cyrilzakka/clinical-trials huggingface dataset:
Collection of Efficacy and Safety Data of Chinese Patients Who Have Received Faslodex 250mg Treatment

This study is a post-authorisation study, committed to Center for Drug Evaluation (CDE) and China Food and Drug Administration (CFDA), in order to provide more effectiveness and safety data about Faslodex in real world clinical practice in China. The primary objective of this study was to evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with oestrogen receptor-positive locally advanced or metastatic breast cancer, for disease relapse on or after adjuvant anti-oestrogen therapy or disease progression on therapy with an anti-oestrogen, in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice.

A Multicenter, non-interventional, prospective study to collect effectiveness and safety data in Chinese patients who have received Faslodex treatment under the condition of actual usage in clinical practice

Eligibility Criteria:
Inclusion Criteria:

* Chinese postmenopausal women with estrogen receptor positive, locally advanced or metastatic breast cancer Failure to previous anti-estrogen therapy, already received Faslodex 250mg treatment as determined by treating physician.
* The prescription of the Faslodex is clearly separated from the decision to include the subject in the NIS, and is part of normal medical practice. The recruitment of the patient to the study should be within 1 month of the first Faslodex injection.
* Provision of subject informed consent.

Exclusion Criteria:

* If participating in any controlled clinical trial, the subject cannot take part in this study.
* Hypersensitivity to the active substance, or to any of the other excipients.
* Pregnancy and lactation, or severe hepatic impairment.
Auriculotherapy in the Cares to the Premenstrual Syndrome

Premenstrual syndrome (PMS) is a collection of physical and emotional symptoms related to a woman's menstrual cycle. These symptoms occurring only during the luteal phase of the menstrual cycle that are of sufficient severity to interfere with some aspects of life of these women, reflecting also in interpersonal relationships, workplace and in their productivity. For these reasons, this research was conducted with the nursing staff of the Samaritan Hospital in order to verify the effectiveness of auricular acupuncture to alleviate some of the symptoms of PMS.

The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semipermanent needles in specific points of the auricular pavilion.

Eligibility Criteria:
Inclusion Criteria:

1. Belong to the nursing staff
2. Present at least one behavioral or physical symptom that is self-perceived as related to the symptoms that precede menstruation (irritability, depression, fatigue, headache, breast tenderness, swelling, anxiety, insomnia, crying spells, changes in appetite)
3. Voluntary participation in the study
4. Availability of time for submission to the sessions

Exclusion Criteria:

1. Medical license or vacation during the period of the research.
2. Pregnancy
Tailoring an Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic Diseases

Cognitive behavioral therapy for insomnia (CBTi) is considered a first-line treatment for insomnia. Access to this treatment option is limited therefore the investigators have been developing an internet delivered cognitive behavioral therapy for insomnia (I-CBTi) to help overcome accessibility barriers.

The purpose of this study is to pilot test a tailored internet-delivered cognitive behavioral therapy for insomnia (I-CBTi) intervention for persons with Inflammatory Rheumatic Diseases showing symptoms of insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported physician diagnosis of one or more of the following Inflammatory Rheumatic Diseases: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or other spondyloarthropathies, systemic lupus erythematosus
* Have an e-mail address and internet access
* Speak and read English or French
* Resident of Canada and living in Canada for the duration of the trial
* Have insomnia symptoms ( score ≥8 on the Insomnia Severity Index (ISI) )

Exclusion Criteria:

* Self-reported sleep disorder diagnosed by a physician other than insomnia (e.g. obstructive sleep apnea)
* Severe psychiatric disorder (e.g. schizophrenia, bipolar disorder) or neurological disorders (e.g diagnosis of dementia, Parkinson disease, epilepsy)
* Already involved in psychotherapy addressing sleep difficulties
* Shift work in the past 3 months or next 6 months
Mobility and Attention Capacity in Former Premature Children

Attention functions have a major impact on children's social and school behavior. They are an important issue for prematurely born children often seen as having learning difficulties and being restless, when it could be an adaptative answer to attention disorders. The aim of this study is to evaluate attention capacity in former premature children aged 6-7 years old with regards to different postures or mobility, for the attention functions of orienting, alerting and executive control. The Attention Network Test using reaction time and accuracy to visual stimuli will be used to evaluate attention functions in each posture and mobility.

