Kornimate/medical-research-clean huggingface dataset:
detection program for patients with primary biliary cholangitis lost in the system

Conditions: Primary Biliary Cholangitis

Summary: primary biliary cholangitis (pbc) has been considered a rare disease and its management has been limited by the lack of therapeutic alternatives. pbc is a slowly progressing chronic liver disease characterized by an immune-mediated destruction of the intrahepatic bile ducts, which leads to cholestasis, portal inflammation, and ultimately liver cirrhosis and its associated complications (ascites, portal hypertension, etc), if not treated effectively. thus, early diagnosis and close management of these patients with pbc is essential. first-line treatment with ursodeoxycholic acid (udca) improves liver biochemical parameters, delays histological progression, and increases liver transplant-free survival and overall survival. however, up to 40% of patients are non-responders to udca. obeticholic acid (oca) is recommended as second-line therapy in combination with udca for patients with an inadequate response to udca or as monotherapy in cases of udca intolerance. according to current clinical guidelines, the diagnosis of pbc includes a combination of elevated alkaline phosphatase (alp) levels and the presence of anti-mitochondrial antibodies (ama) (titer \>1:40) and/or anti-nuclear antibodies (ana) anti-gp210 or anti-sp100. ama are highly sensitive and specific for pbc and are detected in nearly 95% of pbc patients. a liver biopsy is not necessary unless there is an elevation of alp without the presence of specific ama and/or anti-gp210 or anti-sp100 ana or if coexistence with other liver diseases is suspected (autoimmune hepatitis, hepatic steatosis). the incidence of pbc has increased in recent years due to an increase in the diagnosis of cases in the initial phases, better awareness in the medical community and the development of more sensitive diagnostic tests. however, up to 31% of patients with pbc are lost without follow-up. the correct identification of patients with pbc is essential so that they can benefit from an adequate treatment and modify disease progression. to date, two studies (one spanish and one portuguese) showed that 27% and 45.5% of the patients lost with pbc presented advanced fibrosis, respectively. the objective of this study is to identify, through computerized data, patients with pbc who may be lost in the system and evaluate their clinical, analytical and demographic characteristics, and in a second phase, provide access to follow-up in specialized consultations.


Eligibility criteria:
inclusion criteria: * patients with positive ama and/or with positive ana anti-gp210 or anti-sp100 identified in the computer databases of each of the participating centers. * adults (≥18 years) exclusion criteria: * patients with overlap syndrome (pbc overlap with autoimmune hepatitis (aih))
study of predictive immunological parameters of molecular complete remission in patients with chronic myelogenous leukemia in chronic phase and treated with tyrosine kinase inhibitor

Conditions: Chronic Leukemia

Summary: the investigators recently identified promiscuous hla-dr-derived epitopes from the human telomerase reverse transcriptase (tert) called universal cancer peptides (ucp), to study tumor-specific cd4+ t cell responses. the aim of this prospective preliminary study is to evaluate the presence of ucp-specific th1 responses in patients in complete remission of cml two years after end of tyrosine kinase inhibitor (tki) treatments.


Eligibility criteria:
inclusion criteria: * for cohort a : * patient with chronic myelogenous leukemia in chronic phase in deep molecular response (mr4.0) persistent for 2 years or more after end of tki treatments * patient with total cessation of tki treatment * signed written informed consent * for cohort b : * patient with chronic myelogenous leukemia in chronic phase, for whom a diagnosis of relapse was increased 1 year or less after stopping treatment with tkis (inclusion of patient under tki treatment after relapse is possible). * signed written informed consent exclusion criteria (for all patients) : * patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (corticoids ≤ 10 mg/day is allowed) * active autoimmune diseases, hiv, hepatitis c or b virus * patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study. * patient under guardianship, curator or under the protection of justice.
action mechanisms of shock waves on pain

Conditions: Asymptomatic Condition

Summary: the aim of this study is to evaluate whether the intensity of pain perceived during the application of extracorporeal shockwave therapy (eswt) is determinant for producing changes in pressure pain threshold (ppt) in asymptomatic subjects. the investigators will perform a single controlled random trial to three groups. two of them will receive eswt whereas the third group will get a cold pressure test (cpt).


