Kornimate/medical-research-clean huggingface dataset:
do patient anxiety levels decrease urodynamic test reproducibility?

Conditions: Anxiety; Overactive Bladder; Urinary Incontinence, Stress; Urinary Incontinence, Urge; Urinary Retention

Summary: this study will look at how pre-test anxiety levels affect the reproducibility of symptoms during routine urodynamic testing in women. urodynamics is a test that assesses the function of the lower urinary tract, including the bladder.

the results of urodynamic tests often determine treatment for patients, which may include bladder retraining, medication and/or surgery. thus, it is important for the results of urodynamics to be accurate and representative of the patient's symptoms outside of the clinic. pre-test anxiety levels in women undergoing urodynamics will be measured using a validated questionnaire hads (hospital anxiety and depression scale). the patient, prior to their routine urodynamics test, will fill out this self-administered questionnaire. reproducibility of patient symptoms will be measured using a non-validated quantitative bladder test assessment. the patient will fill out this self-administered quantitative bladder assessment after their urodynamics test. the pre-test anxiety and symptom reproducibility variables will be correlated against each other to assess whether there is correlation between the two. a spearman rho test will be used to assess the strength of the relationship.

Eligibility criteria:
inclusion criteria: * women attending for their first time to the urodynamics clinic for the assessment of their bladder function * must be over the age of 18 years old * must be able to consent for themselves exclusion criteria: * any patients not covered in the inclusion criteria

Keywords: anxiety urodynamics symptom reproducibility lower urinary tract symptoms women
combination lucentis and ocular photodynamic therapy with visudyne, with evaluation-based retreatment

Conditions: Age-Related Macular Degeneration

Summary: this is a one-year, randomized, single-center open-label pilot study of the safety and efficacy of combination ranibizumab and pdt for amd. eligible subjects will be randomized to either combination treatment, or ranibizumab monotherapy (control group). the combination treatment group will receive ranibizumab, followed 1 week later by verteporfin pdt. additional treatments will be based on evidence of active disease (subretinal fluid on oct or leakage on fa): repeat ranibizumab injections will be allowed monthly, and repeat pdt will be allowed every 3 months. the control group will receive "standard-of-care" ranibizumab monotherapy according to the protocol currently followed by most retinal specialists. ranibizumab injections will be given at baseline and months one and two. additional injections will be given at each monthly visit at which there is evidence of active disease by visual acuity, oct and fa criteria.


Eligibility criteria:
inclusion criteria: * presence of subfoveal cnv due to amd, less than 9 disc areas in extent * vision 20/40 to 20/800 snellen equivalent * age \> 50 years * ability to provide written informed consent and comply with study assessments for the full duration of the study exclusion criteria: * intraocular surgery or injection within 30 days prior to enrollment in the study eye * intravitreal triamcinolone within the past 6 months in the study eye * history of prior pdt treatment in the study eye * history of argon laser treatment of subfoveal cnv in the study eye * other vision-limiting disease (e.g. advanced glaucoma, prior vascular occlusion, dense amblyopia) in the study eye * clinically significant intraocular inflammation in the study eye * no light perception in the fellow eye * anterior segment opacity preventing adequate visualization of fundus for fa or oct * are currently participating in another clinical trial * women of childbearing potential not using adequate contraception, as well as women who are breastfeeding * known sensitivity to study drug(s) or class of study drug(s) * patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study * use of any other investigational agent in the last 30 days

Keywords: age-related macular degeneration ranibizumab lucentis photodynamic therapy verteporfin visudyne
comparison of a new needle navigation device for ct-guided interventions to the conventional free-hand method

Conditions: Lumbar Pain

Summary: in a prospective, randomized, controlled, parallel group study the accuracy, intervention time and radiation dose of ct-guided punctures using the puncture cube® will be compared to the conventional free-hand method in patients requiring a percutaneous diagnostic or therapeutic ct-guided intervention for lumbar pain (facet joint-, nerve root-, epidural infiltrations at the lumbar/lumbosacral level).

computed tomography (ct)-guided interventions for diagnostic and therapeutic purposes are standard approaches in clinical routine (e.g. in patients with low back pain). numerous ct needle navigation systems have been developed with the aim to improve accuracy (and thus safety) of punctures while decreasing radiation exposure and procedure time. their usability in clinical routine is limited either because of high sensitivity to interference, high expenses, bulkiness, or incompatibly with daily clinical practice and thus increasing procedure time and workflow complexity. the puncture cube® takes into account all these requirements. furthermore, in an in vitro-phantom study (study submitted for publication), punctures with the cube were found to be faster and more accurate compared to the free-hand conventional method. in a prospective, randomized, controlled, parallel group study the accuracy, intervention time and radiation dose of ct-guided punctures using the puncture cube® will be compared to the conventional free-hand method in patients requiring a percutaneous diagnostic or therapeutic ct-guided intervention for lumbar pain (facet joint-, nerve root-, epidural infiltrations at the lumbar/lumbosacral level).

