implant ELAPR in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Good general health status

Exclusion Criteria:

* Clinically significant abnormalities of haematology or biochemistry testing
* Bleeding diathesis, anticoagulant drugs,thrombocytopenia or clinically significant prolonged APTT or PT
* Chronic use of aspirin, other non-steroidal antiinflammatory drugs or other anti-platelet agents
* History of keloid formation
* Systemic corticosteroids within last 12 weeks
* Diabetes or metabolic disorders
* Any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication
* Pregnancy/lactation
* A history of anaphylaxis or allergic reactions including any known hypersensitivity to Hyaluronic acid or lidocaine
Sour Taste and Cold Temperature in Dysphagia

The objective is to establish the effect of sour taste and cold temperature on the pharyngeal swallowing transit time after ischemic hemisphere stroke.

Over the past decade there were many studies over normal and pathological swallowing that discuss the influence of taste and temperature. Nevertheless there were many questions on the issue that remains to be solved, including the hemispheric lateralization of lesions dysphagic patients remains also to be fully understood.Swallowing disorder is defined as oropharyngeal dysphagia in presence of alterations in any phase of the complex swallowing dynamics. It could be congenital or acquired, affecting nutritional aspects, hydration, lung function and the individual's social integration \[1\]. Stroke, has a high incidence among neurological diseases, and cause disturbs on swallowing dynamics presenting signs of dysphagia in at least 50% of cases.A study that analyzed swallowing dynamics by videofluoroscopy in individuals with history of one or more stroke episodes with oropharyngeal dysphagia shows shorter pharyngeal and oropharyngeal transit times with cold stimulus than without them. Other study of heterogeneous neurological diseases such as cerebral palsy, brain trauma, stroke, and Alzheimer's disease, concluded that sour taste improved swallowing, minimizing laryngotracheal penetration and aspiration in individuals with neurological damaged. Chen et al. in an analysis of 42 healthy individuals with several taste bolus found that awareness and arousal could also influence the swallowing function.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stroke

Exclusion Criteria:

* instability clinic