Kornimate/medical-research-clean huggingface dataset:
rapid 10-minute liver mri protocol in patients with suspected hepatocellular carcinoma

Conditions: Underlying Liver Disease; Hepatitis; Fibrosis of Liver; Cirrhosis With Suspicion of Liver Cancer; Lesion on a Prior Ultrasound, CT or Outside MRI

Summary: the purpose of this study to assess the image quality of the rapid magnetic resonance imaging (mri) compared to the standard mri.

this is a pilot study to compare a rapid 10-minute liver magnetic resonance imaging (mri) protocol to standard mri in participants with suspected hepatocellular carcinoma.

Eligibility criteria:
inclusion criteria: 1. underlying liver disease 2. have a lesion on a prior imaging study 3. must have prior standard mr exclusion criteria: 1. contra-indication for mr imaging including pacemaker, claustrophobia, pregnancy, electronic or vascular devices that are contraindicated; 2. patients with severe kidney dysfunction

Keywords: liver disease hepatocellular carcinoma
observational study of apremilast in patients with psoriasis in the netherlands

Conditions: Psoriasis

Summary: this is a multicenter, prospective, non-interventional, observational single arm study. two-hundred patients will be recruited in the netherlands over a one year period. in all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into this study. treatment will be according to routine clinical practice and based on recommendations as per the spc of apremilast (otezla®). recruitment will continue until 200 patients have entered the study. each patient will be followed for 12 months.

baseline demographics, disease characteristics and medication history prior to start of treatment with apremilast will be collected. patients will be asked to complete baseline dlqi, sf36, eq5d, tsqm,wpai and pbi questionnaires. photographs of the finger nails will be taken. follow-up visits follow-up assessments will take place at the regularly scheduled outpatient visits at 6 and 12 months (+/- 1 month) after initiation of apremilast. * skin-specific disease measures (psoriasis activity and severity index (pasi), (static) physician global assessment (spga), body surface area (bsa)) * patients will be asked to complete the following questionnaires: * dlqi * tsqm * eq5d * sf36- itch visual analog scale (vas) * wpai work productivity and activity index * patient benefit index pbi end of treatment upon discontinuation of treatment with apremilast, the date, the dose and reason for discontinuation will be documented. ae monitoring all patients will be monitored for adverse events throughout the study. from the time of the patient signing informed consent until treatment with apremilast is permanently abrogated, all non-serious adverse events that are considered related to apremilast and all serious adverse events (saes) regardless of causality will be reported.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age who understand and voluntarily sign an informed consent form. * patients starting treatment for psoriasis with apremilast in clinical practice. exclusion criteria: * refusal to participate in the study. * women who are pregnant or breast-feeding. * hypersensitivity to the active substance or to any of the excipients. * prior exposure to apremilast * psoriatic arthritis treated by a rheumatologist in the previous year

Keywords: psoriasis observational apremilast april non-interventional the netherlands
assessment of early outcomes of roflumilast in patients with non cystic fibrosis bronchiectasis

Conditions: Bronchiectasis

Summary: aim of the work assessment of early outcome of using roflumilast in patients with bronchiectasis regarding: * severity of symptoms * frequency of exacerbations * change in pulmonary function * systemic inflammation

