Kornimate/medical-research-clean huggingface dataset:
monitoring of noac therapy: standardizing reference intervals

Conditions: Ischemic Stroke; Stroke, Acute; Stroke Syndrome; Ischemic

Summary: this study is aimed to establish reference intervals of noac (dabigatran, apixaban and rivaroxaban) in ethnic chinese patients.

360 patients who are on dabigatran, apixaban and rivaroxaban based on the above inclusion and exclusion criteria will be recruited. after the informed consent, the patient will be needed for blood taking before and 2 hours after the medication (noac). the patient's demographic data and medical history will also be retreived from central medical syetem too.

Eligibility criteria:
inclusion criteria: 1. ethnic chinese only 2. 18 years old or above 3. non-valvular atrial fibrillation 4. duration of noac use at least 3 months 5. no changes in noac dosage or type within 3 months 6. creatinine clearance (by cockcroft-gault formula) \>/=30ml/min exclusion criteria: 1. valvular atrial fibrillation or no atrial fibrillation 2. recent haemorrhage or ischemia within 1 year 3. active liver disease 4. abnormal baseline clotting profile 5. abnormal baseline thrombocytopenia or thrombocytosis 6. thromboembolic tendency other than atrial fibrillation (e.g. antiphospholipid syndrome, protein c, s, anti-thrombin iii deficiency) 7. non-compliant patients, defined as missing any doses of noac in recent 1 month 8. anticoagulation for disorders other than af 9. pregnancy

Keywords: stroke ischemic stroke
a registry of chinese al amyloidosis patients treated with subcutaneous or intravenous daratumumab

Conditions: AL Amyloidosis

Summary: the purpose of this protocol is to generate a registry of chinese patients with al amyloidosis treated with subcutaneous/intravenous daratumumab alone or subcutaneous/intravenous daratumumab combined with chemotherapy.


Eligibility criteria:
inclusion criteria: * 18 years and older * newly diagnosed or refractory/relapsed al amyloidosis * treated with subcutaneous/intravenous daratumumab alone or subcutaneous/intravenous daratumumab combined with chemotherapy exclusion criteria: * co-diagnosis of multiple myeloma or waldenström's macroglobulinemia
the effect of right ventricular pacing on myocardial oxidative metabolism and efficiency

Conditions: Bradycardia

Summary: right ventricular (rv) apical pacing induces a left bundle branch block (lbbb) type electrical activation sequence in the heart. this abnormal activation pattern of the ventricles may have detrimental effects on cardiac structure and function. rv pacing has been shown to impair left ventricular (lv) function both in normal and failing hearts. importantly, it has been demonstrated that this deterioration in lv function is related to the presence of lv dyssynchrony during rv pacing. the exact effects of rv pacing on myocardial perfusion, oxidative metabolism and cardiac efficiency have not been fully elucidated. the objective of the present study is to evaluate the effect of rv pacing on both global and regional oxidative metabolism and perfusion, and myocardial efficiency. in addition, the effect of rv pacing induced lv dyssynchrony on myocardial oxidative metabolism and efficiency will be studied. our hypothesis is that lv dyssynchrony during rv pacing results in regional abnormalities in lv perfusion and oxidative metabolism. lv dyssynchrony will also result in altered myocardial efficiency.

right ventricular (rv) apical pacing induces a left bundle branch block (lbbb) type electrical activation sequence in the heart. this abnormal activation pattern of the ventricles may have detrimental effects on cardiac structure and function. several clinical trials have demonstrated an association between rv pacing and an increased risk of heart failure and death. in addition, rv pacing has been shown to impair left ventricular (lv) function both in normal and failing hearts. importantly, it has been demonstrated that this deterioration in lv function is related to the presence of lv dyssynchrony during rv pacing. the exact effects of rv pacing on myocardial perfusion, oxidative metabolism and cardiac efficiency have not been fully elucidated. importantly, the relation between the presence of lv dyssynchrony during rv pacing and changes in myocardial perfusion, oxidative metabolism and cardiac efficiency has not been studied. ten patients with normal lv ejection fraction and vvi/ddd pacemaker will be studied during aai-pacing/sinus rhythm without rv pacing (pacing-off) and with rv-pacing (pacing-on) at the same heart rate. dynamic \[15o\]water and \[11c\]acetate positron emission tomography is used to measure perfusion and oxidative metabolism (kmono) of the lv. an echocardiographic examination is used to assess lv stroke volume (sv) and lv dyssynchrony. the pet data will be first analyzed based on rv pacing mode only, comparing the two pacing conditions (pacing-on vs. pacing-off). thereafter, the study population will be divided into two groups, according to the presence of lv dyssynchrony during rv pacing.

