Kornimate/medical-research-clean huggingface dataset:
rate responsive pacing in patients with permanent af underwent av node ablation and biventricular pacing (responsible)

Conditions: Left Ventricular Dysfunction; Atrial Fibrillation

Summary: the purpose of this study is to evaluate the effect on distance covered in a 6 minute walking test of rate responsive pacing in patients with permanent atrial fibrillation and reduced left ventricular ejection fraction treated with atrioventricular junction ablation and biventricular pacing.

patients with permanent atrial fibrillation and reduced left ventricular ejection fraction treated with atrioventricular junction ablation and biventricular pacing will be enrolled. two 6' walking test (6wt), one during vvi 70/min biventricular pacing (rr off) and the other during vvir 70-120/min biventricular pacing (rr on), will be performed one week apart; patients will be randomly and blindly assigned with a 1:1 ratio to group a (first 6wt rr off) or b (first 6wt rr on). the difference between the two tests will be recorded.

Eligibility criteria:
inclusion criteria: * permanent, refractory atrial fibrillation treated with atrio-ventricular node ablation and biventricular pacing * left ventricular systolic dysfunction * ability to perform a 6-minute walking test * completion of the 18th year of age exclusion criteria: * contraindications to 6 minute walking test * iv nyha class
randomized blinded evaluation of the effects of tens and ifc compared to a sham device and soc in patients with non-specific clbp

Conditions: Non-Specific Chronic Lower Back Pain

Summary: this is a prospective, sham-controlled, randomized, single-blinded, multi-center study comparing two different modes of the nexwave device, transcutaneous electrical nerve stimulation (tens) and interferential current (ifc), with an identical non-functioning nexwave sham device or self-defined standard of care for improvement of pain intensity of non-specific clbp.


Eligibility criteria:
inclusion criteria: * ages 18-70, or older if specified by law * non-specific chronic lower back pain defined as: 1. having lasted ≥3 months in duration 2. current visual analogue scale (vas) pain rating ≥50 out of 100 (or an equivalent of 5 out of 10 on a 10-point scale) 3. no radiating pain below the knee 4. ≥75% back or buttock pain rather than lower extremity pain * subjects who are willing and capable of providing informed consent * subjects who are willing and capable of participating in all testing and questionnaire requirements associated with the clinical study exclusion criteria: * any prior home use of the nexwave or any tens/ifc device * any history of lumbar spine surgery or spinal fractures * subjects with a history of rheumatic disease * subjects with spine disorders, deformities, or severe spinal conditions such as scoliosis and kyphosis, pott's disease, disc protrusion, or others that can be attributed to specific causes of back pain * subjects currently prescribed and adherent to opioid therapy * current implanted cardiac pacemakers, defibrillators, cardiac pumps, spinal stimulators, or other implanted electronic devices * active psychiatric or uncontrolled mood disorders including subjects on antipsychotic medication, diagnosis of bipolar disorder or schizophrenia, or uncontrolled anxiety or clinical depression * subjects with a known history of allergic reactions to medical adhesives or any condition that could affect placement of the electrodes * women of childbearing potential who are pregnant or who are planning to become pregnant during the anticipated study period * subjects with health conditions that in the investigator's medical opinion would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation * subjects who are currently enrolled in another investigational study that would directly interfere with the current study

Keywords: tens ifc
carvedilol vs. propranolol in second prophylaxis of variceal bleeding

Conditions: Portal Hypertension; Varice Bleed; Cirrhosis, Liver

Summary: this randomized controlled trial was conducted to evaluate the efficacy and safety of carvedilol versus propranolol, combined with routine endoscopic treatment, in the secondary prophylaxis of variceal bleeding in patients with cirrhosis.

non-selective beta blockers combined with endoscopic variceal band ligation (evl) is the most effective methods for the prevention of variceal bleeding. carvedilol has emerged as the preferred nsbb for treating portal hypertension in compensated cirrhosis due to strong evidence demonstrating that it has a more pronounced effect than propranolol to reduce the hepatic vein pressure gradient (hvpg), together with good patient acceptability and safety profile. however, no data from prospectively designed trials are available on the efficacy of carvedilol in the secondary prophylaxis of variceal bleeding. the aim of this randomized controlled trial was to evaluate the effectiveness and safety of carvedilol compared to propranolol as secondary prophylaxis of variceal bleeding in patients with cirrhosis. all cirrhotic patients with at least one episode of variceal bleeding were included and randomized to the carvedilol or propranolol groups. evl protocol was routinely performed in both groups. variceal rebleeding, further decompensation, liver-related death, and overall survival was the outcomes of this trial.

