Kornimate/medical-research-clean huggingface dataset:
extended one-level interbody fusion for adjacent vacuum phenomenon in lumbar degenerative disc disease

Conditions: Adjacent Segment Degeneration

Summary: the main objective of this study was to validate the clinical effectiveness of interbody fusion with a one-segment extension for the treatment of adjacent segmental space discs in the surgical treatment of lumbar degeneration.

the study will include patients with lumbar degeneration who underwent 1-2 segment interbody fusion, and for patients with vacuum signs but no symptoms and no instability of the discs in the adjacent segments of the operated segments, lumbar interbody fusion will be extended by one segment, and the patients will be followed up annually in the immediate postoperative period, in march, june, and in the period of 1-5 years, and lumbar mr will be taken at the time of follow-up to determine the degree of progression of the degeneration in the neighboring segments, and whether or not revision surgery is needed. the lumbar spine was photographed in the frontal and lateral + anterior flexion and posterior extension x-rays and ct-3d reconstruction to determine the bony fusion of the interbody fusion. in addition, the lumbar spine odi score was applied for evaluation at the follow-up visit, and the total lumbar spine-related expenses of the patients up to the follow-up visit were recorded.

Eligibility criteria:
inclusion criteria: * the age was between 18-60 years old; patients with lumbar degeneration required 1-2 segment interbody fusion, and there were vacuum signs but no symptoms and no instability of the discs in the adjacent segments (power position slip ≤3mm and segmental angle change ≤10°); they agreed with the surgical plan and were willing to undergo long-term clinical follow-up, and signed an informed consent form. exclusion criteria: * drug or alcohol abusers; those with abnormal liver or kidney function unsuitable for surgery; those with cardiac insufficiency unsuitable for surgery; those with severe metabolic and endocrine diseases unsuitable for surgery; those with severe lung disorders such as asthma and abnormal lung function unsuitable for surgery; pregnant and breastfeeding women as well as those who are planning to become pregnant in the near future; those who have participated in other clinical trials within 3 months; and those who are not suitable for participation in the experiment in the opinion of the investigator.
an investigational study of experimental medication bms-986165 in healthy participants to study electrocardiogram effects

Conditions: Systemic Lupus Erythematosus; Healthy Participants

Summary: this is a study to investigate the experimental medication bms-986165 in healthy participants in order to study the effects it has on electrocardiogram results.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * healthy as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations in the opinion of the investigator * body mass index of 18.0 to 32.0 kg/m2, inclusive, and body weight ≥ 50 kg, at screening * normal renal function at screening as evidenced by an estimated glomerular filtration rate (gfr) \> 80 ml/min/1.732 m2 exclusion criteria: * any medical condition that presents a potential risk and/or may compromise the objectives of the study, including a history or presence of active liver disease * a personal history of clinically relevant cardiac disease as determined by the investigator, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure) * history of hypokalemia, personal history or family history of prolonged qt interval, or family history of sudden cardiac death at a young age other protocol defined inclusion/exclusion criteria could apply
dose escalation study of qr-010 in homozygous δf508 cystic fibrosis patients

Conditions: Cystic Fibrosis

Summary: a randomized, double-blind, placebo-controlled study of single and multiple ascending doses of qr-010 in adults homozygous for δf508 cystic fibrosis.

the purpose of this study is to evaluate the safety, tolerability, and to determine the pharmacokinetics of qr-010 administered via inhalation in adult homozygous for δf508 cystic fibrosis.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cf as defined by iontophoretic pilocarpine sweat chloride test (sweat chloride) of \> 60 mmol/l * confirmation of cftr gene mutations homozygous for the δf508 mutation * body mass index (bmi) ≥ 17 kg/m2 * non-smoking for a minimum of two years * fev1 ≥70% of predicted normal for age, gender, and height, at screening * stable lung function * adequate hepatic and renal function exclusion criteria: * breast-feeding or pregnant * use of lumacaftor or ivacaftor * use of any investigational drug or device * history of lung transplantation * hemoptysis

Keywords: cystic fibrosis δf508 rna therapies antisense oligonucleotide cftr f508del cf rna therapy
food groups associated with anaemia in pregnant women

Conditions: Anemia; Dietary Habits; Food Habits

Summary: this study investigates the association between locally consumed food items with anemia among pregnant women, in addis ababa city, ethiopia.

prevention of anemia among women, particularly pregnant women, is a priority nutrition agenda in ethiopia. anemia is a significant contributor to poor pregnancy outcomes, including low birth weight and maternal mortality. anemia is of multiple influences, which in most of the cases include dietary factors. consumption food items rich in iron and other nutrients involved in red blood cell production promotes optimal hemoglobin level. dark green leafy vegetables, meat, and beans are some of the food groups reported to be associated with lesser risk of anemia. studies on the relation of indigenous food items with health outcome are limited in developing countries. for example, teff, consumed only in ethiopia and parts of eritrea, is traditionally believed to be protective of anemia because of its high iron content, but khat chewing, a pervasive social practice in ethiopia, has been associated with restrictive eating pattern and anemia. in this study, the association of locally consumed food groups with anemia was investigated among pregnant ethiopian women.

