Kornimate/medical-research-clean huggingface dataset:
post-marketing clinical trial of kad-1229 in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the safety and efficacy of kad-1229 as combination therapy with insulin for 16 weeks and up to 52 weeks administration in patients with type 2 diabetes mellitus who show inadequate glycemic control with diet, and insulin monotherapy, or insulin and oral hypoglycemic agent.


Eligibility criteria:
inclusion criteria: * patients who has been receiving dietary therapy and a stable dose and regimen of insulin over 8 weeks before at the time of an observation term start * patients whose hba1c at the time of an observation term start is 7.5% or more and less than 10.0% exclusion criteria: * type 1 diabetes mellitus * patients with serious diabetic complications and other serious complications

Keywords: type 2 diabetes mellitus hba1c
alpha-synuclein level in saliva to differentiate between idiopathic parkinson disease and iatrogenic parkinsonian syndrome

Conditions: Parkinson Disease; Parkinsonian Disorders

Summary: the aim of this study is to determine whether a significant reduction in the total level of alpha-synuclein and significant increase in the oligomeric form of alpha-synuclein and therefore the ratio oligomeric:total alpha-synuclein occurs in patients with parkinson disease compared to patients with drug-induced parkinsonian syndrome.


Eligibility criteria:
inclusion criteria * the patient must have given their free and informed consent and signed the consent form * the patient must be insured or the beneficiary of an insurance policy * the patient is less than 55 years old * for patients with acquired parkinsonian syndrome (ukpdsbb criteria) currently at hoehn and yahr stage ≤3: * for patients recruited via a psychiatrist: after anti-dopamine treatment * for patients recruited via a neurologist: having a recent diagnosis (≤2 years) of parkinson disease exclusion criteria: * the subject is participating in another study * the subject is in an exclusion period determined by a previous study * the patients is under judicial protection * the subject or their representative refused to sign the consent form * it proves impossible to give the subject or their representative clear information. * patients with atypical degenerative parkinsonian syndrome * patients with vascular, post-traumatic, metabolic, toxic or genetic parkinsonian syndrome * appearance of parkinsonian syndrome prior to treatment with anti-dopamine * injection of botulinum toxin into the salivary glands * contra-indication on dat-scan (unbalanced dysthyroidism, allergy, treatment with bupropion or amphetaminergics) * poor oral health (polyposis, gingivostomatitis) observed during the odontologist visit * patients not taking anti-psychotics with parkinsonian syndrome and normal dat-scan
efficacy of generic pegfilgrastim vs brand name pegfilrastim for neutrophil recovery after autotransplant

Conditions: Myeloma Multiple; Lymphoma

Summary: this is a phase 2 clinical trial comparing time to neutrophil recovery after autotrasplant using generic pegfilgrastim vs brand-name pegfilgrastim.

thirty consecutive adults with lymphoma or myeloma receiving autologous peripheral blood stem cell transplant will be included in this phase 2 clinical trial. patients will be allocated 1:1 in two groups: one subcutaneous 6 mg dose of generic pegfilgrastim (control group) or one 6mg dose of brand-name pegfilgrastim (intervention group) both at day +1 after the autotransplant. daily complete blood counts were collected and time to neutrophil (\>0.5x10\^3/microl) and platelet recovery (\>20x10\^3/microl) will be obtained. the investigators will describe the proportion of adverse events and median time to neutrophil and platelet recoveries. median or mean time to neutrophil recovery and time to platelet recovery will be calculated and compared with mann-whitney-wilcoxon test or student t.

Eligibility criteria:
inclusion criteria: * patients undergoing autologous peripheral blood stem cell transplantation * patients with multiple myeloma or lymphoma * adults (\>18 years) * both genders * eastern cooperative oncology group (ecog) \<=2 exclusion criteria: * alanine aminotransferase or bilirubin values \>2.5 times the superior normal limit * creatinin \>2.2mg/dl * fever \>37.6°c * active infection * hepatitis b, c or hiv infection * congestive heart failure (ejection fraction \<40%)

Keywords: autotransplant neutrophil recovery pegfilgrastim
full-mouth and partial-mouth scaling and root planing in type 2 diabetic subjects

