Kornimate/medical-research-clean huggingface dataset:
liver fibrosis in zambian hiv-hbv co-infected patients

Conditions: Human Immunodeficiency Virus; HBV; Fibrosis, Liver; Cirrhosis, Liver; Hepatocellular Carcinoma; Hepatitis Delta Virus; Alcoholic Hepatitis

Summary: a cohort of adults with hiv-hbv co-infection will be created in lusaka, zambia, to describe the short and long-term (up to 10 years of follow-up) hbv and liver outcomes, including the effectiveness of current therapies, and to identify the risk factors for major endpoints of interest, including hcc and hbv functional cure. this cohort will also create a pool of potential participants for in-depth mechanistic studies and clinical trials of novel hbv cure drugs.

among people with hiv in africa, liver disease is a neglected area of investigation but is anticipated to become increasingly common as patients live longer due to antiretroviral therapy. in lusaka, zambia, we previously (nct02060162, clinicaltrials.gov) described that hiv-hbv co-infection was the most important liver risk factor. however, in that study, only very short-term outcomes could be assessed. building on these preliminary results and addressing the need to study hiv-hbv during a longer duration of follow-up, the current protocol will focus exclusively on people with hiv-hbv in zambia. zambia is an ideal site for this research as it has \~12% hiv prevalence and 6% hbsag-positivity among adults nationwide. in fact, \~70% of people with hiv-hbv globally reside in africa. in the proposed study, we will obtain consent from people with hiv-hbv to participate in an observational cohort study with up to 10 years of follow-up. standard of care antiviral therapies will be received by participants. more in-depth analysis of liver and hbv viral and serological outcomes will occur. screening for liver cancer will also occur. this study will provide useful clinical and epidemiological information to health policymakers in zambia and beyond. it will also provide a platform for the training of health workers in zambia in hbv clinical management.

Eligibility criteria:
inclusion criteria: * age 18 years or older * living with hiv infection * living with active hbv infection, defined as any single positive hbsag assay * naïve to antiretroviral therapy or currently participating in hiv/hbv co-infection in iedea-sa exclusion criteria: * unable or unwilling to provide informed consent * planning to relocate out of lusaka district
a multi-center trial to evaluate the safety and efficacy of pegaptanib sodium(macugen) injected into the eye every 6 weeks for up to 2 years for macular swelling associated with diabetes, with an open-label macugen year extension.

Conditions: Macular Edema Associated With Diabetes Mellitus

Summary: the purpose of the study is to test whether macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. the safety of macugen compared to standard of care laser will also be evaluated.


Eligibility criteria:
inclusion criteria: * macular edema associated with diabetes * visual acuity between 20/50 and 20/200 exclusion criteria: * recent laser therapy in the eye * recent signs of uncontrolled diabetes * blood pressure worse than 160/100 * severe cardiac disease

Keywords: randomized sham-controlled multicenter macular edema
a study of mircera for the maintenance treatment of participants with chronic renal anemia

Conditions: Chronic Renal Anemia

Summary: this single-arm study will assess the efficacy and safety of intravenous (iv) mircera when administered for the maintenance of hemoglobin (hb) levels in participants with chronic renal anemia. individuals currently receiving maintenance treatment with epoetin alfa or darbepoetin alfa will receive monthly injections of mircera, with the starting dose (120, 200, or 360 micrograms \[mcg\] iv injection) derived from the dose of epoetin alfa or darbepoetin alfa they were receiving in the week preceding study start.


Eligibility criteria:
inclusion criteria: * adults greater than or equal to (≥) 18 years of age * chronic renal anemia * stable epoetin alfa or darbepoetin alfa therapy for past 2 months * hemodialysis therapy for ≥3 months exclusion criteria: * transfusion of red blood cells during previous 2 months * poorly controlled hypertension requiring hospitalization or interruption of esa treatment in previous 6 months * acute or chronic bleeding
elsamitrucin (spp 28090) in patients with relapsed or refractory non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: the purpose of this study is to evaluate the safety of an experimental drug called elsamitrucin in people with non-hodgkin's lymphoma and to see if it can shrink their tumors. elsamitrucin has not been approved by the food and drug administration (fda). however, the fda is permitting the use of this drug for this study.


