Kornimate/medical-research-clean huggingface dataset:
rosa total knee post market study emea

Conditions: Knee Pain; Chronic Osteoarthritis; Avascular Necrosis of the Femoral Condyle; Moderate Varus, Valgus or Flexion Deformities; Rheumatoid Arthritis

Summary: this is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of surgical workflow efficiency, patient pain and function outcome and adverse events data. this study might include persona, nexgen and vanguard product families using the rosa total knee robotic system or conventional instrumentation. the primary objective is to evaluate the accuracy of implant alignment for rosa total knee robotic instrumentation compared to conventional instrumentation.

the main purpose of this study is to collect and compare clinical outcomes data using the commercially available rosa total knee robotic instrumentation and conventional instrumentation. this will be achieved by assessing: planned vs actual component positioning, operative workflow efficiency, patient safety based on incidence and frequency of adverse events, clinical performance measured by overall pain and function, health-related quality of life data and radiographic parameters. the primary endpoint will report on the accuracy of implant alignment for rosa total knee robotic instrumentation compared to conventional and the secondary endpoints will record surgery time points and evaluate the change of clinical outcomes scores between baseline and post operative follow up for performance and clinical benefits

Eligibility criteria:
inclusion/exclusion criteria inclusion criteria: * patient is a minimum of 18 years of age * independent of study participation, patient is a candidate for commercially available persona, nexgen, or vanguard knee components implanted in accordance with product labeling * patient has participated in this study-related informed consent process * patient is willing and able to provide written informed consent by signing and dating the ec approved informed consent form * patient is willing and able to complete scheduled study procedures and follow-up evaluations exclusion criteria: * patient is currently participating in any other surgical intervention studies or pain management studies * patient has underwent contralateral uka or tka within the last 18 months * hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum) * hip pathology severely limiting range of motion (e.g. arthrodesis, severe contractures, chronic severe dislocation) * patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.) * patient has previously received partial or total knee arthroplasty for the ipsilateral knee
use of discarded surgery human tissue specimens for basic science research

Conditions: Osteoblast; Vascular Calcification

Summary: although it is now established that calcification process result from the joint and coordinated action of different cell types, many areas of shadow remain regarding the spatio-temporal implementation of these events. highlighting these processes requires additional research to consider new approaches to clinical management of patients with such conditions. it is in this context that the investigators need to use residual human tissue fragments resulting from surgery which are not intended to be used for clinical-biological management of patients. the use of these pseudonymised human tissues will allow the investigators to conduct in vitro cell culture experiences.


Eligibility criteria:
inclusion criteria: * patients undergoing surgery in the cardiac surgery and orthopedic surgery departments of the chu amiens-picardie * patients who will be beforehand informed * patients who will not be opposed to this study. exclusion criteria: * hiv and hepatitis positive patients

Keywords: osteoblast vascular calcification vascular smooth muscle cell cardiac valve calcification valvular interstitial cell bone tissue
comparison of mbr + suture tape and mbr for clai in gjl cases: a prospective cohort study

Conditions: Ankle Sprain; Hypermobility, Joint

Summary: gjl is a risk factor for postoperative recurrent instability following an mbr for clai. additional suture tape augmentation has been suggested to provide more strength and stability. however, the outcomes of the mbp with suture tape augmentation were unknown, which requires further exploration.

generalized joint laxity (gjl) is a risk factor for postoperative recurrent instability following an open modified broström repair (mbr) for chronic lateral ankle instability (clai). mbr with suture tape augmentation may provide more strength and stability. however, bpr with suture tape augmentation may lead to rejection of the suture tape. in addition, the outcomes of the mbp with suture tape augmentation were unknown.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of lateral ankle instability * beighton score ≥4 * age with 18 to 60 years exclusion criteria: * patients with an acute or subacute ankle injury * injury of the deltoid ligament * alignment of lower extremity greater than 5 degrees * fractures of the lower extremity * stage iii or iv osteoarthritis * patients who refused to participate in the study
imrt versus impt with concurrent chemotherapy for locally advanced anal canal cancer

Conditions: Malignant Neoplasm of Anal Canal

Summary: the standard practice in management of carcinoma of anal canal is to treat patients with radiotherapy using the imrt technique along with chemotherapy. it is known that while imrt has reduced treatment related side effects as compared to the older radiation techniques, reducing these side effects further still remains a major challenge. these side-effects include gastrointestinal (diarrhea, altered bowel habits, weight loss, bleeding, obstruction), genitourinary (difficulties in passing urine, passing blood in urine, difficulty in holding urine) and hematologic toxicities (anemia, low platelet count and increased predisposition to infections). proton therapy (impt) is a form of radiation treatment in which high doses can be delivered within the tumor while the surrounding normal tissues receive a lesser radiation dose. it is believed that these physical properties of proton therapy may help reduce the side effects of treatment. patients will be randomly assigned to either receive imrt or impt based treatment so as to see whether it is possible to reduce the acute treatment related toxicities. in this study, there is a 66.7% chance that the patient will get impt based treatment, which may be able to reduce the toxicities.