Eligibility criteria:
inclusion criteria: * pregnant women * age 18 years and above * residence in addis ababa city exclusion criteria: * serious medical illness
effect of mediterranean diet in dyslipidemic patients

Conditions: Dyslipidemias

Summary: the purpose of this randomized cross-over clinical trial is to examine the effects of mediterranean diet based intervention on inflammation, metabolic risk and microbiome in patients with dyslipidemia.


Eligibility criteria:
inclusion criteria: * one or more of this criteria (total cholesterol ≥ 200mg/dl, ldl- cholesterol ≥130 mg/dl, triglyceride ≥ 200mg/dl) * if woman of child bearing potential, agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug * able to speak and read korean * able to comply with all required study procedures and schedule * willing and able to give written informed consent * participants who are not participating in other clinical trials. exclusion criteria: * participants with cancer treatment * participants with uncontrolled hypertension (systolic blood pressure (sbp) \>180 mmhg, or diastolic blood pressure (dbp) \>120 mmhg) * participants with uncontrolled diabetes or fasting glucose ≥ 200mg/dl) * participants with hepatic disease (aspartate aminotransferase (ast)/alanine aminotransferase (alt) \>3 x institutional upper limit of normal) or renal disease (serum creatinine \>2.0 mg/dl) * participants with significant cardiovascular disease (ischemic heart disease or stroke) * participants who are taking lipid-lowering medications. * participants who are taking other clinical trial medications. * participants with acute infectious disease such as pneumonia, acute gastroenteritis, and urinary tract infection. * vegetarian (does not eat red meat, poultry or fish) * participants with food allergy (sea food, fish, nuts, egg, meat, tomato, wheat, or soybean) * participants who are not able to eat more than 10 mediterranean meal in a row. * any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study

Keywords: dyslipidemia mediterranean diet microbiome inflammation metabolic risk
pacing in first-degree av-block

Conditions: First-degree AV-block; Pacing

Summary: the purpose of this study is to explore if there is a less harmful way to pace patients with first-degree av-block to ensure that the negative effects inferred by the pacing do not outweigh the positive effects of av-synchrony. the main hypothesis of the study is that his-bundle pacing will offer a more physiological mode of pacing in patients with first-degree av-block than conventional pacing. patients scheduled for catheter ablation of atrial fibrillation (af) in sinus rhythm, with first degree av-block, normal qrs duration less than 120 ms and normal left ventricular ejection fraction will be included. during the af ablation three different pacing modes (atrial, av-synchronous and his-bundle pacing) at two different rates (5 to10 bpm above the basal rate and at 100 bpm) will be performed and evaluated using echocardiography. after the completion of all six pacing protocols (i.e., three modes at two different rates) the experimental part of the procedure ends. the primary end-point will be echocardiographic evidence of dyssynchrony. secondary end-points will include left ventricular ejection fraction, left ventricular volume, mitral regurgitation, septal to posterior wall motion delay and inter-ventricular wall motion delay. since the research study is conducted in parallel with the standard catheter ablation, we do not anticipate any additional side effects as a result of the study.


Eligibility criteria:
inclusion criteria: * patients scheduled for catheter ablation of atrial fibrillation in sinus rhythm and pr prolongation exceeding or equal to 200 ms * qrs duration less than 120 ms * normal left ventricular ejection fraction on echocardiography. exclusion criteria: * any bundle branch block * second- or third-degree av-block * congestive heart failure, cardiomyopathy, myocardial infarction or major surgical procedure.
effectiveness of paritaprevir/ritonavir, ombitasvir, + dasabuvir, ± ribavirin in patients with chronic hepatitis c in romania

Conditions: Chronic Hepatitis C

Summary: this study seeks to provide evidence of the effectiveness and obtain patient reported outcome (pro) data for the interferon-free regimen of paritaprevir (ptv)/ritonavir (r) + ombitasvir (obv), + dasabuvir (dsv), +/- ribavirin (rbv) in participants with chronic hepatitis c (chc) in a real life setting across clinical practice patient populations in romania.


