Kornimate/medical-research-clean huggingface dataset:
phase ii clinical trial of concurrent chemoradiotherapy combined nimotuzumab for stage iib-iva cervical cancer

Conditions: Cervical Cancer

Summary: the purpose of this phase ii trial is to determine the feasibility and efficacy of nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical cancer.

for locally advanced cervical cancer, radical radiation with concurrent chemotherapy remains the standard treatment recommended by nccn. however, in more than 35% of cases, tumor persistence recurrence or metastasis would occur after chemoradiation. nimotuzumab, belongs to anti-egfr monoclonal antibodies, has proved to be useful in multiple solid tumors, such as npc, colorectal cancer, etc. in recent years, nimotuzumab was also applied in recurrence or metastasis cervical cancer. it was proved to be well tolerated and might have a role in the treatment of advanced cervical cancer. however, there is no publication about nimotuzumab used in locally advanced cervical cancer.

Eligibility criteria:
inclusion criteria: * 18 years to 70 years，female * histological diagnosis of squamous cell carcinoma of cervix, figo stage iib-iva,with diameter 4-6 cm, without distant metastasis. * no chance of surgery confirmed by more than two deputy chief doctors of gynecology. * moderate or high expression of egfr * the function of main organ is normal, including blood, heart, lung, liver, and kidney. without history of hypertension, stroke. blood pressure is normal before treatment. * wbc≥3.5×10e9/l，anc≥1.5×10e9/l；hb≥90g/l，plt≥100×10e9/l * alt, ast and cr below 1.5 times of normal level * willing to accept treatment * ability to comply with trial requirements kps≥70 exclusion criteria: * evidence of distance metastasis * impossible to measure the diameter of tumor, or the tumor is too huge (diameter\>6cm) * couldn't examine with pelvic mri due to a variety of reasons * used to treat with radiotherapy chemotherapy or molecular target therapy and immune therapy * diagnosed with another malignant tumor in 5 years * used to be a volunteer of other clinical trial. * used to be allergic reaction with grade 3 or 4 degree to any experimental drugs * severe medical history of lung ,liver, kidney or heart. * active infection in any part of the whole body. * examination results showed radiotherapy contraindications

Keywords: cervical cancer cisplatin nimotuzumab
treatment of pectus excavatum deformity using macrolane filler

Conditions: Pectus Excavatum Deformity

Summary: this is a prospective, open, non-comparative and baseline-controlled study to evaluate efficacy and safety of macrolane vrf20 treatment in 40 subjects with pectus excavatum deformity. each subject participating in the study will be treated with approximately 50-150 ml of macrolane vrf20. the amount of study product used will be individually determined in order to achieve an optimal correction of the deformity in each subject.


Eligibility criteria:
inclusion criteria: 1. give verbal and written informed consent to participate in the study. 2. be a healthy male of 18 years or more. 3. have a pectus excavatum deformity without functional problems; score 4 in items 10, 11 and 12 of the peeq, indicating there is no functional impairment due to the pectus excavatum deformation. 4. present normal cardiac function as assessed by ecg and echocardiogram. 5. present normal pulmonary function as assessed by pulmonary function test. 6. present a chest x-ray taken within 12 months prior to the baseline visit, without clinically significant defects to heart, lungs, skeleton, ribs, sternum or spinal cord except for the pectus excavatum defect, in the opinion of the investigator. 7. have the ability to understand and comply with the requirements of the study. exclusion criteria: 1. score 1, 2 or 3 in either of items 10, 11 and 12 of the peeq, indicative of functional problems due to the pectus excavatum deformity. 2. previous treatment for the same indication. 3. known or suspected hypersensitivity to hyaluronic acid based products. 4. bmi \< 20. 5. a history of severe allergies manifested by a history of anaphylaxis, or a history or presence of multiple severe allergies (as judged by the investigator). 6. known allergy to any anesthesia planned during the study. 7. presence of autoimmune disease or other chronic disease that in the opinion of the investigator may interfere with the outcome of the study. 8. subjects with bleeding disorders or subjects who are taking thrombolytics or anticoagulants, or have taken inhibitors of platelet aggregation, including non-steroidal anti-inflammatory agents and acetylsalicylic acid, two weeks before treatment. 9. subjects on immunomodulatory therapy (suppressive or stimulatory). 10. subjects with contraindications for mri, such as presence of pacemaker, clips or splinter, or tendency for claustrophobia. 11. any condition which in the opinion of the investigator makes the subject unsuitable for inclusion (e.g., subjects not likely to participate for the duration of the study). 12. use of any investigational drugs or devices within 30 days prior to baseline. 13. subjects who are study site staff for this study, or close relatives of the study site staff, as well as subjects who are employed by the sponsor company, or close relatives of employees at the sponsor company.