Eligibility criteria:
inclusion criteria: 1. age \> 18 and \< 80 years of age 2. histologically confirmed squamous cell carcinoma of the anal canal or distal rectum 3. the patients may have tnm stage t1-2 n+m0 or t3-4 n0-1c m0 (uicc 8th edition) 4. involvement of lower para-aortic lymph nodes (till renal hilum) as the only site of disease extension on pet cect may also be included as they receive radical chemoradiation as standard treatment. 5. who or ecog performance status 0-1 6. hiv testing is known and hpv (p16) testing done on tissue sample. 7. with suitable blood test values for standard concurrent chemotherapy (hb \> 10 mg/dl, anc \> 1.5 cells/mm3, platelets \> 100,000 cells/mm3, creatinine \< 1.5 x uln, bilirubin \< 3 x uln, alt \< 3 x uln) as deemed by a medical oncologist in team. 8. the patient must be expected to tolerate the treatment and be compliant for follow up. 9. no contradiction for chemoradiation such as inflammatory bowel disease, pregnancy, etc. 10. willing to consent to participate in the study. exclusion criteria: 1. two or more synchronous primary cancers. 2. when prosthetic materials (e.g. hip prostheses) are present close to the target volume, it must be considered if this may introduce uncertainties in dose calculations, which may affect the treatment planning process. 3. ulcerative colitis or any other histologically confirmed inflammatory bowel disease. 4. poor reliability for follow-up and treatment completion.

Keywords: impt imrt anal canal
spectacles for patients with down syndrome

Conditions: Vision, Low

Summary: this study tests the hypothesis that objectively derived spectacle prescriptions based on wavefront aberration measurements of the eyes of individuals with down syndrome can provide an improvement in visual acuity over that obtained with spectacle prescriptions based on standard clinical prescribing techniques. the objectively derived prescriptions are derived using strategies to optimize retinal image quality as measured by image quality metrics, and thus these prescriptions will be referred to as metric-derived.

individuals with down syndrome suffer from significant ocular complications including high levels of lower-order refractive error (sphere and cylinder) and elevated levels of higher-order aberrations. these optical factors likely contribute to the poor acuity observed in this population. current clinical prescribing practices may under-serve this community, as the cognitive demands of the subjective refraction sequence are difficult for this population and often leave clinicians to prescribe from objective clinical findings that target full correction of sphero-cylindrical refractive error. this prescribing practice can lead to sub-par outcomes given the fact that full lower-order corrections can exacerbate the effects of higher-order aberrations in more aberrated eyes. for this study, individuals with down syndrome will be dispensed three pairs of spectacles for 2 months each, in random order: one clinically-derived, and two objectively-derived refractions based upon methods designed to optimize a given metric of retinal image quality which takes into consideration the wavefront aberration measurements of the eye. both initial and adapted visual acuity in the presence of each correction will be evaluated to determine whether the objectively-derived refractions outperform clinically-derived refractions.

Eligibility criteria:
inclusion criteria: * diagnosis of down syndrome exclusion criteria: * nystagmus (involuntary beating movement of the eyes) * visually significant media opacities (e.g. cataracts or corneal scars) * strabismic amblyopia (reduced vision in one eye related to a constant eye-turn) * anisometropic amblyopia (reduced vision in one eye related to a long-standing uncompensated difference in prescription between the two eyes)
rhythmic auditory stimulation on upper-limb movements in pd patients

Conditions: Acoustic Stimulation; Parkinson Disease; Movement, Abnormal; Bradykinesia; Arm

Summary: the goal of this clinical trial is to examine effects of training involving rhythmic auditory stimulation (ras) on upper-limb movements and functions in patients with parkinson's disease (pd). this study employed a 21-day randomized controlled trial design to evaluate the efficacy of upper-limb training involving ras on upper-limb function and neural activity in pd patients. the ras group showed sustained improvements at one-month follow-up.

this study employed a randomized controlled trial design. we randomly assigned pd patients into either the ras group (experimental) or the noras group (control). both groups underwent a 21-day training program (40 minutes per session, one session daily), with the only difference being the presence or absence of ras. assessments were conducted at five time points: baseline (t1), day 8 (t2), day 15 (t3), post-intervention (t4), and one-month follow-up (t5). behavioral assessments were performed at all time points, while eeg recordings were only conducted at baseline (t1) and post-intervention (t4). all assessments and training sessions were scheduled during participants' medication 'on' state (1-2 hours after medication intake) to ensure consistency and optimal motor function.

