Kornimate/medical-research-clean huggingface dataset:
alk inhibitor in metastatic colorectal cancer with alk mutation.

Conditions: Colorectal Cancer

Summary: this clinical trial aims to evaluate the efficacy, safety of alk inhibitor in metastatic colorectal cancer patients with alk mutation.


Eligibility criteria:
inclusion criteria: patients should be histologically diagnosed with metastatic colorectal cancer or postoperative recurrence; patients with alk mutation(including mutation, fusion, rearrangements ); patients have measurable lesions; patients are not available for targeted therapy or patients refuse to receive targeted therapy afer second-line treatment; over 3 weeks after radiotherapy and the radiotherapy focus was not be measured; age should be 18-25 years; performance status should be 0-2; life expectancy should be more than 12 weeks; exclusion criteria: patients underwented major surgery or severe trauma within 4 weeks; patients allergiced to experimental drugs; patient ready to give birth or who is pregnant; patients with brain metastases; patients with chemotherapy contraindication; patients could not tolerate chemotherapy; patients have secondary primary tumor.

Keywords: alk mutation alk inhibitor metastatic colorectal cancer
parent-mediated developmental behavioral intervention

Conditions: Autism Spectrum Disorder

Summary: this study explores the effectiveness of two intervention programs: "long-distance developmental behavioral intervention" and "developmental behavioral interventions" for children with autism spectrum disorder or multiple developmental delays.


Eligibility criteria:
inclusion criteria: * child's age between 30-84 months old. * children have a diagnosis of autism spectrum disorder or multiple developmental delays. * children without physical disabilities or major health problems, such as congenital limb defects. * one of the fathers or mothers involved in the study shall be the primary caregiver of the child. * the father or mother participating in the study has at least 9 education years and can read and understand chinese. * the father or mother participating in the study is willing to allow the child to undergo a comprehensive development assessment and is willing to video during the training process. exclusion criteria: * absence of chromosome abnormalities, congenital anomalies, and major neurological or sensory impairments or disorders (e.g., cerebral palsy, microcephalus, macrocephalus, severe brain damage, uncorrected vision, or hearing loss).

Keywords: asd early intervention development
late phase acute pancreatitis: a tailored step-up approach

Conditions: Acute Pancreatitis

Summary: several interventional and surgical procedures are available to treat moderate-to-critical acute pancreatitis (ap) in its late phase. the ongoing debate on these options, together with the scarcity of reported mid-term follow-up information in the literature, prompted the investigators to conduct a review of our surgical experience, focused on those issues. the investigators reviewed retrospectively all the patients treated for moderate-to-critical ap according to determinant-based classification (dbc), in the last nine years. patients treated conservatively or operated within 4 weeks of the onset of the pancreatitis were excluded. all the included patients were managed following a "tailored" step-up approach, and divided into four groups, according to the first interventional procedure performed: percutaneous drainage (pd), endoscopic approach (end), internal derivation (int), and necrosectomy (ne). in-hospital and mid-term follow-up variables, including a quality-of-life assessment, were analyzed and compared.

the following variables were evaluated: sex, age, severity of inflammation according to the dbc classification, pa etiology, ct scan severity index according to balthazar criteria , clinical prognostic score using bedside index of severity of acute pancreatitis (bisap) score. total length of hospitalization, operative management, necrosis cultures, total and post-interventional intensive unit care (icu) were also recorded and analyzed together with the in-hospital morbidity, mortality and re-admissions. patients were checked after discharge within 14 days and followed monthly as outpatients by gastroenterologists. a ct scan was performed within 4 months, or before in case of recurrent symptoms. during the follow-up, the english standard short form 36 (sf-36) questionnaire was used to evaluate the general quality of life at three and six months, one and two years. the sf-36 examines 8 areas consisting of social and physical function, physical and emotional well-being, bodily pain, vitality, mental health and overall general health perception. at the six-month follow-up, the patients also completed a specific questionnaire about the pancreatic function. in particular, the total score takes in consideration abdominal pain using visual analogue pain score, diarrhea, unintentional weight loss, new onset of diabetes and use of enzyme supplementation. the score ranges between zero to five (all symptoms present). the work has been reported in line with the strocss criteria