Eligibility criteria:
inclusion criteria: * histologically confirmed nhl both b and t-cell that is refractory to or has relapsed after standard therapy or for which there is no known effective treatment. * ct or mri scans confirming measurable tumor size (lymph node must be \>1.0 cm in its longest transverse diameter). measurement by pe is acceptable, in the case of palpable and reproducibly measurable tumors. patients with cll/smal lymphocytic lymphoma are eligible without bidimensional measurable disease. * ecog performance status 0-2 * age greater or equal to 18 years of old * agc greater or equal to 1.0; platelets greater or equal to 75,000;ggb greater or equal to 9.0. (lower values may be accepted for cytopenias due to bone marrow involvement by lymphoma, after discussion with sponsor) * bilirubin less or equal to 2.0; sgot and sgpt less of equal to 3 times upper limit of normal * creatinine \<1.5; bun \<25 * expected survival \>6 months exclusion criteria: * prior therapy with elsamitrucin * any therapy for lymphoma, including chemotherapy, antibody therapy, rt, or any investigational therapy within 28 days prior to study drug administration * steroid therapy within the last 4 weeks prior to study drug administration * evidence of clinically significant uncontrolled condition/s and/or is considered by investigator to be unable to tolerate the required therapy or procedures * known aids syndrome or hiv-associated complex (severely depressed immune system) * prior or other current malignancy within 5 years, except for adequately treated cone-biopsied in-situ cervical cancer or resected basal cell or squamous cell skin cancer * any current medical or psychiatric disease that would prevent informed consent and expected cooperation of the patient for therapy and follow-up * pregnant or lactating women.
non-invasive phrenic nerve stimulation in ards patient

Conditions: ARDS, Human; Ventilator-Induced Lung Injury; Diaphragm Injury

Summary: reduced diaphragmatic activity during mechanical ventilation can lead to diaphragmatic disuse atrophy, atelectasis, increased lung stress and strain, and hemodynamic impairment. this, in turn, may prolong the duration of mechanical ventilation, make weaning more difficult, and even increase mortality. synchronizing phrenic nerve stimulation to promote diaphragmatic activity may prevent ventilator-induced lung injury and ventilator-induced diaphragm dysfunction, thereby improving patient outcomes. surgically implanted phrenic nerve stimulation has been used in certain neurological disorders, but the effects of percutaneous non-invasive synchronized phrenic nerve stimulation in patients with ards undergoing mechanical ventilation remain unclear and require further investigation.

mechanical ventilation is an important treatment for patients with acute hypoxemic respiratory failure (ahrf). however, reduced diaphragmatic activity during mechanical ventilation can lead to diaphragmatic disuse atrophy, atelectasis, increased lung stress and strain, and hemodynamic impairment. this, in turn, may prolong the duration of mechanical ventilation, make weaning more difficult, and even increase mortality in these patients. in patients with ahrf undergoing mechanical ventilation, maintaining moderate spontaneous breathing under lung and diaphragm protective ventilation remains challenging. synchronizing phrenic nerve stimulation to promote diaphragmatic activity may prevent ventilator-induced lung injury (vili) and ventilator-induced diaphragm dysfunction (vidd), thereby improving patient outcomes. surgically implanted phrenic nerve stimulation has been used in certain neurological disorders, but the effects of percutaneous non-invasive synchronized phrenic nerve stimulation in patients with acute respiratory distress syndrome (ards) undergoing mechanical ventilation remain unclear and require further investigation.

