cyrilzakka/clinical-trials huggingface dataset:
RSA Study of Persona TKA With CR vs MC Polyethylene

The aim of this study is to evaluate, over a 2 year period, the migration pattern, function and the possibility of anatomical reconstruction of a relatively new total knee arthroplasty (TKA) concept, the Persona. Sixty patients will be randomized into 2 groups of 30 patients each, with one group receiving the Persona TKA with a conventional Cruciate Retaining (CR) polyethylene articular surface and the other group with a newly developed Medial Congruent (MC) articular surface. Patients will be followed up with Radiostereometry (RSA), conventional radiography, outcome questionnaires, clinical evaluation and Computer Tomography (CT). The migration pattern of the components will be evaluated as well as the degree of anatomical reconstruction and clinical result.

We plan also to do a 5 year follow-up of the patients with RSA and PROMS.


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the knee necessitating knee replacement
* ASA I-III
* BMI 18 - 35

Exclusion Criteria:

* Joint sepsis in history
* immunosuppresive drugs last 5 years
* Rheumatoid arthritis
* Severe osteoporosis or other metabolic bone diseases
* Neuromuscular diseases
* Personal disorders suspected of limiting rehab and completion of the trial period
* Previous osteotomy of affected limb
* Intra-articular knee fracture of affected limb
* Peroperative fracture
* Severe deformity of affected joint in need of augmentation or excessive release
* Obvious need for more constrained knee than CR
Body Awareness and Physical Activity Levels of Pregnant Women and Age, Number of Pregnancies and Gestational Week

The aim of this study was to investigate the relationship between body awareness and physical activity levels of pregnant women according to variables such as age, number of pregnancies and gestational week. The main question it aims to answer is: do physical activity levels of pregnant women and age, number of pregnancies and gestational week have an impact on body awareness in pregnant women


Eligibility Criteria:
Inclusion Criteria:

* being in the 2-3rd trimester of pregnancy and
* volunteering to participate in the study

Exclusion Criteria:

* having a risky pregnancy,
* being prohibited from physical activity by a physician,
* having any limb deficiency,
* neurological disease,
* mental deficiency
Treatment Efficacy of Budesonide/Formoterol in Cough Variant Asthma and Typical Asthma Patients

Bronchial asthma is a common respiratory disease characterized by chronic airway inflammation, which have been affecting about 1-18% of the population in the world, causing tremendous economic burden for the patients and countries. Generally, asthma is a heterogeneous disease, and it could be classified into many types on the basis of symptoms, that is, typical asthma, cough variant asthma, and chest tightness variant asthma etc. Typical asthma (TA) is defined according to the history of repeated respiratory symptoms such as wheeze, shortness of breath, chest tightness, and cough, usually with reversible airflow limitation, airway hyper-responsiveness, and airway remodeling. Cough variant asthma (CVA) is characterized by the single manifestation, recurrent cough, which could be improved after the use of bronchodilators. However, according to different guidelines, it is still controversial on the treatment of CVA and TA. The guidelines of Global Initiative for Asthma(GINA) in 2014 put forward the treatment of TA patients, but did not list the treatment specific to CVA. The guideline of ACCP（American College of Chest Physicians） and cough guidelines of China are proposed to treat the CVA effectively with bronchial diastolic drug. Inhaled corticosteroids (ICS) and leukotriene receptor antagonists are effective for the treatment of CVA. Currently, more and more studies supported that application of ICS combined with bronchial dilation agents is more beneficial to CVA patients. Budesonide/formoterol is a compound of ICS and long-acting beta2-agonist(LABA), which can not only be used as a maintenance medication, but also be used as a relief medication, namely, budesonide/formoterol treatment regimen for SMART (Symbicort as both maintenance and reliever therapy). Most studies show that SMART treatment can be used in the treatment of TA patients. But the study on whether budesonide/formoterol can be used to treat CVA is still little. To provide basis for clinical medication guidance for patients with CVA and TA, this study will enroll 30 patients with TA or CVA , who will be required to adopt the SMART regimen in the following 6 months.The symptom score, airway inflammation, pulmonary function and airway reactivity changes, will be measured every mouth. After the study finished, the investigators will compare the difference between the two groups.


