Kornimate/medical-research-clean huggingface dataset:
a study to assess the survival of non-small cell lung cancer patients treated with tarceva after failed chemotherapy treatment

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this study will evaluate the survival of non-small cell lung cancer (wild-type egfr) participants treated with tarceva after at least one failed chemotherapy treatment, and the impact of prior chemotherapy treatments.


Eligibility criteria:
inclusion criteria: * adults \>/= 18 years * histologically documented locally advanced, metastatic, or recurrent non-small cell lung carcinoma with wild-type egfr eligible for tarceva treatment. * at least one failed chemotherapy treatment. exclusion criteria: - unknown egfr mutation status
aba-101 in participants with progressive multiple sclerosis

Conditions: Progressive Multiple Sclerosis

Summary: this study will test the safety and effects of aba-101 when given as a single dose to participants with progressive multiple sclerosis. it is the first study of this treatment in humans. after safety is demonstrated with a low dose of aba-101, a higher dose will be evaluated.


Eligibility criteria:
inclusion criteria: * is ≥18 years old at signing of consent. * has a diagnosis of ms per the 2017 revised mcdonald criteria. * has documented evidence of progression of disability independent of ms relapse activity (clinical or radiographic). * expresses the hla that matches the tcr restriction. * presence of a radiographic biomarker of cns inflammation as identified by mri. * meets expanded disability status scale (edss) criteria. * meets the nine-hole peg test (9hpt) criteria. exclusion criteria: * presents with clinical or radiographic evidence of relapse within 24 months prior to or at screening. * is considered by the investigator to be immunocompromised. * current treatment with disease-modifying therapies (dmts).

Keywords: progressive multiple sclerosis cell therapy multiple sclerosis treg regulatory t cell
incisional hernia rate after single-incision laparoscopic cholecystectomy

Conditions: Cholelithiasis

Summary: single-incision laparoscopic cholecystectomy (silc) requires a larger incision than standard laparoscopy, which may increase the incidence of incisional hernias. this study evaluated silc and standard multiport cholecystectomy with respect to perioperative outcomes, hospital stay, cosmetic results, and postoperative complications, including the 5-years incisional hernia rate.

a cohort study was performed for patients who underwent a laparoscopic cholecystectomy under an institutional review approved protocol. between 2009 and 2011, 45 unselected patients underwent silc performed by the same two surgeons. the study inclusion criteria were the following: patients over 18 years with cholelithiasis, and candidates for elective surgery with no significant cardiopulmonary, hepatic or renal impairment (asa score less than 4). the exclusion criteria included the following: acute cholecystitis, associated cbd stones or pancreatitis, an emergency operation for complicated disease, mental illness, or patient refusal and/or absence of informed consent. all included patients signed a standard consent form after being informed about the characteristics of the silc procedure. the outcomes of these patients were compared with those of a control cohort series of 140 patients who underwent standard lc (with the same inclusion and exclusion criteria) during the same period. the primary endpoint of the study was to determine the incisional hernia rate at the umbilical wound after 5 years of follow-up. hernias were defined as evidence of a hernia at the clinical examination or those confirmed by ultrasound examination in case of clinical doubt. the study secondary endpoints included the following: duration of surgery (from the start of the incision to skin closure), intraoperative and postoperative complications (30 days), hospital stay, and cosmetic satisfaction results (measured using a visual analogue scale score ranging from 0 to 10). the following variables were also collected: age, gender, body mass index (bmi) and comorbidities. the anesthetic risk was measured according to the asa classification system. prolonged hospital stay (more than 24 h) and readmission (patients who returned for medical consultation before scheduled follow-up) were also recorded. all data were collected prospectively.

