cyrilzakka/clinical-trials huggingface dataset:
Danish Observational Study of Everolimus Plus Exemestane in Hormone Receptor (HR) Positive, Human Epidermal Growth Factor 2 (HER2) - Metastatic Breast Cancer

An observational study in patients with advanced ER+, HER2 negative breast cancer, who are treated with everolimus and exemestane in combination. The objective of the study is to assess the safety pattern of everolimus in a real world setting.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with HR-positive, HER2-negative advanced breast cancer who are treated with everolimus and exemestane according to the approved Summary of Product Characteristics (SmPC).
* Patients who started treatment after approval of this indication but before the initiation of this study can be retrospectively included, provided that they have systematically been assessed for adverse events.
* The decision to treat the patient with everolimus and exemestane must be independent of the patient's participation in the study.
* The patient must provide signed Informed Consent before any data can be captured.

Exclusion Criteria:

- No formal exclusion criteria
Influence of Smoking on Periodontal Healing One Year After Active Treatment

The aim of this study was to investigate whether cigarette smoking had any impact on the clinical outcomes 1 year after active periodontal treatment. Eligible for the study were 5680 individuals 20-85 years, referred to the specialised clinic for periodontal treatment at Gävle County Hospital between the years of 1980 and 2015. Before examination, all individuals filled in a questionnaire regarding their medical health, medication and smoking habits.

Excluded were edentulous individuals and where clinical data 1-year after active treatment, or smoking habits were missing (n=1453). Complete data for analyses was available for 4227 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Individuals referred to a specialist clinic for periodontal treatment

Exclusion Criteria:

* edentulous individuals
Evidence-Based Neurorehabilitation in Children With CP

This 3-year research project aims to investigate and compare the treatment effectiveness (in terms of motor and psychosocial outcomes) and potential predictors (in terms of demographical, biological and psychosocial domains) of the intensive and distributed Child- and Family-Friendly CIT protocols with an equivalent intervention period in children with CP by quasi randomized controlled study design. In addition, the selection and examination of outcome measures were based on the ICF-CY model to provide comprehensively documents.

Upper limb dysfunction is a common and disabling consequence of children with cerebral palsy (CP). As children with hemiplegia primarily have one better funcitoning side of their body and one more affected side, they often tend not to use the affected extremity resulting in the phenoema of developmental disregard. Recent evidence suggests that constraint-induced therapy (CIT) is the most effective technique to improve the use of the affected hand and reduce the developmental disregard in children with CP. However, despite the cumulative evidence supporting the effects of pediatric CIT, the concerns of feasibility and gaps of current knowledge prompt us to conduct this current proposal. The concerns of the feasibility include this approach is emotionally problematic at early stages and researchers suggested that the orginal CIT protocols may be too intrusive for children and their families. The gaps of current knowledge include: no study has directly investigated the effectiveness differences between various CIT models; no study examines, monitors and compares the psychosocial outcomes while receiving the CIT protocols for children and their parents systematically and comprehensively; and no study investigates the possible clinical characteristics of children that may influence the training effects of the various CIT models.

Investigators will recruit a total of 60 children with CP from the CP Association, medical centers, and special educational systems and participants will be assigned to the two intervention groups. The intensive CIT is delivered by the group-based design with 6 hours a day for 6 days (36 hours in total) and the distributed CIT will be delivered by individualized home-based intervention with 2.25 hours a day, two times a week, for 8 weeks (36 hours in total).

Eligibility Criteria:
The inclusion criteria of this study are:

1. aged between 5 and 13 years
2. diagnosed with congenital hemiplegic or children with CP with one more affected side
3. apparently disuse phenomenon of the more affected hand at spontaneous contexts

Participants will be exclude for:

1. excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment
2. severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation
3. injections of botulinum toxin type A or operations on the UE within 6 months
For Nasotracheal Intubation With Video Rigid Stylet, Which Nostril is Better?