Eligibility criteria:
inclusion criteria: 1. adult ards patients undergoing controlled mechanical ventilation 2. the duration of endotracheal intubation \< 48 hrs exclusion criteria: 1. neurological condition affecting motor neuron or muscle (e.g. als) 2. paralysis of the phrenic nerve 3. proven or suspected spinal cord injury 4. conditions that limit diaphragm movement 5. patients with implanted cardiac support systems (pacemaker, implanted defibrillator) 6. patients with implanted medical pumps 7. pregnancy 8. patients with skin lesions, infections or strictures in throat/neck area 9. patients with metallic implants 10. refusal to sign informed consent

Keywords: ards diaphragm injury mechanical ventilation
vaginal cuff anesthesia and post-operative pain medication use

Conditions: Hysterectomy; Post Operative Analgesia

Summary: the purpose of this study is to determine whether an injection of a local anesthetic (bupivacaine with epinephrine) in the vaginal cuff prior to closure would result in less immediate postoperative pain medication and increase patient comfort/satisfaction.


Eligibility criteria:
inclusion criteria: * patients 18 years and older requiring total laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy for benign conditions * presence of malignancy exclusion criteria: * conversion to laparotomy * previous multiple abdominal and/or pelvic surgeries * significant medical comorbidities or cardiac history * poor initial aldrete score4 (\<10) * significant pre-op pain medication use * contraindication to any medication that would be used in the study (bupivacaine, epinephrine, tramadol or oxycodone)
diagnostic accuracy and performance of 18f-psma-1007

Conditions: Prostate Cancer

Summary: whereas 18f-psma-1007 has rapidly established itself as a radiotracer for the investigation of prostate cancer, there are no studies confirming its diagnostic performance. the purpose of this study is to determine the diagnostic performance for this radiotracer.

in this prospective, single-armed diagnostic imaging study men undergoing standard-of-care psma pet/ct using \[18f\]psma-1007 shall be studied. the primary objective is to confirm the positive predictive value (ppv) of this tracer at a patient-based level by recruiting until 53 patients with follow-up to a composite reference standard are available. secondary outcomes shall include patient based rate of pathological-scans stratified by psa, the ppv stratified by region , interrelate agreement, frequency of indeterminate lesions and the safety and tolerability of the examination.

Eligibility criteria:
inclusion criteria: * adult patients referred for investigation of recurrent pc by psma pet/ct. * patients with known biochemical recurrence of a histologically confirmed primary prostate cancer, defined as: post prostatectomy: two consecutive psa \> 0.2 ng/ml post-radiotherapy: a rise of 2ng/ml \> post-therapy nadir (astro consensus definition) * male patients \>18 years old * psa measured ± 4 weeks of the psma-pet/ct * patients willing and able to consent to the informed consent document exclusion criteria: * patients with adt within 6 months prior to the psma-pet/ct * inability to provide informed, written consent * patients undergoing active treatment for a second non-prostatic malignancy

Keywords: psma recurrent prostate cancer diagnostic accuracy 18f-psma-1007 [18f]psma-1007
to identify the proportionality of respiratory work under different nava level

Conditions: Respiratory Failure

Summary: the primary purpose of mechanical ventilation is to sufficiently unload the respiratory muscles and maintain adequate ventilation in spontaneously breathing patients. when the mechanical ventilatory assist is synchronized to the patient's inspiratory effort, both the patient and the mechanical ventilator will contribute to the lung-distending pressure, necessary to overcome inspiratory load and generate the tidal volume (vt). unfortunately, conventional modes of mechanical ventilation cannot quantify the impact of the ventilatory assist performed by the ventilator and the patient. inadequate levels of assist are associated with adverse effects such as development of fatigue or patient-ventilator dissynchrony and diaphragm impairment, and over assist also lead to diaphragm atrophy and weaning delay. the newly introduced neurally adjusted ventilatory assist (nava) has made it possible to measure the neural activity of the respiratory centers (expressed by the diaphragm electrical activity, eadi). eadi is a validated variable to quantify the neural respiratory drive, little is known about its usefulness to evaluate the contribution of the patient's inspiratory muscle effort relative to that of the mechanical ventilator, which would be of crucial importance to appropriately titrate the level of assist. during nava, the patient's efficiency to transform neural effort (eadi) into vt, expressed as neuroventilatory efficiency (nve), may be a useful predictor for determining the contribution of the patient and the ventilator to generate a breath.


