Kornimate/medical-research-clean huggingface dataset:
study of the efficacy and safety of sch 619734 in subjects with chronic cough from an unknown cause (study p04888)

Conditions: Cough

Summary: this is a randomized, double-blind, placebo-controlled, crossover, single center study of sch 619734 in subjects with chronic cough from an unknown cause. subjects will be randomized to receive sch 619734 or placebo for 7 days with 7 days' follow-up. after a 6 week washout period, subjects will be crossed over to the other treatment. the primary objective is to evaluate the effectiveness of sch 619734 in reducing cough reflex sensitivity as determined by a challenge with capsaicin, an agent that induces cough.


Eligibility criteria:
inclusion criteria: * male and female subjects, 18 to \ 6 months. * by history, evaluation of gastroesophageal reflux disease was done and ruled out by a minimum of an 8-week trial of antacid therapy (with a proton-pump inhibitor \[ppi\] given twice daily) with no clinical response in cough. * by history, if there are clinical signs and symptoms of postnasal drip, these signs and symptoms will have been treated with a combination of an antihistamine and decongestant for a minimum of 8 weeks with no clinical response in cough. * by history, if there are clinical signs and symptoms of asthma, these signs and symptoms will have been treated with a combination of an inhaled steroid and a short-acting beta-agonist for a minimum of 8 weeks with no clinical response in cough. exclusion criteria: * subjects with current evidence of clinically significant pulmonary (especially conditions that involve coughing), hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune, or other disease that precludes the subject's participation in the study. in particular, diabetics, uncontrolled hypertensives, and subjects with clinically significant cardiomyopathy, prostatic hypertrophy, glaucoma, seizure disorders, and psychiatric disorders are to be excluded from participation in this study. * subjects with asthma or chronic obstructive pulmonary disease who require chronic use of inhaled or systemic corticosteroids. * subjects receiving concurrent prohibited medications unless they observe the washout period prior to the baseline visit. these medications would include opioid- and non-opioid-containing cough suppressants and potent cyp3a inhibitors, such as ritonavir, ketoconazole, and clarithromycin. subjects receiving ace inhibitors or maois will be excluded from the study. * subjects with a history of allergies to more than two classes of medications. * current smokers, ex-smokers who stopped smoking in the previous 6 months, or subjects with a cumulative smoking history \>10 pack-years will be excluded. (pack-years is a way to measure the amount a person has smoked over a long period of time. it is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked, eg, a 10 pack-year history is equal to smoking 1 pack per day for 10 years or 2 packs per day for 5 years, etc.)
comparation of radial and focused extracorporeal shock waves in calcaneal spur: a randomised sham-controlled trial

Conditions: Calcaneal Spur

Summary: to date, focused and radial types of eswt have been effectively used in calcaneal spur. however, studies directly addressing a comparison between radial and focused types of eswt in calcaneal spur have not been done. therefore, this study aims to evaluate comparative effects of radial and focused eswt options on calcaneal spur.


Eligibility criteria:
inclusion criteria: * clinical and radiological diagnosis of plantar calcaneal spur * be aged ≥18 at the time of diagnosis * be give informed consent exclusion criteria: * have not completed the assessment process. * foot deformity * psychological disease
evaluation of an advanced borderless dressing

Conditions: Pressure Ulcer; Leg Ulcer; Diabetic Foot Ulcer

Summary: this study will gather preliminary clinical, health economic, and safety data on the treatment of chronic wounds with the allevyn life non-bordered dressing compared to standard of care treatment when used on a wound.

the study is a pilot rct, which will generate the first comparative clinical, economic, and safety data for use of alnb in subjects. a small sample of subjects with a range of chronic, moderate to highly exuding ulcer types (lu \[arterial/mixed etiology leg ulcers or venous leg ulcers requiring compression therapy\], pu, and non-ischemic dfu) will be enrolled and followed for 12 weeks to study the impact on health-related quality of life, ulcer progression and healthcare resource utilization.

