Kornimate/medical-research-clean huggingface dataset:
gastrointestinal tolerability of mmf vs ec-mps in maintenance transplant patients treated with calcineurin inhibitors

Conditions: Organ Transplantation

Summary: the purpose of the study is to assess the gastrointestinal tolerability of ec-mps compared to mmf in maintenance transplant patients on a calcineurin inhibitor regimen, who require mmf dose reductions of 25% or more due to gi complications. the tested hypothesis is that the ec-mps treatment is superior to the mmf therapy in terms of tolerability and that patients on the ec-mps formulation will be able to tolerate higher doses compared to those on mmf.

the use of mycophenolate mofetil (mmf) in combination with a calcineurin inhibitor (cni: tacrolimus or cyclosporine) has been shown to improve graft survival in renal, cardiac and liver transplantation patients. however, its use has been associated with significant side effects, including gastrointestinal complications, causing dose reductions, interruption or termination of the therapy. an alternate formulation: enteric coated mycophenolate sodium (ec-mps) was designed to alleviate the severity of upper gastrointestinal side effects. several trials detailed in the protocol suggest a benefit in gi related health following conversion from mmf to ec-mps, however we believe that robust data are lacking.

Eligibility criteria:
inclusion criteria: * recipients of liver or kidney or heart or lung or kidney/pancreas transplants * at least 1 month post solid organ transplant * on an immunosuppressive regimen which includes mmf in combination with cyclosporine a or tacrolimus * previous mmf dose reduction of minimum of 25% of total dose due to at least one gastrointestinal complication with mmf therapy * age of 18-75 years exclusion criteria: * less than 1 month post transplant * allergy (hypersensitivity) to mpa, mmf, ec-mps or to any ingredients of myfortic or cellcept * unwillingness or inability to give written consent * pregnant or nursing women, or women planning to become pregnant * patients with gi symptoms due to reasons other than related to mmf therapy * active post transplant lymphoproliferative disease (ptld) * significant or uncontrolled concomitant infections or other serious medical problems * active bacterial, viral or fungal infection * inability to self-administer the quality of life questionnaires

Keywords: drug tolerance quality of life
work of breathing and oxygen saturation in infants receiving high flow nasal cannula (hfnc)

Conditions: High Flow Nasal Cannula

Summary: the purpose of this study is to compare work of breathing on different levels of high flow respiratory support on infants born between 27 and 37 weeks gestation.


Eligibility criteria:
inclusion criteria: * infants between 27 and 37 weeks corrected gestational age * \>4 days pna * stable (i.e. not meeting exclusion criteria) and receiving non-invasive respiratory support (hfnc) for ≥ 12 hours * requiring ≤ 40% supplemental fio2 as determined by the clinical care team for clinical care purposes independent of this study exclusion criteria: * infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of wob measurements
fibromyalgia in men suffering from ptsd

Conditions: Fibromyalgia; Posttraumatic Stress Disorder; Major Depressive Disorder

Summary: assessing fm and psychiatric state among ptsd, mdd and healthy participants


Eligibility criteria:
inclusion criteria: * healthy volunteers without any current or past psychiatric disorder * current diagnosis of ptsd * current diagnosis of mdd exclusion criteria: - psychotic features
effectiveness and safety of transcatheter patent foramen ovale closure for migraine

Conditions: Foramen Ovale, Patent; Migraine

Summary: the purpose of the study is to evaluate effectiveness and safety of transcatheter patent foramen ovale closure for migraine.


