Kornimate/medical-research-clean huggingface dataset:
lamivudine therapy in patients with prior entecavir treatment and undetectable viral load

Conditions: Hepatitis B, Chronic

Summary: patients with chronic hepatitis b and treated with entecavir for over 6 months (with no previous other antiviral treatment) will be invited to participate in this study. they will be eligible if their liver tests are normal and their viral load is undetectable. patients will be switched to lamivudine treatment to assess whether lamivudine can maintain adequate suppression of the hepatitis b virus after successful treatment with entecavir. patients will be monitored closely after switching treatment at 1 months and then every 3 monthly. if there is any evidence of increase in viral load then patients will be given the option of changing back to entecavir.


Eligibility criteria:
inclusion criteria: * patients with chronic hepatitis b treated with entecavir for 6 months or more * normal alt * undetectable hbv dna by roche taqman pcr assay * no other previous therapy with nucleoside/nucleotide analogues exclusion criteria: * presence of other liver diseases including hepatitis c co-infection, autoimmune hepatitis , primary biliary cirrhosis, primary sclerosing cholangitis, alcoholic liver disease, and wilson's disease * history of hepatocellular carcinoma * history of decompensated liver disease

Keywords: entecavir lamivudine sequential therapy
window trial 5-aza in hnscc, t-tare

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: the purpose of this study is to assess the activity of 5-azacitidine in patients with human papilloma virus (hpv)-positive and hpv- negative head and neck squamous cell carcinoma (hnscc). the response activity will be determined by analyzing your tumor tissue prior to and after treatment with 5-azacitidine. preliminary studies in mice bearing human head and neck cancers or head and neck cancer cells cultured in laboratories suggest that treatment with 5-azacitidine increases changes in cancer cells that lead to their death. this study is designed to determine if similar changes occur in cancer cells of patients with head and neck cancer. the study also aims to determine the amount of a specific type of protein, p53 before and after treatment. research has shown that the p53 protein is associated with anti-tumor activity. finally, this study is measuring the amount of a specific type of protein called interferon in your tumor tissue. interferons are proteins made and released by the body in response to pathogens (disease causing agents) such as viruses, bacteria, or tumor cells. interferons allow for communication between cells to trigger the protective defenses of the immune system that remove pathogens (disease causing agents) or tumors.

primary objectives: the primary objectives of this study are: • to determine the proportion of hpv-positive patients in whom 5-azacytidine increases apobec rna expression. secondary objectives the secondary objectives of this study are: * to investigate response (proliferation, apoptosis), as well as reactivation of ifn pathways in patients treated with 5-azacitadine for hpv-positive and hpv-negative hnscc. * to investigate the clinical activity of 5-azacitadine in patients with hpv-positive and hpv-negative hnscc. * to investigate the safety of 5-azacitadine in patients with hpv-positive and hpv-negative hnscc

Eligibility criteria:
inclusion criteria: 1. histologically confirmed p16 or hpv pcr positive hnscc with surgically resectable disease 2. age ≥18 years of age. 3. eastern cooperative oncology group (ecog) performance status score of 0, 1 or 2 4. anc greater than or equal to 1500, hb greater than or equal to 8, platelet count greater than or equal to 100,000 exclusion criteria: 1. ast or alt greater than 2.5 x uln 2. known brain metastases 3. women must not be pregnant or breastfeeding 4. known allergy to 5-azacitadine 5. patients receiving any other investigational agents within 4 weeks of starting the study

Keywords: hnscc
pulmonary artery denervation clinical study using the gradient denervation system in heart failure patients with pulmonary hypertension group 2 (prevail-ph2 study)

Conditions: Group 2 Pulmonary Hypertension; Heart Failure

Summary: this early feasibility study is intended to characterize the impact of pulmonary artery denervation on the quality of life in heart failure patients with group 2 pulmonary hypertension

gradient has developed a novel system for pulmonary artery denervation (padn) to treat patients with heart failure who also developed pulmonary hypertension (ph). pulmonary hypertension is frequently associated with left heart failure and is a strong independent predictor of clinical worsening and higher mortality. no therapeutic options are available to treat ph in this selected group of patients with heart failure. the objective is to improve exercise capacity and quality of life by targeting ph in these patients.

