Kornimate/medical-research-clean huggingface dataset:
a phase i study of irinotecan (cpt-11) administered as a prolonged infusion in adult patients with solid tumors

Conditions: Neoplasms

Summary: this study examines a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the maximum tolerated dose of this regimen.

irinotecan (cpt-11) is a promising camptothecin analogue with activity in solid tumors. in phase i studies using short intravenous infusion schedules, the predominant drug toxicities have been gastrointestinal, such as diarrhea, and myelosuppression. in animal studies, prolonged infusion schedules followed by short drug-free intervals have resulted in preservation of antitumor activity and decreased drug toxicity. therefore, we propose to examine a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the maximum tolerated dose of this regimen. the duration of these treatments will be escalated in our phase i study until patients are receiving therapy for 2 out of every 3 weeks. standard phase i drug toxicity and tumor response information will be monitored and the pharmacokinetics of irinotecan and its active metabolite, sn-38 will also be examined. we will also attempt to monitor the intracellular molecular effects of sn-38 therapy in blood, bone marrow, and, whenever possible, tumor tissue.

Eligibility criteria:
disease characteristics: recurrent or metastatic cancer, including lymphoma. no leukemia. no active cns disease. refractory to all effective therapy or no effective therapy exists. measurable disease not required. prior/concurrent therapy: biologic therapy: greater than 4 weeks and recovered from immunotherapy. chemotherapy: greater than 4 weeks and recovered from chemotherapy. previous therapy with irinotecan is permitted. endocrine therapy: not specified. radiotherapy: greater than 4 weeks since radiotherapy. surgery: recovered from prior surgery. patient characteristics: age: 18 and over. performance status: ecog 0-2. hematopoietic: agc greater than 1,500. platelets greater than 100,000. hepatic: bilirubin no greater than 1.5 mg/dl. ast no greater than 2 times normal. renal: creatinine no greater than 1.5 mg/dl. other: hiv negative. no active infection requiring antibiotics. no concurrent medical illness that would interfere with chemotherapy. no pregnant or nursing women. adequate contraception required of fertile patients. imaging/exams for tumor measurement within 28 days prior to registration.

Keywords: camptothecin cancer chemotherapy natural products neoplasms
the effect of zinc acetate lozenges on the rate of recovery from the common cold

Conditions: Common Cold; Respiratory Tract Infections

Summary: a randomized parallel-group two arm superiority trial with an allocation ratio 1:1, both participants and investigators blinded. the zinc lozenge that will be used in the study is a commercial product available from the university pharmacy, helsinki, finland. the product is classified as a "medical device" and it is not regulated according to the jurisdiction for medicines. each lozenge contains 13 mg elemental zinc as zinc acetate. the instruction in the commercial package for common cold patients is to dissolve slowly 6 lozenges per day in their mouth, which totals to 78 mg/day of elemental zinc, at most for 5 days. the same instruction will be used in this trial. the university pharmacy prepared 200 placebo lozenge packages so that the placebo lozenges contain sucrose octaacetate, and they are similar with the zinc lozenges in visual appearance and in taste. 200 packages of zinc lozenges will be used as the active intervention. the packages will contain 30 lozenges (6 lozenges/day × 5 days). the packages of lozenges will be distributed to the enrolled participants in november 2017. the participants will be instructed to keep the package readily available so that, when they catch the common cold, they will find the package and they can start to take the lozenges according to the instructions. the participants will be instructed to start taking zinc lozenges as soon as they start to suffer from the first symptoms of the common cold. the participants will be instructed to take 6 lozenges daily over the time awake, evenly distributed, allowing the lozenge to dissolve in the mouth as slowly as possible. the duration of intervention is for the maximum of 5 days. if the symptoms disappear before 5 days, the participant may stop the usage of the lozenges. there will be no limitations for other treatments that participants wish to use for treating their colds. participants will be requested to respond to a web-based symptom questionnaire daily from the first day of the treatment to the recovery from the common cold, or to a maximum of 2 weeks.