To determine which nostril is more suitable for nasotracheal intubation with video rigid stylet.

Head and neck surgeries usually require nasal intubation, which allows leeway for operative maneuvering in the mouth, pharynx, larynx, and neck. Previous studies have found that the right nostril is more appropriate for nasal intubation using direct laryngoscope or videolaryngoscope. It has been shown that the optical rigid stylet was also an appropriate tool for nasal intubation. However, nasal intubation with rigid optical stylet is technically different from that with laryngoscope. It is unknown whether the choice of nostril could affect the intubation using rigid optical stylet. The main aim is to determine which nostril is more suitable for nasal intubation with video rigid stylet.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. American Society of Anesthesiologists physical status I\~II;
3. Scheduled to undergo elective oral and maxillofacial surgery requires nasal intubation;
4. The expected operation time \< 3 hours;
5. Extubation in operation room and do not scheduled to preventive tracheotomy;
6. Patients who were able to breathe clearly and equally through both nostrils.

Exclusion Criteria:

1. Patients had history of difficult intubation or presented with an anticipated difficult airway;
2. Patients requiring nasogastric tube insertion;
3. Presence of contraindications of nasal intubation;
4. Due to surgical requirement, intubation must be completed through one nostril;
5. Presence of severe nasal obstruction,deformities of the nasal cavity, or other serious nasal diseases;
6. History of severe epistaxis or epistaxis within a month;
7. Previous history of nasal and/or laryngeal surgery;
8. Previous experience with nasal intubation;
9. History of schizophrenia, Parkinson's disease or profound dementia, or language barrier;
10. Participate in other clinical studies;
11. Refusal to sign informed consent.
A Comparison of AIR OPTIX® COLORS Versus FRESHLOOK® COLORBLENDS

The purpose of this study was to evaluate the overall comfort of AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS in habitual wearers of the FRESHLOOK® COLORBLENDS .


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to sign the Informed Consent document. If under legal age of consent, legally authorized representative must sign also Informed Consent document.
* Able to achieve visual acuity of at least 20/30 (Snellen) in each eye at distance with contact lenses and best corrected visual acuity (BCVA) ≥ 20/25 in each eye.
* Manifest cylinder less than or equal to 0.75 diopters (within the previous year) in each eye.
* Successful wear of FRESHLOOK® COLORBLENDS spherical soft contact lenses in both eyes (in the protocol-specified colors) during the past three months for a minimum of 5 days per week and 8 hours per day.
* History of at least 5 days of successful use with both lenses (minimum of 8 hours/day) of one of the protocol-specified lens care solutions/multi-purpose solutions (MPS).
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of this study.
* Wears habitual lenses in an extended wear modality (sleeping in lenses overnight / not removing lenses on a daily basis).
* Monovision, monocular (only one eye with functional vision) or fit with only one lens.
* History of intolerance or hypersensitivity to any component of the test articles.
* Use of any over-the-counter or prescribed topical ocular medications within the previous 7 days (excluding rewetting drops).
* Moderate or severe corneal edema, corneal vascularization, corneal staining, injection, tarsal abnormalities, "other" complications; and any corneal infiltrates.
* Current or history of ocular infection, severe inflammation, or disease within previous 6 months.
* Any systemic disease (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions.
* Participation in any investigational clinical study within previous 30 days.
* Other protocol-defined exclusion criteria may apply.
Natural History of Patients With Inherited Retinal Diseases Due to Mutations in RPE65 Gene

Rationale:

In preparation for treatment with gene therapy, this study is being conducted in order to investigate the natural history of Inherited Retinal Dystrophies (IRDs) due to mutations in RPE65 gene. Such a study will help identify suitable patients for therapeutic intervention.

Methodology:

This is a multicenter retrospective, descriptive chart review study designed to assess retinal structure and function in subjects with IRDs due to mutation in RPE65 gene by visual acuity, visual field measurements, Optical Coherence Tomography (OCT), and a number of other vision-related assessments.


