Kornimate/medical-research-clean huggingface dataset:
clinical study to evaluate the efficacy and safety of da-2803 in chronic hepatitis b patients

Conditions: Hepatitis B

Summary: this study is a multi-center, double-blind, active-controlled, randomized, parallel clinical study to evaluate the efficacy and safety of da-2803 in chronic hepatitis b subjects


Eligibility criteria:
inclusion criteria: * adult male and female subjects of ages in the range over 19 * the subjects hbsag positive for at least 6 months or has history of chronic hepatitis b * the subjects whose hbv dna above 20,000 iu/ml when hbeag positive or above 2,000 iu/ml when hbeag negative or positive when has history of chronic hepatitis b * the subjects completely understood the clinical trial through detailed explanation presented, determined to participate in the clinical trial spontaneously, and agreed to observe precautions suggested thereby through written consent exclusion criteria: * the subjects who have been infected with hcv, hdv, hiv * the subjects who have hemochromatosis, wilson's disease, autoimmune liver disease, and α-1 antitrypsin deficiency * the subjects whose α-fetoprotein over 50 ng/ml and who are persumed to be hepatocelluar carcinoma
symptom collection of lung cancer patients

Conditions: Lung Cancer

Summary: this study is conducted to collect the symptoms of lung cancer patients and to observe the relationship with proteomics.


Eligibility criteria:
inclusion criteria: * adult over 18 years old * patients are scheduled for surgery with lung cancer diagnosis. * ecog status score 0 to 2 * individual who can read and understand korean * participant is willing and able to give informed consent for participation in the study exclusion criteria: * patient who was diagnosed with lung cancer in the past. * individuals who are judged inappropriate for the study
design of an affordable gym for post stroke rehabilitation

Conditions: Stroke; Cerebral Palsy; Healthy

Summary: rehab in a crate is a therapy gym designed to be affordable, compact and easily transportable. the purpose of this particular study is to gain feedback on the initial design of the rehab in a crate system. this will be accomplished by using qualitative ethnographic research methods (i.e. human centered design) in the form of surveys that have been carefully designed by members of the research team. the eligibility criteria of this survey research reflects the intended user base of an eventual finished product, which is survivors of stroke and cerebral palsy across the globe. and while healthcare professionals are not the user base per se, their expertise and feedback should be instrumental in the design of future iterations of the rehab in a crate. ease of use, utility, design, and various features, both existing and intended, will all be surveyed items.

the investigators aim to survey stroke survivors and healthcare professionals on the design, ease of use, utility, and various features of, both existing and those yet-to-be-developed. this feedback will help to fine tune further development of this therapy gym, rehab in a crate, and move forward in the iteration process. note: the device is not being used at this moment for diagnostic or evaluation.

Eligibility criteria:
inclusion criteria: * stroke survivors who are more than 3 months post stroke and persons with cerebral palsy adults - have hemiplegia or diplegia * health professionals who have considerable experience in stroke rehabilitation. exclusion criteria: * anyone who is not 18 years of age. * more than mild spasticity in the upper of lower extremities. * a cognitive score on the montreal cognitive assessment that indicates that the participant is cognitively impaired. * motor impairment that precludes interaction with the rehab in a crate (e.g. unable to grip a handle).

Keywords: stroke rehabilitation robotics cerebral palsy therapy
comparison of the blood sugar lowering effect of biphasic insulin aspart 30 and insulin glargine both combined with metformin and glimepiride in chinese and japanese subjects with type 2 diabetes new to insulin treatment

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of this clinical trial is to investigate the blood sugar lowering effect of biphasic insulin aspart 30 once daily compared to insulin glargine once daily both in combination with metformin and glimepiride in chinese and japanese subjects with type 2 diabetes who have never received insulin before. the trial is conducted as a phase 4 trial in china and phase 3 in japan.


Eligibility criteria:
inclusion criteria: * type 2 diabetes treated with a maximum of three different types of oral anti-diabetic drugs (oads) (including traditional chinese medicine which contains active ingredients of known oads) for more than 6 months * unchanged total daily dose of at least 1500 mg (chinese patients) or 500 mg (japanese patients) metformin for the last two months * unchanged total daily dose of at least half maximum recommended total daily dose of any insulin secretagogue for the last two months * insulin naive * hba1c between 7.0% and 10.0% * fpg (fasting plasma glucose) equal to or above 6.1 mmol/l (110mg/dl) * body mass index (bmi) below 40.0 kg/m\^2 exclusion criteria: * treatment with any thiazolidinedione (tzd) and glp-1 (glucagon like peptide-1) receptor antagonists during the last 3 months before visit 1 in this trial * any disease or condition which the investigator feels would interfere with the trial * any contraindication to metformin or glimepiride (according to local labelling)
sbrt followed by neoadjuvant chemoimmunotherapy of sindilizumab plus docetaxel and cisplatin for locoregionally advanced squamous carcinoma of oral cavity and oropharynx

