Kornimate/medical-research-clean huggingface dataset:
the study of gemcitabine in the maintenance treatment of advanced non-small cell lung cancer

Conditions: THE Efficacy and Safety of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer

Summary: assess the efficacy and safety of gemcitabine in the maintenance treatment of advanced non-small cell lung cancer


Eligibility criteria:
inclusion criteria: 18\~75 years patients who were diagnosed by the histologic, cytologic diagnosis of iiib-iv non-small cell lung cancer patients who have acceptted combination chemotherapy based on platinum 4 course,sd or pr,the cr patients should accept 6 course of combination chemotherapy. 3\~8 weeks after patients complete first line chemotherapy(include radiotherapy) ecog0-2 expected life time longer than 3 monthes normal laboratory values: * leucocyte ≥ 4×109/l * neutrophil ≥ 1.5×109/l * platelet ≥ 100×109/l * hemoglobin ≥ 10g/l * alt and * ast ≤ 2.5×uln (≤ 5×uln if liver metastasis) signed written informed consent exclusion criteria: * patients have used drugs according to protocol * uncontrolled infection of bacterial or virus or fungal * patients with other malignant tumor * uncontrolled brain metastases * female patients during their pregnant and lactation period, or patients without contracep
micro-movements in patients with prolonged disorders of consciousness

Conditions: Consciousness Disorders

Summary: the goal of this observational study is to learn about the micro-movements in patients with prolonged disorders of consciousness. the main questions it aims to answer are: use the neuropsychological paradigm model to monitor micro-movements, assess the patient's remaining level of consciousness and accurately classify it; screen out patients with cognitive-motor dissociation to improve the prognosis of cognitive function; explore the remaining brain function of patients with chronic disorders of consciousness and promote relevant study of neural mechanisms. participants will be subjected to consciousness assessment by crs-r scale, and their micro-movement changes in response to various emotional stimuli will be captured, along with the collection of eeg and mri data. follow-up evaluations will be conducted using the crs-r scale and gos scale, with a follow-up period of 6 months.

in accordance with the inclusion and exclusion criteria, a total of about 178 participants will be recruited, including about 89 confirmed cases of prolonged disorders of consciousness and 89 healthy control subjects (hcs). utilizing the random split algorithm from the machine learning library sklearn, the dataset will be randomly divided into a training set (70%) and a testing set (30%). general information about the participants such as age, gender, time and location of injury, as well as medical history, family history, medication history, and surgical history will be collected. participants will undergo dual-person, multiple assessments using the crs-r scale to evaluate auditory, visual, motor, speech responsiveness, communication, and arousal levels. micro-movement changes in response to various emotional stimuli will be collected, along with eeg and mri data. follow-up evaluations will be conducted on all enrolled patients using the crs-r scale and the gos scale, with a follow-up period of 6 months.

Eligibility criteria:
inclusion criteria: 1. patients with consciousness disorders for more than 28 days following severe brain injury, assessed by the crs-r scale to meet the criteria for vs or mcs; 2. aged between 18 and 80 years; 3. stable vital signs; 4. voluntary participation of family members with signed informed consent; 5. good cooperation, minimal facial and spontaneous activities, no use of antiepileptic or sedative drugs. exclusion criteria: 1. locked-in syndrome; 2. contraindications for eeg examination; 3. contraindications for mri scanning, such as the presence of internal metallic implants; 4. diseases and factors that may affect brain function assessment, such as metabolic disorders, poisoning, shock, etc.

Keywords: disorders of consciousness consciousness disorders micro-movement consciousness multidimensional paradigm stimulation
post-licensure study of the safety of gardasil™ in males (v501-070)

Conditions: Human Papilloma Virus Infection

Summary: this is a post-licensure safety observation cohort study to describe the general safety of gardasil™ (a quadrivalent human papillomavirus vaccine) in males.