Eligibility Criteria:
Inclusion Criteria:

1. aged 15-75
2. first diagnosed corresponding to the diagnostic standards established by Asthma Committee, Respiratory Society, Chinese Medical Association, or previously diagnosed asthma without regular treatment
3. Mch bronchial provocation test is positive
4. the chest X-ray is normal.

Exclusion Criteria:

1. accompanied by other disease of respiratory system
2. combined with serious illness of other system, such as myocardial infarction, severe arrhythmia, malignant tumors and so on
3. women with pregnancy or lactation.
Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History

The aim of this study is preliminary exploration of the effectiveness and duration of autologous decidual-like NK cells therapy in improving uterine NK cells dysfunction.

Menstrual blood analysis will be performed on patients with infertility or a history of adverse pregnancy outcomes who have fertility needs. Those with abnormal uterine NK cells function will be screened and given informed consent forms pre-treatment. Collecting peripheral blood from the patients, isolating and inducing in vitro culture to obtain autologous decidual like NK cells which will be perfused into their uterine. Perform continuous menstrual blood analysis within 6 months after the first treatment to assess the improvement of uterine NK cell function. If the function of uterine NK cells improves, enter the stage of attempting pregnancy and follow up pregnancy outcomes; If the function of uterine NK cells does not improve, then autologous decidual like NK cells uterine cavity perfusion therapy will be performed again. NK cells intrauterine infusion will be treated up to 2 times.

Eligibility Criteria:
Inclusion Criteria:

* abnormal uterine NK cell function;
* have one of the following medical history: unexplained recurrent spontaneous abortions (≥2 spontaneous abortions, including biochemical pregnancy), repeated implantation failure (failure of implantation of good-quality embryos in at least two IVF cycles), unexplained infertility, early-onset severe gestational hypertension or early-onset fetal growth restriction;
* have clear fertility desires;
* normal ovarian function or with frozen embryos;
* edometrium thickness measured by vaginal ultrasound before ovulation or at mid-luteal phase \>= 7mm;
* 18kg/m\^2 \< Body mass index \< 30kg/m\^2;

Exclusion Criteria:

* using progesterone receptor modulator;
* chromosomal karyotype abnormalities in one spouse;
* severe endometriosis, uterine fibroids affecting the shape of the uterine cavity or the size of the whole uterus more than 2 and a half months of pregnancy, uterine malformation, uterine adhesion or thin endometrium;
* uncontrolled autoimmune diseases;
* abnormal blood coagulation function, abnormal liver and kidney function, or other uncontrolled basic diseases (hypertension, diabetes, thyroid disease, etc.) that the researcher access which may affect the progress of the study;
* history of pelvic malignant tumors;
* currently participating in other clinical studies;
* allergic to blood products.
Development and Pilot Testing of the Students With Autism Accessing General Education (SAAGE) Model

Study personnel will use evidence based behavioral skills training procedures to coach educators to implement modules designed to increase the quality of educational services and access to inclusive settings in elementary school for students with Autism Spectrum Disorder.

This project brings together the expertise of investigators at three centers to develop and conduct a pilot test of a new comprehensive intervention to increase the quality of educational services and access to inclusive settings for students with autism spectrum disorder (ASD) in elementary school (kindergarten through 5th grade). The intervention model, Students with Autism Accessing General Education (SAAGE), integrates evidence-based strategies to teach skills to students with ASD in schools, best practices derived from this literature by the project investigators, a recent guidebook written by the principal investigator, and research on collaboration with community providers such as school teams to implement interventions efficaciously and sustainably. SAAGE begins with strategies to help a school form a cohesive team to oversee implementation of the model in the school. For each student, SAAGE uses a modular approach for identifying goals for a student, selecting appropriate teaching strategies, and systematically monitoring progress and trouble-shooting. The modules center on core and associated features of ASD. Study personnel will use well established behavioral skills training procedures to coach educators to implement the modules.

