Kornimate/medical-research-clean huggingface dataset:
biweekly gemcitabine and docetaxel as first line treatment for advanced disease in elderly non-small cell lung cancer (nsclc) patients

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: lung cancer is one of the most common malignancies worldwide and the leading cause of cancer-related deaths in western countries. standard treatment for patients with good performance status (ps) stage iiib/iv nsclc currently includes a two-drug platinum-based chemotherapy regimen, but optimum treatment for elderly patients is less well-defined due to platinum related toxicities. several drugs with novel mechanisms of action and significant activity in nsclc have been developed; including docetaxel and gemcitabine that are also active in patients previously treated with cisplatin-based regimens and have a more favorable toxicity profile. the more favorable toxicity profile of docetaxel and gemcitabine supports its use as first-line chemotherapy, especially in patients with severe comorbidities as elderly patients. to improve the therapeutic index of this combination, the investigators performed a study with biweekly gemcitabine and docetaxel in elderly patients.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of advanced nsclc. * stage iii with pleural effusion and stage iv. * patients are 70 years old. * patients with 1 \> ecog ps =1. * patients must have at least one measurable lesion, no previously irradiated. * life expectancy of at least 12 weeks. * adequate organ function according to the following criteria: * bone marrow: anc \>= 2.0x10(9)cells/l; platelet count \>= 100x10(9)cells/l; leukocyte count \>= 4000x10(6)/l; hemoglobin \>= 10 g/dl. * liver function: bilirubin \<= 1.5 x uln; alkaline phosphatase \<= 5 x uln;ast and alt \<= 1.5 x uln. * renal function: serum creatinine \<= 2mg/dl. exclusion criteria: * prior systemic chemotherapy for advanced disease. * patients with symptomatic brain metastases. * no measurable bone metastases or malignant pleural effusion as only measurable lesion. * history of prior malignancies, except curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years. * history of hypersensitivity reaction to study drugs. * concurrent treatment with other experimental drugs. * current peripheral neuropathy nci grade 2. * participation in clinical trials within 30 days of study entry. * major surgery, open biopsy or traumatic lesion 28 days before to study start.

Keywords: carcinoma, non-small-cell elderly patients docetaxel gemcitabine
transfer accuracy of indirectly bonded orthodontic braces with different transfer trays

Conditions: Malocclusion

Summary: the aim of this study is to comparatively investigate the performances of two different and widely used transfer trays during indirect bonding of the orthodontic braces.

the aim of the study is to compare the accuracy of orthodontic bracket and tube transfer between double layer silicone and double layer vacuum formed trays. the sample included 368 attachments bonded in 16 patients. each patient received one silicone and one vacuum formed tray which were randomly allocated to provide 8 trays of each type for the upper and lower arches. 3d scan data and local best-fit alignments were used to calculate the translational and rotational movements of the orthodontic attachments. chi-square and mann-whitney u tests were used to compare transfer accuracy and success between the groups.

Eligibility criteria:
inclusion criteria: * the presence of indication for both arches to be bonded in the same appointment exclusion criteria: * presence of restorations, hypoplasia or decalcification on vestibular tooth surfaces * abnormal crown morphology

Keywords: indirect bonding accuracy
biomarkers in clozapine-responding schizophrenia

Conditions: Schizophrenia; Psychosis

Summary: the outline of the current project is to establish a cohort of patients with treatment refractory schizophrenia eligible for clozapine, to identify clinical and biological characteristics of clozapine responding patients. patients will be offered treatment with clozapine according to national clinical guidelines. before clozapine is initiated, patients will be offered a thoroughly neurobiological examination, and re-examination will be carried out after 12 weeks of treatment. the primary focus of the examinations will be immunological markers and autoantibodies in the blood and cerebrospinal fluid, permeability of the blood-brain barrier and magnetic resonance imaging of structural, neurochemical and functional brain changes.

patients will be examined before and after 12 weeks of treatment with clozapine examinations at baseline and follow up will be: * clinical ratings * blood inflammatory markers * inflammatory markers in cerebro spinal fluid * mri : examination of grey \& white matter, glutamate and gaba in anterior cingulate cortex and glutamate in thalamus, * selected cognitive measures

