Kornimate/medical-research-clean huggingface dataset:
tens used for pain management during office cystoscopy botox injections

Conditions: Overactive Bladder

Summary: the purpose of this study is to determine how transcutaneous electric nerve stimulation (tens) units affects pain management during office cystoscopic botox injections and patient satisfaction with the procedure .

overactive bladder (oab) is a symptom complex pronounced by urinary urgency, affecting up to 12% of the adult population, with a significant negative impact quality on the life. cystoscopic intra-detrusor onabotulinumtoxin a is used for the treatment of oab in participants who do not tolerate or adequately respond to oral anticholinergic medications. the response to the onabotulinumtoxin a injection is transient and requires repeat injections roughly every 6-7 months. adequate pain control during this procedure is essential for success in the office setting. options for adequate pain control during office-based cystoscopy procedures are limited. currently, varying pain control strategies are being used including local anesthesia (intra-urethral lidocaine, intra-vesicular lidocaine solution), distraction techniques (conversation/music/'squeeze balls'), aromatherapy, intramuscular analgesia, sedation and a combination of these techniques. despite this, participants often experience pain during the procedure. trans-cutaneous electrical nerve stimulation (tens) is a non-pharmacologic, non-invasive and safe method of pain control that involves delivery of electrical impulses to the skin, resulting in a reduction in perceived pain. tens units have been successfully used for procedural pain management during office hysteroscopy and office colonoscopy. tens may also help reduce pain during office cystoscopy. the study is a two arm phase iii double-blind, randomized, placebo-controlled trial looking at the effect of tens unit on pain in participants receiving office based cystoscopic onabotulinum toxin a injection for overactive bladder at the mayo clinic in rochester, minnesota.

Eligibility criteria:
inclusion criteria: * females age 18 years or older * scheduled to receive intra-detrusor onabotulinumtoxin-a injection for overactive bladder in the outpatient clinic * reads, speaks, and understands the english language * able to understand the requirements of the study, including randomization * willing and able to provide written informed consent exclusion criteria: * previous use of tens therapy within one year prior to study enrollment * has a spouse or first degree relative who has previously used tens therapy within one year prior to study enrollment * currently has an implanted pacemaker or automatic cardiac defibrillator * history of epilepsy * currently pregnant or within 12 weeks postpartum * unwilling to be randomized

Keywords: overactive bladder botox injection - bladder tens
catheter ablation versus medical treatment of af in heart failure

Conditions: Atrial Fibrillation; Heart Failure

Summary: heart failure and atrial fibrillation (af) often coexist, and each increases the morbidity and mortality associated with the other. the investigators hypothesized that restoration of normal sinus rhythm by catheter ablation is superior to medical treatment of af in heart failure. this study randomizes patients with heart failure and persistent af to medical treatment of af or catheter ablation to restore sinus rhythm.


Eligibility criteria:
inclusion criteria: * persistent atrial fibrillation * symptomatic heart failure exclusion criteria: * reversible causes of heart failure * contraindications to catheter ablation

Keywords: atrial fibrillation heart failure catheter ablation
protecting the corneal endothelium during cataract surgery using the anterior capsule

Conditions: Endothelial Cell Loss, Corneal

Summary: cataract surgery is one of the most frequently performed surgical procedures worldwide. since the introduction of phacoemulsification to remove the cataractous lens, risk and complication rates of cataract surgery decreased significantly. the phacoemulsification technique utilizes a high-intensity ultrasound energy for the fragmentation and emulsification of the lens. one of the main complications during phacoemulsification, is damaging of the endothelium due to contact with lens fragments of the nucleus following turbulent flow of irrigating solution, resulting in corneal damage, inflammation of the endothelium and corneal edema. in this study we want to evaluate the effect of the anterior capsule, gained by capsular rhexis, as a corneal shield during phacoemulsification on the corneal endothelium.