Eligibility criteria:
inclusion criteria: * patients over 18 years with cholelithiasis and candidates for elective surgery (cholecystectomy) * abscence of significant cardiopulmonary, hepatic or renal impairment (asa score less than 4) exclusion criteria: * acute cholecystitis * associated common bile duct stones or pancreatitis * emergency operation for complicated disease * asa 4 (american society of anesthesiologists) * pregnancy * mental illness * patient refusal and/or absence of informed consent

Keywords: cholecystectomy laparoscopy single-incision laparoscopic surgery incisional hernia trocar-site hernia
new techniques for diagnosis and treatment of cognitive impairment in affective disorder

Conditions: Affective Disorder

Summary: the purpose of this study is to explore the pathological mechanism of cognitive impairment in patients with affective disorder based on brain gut axis research, preliminarily verify the clinical efficacy of new neural regulation technology on cognitive impairment, and establish an evaluation model to predict the efficacy of physical therapy for affective disorder.


Eligibility criteria:
inclusion criteria: 1. age 16-65 years old, regardless of gender; 2. meet dsm-v diagnostic criteria for depression or bipolar disorder; 3. duration of stable period ≥ 3 months; 4. young mania rating scale (ymrs) ≤ 6 points; 5. hamilton depression rating scale 17 - item (hdrs-17) score ≤ 7; 6. the score of cognitive defects questionnaire (pdq) ≥ 17; 7. han nationality, right-handed; 8. more than 9 years of education. exclusion criteria: 1. history of severe somatic or brain organic diseases and craniocerebral trauma; 2. abnormal brain structure or any mri contraindications were found by magnetic resonance examination; 3. those who do not cooperate or cannot effectively complete the experiment; 4. drug, alcohol or other psychoactive substance abusers; 5. pregnant, lactating or planned pregnancy.
primary uvb-311nm and adalimumab in psoriasis patients

Conditions: Psoriasis

Summary: adalimumab, a fully human anti-tumor necrosis factor (tnf) monoclonal antibody has been approved for the treatment of moderate to severe psoriasis. however, in a portion of cases adalimumab does not induce reduction of psoriasis area and severity index (pasi) of 75% or greater, now being considered as gold standard for treatment efficacy. in this study we aim to determine in a randomized half-side comparison whether initial narrowband uvb-311nm phototherapy accelerates and improves the clearance of skin lesions in adalimumab-treated patients.

patients with moderate to severe psoriasis who are scheduled to receive a standard treatment course of adalimumab (loading dose of 80 mg and thereafter 40 mg s.c. biweekly) are exposed to uvb-311nm phototherapy on a randomized body half (left or right; head exempt) 3 x per week for six weeks and/or until complete response (defined as reduction in pasi to \ 90%, \> 75% and/or 50% between body sites.

Eligibility criteria:
inclusion criteria: * psoriasis patients who are scheduled for treatment with adalimumab. exclusion criteria: * pregnancy or lactation * history of skin cancer * presence of or history of malignant skin tumors * dysplastic melanocytic nevus syndrome * antinuclear antibodies (ds-dna, ro/ssa, la/ssb) * autoimmune disorders such as lupus erythematosus or dermatomyositis * photosensitive diseases such as porphyria, chronic actinic dermatitis, xeroderma pigmentosum, basal cell nevus syndrome, and others * general poor health status

Keywords: psoriasis biologic adalimumab narrow-band uvb phototherapy half-side comparison
better sleep study

Conditions: Depression in Adolescence; Delayed Sleep Phase

Summary: the overall aim of this proposal is a confirmatory efficacy trial sufficiently powered and designed to test the hypothesis that improving the relationship between biological circadian timing and waketime, a novel modifiable target, improves depression outcomes in a subgroup of adolescents with depression and a misaligned relationship between biological circadian timing and waketime utilizing a cognitive-behavioral sleep intervention.


Eligibility criteria:
inclusion criteria: exclusion criteria: * mental health/behavioral symptoms that would preclude productive engagement in study assessments or intervention (e.g., active psychosis; bipolar disorder; drug dependence * severe or unstable medical or psychiatric condition such that treatment has changed within the last month or is expected to change during the course of the study or that would preclude ability to adhere to study procedures (e.g. terminal end-stage cancer) * current use of medications or herbs with known effects on sleep * plan to undergo or have had medication change in the last 8 weeks

Keywords: depression adolescents sleep intervention
acetylcholine receptors from human muscles as pharmacological target for als