Attention functions have a major impact on children's social, school and emotional adjustment. They are one of the most common issues for prematurely born children with implications in academic and social-behavioral functioning. Prematurely born infants are often seen as having excessive mobility or being restless when it could be an adaptative answer to attention disorders leading to learning difficulties. Respecting spontaneous mobility could improve attention performance in vulnerable children. The aim of the study is to evaluate global attention performance of former premature children at the preschool age of 6 to 7 years. This evaluation will be done in three usual postures or mobility, and for the 3 attentional functions of orienting, alerting or executive control. They will be compared within the prematurely born children group and to term born controls of the same age. The Attention Network Test adapted to children by Rueda et al (Neuropsychologia 2004) using reaction time and accuracy to visual stimuli will be used to evaluate attention functions. Presentation of stimuli through virtual video glasses and collection of answers will be done thanks to a specific software.

Eligibility Criteria:
Main Inclusion Criteria:

* Children born before 35 weeks gestation and routinely followed for their prematurity in the follow-up clinic of the Maternite Regionale Universitaire

Healthy term born children recruited after information leaflet displayed in the University but not the Hospital

Main Exclusion Criteria:

* Children with a visual or motor disability preventing the realization of the test
Observational Trial on the Impact of Hypnose Used as a Sedation in Oncology Surgery in Breast Cancer

The investigators will compare the operated patients for a beginning breast cancer in the Hypnose arm and the patient in the classical general anesthesia arm. It is a Observational study as we cannot randomized patient, (they need to be compliant with Hypnose).

Patient will be informed that some parameters, about his recovery, will be collected from their medical file. They will not have another particular treatment because they are in the study. It is just a prospective data collection.

The patient will be compared on several items after the surgery ( as pain and pain killer intake, the heal process of the scar, etc...) Also the investigators will compare the impact of hypnose on the other treatments the patient received.

The investigators need approximately 150 patients (Half in each arm).


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent Form
* In situ breast cancer (early stage)
* Infiltrated Breast cancer (early stage)

Exclusion Criteria:

* No hypnoses is possible for this patient surgery
Validation of Low Anterior Resection Syndrome Score in Korean Version

In contemporary era of rectal cancer treatment, development of surgical technique and tool, adaptation of chemoradiation therapy, as well as multidisciplinary approach have led increased survival as well as rate of sphincter preservation. However, poor anorectal function, such as fecal incontinence and/or urgency, has also been increased. Such anorectal dysfunction is named as low anterior resection syndrome, and its rate has been reported in 40 to 90% in rectal cancer patients who received sphincter preserving surgery. Low anterior resection syndrome is known to debilitate quality of life in survivors of rectal cancer. Previously, several studies attempted to evaluate the low anterior resection syndrome via questionnaires and scoring system. Adapting the low anterior resection syndrome score system created in Denmark, this study investigates the validity of the scoring system in Korean language.

In this study, the low anterior resection syndrome score questionnaire proposed by Therese Juul is translated to Korean language by 3 different professional translators. Patients who received sphincter saving surgery to treat rectal cancer will be asked to fill up the questionnaire. Compiling the results, the quality of life after sphincter preserving surgery will be investigated in the association with the low anterior resection syndrome.

Eligibility Criteria:
Inclusion Criteria:

* age 20-80
* surgery undertook from Jan. 2009 to Dec. 2016
* diagnosed with adenocarcinoma
* curative intent of surgery
* planned surgery
* sphincter saving surgery

Exclusion Criteria:

* patients with stage IV
* emergency surgery
* patients with recurrent disease
Effect of Anti CD20 in Pemphigus Desease

to treat in an open non comparative clinical study patients presenting pemphigus with corticodependance, corticoresistance and contre-indication to systemic steroids.


