cyrilzakka/clinical-trials huggingface dataset:
Efficacy of an Intervention to Teach Zippering: A Two-Group Control Study

Preschoolers are assigned to a control group or a comparison group to examine the efficacy of a new intervention to teach the skill of engaging and pulling up a zipper.

Purpose: This pilot study compares the efficacy of a standard teaching zippering vest presented with general verbal prompts to a modified teaching zippering vest presented with a related story and vocabulary in the acquisition of zippering skills among typically developing preschoolers. Institutional Review Board approval and parent consent was obtained.

Design: An experimental two group pre-post test design was used. Setting: Research occurred in a local preschool. Participants: Participants were recruited from fifty 3.6-to 4.11-year-old preschoolers.

Intervention: Eligible children received 3 zippering practice sessions with either a standard zippering vest (control group) or a modified vest with added visual and language cues (comparison group).

The treatment protocol for both cohorts of participants was administered over a three-week time period to minimize the impact of normal development.

Eligibility Criteria:
Inclusion Criteria: Child must be typically developing as assessed by the Developmental Assessment of Young Children 2 (DAYC-2) developmental screening.

Child must be between 42 and 60 months of age. Child must be unable to zip by a) parent report and b) three observed attempts to zipper -

Exclusion Criteria:

Child must meet inclusion criteria and be present at school during three researcher visits to the preschool within three consecutive weeks.

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Survivorship, Radiographic, and Functional Outcomes of the Multihole Revision Acetabular Cup

This study will evaluate patients receiving a multihole revision acetabular implant for total hip arthroplasty (THA) and will be followed for 10 years to collect data on survivorship of the implanted prosthesis.

Data will be collected preoperatively, and at the standard of care (SOC) office visits at 4 weeks, 1 year, 2 years, 5 years and 10 years postoperatively. The research coordinator at each site will identify, recruit, and prospectively follow the 60 patients at his/her site. Patient demographics (e.g., age, gender, body mass index (BMI)), comorbidities, reason for revision, Paprosky classification, native femoral head measurement (mm) etc. will be collected preoperatively. The study coordinator will contact patients prior to each visit to ensure patient compliance. At each visit, A-P and cross-lateral radiographic evaluation (i.e., use of Engh classification to quantify osteolysis/loosening) will occur. In addition, patients will be assessed for any complications (e.g., dislocation, emergency department visits, infection, reoperation, etc.). Patients will complete the Hip disability and Osteoarthritis Outcome Score (HOOS) and Veterans Rand 12 (VR-12) forms (including a specific question regarding groin pain) and a pain assessment. In the event that a patient has relocated and/or refuses to return to the office for the 5-year visit, a script will be sent to the patient to have x-rays done and sent to the PI, and questionnaires will be mailed. All data will be entered and maintained in RedCap.

Eligibility Criteria:
Inclusion Criteria:

1. Patients requiring revision total hip replacement of the acetabular component or complicated primary total hip replacement.
2. Femoral stem (either retained or replaced) is a compatible Stryker stem.
3. Patient is willing to comply with follow-up requirements (e.g. will return for long-term follow-up visits)
4. Age: 18-85 years

Exclusion Criteria:

1. Patient has a BMI \> 40
2. Exclude revision for infection
3. Patient is undergoing bilateral THA surgery or had prior hip arthroplasty on contralateral side less than 6 months from date of surgery
4. Patient has history of radiation therapy
5. Patient has known diagnosis of renal disease
6. Patient has known diagnosis of osteoporosis
Cryotherapy for the Prevention of Taxane-Induced Sensory Neuropathy of the Hands and Feet in Breast Cancer Patients

This clinical trial investigates the effect and tolerability of cryotherapy and to evaluate whether they can prevent or improve taxane-induced sensory peripheral neuropathy in breast cancer patients. Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Patients receiving cryotherapy during infusion of taxane therapy may have lower incidence of peripheral neuropathy, better physical function, and higher quality of life as compared to patients previously reported in literature.

PRIMARY OBJECTIVE:

I. To investigate the efficacy and tolerability of cryotherapy (Elasto Gel frozen mittens and foot wraps) and to evaluate whether they can prevent or ameliorate taxane-induced sensory peripheral neuropathy.

OUTLINE:

Patients wear Elasto Gel Therapy Mittens and Foot Wraps on both hands and feet 15 minutes prior to each infusion, during the entire infusion, and for 15 minutes after the completion of each infusion during their three months of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>= 18 years of age with a diagnosis of breast cancer
* Patients receiving 12-18 weeks of chemotherapy with a taxane-based regimen (4 cycles of weekly x 3 paclitaxel or 4-6 cycles of docetaxel every 3 weeks)
* Absence of sensory peripheral neuropathy, skin or nail disorders at the start of treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Ability to complete questionnaires by themselves or with assistance
* Ability to give signed informed consent

Exclusion Criteria:

* History of prior sensory/motor peripheral neuropathy from any cause
* History of prior Raynaud's phenomenon
* History of cryoglobulinemia
* Active peripheral vascular disease
* Cold intolerance
* Prior exposure to neurotoxic chemotherapy in the last 10 years
* Hand-foot syndrome
* Tumor metastasis in bone, soft tissue, or skin of the hands or feet
* Absence of one or more fingers or toes
* Prior exposure to taxane chemotherapy
PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation

The purpose of this extended study is to collect confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in the treatment of aortoiliac and iliac aneurysms.