Eligibility criteria:
inclusion criteria: * cataract * age 21 and older * written informed consent prior to surgery * moderate to severe nuclear or mixed cataract exclusion criteria: * corneal pathologies * pregnancy * patients with an increased surgical risk (i.e. patients with pseudoexfoliation syndrome, patients with the potential risk of intra-operative floppy iris syndrome)
severe anemia treatment trials, pakistan

Conditions: Anemia

Summary: the purpose of this study is to test the efficacy of two enhanced regimens (deworming and multivitamins) in the treatment of severe anemia in pregnant women and children 6-24 months of age in karachi, pakistan.

anemia continues to be a public health problem of global proportions. severe anemia (hemoglobin, hb\< 70 g/l) is of special concern as it poses a significant health and mortality risk. pregnant women and young children (6-24 months of age) are the two groups at highest risk. severe anemia in pregnant women is associated with an elevated risk of maternal and perinatal mortality as well as case fatality. pakistan, the country in which this study is ongoing, may harbor the highest prevalence of severe anemia in south asia, with as high as 15% being reported among pregnant women. comparable rates (11-12%) are also seen among 6-24 month old children. iron deficiency is one of the major causes of anemia in young children and pregnant women in south asia. in addition to iron, deficiency of vitamins such as folic acid, vitamin a, vitamin c, riboflavin and vitamin e can also inhibit erythropoiesis. apart from these nutritional causes, two other infectious causes of severe anemia are malaria and geohelminths. the current international recommendation for treatment of anemia includes iron and folic acid but not other vitamins. comparisons: severely anemic pregnant women and children 6-24 months are randomized to receive enhanced treatment of deworming and multivitamins over and above the standard of care of iron-folic acid using a 2x2 factorial design.

Eligibility criteria:
inclusion criteria: * pregnant women with severe anemia (hb\<70g/l) * children 6-24 months with severe anemia (hb\<70 g/l) exclusion criteria: * gestational age \>=36 weeks * edema * breathlessness

Keywords: severe anemia anthelminthic multivitamins pregnancy children pakistan
the effect of carotid imt (intima media thickness) on postoperative cognitive dysfunction in patients undergoing off-pump coronary artery bypass graft surgery

Conditions: Coronary Artery Occlusive Disease

Summary: the patients who have undergone cardiac surgery have higher likelihood of postoperative cognitive dysfunction (pocd). the carotid intima-media thickness (imt) is associated with cognitive dysfunction in the old. the aim of this study is to evaluate the effect of carotid imt in patients undergoing opcab(off-pump coronary artery bypass surgery) on postoperative cognitive dysfunction. two hundred twenty four patients, aged 20 to 79 years, scheduled for opcab will be divided into increased imt (n=112) and normal imt (n=112) group by preoperative b-mode ultrasonography. the cognitive function measured by k-mmse, moca-k before the operation, and on the 7 day, 3 months after operation. the patients in the non-surgical group are measured three times: baseline, after 7days, after 3 months.


Eligibility criteria:
inclusion criteria: - patients who are scheduled to undergo opcab exclusion criteria: * severe cognitive dysfunction * disabling mental change disorder * unable to communicate or speak korean * do not have carotid imt measurement.
large overuse of post-polypectomy surveillance colonoscopy

Conditions: Colonic Polyps; Surveillance; Colonoscopy

Summary: in colorectal cancer screening era a huge burden of medical resources has been applied to surveillance. although the adherence to post-polipectomy recommendations is a advocated as a mainstay for quality assurance colonoscopy programs, prospective data on appropriateness of surveillance are lacking. the aim of present study was to evaluate the percentage of subjects in which timing of surveillance colonoscopy in practice agrees with that recommended by guidelines and to identify factors associated to the appropriateness of surveillance.