bronchiectasis is defined by the presence of permanent and abnormal dilation of the bronchi. this usually occurs in the context of chronic airway infection causing inflammation. the main clinical manifestation is a productive cough. bronchiectasis is currently nearly always diagnosed using high-resolution computed tomography (hrct) scanning. the main diagnostic features are: 1) internal diameter of a bronchus is wider than its adjacent pulmonary artery; 2) failure of the bronchi to taper; and 3) visualization of bronchi in the outer 1-2 cm of the lung fields. * from a series of benzamide derivatives, roflumilast (3-cyclo-propylmethoxy-4-difluoromethoxy-n-\[3,5-di-chloropyrid-4-yl\]-benzamide) was identified as a potent and selective pde4 inhibitor. it inhibits pde4 activity from human neutrophils. pde4 inhibitors were demonstrated to inhibit inflammatory cytokine and mediator release from inflammatory cells. in addition, it inhibits neutrophil chemotaxis or migratory activity. lastly, pde4 inhibitor promotes apoptosis of these cells . * studies have demonstrated the efficacy of roflumilast in patients with both asthma and copd, where roflumilast improved lung function and reduced exacerbation rates. * bronchiectasis is a chronic destructive lung disease, which is characterised by persistent bacterial colonization, bronchial inflammation, reduced mucociliaryclearance, and in some patients progressive tissue damage. there is evidence of an associated influx of neutrophils into the lungs of these patients , resulting in the expectoration of large volumes of purulent sputum containing neutrophils and their products, so in patients with bronchiectasis, there is also neutrophilic inflammation as in copd. * the pde4 inhibitor, roflumilast, was evaluated in short term clinical trial of non-cystic fibrosis bronchiectasis. it has been shown symptomatic improvement from baseline park j. found that 16 weeks roflumilast treatment in patients with non cystic fibrosis bronchiectasis significantly reduce cat score and improve the symptoms of non-cf bronchiectasis.

Eligibility criteria:
inclusion criteria: * aged 18 years or above, male or female. * non / ex-smokers. * confirmed diagnosis of bronchiectasis based on high-resolution computed tomography scan. * significant sputum production (≥ 10 ml per day). exclusion criteria: * non-stable patients who need icu admission /mechanical ventilation. * active smokers. * moderate to severe liver impairment (child-pugh b or c) and/or sever renal impairment (c. clearance less than 30ml/min). * known psychiatric illness * concomitant use of strong cytochrome p450 inducers (e.g. rifampicin) * patients who are hypersensitive to roflumilast. * pregnant or lactating women
desmopressin response in the young

Conditions: Primary Nocturnal Enuresis

Summary: the purpose of this study is to determine whether desmopressin administered as a melt tablet is effective in reducing the number of wet nights in children and adolescents who suffer from bedwetting.

primary nocturnal enuresis (pne), or bedwetting, is a common childhood urological disease. factors contributing to nocturnal enuresis include nocturnal polyuria due to, at least in part, a relative deficiency of antidiuretic hormone arginine vasopressin (avp) which has been supported by the finding that some enuretic children lack a nocturnal increase in endogenous avp secretion. desmopressin, a synthetic, structural analogue of avp, selective for v2-receptors and with a longer half life than the natural hormone, has been found to be especially beneficial in pne subjects with nocturnal polyuria and normal functional bladder capacity. a melt tablet formulation offers benefits compared to regular tablets and nasal spray. regular tablets are more difficult to swallow for some patients and require fluid intake for swallowing. nasal spray absorption may be altered by seasonal allergies, upper respiratory infections or improper administration.

Eligibility criteria:
inclusion criteria: * children and adolescents (age 5-16 years) with diagnosed primary monosymptomatic nocturnal enuresis. * a minimum of 3 wet nights per week in the 2-week screening period without treatment. exclusion criteria: * presence or a history of organic urological disease, diurnal urinary incontinence, polydipsia, diabetes insipidus, ongoing urinary tract infection, clinically significant renal, hepatic, gastrointestinal, pulmonary, cardiovascular, endocrinological or neurological disease that would interfere with evaluation. * ongoing systemic antibiotic use, use of diuretics or any drugs affecting urinary concentration, or medical treatment for hyperactivity. * usage of any experimental drug or device during 30 days before study entry.
genentech validation tool for pulmonary fibrosis

Conditions: Interstitial Lung Disease

Summary: radiology is an important component of the multidisciplinary team. the primary goal of this project will be to create a tool using findings on chest computed tomography (ct) for nearly 300 patients with the most common types of fibrosis. the tool will be tested using chest ct scans of an additional 100 patients with the 3 most common diagnoses of fibrosis. the second objective will be to further validate the tool by performing a reader study with 3 co-investigating radiologists and ask them to look at 100 ct scans of patients with fibrosis without tool and then with tool and see if accuracy of diagnosis improves compared to the working diagnosis when using the tool.


