Kornimate/medical-research-clean huggingface dataset:
rosuvastatin for hepatitis c

Conditions: Hepatitis C

Summary: objective: determine if maximum doses of rosuvastatin are safe in patients infected with hepatitis c and if the so called pleiotropic effects of rosuvastatin cause a decrease in the hcv viral load. primary study parameters: 1. to which extend causes rosuvastatin serious side effects like rhabdomyolysis and hepatotoxicity in patients chronically infected with hepatitis c? 2. does treatment with rosuvastatin in hcv infected patients lead to lower hcv-rna viral load? 3. is a decrease in ldl correlated to a decrease in hcv-rna load?

study design: it's a pilot study in which the patients form their own control group. a total of 10 patients will be included. to evaluate the effect of maximum doses of rosuvastatin on liver function and side effects, first 2 patients will be treated and evaluated. if they experience no serious adverse events then a further 8 patients will be included. the dose of rosuvastatin will be increased over a period of 4 weeks. intervention: based on experience in treating dyslipidemia, gradually increasing the dose of rosuvastatin diminishes the experienced side effects and decreases the chances of developing hepatotoxicity. therefore in this study we chose to increase the dose (see flowchart). patients will start with 5 mg a day wich will be increased after 1 week to 10 mg per day. after the second week of therapy a further increase to 20 mg per day is executed. this dose will be given for another 2 weeks. at week 4 of treatment a further increase to 40 mg is done.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years * all patients with hepatitis c (all genotypes) * negative for hepatitis b and hiv * alat \< 2,5 x below the upper limit of normal * serological evidence of hepatitis c infection with detectable hcv-rna (with bayer versant hcv bdna v3.0) * failed current standard of care treatment with peginterferon and ribavirin * who-score ≤1 * fertile women must have a negative pregnancy test in the week before start of medication. use of contraceptives during the whole study-period * physically and mentally able to attend outpatients clinics exclusion criteria: * hepatitis c patiënts naive for (peg)interferon and ribavirin treatment * alcohol abuses (\> 20 grams per day) in the last year * liver cirrhosis detected through liver biopsy or decompensated liver disease (child-pugh b or c) * concomitant treatment with hepatotoxic medication / interfering with cyp450 system: anti-fungal medication (voriconazole), antibiotics (gentamycine, azitromycine, claritromycin, erytromycin), immuun-suppresive drugs (cyclosporine), anti-arythmia (diltiazem, verapamil) and tuberculostatic drugs (rifampicin). * current statin use * active pregnancy or wish of pregnangy * use of grapefruit juice * mentally not fit to participate in the study * daily use of more than 2 grams of paracetamol

Keywords: rosuvastatin hepatitis c geranylgeranylation hcv-rna load
development, standardisation and standardisation project for a new memory assessment

Conditions: Memory Disorders

Summary: episodic memory (em) is a neuropsychological marker of alzheimer's disease (ad) (thomas-anterion, 2006). current tests for its assessment do not take into account the identity and emotional aspects of memory (van der linden et al., 2018). however, there are models that integrate links with identity, self-awareness and experience. pause et al. (2013) propose criteria to create ecological tools, including consideration of the emotional valence of memories and the spatio-temporal context of acquisition. in line with these criteria, we have developed a new tool: the nem (new evaluation of episodic memory). preliminary studies show different response profiles on the nem among patients (launay et al., 2023). we now want to evaluate the relevance of this tool in the differential diagnosis of ad.


Eligibility criteria:
inclusion criteria: * age ≥ 50 years * ability to understand judged sufficient by the assessor; * amnesic mci profile (petersen, 2003) during the 1st medical consultation prior to the assessment being prescribed. exclusion criteria: * severe auditory and/or visual sensory impairment not compatible with neuropsychological assessment; * judged fit to take the test by the assessor; * patient under guardianship, curatorship or family guardianship; * opposition to data processing.