Eligibility criteria:
inclusion criteria:(1) intubated or tracheostomied patients with arf due to copd (10 patients) or other reasons (10 patients) who were undergoing assisted mechanical ventilation, (2) be able to tolerate short time (30 minutes) spontaneous breathing (peep≤5cmh2o, without assist), (3) awake and do not need high dose of sedation exclusion criteria:(1) age \ 80 years, (2) ready for extubation, (3) history of esophageal varices, (4) gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 30 days, (5) coagulation disorders (inr ratio\>1.5 and aptt\>44 s), (6) history of acute central or peripheral nervous system disorder or severe neuromuscular disease, (7) history of leukemia, severe chronic liver or chronic cardiac disease, (8) solid organ transplantation, (9) malignant tumor.
symptom management program for hemodialysis patients

Conditions: Haemodialysis-induced Symptom

Summary: self-management intervention may decrease symptom burden and improve functioning over time.

self-management intervention (strategies) may decrease symptom burden (sleep disturbance, tiredness; itching and numbness) and improve functioning (social, physical and emotional) over time(baseline, 3 weeks and 8 weeks).

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old, 2. on hd three times a week, 3. received hd for ≥ six months, 4. read and write english, 5. have telephone service. exclusion criteria: * history of dementia, * acquired immunodeficiency syndrome (aids) and active cancer, and * inability to give informed consent.

Keywords: sleep disturbance tiredness itching & numbness
re-evaluation of tumor samples from women with breast cancer with the in vitro diagnostic kit "mammatypertm"

Conditions: Invasive Breast Cancer

Summary: this is a prospective examination of tumor material of breast cancer patients randomized into the finher-trial (= (= comparison of vinorelbine and docetaxel and trastuzumab as adjuvant treatments of breast cancer patients wirh a high risk of cancer recurrence). the formalin-fixed, paraffin-embedded tissue samples will be analysed for estrogen receptor 1 (esr1), progesterone receptor (pgr), human epidermal growth factor receptor 2 (her2) and antigen ki-67 (ki-67) with the molecular in vitro diagnostic kit mammatyper™. according to the new subtyping the 5 year distant disease free survival (ddfs) and overall survival (os) will be re-evaluated.

despite the fact that reliable measures for the markers esr1, pgr, her2, ki-67 are necessary with the currently used methods up to 20% of determinations are inaccurate and especially ki67- measures are not very reproducible. therefore new evaluation systems or new methods are necessary to improve diagnostic. at least 4 subtypes can be distinguished to date depending on the expression of esr, pgr, her2 and ki-67: * luminal a-type * luminal b-type * her2-type * triple-negative-type mammatyper™ uses a new approach. instead of detection of the marker proteins, the messenger ribonucleic adic (mrna) of marker proteins is quantitated. this prospectively planned diagnostic study will investigate the potential of subgrouping of patients at baseline according to results of mammatyper™ methodology for predicting survival. patients will be subgrouped according to the new marker determination and the ddfs and os will be evaluated and compared to the ddfs and os of subgrouping with former marker determination.

Eligibility criteria:
inclusion criteria: * invasive breast cancer verified in a histological biopsy * age 65 or younger * estrogen receptor (er), pgr and her2 expression have been determined * no distant metastases present (m0) * the patient provides a written informed consent for study participation * the estimated risk of breast cancer recurrence is high (25% or higher within the first 5 years from the date of the diagnosis, over \>35% within the first 10 years from the diagnosis) exclusion criteria: * patients with breast cancer with "a special histological type" (mucinous, papillary, medullary, or tubular type of breast cancer) when no metastases are present in the ipsilateral axillary lymph nodes * the who performance status is moderate/poor, z \>1 * the peripheral blood leukocyte count is less than 3.0 x 109/l, the blood granulocyte count is less than 1.5 x 109/l, or the blood thrombocyte count is less than 120 x 109/l * any physical or mental disorder that is considered to prohibit administration of chemotherapy * cardiac failure; severe cardiac arrythmia requiring regular medication

