Kornimate/medical-research-clean huggingface dataset:
icotinib with whole brain radiation therapy in nsclc patients with brain metastases

Conditions: Non-small-cell Lung Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of icotinib in combination with whole brain radiotherapy for nsclc patients with brain metastases. the primary endpoint is objective response rate of intracranial lesions.

non-small cell lung cancer (nsclc) is one of the malignant tumors with the highest incidence of brain metastases. patients with multiple brain metastasis showed poor prognosis and displayed an untreated median survival of only 3-6 months, and most patients died due to the progression of brain metastases. this study is designed to evaluate the safety and efficacy of icotinib combined with whole brain radiotherapy for nsclc patients with brain metastases. the primary endpoint is intracranial objective response rate .

Eligibility criteria:
inclusion criteria: * histological or cytological confirmation of non-small-cell lung cancer (nsclc). * diagnosis of non-systematic brain metastases on a gadolinium-enhanced mri. more than 2 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 3cm. * no other metastases except for brain metastases. exclusion criteria: * previous usage of egfr-tki or antibody to egfr: gefitinib, erlotinib, herceptin, erbitux. * csf or mri findings consistent with metastases of spinal cord, meninges or meningeal.
safety and reactogenicity of bioconjugate vaccine to prevent shigella

Conditions: Shigellosis

Summary: healthy volunteers will receive a 2-dose vaccination with shigella dysenteriae candidate vaccine spaced 8 weeks apart. the objective is to demonstrate the safety and reactogenicity of the shigella dysenteriae bioconjugate vaccine (gvxn sd133) alone or in combination with an adjuvant (aluminium hydroxide). the safety and reactogenicity of the gvxn sd133 vaccine will be also evaluated at two different concentrations of antigen, shigella polysaccharide o1. blood samples will be collected at intervals to examine systemic vaccine antigen-specific immune responses.


Eligibility criteria:
inclusion criteria: * subjects of both sexes, aged between 18 and 50 years. * subjects who have undergone a detailed medical history, clinical checkup and are in good health. * subjects who have understood the purpose of the study and have freely signed the informed consent. * subjects who consent with repeated blood samples taking. * subjects who will be available to perform the follow-up visits, are reachable by telephone, and are able to complete the diary cards throughout the study duration. * for female volunteers, a negative pregnancy test and an adequate contraception throughout the study duration. exclusion criteria: * known history of recent contact shigella infection or long-term residence in a shigella endemic region (central america, africa, and india). * known history of hypersensitivity to any component of the vaccine (epa; aluminium hydroxide). * subjects with compromised immune system. * family history of congenital or hereditary immunodeficiency. * chronic administration of an immunosuppressive treatment or other immune-modifying drugs within six months prior to the first vaccine dose. * subjects that received any other vaccine during the 1 month preceding the 1st injection and may receive before the 2nd injection. if the subject needs to be vaccinated during this period, he/she will be withdrawn from the study. * subjects suffering of a disease at the time of enrolment. 'disease' is defined as the presence of a mild or severe illness with or without fever. * acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * any laboratory data collected during the screening phase found to be outside the normal range defined by the laboratory. * positive test for hiv, and evidence of hbv or hcv. * pregnant or breast-feeding women. * history of alcohol, drug or psychotropic drug abuse (which interferes with a normal lifestyle) during the previous year. * subjects for which follow-up is compromised due to socio-cultural, geographic or psychological reasons. * any other significant finding that in the opinion of the investigator that would increase the risk of having an adverse outcome from participating in the study. * subjects that are participating or have participated in another clinical trial in the last 6 months.

Keywords: s.dysenteriae healthy volunteers conjugate vaccine safety immunogenicity dose scaling
a118g snp and oprm1 gene opioid-mediated effects in humans

Conditions: Opioid Sensitivity; Individual Difference; Abuse Opioids

Summary: within-subject, double-blind, placebo-controlled examination of opioid abuse potential in healthy individuals as a function of a118g snp on the oprm1 gene.

participants completed a 5-day, within-subject, double-blind, placebo-controlled, randomized, human laboratory abuse potential trial. healthy individuals were admitted to a residential research unit for 5 consecutive days. blood samples were drawn for genome wide analyses using the global screening array on day 1. participants were administered an oral dose of the opioid hydromorphone (4mg) on day 2 of the study. persons who did not evidence strong agonist effects then proceeded into the randomized period wherein they received 0mg, 2mg, and 8mg of oral hydromorphone on the remaining three study days. the order of dosing was randomized, with only 1 dose administered per day and all participants receiving 1 exposure to each dose. outcomes were standard human abuse potential metrics, including self-reported drug effects and feeling high. data were analyzed as a function of the a118snp on the oprm1 gene that codes for the mu opioid receptor. the overall aim was to determine whether signal for abuse potential among persons with no history of opioid misuse was associated with genotype.

