Kornimate/medical-research-clean huggingface dataset:
telbivudine versus lamivudine for maintenance therapy of patients with chronic hepatitis b and negative hbv viral load after 6 month of treatment with telbivudine

Conditions: Hepatitis, Chronic

Summary: the aim of this randomized clinical study is to show non-inferiority of a change of anti-viral therapy from telbivudine to lamivudine in patients who have achieved an undetectable viral load at week 24 of telbivudine therapy compared to continuous treatment with telbivudine with respect to the viral breakthrough rate at week 108 as the primary clinical outcome.


Eligibility criteria:
inclusion criteria: * male or female patients, \> 18 (having completed their 18th birthday). there is no upper limit of age * documented hbeag negative chb * hbsag positive \> 6 months * hbv dna \> 2000 iu/ml * patient is willing and able to comply with the study drug regimen and all other study requirements. * written informed consent * anti-viral hbv treatment naïve or previous treatment with interferon-alpha or pegylated interferon-alpha stopped at least 1 month prior to screening exclusion criteria: * decompensated liver cirrhosis according to the judgment of the local investigator * hepatocellular carcinoma * history of or laboratory signs of co-infection with hiv or hcv, hdv * previous treatment with anti-viral drugs (previous treatment with interferon-α or pegylated interferon-α is not an exclusion criteria, but has to be stopped one month before screening) * history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures or their excipients * any medical condition that requires frequent or prolonged use of systemic corticosteroids (inhaled, topic or intra-articular corticosteroids are allowed) * any medical condition requiring the chronic or prolonged use of potentially hepatotoxic drugs or nephrotoxic drugs. * current abuse of alcohol or illicit drugs. * use of other investigational drugs at the time of randomization, or within 30 days or 5 half-lives of enrollment, whichever is longer. * any other concurrent medical or social condition which is, in the opinion of the investigator, likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study. * any of the following laboratory values during screening: * hemoglobin (hgb) \<11 g/dl for men or \<10 g/dl for women * total wbc \<3000/mm3 * absolute neutrophil count (anc) \<1,500.mm3 * platelet count \<50'000/mm3 * serum amylase or lipase ≥ 1.5 x uln * serum albumin \<3 g/dl * total bilirubin \> 51 μmol/l (\> 3.0 mg/dl) * estimated calculated serum creatinine clearance \< 50 ml/min using the cockcroft-gault method using actual or ideal body weight whichever is less (cockcroft and gault 1976) * afp (alpha-fetoprotein) \> 100 ng/ml * alt \> 10x uln * women who are pregnant or breastfeeding. women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hcg) during screening.
host immune response to clostridium difficile infection (icd)

Conditions: Diarrhea Due to Clostridium Difficile

Summary: clostridium difficile is responsible for up to 25% of reported antibiotic associated diarrhea cases and virtually all cases of pseudomembranous colitis (pmc). the clinical spectrum of c. difficile infection (cdi) varies in severity from asymptomatic carriage to self-limited, mild, watery diarrhea, to pmc, intestinal perforation, toxic megacolon, sepsis, fulminant colitis, and death. in the past decade, the 027/nap1/bi strain has emerged world-wide and has been implicated in large outbreaks with increased severity, frequent recurrence, and significant mortality. the host immune responses can influence the severity of cdi and play crucial roles in cdi onset, progression, and overall prognosis. low serum concentrations of antibodies directed against the toxins a\&b of c. difficile have been associated with a higher risk of recurrence. however, there are conflicting reports.


Eligibility criteria:
inclusion criteria: * hospitalized * suffering from diarrhea related to c. difficile * confirmed diagnosis of cdi * informed consent by the patient * affiliated to the social security regime exclusion criteria: * out-patient * no confirmed diagnosis of cdi * decline of participation * patient not affiliated to the social security regime

Keywords: clostridium difficile, recurrence, relapse, antibodies, immune response, prognosis
a randomized trial comparing optimized rhtpo treatment with eltrombopag treatment in pre-treated itp pts

Conditions: Previously Treated Primary Immune Thrombocytopenia

Summary: te-itp study: compare the efficacy and safety of optimized rhtpo treatment versus eltrombopag treatment in previously treated primary immune thrombocytopenia patients.

a multicenter randomized open-label trial to compare the efficacy and safety of an optimized rhtpo treatment versus eltrombopag treatment in previously treated primary immune thrombocytopenia. total treatment duration is 6 weeks, the primary endpoint is "median time to achieve platelet count ≥50x10\^9/l during 6 weeks observation".

