Kornimate/medical-research-clean huggingface dataset:
hiv liver regeneration project for hiv patients with cirrhosis by autologous bone marrow transplantation

Conditions: HIV Infection; AIDS; Cirrhosis

Summary: an international investigation to evaluate if, and if so how long, autologous bone marrow hematopoietic stem cell transplantation can safely restore liver functions for hiv infected patients who have decompensated liver cirrhosis.

an international investigation to evaluate if, and if so how long, autologous bone marrow (abm) hematopoietic stem cell transplantation (hsct) can safely restore liver functions for hiv infected patients who have decompensated liver cirrhosis.

Eligibility criteria:
inclusion criteria: outpatients or inpatients that are treated for hiv infection at aids clinical center of national center for global health and medicine who meet all criteria following: * have cirrhosis with 7 or higher child-pugh score in child-pugh score b * able to consent and willing to participate in the study * under good control for hiv infection exclusion criteria: cases applicable to any condition of the following: * hepatocellular carcinoma (hcc), except for cases having been completely treated without history of recurrence * malignant tumors other than hcc * alcoholic liver disease (ald) * hemoglobin under 8g/dl or platelets under 20/ml at the registration * esophageal or gastric varices with a risk of bursting, except for cases with only cured history of such conditions * cases that cannot obtain the informed consent to autologous blood transfusion * pregnancy * renal dysfunction with 2mg/dl or higher serum creatinine * performance status 3 or 4 (assessment excludes hemophilic arthritis related daily life limitations) * cases not fit for general anesthesia * other conditions considered not suitable for the study by doctors
evaluation of pancreatic steatosis in patients with cancer of pancreas

Conditions: Cancer of Pancreas

Summary: prognostic importance of quantitative magnetic resonance imaging for evaluation of pancreatic steatosis in patients with pancreatic cancer

1. finding patients with pancreatic cancer (in all stages), before any treatment. 2. non invasively quantify fatty infiltration of pancreas using, mri dixon scan in pancreatic cancer patient relatively to liver. 3. measuring cell-free blood dna in those patients for evaluating the aggressiveness of the disease. 4. quantify the prognostic significance of pancreatic steatosis in comparison with clinical and pathological prognostic indexes used today.

Eligibility criteria:
inclusion criteria: * patients diagnosed with any pancreatic cancer, in any stage, before treatment. * \>18 y.o exclusion criteria: * claustrophobia * gfr\<30 * patients with non mri compatible devices (e.g. orthopaedic external fixation system) * after chemotherapy treatment or surgical procedure

Keywords: cancer of pancreas steatosis mri
voriconazole or placebo in the prophylaxis of lung infiltrates in patients undergoing induction chemotherapy for acute myelogenous leukemia

Conditions: Leukemia, Myelocytic, Acute

Summary: the purpose of the study is to determine whether voriconazole is as effective as antifungal prophylaxis in patients undergoing chemotherapy for acute myelogenous leukemia (aml). hypothesis: voriconazole is superior to placebo in the prophylaxis of lung infiltrates until day 21 after the start of induction chemotherapy.


