Kornimate/medical-research-clean huggingface dataset:
effect dietary fructose on fructose kinetics in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: determine the kinetics of fructose metabolism and its role as a metabolic substrate following a high (100gr/day) vs low fructose diet (\<30 gram fructose intake per day isocaloric correction with dextrose) in type 2 diabetic subjects of sas or caucasian ethnicity.

the prevalence and accompanying morbidity and mortality of obesity and type 2 diabetes (t2d) is increasing on a global scale. unfortunately the underlying (patho)physiological mechanisms are only partially understood. a key step in the development of negative health effects of metabolic disease might be via dietary fructose metabolism and its accompanying aberrant metabolite production, in which our gut microbiota plays a crucial role. by bypassing the normal glucose metabolism pathway, fructose plays a role in the development of metabolic disease such as diabetes en fatty liver disease. the mechanism of this effect is unclear and possibly plays in the observation of ethnic specific metabolic risk factors. that is, subjects of different ethnicties (for instance south-asian surinamese (sas)) have a higher risk and worse trajectory of metabolic diseases than caucasians. since gut microbiota is altered between these two ethnicities, we hypothesize that aberreant fructose catabolism in patients of sas descent results in production of specific (gut microbiota derived) metabolites such as ethanol. in this study, fructose metabolism will thus be studied in patients of sas and caucasian dutch descent. to this end the investigators will examine (13c stable isotope based) fructose fluxes before and after randomizing subjects into a four-week high- or low fructose diet. this study aims to elucidate the physiological and microbial catabolism of fructose and possible differences between these two ethnicities.

Eligibility criteria:
inclusion criteria: * 40 t2d patients (20 caucasian and 20 sas) * 40-70 years old * male-female * bmi 25-35 kg/m2 * stable anti diabetic drugs for 3 months (metformin is obligatory) * stable medication use past 3 months * able to give informed consent exclusion criteria: * - proton-pump inhibitor usage (known to effect gut microbiota) * glp1, sglt2i or insulin use (known to effect gut microbiota) * antibiotic for the past 3 months (known to effect gut microbiota) * probiotic or symbiotic usage (known to effect gut microbiota) * pregnant women * chronic illness (including a known history of heart failure, renal failure (egfr \<30 ml/min), pulmonary disease, gastrointestinal disorders, or hematologic diseases), or other inflammatory diseases * active infection * previous intestinal (e.g., bowel resection/reconstruction) surgery * smoking (due to its influence on gut microbiome) * vegetarian diet (since they have different microbiota) * \>6 alcohol units per day or \>14 alcohol units per week * active malignancy * hba1c \>9% (75mmol/mol)
dilute betadine soak and scrub for foot and ankle surgery

Conditions: Postoperative Infection; Postoperative Complications

Summary: infection and wound complications are the most common complications following orthopaedic foot and ankle procedures, and the infection rate following these procedures is higher than in procedures involving other areas of the body.the purpose of this randomized controlled trial is to determine whether a standard chlorhexidine prep can be augmented with a soak \& scrub of the foot in dilute betadine to reduce the rate of positive cultures from the hallux nail fold prior to surgery.

infection and wound complications are the most common complications following orthopaedic foot and ankle procedures, and the infection rate following these procedures is higher than in procedures involving other areas of the body. this is at least in part because the anatomy of the human foot presents inherent challenges for preoperative sterilization techniques due to the many folds and crevices associated with the toes. in particular, the nail folds of the toes are known to harbor large amounts of bacteria. a systematic review and meta-analysis of previous studies that have investigated the efficacy of various foot and ankle preparation agents (including alcohol, chlorhexidine, chloroxylenol, and iodine/iodophors) showed that no single agent or combination of agents eliminates positive culture growth to undetectable levels for all patients. articles have suggested superiority of a chlorhexidine prep solution over other types of preps; hence, chlorhexidine prep is now considered the gold standard at many institutions. but even a chlorhexidine prepped foot has been shown to contain culturable bacteria in the nail folds in 30% of cases. the purpose of this randomized controlled trial is to determine whether a standard chlorhexidine prep can be augmented with a soak \& scrub in dilute betadine to reduce the rate of positive cultures from the hallux nail fold. it is hypothesized that in comparison to feet receiving the standard chlorhexadine prep, feet receiving the standard prep plus the betadine soak \& scrub will be less likely to have culture positive swabs of the hallux nail fold.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age 2. patient requires a foot or ankle operative procedure 3. patient provides informed consent exclusion criteria: 1. patient refuses 2. patient is incarcerated, incapacitated, or otherwise unable to provide appropriate informed consent