Eligibility criteria:
inclusion criteria: * subject is ≥18 years old. * disease duration is ≥3 months, diagnosed and treated as itp prior to screening. * baseline platelet count \<30×10\^9/l. * subjects treated with maintenance corticosteroids or immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month. * informed consent has been signed. exclusion criteria: * classified as refractory itp. * subjects with any prior history of arterial or venous thrombosis, or thrombophilia in recent 1 year. * subjects who have previously received any platelet increasing drug such as rhtpo, thrombopoietin receptor agonist(tpo-ra), etc. within 30 days. * subjects who are known nonresponders to rhtpo or tpo-ra therapy. * subjects with positive hepatitis c virus antibody or human immunodeficiency virus(hiv) antibody, positive hbsag and serum levels of hepatitis b virus (hbv) dna \>1000cps/ml. * tbil or scr\> 1.5 x upper limit of normal (uln), alt or ast\> 3.0 x uln in recently 2 weeks. * subjects with any prior history of tumor. * female subjects who are nursing or pregnant. * any situation that investigate consider not suitable for pts to join the study.

Keywords: rhtpo eltrombopag pre-treated primary immune thrombocytopenia
carotid b-mode ultrasound study to compare anti-atherosclerotic effect of torcetrapib/atorvastatin to atorvastatin.

Conditions: Mixed Hyperlipidemia

Summary: the torcetrapib project was terminated on december 2, 2006 due to safety findings. to look at ultrasound images taken in the carotid arteries and to look at various lipids in the blood of people with mixed hyperlipidemia

for additional information please call: 1-800-718-1021

Eligibility criteria:
inclusion criteria: * diagnosis of mixed hyperlipidemia * at least 18 years of age exclusion criteria: * women who are pregnant or lactating, or planning to become pregnant. * subjects with a clinically indicated need for statin (hmg-coa reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on ldl-c and hdl-c including fibrates and nicotinic acid (high doses) * subjects taking any drugs known to be associated with an increased risk of myositis in combination with hmg-coa reductase inhibitors * subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluationof response, or render unlikely that the subject would complete the study
the safety and effectiveness of nv-a01 in glioma patients

Conditions: Advanced Glioblastoma Patients

Summary: the goal of this clinical trial is to learn about the safety and effectiveness of nv-a01 in the treatment of advanced glioma patients. the main questions it aims to answer are: 1. the safety of nv-a01 in the treatment of advanced glioblastoma patients. 2. the effectiveness of nv-a01 in treating patients with advanced glioblastoma.


Eligibility criteria:
inclusion criteria: 1. patients with advanced malignant glioma confirmed by histopathology; 2. patients who have received radiotherapy and/or temozolomide (tmz) treatment and have residual or recurrent tumors; 3. patients diagnosed with lesions ≥ 1.0 cm after qualified assessment; 4. kps score ≥ 60 points; 5. the subjects had informed consent to this study before the experiment and voluntarily signed an informed consent form. exclusion criteria: 1. patients with unstable central nervous system metastases or meningeal metastases with clinical symptoms, with a risk of brain herniation or severe brain herniation, and judged by researchers as unsuitable for inclusion; 2. patients with severe cardiovascular diseases, active autoimmune diseases, and other diseases that have been determined by researchers to be unsuitable for enrollment; 3. patients who have received immunotherapy in the past and have an irae level ≥ 3, and have been determined by the researchers to be unsuitable for enrollment; 4. patients with an expected survival period of less than 3 months and judged by the researchers as unsuitable for enrollment; 5. researchers believe that patients with other serious systemic diseases or other reasons are not suitable for participating in this clinical study.
quantification of inspiratory effort through nasal pressure in patients undergoing weaning from invasive mechanical ventilation and correlation with clinical outcomes

