Kornimate/medical-research-clean huggingface dataset:
comparison of software-assisted implantation of elastic spine pad (tm) with respect to postoperative change in neck disability index (ndi) with the conventional disc prosthesis rotaio (tm) after anterior cervical discectomy for cervical disc prolapse

Conditions: Intervertebral Disc Displacement

Summary: this is an investigator-initiated study. the primary goal is to evaluate the efficacy of two different cervical disc prosthetic devices with respect to postoperative change in neck disability index. the evaluation will include clinical and radiological parameters.


Eligibility criteria:
inclusion criteria: * indication for monosegmental anterior cervical discectomy with implantation of a disc prosthesis exclusion criteria: * radiologic signs of extensive bone degeneration in the affected segment * necessity of implantation of a device smaller in height than 5 mm (as predicted with teh use of the vertaplan (tm) software * transversal spine cord lesion * cervical myelopathy * preceding surgery on the cervical spine * traumatic lesions of the cervical spine * radiographic instability in the affected segment: flexion / extension: shift sagittal plane\> 3.5 mm or 20% and rotation in the sagittal plane \> 20 °, or in static x-ray examinations: shift in the sagittal plane 3.5 mm or 20% of the vertebral body width and relative sagittal plane angulation \> 11º * signs of instability (olisthesis) in another segment of the cervical spine * active systemic infection * diseases of the rheumatic type and all autoimmune diseases * bone metabolic diseases (for example, paget's disease) * skeletal metastases * infections in the cervical spine * neurological seizure disorders or other serious neurological disease with risk of falls * severe heart failure (nyha iii-iv) * bleeding disorders or clopidogrel / coumarins - treatment * systemic use of corticosteroids for more than a month in the last 12 months * pregnancy * legally incompetent patient * lactation * deformity, anomalies, not fully developed skeleton * local tumor disease * pre-existing neurologic abnormalities or other shortcomings, such as a parkinson's disease, diabetic neuropathy, multiple sclerosis, peripheral neuropathy * drug / drug or alcohol dependence
iron absorption from iron fortified extruded rice co-fortified with various solubilizing agents

Conditions: Iron-deficiency

Summary: food fortification is regarded as a safe and cost-effective approach to counteract and prevent iron deficiency. rice is a staple food for millions of people living in regions where iron-deficiency anaemia is a significant public health problem. therefore, rice may be a promising fortification vehicle. ferric pyrophosphate (fepp) is an acceptable iron compound for rice fortification, due to its white colour and low reactivity with the rice matrix. however, iron from fepp generally has a low bioavailability. to increase the low iron bioavailability of fepp in fortified rice, ligands acting as solubilizing agents have been suggested, such as citric acid/trisodium citrate (ca/tsc), ethylenediaminetetraacetic acid (edta) and sodium pyrophosphate (napp). it is however unclear to which extent ca/tsc would enhance iron bioavailability in presence of phytic acid, a common inhibitor of iron absorption found in whole grains and legumes. zinc oxide reduces iron bioavailability from fepp with and without ca/tsc, in contrast to zinc sulphate. it is however unclear if this decrease would be also expected in presence of edta as solubilizing agent. further, napp has been suggested as a solubilizing agent, enhancing the bioavailability from fepp in bouillon cubes. this study aim to test its effect in rice. meals containing a high (bean sauce) and low (mixed vegetable) phytic acid level sauce will be used to simulated varying dietary backgrounds, allowing to answer the question which solubilizing agent is viable in enhancing iron bioavailability.


Eligibility criteria:
inclusion criteria: * female, 18 to 40 years old * normal body mass index (18.5 - 25 kg/m2) * body weight ≤ 65 kg * signed informed consent exclusion criteria: * pregnancy (assessed by self-declaration) * lactating up to 6 weeks before study initiation * anaemia (hb \< 12.0 g/dl) * elevate crp (\>5.0 mg/l) * any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) * continuous/long-term use of medication during the whole study (except for contraceptives) * consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration * blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months * earlier participation in a study using fe stable isotopes or participation in any clinical study within the last 30 days * participant who cannot be expected to comply with study protocol (e.g. not available on certain study appointments) * smokers (\> 1 cigarette per week) * difficulties with blood sampling * male gender * do not understand english

Keywords: iron deficiency iron fortified rice extruded rice
incidence of significant mitral regurgitation in acute heart failure patients

Conditions: Acute Heart Failure; Mitral Regurgitation

Summary: the purpose of this study is to determine the prevalence of moderate-to-severe mitral regurgitation (mr) in acute heart failure (hf) patients requiring hospital admission.