Keywords: pectus excavatum funnel chest sunken chest
results of rotator cuff repair

Conditions: Shoulder Dislocation

Summary: the primary objective of this research is to examine the result of rotator cuff repairs following acute shoulder dislocations and to investigate whether timing of surgery following acute shoulder dislocations affects patients perception of pain, function, and strength following surgery.

there is a higher risk of rotator cuff tears following dislocation when the individual is greater than 40 years old. rotator cuff tears after dislocation of the shoulder are more of a challenge to repair particularly if there is a delay in diagnosis. clinical experience would suggest that rotator cuff repair within the first month of injury allows for better results in acute rotator cuff tears without shoulder dislocation. there are no reported results for rotator cuff repairs following shoulder dislocation and timing of repair. if we find that early repair provides better results this will be important for primary care providers and emergency department physicians to refer these patients early for evaluation and subsequently earlier treatment.

Eligibility criteria:
inclusion criteria: * age 35 years or older with acute rotator cuff tear following documented shoulder dislocation requiring reduction, subjects sustained acute rotator cuff tear following shoulder dislocation that was treated surgically with open and/or arthroscopic technique between january 1, 2001 and june 1, 2011, surgical intervention within 6 months of dislocation, minimum follow up time of one year from surgery. exclusion criteria: * rotator cuff tears without shoulder dislocation, known previous rotator cuff disease, history of other trauma to the shoulder, inability to provide informed consent, other suspect pathology (ie: tumor, infection).

Keywords: rotator cuff tears dislocation shoulder dislocation
comparative study of cardiac adrenergic function explored by i-123-mibg and czt camera (d-spect) versus anger camera in patients with heart failure

Conditions: Heart Failure

Summary: cardiological examination constitute one of the major directions in nuclear medicine for detection of myocardial ischemia in patients suspected of coronary disease. in caen, they constitute 20% of the activity of nuclear medicine. systolic heart failure (hf) ischemic or nonischemic origin represents a new area of activity of the nuclear cardiology. this is hf stratification study based on cardiac adrenergic function after injection of a tracer: i-123-mibg. the team caen nuclear cardiology is one of two teams recognized internationally in the field of evaluating the cardiac sympathetic innervation in cardiomyopathies. numerous publications from 1992 to the present day have reported encouraging results for the daily use of this tracer in the evaluation of patients with lv dysfunction ic. recently, interest in using the mibg has been shown as a prognostic marker of hf in a prospective study of 961 patients. typically, the camera used was an anger camera with collimating nai standard called parallel holes. the main objective is to validate the measurements of cardiac adrenergic function evaluated by cardiopulmonary mediastinal reports and sympathetic innervation scores vg after injection of i-123-mibg in 80 patients with heart failure.


Eligibility criteria:
inclusion criteria: * age above 18 years (except major patients under guardianship) * patient who signed the consent form * written and spoken french * beneficiaries of the social security system * stable heart failure with lv dysfunction (\<45%) of ischemic or nonischemic origin exclusion criteria: * patients with a recent history (\<21 days) acute coronary failure (myocardial infarction, unstable angina) * patients with severe extra-cardiac disease may interfere with treatment decisions (cancer, severe hepatic or renal impairment) * major patients under guardianship * pregnant or lactating women * women in age and condition of childbearing * patients unable to understand the purpose of the study
supporting the wellness of ontario physicians during covid-19

Conditions: Mental Health Wellness 1; Anxiety; Happiness

Summary: in light of the coronavirus pandemic, the challenge of physician burnout has taken on a new urgency. long-hours and difficult, sometimes unsafe work conditions are creating a severe strain for emergency physicians and others on the frontlines of ontario's response to covid-19. there are a variety of evidence-informed ways that physicians can protect their wellbeing with modest investments of time and energy that will be applied. the evaluation will be a randomized trial comparing the outcomes from each of the three treatment arms. researchers may also use a pre-post comparison with control parameters to conduct an exploratory analysis to assess efficacy.


Eligibility criteria:
inclusion criteria: * active membership to the ontario medical association (oma). up-to-date cell phone information registered to the oma. exclusion criteria: * participation in the oma physician burnout task force. opt-out from the intervention.
comparison of two different procedures for plexus anesthesia

Conditions: Wounds and Injuries

Summary: the purpose of this study is to investigate the influence of difference positioning on extension and efficacy of brachial plexus anesthesia at 20 minutes by using the axillary plexus block with supine positioning and a lateral positioning onto the non-anaesthetized side, combined with 20° trendelenburg positioning.