Eligibility criteria:
inclusion criteria: * patients requiring a percutaneous therapeutic ct-guided intervention for * lumbar pain (joint-, nerve root-, epidural infiltrations at the lumbar/lumbosacral level) * age ≥ 18 years * signed informed consent prior to intervention exclusion criteria: * patients suffering from severe obesity (bmi \> 30 kg/m2)
when the alarm goes off, you're already awake

Conditions: Anxiety

Summary: this is a behavioral observational study aimed at evaluating the impact that anxiety exerts on working people at the moment of awakening in the morning. it consists of a short self-administered questionnaire which will be given to workers to complete. relationships between workers' answers and anxiety will be evaluated.

this is a behavioral observational study aimed at evaluating the impact that anxiety exerts on working people at the moment of awakening in the morning. literature found out that anticipatory anxiety plays a key role as for awakening quality (experiencing self). this evaluation could change at the end of the working day due to biased memory effects (remembering self). in literature there are not studies which investigate the relationships between time to awakening before the alarm sounds and anxiety. the study consists of a short self-administered questionnaire which will be given to workers to complete. in more details, the survey is made of five questions collecting information on type of work, people who use an alarm, time of awakening before the alarm goes off, feelings on the moment of awakening, and feelings as for the working day spent. further, participants will have to complete an anxiety self-administered questionnaire on anxiety, and namely the zung self-rating anxiety scale. descriptive statistics will be presented by taking into account the characteristics of the sample being investigated. statistical correlations between workers' answers and anxiety will be also evaluated. this study's usefulness relies on detecting on advance mood disorders (like anxiety is) and maladaptive behaviors, in order to build persons' positive routines (i.e. well-being) and improve their productive quality at work.

Eligibility criteria:
inclusion criteria: * being workers (any type) * adult age * ability to understand the italian language exclusion criteria: * people who do not use the alarm clock to wake up in the morning * refuse to adhere to the study

Keywords: behavioral medicine anticipatory anxiety alarm work experiencing self remembering self
study evaluating lecozotan sr in mild to moderate alzheimer's disease (ad)

Conditions: Alzheimer Disease

Summary: the purpose of this study is determine the safety, tolerability, and efficacy of 3 doses of lecozotan sr in patients with mild to moderate alzheimer's disease over 12 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of probable ad according to the nincds-adrda criteria. * able to give informed consent. patient' s caregiver must consent to participate in the study. exclusion criteria: * use of medications for cognitive enhancement within 3 months of baseline. * significant neurologic disease other than ad that may affect cognition.
management of gestational weight gain by family physicians: seeking congruence with guidelines

Conditions: Gestational Weight Gain

Summary: background the institute of medicine (iom) published guidelines in 2009 for optimal gestational weight gain (gwg) during pregnancy. these guidelines include trajectories for optimal gwg, based on a woman's pre-pregnancy body mass index (bmi), to be used throughout the duration of a pregnancy. although there is a significant association between the total gwg recommended by these guidelines and maternal and perinatal outcomes, research has demonstrated that only approximately one-third of pregnant women have total gwg within the recommended amounts. factors known to influence gwg include maternal age, parity, being in a committed relationship and smoking. in addition, recommendations by primary care providers have been shown to influence actual gwg. women appreciate advice from their primary care providers, however, despite this, there is evidence that many patients report not being advised at all about gwg by their primary care providers. relevance excess weight gain in pregnancy has been shown to be a modifiable risk factor for excess weight in childhood, thus contributing to the intergenerational cycle of obesity. there is an opportunity to interfere with this cycle during the peri-pregnancy period, as women's motivation to engage in behaviour change is elevated and contact with their primary care providers is frequent. research question and hypothesis what impact does training family physicians to regularly refer to the iom trajectories and provide feedback about gwg ("training in the use of iom charts") during routine prenatal visits, compared to usual care, have on congruence of total gwg with iom guidelines? null hypothesis: there is no difference in the congruence of total gwg with iom guidelines between women whose family physicians were assigned to training in the use of the iom charts and those whose family physicians were assigned to usual care. objectives the following are the objectives for this study: 1. to compare the congruence of total gwg with iom guidelines between women whose family physicians were assigned to training in the use of iom trajectories and those whose family physicians were assigned to usual care. 2. to explore the relationship between other independent variables (maternal age, parity, committed relationship and smoking) and congruence of total gwg with iom guidelines, for women whose family physicians were assigned to training in the use of iom trajectories and for those whose family physicians were assigned to usual care.