Eligibility criteria:
inclusion criteria: * according to icd-10 fulfill diagnostic criteria for schizophrenia (f20.x), chronical paranoid psychoses (f22), schizoaffective psychoses (f25) or other non-organic psychoses (f28/f29); * age 18-65 years; * legally competent; * stabil antipsychotic treatment during last month * being treatment refractory according to tripp-guidelines (howes et al. 2017) defined as having tried at least two antipsychotic drugs in sufficient dosage (≥600 mg chlorpromazine equivalent) for a sufficient time (≥ 6 weeks) without sufficient symptom improvement (still a moderate level of positive symptoms). * recreational use of substances is allowed as long as it does not interfere with compliance * fertile females must use safe contraception (spiral or any hormonal contraception). exclusion criteria: * involuntarily psychiatric admittance during the study * substance abuse that interfere with compliance * pregnancy (will be verified by urine-hcg-test in fertile females) * toxic or idiosyncratic agranulocytosis in the past * reduced bone marrow function according to blood samples * according to information from patient and available files, nouncontrolled * current uncontrolled epilepsy * current circulatory collapse and / or cns depression for any cause * current severe kidney, heart or liver disease * current paralytic ileus
effective adjunctive use of pergolide for cognitive impairment and negative symptoms in schizophrenia

Conditions: Schizophrenia; Negative Symptoms; Cognitive Impairments

Summary: dopamine has been closely associated with prefrontal function. the hypothesis that a lower dopaminergic activity is associated with negative symptoms and cognitive dysfunction observed in the patients of schizophrenia is of a heuristic value in guiding research in this area. this hypothesis led us to test whether pergolide, a d1/d2 agonist, could improve negative symptoms and cognitive impairments prevailing in most patients with schizophrenia. this double-blind placebo controlled study will investigate the remedial effect of pergolide on negative symptoms and cognitive impairments in schizophrenia.


Eligibility criteria:
inclusion criteria: patients * were age 18-50 years, met the dsm-iv criteria for schizophrenia * were treated with a stable dose of risperidone, raging 2 to 6mg, for more than 8 weeks * had a score ≥15 on negative subscale items in positive and negative syndrome scale (panss) * had a minimum period of symptom stability, defined as no more than 20% change on consecutive ratings on panss for at lease 4 weeks exclusion criteria: * had a history of medical condition or drug treatment that may have affected cognitive performance * had a history of other psychiatric disorders

Keywords: pergolide dopamine d1 schizophrenia cognitive disturbance negative symptoms
sensory mapping following video-assisted thoracic surgery

Conditions: Paresthesia; Dysesthesia; Pain

Summary: this is a prospective observational cohort study on changes in sensory mapping.


Eligibility criteria:
inclusion criteria: * age \< 18 years old * elective lung cancer surgery (vats) exclusion criteria: * does not understand danish * cognitive reduction * bilateral procedure planned * previous thoracic surgery * pregnant or nursing * known nerve affection from other cause * alcohol/substance abuse * inability to cooperate to pain scoring/sensory examination * \> 5 mg methylprednisolone/day
monitored anesthesia care with propofol plus remifentanil during endoscopic submucosal dissection: evaluation of bispectral index monitoring

Conditions: Early Gastric Cancer

Summary: there are clinical usefulness issues associated with bispectral index (bis) for sedation of endoscopic submucosal dissection (esd). however, the clinical usefulness of bis for deep sedation is incompletely described. the purpose of this study is to show that bis-guided sedation is safe and useful clinically and may provide stable sedation status to physicians and patients.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status i to ii. exclusion criteria: * body mass index (bmi) over 35 (kg/m2) * hepatic or renal insufficiency * history of allergy to the drugs used * history of administration of anxiolytics, narcotics, antipsychotics, opioid.

Keywords: propofol, endoscopy, bispectral index
placebo and active controlled, double dummy study to compare efficacy of aspirin and ibuprofen in treatment of episodic tension-type headache

Conditions: Headache; Tension-Type Headache; Tension-Type Headache (Episodic)

Summary: the purpose of this study is to determine the efficacy and tolerability of 500 mg and 1000 mg aspirin® (study medication) by comparing it to placebo (the control group without active substance) or 200 mg or 400 mg ibuprofen (study medication) in treating the symptoms of episodic tension-type headache. the study is designed to develop a treatment method against episodic tension-type headache which will have more advantages for patients than the methods that are currently available.