Keywords: alzheimer episodic memory
safety, tolerability and efficacy of nidufexor in patients with diabetic nephropathy

Conditions: Diabetic Nephropathy

Summary: nidufexor addresses fibrosis, oxidative stress, inflammation and cell death, and therefore has the potential to improve the management of diabetic kidney disease when added to the standard of care (soc) (angiotensin converting enzyme inhibitor (acei) or angiotensin receptor blocker (arb)). this non-confirmatory phase 2 study was designed to determine the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of nidufexor in combination with acei or arb at a dose level that is soc as judged by the study doctor in patients with type 2 diabetes and nephropathy.

this was a non-confirmatory, multicenter, patient- and investigator-blinded, randomized, and placebo-controlled, proof-of concept trial assessing nidufexor vs. placebo in patients receiving standard of care (optimal tolerated doses of arb or acei) for diabetic nephropathy due to type 2 diabetes. the study consisted of three distinct study periods: screening (day -30 to day-1): lasted up to a maximum of 30 days and comprised a screening / baseline assessment. this visit was used to confirm that the study inclusion and exclusion criteria were met and served as baseline assessment prior to randomization. participant randomization occurred prior to day 1 as soon as participant eligibility was confirmed. treatment period (day 1-168): participants were randomized in a 1:1 ratio to receive nidufexor 50 mg or placebo once daily for 24 weeks. nidufexor and placebo were given in addition to soc (optimal tolerated doses of arb or acei). end of study (eos) and safety follow-up (day 169 to day 197): study assessments were performed until the eos visit (day 169). post study safety contact occurred approximately 28 days after discontinuing study treatment until day 197.

Eligibility criteria:
inclusion criteria: * male/female patients, 18-75 years * written informed consent * diagnosis of type 2 diabetes mellitus, with diagnosis made at least 6 months prior to screening * diabetic nephropathy as evidenced by urine albumin-cr ratio (uacr) ≥300 mg/g cr at screening while receiving a dose of angiotensin converting enzyme inhibitor or angiotensin receptor blocker that is the standard of care as judged by the study doctor. exclusion criteria: * history of type 1 diabetes mellitus * severe renal impairment manifesting as serum creatinine egfr \< 30 ml/min/1.73 m\^2 at screening * pregnant or nursing (lactating) women * women of child-bearing potential, unless they are using basic methods of contraception during dosing of study treatment * uncontrolled diabetes mellitus at screening * history or current diagnosis of ecg abnormalities prior to first study dose * history of kidney disease other than diabetic nephropathy at screening * uncontrolled hypertension at screening * use of prohibited medications, including but not limited to glp-1 agonists and sglt2 inhibitors.

Keywords: diabetes
central hemodynamics

Conditions: Hypertension

Summary: guidelines recommend measuring end organ damage and in particular arterial stiffness in patients with hypertension. however, until now it was not possible to measure arterial stiffness with the use of simple methods. recently, novel and innovative devices offering determination of arterial stiffness and central hemodynamics from simple and non-invasive arm cuff measurements have now become available. this study therefore evaluates the value of non-invasively measured arterial stiffness and central hemodynamics for guiding antihypertensive treatment in selected patient populations (i.e. elderly patients, patients with diabetes mellitus, patients with heart failure, and patients with resistant hypertension).


Eligibility criteria:
inclusion criteria: * patients \>70 years (elderly cohort) * patients with diabetes mellitus (diabetes cohort) * patients with heart failure (heart failure cohort) * patients with resistant hypertension (resistant hypertension cohort) exclusion criteria: * patient refuses study participation * severe renal failure * reduced life expectancy
comparison of albuterol for status asthmaticus

Conditions: Status Asthmaticus

Summary: this study is designed to compare the length of continuous albuterol administration between two different albuterol formulations, bac containing albuterol versus preservative free albuterol.

the primary objective of this study is to compare the length of continuous albuterol administration between patients receiving bac containing albuterol versus preservative free albuterol. secondary objectives include comparison of therapy escalation, asthma scores, forced expiratory volume in one second (fev1) at discharge, length of hospital stay, and cost.