Eligibility criteria:
inclusion criteria: * patients treated at our referral center for moderate to critical ap, as classified by determinant-based classification of acute pancreatitis severity exclusion criteria: * patients who had undergone conservative treatment, * patients who has been operated within 4 weeks (early phase)

Keywords: acute pancreatitis walled-off necrosis surgical treatment quality of life
a study investigating the relationship between the development of laronidase antibody and urinary gag (glycosaminoglycan) levels in aldurazyme® treated patients

Conditions: Mucopolysaccharidosis I; Hurler's Syndrome; Hurler-Scheie Syndrome; Scheie's Syndrome

Summary: the purpose of this study is to determine whether the development of antibodies to laronidase in patients with mps i receiving aldurazyme® impairs the clearance of gag substrate.


Eligibility criteria:
inclusion criteria: * have a documented diagnosis of mps i confirmed by measurable signs and symptoms and deficient α-l-iduronidase activity (\<10% of the lower limit of normal). * for a patients receiving aldurazyme therapy prior to study entry: have available as baseline data the results of urinary gag levels and igg antibody titers collected prior to the patient's first aldurazyme infusion. * provide signed, written informed consent prior to any protocol-related procedures being performed. consent of a legally authorized guardian(s) is (are) required for patients under 18 years. exclusion criteria: * have previously received aldurazyme without the collection of baseline samples as specified. * have a suspected hypersensitivity to aldurazyme or a know hypersensitivity to components of infusion solution. * have received a hematopoietic stem cell transplantation, injection fibroblast therapy, or major organ transplant. * are receiving chronic immunosuppressant therapy. * have a medical condition, serious intercurrent illness, or other extenuating circumstances that may interfere with study compliance including all prescribed evaluations and follow-up activities. * are pregnant or lactating * have received investigational drug within 30 days prior to study enrollment
expiratory muscle training in stroke

Conditions: Stroke; Mastication Disorder; Temporomandibular Disorders; Dysphagia; Stomatognathic Diseases

Summary: stroke affects the vital activities of daily living such as breathing and swallowing. after stroke excursion of the diaphragm reduces about 50%, and also the maximum expiratory pressure of the individual 50% or higher. dysphagia occurs in 29% to 45% of the acute stroke cases.

as a third leading cause of death and one of the major causes of disability, stroke still maintain its bad reputation in worldwide. stroke owes its fame on wide range of symptoms mostly the musculoskeletal system symptoms such as spasticity, equilibrium and gait problems. although mentioned symptoms keep their popularity devious two dysfunction caused by stroke; stomatognathic system dysfunction and respiratory dysfunction appears to change this equation. considering the high incidence of dysphagia and the reduced cardiopulmonary capacity of the stroke patients, it seems inevitable. from this perspective aim of this study is to assess the effect of expiratory muscle training on the stomatognathic system in patients with stroke and as mentioned aid to shatter the mentioned equation.

Eligibility criteria:
inclusion criteria: * mini mental score is 24 or higher * 55 years of age or higher * currently not taking respiratory muscle training * fonseca questionnaire score is 20 or higher * onset of stroke is between 3 months and 5 years exclusion criteria: * developed dysphagia caused by other diseases rather than stroke * repetitive stroke story * cancer in head and neck region * abdominal or thoracic surgery story * existence of neurodegenerative disease

Keywords: stroke mastication dysphagia temporomandibular joint
a study to determine the effect of bi-ventricular pacing on cardiac hemodynamics after coronary artery bypass graft

Conditions: Coronary Disease

Summary: the purpose of this study is to determine, using echocardiography, whether bi-ventricular pacing improves the contractile force by resynchronizing both ventricles, thereby improving and/or correcting the paradoxical septal movement. primary hypothesis: * bi-ventricular pacing post cardiac surgery will result in at least a 10% increase in cardiac index (ci) as compared with standard atrio-right ventricular pacing. secondary hypothesis: * bi-ventricular pacing post cardiac surgery will result in at least a 10% increase in cardiac index (ci) as compared with atrio-left ventricular pacing and right atrium pacing.