Eligibility criteria:
inclusion criteria: * informed consent * age over 18 years * previously implanted permanent pacemaker (ddd or vvi) * normal left ventricular function exclusion criteria: * pacemaker dependency * symptomatic coronary artery disease * pregnancy

Keywords: pacing perfusion oxidative metabolism efficiency
immunogenicity and safety of meningococcal groups a and c and haemophilus b conjugate vaccine in infants 2 to 5 months of age

Conditions: Meningitis; Meningococcal Meningitis; Meningococcal Infections

Summary: to evaluate immunogenicity and safety of adjuvant and adjuvant-free meningococcal groups a and c and haemophilus b conjugate vaccine in infants 2 to 5 months of age. primary objective: * to demonstrate the non-inferiority of the antibody responses to meningococcal serogroups a, c and haemophilus influenzae type b following the administration of adjuvant-free menac-hib conjugate vaccine compared to those observed following the administration of adjuvant menac-hib conjugate vaccine. * to describe the safety profile of adjuvant-free menac-hib conjugate vaccine compared to that of adjuvant menac-hib conjugate vaccine. secondary objective: •to compare the antibody level of meningococcal serogroups a, c and haemophilus influenzae type b following the administration of adjuvant-free menac-hib conjugate vaccine to those observed following the administration of adjuvant menac-hib conjugate vaccine.


Eligibility criteria:
inclusion criteria: * health infants aged 2 to 5 months. * legal guardian has signed written informed consent. * guardian may finish the whole visit in the judgment of investigator. * 2-5 months health infants who haven't immuned with any meningococcal a and c conjugate vaccine or haemophilus b conjugate vaccine. * subject who did't vaccinated with any live vaccine within 14 days or inactivated vaccine within 10 days before vaccination. exclusion criteria: * fever, body temperature ≥37.1℃. * history of severe allergic reaction that needs medical intervention including throat swelling, dyspnea, hypotension or shock; history of allergic reaction to vaccine or to any of the vaccine components especially to tetanus toxoid or history of other severe adverse reaction to vaccine. * clear diagnosis of thrombocytopenia or history of other coagulation disorders that may cause contraindications of intramuscular injection. * subject with history of abnormal labor, asphyxia rescue history,congenital malformations,eccyliosis or severe chronic disease. * severe cardiovascular or liver and kidney disease, active tuberculosis and hiv infection. * subject with encephalopathy, uncontrolled epilepsy and other progressive nervous system disease. * subject suffer from acute disease, severe chronic disease, acute episode of chronic disease and febrile illness (temperature ≥ 38°c) within 3 days. * any condition that, in the judgment of investigator, subject is not suitable for participation in this clinical trial.
osteopathy non-manipulative in patients with crohn's disease.

Conditions: Crohn´s Disease

Summary: crohn's disease (cd) is an inflammatory bowel disease with a high prevalence. its etiology is unknown and is considered a multifactorial disease. it is known that the existence of a genetic factor, industrialization and development of the country and environmental factors have great influence on the appearance of intestinal pathology (the val; buderus; molodecky). cd is a chronic inflammatory bowel disease localized throughout the course of the digestive tract (oral-anal). the aim of this study is to evaluate the effect of a treatment program combining technical nonmanipulative appropriate in affected patients (cd) to increase the overall quality of life and related ec, lower abdominal pain direct and indirect osteopathic soft, observe the sense of change after treatment, and psychological aspects.

