Kornimate/medical-research-clean huggingface dataset:
treatment patterns in advanced small cell lung cancer (sclc)

Conditions: Lung Cancer

Summary: non-interventional, retrospective study of advanced sclc patients in 4 european countries (france, germany, italy, and united kingdom \[uk\]) with the aim to produce evidence across different sclc treatment lines to characterize the clinical and economic burden of the disease in europe.


Eligibility criteria:
inclusion criteria: cohort 1 and 2: * patients 18 years of age or older at sclc diagnosis * confirmed diagnosis of sclc within the patient identification period (between october 2013 and october 2015) * initiated on first-line treatment (radiotherapy and/or chemotherapy) for their sclc * full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first) * signed informed consent (where required as per local requirements) cohort 3: * patients 18 years of age or older at sclc diagnosis * confirmed diagnosis of sclc not earlier than october 2013 * initiated on second-line treatment due to relapse after first-line therapy not later than august 2016 * full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first) * signed informed consent (where required as per local requirements) exclusion criteria: * participants with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to first treatment and no additional therapy is required or anticipated to be required during the study period. other inclusion/exclusion criteria may apply

Keywords: small cell lung cancer (sclc)
cognitive rehabilitation of glioma patients

Conditions: Glioma; Cognition Disorders

Summary: the purpose of this study is to determine whether cognitive rehabilitation is effective in patients with gliomas (brain tumour), by comparing direct and follow-up neuropsychological functioning and quality of life of the experimental group to the control group.

the majority of patients with (low-grade) glioma exhibit cognitive symptoms and objective deficits, which have a sustained, negative impact on daily functioning and quality of life. adult patients with a low-grade glioma, either histologically proven, or suspected (1), as well as adult anaplastic glioma patients with favorable prognostic factors (2), who are clinically stable for at least 6 months, will be recruited from 9 hospitals in the netherlands. consenting patients with both subjective cognitive symptoms and objective deficits will be randomized to either the cognitive rehabilitation program (n = 75) or a "waiting-list" control group (n = 75). upon completion of the study, those patients assigned to the control group will be given the opportunity to undergo the cognitive rehabilitation program. the cognitive rehabilitation program incorporates both retraining of impaired cognitive functions, and teaching of compensatory strategies. rehabilitation will be directed towards attention, memory and executive functioning. the intervention will consist of 6 weekly, individual, 2-hour sessions plus two hours of homework. to evaluate the efficacy of the rehabilitation program, objective neuropsychological functioning, self-reported cognitive symptoms and health-related quality of life will be assessed before rehabilitation, directly following rehabilitation, and at 6-month follow-up.

Eligibility criteria:
inclusion criteria: * adult patients with a histologically proven low-grade glioma or presumed (i.e., suspected) low-grade glioma based on both clinical and mr imaging feature, and * adult patients with an anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligo-astrocytoma) under age 50 and with good performance status (kps \> 70); * who are clinically stable for a minimum of 6 months prior to study entry (as determined by recent ct or mri imaging) and no anti-tumor treatment during that period of time (i.e., surgery, radiotherapy, chemotherapy, corticosteroids); * who report at least one symptom of impaired cognitive functioning based on a standardized self-report questionnaire, administered by researcher; * and who meet criteria for neuropsychological impairment based on objective test results (assessed by researcher). exclusion criteria: * lack of basic proficiency in dutch; * iq below 85; * severe reading problems; * an additional (history of) neurological or psychiatric disorder; * participating in a concurrent study in which neuropsychological testing and/or health-related quality of life assessments are involved

Keywords: glioma brain tumor cognit neuropsycholog attention memory executive function rehabilitation remediation training
rasagiline (azilect) - neuroprotection for macula-off retinal detachment

Conditions: Retinal Detachment

Summary: this randomised, double-blind, placebo-controlled clinical trial investigates the neuroprotective effect of rasagiline in patients suffering from a retinal detachment affecting central vision. based on results from a study in mice suffering from retinal degeneration, the investigators hypothesize that rasagiline delays neurodegeneration in the retina and improves visual acuity outcomes after retinal detachment surgery. rasagiline is a second-generation propargylamine with neuroprotective properties modulating the caspase-dependent pathway of programmed cell death.

background in previous experimental studies neuroprotection by rasagiline has been shown in rds-mice, a model for slow retinal degeneration. it is known from these experiments that rasagiline specifically delays apoptosis, but also modifies inflammation and autophagy. the bioavailability of the drug in the central nervous system is high, and based on the literature is sufficient in the retina. in retinal detachments the outer layers of the neurosensory retina are deprived of nutrients and degeneration of the photoreceptors occurs fast. this is particularly relevant in the macular area of the retina where the density of photoreceptors is high, such that visual acuity recovery can be significantly limited by photoreceptor loss. objective to assess the neuroprotective effect of oral rasagiline (1mg daily for 7 days) administered perioperatively in patients undergoing surgical retinal detachment repair for central vision involving retinal detachments. methods in this clinical trial, patients suffering from retinal detachments affecting the fovea get randomly assigned to perioperative oral treatment with either rasagiline (1mg) or placebo once daily for 7 days. pharmacologic treatment is initiated at the time of hospital admission, usually the day before surgery. the main outcome of the study is visual acuity six months after surgical retinal detachment repair. structural differences of the neurosensory retina between groups will be analysed by optical coherence tomography, a non-invasive imaging method for retinal pathology.

