Kornimate/medical-research-clean huggingface dataset:
colorado adult joint assessment scale (cajas) validation

Conditions: Hemophilia A

Summary: to obtain evidence of content validity and reliability of the colorado adult joint assessment scale (cajas), a clinician-reported outcome (clinro) measure, as adapted for use in a population of adults with moderate to severe hemophilia a treated with coagulation factor viii (fviii) therapy as secondary prophylaxis or episodic treatment.


Eligibility criteria:
inclusion criteria: * male, 18 to 50 years of age * diagnosis of moderate to severe hemophilia a (documented \<1-2% factor viii concentration \[fviii:c\]) * willing to maintain current fviii treatment regimen, whether prophylactic or on-demand, for the duration of the study exclusion criteria: * routine need for wheelchair or routine need for two canes or crutches * diagnosis of another bleeding disorder such as von willebrand disease * known event that would interfere with the scheduled cajas evaluations (e.g., elective joint surgery, vacation)

Keywords: hemophilia
ventfirst pilot: ventilating preterm infants during delayed cord clamping

Conditions: Infant, Premature, Diseases

Summary: delayed clamping of the umbilical cord (dcc) has been shown to have some benefits for preterm infants. initiation of breathing before cord clamping is also thought to be beneficial. since some preterm infants do not breathe well on their own immediately after birth, assisting ventilation during delayed cord clamping might have additional benefit beyond dcc alone. "ventfirst pilot" will assess feasibility and safety of assisting ventilation of preterm infants during 90 seconds of dcc which is essential before proceeding to a randomized clinical trial.

mothers expected to deliver an infant at 24-32 completed weeks' gestation will be approached for consent. when the infant is delivered, members of the neonatology team will be at the mother's side and will provide initial steps of resuscitation (position, suction, stimulate) per guidelines of the neonatology resuscitation program (nrp). at 30 seconds after birth, the infant will receive continuous positive airway pressure (cpap) if breathing well, or positive pressure ventilation (ppv) if not breathing well. at 90 seconds, the umbilical cord will be cut and the remainder of the resuscitation and stabilization will be carried out in the usual location.

Eligibility criteria:
inclusion criteria: - 24 0/7 to 32 6/7 weeks gestation at birth exclusion criteria: * major congenital anomalies * monochorionic twins * twin-twin transfusion syndrome * hydrops fetalis

Keywords: preterm infant
good eular response in patients with early rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this open-label, prospective, observational study will evaluate the clinical response to etanercept + methotrexate therapy in patients with moderate to severe rheumatoid arthritis, as prescribed by the rheumatologist in a normal clinical setting in greece

all subjects enrolled should meet the usual prescribing criteria for etanercept as per the local product information and should be entered into the study at the investigator's discretion

Eligibility criteria:
inclusion criteria: 1. signed and dated informed consent document 2. 18 years of age and older at the time of consent 3. patients with moderate-to-severe active rheumatoid arthritis, who satisfy the 2010 rheumatoid arthritis classification criteria 4. patients who have been prescribed for first time to receive treatment with mtx + etanercept prior to enrollment to this study, following routine clinical practice and according to the approved smpc, 5. patients with das28 ≥ 3.2 6. duration of disease symptoms ≥ 6 weeks and ≤2 years 7. failure to respond to prior dmards including mtx monotherapy according to routine clinical practice. exclusion criteria: 1. contraindications according to the smpc 2. history of or present anti-tnfa or other biologic therapy for the treatment of ra 3. known significant concurrent medical disease according to investigator's opinion and the current smpc
evaluation of the tensi+ device for the treatment of overactive bladder