Eligibility criteria:
inclusion criteria: * retrospective review of adults (age \> 21) with diagnosis of pulmonary fibrosis on chest ct and a pulmonologist report in electronic medical record confirming the working diagnosis from 1/1/2010 through 7/1/2019. exclusion criteria: * failure to meet inclusion criteria including age \< 21 and lack of a pulmonologists report in the medical record with a working diagnosis of patient's type of pulmonary fibrosis.
dose-exposure-response in type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type I

Summary: to investigate the dose-exposure-response relationship of insulin glulisine (hmr1964) after single subcutaneous injections of 0.075, 0.15 and 0.3 u/kg body weight with the euglycaemic clamp technique using the biostator (tm).


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus exclusion criteria: -

Keywords: insulin glulisine euglycaemic clamp diabetes mellitus type 1
molecular mechanisms of antipsychotic-induced insulin resistance

Conditions: Adverse Effect of Other Antipsychotics and Neuroleptics; Insulin Resistance

Summary: this study will investigate the molecular mechanisms of atypical-antipsychotic induced insulin resistance. this will be accomplished by administering olanzapine or placebo to healthy subjects for 7 days and analyzing genetic and protein changes in peripheral tissues known to play an important role in insulin resistance pathophysiology.


Eligibility criteria:
we will include persons that meet the following criteria: 1. 21-45 years old 2. bmi 18.5-24.9kg/m2 3. no history of drug or alcohol dependence or abuse 4. no current or past history of psychiatric or neurologic disease 5. minimal exercise routine prior or during study (light walking allowed) 6. normal liver function tests 7. minimal alcohol intake (\<1 drink per day). the following persons will be excluded: 1. has 1st degree relative with diabetes (i or ii) 2. current or re-cent nicotine intake 3. presence of organic/physical disease that could affect glucose 4. currently taking prescription or over-the-counter medications that could affect glucose 5. currently pregnant or lactating 6. unwilling to take acceptable birth control method 7. current or previous exposure to antipsychotics 8. history of unstable weight 9. personal or family history of cardiac arrhythmias or seizures 10. current or past history of eating disorder(s) or restricted diet 11. allergy to lidocaine or drug excipients 12. history of difficulty with intravenous line placement 13. history of fainting.
growth of high-quality oxides on the inner surface of ecmo circuit by ald to reduce thrombus formation

Conditions: Anticoagulation

Summary: this study evaluate thermal ald (t-ald) and plasma-enhance ald (pe-ald) processes modified cardiopulmonary bypass (cpb) tubing to investigate anticoagulation properties.

ecmo is a technique which is currently being used worldwide for providing life support for patients experiencing both pulmonary and cardiac failure. though ecmo can effectively rescue life at the initial scene, being invasive, complex, resource intensive, and serious related complications developing on the following days of ecmo support have greatly restricted it use. the major causes of ecmo-related mortality and morbidity are serious coagulopathy, either bleeding (7-34%) or thrombosis (8-17%). contact of high extracorporeal blood flow and the large artificial surfaces plays a critical role leading to the subsequent coagulopathy. systemic heparin and heparin-bonded circuits is usually used to reduce thrombus. however, non-urgent invasive procedures should be avoided or minimized during that support and regular clinical monitoring to guide the adjustment of optimal dosage is mandatory making the clinical care intensive. whereas the pharmacological interventions may bring the risk of critical imbalance between hemostasis and thrombosis, efforts to modify the ecmo system focusing on improvement of biocompatibility seem a fundamental way particularly regarding the extended periods of ecmo use. zro2 and al2o3 are more excellent biocompatible and hemocompatible materials compared with pvc (polyvinylchloride) which is the current material of ecmo circuit. despite the broad applications of zro2 and al2o3 in artificial implants, traditional thin-film coating techniques are unable to deposit these hemocompatible oxides on the inner surface of the pvc tubing in ecmo circuit. in this subproject, the investigators will apply a new technique of atomic layer deposition (ald) to coat biocompatible and hemocompatible zro2/al2o3 nanolaminate thin films on the inner surface of ecmo tubing to suppress the device-induced coagulopathy. ald is a thin-film deposition technique for preparing high-quality oxides with atomic-layer accuracy. it offers many benefits including accurate thickness control, excellent conformality, high uniformity, low defect density, good reproducibility, and low deposition temperature. these characteristics clearly accounts for the feasibility to deposit high-quality hemocompatible oxide thin films on the whole surface of complex 3-d structures, such as the inner surface of ecmo tubing, using the ald technique. the newly-prepared ecmo circuit will then undergo in vitro tests and animal study to carefully examine the safety and effectiveness of improvement of hemocompatibility.

