Kornimate/medical-research-clean huggingface dataset:
renal and hormonal effects of pioglitazone

Conditions: Diabetes; Hypertension

Summary: this study examines the effects of pioglitazone on renal sodium handling in subjects prone to insulin resistance, i.e. diabetic and/or hypertensive subjects.

aim: glitazones are powerful insulin sensitizers prescribed for the treatment of type 2 diabetes. their use is however associated with fluid retention and an increased risk of congestive heart failure. we previously demonstrated that pioglitazone increases proximal sodium reabsorption in healthy volunteers. this study examines the effects of pioglitazone on renal sodium handling in subjects prone to insulin resistance, i.e. diabetic and/or hypertensive subjects. methods: in this double-blind, randomized, placebo-controlled, four-way, cross-over study, we examined the effects of pioglitazone (45mg daily during 6 weeks) or placebo on renal, systemic and hormonal responses to changes in sodium intake in 16 individuals, 8 with type 2 diabetic and 8 with hypertension.

Eligibility criteria:
inclusion criteria: * type ii diabetes * hypertension exclusion criteria: * cardiac or renal diseases * anaemia * drugs like aspirin, non steroidal anti-inflammatory drugs and hormonal replacement therapy.

Keywords: diabetes blood pressure pioglitazone sodium insulin resistance, renal function, sodium, pioglitazone
long-term coated and non-coated tibia nails

Conditions: Implant Infection

Summary: for this retrospective cohort study, medical records of patients treated between 2005 to 2019 with the utn protect and/or etn protect for tibia fractures or tibia revision cases will be examined. in comparison to this cohort, patients who received an uncoated tibia nail are examined as well. demographics, pre-surgical health status, details on fracture type or on revision, treatment decision and surgery details, postoperative reoperation and revision, surgical site infections, time to union, and adverse events will be registered. in a subgroup, additional information including clinical outcomes and patient satisfaction will be assessed by clinical exam. patients who still carry a nail and feel discomfort at the surgical site or present with a medical condition which demands an imaging will receive an x-ray of the tibia. the xray is not part of the standard study protocol.

primary objective: the primary objective is to assess the proportion of patients who experienced a surgical site infection. surgical site infection is defined as either deep or superficial. the presence of tibia infection will be defined by the criteria of cdc. secondary objective(s): * proportion of patients with reoperation (secondary procedures) * bone union (until radiographically healed) * proportion of patients with complications / adverse events related to implant or surgery * only subgroup: womac-score, aofas, sf36, eq5d. hypothesis and statistical considerations and estimated enrollment: we hypothesize that with the use of antibiotic coating implants like the etn/ utn-protect the risk of implant-associated infections and osteomyelitis is reduced in treatment of tibia fractures or in cases of revision surgery in the tibia. in a retrospective manner the implanted gentamicin-coated and uncoated tibia nail procedures are evaluated. in the subgroup of patients with a currently implanted gentamicin-coated nail the incidence of surgical site infection and implant-associated infections will be assessed prospectively. this study is exploratory in nature. therefore, there is no formal statistical hypothesis and no formal sample size calculation. approximately 620 tibial shaft fractures are expected to be included in the 12 months enrollment period. data will be analyzed with the use of simple summary statistics. depending on the volume and quality of the collected data, different statistical analyses will be applied. exploratory analyses will be conducted to investigate relationships between the different treatment options and the outcomes.

Eligibility criteria:
inclusion criteria: * primary tibial shaft fracture (fracture type 42 according to the ao/ota fracture and dislocation classification) treated operatively with an intramedullary nail as standard of care. * signed informed consent, if required by irb/ec exclusion criteria: - prisoner at date of inclusion

Keywords: fracture associated infection antibiotic coating infection prophylaxis tibia nail fracture long bone
comparison of basal (fasting) glycemic control in type 1 diabetic patients with csii achieved by the circadian slide ruler scale or flat basal rate

Conditions: Diabetes Mellitus Type 1

Summary: this is a pilot trial to establish study procedures that allow comparison of various starting basal rate profiles used in continuous subcutaneous insulin infusion (csii). glycemic control achieved by circadian 'slide ruler scale' basal rate versus that achieved by one constant basal rate (flat profile) will be compared during a composite fasting day as well as therapeutic success after 2 weeks of normal activity.


