Kornimate/medical-research-clean huggingface dataset:
clinical implications of hiv low-level viremia at times of highly active antiretroviral treatment regimens

Conditions: HIV-infection

Summary: retrospective analysis of hiv-1 positive patients treated with antiretroviral therapy in essen (germany) from 2004 on. stored samples from selected patients (n=50) obtained for routine diagnostics will be used to analyze the gag gene, the v3-region of the env gene and immune cells.

the underlying study is a retrospective analysis of hiv-1 positive patients treated with antiretroviral therapy from essen since 2004. stored samples obtained for routine diagnostics will be used to analyze the gag gene, the v3-region and immune cells from selected patients. by comparing different groups of patients this study aims to identify clinical implications of low-level viremia (llv) and persistent viremia (pv) at times of highly active antiretroviral treatment regimens (cart). the objectives of this study is to (1) determine how often llv and pv occured during cart in essen in the last 10 years and whether specific patterns can be correlated, (2) whether the evolution of pi drug resistance can be detected earlier in the gag than in the protease gene, (3) what kind of cellular tropism do hiv-1 isolates (rna and proviral dna) have at times of llv, and (4) what kind of immune cells circulate in the blood during llv and pv and what kind of functional properties do they have. the groups include patients starting cart as well as patients with cart. furthermore, clinical data of patients are routinely documented and will be combined with results specifically obtained in this study in an anonymized data set. since this is a retrospective study, there are no specific endpoints.

Eligibility criteria:
inclusion criteria: * chronic hiv-1 infection * age \> 18 years * patients treated in essen in the last 10 years exclusion criteria: - no antiretroviral therapy / treatment

Keywords: hiv-1 antiretroviral treatment low viral load low-level viremia
immune response to hepatitis b virus booster vaccination after 20-23 years

Conditions: Hepatitis B Vaccination

Summary: this study will evaluate the humoral and cellular immune responses to a hepatitis b vaccine booster in healthy adults which received a full course of neonatal hepatitis b vaccination 20-23 years ago.


Eligibility criteria:
inclusion criteria: * healthy adults 20-25 years old exclusion criteria: * hepatitis b surface antigen (+) * hepatitis b core antibody (+) * any history of liver disorders including hepatitis * hiv ag or ab(+)
the efficacy and safety of haic with folfox vs sorafenib for patients who showed tace-resistant: a retrospective study

Conditions: Hepatocellular Carcinoma

Summary: transarterial chemoembolization (tace) is considered the gold standard for treating intermediate-stage hepatocellular carcinoma (hcc). however, any treatment guidelines do not specify the criteria for repeating tace. this study was to compare haic with folfox with sorafenib who showed tace-resistant.


Eligibility criteria:
inclusion criteria: * diagnosed with hcc according to the european association for the study of the liver (easl) diagnostic criteria * tace failure/refractoriness by liver cancer study group of japan (lcsgj) criteria * without extrahepatic metastasis * the following laboratory parameters: platelet count ≥ 60,000/μl hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 1.5 mg/dl serum albumin ≥ 35 g/l asl and ast ≤ 5 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 exclusion criteria: * known history of hiv * history of organ allograft * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * serious non-healing wound, ulcer, or bone fracture * evidence of bleeding diathesis. * any other hemorrhage/bleeding event \> ctcae grade 3 within 4 weeks of first dose of study drug

Keywords: hepatocellular carcinoma tace failure sorafenib hepatic arterial infusion chemotherapy oxaliplatin, fluorouracil, and leucovorin
post-marketing assessment of immunogenicity and safety of unituxin® in high-risk neuroblastoma patients

Conditions: Neuroblastoma

Summary: the purpose of this study was to assess the incidence of human anti-chimeric antibody (haca) in high-risk neuroblastoma patients treated with unituxin combination therapy.

this was a multi-center, non-randomized, open-label study in patients with high-risk neuroblastoma to assess the immunogenicity, safety and tolerability of unituxin combination therapy. patients enrolled in the study were prescribed unituxin for the treatment of high-risk neuroblastoma.

