Kornimate/medical-research-clean huggingface dataset:
low salicylate diet in aspirin exacerbated respiratory disease

Conditions: Aspirin Exacerbated Respiratory Disease; Samter's Triad

Summary: the purpose of this study is to determine whether a low salicylate diet will improve the quality of life of patients with aspirin exacerbated respiratory disease (aerd).

aspirin-exacerbated respiratory disease (aerd) is clinically diagnosed in patients who suffer from allergy to aspirin, asthma, nasal polyps, and chronic sinusitis. patients with aerd are often resistant to medical management of nasal polyps, and require multiple endoscopic sinus surgeries to manage recurrences of nasal polyps. control of aerd can be obtained through aspirin desensitization, which consists of taking aspirin every day. however, there are substantial risks and adverse side effects to taking moderate amounts of aspirin daily. furthermore, patients experience progressively worsening nasal and respiratory disease even with complete avoidance of aspirin and other nsaids. the active and major component in aspirin/nsaids is salicylate, which is also found naturally in some foods. diet modification is a cost-effective intervention that has the potential to provide long-term remission of aerd. our study will evaluate whether a low salicylate diet, which is a more cost effective and benign intervention with minimal risks, will improve nasal, sinus or respiratory symptoms, such as congestion, sinusitis, smell, or asthma.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of aerd exclusion criteria: * recent use of prednisone or other systemic steroid (greater than three (3) doses in past three (3) months). this does not include the use of nasal steroids. * endoscopic sinus surgery / polypectomy within the past six (6) months * other significant systemic disease or immunocompromised state
the efficacy of manual therapy and pressure biofeedback guided strength training on pain and functional limitations

Conditions: Cervicogenic Headache

Summary: cervicogenic headache (cgh) is a widespread illness that results in excruciating pain and a sizable functional handicap. deep cervical flexor muscle (dcfm) strength and endurance were also worse in cgh patients. this study aimed to determine the efficacy of manual therapy and pressure biofeedback-guided dcfm strength training on pain intensity and functional limitations in individuals with cgh.

the study followed a two-arms parallel group randomized comparative design, including sixty individuals with cgh, and they were allocated into two groups at random. for three consecutive weeks, in addition to the conventional treatment common to both groups, groups 1 and 2 received pressure biofeedback-guided dcfm strength training and manual therapy, respectively. at baseline, the first week, the second week, and the third week post intervention, pain intensity and functional limitations were evaluated using the visual analog scale (vas), the number of headache days per week, and the headache disability inventory (hdi) questionnaire. the main effects of the intervention were evaluated for a between-group factor, within-group factor, and interaction between time and groups over/at multiple time points. data was analyzed using an independent t-test, mixed design 2-way anova, with keeping the level of significance 'p' at 0.05.

Eligibility criteria:
inclusion criteria: * individual with a diagnosed case of cervicogenic headache with unilateral head pain without side shift or bilateral head pain with a dominant side that hurts more than the other side, sustained awkward head positioning, external pressure over the upper cervical or occipital region on the symptomatic side. * aged between 25 and 50 years * patients with recurrent cgh and chronic mechanical neck discomfort that has persisted for longer than three months. * a positive cervical flexion rotation test. exclusion criteria: * a negative cervical flexion rotation test. * subjects had a history of any of the following conditions: a fractured vertebral column or previous surgery on it; spinal stenosis; a prolapsed disc; temporomandibular joint dysfunction or headaches involving the autonomic nervous system; vertigo or visual disturbance; or a congenital condition of the cervical spine. * showed non-cooperation

Keywords: pressure biofeedback deep cervical flexor muscles muscle strengthening manual therapy pain disability
effects of message content on intention to quit smoking

Conditions: Peripheral Artery Disease

Summary: message framing involves "the presentation of choice alternatives, either in a positive or negative manner" (huber, neale, \& northcraft, 1987; p.137). positively framed health messages contain potential gains of participating/refraining in specific health behaviour. alternatively, negatively framed health messages contain potential losses of participating/refraining in specific health behaviour (verlhiac, chappe, \& meyer, 2011). the primary aim and rationale of this study will be to investigate which type of framing has the greatest effect on intentions to quit smoking in patients with vascular arterial disease. the secondary aim is to investigate what other factors may have an effect on intention to quit and also what factors play a part in a patient's intention to quit smoking.


Eligibility criteria:
inclusion criteria: * peripheral artery disease * daily smoker exclusion criteria: * psychiatric illness or those who are not literate in english will be excluded from the study as informed consent cannot be obtained. also, patients who are already participating in any other research involving smoking cessation will be excluded

Keywords: message framing smoking cessation peripheral artery disease
a study of timunox (thymopentin) in hiv-infected patients receiving other anti-hiv drugs

Conditions: HIV Infections

Summary: to evaluate the mechanism whereby thymopentin appears to retard the progressive immune suppression attributable to hiv infection.

patients are randomized to receive subcutaneous thymopentin or placebo thrice weekly for 4 weeks.

