Kornimate/medical-research-clean huggingface dataset:
aliskiren for proteinuric igan despite angiotensin blockade

Conditions: IgA Nephropathy

Summary: study objective: to investigate the potential anti-proteinuric efficacy of aliskiren, a novel direct renin inhibitor (dri), in addition to angiotensin receptor blocker (arb) in immunoglobulin a nephropathy (igan) patients at risk of developing progressive renal failure.

this will be an open-label pilot study in which igan patients with persistent proteinuria despite maximum dose of arb treatment will be assigned to receive aliskiren. there is the optional addition of other anti-hypertensive agents to achieve an optimal target blood pressure of \<130/80 mmhg.

Eligibility criteria:
inclusion criteria: * male or female 18 - 70 years of age * histologic diagnosis of iga nephropathy * proteinuria \> 1 g/day or upc \> 1 mg/mg or 113 mg/mmol at least twice * receiving treatment with the maximum dose of arb for at least 3 months * patients who are willing to give written, informed consent exclusion criteria: * egfr \< 15 ml/min/1.73 sq.m * upc \>5000 mg/g or 570 mg/mmol, or \<500 mg/g or 57 mg/mmol * serum k+ \> 5.2 mmol/l * presence of bilateral renal artery stenosis * presence of diabetes mellitus * renal histology showing pathologies other than igan * known allergy to arb or dri * patients on arb/acei combination within 12 weeks of randomization * concurrent treatment with corticosteroids, nsaid, or immunosuppressant * patients with connective tissue disease or obstructive uropathy * patients with malignancy or conditions severely limiting life expectancy * female who are pregnant or intending to conceive * female of child-bearing age unwilling to practice contraception * patients who are unable to give informed consent * patients simultaneously participating in another study

Keywords: proteinuria
study evaluating the efficacy of an ibuprofen effervescent tablet in the treatment of post-surgical dental pain

Conditions: Pain

Summary: evaluation of the efficacy and safety of a single dose of an ibuprofen effervescent tablet in the treatment of pain following third molar extraction in comparison to single doses of placebo, standard ibuprofen tablets, and effervescent aspirin plus vitamin c tablets.


Eligibility criteria:
inclusion: * moderate or severe post-operative pain following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction * in general good health with no contraindications to the study medication or rescue medication (tramadol or acetaminophen + hydrocodone) * use of only short-acting local anesthetics with or without vasocontrictor and/or nitrous oxide exclusion: * presence of a serious medical condition (e.g., poorly controlled hypertension, diabetes, or hyper-/hypo-thyroidism; significantly impaired renal, cardiac, or hepatic function) * acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation * females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically-approved method of contraception

Keywords: dental pain analgesic nsaid ibuprofen aspirin
a study of cspcha131 in patients with advanced solid tumor

Conditions: Advanced Solid Tumors

Summary: the study was designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of cspcha131 alone or plus chemotherapy in patients with advanced solid tumors.

this is a dose escalation and expansion study with the aim to evaluate and characterize the tolerability and safety profile of cspcha131 alone (stage i) or plus chemotherapy (stage ii) in patients with advanced solid tumors.

Eligibility criteria:
inclusion criteria: * 1.18-75 years of age. * 2. histologically or cytologically confirmed diagnosis of advanced or metastatic malignant solid tumors, for which standard therapy either does not exist or has been proven ineffective or intolerable for the patient. * 3. at least one measurable tumor lesion according to recist version 1.1. * 4. ecog performance status of 0 or 1. * 5. life expectancy ≥ 3 months. no cardiac insufficiency or serious abnormalities in the electrocardiogram at baseline. exclusion criteria: * 1. administration of chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, other anti-tumor treatments or an investigational drug within 4 weeks or 5 half-lives, whichever is longer, preceding the first dose of study treatment. * 2. have undergone surgery within 4 weeks prior to the study treatment or have not fully recovered from any previous invasive procedure. * 3. adverse reactions to previous anti-tumor treatments that levels have not recovered to grade 1 or less. * 4. patients with evidence of uncontrolled nervous system metastasis or meningeal metastases, in the opinion of the investigator, not suitable for enrollment. * 5. active infections of grade 2 or above. * 6. peripheral neuropathy of grade 2 or above.
metabolic study of sleep apnea in men and women

Conditions: Obstructive Sleep Apnea (OSA)

Summary: the purpose of this study is to look at the metabolic (use of energy) and hormonal features of sleep problems in men and women.