Eligibility criteria:
inclusion criteria: * ≥18 years, recollecting that they usually have had ≥1 colds per winter. exclusion criteria: * pregnancy or lactation; chronic runny nose or chronic cough.

Keywords: cough laryngitis pharyngitis rhinitis zinc acetate zinc lozenge
fet pet in differentiating tumour progression from pseudoprogression in high grade glioma

Conditions: Glioma, Malignant

Summary: the goal of this clinical trial is to evaluate the performance characteristics of o-(2-\[18f\]fluoroethyl)-l-tyrosine (fet) pet in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging and determine the sensitivity and specificity of \[18f\]fet-pet in delineating disease. the main question\[s\] it aims to answer are: * whether 18f-fet-pet will demonstrate high diagnostic accuracy to detect true tumour progression * whether we can optimise the threshold cut-offs for tbrmax and other relevant parameters in discriminating pseudoprogression and disease progression participants will undergo a limited 18f-fet pet/ct of the brain in sgh.


Eligibility criteria:
inclusion criteria: * men or women, aged 21 years or older at time of screening * histologically confirmed diagnosis of malignant glioma (defined as who grade iii or iv) with previous rt to tumour * with enlarging contrast-enhancing and/or t2w/flair-hyperintense lesion(s) on mri within the previous rt field * gliomas with isocitrate dehydrogenase (idh) wild-type status, as defined on immunohistochemistry * subject must consent to undergo all study procedures exclusion criteria: * low-grade gliomas (histology grade 1 or 2 by who classification)16,17 * previous bevacizumab or other vascular endothelial growth factor (vegf) targeting agents or anti-angiogenic treatments. * proven cerebral metastases * idh-mutated gliomas * pregnancy/ breast-feeding
ovarian reserve testing in female young adult cancer survivors

Conditions: Cancer; Infertility

Summary: young adult cancer survivors constitute an under served population to whom fertility potential is particularly important. for female young adult patients, cancer treatment such as alkylating chemotherapy are toxic to the finite number of eggs they have, resulting in risks of infertility and premature menopause related to ovarian failure. reproductive issues are a major concern for young cancer survivors, but one that is understudied. young cancer survivors have few tools to measure post-treatment ovarian reserve, or the quantity and quality of remaining eggs4. accurate determination of ovarian reserve and fertility potential would not only be an important research tool, but also directly impact clinical management. the purpose of this study is to test if basal and provocative ovarian reserve testing can predict return of menses in female young adult cancer survivors, to compare basal and provocative ovarian reserve testing results between female young adult cancer survivors and healthy controls, and to compare basal and provocative ovarian reserve testing results between female young adult cancer survivors on and off of combined estrogen and progesterone hormone products. participants will be asked to keep track of their periods over three months. if a participant is taking birth control pills, patches, or vaginal ring, they will asked to come off the birth control for 3 months. participants will also be asked to undergo ovarian reserve testing by blood draws and pelvic ultrasounds at the start and end of the 3 months.

same as brief summary

Eligibility criteria:
inclusion criteria: * postmenarchal * cancer diagnosis * prior exposure to gonadotoxic therapy, inclusive of chemothearpy, pelvic or total body irradiation, unilateral oophorectomy * a minimum of 1 year since completion of gonoadotoxic therapy * intact uterus * at least one ovary exclusion criteria: * estrogen receptor positive cancers

Keywords: fertility adolescent young adult cancer survivors
spinal anaesthesia and severe preeclampsia

Conditions: Preeclampsia

Summary: the use of spinal anesthesia in pre-eclamptic pregnant woman is of considerable benefit, as these patients present particular hazards with general anaesthesia, such as concerns for rapid airway control and cerebral blood flow alterations during induction of general anaesthesia and intubation however, the incidence of hypotension is high during spinal anesthesia for cesarean section and it may approach values up to 95 %.