Eligibility criteria:
inclusion criteria: * heart failure with ef ≥ 40% (by tte within last 3 months) * mean pulmonary artery pressure (mpap) \>20 mmhg at rest * pulmonary vascular resistance (pvr) ≥ 3wu at rest * pulmonary capillary wedge pressure \> 15 mmhg (at rest) or \> 18 with passive leg raise * cardiac index (ci) ≥ 1.7 l/min/m2 * nyha class ii or iii * glomerular filtration rate (gfr) ≥ 25 ml/min * stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment exclusion criteria: * ambulatory with a life expectancy of \< 1 years * inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel * unable to tolerate right heart catheterization * pulmonary artery aneurysm, moderate or greater pa stenosis or other pa anatomy that would prevent safe or proper use of the study device * severe aortic, mitral or pulmonary valve regurgitation * tricuspid regurgitation in conjunction with the presence of cirrhosis or congestive hepatopathy * clot or thrombus in any potential target ablation zone (right, left or main pulmonary artery)
comparison of prostate cancer-related quality of life in sexually active men with favourable intermediate-risk localised prostate cancer treated with total prostatectomy or focal hifu

Conditions: Prostate Cancer

Summary: the goal of this trial is to assess the impact of focal hifu therapy on quality of life in patients with favourable intermediate-risk localised prostate cancer. the main question it aims to answer is: what is the prostate cancer-related quality of life in patients with favourable intermediate-risk localised cancer treated by total prostatectomy or focal hifu ? researchers will compare patients with favourable intermediate-risk localised cancer treated by total prostatectomy to patients with favourable intermediate-risk localised cancer treated by focal hifu to see their quality of life. participants will answer epic-cp questionnaire 6 months, 12 months and 24 months after treatment


Eligibility criteria:
inclusion criteria: * patient, male, aged between ≥ 40 and ≤ 75 years * patient with a life expectancy \> 10 years at the time of inclusion. * patient with a therapeutic strategy (prostatectomy or focal hifu) defined during a pcr. * patient with a diagnosis of localised prostate cancer at favourable intermediate risk * patient able to tolerate general anaesthesia or type iv sedation * patient with normal urinary continence status * patient with satisfactory erectile function allowing penetration: * patient with targeted biopsies and systematic biopsies * patient affiliated to or benefiting from a social security scheme * french-speaking patients who do not object to the use of their data. exclusion criteria: * patients with a contraindication to mri * stage t3a or b on mri * patient on long-term anticoagulants and unable to stop them. * patient already included in another study * protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
improved use of antibiotic guidelines in hospital environment

Conditions: Community-Acquired Pneumonia

Summary: the purpose of this study is to determine if the use of antibiotic guidelines and thus antibiotics can be improved through a description of possible barriers leading to tailored interventions.


Eligibility criteria:
inclusion criteria: * diagnosed community-acquired pneumonia (cap) * diagnosed community-acquired pyelonephritis exclusion criteria: * cap: hospital-acquired pneumonia; patients transferred from other hospital; death within 24h, aspiration pneumonia, immunocompromised status, palliative status, admission due to social reasons * pyelonephritis: urinary tract with functional or physical abnormalities, urinary catheterisation, pregnancy, (immunocompromised status, palliative status, admission due to social reasons and history of renal transplant.