Eligibility criteria:
inclusion criteria patients must have: * asymptomatic or minimally symptomatic hiv infection (no evidence of aids). * cd4 count \<= 400 cells/mm3 within 6 weeks prior to study entry (cd4 count changed to 100 - 400 cells/mm3 per amendment). * tolerated the current nucleoside analog antiretroviral treatment for at least 4 weeks prior to study entry. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * known hypersensitivity to thymopentin or any component of the formulation. * significant chronic underlying medical illness that would impede study participation. * grade 2 or higher peripheral neuropathy related to nucleoside analog antiretroviral treatment. concurrent medication: excluded: * any antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine. * hiv vaccines or any investigational or non-fda approved medication or immunomodulatory or experimental therapy within 30 days prior to study entry. patients with the following prior condition are excluded: abnormal chest x-ray consistent with active opportunistic infection within 6 weeks prior to study entry. prior medication: excluded: * any prior antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine within 30 days prior to study entry. required: * current nucleoside analog antiretroviral treatment. required: * nucleoside analog antiretroviral treatment for at least 4 weeks prior to study entry. significant active alcohol or drug abuse sufficient to prevent study compliance.

Keywords: thymopentin aids-related complex
point of care testing for presence of current and or previous t. gondii infection

Conditions: Toxoplasma Infections

Summary: this is part of a feasibility study to compare the predicate standard fda cleared test for serum to a point of care test toxoplasma ict igg-igm bk produced by ld bio diagnostic. the specificity and sensitivity in testing serum and whole blood will be compared. this study includes 70 persons either pregnant or non pregnant. this is being done in accordance with fda requirements for clearance of a testing device . the investigators will use a standard fda cleared test in all studies. the fda has suggested that the investigators submit a pre subq for a 510k and dual clia waiver. this allows the investigators also to determine feasibility of use of the predicate test in conjunction with the experimental test with volunteers, including men, women, and pregnant women.

this study will determine the feasibility of using the point of care toxoplasma ict igg-igm bk test produced by ld bio diagnostic to detect toxoplasma gondii in clinical settings. the result of testing from toxoplasma ict igg-igm bk test will be compared with the standard predicate test. these results will be provided to fda for consideration for clearance of this test.

Eligibility criteria:
inclusion criteria: * any adult who is willing to participate in the study exclusion criteria: * pregnant women who are in their 17-27 weeks of gestation.

Keywords: toxoplasma test feasibility
cap assisted colonoscopy for the detection of colon polyps

Conditions: Adenoma; Colon Polyps; Colon Cancer

Summary: this simple technique of attaching a transparent cap to the tip of the colonoscope has been evaluated in japan for improving the detection of polyps and cecal intubation but has not been formally evaluated in the us and other western countries. in one study (19), the polyp detection rate was higher with the transparent cap compared to no cap (49% vs. 39%, p=0.04). also, the cecal intubation time was shorter with the cap (11.5 min vs 14 min, p=0.008). in a recently published study, a variation of the cap called the transparent retractable extension device was used (21). overall, the number of adenomas detected were significantly higher with the device compared to without it (205 vs. 150, p=0.04). in an earlier study by tada et al (22), use of a transparent cap improved the detection rate of lesions per patient (0.86 vs. 0.58) but did not increase the cecal intubation time. finally, lee et al (20) used cap assisted colonoscopy in patients with difficult colonoscopy procedure (defined as failure to pass through sigmoid colon after 20 minutes or failure to reach cecum). using the cap, cecal intubation was achieved in 94% of patients and this proved to be an effective rescue method for failed or difficult colonoscopy. the major appeal of this technique is that it is inexpensive, very practical, and easy to use. furthermore it is safe and there are no reported complications from this. if found to be effective in increasing the polyp yield it has the potential to being incorporated by busy gastroenterologists in their day to day clinical practice. these features and the preliminary data from japan merit the evaluation of this promising technique in the us.

the investigators hypothesize that adenoma detection rate will be higher using cap assisted colonoscopy compared to standard colonoscopy. also, cap assisted colonoscopy will be safe and cecal intubation rate will be similar compared to standard colonoscopy. specific aim 1 - to compare the prevalence of adenomas detected by standard colonoscopy and cap assisted colonoscopy. specific aim 2 - to compare the number of adenomas detected per subject by standard colonoscopy and cap assisted colonoscopy. specific aim 3 - to compare the cecal intubation rate, insertion time, withdrawal time and complications of standard colonoscopy and cap assisted colonoscopy.