Eligibility criteria:
inclusion criteria: * between 18 and 80 years old; * with liver cirrhosis diagnosed by previous biopsy or by clinical criteria, and analytical image; * at least 5 days after index variceal bleeding; * informed consent. exclusion criteria: * refusal to participate in the study; * portal hypertension resulting from other causes than liver cirrhosis; * more than 42 days after index variceal bleeding; * bleeding from cardiofundal gastric varices; * portal venous thrombosis \>50% of the portal vein trunk; * contraindications to beta-blockers (asthma, chronic obstructive pulmonary disease, atrioventricular block, heart failure, bradycardia with hr ≤40 bpm, arteria hypotension with systolic blood pressure \<90 mm hg, peripheral arterial disease, uncontrolled diabetes); * prior nsbb+evl combined treatment, tips implantation or surgical shunt as secondary prophylaxis of variceal bledding; * chronic kidney disease; * pregnancy or lactation; * neoplastic disease.
comparison of restoration in vitreous hemorrhage patients with dme after or not removing inner limiting membrane

Conditions: Macular Edema Due to Diabetes Mellitus; Vitreous Hemorrhage

Summary: this study is conducted to compare the anti-vegf effect and visual function in vitreous hemorrhage patients with diabetic macular edema after pars plana vitrectomy with inner limiting membrane peeling or not


Eligibility criteria:
inclusion criteria: * patients with vitreous hemorrhage with diabetic macular edema and require vitreous surgery exclusion criteria: 1. the patient's preoperative vitreous hemorrhage resulted in the failure of oct to scan the macular region 2. the patient with a history of anti-vegf therapy 3. patients with dme in the contralateral eye requiring anti-vegf therapy 4. patients with contraindications of vitreous cavity resection 5. the patient has a history of intraocular surgery 6. the patient has active inflammatory disease 7. the patient has other retinal diseases that affect vision 8. the patient has other systemic diseases that required treatment with anti-vegf drugs 9. patient with contraindications to anti-vegf therapy
effect of kinesio tape on oral and pharangeal swallowing phases in children with spastic cerebral palsy

Conditions: Dysphagia, Oropharyngeal, Cerebral Palsy

Summary: the purpose of current study is to investigate the effect of kinesio tape in children with spastic cerebral palsy having oropharyngeal dysphagia

the study tageted rhe children with spastic cerebral palsy from both sexes will be selected from hospital of tanta university inclusion criteria: 1. age ranges from 2 to 7 years. 2. the degree of dysphagia ranges from 4 to 6 level according to functional oral intake scale (appendix ii). 3. diagnosed as spastic diplegia or quadriplegia. 4. able to understand and follow instructions. exclusion criteria: children will be excluded if they have any of the following criteria: 1. severe visual and auditory problems. 2. history of maxillary, head or neck surgical procedures. 3. botulinum toxin treatment of upper esophageal sphincter dysfunction, esophageal dysphagia and/or gastroesophageal reflux disease during the previous six months.

Eligibility criteria:
inclusion criteria: 1. age ranges from 3 to 7 years. 2. the degree of dysphagia ranges from 4 to 6 level according to functional oral intake scale (appendix ii). 3. diagnosed as spastic diplegia or quadriplegia. 4. able to understand and follow instructions. exclusion criteria: children will be excluded if they have any of the following criteria: 1. severe visual and auditory problems. 2. history of maxillary, head or neck surgical procedures. 3. botulinum toxin treatment of upper esophageal sphincter dysfunction, esophageal dysphagia and/or gastroesophageal reflux disease during the previous six months.
an open-label study of the use of azithromycin in patients with symptomatic disseminated mycobacterium avium-intracellulare complex (mac) infection failing current therapy

Conditions: Mycobacterium Avium-Intracellulare Infection; HIV Infections

Summary: to evaluate the efficacy and safety of azithromycin given chronically for the treatment of mycobacterium avium (mac) bacteremia in patients failing or intolerant of current available mac therapy.