Eligibility Criteria:
Inclusion Criteria:

* Must be willing to adhere to protocol as evidenced by written informed consent or parental permission and subject assent.
* Subjects diagnosed with Retinitis Pigmentosa or Leber Congenital Amaurosis.
* Molecular diagnosis showing mutations (homozygotes or compound heterozygotes) in RPE65 gene.
* Age three years old or older.
* Minimum of two office / clinic visits encounters with ophthalmic assessment that span a follow-up period of at least 1 year with the last visit occurring within the last six months (before signature of informed consent and of study start).

Exclusion Criteria:

* Unable or unwilling to meet requirements of the study.
* Participation in a clinical study with an investigational drug during the retrospective study time period (i.e., from 01/01/1990 to study start date).
A Safety and Efficacy of CCRT With Paclitaxel/Carboplatin as Adjuvant Therapy to Post-operative Cervical Cancer Patients

The purpose of this study is to determine whether post-operative concurrent chemoradiation with paclitaxel/carboplatin is effective and safe in the treatment of high risk cervical cancer patients.

Stage Ib to IIa cervical cancer can be treated effectively with either radioterapy or radical hysterectomy plus pelvic lymph node dissection. However, several pathological risk factors have been identified to compromise the treatment outcome. They include lymph node metastasis, the involvement of vaginal resection margin, and the parametrial invasion. In these patients, postoperative RT is commonly recommended and has been demonstrated to improve the local control, but not survival rate. Recently, It is reported that the additon of concurrent chemotherapy to postoperative RT reduced pelvic failures and enhanced progression free survival. In addition, paclitaxel/platinum combination chemotherapy was demonstrated to have superior progression-free survical over single agent platinum in a primary treatment of stage IV or recurrent cervical cancer.

Based on this obseration, we evaluated the efficacy and safety of CCRT with paclitaxel/carboplatin in patients with postoperative high risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Patients undertaken radical hysterectomy with diagnosis of invasive cervical cancer Ib-IIa (non-small cell type)
* Patients must have at least one of the following risk factors; pelvic lymph node involvemet, involvement of vaginal resection margin,parametrial invasion.
* Patients must have a GOG performance of 0, 1, or 2.
* Patients must have expected life span over 6 months.

Exclusion Criteria:

* Patients with peripheral neurotoxicity over grade 2 in CTC criteria.
* Patients with history of chemotherapy or radiation treatment.
* Patients with histologicallly proven or highly suspected metastasis to paraaortic lymph node.
* Patients with history of hypersensitive reaction to platinum agent.
Resuscitation Fluid Choice and Clinical Outcomes

This observational study evaluates the potential benefits, costs and clinical outcomes of albumin over saline and other non-saline fluids in patients receiving large volume resuscitation.

Currently, recommended resuscitation paradigms involve a "crystalloid-first" approach. This approach reserves more potent and potentially more toxic colloids for patients that have already been exposed to large amounts of crystalloid and may have also experienced a delay in correcting their shock.

This observational retrospective cohort study aims to identify predictors for large volume resuscitation (LVR) and model the potential benefits, costs and clinical outcomes of albumin over saline and other non-saline fluids in patients receiving large volume resuscitation. Further analyses will assess the risk of acute kidney injury (AKI) and hyperchloremic metabolic acidosis (HCA) associated with resuscitation fluid choice and examine long term outcomes such as development of end stage renal disease and post-discharge mortality up to 1 year following hospital discharge in patients treated with various fluid types