Eligibility Criteria:
Inclusion Criteria:

* An aortoiliac or iliac aneurysm of appropriate size
* Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac artery

Exclusion Criteria:

* Less than 18 years of age
* Inability or refusal to give informed consent
* Disease considerations that would compromise patient safety or study outcomes
* Unsuitable arterial anatomy
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the Southern Hemisphere 2015 Season

Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. The current study is a phase III A clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. The objective of this study is to investigate the immunogenicity and safety and tolerability of the changed influenza vaccine virus composition in two groups of subjects in good health: subjects aged \>= 18 and \<= 60 years and subjects \>= 61 years of age (elderly).


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent and able to adhere to all protocol required study procedures.
* Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination.
* Being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the Investigator

Exclusion Criteria:

* Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
* A serious adverse reaction after a previous (influenza) vaccination.
* Presence of any significant condition that may prohibit inclusion as determined by the investigator.
* Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period.
* A history of Guillain-Barré syndrome or active neurological disease.
Evidence-based Analysis of Low-dose CT in Management of COPD

Background: Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of chronic morbidity and mortality worldwide. There is debate about diagnosis and management of COPD because it was described as complex syndrome accounting for various pulmonary and extrapulmonary abnormalities. As a result, there is consensus that both clinical evaluation and pulmonary function tests (PFTs) data by themselves do not adequately describe the complexity of the disease. The chest radiograph is the sole imaging examination recommended for the routine evaluation of these patients by the physicians guidelines (GOLD guidelines),which, however, are also debating on the utility of computed tomography (CT) in this setting. Indeed, a number of studies reported a dramatic increasing use of CT of the chest for COPD assessment, in both clinical and research settings. COPD assessment by CT seems to improve the accuracy and completeness of the clinical evaluation of these patients. Nevertheless, the clinical utility of CT has yet to be proved by prospective studies or defined by guidelines.

Objectives: To evaluate the change in the diagnosis and management of COPD when multiple CT-derived information is added to pre-test evaluation.

Methods: Four pulmonologists with various expertise in the field will review clinical data, PFTs results, and chest radiographs of 200 consecutive COPD patients diagnosed according to current guidelines. Therefore, after two months from the first evaluation, the pulmonologists will review the clinical and PFTs records with comprehensive information about low-dose CT (LDCT) previously performed in a week from the chest radiograph. Information about LDCT findings will include qualitative assessment by an experienced chest radiologist and quantitative analysis by means of an innovative 3D imaging dedicated software. Phenotype assessment and patient care decisions (e.g. therapeutic and follow-up strategies, need of additional tests etc.) will be recorded before and after assimilation of LDCT data.

Expected results: This evidence-based prospective study will test the impact of chest LDCT on management of COPD patient. In addition, the level of agreement between pulmonologists in terms of diagnosis and therapeutic strategies will be assessed. Furthermore, the study will evaluate the need for additional tests referable to LDCT information and their impact on the health care system (e.g. in terms of additional costs).


Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis according to ATS/ERS criteria (post-bronchodilator FEV1 to FVC ratio \< 0.7);
* clinical stability, namely no acute exacerbation in the previous 4 weeks;
* clinical indication for low-dose computed tomography (LDCT) to investigate bronchiectasis, interstitial lung disease, or pulmonary hypertension.

Exclusion Criteria:

* pregnancy;
* patients with congenital or acquired immune deficit;
* patients with lung transplantation;
* patients under oxygen therapy;
* patients with diagnosis of asthma or other clinically relevant pulmonary disease other than COPD.
" Effect of Affordance of Objects on the Memory: Study in Transcranial Magnetic Stimulation "

The purpose of this study is determine the involvement of motor system in the memory of manipulable objects. The idea is to stimulate the ventral premotor cortex with transcranial magnetic stimulation to see whether this stimulation will affect memory of manipulable objects.