Eligibility criteria:
inclusion criteria patients must have: * disseminated mac as defined by current (within the last month) positive blood, bone marrow, or liver biopsy culture for mac, and considered symptomatic (fever, night sweats, anorexia, weight loss, fatigue, or malaise). * at least 2 months of prior treatment with available combination mac therapy or less than 2 months of such accompanied by unacceptable adverse effects. * life expectancy of more than 2 weeks. * approval of eligibility from pfizer clinical monitor. * consent of parent or guardian if under legal age of consent. note: * patients who have completed acute treatment with azithromycin for mac in protocol 066-131 or 066-148 will be exempt from inclusion criteria 1 and 2 and can continue therapy through this protocol if their physician feels they have benefitted from prior azithromycin therapy. exclusion criteria co-existing condition: patients with the following symptoms and conditions are excluded: * known hypersensitivity or intolerance to macrolide antibiotics. * inability to take oral medications or current condition that is likely to interfere with absorption (e.g., gastrectomy). concurrent medication: excluded: * other mac therapy instituted during the first 2 months of the study. * other investigational drugs, with the exception of those available through a treatment ind program. patients with the following prior conditions are excluded: history of hypersensitivity or intolerance to azithromycin. prior medication: excluded: * other investigational drugs within 7 days of enrollment, with the exception of treatment ind drugs (such as ddc).

Keywords: mycobacterium avium-intracellulare infection acquired immunodeficiency syndrome azithromycin
docetaxel, vinorelbine and trastuzumab in the treatment of patients with metastatic her-2 positive breast cancer

Conditions: Breast Cancer

Summary: in this phase ii trial we attempt to improve upon the efficacy of the trastuzumab/vinorelbine combination by adding weekly docetaxel. when administered on a weekly schedule, docetaxel is well tolerated with minimal myelosuppression, so that it is likely that fully efficacious doses of all three drugs can be administered

upon determination of eligibility, all patients will be receive: trastuzumab + vinorelbine + docetaxel

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * metastatic breast cancer confirmed by biopsy * overexpression of the her-2 oncogene * age \> 18 years * measurable disease * able to perform activities of daily living with minimal assistance * no previous chemotherapy for metastatic disease * one or more previous hormonal therapies for metastatic disease. * adequate bone marrow, liver and kidney function * patients with \< grade 1 peripheral neuropathy are eligible. * must give written informed consent prior to entering this study. exclusion criteria: you cannot participate in this study if any of the following apply to you: * abnormal heart function * previous treatment with trastuzumab * brain metastases untreated * pre-existing symptomatic peripheral neuropathy * serious underlying medical conditions please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
study to assess the tolerability and efficacy of anacetrapib (mk-0859) co-administered with statin in participants with heterozygous familial hypercholesterolemia (mk-0859-020)

Conditions: Hyperlipoproteinemia Type II; Hypercholesterolemia, Familial

Summary: the objective of this study is to evaluate the efficacy and tolerability of adding anacetrapib to ongoing statin therapy in participants with heterozygous familial hypercholesterolemia (hefh).


