Kornimate/medical-research-clean huggingface dataset:
progressive ventricular dysfunction prevention in pacemaker patients

Conditions: Cardiac Pacing Indication classI/IIa According AHA/ACC

Summary: the purpose of this pilot study is to evaluate the progression of ventricular dysfunction in patients with ventricular dysfunction within the permanent pacing population.

the interventricular synchrony is one of the components of a proper cardiac function. when there is no synchrony -as in left bundle block (lbbb)- the clinic consequences should have little importance in patients with a healthy heart or a great importance in patients suffering heart failure (hf), specially in those with severe grade of hf, the benefit of cardiac resynchronization by pacing both ventricles or left ventricle (lv)should means healthy improvement in patients. all previous studies done in hf, are in patients with symptomatic hf. the importance of stop progression of latent hf in patients with asymptomatic ventricular dysfunction (vd)in permanent pacing indication patients. pacing may accelerate hf progression by dissincronyzing ventricles. ace inhibitors studies in asymptomatic vd gave positive results. the prevent-hf is an international, multicenter, prospective, randomized, single-blinded pilot trial specifically designed to evaluate as main objective the progression of vd in permanent pacing population.

Eligibility criteria:
inclusion criteria: * meet class i and/or class iia implantation criteria for permanent cardiac pacing according to the guidelines given by the american college of cardiology (acc)/american heart association(aha). exclusion criteria: * expected ventricle stimulation \<80% of the time * impossibility of dual chamber stimulation in the absence of af * severe heart failure (nyha functional class iii-iv) previous to indication for pacing device implant * patient needs revascularization within 3 months * myocardial infarction in the last 3 months * cardiac surgery performed in the last 3 months * hypertrophic cardiomyopathy * constrictive pericarditis * bad echo window * previous system implanted (icd or pacemaker) * aortic stenosis * patient has a mechanical right heart valve * patient \<18 years * pregnancy * patient has medical conditions that would preclude the testing required by the protocol, or limit study participation * life expectancy \<1year * patient is unwilling or unable to cooperate or give written informed consent. * patient is or will be inaccessible for follow-up at the study center. * patients who are participating or planning to participate in other clinical trials during the clinical study

Keywords: permanent pacing artificial internal
a trial to compare the pharmacokinetics of tralokinumab in healthy subjects

Conditions: Healthy

Summary: the purpose of this trial is to compare the pharmacokinetics (pk), safety, tolerability and immunogenicity of a single dose of 300 mg tralokinumab administered as a 1 × x ml subcutaneous (sc) injection with device a and 2 × y ml consecutive sc injections with device b.

this is a single center, randomized, open label, 2 period, 2 sequence cross over trial designed to compare the pk and to evaluate the safety, tolerability and immunogenicity of 300 mg tralokinumab administered as a 1 × x ml sc injection with device a (test treatment \[t\]) and 2 × y ml consecutive sc injections with device b (reference treatment \[r\]) in healthy subjects. additionally, the experience of tralokinumab being administered with device a compared to device b will be evaluated. after being informed about the study and the potential risks, all subjects giving written informed consent will be enrolled and randomized to 1 of 2 treatment sequences, sequence tr or sequence rt in a 1:1 ratio (i.e., subjects receive the 2 treatments in the specified order).

Eligibility criteria:
inclusion criteria: * healthy male or female aged 18 to 55 years (both included) at the time of screening. * female subjects of childbearing potential must use a highly effective form of birth control throughout the trial and at least for 16 weeks after last administration of the investigational medicinal product (imp) and must have a negative serum pregnancy test at screening. exclusion criteria: * systemic (non biologic) or topical treatment within 21 days prior to first dose administration unless in the opinion of the investigator the medication will not interfere with the trial procedures or compromise safety. * active tuberculosis or history of incompletely treated tuberculosis based on medical history or medical report. * history of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (hiv) test at screening, or the subject taking antiretroviral medications as determined by medical history and/or subject's verbal report. * history of a clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to randomization. * history of a helminth parasitic infection within 6 months prior to the date of informed consent that has not been treated with or has failed to respond to standard of care therapy. * history of anaphylaxis or severe allergic reaction following any biologic therapy
prospective multi-centre outcomes study of persona knee system in total knee arthroplasty

Conditions: Knee Osteoarthritis

Summary: this is a prospective, multi-centre, non comparative, post market clinical follow-up study involving orthopaedic surgeons skilled in tka and experienced implanting the devices included in this study.

the objectives of the study are to document the implant survivorship and clinical outcomes data for the persona fixed bearing implants used in primary total knee arthroplasty (tka). the study will include a maximum of 20 centres and up to 1000 implanted knees. each centre may enrol up to a maximum of 100 implanted knees to permit assessment of the consistency of outcomes across a variety of investigators and clinical settings.