obesity is a major risk factor for obstructive sleep apnea (osa), a condition characterized by repetitive respiratory disturbances, intermittent hypoxia, sleep fragmentation by frequent microarousals and low amounts of deep slow wave sleep (sws). today, more than 10 million american women suffer from osa. osa has been identified as an independent risk factor for the metabolic syndrome. because osa is more prevalent in men than in women, a disproportionate number of studies of osa and its consequences have been conducted in men. thus, osa has been characterized as a disorder associated with gender-based health care inequity. recent evidence, including data from our group, suggests that reduced amounts and intensity of sws (i.e. slow-wave activity \[swa\]) may play a pivotal role in the development of metabolic and cardiovascular disturbances in obese men and women, particularly those with osa. this project will focus on sex differences in swa and their relationship with daytime sleepiness and metabolic vulnerability in obese men and women with and without osa. we propose to simultaneously characterize: 1. sleep-wake regulation; 2. measures of diabetes risk; 3. measures of cardiovascular risk; and 4. profiles of sex steroids, cortisol and adipokines in a. obese men without osa, b. obese men with osa before and after treatment with continuous positive airway pressure (cpap), c. obese pre-menopausal women without osa, and d. obese pre-menopausal women with osa before and after cpap treatment. the completion of these interdisciplinary studies will provide a unique data set contrasting in obese women versus obese men the relationships between sleep and the metabolic syndrome, osa and the metabolic syndrome and the impact of cpap treatment on the metabolic syndrome. this work will provide important insights regarding the pathophysiology of osa and its adverse consequences in obese men and women, and the basis for the development of effective sex-specific prevention and treatment strategies.

Eligibility criteria:
inclusion criteria: * obese (bmi of at least 30 kg/m2) exclusion criteria: * clinically significant depression * positive pregnancy test * diagnosis of diabetes mellitus * hypertension (systolic \> 140 mmhg and/or diastolic \> 90 mmhg) not well-controlled on stable medication with either ace inhibitors or diuretics * habitual alcohol use * excessive caffeine intake of more than 300 mg/day * hemoglobin \< 11g/dl and/or hematocrit \< 33% * systemic illnesses, including heart, renal, liver, or malignant disease * taking steroid preparations (including oral contraceptives), medications known to alter insulin secretion and/or action, or medications known to influence sleep during the 2 months prior to starting the study * travel across time zones during the 4 weeks prior to starting the study * irregular sleeping habits (including shift work)

Keywords: osa diabetes metabolism gender
effect of the dietary supplement same on blood homocysteine levels

Conditions: Heart Disease

Summary: the purpose of this study is to determine if the oral intake of the dietary supplement same increases blood homocysteine levels in healthy human subjects.

s-adenosyl-l-methionine (same or adomet) is a commonly used nutritional supplement available in the united states since 1999. same is metabolized to homocysteine, a known cardiovascular risk factor. no study has determined the effect exogenous same administration has on the long-term levels of homocysteine in humans. as a nutritional supplement, same is not regulated by the food and drug administration, despite being used to treat clinical diseases such as depression and osteoarthritis.

Eligibility criteria:
inclusion criteria: * women and men age 18 - 65 * able to understand and sign a consent form exclusion criteria: * smoking * pregnant or lactating * women actively trying to conceive * diagnosis of panic disorder or bipolar disorder

Keywords: same adomet methylation homocysteine dietary supplement s-adenosyl-l-methionine
surgical intervention for refractory granulomatous lobular mastitis

Conditions: Refractory Granulomatous Lobular Mastitis

Summary: granulomatous lobular mastitis (glm) belongs to a group of benign diseases, which is mainly treated with glucocorticoids and surgical treatment. nowadays, in china, surgical treatment has gradually become the mainstream, but the timing and the extent of surgery are still controversial, and different literatures report that the recurrence rate after surgery is 20-50%. empirical lesion resection is generally used. we believe that the main reason for the high recurrence rate is the incomplete removal of the breast lesions. because glm is often characterized with microabscesses formation, empirical resection is likely to have residual lesions that are not visible to the naked eye. in order to reduce the postoperative recurrence rate and protect the breast appearance as much as possible, we propose a surgical plan : granulomatous lobular mastitis "lesion removal + whole breast exploration and flushing + one-stage microplastic surgery". the purpose of this study was to compare this surgical scheme of granulomatous lobular mastitis with existing surgical schemes, and to compare the overall benefits of the two for patients with glm. we aim to protect the breast appearance on the premise of low recurrence, improve the quality of life of glm patients, and standardize glm surgical schemes.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older with granulomatous lobular mastitis * patients without surgical treatment; * extensive lesions involving two or more quadrants of the breast, or accompanied by abscess, sinus fistula formation, skin rupture and other complex lesions; * patients volunteered to participate in the study after informed consent. exclusion criteria: * patients were diagnosed with mastitis with other definite etiology confirmed by pathology * patients who chose conservative treatment and did not receive surgical treatment * combined with other basic diseases, unable to tolerate surgery * patients in pregnancy.