Keywords: time series implementation
ozonated olive oil in treatment of pemphigus vulgaris and bullous pemphigoid

Conditions: Pemphigus Vulgaris; Bullous Pemphigoid

Summary: this study assesses the disinfectant and healing promoting effect of ozonated olive oil in treatment of pemphigus vulgaris and bullous pemphigoid in comparison to conventional topical treatment with topical antibiotic.

all participants will be subjected to the following: * written informed consent. * detailed history and clinical examination and photographic documentation * patients with pemphigus vulgaris (epidermal skin blisters) as well as those with bullous pemphigoid (subepidermal skin blisters) will receive systemic treatment, namely; pulse steroid therapy and either mycophenolate mofetil or azathioprine +/- monthly iv cyclophosphamide. * two comparable contralateral lesions will be selected in every patient, which will be randomly assigned to either ozonated oil or conventional treatment. * patients will apply ozonated oil to on one lesion followed by gauze compared to conventional topical gentamycin and potassium permanganate followed by gauze on the contralateral lesion. role of topical treatment is essentially to prevent / treat secondary bacterial infection of skin erosions as well as promote wound healing by maintaining moist clean environment. * surface area of both lesions will be calculated using digital planimetry, prior to starting treatment and by the end of treatment; namely end of the first cycle of intravenous pulse steroids on day 6 which defines end of intervention. percent reduction on either side will be calculated. * for assessing disinfectant effect, swabs will be taken from the 2 selected lesions at the same intervals for assessing for bacterial as well as fungal growth. * patients with positive cultures for bacterial growth will be given systemic antibiotics according to culture and sensitivity

Eligibility criteria:
inclusion criteria: pemphigus vulgaris or bullous pemphigoid with bilateral skin erosions. exclusion criteria: - age \< 18 years . pregnant/ lactating females.

Keywords: ozonated olive oil healing disinfection
a phase ii study of hr070803 in the treatment of advanced esophageal cancer

Conditions: Advanced Esophageal Cancer

Summary: to evaluate the efficacy, safety and pharmacokinetic characteristics of hr070803 in the treatment of advanced esophageal cancer.


Eligibility criteria:
inclusion criteria: 1. ecog performance status 0 or 1 2. histologically confirmed advanced esophageal carcinoma 3. at least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (recist 1.1) 4. able and willing to provide a written informed consent exclusion criteria: 1. the tumor obviously invades adjacent organs of esophageal lesions 2. bmi≤18.5 kg/m2 or weight loss ≥10% within 2 months prior to screening 3. subjects with unresolved adverse effects of prior therapy at the time of enrolment 4. subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently
risk factors for venous thromboembolism

Conditions: Deep Venous Thrombosis; Pulmonary Embolism

Summary: deep venous thrombosis is the presence of blood clots, usually in the legs that lead to either local problems or breathing problems if the clot moves to the lungs. this study is designed to assess both clinical conditions as well as common genetic factors that lead to more risk of deep venous thrombosis. clinical conditions of venous thrombosis include: stroke, malignancy, and situations such as surgery, pregnancy, trauma, or travel.


Eligibility criteria:
patients must be 18 years with the ability to understand and consent to questionnaire and blood draw, including understanding of genetic testing..

Keywords: coagulation thrombosis genetic markers
an investigational drug study in adults with type 2 diabetes on basal insulin (mk-0941-006)

Conditions: Type 2 Diabetes Mellitus

Summary: a study to assess safety, pharmacokinetics (pk), and pharmacodynamics (pd) of mk-0941 in type 2 diabetics being treated with basal insulin.


Eligibility criteria:
inclusion criteria: * male or female (of non-childbearing potential) between 18 to 70 years of age * diagnosed with type 2 diabetes and currently being treated with basal insulin * smokers may participate, but they are limited to 10 cigarettes per day while at the clinic and must follow clinic smoking rules exclusion criteria: * history of type 1 diabetes * treated with peroxisome proliferator-activated receptor (ppar) agonists within 12 weeks prior to study start * history of severe hypoglycemia * allergic to insulin
clinical effect and safety of autologous umbilical cord blood transfusion in the treatment of cerebral palsy

Conditions: Safety Issues; Effect of Drugs

Summary: to study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of cerebral palsy.

this is a phase 1 clinical trial that constitutes two time points cohorts with participants who will receive intravenous autologous umbilical cord blood and 0.9% sodium chloride respectively. the timing of treatment is any time after the diagnosis of cerebral palsy. the investigator will proceed the groups during the same period. 1. demographic data and baseline characteristics of the studied group were collected: * basic patient's information survey * medical history * physical examination * basic blood test result * children's developmental disorders evaluation before the treatment * brain magnetic resonance imaging-diffusion tensor imaging (mri-dti) before the treatment * neurocognitive function test before the treatment 2. assessment of clinical condition in the course by measurement of blood pressure, heart and respiratory rates, temperature and adverse events was recorded. 3. autologous cord blood doses is 20-30ml (total mononuclear cells\>1\*10\^7/kg)，the infusion speed is 1ml/min, and with same volume of 0.9% sodium chloride as placebo. 4. the follow-up: clinical test until 30th month in 3 month gaps.