Embodied cognition claims that representations shares processing resources with sensorimotor systems. More specifically, it has been proposed that language comprehension relies on internal simulation of the meaning. For instance, numerous studies have shown that the processing of action-related concepts involve a motor activation similar to when the action is actually performed. However, even if those studies show clearly that action-related concepts involve a motor activation, such activations may be incidental to the activation of their representations, rather than part of it. Another way to show that this motor component takes part in the representation of manipulable objetcs is to investigate whether an impairment of motor system would impair the memory of manipulable object. In this study, investigators will use Transcranial Magnetic Stimulation (TMS) to stimulate ventral premotor cortex (PMv) to see whether this stimulation will affect memory of manipulable objects, but not memory of nonmanipulable objects. For this purpose, three TMS conditions will be assessed: cTBS to inhibit the motor cortex, iTBS to excite the motor cortex, and a SHAM condition as control.

Eligibility Criteria:
Inclusion Criteria:

* 18 and 35 years
* Right-handers (score between 70 and 100 on the scale of Edinburgh)
* Native language : French
* Not depressed (score lower than 14 in the BDI)
* health insurance
* Consent

Exclusion Criteria:

* Psychiatric family history up to the second degree
* Medical treatment, in particular psychotropic being able to affect the memory and the attention
* view or hearing disorders (not compensated)
* neurological histories (epilepsy, alcoholism in particular) or psychiatric or important memory complaints
* Contraindications for the SMT
* contraindications in the MRI
Accuracy of Host-derived Biomarkers in Diagnosing Symptomatic and Asymptomatic Apical Periodontitis

Apical lesions usually present clinically as a chronic infection, remaining as asymptomatic apical periodontitis(AAP). Because the balance among inflammation and bacteria is a dynamic process, AAP may undergo an acute exacerbation and become symptomatic, presenting as symptomatic apical periodontitis or acute abscess, or it may evolve from the acute to the chronic stage. Identification of specific biomarker could help in establishing more accurate diagnosis. Biological marker serves as a parameter that is indicative of underlying physiology and health of the tissue. It is measurable as well as quantifiable. The aim of this study: To assess the level of potential biomarkers in asymptomatic and symptomatic apical Periodontitis, and to determine the prediction potential of the same biomarkers for the outcome of endodontic treatment after 1year recall...

Participants will be selected from patients attending the Restorative and Aesthetic Department in the College of Dentistry University of Baghdad. Consent form will be assigned with all participants prior to the study to take their agreement for participation. Also case sheet including all diagnostic procedures will be prepared and used with all cases. The involved tooth should not have more than 3 surfaces affected with caries including mesioocclusal(M0), distoocclusal(DO) or mesio occlusodistal( MOD). Cone beam computed tomography (CBCT) will be taken for the accused teeth. Gingival crevicular fluid(GCF) samples will be collected from the gingival sulcus of the test and healthy teeth within the same participant. The GCF samples will be centrifuged at 400-500 g for 4-5 min and Concentrations of Matrix metaloproteinases(MMP8), Tissue inhibitor(TIMP1),receptor activator of nuclear factor kappa-B(RANK), RANK ligand(RANKL) andosteoprotegerin( OPG) will be determined using ELISA test.

Eligibility Criteria:
Inclusion Criteria:

* Systematically healthy individuals with healthy periodontal status which can be detected by periodontal probing depth (PPD) and bleeding on probing (BOP).
* Both sexes and ages between 25-45 years old will be targeted.
* Patients with one or more SAP or AAP teeth will be included within this study.
* The involved tooth or teeth have to be one or both of the maxillary premolars either In one or both sides.
* Selected SAP and AAP has to be without periodontal diseases.

Exclusion Criteria:

Systematically unhealthy individuals or those who consumed any treatment that may affect periodontal condition.

* Consumption of antibiotics within 3-months prior to the study first examination.
* Periodontitis.
* Smoker.
* Pregnancy and lactation
Partnering With Autistic Adults to Improve Healthcare

The goal of this proposal is to develop and evaluate patient-centered care tools for autistic adults and their primary care providers (PCPs).

The goal of this study is to develop and evaluate patient-centered care tools for autistic adults and their primary care providers (PCPs). One tool will allow autistic adults and/or their supporters to provide individualized information to PCPs about how being on the spectrum affects their healthcare and possible strategies to facilitate quality care. Another tool will capitalize on the power of patient narrative to educate PCPs about autism. These tools and other resources will be housed on an interactive website for autistic adults, supporters, and PCPs. The research team will evaluate the feasibility and acceptability of using the new web-based patient-centered care tools with autistic adults and their primary care providers. This study will provide data for a future trial testing the effectiveness of these tools in improving the health of autistic adults by increasing patient-centered care and patient activation.

Eligibility Criteria:
Inclusion Criteria:

* Medical diagnosis of autism spectrum disorder (including autistic disorder, Asperger's disorder, Childhood Disintegrative Disorder, and pervasive developmental disorder NOS)
* Understands written or spoken English or has a support person available who understands written or spoken English
* Has a primary care provider

Exclusion Criteria:

* Is not a resident of the United States
Application of Proteome Profiler Antibody Arrays to Find Angiogenetic Predictors in Glioma Paitents.