Eligibility criteria:
inclusion criteria: * idiopathic pd diagnosed by a neurologist based on the movement disorders society clinical diagnostic criteria; * the hoehn and yahr stage is 2 or 3, meaning that bilateral movement problems or combination with mild postural instability; * a score of montreal cognitive assessment is equal to or higher than 21 to ensure that they understand experimental instructions; * a score of edinburgh handedness inventory is above 60 to ensure that they are right-handed; * types and doses of medications remain unchanged in the past month right before participation. exclusion criteria: * the presence of medical conditions or diseases that may affect hand movements, vision, or hearing based on self-report.
stereotactic radiotherapy for oligo-progressive metastatic cancer (the stop trial)

Conditions: Metastatic Cancer

Summary: a multicenter randomized phase ii trial of stereotactic body radiotherapy for oligo-progressive metastatic cancers. eligible patients will be randomized in a 1:2 ratio between receiving their standard of care therapy or stereotactic ablative radiotherapy (sabr) to all sites of oligo-progressive lesions.radiotherapy will be administered as soon as possible following randomization, and subjects will be followed until next disease progression. the primary outcome is progression-free survival (pfs).


Eligibility criteria:
inclusion criteria: * age 18 or older * willing to provide informed consent * histologically confirmed non-small cell lung cancer (nsclc) with metastatic disease detected on imaging. biopsy of metastasis at some time point prior to enrollment is preferred, but not required. * eastern cooperative oncology group (ecog) performance status 0-2 * life expectancy \> 3 months * patient has received treatment with systemic therapy (either cytotoxic or targeted, including maintenance therapies) during the past 6 weeks. this most recent systemic therapy agent must have been delivered for a total of at least 3 months, with an initial partial response (pr), complete response (cr) or stable disease (cr) prior to the development of oligo-progressive lesions. * oligoprogression, defined as response evaluation criteria in solid tumors (recist)-documented progression in up to 5 individual lesions, with no previous radiation or radiofrequency ablation to those sites. oligoprogression may be defined as: * progression of an individual metastasis according to recist 1.1 criteria * unambiguous development of a new metastatic lesion at least 5mm in size * progressive enlargement of a known metastasis on 2 consecutive imaging studies 2- 3 months apart with a minimum 5mm increase in size from baseline * all sites of oligoprogression can be safely treated * maximum 3 progressing metastases in any single organ system (i.e. lung, liver, brain, bone), and the total number of metastases must be 5 or less note for patients with brain metastases: for patients with brain metastases and oligo-progression elsewhere where stereotactic radiation to the brain is deemed to be warranted, this must be specified prior to randomization. if randomized to standard arm, patient would receive stereotactic radiation to brain only. if randomized to experimental arm, patient would receive stereotactic radiation to brain and to body lesions exclusion criteria: * serious medical comorbidities precluding radiotherapy, such as ataxia-telangiectasia or scleroderma. for patients with oligoprogressive lesions in the lung or thorax, this includes interstitial lung disease * prior radiotherapy to a site requiring treatment * malignant pleural effusion * inability to treat all sites of enlarging, oligoprogressive disease * clinical or radiological evidence of spinal cord compression or tumor within 3mm of spinal cord on mri * any other condition which in the judgment of the investigator would make the patient inappropriate for entry into this study
periodized aerobic interval training in metabolic syndrome

Conditions: Metabolic Syndrome; Metabolic Syndrome X

Summary: autonomic disfunction present in metabolic syndrome subjects is related by a greater vulnerability of the heart and risk of cardiovascular events. in this context, aerobic interval training has been highlighted by its easy applicability and benefits effects in autonomic modulation in different populations. therefore the studies that use de aerobic interval training in this different populations didn't realize a periodization of training with preparatory periods with progressive increase of load, specific phases with less duration predominating the intensity and transition periods for recuperation. additionally, there isn't studies that investigate the effects of aerobic interval training in autonomic modulation of individuals with metabolic syndrome. in this context, periodized aerobic interval training can arise like a new type of treatment that offering security and efficacy in subjects with metabolic syndrome. so, the aim of the study is evaluate the effect of periodized aerobic interval training in cardiac autonomic modulation and cardiovascular and anthropometric parameters of individuals with metabolic syndrome.