Keywords: betadine foot ankle nail fold scrub infection prevention postoperative
safety and efficacy study of repeated doses of dx-88 (ecallantide) to treat attacks of hereditary angioedema (hae)

Conditions: Hereditary Angioedema (HAE)

Summary: the purpose of this study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow hae patients continued access to ecallantide. in addition, patients enrolled in dx-88/20 (edema4) trial will be followed up and treated for subsequent attacks in this trial.

this is an open label trial. the study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide in the treatment of acute attacks of hereditary angioedema. this study is designed to provide efficacy and safety data on repeated use of ecallantide. these data are intended to support the marketing authorization of ecallantide in the treatment of acute attacks of hereditary angioedema. efficacy and safety of ecallantide will be evaluated in this study.

Eligibility criteria:
inclusion criteria: * 10 years of age or older * documented diagnosis of hae (type i or ii) * willing and able to give informed consent * acute hae attack at time of presentation exclusion criteria: * receipt of an investigational drug or device, within 30 days prior to study treatment, other than dx-88 (ecallantide) * pregnancy or breastfeeding * receipt of non-investigational c1-inh or dx-88 within 72 hours of treatment * patients eligible for current, ongoing clinical trial in which dx 88 (ecallantide) is offered
molecular profiling in lung cancer patients

Conditions: Non-Small Cell Lung Cancer; Carcinoma

Summary: the main purpose of this study of pemetrexed combined with cisplatin used as neoadjuvant chemotherapy (2 or 3 cycles) in participants with operable non-small cell lung cancer (nsclc) is to look at various genes present in participants' blood and tumor tissue to see if there is any link between the levels or changes in the genes and how participants with lung cancer respond to pemetrexed and cisplatin treatment.


Eligibility criteria:
inclusion criteria: * pathologic documentation of non-small cell lung cancer (nsclc) * tumor must be accessible by bronchoscopy for tumor tissue sample collection * patients must have lung cancer with clinical stage ib, ii, iiia * eastern cooperative oncology group (ecog) performance status 0 or 1 * patients must not have received prior systemic chemotherapy or radiation therapy for nsclc (prior resection of lung is allowed provided at least 5 years have elapsed between prior surgery and enrolment) exclusion criteria: * bronchoalveolar carcinoma or stage iiia tumor involving the superior sulcus (pancoast tumors) * pregnant or breast feeding patients * patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry * patients with history or presence of other malignancy except in situ carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma) * unwillingness to take folic acid or vitamin b12 supplementation
hormone therapy on serum ischemia modified albumin in menopausal women

Conditions: Hormone Therapy Induced Morphologic Change; Surgical Menopause

Summary: women suffer from cardiovascular diseases 10 years later than men, therefore female sex has been considered as a 'protective factor'. however, the risk of cardiovascular disease in women increases rapidly after menopause and the declining levels of endogenous estrogen is thought to be the causative factor. furthermore, postmenopausal hormone therapy (ht) decreases the severity and intensity of menopausal symptoms and improves women's quality of life. until the last 10 years, based on the results of observational studies, postmenopausal ht may protect women against cardiovascular events and decrease the risk of coronary artery disease by 35-50%. however, recent randomized primary and secondary prevention trials did not support the cardioprotective effect of ht. the aim of this study is to assess the effect of hormone therapy on serum ischemia modified albumin (ima) levels. thirty surgical menopausal women who admitted to karadeniz technical university, faculty of medicine, department of obstetrics and gynecology during 1-year period and diagnosed as menopause and planned to have hormone therapy for menopausal symptoms were enrolled for this prospective study. the serum i̇ma levels were recorded before and after (3 months, 6 months, 12 months later) hormone treatment (2 mg estradiol hemihidrat).