Eligibility criteria:
inclusion criteria 1. the subject must provide informed consent to participate in the study. 2. the subject must be eighteen (18) years of age or older. 3. the subject must be willing and able to make all required study visits. 4. the subject must be able to follow instructions and be deemed capable of completing the cwis questionnaire. 5. the subject must present with a chronic (≥ 4 weeks duration) ulcer which meets all of the following criteria: 1. the ulcer is classified as either: * a pressure ulcer * a non-ischemic diabetic foot ulcer * a leg ulcer (arterial/mixed etiology leg ulcers or venous leg ulcers requiring compression therapy) 2. the ulcer is, in the opinion of the investigator, moderate to highly exuding. 3. the ulcer would, in the opinion of the investigator, benefit from a protective dressing. 4. the ulcer is not infected based on clinical signs/symptoms. 6. a subject with a dfu must have an ankle-brachial index (abi) of 0.7 or greater, as measured within 30 days of the screening visit. exclusion criteria 1. contraindications or hypersensitivity to the use of the allevyn life non-bordered, comparator, ancillary products, or their components. 2. participation in the treatment period of another clinical trial within 30 days of visit 1 or planned participation overlapping with this study. 3. the subject's reference ulcer is being treated with a topical antimicrobial dressing. 4. subjects with skin features (e.g. tattoos, skin color, pre-existing scarring) which, in the opinion of the investigator, could interfere with the study assessments. 5. subjects who have participated previously in this clinical trial. 6. subjects with a history of poor compliance with medical treatment. 7. subjects with a medical or physical condition that, in the opinion of the investigator, would preclude safe subject participation in the study.

Keywords: diabetic foot ulcer pressure ulcer leg ulcer
targeting of immune response after pneumococcal vaccination

Conditions: Pneumococcal Pneumonia

Summary: pneumococcal polysaccharide vaccine does not confer protection against noninvasive pneumonia. the study aims to compare lymphocyte homing in pneumonia and in those receiving pnc polysaccharide vaccine (ppv) or pnc conjugate vaccine (pcv)

pneumococcal polysaccharide vaccine does not confer protection against noninvasive pneumonia. the study compares the homing profiles of pnc-specific plasmablasts in 15 patients with pneumonia and in 15 volunteers receiving pnc polysaccharide vaccine (ppv) and 12 volunteers receiving pnc conjugate vaccine (pcv)

Eligibility criteria:
inclusion criteria: * males and females ≥ 18 and \<65 years of age. * general good health. * written informed consent. * no previous vaccination against pnc * no previous history of pnc pneumonia * in pneumonia: diagnosis of pnc pneumonia within a week exclusion criteria: * \< 18 years, ≥65 of age. * in vaccinees: acute disease at the time of enrollment. * pregnancy or lactation. * known immunodeficiency or immune suppressive treatment. * any chronic illness that might interfere with the immune response * alcohol or drug abuse * any clinically significant history of known or suspected anaphylaxis or hypersensitivity (based on the investigator's judgement).

Keywords: pneumonia pneumococcal polysaccharide vaccine pneumococcal conjugate vaccine
real-world evaluation of eko algorithms in a point of care setting

Conditions: Murmur, Heart; Innocent Murmurs; Heart Murmurs; Pathologic Murmur; Atrial Fibrillation

Summary: the purpose of this research is to prospectively test and validate the utility of eko artificial intelligence (ai) plus eko murmur analysis software (emas) murmur characterization in algorithm in a real world, point-of-care setting.

eko has developed a platform to aid in screening for cardiac conditions using a digital stethoscope and machine-learning algorithms to detect the presence or absence of heart conditions such as heart murmurs and atrial fibrillation. in november 2019, the us food and drug administration (fda) granted eko a 510(k) clearance for the marketing of "eko ai", a set of machine learning algorithms that includes atrial fibrillation (af) and heart murmur detection. the detection of heart murmurs may aid in detecting occult and dangerous valvular heart disease (vhd). other eko ai outputs include bradycardia, tachycardia, noisy signal, qrs duration, and unclassified data. eko ai has accuracy comparable to physician judgment (atrial fibrillation sensitivity of 98.9% and specificity of 96.9%, murmur sensitivity of 87.6% and specificity of 87.8%). both af and vhd can cause significant morbidity and mortality when missed or diagnosed late. eko has further developed the murmur detection function of eko ai to now not only identify whether a murmur is present, but also to inform the clinician of its timing during the cardiac cycle (systole vs diastole), and whether it is innocent or structural. we are calling this product the eko murmur analysis software (emas) and submitted a premarket notification to fda in december 2021. this study sets out to understand the utility of the eko ai plus emas murmur characterization algorithm in real world use. collecting data in a point-of-care setting will demonstrate how accurately the algorithm characterizes murmurs in comparison to an ai-unassisted clinical examination. algorithm output and clinical determination will be confirmed by echocardiographic ground truth, with the results being blinded until the end of the patient visit.