Eligibility Criteria:
Inclusion Criteria:

* age\>18
* pemphigus corticoresistant
* pemphigus cortico dependant
* contre-indications : systémic steroids

Exclusion Criteria:

* age \< 18
* cardiopathie
* pregnant woman
* absence contraception
* no consentment
Maternal Body Composition Regulates Placental Function

This study examined the relationships between maternal body composition, placental function, and fetal nutrition and body composition, and sought to determine the most accurate method of maternal body composition analysis in late pregnancy.

This study examined the relationships between maternal body composition, placental function, and fetal nutrition and body composition, and sought to determine the most accurate method of maternal body composition analysis in late pregnancy. This project integrates body composition analysis, nutrition, and metabolic factors to study the impact of maternal body composition and diet on placental function and fetal growth.

Research Project: The proposed enrollment of 41 pregnant women at term (\>37 weeks gestation) was completed in September 2013. The subjects underwent four body composition measurements (bioelectrical impedance, skin-fold thickness, BodPod, and deuterium dilution) and dietary surveys along with a fasting blood draw. The subjects returned 2 weeks postpartum for repeat measurements along with a DEXA scan.

Eligibility Criteria:
Inclusion Criteria:

Healthy pregnant women at term with singleton gestation

Exclusion Criteria:

Medical condition requiring daily medication Fetal congenital anomalies Diabetes
Evaluation of Root Migration Distance After Coronectomy of Impacted Third Molars

The aims of this study were to investigate postoperative pain, edema, and trismus after coronectomy procedure, to assess the risk of endodontic lesion formation at sixth month, and to determine relationship of the root migration distance with age.

The roots of impacted lower third molars may be associated with the inferior alveolar nerve (IAN). To mitigate this risk and reduce trauma to the patient, a conservative approach involving the removal of the problematic crown portion and leaving the root may be adopted.

This clinical study was conducted between 2021-2022 years and was accordance with the Helsinki Declaration of 1975, as revised 2013. All subjects were informed about the study and clinical procedures and provided written consent The study included 73 patients aged between 18-55 years. These patients were divided into two age groups: The first group, consisting of patients aged 18-30. The second group, consisting of patients aged 31-55.

The coronectomy was surgically performed. Postoperative pain, swelling, and interincisal distance were evaluated based on age. Pain was assessed using a 10 cm Visual Analog Scale (VAS) with patients providing ratings before the operation and on the 3rd and 7th postoperative days. The progresion of endodontic lesion was evaluated in 6 months after coronectomy.

The distance of root migration achieved at 6 months after coronectomy was measured by independent examiner. Calibrated panoramic radiographs were used to determine the level of migration.

The statistical analysis of the data obtained in our study was performed using SPSS software The needed statistical analyses were used for comparison of the data. The Levene test was used for comparison of the root migration distances in the age groups. The significance level was set at 0.05.

Eligibility Criteria:
Inclusion Criteria:

* The study focused on applying coronectomy, a more conservative approach, instead of extraction for mandibular third molars associated with the inferior alveolar nerve that were indicated for prosthetic, orthodontic, prophylactic purposes, or those causing pericoronitis

  * Systemically health,
  * To maintain ideal oral hygiene,
  * Absence of caries, pulpal and endodontic lesions in the impacted third molar indicated for extraction
  * No known allergies to any antibiotics, or no use or history of bisphosphonate medication
  * No use of tobacco or any illicit drugs by the patient.
  * Not being pregnant

Exclusion Criteria:

* Other conditions unlike abovementioned items.
Evaluation of Anterior Quadratus Lumborum Block for Postoperative Analgesia in Hip Arthroscopy