Eligibility criteria:
inclusion criteria: * patients will be included in the study if they are admitted to the 5th floor of norton children's hospital for the treatment of an acute asthma exacerbation, initiated on continuous albuterol inhalation therapy, and are between 5 and 17 years of age. exclusion criteria: * patients will be excluded from the study if they are transferred from the 5th floor to the pediatric intensive care unit (picu), admitted for any indication other than acute asthma exacerbation, or removed from the inpatient asthma protocol for any given reason.
pudendal nerve block for hemorrhoidectomy

Conditions: Hemorrhoids; Postoperative Pain

Summary: patients undergoing milligan-morgan hemorrhoidectomy will be randomized to receive or not the pudendal nerve block after the spinal anesthesia.

patients included were those undergoing milligan-morgan hemorrhoidectomy under spinal anaesthesia from january 2018 to december 2019. exclusion criteria were age \< 18 years old, pregnancy and allergy to local anaesthetics. patients meeting inclusion and exclusion criteria were randomized to undergo an ultrasound-guided pudendal nerve block. per-protocol all patients received postoperative metronidazole 500 mg for 3 days, laxative, a basis analgesia with nsaid and opioids as needed. postoperative pain on the visual analogue scale (vas) at 6, 12, 24 and 48 hours, opioids needed, complications and length of hospital stay were recorded. patients and ward personnel were not informed about the treatment arm. all patients were further controlled 6 weeks after the intervention.

Eligibility criteria:
inclusion criteria: * patients affected by haemorrhoids (grade iii and iv) and treated with milligan-morgan hemorrhoidectomy under spinal anaesthesia * signed informed consent exclusion criteria: * age \< 18 years old * pregnancy * allergy to local anaesthetics
pharmacogenetic testing on an outpatient population with a depression diagnosis

Conditions: Major Depressive Disorder

Summary: this is a randomized, control group design of pharmacogenetic implementation in a mental health population of subjects taking anti-depressants and/or anti-psychotics with a new or current primary or secondary diagnosis of major depressive disorder (mdd) or depressive disorder not otherwise specified (ddnos).

mental illness affects one in four adults in the united states; approximately 61.5 million americans experience mental illness in a given year. according to the national alliance for the mentally ill, the impact of serious mental illness costs americans $193.2 billion in lost earnings per year. in addition, mental illness patients have an increased risk of having chronic medical conditions, leading to increased costs and emergency service utilization for those conditions. in addition to substantial costs, patients with psychiatric illness are difficult to treat. more than two-thirds of patients with depression do not respond to first line therapy. treatment often involves numerous trials of individual agents and combinations of medications in order to achieve optimal response. pharmacogenetic testing is being used in more settings to guide treatment decisions.

Eligibility criteria:
inclusion criteria: * current primary or secondary diagnosis of major depressive disorder or depressive disorder not otherwise specified * have moderate to severe depression as identified by phq-9 scoring of 10 or greater * taking or be newly prescribed an anti-depressant or anti-psychotic medication * able to provide informed consent exclusion criteria: * pregnant or breastfeeding * active and/or unstable diagnosis of substance abuse, excluding nicotine * primary diagnosis of dementia, bipolar disorder (any type), schizophrenia, schioaffective disorder, or personality disorder

Keywords: depression pharmacogenetics pharmacogenomics major depressive disorder genetics anti-depressants
cervix monitor for elasticity and length measurements

Conditions: Preterm Birth

Summary: preterm birth is a leading global cause of neonatal mortality despite of numerous advances and intensive research in perinatal medicine. almost one million children die each year due to complications of preterm birth and in almost all countries with reliable data, preterm birth rates are increasing. of the 14 million survivors per year, many face a lifetime of disability, including learning disabilities, visual and hearing impairments. spontaneous preterm delivery (sptd) is often multi factorial event, precocious cervical softening, shortening and dilatation are a common denominator. the majority of preterm births happen spontaneously, though some are due to early induction of labor or cesarean birth, typically due to medical maternal of neonatal conditions.