all patients admitted with symptoms of hf- (shortness of breath (sob), peripheral oedema, palpitations and irregular heart beats) will be assessed by the research team. the level of bnp will be checked using a small device (i-stat bnp) at the bedside. if results of the test suggest hf they will undergo special procedure called transthoracic echocardiography (tte). tte is an ultrasound scan of the heart which will enable the investigators' to grade severity of mitral regurgitation (mr) as well as strength of the heart muscle. the investigators will use bi-plane simpton's method to calculate left ventricular (lv) ejection fraction (ef). colour doppler and pisa method will be used to quantify severity of mr or valve leak. simultaneously there will be recording of heart sounds to find out if auscultation is reliable in identifying leaky valves.

Eligibility criteria:
inclusion criteria: * acute heart failure patients admitted to the hospital * elevated bnp level (\>30pg/ml) exclusion criteria: * patients with bnp level (\< 30pg/ml)
a comparative, randomized, prospective, performance evaluation of abutments in single tooth gaps

Conditions: Tooth Loss

Summary: immunologically evaluation of myeloperoxidase level as indicator for inflammatory reactions on modified surface abutments compared to machined surface abutments.

one study abutment per patient will be placed. after healing for 6 to 7 weeks, patients will be asked to stop oral hygiene at the study site for 2 weeks. sulcus fluid and plaque samples will be taken at the abutment site at several visits before and during abdication of oral hygiene. the study finishes with biopsy visit. afterwards a regular abutment will be placed and the patients will be treated according to the standard protocol of the clinic to obtain their final restoration

Eligibility criteria:
inclusion criteria: * subjects must have voluntary signed the informed consent form before any study related action. * males and females with at least 18 years of age * non-smokers * straumann bone level implant (healed for at least 4 weeks) in a tooth gap in the maxilla or mandible with thick tissue biotype * adequate oral hygiene (full mouth plaque index; o'leary, et al. 1972) \<25% at abutment placement * the patient must be able to open the mouth to allow removal of the abutment at the planned abutment site exclusion criteria: * systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes) * any antibiotic treatment or anti-inflammatory treatment within the past 2 month * any contraindications for oral surgical procedures * mucosal diseases (e.g. lichen planus, mouth ulcer) * history of local irradiation therapy * current treated (within the last 12 month) or untreated periodontitis * current treated (within the last 6 month) or untreated gingivitis * probing pocket depth of ≥4 mm on one of the teeth immediately adjacent to the dental implant site * severe bruxing or clenching habits * lack of primary stability of the implant at abutment placement * subjects who have undergone administration of any investigational device within 30 days of enrolment in the study * conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability * physical or mental handicaps that would interfere with the ability to follow protocol procedures * pregnant or breastfeeding wome * insufficient soft tissue attachment to the neck of the abutment (e.g. visibility of the abutment platform or exposed estansurface) after abutment placement

Keywords: edentulous roxolid slaclive surface titanium/zirconium
a study evaluating the safety and efficacy of curcumin in patients with primary sclerosing cholangitis (psc)

Conditions: Primary Sclerosing Cholangitis

Summary: the purpose of this study is to determine whether curcumin, a drug and naturally-occurring plant compound, is safe and effective in the treatment of primary sclerosing cholangitis (psc).


Eligibility criteria:
inclusion criteria: * diagnosis of primary sclerosing cholangitis (psc) established by all of the following criteria: * alkaline phosphatase \>1.5x upper limit of normal for at least 6 months prior to study enrollment * cholangiography demonstrating intrahepatic and/or extrahepatic biliary dilation, beading, and/or strictures consistent with psc * liver histology (if available for review) consistent with or diagnostic of psc * women of child-bearing potential willing to use birth control for the duration of the study. exclusion criteria: * treatment with any investigational agents within three months prior to or during the study * treatment with systemic antibiotics, azulfidine, systemic corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil, budesonide, pentoxifylline, tacrolimus, or vitamin e within three months prior to or during the study. * concomitant treatment with nsaids, antiplatelet agents, antihyperlipidemics, and anticoagulant warfarin. * anticipated need for liver transplant within one year as determined by mayo psc risk score (\<80% one-year survival without transplant) * active drug or alcohol use * findings suggestive of liver disease of an alternative or concomitant etiology, such as chronic alcoholic liver disease, chronic hepatitis b or c infection, hemochromatosis, wilson's disease, α1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or secondary sclerosing cholangitis (e.g., post-liver transplantation biliary stricture) * pregnancy or lactation * any condition that, in the opinion of the investigator, would interfere with the patient's ability to complete the study safely or successfully.
the three-dimensional gait analysis of medial knee osteoarthritis