Eligibility criteria:
inclusion criteria: * male vaccinated with at least one dose of gardasil™ after the october 2009 fda date of first licensure of gardasil™ for males exclusion criteria all cohorts: * female * male vaccinated prior to the october 2009 fda date of first licensure of gardasil™ for males * male who received all doses of gardasil™ outside of the health plan exclusion criteria, regimen completers cohort: * male \ 26 years of age at first dose * male not part of health plan at each dose * 3-dose vaccination regimen given over a period \> 12 months * less than 28-day interval between first and second dose * less than 12 weeks between the second and third dose * less than 24 weeks between first and third dose exclusion criteria, autoimmune cohort: - male with less than 12 months of health plan membership prior to first dose of gardasil™

Keywords: warts papillomavirus infections dna virus infections virus diseases skin diseases, viral tumor virus infections skin diseases, infectious skin diseases
human papilloma virus vaccine immunogenicity and safety trial in young adult women with gsk bio's novel hpv vaccine.

Conditions: Infections, Papillomavirus

Summary: human papilloma viruses (hpv) are viruses that cause infections of the skin and genitals in men and women. several types of hpv infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). this infection, if it persists, can lead over a long period of time to cancer of the cervix in women. in collaboration with medimmune inc., glaxosmithkline biologicals has developed a hpv vaccine against the oncogenic types hpv-16 and hpv-18 formulated with the adjuvant as04. gsk biologicals is also evaluating novel hpv vaccine formulations.this study will evaluate the immunogenicity and safety of a novel gsk biologicals hpv vaccine in women 18-25 years of age at study start. approximately 376 study subjects will receive the novel hpv vaccine or the control vaccine administered intramuscularly according to a 0-1-6 month schedule.


Eligibility criteria:
inclusion criteria: * a woman between, and including, 18 and 25 years of age at the time of the first vaccination * written informed consent from the subject prior to enrolment * subject must be free of obvious health problems * subject must be of non-childbearing potential and have had no more than 6 lifetime sexual partners exclusion criteria: * pregnant or breastfeeding * a woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (month 0-8) * known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality * history of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease * previous vaccination against human papillomavirus (hpv)
breath analysis of patients diagnosed with covid-19 using infrared spectroscopy

Conditions: SARS-CoV-2 Infection; Covid19

Summary: to analyze volatile organic compounds (vocs) in the breath of patients with sars-cov-2 and controls in sars-cov-2 breath specimens.

the study is a prospective cohort study, which enrol patients presenting to hospital and are tested for sars-cov-2. there will be two cohorts, covid-19 positive and covid-19 negative, who will have exhaled breath collection and analysis by infrared spectroscopy to characterize the composition of vocs and identify differences in voc profiles between the two groups.

Eligibility criteria:
inclusion criteria for covid-19 positive patients: * clinically tested for sars-cov-2 (as completed by standard laboratory testing e.g. rt-pcr) with a positive result * clinical features in keeping with covid-19 illness. inclusion criteria for covid-19 negative patients: * negative rt-pcr covid-19 test * without any clinical features to suggest covid-19 illness. * no known or current features of respiratory infection, copd, asthma, interstitial lung disease, other respiratory inflammatory conditions or lung cancer. * able to provide a breath sample (as based on clinical judgement). exclusion criteria for covid-19 positive and negative patients: - unable to provide a breath sample
stepwise for the treatment of lateral incisional hernias

Conditions: Incisional Hernia; Abdominal Wall Defect; Abdominal Wall Hernia; Hernia