Eligibility criteria:
inclusion criteria: * accepting consent to participate in the trial and signing the form * surgical menopausal women aged 45-55 (having tah + bso for benign reasons) * presence of vasomotor or menopausal symptoms (moderate to severe); * no systemic disease or infectious disease in the past 2 weeks * not taking any other hormone therapy or medication until postoperative 6th week; * no contraindications for hormone therapy in routine menopause evaluation; * willingness to take hormone therapy * no smoking. exclusion criteria: * any systemic disease presence * smoking * contraindications for hormone therapy * failure to follow-up * inability to complete three months of hormone therapy * quitting hormone therapy for other medical reasons during hormone therapy * cases reported as preinvasive and invasive genital tumors as a result of tah + bso * cases reported as suspicious findings in the mammography report

Keywords: ima menopause hormone therapy cardiovascular risk
split-face tolerability comparison between metrogel® 1% versus finacea® 15% in subjects with healthy skin

Conditions: Skin Manifestations

Summary: the purpose of this study is to compare the tolerability of metrogel® (metronidazole gel) 1% to finacea® (azelaic acid) gel 15% in subjects with healthy skin applied according to product labeling for three weeks.


Eligibility criteria:
inclusion criteria: * healthy male and female adults (ages 18 years or older) * subjects with healthy skin as determined by the clinical grader exclusion criteria: * subjects with a degree of skin pigmentation that interferes with the reading of skin reactions * subjects with known allergy to one of the components of the study drugs (refer to the package inserts for metrogel® 1% and finacea® gel 15%) * subjects who have participated in another investigational drug or device research study within 30 days of enrollment * subjects with a washout period for topical treatment on the treated area less than 1 week for corticosteroids and/or 4 weeks for retinoids * subjects with a washout period for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids * subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or other topical conditions on the area to be treated * subjects who foresee unprotected and intense uv exposure during the study (mountain sports, uv radiation, sunbathing, etc.)
biomarkers of the locus coeruleus nucleus: links with early tau pathology, cognition and alzheimer's disease risk

Conditions: Alzheimer Disease

Summary: alzheimer's disease (ad) is characterized by a long-lasting silent phase. among initial events, emergence of tau pathology in locus coeruleus (lc) brainstem nucleus, well before the one observed in medial temporal cortex, is highly relevant. lc integrity and function can be assessed in vivo with mri and pupil measures. the current research proposes to evaluate these lc markers in an aged healthy cohort (n=100, with half apoe4 positive) and to relate these markers with cerebral tau pathology, ad risk and cognitive function.

early tau pathology in the lc may induce dysfunction of the lc-na system, contribute to initial cognitive decline and possibly be predictive of future ad occurrence. the present project has the following objectives: 1) to relate different biomarkers of lc function measured in vivo with ad risk and future ad occurrence, in order to evaluate their relevance for earliest ad diagnosis, 2) to investigate how lc biomarkers can account for underlying brain tau pathology in asymptomatic older individuals; a related objective will be to validate lc biomarkers as reliable proxies of tau pathology occurrence, and 3) to study the link between lc biomarkers and cognitive performance. to complete these objectives, the project will evaluate, in healthy older volunteers from the inspire-t cohort (n=100, \> 60 years old), biomarkers of lc neuronal integrity, lc-forebrain connectivity, and lc tonic and phasic activity. additionally, a positon emission tomography (pet) exam will be conducted using tau-specific tracer. detailed cognitive assessment will also be performed, including assessment of a priori na-dependent and na-independent cognitive functions. in the studied cohort (n = 100), half volunteers will be recruited based on genetic ad risk (apoe4 positive) and the other half based on the absence of risk (apoe4 negative).