Eligibility criteria:
inclusion criteria: * a patient who was diagnosed with a mild case, and severity case of cerebral palsy or developmental disability through developmental assessment from more than two specialists including a specialist in pediatrics and rehabilitation medicine.. * in case there is a sign of the general decrease in white matter, or periventricular leukomalacia near cerebral ventricles in mri dti test. * a subject who did a written consent to participation in this clinical trial through the very person and a legal representative. exclusion criteria: * in case a patient underwent a surgical procedure, or was administered autologous cord blood within one year before participating in a clinical trial. * accompanied by a serious disease, such as chromosome abnormality, etc. * in case where a patient's medical condition is judged to be maladapted by a researcher. * in case a patient or his or her legal representative doesn't agree to participation in a clinical trial. * a patient having a predisposition to allergies. * a patient having serious disorders in the liver, kidney, and cardiopulmonary function.

Keywords: cerebral palsy autologous umbilical cord blood safety effect
cetuximab+mfolfox6 vs. mfolfox6 alone in ras/braf wild type patients with high-risk resectable crlm

Conditions: Colorectal Cancer; Liver Metastases

Summary: for patients with initially resectable colorectal cancer liver metastases who have high-risk factors, neoadjuvant therapy is currently considered a consensus approach. however, there is ongoing debate regarding the optimal treatment strategy. our study aims to investigate whether the addition of cetuximab to neoadjuvant chemotherapy improves outcomes compared to neoadjuvant chemotherapy alone. the objective of this phase iii clinical trial is to determine whether the combination of cetuximab and mfolfox6 chemotherapy is superior to neoadjuvant mfolfox6 chemotherapy alone for patients with initially resectable colorectal cancer liver metastases who have wild-type ras/braf and high-risk factors.

primary • to determine whether the addition of cetuximab to neoadjuvant mfolfox6 chemotherapy results in improved event-free survival when compared with neoadjuvant mfolfox6 chemotherapy alone in patients with high-risk \& ras/braf-wild-type \& resectable colorectal liver metastases. secondary * to evaluate the overall survival of patients treated with these regimens. * to evaluate the quality of life of patients treated with these regimens. * to evaluate the preoperative remission rate, safety, surgical complications, actual resection rate, pathological resection status of patients treated with these regimens.

Eligibility criteria:
inclusion criteria: 1. histological proof of colorectal adenocarcinoma; 2. age ≥ 18 years and ≤75 years; 3. ras wild type； 4. crs≥3； 5. simultaneous liver-limited metastases; 6. at least one measurable liver metastases; 7. world health organization (who) performance status 0-1; 8. life expectancy ≥ 3 months; 9. adequate hematologic function: absolute neutrophil count (anc)≥1.5×109/l, platelets≥100×109/l, and hemoglobin(hb) ≥ 9g/dl; 10. adequate liver and renal function: total bilirubin ≤2.0 mg/dl, serum transaminases ≤ 5x upper limit of normal(uln), and serum creatinine ≤ 1.5x uln and creatinine clearance ≥ 30 ml/min; 11. written informed consent. exclusion criteria: 1. previous systemic treatment for metastatic disease; 2. previous surgery for metastatic disease; 3. extrahepatic metastases; 4. unresectable primary tumor; 5. major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, cva) within 12 months before randomisation; 6. acute or subacute intestinal obstruction; 7. second primary malignancy within the past 5 years; 8. drug or alcohol abuse; 9. no legal capacity or limited legal capacity; 10. pregnant or lactating women; 11. uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs; 12. peripheral neuropathy;
telemonitoring in niv mnd (optnivent)