Eligibility criteria:
inclusion criteria: * rhegmatogenous retinal detachment * central vision affected for less than 72 hours * pseudophakic * age 18 or over * not participating in other clinical trials * willing to attend follow-up visits * written informed consent exclusion criteria * phakic * narrow angle glaucoma * previous intraocular surgery other than cataract operation * retinal disease * concurrent treatment with mao inhibitors * pregnancy * malignant arterial hypertension * liver or kidney failure * life-threatening or malignant disease

Keywords: retinal detachment rasagiline optical coherence tomography visual acuity neuroprotection azilect
retrospective study of high dose follitropin delta in a mixed protocol with human chorionic gonadotropin

Conditions: IVF; Infertility

Summary: follitropin delta is a rfsh, uniquely expressed in a human fetal retinal cell line, which owing to differences in glycosylation profile has a lower clearance and induces a higher ovarian response in humans than existing rfsh preparations when administered at equal doses of biological activity. a noninferiority clinical trial (esther-1) in which individualized dosage of follitropin delta according to each patient's profile (amh and weight) was compared to conventional follitropin alfa dosing for ivf have demonstrated that an individualized follitropin delta dosing is noninferior to conventional follitropin alfa with respect to ongoing pregnancy rate, ongoing implantation rate, and also live births, with a concomitant reduction in iatrogenic complications, including ohss


Eligibility criteria:
inclusion criteria: * women 18 to 42 years of age undergoing ivf/icsi cycle * ivf antagonist protocol * regular menstrual cycles of 24-35 days * presence of both ovaries exclusion criteria: * endometriosis stage iii/iv * history of recurrent miscarriages, defined as ≥ 3 consecutive losses * women undergoing ovarian stimulation for oncologic or elective fertility preservation * women participating in any other research project * hypersensitivity to follitropin delta and/or human chorionic gonadotropin * use of growth hormone (gh) during the stimulation cycle
vitamin a equivalence of the provitamin a in biofortified bananas

Conditions: Vitamin A Deficiency

Summary: the objective will be to quantify the vitamin a equivalence of the provitamin a in transgenic biofortified bananas.


Eligibility criteria:
inclusion criteria: * general good health as determined by interview, blood biochemistry profile, and complete blood count * antecubital veins amenable to blood collection exclusion criteria: * adverse reactions to blood sample collection * history of anemia or excessive bleeding * cigarette smoking, frequent alcohol consumption * use of vitamin/mineral supplements * food allergies * lactose intolerance * abnormal thyroid status * chronic disease, lipid malabsorption or gastrointestinal disorders * hyper- or hypolipidemia * body mass index (bmi) \> 28 * history of eating disorder or restrained eating * current or planned pregnancy; menstrual cycle irregularities or abnormalities * use of hormonal contraceptives (affects chylomicron clearance); use of medications that may affect lipid absorption or transport

Keywords: bananas biofortified carotenoids vitamin a
a phase iib study for alx-0061 monotherapy in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the primary objective of this study is: - to assess the efficacy and safety of dose regimens of alx-0061 monotherapy administered subcutaneously (s.c.) to subjects with active rheumatoid arthritis (ra). the secondary objectives of this study are: * to assess the effects of alx-0061 on quality of life, the pharmacokinetics (pk), pharmacodynamics (pd), and immunogenicity of alx-0061 and to explore potential dose regimens for alx-0061 monotherapy, based on safety and efficacy, for further clinical development. * to obtain parallel descriptive information concerning the efficacy and safety of tocilizumab (tcz) s.c. in the same clinical trial ra population.