Keywords: subtyping of invasive breast cancer
dexmedetomidine versus placebo in endoscopic retrograde cholangiopancreatography (ercp) sedation

Conditions: Pancreatitis

Summary: in this pilot prospective non-commercial clinical trial the investigators will study the use of dexmedetomidine as an adjuvant to the patient-controlled propofol sedation in a placebo-controlled and randomized manner in patients with drug addiction during endoscopic retrograde cholangiopancreatography (ercp). dexmedetomidine is a sedative medication used mostly in intensive care units,and is marketed under the brand name precedex. dexmedetomidine has sedative, analgesic, sympatholytic, and anxiolytic properties. it produces sedation without causing significant respiratory depression. recent research has suggested dexmedetomidine to be effective in treatment of alcohol withdrawal signs. in previous studies dexmedetomidine was insufficient as an only sedative agent in ercp and colonoscopy, but it has not been assessed for sedation in patients with chronic pancreatitis. the main objective of this trial is to evaluate if dexmedetomidine can reduce propofol and opioid consumption and facilitate the performance of ercp in patients with chronic pancreatitis due to drug addiction.secondary objectives of the trial are the stability of vital signs and safety, patients´ satisfaction plus recovery time from sedation. 50 elective ercp patients with chronic pancreatitis after written informed consent and randomisation will be recruited to the study. exclusion criteria are:allergy to propofol, opioid or dexmedetomidine, asa class greater than 3. all the patients will receive patient-controlled propofol sedation. in dexmedetomidine group dexmedetomidine infusion will be started before sedation beginning and in placebo group placebo-solution (nacl0,9%) will be administered in the similar manner.standard monitoring for vital signs will be applied,also sedation degrees will be evaluated with sedation scores. at the end of procedure total amount of propofol and opioid will be calculated,patients and endoscopists satisfaction and the difficulty of ercp will be assessed.


Eligibility criteria:
inclusion criteria: * elective ercp-patients with chronic alcohol pancreatitis exclusion criteria: * allergy to the dexmedetomidine, propofol or any opioid, asa(american society of anaesthesiology)class grater when 3

Keywords: ercp dexmedetomidine propofol patient-controlled sedation chronic alcoholic pancreatitis
a study to evaluate efficacy of rfviiifc for immune tolerance induction (iti) in severe hemophilia a participants with inhibitors undergoing the first iti treatment (veriti-8 study)

Conditions: Hemophilia A With Inhibitors

Summary: the primary purpose of this study was to describe the time to tolerization (i.e., iti success) with rfviiifc in participants within a maximum of 48 weeks (12 months) of iti treatment.


Eligibility criteria:
inclusion criteria: * ability of the participant or his legally authorized representative (e.g., parent or legal guardian) to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local participant privacy regulations * male participants of any age diagnosed with severe hemophilia a (as confirmed from the medical record) * currently diagnosed with high titer inhibitors (historical peak greater than or equal to (\>=) 5 bethesda units per milliliter (bu/ml), according to medical records) * previously treated with any plasma-derived or recombinant conventional or extended half-life fviii exclusion criteria: * other coagulation disorder(s) in addition to hemophilia a * previous immune tolerance induction (iti) * history of hypersensitivity or anaphylaxis associated with any factor viii (fviii) administration * planned major surgery scheduled during the study unless deferred until after study completion (minor surgery such as tooth extraction or insertion/replacement of central venous access device is allowed) * abnormal renal function (serum creatinine \>1.5 milligram per deciliter (mg/dl) or 2 × upper limit of normal (uln) for participant age based on local laboratory range) as assessed by local laboratory * serum alanine aminotransferase or aspartate aminotransferase \> 5 × upper limit of normal (uln) as assessed by local laboratory