the parturient will be allocated into one of two equal groups (n=30), a severe preeclampsia group (a) and a normotensive group (b). all will receive colload (500 ml voluven) as a coload via wide bore (16 gauge ) cannula within 5-10 minutes during induction of spinal anesthesia. standard monitoring with electrocardiography, automated non-invasive arterial pressure (niap) measurement, and pulse oximetry will be performed. systolic arterial pressure (sap), mean arterial pressure (map) and diastolic arterial pressure (dap) will be monitored. baseline values will be recorded in the supine position. central venous line will be inserted in severe preeclampsia group and central venous pressure will be measured every 10 minutes. spinal anesthesia will be induced with a total of 10 mg of 0.5% hyperbaric bupivacaine and 25 µg fentanyl (total volume 2.5 ml) at the l3-4 interspace in the sitting position then the patient will be returned immediately to the supine position with left lateral tilt.

Eligibility criteria:
inclusion criteria: * age: 18 - 40 years * severely pre-eclamptic females, severe pre-eclampsia is defined as hypertension( bp \> 159/109) ,proteinuria ( urinary protein excretion of greater than 5 gm per day) and oliguria(\<500 ml in 24 hours) with at least one maternal organ dysfunction . exclusion criteria: * age : \<18 years * obese patients with bmi \> 35 kg/m2 * preterm delivery * patients with contraindication to spinal anesthesia. * patients in active labor
armodafinil treatment as adjunctive therapy in adults with major depression associated with bipolar i disorder

Conditions: Bipolar I Depression

Summary: the primary objective of the study is to determine if armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with bipolar i disorder and who are inadequately responsive to their current treatment for a current major depressive episode.


Eligibility criteria:
key inclusion criteria: * the patient has a diagnosis of bipolar i disorder and is currently experiencing a major depressive episode. * the patient is currently being treated with 1 or 2 of the following drugs: lithium, olanzapine, or valproic acid. key exclusion criteria: * the patient has any axis i disorder apart from bipolar i disorder that was the primary focus of treatment within 6 months before the screening visit (with the exception of nicotine dependence). * the patient has any clinically significant uncontrolled medical or surgical condition. * the patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets. * the patient is a pregnant or lactating woman. (any woman becoming pregnant during the study will be withdrawn from the study.)
effects of moderate physical activity on hb, physical fitness and psychological well being in females

Conditions: Anemia; Quality of Life

Summary: the study is design to determine the effectiveness of moderate physical activity on hb, physical fitness and psychological well-being in females.

the majority of literature showed that level of physical activity is associated with hb level. but there is paucity in the literature regarding the cause and effect relationship of pa and hb. literature shows lacking that there is any defined physical activity, which can affect the hb concentration. according to literature, different studies conduct at hb level in individuals with different diseases i.e. rheumatic arthritis, diabetes mellitus etc. the aim of my study is to determining the cause and effect relationship of moderate physical activity on hb level in healthy female population, one of the easiest moderate physical activity is brisk walk. brisk walk is an aerobic exercise. people do get best physiological results of aerobic exercise with intensity of exercise 60-70% of the maximum pulse with longer time duration as well as increase frequency of exercise, which increase no of hemoglobin level due to this need more oxygen to performing physical activity in return basal metabolic rate increases and achieve physical fitness and gain relieve from the psychological problems.

Eligibility criteria:
inclusion criteria: 1. female 2.18-25 years 3. hb\<12 exclusion criteria: 1. lower limb musculoskeletal injury 2. any head injury or trauma in past 6 months. 3. any neurological or musculoskeletal condition 4. acute or chronic infections diseases
effect of the transcranial direct current stimulation (tdcs) on dependent smoking people

Conditions: Tobacco Abuse Smoke

Summary: the purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial direct current stimulation (tdcs - 1 ma) applied to left vs right cdlpf of tobacco-dependent subjects compared to the application of a placebo tdcs (sham procedure) on the craving, which is evaluated by the item 1 of fagerström test between day 1 and day 10. craving is also evaluated 1 month post-treatment.

tobacco is the second leading cause of death worldwide. it is currently responsible for the death of one in 10 adults (about 5 million deaths per year) and it is the fourth disease risk factor in the world. many methods to quit smoking are available but in all cases, relapse is a common phenomena. the main risk factor for relapse is craving. so, acting on the craving seems essential to modulate tobacco consumption. many functional neuroimaging studies have established a neuroanatomical substrate for craving process, in particularly dorsolateral prefrontal cortex (dlpfc), accessible par neuromodulation.