Eligibility criteria:
inclusion criteria: * diagnosis of ra (according to the 2010 eular/american college of rheumatology (acr) classification criteria) for at least 6 months prior to screening, and acr functional class i-iii. * received previous or current treatment with methotrexate (mtx), and is considered intolerant to mtx, or for whom continued treatment with mtx is inappropriate or has contraindications for mtx use. * subjects must not have received mtx for at least 4 weeks before first administration of the study drug. * have active ra with at least 6 swollen and 6 tender joints(66/68 joint count) at the time of screening and baseline * others as defined in the protocol exclusion criteria: * have been treated with dmards (disease modifying antirheumatic drugs)/systemic immunosuppressive drugs during the 4 weeks, or 12 weeks for hydroxychloroquine, chloroquine, or leflunomide (except when an adequate wash-out procedure for leflunomide was completed), prior to first administration of study drug. * have received approved or investigational biological or targeted synthetic dmard therapies for ra (including tumor necrosis factor alpha-inhibitors, abatacept, rituximab, or janus kinase \[jak\]-inhibitors) less than 6 months prior to screening. * have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic dmards (including jak inhibitors), for ra. * have received prior therapy blocking the interleukin-6 (il-6) pathway, at any time. * others as defined in the protocol.
the role of nebulized budesonide in the treatment of acute exacerbations of copd

Conditions: COPD Acute Exacerbation

Summary: this study was designed to evaluate the hypothesis that nebulized budesonide) might be an alternative to systemic corticosteroids (sc) in the treatment of patients with acute exacerbations of copd (aecopd).

patients, hospitalized with aecopd, were randomized into three groups. group i received only bronchodilator treatment (bdt), group ii received sc (40 mg prednisolon) plus bdt, and group iii received nebulized budesonide (nb)(1500 mcg qid) plus bdt. improvement rates in multiple parameters during 10-day hospitalization, and acute exacerbation and re-hospitalization rates within one-month after discharge were compared between the groups.

Eligibility criteria:
inclusion criteria: * copd patients who were admitted to our pulmonary department for an acute exacerbation were prospectively enrolled in the study exclusion criteria: * copd patients hospitalized with specific reasons like pneumonia, pulmonary emboli, congestive heart failure, pneumothorax etc. as the cause of acute exacerbation, or patients with risk of imminent respiratory failure requiring mechanical ventilation or direct admission to the icu were excluded.

Keywords: copd, nebulized budesonide, systemic corticosteroids
treatment strategy for stage iv gastric cancer with positive peritoneal cytology as the only non-curable factor

Conditions: Stomach Neoplasm

Summary: gastric cancer with positive is defined as stage iv disease in 7th ajcc/uicc tnm staging system. controversy exists on the treatment of this part of patients. this trial aimed to explore the optimal treatment strategy for stage iv gastric cancer with positive peritoneal cytology as the only non-curable factor.

in the 7th ajcc/uicc tnm staging system, gastric cancer with positive peritoneal cytology (cy+) is defined as stage iv disease. in nccn clinical practice guidelines, it is suggested that positive peritoneal cytology in the absence of visible peritoneal implants should be considered as m1 disease and surgery as initial treatment is not recommended for patients with positive peritoneal cytology. however, in the japanese gastric cancer treatment guidelines 2014, it is suggested that standard gastrectomy can be proposed for patients with no other non-curative factors and if the cy+ status was revealed after surgery, postoperative treatment with s-1 can be recommended as the tentative standard. previous studies have also proved that extensive intraperitoneal lavage(eipl) and hyperthermic intraperitoneal chemotherapy(hipec) are effective methods for the treatment of peritoneal metastasis. in order to optimize the treatment strategy of this part of patients, this trial is designed to compare the effectiveness of 2 treatment strategies.

Eligibility criteria:
inclusion criteria: * pathologically diagnosed gastric adenocarcinoma with endoscopic biopsy; * pretreatment clinical stage with computed tomography and/or endoscopic ultrasonography; * clinical stage ct2-4 n0-3 m0; * standard gastrectomy with d2 lymphadenectomy is needed according to the clinicians' evaluation; * ecog performance score ≤2, with tolerance of standard gastrectomy and d2 lymphadenectomy; * positive peritoneal cytology; * signed informed consent. exclusion criteria: * remnant gastric cancer, recurrence gastric cancer or multi-primary cancers; * intraoperative identified other unresectable factors including other metastasis except positive peritoneal cytology; * postoperative pathologically diagnosed as non adenocarcinoma; * pregnant or lactate women; * child-bearing period adults who refuse to birth control during the trial; * uncontrolled epilepsy, cns disease or mental disorder that may influence the compliance of the patient; * severe/active heart disease, including but not limited to acute coronary syndrome, congestive heart failure with less than nyha ii cardiac function, severe arrhythmia that needs drug control, cardiac infarction within 12 month; * organ transplantation patients who needs immune suppression therapy; * patients who needs emergency surgery because of bleeding, perforation or obstruction.

Keywords: gastric cancer peritoneal cytology
a prospective study on the treatment of clm based on icg imaging

Conditions: Lymphatic Malformation

Summary: the goal of this prospective randomized controlled study is to explore the role of indocyanine green-fluorescence imaging in management of cystic lymphatic malformation.. to clarify the application value of indocyanine green-fluorescence imaging in both diagnosis and treatment of cystic lymphatic malformation (clm) in children, is helpful for exploring pathogenesis of clm, and providing a clearer scientific basis for subsequent surgical intervention. it also provides alternative for the future diagnosis and treatment of clm. participants will receive indocyanine green-fluorescence imaging before operation, while the patients in control group will receive traditional operation. researchers will compare difference in curative effect between two groups.