the uterine cervix has to provide structural integrity and mechanical resistance to ensure normal development of the fetus as the uterus expands to accommodate the fetus growth. preterm delivery is closely related to a premature cervical ripening. the scientific bases for the proposed project is the elasticity modulus of a cervix is a more sensitive parameter characterizing the stage of cervical ripening. the main component of the cervix tissue is a collagen. cervical ripening is the result of realignment of collagen, degradation of collagen cross-linking due to proteolytic enzymes. these processes affect the elasticity modulus of the cervical tissue. therefore, assessment of cervix by a device measuring cervical elasticity and cervical length appears to be and adequate approach for identifying pregnant women at high risk of spontaneous preterm delivery. the primary cervical elasticity assessment currently used in clinical practice is relying on the evaluation of the cervix as "hard, medium or soft". in the scope of this project the investigators propose to develop and clinically validate a new and cost-effective device, cervix monitor for detecting cervix conditions leading to sptd and its risk assessment. the cm will be based on measuring of the applied pressure to the cervix by a tactile sensor array and ultrasound measurement of cervix length .

Eligibility criteria:
inclusion criteria: 1. adult women age 21-44 years 2. non-pregnant women, or 3. pregnant women exclusion criteria: 1. active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder 2. ongoing or prior radiation therapy for abdominal or pelvic cancer 3. recent (less than four months) pelvic surgery 4. surgically absent uterus, rectum or bladder 5. significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician 6. severe abdominal or pelvic adhesions preventing access to pertinent anatomy 7. known or suspected bleeding disorder 8. hiv or hepatitis b positive serology 9. warty lesions on the vulva 10. extensive varicose veins on the vulva 11. active skin infection or ulceration within the vagina/vulva (herpes infection) 12. presence of a vaginal septum 13. severe hemorrhoids
the coherence of scatter identification and exclusion algorithm study

Conditions: Steatohepatitis, Nonalcoholic

Summary: non-alcoholic fatty liver disease (nafld) is currently the most common liver condition worldwide; approximately 55% of the world population will have nafld by 2040. nafld is an unwanted side effect of common cancer therapies, such as chemotherapy. ultrasound can detect nafld via measurement of the backscatter coefficient (bsc). it is an attractive technique because of its low cost and availability, potentially enabling earlier detection of nafld in a larger population through screening. this approach has shown promise in detecting nafld but is limited by variability in measurement due to several factors. measurement of the bsc requires assumptions about the nature of the tissue being measured; if these assumptions are incorrect, they can lead to inaccurate bsc measurements. to improve accuracy, an algorithm (cosie) was developed to quantify the suitability of tissue for bsc analysis. the investigators believe cosie will enable more reliable bsc measurements by selecting the optimal regions of tissue to measure. by measuring the bsc in the livers of healthy volunteers and patients with evidence of fatty liver, the algorithm can be evaluated against liver fat percentage values obtained from mri imaging. this study will assess whether applying the cosie algorithm enhances the reliability of bsc measurements, bringing them closer in quality to mri imaging.


Eligibility criteria:
inclusion criteria: healthy volunteers: * healthy male or female adults (18 or above). * volunteers must consider themselves fit and healthy. * rmh and/or icr employees. patients: * patients undergoing liver mri as part of clinical standard of care with evidence of steatosis on preceding mri. * aged 18 and above. exclusion criteria: healthy volunteers: * volunteers that are under investigation or planning to consult their gp to seek investigation for an undiagnosed condition, particularly regarding pelvic or abdominal disease or injury. * healthy volunteers who do not have an nhs number or who are not registered with a gp will be excluded. patients: • severe liver fibrosis (fibrosis stage f4) or severe cirrhosis.

Keywords: liver ultrasound backscatter coefficient non-alcoholic fatty liver disease steatosis
effect of opioids on experimental hyperalgesia in oesophagus, skin and muscles

Conditions: Pain

Summary: the study is a multi-modal multi-tissue human experimental pain study in 24 healthy volunteers. the study is a randomized cross-over study. the effect of 2 opioids will be compared on pain stimuli in skin, muscle an oesophagus. hyperalgesia will be induced in skin and oesophagus, to sensitize these tissues. the pain thresholds before and after opioid administration will be compared. the hypothesis is that the difference in effect of the opioids is more pronounced in the presence of hyperalgesia. as hyperalgesia is a common phenomenon the clinic, the findings in this study may lead to a better understanding of the treatment of pain. the study will include an explorative study of the effect of morphine of pain processing in the brain, this will provide us with new insight in the effect of the opioids of pain processing in the brain.