Bevacizumab has become the standard of care of recurrent glioblastoma based on promising clinical trial results with with response rates up to 50% and progression-free survival up to 9 months. In our study, we set to find the serum angiogenesis biomarkers of bevacizumab response.

Pre-chemoradiation and post-chemoradiation peripheral blood will be obtained to see if there are some angiogenesis biomarker available for prediction of bevacizumab response later.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 20 year old.
* Glioblastoma patients who will receive chemoradiation treatment.

Exclusion Criteria:

* None
Impact of DMSO Concentrations on Hematopoietic Recovery After Autologous HSC Transplantation.

The main aim of the study was to evaluate the clinical impact of different DMSO concentrations in cryopreservation mixture (5%, 7.5%, 10%) on reconstitution of hematopoiesis after autologous hematopoietic stem cell transplantation.

The procedure of autologous hematopoietic stem cell (HSC) transplantation requires cryopreservation of HSCs. Addition of DMSO (dimethyl sulfoxide) is necessary to secure the viability of such cells, but this cryoprotectant is potentially toxic to stem cell recipient. The concentrations of DMSO in cryopreservation mixture vary strongly between protocols in different transplant centers. Usually, the HSCs are stored in mixtures containing 10% DMSO, but there is no sufficient evidence that this concentration of DMSO is indeed optimal.

The main aim of the study is to evaluate the clinical impact of reduction of DMSO concentration in cryopreservation mixture on engraftment after autologous hematopoietic stem cell transplantation. 150 consecutive patients will be randomly assigned to one of three study arms (50 patients each). HSCs obtained by leukapheresis will be cryopreserved in three concentrations of DMSO: 5%, 7.5%, 10%, respectively. Evaluation of the mixtures will be carried out by monitoring reconstitution of hematopoiesis and the frequency the side effects in patients. The most important aspect of our evaluation will be the speed of neutrophil recovery after transplantation (defined by the first day, when absolute neutrophil count in peripheral blood will be higher than 0.5 G/L). The investigators will also evaluate the toxicity of cell suspension by monitoring the frequency of infusion-related adverse events (like nausea or vomiting) during infusion and 24 hours after transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hematological malignancies or solid tumors, refered for autologous HSC transplantation
* Written informed consent
Non-invasive Diagnosis of Pulmonary Embolism by Use of Biomarkers in Exhaled Breath Condensate

In this study, a new, non-invasive method for diagnosis of pulmonary embolism (PE) will be tested. In pre-clinical studies, we have identified 151 putative biomarkers for pulmonary embolism in the exhaled breath condensate (EBC). These biomarkers needs validation/consolidation in a clinical setting before further test of this new diagnostic method.

The study will compare the protein profiles of EBC collected from patients admitted to the department of cardiology with suspected pulmonary embolism and controls with same age (within a range of 10 years) and gender from the outpatient clinic awaiting elective cardiovascular surgery. The main-outcome (i.e. means of the relative amounts of specific proteins in the EBC samples) will be compared by unpaired t-tests after assessment of normality and standard deviations within the three groups (PE confirmed, PE suspected but not confirmed and controls). Furthermore, sensitivity and specificity will be calculated for relevant proteins. The results from analysis of EBC samples from the patients and controls will be compared with results from the porcine model in order to confirm and reduce the number of putative biomarkers for PE. Blood samples (i.e. excess plasma from routine blood samples drawn as a part of routine diagnostic work-up) from the study participants will be stored for standardization of the putative markers and verification and supplementing analysis of the EBC markers. In order to qualify the most suitable markers and substrates for standardization, the analysis of the EBC samples must be completed before the blood samples can be analyzed. Only biochemical, no genetic analysis will be conducted.

Eligibility Criteria:
Inclusion Criteria - Suspected/confirmed PE patients:

* Admitted to the emergency department with initial diagnosis of PE, visited to the Department of Cardiology at Aalborg University Hospital.
* Are conscious and able to understand the given study information.
* Possess legal capacity.
* Age above 18 years.
* Informed, signed consent is obtained.
* Clinically stable, which is defined as patients with stable blood pressure and not in need for other treatments .
* No need for organ support, which comprises need for vasopressors or inotropes, mechanical ventilation, extra corporal circulation or renal replacement therapy.

Inclusion Criteria - Controls:

• Patients as the PE patients, but where the diagnosis of PE is rejected.

The rest of the control persons will be recruited as described:

* Patients who are going to have elective procedures at the Department of Cardiology, Aalborg University Hospital.
* Same gender and age (within a 10-year range) as an included PE patient.
* Are conscious and able to understand the given study information.
* Possess legal capacity.
* Age above 18 years.
* Informed, signed consent is obtained.

Exclusion Criteria:

* Active malignant disease (i.e. ongoing anti-cancer therapy or palliation).
* Current smokers