Conditions: Overactive Bladder

Summary: tensi+ (stimuli technology, boulogne billancourt, france) is a newly released, medical transcutaneous-posterior tibial nerve stimulation (tc-ptns) device marketed for overactive bladder (oab) management. while effectiveness of tc-ptns has been demonstrated in the literature, the success rate is heterogeneous, depending on the clinical picture. in an effort to ascertain clearly the efficacy of tensi+ device, as well as its safety of use and assess comfort of use, the present study will evaluate the results of tensi+ treatment in real life conditions in a prospective study. the main objective is to assess the efficacy (actual clinical benefit) of tc-ptns with tensi+ device for management of overactive bladder in an adult population at 3 months. included patients are prescribed a treatment with tensi+ for 3 months. an evaluation visit is scheduled at 3 months. in treatment is continued, a follow-up visit is scheduled at 6 months. primary outcome measure success at 3 months defined as a composite parameter: (i) objective improvement, with at least 30% decrease of urgency episodes compared to baseline on 3-day bladder diary and (ii) subjective improvement, with patient global impression of improvement score of 1 or 2 time point(s) at which primary outcome measure is assessed : 3 months secondary outcome measures (i) evaluation of urinary symptoms based on bladder diary parameters (urinary frequency, incontinence episodes, maximum bladder capacity, nocturia episodes) and the urinary symptom profile (usp) questionnaire (ii) evaluation of adverse events (iii) patient-reported outcomes measures (proms): comfort of use (vas in deciles), recommendation to another patient (binary), consumer grading regarding device usability details (iv) quality of life measures (oabq questionnaire, vas scale) (vii) assessment of treatment persistence time point(s) at which secondary outcome measure is assessed\* : at 3 months and 6 months inclusion criteria : age ≥ 18 years overactive bladder symptoms number of subjects : 100


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients suffering from overactive bladder symptoms exclusion criteria: * pregnancy * patients with active implantable device or ankle orthopedic implant, * ankle articular diseases. * prior treatment with transcutaneous ptns or percutaneous ptns (any time), * sacral neuromodulation (anytime) or, * intradetrusor botulinum toxin injection within the past 6 months * antimuscarinic use within 1 month prior to the study * 24hour diuresis \> 2800cc on bladder diary * known bladder disease * active urinary tract infection * pvr\> 150 ml * pelvic organ prolapse stage \>2 * predominant stress urinary incontinence * cognitive impairment * inability to use the device without a third party * inability to complete a bladder diary * no health insurance coverage

Keywords: urology tens overactive bladder
glucagon-like peptide (glp) utilization and safety

Conditions: Diabetes Mellitus, Type 2

Summary: this study will assess the utilization patterns (adherence, source of the index antidiabetic agent (ada) and treatment modification) of the marketed glucagon-like peptide-1 (glp-1) receptor agonists (exenatide and liraglutide), dipeptidyl-peptidase-4 (dpp-4) inhibitors (sitagliptin, saxagliptin, and linagliptin) and other adas and the incidence rate of acute pancreatitis among the users of these glp-1 receptor agonists and users of dpp-4 inhibitors, separately, in comparison to other adas. the proposed study will help in understanding the treatment utilization patterns and the incidence rate of acute pancreatitis among users of the marketed glp-1 receptor agonists. this study differs from previous observational studies by including both exenatide and liraglutide and follow-up time is expected to be longer in the current study (2005 - 2011). this study will be a retrospective cohort study conducted in the truven (thomson reuters) commercial health insurance database from 2005-2011.


Eligibility criteria:
inclusion criteria: * subjects aged ≥ 18 and ≤ 64 years as of index date and those who have continuous enrolment for at least 12 months in truven * subjects should have complete medical and pharmacy benefits and continuous enrolment in the health plan for at least 12 months before the index date (pre-index period). * subjects should also have at least 1 claim of t2d diagnosis identified using icd-9 codes 250.x0 or 250.x2 (excluding 250.x1 and/or 250.x3 - type 1 diabetes and 648.0x - gestational diabetes) exclusion criteria: * for the objective of evaluating the association between glp-1 receptor agonists, dpp-4 inhibitors and acute pancreatitis as compared to the association observed between this outcome and the use of other adas, subjects having evidence of pancreatic disease (icd 9 code of 577.xx) in the pre-index period (12 months before the index date) will be excluded.