Eligibility criteria:
inclusion criteria: * consecutive colonoscopy outpatients * adults (18-80 yrs) exclusion criteria: * subjects with missing data on polyp findings at previous colonoscopy (number, endoscopic or histological features) * subjects with unsatisfactory quality standards of previous examination (no cecal intubation, inadequate bowel preparation, incomplete polyp resection) * patients with a medical history of inflammatory bowel disease, inherited or other polyposis syndrome and colorectal cancer.
pilot feasibility study of laryngeal ultrasound in the paediatric population - echo larynx

Conditions: Laryngeal Diseases; Ultrasound

Summary: nasofibroscopy is the gold standard for laryngeal pathology diagnosis. however, this examination is invasive and can be poorly tolerated in the pediatric population. laryngeal ultrasound appears to be a better tolerated alternative. however, few data exist in the pediatric population in the literature. the aim of this study is to evaluate the feasibility of laryngeal ultrasound in a larger pediatric population of pathological and non-pathological subjects.

according to current knowledge, the gold standard for diagnosing laryngeal pathologies is flexible fiberoptic laryngoscopy (ffl), as it allows visualisation of the motricity of the laryngeal structures and the appearance of the mucous membranes. however, this is an invasive examination, which can be poorly tolerated in the pediatric population. this poor tolerance can make it difficult to obtain an accurate diagnosis because of the child's movements. with the aim of improving patient comfort without compromising diagnostic performance, some studies describe laryngeal ultrasound (lus) as an alternative to ffl. this imaging examination appears to be better tolerated than ffl because it is less invasive for the patient. however, there are few data available in the infant population. the main limitations of lus are obtaining a satisfactory ultrasound window and inter-rater reproducibility. for these reasons, the aim of this study is to assess the feasibility of lus in the pediatric population and to obtain reference frame enabling the different laryngeal structures to be visualised. we will include around one hundred patients treated in the pediatric ent unit, with or without laryngeal pathology. an ultrasound record will be performed during the consultation in addition to the usual examination. the record will be analysed by a blinded assessor. a single consultation will be required and no follow-up is planned.

Eligibility criteria:
inclusion criteria: * patients treated in the pediatric ent unit at bordeaux university hospital, aged between 0 and 15 years exclusion criteria: * intubated patient, * haemodynamic * respiratory instability * opposition to participation expressed by parents or patient

Keywords: transcutaneous laryngeal ultrasound pediatric population otorhinolaryngology ent
growth hormone treatment of young growth hormone-deficient adults

Conditions: Growth Hormone Deficiency

Summary: hypopituitary adults with all the hormonal deficiencies are well subsituted excepted for the growth hormone (gh) and died earlier than the rest of the population. gh deficiency involves a fat mass increase with regard to lean mass, an atherogenic lipidic profile and participating to osteopenia mechanism and decrease the life quality. all these dysfunctions are partially or totally corrected by the gh prescription with patient deficient since adulthood. however, for patients deficient since childhood, no study have demonstrated that gh treatment during childhood present these same benefit when they are treated during adulthood. primary objective of this study is to examine that fat mass significantly decrease due to gh treatment in adulthood for patient gh deficient since childhood, treated by gh during childhood but stopped since the end of adolescence. we compare the body composition and others energetic metabolism parameters in two patient groups, one treated by gh during 18 months, and the other with no treatment. body composition and bone density are measured by pletysmography (dexa). metabolic parameters are : energetic balance (energy intake evaluation by questionnaire, energetic expenditure evaluated by doubly labelled water) and biologic parameters (lipidic profile, thyroid hormones). this study will evaluate if the gh treatment of young gh deficient adults since childhood can be a benefit for body composition, lipidic profile and bone density.