Eligibility criteria:
inclusion criterion: 1. provide a urine sample that tests negative for opioids, methadone, buprenorphine, oxycodone, amphetamine, cocaine, and benzodiazepines 2. negative ethanol breath test (0.000) 3. aged 21-50 4. deemed medically eligible to take hydromorphone exclusion criterion: 1. answer "yes" to question 1 of the brief pain inventory (89) to assess the presence of chronic pain. 2. current use of opioids or other medications for pain 3. meet dsm-5 criteria for current or lifetime alcohol or drug use disorder (excluding nicotine) 4. self-report any illicit drug use in the past 7 days 5. self-report opioid use \>5 days in the past 30 6. evidence of opioid physical dependence at screening or following 1st residential overnight (following confirmed opioid abstinence) 7. allergy to hydromorphone or other opioid agonists 8. experience an adverse event that warrants opioid antagonist treatment following 1st hydromorphone dose. 9. if female, not be pregnant or breastfeeding 10. presence of any clinically significant medical (e.g., chronic renal insufficiency, history of myocardial infarction, seizure disorder) and/or psychiatric illness (e.g., schizophrenia, bipolar disorder) that may interfere with study participation. 11. bmi \>30 (obese category)

Keywords: opioid abuse genetic a118g oprm1
evaluation of the effects of treatments applied to patients with facial myalgia on occlusion parameters

Conditions: Occlusion; Quality of Life

Summary: the temporomandibular joint (tmj) is closely related to neuromuscular components. a problem occurring in any of these components or parts of the tmj interferes with the harmonic functioning of the tmj and invites temporomandibular joint disorders (tmd).management of tmd can be conservative or surgical. physiotherapy, local steam application, external muscle massage, occlusal adjustment, analgesic and physiotherapeutic medication and splint treatments are the most frequently recommended conservative treatments. today, occlusal adjustments are made with the help of a prosthetic or orthodontic appliance. with these intraorally used occlusal splints, a balanced occlusal contact is achieved without applying any force to the mandible in the resting position. occlusal splints are available in different designs and different construction materials. the stabilization splint, which is one of the most frequently used occlusal splints, and the modified hawley splint are appliances produced from hard materials. however, some researchers have commented that soft splints produced from resilient materials may also be useful in the distribution of excessive force formed in parafunctional habits. while there are studies stating that hard splints provide more successful results than soft splints in functional problems of the chewing system, there are also studies reporting that they have similar efficacy on muscle pain after short-term use. however, there are no studies in the literature that compare their efficacy in short-term and long-term myalgia patients and demonstrate their efficacy using an objective test such as digital occlusion analysis. there was no study on the effectiveness of different splints on the patient's quality of life. it would be appropriate to carry out our study to fill this gap in the literature.the main purpose of this study is to digitally examine and compare the effects of three different treatment methods (medical therapy, medical therapy+soft splint, medical therapy +hard splint) applied to patients diagnosed with facial myalgia after temporomandibular joint examination on the existing occlusion changes.


Eligibility criteria:
inclusion criteria: * no systemic disease that may have effects on masticatory muscles or tmj * individuals who do not have any tooth loss other than molar teeth and accept the treatments to be performed. exclusion criteria: * individuals with total or partial prosthesis with distal extension * individuals who have previously received medical, pharmacological or any type of treatment for tmd * individuals who have recently been exposed to facial or cervical trauma * individuals with the syndrome who have the potential to affect any component of the stomatognathic system * individuals with parafunctional habits such as clenching or grinding their teeth.

Keywords: t scan facial myalgia
vitamin e supplementation in burned patients

Conditions: Burn

Summary: a dietary antioxidant, alpha-tocopherol, will be used to potentially attenuate vitamin e short- and long-term losses in plasma and adipose, reverse the oxidative stress of burn injury and, in the process, decrease the secondary consequences of burn injury, including lung injury and impaired wound healing. this may improve the quality of life of the burn patient by preventing pathophysiology that may result from oxidative stress and may reduce hospital stay. our research will lay the foundation for the future development of effective, safe, and economic therapeutic interventions to treat burn injury-associated metabolic abnormalities. also, it will provide the basis for the development of supplemental regulations and pharmacotherapy to treat burn patients with vitamin e. the risks are very reasonable in relation to the anticipated benefits to our subjects because a) vitamin e is a simple vitamin that is abundant and approved for clinical use, and b) the subjects will be monitored consistently for the minimal increased tendency to bleed.

please see above.