Keywords: utilization acute pancreatitis exenatide dpp-4 inhibitors liraglutide glp-1 receptor agonist adherence
benefits of immunonutrition in patients with head and neck cancer receiving chemoradiation

Conditions: Oral Mucositis

Summary: this study evaluated the benefits of immunonutrition regarding the prevention of severe mucositis. patients with head and neck cancer (hnc) undergoing definitive concurrent chemoradiation including 3-week cycles of cisplatin were enrolled in this double-blind phase ii study. patients were randomly assigned to receive an immunonutrition containing omega-3-fatty acids, arginine, dietary nucleotides, and soluble fiber or an isocaloric isonitrogenous control. all patients received the assigned product 5 days before each chemotherapy session. the proportion of patients with severe mucositis was compared between the immunonutrition and control groups.


Eligibility criteria:
inclusion criteria: * age of 18-65 years * histological confirmation of stage ii-ivb non-metastatic hnc according to the seventh edition of the american joint committee on cancer staging system (ajcc 2010) * receipt of definitive ccrt * eastern cooperative oncology group performance status of 0-1 * creatinine clearance ≥ 60 ml/min/1.73 m2 calculated by the cockcroft-gault formula * absence of mucositis * able to tolerate oral feeding exclusion criteria: * receipt of curative surgery for hnc * allergies to any component of the immunonutrition

Keywords: head and neck cancer nasopharyngeal cancer immunonutrition concurrent chemoradiation survival
safety and efficacy of tafamidis in patients with transthyretin cardiomyopathy

Conditions: Transthyretin (TTR) Amyloid Cardiomyopathy

Summary: this phase 3 study will investigate the efficacy, safety and tolerability of an oral daily dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy.

phase 3, multicenter, global, three-arm, parallel design, placebo-controlled, double-blind, randomized study to determine efficacy, safety and tolerability of tafamidis on clinical outcomes (all-cause mortality and frequency of cardiovascular-related hospitalizations) in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy.

Eligibility criteria:
inclusion criteria: * medical history of heart failure (hf) with at least 1 prior hospitalization for hf or clinical evidence of hf (without hospitalization) manifested by signs or symptoms of volume overload or elevated intracardiac pressures (e.g., elevated jugular venous pressure, shortness of breath or signs of pulmonary congestion on x-ray or auscultation, peripheral edema) that required/requires treatment with a diuretic for improvement, * evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness \> 12 mm, * presence of amyloid deposits in biopsy tissue and presence of a variant ttr genotype and/or ttr precursor protein identification by immunohistochemistry, scintigraphy or mass spectrometry exclusion criteria: * a new york heart association (nyha) classification of iv. * presence of primary (light chain) amyloidosis. * prior liver or heart transplantation or implanted cardiac mechanical assist device.

Keywords: amyloidosis amyloid transthyretin ttr
evaluation of an absorbable implant for the treatment of nasal valve collapse

Conditions: Nasal Valve Collapse

Summary: to evaluate the safety and feasibility of the inex nasal implant in subjects with moderate to severe nasal valve collapse.

this study is a multicenter, nonrandomized, prospective exploratory study of the inex nasal implant. the purpose of this study is to evaluate the safety and feasibility of the inex nasal implant in subjects with moderate to severe nasal valve collapse.

Eligibility criteria:
eligible participants are: 1. adult patients seeking treatment for nasal obstruction on one or both sides of the nose who are willing to undergo an office-based or intraoperative nasal implant procedure in lieu of alternative treatments (ie, surgical repair or use of an external dilator). 2. nasal valve collapse (nvc) must be a primary or significant contributor to the subject's nasal obstruction based on clinical presentation, physical examination and nasal endoscopy. 3. baseline nasal obstruction symptom evaluation (nose) score must be ≥55. participants are excluded for the following: 1. surgical or non-surgical treatment of the nasal valve or rhinoplasty within 12 months before enrollment. 2. septoplasty, inferior turbinate reduction, or other surgical nasal procedures within 6 months before enrollment. 3. recurrent nasal infections. 4. use of intranasal steroids within 2 weeks preimplant and 2 weeks post implantation. 5. presence of a permanent implant, dilator, or uses an external device in the nasal area. 6. cancerous or precancerous lesions and/or radiation exposure in the treatment area or chemotherapy within 24 months of the study. 7. significant bleeding disorders. 8. significant systemic diseases. 9. currently using nasal oxygen or continuous positive airway pressure (cpap).
value of f-18 fdg pet/ct for the prediction of egfr mutation in lung cancer patients