Eligibility criteria:
inclusion criteria: * patient consents to participation * willing to have heart sounds recorded with an electronic stethoscope * willing to undergo echocardiography * willing to undergo a 12-lead electrocardiogram * adults aged 65 years and older * history of at least one of the following: hypertension, bmi ≥ 30, diabetes mellitus, hyperlipidemia, atrial fibrillation, myocardial infarction, stroke/tia, previous coronary surgery, or previous coronary angiography * no prior diagnosis of valve disease or heart murmur exclusion criteria: * patient is unwilling or unable to give written informed consent * patients experiencing a known or suspected acute cardiac event * under the age of 65 years old * prior diagnosis of valve disease or heart murmurs

Keywords: artificial intelligence machine learning
tandem high-dose chemotherapy and autologous stem cell rescue in patients with high-risk neuroblastoma

Conditions: Neuroblastoma

Summary: the purpose of this study is to evaluate the efficacy and toxicity of tandem hdct/ascr in children with high-risk neuroblastoma. in the present study, a single arm trial of tandem hdct/ascr will be carried out. in the present study, the investigators will investigate whether tandem hdct/ascr might improve the survival of patients with high-risk neuroblastoma with acceptable toxicity.

the prognosis of high-risk neuroblastoma after conventional chemoradiotherapy is generally poor. therefore, a strategy using high-dose chemotherapy and autologous stem cell rescue (hdct/ascr) has been explored to improve the prognosis of patients with high-risk neuroblastoma. this strategy is based on the hypothesis that dose escalation might improve the survival of children with high-risk neuroblastoma. the results of randomized trials comparing hdct/ascr with chemotherapy alone showed a better event-free survival (efs) in the hdct/ascr arm than in the continuous chemotherapy arm. however, the overall efs was unsatisfactory. in this context, investigators have examined the efficacy of double or triple tandem hdct/ascr to further improve the outcome of high-risk neuroblastoma patients. george et al. carried out a single arm trial of tandem transplantation as consolidation therapy, and reported improved long-term survival (5-year progression-free survival 47%) with acceptable toxicity. kletzel et al. also conducted a single arm trial of triple tandem transplantation and reported improved survival (3-year efs 57%). they demonstrated that further dose escalation using sequential hdct/ascr might result in further improvements in the survival of patients with high-risk neuroblastoma. investigators in the present study also carried out tandem transplantation as consolidation therapy, and reported improved long-term survival (5-year progression-free survival 62%) with acceptable toxicity. however, throughout our previous study, multiple modifications were made in the treatment plan, which resulted in significant variability over time between patients. this variability may create doubt as to whether tandem hdct/ascr itself resulted in the improved outcome. in addition, toxic death rate was relatively high (15.4%), although final survival rate was very high (best survival rate ever reported). therefore, prospective study is needed to evaluate the efficacy and toxicity of tandem hdct/ascr.

Eligibility criteria:
inclusion criteria: * patients with high-risk neuroblastoma * patients with intermediate-risk neuroblastoma if gross tumor remained after surgery exclusion criteria: * patients with progressive disease before high-dose chemotherapy * patients whose parents want to stop or change the planned treatment * patients with organ toxicities of nci grade \>2 before high-dose chemotherapy

Keywords: tandem high-dose chemotherapy for high-risk neuroblastoma
effect of low intensity exercise and protein intake on skeletal muscle protein synthesis in elderly

Conditions: Skeletal Muscle Protein Synthesis in Elderly; Protein Kinetics; Sarcopenia

Summary: maintenance of skeletal muscle mass is crucial during lifespan to retain health and functional autonomy. sarcopenia, being the loss of muscle mass during aging, is a well-known phenomenon in the elderly and a major challenge viewed from an individual, and a socioeconomic point of view. nevertheless, several studies have proved muscle tissue to be markedly affected by physical activity and nutritional interventions even at old age. recently, a study in young individuals showed that an acute bout of easily tolerated low intensity exercise can prolong the muscle building effects of a milk protein intake compared to a non-exercised situation. therefore, the major aim of the present project is to evaluate, whether a low intensity exercise regime in conjunction with milk protein supplementation can induce positive adaptations on parameters related to muscle size and function in elderly. the study focuses on the acute muscle protein synthesis response to low intensity exercise and protein supplementation measured with stable isotope tracer techniques. it is hypothesized that light muscle activity can augment and prolong the effects of protein feeding. if a light resistance exercise protocol as investigated in the present project can prove beneficial, elderly, frail elderly, and individuals undergoing rehabilitation can challenge sarcopenia in a new and tolerable way.