Eligibility criteria:
inclusion criteria: * adult patients \>= 18 years of age * type 1 diabetes * diabetic for \>2 years, and treated with csii for \>= 3 months * hba1c \<=8.5% exclusion criteria: * excessive fibrosis or lipo-hypertrophy at injection or infusion sites * unstable chronic disease other than type 1 diabetes * severe hypoglycemic event within last week prior to study start * severe diabetic ketoacidosis within last month prior to study start
a double-blind, randomised, parallel group,comparative study with rose-hip liquid and placebo given to healthy volunteers in the winter season aiming to evaluate the occurences of flu and catching a cold

Conditions: Flu; Common Cold

Summary: the trial is an investigator-initiated, double-blind, randomized, placebo-controlled phase iii study. after the patient has receiving information about the study and after given written informed consent, the patient will be screened. the patient's medical history and demographic information will be recorded. the patient will then be asked questions in accordance to the study questionnaires, and they will also be asked to complete questionnaires regarding quality of life - and finally they be instructed on how to complete the diary. all patients are randomized to receive standardized rose hip liquid or matching placebo. the subject is instructed to take the liquid form of rose hips in the morning and evening meal. the subject will also be advised to call the clinic if there is an acute attack of cold and / or flu because they must then increase the in-take of study treatment to 3 double dose for 5 days and then return to normal dose. the subject will then be asked a series of questions under study questionnaires, and be instructed in how questionnaires (sf-12) and diary filled. this is to provide security to the validation output values investigator or study nurse will take telephone contact with the subject once a month, subjects will be asked about how things are going and to remember to take the liquid and whether they have completed the diary. the last patient visit will take place after 6 months. any side effects will be reported to and reviewed with hybenvital aps in collaboration with medical experts.


Eligibility criteria:
inclusion criteria: * first men and women aged 50 + years * it is accepted that the subjects can be treated for medical diseases. * it is also accepted that the subjects receiving daily medication such as diuretics and medication for hypertension, hypercholesterolemia and blood glucose-lowering treatment, medicine that strengthens the heart, symptom-relieving medication for joint disease, etc. * subjects may also use n-3 fatty acids (fish oil), as long as the fixed dosage. exclusion criteria: * subjects who have been treated with rose hip extracts or powder within 3 months before screening. * subjects who have been treated with ginger, avocado / soy, large doses of vitamins (including vitamin c) or other known dietary supplements within 3 months before screening * subjects that have been deemed to be have a hard time collaboration * subjects who abuse narcotics. * subjects who abuse alcohol * subjects with a current mental illness * subjects with known allergy to rose hips * subjects participating in another clinical trial, or have participated in another clinical trial within 3 months before this trial started.

Keywords: occurences of flu occurences of common cold
clinical trial to assess the influenza vaccination (fluvac 02)

Conditions: Adult Hospitalized

Summary: this study assesses the seasonal of influenza vaccine effectiveness in adults hospitalised with laboratory-confirmed influenza through a network of hospitals in france

influenza vaccination strategies aim at protecting high-risk population from severe outcomes. estimating the effectiveness of seasonal vaccines against influenza related hospitalisation is important to guide these strategies. the objective is to measure the population effectiveness of influenza vaccine in patients hospitalized with virologically confirmed influenza laboratory during the influenza season 2012/2013 in a french hospitals network. this is a study "case-control" involving a nasopharyngeal sample for all hospitalised patients presenting an influenza-like illness within seven days. cases will be patients rt-pcr positive for influenza. controls will be patients negative for any influenza virus.

Eligibility criteria:
inclusion criteria: * age ≥ 18 year * affiliated with social security health insurance * written informed consent * patients hospitalized for 24 hours and presenting an influenza-like illness in the last 7 days before the hospitalization exclusion criteria: * against indication for influenza vaccination(hypersensitivity to the active substances, to any of the excipients and to trace eg eggs, including ovalbumin, chicken protein) * patients institutionalized without regular community interaction * patient already hospitalized for respiratory infection during the 2012-2013 influenza season * flu already virologically documented in the current influenza season 2012-2013 (rt-pcr, multiple rt-pcr and / or culture.)

Keywords: prevention, influenza, adults hospitalized, vaccines, effectiveness
effectivity and safety of ultrasound-guided percutaneously radiofrequency ablation for liver cancer

Conditions: Liver Cancer

Summary: to evaluate the safety and efficacy of ultrasonography (us) -guided radiofrequency ablation for liver tumors, the investigators used preoperative and postoperative us/ceus(contrast-enhanced ultrasonography)/ct/mri to assess lesions, and laboratory tests including the tumor markers to evaluate the general condition of patients. intraoperative us/ceus/ct would be applied to monitor ablation lesions.


Eligibility criteria:
inclusion criteria: * patients with small hepatocellular carcinoma (single or multiple nodules of less than 3 cm in diameter), patients with child-pugh a/b, patients with plt(platelet count) ≥ 50\*10e9/l and pt(prothrombin time) ≤ 20s. exclusion criteria: * patients with blood coagulation dysfunction, childpugh score≥3, severe cardiopulmonary disease, intolerant anesthesia and upper gastrointestinal bleeding in shock.
effect of nordic walking on gait-asymmetry patterns in children with hemiparesis

Conditions: Cerebral Palsy

Summary: nordic walking is a physical activity consisting of walking with poles similar to ski poles. the poles are designed for the purpose of activating the upper body during walking. the poles are equipped with rubber or spike tips and the walking itself resembles.

compared to normal walking in nordic walking there is a stronger involvement of the upper body. furthermore, by using the poles, the muscles in the upper body can be activated, and the length of each step taken is supposedly increased, resulting in a faster gait .