Conditions: Amyotrophic Lateral Sclerosis

Summary: amyotrophic lateral sclerosis (als) is a fatal disease leading to motor neuron degeneration and progressive paralysis. other studies have revealed defects in skeletal muscle even in absence of motor neuron anomalies, focusing on acetylcholine receptors (achrs) and supporting the so-called "dying-back" hypothesis. outcome of this study will be to understand if the endocannabinoid palmitoylethanolamide (pea) can reduce the rundown of achrs currents in als muscle, and if it can modify als patients' clinical and electrophysiological parameters.

outcome: monitoring the efficacy and safety of pea in the treatment of patients with als. analysis of achr currents and description of the composition of achrs subunits in als muscles design of the study: a randomized controlled blinded study. patients with sporadic als will receive riluzole alone or riluzole+pea in order to investigate the clinical and electrophysiological effects of treatment. the expected number of enrolled patients will be 50. all patients satisfying the selection criteria will be randomized into two groups: a first group will be treated only with riluzole, the second group with riluzole associated with pea (normast 600 mg microgranular, 2 sachets/day). the randomization will be done stratifying patietns according to type of clinical onset (bulbar vs. spinal). the patients will be enrolled in the department of neurology and psychiatry, university of rome "sapienza". the visits will be performed at 0 (randomization), 3 and 6 months. at each visit the als functional rating scale-revised (alsfrs-r), the percentage of predicted forced vital capacity (fvc%), the medical research council (mrc) score for muscle strength limited to the right upper limbs, and the compound muscle action potentials (cmap) from right ulnar and phrenic nerves will be assessed. a muscle biopsy will be done at the end of the study. the obtained results will be compared with those observed in muscle samples from denervated (non-als) control patients.

Eligibility criteria:
inclusion criteria: * diagnosis of als according to the el-escorial criteria; * age\> 18 years; * als functional rating scale-revised (alsfrs- r) score\> 20; * forced vital capacity (fvc)\> 30%; * treatment with riluzole. exclusion criteria: * other diseases motor neurons; * experimental treatments in the previous three months; * pregnant or breast-feeding; * contraindications to the use of riluzole; * patients undergoing tracheostomy, enteral or parenteral supply; * severe psychiatric disorders.
prostatic artery embolization before radical prostatectomy in prostate cancer: a proof-of-concept study

Conditions: Prostate Cancer

Summary: mri findings after successful pae in patients suffering from bph suggest a complete necrosis of the prostate after this intervention. thus, pae might also play a role in the treatment of prostate cancer. this proof of concept study assess the impact of pae in patients with proven prostate cancer.

mri findings after successful pae in patients suffering from bph suggest a complete necrosis of the prostate after this intervention. thus, pae might also play a role in the treatment of prostate cancer. this proof of concept study assess the impact of pae in patients with proven prostate cancer. pae is performed in patients that are planned to undergo robot-assisted laparoscopic prostatectomy for proven localized prostate cancer. the impact of neo-adjuvantly performed pae on histological tumor regression, surgical margins as well as on safety parameters are assessed.

Eligibility criteria:
inclusion criteria: * men 45 - 75 years old undergoing ralp * patient has biopsy-proven prostate adenocarcinoma * localized disease (tumorstage ct1-ct2), assessed by clinical and mri findings * written informed consent exclusion criteria: * severe atherosclerosis * severe tortuosity or ectasia in the aortic bifurcation or internal iliac arteries * tumor stage \> ct2 assessed by clinical and mri findings * allergy to intravenous contrast media * contraindication for mri imaging * renal failure (gfr\<60ml/min) * history of pelvic irradiation or radical pelvic surgery

Keywords: prostate prostatic neoplams therapeutic embolization prostatectomy
use of ibandronate in diabetic patients

Conditions: Osteoporosis, Postmenopausal; Type 2 Diabetes

Summary: the purpose of this study is to examine whether monthly oral administration of ibandronate to postmenopausal osteoporosis patients with type 2 diabetes differs in safety and efficacy compared to patients without diabetes.

there are two major considerations in the use of bisphosphonates in diabetic patients. * the low rate of bone turnover in diabetic patients is at risk of side effects such as excessive inhibition of bone turnover associated with the use of bisphosphonates. * a decrease in osteocalcin following bisphosphonate use may lead to deterioration of glucose metabolism. the efficacy of ibandronate in t2dm is not thought to be significantly different based on previous studies, but there is few study on ibandronate.