Eligibility criteria:
inclusion criteria: * adults * weighing more than 50 kg exclusion criteria: * pregnancy * smoking * chewing betel nut * history of any blood or cancer * taking anticoagulants

Keywords: anticoagulation
cytoreduction and intraperitoneal chemotherapy versus systemic chemotherapy in colorectal peritoneal carcinomatosis

Conditions: Colorectal Peritoneal Carcinomatosis

Summary: the purpose of this study is to see if there is a difference in survival between two different treatment strategies for colorectal peritoneal surface disease. the control arm administered the currently considered standard treatment which is palliative systemic chemotherapy. the experimental arm received the combination treatment cytoreductive surgery and intraperitoneal chemotherapy. the investigators hypothesis is that the combination treatment will improve the overall survival.


Eligibility criteria:
inclusion criteria: * metastatic disease to the peritoneum from colon or rectum (at least two isolated sites of disease) * verified primary tumor of adenocarcinoma of the colon or rectum * potential resectability as judged by the treating surgeon * patient is available for follow-up according to the study protocol * signed informed consent exclusion criteria: * extraabdominal metastases or liver metastases * paraaortic or other inoperable lymph node metastases * clear indication for surgery only (such as obstruction, bleeding or peritonitis) * prior treatment of either arm in the study * clinical or histopathological diagnosis of peritoneal pseudomyxoma * age \> 80 * contraindications for chemotherapy * pregnancy or breastfeeding * ongoing infection

Keywords: colorectal cancer cytoreductive surgery intraperitoneal chemotherapy systemic chemotherapy peritoneal metastatic disease from the colon or rectum
kidney stone risk factors in patients infected with hiv

Conditions: Nephrolithiasis; HIV

Summary: the purpose of this study is to define the cause of renal stones and the risk pattern for recurrence of renal stones episodes (any kind of stones) in hiv1 patients.

this study aims at defining the cause of renal stones and the risk pattern for recurrence of renal stones episodes (any kind of stones) in hiv1 patients. primary objective : * finding the cause of renal stone in hiv patients defined as stone composition if stone is available or more probable pathophysiological mechanism * risk profile for stone recurrences estimated on risk indices in hiv1 patients secondary objective(s) * identify prevalence of recurrences and describe co-morbidities associated with stone disease * describe urological management for renal stones in hiv patients * describe the causes of drug induced renal stones

Eligibility criteria:
inclusion criteria: * adult male or female hiv1 infected patients willing to participate in the study * having experienced a renal stone episode within the past six months or living with a renal stone * able to understand the protocol * giving oral consent exclusion criteria: * ct scan impossible * follow up impossible over 1 year

Keywords: calvih renal stone hiv1 renal colic atazanavir crystalluria chronic kidney disease calcium oxalate
phase 1 clinical study of qls5132 monotherapy in advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the phase 1 trial includes phase 1a (dose-escalation) and phase 1b (dose-expansion): * phase 1a: assesses safety, tolerability, pk, and preliminary efficacy of qls5132 in advanced solid tumors using atd + boin, given iv every 3 weeks. up to 12 subjects may be enrolled in promising dose levels. * phase 1b: evaluates qls5132's anti-tumor efficacy in specific cldn6-positive solid tumors, including ovarian cancer, nsclc, gastric cancer, and others. expansion studies at 1\~3 selected dose levels follow successful phase 1a results.