the study is a multi-modal multi-tissue human experimental pain study in 24 healthy volunteers. the study is a randomized cross-over study. the effect of 2 opioids, oxycodone and morphine will be compared on pain stimuli in skin, muscle an oesophagus. hyperalgesia will be induced in skin by capsaicin and in oesophagus by a mixture of capsaicin and acid, to sensitize these tissues. the pain thresholds before and after opioid administration will be compared. the hypothesis is that the difference in effect of the opioids is more pronounced in the presence of hyperalgesia. as hyperalgesia is a common phenomenon the clinic, the findings in this study may lead to a better understanding of the treatment of pain. the study will include an explorative study of the effect of morphine of pain processing in the brain, this will provide us with new insight in the effect of the opioids of pain processing in the brain.

Eligibility criteria:
inclusion criteria: * between 18 and 65 years * signed informed concent * healthy * women must use a safe contraceptive method * negative pregnancy test exclusion criteria: * pregnancy * allergy to study medication * participating in another medicine study * previous addictive behaviour * need for other treatments * use of strong analgesics * use of any analgesics 24 hours before the study
pilot study of fosamax in spinal cord injury

Conditions: Spinal Cord Injury; Osteoporosis

Summary: study is designed to evaluate the efficacy of oral fosamax in prevention on osteoporosis in acute spinal cord injury. efficacy will be measured by a duel energy x-ray absorptiometry (dexa) scan every 6 months. patients will complete 3 visits, screening, 6 months, 12 months and be required to take oral fosamax versus placebo weekly.

the project was funded on august 13, 2009 and was awarded to one of our trainees, dr. matthew abraham, a pgy3 in our program and our irb approval was obtained with much time and effort on february 24, 2010. we followed the protocol and so far we recruited just one patient on september 19, 2011 who completed the study but we encountered with many unexpected obstacles to recruit any more patients to the study. the main obstacle was that the spine surgeons' refusal to start the study drug for months after surgery for fear of complications with wound healing. secondly, the few appropriate and eligible patients we tried to recruit declined to participate. we were unable to recruit any more patients to this study and hence the study was closed. the one patient that was recruited completed the study. since it is only one subject in the study, no conclusions can be drawn.

Eligibility criteria:
inclusion criteria: * american spinal cord injury association (asia) a or american spinal cord injury association (asia) b spinal cord injury exclusion criteria: * history of hypersensitivity to alendronate or other bisphosphonates * esophageal abnormality * inability to sit/stand upright for 30 minutes * creatinine clearance less than 35 milliliters/minute * hypothyroidism * malignancy * pregnancy * prolonged steroid use

Keywords: asia a or asia b spinal cord injury
comparison of cow milk and 15% hypertonic saline in the treatment of rectal prolapse in children

Conditions: Rectal Prolapse

Summary: to see the outcome of results of cow milk \& hypertonic saline in the treatment of rectal prolapse in children

sclerotherapy is the least invasive procedure used in management of grade i/ii rectal prolapse, with a success rate of around 80%, and generally considered as the first choice for uncomplicated and recurrent prolapse. several sclerosing agents such as 15% hypertonic saline, 5% phenol in almond oil and cow milk have been used and reported in the literature. present study is designed to determine the efficacy of cow milk and 15% hypertonic saline in the management of children with grade i/ii rectal prolapse. all the details will be entered on the proforma which will include resolvement of rectal prolapse and which agent has adverse effects like recurrence, fecal incontinence and anal stenosis.

Eligibility criteria:
inclusion criteria: * all children with grade i and ii rectal prolapse * age \<12 years * both genders exclusion criteria: * rectal prolapse secondary to causes like ulcerative colitis and crohn's disease * past surgical history on the pelvic floor, * neurological diseases like rectal polyps, congenital megacolon, hirschsprung disease, sacrococcygeal teratoma, neural tube defects, cauda equina syndrome * where parents are not willing to participate in the study