Eligibility criteria:
inclusion criteria: * single shot axillary block exclusion criteria: * lateral position not possible

Keywords: nerve block regional anesthesia injuries diverse malformations
compassionate use of the becker expander/breast implant

Conditions: Breast Reconstruction

Summary: to provide access of the becker expander/breast implant to women who do not meet inclusion/exclusion criteria of the becker continued access study patients' physician will contact mentor to request use of the device and each request will be reviewed by mentor, an irb, and the fda on a case-by-case basis


Eligibility criteria:
inclusion criteria: * women who require a becker expander/breast implant who do not meet inclusion/exclusion criteria of the becker continued access study
ultrasonic system for cataract characterization and optimal phacoemulsification energy evaluation

Conditions: Cataract; Ultrasound Therapy; Complications

Summary: this study aims to assess the performance of an ultrasonic system for automatic classification of cataract type and severity, as well as the estimation of the optimal phacoemulsification energy. ultrasonic signals from the lens will be acquired with the experimental medical device (esus) in participants with cataract, and in healthy subjects (control). the proposed technique may represent an important advance in cataract treatment. the quantitative and automatic classification of cataract type and severity, and the estimation of the optimal phacoemulsification energy is may represent a valuable tool for surgical planning, reducing complications associated to excessive levels of phacoemulsification energy, as well as the times spent on surgeries. this device may be relevant not only for patients, but also for public health systems, reducing waiting lists and associated costs.

this is a prospective, pivotal, non-blinded study. fifty (50) participants will be recruited at the coimbra surgical center of portugal. the study will be conducted on subjects with age-related cataract, and on healthy subjects as control group. since this is a pilot study, no sample size estimation has been implemented. the statistical power will be determined at the end of the study. only per-protocol participants will be considered on statistical analysis. procedures involved. the ultrasonic system (experimental medical device - esus) works in a-scan mode, with an acoustic working frequency of 20 mhz. from the ultrasonic signals backscattered from the lenses, acoustic parameters will be extracted, and used for automatic algorithms implementation. this study will be implemented once. slit lamp with locs iii classification will be used as comparator. contrast sensitivity test results will be used for incipient cataract detection, where slit lamp may present some limitations. optical coherence tomography and specular microscopy will help on detecting postoperative complications; other complications identified by the physician will be also considered. surgical parameters as phacoemulsification energy and surgical time will help on phacoemulsification energy evaluation. safety assessment. the system uses an ophthalmic probe. there are not anticipated adverse events related to the procedures involved in the use of the ultrasonic system, or any other procedure in the protocol. the safety conditions will be monitored through the occurrence of unanticipated adverse events or serious adverse events. if these situations occur, the event will be reported to the competent authorities (in agreement with the current regulation) and the corrective actions will be implemented.

Eligibility criteria:
inclusion criteria: cataract group: * patients with age-related cataract; * indication of phacoemulsification surgery control group: • patients without cataract exclusion criteria: • presence of any other ophthalmological condition or systemic disease that could affect the results
dronabinol versus standard ondansetron antiemetic therapy in preventing delayed-onset chemotherapy-induced nausea and vomiting

Conditions: Chemotherapy Induced Nausea and Vomiting

Summary: the primary purpose of the study is to determine the efficacy of oral dronabinol versus standard ondansetron antiemetic therapy in preventing delayed-onset chemotherapy-induced nausea and vomiting (cinv) or retching by measuring the incidence of total response of nausea and vomiting and/or retching following administration of moderate-to-high emetogenic chemotherapeutic agents.


Eligibility criteria:
inclusion criteria: * histological evidence of non-cns malignancy (primary or metastatic disease) and lymphomas which are not involving the bone marrow. * undergoing single or multiple days of chemotherapy as long as day 1 chemotherapy includes: 1. a moderate-to-high emetogenic regimen, or 2. oxaliplatin at doses employed for treatment of colon cancer, or 3. the combination of ac \[adriamycinò (60 mg/m2) with cyclophosphamide (600 mg/m2)\] as to be used for the chemotherapeutic drug regimen involving taxanes in the treatment of breast cancer. exclusion criteria: * chemotherapy agents falling into the low (level 1), moderate-to-low (level 2), moderate (level 3) unless used in combination with a level 4 chemotherapy agent on day 1 of the study. * chemotherapy agents falling into the high (level 5) classification during study. * any combination of chemotherapy agents that does not fall into the moderate-to-high (level 4) classification

Keywords: cinv chemotherapy nausea vomiting retching
subcutaneous carbon dioxide insufflations for acute non specific neck pain

Conditions: Neck Pain

Summary: the purpose of the trial is to evaluate whether patients with acute non specific neck pain get pain free sooner, if treated with subcutaneous carbon dioxide insufflations compared to sham ultrasound.

subcutaneous carbon dioxide insufflations popular in central und eastern europe are a safe and inexpensive treatment modality in complementary medicine and are used mainly in musculoskeletal pain and vascular conditions. however, no rigorous trial exists on their efficacy. the study is designed as a double blind sham controlled randomized trial to evaluate whether patients with acute non specific neck pain get pain free sooner, if treated with subcutaneous carbon dioxide insufflations compared to sham ultrasound.since acute non specific neck pain is often self limiting, speed of recovery rather than outcome at fixed points in time is evaluated. participants receive either a maximum number of 9 subcutaneous carbon dioxide insufflations or a maximum number of 9 sham ultrasound administered by 4 therapists in a randomized order, thrice weekly. carbon dioxide gas is insufflated subcutaneously at the locations of neck muscle tenderness. per tender location 25 ml carbon dioxide gas is administered. primary outcome measure is recorded daily by means of a diary. analysis is done by intention to treat. differences in time curves are tested using the logrank test. time curves are graphically displayed by a 1 minus survival kaplan-meier plot.