Eligibility criteria:
inclusion criteria: * absence of pain or illness * no changes in cognitive ability * good command of spanish, both spoken and written exclusion criteria: * people with systemic diseases, tumors, infections, pacemakers, clotting disorders, skeletally immature, fibromyalgia, whiplash history, dizziness or in physiotherapeutic or pharmacological treatment * pregnant women
study evaluating sra-333 in mild to moderate alzheimer's disease (ad)

Conditions: Alzheimer's Disease

Summary: to determine the safety and tolerability of multiple ascending fixed oral doses of sra-333 in subjects with mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: * diagnosis of probable ad according to the nincds-adrda criteria. * men and postmenopausal or surgically sterile women aged from 50 to 85 inclusive. * able to give informed consent. patient's caregiver must consent to participate in the study. exclusion criteria: * significant neurologic disease other than ad that may affect cognition. * current clinically significant systemic illness which is likely to deteriorate or affect the subject's safety during the study. other exclusions apply
advanced benefits of alpha-blocker monotherapy on lower urinary tracts symptoms(luts) patients

Conditions: Benign Prostate Hyperplasia

Summary: the purpose of this study is to evaluate the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in benign prostate hyperplasia patients, and suggest guidelines of the combination therapy.

even though it should be decided on patients cautiously under careful consideration about prostate volume, prostate specific antigen(psa) level, symptom score and maximum uroflow, recently the combination therapy of alpha-blocker and 5-alpha reductase inhibitor has been tried imprudently in korea. as a result of several clinical trials which had conducted overseas for releasing the combination drug of alpha-blocker and 5-alpha reductase inhibitor, the superiority of the combination therapy has been proved, however, plenty of patients still don't derive additional profit from it. therefore, in this study, the investigators anticipate to meet with meaningful results on the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in korean benign prostate hyperplasia patients, and provide guidelines of the combination therapy.

Eligibility criteria:
inclusion criteria: * male patients aged over 50 * clinically diagnosed benign prostate hyperplasia(bph) * 8 ≤ ipss ≤ 30 * 4 ml/sec ≤ q max ≤ 15 ml/sec * minimum voided volume ≥ 125 ml * post voided residual volume ≤ 250 * volunteer who singed on informed consent documents exclusion criteria: * past history of surgical procedure experience related to bph * past history of taking 5-alpha reductase inhibitor(5-ari) within 6 months before screening, or for more than 12 months regardless of the point of time * past history of taking alpha blocker within 2 weeks before screening * past history of acute urinary retention within 3 months before screening * serum psa ≥ 10 ng/ml (but, in the case of 4 ng/ml ≤ psa \< 10 ng/ml, the patients can be included only if prostate cancer is excluded by prostate biopsy) * anatomical abnormalities of lower urinary tracts(urethrostenosis, diverticulosis, bladder neck contracture) * clinical status that affects voiding other than bph(neurogenic bladder, chronic prostatitis/chronic pelvic pain syndrome, urinary infection, etc.) * unstable and significant medical condition including below * unstable angina pectoris, myocardial infarction, cerebrovascular disease within 6 months before screening * past history of malignant tumor including skin basal cell carcinoma within 5 years before screening * medically uncontrollable diabetes mellitus, peptic ulcer disease * severe hepatic diseases * past history of renal failure or renal disease (serum creatinine \> 1.4mg/dl) * condition expected serious adverse event due to the investigational drug * other conditions considered not eligible for the trial upon investigator's judgement

Keywords: lower urinary tracts symptoms 5 alpha reductase inhibitor proscar finasteride alpha blocker tamsulosin harnal d
combination therapy of gemcitabine and trabectedin in l-sarcomas