Eligibility criteria:
inclusion criteria: * age: 16 - 85 years * ≥40% total body surface area burn exclusion criteria: * septic shock * bleeding disorders * diabetes, or on diabetes medications or anti-lipidemic agents * arthritis * known kidney/renal disease, endocrine disease, cancer, heart disease, osteoporosis, liver disease * congestive heart failure * positive hepatitis or hiv screens * pregnancy (women)

Keywords: alpha-tocopherol inflammation oxidative stress malondialdehyde isoprostanes lung dysfunction wound healing
zephyr: a study evaluating surgical outcome after implantation of the zephyr zsi 475 ftm inflatable penile implant in the neophallus after female-to-male sex reassignment surgery

Conditions: Erectile Dysfunction; Gender Dysphoria

Summary: this study will look into the surgical outcome after implantation of the zephyr zsi 475 ftm in the neophallus.

obtaining erectile function after phalloplasty in female-to-male transsexuals remains a challenging issue and requires the implantation of a device. for biological males, several erectile implants exist and widespread research has demonstrated the successful outcome of these devices. however, substantial differences exist between a native penis and a neophallus and explain the poorer outcome of these devices in female-to-male transsexuals. in 2018, falcone et al. published the largest retrospective series on this subject so far and reported that after a mean follow-up of 20 months, only 58% of their patients still had their original implant in place. the main obstacle in these female-to-male transsexuals is represented by the lack of corpora cavernosa in the neophallus which leads to difficult anchorage of the prosthesis, little stability of the prosthesis and a higher risk of cylinder erosion. until recently, all penile implants were manufactured for erectile dysfunction in biological males and thus presumed the presence of two corpora cavernosa. in 2016 however, the swiss company, zephyr surgical implants (zsi), created a 3-piece inflatable erectile device specifically for female-to-male transsexuals: the zephyr zsi 475 ftm. this prosthesis has a realistic gland shape, only one cylinder, and a specific anchorage device made of titanium and silicone to anchor the system to the pubic bone of the patient. these specific features could potentially address the aforementioned issues with implanting erectile devices in the neophallus and hopefully lead to better surgical outcomes in these particular patients. so far, no literature regarding surgical or functional outcome of the zephyr zsi 475 ftm exists. the aim of this study is to prospectively collect data of all female-to-male transsexuals that are treated with the implantation of this device at ghent university hospital.

Eligibility criteria:
inclusion criteria: * voluntarily signed written informed consent according to the rules of good clinical practice (declaration of helsinki) and national regulations. * age ≥ 18 years. * female-to-male transsexual patient. * implantation of zephyr zsi 475 ftm erectile device. exclusion criteria: * absence of signed written informed consent. * age \< 18 years. * biological males. * patients opting for penile implants other than the zephyr zsi 475 ftm.

Keywords: female-to-male transgender transsexual zephyr erectile device erectile implant neophallus phalloplasty gender reassignment surgery sex reassignment surgery
electronic cigarettes or nicotine inhaler for smoking cessation

Conditions: Tobacco Use Disorder

Summary: electronic cigarettes have shown promise but have yet to proven effective for smoking cessation. this trial will evaluate the effectiveness of electronic cigarettes in smokers who are trying to quit smoking compared with a standard therapy, the nicotine inhaler. the investigators hypothesize that electronic cigarettes will be comparable to the nicotine inhaler in terms of smoking cessation.

cigarette smoking remains the leading cause of preventable death and disease worldwide. the purpose of this trial is to evaluate the effectiveness of electronic cigarettes for smoking cessation compared to a similar nicotine replacement therapy, the nicotine inhaler.

Eligibility criteria:
inclusion criteria: * 18-60 year old * meet dsm-iv criteria for nicotine dependence * seeking treatment for smoking cessation * smoking at least 15 cigarettes per day * capable of giving informed consent and complying with study procedures exclusion criteria: * lifetime history of dsm-iv diagnosis of schizophrenia, schizoaffective disorder, and bipolar disorder or current diagnosis of major depressive disorder * current dsm-iv criteria for any other psychiatric disorder that may, according to the investigator's judgment, require either pharmacological or non- pharmacological intervention over the course of the study * currently receiving any treatment for nicotine dependence, including nicotine replacement therapy * pregnancy, lactation, or failure to use adequate contraception methods in women who are currently having sex with men * unstable medical condition, such as uncontrolled hypertension, angina, and oropharyngeal conditions which may make participation hazardous * current dsm-iv diagnosis of substance dependence, other than nicotine * use of cannabis or alcohol on more than 20 days in the past 30 days * risk for suicide

Keywords: electronic cigarette nicotine inhaler smoking cessation
effectiveness and safety of salba on weight loss in overweight individuals with type 2 diabetes