Eligibility criteria:
inclusion criteria: * participants must report neck pain lasting for less than 7 days * participants must report a current pain intensity of ≥ 40 mm on a 100 mm visual analogue scale. * participants must state local neck muscles tenderness during clinical examination at one or more locations exclusion criteria: * neck pain of specific etiology (e.g., radiculopathy, infection, inflammation, primary tumor, or metastases) * whiplash injury * former neck surgery * pregnancy * breast feeding.

Keywords: neck pain complementary therapies subcutaneous carbon dioxide insufflations acute treatment
observational study on the patients with pain medications

Conditions: Pain

Summary: the purpose of this study is to describe the use of pain treatments in taiwan, the demographics, clinical characteristics of patients requiring pain treatments, current treatments, outcomes of treatments and the reasons for changing pain medication during treatment.

this is a phase iv, multi-center, observational study to describe the use of pain treatments, the demographics, clinical characteristics of patients requiring pain treatments, current treatments, outcomes of treatments and the reasons for changing pain medication during treatment. the study is conducted in an effort to understand the status of pain control in taiwan. currently in taiwan, there is no approved documentation showing the most effective standard medication for treatment of patients in pain. observational study with no study medication administered.

Eligibility criteria:
inclusion criteria: * outpatients only * patients must have pain, previously treated with and without medication and have a vas (visual analogue scale) score recorded at the enrolment time * patient must have a vas score \>4 exclusion criteria: * patients who are receiving any investigational drug during the study * patients with known or suspected psychotic disease or mental retardation.

Keywords: pain observational taiwan
a study of targretin capsules in patients with aids-related kaposi's sarcoma

Conditions: Sarcoma, Kaposi; HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to give targretin capsules to patients with aids-related kaposi's sarcoma (ks).

this is a multicenter, open-label study to evaluate the safety and efficacy of targretin capsules in patients with aids-related ks. note: the daily dose may be reduced as necessary for toxicity management.

Eligibility criteria:
inclusion criteria patients must have: * serum hiv antibody positive by elisa. * ks documented by biopsy (repeat biopsy is not required for entry if ks has been previously confirmed histologically and the histopathology report has been reviewed). * a minimum of 6 mucocutaneous ks lesions, including at least 3 raised lesions, each of which has been present for at least 30 days or has a longest dimension of at least 10mm, and has not received prior local or topical therapy within 60 days of study entry. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * concurrent, serious, uncontrolled infection including, but not limited to: * mycobacterium avium intracellulare or other mycobacterium infection; pneumocystis carinii pneumonia; cmv retinitis or colitis; toxoplasma brain abscess; cryptococcal meningitis. * serious intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program. * known allergy or sensitivity to retinoid class drugs. concurrent medication: excluded: * local or topical therapy such as, but not limited to, vitamin a, tretinoin (all-trans-retinoic acid), other retinoid class drugs, or intralesional (injection) therapy to any ks indicator lesion. * systemic anticancer chemotherapy, systemic anticancer hormonal therapy, and/or systemic anticancer immunotherapy. * systemic use of retinoid class drugs, beta-carotene compounds, or vitamin a in doses greater than 15,000 iu (5,000 mcg) per day (equivalent to approximately 3 times the rda) for any indication. * human chorionic gonadotropin. concurrent treatment: excluded: radiotherapy, cryotherapy, photodynamic therapy, and/or laser therapy for any ks indicator lesion. prior medication: excluded: * systemic treatment of ks within 30 days of study entry. * systemic treatment with either vitamin a in doses greater than 15,000 iu (5,000 mcg) per day (equivalent to approximately 3 times the rda) or other retinoid class drugs for any indication within 30 days of study entry. * previous local or topical therapy of any ks indicator lesion such as, but not limited to, vitamin a, tretinoin (all-trans-retinoic acid), other retinoid class drugs, or intralesional (injection) therapy within 60 days of study entry. prior treatment: excluded: * radiotherapy, cryotherapy, photodynamic therapy and/or laser therapy within 60 days of study entry.

Keywords: sarcoma, kaposi acquired immunodeficiency syndrome anticarcinogenic agents