Conditions: Periodontitis; Diabetes

Summary: the aim of this study will be to evaluate: 1- the effect of full-mouth (fm) scaling and root (srp) planing in 24 hours associated with or without extensive application of chlorhexidine (clx) on clinical, microbiological, glycemic and immunological parameters in diabetic subjects with chronic periodontitis at 3, 6 and 12 months post-therapy. the hypothesis is that fmsrp associated with clx use will provide the best clinical, microbiological, glycemic and immunological outcomes for the treatment of diabetic subjects with periodontitis. sixty diabetic subjects with chronic periodontitis will be divided in the following therapeutic groups (n=20 subjects per group): fmsrp+clx group - fmsrp in a maximum of 24 hours, application and irrigation of chlorhexidine 2% gel, rinsing chlorhexidine 0.12% solution during 60 days; fmsrp + placebo group - fmsrp in a maximum of 24 hours, application and irrigation of placebo, rinsing placebo solution during 60 days; partial-mouth (pm) srp group: srp in 4-6 sessions in a maximum of 2 weeks. the following clinical parameters will be evaluated at 3, 6 and 12 months post-therapy: plaque accumulation, gingival bleeding, probing depth, clinical attachment level, bleeding on probing and suppuration. at these same periods, glycated hemoglobin levels will be obtained from all subjects. in addition, six subgingival biofilm samples per subject will be analyzed by checkerboard dna-dna hybridization for 40 bacterial species at baseline, 3, 6 and 12 post-therapy. finally, gingival crevicular fluid samples from two shallow and two deep sites will be evaluated for the levels of cyto/chemokines by elisa. data will be submitted to appropriate statistical analysis.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes mellitus * clinical diagnosis of generalized chronic periodontitis * \> 30 years old * at least 15 teeth excluding third molars and teeth indicated to exodontia * more than 30% of the sites with probing depth and clinical attachment level ≥ 4 mm at baseline exclusion criteria: * pregnancy * lactation * current smoking * smoking within the past 5 years * periodontal or/and antibiotic therapies in the previous 6 months * regular use of mouthrinses containing antimicrobials in the preceding 2 months * other systemic condition that could affect the progression of periodontal disease * long-term use of anti-inflammatory and immunosuppressive medications * presence of periapical pathology * use of orthodontic appliances * multiple systemic complications of dm.

Keywords: diabetes mellitus chronic periodontitis root planing cytokines microbiology glycated hemoglobin diabetic subjects
risk stratification for patients with hospital-diagnosed advanced lung cancer

Conditions: Lung Cancer

Summary: this study explores whether supportive care interventions that might reduce rehospitalization could be implemented and feasible, in subjects within a high-risk group of subjects with newly diagnosed hospitalized advanced lung cancer (alc). this study screened 50 subjects from health records and consented to 15 of these screened subjects. these 15 subjects responded to pro questionnaires.

subjects will be considered high risk if they have small cell histology, longer than 8 days hospitalization, high comorbidity, emergency department use or hospitalization in the previous 6 months, prescription of a wheelchair on hospital discharge, or black and/or hispanic race. supportive care interventions such as navigation and palliative care will be recommended for this group. all hospitalized subjects with newly diagnosed alc will be offered web- or telephone-based patient-reported outcome (pro) symptom monitoring for 90 days following hospital discharge if they provide consent. medical record evaluation of consented subjects will provide data for risk assessment and the high-risk group definition. healthcare utilization including emergency department visits, hospitalizations, outpatient palliative care, and cancer treatment received will be compared.

Eligibility criteria:
inclusion criteria for patient participants: 1. age ≥ 18 years at the time of screening. 2. hospital-diagnosed advanced lung cancer with histological confirmation of disease or suspected lung cancer in the opinion of the treating oncologist. for pros only 1. able to complete a web-based or telephonic symptom survey. exclusion criteria for patient participants: 1. enrollment in hospice upon discharge from the index hospitalization for pros only 1. inability to read or speak english. 2. dementia, altered mental status, or any psychiatric condition as determined by the clinical or study team that would prohibit the understanding or rendering of informed consent. 3. current incarceration. 4. any condition that would prohibit the patient from completing pros inclusion criteria for health care provider participants: 1. thoracic medical oncology physicians, advance practice providers, and nurse navigators work in the study site and respond to the survey that assesses acceptability.

Keywords: advanced cancer high-risk patient reported outcome
intermittent catheterization versus trial without catheter

Conditions: Benign Prostatic Hyperplasia

Summary: this is a prospective, comparative, multicenter, randomized controlled trial. the aim of this study is to compare the efficacy, safety and quality of life within patients with acute urinary retention managed by the intermittent catheterization compared or indwelling foley catheter.