Hip arthroscopy is performed frequently and the postoperative course often involves moderate to severe pain. There remains no definitive perioperative pain regimen that has been proven to be effective and safe for this ambulatory procedure. Some institutions perform peripheral nerve blocks either preoperatively or postoperatively as a rescue block. All of these PNBs lead to quadriceps weakness which may impede earlier mobilization and physical therapy. While some case reports exist, there have not been any studies evaluating the QLB for hip arthroscopy patients. As previously mentioned, the technique is easy to perform, well-tolerated by patients, and avoids side effects such as hypotension, urinary retention, or the quadriceps weakness associated with lumbar plexus blockade.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for hip arthroscopy
* Ability to follow study protocol
* English Speaking

Exclusion Criteria:

* Hepatic or renal insufficiency
* Younger than 18 years old and older than 80
* Allergy or intolerance to one of the study medications
* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
* Chronic opioid use (daily opioids use for longer than 3 months)
* Patients contraindicated to undergo a spinal anesthetic
* Non English Speakers
Effects of Virtual Reality MRI Preparedness

Magnetic resonance imaging is an important and increasingly prevalent imaging modality used in healthcare. Children often find the procedure anxiety provoking causing difficulty in staying still and providing quality images. The use of preparation techniques including play therapy and role play utilizing such tools as a fiberglass mock MRI have shown to reduce anxiety and facilitate better image quality. Modalities of preparation including Virtual Reality (VR) pose as an alternative to habituate children for a MRI procedure.


Eligibility Criteria:
Inclusion Criteria:

* Child is between the ages of 8-9 years inclusive
* Child scheduled for a clinical MRI at CHLA.

Exclusion Criteria:

* Child is younger than 8 years or older than 9 years. These are the bottom end of age ranges that are frequently sedated.
* Children who have metal in their bodies that cannot participant in an MRI.
* Medical history that may affect brain development that may confound ability to complete an MRI without sedation.
* Children suffering from epilepsy or history of seizures who may react poorly to a virtual reality intervention.
* Child who has a history of MRI acquisition where habituation and preparedness may not be needed.
* Child with English as a second language due to restrictions of research team.
* Child with implantable medical devices or personal medical devices that may be affected by the study device's radio waves
Effect of Micro-osteoperforation on the Rate of Canine Retraction

The current study Is a split-mouth Randomized Controlled Trial that was performed to investigate three dimensionally, using digital models and Cone Beam Computed Tomography imaging, the effect of micro-osteoperforations (MOPs) on the rate of tooth movement in a canine retraction model.

Sample size calculation was carried out and resulted in enrolment of 18 female patients requiring bilateral upper first premolars extraction and canine retraction with maximum anchorage. The sample was recruited from the outpatient clinic of the Orthodontic Department, Faculty of Dentistry, Cairo University.

After placement of the fixed orthodontic appliance, leveling and alignment proceeded till 0.016" × 0.022" NiTi upper archwire. Indirect skeletal anchorage was then prepared using TADs inserted bilaterally between the upper 1st molar and 2nd premolar, and the patient was referred for upper 1st premolars extraction.

Three months after extraction, 0.017" × 0.025" stainless-steel upper archwire was inserted and three vertically aligned MOPs were randomly allocated and performed in one side using a single TAD, while the other side served as control. The three MOPs were performed distal to the canine, equidistant in the extraction space. Bilateral canine retraction was then commenced using NiTi closing coil springs delivering 150 gms of force. Before leaving the clinic, a pain questionnaire was given to each patient.

Data were collected from monthly upper impressions, which were poured into stone models and scanned to obtain sequential digital models (T0, T1, T2, T3 \& T4), in addition to pre- and post-retraction maxillary CBCT images.

The assessed outcomes were the rate of canine retraction per month, the total distance travelled by the upper canines, first molars anchorage loss, tipping, torque and rotation of upper canines and first molars, canine root resorption and finally the pain related to MOP procedure. Statistical analysis was performed on the gathered data and results were withdrawn.