Eligibility criteria:
inclusion criteria: * patient had been diagnosed with high-risk neuroblastoma. * patient had been prescribed unituxin and plans to start unituxin therapy within 30 days of study entry. * patient started unituxin therapy no later than 200 days after autologous stem cell transplantation (asct). * written informed consent / assent was obtained in accordance with institutional and international conference on harmonisation (ich) guidelines. exclusion criteria: * patient had received prior anti-disialoganglioside (anti-gd2) antibody therapy. * patient had participated in an investigational clinical trial with tumor therapeutic intent within 30 days of informed consent. * patient underwent autologous stem cell transplantation (asct) more than 200 days prior to receiving unituxin therapy.
efficacy of a combination of amlodipine/valsartan on 24h blood pressure control with one nocturnal or diurnal intake a day

Conditions: Hypertension

Summary: this study was a multicenter, randomized, probe-type (prospective, randomized, open label, blinded end-point) study of 12 weeks duration comprising four visits, carried out in patients with essential arterial hypertension not controlled on four weeks treatment with amlodipine 5 mg alone.


Eligibility criteria:
inclusion criteria: * age \>= 18 years * essential uncontrolled or naive hypertensive patients (sbp ≥= 140 mmhg, dbp - \>/=90 mm hg, or sbp \>= 130 mmhg, dbp \>= 80 mmhg if diabetes or renal impairment) except patients treated with amlodipine, or intolerant of arbs and/or calcium channel blockers. exclusion criteria: * severe hypertension : sbp \>= 180 mmhg, dbp \>= 110mmhg * pregnancy * allergia to arbs and/or to calcium channel blockers * antihypertensive tritherapy at v1 * history of heart failure, pectoris angina, stroke, myocardial infarction * diabetes type i * renal impairment

Keywords: hypertension ambulatory blood pressure monitoring
memantine and validation of a new alzheimer's disease scale

Conditions: Alzheimer's Disease

Summary: to validate a new alzheimer's disease scale against other rating tools in subjects with dementia of alzheimer's type, treated with memantine.


Eligibility criteria:
inclusion criteria: * diagnosis of probable alzheimer's disease consistent with nincds-adrda criteria or with dsm iv tr criteria for dementia of alzheimer's type. * signed informed consent prior to the initiation of any study specific procedures. * sight and hearing (a hearing aid is permitted) are sufficiently good to allow the undertaking of study-related procedures and psychometric tests. exclusion criteria: * evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease. * intake of any medication that is contra-indicated in combination with memantine. * history of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to ingredients of memantine or lactose. * known or suspected history of alcoholism or drug abuse within the past 2 years. * current or previous treatment with memantine or participation in an investigational study with memantine.
telephone enhancement procedure for continuing care - 1

Conditions: Substance-Related Disorders

Summary: the purpose of this study is to test a feasibility study of a telephone enhancement procedure (tele) to improve participation in continuing care activities.


Eligibility criteria:
inclusion criteria: * residential substance abuse treatment patients who reside within the pre-specified catchment area who complete continuing care plans prior to discharge. * voluntary admit to residential treatment center; substance abuse or dependence; reside in targeted counties; and may be reached by telephone.

Keywords: behavioral intervention
consequences of hypoglycaemia on cardiovascular and inflammatory responses

Conditions: Hypoglycemia; Inflammatory Response; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: people with type 1 diabetes (t1dm), type 2 diabetes (t2dm) and healthy volunteers will undergo a hypoglycaemic clamp to to investigate the effect of hypoglycaemia on cardiovascular and inflammatory responses.

objectives: the overall aim of the present study is to investigate the effect of hypoglycaemia on cardiovascular and inflammatory responses, molecular mechanisms and epigenetic profiles in various groups of people with diabetes type 1, type 2 and healthy volunteers. study design: intervention study intervention: all subjects will undergo a hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp (nadir 2.8 mmol/l), during and after which blood and urine will be sampled for further examination for up to one week.