Eligibility criteria:
inclusion criteria: * male * \>65 year old * healthy * bmi \<28 exclusion criteria: * smoker * type ii diabetic * intake of medicine or supplements which will affect skeletal muscle protein synthesis * alcohol intake \>21 units/week. * frequent exercise or hard physical labor
vision performance evaluation of tecnis eyhance™ with tecnis simplicity™ compared to tecnis® 1-piece intraocular lenses

Conditions: Cataract

Summary: this study is a 6-month, prospective, multicenter, bilateral, randomized subject- and evaluator-masked, clinical investigation of the tecnis eyhance iol versus the tecnis 1-piece iol. the study will be conducted at up to 15 sites in the u.s.a and will enroll approximately 220 subjects to achieve approximately 200 randomized and bilaterally implanted subjects, resulting in approximately 100 evaluable subjects in each lens group at 6 months. subjects are to be implanted with the same iol in both eyes: tecnis eyhance iol or the tecnis 1-piece iol. the eye implanted first will be considered the primary study eye.


Eligibility criteria:
inclusion criteria: * minimum 22 years of age * bilateral cataracts for which posterior chamber iol implantation has been planned * preoperative best corrected distance visual acuity (bcdva) of 20/40 snellen or worse with or without a glare source * potential for postoperative best corrected visual acuity of 20/30 snellen or better * corneal astigmatism parameters: * normal corneal topography and no irregular corneal astigmatism * postoperative astigmatism can be surgically managed to be less than 1 d in each eye * clear intraocular media other than cataract in each eye * availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures and study visits * signed informed consent and hipaa authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries * ability to understand and respond to a questionnaire in english exclusion criteria: * any conditions or circumstances, including those specified in the tecnis eyhance™ iol directions for use, that, in the opinion of the investigator, may increase risk over benefit or result in an adverse event during the study. * inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.) * concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial * desire for monovision correction
visual feedback balance training system combined with rfe in stroke

Conditions: Stroke

Summary: the goal of this clinical trial is to learn if visual feedback balance training system combined with repetitive facilitative exercise (rfe) work to treat stroke in adults. the main questions it aims to answer are: does visual feedback balance training system combined with rfe reduce the fall risk of participants? can the combination of intelligent rehabilitation robot training system and rfe achieve better effects? researchers will compare 3 groups (rfe, visual feedback balance training system under rfe, and conventional therapy) to see if visual feedback balance training system and rfe works to treat stroke. participants will: receive treatment for 4 weeks receive scale and instrument testing before and after treatment


Eligibility criteria:
inclusion criteria: * patients (18 to 74 years old) who suffered a first or second unilateral stroke * chronic stroke (over 6 months from the onset) * moderate or higher risk of falls (tug \> 15s, or 10-mwt ≤ 0.8m/s) * ability to understand and follow simple directions exclusion criteria: * pregnant or lactating * lower extremity contracture, pain, or trauma * perceptual, apraxic, or cognitive deficits that lead to inability to follow verbal instructions * unable to maintain standing posture * cerebellar lesion * clinically unstable medical disorders * inability to provide informed consent
a nursing triage protocol for minor orthopedic traumata: the effect on flow time, quality of care and patient satisfaction in an emergency department

Conditions: Trauma Injury

Summary: in 2019, nearly half of all hospital contacts in belgium took place through the emergency department, and more than a third of patients arrived after an accident or trauma. in instances of overcrowding, patients with minor orthopedic injuries face prolonged waiting times. previous studies have shown that implementing triage protocols for medical imaging conducted by a triage nurse can reduce the total length of stay (tlos) for this patient group. this is a single-center, unblinded, randomized, controlled trial that aims to evaluate the impact of a nurse triage protocol on turnaround time (primary outcome), quality of care, and patient satisfaction. the study population consists of adults who present with minor orthopedic injuries below the elbow or knee and have an emergency severity index (esi) of 4 or 5. participants are randomly assigned to either the 'nurse triage protocol' group (n=110) or the 'usual care' group (n=110).


Eligibility criteria:
inclusion criteria: * adults (18 years old) * esi 4 or esi 5 recent trauma (\< 10 days after trauma) * accidental trauma mechanism * trauma below the elbow (forearm, wrist, hand, finger) * trauma below the knee (lower leg, ankle, foot, toe) exclusion criteria: * esi 1 or esi 2 or esi 3 * return visit after previous emergency department contact for the same injury (e.g. increased pain, tight cast, ...) * trauma resulting from underlying somatic pathology (e.g. syncope, epileptic attack, vertigo, vasovagal collapse, ...) * atraumatic (pain) complaints (e.g. pain in the calf, toe, foot, wrist, ... without a clear trauma mechanism) * additional, non-orthopedic injuries (e.g. laceration, signs of cerebral commotion, ...) * pregnancy or a suspicion of pregnancy