Eligibility criteria:
inclusion criteria: * fagerström score ≥ 5 * q-mat score ≥ 6 * smoking subjects from 10 to 30 cigarettes a day * right-handed subjects * w/o severe progressive somatic pathology (especially tumor diseases, degenerative diseases) * hamilton depression rating scale-17 score \<18 exclusion criteria: * pregnancy and/or lactation * presence of a specific contraindication for tdcs (e.g. personal history of epilepsy, metallic head implant, cardiac pacemaker...)

Keywords: tobacco craving tdcs attentional tasks
incidence, prevalence, and symptom burden associated with advanced renal cell carcinoma in commercially insured population (ihcis)

Conditions: Carcinoma, Renal Cell

Summary: information on the prevalence of advanced/metastatic renal cell carcinoma and its symptom burden is limited in commercially insured patients (age \>= 18 years and \< 65 years). additionally, limited information exists on economic burden of adverse events associated with treatments for advanced/metastatic renal cell carcinoma. an objective of the current study is to estimate the incidence, prevalence, and symptom burden associated with advanced/metastatic rcc in a us "real-world" setting. another objective is to quantify the economic burden of severe adverse events with agents used in management of first line advanced/metastatic rcc (sunitinib, sorafenib, bevacizumab, and pazopanib). this study will employ a retrospective cohort design. analyses of health insurance claims data from a large commercially insured population will be employed in the current study. study subjects will consist of all persons, aged ≥18 years, with evidence of advanced rcc between january 1, 2000 and december 31, 2009; these persons will be identified based in part on case-ascertainment algorithms. analyses will be directed at estimating annual rates of incidence and prevalence of advanced/metastatic rcc, as well as symptom burden and costs of common severe adverse events associated with treatments used in management of advanced/metastatic rcc (sunitinib, sorafenib, bevacizumab, and pazopanib).


Eligibility criteria:
inclusion criteria: * evidence of two or more medical encounters with a diagnosis of kidney cancer (icd-9-cm 189.0) or malignant neoplasm of the renal pelvis (189.1), and * two or more medical encounters with a diagnosis of distant secondary malignant neoplasm (icd-9-cm 197.xx-199.0, excluding 198.0 \[kidney metastasis\]) on different days \<120 days apart (the date of the earliest such encounter will be designated the "index date"). exclusion criteria: * evidence of receipt of chemotherapeutic agents indicated or used in the treatment of advanced tcc, or * evidence of cystoscopy, biopsy of the bladder, or radical cystectomy * subjects with evidence of any other primary cancer

Keywords: retrospective database analysis economic burden
mode of delivery on newborn hearing test

Conditions: Hearing Loss, Neonatal

Summary: neonatal hearing screening may fail due to some perinatal and neonatal factors. it is well known that false positivity increases cost and maternal anxiety and anxiety in the neonatal hearing screening. the effect of the type of delivery to hearing screening is not yet clear. the first automated mode of delivery of babies born in turkey auditory brainstem response (sad's), the authors aimed to evaluate the effects of the test results and false positive rate. newborns were evaluated with brainstem response test. the aabr test was performed before patients were discharged. perinatal and neonatal variables and aabr test results were recorded retrospectively.


Eligibility criteria:
inclusion criteria: * records of birth process and * pregnancy test results of newborns. exclusion criteria: * newborn; * she was in a neonatal intensive care, * congenital / chromosomal anomaly, * undergoing congenital cmv infection, * facial / ear deformity, * families with hearing problems, * those with hyperbiliromyemia, * \<12 hours after delivery, * maternal infection, * dm, * recurrent abortion, * smoking, * plesanta previa,

Keywords: newborn hearing screening automated auditory brainstem response mode of delivery
3d structural imaging of human breast tissues

Conditions: Human Breast Tissues

Summary: this project aims to develop an advanced ex vivo medical microscopic imaging technology. by developing breast tissue staining techniques, acquiring microscopic images, and performing structural reconstruction, we seek to observe the 3d structure of breast tissue. this includes examining cell distribution, mammary ducts, and blood vessel distribution, to explore the different biological characteristics between normal breast tissue and various types of cancerous tissues.