Eligibility criteria:
inclusion criteria: * if of reproductive potential, must agree to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control for the duration of the study * diagnosed with heterozygous familial hypercholesterolemia (hefh) * have been treated with an optimal dose of statin for at least 6 weeks exclusion criteria: * received treatment with low-density lipoprotein (ldl) apheresis within 4 weeks of screening or expect to undergo treatment with ldl apheresis during the course of the study * homozygous familial hypercholesterolemia * severe chronic heart failure * uncontrolled hypertension * uncontrolled cardiac arrhythmias, myocardial infarction (mi), percutaneous coronary intervention (pci), coronary artery bypass graft (cabg), unstable angina, or stroke within 3 months * uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins * active or chronic hepatobiliary, hepatic, or gall bladder disease * pregnant or breast-feeding, or plans to become pregnant during the study or within 2 years after stopping study medication * history of ileal bypass, gastric bypass, or other significant condition associated with malabsorption * human immunodeficiency virus (hiv) positive * history of malignancy ≤5 years * donated blood products or has had phlebotomy of \>300 ml within 8 weeks or intends to donate 250 ml of blood products or receive blood products within the projected duration of the study * currently taking medications that are potent inhibitors or inducers of cytochrome p450 3a4 (cyp3a) (including but not limited to cyclosporine, systemic itraconazole or ketoconazole, erythromycin, clarithromycin, or telithromycin, nefazodone, protease inhibitors, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, st john's wort) or has discontinued treatment \<3 weeks prior * consumes more than 2 alcoholic drinks per day * currently participating or has participated in a study with an investigational compound or device within 3 months * receiving treatment with systemic corticosteroids or taking systemic anabolic agents
the snap trial: sprint® peripheral nerve stimulation for the treatment of neuropathic post-amputation pain

Conditions: Neuropathic Pain; Amputation

Summary: the purpose of this study is to determine if pain can be relieved by delivering small amounts of electricity (called "electrical stimulation") to the nerves in an individual's amputated leg.this study will involve the use of a peripheral nerve stimulation (pns) system that is made by spr therapeutics (the sponsor of the study). the pns system was cleared by the fda for up to 60 days of use for the management of chronic pain, including extremity (leg) pain.


Eligibility criteria:
key inclusion criteria: * at least 21 years old * lower extremity amputation * experiencing residual limb (stump) and/or phantom limb pain * healed amputation and healthy residual limb based upon the investigator's evaluation key exclusion criteria: * conditions with increased risk of infection (e.g., compromised immune system or history of recurrent skin infections) * implanted electronic device * pregnancy
budesonide for prevention of acute gastrointestinal gvhd following allogenic stem cell transplantation

Conditions: Leukemia; Graft-Versus-Host Disease

Summary: the purpose of this study is to determine whether orale budesonide is effective in the prevention of acute gastrointestinal graft-versus-host disease (gvhd) following allogenic stem cell transplantation.

the purpose of this study is to determine whether orale budesonide is effective in the prevention of acute gastrointestinal graft-versus-host disease (gvhd) following allogenic stem cell transplantation.

Eligibility criteria:
inclusion criteria: * planned allogenic stem cell or bone marrow transplantation * hla identity (max. 1 mismatch) * standard gvhd prophylaxis with cyclosporin a or tacrolimus combined with mtx, +/- atg or campath1h * written informed consent exclusion criteria: * history of allogenic transplantation * in vitro t-cell depleted transplant * pretreatment with budesonide within the previous 4 weeks * known intolerance to budesonide * gastrointestinal infections * portal hypertension * concomitant infectious diseases * liver cirrhosis, impaired liver function * severe mental disorder * lack of compliance * drug or alcohol abuse * pregnancy, lactation * childbearing potential without effective contraception

Keywords: graft-versus-host disease budesonide stem cell transplantation
can dietitians reduce interdialytic weight gain in at risk hemodialysis patients through tailored education on dietary sodium and fluid intake?

Conditions: End Stage Renal Disease Requiring Hemodialysis

Summary: the purpose of this project is to understand if more frequent education of dialysis patients (patients with kidney failure who get their blood cleaned and fluid removed by a machine instead of their kidneys) on reducing sodium intake reduces the amount of fluid weight that patients gain between dialysis sessions. patients who usually gain more fluid than is considered ideal will be recruited for this project. because all patients gain different amounts to start, data will be collected for 3 months while the patients receive their usual amount of dietitian education. then the patients will receive intensive (2x/month) education on reducing sodium intake from the dietitian and the same data will be collected to see if they gain less after the education. after 3 months of intensive education, data will be collected for one more month to see if patients keep gaining less or if they go back to their old patterns.