Summary: the best approach for lateral incisional hernia is not known. posterior component separation (reverse tar) offers the possibility of using the retromuscular space for medial extension of the challenging preperitoneal plane. the main objective of the study was to describe the surgical techniques used and their outcomes in the open lateral approach for the treatment of l3-l4 european hernia society (ehs) classification incisional hernias, comparing the results between reverse tar and pure lateral retromuscular preperitoneal, and analyzing the short- and long- term complications, including patient-reported outcomes measures (proms). the study report followed the recommendations for reporting outcomes in abdominal wall hernias, and the new international classification of abdominal wall planes (icap). a multicenter retrospective observational study was conducted using a prospectively maintained database from three university hospitals in spain specialized in complex abdominal wall reconstruction. all patients undergoing open abdominal wall repair through the previous lateral incision for l3-l4 ihs between february 2012 and january 2020 were identified. all patients were operated on by the senior surgeons responsible for the complex abdominal wall units of each participating center. prior to conducting the study, the approval of the local ethics committee was obtained (id:39/2019). written informed consent was also obtained. the diagnosis of ih was based on clinical examination and imaging from a computed tomography (ct). the investigator only included patients with l3-l4 ihs. patients with primary lateral hernias, such as spiegel, grynfelt and petit hernias were excluded. we also excluded all patients in which the lateral ih was a parastomal hernia. demographic data, patient comorbidities, different classifications of hernia complexity, carolinas equation for determining associated risks (cedar) and intraoperative and postoperative data were collected all patients followed a similar preoperative optimization program, which included endocrinologic and nutritional evaluations, respiratory physiotherapy, and abstinence from smoking at least 1 month before surgery. weight loss was extremely recommended but without any mandatory prerequisite.


Eligibility criteria:
inclusion criteria: * patients with a lateral incisional hernia l3 european hernia society classification * patients with a lateral incisional hernia l4 european hernia society classification * patients older than 18 years old exclusion criteria: * midline incisional hernia. * patients with a parastomal hernia * patients with a primary midline ventral hernia * patients with a primary lateral hernia. * age under 18 years old
a multicenter, randomized placebo controlled pilot microct study to estimate the effect of treatment with denosumab (amg 162) and alendronate sodium in postmenopausal women with low bone mineral density

Conditions: Postmenopausal Osteoporosis

Summary: this study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.


Eligibility criteria:
key inclusion criteria: * postmenopausal, ambulatory women between 50 and 70 years old who are generally in good health. * must have low bone mineral density and meet specific eligibility criteria. key exclusion criteria: -subjects must not currently be receiving any medication that affects bone metabolism or have an underlying condition that affects their ability to take alendronate or receive denosumab.

Keywords: post menopausal osteoporosis microct amgen denosumab extreme ct xct fosamax alendronate
outcomes of patients who had an incomplete colonoscopy after a positive fecal immunological test

Conditions: Colorectal Cancer

Summary: in france, colorectal cancer (crc) is the second leading cause of cancer death. its organized screening (organized colorectal cancer screening: doccr), now carried out by immunological test for occult blood in the stool, has proven its effectiveness. when the immunological test is positive, the haute autorité de santé recommends a total colonoscopy. in 5 to 10% of cases, this colonoscopy is incomplete. the renewal of the endoscopic procedure or the performance of additional second-line examinations are then recommended. at present, however, the respective place of second-line examinations to be performed in this situation is not the subject of specific and validated recommendations.


Eligibility criteria:
inclusion criteria: * age between 50 and 75 years old at the time of the colonoscopy * with incomplete colonoscopy performed in 2018 after a positive fecal immunological test as part of the doccr * patient whose follow-up has ended * patient living in the grand-est region and in the department of the site concerned * examination carried out by a gastroenterologist from the grand-est region * subject not having expressed, after information, his opposition to the reuse of his data for the purposes of this research exclusion criteria: * age ≥ 76 years at the time of colonoscopy * colonoscopy performed after a positive hemoccult® test (screening technique older than the immunological test and different sensitivity / specificity) * colonoscopy performed before the fecal immunological test * gastroenterologist performing the examination practicing outside the grand-est region * subject not able to understand the objectives of this research * subject under judicial control * subject under tutorship or curatorship

Keywords: colorectal cancer immunological test colonoscopy
dog-rose, cranberry leaves, cranberry berries, alfalfa, fenugreek, lemon beebrush, urtica and sumac in diabetes mellitus