Conditions: Leiomyosarcoma; Liposarcoma

Summary: l-sarcomas represent about one third of all adult soft tissue sarcomas (24 % liposarcomas and 12 % leiomyosarcomas). approval for the induction of trabectedin into the treatment armamentarium of advanced and/or metastatic soft tissue sarcomas after treatment failure with anthracyclines and/or ifosfamide depended mainly on its activity in the l-sarcomas (garcia-carbonero 2004, le cesne 2005, and demetri 2009). significant activity has been described for the use of gemcitabine and especially the combination of gemcitabine and docetaxel mainly in leiomyosarcomas and liposarcomas (maki 2007). however, the combination of gemcitabine and docetaxel is associated with significant toxicity. pulmonary toxicity and refractory peripheral oedema are the most common severe adverse events. the aim of the present phase i study will be to examine safety data of this promising treatment combination of gemcitabine and trabectedin in l-sarcomas.


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed l-sarcomas (leiomyosarcoma and liposarcoma) * measurable disease according to recist 1.1 * any treatment line except adjuvant setting: evidence of primary metastatic situation or disease progression within the last 6 months (based on recist 1.1) in computed tomography or magnetic resonance imaging * any prior treatment possible * age \>= 18 years * who ps =\< 1 * effective contraception during study medication and up to 3 months from treatment discontinuation * signed informed consent form exclusion criteria: * surgical intervention \< 4 weeks * pregnancy or lactation * known allergic reaction to trabectedin or gemcitabine or one of their components * the following laboratory values: absolute neutrophil count \ = 2.5 mg/dl sgot and/or sgpt and/or alkaline phosphatase and/or cpk \> 2.5 x uln total bilirubin \> 1 x uln except in the case of gilbert's syndrome * participation in another study (four weeks before and during the study) * prior malignancy apart from completely resected basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix

Keywords: l-sarcomas
effects of napping in pregnant women with sleep disturbances on offspring neurodevelopment

Conditions: Sleep

Summary: to examine the effects of napping in pregnant women with sleep disturbances on offspring neurodevelopment, the researchers will recruit 80 pregnant women with sleep disturbances. these women will receive lifestyle recommendations to nap regularly and will choose whether or not to nap. the participants will wear wrist-worn accelerometers to record their 24-hour sleep patterns for seven consecutive days during the early, middle, and late stages of pregnancy. the neurodevelopment of their offspring will be assessed at 6 months, 12 months, 18 months, and 2 years of age.

participants will be recruited based on the early life plan project, an ongoing hospital-based prospective birth cohort study. pregnant women will be recruited at the time of booking for prenatal care. the sleep patterns of pregnant women will be assessed at 12-16 weeks of gestation using the pittsburgh sleep quality index (psqi) questionnaire. women with a psqi score greater than 5 and who self-report as not being habitual nappers in the last 3 months will be recruited. these women will receive lifestyle recommendations to nap regularly for 15-30 minutes between 12:00 and 15:00. whether they adopt this lifestyle change or the actual duration of their naps will be entirely up to the participants. an actiwatch will be given to the participants during early pregnancy (12-14 weeks), mid-pregnancy (22-24 weeks), and late pregnancy (29-32 weeks). instructions will be included on how to wear the watch, with participants advised to wear it on the non-dominant wrist continuously for 7 days, except when swimming or bathing. in addition to the actiwatch, participants will complete a sleep questionnaire during early pregnancy (12-14 weeks), mid-pregnancy (26-27 weeks), and late pregnancy (35-37 weeks) to subjectively assess their nighttime sleep and napping over the past month. the neurodevelopment of the participants' offspring will be followed up and assessed using the bayley scales of infant and toddler development at 6 months, 12 months, 18 months, and 2 years of age.

Eligibility criteria:
inclusion criteria: 1. pregnant women with a psqi score greater than 5 at enrollment. 2. not a habitual napper in the past 3 months (defined as napping 5 or more days per week on average for the past month). exclusion criteria: women with severe respiratory or cardiovascular diseases, liver or kidney dysfunction, or malignant tumors.