Eligibility criteria:
inclusion criteria: * clinical history of migraine diagnosed by a neurologist according to the international classification of headache disorders * transcranial doppler evidence of right-to-left shunt(rls) and echocardiographic evidence of pfo，of which the degree is moderate to large rls * subjects who have not responded to or cannot take common migraine preventive medications * willing to participate in follow-up visits additional inclusion criteria: * transcatheter closure group: closure of pfo is performed * contrast group: subjects who meet the inclusion criteria, but refuse to undergo closure procedure exclusion criteria: * seizure disorder * other organic central nervous system disease * subjects whose headaches are other than migraine, such as a result of traumatic head or neck injury * evidence of alcohol, drug or substance abuse within the previous year additional exclusion criteria for transcatheter closure group: * subjects with intracardiac thrombus or tumor * subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina * subjects with left ventricular aneurysm or akinesis * subjects with atrial fibrillation/atrial flutter (chronic or intermittent) * subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum * subjects with contraindication to aspirin or clopidogrel therapy * pregnant or desire to become pregnant within the next year

Keywords: foramen ovale, patent migraine transcatheter patent foramen ovale closure contrast-enhanced transcranial doppler transthoracic echocardiography
study on the effect of prkcb1 modulating inflammatory factors and the role for developing major depressive disorder

Conditions: Major Depressive Disorder

Summary: depressive disorder is known as being accompanied with the activation of immune system which could lead to a series of changes including the neuron apoptosis, synapses transmission inhibition and emotional symptoms. the activation of protein kinase c (pkc) can reverse the immune/inflammatory process and restore the neuroplasticity and neurotransmitters transmission. based on our finding that patients with major depressive disorder (mdd) showed a significantly lower gene expression of prkcb1, while the pkc activation mediated by prkcb1, we hypothesize that prkcb1 contribute to the development of mdd and treatment response by its specific expression in brain, regulating erbb, chemokine signaling pathways and pkc activation during the neuroinflammatory process. in the present study, we aim to evaluate and verify the regulation effect of prkcb1 on the neuroimmune and inflammatory mechanism in depressive disorder by a serious of studies focus on prkcb1 gene expression modulating process and different downstream biomarkers which associated with prkcb1 effect, combined with the specified treatment (plus omega-3 poly unsaturated fat acids). this study may provide scientific evidences for using neuroinflammatory biomarkers to diagnose mdd, as well as personalized treatment.

(1）to find out the differences of expression of mrna, lncrna, mirna and proteins of prkcb1 between patients with depressive disorder and healthy subjects. (2) patients with depressive disorders will be randomized into two groups that they will be treated with escitalopram or escitalopram plus omega-3 pufas. to observe the effects of omega-3 pufas on prkcb1 and related neuroimmune/neuroinflammatory pathway which may improve understanding the relationship between neuroinflammatory regulation and depressive disorder treatment.

Eligibility criteria:
inclusion criteria for patients: 1. drug-naive or medication free for no less than 4 weeks; 2. 18-60 years old, han nationality; 3. junior high school diploma or above; 4. meeting with the criteria of major depressive disorder in the diagnostic and statistical manual of mental disorders (dsm)-iv-tr; 5. scored 17 or higher on the hamilton's depression scale with 17 items (hamd-17) and scored 2 or higher for the 2nd item (depressive mood); 6. written informed consent has been obtained. exclusion criteria for patients: 1. concurring psychotic disorders; 2. woman who is pregnant or breast feeding or is planning to get pregnant; 3. scores 3 or higher on item 3 (suicidal) of hamd-17; 4. serious allergy or disease of immune system; 5. had anti-inflammatory drug or immunosuppressant in the past 1 month; 6. serious medical or surgical illness or history; 7. had mect in the past 1 month. eligibility criteria for healthy volunteers: 1. match the patient group in age, gender, education and handedness; 2. no history of psychiatric disorders or debilitating general medical disorders.