Conditions: Type 2 Diabetes

Summary: this study investigates the safety and combined effect of cranberry leaves, cranberry berries, alfalfa, fenugreek, lemon beebrush, urtica, dog-rose, and sumac on improving the glycemic profile of patients with type 2 diabetes mellitus compared to the placebo group.

the present double-blind, randomized and placebo-controlled study will be conducted on type 2 diabetes mellitus patients to evaluate the safety and combined effect of cranberry leaves, cranberry berries, alfalfa, fenugreek, lemon beebrush, urtica, dog-rose, and sumac on improving glycemic profiles (fasting blood sugar, glycosylated hemoglobin, 2 hours postprandial blood sugar, insulin concentration, insulin resistance, and beta-cell function). the study also evaluates systolic blood pressure, diastolic blood pressure, anthropometric variables, lipid profile, c-reactive protein, and renal and liver function tests. a pilot study with 30 participants will be conducted to estimate the sample size considering 0.05 first type error and a power of 80%. individuals aged between 18-70 with a diagnosis of type 2 diabetes mellitus based on who criteria for at least one year will be enrolled. participants will be randomized in the placebo or intervention group to receive two capsules per day before lunch and dinner for six months containing 200 milligrams of equally combined extracts of cranberry leaves, cranberry berries, alfalfa, fenugreek, lemon beebrush, urtica, dog-rose, and sumac. participants will be followed up with four office visits (t0= baseline, 1=15th day, 2t=3rd month, 3t=6th month) to assess outcomes. also, the complications and adherence of patients to intervention will be checked every two weeks by telephonic discussion. the analysis will be performed based on the intent-to-treat method.

Eligibility criteria:
inclusion criteria: * at least one year of diagnosis of type 2 diabetes according to the criteria of the world health organization, * hemoglobin a1c (hba1c) \> 7.0% or fasting blood glucose \> 7.0 mmol/l, * body mass index (bmi) more than 23 kg/m2 and less than 35. exclusion criteria: * comorbidities, including type 1 diabetes, cardiovascular disease, thyroid disease, liver disease, kidney disease, cancer, mental disorders, and the use of drugs related to the aforementioned diseases, * pregnancy, * patients with a bmi over 35 who were on a weight loss diet or had taken weight loss supplements for less than 6 months * a history of allergy to one of the components of the nestling fruit, carob leaf, carob fruit, alfalfa seed, fenugreek seed, lemon, nettles and sumac and also * lactating women * regularly consuming cigarettes or alcohol * using psychiatric drugs or insulin * changing in the medication regimen during the trial period. for example, to start receiving insulin therapy, become pregnant, or no longer follow medication and dietary instructions.

Keywords: type 2 diabetes insulin resistance lipochromin vaccinium macrocarpon medicago sativa trigonella fenugreek lemon beebrush urtica dioica rhus sumac
bispecific antibody plus white blood cells in treating patients with recurrent or refractory glioblastoma multiforme

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: bispecific antibodies plus white blood cells may be able to locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. purpose: phase i trial to study the effectiveness of combining bispecific antibodies with white blood cells in treating patients who have recurrent or refractory glioblastoma multiforme.