Eligibility Criteria:
Inclusion Criteria:

Children subjects:

* Are enrolled in school grades kindergarten through 5th
* Have an IEP educational classification of Autism, confirmed by the Autism Diagnostic Observation Schedule, Second Edition, and DSM-5 checklist
* No planned changes in school placement or core team members during the school year of participation

Adult subjects (teachers, para educators):

* Instructional personnel who currently support a participating child with ASD at school (e.g., teacher, instructional assistant, speech pathologist, occupational therapist)
* Letter from instructional personnel's district or school indicating agreement to take part in the research project

Exclusion Criteria:

Children subjects • Diagnosis of (1) genetic disorders such as Fragile X, Down syndrome, or tuberous sclerosis; 2) profound vision or hearing loss; or (3) motor disabilities such as cerebral palsy (these multiple disabilities would prevent standard implementation of the intervention protocol).

Adult subjects

• Instructional personnel whose written consent was not obtained
Immunotherapy in Treating Patients Who Are Undergoing Bone Marrow or Peripheral Stem Cell Transplantation

RATIONALE: White blood cells from donors who have been exposed to cytomegalovirus may be able to help prevent this infection from occurring in patients who are undergoing bone marrow or peripheral stem cell transplantation.

PURPOSE: Phase II trial to study the effectiveness of donated white blood cells to prevent cytomegalovirus infection in patients who are undergoing bone marrow or peripheral stem cell transplantation.

OBJECTIVES: I. Determine whether adoptive immunotherapy comprising donor-derived CD8+, CMV-specific, major histocompatibility complex class I-restricted cytotoxic T-lymphocyte (CTL) clones (CD8+ CMV-specific CTL clones) and CD4+ CMV-specific T-helper (Th)-cell clones is effective in preventing CMV viremia and disease in CMV-positive patients with malignancies requiring allogeneic bone marrow or peripheral blood stem cell transplantation. II. Determine whether the transfer of CD4+ CMV-specific Th-cell clones to patients with deficient responses can reconstitute CD4+ Th-cell activity and augment adoptively transferred CD8+ CMV-specific CTL clones.

OUTLINE: Allogeneic CD8+ CMV-specific, major histocompatibility complex class I-restricted cytotoxic T-lymphocyte (CTL) clones (CD8+ CMV-specific CTL clones) and CD4+ CMV-specific T-helper (Th)-cell clones are harvested and cultured in vitro at least 2 weeks before bone marrow or peripheral blood stem cell (PBSC) transplantation. Bone marrow or PBSC are infused on day 0. Patients receive the first infusion of CD8+ CMV-specific CTL clones beginning between days 28 and 45 posttransplantation, followed 8 days later by the second infusion, followed 2 days later by the first infusion of CD4+ CMV-specific Th-cell clones. Patients who receive prednisone posttransplantation or have deficient CD8+ CTL responses (i.e., less than 50% of the response measured in the immunocompetent bone marrow donor) after the second infusion of CD8+ CMV-specific CTL clones receive a third infusion of CD8+ CMV-specific CTL clones and a second infusion of CD4+ CMV-specific Th-cell clones before day 67.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12-18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: See General Eligibility Criteria

PRIOR CONCURRENT THERAPY: See Disease Characteristics --Patients Characteristics-- Age: 12 to 60 Performance status: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified
"Vestibulitis Educational Seminar Trial" Study

The purpose of this study is to investigate the efficacy of an educational seminar series for women with vulvar vestibulitis syndrome (VVS).

HYPOTHESIS: It is hypothesized that this educational seminar series might be effective in reducing the pain experienced and improving sexual response and quality of life of women with Vulvar Vestibulitis Syndrome (VVS) by providing an open forum for discussion of the pathology, etiological theories, treatment plans as well as the impact of sexual pain on sexual relationships and ways to cope with VVS.