Eligibility criteria:
inclusion criteria: * age of at least 55 years at the time of screening * postmenopausal woman * diagnosis of osteoporosis exclusion criteria: * history of osteoporosis treatment * underlying disease (e.g., heart failure, liver disease, renal disease, or malignancy) * the use of drugs that affect bone metabolism (e.g., steroids, immunosuppressants, gonadotropin-releasing hormone agonists, aromatase inhibitors, thiazolidinedione drugs, anticonvulsants, and antidepressants) * history of adverse effects of bisphosphonate or difficulty taking the drug due to an inability to sit or the presence of upper gastrointestinal disease
effect of smart phone addiction on pulmonary function, and functional capacity in children

Conditions: Smartphone Addiction; Pulmonary Function; Functional Capacity; School Age Children

Summary: statement of the problem: are there relations between smartphone addiction, neck posture, pulmonary functions and functional capacity in children? null hypothesis it will be assumed that: * there will be no effect of smart phone addiction on head posture, pulmonary function and functional capacity in children. * there will be no relation between smartphone addiction, head posture, pulmonary function and functional capacity in children.

subjects: sample size estimation will be carried out to determine the recruited number of children selected randomly from both governmental and private primary and preparatory schools at el mansoura educational administration, dakahlia governorate and damietta governorate to participate in this study. the survey targets the normal students from both sexes. they will be selected based on the following: inclusion criteria: * all children will be age ranges from 10 to 12 years * the bmi \<95th percentile (who, 2007) * smartphone addiction scale short version will be used to categorize the children to addicted group (score \> 32) (kwon et al., 2013) . * they will be cooperative and followed the instructions. exclusive criteria: children will be excluded from the study if they have: * neurological diseases. * respiratory disorders. * congenital deformities. * vision disorders not corrected by glasses. * children who participate in competitive sports. * obesity.

Eligibility criteria:
inclusion criteria: * all children will be age ranges from 10 to 12 years * the bmi \<95th percentile (who, 2007) * smartphone addiction scale short version will be used to categorize the children to addicted group (score \> 32) (kwon et al., 2013) . * they will be cooperative and followed the instructions. exclusion criteria: * • neurological diseases. * respiratory disorders. * congenital deformities. * vision disorders not corrected by glasses. * children who participate in competitive sports. * obesity.
examining the impact of high-protein oral supplement on protein status of adults on peritoneal dialysis

Conditions: Renal Failure; Protein-Energy Malnutrition

Summary: this is a 6-month prospective interventional clinical trial designed to evaluate the impact of whey protein isolate oral supplement on protein status. differences in protein status will be evaluated with review of the medical chart from standard of care monthly blood collection for serum albumin, total protein, and normalized protein catabolic rate (npcr) as detected by serum urea nitrogen. mid-arm circumference and weight will be measured to ensure no significant changes. quality of life will be measured to detect if the addition of protein aided in overall quality of life. there will be a 3-month recruitment period prior to the start of the trial to ensure the potential participants are familiarized with the clinical trial. after the recruitment period has finished, eligible participants will sign the consent form in order to participate in the study. at this point, participants will be provided the supplements for the month and instructed with the amount of water and how to mix with the provided measuring and drinking cup.


Eligibility criteria:
inclusion criteria: * 18 years old or older * diagnosed with stage 5 chronic kidney disease for at least 3 months prior to the starting date of the trial * on peritoneal dialysis at least three months prior to the starting date of the trial * can provide signed informed consent * have no dietary restriction * no food allergies * no chewing/swallowing difficulties. exclusion criteria: * not meeting the above * pregnant/lactating as either self-reported or determined by the medical director * chronic kidney disease patient stages 1-4. * chronic kidney disease patient undergoing hemodialysis. * use of other protein supplement

Keywords: peritoneal dialysis
study evaluating the effect of sirolimus on non-melanoma skin cancer in kidney transplant recipients

Conditions: Skin Neoplasms; Kidney Transplantation

Summary: the purpose of this study is to determine the effect of sirolimus on the prevention of new non-melanoma skin cancer (nmsc) in kidney transplant recipients.