Eligibility criteria:
inclusion criteria: * advanced solid tumors; * measurable disease, per recist v1.1; * eastern cooperative oncology group (ecog) performance status 0-1; * adequate organ function; * recover from all reversible aes from previous anti-tumor treatment (i.e., grade ≤ 1, according to nci-ctcae v5.0), excluding alopecia (any grade) and grade ≤ 2 neuropathy peripheral; exclusion criteria: * previous treatment with drugs targeting cldn6 (including adcs), or any drug containing topoisomerase i inhibitors (including adcs); * received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 2 weeks with small molecule and within 4 weeks with biologic before the first dose of qls5132; * progressive or symptomatic brain metastases; * serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection; * history of significant cardiac disease, or poorly controlled diabetes mellitus; * history of recurrent autoimmune diseases; * history of myelodysplastic syndrome (mds) or aml; * history of other active malignant tumors within 3 years before signing the informed consent form; * if female, is pregnant or breastfeeding; * be allergic to any component of qls5132 or its excipients.
the psychosocial and economic burden of genital warts

Conditions: Female Genital Warts

Summary: considering the importance of hpv(human papilomavirus) and related diseases in brazil, and the lack of studies about both the economic and the psychosocial burden of these diseases, bemfam, a brazilian non-governmental organization that provides reproductive health services and technical support to local governments proposes a study to measure the psychosocial and economic burden of genital warts.

cervical cancer is a public health issue in brazil. the cancer national institute estimates that cervical cancer will be the second most incident among women, with 18.430 new cases in 2010. human papillomavirus (hpv) is related to cervical cancer and is also responsible for benign lesions, such as genital warts.the brazilian ministry of health estimates the prevalence of genital warts to be 5,7% among pregnant women and 21,5% among women attending sexually transmitted infections treatment clinics.the study will measure the psychosocial burden of genital warts using hpv impact profile questionnaire and the economic burden of genital warts among women attending its six reproductive health clinics. there are two study objectives: 1 - to measure the psychosocial burden of genital warts in women attending six reproductive health clinics in brazil. 2- to measure the economic burden of genital warts treatment for women attending six reproductive health clinics in brazil. hypothesis testing: for objective 1, the experiment compare differences on psychosocial burden of genital warts among subgroups and therefore does not include any formal hypothesis testing about the psychosocial burden of the disease in agreement with the extant literature on the subject (xingshu zhu et al., 2009). objective 2 aims to measure differentials in the economic burden of the disease among subgroups with different type of genital warts (newly diagnosed, recurrent and resistant), site of the lesion, age, duration of treatment, number of medical visits, type and number of medical procedures. no formal hypothesis will be tested.

Eligibility criteria:
inclusion criteria: * women aged 18 to 45 years, who had a pap-smear in the preceding 90 days or were diagnosed with genital warts during physical examination. * good health exclusion criteria: * women self reported hiv-positive * women undergoing antiretro-viral treatment * illiteracy * pregnancy

Keywords: genital warts hpv psychosocial burden economic burden female genital warts
a study to evaluate the safety of medi2338 in subjects with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: phase i study to evaluate the safety and tolerability of single ascending intravenous doses of medi2338 in subjects with stable, mild to moderate chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: * aged ≥ 40 years at time of screening. * females of non-childbearing potential defined as surgically sterile or at least 2 years postmenopausal. * males, unless surgically sterile, must use 2 highly effective methods of birth control from screening through end of trial. * a diagnosis of mild to moderate copd. * cigarette smoking history of ≥10 pack years. * ability to understand and comply with protocol requirements, instructions and restrictions. * copd symptoms adequately controlled on a therapeutic regimen that has not changed in the 4 weeks prior to screening. exclusion criteria: * current diagnosis of any respiratory condition other than copd. * active or history of any disease or condition that would, in the opinion of the investigator and/or medical monitor, place the subject at an unacceptable risk to participate in this study. * history of or suspected history of alcohol misuse or recreational substance abuse. * treatment with oral or iv corticosteroids within 8 weeks prior to screening. * concurrent enrolment in another clinical study. * receipt of any investigational drug therapy of use of any biologicals within 6 months prior to screening. * known history of allergy or reaction to any component of the investigational product.

Keywords: chronic obstructive pulmonary disease copd