Eligibility criteria:
inclusion criteria: * ambulatory male or female, 18 to 65 years of age * normal blood pressure * patients suffering from episodic tension-type headache * headache lasting from 30 minutes to 7 days * headache had at least two of the following characteristics: bilateral location. pressing/tightening (non-pulsating). mild or moderate intensity. not aggravated by routine physical activity such as walking or climbing stairs. - both of the following: no nausea or vomiting. no more than one of photophobia or phonophobia. exclusion criteria: * other headaches, including migraine, that required medical treatment * hypersensitivity to acetylsalicylic acid, salicylates, ibuprofen or other non-steroidal anti-inflammatory drugs (nsaids) * serious physical illness especially uncontrolled disorders of kidney, liver, lung, heart or brain function, neurological disorders or severe chronic or terminal disease * mental illness, including depression * needed or were using or likely to need or use any of the prohibited concomitant medications: antidepressants, oxicams * pregnant or lactating women, or sexually active women of child-bearing potential unless using effective contraception * participating in any other clinical study or had done within the previous 4 weeks * had been previously enrolled in this study
elranatamab post cilta-cel in patients with clinical high risk relapsed myeloma

Conditions: Myeloma

Summary: the purpose of the study is to evaluate the effect of elranatamab therapy after cilta-cel measuring how long a patient with high risk relapsed myeloma lives without the myeloma getting worse(progressing), also known as progression-free survival (pfs). patients with clinical high-risk myeloma, defined as having history of myeloma that has grown outside of the bones or having high risk mutations in the myeloma cells, benefit less from cilta-cel compared to myeloma patients without these characteristics.


Eligibility criteria:
inclusion criteria: * understand and voluntarily sign an informed consent form. * have received commercial cilta-cel within 3-6 months for relapsed refractory myeloma and have high risk cytogenetics by imw (del17p, or t(4;14) or t(14;16) or history of emd, and must not have evidence of progressive disease by imwg criteria(appendix b) following car-t cell therapy. * have received \>2 prior treatment regimens including an immunomodulatory drug, a proteasome inhibitor and a cd38 monoclonal antibody. * able to adhere to the study visit schedule and other protocol requirements. * patients must have available clonoseq id prior to enrollment to track mrd status. * eastern cooperative group (ecog) performance status of 0 or 1. * serum bilirubin levels ≤1.5 times the upper limit of the normal range for the laboratory (uln), unless related to gilbert syndrome. * serum ast or serum alt levels ≤2 x uln. * must have adequate bone marrow function. exclusion criteria: * ongoing active infection defined as an infection that is worsening despite therapy and causing symptoms or requiring intravenous antibiotic treatment. * ongoing crs or icans of any grade. * active plasma cell leukemia. * patients with cns involvement, including meningeal involvement. * patients with history of guillain-barre syndrome. * uncontrolled medical problems such as diabetes mellitus, congestive heart failure, coronary artery disease, hypertension, unstable angina, arrhythmias), pulmonary, hepatic and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma, which in the opinion of the treating physician pose an unacceptable risk to the patient. * pregnant or lactating females. * concurrent use of other anti-cancer agents or treatments. * known seropositive for or active viral infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv) or hepatitis c virus (hcv). patients who are seropositive because of hepatitis b virus vaccine are eligible. note: patients with hepatitis c previously treated with curative intent are considered eligible. * patients with renal failure requiring dialysis.
non-motor symptoms (depressive symptoms) of parkinson's disease and their course under pramipexole treatment

Conditions: Parkinson Disease

Summary: the objective of this pms study is the evaluation of depressive symptoms measured with unified parkinson's disease rating scale (updrs) part i (mentation, behavior and mood) and with hospital anxiety and depression scale depression subscore (hads-d) under pramipexole treatment in early and advanced pd patients. in addition it will be investigated whether improvement of depressive symptoms is linked to improvement in motor function (updrs part iii). 250 patients diagnosed with parkinson's disease (pd) will be investigated by 80 specialists (neurologists or neurologists/psychiatrists) across austria. pramipexole will be taken orally at an initial dosage of 0.375 mg/day (using a three times daily schedule independently of food intake) and can be titrated upwards, as required, at weekly intervals to a maximum total daily dose of 4,5 mg (tid) as per summary of product characteristics (spc).