objectives: * assess the safety and tolerability of bispecific antibody mdx447 and activated monocytes in patients with recurrent or refractory glioblastoma multiforme. * determine the response, time to tumor progression, and overall survival of these patients treated with this regimen. outline: this is a dose escalation study. patients undergo maximal surgical debulking of the tumor at the time of reservoir placement. within 2-4 weeks after surgery, patients receive one treatment of intratumoral bispecific antibody mdx447 and activated monocytes. stable or responding patients may receive a second treatment 1 month later. cohorts of 1 or 3 patients receive escalating doses of bispecific antibody mdx447 and activated monocytes until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities. projected accrual: a total of 13 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically proven glioblastoma multiforme with evidence of epidermal growth factor receptor (egfr) expression on tumor cell surfaces * no astrocytoma, anaplastic astrocytoma, or oligodendroglioma * no infratentorial or multifocal tumor * recurrence or progression following at least one prior therapy patient characteristics: age: * 18 and over performance status: * karnofsky 60-100% life expectancy: * greater than 2 months hematopoietic: * wbc at least 3,000/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin greater than 10 g/dl hepatic: * bilirubin no greater than 2.0 mg/dl * alt, ast, and alkaline phosphatase no greater than 2.5 times upper limit of normal (uln) renal: * creatinine no greater than 2.0 times uln other: * not pregnant or nursing * fertile patients must use effective contraception * no other medical or psychiatric illness that would preclude study * no other concurrent malignancy except nonmelanoma skin cancer prior concurrent therapy: biologic therapy: * not specified chemotherapy: * at least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) endocrine therapy: * concurrent steroid therapy allowed radiotherapy: * at least 4 weeks since prior radiotherapy surgery: * not specified

Keywords: adult glioblastoma adult giant cell glioblastoma adult gliosarcoma
virtual agent feasibility in oncology patients (ntt data)

Conditions: Lung Cancer

Summary: the purpose of this study is to compare the use of a virtual agent vs. a human agent when onboarding oncology patients over the telephone to remote patient monitoring (rpm) devices. rpm devices are instruments that a patient can use to measure their own weight and vital signs. both the virtual and human agents will be available by telephone to instruct the patient on how to use the rpm devices to measure weight, blood pressure, heart rate, temperature, and oxygen saturation. patients will be randomized to either the virtual or human agent, have assessments of their medical and oncological history, overall well-being, body measurements, and vital signs, and will complete questionnaires about their experience.


Eligibility criteria:
inclusion criteria: 1. willing and able to provide written informed consent and hipaa authorization for the release of personal health information. 2. age ≥18 3. lung cancer 4. planning to return to duke cancer center clinic for three days in a row * patients whose treatment does not require that they return to clinic for three days in a row, but who are willing to voluntarily return to participate in this study are permitted to enroll. 5. eastern cooperative oncology group (ecog) score of 0-2 6. native fluency of spoken english as determined by the investigator * non-native english speakers are permitted to enroll if they have achieved native fluency. 7. vitals as collected by the clinic using duke maintained equipment must be within the ranges specified by the remote patient monitoring devices. * weight ≤ 180 kg * systolic blood pressure ≤ 300 mmhg * pulse rate of 40-200 bpm * spo2 of 70-100% * temperature 34.0-42.2°c 8. arm circumference of 22-42 cm exclusion criteria: 1. vision, speech or auditory impairment that has the potential to interfere with the use of the remote patient monitoring device or agent, in the opinion of the investigator. 2. has an implanted pacemaker, arterio-venus (a-v) shunt, a history of mastectomy or lymph node clearance, history of severe blood flow problems or blood disorders, or a history of severe circulatory deficit in the arm. 3. is pregnant 4. has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the investigator.
improving adherence to cognitive rehabilitation

Conditions: Psychosis

Summary: purpose of study is to evaluate impact of brief motivational interviewing vs. feedback on learning styles in improving attendance to cognitive training

this study is evaluating whether motivational enhancement can improve outcomes of cognitive rehabilitation in veterans with schizophrenia spectrum disorders. approximately 120 individuals will be randomized to either a 2-session motivational interview (mi, experimental condition) or a 2-session assessment and feedback on learning styles (ci, active control), and will then be asked to participate in 4 months of cognitive rehabilitation. booster mi or ci sessions will be administered monthly over the course of the cognitive rehabilitation. primary outcome is number of cognitive rehabilitation sessions attended.

Eligibility criteria:
inclusion criteria: * diagnosis of psychotic disorder * 18 years old or older exclusion criteria: * meeting criteria for substance abuse/dependence in past 30 days * psychiatric hospitalization in past 30 days * change in psychiatric medications in past 30 days * severe auditory/visual impairment * evidence of developmental disability

Keywords: psychosis adherence motivation