Conditions: Respiratory Failure

Summary: weaning from invasive mechanical ventilation (mv) constitutes a fundamental procedure in intensive care, covering up to 50% of time spent on ventilation (1). endotracheal tube (ett) removal might be an important but delicate step in intensive care setting. failure and subsequent need for re-intubation can occur in up to 20% of cases leading to a significant increase in mortality rates (24%), longer hospital stay and prolonged need for ventilation. comorbidities such as obesity, copd and cardiac related diseases might further increase this risk reaching up to 60% of failure in extubation. in this scenario, accurate predictors of weaning failure are far welcomed. the recurrence of respiratory failure after extubation might considerably raise rates of failure, probably due to increased work of breathing in patients after ett removal. most recent guidelines on the use of non-invasive ventilation (niv) suggest using niv after ett removal in subjects with high risk of failure. niv could contribute to reduce work of breathing hence preventing the onset of respiratory failure after extubation. therefore, measuring inspiratory effort and its variation in weaned patients might help in identifying patients with significant risk of failing extubation. esophageal pressure swings (deltapes) can be measured through a nasogastric tube with a pressure transducer located in the inferior part of the esophagus. deltapes is an extremely precise and accurate method to quantify inspiratory effort, however its use in daily clinical practice is limited due to the invasive nature of the maneuver, elevated costs and need for considerable clinical training of operators. physiological studies have shown a correlation between nasal pressure measured at nostril entrance and esophageal pressure (which in turn is a measure of respiratory effort . therefore, measuring nasal pressure could represent a method to quantify inspiratory effort non-invasively, proving to be useful in daily clinical practice.


Eligibility criteria:
inclusion criteria: - candidates for endotracheal tube removal. exclusion criteria: * age under 18 * pregnancy * patient unable or unwilling to sign informed consent * neuromuscular diseases * patient with compromised neurological state (glasgow coma scale (gcs) under 14/15)

Keywords: weaning failure inspiratory effort nasal pressure
observational study of the management of patients with chronic pain

Conditions: Chronic Pain

Summary: the aim of this study is to evaluate the safety of use, benefits and risks of repeated use of ketamine for each patient with chronic pain in different structures of pain management.

this is an observational, longitudinal and multicenter study about use of ketamine. benefits are assessed with pain intensity, anxiety, depression, quality of life and global impression of change. risks are also assessed with adverse event collection.

Eligibility criteria:
inclusion criteria: * aged over 18 years * patients with chronic pain (more than 6 months) * patients with peripheral or central neuropathic pain, fibromyalgia, algoneurodystrophy exclusion criteria: * patient under 18 years of age, * patient not requiring prescription of ketamine

Keywords: chronic pain neuropathic pain ketamine concomitant treatment adverse effect
menopausal health training for husbands on women's quality of life and marital satisfaction

Conditions: Menopause

Summary: the investigators conducted a clinical trial to evaluation the effect of a menopausal health training for husbands of 45-60 years women on the women's quality of life and marital satisfaction during transitional period to menopause.

the investigators applied a menopausal health training program for husbands of 45-60 years women. the content of menopausal health training program was about the nature of menopause, signs and symptoms, complications, treatment option and health behavior during transitional period. training program lasted 3 sessions. the investigators assessed quality of life and marital satisfaction using hildich marital satisfaction questionnaire and menopause quality of life questionnaire(menqol), respectively, three month after intervention.