Eligibility criteria:
inclusion criteria: 1. newly diagnosed or relapsed, de novo or secondary aml 2. first induction chemotherapy cycle 3. expected neutropenic phase of a minimum duration of 10 days 4. age \>= 18 years 5. legally signed consent form exclusion criteria: 1. known proven, probable or possible invasive fungal infection at randomization or in patient history 2. computed tomography (ct) with any signs of a fungal infection according to the european organisation for the research and treatment of cancer (eortc)/mycosis study group (msg) criteria, i.e. with any infiltrate (ascioglu, et al 2002) 3. any current fever unless explained by non-infectious causes 4. antibacterial prophylaxis other than tmp/smx 5. liver function test \[lft\] (ast/alt/bilirubin) more than 3x the upper normal limit 6. subjects who are receiving and cannot discontinue one of the following drugs at least 24 hours prior to randomization: * drugs with a known possibility of qtc prolongation (e.g. terfenadine, astemizole, cisapride, pimozide, quinidine); * drugs whose plasma levels may be increased by voriconazole therapy (e.g. sulfonylureas, ergot alkaloids, sirolimus, vinca alkaloids). 7. subjects who have received the following drugs within 14 days prior to randomization: potent inducers of hepatic enzymes that will reduce voriconazole levels (e.g. rifampicin, carbamazepine and barbiturates) 8. concomitant therapy with absorbable antifungals 9. patient has a diagnosis of acute hepatitis or cirrhosis due to any cause 10. known hypersensitivity or other contraindication to voriconazole 11. patient is unwilling or unable to comply with the protocol. 12. diseases or disabilities preventing the patient from participating in the trial 13. females of childbearing potential without negative serum pregnancy test at baseline or within 72 hours prior to start of study drug
rosuvastatin versus pravastatin in hiv patients treated with boosted protease inhibitors (pi) (anrs126)

Conditions: Hyperlipidemia; HIV Infections

Summary: in hiv hypercholesterolemic patients treated with protease inhibitors, some drugs of the statin group are used to control cholesterol level. new and potentially more efficient statins may interfere with protease inhibitors and hence loose a part of their activity. they have thus to be compared with a more established drug of the same class (e.g. pravastatin). the protocol compares the efficacy and safety of rosuvastatin and pravastatin.

the study compares the efficacy and safety of rosuvastatin and pravastatin among dyslipidemic hiv-seropositive patients treated with antiretroviral agents including a boosted protease inhibitor. it is an open, multicenter, randomised trial, with two parallel groups comparing rosuvastatin with pravastatin. statins are administered from d0, with a single daily dose in the morning, for 45 consecutive days. the duration of the study for each patient will be 45 days not including the preselection period (maximum 15 days). the primary end-point compares the change in ldl cholesterol between d0 and d45, in patients receiving rosuvastatin (10 mg/day) or pravastatin (40 mg/day) and treated by antiretroviral agents including a boosted protease inhibitor. secondary end-points compares changes in triglycerides and hdl cholesterol; percentage of patients with a normal value of ldl cholesterol, hdl cholesterol and triglycerides on d45; clinical safety and laboratory safety parameters of rosuvastatin and pravastatin; distribution profile of the diameter of ldl cholesterol particles. cmin of rosuvastatin, pravastatin and protease inhibitors (pi) are controlled at d15 for statins and pi.

Eligibility criteria:
inclusion criteria: * fasting ldl cholesterol over 4.1 mmol/l (1.6 g/l) * blood triglycerides over 8.8 mmol/l (8 g/l) * hiv-1 infection * viral load above or equal to 10.000 copies/ml * stable antiretroviral regimen for past two months exclusion criteria: * coronary disease * genetic muscular disease * cpk over 5n * hepatic or renal insufficiency * alcohol intake more than 40g/d * hypothyroidism * pregnancy and breast feeding

Keywords: hyperlipidemia hiv infections statins, hmg-coa protease inhibitor treatment experienced
ams insight 1 study - bioabsorbable metal stent investigation in chronic limb ischemia treatment

Conditions: Peripheral Artery Disease

Summary: prospective, multicenter, randomized clinical trial, follow-up at 1-, 6- and 12 months this clinical investigation is first of all designed to demonstrate the safety and effectiveness of the magic explorer stent system. the primary objectives of the study are to evaluate the safety and 6-month patency of the bioabsorbable magic explorer stent in patients with stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries. secondary endpoints are the procedural success, patency at all follow-ups, late lumen loss and limb-salvage rate. peri-procedural complications (within 24 hours) will be evaluated. furthermore, data of the balloon catheter pleon explorer will be collected to demonstrate its effectiveness and safety.