Eligibility criteria:
inclusion criteria: * participant in the inspire-t cohort * normal cognitive assessment * mmse score ≥ 27 out of 30 (mini-mental state examination) * normal visual abilities (in corrected or uncorrected vision) * normal motor skills exclusion criteria: * subjects with a contraindication to mri exam * subjects with a known allergic reaction to the pet radiopharmaceutical (\[18f\] flortaucipir) or any of its excipients * subjects with an ophthalmological pathology making oculometric measurements difficult * subjects with neurological or psychiatric pathologies

Keywords: pet mri occulometry locus coeruleus alzheimer disease
investigating clinical indicators of spine related dysfunction patterns. a clinical study on neck pain patients.

Conditions: Neck Pain; Neck Disorders

Summary: the goal of is this study is to investigate the reliability and validity of a classification system for neck pain patients. in a previous study clinical experts were asked about the clinical criteria they considered to be determinative for 5 predefined dysfunction patterns in patients with neck problems: 1) articular, 2) myofascial, 3) neural, 4) central, and 5) sensorimotor control dysfunction pattern. this delphi survey revealed a list of pertinent anamnestic and clinical criteria per dysfunction pattern. in the present study we will collect anamnestic and clinical data of 200 neck pain patients. this will be obtained by approximately 20 clinicians that fill out a standardized registration form at the intake of their patients with neck pain. the therapists and patients will receive an informed consent that clarifies the purpose of the study and what happens next with the collected data. per patient the therapist indicates the dominant clinical pattern based on his/her experience. prior to the data analysis, the researchers will be blinded to the patient identification data. subsequent, the registration forms will be screened for the presence of clinical criteria (obtained from previous delphi study), independent of the therapist's diagnosis/conclusions. a second independent researcher will gather this information, which will be used for statistical analysis, in order to investigate which clinical criteria can be considered as determinative for a particular pattern. outcome measures for these analysis are: * sensitivity and classification specificity * (positive and negative) likelihood ratios * odds ratios * diagnostic accuracy


Eligibility criteria:
inclusion criteria: * patients suffering from neck pain exclusion criteria: known serious underlying pathology (red flags): cancer, metastatsis, untreated fractures, history of diabetes or pathology of the central nervous system, non-musculoskeletal neck pain

Keywords: diagnostics, clinical criteria, clincal reasoning, neck pain
pulmonary contusion flail chest complex

Conditions: Pulmonary Contusion

Summary: the study included 20 adult patients presented by multiple fractured ribs (flail segment) with thoracic trauma severity score (ttss) between 5 and 15. all patients received mid-thoracic epidural analgesia with 0.125% bupivacaine and 1 μg/ml fentanyl. the patients were ventilated using non-invasive positive pressure ventilation (nippv). follow up arterial blood gases, chest x-ray and ct scan were obtained. parameters to be recorded: patient's characteristics and clinical data including pulmonary contusion, number of fractured ribs, pleural involvement, pao2/fio2 ratio on admission, weaning outcome, duration of nippv, length of stay in icu (los icu), complications and mortality rate.

20 patients fulfilling the inclusion criteria were submitted to strapping and packing in the form of dressing and fixing with elastoplast. all patients were ventilated using nippv (engstrom carestation), which was delivered to the patient through full-face mask and was started with pressure support of 8-12 cmh2o and peep of 3-5 cmh2o and gradually increased in 2 cmh2o steps. when patients tolerate fio2 ≤ 0.5 with pressure support ≤ 8 cmh2o and peep ≤ 5 cmh2o for \> 6 consecutive hours, withdrawal from nippv was attempted daily in 30 minutes spontaneous breathing trials. therapy was considered successful if endotracheal intubation was avoided and the patient could be discharged from the icu. during this period follow up arterial blood gases, chest x-rays and ct scans were obtained.