Eligibility criteria:
inclusion criteria: * family physicians who provide prenatal care * pregnant women with low risk pregnancy exclusion criteria: * pregnant women \< 18 years old * pregnant women with multiple gestation * pregnant women with chronic disease * pregnant women initially presenting in second trimester or later.

Keywords: pregnancy gestational weight gain primary care guidelines
incidence of hpv infection and hpv-associated disease in screening indian men who have sex with hiv-positive men

Conditions: HIV Infection; Human Papillomavirus Infection; Human Papillomavirus-Related Carcinoma

Summary: this research trial studies the incidence of human papilloma virus (hpv) infection and hpv-associated disease in screening indian men who have sex with human immunodeficiency virus (hiv)-positive men. gathering health information over time from indian men who have sex with men (msm) may help doctors determine how many hiv -positive msm develop new hpv infections and how many hiv-positive msm have hpv related disease.

primary objectives: i. determine the prevalence of hpv-associated premalignant lesions in the anus and penis in indian hiv-seropositive men who have sex with men (msm). secondary objectives: i. describe risk factors for prevalent premalignant lesions in the anus and penis in indian hiv-seropositive msm. ii. describe the prevalence and incidence of penile and anal hpv infection in indian hiv-seropositive msm. outline: participants receive a questionnaire and undergo a targeted physical and anal clinical exam at months 0, 6, and 12. participants also undergo a penile skin cell and anal swab at months 0, 6, and 12 for cytology, hpv deoxyribonucleic acid (dna), and cd4+ t-cell count at months 0 and 6 and hiv viral load testing at months 0 and 12. participants also undergo high-resolution anoscopy (hra) and penile clinical exam at month 12.

Eligibility criteria:
inclusion criteria: * hiv positive, as documented by any licensed hiv test according to the indian national acquired immune deficiency syndrome (aids) control organization (naco) guidelines * participants report any sex with a man in the past 6 months * participants must speak hindi, marathi, or english * participants should not have any plans to move out of the area in the next 12 months and commit to attending two additional visits one at 6 months and one at 12 months exclusion criteria: * active drug or alcohol use or dependence, or other impairment that, in the opinion of the site investigator, would interfere with adherence to study requirements * participants with impairments that, in the opinion of the site investigator, are temporary, will be asked to return another day for enrollment * inability to provide informed consent * history of a sex change operation that would preclude collection of penile or scrotal specimens
bexarotene and fenretinide as addition to antipsychotic treatment in schizophrenia patients

Conditions: Schizophrenia; Schizoaffective Disorder; Cognition

Summary: background: in this proposed study, we aim to investigate safety and efficacy of two synthetic retinoids - bexarotene (targretin; lgd1069; 4-\[1-{5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl} ethenyl\] benzoic acid) and fenretinide (dihydroceramide n-(4-hydroxyphenyl retinamide) on severity of psychopathology and cognitive impairment in schizophrenia patients in an double-blind, placebo-controlled study. the rationale behind add-on these medications to ongoing antipsychotic treatment in schizophrenia patients is based on both the retinoid dysregulation hypothesis: the growth factors deficiency and synaptic destabilization hypothesis of schizophrenia. furthermore, in our preliminary open clinical trial, we found that a low dose of bexarotene (targretin, 75 mg/day) was safe and led to significant improvement on total panss scores, general psychopathology, on the positive and the dysphoric mood factor scores. the aim of the present study was to provide further insight into the safety and efficacy of bexarotene in comparison to fenretinide (a medication with smaller potential of adverse effects) and placebo in patients suffered from schizophrenia.

in this clinical trial, a minimal dose of bexarotene (targretin, 75 mg/day) or fenretinide 5 mg/day or placebo will be added for 8 weeks to the stable ongoing antipsychotic treatment of 90 schizophrenia patients. participants will be assessed at baseline and after 2, 4 and 8 weeks of treatment. a battery of research instruments will be used for assessment of efficacy and safety (psychopathology, and side effects). in addition, cholesterol and triglyceride levels, liver and thyroid function tests and a blood cell count will be monitored at baseline and during therapy.

Eligibility criteria:
inclusion criteria: 1. age 18-60 years, male or female 2. dsm-iv criteria for schizophrenia 3. ability and willingness to sign informed consent for participation in the study 4. stable blood parameters 5. only patients who had a normal baseline fasting triglyceride exclusion criteria: 1. lipid abnormalities. 2. leukopenia or neutropenia. 3. evidence of organic brain damage, mental retardation, alcohol or drug abuse 4. renal disease 5. hepatic dysfunction. 6. a history of pancreatitis. 7. thyroid axis alterations 8. suicide attempt in past year. 9. cataracts. 10. high dose of vitamin a daily treatment. 11. patients with a known hypersensitivity to bexarotene or other components of the product. 12. pregnant women or a woman who intends to become pregnant.
mr in patients with collagen vi related myopathies