Conditions: Motor Neuron Disease, Amyotrophic Lateral Sclerosis

Summary: this is a feasibility study of telemonitoring system for people with mnd/als, who are on niv, via a call centre operated by a local clinical commissioning group.

this study will test the feasibility of previously developed telehealth system, using a device called careportal®, to monitor people with mnd/als who are using non-invasive ventilation (niv). the careportal® is a ce marked portable tablet computer device allowing telecommunication between patients and their care team through bespoke question sets, overnight oximetry test, and patient-ventilator interaction(pvi) data. previously, the weekly telemonitoring via careportal® was found to be an effective method to monitor symptom changes, allowing clinicians to optimise the care of ventilated patients with mnd. this study will assess the practicality of using careportal® in the care of ventilated patients with mnd by monitoring patients through a patient support call centre. the call centre will screen the data and liaise with appropriate clinicians regarding changes of symptoms.

Eligibility criteria:
inclusion criteria (patients): * confirmed diagnosis of mnd with respiratory muscle weakness * adults who are capable of informed consent * patients for whom we anticipate survival of 6 months or more * able to communicate with an interviewer. alternative communication methods will be used as required in order to mitigate communication difficulties. exclusion criteria (patients): * patients who have declined niv

Keywords: non-invasive ventilation telehealth telemonitoring
multimodal analgesic treatment versus traditional morphine analgesia after cardiac surgery

Conditions: Analgesia; Postoperative Pain

Summary: to test if multimodal analgesia with different analgesic medication offer better pain relief, lesser side effects and is safe compared to conventionel opiod analgesia after cardiac surgery.


Eligibility criteria:
inclusion criteria: * age\>18 * any cardiac procedure with sternotomy * able to give informed consent exclusion criteria: * cardiac surgery without sternotomy * peripheral neuropathy * neurological disease * psychiatric illness * history of gi bleeding * chronic pain (i.e. back pain, cancer, arthritis) * serum creatinine \>150 μmol/l * hepatic disease with elevated liver enzymes (sgpt and sgot elevated to 1.5 times maximum normal value) * allergic to study medication * alcohol abuse * abuse of narcotics or medication * pregnancy * participation in other clinical trials * insufficient language skills * in addition intensive care unit (icu) stay for more than 24 hours was used as a pre-defined post randomization exclusion criteria, because prolonged icu stay and ventilator treatment would interfere with study analgesic protocol.

Keywords: nsaid, gabapentin, multimodal, morphine, dexamethasone, cardiac surgery, postoperative pain, analgesia.
sudarshan kriya yoga and cardiac autonomic control in patients with anxiety-depression disorders

Conditions: Anxiety; Depression

Summary: the effects of sudarshan kriya yoga (sky) on autonomic function in patients with anxiety-depression disorders is unknown. thus, the authors will investigate cardiac autonomic control in a population of patients with anxiety-depression disorders which will undergo a specific sky treatment.

several studies have demonstrated that adjuvant therapies as exercise and breathing training are effective in improving cardiac autonomic control (cac) in patients with affective spectrum disorders. however, the effects of sudarshan kriya yoga (sky) on autonomic function in this population is unknown. to test the hypothesis that sky training improves cac, cardiorespiratory coupling and adaptive response of sympatho-vagal balance to orthostatic changes were evaluated in patients with anxiety and/or depression disorders. the authors will enroll patients with a diagnosis of anxiety and/or depression disorders (dsm-iv) and they will divide them in two groups: 1) conventional therapy (control) and 2) conventional therapy associated with sky (treatment) for 15 days. anxiety and depression levels will be determined using quantitative questionnaires. for the assessment of cac and cardiorespiratory coupling, cardiorespiratory traces will be analyzed using monovariate and bivariate autoregressive spectral analysis, respectively.

Eligibility criteria:
inclusion criteria: * diagnosis of anxiety-depression disorder exclusion criteria: * absence of sinus rhythm on ecg * absence of any cardiovascular and metabolic disorder