Eligibility criteria:
inclusion criteria: overall inclusion criteria * ability to provide written informed consent * must be able to speak and read danish (for hillerød-site) and dutch (for nijmegen-site) * insulin treatment according to basal-bolus insulin regimen (injections or insulin pump) (except for group 5) * body-mass index: 19-40 kg/m2 * age ≥18 years, ≤ 80 years * blood pressure: \<140/90 mmhg * duration of diabetes \> 1 year (except for group 5) * hba1c \< 100 mmol/mol group specific * group 1: hba1c \>64 mmol/mol * group 2: impaired awareness of hypoglycaemia (iah) as assessed by a score of ≥3 on the modified clarke questionnaire, ≥4 on the gold questionnaire and a positive score on the pedersen-bjergaard questionnaire. * group 3: normal awareness of hypoglycaemia (nah) as assessed by a score of \<3 on the modified clarke questionnaire, \<4 on the gold questionnaire and a negative score on the pedersen-bjergaard. * group 4: insulin treatment for at least 1 year * group 5/6: hba1c \<42 mmol/mol exclusion criteria: * - severe medical or psychological conditions interfering with the perception of hypoglycaemia other than iah such as brain injuries, epilepsy, a major cardiovascular disease event or anxiety disorders * use of immune-modifying drugs or antibiotics * treatment with glucose-modifying (other than insulin, sglt-2 inhibitors and metformin) agents (e.g. prednisolon) * use of anti-depressive drugs * pregnancy or breastfeeding or unwillingness to undertake measures for birth control * use of statins (e.g. stop statins \>2 weeks before performing blood sampling. this can be safely done in the context of primary prevention) * any event of cardiovascular disease in the past 5 years (e.g. myocardial infarction, stroke, heart failure, symptomatic peripheral arterial disease) * auto-inflammatory or auto-immune diseases * any infection in past three months * previous vaccination in the past three months * laser coagulation for proliferative retinopathy in the past six months * proliferative retinopathy * diabetic nephropathy as reflected by an albumin-creatinine ratio ˃ 30 mg/gor an estimated glomerular filtration rate (by mdrd) ˂60ml/min/1.73m2 * history of pancreatitis (acute or chronic) or pancreatic cancer
study of combination of cetuximab and radiotherapy added to the standard treatment for oesophageal adenocarcinoma

Conditions: Resectable Esophageal Cancer

Summary: the purpose of this study is to determine whether the addition of the combination between cetuximab and radiotherapy to the standard chemotherapy for resectable oesophageal cancer is safe and adds efficacy.

this study aims at developing a novel strategy to optimize the treatment of oesophageal adenocarcinoma and gastro-oesophageal junctional tumors with curative intent. surgery in combination with peri-operative chemotherapy, using the combination epirubicin, cisplatin and 5-fu, as defined by the recent magic trial, results in 13% increase in 5-yr survival. to improve the outcome of patients with this disease we hypothesize that the addition of pre-operative combined cetuximab-radiotherapy (cetux-rt) treatment could improve the outcome of this patient category through better local control.

Eligibility criteria:
inclusion criteria: * histologically proven resectable adenocarcinoma of the lower oesophagus and gastric-oesophageal junction * tumour stage: t2-3 n0-1 m0, as assessed by endoscopic ultrasound and ct-scan of thorax and abdomen and ultrasound neck region. for the patients treated in this study the gastro-oesophageal junctional tumors will be staged as oesophageal tumors with respect to their lymphnode metastases. * age \>18y and written informed consent after at least 4 days of deliberation time from the moment the patient information has been given and has been explained. * weight loss \< 10% in 0.5 yr * who performance status 0-1 * no prior radiotherapy or chemotherapy for the adenocarcinoma of the oesophagus exclusion criteria: * previous malignancy other than basal cell carcinoma of the skin or local resection for cervical carcinoma in situ. * inadequate organ function as defined by: * inadequate haematology (hb \< 5,5 mmol/l (red blood cell transfusions are allowed to increase the hb at the discretion of the investigator) - neutrophils \< 1,5 109/l -platelets \<100\*109/l), * liver enzyme elevation (bili \> 1,5\*uln - asat \> 2,5\*uln - alat \> 2,5\*uln) or * impaired renal function (creatinine clearance by cockcroft \< 60 cc/min) * proteinuria \>1,0gr/24hr * tumour stage: m1a and/or tumour length \> 8 cm and/or \> 5 cm radially * major surgery within 4 weeks prior to the start of study treatment * bleeding disorder * known allergy to one of the study drugs used * use of any substance known to interfere with the chemotherapy clearance * previous radiotherapy to the chest * significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments * uncontrolled angina pectoris; cardiac failure or clinically significant arrhythmias * continuous use of immunosuppressive agents * concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine * prior exposure to anti-egfr targeting agents. * hearing loss \> 25 db under normal * neurotoxicity \> ctc grade 1 * pregnancy or breast feeding * patients (m/f) with reproductive potential not implementing adequate contraceptive measures
effect of occlusal reduction on post-operative pain