Eligibility criteria:
inclusion criteria: (1) no previous intervention; (2) clm diagnosed by pretreatment magnetic resonance imaging (mri); (3)3 to 6 months post-treatment follow-up; (4) superfacial clm exclusion criteria: (1) history of iodine allergy; (2) syndromic clm ; (3) severe liver and kidney dysfunction; (4) intralesional hemorrhage; (5) intralesional infection

Keywords: indocyanine green children inflow lymphography
adapting an evidence-based intervention for stigma-related stress, mental health, and hiv risk for msm of color in small urban areas

Conditions: HIV in MSM

Summary: the purpose of this study is adapt an evidence-based intervention for stigma-related stress, mental health, and hiv risk for bay, bisexual, and other men who have sex with men (msm) of color in small urban areas.

this study has two specific aims. aim 1 will focus on the modification of an existing intervention manual (created by the study pi) using feedback from previous qualitative interviews with msm in new haven and hartford, ct. also incorporated will be recent qualitative research on msm of color's resilience. specifically, the ways in which racial minority stigma impacts the mental health of msm in small urban areas and adaptive coping skills that msm can use in the face of these health threats. aim 2, will consist of the deliver of the adapted intervention to approximately 30 young msm (15 hiv-negative and 15 hiv-positive) to gather data on the feasibility and acceptability of the newly adapted program. the evaluation of the new program will be conducted using pre-post comparisons of quantitative assessments and from qualitative interviews hoped to provide information regarding intervention feasibility, acceptability, and any needed refinement. this project integrates expertise in culturally-sensitive evidence-based interventions for msm's hiv risk into a community-based hiv prevention and care context at the fair haven community health center, where the intervention will be delivered to the existing patient population. as of april, 2019, the study protocol was updated and approved by the yale irb such that the two intervention cohorts did not differ by hiv serostatus. this decision was made: (1) because of the greater number of hiv-negative men, compared to hiv-positive men, who expressed interest in the study and (2) because participants could decide whether or not to disclose their serostatus in the group, as they do in other real-life interactions with other msm, as reviewed during the consent process. thus, there was no group assignment based on hiv serostatus.

Eligibility criteria:
inclusion criteria: participants must: * report anticipated 6-month residential stability in new haven county * self-identify as a gay or bisexual man or report being a man who has had past-12-month sex with a man * self-identify as an ethnic or racial minority, including black, african american, caribbean american, hispanic, and latinx * speak fluent english exclusion criteria: * participants not meeting the inclusion criteria will not be eligible to participate.

Keywords: hiv msm
in-depth survey for the reasons of weight control difficulties

Conditions: Weight Control

Summary: the aim of this study was to investigate the causes of weight control difficulties in overweight or obese patients .overweight or obese chinese patients were enrolled. according to their age, 3 males and 3 females (24 in total) aged 14-20 years, 21-40 years, 41-60 years and 61-80 years were included for interview for about 1 hour. the interview included demographic basic information and other characteristics, time and results of weight control, and causes of weight control difficulties. after collecting the information, classification and summary analysis were performed.

the aim of this study was to investigate the causes of weight control difficulties in overweight or obese patients of all ages by in-depth interview, in order to explore more causes of weight control difficulties, to make early exploration for targeted large-scale cross-sectional survey studies on the causes of weight control difficulties in the future, and to find the causes of weight control difficulties, which will help to study measures to solve weight control difficulties. study design: overweight or obese chinese patients were enrolled. according to their age, 3 males and 3 females (24 in total) aged 14-20 years, 21-40 years, 41-60 years and 61-80 years were included for interview for about 1 hour. the interview included demographic basic information and other characteristics, time and results of weight control, and causes of weight control difficulties. after collecting the information, classification and summary analysis were performed.

Eligibility criteria:
inclusion criteria: 1. fully understand the purpose, nature and method of the study, voluntarily participate in the study, agree to record the interview content through a tape recorder during the interview, and sign the informed consent form (icf) before the interview; 2. chinese aged 14-80 years (including boundary value, subject to the time of signing the informed consent form), male or female; 3. patients with body mass index (bmi) greater than 24 kg/m 2 , who have taken any weight control measures; 4. willing and able to comply with study requirements. - exclusion criteria: 1. inability to communicate in speech; 2. known mental or psychological disorder of any kind; 3. other conditions that, in the opinion of the investigator, would make participation in this study inappropriate. -

Keywords: deep survey of weight control difficulty