Eligibility criteria:
inclusion criteria: men with acute urinary retention due to prostatic hyperplasia exclusion criteria: * patient's with serious conditions and incapacity * previous urethral or prostate surgery. * urethral stricture. * urethrorrhagia. * injuries of urethra and perineum. * attempts of bladder catheterization within 15 days before the acute urinary retention episode. * urinary tract infection. * neurogenic bladder. * chronic urinary retention with a bladder volume of more than 1 liter. * obstructive uropathy due to the acute urinary retention.

Keywords: benign prostatic hyperplasia acute urinary retention intermittent catheterization urethral catheter trial without catheter
abbott dbs post-market study of outcomes for indications over time

Conditions: Movement Disorders; Parkinson Disease; Essential Tremor; Tremor; Dystonia; Primary Dystonia; Secondary Dystonia

Summary: the purpose of this international study is to evaluate long-term safety and effectiveness of abbott deep brain stimulation (dbs) systems for all indications, including parkinson's disease, essential tremor or other disabling tremor and dystonia.

adroit is an international, prospective, multicenter, observational, post-market study intended to collect worldwide long-term safety and effectiveness data on subjects implanted with market-released abbott dbs systems in routine clinical practice. subjects will be followed for 5 years after the initial programming visit.

Eligibility criteria:
inclusion criteria: 1. subject is scheduled for a new implant or ipg device replacement surgery with a market-released abbott dbs system within 180 days. 2. subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure. exclusion criteria: 1. subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study. 2. subject has anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results. 3. study center is located in the united states, and indication for dbs implant is not parkinson's disease or disabling tremor. 4. study center is located in the united states, and the intended lead implant location is not at, or in close proximity to, the stn, gpi, or vim thalamus.
perioperative treatment of combined sox with apatinib and camrelizumab for oesophagogastric cancer

Conditions: Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Summary: the study is being conducted to evaluate the efficacy, safety and tolerability of chemotherapy and apatinib with or without camrelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (gej) adenocarcinoma.


Eligibility criteria:
inclusion criteria: * has previously untreated localized gastric or gej adenocarcinoma as defined by t3-4n+m0; * plans to proceed to surgery following pre-operative chemotherapy. * has an eastern cooperative oncology group (ecog) performance status score of 0 to 1. * has adequate organ function. * male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy. * female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy. * has life expectancy of greater than 12 months. exclusion criteria: * uncontrolled hypertension ( systolic ≥140 mmhg or diastolic ≥90 mmhg despite antihypertensive therapy) * known hypersensitivity to any of the study drugs or excipients. * known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.); * congenital or acquired immune deficiency (e.g. hiv infected)
intermittent versus continuous tarceva study

Conditions: Metastatic Colorectal Cancer

Summary: this is a randomized phase ii study comprising of two treatment arms in patients who are previously untreated for metastatic or recurrent colorectal cancer.

to evaluate two different schedules of erlotinib in combination with a modified xelox regimen in terms of response rate

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * ecog performance status of 0-2. * histological proof of adenocarcinoma of colon or rectum with evidence of metastatic disease. * at least one unidimensionally measurable lesion with a diameter \>20 mm using conventional ct or mri scans, or \> 10 mm with spiral ct * no prior drug treatment or chemotherapy for metastatic disease. * no prior her2 or egfr inhibitors. no prior oxaliplatin in any clinical setting. * absolute granulocyte count \> 1.5 x 109/l, platelet count \> 100 x 109/l, hemoglobin level \> 9.0 g/l, inr \< 1.5. * adequate renal \& hepatic functions: serum creatinine \ 50ml/min, serum bilirubin \ 30g/dl). * prior adjuvant or neoadjuvant chemotherapy for non-metastatic crc is allowed if \> 3 months has elapsed since the last dose of chemotherapy. * prior open surgery is allowed if \> 28 days\* has elapsed since the date of surgery, wound healing is satisfactory and recovery from any complications from the surgery is adequate. (\*for laparoscopic surgery, \> 14 days from the date of surgery). * no serious medical conditions such as myocardial infarction within 6 months prior to entry, or any other medical conditions that might be aggravated by treatment exclusion criteria: * prior history of any malignancies, except basal cell cancer of skin, cervical cin. * treatment with radiotherapy \< 30 days. * pregnant or lactating females * sexually active males and females (of childbearing potential) unwilling to practice contraception during the study. * patients who have not recovered from surgery or other medical illness such as infection. * evidence of central nervous system disease. patients with a history of uncontrolled seizures, central nervous disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake should be excluded from the study * patients lacking physical integrity of upper gastrointestinal tract or malabsorption syndrome or unable to swallow tablets. * prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dpd deficiency). * interstitial pneumonia or extensive symptomatic fibrosis of the lungs. * requirement for concurrent use of the antiviral agent sorivudine (antiviral) or chemically related analogues, such as brivudine. * known peripheral neuropathy ≥ nci ctc grade 1. * current or recent (within 10 days prior to study treatment start) use of full-dose oral anticoagulant (e.g. warfarin) or thrombolytic agent.