Keywords: granulomatous lobular mastitis ；refractory；surgery
endothelin blockade in patients with single ventricle physiology

Conditions: Congenital Heart Disease

Summary: recent studies have shown beneficial effects of sildenafil in patients with single ventricle congenital heart disease. the purpose of this study is to determine whether bosentan, a drug with similar effects, will have similar benefit in this patient population.

patients enrolled in the study will take bosentan. baseline and follow up measurements will be collected then analyzed.

Eligibility criteria:
inclusion criteria: * at least 12 years of age * single ventricle congenital heart disease * require cardiac magnetic resonance imaging (mri) for clinical purposes. exclusion criteria: * \< 12 years of age * pregnancy or women who may become pregnant (sexually active and unwilling to use birth control) * patients taking cyclosporin or glyburide * patients with baseline liver dysfunction (aspartate aminotransferase or alanine aminotransferase \> 3 times upper limit of normal) * contraindications to mri (including pacemakers) * use of bosentan within one month prior to enrollment

Keywords: single ventricle congenital heart disease
salbutamol tolerance onset

Conditions: Asthma

Summary: overuse of inhaled bronchodilator beta agonist medication results in a loss of effectiveness (i.e. tolerance). this has been shown for the short acting beta agonist salbutamol and the long acting beta agonist salmeterol. tolerance to salmeterol is present within 24 hours. the onset of tolerance to salbutamol is not known.


Eligibility criteria:
inclusion criteria: * male or female * 18 to 65 years of age * non smoker * beta agonist naive for at least 14 days * baseline fev1 at least 70% predicted * no respiratory tract infection or allergen exposure (if atopic) within 4 weeks of visit 1 exclusion criteria: * poorly controlled asthma * pregnant or lactating women
intraosseous access during pediatric resuscitation

Conditions: Cardiac Arrest

Summary: the purpose of this study was to compare the jamshidi, the big, the cook, the ezio intraosseous devices to standard peripheral venous catheterization during pediatric resuscitation.


Eligibility criteria:
inclusion criteria: * give voluntary consent to participate in the study * minimum 1 year of work experience in emergency medicine * experienced emergency medical personnel - ems-paramedics exclusion criteria: * not meet the above criteria * wrist or low back diseases

Keywords: catheterization peripheral
radiostereometric analysis (rsa) of the profemur® preserve classic femoral components

Conditions: Joint Disease; Osteoarthritis

Summary: microport orthopedics (mpo) is conducting this study to investigate the primary stability of its profemur® preserve femoral components using radiostereometric analysis (rsa). rsa allows precise measurement of micromotion around orthopedic implants and hence, may estimate long-term fixation to bone.


Eligibility criteria:
inclusion criteria: * subject is a candidate for primary tha for osteoarthritis * subject is able to undergo primary tha procedure * subject is a candidate to be implanted with the specified combination of components * subject is willing and able to complete required study visits and assessments * subject is willing to sign the approved informed consent document exclusion criteria: * subject has any of the following contraindications at the time of the implantation: * overt infection; * distant foci of infections (which may cause hematogenous spread to the implant site); * rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram; * skeletally immature (less than 21 years of age at time of surgery); * inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable; * subjects 76 years of age or older * subjects with post-traumatic arthritis in the affected hip * subjects with rheumatoid arthritis in the affected hip * subjects with hip dysplasia in the affected hip * subjects with prior arthroplasty of the affected hip * subjects that are morbidly obese (bmi \> 35) * subjects that are immuno-suppressed * subjects with known or tested-positive allergy to metals * subjects currently enrolled in another clinical investigation which could affect the endpoints of this protocol * subjects unwilling or unable to sign the informed consent document * subjects with substance abuse issues * subjects who are incarcerated or have pending incarceration

Keywords: osteoarthritis radiostereometric analysis correction of functional deformity procedures total hip arthroplasty musculoskeletal diseases
spanish registry of digestive tumours retud

Conditions: Digestive Cancers; Bile Duct Cancer; Hepatocellular Cancer (HCC); Colorectal Cancer (CRC); Pancreatic Cancer; Rectal Cancer

Summary: the aim of this observational study is to assess the current state of digestive tumours in spain. by doing so, it seeks to enhance the quality of care, optimize the diagnosis and treatment of digestive tumours, and identify opportunities for improvement that can benefit patients. the study will investigate the epidemiological, biological, and clinical characteristics of digestive tumors diagnosed in patients aged 18 and older across healthcare centres in spain. it also aims to generate knowledge and scientific evidence for events and situations that may impact on patients with digestive tumours (e.g. covid-19 coronavirus pandemic). furthermore, subject to the patient's consent, biological samples may be collected for use in translational research projects and for the identification of molecular markers that may be useful in healthcare decision-making.

data will be collected ambispectively, recording those patients who were diagnosed with digestive tumours before the start of the study (from 2017) and also those who are diagnosed after the start of the study.