Eligibility criteria:
inclusion criteria: * their age will range from 6-10 years, from both sexes. * level i, ii and iii of gross motor functional classification system (gmfcs) (jooyeon et al., 2011) * grade 1 and 1+ spasticity according to the modified ashworth scale (mas). (cloptonetal et al., 2005). exclusion criteria: * uncontrolled epilepsy. * mental retardation or autistic features. * significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination), * structural or fixed soft tissue deformities of the lower and/or upper extremities. * neurological or orthopedic surgery in the past 12 months in the lower and/or upper extremities. * botox injection in the lower and/or upper extremities in the past 6 months.

Keywords: cerebral palsy gait spatio-temporal gait parameters unilateral cerebral palcy nordic walking
a multicenter, randomized, double-blind, placebo-controlled phase iii clinical study evaluating the efficacy and safety of shr-1918 in patients with homozygous familial hypercholesterolemia

Conditions: Homozygous Familial Hypercholesterolemia

Summary: this is a multicenter, randomized, double-blind, placebo-controlled phase iii clinical study to assess the reduction of low-density lipoprotein cholesterol (ldl-c) by shr-1918 in patients with homozygous familial hypercholesterolemia (hofh).


Eligibility criteria:
inclusion criteria: 1. diagnosis of functional hofh by either genetic or clinical criteria as defined in the protocol 2. ldl-c ≥2.6mmol/l at the screening visit 3. body weight ≥40 kg 4. receiving stable lipid-lowering therapy for at least 28 days before enrollment. exclusion criteria: 1. treatment with an angptl3 inhibitor within 24 weeks prior before screening 2. previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (hba1c \> 8.5%) 3. egfr \<30ml/min/1.73m2 at the screening visit 4. ck \>5times uln at the screening visit
the progressively lowered stress threshold model

Conditions: Alzheimer Disease; CAREGİVER

Summary: today, with the prolongation of human life, the elderly population has increased and the frequency of diseases seen in old age has increased due to this situation. the most common of these diseases is alzheimer's disease. the progressively lowered stress threshold (plst) is a conceptual model for reducing behavioral symptoms in individuals with dementia. in this study, it is aimed to determine the effect of interventions according to decreased stress threshold model on the level of neuropsychiatric symptoms and agitation of alzheimer's patient and caregivers care satisfaction and life satisfaction.

today, with the prolongation of human life, the elderly population has increased and the frequency of diseases seen in old age has increased due to this situation. the most common of these diseases is alzheimer's disease. alzheimer's disease is a progressive neurodegenerative disease which causes cognitive decline and various neuropsychiatric behavioral disorders and disorders in daily living activities. the emergence of these symptoms of alzheimer's disease leads to an increase in the costs of care provided and a great distress for caregivers. in the literature, it is recommended to use nonpharmacological approaches as the first choice in the treatment of behavioral and psychological symptoms. one of the non-pharmacological approaches is the interventions according to the progressively lowered stress threshold model. in this method, taking into account the individuality of the patient, focusing on the interaction of the alzheimer's patient with the environment and the rearranging of the environment for the reduction of cognitive abilities, focuses on creating a less stressful environment. since this model uses the steps of the nursing process, home visits are made. this study will be carried out with alzheimer's patients and caregivers from aksaray university education and research hospital's home health services unit. in this study, it is aimed to determine the effect of interventions according to decreased stress threshold model on the level of neuropsychiatric symptoms and agitation of alzheimer's patient and caregivers care satisfaction and life satisfaction.

Eligibility criteria:
inclusion criteria: * 18 years and above, * caring for moderate to mild alzheimer's patients (test cognitive levels score is 19 and below) * being a close relative of the patient, * being the primary caregiver, * having volunteered to participate in the study * there is no problem with communication exclusion criteria: * younger than 18, * caring for an advanced alzheimer's patient * paid caregiver * having a communication problem the standardized mini-mental state examination (mmse) test cognitive levels score is above 20 points

Keywords: alzheimer disease caregivers care satisfaction agitation
a study to examine the efficacy of a therapeutic thx-110 for obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: this is a sponsored proof of concept study with the purpose to examine the safety, tolerability and feasibility of thx-110 (dronabinol (synthetic δ9-thc) and pea) for the treatment of adults with obstructive sleep apnea.

this is a 30-day sponsor-initiated, open-label trial of the therapeutic treatment thx-110 (a combination of dronabinol and pea) in 30 adults with obstructive sleep apnea (osa). participants will receive thx-110 for the duration of the trial. the goal for this pilot study is to provide initial safety, feasibility and tolerability data on thx-110 in an osa population.