Eligibility criteria:
inclusion criteria: * idiopathic pd with or without fluctuations * indication for treatment with pramipexole * presence of at least mild depressive symptoms (as judged by the treating physician) * ability to reliably complete a self-rating scale (hospital anxiety and depression scale (hads)) exclusion criteria: * any contraindications according to the summary of product characteristics (spc), hypersensitivity to pramipexole or to any of the excipients * ongoing treatment with pramipexole
gwas and ewas in patients with erdheim-chester disease

Conditions: Erdheim-Chester Disease

Summary: erdheim-chester disease (ecd) is a rare form of histiocytosis characterized by the proliferation of blood cells, known as histiocytes, which infiltrate various organs and tissues, often causing irreversible damage. the causes of the condition are still unknown, and although some mutations in genes involved in cell proliferation have been identified, other factors may be involved. susceptibility to developing rare diseases like ecd is typically associated with genetic factors, including dna polymorphisms and epigenetic modifications. this study aims to analyze the entire genome of a large cohort of patients with ecd and healthy controls to determine whether there are polymorphisms and epigenetic variants associated with susceptibility to developing the disease. the study could thus clarify the genetic predisposition to ecd development, provide insights into disease pathogenic mechanisms, and identify proteins or cellular mechanisms potentially targeted by specific treatments.


Eligibility criteria:
inclusion criteria: - ecd with histological confirmation of disease exclusion criteria: - previously treated patients (for methylation and gene expression)
the effect of e-health management on gestational diabetes control

Conditions: Gestational Diabetes Mellitus in Pregnancy

Summary: the purpose of this study was to develop an e-heath management platform(ehmp) for women with high risk of gestational diabetes mellitus (gdm) and to evaluate the longitudinal effects between groups of ehmp intervention.

background: women with previous gestational diabetes mellitus are at increased risk for developing type2 diabetes mellitus or metabolic syndrome in their later life. infants of mothers with gdm are more susceptible to stillbirth and more serious health concerns. with limited time for visits and the predicament of education, applying web-based intervention has become a convenient tool for health management. objectives: the approved project aimed to develop an e-heath management platform(ehmp) for women with high risk of gestational diabetes mellitus (gdm) and to evaluate the longitudinal effects between groups of ehmp intervention. the ehmp integrate gdm health care knowledge, self-awareness of health, self-monitoring of health status (i.e., recording weight and measurement data of metabolic syndrome risk factors and monitoring changes in data trends); participation in discussions or browsing forums; healthy lifestyle guidance and counseling; reminder systems, a token system of earning points in exchange for prizes. methods: pregnant women aged 18-45 years with high risk of metabolic syndrome who have a singleton pregnancy, are eligible to participate in this study. women who agree to participate in the study will be given a participant information sheet and consent form. participants will be recruited from the pregnancy diabetes clinic, at chang gung memorial hospital and introduced to the ehmp using the mobile phone in the clinic. participants will also be given the url to access to the program and they can learn the modules at home by using their home pcs, mobile phones, or tablets. they were followed up for three times: 28 weeks' gestation, 36-40 weeks' gestation and 6-12 weeks postpartum. spss version 20.0 software was used to compile and analyze the research data, including questionnaires and blood test for metabolic index.