Eligibility criteria:
inclusion criteria: treatment-naïve or -experienced adult male or female patients with confirmed chc, genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir and ombitasvir with dasabuvir ± rbv according to standard of care and in line with the current local label if rbv is co-administered with the paritaprevir/ritonavir and ombitasvir with dasabuvir, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy) patients must voluntarily sign and date a patient authorization to use and/or disclose his/her anonymized health data prior to inclusion into the study patient must not be participating or intending to participate in a concurrent interventional therapeutic trial exclusion criteria: none

Keywords: chronic hepatitis c paritaprevir ombitasvir dasabuvir hcv
effect of remifentanil on the bispectral index in women undergoing caesarean delivery under general anaesthesia

Conditions: Intraoperative Awareness

Summary: patients undergoing caesarean delivery under inhalation anaesthesia are at a high risk of awareness, especially in the period before delivery. the investgators assessed the effects of remifentanil on the bispectral index (bis) in the interval before delivery.

sixty primipara undergoing elective cesarean delivery were randomly assigned to receive remifentanil 1 μg kg-1 (r1) or 0.5 μg kg-1 (r0.5), or saline (control) over 15 s with induction of anesthesia using propofol 2 mg kg-1 and suxamethonium 1.5 mg kg-1.the investgators assessed the average value of bis at the time period of before, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery. the investgators also determined the neonatal apgar scores, and conducted umbilical artery blood gas analysis.

Eligibility criteria:
inclusion criteria: * asa physical status i or ii who elected to undergo caesarean section, under general anaesthesia exclusion criteria: * multiple fetuses,preterm delivery, known fetal anomalies, pregnancy-induced hypertension, or any other medical complication

Keywords: remifentanil bispectral index caesarean delivery general anesthesia
study of immunogenicity and safety of a booster dose of dtap-ipv-hb-prp~t combined vaccine in healthy turkish infants

Conditions: Diphtheria; Polio; Pertussis; Hepatitis B

Summary: this is a follow-up of study a3l10 (nct00315055) immunogenicity * to describe the antibody persistence following a primary series vaccination of either dtap-ipv-hb-prp\~t or pentaxim™ and engerix b®. * to describe the immunogenicity of a booster dose of dtap-ipv-hb-prp\~t. safety - to describe the safety profile after a booster dose of dtap-ipv-hb-prp\~t.


Eligibility criteria:
inclusion criteria: * toddler previously included in study a3l10 who completed the three-dose primary series vaccination of either dtap-ipv-hb-prp\~t or pentaxim™ and engerix b® at 2, 3 and 4 months of age. * toddler of 15 to 18 months of age (range: 456 to 578 days of age inclusive). * informed consent form signed by the parent(s) or other legal representative(s) and an institution official other than an investigator. * able to attend all scheduled visits and to comply with all trial procedures. exclusion criteria: * participation in another clinical trial in the 4 weeks preceding the booster vaccination. * planned participation in another clinical trial during the present trial period. * congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy. * systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances. * chronic illness at a stage that could interfere with trial conduct or completion. * blood or blood-derived products received in the last 3 months. * any vaccination in the 4 weeks preceding the booster vaccination. * any vaccination planned until second visit. * history of documented pertussis, tetanus, diphtheria, polio, haemophilus influenzae type b or hepatitis b infection(s) (confirmed either clinically, serologically or microbiologically). * previous booster vaccination against pertussis, tetanus, diphtheria, polio or haemophilus influenzae type b, and hepatitis b infection(s). * coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination. * any vaccine-related serious adverse event that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in study a3l10 (nct00315055). * febrile (temperature ≥ 38.0°c) or acute illness on the day of inclusion. * known contraindication to further vaccination with a pertussis vaccine, i.e.: encephalopathy; temperature \> 40.0°c within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series; inconsolable crying that occurred for \> 3 hours within 48 hours following vaccine injection during the primary series; hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series; seizures with or without fever within 3 days following vaccine injection.

Keywords: hepatitis b polio diphtheria pertussis h.influenzae type b
weighted pacifier vs. non-weighted pacifier

Conditions: Non-nutritive Sucking

Summary: this study will determine if it is beneficial to use a weighted pacifier in neonates.

rci-pacifiers have been utilized for decades in the nicu to provide benifical non-nutritive suck. they have been instrumental in transitioning premature infants from gavage to breast feeding yiallouerou, s, et al, studied the effects of dummy/pacifier on autonomic activity during sleep and found pacifier use to be protective during sleep. risks and benefits of pacifiers have cleary been identified sexton, s and natsale, r have identified that nonnutritive suck is a natural reflex for a fetus and newborn. traditionally, the pacifier has been used as a method for fulfilling an infants innate desire to suckle. study subjects will be introduced to either a standard/traditional pacifier (without stabilizing/weighted attachment) or a stabilizing/weighted pacifier. standard/traditional pacifiers will be issued to patients that have been assigned an odd number study identifier and , stabilzing/weighted pacifiers will be issued to patients that have been assigned an even number study identifier. all eligible infants born at 30 weeks to 37.6 weeks who meet study criteria will be included. all staff/caregivers will be trained in proper placement of a stabilizing pacifier prior to use. stabilizing pacifiers will not be placed on the infants chest. traditional pacifiers will be used as standard of care at eh. the neonatal infant pain score (nips) scale and a caregiver survey will be used to determine efficacy.