Conditions: Osteoarthritis, Knee; Osteoarthritis

Summary: static imaging has been commonly and clinically accepted to assess the severity of medial knee osteoarthritis (koa), especially the radiography. gait analysis has been adopted to evaluate the kinematic characteristics of the knees in patients with koa. most of the current studies focus on the sagittal plane of the knee, but very few of them focus on the frontal or horizontal plane. with the different severity of medial koa, anatomical structures of the knees will change and influence kinematics of the knees, such as osteophytes and deformity. at present, there has been no study focusing on the relations between the imaging assessment of the severity and quantitative kinematics of medial koa. the aim of the study is to explore the relationship between the imaging assessment based on the kellgren-lawrence scores and in vivo 3d knee kinematic characteristics in chinese patients with medial koa during walking using a new portal gait system.

all patients are assessed according to the kellgren-lawrence score.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of medial knee osteoarthritis according to the american college of rheumatology criteria. 2. the patients are confirmed by radiographic evidence that medial tibiofemoral joint space grade was narrower than lateral tibiofemoral joint space. 3. the patients have clinical symptom of medial pain of the knee. 4. clinical examinations are taken to examine the asymptomatic subjects to avoid knee diseases. exclusion criteria: 1. traumatic knee osteoarthritis. 2. lateral tibiofemoral koa or any other types of knee oa. 3. ambiguity of kellgren-lawrence scores 4. history of surgery. 5. neuromuscular disease, cardiovascular disease or trauma that can affects gait. 6. body mass index greater than 35. 7. needing stick or assistance to walk or unable to walk at a speed of less than 2.0 km/h and less than 300 m.

Keywords: knee osteoarthritis gait kellgren-lawrence scores
prioritising and optimising multi-medication in multimorbidity

Conditions: Chronic Disease

Summary: objective: to investigate whether the complex intervention will improve the appropriateness of prescriptions in elderly multi-morbid patients with multi-medication in general practices. study hypothesis: the primary objective of the study is to determine whether the complex intervention will improve the appropriateness of prescriptions compared to usual care. the primary efficacy endpoint is the change in the medication appropriateness index (mai) score from baseline (t0) to 6 months after baseline (t1), i.e. the difference mai t1-t0.

key elements (1 to 4) of the complex intervention: 1. basic assessment of medicines that were actually taken (brown bag review) by a general practice based health care assistant (hca) and 2. checklist-based (medimol - medication-monitoring-list) pre-consultation interview on problems relating to medicines (technical handling, potential adverse drug reactions) and patient's therapeutic aims by hca provides structured information in the medication-monitoring-list (medimol) for the general practitioner (gp) and enables patients to discuss their problems with the gp. 3. gp uses a computerized decision support system (pharmaceutical information system, aid+) to optimize medication (reducing number of inappropriate prescriptions, e.g. pharmaceutical interactions, renal dose adjustments, duplicate prescriptions) and 4. prioritizes medication in the physician-patient consultation taking into consideration patient's preferences.

Eligibility criteria:
inclusion criteria: * at least 60 years old of both sexes * at least three chronic diseases affecting two or more organ systems, which require pharmaceutical treatment * at least five long-term prescriptions with systemic effects * health care provided by gp (at least one contact in most recent quarter) * patient is legally competent to sign any documents * ability to understand and participate in trial of own free will, to fill out questionnaires and participate in telephone interviews * written informed consent to participate in trial exclusion criteria: * diseases cause life expectancy of less than 12 months * abuse of alcohol or illegal drugs and visible clinical signs or symptoms thereof * cognitive impairment that prevents trial participation (mmse \< 26) * emotional stress that prevents trial participation * participation in a clinical trial within the last 30 days

Keywords: elderly multimorbidity polypharmacy multimedication medication appropriateness medication appropriateness index cluster-randomised controlled trial pragmatic trial
cart-19 cells for mrd positive cd19+ all

Conditions: Acute Lymphoblastic Leukemia

Summary: cart-19 cells has emerged as a powerful targeted immunotherapy, showing striking responses in highly refractory cd19+ acute lymphoblastic leukemia (all). this study aims to assess the safety and toxicity of cart-19 cells to patients who are refractory or at highest risk of relapse as defined by mrd+ status.