Eligibility criteria:
inclusion criteria: * living with their spouse * no history of premature menopause * no history of hysterectomy * no history of oophorectomy * no history of acute disease * no history of burden chronic disease exclusion criteria: * no participation of spouse in all of training session * uncompleted all of equation * favorite to exclude from study

Keywords: menopause quality of life marital satisfaction training
pulsed radiofrequency versus pulsed dose for shoulder pain

Conditions: Unilateral Chronic Shoulder Pain; Bilateral Chronic Shoulder Pain

Summary: the "pulsed dose" rf treatment in various painful disorders may provides better pain relief with longer duration compared to previous pulsed radiofrequency (prf) treatment in similar clinical settings. also, there would has not been any worrisome complications from the procedures.

pain scores on visual analog scale (vas) of 0_10 before and two hours immediately after radiofrequency lesioning and at 30 , 60, 90 day after procedure. along with oxford shoulder score (oss) is a 12-item patient-reported specifically designed and developed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. . the reduction in medications and the number of complications associated with the technique will be assessed. diagnostic suprascapular nerve block will done by 1.0 ml of 0.5% bupivacaine under fluoroscopic guidance using non-ionized dye (iohexol). pain reduction more than 50% based on mean vas assessment for at least three hours consider diagnostic. machine used is,(neurotherm 1100) rf lesion generator. the standard radiofrequency technique used, patient in sitting position , non-invasive blood pressure and peripheral oxygen saturation will monitored with non invasive pulse oxymetry. vascular peripheral intravenous routes will opened shoulder region exposed and under complete aseptic technique skin will be anesthetized with 2.0 ml of 2% lidocaine at puncture site, suprascapular notch was identified. the landmark to guide the initial entry point was a line drawn along the length of the scapular spine, bisected with a vertical line from the angle of the scapula. a radiofrequency needle was introduced through the skin, 2.5 cm along the line of the spine in the upper outer quadrant, and then guided to the edge of the suprascapular notch by use of c_arm guide fluoroscopy with the image intensifier (22-gauge, 50-mm needle; 5-mm active tip) the nerve was located accurately by stimulating at 2 hz (threshold \ 400 1 ml of 1% lidocaine will be injected.

Eligibility criteria:
inclusion criteria: * aged at least 18 years old * both male and female * had unilateral or bilateral chronic shoulder pain longer than one month * rotator cuff tear arthropathy * adhesive capsulitis shoulder instability * post-traumatic pain * post-surgical pain exclusion criteria: * duration of shoulder pain \< 1 month * patients had any previous surgical intervention or nerve blocks to the shoulder. * patient refused or declined treatment * allergy to local anesthetics or steroid or contrast material. * severe psychiatric illness disorder, * infection at site of injection * patients with a pacemaker or neurostimulator. * pregnancy.

Keywords: pulsed radiofrequency single-dose shoulder pain pain lasts more than one month patients referred to the pain clinic from the shoulder clinic failed all conservative therapies available
fluorouracil, irinotecan, leucovorin, and cisplatin as first-line therapy in treating patients with metastatic esophageal cancer

Conditions: Esophageal Cancer

Summary: rationale: drugs used in chemotherapy, such as fluorouracil, irinotecan, leucovorin, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. giving more than one chemotherapy drug may kill more tumor cells. purpose: this phase ii trial is studying how well giving combination chemotherapy as first-line therapy works in treating patients with metastatic esophageal cancer.