Eligibility criteria:
inclusion criteria: * referral for screening and/or surveillance colonoscopy and the ability to provide informed consent. exclusion criteria: * prior surgical resection of any portion of colon, * prior history of colon cancer, * history of inflammatory bowel disease, * use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure, * poor general condition or any other reason to avoid prolonged procedure time * inability to give informed consent, * inadequate bowel preparation. * history of polyposis syndrome or hnpcc,

Keywords: colon polyps adenoma detection cap standard colon cancer
zika virus infection's pregnancy consequences in french department of america

Conditions: Incidence of ZIKV Infection on Fetus During the Pregnancy

Summary: the zika (zikv) epidemic has spread into the three french overseas departments in the caribbean (dfas). it is therefore urgent to set up tools to collect clinical and paraclinical data for the evaluation of potential complications due to having zikv infection during pregnancy. this study is meant to collect, within usual care practices, clinical and paraclinical information which will allow the precise description of the consequences of zikv infection occurring during pregnancy.

this is a prospective observational, non-interventional study that has been integrated into the usual standard of care practices. all information and biological samples collected during the course of this project will be done through the new medical standard of care which has been put in place during the zikv epidemic in the dfas; this new standard of care is a result of existing recommendations from medical professionals and/or public health authorities. outside of these recommendations, no invasive procedure will be done simply to satisfy an objective of this study.

Eligibility criteria:
m1: inclusion criteria: * on-going pregnancy regardless the presumed date of birth * clinical signs suggestive of zikv infection * whatever the rt-pcr analysis exclusion criteria: * minor * no consent m2: inclusion criteria: * head circumference \< 5th percentile * other brain morphological abnormality * hydramnios * intrauterine growth restriction (iugr) exclusion criteria: * minor * no consent m3: inclusion criteria: * pregnant woman during epidemic period of zikv exclusion criteria: * minor * opposition m4: inclusion criteria: * delivery during epidemic period of zikv exclusion criteria: * minor * no consent m5: inclusion criteria: * spontaneous abortion or fetal death in utero during epidemic period of zikv exclusion criteria: * minor * no consent

Keywords: asymptomatics microcephaly abnormalities
safety,effectiveness and acceptability of sino-implant ii in dr

Conditions: Contraception

Summary: a study to assess the contraceptive effectiveness of sino-implant (ii).

randomized trial to assess the contraceptive effectiveness of sino-implant (ii) and to compare levonorgestrel concentrations, safety and acceptability of sino-implant (ii) and jadelle.

Eligibility criteria:
inclusion criteria:• in good general health * aged between 18 and 44 years, inclusive * not pregnant * not lactating * not wishing to become pregnant in the next five years * request long-acting reversible contraception * if previously used injectable contraceptives for pregnancy prevention, be more than 9 months since last injection of depo-provera and more than 3 months after the last injection of a combined injectable contraceptive * if previously used lng-containing oral pills or implants, be more than 1 week after last hormone intake or implant removal * be able to understand the information provided and to make personal decisions on participation * consent to participation and sign a consent form * agree and be able to return to the clinic for follow-up visits over five years exclusion criteria: * acute deep venous thrombosis and/or pulmonary embolism or history of thromboembolic disease * systemic lupus erythematosus with positive or unknown antiphospholipid antibodies * unexplained vaginal bleeding * current or history of breast cancer * acute liver disease or cirrhosis * benign or malignant tumor of the liver * use of rifampicin, and/or anticonvulsants (barbiturates, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, primidone, topiramate), and/or herbal products containing st. john's wort (hypericum perforatum) * more than one sexual partner in the last 3 months * diagnosis or treatment for a sexually transmitted infection (sti) within the past 30 days for her or partner (excluding recurrent genital herpes or condyloma) * known hiv positive status for her or partner * any condition (social or medical) which in the opinion of the investigator would make study participation unsafe, would interfere with adherence to study requirements or complicate data interpretation * bmi greater than or equal to 30 (for the sub-group of women with intensive lng sampling)

Keywords: ae adverse event aids acquired immunodeficiency syndrome alt (sgpt) alanine aminotransferase art antiretroviral therapy ast (sgot) aspartate aminotransferase dcf data collection forms dmc data monitoring committee fda (u.s.) food and drug administration gcp good clinical practice guidelines hb sag hepatitis b surface antigen ich international conference of harmonization ind investigational new drug application irb institutional review board iu international units mg milligram(s) mm3 cubic millimeter(s) pcr polymerase chain reaction sae serious adverse event µg microgram uln upper limit of the normal range wb western blot
cognitive impairment following cardiac arrest and target temperature management

Conditions: Heart Arrest; Out-of-hospital Cardiac Arrest; Cognition Disorders; Brain Injury