Keywords: major depressive disorder neuroimmunology prkcb1 gene modulation biomarker
the effect of tracleer on tourniquet-associated hypertension

Conditions: Tourniquets; Hypertension; Bosentan

Summary: tourniquet is widely used in orthopedic surgery. however, prolonged tourniquet inflation may cause a gradual rise in blood pressure, which named as tourniquet-associated hypertension. thus, to effectively prevent the tourniquet related hemodynamic responses is important for patients receiving limb surgery. tracleer is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension. tracleer can also be used to treat retistant hypertension. at present trial, the investigators are going to investigate the effect of tracleer on tourniquet-associated hypertension during total knee arthroplasty.

at present study, the investigators will use endothelin receptor antagonist, tracleer (bosentan), to investigate the effect of tracleer on tourniquet-associated hypertension during unilateral total knee arthroplasty, and evaluate its safety and effectivity. the purpose of this study is to find a new therapy to prevent and treat tourniquet-associated hypertension.

Eligibility criteria:
inclusion criteria: * patients underwent selected total knee arthroplasty under general anesthesia * asa ii-iii * 18\~65 years old * signed informed consent voluntarily exclusion criteria: * do not apply tourniquet during the surgery * patients underwent emergency surgery * having applied tourniquet in last three months * patients underwent bilateral total knee arthroplasty * dysfunction of liver or kidney * anemia (hb \<90 g/l) * serious myocardial disease (eg. coronary heart disease, heart failure, severe arrhythmia) * coagulation disorder * diabetic * leukocyte higher than normal value * pneumonia, asthma, chronic obstructive pulmonary disease * hypotension before surgery (systolic pressure \< 90 mmhg) * pregnant woman or puerpera * having being enrolled in other clinical trial in last 3 months
risk factors for thromboembolic and infectious complications related to percutaneous central venous catheters in cancer - prospective multicenter study

Conditions: Cancer

Summary: the purpose of this study is to identify risk factors for thromboembolic and /or infectious complications in 3,000 patients with solid tumor and receiving a percutaneous central venous catheter (pcvc). a better understanding of the risk factors for these complications in this population would then allow interventional studies to be proposed to assess the benefit of prophylactic procedures in a sub-group of patients at most risk.


Eligibility criteria:
inclusion criteria: * patient with a neoplastic solid tumour with an indication for insertion of a pcvc. exclusion criteria: * haematological neoplasm pathology, pcvc removal scheduled within 2 weeks of insertion, * therapeutic doses of anticoagulants required at inclusion, * pcvc inserted by the femoral vein

Keywords: neoplastic solid tumour pcvc thromboembolic complications infectious complications risk factors
promoting adolescent investment in diabetes care

Conditions: Type 1 Diabetes

Summary: two financial incentive strategies targeting adolescents with type 1 diabetes will be compared to usual care for motivating adolescents to engage in improved self-care to manage their diabetes.

participants will be asked to choose a self-care goal relevant to the device(s) they use to manage their diabetes from a pre-defined list of self-care targets. a randomized 3 (treatment) x 3 (occasion) crossover design will be used to compare treatments that are administered to participants in a predetermined sequence. the intervention arms include financial incentives administered in a gain- and loss-frame for adherence to daily self-care goals. the control arm is usual care. participants can also earn additional incentives for meeting clinical care goals such as an improvement in the percentage of time glucose levels are consistent with hyperglycemia (\>180 mg/dl). the primary outcome will be hba1c at 12 weeks compared to baseline. secondary outcomes will include frequency of insulin administration, engagement in diabetes self-care (sci-r), patient-reported outcomes (problem areas in diabetes - teen version and diabetes family conflict scale).

Eligibility criteria:
inclusion criteria: * \>12 and ≤18 years old * diagnosed with type 1 diabetes ≥12 months * speaks english fluently * cognitively able to participate in incentive program and complete surveys. * have access to a mobile phone to receive goal-obtainment and incentive updates * receives diabetes-related clinical care from seattle children's hospital diabetes clinic * have the ability to upload medical data remotely from home per usual care processes employed by seattle children's hospital diabetes clinics exclusion criteria: * patient is already participating in another research study to improve diabetes self-care and/or glycemic control * baseline daily average glucose checks are greater than 4 checks per day or baseline daily cgm active wear is greater than 70% of the time and baseline average insulin bolus score is greater than 3 times a day or they do not use an insulin pump (or are unwilling to use a smart insulin pen) * patient refusal to participate (any age), or caregiver refusal to participate for patients less than 18 years of age * cognitively or physically unable to participate * patient is unable to speak in the english language * patient is unable to read in the english language * patient is a ward of the state * patient has severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes

Keywords: behavioral economics financial incentive diabetes type 1 diabetes adolescent aya young adult
methotrexate and temozolomide versus methotrexate, procarbazine, vincristine and cytarabine

Conditions: Lymphoma

Summary: the purpose of this study is to evaluate two types of chemotherapy for primary central nervous system lymphoma in the elderly (age older than 60) : * methotrexate, procarbazine, vincristine and cytarabine * methotrexate and temozolomide

the aim of the study is to evaluate efficacy and toxicity associated with both protocols in this population, without radiotherapy. patients will be randomized to receive one of the two regimens in one of the participating centers. neuropsychological evaluation will be performed in all patients. patients will be followed with serial mris.

Eligibility criteria:
inclusion criteria: * primary central nervous system lymphoma histologically confirmed by brain biopsy, csf cytology or vitrectomy * kps 40 or higher * absence of systemic disease as evaluated by chest-abdomen-pelvis ct scan * leucocytes\>3.500/mm3, platelets\>130.000/mm3, bilirubin \ 40 ml/min * age ≥ 60 years * negative hiv test * signature of informed consent exclusion criteria: * previous cranial radiotherapy * prior chemotherapy for primary central nervous system lymphoma * presence of another cancer (excepting basal cell carcinoma of the skin and cervical carcinoma in situ ) * systemic lymphoma (outside the cns) * isolated ocular lymphoma * immunosuppressed patients (hiv , use of immunosuppressors) * other uncontrolled or progressive disease compromising shot-term survival * severe renal or hepatic disease * patients not legally covered by the french social security * inability to swallow the medication

Keywords: primary central nervous system lymphoma brain lymphoma elderly chemotherapy methotrexate temozolomide procarbazine vincristine cytarabine
tai chi or hydrotherapy for people with osteoarthritis of the hip(s) or knee(s)

Conditions: Osteoarthritis, Hip; Osteoarthritis, Knee

Summary: the aim of this study is to determine, in the framework of a randomized controlled clinical trial, whether tai chi can affect measurable improvements in self-reported outcomes such as pain, physical function and psychological well-being in people with osteoarthritis (oa) mainly affecting the hips or knees. the effectiveness of tai chi will be compared with both a non-intervention control group as well as with a formal exercise program, hydrotherapy. hydrotherapy has long been considered an effective intervention for people with chronic oa although scientific evidence is weak at present. the main study hypotheses are that tai chi or hydrotherapy can significantly decrease pain and physical limitations; improve health-related quality of life; and promote psychological well being in patients with oa of the hip(s) or knee(s); and that tai chi and hydrotherapy are of equal efficacy.

a single blinded randomized controlled clinical trial with 3 allocation groups: * tai chi: maximum 15 people per group, twice weekly, 12 weeks. * hydrotherapy: maximum 15 people per group, twice weekly, 12 weeks. * control: 12 weeks waiting time prior to allocation to active intervention. a specially designed tai chi program (tai chi for arthritis, paul lam) will be provided in a community setting by trained instructors. hydrotherapy sessions will be held at the st. george hospital under supervision of registered physiotherapists with rheumatology and hydrotherapy experience. outcomes will be measured twice: 12 and 24 weeks after randomisation.

Eligibility criteria:
inclusion criteria: * symptomatic osteoarthritis of the hip(s) or knee(s) according to american college of rheumatology (acr) clinical and radiographic (hip) criteria. exclusion criteria: * currently participating in recreational physical activity more than twice a week. * unable to walk indoors for more than 10 minutes without a walking aid. * unable to exercise at a moderate level due to major co-morbidity. * incontinent, afraid of water or uncontrolled epilepsy. * low back pain referring to limbs. * joint replacement surgery in past year. * arthroscopic surgery or intra-articular injections in knee or hip in past 3 months.