Eligibility criteria:
inclusion criteria: * adults (age \> 18-35 years) * stable body mass +/- 5 kg in 3 months * gh deficiency since childhood, treated by gh during childhood, having stopped gh treatment at the end of adolescence * want to receive again gh treatment or refusing new gh treatment * gh deficiency confirmed at adulthood by ghrh-arginine test * women receiving gh treatment must have a efficient contraceptive method * have given a writing informed consent exclusion criteria: * somatotropic insufficiency * all pathologies or treatment modifing energetic metabolism, excepted diabet mellitus and obesity * participating to another clinical trial during the three months befor inclusion * pathologies modifing bone metabolism * pregnancy/feeding * refusal to consent

Keywords: growth hormone deficiency growth hormone energy expenditure body composition
neurobiology of opioid dependence: 2 - 2

Conditions: Opioid-Related Disorders

Summary: the purpose of this study is to evaluate the effects of gamma hydroxybutyric on naloxone-precipitated opiate withdrawal.


Eligibility criteria:
please contact site for information.

Keywords: opioid disorders
longitudinal pattern of streptococcus pneumoniae nasopharyngeal carriage and antimicrobial susceptibility in healthy children aged less then 5 years, in the area of milan and surroundings, lombardy, italy.

Conditions: Streptococcus Pneumoniae Nasopharyngeal Carriage

Summary: the objective of this active surveillance study is to make available crucial data about epidemiology, serotype distribution, and longitudinal pattern of antibiotic susceptibility of nasopharyngeal strains of streptococcus pneumoniae carried in the population of healthy children aged less than years and living in the area of milan and surroundings, lombardy, italy. * to estimate the nasopharyngeal carriage rate and longitudinal pattern of streptococcus pneumoniae in healthy children aged less than 5 years living in the area of milan, italy; * to describe the circulation of antimicrobial non-susceptible streptococcus pneumoniae strains in healthy children aged less than 5 years secondary objectives: * to describe the nasopharyngeal carriage distribution of streptococcus pneumoniae strains in healthy subjects less than 5 years old; * to examine the role of risk factors in the streptococcus pneumoniae carriage rate in healthy children; * • to evaluate the possible impact of vaccination policy in the referenced population.


Eligibility criteria:
inclusion criteria: * to estimate the nasopharyngeal carriage rate and longitudinal pattern of streptococcus pneumoniae in healthy children aged less than 5 years living in the area of milan, italy; * to describe the circulation of antimicrobial non-susceptible streptococcus pneumoniae strains in healthy children aged less than5 years exclusion criteria: * to describe the nasopharyngeal carriage distribution of streptococcus pneumoniae strains in healthy subjects less than 5 years old; * to examine the role of risk factors in the streptococcus pneumoniae carriage rate in healthy children; * to evaluate the possible impact of vaccination policy in the referenced population..
accuracy of 68ga-pentixafor pet/ct for subtypting diagnosis in patients with primary aldosteronism concurrent with autonomous cortisol secretion

Conditions: Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion

Summary: to evaluate the accuracy of 68ga-pentixafor pet-ct in the classification diagnosis of primary aldosteronism concurrent with autonomous cortisol secretion patient, using avs and/or postoperative remission as the reference standard for classification diagnosis.

this study is a multicenter, prospective, diagnostic trial involving patients with primary aldosteronism (pa) concurrent with autonomous cortisol secretion (acs) patients with adrenal nodule (≥1cm) who completed both avs and 68ga-pentixafor pet/ct. we will enroll 97 pa concurrent with acs patients with adrenal nodule (≥1cm) .the treatment plan was determined according to the avs results. avs and/or postoperative remission were used as the reference standard for classification diagnosis to evaluate the accuracy of 68ga-pentixafor pet-ct in the classification diagnosis of pa concurrent with acs patients.