This study will utilize data in a large, heterogeneous cohort (n=\~65,800) of critically ill patients admitted to the ICU over a 12 year period at the University of Pittsburgh Medical Center. The study population will consist of patients who receive large volume resuscitation (defined as \> 60ml/kg in a single 24 hour period) separated into analysis groups based on fluids administered during the defined 24 hour large volume resuscitation window. Patients presenting with AKI or HCA prior to large volume resuscitation will be excluded. AKI and "Severe" AKI will be diagnosed based on KDIGO criteria within 72 hours following LVR. Metabolic acidosis will be based on arterial blood gas measurements with a base deficit \> 2 mEq/l, with patients having chloride as the ion contributing to the majority of the acidosis being diagnosed with Hyperchloremic metabolic acidosis. Mortality at 30, 90, and 365-days from ICU admission will be ascertained using the social security death master file. Propensity score models will be used to determine the adjusted relationship between these clinical outcomes and type of fluid resuscitation employed.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patient admitted to ICU

Exclusion Criteria:

* History of chronic dialysis and/or renal transplant
* Baseline serum creatinine \>= 4 mg/dl
* Develop AKI or MA prior to LVR
* Received OR fluids during LVR
Interest of Mycophenolate for CIDP Weaning

The main objective is to study if the mycophenolate could decrease the proportion of patients who relapse during the IVIG tapering period and after the IVIG withdrawal.

The secondary objectives are :

* Study if the mycophenolate could improve the proportion of withdrew patients.
* Study if the mycophenolate could improve the reduction of IVIG dose or could prolong the interval between two courses of IVIG compared to the baseline interval at month 12 and month 24 (= sparing treatment criteria).
* Study if mycophenolate could short the delay to perform the IVIG withdrawal.
* Study if mycophenolate could improve the clinical scores (ONLS, R-ODS MRC, INCAT sensory, 10 meters test) or pain score at month 12 and month 24.
* Study if mycophenolate could improve the quality of life at month12 and month 24.
* Identify clinical, biological and electrophysiological factors associated with withdrawal.
* To assess the pharmacokinetics factors (Area under the curve measuring the exposure to mycophenolate) and the pharmacogenetic factors (cytochrome and carrier, FcgammaR) associated with withdrawal.
* Evaluate the tolerance of Mycophenolate in this new indication.

Eligibility Criteria:
Inclusion criteria :

* Patient older than eighteen
* Written informed consent for study participation
* Definite or probable CIDP according to EFNS/PNS criteria or atypical CIDP (need to meet clinical EFNS/PNS criteria and at least 2 criteria among the EFNS/PNS supplementary criteria)
* Being responder (= decrease of at least 1 point on the ONLS score after IVIG) and dependent to IVIG (= increase of at least 1 point on the ONLS score after IVIG withdrawal or during the tapering period)
* Having received at least 3 courses of IVIG
* Negative pregnancy test for women of child-bearing age

Exclusion criteria :

* No social security benefit
* Pregnancy or intention to become pregnant
* Nursing mother
* Recent or active VIH or hepatitis B or C , or lyme infections
* Monoclonal IgM gammapathy with anti MAG antibodies or CANOMAD syndrome
* Neutropenia \< 1G/L
* Malignancy during the 10 years before the inclusion
* Patients having received Mycophenolate
* History of allergy to mycophenolate or placebo excipient
* Patients having received immunosuppressive drugs during the 3 months period before the inclusion
* Patients receiving : plasma exchange, magnesium hydroxide, aluminium hydroxide, cholestyramine
Incentives for Daily Tooth Brushing to Reduce Gingivitis

In this randomized controlled study, the investigators compare two classes of behavioral approaches to change habits and health outcomes with an application to dental health: cognitive vs. behavioral financial incentives. Under cognitive incentives subjects are paid to correctly answer health-related quizzes. Under behavioral incentives subjects earn money for making healthy choices. The investigators apply these incentives to toothbrushing, a daily health-related behavior critical to the prevention of dental caries and periodontal disease, two high-burden conditions among US adults.


Eligibility Criteria:
Inclusion Criteria:

* Male or female older than 18 years, with at least 10 teeth present.