Eligibility criteria:
inclusion criteria: * osa diagnosis; osa severity ahi: 15-30 * population aged 20-65 * gender: males and females * bmi \< 30 * osa patients that cannot tolerate cpap * osa patients who use cpap will not use the device during the entire duration of the study exclusion criteria: * minors * severity of osa outside the determined boundaries * pregnancy * bmi \> 30 * medical history of narcotic dependency
prospective cohort study of the clinical applications for the pathologic type, staging, and grading of gist

Conditions: Gastrointestinal Stromal Tumor

Summary: evaluate the reliability of morphology standards for gist pathologic type, staging and grading by retrospective analyzing clinical data; on this basis, establish a gist standardized and individualized treatment mode to maximum benefit gist patients, avoid under- and over-treatment.

1. retrospective analysis of gist cases in the recent five years: the gist clinical data of fudan university zhongshan hospital from 2007 january to 2012 december were collected. by reviewing the he slides, gist was evaluated by 12 indicators, nih scheme and who standard. accomplish the gene sequencing of kit, pdgfra, b-raf, and sdh. follow up the patients about their treatment and prognosis. analyze and compare the advantages and disadvantages of the histomorphology indicators, nih scheme, and who standard. 2. organize the first prospective cohort study of gist individualized treatment based on the histomorphology. obtain the evidence of histological assessment for gist by following up patients for 3 years. 3. establish an evaluation criteria based on the morphology of gist. make objective evaluations about gist tumor size, tumor location and gene mutation status in the prognosis estimate. make rules to effectively guide individualized treatment of gist.

Eligibility criteria:
all patients pathologically diagnosed with gist during the period from 2013 to 2015

Keywords: morphology standards
vitamin d, insulin resistance and inflammation in esrd

Conditions: End Stage Renal Disease

Summary: the broad goal of this study is to understand the mechanisms by which vitamin d receptor activation leads to changes in insulin signaling in advanced uremia. we hypothesize that 1,25-dihydroxyvitamin d3 deficiency due to advanced chronic kidney disease leads to insulin resistance and that administration of a vitamin d3 analog will restore insulin sensitivity in end stage renal disease patients.


Eligibility criteria:
inclusion criteria: * ckd and receiving hemodialysis for ≥ 3months * kt/v ≥ 1.2 * ≥ 18 years of age * medically stable * avf or ptfe dialysis access * no acute inflammatory disease within 4 weeks prior to the study * on stable dose of paricalcitol for 4 weeks prior to the study * ipth value between 150 - 1500 within the past 3 months * ca \< 10.5 * po4 \< 10 exclusion criteria: * pregnancy * intolerance to the study medication * severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, hiv, liver disease) * type 1 diabetes mellitus * uncontrolled type 2 diabetes mellitus (hba1c \> 10) * hospitalization within 1 month prior to the study * malfunctioning arterial-venous vascular access (recirculation and/or blood flow \< 250 ml/min) * presence of hemodialysis catheter * patients receiving steroids and/or other immunosuppressive agents (\> 10 mg prednisone qd) * bmi \ 45

Keywords: insulin resistance end stage renal disease
alprostadil in peripheral arterial occlusive disease (paod) stage iv

Conditions: Peripheral Arterial Occlusive Disease

Summary: the study is to confirmatorily show a superior effect of alprostadil compared to placebo on the rate of complete healing of ischemic necroses and ulcerations as well as on the frequency and height of major amputations in patients suffering from paod stage iv.


Eligibility criteria:
inclusion criteria: * subject is at least 45 years of age * subjects with macro-angiopathy, proven paod stage iv with up to 2 ischaemic skin lesions for more than 2 weeks * subject has a complete angiography of pelvis, thigh and calf within one month of inclusion * systolic ankle pressure ≤ 70 mmhg in subjects without media sclerosis of the lower limb artery or systolic big toe pressure ≤ 50 mmhg in diabetics with media sclerosis of the lower limb artery * subject is not in the position to be primarily revascularized or refuses surgery exclusion criteria: * imminent or foreseeable amputation * major amputation on the affected extremity * history of chronic alcohol or drug abuse * more than two ischemic ulcerations * one ulcer ≥ 6 cm\^2, both ulcers ≤ 1 cm\^2 or at least one ulcer affecting the bone or tendons * acute ischemia and peripheral vascular disorders of inflammatory or immunologic origin * neuropathic or venous ulcers * buerger's disease * septic gangrene * use of vasoactive medication or prostaglandins * treatment with prostanoids within 3 months prior to inclusion * surgical or interventional measures performed on the affected extremity within 3 months prior to study drug treatment

Keywords: alprostadil prostavasin paod fontaine stage iv