Eligibility criteria:
inclusion criteria: 1. getting the written informed consent 2. the clear diagnosis of primary aldosteronism； 3. combined with autonomous cortisol secretion, cortisol after 1mg dexamethasone suppression test (dst) ≥50 nmol/l； 4. patients who are willing to undergo surgery； 5. adrenal ct or mri scan of the adrenal glands with nodule (≥1cm). exclusion criteria: 1. pa patients who meet the by-passing avs criteria \[i.e., younger than 35 years old, spontaneous hypokalemia, adrenal ct indicated unilateral low-density adenoma (≥1cm), plasma aldosterone \&gt;300pg/ml\]； 2. suspicion of familial hyperaldosteronism or liddle syndrome. \[i.e., age \&lt;20 years, hypertension and hypokalemia, or with family history\]； 3. suspicion of pheochromocytoma or adrenal carcinoma； 4. patients with actively malignant tumor； 5. patients who have adrenalectomy history； 6. long-term use of glucocorticoids； 7. patients who are allergic to contrast media and cannot tolerate avs； 8. pregnant or lactating women; with alcohol or drug abuse and mental disorders； 9. congestive heart failure with new york heart association (nyha) functional classification iii or iv; history of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 3 months; severe anemia (hb\&lt;60g/l); serious liver dysfunction or chronic kidney disease aspartate aminotransferase (ast) or alanine transaminase (alt) ≥3 times the upper limit of normal, or estimated glomerular filtration rate (egfr) \&lt;30 ml/min/1.73 m2); systemic inflammatory response syndrome (sirs); uncontrolled diabetes (fbg≥13.3 mmol/l); obesity (bmi≥35 kg/m²); untreated aneurysm; other comorbidity potentially interfering with treatment； 10. consider patients with bilateral cortisol hypersecretion such as pbmah or ppnad.

Keywords: primary aldosteronism autonomous cortisol secretion adrenal venous sampling 68ga-pentixafor pet/ct
choices-teen: a bundled risk reduction intervention for juvenile justice females

Conditions: Alcohol Use; Smoking; Contraception; HIV

Summary: this pilot study will: 1) demonstrate the feasibility of delivering choices-teen with master's level mental health professionals within a juvenile justice setting; 2) determine acceptance of choices-teen as measured by client adherence, retention, and treatment satisfaction; and 3) assess client improvement at 3-month follow-up (e.g., reduction of risk of hiv, nicotine-exposed pregnancy, and alcohol-exposed pregnancy).

the overall objective of this study is to assess the feasibility and promise of an adapted choices preconception intervention (choices-teen) in reducing the risk of hiv, nicotine-exposed pregnancy (nep), and alcohol-exposed pregnancy (aep) in adolescent females on intensive community probation. the current study posits that a two-session choices intervention adapted to target multiple bundled health risks-aep, nep, and hiv-will be feasible, acceptable, and promising in reducing these risks among females on community-based juvenile probation. this study will: aim 1: modify the efficacious choices preconception intervention to target the prevention of hiv, aep, and nep. the result will be a two session individual intervention (choices-teen) and accompanying therapy manual based on the transtheoretical model (ttm) and motivational interviewing. aim 2: conduct a one-arm feasibility trial with females in the juvenile justice system to assess the promise of choices-teen. this pilot study will: 1) demonstrate the feasibility of delivering choices-teen with master's level mental health professionals within a juvenile justice setting; 2) determine acceptance of choices-teen as measured by client adherence, retention, and treatment satisfaction; and 3) assess client improvement at 3-month follow-up (e.g., reduction of risk of hiv, nep, and aep). this study will inform subsequent stage ii/iii behavioral intervention studies and contribute to a missing, fundamental element in the knowledge base - further understanding of the feasibility of targeting bundled health risks in high-risk adolescents, and the potential promise of a gender-specific intervention for this population.

Eligibility criteria:
inclusion criteria: * have had vaginal intercourse with a male in the last 90 days * inconsistent/ineffective contraception use * inconsistent/ineffective condom use * drinking at risk levels * smoking * available for the follow-up period exclusion criteria: * pregnant * infertile * insufficient locator information * language other than english

Keywords: alcohol-exposed pregnancy nicotine-exposed pregnancy tobacco-exposed pregnancy alcohol contraception smoking pregnancy hiv prevention