Conditions: Lung Cancer

Summary: to detect value of f-18fdg pet/ct as a non-invasive method for the prediction of egfr mutations in lung cancer patients.

* globally, lung cancer cases and deaths are rising. in 2018, globocan estimated 2.09 million new cases (11.6% of total cancer cases) and 1.76 million deaths (18.4% of total cancer deaths). it is the most frequent cancer and cause of cancer death in men. * epidermal growth factor receptor (egfr) mutations are the second most common oncogenic driver event in non-small cell lung cancer (nsclc) and classical activating mutations are well defined as strong predictors for good clinical response to egfr tyrosine kinase inhibitors (egfri). * over the last decade, the introduction of tyrosine-kinase inhibitors (tkis) has showed a remarkable paradigm shift in the treatment of non-small cell lung cancer (nsclc). however, genetic testing is sometimes unavailable. * data from previous studies that have investigated the value of f-18 fdg pet/ct for predicting egfr status are conflicting.

Eligibility criteria:
inclusion criteria: * nsclc patients who underwent egfr mutation testing. * all patients ≥ 18 years. exclusion criteria: * time interval between egfr sampling and pet/ct more than 1 month. * patients had been treated before sampling for the gene alteration analysis * patients with glucose level \< 200 mg/dl.
transcutaneous electrical nerve stimulation (tens) for advanced cancer pain patients

Conditions: Advanced Cancer

Summary: pain is the most common symptom (ca. 80% of patients) on german palliative care units and thus, pain control plays a central role in palliative care. transcutaneous electrical nerve stimulation (tens) is a complementary treatment option for patients who experience suboptimal pain control. however, the evidence for the efficacy of tens in cancer patients is not unambiguous. the present study is a double blind, placebo-controlled cross-over trial with a short-term follow-up. the primary aim of this study is to evaluate the efficacy and safety of tens for cancer pain reduction in advanced cancer patients. the secondary aim is the explorative identification of subgroups that benefit or do not benefit from tens.


Eligibility criteria:
inclusion criteria: * patients with cancer pain (caused by tumor or therapy; or associated with tumor) ≥ 3 on an 11-point nrs the last 24 hours * age: ≥ 18 years * patients receive at least 24 hours palliative care: on palliative care ward, palliative care consultant service or acute pain consultant service exclusion criteria: * verbal or cognitive inability to use tens or to answer the questionnaire * high probability of dying within the next week * pain that is not directly or indirectly related to tumor contraindications: jones (2009) \& disselhoff (2012) * electronic implants like pacemakers * metal implant on electrode site * arrhythmia * pregnancy * epilepsy * dermatological conditions or frail skin on electrode site * anamnestically known distinct allergy regarding electrodes drop-out criteria after inclusion: * patients that decide to stop tens treatment (at any time or any reason). * further treatment is not indicated due a rapid deterioration of the patients' clinical status according to the treating physician.
arterial puncture using insulin syringe is less painful than standard syringe

Conditions: Pain

Summary: the primary objective is to compare the difference in the pain score in radial arterial puncture using the insulin needle versus the standard 23g hypodermic needle.

in a randomised, crossover design, healthy volunteers were recruited to receive bilateral radial arterial punctures. they were assigned to receive either the insulin or the standard needle as the first puncture using block randomisation. the primary outcome was the pain score measured on a 100mm visual analogue scale (vas) and the secondary outcomes were procedural complications and rate of haemolysis.