clinical trials done to date have focused on the efficacy of biventricular pacing (bvp) in the treatment of patients with congestive heart failure, intraventricular conduction delay, dilated cardiomyopathies, and post cardiac surgery. however, studies done in post cardiac surgery patients are limited by their small sample size (4-22 patients with overall of 51 patients), non-randomized pacing protocol and by their inability to determine a definitive mechanism for the improved hemodynamics observed with bvp. therefore, we propose to complete a pilot study aimed at determining both the magnitude of the hemodynamic benefit associated with bvp, if any. in addition, we will investigate changes in intra-ventricular septal motion as a possible mechanism for the previously observed changes in cardiac hemodynamics.

Eligibility criteria:
inclusion criteria: * all elective/emergent patients requiring isolated coronary artery bypass graft (cabg) at st. michael's hospital. exclusion criteria: * patient's age \< 18 years. * known atrial fibrillation. * sinus tachycardia \> 100 beats per minute (bpm). * post-operative ci \< 2. * high inotrope dosage post-operation: * dopamine (intropin) if \> 10 µg/kg/min. * dobutamine (dobutrex) if \> 10 µg/kg/min. * norepinephrine (levophed) if \> 0.1 µg/kg/min. * epinephrine if \> 0.1 µg/kg/min. * need for intraaortic balloon pump (iabp). * unable or unwilling to give informed consent. * already participating in another clinical trial.

Keywords: bi-ventricular pacing post coronary artery bypass graft coronary artery bypass graft
assessment of lumpectomy margins with the histolog scanner in comparison with intraoperative imaging techniques

Conditions: Breast Cancer

Summary: study to assess the capability of using the histolog scanner, a recent large field-of-view confocal laser scanning medical imaging device for the breast cancer detection in fresh lumpectomy margins.

breast cancer is the most common cancer in women. for early-stage breast cancers, breast-conserving surgery (bcs) is applied to excise the tumor while saving surrounding healthy tissue as much as possible to avoid radical excisions and achieve better aesthetic and psychological outcomes for the patient. this surgical approach requires postoperative tumor-free margin assessment of the surgical resection in order to carry on with next steps of the patient care treatment (e.g. radiotherapy). unfortunately, at least 20% of patient undergo more than one procedure to achieve acceptable margin status due to difficulties to identify subclinical and deep-seated tumor during bcs. during the surgery, the surgeon mainly relies on nonspecific visual changes and manual palpation of subtle irregularities to guide cancer excision. while these determinants enable bulk tumor assessment, they do not offer the information to adequately identify tumor infiltrates on lumpectomy margin. an efficient intraoperative assessment of the margin may solve these issues and confocal imaging has shown some promises by providing real-time imaging of fresh tissue with the resolution sufficient to visualize microscopic tissue features. the histolog scanner is a recent confocal microscope designed for clinical use on large surgical specimens. the main objective of this study is to confirm that the use of the histolog scanner by surgeons allows to detect breast cancer on lumpectomy margins and compare the performance of the detection with local standard-of-care intraoperative imaging techniques (ultrasound and radiography) using the final assessment performed in pathology as reference.

Eligibility criteria:
inclusion criteria: * adult female patient ≥18 years old * patient scheduled for breast conserving surgery of invasive and/ or in situ ductal carcinoma (dcis). * patient able to read, understand and give informed consent exclusion criteria: * patient previously treated for ipsilateral breast cancer surgery * patient with previous radiotherapy of the breast * patient with multicentric breast cancer * patients with planed mastectomy, tumor-adapted breast reduction * patient with presurgical neo-adjuvant treatment * patient is pregnant/lactating * participation in any other clinical study that would affect data acquisition

Keywords: breast cancer confocal microscopy fresh tissue imaging intraoperative assessment breast conserving surgery
evaluation of a novel integrative and intensive virtual rehabilitation program for service members post tbi