Conditions: SBRT

Summary: in resectable locally advanced oral cavity cancer and oropharyngeal cancer, sbrt with the total dose of 18 gy by three fractions will be delivered to the primary tumor and metastatic lymph nodes every other day. one week later, neoadjuvant chemoimmunotherapy of sindilizumab (200mg) plus docetaxel (75mg/m2) and cisplatin (75mg/m2) will be administered every three weeks for three cycles. then radical surgical resection will be performed and postoperative radiotherapy with or without chemotherapy will be supplemented according to the initial tumor staging and postoperative pathologic characteristics. the investigators aim to evaluate the pathological complete response rate and safety of the combined treatment of sbrt with chemoimmunotherapy in locally advanced cancers of oral cavity and oropharynx.


Eligibility criteria:
inclusion criteria: * pathologically confirmed squamous carcinoma of oral cavity or oropharynx * iii-iva based on the eighth edition of ajcc * aged 18 to 70 * ecog ps 0-1 * no organ dysfunction * expected survival ≥ 3 months exclusion criteria: * diagnosed with other malignant tumors * has autoimmune diseases or serious mental illness * at high risk of hemorrhage * systemic or local glucocorticoid therapy within 4 weeks * comorbidities requiring long-term treatment with immunosuppressive drugs or systemic or topical corticosteroids in immunosuppressive doses * patients with active tuberculosis (tb) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year prior to screening. * prior use of anti-pd-1 antibody, anti-pd-l1 antibody, anti-pd-l2 antibody, or anti-ctla-4 antibody * hiv or hcv * hbsag positive with positive hbv dna copy number (quantitative test) ≥1000cps/ml

Keywords: sbrt immunotherapy oral cancer oropharyngeal cancer
an extension study administering ym155 to subjects previously enrolled in another protocol administering ym155

Conditions: Prostate Cancer; Melanoma; Non-Hodgkin's Lymphoma

Summary: this protocol is open to subjects previously enrolled in and who had completed a phase i or phase ii study administering ym155. subjects who are receiving benefit from treatment with ym155 are eligible after completing the previous study.

the main objective of the study is to continue to evaluate the safety and efficacy of ym155. each subject will be treated at the dose he/she was receiving at the completion of his/her previous phase i or phase ii ym155 study.

Eligibility criteria:
inclusion criteria: * completed a phase i or ii ym155 study with at least stable disease and continues to meet the criteria as stated in the previous ym155 study that allows for additional treatment with ym155 * lack of progression based on the most recent radiological imaging, biochemical assessments and/or physical examination * negative pregnancy test result (females of child-bearing potential) exclusion criteria: * more than 21 days (or 14 days depending on the study of origin) between the time the last infusion of ym155 was stopped in the previous study and the proposed start of the first infusion in this study

Keywords: prostate cancer melanoma lymphoma ym155
early childhood malaria prevention with maloprim in the gambia

Conditions: Malaria

Summary: a trial was conducted in the 1980s to compare two strategies for control of malaria in young children aged 3-59 months: treatment with chloroquine versus treatment combined with fortnightly chemoprophylaxis with maloprim. the impact on mortality and morbidity was assessed at the time, and their cognitive abilities and educational outcomes were assess 14 years later in 2001. the hypothesis was that the chemoprophylaxis would reduce morbidity and mortality and would improve cognitive abilities and educational outcomes in the long term

two drug strategies for the control of malaria in children aged 3-59 months have been compared in a rural area of the gambia - treatment of presumptive episodes of clinical malaria with chloroquine by village health workers, and treatment combined with fortnightly chemoprophylaxis (pyrimethamine/dapsone) which was also given by village health workers. treatment alone did not have any significant effect on mortality or morbidity from malaria. in contrast, treatment and chemoprophylaxis reduced overall mortality in children aged 1-4 years, mortality from probable malaria, and episodes of fever associated with malaria parasitaemia. a high level of compliance with chemoprophylaxis was obtained and no harmful consequences of chemoprophylaxis were observed. chemoprophylaxis was offered to all children at the end of the trial. 14 years after the end of the trial, participants cognitive abilities and educational attainment were assessed. associations have been found between malaria infection and poor cognitive ability but causality has not yet been demonstrated through preventative trials and the long-term impact of malaria has not been investigated. 1190 children who had participated in the original trial for at least one year were targetted for follow-up. 579 were traced. those who had received chemoprophylaxis attended school for 0.52 years more than the placebo group (p=.069). there was no overall effect on cognitive abilities but there was a significant treatment effect for cohorts that had not received chemoprophylaxis at the end of the trial or who had received less than one year of post-trial prophylaxis