Eligibility criteria:
inclusion criteria: * age above 21 exclusion criteria: * concurrent antipyretic use in the last 24 hrs, * presence of painful conditions eg fracture, rheumatoid arthritis * history of peripheral vascular disease
effect of intradialytic electrical muscle stimulation and passive leg mobilisation on blood pressure and dialysis efficacy

Conditions: Hypotension

Summary: hypothesis: intradialytic blood pressure and dialysis efficacy (in terms of urea removal) improve under electrical muscle stimulation or passive leg movement on a treadmill.


Eligibility criteria:
inclusion criteria: * dialysis patients able to put legs on a treadmill exclusion criteria: * dialysis duration shorter than 3 months

Keywords: dialysis associated hypotension urea removal
clinical trial of jinzhen oral liquid in treating children with covid-19 infection

Conditions: COVID-19; Child, Only

Summary: jinzhen oral liquid and jinhuaqinggan granules were used in the treatment and the control group for 14 days, respectively, to evaluate the effect of jinzhen oral liquid in treating children with novel coronavirus infection.

to evaluate the effect of jinzhen oral liquid in treating children with novel coronavirus infection by shortening the time of first negative turn of virus, improving clinical symptoms and shortening hospital stay, and to observe the safety of jinzhen oral liquid in clinical application.a total of 240 patients aged 3 to 18 years old or asymptomatic infected persons who meet the diagnostic criteria for novel coronavirus infection in the covid-19 diagnosis and treatment protocol (trial version 9)were planned to be enrolled. jinzhen oral liquid was used in the treatment group, and jinhuaqinggan granules was used in the control group, with 120 patients in each group. the subjects took the medication for 14 days (the medication could be stopped in advance if they reached the discharge criteria), and were followed up for 14 days after discontinuation. during the treatment period, the subjects' vital signs, chest imaging examination, novel coronavirus nucleic acid test, blood routine, urine routine, liver and kidney function, and condition and symptoms should be monitored on the follow-up day specified in the protocol.

Eligibility criteria:
inclusion criteria: * 1. meet the diagnostic criteria of novel coronavirus infected patients in covid-19 diagnosis and treatment protocol (trial version 9); 2. asymptomatic infection or clinical classification of mild or common type; 3. aged from 3 to 18 years; 4. the informed consent process was in accordance with the regulations, and the legal guardian or the children (≥8 years old) signed the informed consent form. exclusion criteria: * 1. meet the severe/critical early warning indicators; 2. children who used proprietary chinese medicine of the same type for more than 3 days before enrollment; 3. children with diarrhea.
observational study of the predictability of levemir® in terms of metabolic control, change of body weight and hypos

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to evaluate the effect of levemir® (insulin detemir) on glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes.


Eligibility criteria:
inclusion criteria: * any subject with type 1 or type 2 diabetes treated with insulin in whom at the discretion of the participating physicians it was decide to switch insulin treatment to the long-acting insulin analogue insulin detemir (levemir®) in combination with either insulin aspart (novorapid®) or human insulin (actrapid®)
perioperative fluid therapy in pediatric patients undergoing penile hypospadias repair

Conditions: Volume Overload

Summary: optimization of perioperative fluid management is important for preventing adverse events, such as hypovolemia, cardiogenic shock, volume overload, and pulmonary edema, in both adult and pediatric patients. if the intravascular (iv) fluid volume is not optimized, pediatric patients are at risk of dehydration or volume overload. perioperative iv fluid therapy is important during and after induction of general anesthesia (ga).the aim of this study is to investigate the difference between conventional and restrictive fluid replacement regimens using lung ultrasound in pediatric patients undergoing penile hypospadias repair, as a surgery with minor fluid loss.


Eligibility criteria:
inclusion criteria: * scheduled for repair of penile hypospadias with american society of anaesthesiologists' physical status of class i-ii. exclusion criteria: * patients with pulmonary, cardiovascular, or hematological disorders or a family history of allergy to local anesthetics or lung disease

Keywords: conventional regimen restrictive regimen lactated ringer's solution lung ultrasound fluid management