Eligibility criteria:
inclusion * 30 week-37.6 gestational age * patient is admitted to the nicu * the patient has the ability to suck as noted in the patient's infant assessment flow sheet prior to enrollment exclusion * patient with an oral pharyngeal defect * patient with an oral feeding tube * patient with any medical reason that deems them unfit for the study as '''''''determined by the neonatologist * patient with sustained apnea during sucking
study of dacomitinib (pf-00299804) in advanced nsclc patients (post chemo or select first line) to evaluate prophylactic intervention on derm and gi aes and pro

Conditions: Non Small Cell Lung Cancer (NSCLC)

Summary: to assess the impact of prophylactic treatment on the incidence of adverse events in advanced nsclc patients (post chemotherapy) treated with dacomitinib daily as a single agent. to assess the impact of an interrupted dacomitinib dosing schedule in cycle 1 on the incidence of adverse events in first-line advanced nsclc patients with an egfr mutation (her-1 mutation, her-2 mutation or her-2 amplification).


Eligibility criteria:
inclusion criteria: * advanced non-small cell lung cancer (nsclc). * for cohort i and cohort ii, advanced nsclc patients must have received at least one prior regimen of systemic therapy which includes at least one standard chemotherapy for advanced nsclc and who have failed (ie, progressed or intolerant due to toxicity which precludes further treatment) standard therapy for advanced or metastatic disease. to be considered intolerant to treatment, a patient must have received at least two cycles to be considered previously treated. * for cohort iii, advanced nsclc patients must not have received prior systemic treatment for their advanced disease and require a known egfr (her-1) mutation, her-2 mutation or her-2 amplification. cohort iii patients could have received prior adjuvant chemotherapy for stage i-iii disease or combined modality chemotherapy-radiation for stage iiia disease is allowed if treatment completed\>12 months prior to enrollment. * all cohorts, patients must have evidence of disease; however, measurable disease is not required to enroll. * eastern cooperative oncology group (ecog) performance status 0-2 * estimated creatinine clearance ≥15 ml/min. exclusion criteria: * prior treatment with an egfr-targeted or her-targeted agent (all cohorts). * chemotherapy, radiotherapy, biological or investigational agents within 2 weeks of baseline disease assessments (all cohorts). * patients with known diffuse interstitial lung disease (all cohorts). * investigational therapy as only treatment for advanced nsclc without administration of an approved chemotherapy for advanced nsclc (for cohort i and cohort ii)

Keywords: non-small cell lung cancer advanced previously treated
association of asprosin in periodontitis and acute coronary syndrome

Conditions: Cardiovascular Diseases; Periodontal Diseases

Summary: asprosin, a recently discovered glucogenic adipokine, is mainly synthesized by white adipose tissue and released during fasting. appetite, glucose metabolism, insulin resistance, cell apoptosis, etc. asprosin is associated with diseases such as diabetes, obesity, polycystic ovary syndrome, and cardiovascular diseases. periodontal tissue may act as a source of endocrine-like inflammatory mediators (such as tnf-α, il-6 and il-1) that are important in periodontal inflammation and can affect glucose and lipid metabolism. production of tnf-α and il-6 in adipose tissues strengthens the relationship between cardiovascular diseases and periodontitis. investigators postulated that asprosin may be a candidate for explaining the triangular relationship between cardiovascular and periodontal disease.

periodontal disease is a chronic, multifactorial, and infectious disease caused by bacteria. it is characterized by the formation of an inflammatory response in the supporting bone and connective tissue against microbial dental plaque, and the nature of the resulting inflammatory response determines the course of periodontal disease. cardiovascular and periodontal diseases are closely related, presenting a triad association. asprosin circulates in the blood at nanomolar levels and is taken to the liver, where it activatesinvestigators the g protein-camp-pka pathway, causing rapid glucose release into the circulation.

Eligibility criteria:
inclusion criteria: for healthy group * all individuals were generally healthy, * non-smoking for myocard infarctus group * patients with st elevation of myocardial infactus * patient with less than ten teeth exclusion criteria: * smokers or those with diabetes or other inflammatory disease * pregnant or breastfeeding women * none had undergone periodontal therapy and/or antibiotic therapy in the past 6 months. * none has a contagious disease such as hiv or aids