Keywords: sleep disturbance neurodevelopment
multicenter study to evaluate a systematized communication model for breast cancer patients

Conditions: Breast Cancer Stage IV; Breast Cancer Metastatic; Communication

Summary: both in mexico and in the world, breast cancer is the most common malignancy in women. it is estimated that in 2020, 28.2% of the new cancer cases reported in our country correspond to breast cancer, which translates to 30,000 new cases. in addition, it is relevant to mention that approximately 12% of mexican patients are diagnosed with stage iv breast cancer and it is estimated that 20-30% of women with early stage cancer will have a distant recurrence of the disease. thus, about 40% of patients will find themselves in a metastatic stage at some point in their breast cancer journey. various studies, including mexico, report that only half of patients with metastatic breast cancer are aware that their disease is not curable, 31% say they are not sure, and 17% think it is curable. likewise, 58% considered that they did not have enough knowledge to actively participate in conversations about their therapeutic options, which means that 40% reported difficulty talking about treatments with their doctors. this has shown that there are suboptimal levels of knowledge information on curability, treatment objectives and prognosis of their condition in patients with metastatic breast cancer. this lack of understanding is alarming given that a general understanding of the disease is crucial for informed decision making and adherence to cancer treatment. due to these alarming results, we seek to recruit women ≥18 years of age who are candidates to start first- or second-line treatment for de novo or recurrent metastatic breast cancer from various hospital centers in the country with public and private coverage, including hospital zambrano hellion tecsalud as coordinating center in nuevo león. the objective will be to evaluate whether a systematized communication model for patients with metastatic breast cancer allows increasing knowledge about the non-curative nature of treatment, compared to usual care.


Eligibility criteria:
inclusion criteria: * diagnosis of de novo or recurrent metastatic breast cancer * candidate to start the first or second line of treatment for metastatic breast cancer exclusion criteria: * receipt of a line of treatment for metastatic breast cancer posterior to the second line
determine the frequency of variants in the gba/psap genes in patients with mm or mgus

Conditions: Monoclonal Gammopathy of Undetermined Significance; Myeloma Multiple

Summary: no effective specific treatment is currently available for the management of multiple myeloma (mm) and monoclonal gammopathy of undetermined significance (mgus). a better understanding of the pathophysiological mechanisms would make it possible to propose treatments specifically targeting the deregulated pathways.

this study will characterise the links between rare diseases and complex, chronic diseases. metabolism can be visualised as a complex network in which the various biomolecules represent metabolic nodes and are linked together by connections. the number of connections at a node influences the effect of that biomolecule on the metabolic network(s) as a whole. if a biomolecule has a large number of connections, altering a metabolic pathway involving it will have an effect that will spread throughout the network. on the other hand, metabolic pathways with a high flux have a major impact on the homeostasis of the network. thus, alteration of such a metabolic pathway cannot be without consequence: a major alteration could induce a rare hereditary metabolic disease with an early-onset clinic, whereas an alteration with a moderate effect could participate in the pathogenesis of complex diseases, and may open up new therapeutic prospects for these tumour pathologies.

Eligibility criteria:
inclusion criteria: * major patients with multiple myeloma (mm) (defined by clonal proliferation of tumour plasma cells (\>10%), presence of a monoclonal peak in serum or urine (excluding non-secretory myeloma) and organ involvement secondary to bone marrow invasion) or with mgus (defined as bone marrow plasmacytosis of less than 10%, associated with a monoclonal protein of less than 30g/l and no clinical involvement). * membership of a social security scheme * adult having read and understood the information letter and signed the consent form exclusion criteria: * person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub-guardianship or guardianship
the effect of dexamethasone on pain after total knee replacement surgery

Conditions: Arthroplasty, Knee Replacement; Pain, Postoperative

Summary: the purpose of this study is to examine, if a single-dose of dexamethasone given during the operation, alleviates pain after knee replacement surgery.

