Kornimate/medical-research-clean huggingface dataset:
neck surgery in treating patients with early-stage oral cancer

Conditions: Head and Neck Cancer

Summary: rationale: surgery may be an effective treatment for oral cancer. it is not yet known whether surgery to remove the tumor and lymph nodes in the neck is more effective than surgery to remove the tumor alone in treating patients with early-stage oral cancer. purpose: this randomized clinical trial is comparing two types of neck surgery to see how well they work in treating patients with early stage oral cancer.

objectives: * to determine whether the use of a selective neck dissection (send) used electively on all patients presenting with stage i-ii oral cavity squamous cell carcinoma (scc) improves survival, disease-free survival, and loco-regional disease control rates. * to determine how send and complex reconstruction affect quality of life and mental health. * to determine whether the use of send on all patients presenting with stage i-ii oral cavity scc represents a cost-effective use of resources. outline: this is a multicenter study. patients are stratified by age (\< 40 vs 40-64 vs ≥ 65 years of age), tumor stage (t1 vs t2), and surgeon. * arm i: patients undergo resection of the primary tumor with neck dissection. * arm ii: patients undergo resection of the primary tumor alone. patients complete the eortc qlq-c30, eortc qlq - h\&n35, and the hospital anxiety and depression scale (hads) before surgery and at 6, 12, and 24 months after surgery. patients also complete the eq-5d questionnaire at baseline, 6 months, 12 months, and 24 months. additionally, a self-completion health service use questionnaire is completed every 2 months, during the first 24 months after treatment, to enable costs to the nhs to be monitored. after surgery, patients are followed periodically for up to 5 years. peer reviewed and funded or endorsed by cancer research uk.

Eligibility criteria:
disease characteristics: * patients with oral squamous cell carcinoma measuring 1 to 3 cm at the primary site * no clinical or preoperative imaging evidence of nodal involvement in the neck (n0) * surgery is the primary mode of treatment * dose not need reconstruction that necessitates opening the neck, as assessed by the surgeon * no cancer of the lip * no prior head and neck tumor patient characteristics: * no technical, medical, or anaesthetic difficulties that preclude patients being entered into one of the trial arms * not considered to be medically, socially, or psychiatrically unfit for surgery as first-line treatment by the multidisciplinary team * no other synchronous tumor * no preference for non-surgical treatment prior concurrent therapy: * see disease characteristics

Keywords: stage i squamous cell carcinoma of the lip and oral cavity stage ii squamous cell carcinoma of the lip and oral cavity tongue cancer
effects of early use of nitazoxanide in patients with covid-19

Conditions: Covid19; Coronavirus

Summary: multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms. population: 392 patients with covid-19 (coronavirus disease-19), confirmed by rt-pcr (real time polymerase chain reaction), symptomatic in the early phase of the disease. experimental group: 196 patients, nitazoxanide 500mg 8 / 8 hours for 5 days. control group: 196 patients, placebo 8/8 hours for 5 days.

sarita-2 is a multicenter, randomized, placebo-controlled, parallel, -blinded, interventional, treatment clinical trial with two arms, which aims to study the impact of nitazoxanide in the early phase of the covid-19 (coronavirus disease-19). experimental group: 196 patients received nitazoxanide 500mg 8 / 8 hours for 5 days. control group: 196 patients received placebo 8/8 hours for 5 days. population: 392 patients with covid-19, confirmed by rt-pcr (real time polymerase chain reaction), symptomatic in the early phase of the disease. calculation of the sample size was based on a previous study which demonstrated that 78% of covid-19 patients in group 4 (hospitalized without oxygen therapy), according to the who ordinal classification, experienced complete resolution of symptoms after receiving placebo.10 in the present trial, patients were classified as group 2 (symptomatic and independent), and a greater degree of recovery as measured by symptom-free days (80%) was expected even after placebo. thus, assuming an 11% increase in symptom-free days in those patients who would receive nitazoxanide compared to placebo, we would need approximately 196 patients per experimental group, admitting a beta error of 15% and alpha error of 5%, for a total n of 392 patients. calculation of the sample size was done by g\*power 3.1.9.2 (universität düsseldorf, düsseldorf, germany).