Keywords: taichi hydrotherapy exercise joint pain disability
survival benefit of compound kushen injection in the treatment of advanced colorectal cancer

Conditions: Advanced Colorectal Carcinoma

Summary: to clarify the effectiveness and safety of compound kushen injection in the treatment of advanced colorectal cancer.

this study include a multi-center, randomized, parallel controlled clinical trial. the randomized clinical trial will enroll approximately 320 patients. participants will be randomly divided into experimental (n=160) and control groups (n=160). patients in the experimental group was treated with first-line scheme + compound kushen injection. patients in the control group will receive first-line scheme. the primary endpoint is pfs. the research protocol was approved by the relevant ethics committees, and the study was conducted according to the declaration of helsinki and good clinical practice guidelines. patients gave written informed consent to participate in the trial.

Eligibility criteria:
inclusion criteria: ① patients with advanced crc confirmed by pathology or cytology and receiving first-line therapy;② aged ≥ 18 years old, male or female;③ ecog score 0-2 points;④ expected survival ≥ 3 months;⑤ according to recist1.1 criteria, at least one detectable lesion;⑥ voluntarily join the study, sign informed consent, compliance with good cooperation with follow-up. exclusion criteria: * combined with other malignant primary tumors; * immunohistochemistry/polymerase chain reaction/second-generation sequencing results suggest msi-h/dmmr patients; * patients with recurrence and metastasis within 6 months after radical tumor surgery; * patients who have previously or are undergoing cancer immunotherapy ; patients undergoing radiation therapy; * pregnant or lactating women; women of childbearing age and their spouses can not take effective contraceptive measures during and within 6 months after the end of clinical study; ⑥ psychiatric patients; ⑦ patients with severe, uncontrolled organic disease or infection, such as decompensated heart, lung, kidney failure caused by intolerance to chemotherapy; ⑧ patients who have received clinical trials of small molecule drugs within 28 days or received clinical trials of large molecule drugs within 3 months; ⑨ patients who are known to be allergic to or intolerant of study drugs.

Keywords: compound kushen injection traditional chinese medicine
non-invasive pressure-volume analysis (nipva)

Conditions: Heart Failure

Summary: if the heart fails to pump a sufficient amount of blood, it is crucial to know why in order to provide the best treatment. pressure-volume analysis is the gold standard for evaluating the heart's pumping function. unfortunately, current techniques are invasive, so most patients will not get this examination. by combining the strengths of echo-doppler ultrasound, blood pressure monitoring and biomedical computing, the investigators aim to develop a non-invasive method for pressure-volume analysis, extending its applicability to more patients and settings.

background: current methods to evaluate left ventricular (lv) function either are invasive, precluding routine use in the majority of patients, or fail to discriminate myocardial, hemodynamic and structural factors, rendering assessment imprecise and incomplete. key question: can we reliably obtain lv functional characteristics by non-invasive means, while being able to differentiate more precisely the factors involved? proposed research: the study team aims to develop a non-invasive method for pressure-volume analysis (nipva) of the lv by combining echo-doppler, peripheral blood pressure measurements and biomechanical modelling. the validity of this approach will be established by comparison with gold standard invasive measurements of pressure-volume relationships in patients undergoing cardiac catheterization. test-retest reproducibility will be also assessed. the study team hypothesises that nipva will provide reproducible and valid measures of lv function and be more widely applicable.

Eligibility criteria:
inclusion criteria: * individuals, male or female, aged 18-80 years. * 30 patients awaiting elective diagnostic coronary angiography will be recruited. * 30 patients attending cardiology out-patient clinics will be recruited. exclusion criteria: * patients with atrial fibrillation or other dysrhythmias or those unable to fully comply with the protocol will be excluded

Keywords: heart failure