the purpose of this study is to examine, if a single-dose of dexamethasone given during the operation, alleviates pain after knee replacement surgery. this is also a dose-finding study comparing two doses of dexamethasone. total knee arthroplasty causes considerable pain. multimodal analgesia and peripheral nerve blocks are used for treatment of pain. some studies suggest that glucocorticoids alleviate postoperative pain. the optimal dose of dexamethasone in treatment of postoperative pain is not known. studies on this subject in patients with total knee replacement are sparse. potential side-effects of dexamethasone (hyperglycemia, wound infection) need to be studied. patients coming for primary knee replacement surgery are enrolled. the patients in each study group receive multimodal therapy for postoperative pain: etoricoxib, paracetamol, gabapentin and oxycodone. a single dose of intravenous dexamethasone (0,15 mg/kg or 0,25 mg/kg) or a placebo (saline) is administered to the patient during the operation. the effect of dexamethasone on postoperative pain is observed: main outcome is dynamic pain at 24 h postoperatively. the extent of inflammatory reaction is measured (crp). serial blood glucose measurements are done.

Eligibility criteria:
inclusion criteria: * primary total knee replacement surgery * asa (american society of anesthesiologists) class 1-3 exclusion criteria: * severe coronary artery disease, heart failure, kidney failure * insulin-dependent dm (diabetes mellitus), poorly controlled type ii dm * gastric/duodenal ulcer * allergy/contra-indication for any drug used in the study * corticosteroid use during last 3 months * preoperative use of opioid drugs (excl. codeine, tramadol) * neuropathy/sensory impairment of lower limbs * lack of co-operation, e.g. inability to use a pca (patient controlled analgesia)-device

Keywords: arthroplasty knee replacement pain, postoperative glucocorticoids dexamethasone
the effect of high dose ascorbic acid on critically ill patients with ards

Conditions: Acute Respiratory Distress

Summary: 1. to access role of vitamin c supplementation in ards patients on the following: oxidants/ antioxidants imbalance length of hospital stay mortality rate weaning from mechanical ventilator incidence of adverse drug reaction 2. to access tolerability of vitamin c supplementation in patients with ards.

acute respiratory distress syndrome (ards) is a form of severe hypoxemic respiratory failure due to severe impairment of gas exchange and lung mechanics that is characterized by inflammatory injury to the alveolar capillary barrier, with extravasation of protein-rich edema fluid into the air space. current ards antioxidant treatment strategy, is based upon supportive therapies including low tidal volume ventilation, fluid management, nutritional support and glucocorticoids. ascorbic acid or vitamin c is an important dietary water-soluble antioxidant, it significantly decreases the adverse effects of ros such as reactive oxygen and nitrogen species that can cause oxidative damage to macromolecules. recent studies show that high dose of vitamin c have protective effects against overwhelming oxidative stress due to critical illness. vitamin c improves immune function and improves tissue perfusion and reduce tissue hypoxia and subsequent organ dysfunction. also, ascorbate, the redox form of vitamin c is physiological antioxidant and has bacteriostatic activity hence the study aims to evaluate the impact of iv vitamin c in ards, as a novel pharmaceutical approach in an attempt to improve the clinical outcome of ards patients, decrease other medications toxicities and improve patients' quality of life. the objective of the current study was to evaluate the efficacy, safety and tolerability of iv vitamin c administration in addition to conventional therapy in patients with ards by assessing the following: 1. oxidants/ antioxidants imbalance 2. length of hospital stay 3. mortality rate 4. weaning from mechanical ventilator 5. incidence of adverse drug reaction 6. serum il8 levels 8. serum vitamin c levels

Eligibility criteria:
inclusion criteria: 1. all ards cases presenting to the chest department icu within 48 hours of diagnosis 2. who don't have an exclusion criteria will be included. exclusion criteria: 1. known allergy to vitamin c 2. inability to obtain consent; 3. age \< 18 years; 4. more than 48 hours since meeting ards criteria; 5. pregnancy or breast feeding, 6. moribund patient not expected to survive 24 hours; 7. patients not eligible to cpr 8. active kidney stone