all of the participants were recruited, in a non-probabilistic way, from the valencian association of enfermos de crohn y colitis ulcerosa (accu) the participants were allocated to two different groups depending on their possibility of participation in the therapeutic sessions. the group that received the therapy was called experimental group (eg) and the group, who did not, control group (cg). the participants were allocated independently of their disease status (outbreak or remission). an experimental study carried out during a period of four weeks in order to explore the effect of the specific treatment on the following outcomes: global quality of life, quality of life in cd and pain. the participants, in the eg were treated in three sessions, that lasted 45 minutes, during the study duration (1 session each 9-10 days). the physiotherapist who applied the treatment had an extensive experience in manual therapy. both groups come to laboratory two times for the assessment, one at the beginning of the study and the other one at the end. in each session several questionnaires were administered by a physiotherapist who was blinded to the group assignment.

Eligibility criteria:
inclusion criteria: * patients diagnosed with active cd of at least one year of evolution, aged between 18 and 65, with a presence of abdominal pain, receiving conservative or surgical treatment (after 6 months after surgery and absence of diverting ileostomy) were included. once they expressed their interest in taking part of the study, potential participants underwent an examination by a specialist of the association to confirm the diagnosis of cd. exclusion criteria: * conversely, patients with non-specific inflammatory bowel, abdominal tenderness, infection, ischaemia, physical damage, or specific immunologic sensitivity or pregnancy be excluded of this study were discarded for the study.

Keywords: pain effectiveness manual therapy
a prospective, randomised long-term follow-up of operative versus non-operative treatment of gr. 3 acromioclavicular dislocation

Conditions: Acromioclavicular Joint; Dislocation; Surgical Procedures, Operative

Summary: the purpose of this study is to compare the long-term clinical and radiological results of operative and conservative treatment of tossy type 3 acromio-clavicular dislocation.

the optimal treatment of rockwood type 3 ac joint injuries is still controversial. this controversy results from the low level of evidence of the early literature and the evaluation of all ac joint injuries with a type i through iii classification system. there are no prospective randomized controlled long-term studies on the treatment of tossy type 3 ac dislocation using primary repair and minimal pin fixation. in this study, the non-surgical treatment consisted of immobilisation of the injured ac-joint in a kenny-howard-type splint for four weeks. the surgical treatment consisted of an open reduction and fixation of the ac joint with two smooth kirschner wires (2 mm in diameter) across the ac-joint. the k-wires were bent at the proximal ends, with suturing of the superior ac ligament.

Eligibility criteria:
inclusion criteria: * patient with tossy grade 3 ac-dislocation was recruited between the years 1989 and 1991 at kuopio university hospital for a randomized controlled study * a written informed consent. exclusion criteria: * not written informed consent

Keywords: acromioclavicular joint dislocation trials, randomized clinical surgical procedures, operative
personality of diabetic patients will influence their medical compliance-a 5 years cohort follow up with type d personality

Conditions: Type 2 Diabetes Mellitus

Summary: diabetes is one of the most common causes of death in taiwan. with the raising prevalence of diabetes, it became the fourth most common cause of death since 2002. up to one-tenth of the national health insurance expenditure was used directly in diabetic care. besides, more expenditure was used in the management of the complications of diabetes, like vascular diseases, renal disease, blindness and neuropathy. diabetes is a chronic disease, the target treatment is to control hba1c below 7%, by intensive life style modification, diet control, exercise and medications. diabetic patient should have a good medical compliance, in order to prevent the tragedy of the complication. a good medical compliance is depended on the individual personality. personality is the major cause of chronic stress, which is one of the most important cause of psychological stress and the risk factors of the vascular disease and hypertension. recently, type d personality had shown the close relationship with patients' prognosis, morbidity, mortality and life quality in different vascular diseases. these vascular diseases are the result of the atherosclerotic process, and diabetes is one of the most important risk factors of the atherosclerotic changes. the investigators believed that type d personality may also affect the medical compliance, the severity (in terms of hba1c), and the prognosis of diabetic patients. the first part of this study is a cross sectional study, the investigators will try to figure out the relationship of the type d personality toward diabetic medical compliance, and their comorbidity. the second part of this study is a cohort study, base on the population in first part of the study, the investigators will like to construct the correlation of type d personality and diabetic patients' 5-years complication and mortality. the investigators want to establish a more complete vascular care system, improve the medical compliance, lower the complication rates, and improved the quality of life.