Eligibility criteria:
inclusion criteria: * stenotic (\> 50%) or occlusive atherosclerotic disease of the infrapopliteal arteries * length of lesion \< 20mm (less than one stent length) * reference vessel diameter should be 3.0-3.5 mm * a maximum of two lesions in one infrapopliteal vessel treated within the study, or in two vessels of two different legs. (pta treatment of other infrapopliteal lesions in non-study vessels is allowed outside the study). * symptomatic critical limb ischemia (rutherford 4, 5) * the patient must be ≥ 50 years. * life-expectancy of more than 6 months * the subject or legal guardian has been informed of the nature of the study; agrees to its provisions and has signed informed consent * the patient must be available for the appropriate follow-up times for the duration of the study * the patient is capable to follow all study requirements. exclusion criteria: * patient refusing treatment * the reference segment diameter is not suitable for available stent design * length of lesion requires more than one stent implantation * previously implanted stent(s) or pta at the same lesion site * lesion lies within or adjacent to an aneurysm * inflow-limiting arterial lesions left untreated * the patient has a known allergy to heparin, aspirin or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies. * the patient takes phenprocoumon (marcumar). * the patient has a history of prior life-threatening contrast media reaction. * the patient is currently enrolled in another investigational device or drug trial. * the patient is currently breast-feeding, pregnant or intends to become pregnant. * the patient is mentally ill or retarded. * the patient is liable for military or civilian service.

Keywords: tibial arteries absorbable implants stents limb salvage
planned semi-elective lung transplantation using 10c cold static preservation

Conditions: Pulmonary Disease

Summary: this is a prospective, single-arm study to demonstrate the proof-of-concept of semi-elective lung transplantation. we plan to evaluate 15 patients that receive lung(s) delayed for transplantation under our study criteria.


Eligibility criteria:
inclusion criteria: * recipient is ≥ 18 years old * recipient, or their legally authorized representative is able and willing to sign informed consent * recipient meets standard listing criteria for lung transplantation exclusion criteria: * donor lungs meet criteria for transplantation with ex vivo lung perfusion (evlp) * recipient is \< 18 years old * recipient, or their legally authorized representative is unable to sign informed consent for re-transplantation * recipient has any condition that, in the opinion of the investigator, would make study participation unsafe or would interfere with the objectives of the study
virtual reality relaxation to decrease dental anxiety

Conditions: Dental Anxiety

Summary: the aim is to apply short-term virtual reality relaxation to examine if it is effective in reducing pre-operative dental anxiety in primary health care using an rct.

randomized controlled single-center trial with two parallel arms: virtual reality relaxation (vrr) and treatment as usual (tau) in a public oral health care unit. vrr group receiving a 1-3.5 minute 360° video immersing them in peaceful virtual landscape with audio features and sound supporting the relaxing experience. tau groups remaining seated for 3 minutes in similar setting.

Eligibility criteria:
inclusion criteria: * attending for dental treatment * consenting * able to complete finnish questionnaire without assistance * age 18 years or older exclusion criteria: * those not meeting inclusion criteria

Keywords: dental anxiety virtual reality
chidamide combined with vddt regimen in the relapse and refractory diffuse large b cell lymphoma

Conditions: Diffuse Large B-cell Lymphoma

Summary: this is a prospective phase ii clinical trial to observe the efficacy and safety of chidamide combined with vddt(vinorelbine，liposomal doxorubicin，dexamethasone and thalidomide) in relapsed and refractory patients with diffuse large b-cell lymphoma(dlbcl).

there are one third of diffuse large b-cell lymphoma patients suffering relapse and refractory, which are the major cause of death among these patients. vinorelbine，liposomal doxorubicin，mitoxantrone, dexamethasone and thalidomide have been used in the therapy of patients who failed with second-line treatments in our center. this regimen is well tolerated but the effect needs to be improved. chidamide，a histone deacetylase inhibitor has been approved for the treatment of refractory t-cell lymphoma in china. the goal is to assess the efficacy and safety of chidamide combined with vddt（vinorelbine，liposomal doxorubicin，dexamethasone and thalidomide） in relapse and refractory patients with diffuse large b-cell lymphoma.