Eligibility criteria:
inclusion criteria: * for original trial: children aged 3-59 months present in participating villages * for follow-up: children who were in original trial for at least 1 year. exclusion criteria: * for original trial: none * for follow-up: children with mental or physical disabilities who were unable to do cognitive tests

Keywords: malaria cognition prevention & control anemia chemoprophylaxis mortality children randomized controlled trial education long-term effects the gambia africa, west
impact of body composition on bisoprolol and ramipril pharmacokinetics in patients with chronic heart failure

Conditions: Chronic Heart Failure; Cachexia

Summary: the purpose of this study is to determine if cachexia and changes in body composition influence pharmacokinetics of bisoprolol and ramipril and the accuracy of equations for renal function estimation.

patients with chronic heart failure on treatment with bisoprolol and/or ramipril will be included. study will consist of two study visits: baseline visit (v1) and visit which will be performed at least 6 months after baseline (v2). at both visits same procedures will be performed. on the day of the visit, patients will be asked to take their morning dose of bisoprolol and/or ramipril after the withdrawal of the first morning plasma sample. additional 3 to 5 plasma samples will be taken within 5 hours post bisoprolol and/or ramipril dose in order to determine pharmacokinetic profile of both drugs. body composition will be measured by bioimpedance and dual-energy x-ray absorptiometry. renal function will be measured by clearance of intravenously administered iohexol. biochemical parameters, muscle strength, fatigue and anorexia will be assessed in order to determine presence of cachexia. changes in body composition will be correlated with changes in pharmacokinetic parameters of bisoprolol and ramipril. pharmacokinetic parameters in cachectic patients will be compared to pharmacokinetic parameters in non-cachectic patients. parameters of body composition will be correlated with the difference between measured and estimated renal function.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic heart failure of new york heart association functional classification (nyha) class ii and iii * on treatment with bisoprolol for at least 3 days and/or ramipril for at least 4 days before v1 * able and willing to provide freely given written informed consent exclusion criteria: * chronic renal disease with estimated glomerular filtration rate calculated by modification of diet in renal disease (mdrd) equation \< 40 ml/(min x 1,73 m2) at v1 or v2 * liver disease or increased serum liver enzymes (bilirubin \> 1.5 x normal, gamma-glutamyl transpeptidase (ggt) \> 2.5 x normal, aspartate transaminase (ast) \> 2.5 x normal, alanine transaminase (alt) \> 2.5 x normal) at v1 or v2 * absence of bisoprolol or ramipril steady state concentrations at v1 or v2 or withdrawal of bisoprolol and/or ramipril in-between both visits * acute decompensation of heart failure in less than 4 weeks before v1 or v2 * addition, withdrawal or change in dose of drugs that importantly influence bisoprolol or ramipril pharmacokinetics in-between v1 and v2 * unable to understand and comply with protocol or to give informed consent

Keywords: chronic heart failure bisoprolol ramipril pharmacokinetic cachexia body composition renal function iohexol
intrapartum ultrasound for assessment of fetal progression

Conditions: Labor, Obstetric

Summary: the use of ultrasound has been suggested to support the management of labour. according to several studies, ultrasound examination is more accurate and reproducible than clinical examination in diagnosing fetal head position, fetal station, and the prediction of labour arrest. furthermore, there is growing evidence that ultrasound in labour may predict the outcome of instrumental vaginal delivery: a support to assess when an operative delivery is necessary. ultrasound in labour can be performed using a transabdominal approach, mainly to determine head and spine position, or a transperineal approach, to assess head station and the situation at low stations. several sonographic parameters have been proposed to evaluate the head station. furthermore, all ultrasound parameters studied so far, have always been measured with the woman in a supine position. while the biomechanics of childbirth with its mechanisms (known as nutation, counter-nutation of the pelvis, and the coccyx retropulsion) together with maternal movement, promote fetal rotation and the adaptation of its diameters with those of the maternal pelvis, allowing to gain more room for the fetal descent. moreover, in most of the studies on intrapartum ultrasound, the mobility of the pelvis has not been mentioned. the contracted pelvis is the absence of mobility that leads to fetal-pelvic disproportion, arrest of labour, and operative delivery. maternal pelvis biomechanics studies by high technological techniques have shown that maternal shifting positions during pregnancy and childbirth can create more room in the pelvis for safe delivery. the external and internal pelvic diameters are closely related. for this reason, the evaluation of the mobility of the pelvis appears to be a necessary element to understand the ability of that pelvis to widen its diameters for fetal descent. the aim of the study is to measure the variation of aop, hsd, hpd, paa in the supine position and in kneeling-squat position in the same woman and the cut-offs of the new ultrasound parameters and predictive capacity for vaginal birth.