Conditions: Evaluate Occlusal Reduction on Post-operative Pain; Teeth With Symptomatic Irreversible Pulpitis; Apical Periodontitis

Summary: effect of occlusal reduction on post-operative pain is evaluated after single visit root canal treatment in upper and lower molar teeth in patients with sypmtomatic irreversible pulpitis and apical periondontis


Eligibility criteria:
inclusion criteria: 1. patient's age between 20-50 years with no sex predilection. 2. medically free patients. 3. patients suffering from symptomatic irreversible pulpitis with symptomatic apical periodontitis in maxillary and mandibular molars with: * preoperative pain. * vital pulp. * sensitivity to percussion. * occlusal contact with the opposing teeth. * normal periapical radiographic appearance or slight widening in the periodontal membrane space. exclusion criteria: 1. pregnant females. 2. patients having a significant systemic disorder. 3. patients who had administered analgesics or antibiotics during the last 12 hours preoperatively. 4. patients having bruxism or clenching. 5. teeth having : * no occlusal contact. * no sensitivity to percussion. * association with swelling or fistulous tract. * acute or chronic peri-apical abscess. * greater than grade i mobility. * pocket depth greater than 5mm. * no possible restorability. * previous endodontic treatment
effect of goal directed ammonia lowering therapy in acute on chronic liver failure patients with hepatic encephalopathy.

Conditions: Acute-On-Chronic Liver Failure

Summary: in this study, all patients with aclf (acute on chronic liver failure) with grade iii/iv he (hepatic encephalopathy) getting admitted in our institute will be enrolled after the fulfilment of inclusion/exclusion criteria and consent of the patient's attendants. investigation of the patient (as mentioned in the proforma) will be done. intervention step 1: liq lactulose 100 ml stat followed by 30 ml/ hourly through ng/nj route + lactulose enema 3rd hourly - till 4 time soft stool is passed, then 30 ml through enteral route 6th hourly (if patient has no bowel sounds, only enema will be given) intervention step 2: (after 24 hours of introduction of step 1, if no rapid reduction in ammonia to \<70mcg/dl) randomization to l or r arm r arm (addition of rifaximin) continuation of lactulose + addition of rifaximin 400 mg 8th hourly through enteral route l arm (lactulose only) continuation of lactulose therapy for further 48 hours.


Eligibility criteria:
inclusion criteria: 1. age 18 years and above 2. patients with aclf with grade iii/iv he exclusion criteria: 1. patients with prior decompensation 2. grade i,ii he 3. chronic he 4. cv stroke 5. patients with ammonia level \<70 mcg/dl 6. patients with septic shock 7. pregnant lady
validation of the quark rmr calorimeter (cosmed) versus deltatrac ii (ge health care clinical systems)