Eligibility criteria:
inclusion criteria: 1. diagnosed as diffuse large b-cell lymphoma based on the 2008 who classification of tumors of haematopoietic and lymphoid tissues 2. failed with second-line therapy 3. having at least one measurable lesions 4. age between 18 to 75 years old 5. world health organization-eastern cooperative oncology group performance status (ecog) 0-1 6. neutrophils more than 1.5\*10\^9/l; platelets more than 90\*10\^9/l hemoglobin: more than 90g/l. 7. life expectancy no less than 3 months 8. no receiving chemotherapy in 4 weeks before enrollment 9. agreeing to sign the written informed consents exclusion criteria: 1. pregnant ，lactating and patients at reproductive age who refuse to practice contraception 2. qtc prolonging \>450ms，ventricular tachycardia，atrial fibrillation，cardiac conduction block， myocardial infarction in less than 1 year， congestive heart failure，coronary heart disease which needs medication. 3. organ transplant recipients 4. active bleeding 5. thrombus，embolism，cerebral hemorrhage，cerebral infarction 6. important organ operation in less than 6 weeks 7. abnormal liver function（note：total bilirubin \>1.5 times the upper limit of normal，ast or alt \>2.5 times the upper limit of normal （note：5 times the upper limit of normal for patients with liver involvement）），abnormal renal function（note：serum creatinine \>1.5 times the upper limit of normal），fluid and electrolyte disorders 8. mental illness or unable to sign the informed consent 9. drug addiction history or alcoholism which may interfere the experimental results. 10. researchers determine unsuited to participate in this trial 11. known allergy to any kind of study drugs

Keywords: diffuse large b-cell lymphoma relapsed and refractory histone deacetylase inhibitor chidamide
effect of prosthetic rehabilitation on nutritional status of geriatric patients

Conditions: Nutrition Disorders; Edentulous Jaw

Summary: this study examines the effects of prosthetic treatment options applied to edentulous geriatric individuals who applied to marmara university faculty of dentistry on chewing function, food consumption status, malnutrition status and oral health-related quality of life.


Eligibility criteria:
inclusion criteria: * ≥ 50 years old, * those who volunteer to participate in the study, * those who have adequate bone height and thickness in the intraforaminal region * those who have upper and lower fully edentulous jaws exclusion criteria: * those who have systemic diseases that may cause systemic neuropathy, such as diabetes, hypertension, kidney disease, * those who do not want to sign the consent form, * clinical or radiographic pathological condition in the intraforaminal region * patients with a history of malignancy, radiotherapy or chemotherapy will be excluded from the study.

Keywords: aged nutrition physiology dental implants overdenture
efficacy of fixed-doses of antihypertensive and statin drugs

Conditions: Hypertension; Dyslipidemia

Summary: the purpose of this study is to evaluate the efficacy of different fixed-dose combination of viena ii in treatment of hypertension and dyslipidemia.

* fase ii, national, multicenter, randomized, double-blind. * maximal duration: 8 weeks; * 04 visits; * safety and efficacy evaluation.

Eligibility criteria:
inclusion criteria: * participants of both sexes aged between 18 and 65 years; * participants diagnosed with uncontrolled hypertension (stage 1), according vii brazilian guideline of hypertension; * participants diagnosed with dyslipidemia, according to the v brazilian guidelines on dyslipidemia and prevention of atherosclerosis; * signed consent. exclusion criteria: * participants with a previous diagnosis of familial hypercholesterolemia (homozygous); * concomitant use of angiotensin ii receptor blocker (arb) or inhibitor of angiotensin converting enzyme (ace); * participants with total cholesterol (tc) above 500 mg / dl or triglyceride (tg) above 500 mg / dl; * participants with hypertension (stage 2 or 3) according vii brazilian guideline of hypertension; * history of congestive heart failure (chf) functional class iii or iv (nyha);; * any clinical, laboratory and electrocardiographic that, in the judgment of the investigator, may interfere with the safety of research participants; * creatine phosphokinase (cpk) levels above the established laboratory normal range; * transaminases (alt and asl) serum above 2 times the established laboratory normal range; * body mass index (bmi) ≥35 kg / m²; * immunocompromised participants (eg.: malignancies, patients with acquired immunodeficiency syndrome etc); * chronic use of drugs that may interact with the drugs of the study; * history hypersensitivity to the active ingredients used in the study; * pregnancy or risk of pregnancy and lactating patients; * history of alcohol abuse or illicit drug use; * participation in clinical trial in the year prior to this study.
dispersal pattern for spine injections (gadolinium contrast)