Summary: this is a steering group approved substudy to the target temperature management trial (ttm, clinicaltrials.gov identifier: nct01020916). ttm compares the effect of two strictly controlled temperature regimes for survivors of out-of-hospital cardiac arrest. the primary aim of this sub-study is to compare the amount of cognitive impairment in cardiac arrest survivors treated with 33 degrees and 36 degrees and with a matched group of control patients with myocardial infarction. our secondary aims are: * to investigate the impact of cognitive impairment on our patients' ability to participate in society and their health related quality of life. * to investigate the relationship between our patients cognitive impairments and their relatives/informants health related quality of life and feelings of burden. * to test the hypothesis that the simple cognitive screening battery used in the ttm main trial is sensitive enough to detect all patients with significant cognitive disability.


Eligibility criteria:
inclusion criteria: * age 18 years or older * out-of-hospital cardiac arrest (ohca)of presumed cardiac cause * unconsciousness after sustained return of spontaneous circulation (rosc) exclusion criteria at time for inclusion in the ttm study: * known bleeding diathesis * suspected or confirmed acute intracranial bleeding * suspected or confirmed stroke * unwitnessed asystole * known limitations in therapy and do not resuscitate-order * known disease making 180 days survival unlikely * known prearrest status cerebral performance category (cpc)3 or 4 * temperature \<30°on admission * 4 hours (240 minutes) from rosc to screening * systolic blood pressure \<80 mm hg in spite of fluid loading/vasopressor and/or inotropic medication/intra aortic balloon pump * in-hospital cardiac arrest * ohca of presumed non-cardiac arrest cause additional exclusion criteria for the sub-study: * disability to speak the site language well enough to complete tests without interpreter * controls should never have suffered a cardiac arrest

Keywords: induced hypothermia mild induced hypothermia resuscitation therapeutic hypothermia neurological function cardiovascular diseases rehabilitation quality of life cognition
determining patterns in study experiences of neuroblastoma patients

Conditions: Neuroblastoma

Summary: historically, participation in clinical research is highly skewed towards particular demographic groups of people. this study will invite several participants to gather a wide range of information on clinical trial experiences for neuroblastoma patients. the aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of neuroblastoma. the data collected from this study will help improve future outcomes for all neuroblastoma patients as well as those in under-represented demographic groups.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of neuroblastoma * aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed * subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination. exclusion criteria: * women of childbearing potential without a negative pregnancy test; or women who are lactating. * any serious and/or unstable pre-existing medical disorders * enrolled in another research study

Keywords: neuroblastoma
iron sucrose in the treatment of restless legs syndrome: safety of three dose regimens as evaluated by clinical assessments

Conditions: Restless Legs Syndrome

Summary: non-randomized open label phase ii clinical trial in which subjects meeting criteria for rls were assigned to 1 of 3 treatment cohorts. the first cohort received one 500 mg iv iron sucrose infusion in 500 ml normal sterile saline (nss) administered over four hours. the second cohort received two 500 mg iv iron sucrose infusions in 500ml of nss administered over four to six hours on two separate dates, separated by two to seven days. the third cohort received two 500 mg iv iron sucrose infusions in at least 500 ml of nss over six hours within 30 hours of the start of the first infusion. cohorts were enrolled and treated subsequently.


Eligibility criteria:
inclusion criteria: * signed consent. * male or female subjects \> 18 yrs. old. * rls signs and symptoms affirming diagnosis. * a baseline score \> or = to 15 is required on the international rls study group rating scale (irlssg). * at least one leg with an average baseline periodic leg movement (plm) while asleep \> or = to 15 movements per hour by actigraphy. * subjects on dopa-adrenergic therapy or other rls treatments must be off therapy at least one week before any baseline rls assessments and actigraphy measurement are obtained. * subject has regular sleep hours between 9 p.m. and 9 a.m. * subjects at risk for pregnancy must have a negative pregnancy test at baseline and be practicing an acceptable form of birth control. exclusion criteria: * known intolerance to venofer. * rls which is ascribed to renal disease. * rls 2° to other cns disease or injury. * any pain related or sleep related disorders which may confound the outcome measures. * history of neuroleptic akinesia. * concurrent use of oral iron supplement. * parenteral iron use within the past 6 months. * active infection. * currently being treated for asthma. * severe peripheral vascular disease with significant skin changes. * seizure disorder currently being treated with medication. * serum ferritin level \> 300 ng/ml or a tsat \> or = to 45% at baseline or a history of hemochromatosis. * significant cardiovascular or hepatic disease or any other pre-existing medical condition or disease which in the view of the investigator participation in this study would put the subject's disease management at risk or the subject would be unable to comply with the study requirements.