Eligibility criteria:
inclusion criteria: * male and female patients ≥18 years old diagnosed with oesophageal cancer, gastric cancer, pancreatic cancer, hepatocarcinoma, gallbladder and bile duct cancer, cancer of the small intestine, appendix and gastrointestinal stroma, colorectal cancer, anal canal cancer or digestive hereditary cancer. * written informed consent available. exclusion criteria: * patient for whom, for whatever reason, it is not possible to know or obtain the information necessary to complete the data collection base.

Keywords: digestive cancer tumours cholangiocarcinoma hepatocellular colorectal pancreas rectal
cranial nerves tractography

Conditions: Cranial Nerve Palsy

Summary: introduction: the skull base tumors surgery remains a challenge since numerous cranial nerves or vessels closely surround them. recently, diffusion tensor imaging has developed with the tractography following white fibers and visualizing functional tracts. cranial nerves tractography could allow predicting their displacement by skull base tumors that may help the surgeon to spare them along the surgery. methods: preoperative cerebral mri was performed on patients who presented with skull base tumors. a 3 tesla mri machine was used to acquire dti sequence with specific parameters: 32 directions, slice thickness 2 mm, echo time 86 ms, repetition time 12000 ms, matrix 128x128, b-value 1000 s.mm-1. an anatomic sequence hypert2 was overlaid as reference. distortion was corrected by topup and eddy functions from fsl. cranial nerves fibers were probabilistically tracked with mrtrix3. cranial nerves were selected according to their location around the tumor. the "radiological" expected position of the cranial nerve was compared to its "operative" real position.


Eligibility criteria:
inclusion criteria: * patients who present a skull base tumor that requires surgical removal * patients adult, informed and agreed exclusion criteria: * pregnant women * patients under 18 years old, unable to legally consent

Keywords: rmi
nad+ precursor supplementation in friedreich's ataxia

Conditions: Friedreich Ataxia

Summary: the primary objective is to test the safety and tolerability of short-term therapy with a nicotinamide adenine dinucleotide (nad+) precursor (mib-626) in adults with friedreich's ataxia (fa) without overt heart failure and with a left ventricular ejection fraction ≥ 40%. a key secondary objective is to test the effects of mib-626 on cardiac and skeletal muscle bioenergetics.

the primary focus for this protocol is safety and tolerability. we will systematically assess for adverse events using a safety monitoring uniform report form. we will also use cardiac 31-phosphorus-magnetic resonance spectroscopy (mrs) to measure the phosphocreatine(pcr)/adenosine triphosphate (atp)- γ ratio before and after treatment with mib-626. in addition, if time permits we will use proton (1h)-mrs to measure skeletal muscle nicotinamide adenine dinucleotide (nad+) before and after treatment.

Eligibility criteria:
inclusion criteria: * molecular diagnosis of friedreich's ataxia (fa). * males and females, ages 18 years to \< 65 years. exclusion criteria: * known sensitivity to nicotinamide-containing compounds. * concurrent use of vitamin b3 supplements and/or any medications likely to increase risk of mib-626 toxicity. * hgba1c \> (great than or equal to) 8.5% and or diabetes mellitus (dm) requiring insulin or insulin secretagogue. * kidney disease (estimated glomerular filtration rate (egfr) \< 60 ml/min/1.73 m2) using serum creatinine and mdrd equation. the egfr levels will be calculated using the modified diet in renal disease study (mdrd) equation, which is the equation used by the children's hospital of philadelphia laboratory. * liver disease (aspartate aminotransferase (ast)/alanine aminotransferase (alt) \> 3 x upper limit of normal) * severe co-existing cardiac disease (ejection fraction (ef) \< 40%, known arrhythmia) as demonstrated by an echocardiogram within 12 months of screening. * any contraindication to mri, including spinal rods (related to unknown safety considerations for cardiac 31-phosphorus -mrs). * use of any investigational agent within 4 weeks of enrollment. * females: pregnant/lactating or planning to become pregnant during their participation. * any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the study.
prolonged prone positioning for covid-19-induced acute respiratory distress syndrome (ards)

Conditions: ARDS; Covid19; Acute Hypoxemic Respiratory Failure

Summary: prone positioning is one of the few therapies known to improve mortality in ards. traditionally, patients are proned for 16 hours per 24 hour period. some retrospective data suggests improvement may persist beyond 16 hours. we aim to perform a pilot study comparing traditional prone positioning to prolonged prone positioning in patients with covid-induced ards.


Eligibility criteria:
inclusion criteria: positive covid test endotracheal intubation p:f \<150 within 1hours of inclusion on at least 60% fio2, 10cmh20 peep treating physician plans to implement prone positioning imminently housed in the uab micu. exclusion criteria: pre-existing treatment limitation (e.g. dnr order) prisoner pregnant female children (\ 48 hours prior to initiation of prone positioning contraindication to proning physician discretion