Conditions: Bethlem Myopathy; Ullrich Disease

Summary: collagen vi-related diseases include bethlem myopathy and ulrich dystrophy. they are both caused by decreased levels or a lack of collagen vi. the first symptoms can be present at birth as joint laxity and hypotonic muscles; often seen with luxation of the hip and scoliosis. during childhood, patients may develop contractures of fingers, wrists, elbows and ankles. muscle weakness often appears in childhood to early adulthood and is progressive. it often results in walking difficulties. there is no treatment available for behtlem and ulrich dystrophies. the primary aim of this study is to investigate the pattern of involved muscles, the function and quality of the muscles and the disease severity using mri.

see above

Eligibility criteria:
inclusion criteria: * confirmed bethlem myopathy or ulrich disease exclusion criteria: * all contraindications for undergoing an mri scan
zolpidem postmarketing study in adolescent patients with insomnia

Conditions: Insomnia

Summary: to investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized double blind-controlled trial


Eligibility criteria:
inclusion criteria: * patients diagnosed as having nonorganic insomnia of nonorganic sleep disorder in icd10 * patients whose age at the time of obtaining consent is 12 years or over and 18 years or below exclusion criteria: * patients with schizophrenia or manic-depressive illness * patients with insomnia caused by physical diseases * patients having a history of hypersensitivity to zolpidem * patients with attention-deficit hyperactivity disorder

Keywords: insomnia zolpidem adolescent
midazolam versus morphine in acute pulmonary edema (mimo trial)

Conditions: Acute Pulmonary Edema

Summary: acute pulmonary edema (ape) is a common condition in the emergency room, associated with considerable mortality. the use of intravenous morphine in the treatment of ape remains controversial and benzodiazepines have been suggested as an alternative for morphine to relieving dyspnoea and anxiety in the patients with ape. the midazolan versus morphine in ape trial (mimo) is a multicenter, prospective, open-label, randomized study designed to evaluate the efficacy and safety of morphine in patients with ape.


Eligibility criteria:
inclusion criteria: * patients with acute pulmonary edema with dyspnoea and anxiety exclusion criteria: * patients with known severe liver disease. * patients with known severe renal disease. * patients with expectation of death from other illness during the course of the trial.

Keywords: acute heart failure morphine midazolam in-hospital mortality
senofilcon a lenses in moderate to severe dry eye disease

Conditions: Moderate to Severe Dry Eye Disease

Summary: a clinical trial using senofilcon a daily lenses in the treatment of moderate to severe dry eye. this a comparison between signs and symptoms prior to and during treatment.

32 patients with moderate to severe dry eye will be enrolled in this short-term proof of concept study to determine the efficacy in using soft lenses made of senofilcon a in reducing signs and symptoms.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of moderate to severe dry eye associated with either graft-versus-host disease (gvhd), sjogren syndrome, idiopathic dry eyes, or minimal limbal cell deficiency * a baseline schirmer tear test (1) of less than 5 mm at 5 minutes without anesthesia * have a visual analog score for comfort of 50 or less (scale of 1-100, with 100 meaning perfect ocular comfort and 1 meaning severe ocular pain) * ability or the resources to insert and remove the study lenses * an osdi score greater than 42 * a willingness to sign an informed consent exclusion criteria: * no dry eyes or mild dry eyes * a baseline schirmer tear test (1) of greater than 5 mm of wetting at 5 minutes * dry eye comfort score of greater than 50 on a visual analog scale * unable to insert or remove the study lenses (or have a family member do so) * have an osdi score less than 42 * has been diagnosed with neurotrophic keratopathy in either eye * unwilling to enroll in the study, and unwilling to provide signed informed consent to participate in the study

Keywords: dry eye
a single dose study of antimineralocorticoid activity of pf-03882845 in healthy volunteers

Conditions: Healthy Volunteers

Summary: 24-hr urinary sodium/potassium ratio will be a sensitive biomarker of antimineralocorticoid activity. the dose-response relationship of the antimineralocorticoid activity of pf-03882845 can be established following single oral doses.


Eligibility criteria:
inclusion criteria: * male and/or female healthy volunteers, age 18 to 55 years. females must be of non-childbearing potential. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, diet restrictions and other trial procedures. exclusion criteria: * subjects with a supine bp \>140 mm hg systolic or \>90 mm hg diastolic or \<100 mm hg systolic or \<60 mm hg diastolic based on the average of the triplicate * serum potassium \>=5.1 mmol/l or \<3.5 mmol/l at screening, confirmed by a single repeat if deemed necessary. * estimated gfr \<60 ml/min/1.73 m2 using the cockcroft-gault formula measurement of the individual parameters following at least 5 minutes of rest at screening.

Keywords: single dose cross-over active-control placebo control antimineralocorticoid activity