Eligibility criteria:
inclusion criteria: * t2dm patients for opd * age 18-80 y/o * inform consent

Keywords: type d personality diabetes medical compliance hba1c complication mortality t2dm
study of durvalumab with tremelimumab versus soc as 1st line therapy in metastatic non small-cell lung cancer (nsclc) (neptune)

Conditions: Non Small Cell Lung Carcinoma NSCLC

Summary: this is a randomized, open-label, multi-center, global, phase iii study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy versus platinum-based soc chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (egfr) and anaplastic lymphoma kinase (alk) wild-type advanced or metastatic nsclc.

patients will be randomized in a 1:1 to receive treatment with durvalumab + tremelimumab combination therapy or soc therapy. the primary objective of this study is to assess the efficacy of combination treatment compared with soc in terms of overall survival (os) in patients.

Eligibility criteria:
inclusion criteria: for inclusion in the study, patients should fulfill the following criteria: * aged at least 18 years * documented evidence of stage iv nsclc * no activating egfr mutation or alk rearrangement * no prior chemotherapy or any other systemic therapy for recurrent/metastatic nsclc * world health organization (who) performance status of 0 or 1 * no prior exposure to immune mediated therapy (imt), including, but not limited to, other antictla4, antipd1, anti pdl1,or antipdl2 antibodies, excluding therapeutic anticancer vaccines exclusion criteria: patients should not enter the study if any of the following exclusion criteria are fulfilled: * mixed small cell lung cancer and nsclc histology, sarcomatoid variant * brain metastases or spinal cord compression unless the patient is stable (asymptomatic; no evidence of new or emerging brain metastases) and off steroids for at least 14 days prior to start of study treatment. * active or prior documented autoimmune or inflammatory disorders (e.g., crohn's disease, ulcerative colitis)

Keywords: nsclc pdl1 tmb medi4736 durvalumab tremelimumab os
taiz -monocytes for the induction of donor specific tolerance in renal allograft recipients (cadaver kidney)

Conditions: Renal Transplantation

Summary: induce tolerance or reduce the amount of immunosuppression after renal transplant patient (receiving cadaver kidney)with so called taiz-monocytes


Eligibility criteria:
4.3.1 inclusion criteria patients must meet all the following inclusion criteria to be considered for admission to the trial: 1. male or female adult patients aged between 18 and 64 years (inclusive). a female of childbearing potential may be enrolled provided she: * has a negative pregnancy test at screening and * is routinely using adequate contraception prior to and during the study and * agrees not to attempt to become pregnant during the study and * is not lactating a female of non-childbearing potential will be defined as one who has been postmenopausal for at least one year or has been surgically sterilised. 2. patients receiving a first renal transplant. 3. patients who fulfil the criteria to receive an allogeneic renal transplant from a cadaver (according to the eurotransplant (et) manual on organ allocation and the bundesärztekammer allocation criteria). 4. patients who, after the nature of the study and the disclosure of their data has been explained to them, have freely given informed consent in writing. 4.3.2 exclusion criteria patients presenting any of the following exclusion criteria must not be included in the trial: 1. patients who have received a renal transplant. 2. patients who have an active infection at the time of entry into the study (screening). 3. recipient and donor pairs who show the following incompatible cmv constellation: the donor is cmv positive and the recipient is cmv negative. 4. patients and donor who have positive evidence of hiv or have active virus hepatitis b and c. 5. patients with a history of alcohol and/or drug abuse. 6. patients who are pregnant women or nursing mothers. 7. known hypersensitivity or contraindication to one of the immunosuppressives administered during the course of the study: tacrolimus, sirolimus or steroids (prednisolone and methylprednisolone). 8. patients with a history or present symptoms of autoimmune vasculitis. 9. detection of \>5% hla antibodies (current values determined during the last three months). 10. patients with a malignancy or history of malignancy. 11. patients with renal insufficiency due to a vasculitis. 12. recipient and donor pairs with complete hla matching. 13. patients whose condition requires continuous systemic steroid administration. 14. patients who are simultaneously participating or plan to participate in any other clinical study. 15. psychiatric or emotional problems or lack of knowledge of the german language which would invalidate the giving of informed consent or limit the ability of the subject to comply with study requirements. 16. unwillingness or inability to provide informed consent or to participate satisfactorily for the entire trial period