Eligibility criteria:
inclusion criteria: * clinical scenario compatible with infection by the sars-cov-2 \[characteristic symptoms of covid-19 (fever and / or cough and / or fatigue) * beginning 1 to 3 days before inclusion in the study * age equal or superior to 18 years * willingness to receive study treatment * providing written and informed consent or the same consent signed by a family member exclusion criteria: * negative result of rt-pcr for sars-cov2 collected on admission * impossibility to use oral medications * history of severe liver disease (child pugh c class) * previous renal failure * severe heart failure (nyha 3 or 4) * copd (gold 3 and 4) * neoplasia in the last 5 years * known autoimmune disease * individuals with known hypersensitivity to study drug * previous treatment with the study medication during the last 30 days * clinical suspicion of tuberculosis and bacterial pneumonia

Keywords: covid19 coronavirus early treatment covid-19 new coronavirus treatment brazil nitazoxanide
sofosbuvir plus ribavirin in treatment-naive and treatment-experienced egyptian adults with chronic genotype 4 hepatitis c virus (hcv) infection

Conditions: Hepatitis C Virus

Summary: this study is to evaluate the safety, tolerability, and antiviral activity of sofosbuvir (sof) with ribavirin (rbv) in egyptian adults with chronic genotype 4 hepatitis c virus (hcv) infection.


Eligibility criteria:
inclusion criteria: * first generation egyptian; must have been born in egypt and can trace both maternal and paternal egyptian ancestry * treatment-experienced or treatment-naive * chronic genotype 4 hcv infection * not co-infected with hiv * screening laboratory values within defined thresholds * use of highly effective contraception methods * must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments exclusion criteria: * history of any other clinically significant chronic liver disease * pregnant or nursing female or male with pregnant female partner * history of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol * excessive alcohol ingestion or significant drug abuse
a study of brodalumab in subjects with axial spondyloarthritis (axspa)

Conditions: Axial Spondyloarthritis

Summary: to evaluate the efficacy of brodalumab in axspa (ankylosing spondylitis \[as\] and non-radiographic axial spondyloarthritis \[nr-axspa\]) subjects compared to placebo, as measured by the proportion of axspa subjects achieving an assessment of spondyloarthritis international society (asas) 40 response at week 16.


Eligibility criteria:
inclusion criteria: * subject with age at onset \<45 years and continuous chronic back pain for ≥ 3 months fulfills the asas classification criteria of axial spondyloarthritis (with the exception of the crohn's disease) * subject has bath ankylosing spondylitis disease activity index (basdai) score ≥ 4 at screening and enrollment * subject has spinal pain score (basdai question #2) ≥ 4 at screening and enrollment * subject has had adequate therapy with non-steroidal anti-inflammatory drugs (oral nsaids) for back pain for at least 3 months with inadequate treatment response before enrollment exclusion criteria: * complete ankylosis (fusion) of the spine * subject with active ongoing inflammatory diseases other than axspa that might confound the evaluation of brodalumab therapy, including reactive arthritis, spondyloarthritis associated with inflammatory bowel disease, sapho syndrome (pustulotic arthro-osteitis), fibromyalgia, ankylosing spinal hyperostosis, osteitis condensans ilii, spondylosis deformans, or osteoarthritis sacroiliac joint disease * subject has a prior history of \>1 anti-tumor necrosis factor (tnf) therapy * subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the columbia-suicide severity rating scale (c-ssrs) at enrollment * subject has a history or evidence of a psychiatric disorder, alcohol and/or substance abuse * subject has severe depression based on a total score of ≥ 15 on the patient health questionnaire-8 (phq-8) at enrollment (note: subjects with a total score of 10 to 14 on the phq-8 should be referred to a mental health care professional)

Keywords: brodalumab axial spondyloarthritis
a study to analyze data on metastatic ovarian cancer using multi-omics

Conditions: Ovarian Cancer

Summary: as one of the most common malignant tumors in women, the incidence of ovarian cancer is expected to increase year by year. due to its lack of typical symptoms and effective screening methods, and the characteristics of implantation and distant metastasis, more than 70% of ovarian cancers were in the metastatic stage at the time of diagnosis. in this study, the investigators will collect large samples of tissue from patients with ovarian cancer, conduct multi-omics studies, and mapped the characteristic maps of the genome and transcriptome of patients with metastatic ovarian cancer, and explore the molecular mechanisms that can be used as new targets for the treatment of ovarian cancer. besides, the investigators will design and establish a database of metastatic ovarian cancer, integrate multiple omics, imaging, pathology, and clinical information to study their potential relevance, and analyze the relationship between various omics, imaging, pathology, and prognosis, establish ovaries cancer prediction model.


Eligibility criteria:
inclusion criteria: 1. female, ≥18 years old; 2. diagnosed as ovarian cancer by imaging and pathology; 3. did not receive any anti-tumor drug treatment before surgery in the gynecology clinical department of the sun yat sen memorial hospital of sun yat-sen university; 4. received ovarian cancer surgery and follow-up treatment; 5. patients voluntarily participate in the research of this subject, have good compliance, and can complete the enrollment by the requirements of the trial; 6. sign informed consent and agree to the collection and use of their data. exclusion criteria: 1. patients who have received other anti-tumor treatments or received tumor surgery before enrollment; 2. patients with malignant tumors in other parts; 3. patients with uncontrollable neurological, psychiatric, or mental disorders; 4. poor compliance and inability to cooperate and describe treatment responders.