Eligibility criteria:
inclusion criteria: * adults aged 18 and above. * patients clinically diagnosed with breast cancer. exclusion criteria: * patients unable to provide consent (e.g., inability to speak, inability to communicate in chinese, etc.). * patients for whom a definitive pathological diagnosis cannot be established. * patients suitable only for biopsy and not for surgical excision. * excised tissue showing severe radiation-induced changes under pathological examination. * tumor specimens smaller than 1 cm. * patients with ductal carcinoma in situ (dcis).

Keywords: breast tumor tumor assessment tumor microenvironment digital pathology 3d pathology
mobile application for ibd patients with biologics

Conditions: Inflammatory Bowel Diseases

Summary: monitoring of biologic treatment in patients with inflammatory bowel disease (ibd) is important given the increased risk of infections. in this study we aim to evaluate the use of a mobile application to guide ibd patients and facilitate the monitoring of biologic treatment.

biologic treatment can induce and maintain remission in patients with inflammatory bowel disease (ibd). however, biologics are associated with increased risk of infections. therefore, it is important to regularly monitor patients during the course of therapy. this process can be time consuming for patients as well as clinicians. mobile applications, have the potential to guide patients and facilitate monitoring of biologic treatment. in this study we aim to evaluate the use of a mobile application to guide ibd patients during biologic treatment. adult patients with diagnosis of ibd treated with biologics will be included. the mobile application with personalised content will give patients information about their treatment, reminders for example when blood tests and questionnaires to check for adverse events.

Eligibility criteria:
inclusion criteria: * diagnosis of inflammatory bowel disease * treatment with infliximab or vedolizumab * ability to read and understand dutch language exclusion criteria: * patients recently started with biologic treatment

Keywords: biologic treatment mobile application
evaluation of clinical results of patients treated conservatively for distal biceps tendon lesions

Conditions: Tendon Rupture

Summary: a clinical evaluation of the results of conservative treatment after distal biceps tendon rupture with a minimum follow up of 1 year. the results will be evaluated with clinical scores (meps, dash and sf-12) and strenght and fatigue evaluations with dynamometers for both flexion and supination of elbow and forearm. the results of the affected side will be compared with the controlateral side


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years old at time of injury * complete acute distal biceps tendon rupture diagnosed and evaluated at irccs istituto ortopedico rizzoli between 2000 and 2024 treated conservatively exclusion criteria: * \&lt; 18 years at time of injury * patients who present controindications to the strenght evaluation * patients who have developed other non correlated injuries to the affected arm (e.g. fractures or tendon injuries) * patients treated surgically for distal biceps tendon rupture

Keywords: distal biceps tendon rupture elbow tendon ruptures elbow tendon ruptures conservative treatment
effect of using myopia prediction algorithm

Conditions: Eye--Refractive Errors

Summary: in this study, the investigators aim to perform a prospective, randomized controlled study to compare the myopia development between children using myopia prediction algorithm and children without using myopia prediction algorithm.

we propose to enroll grade 3 children from primary schools in china. children will be given examinations of visual acuity, eye refraction and biometrics, and be assigned to two groups: participants in group a use myopia prediction algorithm to predict myopia development, while in group b, the participants do not use myopia prediction algorithm to predict myopia development. the visual acuity, eye refraction and biometrics will be investigated over the one-year follow-up period, aiming at comparison of actual myopia development between the two groups.

Eligibility criteria:
inclusion criteria: * children at grade 3 (aged 8-9) * has the record of eye refraction examined in the past year * written informed consents provided exclusion criteria: * definitive diagnosis of other ocular abnormalities except for refractive error * previous eye surgery * unwilling to participate in this trial