Eligibility criteria:
inclusion criteria: * kidney transplant at least 1 year prior * subjects with a functioning renal allograft with calculated glomerular filtration rate (gfr) ≥40ml/min (nankivell method) and proteinuria ≤500mg/day. * stable on cyclosporine or tacrolimus-based multi-drug immunosuppressive regimen * history of nmsc within last 3 years exclusion criteria: * history of other cancer within last 3 years * nmsc with metastatic disease or more than 20 nmsc lesions in last 12 months * multiple organ transplant

Keywords: kidney transplant skin cancer
new version pulmicort turbuhaler usa children

Conditions: Asthma

Summary: a comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved pulmicort turbuhaler with a new version of the inhaler, in children and adolescents who have asthma. in addition the study evaluated the functionality of the new inhaler at the end of its intended life.


Eligibility criteria:
inclusion criteria: * male or females aged 6 to 17 with a diagnosis of asthma for at least 3 months. have used inhaled corticosteroids for no more than one month before entering the study or none at all. * a forced expiratory volume (fev1) in 1 second of 75% to 90% of predicted normal for those aged 6 to 11 and 60% to 90% for those aged 12 to 17 years. * airway reversibility of at least 12% , use of orally inhaled corticosteroids for no more than one month immediately before entering the study or none at all. exclusion criteria: * life threatening asthma, two or more overnight hospitalisations for asthma within 1 year or any emergency room visit for asthma within 6 months of starting study. * use of steroid tablets or injections during the month prior to visit 1 and use of other asthma medicines (except rescue medication) within 2 weeks prior to the study. * any acute exacerbation of asthma or a respiratory tract infection within 30 days prior to visit 1. must not smoke or have smoked.

Keywords: asthma pulmicort children paediatrics budesonide flexhaler
a global study to assess the effects of medi4736 following concurrent chemoradiation in patients with stage iii unresectable non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: a global study to assess the effects of medi4736 following concurrent chemoradiation in patients with stage iii unresectable non-small cell lung cancer.

a phase iii, randomised, double-blind, placebo-controlled, multi-centre, international study of medi4736 as sequential therapy in patients with locally advanced, unresectable non-small cell lung cancer (stage iii) who have not progressed following definitive, platinum-based, concurrent chemoradiation therapy (pacific)

Eligibility criteria:
inclusion criteria: 1. age at least 18 years. 2. documented evidence of nsclc (locally advanced, unresectable, stage iii) 3. patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy. 4. world health organisation (who) performance status of 0 to 1. 5. estimated life expectancy of more than 12 weeks. exclusion criteria: 1. prior exposure to any anti-pd-1 or anti-pd-l1 antibody. 2. active or prior autoimmune disease or history of immunodeficiency. 3. evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis b, c and hiv. 4. evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris. 5. any unresolved toxicity ctcae \>grade 2 from the prior chemoradiation therapy. 6. active or prior documented inflammatory bowel disease (eg, crohn's disease, ulcerative colitis).

Keywords: locally advanced unresectable non-small cell lung cancer medi4736 pd-l1 stage iii non-small cell lung cancer chemoradiation immune-mediated cancer therapy
radiological dating of child fractures before one year

Conditions: Fractures

Summary: the aim of this study was to use, in a precise manner, defined radiographic semiological criteria to determine an analytical methodology to facilitate the dating of long bone fractures of infants under one year of age. a total of 99 radiographs of infants under one year of age with long bone fractures of known date were studied. four dating groups were established on the basis of data in the literature, with the aim of developing predictive models based on well-defined semiological criteria, in order to construct a simplified dating decision tree.


Eligibility criteria:
inclusion criteria: * had x-rays taken at the university paediatric hospital for the diagnosis and/or follow-up of a fracture of the long bones of the limbs (tibia, femur, fibula, radius, humerus and/or ulna) exclusion criteria: * child maltreatment, * chronic illnesses