Keywords: renal transplantation, taiz-moncytes
distant metastases and long-term survival after complete resection of neuroendocrine tumors of the appendix

Conditions: Neuroendocrine Tumors of the Appendix

Summary: the aim of the present project is to evaluate the frequency of distant metastases and clinically relevant relapse and mortality, respectively, of anen (neuroendocrine neoplasms of the appendix) measuring 1 - 2 cm. the investigators hypothesize that the mortality rate of anet (neuroendocrine tumors of the appendix) measuring 1 - 2cm is less than 1%. furthermore, the investigators hypothesize that regional lymph node metastases of anet measuring 1 - 2 cm are clinically not relevant and are not associated with reduced survival. the investigators therefore hypothesize that oncological right-sided hemicolectomy has no impact on long-term survival after complete resection of anet measuring 1 - 2 cm and that the malignant potential quo ad vitam of these tumors is lower than the risk of oncological hemicolectomy.


Eligibility criteria:
inclusion criteria: * the investigators will include all patients with anet measuring 1 - 2 cm and complete resection between 01.01.2005 and 31.12.2010 of the primary tumor. exclusion criteria: -
short and long term efficacy of combined cabergoline and octreotide treatment in acromegalic patients

Conditions: Acromegaly

Summary: in acromegaly, nearly 40% of patients fail to control gh/igf-i levels with somatostatin analogues (sa). dopaminergic agonists (da) are even less effective, but combination therapy with sa and da normalizes igf-i levels in 33-56% of patients in short-term studies. this study was designed to evaluate short and long term efficacy of cabergoline in controlling igf-i levels in acromegalic patients receiving octreotide.


Eligibility criteria:
inclusion criteria: * active disease, under octreotide treatment at least 9 months exclusion criteria: * cabergoline allergy

Keywords: acromegaly resistant combined-treatment dopamine agonist
experimental autologous mesenchymal stem cell therapy in treatment of chronic autoimmune urticaria

Conditions: Urticaria; Autoimmune Diseases; Immune System Diseases; Skin Diseases

Summary: the aim of this study is to determine whether autologous adipose tissue derived mesenchymal stem cells of treatment for chronic autoimmune urticaria is safe and effective.

chronic urticaria is a distressful disease, which negatively affects the quality of life. pathogenesis isn't exactly clear, treatment is relatively palliative and results are usually suboptimal. 30-40% of the patients have autoimmune origin. patients are forced to use immunosuppressive treatments which have systemic effects. some of the treatments have effects as severe as the disease itself. mesenchymal stem cells (mscs) are the most common used cells in clinical trials. these cells can provide efficient immunosuppression in severe conditions like immunosuppressive resistant graft versus host disease. with this study at the first time and quite a different approach from conventional treatment, it will be tried an experimental treatment that used in the mscs for the chronic autoimmune urticaria patients without of definitive treatment.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with chronic autoimmune urticaria (at least six months before) 2. patients who have \>20 and over of urticaria activity score \[according to european academy of allergy and clinical immunology (eaaci) / global allergy and asthma european network (galen) guidelines\]. 3. patients who capable of own daily findings record. 4. patients who could not be controlled despite the use of a treatment agent in the fourth step for 3 months (according to eaaci / galen guidelines). exclusion criteria: 1. patients who have heart, liver or renal failure. 2. patients who have epilepsy, cerebrovascular or ischemic attack. 3. patients who have atopic dermatitis or another underlying itchy skin disease. 4. patients who have parasitic infection. 5. patients who have antibiotic allergy. 6. history of malignancy.

Keywords: mesenchymal stem cell chronic autoimmune urticaria