Eligibility criteria:
inclusion criteria: * pregnant women with singleton pregnancies * at term gestation (37 weeks) * fetus in cephalic presentation * absence of factors hindering vaginal delivery exclusion criteria: * complicated pregnancies * vaginal birth after cesarean * twin pregnancies * early pregnancy * women condition that exclude vaginal birth
type 1 diabetes and diabetes distress

Conditions: Diabetes Distress; Diabetes Mellitus Type 1

Summary: the goal of this clinical trial is to reduce diabetes distress in emerging adults (18-35 years) with type 1 diabetes and moderate-to-severe diabetes distress. the expectation is that a group-based psychological intervention (actnow) will not only reduce diabetes distress but also improve psychological well-being and glycemic outcomes. the intervention involves a multidisciplinary team, including nurses, psychologists, and physicians, and is designed in a format that can easily be integrated into future standard care. the main research questions are: * does a group-based psychological intervention reduce diabetes distress? * does a group-based psychological intervention improve psychological well-being and glycemic outcomes? researchers will compare the group-based psychological intervention (arm 1) with a waitlist control group, which will receive the intervention after three months (arm 2). participants will first attend a virtual screening interview with a psychologist or nurse to identify if they are eligible to participate in the study. after randomization, the intervention group receives six bi-weekly sessions, each lasting two hours, led by a psychologist and nurse. each session includes a mindfulness exercise, a review of the previous session, a new topic, individual homework assignments, and a conclusion.


Eligibility criteria:
inclusion criteria: * type 1 diabetes for at least 6 months * age between 18 and 35 * t1-dds score ≥ 2, or t1-dds subscale score ≥ 2 * treated in a diabetes clinic in the region of southern denmark * proficient in danish exclusion criteria: * psychiatric diagnosis: diagnosed with substance abuse, alcohol abuse, psychosis, schizophrenia or any other psychiatric diagnosis that may compromise participation in the intervention * cognitive disorders such as brain injury * complex challenges best suited to individual treatment * current therapeutic treatment for depression, anxiety or stress * not stable medication for anxiety/depression for the past two months or planned change in medication for anxiety/depression during the project period

Keywords: rct study type 1 diabetes diabetes distress actnow
the (cost-)effectiveness of generalist versus specialist treatment for severe personality disorders'

Conditions: Severe Personality Disorder

Summary: the goal of this clinical trial is to investigate if generalist treatment (git-pd) is non-inferior in improving level op personality functioning compared to specialist treatment (mbt/st) in patients with severe personality disorders. the main questions it aims to answer are: 1. is generalist treatment (git-pd) non-inferior in improving level of personality functioning compared to specialist treatment (mbt/st) in patients suffering from severe personality disorders (pd)? 2. what patient characteristics predict which patients will benefit more from specialist or generalist treatment? participants will be randomized to either specialist or generalist treatment. interventions included in specialist treatment are mentalization-based treatment (mbt) and schema therapy (st). generalist treatment will be offererd following the principles of the guideline-informed treatment for personality disorders (git-pd), a principle-driven treatment framework based upon common factors and allowing personalized treatment according to patients' needs. all participating institutions offer git-pd and mbt and/or st. before, during and after following this treatment participants will complete measurements at 8 distinct time points. participants will be asked to: * complete a range of instruments at baseline to enable the construction of a personalized advantage index to predict treatment response based on patient characteristics * complete questionnaires at all 7 post-randomization time points * undergo a semi-structured interview at 3 time points * follow treatment for personality disorders (either git-pd or mbt/st)


Eligibility criteria:
inclusion criteria: * 'severe' or 'extreme' personality disorder (pd) according to the alternative model for pds exclusion criteria: * iq \< 75 * legal incapacity * any mental state disorder that requires prior treatment

Keywords: generalist psychotherapy specialist psychotherapy personality disorder ampd schema therapy mentalisation-based treatment guideline-informed treatment for personality disorders level of personality functioning alternative model of personality disorders git-pd mbt st
intra- versus extraarticular injection of ropivacaine in total knee arthroplasty

Conditions: Pain, Postoperative

Summary: the purpose of this study is to evaluate the optimal site for application of local anesthetics in total knee arthroplasty surgery. the hypothesis is, that improved pain relief is obtained when administering local anesthetics in the tissues sourrounding the knee joint compared to the knee joint itself.


Eligibility criteria:
inclusion criteria: * eligible for elective total knee arthroplasty * able to speak and understand danish * able to give informed consent exclusion criteria: * alocohol or medical abuse * allergies to local anesthetics * age \< 18 yrs. * intolerance to opioids

Keywords: pain, postoperative