Conditions: Traumatic Brain Injury

Summary: the purpose of the study is to evaluate the feasibility and effectiveness of a novel virtual reality (vr) therapeutic rehabilitative device (brightbrainertm) to treat patients with traumatic brain injury (tbi). these patients, service members with tbi, can be both with and without upper limb dysfunction and use uni- and bimanual virtual reality (vr) exercises to improve cognitive and motor function, as well as mood.

bright cloud international corp created brightbrainer, a computerized virtual reality system that provides a combination of cognitive as well as motor skill training in an engaging and repetitive manner \[1\]. this project objective is to assess the feasibility and clinical benefit of utilizing the bbvr to augment the rehabilitation of service members with tbi. the brightbrainertm virtual reality (bbvr) rehabilitation system is unique because it is designed to provide integrative, customized, intensive and self-guided therapy that simultaneously addresses the cognitive, emotive and motor deficits. early evidence suggests that it has been effective for patients with cognitive deficits as the result of cerebrovascular accident or dementia, but has not yet been evaluated in a therapeutic intervention for patients with tbi. in addition to assessing the system's effect on patient's symptoms, we will also evaluate the feasibility of utilizing this system in a military environment by obtaining feedback from the patients and therapists, regarding system acceptance, reliability and ease of use.

Eligibility criteria:
inclusion criteria: * male or female military health care beneficiaries 18-67 years of age; * presence of tbi (based on standard veterans affairs (va)/ department of defense (dod) criteria); * with or without upper extremity dysfunction. upper extremity dysfunction includes but is not limited to decreased coordination, increased tone, decreased strength, and decreased sensation; * ability to follow study instructions and likely to complete all required visits for the study; * ability to understand spoken and written english; * at least 6 weeks post tbi. exclusion criteria: * age less than 18 or greater than 67; * blind or otherwise visually impaired to the extent that lack of sight inhibits utilizing the system; * deafness; * inability to understand or comprehend consenting to the study; * active psychosis, suicidal or homicidal ideations or frequent violent episodes; * currently enrolled in active substance abuse treatment * inability to even minimally operate bbvr controllers.

Keywords: tbi virtual reality
igf level in breast cancer patients treated with metformin

Conditions: Breast Cancer Female

Summary: the purpose of this study is to examine the impact of metformin as an adjuvant to chemotherapy on igf levels in both progressing and non progressing cases of metastatic breast cancer in female patients.

one hundred and seven women with metastatic breast cancer (mbc) are randomly assigned to either a metformin (500 mg twice daily) or placebo (placebo) group during chemotherapy. all patients followed the standard chemotherapy protocol developed by the south egypt cancer institute (seci). blood igf-1 levels were measured at the start of treatment (baseline) and again six months later.

Eligibility criteria:
inclusion criteria: * female patients with mbc * patients older than 18 * nondiabetic patients * patients who received only chemotherapy exclusion criteria: * patients with non-metastatic breast cancer * patients receiving hormonal therapy or radiotherapy * patients with diabetes * history of cardiac diseases * hypersensitivity, or allergy to metformin.

Keywords: metformin breast cancer igf
prevalence of coronal femoral bowing in the egyptian arthritic knee

Conditions: Arthritis Knee

Summary: to detect the prevalence of coronal femoral bowing in egyptian arthritic knee. the restoration of normal coronal alignment of the lower extremity is very important to surgeons who perform reconstructive surgery of the knee, such as total knee arthroplasty (tka). the importance of achieving normal coronal alignment of the lower extremity after tka is widely recognized . tkas with coronal malalignment tend to fail earlier than those with neutral alignment. 8 coronal alignment is considered key to the function and longevity of a tka. however, most studies do not consider femoral and tibial anatomical features such as coronal femoral bowing and the effects of these features and subsequent alignment on function after tka are unclear investigators therefore determined the prevalence of coronal femoral bowing, femoral condylar orientation (mldfa ) , and tibia plateau inclination (mmpta ) in osteoarthritic egyptian population