Eligibility criteria:
inclusion criteria: * patients with multiple fractured ribs with flail segment presented by acute respiratory distress that had deteriorated despite effective pain management, their age more than 18 years and less than 70 years, with thoracic trauma severity score (ttss) between 5 and 15 exclusion criteria: * patients requiring endotracheal intubation or emergency surgery following admission, severe associated trauma to other systems, respiratory failure caused by neurological disease or asthmatic attack or any contraindication for nippv.
gambro ak200 ultra hemodiafiltration study

Conditions: Chronic Renal Failure

Summary: this study is designed to assess the safety, efficacy and dialytic capabilities of hemodiafiltration with on-line prepared substitution fluid using the ak200 ultra in comparison to conventional hemodialysis.

the ak200 ultra is a new device in the united states, but has been used for several years in europe. the ak200 ultra is a single unit which is preprogrammed to provide standard hemodialysis as well as hemofiltration and hemodiafiltration with on-line preparation of the substitution fluid the ak200 ultra hemofiltration and hemodiafiltration is performed using a high flux membrane with high ultrafiltration rates compensated by volumetrically controlled infusion of on-line prepared substitution fluid. the ak200 ultra is, therefore, capable of providing dialysis treatments which can improve the removal of medium to high weight molecules without the difficulties associated with the manual measurement and administration of external substitution fluid. this study is designed to assess the safety, efficacy and dialytic capabilities of hemodiafiltration with on-line prepared substitution fluid using the ak200 ultra in comparison to conventional hemodialysis. this study is motivated by the need for a commercially available product capable of administering hemofiltration and hemodiafiltration in a clinical setting. the ultimate goal of this study is to improve morbidity and mortality in the esrd patient population in the united states.

Eligibility criteria:
inclusion criteria: 1. subject received chronic dialysis therapy 2. subject was stable on three dialysis sessions per week 3. subject was able to understand and sign the informed consent exclusion criteria: ) on chronic renal replacement therapy for less than three (3) months 2) hospitalization for reasons other than vascular access complications in the past three (3) months 3) hiv + 4) hepatitis b+ 5) pregnancy, verified by pregnancy test for women of child bearing potential 6) access recirculation \> 10% 7) hematocrit less than 26% 8) history of non compliance 9) pediatric patients, defined as less than 18 years old

Keywords: chronic renal failure hemodiafiltration
phase iii study of pi-88 in post-resection hepatocellular carcinoma

Conditions: Cancer; Liver Cancer; Primary Liver Cancer; Hepatocellular Carcinoma; Hepatoma

Summary: the purpose of this study is to determine if pi-88 is effective and safe in patients who have had surgery to remove primary liver cancer.

primary liver cancer (hepatocellular carcinoma or hcc) is the fifth most common cancer worldwide. surgery to remove the tumour remains the principal form of treatment for liver cancer, however recurrence of the disease after surgery is common and survival after recurrence is poor. at the moment there is no recommended standard treatment for hcc immediately after the tumour has been removed surgically. pi-88 is a new experimental drug which blocks the growth of new blood vessels in tumours to stop the tumour growing (starves it of food) and also stops tumour cells spreading. previous experience with pi-88 has shown it has been well tolerated and has shown some benefit in delaying the time it takes for the hepatocellular carcinoma to reappear after surgery. the purpose of this study is to determine if pi-88 is effective and safe in patients who have had surgery to remove primary liver cancer.

Eligibility criteria:
key inclusion criteria: * histologically-proven primary hepatocellular carcinoma with curative resection performed in the 4 - 6 weeks prior to randomisation. * ecog performance status 0 to 2 * child pugh classification a or b key exclusion criteria: * any evidence of tumour metastasis or co-existing malignant disease * any prior recurrence of hcc or any liver resection prior to the most recent procedure * history of prior hcc therapy

Keywords: hepatocellular carcinoma pi-88 phase iii adjuvant therapy hepatoma liver cancer