Conditions: Healthy; Obesity

Summary: measurement of energy expenditure at rest (12 hours fasting) and in dynamic phase after a meal (600kcal) to compare the results of the two calorimeters in standardized conditions for the validation of quark rmr versus deltatrac ii

clinically, energy expenditure is usually estimated using predictive equations, such as the harris-benedict equation, which consider the patient's weight, height, age and sex to determine energy needs. however these have been shown to be unsystematically incorrect and may vary by 70-140% when compared with indirect and direct calorimetry measurements. that is why the most popular method of measurement of energy expenditure in research is via indirect calorimetry using a metabolic cart. indirect calorimetry is the measurement of the volume of oxygen consumption and carbon dioxide production. actually, there are few numbers of indirect calorimeters available commercialy. the deltatrac ii metabolic cart was the gold standard. it has been extensively used in clinical research both for resting metabolic rate and substrate oxidation measurement during postprandial or an insulin clamp. the quark rmr is also a metabolic cart too which was launched on the market to compete with the others calorimeters measuring resting metabolic rate. as the quark rmr and deltatrac ii use the same measure device (paramagnetic analyser for oxygen detection, infrared absorption for carbon dioxide detection) with the same sensitivity and time response according to constructor's data, we want to compare these two calorimeters for the measurement of energy expenditure and substrate oxidation at rest and during a meal in standardized conditions.

Eligibility criteria:
inclusion criteria: * 18 to 60 years old * bmi between 20 and 35 kg/m² * weight stable for at least 2 months * safety subject during medical consultation * normal tsh -crp -glycemia - creatinin exclusion criteria: * medical or surgical history which may affect energy expenditure (renal -cardiovascular -hepatic- endocrine-inflamatory diseases) * drug use that could affect energy expenditure (steroids, nicotine substitutes, thyroid hormones) * eating disorder * intensive sportive activity (baecke's score \>5) * subjects who smoke * claustrophobic subjects * pregnant women

Keywords: indirect calorimeter validation energy expenditure healthy volunteers
safety/efficacy study of immunoconjugate with docetaxel in non-small cell lung carcinoma

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this randomized phase ii clinical trial evaluates the combination of a monoclonal antibody-based drug (sgn-15) with a chemotherapeutic agent compared to chemotherapy given alone in patients with non-small cell lung cancer that has failed at least one prior systemic therapy. the objective of the study is to determine the safety and clinical benefit, as measured by tumor response and quality of life, to the combination regimen. monoclonal antibody therapy has been used in other types of cancer to target therapy to the tumor, thereby allowing for the chemotherapeutic agent to have a lesser effect on normal, healthy tissue.


Eligibility criteria:
inclusion criteria: patients with pathologically confirmed nsclc which is metastatic or recurrent (non-resectable), who have failed at least one but no more than two prior therapies for advanced stage disease or have a recurrence within 6 months of completing adjuvant chemotherapy. lewis-y antigen expression documented by immunohistochemistry for all patients. patients must have: * bidimensionally or unidimensionally measurable disease on the basis of physical exam or imaging studies, or * evaluable disease: bone metastases defined on bone scan or malignant pleural effusion performance status ≤ 2 (ecog scale) with a life expectancy of at least 3 months patients must be at least four weeks from prior treatment (chemotherapy, hormonal therapy, or definitive radiotherapy) exclusion criteria: prior therapy with taxotere (docetaxel) cumulative anthracycline exposure \> 300 mg/m2. more than one primary malignancy with the exception of: * non-melanoma skin cancer * in situ carcinoma of the cervix * localized prostate cancer * completely resected stage i or ii disease with no evidence of recurrent cancer from which the patient has remained disease free for more than 3 years. uncontrolled significant non-malignant disease (e.g. congestive heart failure, bleeding, renal failure, hepatic failure). uncontrolled, symptomatic brain metastasis. peripheral neuropathy \> grade 2. concomitant therapy with other anti-neoplastic agents or experimental agents except for small volume radiation to a solitary bony metastasis. active viral, bacterial or systemic fungal infections including known hiv or hepatitis b or c. women who are pregnant or breastfeeding any serious underlying medical condition, which would impair the ability of the patient to receive the planned treatment including prior allergic reactions to recombinant human or murine proteins. dementia or altered mental status that would prohibit the understanding and rendering of informed consent. patients with uncontrolled peptic ulcer disease will be excluded.

Keywords: carcinoma, non-small-cell lung