Exclusion Criteria:

* Pregnancy, uncontrolled diabetes, systemic antibiotics taken within the previous 2 months, need for referral for periodontal treatment.
Combined Transcranial and Peripheral Muscle Magnetic Stimulation in Chronic Tinnitus

Magnetic stimulation of the brain (repetitive transcranial magnetic stimulation) and of neck muscles (repetitive peripheral muscle stimulation) is used to alter tinnitus-related cortical activity and neck muscles tension.

Chronic tinnitus is characterized by several comorbid disorders. One of them is neck and back pain. Here, we investigate the feasibility, safety and clinical efficacy of the combination of repetitive transcranial magnetic stimulation (rTMS) and peripheral muscle stimulation (rPMS) in chronic tinnitus in a pilot study. rTMS is considered to interact with neural tinnitus networks. rPMS is suggested to bring relief to muscle tension. This is an one arm study where explorative analyses will be done with special consideration on patients suffering from neck pain in the analysis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bothersome, subjective chronic tinnitus
* Duration of tinnitus more than 6 months

Exclusion Criteria:

* Objective tinnitus
* Treatable cause of the tinnitus
* Involvement in other treatments for tinnitus at the same time
* Clinically relevant psychiatric comorbidity
* Clinically relevant unstable internal or neurological comorbidity
* History of or evidence of significant brain malformation or neoplasm, head injury
* Cerebral vascular events
* Neurodegenerative disorder affecting the brain or prior brain surgery
* Metal objects in and around body that can not be removed
* Pregnancy
* Alcohol or drug abuse
* Acute neck or back pain
* Neck or back pain of unknown etiology
* Implants in the neck or back, that are sensitive to magnetic fields
Knowledge of Adolescent Well-care Visits and Attitudes Amongst Physicians

The goal of this observational study is to be a quality improvement project to assess the knowledge, attitude towards adolescent well visit screening and preventing counseling amongst pediatrician and family medicine physicians in Al-Ain city. We will be conducting an online survey covering general aspects regarding adolescent well-being visits, before and after providing necessary education to the participants

This is a quality improvement project with the following fields to be studied:

* Knowledge of recommendations regarding adolescent well-care visits amongst pediatricians \& primary care physicians in Al-Ain City.
* Compliance of pediatricians \& primary care physicians towards adolescent well-care visits.
* Effectiveness in conducting educatory sessions for physicians to improve the quality of adolescent well-care visits.
* Adolescent behaviour \& knowledge of the availability of well-care visits.
* Adolescent \& family satisfaction in attendance of well-care visits.
* An online survey covering general aspects regarding adolescent well-being visits will be shared with pediatricians and family medicine physicians, before and after providing necessary education to the participants.

Eligibility Criteria:
Inclusion Criteria:

* Pediatricians and family medicine physicians at Al Ain City SEHA Hospitals.

Exclusion Criteria:

* Pediatricians and family medicine physicians who are not part of Al Ain City SEHA Hospitals.
Clinical Study About Fat Measurement on Multifunction Keito by Comparison Versus Its Predicate K014009

The researchers believe that the multifunction Keito devices shares with TANITA TBF-300 (K014009) the same efficacy on the body fat measurement. Even if the body contact points are not the same, the researchers deeply believe that the tetrapolar BIA used by the predicate gives results as similar as the multifunction keito does.

177 volunteers were enrolled in this clinical Study. Before taking the fat measurement by the devices under test, the observers measured the weight and height of each volunteer prior to measure the body fat. This was done to configure a preliminary idea about the body composition of the subject.

Both devices are designed by the same technology to emit a low current through the body, and finally make a measurement of the impedance found between the body contact points. We expected the results to be very similar.

Eligibility Criteria:
Inclusion Criteria:

* All population who meet with the requirements described on the user's manual.

Exclusion Criteria:

* Pregnant women.
* Individuals who have a pacemaker or any other internal medical device.
* Population whose weight is under 15 Kg and less than 135 cm tall.