Conditions: Diabetes Mellitus; Overweight; Obesity

Summary: canadian statistics indicate that the incidence of obesity is increasing and that the occurrence of diabetes in obese individuals is 5-fold greater than those with a healthy weight, making weight control in this population particularly relevant. preliminary clinical data has shown that the whole grain, salba, may improve type 2 diabetes control, reduce after-meal blood glucose, cardiovascular disease (cvd) risk factors and suppress appetite. its use may therefore have potential implications in long-term weight management, while improving diabetes. the objective of this research (weight loss) is to evaluate whether adding salba to an energy reduced diet for six months will result in greater weight loss compared to control in overweight and obese individuals with type 2 diabetes. the study recruited 77 overweight or obese individuals with type 2 diabetes. they were instructed to follow a calorie restricted diet and their regular diabetes therapy together with regular exercise. participants were randomly assigned to receive 30 g salba/1000 kcal of daily energy requirements, or an oat bran control supplement matched for energy. the effect of the supplements on weight-loss (including waist circumference, % body fat) and glucose control (a1c, fasting glucose levels) will be assessed. in addition, related outcomes such as low-grade body inflammation, hunger-regulating hormones (ghrelin, adiponectin), safety measures (urea, creatinine, alt and prothrombin time) and satiety scores were evaluated. modest weight loss has been associated with improved glucose control in individuals with type 2 diabetes. addition of salba to an energy reduced diet may facilitate greater weight loss and improve glycemic control and cvd risk factors compared to such a diet alone. salba may also promote maintenance of weight loss and therefore help prevent weight gain by providing feelings of fullness that reduce appetite. in light of the high incidence of obesity in individuals with diabetes, salba grain may be a useful addition to the diet.


Eligibility criteria:
inclusion criteria: * well-controlled type 2 diabetes for at least 1 year * treated with diet and/or oral hypoglycemic medications * bmi 25-40 kg/m2 exclusion criteria: * weight change in the past three months \>10% of body weight * on insulin therapy * unstable angina, myocardial infarction or stroke (within 6 months) * planned surgery or pregnancy * blood pressure \>160mmhg/100mmhg * surgical procedures for weight loss and concomitant use of medication or supplements that alter body weight or appetite * ala, dietary fibre, fish oil supplements or consuming cold-water fish more than three times per week
sentinel lymph node biopsy versus pelvic lymphadenectomy in early-stage cervical cancer (phenix/csem 010)

Conditions: Cervical Cancer; Surgery; Quality of Life

Summary: the diagnostic value of sentinel lymph node biopsy in early-stage cervical cancer has been well studied. however, there were no randomized controlled study on comparing the long-term outcomes of sentinel lymph node biopsy and conventional procedure. the investigators perform a phase iii, randomized controlled trial to determine whether pelvic lymphadenectomy can be replaced by sentinel lymph node biopsy in surgical treatment for patients with early-stage cervical cancer.

this study comprises two parts: phenix-i: to compare the outcomes of managements with and without pelvic lymphadenectomy for patients with negative sentinel lymph node; phenix-ii: to compare the outcomes of managements with and without pelvic lymphadenectomy for patients with positive sentinel lymph node. patients with newly diagnosed international federation of gynecology and obstetrics (figo) stage ia1 (lymphovascular space involvement), ia2, ib1, and ib2 cervical cancer are eligible for our study. the tumor diameter should be less than 3cm. sentinel lymph node biopsy will be performed at the beginning of operations. after pathological examination of frozen section, patients will be assigned to phenix-i or phenix-ii study according to their status of sentinel nodes. in both parts of this trail, patients have equal chance to be randomly assigned to experimental arms (radical hysterectomy only) and reference arms (radical hysterectomy and pelvic lymphadenectomy).adjuvant treatments will be planned according to postoperative pathological factors. the primary objective is disease-free survival at 3 years for phenix-i and 2 years for phenix-ii. the secondary end points are overall survival, long-term outcome of sentinel lymph node biopsy and the quality of life.

Eligibility criteria:
inclusion criteria: * patients with newly histologically confirmed cervical carcinoma * histopathology squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma * original clinical stage must be figo (2018) stage ia1 (lymphovascular space involvement), ia2, ib1, ib2 and iia1 * no suspected node should be found on imaging examination (resist 1.1) * age between 18-65 * patients must give signed informed consent * p.s status: 0-1 * estimated survival time \> 3 months * tumor diameter ≤ 3 cm exclusion criteria: * the presence of uncontrolled life-threatening illness * receiving other ways of anti-cancer therapy * investigator consider the patients can't finish the whole study * with normal liver function test (alt、ast\>2.5×uln) * with normal renal function test (creatinine\>1.5×uln) * wbc\<4,000/mm3 or plt\<100,000/mm * the whole cervix has been occupied by tumor and there is no normal surface left for tracer injection * history of severe heart disease or deep venous thrombosis; 4) presence or history of other malignant disease * gestation or perinatal period * intention to fertility preservation.

Keywords: sentinel lymph node pelvic lymphadenectomy cervical carcinoma surgery radiotherapy