Eligibility criteria:
inclusion criteria: * age 18 to 80 years old, inclusive * qualifies for a primary tka based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following: 1. rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. 2. collagen disorders and/ or avascular necrosis of femoral condyle. 3. post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. 4. moderate valgus, varus or flexion deformities. 5. the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee. * participated in a study-related informed consent process. * willing and able to provide written informed consent by signing and dating the irb/ec approved informed consent form. * willing and able to complete scheduled study procedures and follow-up evaluations. * independent of study participation, patient is a candidate for commercially available persona fixed bearing knee system implanted in accordance with product labelling. exclusion criteria: * currently participating in any other surgical intervention studies or pain management studies. * previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint. * insufficient bone stock on femoral or tibial surfaces/ * skeletal immaturity * neuropathic arthropathy * any loss of musculature or neuromuscular disease that compromises the affected limb. * stable, painless arthrodesis in a satisfactory functional position. * severe instability secondary to the absence of collateral ligament integrity. * rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin. * known or suspected sensitivity or allergy to one or more of the implant materials. * pregnant or considered a member of a protected population (e.g. prisoner, mentally incompetent, etc.) * previously received partial or total knee arthroplasty for the ipsilateral knee.
grazoprevir and elbasvir without ribavirin for 12 weeks in patients with hcv-related cryoglobulinemic nephropathy

Conditions: Hepatitis C; Cryoglobulinaemic Glomerulonephritis

Summary: cryokid is a no-profit, multi-center, single-arm, open-label, pilot study. the study aims to evaluate the tolerability of mk-8742 (elbasvir) / mk-5172 (grazoprevir) administrated for 12 weeks without ribavirin in patients with hcv chronic hepatitis (g1b and g4) and cryoglobulinemic nephropathy.


Eligibility criteria:
inclusion criteria: 1. informed consent form signed, 2. male or female at least 18 years of age at time of screening. 3. chronic infection with hepatitis c virus g1b 4. chronic infection with hepatitis c virus g4 naïve, and experienced with baseline hcv rna level \<800,000 iu/ml 5. metavir score ranging between f0-f4 (with child-pugh score ranging from a5 to a6) 6. diagnosis of mixed cryoglobulinemia mc (type iii or ii) according to standard criteria 7. chronic renal impairment due to cryoglobulinemic nephropathy. subjects with renal impairment will include ckd stage 5 (egfr \< 15ml/min or dialysis dependent), ckd stage 4 (egfr 15-29 ml/min), ckd stage 3 egfr (30-59 ml/min) and ckd stage 2 (60-89 ml/min) hcv patients. 8. albumin level ≥ 3.0 g/dl, 9. platelet count ≥ 75 x 103/μl. exclusion criteria: 1. age \<18 years 2. chronic infection with hepatitis c virus g4 experienced with baseline hcv rna level \>800,000 iu/ml 3. patients with hcv genotype 1a, 2, 3, 5, 6, 4. coexistence of life-threatening condition(s) unrelated to mc 5. diagnosis of malignancy 6. pregnancy or breast feeding. 7. child-pugh score \> a6 8. decompensated cirrhosis or previous decompensation 9. platelet count \< 75 x 103/μl 10. albumin level \< 3 g/l 11. co-infection with more than one hcv genotype. 12. any serious or active medical illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance 13. hiv or chronic hepatitis b virus (hbv) infection (hbsag positive) 14. known hypersensitivity to grazoprevir, elbasvir or any of its components
a study of taspoglutide versus placebo for the treatment of patients with type 2 diabetes mellitus inadequately controlled with diet and exercise.