Eligibility Criteria:
Inclusion Criteria:

* Malocclusion that requires bilateral extraction of the maxillary first premolars and canine retraction with maximum anchorage; Class II division 1 and bimaxillary dentoalveolar protrusion cases.
* Full permanent dentition with exception of the third molars.
* Good oral hygiene and periodontal condition.

Exclusion Criteria:

* Medically compromised patients.
* Patients suffering from any congenital, hereditary or systemic diseases.
* Chronic use of any medications affecting orthodontic tooth movement (e.g. corticosteroids, hormonal therapy, NSAIDs)
* Patients with dental anomalies (e.g. enamel hypoplasia, root dilacerations in maxillary canines).
* Patients with medical conditions that contraindicate surgeries (e.g. bleeding tendency and immunocompromised patients).
* Radiographic evidence of bone loss.
Novel Guidance Device for Image Fusion and Needle Guidance in Lung, Liver or Kidney Biopsy

This study investigates whether a new image fusion technology can reduce patient radiation dose from CTs and/or procedure time during biopsies of lung, liver or kidney.

This study proposes the use of a new fusion technology, Scenergy (Clear Guide Medical; FDA 510(k) K171677), which fuses CT images to real-time US images to minimize the drawbacks of each modality while enhancing their benefits. Such benefits include, the reduction of radiation dose to the patient with the fusion of initial CT imaging overlaying the live US images. The fused imaging software allows the operator to watch the needle tip advance towards the lesion on both live US and overlaid CT imaging. In such a setting, the operator would only need to perform an initial CT scan, advance the needle into position using fused US/CT images, and a final CT scan to ensure needle tip location. This eliminates interval CT scans that are usually required after each incremental needle position adjustment, and thus, reduces radiation dose to the patient and wasted procedural time during the incremental CT scans.

Eligibility Criteria:
Inclusion Criteria:

* all patients between the ages of 18 and 80 years old at time of procedure who are pre-scheduled for a lung, kidney, or liver biopsy.

Exclusion Criteria:

* any patient who was under the age of 18 or over the age of 80 at time of the procedure or who does not wish to volunteer for the study.
Pilot Study of the Immunogenicity, Reactogenicity and Tolerability of Two Schedules of a 4CmenB Vaccine in Adolescents and Young Adults

The overall aim of this study is to determine if an accelerated "Bexsero® (Multicomponent meningococcal B vaccine)" schedule compared to a standard schedule is immunogenic, safe, and tolerable, in order to increase capacity for rapid outbreak control. In this pilot study no formal hypothesis is tested.

A pilot study to evaluate the feasibility of a rapid clinical trial at the time of a meningococcal B outbreak, comparing an accelerated schedule of 4CMen B (0, 3 weeks) to the 0, 2 months schedule, to determine if the more compressed schedule is immunogenic, safe and tolerable. A shorter schedule offers the potential benefit of more rapid direct and indirect protection, and use of fewer public health resources for implementation.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the trial.
* Male or Female, aged 17 to 25 years.
* Current or intended student at an educational setting in the 2015-2016 year.
* Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.
* In the Investigator's opinion, is able and willing to comply with all trial requirements.

Exclusion Criteria:

* Significant renal or hepatic impairment.
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
* Participant in another research trial involving an investigational product or medical device in the prior 12 weeks.
* Previous bacteriologically confirmed N. meningitidis disease.
* Prior receipt of a meningococcal B vaccine
* Hypersensitivity to any vaccine component of products used in this study (see product monographs)
* Immunodeficiency or autoimmune disease
Percutaneous Electric Neurostimulation of Dermatome T7 Improves Glycemic Profile in Obese and Typo 2 Diabetic Patients

Percutaneous neurostimulation of dermatome T7 increases Insulin segregation by the apancreas and improves glycemic profile in diabetic patients


Eligibility Criteria:
Inclusion Criteria:

* BMI\>30 Kg/m2
* Type 2 diabetes mellitus
* Treatment with Metformin

Exclusion Criteria:

* Under insulin treatment
* Endocrinological disorders causing diabetes mellitus