Conditions: Cervical Radiculopathy

Summary: this study will analyze injectate dispersal patterns after standard-of-care cervical epidural steroid injections using gadolinium as a marker and magnetic resonance imaging (mri) to characterize the pattern. although these procedures are performed with high frequency under the assumption that injectate remains localized to injection site, no peer-reviewed studies have validated this assumption. comprehensive characterization of injectate dispersal patterns will provide important data regarding safety, as well as diagnostic and therapeutic potential of cervical epidural steroid injections.

epidural steroid injections have long had an impact in the treatment of various spine-related conditions, particularly radiculopathy. the efficacy of epidural spinal injections has been attributed to the anatomic location reached by the injectate. cervical epidural steroid injections are also used as an injury location indicator. this application is based on documenting pain relief after injection into a specific location in the cervical spine. both the diagnostic and therapeutic applications for epidurals assume that the injectate remains local to the injection site in order to have its effects. however, in a recently completed study, the investigators group documented substantial diffusion of injectate after lumbar epidurals used computerized tomography (ct) assessments.1 based on the exposure to ionizing radiation associated with ct along with the superior imaging specificity and sensitivity of mri, the investigators are shifting their imaging modality to mri for future studies. the proposed study is designed to evaluate the use of gadolinium and mri to assess nature and amount of diffusion of injectate in the cervical region after standard-of-care epidural injections. to the investigators knowledge, this will be the first study to critically assess this common procedure in order to evaluate safety and efficacy in a clinical setting.

Eligibility criteria:
inclusion criteria: * age 18-85 * cervical radiculopathy patient as identified by principle investigator exclusion criteria: * patients unable to give consent or comply with rehabilitation process * pregnant * co-morbidities such as infection, malignancy, myelopathy or an uncontrolled medical condition * allergy to injectate * anticoagulative state * severe claustrophobia * non-mri compatible pacemaker, neurostimulator, bladder stimulator or other mechanical device * renal disease that would cause the patient to be at an increased risk of complication of receiving the contrast agent

Keywords: cervical radiculopathy
g-pen™ for hypoglycemia rescue in t1d patients

Conditions: Hypoglycemia

Summary: this is an open-label, exploratory pilot study in patients with t1d. the study will involve two daytime clinical research center visits 7-14 days apart. subjects will receive a single injection of g-pen™ (glucagon injection) at each visit.

following eligibility confirmation, each study participant will undergo two episodes of insulin-induced hypoglycemia with plasma glucose \< 50 mg/dl. both episodes will be treated with a single subcutaneous injection of g-pen™ glucagon. for the first treatment visit, all subjects will receive a 1 mg dose of g-pen™ glucagon. the investigator will have discretion to repeat this same dose at the second treatment visit or give a 0.5 mg dose of g-pen™ glucagon. a follow-up phone call will be conducted 3-7 days following administration of the final dose of study drug as a safety check.

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus for at least 24 months exclusion criteria: * pregnant or lactating * hba1c \>10.5% at screening * use of \> 2.0 u/kg total insulin dose per day * inadequate bilateral venous access in both arms * renal insufficiency * congestive heart failure, nyha class ii, iii or iv * active malignancy within 5 years from screening * major surgical operation within 30 days prior to screening * seizure or bleeding disorder * glycogen storage disease * active substance or alchohol abuse