At Vancouver Hospital, the current waitlist for women with distressing, unremitting genital pain is approximately 10 months. Once accepted for management, the diagnosis of VVS is given, where applicable, by Dr. Sadownik. Only women with pure VVS and without a compounding skin condition are then referred on to the 3-session educational seminars given by Dr. Thomson. By the end of the educational series, women have an understanding of current scientific literature on etiology and treatment of VVS, and it's interaction with sexual health factors. At this point they are referred for individualized treatment of the VVS either by Dr. Thomson, Dr. Sadownik or back to their referring physician. This study aims to explore the existing VVS Educational Seminars by measuring sexual function, sexual distress, pain levels (general pain, genital pain and pain upon sexual activity), psychological well-being (depression and anxiety), relationship satisfaction, sexual knowledge and overall quality of life at pre- and post seminar. An age-matched control group of women diagnosed with VVS, but unable to attend the Seminar series, will complete the measures at the same intervals as the treatment group. The use of the control group allows us to accurately evaluate the efficacy of the Educational seminars, above and beyond non-specific factors.

Vulvar Vestibulitis Syndrome Educational Seminars have been run through the Vulvar Disease Clinic at Vancouver Hospital since 2001, however no data has been collected to determine the effects of this program. By collecting pre- \& post seminar and follow up data, this study will allow us to assess the efficacy of the VVS Educational Seminars when compared to a group of women suffering from VVS but unable to attend the information seminars. Given that a large proportion of the women cannot be treated at Vancouver Hospital and are instead referred back to their family physician, the VVS Educational Seminar is a necessary first step in the treatment process for ensuring that women receive accurate and timely treatment. It will also help treatment providers improve and expand their current treatment practices

Eligibility Criteria:
Inclusion Criteria:

* Women who meet the diagnostic criteria for VVS by the Vancouver Hospital Vulvar Disease Clinic
* Women who have been referred to VVS Educational Seminars at Vancouver Hospital
* Proficient in English

Exclusion Criteria:

* Any women referred to the VVS Educational Seminars will be eligible for participation.
The Effect of Pressure Controlled Ventilation on the Pulmonary Mechanics in Prone Position Using the Wilson Frame: A Comparison With Volume Controlled Ventilation

Prone position in spinal surgery can increase airway pressure and decrease dynamic lung compliance by a frame used for postural stabilization. Also, it can increase hemodynamic instability such as reduced blood pressure by aggravating cardiac index.

Former study shows pressure controlled ventilation on the pulmonary mechanics can improve alveolar use and oxygenation than volume controlled ventilation. The latter one means controlling a patient's breathing completely through tidal volume and set breathing rate. This could be useful for the patients not possible to breath by themselves because it guarantees the perfect breathing.

The pressure controlled ventilation is used when there is a possibility to change a patient's environment. The pressure will be maintained steadily, but volume and flux will be changed. That means through the pressure already set, the whole breathing will be maintained from the beginning to end. If a patient's resistance is increased, the volume will be decreased even though the way of blood pressure control is same. However, the tidal volume per minute can be controlled somewhat and barotrauma can be decreased by controlling respiratory rate. Through this study, we are expecting the pressure controlled ventilation in prone position can improve lung mechanics and oxygenation.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for lumbar spine surgery under general anaesthesia

Exclusion Criteria:

* Patients with coronary artery occlusive disease
* morbid obesity (body mass index ≥ 30 kg/m2)
* cerebrovascular disease and major obstructive or restrictive pulmonary disease
The Effect of Personalized Shoe Insole on the Gait of Parkinson's Disease Subjects

This study aims to assess the efficacy of custom-made shoe insoles, for subjects with Parkinson's Disease (PD).

To do that, a sample of PD subjects has been randomly assigned to an intervention group that will receive the custom-made insoles or a control group that will receive a sham insole without any specific manufacturing.