objectives: primary * determine the objective response rate in patients with metastatic esophageal cancer treated with fluorouracil, irinotecan, leucovorin calcium, and cisplatin as first-line therapy. secondary * determine the clinical benefit in patients treated with this regimen. * determine the tolerability of this regimen in these patients. * determine local relapse-free survival of patients treated with this regimen. * determine the overall survival of patients treated with this regimen. outline: this is an open-label, multicenter study. patients receive irinotecan iv over 90 minutes and leucovorin calcium iv over 2 hours on day 1. patients also receive fluorouracil iv continuously over 46 hours and cisplatin iv over 30 minutes on days 1 and 2. treatment repeats every 15 days for up to 12 courses in the absence of unacceptable toxicity or disease progression. projected accrual: a total of 39 patients will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: * histologically confirmed esophageal cancer * metastatic disease * at least 1 unidimensionally measurable metastatic lesion * at least 10 mm by spiral scanner or 20 mm by sequential scanner * outside the field of prior radiotherapy * no known symptomatic brain metastases patient characteristics: age * 18 to 75 performance status * ecog 0-2 life expectancy * at least 3 months hematopoietic * absolute neutrophil count ≥ 1,500/mm\^3 hepatic * bilirubin ≤ 1.5 times normal * alkaline phosphatase ≤ 3 times normal (5 times normal if liver metastases are present) * sgot and sgpt ≤ 3 times normal renal * creatinine ≤ 1.5 mg/dl cardiovascular * no myocardial infarction within the past 6 months * no uncontrolled angina other * not pregnant or nursing * fertile patients must use effective contraception * no other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix * no other illness or medical condition that would preclude study participation * no psychological, social, familial, or geographical condition that would preclude study participation prior concurrent therapy: biologic therapy * not specified chemotherapy * more than 6 months since prior fluorouracil and/or cisplatin * no other prior chemotherapy endocrine therapy * not specified radiotherapy * see disease characteristics * more than 6 weeks since prior radiotherapy surgery * more than 4 weeks since prior surgery other * no concurrent participation in another clinical study

Keywords: stage iv esophageal cancer recurrent esophageal cancer
determination of immune phenotype in glioblastoma patients

Conditions: Glioblastoma Multiforme

Summary: glioblastoma multiforme (gbm) is the most common primary brain tumor in adults. despite intensive research efforts and a multimodal management that actually consists of surgery, radiotherapy and chemotherapy with temozolomide, the prognosis is dismal. the aim of the current observational study is to determine immune phenotypes in individual patients with gbm at the time of diagnosis and to correlate tumor size, location (imaging), tumor properties (isocitrate dehydrogenase - 1 (idh-1), o6-methylguanine-dna-methyltransferase (mgmt), epidermal growth factor receptor (egfr) mutation status, etc.) with clinical data, such as progression free and overall survival, karnofsky index (progression free survival (pfs),overall survival (os), karnofsky score( kfs)), with blood immune phenotypes, biomarkers, and immune histochemical results of tumor infiltrating lymphocytes, macrophages, myeloid derived suppressor cells (mdsc), etc.. the different immunological phenotypes could predict a positive response to specific immunological therapeutic strategies and select the individual therapeutic plan for an individual gbm patient.


Eligibility criteria:
inclusion criteria: * adult glioblastoma multiforme exclusion criteria: * pregnancy, unable to give consent

Keywords: immune phenotype cytokines genetic aberration overall survival progression free survival
lactoferrin supplementation and iron metabolism in healthy pregnant women

Conditions: Iron-deficiency Anemia

Summary: to assess the effects of a lactoferrin supplemented formula on fetal development , iron metabolism and immunity in healthy pregnant women. one hundred and twenty healthy pregnant women (24\<gestational weeks\<26) are enrolled and randomly assigned to lactoferrin-supplemented formula group (active group) or normal formula group (control group, without lactoferrin supplementation). subjects allocated in active group consume lactoferrin supplemented formula (85mg lactoferrin per 100g) 3 times a day (81g totally), while those in control group consume formula without lactoferrin supplementation (\<6mg lactoferrin per 100g formula) according to the same schedule. routine blood test including hemoglobin and serum ferritin, and food frequency questionnaire-based review and 24h\*3 dietary record are performed every 4 weeks during intervention until delivery. body weight of newborns are recorded after delivery. the differences in iron deficiency anemia morbility of pregnant women and anthropometric measurements of newborns between groups would be analyzed after completion of this study.


Eligibility criteria:
inclusion criteria: * healthy pregnant women with gestational weeks between 24 and 26; * with hemoglobin concentration \> 110g / l; * without indication of abortion; * without infectious disease or hereditary disease; * without iron supplementation before enrollment. exclusion criteria: * with red blood count \<3.5\*10\^12/l，hemoglobin concentration\<110g/l or serum ferritin \<20 μg/l； * diagnosed with gestational diabetes mellitus; * enrolled in other intervention study within past 1 month.

Keywords: lactoferrin iron metabolism iron-deficiency anemia pregnant women fetal development