Eligibility criteria:
inclusion criteria: * signed written informed consent * aged between 1-60 years * patients with mrd positive cd19+ all * cardiac: left ventricular ejection fraction ≥ 50% * adequate renal and hepatic function * performance status: karnofsky ≥ 70% exclusion criteria: * pregnant or lactating females. * any co-morbidity precluding the administration of cart-19 cells.
immunotherapy with cd19 car t-cells for b-cell lymphoma, all and cll

Conditions: Leukemia; Lymphoma

Summary: this study aims to evaluate the safety, efficacy and duration of response of cd19 chimeric antigen receptor (car) redirected autologous t-cells in patients with high risk, relapsed cd19+ haematological malignancies.

this is a multi-centre, non-randomised, open label phase i clinical trial of an advanced therapy investigational medicinal product named cd19 chimeric antigen receptor (car) t-cells (cd19 car t-cells) in patients with high risk, relapsed cd19+ haematological malignancies (leukemia and lymphoma). following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the cd19 car t-cells. patients will receive the cd19car t-cells following lymphodepleting chemotherapy. the study will evaluate the safety, efficacy and duration of response of the cd19 car t-cells in patients with high risk relapsed cd19+ malignancies.

Eligibility criteria:
inclusion criteria: 1. relapsed or refractory b cell derived acute lymphoblastic leukemia(all), chronic lymphoblastic leukemia(cll) and non-hodgkin lymphoma. 2. kps\>60. 3. life expectancy\>3 months. 4. gender unlimited, age from 18 years to 70 years. 5. cd19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry. 6. patients who have failed at least one line of a standard treatment. 7. no serious mental disorder. 8. patients must have adequate cardiac function(no cardiac disease, lvef≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(cr≤133umol/l). 9. no other serious diseases(autoimmune disease, immunodeficiency etc.). 10. no other tumors. 11. patients volunteer to participate in the research. 12. patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active gvhd and no longer taking immunosuppressive agents for at least 30 days prior to trial. exclusion criteria: 1. kps\<50. 2. patients are allergic to cytokines. 3. central nervous system leukemia within 28 days. 4. uncontrolled active infection. 5. acute or chronic gvhd. 6. treated with t cell inhibitor. 7. pregnancy and nursing females. 8. hiv/hbv/hcv infection. 9. other situations we think improper for the research.

Keywords: leukemia lymphoma car t
adherence intervention to promote optimal use of insulin pumps in adolescents with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the overall objective of this study is to address the critical need of improving insulin pump adherence in adolescents with type 1 diabetes (t1d) by providing personalized intervention using evidence-based techniques during routine diabetes clinic visits at point of care.

to achieve optimal use of the insulin pump, patients must engage in frequent blood glucose monitoring (bgm) and insulin bolusing, and have an understanding of their relationship. bgm must occur and then it must be followed by a decision about what to do (or not do) regarding insulin bolusing. if insulin bolusing occurs in the absence of bgm, hypoglycemia and less than ideal glycemic control can occur. of the few insulin pump adherence studies, only very basic adherence behaviors such as bgm and insulin bolusing frequency or number of hypoglycemic events have been reported. the overall objective of this study is to address the critical need of improving insulin pump adherence in adolescents with t1d by providing personalized intervention using evidence-based techniques during routine diabetes clinic visits at point of care.

Eligibility criteria:
inclusion criteria: * ages 10-17 years * type 1 diabetes diagnosis at least 1 year * use insulin pump exclusion criteria: * developmental delay
study of ngm395 in adult participants

Conditions: Obesity; NAFLD

Summary: study of ngm395 in adult participants.


Eligibility criteria:
inclusion criteria: part 1: 1. body mass index (bmi) in the range of 27 - 45 kg/m², inclusive, at screening, with maximum body weight of 140 kg. part 2: 2. liver fat ≥8% as assessed by mri-pdff. 3. bmi in the range of 27 - 45 kg/m2, inclusive, with maximum body weight of 140 kg at screening. 4. waist circumference \> 40 inches for males or \> 35 inches for females. exclusion criteria: part 1: 1. diagnosed with type 2 diabetes (t2d) and/or the use of metformin, dipeptidyl peptidase-4 (dpp4) inhibitors, sodium/glucose cotransporter 2 (sglt2) inhibitors, sulfonylurea agents, acarbose, or insulin for t2d within 3 months prior to screening. 2. subjects with t2d managed with diet alone with hba1c level \> 6.5% or fasting glucose ≥ 126 mg/dl at screening. 3. history of bariatric surgery. 4. fasting triglycerides \> 400 mg/dl at screening. part 2: 5. diagnosed with type 2 diabetes with a hba1c \>9.5%, on thiazolidinediones, sodium/glucose cotransporter 2 (sglt2) inhibitors, acarbose, or insulin for t2d within 3 months prior to screening.