Keywords: second line treatment for metastatic colorectal cancer
establishment and clinical application of risk classification model based on molecular typing of medulloblastoma in children

Conditions: Medulloblastoma, Childhood

Summary: the purpose of this study:(1) development of a new risk classification model for childhood medulloblastoma. (2) evaluation and improvement of existing individualized treatment protocols.

medulloblastoma (medulloblastoma, mb) is the most common intracranial malignant tumor in children, accounting for 20% of all central nervous system tumors in children, seriously affecting the quality of life and life span of children. based on a retrospective analysis of previous mb cases in our center, we found that the clinical prognosis of previous mb patients in our center was worse than that in foreign countries, with an overall five-year survival rate of about 65%, and nearly 30% of the patients had tumor recurrence and metastasis within 2 years after the operation, and the prognosis was poor. we analyzed the possible reasons as follows: (1) the compliance to radiotherapy and chemotherapy in children with mb in our center was poor, and some of the patients only completed radiotherapy and had poor compliance with chemotherapy; (2) due to the lack of family doctor system, the tumor of the newly diagnosed patients was huge, which seriously affected the important brain function and clinical prognosis; (3) the patients were not followed up strictly and regularly after operation to monitor tumor recurrence, which led to poor treatment effect after recurrence. (4) the unified treatment standard has not been formed yet, and the treatment mode for patients is complex. as the largest neurosurgery and pediatric neurosurgery center in china, the center intends to prospectively establish a high-quality homogeneous mb observation cohort in children, make use of the center's case resources and biological sample processing advantages, and carry out accurate treatment research on children's mb through regular follow-up and systematic management of the clinical cohort.

Eligibility criteria:
inclusion criteria: * age 0.5-18 years (except neonates). * pathologically confirmed medulloblastoma. * not having received any other relevant treatment before surgery. * completion of enhanced mri of the head and spinal cord. * availability of tumor samples and determination of molecular typing. * postoperative kps score ≥ 70. * voluntary enrollment in the group and the ability to receive long-term follow-up. * the patient or the patient's family voluntarily signed the informed consent form. exclusion criteria: * patients who have recently received other drugs or radiation therapy. * patients suffering from acute or chronic infectious diseases * patients suffering from neurological or psychiatric diseases or mental disorders that cannot be easily controlled, or poor compliance. * patients who cannot receive enhanced mri scans. * other conditions that the investigator believes make the patient unfit to participate in this trial.

Keywords: medulloblastoma glioma medulloblastoma, childhood, recurrent neuroepithelioma
improving medication reviews to polypharmacy patients

Conditions: Polypharmacy Patients; Pharmacist Intervention

Summary: brief summary: the randomised controlled trial investigates the effect of a pharmacist intervention targeting polypharmacy patient at two levels medical clinics and patient level. the purpose is to gain more knowledge to patients and physicians about their medication and to see changes in the patient's medication and health-related quality of life.

the main objective of the randomised controlled trial is to investigate the clinical effects of the roll-out of the systematic offer from nord-kap in the north denmark region at two different levels (medical clinic and patient-level). the primary outcome is changes in the participant's medicine from baseline to follow up and changes in healthcare usage secondary outcomes include investigation of cost-effectiveness and changes in patients health-related quality of life. the hypothesis is that the regional intervention delivered by the pharmacists, from nord-kap, can lead to a decrease in medical products compared with a control group between baseline and at 6-month follow-up. * will the use of a pharmacists intervention lead to a decrease in the number of polypharmacy patients in medical clinics compared to a control group of medical clinics? * will the use of a pharmacist intervention lead to an increase in the polypharmacy patients health-related quality of life compared to a control group?

Eligibility criteria:
inclusion criteria: * patients with more than 5 medicinal products prescribed besides skin remedies and antibiotic * above 18 years * patients in continuous medication treatment exclusion criteria: * terminal patients * patients who are not motivated to comply with the instruction of the trial * do not speak/or understand written danish * patients lacking legal capacity * patients living at nursing homes

Keywords: polypharmacy patients pharmacist intervention health-related quality of life