Eligibility criteria:
inclusion criteria: pregnant women (pre-pregnancy body mass index ≧ 24) must meet at least one of the following conditions and agree to be interviewed: * age over 34 years old; * ever had giant infant delivery (weight ≧ 4.5 kg); * previous diagnosed with gestational diabetes ; * family history of diabetes. exclusion criteria: * pre-existing diabetes (types 1 and 2); * unable to write and understand chinese; * subject has cognitive impairment; * subject has intellectual disability or mental illness; * dependent on medical care (eg, anti-depressants, or any psychiatric medication)

Keywords: gestational diabetes mellitus pregnant women e-health management metabolic syndrome
study of lobaplatin，5-fluorouracil and leucovorin for the treatment of esophageal carcinoma

Conditions: Esophageal Carcinoma

Summary: the purpose of this study is to evaluate the efficacy and the toxicity of lobaplatin, 5-fluorouracil (5-fu) and leucovorin in patients with esophageal carcinoma.

patients with metastatic or recurrent esophageal cancer have a particularly poor prognosis .the overall 5-year survival rate for patients with newly diagnosed esophageal cancer is under 10%. metastatic esophageal carcinoma is an incurable disease and due to the lack of effective therapies to manage this disease,the median survival is only 6 to 8 months chemotherapy which is one of the most effective treatment so far is used as part of combined modality therapy for locally advanced diseases or as a palliative treatment for metastatic diseases.lobaplatin is the third generation of platinum.phase ⅱclinical trials indicate that lobaplatin is effective for esophageal cancer, ovarian cancer, breast cancer and small cell lung cancer.

Eligibility criteria:
inclusion criteria: * histologically proven squamous cell carcinoma of the esophagus(include cardiac cancer) * newly diagnosed patients should be unable or unwilling to surgery * recurrence after surgery must have no adjuvant chemotherapy or radiotherapy are allowed * patients are required to have dimensionally measurable disease,with an objective measurable focus:preferably the use of spiral computed tomography(ct)and measurements of maximum diameter≥1cm. * cooperative oncology group performance status 0-2 or kps score ≥60,survival time ≥3 months * neutrophils(anc)≥1.5×109/l; blood platelets counts(bpc)≥80×109/l * hemoglobin(hgb)≥90g/l ,serum total bilirubin ≤1.0 times the upper normal limit(uln): alanine aminotransferase and glutamic-oxalacetic transaminase (alt and ast)≤2.5 uln * serum creatinine (cr)≤1.5uln exclusion criteria: * pregnant or nursing women; * female patients at child-bearing age, without taking effective contraceptive methods; * patients who have pathologic confirmation of other types of tumors (eg, leiomyosarcoma, malignant lymphoma) rather than esophageal cancer; * patients with tumors other than esophageal cancer ,except cervical carcinoma in situ and skin basal cancer or squamous cell carcinoma received adequate treatment; * patients with cerebral or meningeal metastasis, intestinal obstruction, or symptomatic pathologic changes of peripheral nerve,ncic-ctg standard \>grade 2 * patients with serious complications such as: serious heart disease remained unstable after treatment, or myocardial infarction, congestive heart failure, unstable angina, frank pericardial effusion or unstable arrhythmias in 6 months before being enrolled into the group; confirmed neuropathy or psychosis, including dementia or epilepsia; uncontrolled infection;active disseminated intravascular coagulation;uncontrolled diabetes, fasting serum glucose\> 7.8mmol / l
a study of enfuvirtide (fuzeon) in participants with advanced human immunodeficiency virus (hiv) infection

Conditions: HIV Infections

Summary: this study assessed the safety and tolerability of enfuvirtide in participants with advanced hiv genotype 1 (hiv-1) disease. eligible participants who failed treatment with regimens containing at least one product from each anti-retroviral class, or had experienced intolerance to previous anti-retroviral regimens received enfuvirtide, 90 milligrams (mg) subcutaneously (sc) twice daily (bid) as long as there were no enfuvirtide related treatment limiting toxicities and participants benefited from study treatment as per investigator's discretion. the anticipated time on study treatment was based on the commercial availability of enfuvirtide in thailand, and the target sample size was 30 individuals.


Eligibility criteria:
inclusion criteria: * individuals at least 16 years of age infected with hiv-1 * cd4 lymphocyte count less than equal to (\ =) 10,000 copies/ml while on highly active antiretroviral therapy (haart) * genotypic or phenotypic resistance and/or treatment-limiting toxicity on previous antiretroviral regimens exclusion criteria: * evidence of ongoing alcohol and/or drug or substance abuse * prior non-adherence to antiretroviral treatment regimens * evidence of active, untreated opportunistic infection, intercurrent illness, drug toxicity or any other condition.