Keywords: multi-omics ovarian cancer
the treatment of stage i and ii carcinoma of the breast with mastectomy and axillary dissection versus excisional biopsy, axillary dissection, and definitive irradiation

Conditions: Breast Cancer

Summary: patients with biopsy proven breast cancer, clinical stage i and ii, will be randomized to receive treatment by one of two methods: (1) total mastectomy and axillary dissection; or (2) excisional biopsy, axillary dissection, and definitive irradiation. data from single institutions and from retrospective comparisons suggest that definitive irradiation with cosmetically acceptable breast preservation offers survival and local control results equivalent to extirpative surgery. this study will test this hypothesis in a prospective, randomized manner. after primary therapy, subjects will be followed for: (1) survival; (2) sites of recurrence; (3) anatomic function; (4) complications of therapy; and (5) cosmesis.

patients with biopsy proven breast cancer, clinical stage i and ii, will be randomized to receive treatment by one of two methods: (1) total mastectomy and axillary dissection; or (2) excisional biopsy, axillary dissection, and definitive irradiation. data from single institutions and from retrospective comparisons suggest that definitive irradiation with cosmetically acceptable breast preservation offers survival and local control results equivalent to extirpative surgery. this study will test this hypothesis in a prospective, randomized manner. after primary therapy, subjects will be followed for: (1) survival; (2) sites of recurrence; (3) anatomic function; (4) complications of therapy; and (5) cosmesis.

Eligibility criteria:
* inclusion criteria: female patients of any age with a dominant breast mass meeting the following requirements are eligible for this protocol: on clinical evaluation the tumor must be confined to the breast and axillary lymph nodes (stage i and ii). biopsy of the tumor must be classified as a primary breast neoplasm of epithelial origin. patients must be geographically accessible for follow-up and willing to return for the follow-up at the nci. patient must be mentally competent to understand and give informed consent for the protocol. exclusion criteria: patients will be excluded from this protocol for the following reasons: advanced local disease or distant metastases (stage iii and iv); inflammatory cancer; chronic diseases such as heart, lung, liver, kidney, blood, or metabolic disorders which may render the patient a poor operative risk; history of another cancer other than skin cancer (non-melanoma); concurrent pregnancy or lactation; non-palpable lesions manifested only by nipple discharge or skin rash (paget's disease); previous therapy to the breast cancer other than excisional biopsy; multiple masses or multiple suspicious areas on mammogram unless all but one are proven histologically benign; and bilateral breast carcinoma, either invasive or in-situ.

Keywords: breast cancer surgery radiation
safety and performance evaluation of the rapid ring device

Conditions: Healthy

Summary: the purpose of this study is to demonstrate the safety, performance and initial efficacy of the rapidx device.

the study will be a single center, open label, prospective, non-comparative, randomized trial and assess the safety and performance of the rapid ring device. in order to assess pain reduction, a comparative study will be performed and each subject will serve as his/her own control. clinical assessment for all 100% patients will occur at baseline. all participants will be men and women above the age of 18. the trial will be conducted at a medical center.

Eligibility criteria:
inclusion criteria: * subject is healthy * subject's age is between 18 to 70 years old * subject must be capable of providing informed consent exclusion criteria: * clotting disorders * subject has a clinically significant untreated chronic disease which may unable him/ her to participate in the study. * subject is taking anti-coagulant medication * non-intact finger tip (left middle/ring finger) * skin disease on the subject finger * abnormal blood pressure * pregnant or lactating women * menstrual period * previous diagnosis of hiv or hepatitis * participation in other clinical investigations within previous 30 days * peripheral blood vessels diseases * diabetes * neuropathic pain

Keywords: finger sticks rapid ring finger sticks method of obtaining blood for diagnostic testing
impact of providing nursing support on parental stress related to preoperative care of a newborn with hirschsprung's disease

Conditions: Hirschsprung Disease

Summary: impact of providing nursing support on parental stress related to preoperative care of a newborn with hirschsprung's disease


Eligibility criteria:
inclusion criteria: * families (one or two parents) with a newborn or infant under 2 months with confirmed or suspected hirschsprung disease, for whom nursings are effective and performed 1 to 2 times a day while waiting for surgery. * with a possible return home before surgery * with an information leaflet and non-opposition form signed by one or both parent(s) or by the legal representative. exclusion criteria: * the absence of daily nursings * initial ineffectiveness of nursings requiring a digestive stoma * failure to return home before surgery * refusal of one or both parent(s) or legal representative(s)
study evaluating the performance and safety of global d implants indicated for orthognathic surgery

Conditions: Orthognathic Surgery; Maxillofacial Abnormalities; Maxilla Fracture

Summary: this study is set up within the framework of the european union regulation 2017/745 on medical devices. its objective is to confirm the performance and safety of the global d implants (ortrautek® and minitek®) used for orthognathic surgery.

study design : non-interventional, prospective, multicentric, national, open-label, non-comparative study. investigators : 7 sites in france. a statistical evaluation will be performed on those data in order to determine the performance and the security of those devices.