Eligibility criteria:
inclusion criteria: * average interdialytic weight gain (idwg) for 2 weeks prior to screening period greater than or equal to 4% estimated dry weight * able to sign the locally approved informed consent * willing to receive dietitian education on sodium and fluid control during normal dialysis time * receiving thrice weekly maintenance hemodialysis for greater than or equal to 6 months age greater than or equal to 18 years exclusion criteria: * on hospice or international equivalent * receiving corticosteroid treatment * less than 18 years old * on interdialytic parenteral nutrition * transfer to another facility expected within 3 months * severe malnutrition, as assessed by subjective global assessment (sga) or other standard assessment tool
capturing physiologic autonomic data from clinically indicated magnetic resonance imaging scans in children

Conditions: Pectus Excavatum; Cardiac Anomaly

Summary: the fontan procedure is a palliative surgical procedure used in pediatric patients with one functional ventricle. the procedure, a series of stepwise operations that alter cardiorespiratory physiology, separate the systemic and pulmonary circulations to create fontan physiology, where the systemic venous blood flows passively and without ventricular thrust into the pulmonary circulation. the hallmark of the fontan circulation is a sustained, abnormally elevated central venous pressure combined with decreased cardiac output, especially during periods of increased demands. results of several studies in fontan patients have shown reduced parasympathetic and sympathetic activity compared to controls. in children with congenital heart disease, a differential diagnosis of autonomic dysfunction may be part of their pathophysiology, a compensatory mechanism, a consequence of surgical procedures or a combination of these. in children, measurement of ans function is equally important. children with single ventricle physiology (and other cardiac conditions) have routine surveillance and cardiac magnetic resonance (cmr) imaging to monitor for disease progression. while autonomic data is routinely collected and is available from these scans, these data are rarely, collected and analyzed; however, our group has shown feasibility. therefore, autonomic data is usually unavailable in children. despite the availability of agerelated normal values, the predictive power of autonomic activity is understudied in children and there are no published studies of quantification of autonomic data in this population.


Eligibility criteria:
inclusion criteria: * ages 0 to ≤ 30 years * baseline sinus rhythm (interventricular conduction delays and bundle branch blocks allowed); and undergoing cmr scan in which sequences containing timing of aortic valve opening (cine), vector cardiogram (vcg) and respiratory bellows use will be obtained * fontan physiology - only for the fontan group. chest wall deformity or arrhythmogenic right ventricular cardiomyopathy for the healthy control group exclusion criteria: * patient or family refusal; * contraindication to study procedures * prior participation in the study (ie, we plan to sample without replacement)
respiratory tract infections and prescription drugs in children and in pregnancy

Conditions: Respiratory Tract Diagnoses (ICPC-2); Prescriptions of Antibiotics by General Practitioners; Prescriptions of ATC J01 and R Drugs in Participants

Summary: the main objective is to investigate the incidence of respiratory tract infections (rtis) and antibiotic prescriptions in children and during pregnancy, the different drugs chosen by their doctors according to diagnosis, and compliance by patients. further to investigate the possible effect of antibiotic use during pregnancy on rtis and antibiotics and respiratory drug prescriptions in children the first two years after birth. specific study objectives: * rtis and antibiotic prescriptions in pre-school children * frequency of diagnoses and antibiotic prescriptions * the proportion of broad spectrum antibiotics chosen * prescription patterns and treatment compliance during pregnancy * incidence of diagnoses, compared with not pregnant patients * choice of antibiotics in rtis * prescription collection from pharmacies * antibiotics and respiratory medication in children aged 0-2 yrs * compare prevalence in children of mothers with frequent rtis/antibiotic prescriptions during pregnancy and prevalence in children of mothers with few or no consultations during pregnancy * incidence of wheezing and asthma diagnoses and incidence og respiratory prescription drugs when the mother has received antibiotics in pregnancy


Eligibility criteria:
inclusion criteria: * contact with general practitioner in the time of registration exclusion criteria: * men (except children aged 0-2 yrs) * women in ages 2-14 and above 60 yrs

Keywords: antibiotics prescriptions pregnancy children