Both groups will receive Physiotherapy and Occupational Therapy according to PD rehabilitation guidelines.

The principal outcome will be the Time Up\&Go test time, secondary outcomes 10 Meters Walking test speed, Berg Balance Scale score, SF12 score, and orthesis liking.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Idiopathic Parkinson's Disease;
* Age \> 18 years;
* Subjects should be in a positive therapeutic window or in the ON phase during the evaluations;
* Subjects must be able to walk at least 10 meters independently with or without any walking aid.

Exclusion Criteria:

* Not clinical stable subjects;
* SUbjects in OFF phase during the evaluations;
* Other neurological conditions (e.g. stroke, peripheral neuropathies, etc.);
* Other pathologies that can negatively influence the subject's walking ability (e.g. surgery at the lower limbs in the previous 6 months, important deformities at the lower limbs, etc.)
Transcranial Stimulation Combined With Auditory Training

The goal of this clinical trial is to learn if non-invasive brain stimulation (called transcranial stimulation) can enhance the benefits from auditory training in people who struggle to understand one talker when many people are talking at the same time. The main questions it aims to answer are:

* Does transcranial stimulation improve speech-on-speech understanding in people who struggle with this task?
* Does transcranial stimulation enhance the benefits of a commercially available auditory training program?

Researchers will compare transcranial stimulation to sham stimulation (no stimulation is applied during the listening task).

Participants will:

* Receive login information to an online auditory training program to complete at home over 2 weeks
* Visit the laboratory 4 times to receive transcranial stimulation while listening to speech-on-speech: once before at-home training, two times during the at-home training period, and once after at-home training has ended


Eligibility Criteria:
Inclusion Criteria:

* 50 years of age or older
* Audiometric thresholds that do not exceed 90 dB HL at any frequency from 250-6000 Hz
* Able to provide informed consent and understand experimental instructions
* Able to read print on a computer screen
* Difficulty with speech-on-speech understanding
* Access to computer or mobile phone with access to internet that can play sound (for the at-home training)

Exclusion Criteria:

* Non-native speakers of English
* History of skull fracture, scalp tissue damage, metallic implants around the head, seizures, neurological disorders, or traumatic brain injury, current or suspected pregnancy
Ellume·Lab Flu A+B Test and the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction

The primary purpose of the study is to validate the sensitivity and specificity of the Ellume Home Flu Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to reverse transcriptase polymerase chain reaction (RT-PCR)

Secondary aims are to:

Validate the sensitivity and specificity of the Ellume Home Flu Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture; Evaluate the participant's satisfaction with the convenience and ease of use of the Ellume Home Flu Test; Evaluate the participant's interpretation of the Ellume Home Flu Test results compared to the interpretation by site staff; Evaluate the operator's satisfaction and ease of use of the ellume·lab Flu A+B Test.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants aged ≥ 2 years; and
* Fever ≥ 37.8° C (100° F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8° C or feeling feverish within 24 hours of presentation; and
* Rhinorrhea; and
* ≤ 72 hours from onset of ILI symptoms; and
* Participant (or parent/legal guardian) capable and willing to give informed consent/assent; and
* Participant (or parent/legal guardian) able to read and write in English.

Exclusion Criteria:

* Participants aged \< 2 years.
* Participants who have undergone treatment with Tamiflu (oseltamivir), Relenza (zanamivir) or Symmetral (amantadine) within the previous 7 days;
* Participants who have been vaccinated by means of an Influenza nasal spray/mist vaccine within the previous 7 days;
* Participants who have had a nose bleed within the past 30 days;
* Participants who have had recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
* Participants currently enrolled in another clinical trial or used any investigational device within 30 days preceding informed consent.
* Participants previously enrolled in IE-FLU-AUS-1801;
* Participants 18 years of age or older unable to understand English and consent to participation;
* Parent/legal guardian of participants \< 18 years of age unable to understand English and consent to participation of child.