radiological methods : 1) standing anteroposterior radiographs of the full-length lower limb with patients in the standing position. ( hka long film radiographs ). measurements : 1. mechanical hip-knee-ankle axis (hka) angle: the angle formed by the mechanical axes of the femur and tibia 2. anatomical hip-knee-ankle axis (hka) angle: the angle formed by the anatomical axes of the femur and tibia 3. for condylar orientation : the mechanical lateral distal femoral angle (mldfa) was defined as an angle formed by the mechanical axis of the femur and the line connecting the distal ends of the medial and lateral femoral condyles of the femur. 4. for tibia plateau inclination : the mechanical lateral proximal tibial angle (mlpta) was defined as an angle formed by the mechanical axis of the tibia and the articular surface of the proximal tibia . 5. coronal femoral bowing using the method of yau et al. : the femoral diaphysis was divided into four equal parts, . because yau et al. didn't exactly describe the femoral diaphysis, we had defined the femoral diaphysis from the lower border of the lesser trochanter to upper border of the distal femoral segment which is defined by a square whose sides have the same length as the widest part of the femoral condyle so called rule of square (from the lowest level of the lesser trochanter to 5 cm above the lowest level of the lateral femoral condyle), and the midpoint of the endosteal intramedullary canal was depicted in each quarter. the angulation between midlines drawn in the proximal and distal quarters of the femoral diaphysis will be measured

Eligibility criteria:
inclusion criteria: -any advanced osteoarthritic patient schedual for tka exclusion criteria: * history of femoral or tibial fracture or osteotomy around the knee . * presence of a congenital anomaly in the femur or tibia . * history of prior knee or hip arthroplasty . * diagnosis other than primary osteoarthritis (ra-inflmmatory arthritis..etc) . * position in radiographs preventing complete evaluation of radiographic variables .
a trial of shr-1701 with or without famitinib in patients with advanced or metastatic nsclc

Conditions: Non-Small-Cell Lung Cancer

Summary: the study is being conducted to evaluate the efficacy and safety of shr-1701 with or without famitinib in patients with advanced or metastatic nsclc


Eligibility criteria:
inclusion criteria: 1. voluntarily participate in the study and sign the informed consent form; 2. 18 to 75 years old, both male and female; 3. histologically or cytologically confirmed stage iiib-iv or recurrent nsclc 4. one prior platinum-containing chemotherapy for advanced or metastatic disease; 5. measurable lesions by recist v1.1; 6. ecog score: 0-1; 7. life expectancy ≥ 3 months; 8. adequate hematological, hepatic and renal function; 9. non-surgically sterile female subjects of childbearing age must have a negative serum hcg test. exclusion criteria: 1. histologically or cytologically confirmed mixed sclc and nsclc; 2. known sensitising egfr mutation and/or alk translocation in patients with non-squamous nsclc; 3. tumor infiltration into the great vessels on imaging; 4. active cns metastases; 5. malignancies other than nsclc within 5 years; 6. anticancer therapy within 4 weeks before the start of trial treatment; 7. persisting toxicity related to prior therapy of grade \> 1; 8. treatment with systemic immunostimulatory agents within 4 weeks; 9. treatment with systemic immunosuppressive agents within 2 weeks; 10. autoimmune diseases; 11. interstitial lung disease or other lung diseases that is symptomatic or may interfere the management of suspected drug-related pulmonary toxicity; 12. clinically significant cardiovascular or cerebrovascular diseases; 13. inadequately controlled hypertension; 14. history of hemoptysis (≥ 2.5ml of bright red blood per episode) within 1 month; 15. venous or arterial thrombosis within 6 months; 16. evidence of bleeding diathesis or coagulopathy; 17. use of anticoagulants or thrombolytic agents that has not been stable; 18. active tuberculosis infection; 19. significant acute or chronic infections within 1 month; 20. known history of testing positive test for hiv or known aids; 21. hepatitis b virus or hepatitis c virus infection; 22. allergic to any component of the treatment regimen; 23. other conditions that in the opinion of the investigator would make participation in this clinical trial inappropriate.