Eligibility criteria:
inclusion criteria: * metabolic syndrome according to international diabetes federation (idf) definition * aged between 40 to 60 years exclusion criteria: * participants who are currently participating in any regular exercise programs last six months; * use of drugs or medication (except for risk factors of metabolic syndrome control); * inflammatory or infectious process; * musculotendinous or osteoarticular injuries in the lower limbs and/or spine; * chronic pulmonary disease; * neurological disorders; * cardiovascular disease.

Keywords: metabolic syndrome x autonomic nervous system aerobic exercise exercise heart rate
evaluating effectiveness of dyadic prolonged exposure on 2-4 years old vs. toddler-parent focused treatment

Conditions: Post-Traumatic Stress Disorder in Children

Summary: traumatic events have potentially debilitating long-lasting effects on the child's normal development and, therefore, should be effectively treated. prolonged exposure (pe) therapy has been found to be effective in reducing posttraumatic stress disorder symptoms in adults and in adolescents. it has not yet been tested in toddlers. the purpose of this study is to examine the treatment efficacy of 2 methods of treatment for toddlers with ptsd and their parents. a randomized control trial could examine the efficacy of pe versus dyadic play therapy (tp-ct). exploration of these questions under more rigorous conditions would help broaden our knowledge about developmentally sensitive treatment tools for this age group. our research hypotheses are: 1. pe would more effective than tp-ct in reducing post-traumatic symptoms in toddlers. 2. pe would more effective than tp-ct in reducing post-traumatic symptoms of the toddlers' parents. 3. these results will be preserved in a follow-up of 3-6 months post treatment. following psychiatric assessment, 100 toddlers will be randomly assigned to pe and tp-ct (50 participants in each group).

beyond what was detailed in the previous section of the brief summary, it should be noted that the toddlers will be assessed and treated at least 1 month post-trauma and at least 1 month after discharge from hospital in order to avoid acute reaction either to the traumatic event or to the medical procedures during their hospitalization and adjustment problems.

Eligibility criteria:
inclusion criteria: 1. hebrew speaking toddlers with ptsd related to traumatic experience that occured at least 1 month prior to the study enrollment 2. toddlers whose parents are living together exclusion criteria: 1. toddlers which are still dealing with an active life threatening illness and are hence going through medical procedures. 2. toddlers with intelectual developmental disorder 3. toddlers with an active psychosis 4. toddlers with blindness or deafness 5. toddlers who are currently taking psychotropic medication 6. toddlers and parents that receive psycotherapy outside of the study for their ptsd symptoms 7. toddlers diagnozed with autism spectrum disorder 8. toddlers who were exposed to domestic or sexual violence

Keywords: toddlers; preschoolers; ptsd
histological change of the dentinal-pulp complex and root resorption

Conditions: Laser; Intrusion; Histology; Resorption

Summary: the purpose of the study is evaluate the histological changes of the dentinal-pulp complex and root resorption in maxillary premolars with intrusive orthodontic movement under a low power laser effects.

orthodontics movements can cause inflamatory changes in the pulp and external inflamatory root resorption, different methods have been suggested to control that changes as the use of the low power laser. the objective of this study is to evaluate the low power laser effect on the inflamatory pulpar change and inflamatory external root resorption in maxillary premolars with intrusive orthodontic movements of 4 ounces during 12 weeks. total sample were 34 healthy teeth, 16 were used to evaluate the normal standar and 18 were divided in two groups, the experimental group with the low power laser effect had a dose of 18 joules after activations of the orthodontic intrusion and the control group had a simulated effect in the same orthodontic movement. teeth were extacted after 12 weeks and histological changes were evaluated in the dentinal-pulp complex and the pesence of external inflamatory root resorption. findins suggest that low power. laser decreased the inflamatory changes of the dentinal - pulp complex and the severity of the external inflamatory root resorption.

Eligibility criteria:
inclusion criteria: * patients with first premolar extraction indicated * patients with no sistemic diseases * healthy premolars with completed root and no trauma or restoration exclusion criteria: * sistemics diseased * restoration, trauma in first premolars * root uncompleted

Keywords: root resorption low-power laser orthodontic tooth movement pulp changes
an investigational drug, pf-02341066 is being studied versus standard of care in patients with advanced non-small cell lung cancer with a specific gene profile involving the anaplastic lymphoma kinase (alk) gene

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this is a phase 3 trial comparing the safety and anti-tumor activity of pf-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the alk gene after failure of one previous chemotherapy regimen that included one platinum drug.


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven diagnosis of non-small cell lung cancer * positive for the alk fusion gene (test provided by a central laboratory) * must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug * tumors must be measurable exclusion criteria: * prior treatment with pf-02341066 * current treatment in another clinical trial

Keywords: lung neoplasms alk gene crizotinib