Eligibility criteria:
inclusion criteria: * male or female patient, major or minor, having reached bone maturity according to the judgement of the investigator, * patient having first orthognathic surgery (maxillary, mandibular, maxillomandibular or/with genioplasty) * patient who received orthodontic treatment prior to orthognathic surgery. * patient with abilities to read, understand and answer to the study quality of life questionnaire. * patient (and his legal representative if minor) who signed the study consent form. * patient affiliated to a social security system. exclusion criteria: * patient allergic to one of the components of the implants * patient with physical or mental inabilities that will compromise the follow-up during the study * patient with acute or chronic infection (local or systemic) * person on legal protection * pregnant or breastfeeding women

Keywords: orthognathic surgery performance security plates screw medical device cranio-maxillofacial
egg albumin-based protein supplement versus renal-specific supplement in hemodialysis patients

Conditions: Protein-Energy Malnutrition; Kidney Failure, Chronic; Hemodialysis

Summary: malnutrition is seen frequently in hemodialysis units in most developing countries. malnutrition increases morbidity and mortality in this population and its treatment improves patient survival and health status the purpose of this study is to compare two strategies to improve nutritional status in hemodialysis patients: renal-specific oral supplement (237 ml) versus egg albumin-based protein supplement (30 g) on a daily basis. this trial uses the malnutrition inflammation score (mis) and subjective global assessment (sga) in addition to most used biochemical markers to determine nutritional status.


Eligibility criteria:
inclusion criteria: * chronic kidney disease in hemodialysis exclusion criteria: * infection * liver insufficiency * cancer or neoplasia * acquired immunodeficiency syndrome * intestinal malabsorption syndrome

Keywords: protein-energy malnutrition chronic kidney disease malnutrition-inflammation score subjective global assessment hemodialysis egg albumin
genetics, brain structure and thinking skills in autism

Conditions: Autism Spectrum Disorders

Summary: the purpose of this research is to better understand the genetic, biochemical, cognitive and behavioral symptom abnormalities that contribute to autism spectrum disorders. the investigators anticipate recruiting at least 100 participants with autism spectrum disorder and large head size, at least 100 participants with autism spectrum disorder without large head size and at least 40 healthy siblings. biological parents are expected to be recruited only as genetic changes are identified in individuals with autism spectrum disorders to better understand the nature of these genetic changes. participants are asked to complete cognitive testing, a blood draw, urine collection and measurement of his/her height, weight and head circumference. parents or caregivers may be asked to complete a diagnostic evaluation and will complete questionnaires that examine the participant's medical and family history as well as his/her current symptoms, functioning, and quality of life. a brief report simply listing and giving a basic description of any behavioral diagnostic information, autism symptoms, adaptive functioning, and a listing of results from cognitive testing will be provided as part of this study.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of autism * consent from parents or guardians or an adult with or suspected of having an autism spectrum disorder that does not require a legal guardian or an adult who is the healthy sibling of an individual with an autism spectrum disorder. * youth ages 2-17 and adults ages 18-50. youths and adults who are able (some young or severely impaired participants may not be able to provide assent) will be asked to provide assent. * families with multiple children who meet the above inclusion criteria will be permitted to have as many children participate as they wish. * youth ages 2-17 and adults ages 18-50 who do not have an autism spectrum disorder or are not suspected of having an autism spectrum disorder and who have a sibling with an autism spectrum disorder who has participated in the present study. exclusion criteria: * clinically significant medical disease that would prohibit participation in the study procedures. * children younger than 2 years old and adults older than 50 years old.

Keywords: autism pten macrocephaly
sepsisflags ( fluidandgender)

Conditions: Sepsis

Summary: in this single-center study the investigators will analyze gender differences among patients with suspected sepsis admitted to the emergency department at södersjukhuset during a period of two years. about 11 000 patients will be included. patient data including fluid therapy will be drawn from the electronic medical record; take care and clinisoft. in the logistic regression analysis, the investigators will adjust for age, gender, comorbidities, vital signs, preliminary focus of infection, level of care and renal replacement therapy. the aim is to analyze gender differences in fluid treatment and the response to fluid treatment and if the treatment is associated with differences in mortality.


Eligibility criteria:
inclusion criteria: * patients admitted to the emergency department with suspected sepsis (defined by blood culture taken and intravenous sepsis-antibiotics prescribed within 48 hours) and fulfilling sepsis-3 definition of sepsis (sequential organ failure assesment score of 2 or more) exclusion criteria: * patients transferred from other hospitals or treatment clinics.

Keywords: fluid therapy gender difference