Conditions: Diabetes Mellitus Type 2

Summary: this 3 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly) or placebo. after the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). the anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-80 years of age; * drug naive patients with type 2 diabetes uncontrolled with diet and exercise; * tested negative for anti-glutamic acid decarboxylase (anti-gad) antibodies; * c-peptide (fasting) \>=1.0ng/ml * hba1c \>=6.5% and \<=10.0% at screening; * bmi \>=25 (\>23 for asians) and \<=45kg/m2 at screening; * stable weight +/- 5% for at least 12 weeks prior to screening. exclusion criteria: * history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months; * evidence of clinically significant diabetic complications; * symptomatic poorly controlled diabetes; * myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months; * known hemoglobinopathy or chronic anemia.
prospective randomized controled study on the outcome of greenhouse tec in the arthroscopic treatment of small to medium rotator cuff tear

Conditions: Bone Marrow Stimulating; Modified Suture Bridge

Summary: this study is aprospective cohort study on the outcome of a combination of bone marrow stimulation and modified suture bridge in the arthroscopic treatment of small and medium rotator cuff tear. the patients with small to medium rotator cuff injuries (less than 3cm in diameter) requiring arthroscopic surgery were collected. the patients were followed up before and 6 weeks, 3 months, 6 months and 12 months after surgery, including pain, functional score, joint range of motion, mri and ct findings, complications and other quantitative and qualitative indicators. the self-control and intra group analysis were performed to evaluate the treatment effect; and the correlation analysis was performed on the treatment results to determine the important factors affecting the therapeutic effect.


Eligibility criteria:
inclusion criteria: * arthroscopy confirmed small to medium rotator cuff injury * the data of preoperative functional examination were complete * unilateral rotator cuff injury * clinical follow-up can be completed exclusion criteria: * anterior superior rotator cuff injury with simple subscapular injury or combined subscapular injury * previous shoulder surgery (incision or arthroscopy) * combined with diseases of other parts of the same limb * combined with bankart injury, acromioclavicular joint disease, greater tuberosity fracture, glenoid fracture and so on * bilateral onset * unable or unwilling to receive clinical follow-up

Keywords: rotator cuff repair
respiratory problems and caries in children with bruxism

Conditions: Bruxism; Dental Caries

Summary: the aim of the present study are to determine whether there is an association between respiratory problems and dental caries in children who exhibit the habit of bruxism.

objectives: the aim of the present study was to determine whether there is an association between respiratory problems and dental caries in children who exhibit the habit of bruxism. method: patient histories were taken and clinical exams were performed on 90 children for selection and allocation to one of two groups. for the determination of bruxism, a questionnaire was administered to parents/guardians and an oral clinical exam was performed based on the criteria of the american academy of sleep medicine. thirty-three male and female children between four and seven years of age participated in the present study - 14 children with bruxism and 19 children without bruxism. the data were statistically analyzed using the chi-square test, with level of significance set at 5% (p \< 0.05).

Eligibility criteria:
inclusion criteria: * children with either the complete primary or mixed dentition who were not in dental treatment exclusion criteria: * children in dental treatment

Keywords: bruxism children oral breathing dental caries
postoperative hypofractionated intensity-modulated radiation therapy in cervical cancer

Conditions: Cervix Cancer; Radiotherapy, Adjuvant; Radiotherapy, Intensity-Modulated; Hypofractionated Dose

Summary: to investigate the acute toxicities, late toxicities, and treatment results when the early cervical cancer patients are treated by hypofractionated intensity-modulated radiotherapy (2.5 gy x 16 fractions, once a day) after radical hysterectomy.


Eligibility criteria:
inclusion criteria: * histologically confirmed cervical cancer * radical hysterectomy and pelvic lymph node dissection was done * histologically indicated adjuvant radiotherapy ( more than one as below) 1. tumor size ≥4 cm 2. positive lymphovascular invasion 3. more than half stromal invasion depth * ecog performance status 0 or 1 * bone marrow function: granulocyte ≥1.0 x 1000/µl, platelet ≥30 x 1000/µl, hemoglobin ≥10 g/dl exclusion criteria: * positive pelvic lymph node metastasis * positive distant metastasis (including retroperitoneal lymph node metastasis) * positive tumor involvement on resection margin * positive parametrial invasion * previous history of pelvic radiotherapy * more than 3 months after radical surgery for cervical cancer * neoadjuvant chemotherapy was done * previous history of other carcinoma except for thyroid cancer, skin cancer, in situ carcinoma on cervix
utility of real time continuous glucose monitoring in the care of gestational diabetes versus standard care in pregnancy outcomes

Conditions: Gestational Diabetes

Summary: once a pregnant mother is diagnosed with gestational diabetes mellitus (gdm), she will be treated with either diet, medication (i.e., insulin), or both. the most important factor in gdm management is glycemic control to reduce adverse outcomes. blood glucose levels have become the "key player" for monitoring and directing treatment during pregnancy. large trials have confirmed that treatment of gdm to optimize glycemic control can decrease the incidence of many of these associated adverse maternal and neonatal outcomes. up to now, smbg (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. however, smbg provides an incomplete picture of the daily glucose profile due to long intervals between finger pricking, and inaccurate self-reported measurements, which heavily rely on patients' compliance.

the incidence of obesity and diabetes is rising worldwide even in younger populations. with a rise in maternal obesity also gestational diabetes mellitus (gdm) becomes more prevalent with a prevalence of up to 18% of pregnancies. up to now, smbg (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. the main purpose of this study is to prove that real time continuous glucose monitoring (rt-cgm) can effectively reduce the risk for adverse pregnancy and neonatal outcome in gdm. it is further hypothesized that rt-cgm can optimize maternal glycaemic control, increase patients satisfaction and adherence to management strategies of gdm. this is a open label randomized controlled trial with two parallel groups.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * gdm diagnosis between 24 0/7- 28 0/7 weeks of pregnancy by a 75g oral glucose test (ogtt) * maternal age of 18 to 45 years, * singleton gestation * gestational age ≥ 24 0/7 weeks and \<32 0/7 weeks at enrollment. exclusion criteria: * known hypersensitivity or allergy to the sensor * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders of the participant * participation in another study with investigational drug or product within the 30 days preceding and during the present study * maternal age \< 18 years, * multi-fetal gestations, * known fetal structural or chromosomal anomalies * chronic use of medications associated with hyperglycemia (steroids) * planned preterm delivery * overt diabetes mellitus type 1 or 2 * hba1c by study entry \> 6.5% * history of bariatric surgery or other surgeries that induce malabsorption * fetal growth restriction by study entry
a study of olezarsen administered subcutaneously to participants with severe hypertriglyceridemia

Conditions: Severe Hypertriglyceridemia

Summary: the purpose of this study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (tg) from baseline.

this is a phase 3, multi-center, randomized, double-blind, placebo-controlled study in 446 participants. participants will be randomized to receive olezarsen or placebo in a 53-week treatment period. the length of participation in the study will be approximately 78 weeks, which includes an up to 12-week screening period, a 53-week treatment period, and a 13-week post-treatment evaluation period or transition to open-label extension (ole) study with up to 1-year treatment.

Eligibility criteria:
inclusion criteria: 1. fasting tg ≥ 500 mg/dl (5.65 mmol/l) at screening and qualification 2. participants must be on lipid-lowering therapy that should adhere to standard of care (soc) per local guidelines. lipid-lowering medications should be optimized and stabilized for at least 4 weeks prior to screening to minimize changes in these medications during the study. 3. participants must be willing to comply with diet and lifestyle recommendations as able. exclusion criteria: 1. hemoglobin a1c (hba1c) ≥ 9.5% at screening 2. alanine aminotransferase or aspartate aminotransferase \> 3.0 × upper limit of normal 3. total bilirubin \> 1.5 uln unless due to gilbert's syndrome 4. estimated gfr \< 30 ml/min/1.73 m\^2

Keywords: hypertriglyceridemia hyperlipidemias metabolic diseases
implementation of lucas 2 in helicopter rescue in south tyrol

Conditions: Cardiac Arrest

Summary: cardiopulmonary resuscitation (cpr) is used to maintain adequate perfusion of vital organs in cardiac arrest patients and is fundamental for the neurological outcome and survival of these individuals. unfortunately, the quality of cpr may be inadequate due largely to ineffective chest compressions resulting from rescuer fatigue and interruptions in compressions. the lucas device (lund university cardiopulmonary assist system, jolife, lund, sweden), introduced in 2002, is the most extensively tested and applied automated alternative to manual cpr for in-hospital care of cardiac arrest patients and during ambulance transfer; the feasibility of application of this device in helicopter emergency medical service (hems) operations, however, has never been addressed. the objective of this project is to equip the three active rescue helicopters in south tyrol with the lucas 2 mechanical chest compression device to answer the question: what is the feasibility and efficiency of using this device for prolonged cpr in cardiac arrest patients requiring cpr during hems rescue operations and transport?

this is a non-controlled, observational study. physiological endpoints: map (mean arterial pressure); etco2 (end-tidal expiratory pco2); rosc (return of spontaneous circulation); pao2 (arterial po2); paco2 (arterial pco2); endpoints to assess feasibility: time from arrival to start of mechanical compressions, problems during transfer into the helicopter and in-field manoeuvers, problems with application of device, problems with patient transfer to hospital premises, hands-off time, personnel requirements.

Eligibility criteria:
inclusion criteria: * cardiac arrest with indication of cpr * informed consent for those regaining legal competence exclusion criteria: * declaration of death on site * contraindications of using the device * age \<18 y